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A Union authorisation with authorisation number EU-0033833-0000 is granted to Schülke & Mayr GmbH for the making available on the market and use of the biocidal product family ‘desmanol pure’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 23 October 2025 until 30 September 2035.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
Desmanol pure
Product type(s)
PT01: Human hygiene
Authorisation number: EU-0033833-0000
R4BP asset number: EU-0033833-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
Name
desmanol pure
1.2. Product type(s)
Product type(s)
PT01: Human hygiene
1.3. Authorisation holder
Name and address of the authorisation holder
Name
Schuelke & Mayr GmbH
Address
Robert-Koch-Str. 2 22851 Norderstedt DE
Authorisation number
EU-0033833-0000
R4BP asset number
EU-0033833-0000
Date of the authorisation
23 October 2025
Expiry date of the authorisation
30 September 2035
1.4. Manufacturer(s) of the product
Name of manufacturer
Schülke & Mayr GmbH
Address of manufacturer
Robert-Koch-Str. 2 22851 Norderstedt Germany
Location of manufacturing sites
Schülke & Mayr GmbH site 1 Robert-Koch-Str. 2 22851 Norderstedt Germany
Name of manufacturer
BOCHEMIE a.s.
Address of manufacturer
Lidická 326 735 95 Bohumín Czechia
Location of manufacturing sites
BOCHEMIE a.s. site 1 Lidická 326 735 95 Bohumín Czechia
Name of manufacturer
Prisman Chemie GmbH
Address of manufacturer
Otto-Hahn-Ring 6-18 64653 Lorsch Germany
Location of manufacturing sites
Prisman Chemie GmbH site 1 Otto-Hahn-Ring 6-18 64653 Lorsch Germany
Name of manufacturer
A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH
Address of manufacturer
Otto-Brenner-Straße 16 21337 Lüneburg Germany
Location of manufacturing sites
A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH site 1 Otto-Brenner-Straße 16 21337 Lüneburg Germany
Name of manufacturer
Lysoform Dr. Hans Rosemann GmbH
Address of manufacturer
Kaiser-Wilhelm-Straße 133 12247 Berlin Germany
Location of manufacturing sites
Lysoform Dr. Hans Rosemann GmbH site 1 Kaiser-Wilhelm-Straße 133 12247 Berlin Germany
Name of manufacturer
Sterisol AB
Address of manufacturer
Kronoängsgatan 3 592 23 Vadstena Sweden
Location of manufacturing sites
Sterisol AB site 1 Kronoängsgatan 3 592 23 Vadstena Sweden
Name of manufacturer
Rudolf Dankwardt GmbH
Address of manufacturer
Gutenbergring 50-52 22848 Norderstedt Germany
Location of manufacturing sites
Rudolf Dankwardt GmbH site 1 Gutenbergring 50-52 22848 Norderstedt Germany
Name of manufacturer
Rudolf Dankwardt GmbH - Jessenitz
Address of manufacturer
Lagerstr. 15 19249 Jessenitz - Werk / Lübtheen Germany
Location of manufacturing sites
Rudolf Dankwardt GmbH - Jessenitz site 1 Lagerstr. 15 19249 Jessenitz - Werk / Lübtheen Germany
1.5. Manufacturer(s) of the active substance(s)
Active substance
Propan-2-ol
Name of manufacturer
Ineos Solvents Germany GmbH (formerly Sasol)
Address of manufacturer
Römerstraße 733 47443 Moers Germany
Location of manufacturing sites
Ineos Solvents Germany GmbH (formerly Sasol) site 1 Römerstraße 733 47443 Moers Germany
Ineos Solvents Germany GmbH (formerly Sasol) site 2 Shamrockstr. 88 44643 Herne Germany
Active substance
Propan-2-ol
Name of manufacturer
Shell Chemicals Europe B.V.
Address of manufacturer
Postbus 2334 3000 CH Rotterdam Netherlands (the)
Location of manufacturing sites
Shell Chemicals Europe B.V. site 1 BV/Shell Nederland Raffinaderij B.V. Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the)
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
63,1 - 75 % (w/w)
1-Tetradecanol
Tetradecan-1-ol
Non-active substance
112-72-1
204-000-3
0 - 0,5 % (w/w)
2.2. Type(s) of formulation
Formulation type(s)
AL Any other liquid
PART II
SECOND INFORMATION LEVEL META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
Identifier
desmanol pure meta SPC1
1.2. Suffix to the authorisation number
Number
1-1
1.3. Product type(s)
Product type(s)
PT01: Human hygiene
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 - 75 % (w/w)
1-Tetradecanol
Tetradecan-1-ol
Non-active substance
112-72-1
204-000-3
0,25 - 0,5 % (w/w)
2.2. Type(s) of formulation of the meta SPC 1
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
H412: Harmful to aquatic life with long lasting effects.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local and national regulations.
P501: Dispose of container to in accordance with local and national regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #1 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
The product is restricted to adult use only.
4.1.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.2. Use description
Table 2
Use #2 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.2.2. Use-specific risk mitigation measures
---
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.3. Use description
Table 3
Use #3 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and viruses (limited spectrum virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump 5 ml (a cupped hand) into the palm (2-4 pump strokes). Rub your hands and forearms for at least 45 seconds. Repeat the step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub should only be done under aseptic conditions.
4.3.2. Use-specific risk mitigation measures
---
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.4. Use description
Table 4
Use #4 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Industrial
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.4.2. Use-specific risk mitigation measures
---
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.5. Use description
Table 5
Use #5 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.5.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
The product is restricted to adult use only.
4.5.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.6. Use description
Table 6
Use #6 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.6.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
Product is restricted to adult use only.
4.6.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.7. Use description
Table 7
Use #7 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #7.1.: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry
Use #7.2.: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #7.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Use #7.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #7.1.: as required (typically 25 applications per day)
Use #7.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.7.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against limited spectrum virucidal activity): Pour 5 ml (a cupped hand) (2-4 pump strokes) of the product into the palm or else pump 5 ml (a cupped hand) into the palm. Rub your hands and forearms for at least 45 seconds. Repeat that step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.7.2. Use-specific risk mitigation measures
---
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.8. Use description
Table 8
Use #8 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #8.1.: (Professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice, cosmetic studios, elderly care, and in industrial areas like pharma or food production industry.
Use #8.2.: (Professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #8.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Use #8.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #8.1.: as required (typically 25 applications per day)
Use #8.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.8.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against limited spectrum virucidal activity): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.8.2. Use-specific risk mitigation measures
---
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.9. Use description
Table 9
Use #9 Surgical hand rub - professional user – bacteria, yeasts – pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.9.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.9.2. Use-specific risk mitigation measures
---
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.10. Use description
Table 10
Use #10 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #10.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Use # 10.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #10.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Use #10.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #10.1.: as required (typically 25 applications per day)
Use #10.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.10.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against limited spectrum virucidal activity): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.10.2. Use-specific risk mitigation measures
---
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1. Instructions for use
Application technique:
Step 1:
Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2:
Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3:
Open fingers and rub the finger webs. Reverse and repeat action.
Step 4:
Rub palm to palm with fingers interlocked (5 times).
Step 5:
Rub thumb of each hand using a rotating movement.
Step 6:
Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
---
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
---
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
desmanol® pure
Market area: EU
Septoderm® liquid
Market area: EU
Wrights alcohol hand rub
Market area: EU
Rely alcohol hand rub
Market area: EU
HS Handisinfection liquid
Market area: EU
Profect Hand disinfection liquid
Market area: EU
desmanol® hand disinfection
Market area: EU
sensiva® hand disinfection liquid
Market area: EU
desmanol® N hand disinfection
Market area: EU
unodent hand disinfection
Market area: EU
eurosept hand disinfection
Market area: EU
Innocid Händedesinfektion
Market area: EU
desmanol® pure pro
Market area: EU
desmanol® pure expert
Market area: EU
desmanol® pure clever
Market area: EU
desmanol® pure universal
Market area: EU
desmanol® pure pocket
Market area: EU
desmanol® pure client
Market area: EU
microshield® hand rub
Market area: EU
microshield® pure
Market area: EU
Halasept 792
Market area: EU
Authorisation number
EU-0033833-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 % (w/w)
1-Tetradecanol
Tetradecan-1-ol
Non-active substance
112-72-1
204-000-3
0,5 % (w/w)
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
Identifier
desmanol pure meta SPC2
1.2. Suffix to the authorisation number
Number
1-2
1.3. Product type(s)
Product type(s)
PT01: Human hygiene
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 - 75 % (w/w)
1-Tetradecanol
Tetradecan-1-ol
Non-active substance
112-72-1
204-000-3
0,25 - 0,5 % (w/w)
2.2. Type(s) of formulation of the meta SPC 2
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
H412: Harmful to aquatic life with long lasting effects.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local and national regulations.
P501: Dispose of container to in accordance with local and national regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #11 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
The product is restricted to adult use only.
4.1.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.2. Use description
Table 2
Use #12 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm (1-2 pump strokes) or else pump it into the palm. Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.2.2. Use-specific risk mitigation measures
---
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.3. Use description
Table 3
Use #13 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.3.2. Use-specific risk mitigation measures
---
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.4. Use description
Table 4
Use #14 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Industrial
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.4.2. Use-specific risk mitigation measures
---
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.5. Use description
Table 5
Use #15 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.5.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
The product is restricted to adult use only.
4.5.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.6. Use description
Table 6
Use #16 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio).
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
as required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.6.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
The product is restricted to adult use only.
4.6.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.7. Use description
Table 7
Use #17 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Field of use description:
#Use 17.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio).or in industrial areas, e.g. pharma or food production industry
#Use 17.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards etc.), doctor or dental practice
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
#Use 17.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
#Use 17.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
#Use 17.1.: as required (typically 25 applications per day)
#Use 17.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.7.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.7.2. Use-specific risk mitigation measures
---
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.8. Use description
Table 8
Use #18 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Use #18.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry.
Use #18.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #18.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Use #18.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
#Use 18.1.: as required (typically 25 applications per day)
#Use 18.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.8.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.8.2. Use-specific risk mitigation measures
---
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.9. Use description
Table 9
Use #19 Surgical hand rub - professional user – bacteria, yeasts – pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.9.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.9.2. Use-specific risk mitigation measures
---
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.10. Use description
Table 10
Use #20 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Use #20.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Use #20.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #20.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Use #20.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #20.1.: as required (typically 25 applications per day)
Use #20.2.: as required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.10.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.10.2. Use-specific risk mitigation measures
---
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.11. Use description
Table 11
Use #21 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (in case of special cases, e.g. conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.11.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.11.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
Avoid disinfection in the presence of children <6 years.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.12. Use description
Table 12
Use #22 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.12.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.12.2. Use-specific risk mitigation measures
---
4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.13. Use description
Table 13
Use #23 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.13.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.13.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.14. Use description
Table 14
Use #24 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.14.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.14.2. Use-specific risk mitigation measures
---
4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1. Instructions for use
Application technique:
Step 1:
Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2:
Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3:
Open fingers and rub the finger webs. Reverse and repeat action.
Step 4:
Rub palm to palm with fingers interlocked (5 times).
Step 5:
Rub thumb of each hand using a rotating movement.
Step 6:
Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
---
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
---
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
desmanol® pure gel
Market area: EU
Septoderm® IPA gel
Market area: EU
Wrights alcohol hand gel
Market area: EU
Rely alcohol hand gel
Market area: EU
HS Hand disinfection gel
Market area: EU
Profect Hand disinfection gel
Market area: EU
sensiva® hand gel
Market area: EU
desmanol® N gel
Market area: EU
unodent hand gel
Market area: EU
eurosept gel
Market area: EU
Innocid Händedesinfektions-Gel
Market area: EU
desmanol® pure gel pro
Market area: EU
desmanol® pure gel expert
Market area: EU
desmanol® pure gel clever
Market area: EU
desmanol® pure gel universal
Market area: EU
desmanol® pure gel pocket
Market area: EU
desmanol® pure gel client
Market area: EU
microshield® gel
Market area: EU
microshield® pure gel
Market area: EU
Authorisation number
EU-0033833-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 % (w/w)
1-Tetradecanol
Tetradecan-1-ol
Non-active substance
112-72-1
204-000-3
0,5 % (w/w)
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
Identifier
desmanol pure meta SPC3
1.2. Suffix to the authorisation number
Number
1-3
1.3. Product type(s)
Product type(s)
PT01: Human hygiene
2. META SPC 3 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 - 75 % (w/w)
2.2. Type(s) of formulation of the meta SPC 3
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local and national regulations.
P501: Dispose of container to in accordance with local and national regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #25 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
The product is restricted to adult use only.
4.1.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.2. Use description
Table 2
Use #26 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.2.2. Use-specific risk mitigation measures
---
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.3. Use description
Table 3
Use #27 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and viruses (limited spectrum virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.3.2. Use-specific risk mitigation measures
---
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.4. Use description
Table 4
Use #28 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Industrial
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.4.2. Use-specific risk mitigation measures
---
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.5. Use description
Table 5
Use #29 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.5.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
The product is restricted to adult use only.
4.5.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.6. Use description
Table 6
Use #30 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
as required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.6.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
The product is restricted to adult use only.
4.6.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.7. Use description
Table 7
Use #31 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #31.1.: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry
Use #31.2.: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #31.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Use #31.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #31.1.: as required (typically 25 applications per day)
Use #31.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.7.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.7.2. Use-specific risk mitigation measures
---
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.8. Use description
Table 8
Use #32 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #32.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry.
Use #32.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas, e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices).
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #32.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Use #32.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #32.1: as required (typically 25 applications per day)
Use #32.2: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.8.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.8.2. Use-specific risk mitigation measures
---
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.9. Use description
Table 9
Use #33 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.9.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.9.2. Use-specific risk mitigation measures
---
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.10. Use description
Table 10
Use #34 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #34.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio).
Use #34.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices).
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #34.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Use #34.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #34.1.: as required (typically 25 applications per day)
Use #34.2.: as required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.10.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.10.2. Use-specific risk mitigation measures
---
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1. Instructions for use
Application technique:
Step 1:
Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2:
Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3:
Open fingers and rub the finger webs. Reverse and repeat action.
Step 4:
Rub palm to palm with fingers interlocked (5 times).
Step 5:
Rub thumb of each hand using a rotating movement.
Step 6:
Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
---
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
---
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
desmanol® pure light
Market area: EU
Authorisation number
EU-0033833-0003 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 % (w/w)
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
Identifier
desmanol pure meta SPC4
1.2. Suffix to the authorisation number
Number
1-4
1.3. Product type(s)
Product type(s)
PT01: Human hygiene
2. META SPC 4 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 - 75 % (w/w)
2.2. Type(s) of formulation of the meta SPC 4
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local and national regulations.
P501: Dispose of container to in accordance with local and national regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #35 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases).
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
The product is restricted to adult use only.
4.1.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.2. Use description
Table 2
Use #36 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.2.2. Use-specific risk mitigation measures
---
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.3. Use description
Table 3
Use #37 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.3.2. Use-specific risk mitigation measures
---
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.4. Use description
Table 4
Use #38 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Industrial
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.4.2. Use-specific risk mitigation measures
---
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.5. Use description
Table 5
Use #39 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.5.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
The product is restricted to adult use only.
4.5.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.6. Use description
Table 6
Use #40 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.6.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
The product is restricted to adult use only.
4.6.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.7. Use description
Table 7
Use #41 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Use #41.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry
Use #41.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #41.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Use #41.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
#Use 41.1.: as required (typically 25 applications per day)
#Use 41.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.7.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (Efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.7.2. Use-specific risk mitigation measures
---
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.8. Use description
Table 8
Use #42 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Use #42.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry
Use #42.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #42.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Use #42.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #42.1.: as required (typically 25 applications per day)
Use #42.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.8.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (Efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.8.2. Use-specific risk mitigation measures
---
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.9. Use description
Table 9
Use #43 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.9.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.9.2. Use-specific risk mitigation measures
---
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.10. Use description
Table 10
Use #44 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Use #44.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Use #44.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #44.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Use #44.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #44.1.: as required (typically 25 applications per day)
Use #44.2.: as required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.10.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (Efficacy against bacteria, yeasts, and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.10.2. Use-specific risk mitigation measures
---
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.11. Use description
Table 11
Use #45 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases/special case: conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.11.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.11.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
Avoid disinfection in the presence of children <6 years.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.12. Use description
Table 12
Use #46 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.12.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.12.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.13. Use description
Table 13
Use #47 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.13.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.13.2. Use-specific risk mitigation measures
---
4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.14. Use description
Table 14
Use #48 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases/special case: conjunctivitis).
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.14.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.14.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
Avoid disinfection in the presence of children <6 years.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
5.1. Instructions for use
Application technique:
Step 1:
Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2:
Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3:
Open fingers and rub the finger webs. Reverse and repeat action.
Step 4:
Rub palm to palm with fingers interlocked (5 times).
Step 5:
Rub thumb of each hand using a rotating movement.
Step 6:
Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
---
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
---
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
desmanol® pure light gel
Market area: EU
Authorisation number
EU-0033833-0004 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 % (w/w)
1. META SPC 5 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 5 identifier
Identifier
desmanol pure meta SPC5
1.2. Suffix to the authorisation number
Number
1-5
1.3. Product type(s)
Product type(s)
PT01: Human hygiene
2. META SPC 5 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 5
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
63,1 - 63,1 % (w/w)
2.2. Type(s) of formulation of the meta SPC 5
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local and national regulations.
P501: Dispose of container to in accordance with local and national regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #49 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
The product is restricted to adult use only.
4.1.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.2. Use description
Table 2
Use #50 Hygienic hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.2.2. Use-specific risk mitigation measures
---
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.3. Use description
Table 3
Use #51 Surgical hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
2 x 5 mL per disinfection, corresponding to 2 x 2.76 g a.s.
Contact time 180 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.3.2. Use-specific risk mitigation measures
---
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.4. Use description
Table 4
Use #52 Hygienic hand rub - industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Bactericidal, yeasticidal, virucidal activity against enveloped viruses,:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Industrial
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.4.2. Use-specific risk mitigation measures
---
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.5. Use description
Table 5
Use #53 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.5.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
The product is restricted to adult use only.
4.5.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.6. Use description
Table 6
Use #54 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.6.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
The product is restricted to adult use only.
4.6.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE): 36 months
4.7. Use description
Table 7
Use #55 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #55.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry.
Use #55.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #55.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Use #55.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.
Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
Use #55.1.: as required (typically 25 applications per day)
Use #55.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.7.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
Surgical hand rub disinfection:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.7.2. Use-specific risk mitigation measures
---
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.8. Use description
Table 8
Use #56 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #56.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry.
Use #56.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #56.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Use #56.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.
Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
Use #56.1.: as required (typically 25 applications per day)
Use #56.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.8.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
Surgical hand rub:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.8.2. Use-specific risk mitigation measures
---
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.9. Use description
Table 9
Use #57 Surgical hand rub - professional user – bacteria, yeasts, fungi – pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Bactericide, yeasticide, fungicide:
2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.
Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.9.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.9.2. Use-specific risk mitigation measures
---
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.10. Use description
Table 10
Use #58 Hygienic/surgical hand rub - professional user – bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #58.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Use #58.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #58.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Use #58.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.
Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
Use #58.1.: as required (typically 25 applications per day)
Use #58.2.: as required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: HDPE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.10.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
Surgical hand rub:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.10.2. Use-specific risk mitigation measures
---
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
5.1. Instructions for use
Application technique:
Step 1:
Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2:
Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3:
Open fingers and rub the finger webs. Reverse and repeat action.
Step 4:
Rub palm to palm with fingers interlocked (5 times).
Step 5:
Rub thumb of each hand using a rotating movement.
Step 6:
Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
---
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
---
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Septoderm® soft
Market area: EU
septosoft
Market area: EU
pluradent hand disinfection
Market area: EU
Dezosept
Market area: EU
Authorisation number
EU-0033833-0005 1-5
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
63,1 % (w/w)
1. META SPC 6 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 6 identifier
Identifier
desmanol pure meta SPC6
1.2. Suffix to the authorisation number
Number
1-6
1.3. Product type(s)
Product type(s)
PT01: Human hygiene
2. META SPC 6 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 6
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
63,14 - 63,14 % (w/w)
2.2. Type(s) of formulation of the meta SPC 6
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
EUH208: Contains Isoeugenol. May produce an allergic reaction.
Precautionary statements
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local and national regulations.
P501: Dispose of container to in accordance with local and national regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #59 Hygienic hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2.76 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 125, 500 1 000 ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.1.2. Use-specific risk mitigation measures
---
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed.
Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life: 36 months
4.2. Use description
Table 2
Use #60 Surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 125, 500 1 000 ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.2.2. Use-specific risk mitigation measures
---
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed.
Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life: 36 months
4.3. Use description
Table 3
Use #61 Hygienic/surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Use #61.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Use #61.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #61.1.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2.76 g a.s.
Contact time: 30 sec.
Use #61.2.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
Use #61.1.: as required (typically 25 applications per day)
Use #61.2.: as required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 125, 500 1 000 ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds.
Surgical hand rub: Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.3.2. Use-specific risk mitigation measures
---
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed.
Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life: 36 months
4.4. Use description
Table 4
Use #62 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria and yeasts: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 125, 500 1 000 ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.4.2. Use-specific risk mitigation measures
---
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed.
Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life: 36 months
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 6
5.1. Instructions for use
Application technique:
Step 1:
Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2:
Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3:
Open fingers and rub the finger webs. Reverse and repeat action.
Step 4:
Rub palm to palm with fingers interlocked (5 times).
Step 5:
Rub thumb of each hand using a rotating movement.
Step 6:
Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
---
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
---
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
AntiLy1
Market area: EU
Authorisation number
EU-0033833-0006 1-6
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
63,14 % (w/w)
1. META SPC 7 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 7 identifier
Identifier
desmanol pure meta SPC7
1.2. Suffix to the authorisation number
Number
1-7
1.3. Product type(s)
Product type(s)
PT01: Human hygiene
2. META SPC 7 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 7
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
63,14 - 63,14 % (w/w)
2.2. Type(s) of formulation of the meta SPC 7
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local and national regulations.
P501: Dispose of container to in accordance with local and national regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #63 Hygienic hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2.76 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 125, 500 1 000 ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.1.2. Use-specific risk mitigation measures
---
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed.
Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life: 36 months
4.2. Use description
Table 2
Use #64 Surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 125, 500 1 000 ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.2.2. Use-specific risk mitigation measures
---
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed.
Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life: 36 months
4.3. Use description
Table 3
Use #65 Hygienic/surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Use #65.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Use #65.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #65.1.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2.76 g a.s.
Contact time: 30 sec.
Use #65.2.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
Use #65.1.: as required (typically 25 applications per day)
Use #65.2.: as required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 125, 500 1 000 ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds.
Surgical hand rub: Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:
*
The authorisation number;
*
The trade name of the biocidal product;
*
The identity and content of each active ingredient;
*
The instructions for use, including the incorporation time required for the biocidal action;
*
The information according to CLP.
4.3.2. Use-specific risk mitigation measures
---
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed.
Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life: 36 months
4.4. Use description
Table 4
Use #66 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping – indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub disinfection product for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria and yeasts: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 125, 500 1 000 ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000 l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.4.2. Use-specific risk mitigation measures
---
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed.
Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life: 36 months
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 7
5.1. Instructions for use
Application technique:
Step 1:
Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2:
Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3:
Open fingers and rub the finger webs. Reverse and repeat action.
Step 4:
Rub palm to palm with fingers interlocked (5 times).
Step 5:
Rub thumb of each hand using a rotating movement.
Step 6:
Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
---
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
---
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
AntiLy2
Market area: EU
Authorisation number
EU-0033833-0007 1-7
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
63,14 % (w/w)
1. META SPC 8 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 8 identifier
Identifier
desmanol pure meta SPC8
1.2. Suffix to the authorisation number
Number
1-8
1.3. Product type(s)
Product type(s)
PT01: Human hygiene
2. META SPC 8 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 8
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 - 75 % (w/w)
1-Tetradecanol
Tetradecan-1-ol
Non-active substance
112-72-1
204-000-3
0,25 - 0,5 % (w/w)
2.2. Type(s) of formulation of the meta SPC 8
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
H412: Harmful to aquatic life with long lasting effects.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local and national regulations.
P501: Dispose of container to in accordance with local and national regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #67 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
The product is restricted to adult use only.
4.1.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life: Bottle (PE) and bag/sachet (PE): 6 days
4.2. Use description
Table 2
Use #68 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
4.2.2. Use-specific risk mitigation measures
---
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.3. Use description
Table 3
Use #69 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and viruses (limited spectrum virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump 5 ml (a cupped hand) into the palm (2-4 pump strokes). Rub your hands and forearms for at least 45 seconds. Repeat the step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.3.2. Use-specific risk mitigation measures
---
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.4. Use description
Table 4
Use #70 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Industrial
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
4.4.2. Use-specific risk mitigation measures
---
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.4.4. W here specific to the use, the instructions for safe disposal of the product and its packaging
---
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.5. Use description
Table 5
Use #71 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.5.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
The product is restricted to adult use only.
4.5.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.6. Use description
Table 6
Use #72 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
as required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.6.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
The product is restricted to adult use only.
4.6.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.7. Use description
Table 7
Use #73 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #73.1 .: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry
Use #73.2 .: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #73.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Use #73.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Frequency:
Use #73.1.: as required (typically 25 applications per day)
Use #73.2.: as required (typically 4 applications per day)
Number and timing of application:
Frequency:
Use #73.1.: as required (typically 25 applications per day)
Use #73.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.7.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) (2-4 pump strokes) of the product into the palm or else pump 5 ml (a cupped hand) into the palm. Rub your hands and forearms for at least 45 seconds. Repeat that step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.7.2. Use-specific risk mitigation measures
---
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.8. Use description
Table 8
Use #74 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #74.1.: (Professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice, cosmetic studios, elderly care, and in industrial areas like pharma or food production industry.
Use #74.2.: (Professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #74.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Use #74.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #74.1.: as required (typically 25 applications per day)
Use #74.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.8.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.8.2. Use-specific risk mitigation measures
---
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.9. Use description
Table 9
Use #75 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.9.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.9.2. Use-specific risk mitigation measures
---
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.10. Use description
Table 10
Use #76 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #76.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Use #76.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
---
Application rate(s) and frequency
Application Rate:
Use #76.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Use #76.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #76.1.: as required (typically 25 applications per day)
Use #76.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.10.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.10.2. Use-specific risk mitigation measures
---
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 8
5.1. Instructions for use
Application technique:
Step 1:
Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2:
Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3:
Open fingers and rub the finger webs. Reverse and repeat action.
Step 4:
Rub palm to palm with fingers interlocked (5 times).
Step 5:
Rub thumb of each hand using a rotating movement.
Step 6:
Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
---
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
---
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
desmanol® pure
Market area: EU
Septoderm® liquid
Market area: EU
Wrights alcohol hand rub
Market area: EU
Rely alcohol hand rub
Market area: EU
HS Handisinfection liquid
Market area: EU
Profect Hand disinfection liquid
Market area: EU
desmanol® hand disinfection
Market area: EU
sensiva® hand disinfection liquid
Market area: EU
desmanol® N hand disinfection
Market area: EU
unodent hand disinfection
Market area: EU
eurosept hand disinfection
Market area: EU
Innocid Händedesinfektion
Market area: EU
desmanol® pure pro
Market area: EU
desmanol® pure expert
Market area: EU
desmanol® pure clever
Market area: EU
desmanol® pure universal
Market area: EU
desmanol® pure pocket
Market area: EU
desmanol® pure client
Market area: EU
microshield® hand rub
Market area: EU
microshield® pure
Market area: EU
Halasept 792
Market area: EU
Authorisation number
EU-0033833-0008 1-8
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 % (w/w)
1-Tetradecanol
Tetradecan-1-ol
Non-active substance
112-72-1
204-000-3
0,5 % (w/w)
1. META SPC 9 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 9 identifier
Identifier
desmanol pure meta SPC9
1.2. Suffix to the authorisation number
Number
1-9
1.3. Product type(s)
Product type(s)
PT01: Human hygiene
2. META SPC 9 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 9
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 - 75 % (w/w)
1-Tetradecanol
Tetradecan-1-ol
Non-active substance
112-72-1
204-000-3
0,25 - 0,5 % (w/w)
2.2. Type(s) of formulation of the meta SPC 9
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
H412: Harmful to aquatic life with long lasting effects.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local and national regulations.
P501: Dispose of container to in accordance with local and national regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #77 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
The product is restricted to adult use only.
4.1.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.2. Use description
Table 2
Use #78 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm (1-2 pump strokes) or else pump it into the palm. Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
4.2.2. Use-specific risk mitigation measures
---
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.3. Use description
Table 3
Use #79 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.3.2. Use-specific risk mitigation measures
---
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.4. Use description
Table 4
Use #80 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Industrial
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
4.4.2. Use-specific risk mitigation measures
---
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.5. Use description
Table 5
Use #81 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.5.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
The product is restricted to adult use only.
4.5.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.6. Use description
Table 6
Use #82 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio).
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
as required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.6.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
The product is restricted to adult use only.
4.6.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.7. Use description
Table 7
Use #83 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
#Use 83.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) or in industrial areas, e.g. pharma or food production industry
#Use 83.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards etc.), doctor or dental practice
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
#Use 83.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
#Use 83.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
#Use 83.1.: as required (typically 25 applications per day)
#Use 83.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.7.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.7.2. Use-specific risk mitigation measures
---
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.8. Use description
Table 8
Use #84 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Use #84.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry.
Use #84.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Use #84.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Use #84.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
#Use 84.1.: as required (typically 25 applications per day)
#Use 84.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.8.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
Surgical hand rub disinfection:
Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.8.2. Use-specific risk mitigation measures
--
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.9. Use description
Table 9
Use #85 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.9.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.9.2. Use-specific risk mitigation measures
---
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.10. Use description
Table 10
Use #86 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Use #86.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Use #86.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Use #86.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Use #86.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #86.1.: as required (typically 25 applications per day)
Use #86.2.: as required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.10.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses):
Pour 3 ml of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
Surgical hand rub disinfection:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.10.2. Use-specific risk mitigation measures
---
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.11. Use description
Table 11
Use #87 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (in case of special cases, e.g. conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.11.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.11.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
Avoid disinfection in the presence of children <6 years.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.12. Use description
Table 12
Use #88 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.12.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
4.12.2. Use-specific risk mitigation measures
---
4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.13. Use description
Table 13
Use #89 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.13.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.13.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.14. Use description
Table 14
Use #90 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.14.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
4.14.2. Use-specific risk mitigation measures
---
4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 9
5.1. Instructions for use
Application technique:
Step 1:
Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2:
Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3:
Open fingers and rub the finger webs. Reverse and repeat action.
Step 4:
Rub palm to palm with fingers interlocked (5 times).
Step 5:
Rub thumb of each hand using a rotating movement.
Step 6:
Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
---
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
---
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
desmanol® pure gel
Market area: EU
Septoderm® IPA gel
Market area: EU
Wrights alcohol hand gel
Market area: EU
Rely alcohol hand gel
Market area: EU
HS Hand disinfection gel
Market area: EU
Profect Hand disinfection gel
Market area: EU
sensiva® hand gel
Market area: EU
desmanol® N gel
Market area: EU
unodent hand gel
Market area: EU
eurosept gel
Market area: EU
Innocid Händedesinfektions-Gel
Market area: EU
desmanol® pure gel pro
Market area: EU
desmanol® pure gel expert
Market area: EU
desmanol® pure gel clever
Market area: EU
desmanol® pure gel universal
Market area: EU
desmanol® pure gel pocket
Market area: EU
desmanol® pure gel client
Market area: EU
microshield® gel
Market area: EU
microshield® pure gel
Market area: EU
Authorisation number
EU-0033833-0009 1-9
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 % (w/w)
1-Tetradecanol
Tetradecan-1-ol
Non-active substance
112-72-1
204-000-3
0,5 % (w/w)
1. META SPC 10 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 10 identifier
Identifier
desmanol pure meta SPC10
1.2. Suffix to the authorisation number
Number
1-10
1.3. Product type(s)
Product type(s)
PT01: Human hygiene
2. META SPC 10 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 10
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 - 75 % (w/w)
2.2. Type(s) of formulation of the meta SPC 10
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local and national regulations.
P501: Dispose of container to in accordance with local and national regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #91 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
The product is restricted to adult use only.
4.1.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.2. Use description
Table 2
Use #92 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
4.2.2. Use-specific risk mitigation measures
---
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.3. Use description
Table 3
Use #93 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and limited spectrum virucidal activity: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.3.2. Use-specific risk mitigation measures
---
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.4. Use description
Table 4
Use #94 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Industrial
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
4.4.2. Use-specific risk mitigation measures
---
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.5. Use description
Table 5
Use #95 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.5.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
The product is restricted to adult use only.
4.5.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.6. Use description
Table 6
Use #96 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.6.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
The product is restricted to adult use only.
4.6.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.7. Use description
Table 7
Use #97 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #97.1.: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry
Use #97.2.: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Use #97.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Use #97.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #97.1.: as required (typically 25 applications per day)
Use #97.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.7.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.7.2. Use-specific risk mitigation measures
---
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.8. Use description
Table 8
Use #98 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #98.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry.
Use #98.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas, e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices).
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Use #98.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Use #98.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #98.1: as required (typically 25 applications per day)
Use #98.2: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.8.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.8.2. Use-specific risk mitigation measures
---
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.9. Use description
Table 9
Use #99 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.9.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.9.2. Use-specific risk mitigation measures
---
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.10. Use description
Table 10
Use #100 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #100.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio).
Use #100.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices).
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Use #100.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Use #100.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #100.1.: as required (typically 25 applications per day)
Use #100.2.: as required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.10.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.10.2. Use-specific risk mitigation measures
---
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 10
5.1. Instructions for use
Application technique:
Step 1:
Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2:
Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3:
Open fingers and rub the finger webs. Reverse and repeat action.
Step 4:
Rub palm to palm with fingers interlocked (5 times).
Step 5:
Rub thumb of each hand using a rotating movement.
Step 6:
Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
---
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
---
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
desmanol ® pure light
Market area: EU
Authorisation number
EU-0033833-0010 1-10
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 % (w/w)
1. META SPC 11 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 11 identifier
Identifier
desmanol pure meta SPC11
1.2. Suffix to the authorisation number
Number
1-11
1.3. Product type(s)
Product type(s)
PT01: Human hygiene
2. META SPC 11 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 11
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 - 75 % (w/w)
2.2. Type(s) of formulation of the meta SPC 11
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local and national regulations.
P501: Dispose of container to in accordance with local and national regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #101 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases).
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
The product is restricted to adult use only.
4.1.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.2. Use description
Table 2
Use #102 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
4.2.2. Use-specific risk mitigation measures
---
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.3. Use description
Table 3
Use #103 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.3.2. Use-specific risk mitigation measures
---
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.4. Use description
Table 4
Use #104 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection,
corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Industrial
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
4.4.2. Use-specific risk mitigation measures
---
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.5. Use description
Table 5
Use #105 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.5.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
The product is restricted to adult use only.
4.5.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.6. Use description
Table 6
Use #106 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.6.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
The product is restricted to adult use only.
4.6.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.7. Use description
Table 7
Use #107 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Use #107.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry
Use #107.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Use #107.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Use #107.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
#Use 107.1.: as required (typically 25 applications per day)
#Use 107.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.7.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
Surgical hand rub disinfection:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.7.2. Use-specific risk mitigation measures
---
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.8. Use description
Table 8
Use #108 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Use #108.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry
Use #108.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Use #108.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Use #108.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #108.1.: as required (typically 25 applications per day)
Use #108.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.8.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (Efficacy against bacteria, yeasts and enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
Surgical hand rub disinfection:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.8.2. Use-specific risk mitigation measures
---
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.9. Use description
Table 9
Use #109 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.9.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.9.2. Use-specific risk mitigation measures
---
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.10. Use description
Table 10
Use #110 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Field(s) of use
Indoor use
Use #110.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Use #110.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Use #110.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.
Contact time: 30 sec.
Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.
Contact time: 60 sec. (in total)
Use #110.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 90 sec. (in total)
Number and timing of application:
Frequency:
Use #110.1.: as required (typically 25 applications per day)
Use #110.2.: as required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.10.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (Efficacy against bacteria, yeasts, and enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
Surgical hand rub disinfection:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.10.2. Use-specific risk mitigation measures
---
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.11. Use description
Table 11
Use #111 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases/special case: conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.11.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.11.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
Avoid disinfection in the presence of children <6 years.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.12. Use description
Table 12
Use #112 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.12.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.12.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
--
4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.13. Use description
Table 13
Use #113 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.13.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
4.13.2. Use-specific risk mitigation measures
---
4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.14. Use description
Table 14
Use #114 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas. (e.g. in case of diseases/special case: conjunctivitis)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.
Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.14.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.14.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
Avoid disinfection in the presence of children <6 years.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 11
5.1. Instructions for use
Application technique:
Step 1:
Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2:
Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3:
Open fingers and rub the finger webs. Reverse and repeat action.
Step 4:
Rub palm to palm with fingers interlocked (5 times).
Step 5:
Rub thumb of each hand using a rotating movement.
Step 6:
Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
---
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
---
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
desmanol ® pure light gel
Market area: EU
Authorisation number
EU-0033833-0011 1-11
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
75 % (w/w)
1. META SPC 12 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 12 identifier
Identifier
desmanol pure meta SPC12
1.2. Suffix to the authorisation number
Number
1-12
1.3. Product type(s)
Product type(s)
PT01: Human hygiene
2. META SPC 12 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 12
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
63,1 - 63,1 % (w/w)
2.2. Type(s) of formulation of the meta SPC 12
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local and national regulations.
P501: Dispose of container to in accordance with local and national regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #115 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts, enveloped viruses:
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
The product is restricted to adult use only.
4.1.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.2. Use description
Table 2
Use #116 Hygienic hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activit)y - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
4.2.2. Use-specific risk mitigation measures
---
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.3. Use description
Table 3
Use #117 Surgical hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.
Contact time 180 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.3.2. Use-specific risk mitigation measures
---
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.4. Use description
Table 4
Use #118 Hygienic hand rub - industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 25 applications per day)
Category(ies) of users
Industrial
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
4.4.2. Use-specific risk mitigation measures
---
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.5. Use description
Table 5
Use #119 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.5.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
The product is restricted to adult use only.
4.5.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
---
4.6. Use description
Table 6
Use #120 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 applications per day)
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.6.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub:
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
The product is restricted to adult use only.
4.6.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.7. Use description
Table 7
Use #121 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #121.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry.
Use #121.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Use #121.1.:
Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Use #121.2.: : 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.
Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
Use #121.1.: as required (typically 25 applications per day)
Use #121.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.7.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub:
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
Surgical hand rub disinfection:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.7.2. Use-specific risk mitigation measures
---
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.8. Use description
Table 8
Use #122 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #122.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry.
Use #122.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Use #122.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Use #122.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.
Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
Use #122.1.: as required (typically 25 applications per day)
Use #122.2.: as required (typically 4 applications per day)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.8.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
Surgical hand rub:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.8.2. Use-specific risk mitigation measures
---
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.9. Use description
Table 9
Use #123 Surgical hand rub - professional user - bacteria, yeasts, fungi - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Field(s) of use
Indoor use
Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Bactericide, yeasticide, fungicide:
2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.
Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.9.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product..
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.9.2. Use-specific risk mitigation measures
---
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.10. Use description
Table 10
Use #124 Hygienic/surgical hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Yeasts
Common name: yeasts
Development stage: vegetative cells
Scientific name: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable
Field(s) of use
Indoor use
Use #124.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio)
Use #124.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)
Application method(s)
Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
-
Application rate(s) and frequency
Application Rate:
Use #124.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses:
3 ml per disinfection, corresponding to 1.65 g a.s.
Contact time: 30 sec.
Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy:
2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.
Contact time: 60 sec. (in total)
Use #124.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.
Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
Use #124.1.: as required (typically 25 applications per day)
Use #124.2.: as required (typically 4 applications per day)
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml
Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE
Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;
Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)
4.10.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
Surgical hand rub:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.10.2. Use-specific risk mitigation measures
---
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 12
5.1. Instructions for use
Application technique:
Step 1:
Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2:
Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3:
Open fingers and rub the finger webs. Reverse and repeat action.
Step 4:
Rub palm to palm with fingers interlocked (5 times).
Step 5:
Rub thumb of each hand using a rotating movement.
Step 6:
Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
---
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
---
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 12
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Septoderm® soft
Market area: EU
septosoft
Market area: EU
pluradent hand disinfection
Market area: EU
Dezosept
Market area: EU
Authorisation number
EU-0033833-0012 1-12
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Propan-2-ol
Active substance
67-63-0
200-661-7
63,1 % (w/w)
Commission Implementing Regulation (EU) 2025/1905 of 11 September 2025 granting a Union authorisation for the biocidal product family desmanol pure in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32025R1905
© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.
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