Commission Implementing Regulation (EU) 2024/2194 of 4 September 2024 amending Implementing Regulation (EU) 2020/1991 as regards administrative and minor changes to the Union authorisation for the biocidal product family perform-IPA

ANNEXSummary of product characteristics for a biocidal product family
ANNEX
Summary of product characteristics for a biocidal product family
perform-IPA
Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 - Food and feed area (Disinfectants)
Authorisation number: EU-0023656-0000
R4BP asset number: EU-0023656-0000
PART I
FIRST INFORMATION LEVEL
1.    ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
perform-IPA
1.2.    Product type(s)
Product type(s)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
PT04 - Food and feed area (Disinfectants)
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
Schuelke & Mayr GmbH
Address
Robert-Koch-Str. 2, 22851 Norderstedt Germany
Authorisation number
EU-0023656-0000
R4BP asset number
EU-0023656-0000
Date of the authorisation
27 December 2020
Expiry date of the authorisation
30 November 2030
1.4.    Manufacturer(s) of the biocidal products
Name of manufacturer
Schülke & Mayr GmbH
Address of manufacturer
Robert-Koch-Str. 2, 22851 Norderstedt Germany
Location of manufacturing sites
Robert-Koch-Str. 2, 22851 Norderstedt Germany
Name of manufacturer
BOCHEMIE a.s.
Address of manufacturer
Lidická 326, 735 95 Bohumín Czech Republic
Location of manufacturing sites
Lidická 326, 735 95 Bohumín Czech Republic
Name of manufacturer
Imeco
Address of manufacturer
Am Sägewerk 10, 63773 Goldbach Germany
Location of manufacturing sites
Boschstr. 5, 63768 Hösbach Germany
Neue Straße 2-4, 09471 Köningswalde Germany
Am Gansberg 9, 09481 Elterlein Germany
ul.Wlo'kiennicza 10, 59-800 Luban Poland
Name of manufacturer
Tristel Solutions Limited
Address of manufacturer
Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom
Location of manufacturing sites
Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom
Name of manufacturer
Techtex
Address of manufacturer
Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom
Location of manufacturing sites
Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom
Name of manufacturer
A.F.P. GmbH
Address of manufacturer
Otto Brenner Straße 16, 21337 Lüneburg Germany
Location of manufacturing sites
Otto Brenner Straße 16, 21337 Lüneburg Germany
Name of manufacturer
Innovate GmbH
Address of manufacturer
Gewerbegebietsstraße 30, 06618 Schönburg Germany
Location of manufacturing sites
Gewerbegebietsstraße 30, 06618 Schönburg Germany
Keizersveld 99, 5803 AP Venray Netherlands
Name of manufacturer
Lysoform Dr. Hans Rosemann GmbH
Address of manufacturer
Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany
Location of manufacturing sites
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
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
Gutenbergring 50-52, 22848 Norderstedt Germany
Lagerstr. 15, 19249 Jessenitz - Werk / Lübtheen Germany
Name of manufacturer
BIOXAL SA
Address of manufacturer
ZI Sud Secteur A, Route des Varennes, 71100 Chalon sur Saône France
Location of manufacturing sites
ZI Sud Secteur A, Route des Varennes, 71100 Chalon sur Saône France
Name of manufacturer
Lichtenheldt GmbH
Address of manufacturer
Industriestrasse 7-9, 23812 Wahlstedt Germany
Location of manufacturing sites
Industriestrasse 7-9, 23812 Wahlstedt Germany
Justus-Liebig-Weg 1, 23812 Wahlstedt Germany
Name of manufacturer
NATURELLE CONSUMER PRODUCTS LTD
Address of manufacturer
Unit 5 Bankmore Way, East industrial Park,, BT79 ONZ Doogary, Omagh, Co. Tyrone United Kingdom
Location of manufacturing sites
Unit 5 Bankmore Way, East industrial Park,, BT79 ONZ Doogary, Omagh, Co. Tyrone United Kingdom
Name of manufacturer
Halag Chemie AG
Address of manufacturer
Weiernstrasse 30, 8355 Aadorf Switzerland
Location of manufacturing sites
Weiernstrasse 30, 8355 Aadorf Switzerland
Name of manufacturer
PDI (EMEA) Ltd
Address of manufacturer
Pywell Rd Willowbrook East Industrial Estate, NN17 5XJ Corby United Kingdom
Location of manufacturing sites
Pywell Rd Willowbrook East Industrial Estate, NN17 5XJ Corby United Kingdom
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
Römerstraße 733, 47443 Moers Germany
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
Location of manufacturing sites
Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis Netherlands
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
63,1
2.2.    Type(s) of formulation
Formulation(s)
Any other liquid (AL), ready-to-use
Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
PART II
SECOND INFORMATION LEVEL - META SPC(S)
META SPC 1
1.    META SPC 1 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 1 identifier
Identifier
meta SPC 1 perform IPA liquid
1.2.    Suffix to the authorisation number
Number
1-1
1.3.    Product type(s)
Product type(s)
PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
63,1
2.2.    Type(s) of formulation of the meta SPC 1
Formulation(s)
Any other liquid (AL), ready-to-use
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Keep container tightly closed.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.
4.    AUTHORISED USE(S) OF THE META SPC 1
4.1.    Use description
Table 1
Use # 1 – Disinfection of surfaces - spraying
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)
Method: Spraying
Detailed description:
Product will be sprayed directly on the surface
Application rate(s) and frequency
Application Rate: Ready-to-use. Do not apply more than 25 ml/m 2 .
Dilution (%): -
Number and timing of application:
Disinfection after each production and cleaning process or when required according to standard operating procedure (SOP)
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 250-1000 ml
packaging material: high-density polyethylene (HDPE), surlyn/polypropylene (PP)
closure material is either: PP, polyoxymethylene (POM), low-density polyethylene (LDPE), HDPE, polyethylene (PE), ethylene-vinyl acetate (EVA), stainless steel, polybutylene terephthalate (PBT), (LD)PE, exp. polytetrafluoroethylene (PTFE), linear low density polyethylene (LLDPE), expanded PE (EXPPE), Co Polymer PP
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
closure material: PP/Silicone/EVA
drum: 200 - 220 litre
packaging material: HDPE
closure material is either: PP
IBC: 900-1000 litre
packaging material: HDPE with steel frame
closure material is either: PP, HDPE
4.1.1.    Use-specific instructions for use
Spray ready-to-use product on the surface and allow to take effect at 20± 2°C for at least 1 minute (bactericidal and yeasticidal activity) or 2 minutes (limited spectrum virucidal activity).
4.1.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
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
See general directions for use.
4.2.    Use description
Table 2
Use # 2 – Disinfection of surfaces - wiping
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)
Method: Wiping
Detailed description:
Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use. Do not apply more than 25 ml/m 2 .
Dilution (%): -
Number and timing of application:
Disinfection after each production and cleaning process or when required according to SOP.
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
closure material: PP/Silicone/EVA.
drum: 200 - 220 litre
packaging material: HDPEclosure material is either: PP
IBC: 900-1000 litre
packaging material: HDPE with steel frameclosure material is either: PP, HDPE
4.2.1.    Use-specific instructions for use
Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.2.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
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
See general directions for use.
4.3.    Use description
Table 3
Use # 3 – Disinfection of surfaces with food and feed contact - spraying
Product type
PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)
Method: Spraying
Detailed description:
Product will be sprayed directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use. Do not apply more than 25 ml/m 2 .
Dilution (%): -
Number and timing of application:
Disinfection after each production and cleaning process or when required according to SOP.
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
closure material: PP/Silicone/EVA.
drum: 200 - 220 litre
packaging material: HDPEclosure material is either: PP
IBC: 900-1000 litre
packaging material: HDPE with steel frame
closure material is either: PP, HDPE
4.3.1.    Use-specific instructions for use
Spray ready-to-use product on the surface and allow to take effect at room temperature (20± 2°C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).
4.3.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
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
See general directions for use.
4.4.    Use description
Table 4
Use # 4 – Disinfection of surfaces with food and feed contact - wiping
Product type
PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)
Method: Wiping
Detailed description:
Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use. Do not apply more than 25 ml/m 2 .
Dilution (%): -
Number and timing of application:
Disinfection after each production and cleaning process or when required according to SOP.
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
closure material: PP/Silicone/EVA.
drum: 200 - 220 litre
packaging material: HDPE closure material is either: PP
IBC: 900-1000 litre
packaging material: HDPE with steel frame closure material is either: PP, HDPE
4.4.1.    Use-specific instructions for use
Spray ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.4.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
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
See general directions for use.
5.    GENERAL DIRECTIONS FOR USE   ( 1 )
OF THE META SPC 1
5.1.    Instructions for use
Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Do not apply more than 25 ml/m 2 .
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.    Risk mitigation measures
The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Apply a funnel for refilling.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.    Instructions for safe disposal of the product and its packaging
-
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 36 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.    OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
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)
perform® sterile alcohol IPA
Market area: EU
perform® classic alcohol IPA
Market area: EU
buraton® IPA
Market area: EU
perform® advanced alcohol IPA
Market area: EU
arcana® IPA
Market area: EU
clear IPA
Market area: EU
pure IPA
Market area: EU
disinfectant IPA
Market area: EU
Surface disinfection liquid classic
Market area: EU
sterile IPA
Market area: EU
mikrozid® sterile liquid
Market area: EU
Surface disinfection liquid sterile
Market area: EU
BTS 6000
Market area: EU
Halades Alco
Market area: EU
Authorisation number
EU-0023656-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
META SPC 2
1.    META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
meta SPC 2 perform wipes IPA
1.2.    Suffix to the authorisation number
Number
1-2
1.3.    Product type(s)
Product type(s)
PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
63,1
2.2.    Type(s) of formulation of the meta SPC 2
Formulation(s)
Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Keep container tightly closed.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.
4.    AUTHORISED USE(S) OF THE META SPC 2
4.1.    Use description
Table 5
Use # 1 – Disinfection of surfaces - wiping
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)
Method: Wiping
Detailed description:
Product will be wiped directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
Disinfection after each production and cleaning process or when required according to SOP.
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; biaxially oriented polypropylene (BOPP) + cast polypropylene (CPP)
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE
closure material is either PP, PE3385
4.1.1.    Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
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
See general directions for use.
4.2.    Use description
Table 6
Use # 2 – Disinfection of surfaces with food and feed contact - wiping
Product type
PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)
Method: Wiping
Detailed description:
Product will be wiped directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
Disinfection after each production and cleaning process or when required according to SOP.
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE
closure material is either PP, PE3385
4.2.1.    Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.2.2.    Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
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
See general directions for use.
5.    GENERAL DIRECTIONS FOR USE   ( 2 )
OF THE META SPC 2
5.1.    Instructions for use
Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.    Risk mitigation measures
The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.    Instructions for safe disposal of the product and its packaging
-
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.    OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
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)
perform classic wipes IPA
Market area: EU
buraton® wipes IPA
Market area: EU
perform® advanced wipes IPA
Market area: EU
arcana® wipes IPA
Market area: EU
clear IPA wipes
Market area: EU
pure IPA wipes
Market area: EU
disinfectant IPA wipes
Market area: EU
Surface disinfection wipes classic
Market area: EU
perform® sterile wipes IPA
Market area: EU
sterile IPA wipes
Market area: EU
mikrozid® sterile wipes
Market area: EU
Surface disinfection wipes sterile
Market area: EU
Authorisation number
EU-0023656-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
META SPC 3
1.    META SPC 3 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 3 identifier
Identifier
meta SPC 3 mikrozid liquid
1.2.    Suffix to the authorisation number
Number
1-3
1.3.    Product type(s)
Product type(s)
PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
63,1
2.2.    Type(s) of formulation of the meta SPC 3
Formulation(s)
Any other liquid (AL), ready-to-use
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Keep container tightly closed.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.
4.    AUTHORISED USE(S) OF THE META SPC 3
4.1.    Use description
Table 7
Use # 1 – Disinfection of surfaces - spraying
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)
Method: Spraying
Detailed description:
Product will be sprayed directly on the surface
Application rate(s) and frequency
Application Rate: Ready-to-use. Do not apply more than 25 ml/m 2 .
Dilution (%): -
Number and timing of application:
Disinfection when required according to SOP.
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
Closure : PP/Silicone/EVA
drum: 200 - 220 litre
packaging material: HDPE
closure material is either: PP
IBC:900-1000 litre
packaging material: HDPE with steel frame closure material is either: PP, HDPE
4.1.1.    Use-specific instructions for use
Spray ready-to-use product on the surface and allow to take effect at 20± 2°C for at least 1 minute (bactericidal and yeasticidal activity) or 2 minutes (limited spectrum virucidal activity).
4.1.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
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
See general directions for use.
4.2.    Use description
Table 8
Use # 2 – Disinfection of surfaces - wiping
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)
Method: Wiping
Detailed description:
Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use. Do not apply more than 25 ml/m 2 .
Dilution (%): -
Number and timing of application:
Disinfection when required according to SOP.
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
Closure : PP/Silicone/EVA
drum: 200 - 220 litre
packaging material: HDPE
closure material is either: PP
IBC:900-1000 litre
packaging material: HDPE with steel frame
closure material is either: PP, HDPE
4.2.1.    Use-specific instructions for use
Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.2.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
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
See general directions for use.
4.3.    Use description
Table 9
Use # 3 – Disinfection of surfaces with food and feed contact - spraying
Product type
PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)
Method: Spraying
Detailed description:
Product will be sprayed directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use. Do not apply more than 25 ml/m 2 .
Dilution (%): -
Number and timing of application:
Disinfection when required according to SOP.
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
Closure : PP/Silicone/EVA
drum: 200 - 220 litre
packaging material: HDPE
closure material is either: PP
IBC: 900-1000 litre
packaging material: HDPE with steel frame closure material is either: PP, HDPE
4.3.1.    Use-specific instructions for use
Spray ready-to-use product on the surface and allow to take effect at room temperature (20± 2°C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).
4.3.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
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
See general directions for use.
4.4.    Use description
Table 10
Use # 4 – Disinfection of surfaces with food and feed contact - wiping
Product type
PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)
Method: Wiping
Detailed description:
Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on surface.
Application rate(s) and frequency
Application Rate: Ready-to-use. Do not apply more than 25 ml/m 2 .
Dilution (%): -
Number and timing of application:
Disinfection when required according to SOP.
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
closure material: PP/Silicone/EVA
drum: 200 - 220 litre
packaging material: HDPE
closure material is either: PP
IBC: 900-1000 litre
packaging material: HDPE with steel frame closure material is either: PP, HDPE
4.4.1.    Use-specific instructions for use
Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.4.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
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
See general directions for use.
5.    GENERAL DIRECTIONS FOR USE   ( 3 )
OF THE META SPC 3
5.1.    Instructions for use
Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Do not apply more than 25 ml/m 2 .
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.    Risk mitigation measures
The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Apply a funnel for refilling.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.    Instructions for safe disposal of the product and its packaging
-
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 36 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.    OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
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)
mikrozid® classic liquid
Market area: EU
mikrozid® IPA liquid
Market area: EU
Surface Disinfection liquid pure
Market area: EU
Authorisation number
EU-0023656-0003 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
META SPC 4
1.    META SPC 4 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 4 identifier
Identifier
meta SPC 4 mikrozid wipes
1.2.    Suffix to the authorisation number
Number
1-4
1.3.    Product type(s)
Product type(s)
PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
63,1
2.2.    Type(s) of formulation of the meta SPC 4
Formulation(s)
Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Keep container tightly closed.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.
4.    AUTHORISED USE(S) OF THE META SPC 4
4.1.    Use description
Table 11
Use # 1 – Disinfection of surfaces - wiping
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)
Method: Wiping
Detailed description:
Product will be wiped directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
Disinfection when required according to SOP.
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE
closure material is either PP, PE3385
4.1.1.    Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
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
See general directions for use.
4.2.    Use description
Table 12
Use # 2 – Disinfection of surfaces with food and feed contact - wiping
Product type
PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)
Method: Wiping
Detailed description:
Product will be wiped directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
Disinfection when required according to SOP.
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE
closure material is either PP, PE3385
4.2.1.    Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.2.2.    Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
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
See general directions for use.
5.    GENERAL DIRECTIONS FOR USE   ( 4 )
OF THE META SPC 4
5.1.    Instructions for use
Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.    Risk mitigation measures
The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.    Instructions for safe disposal of the product and its packaging
-
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.    OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
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)
mikrozid® classic wipes
Market area: EU
mikrozid® IPA wipes
Market area: EU
surface disinfection wipes classic
Market area: EU
Authorisation number
EU-0023656-0004 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
META SPC 5
1.    META SPC 5 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 5 identifier
Identifier
meta SPC 5 kodan wipes IPA pro
1.2.    Suffix to the authorisation number
Number
1-5
1.3.    Product type(s)
Product type(s)
PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
63,1
2.2.    Type(s) of formulation of the meta SPC 5
Formulation(s)
Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Keep container tightly closed.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.
4.    AUTHORISED USE(S) OF THE META SPC 5
4.1.    Use description
Table 13
Use # 1 – Disinfection of surfaces - wiping
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)
Method: Wiping
Detailed description:
Product will be wiped directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
-
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE
closure material is either PP, PE3385
4.1.1.    Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
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
See general directions for use.
4.2.    Use description
Table 14
Use # 2 – Disinfection of surfaces with food and feed contact - wiping
Product type
PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)
Method: Wiping
Detailed description:
Product will be wiped directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
-
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE
closure material is either PP, PE3385
4.2.1.    Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.2.2.    Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
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
See general directions for use.
5.    GENERAL DIRECTIONS FOR USE   ( 5 )
OF THE META SPC 5
5.1.    Instructions for use
Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.    Risk mitigation measures
The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.    Instructions for safe disposal of the product and its packaging
-
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.    OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
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)
kodan® wipes pure
Market area: EU
schülke® classic wipes
Market area: EU
Authorisation number
EU-0023656-0005 1-5
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
META SPC 6
1.    META SPC 6 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 6 identifier
Identifier
meta SPC 6 kodan wipes IPA
1.2.    Suffix to the authorisation number
Number
1-6
1.3.    Product type(s)
Product type(s)
PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
63,1
2.2.    Type(s) of formulation of the meta SPC 6
Formulation(s)
Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Keep container tightly closed.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.
4.    AUTHORISED USE(S) OF THE META SPC 6
4.1.    Use description
Table 15
Use # 1 – Disinfection of surfaces - wiping
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)
Method: Wiping
Detailed description:
Product will be wiped directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
-
Category(ies) of users
Industrial
Professional
General public (non-professional)
Pack sizes and packaging material
Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE
closure material is either PP, PE3385
4.1.1.    Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
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
See general directions for use.
4.2.    Use description
Table 16
Use # 2 – Disinfection of surfaces with food and feed contact - wiping
Product type
PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)
Method: Wiping
Detailed description:
Product will be wiped directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
-
Category(ies) of users
Industrial
Professional
General public (non-professional)
Pack sizes and packaging material
Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE
closure material is either PP, PE3385
4.2.1.    Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.2.2.    Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
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
See general directions for use.
5.    GENERAL DIRECTIONS FOR USE   ( 6 )
OF THE META SPC 6
5.1.    Instructions for use
Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.    Risk mitigation measures
The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Keep out of the reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.    Instructions for safe disposal of the product and its packaging
-
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.    OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
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)
schülke Hygiene-Tücher
Market area: EU
SOS Desinfizierende Feuchttücher
Market area: EU
SOS Hygiene-Tücher
Market area: EU
kodan® clean comfort wipes
Market area: EU
schülke clean comfort wipes
Market area: EU
Hygiene-Tücher
Market area: EU
Desinfizierende Feuchttücher
Market area: EU
Desinfektionstücher
Market area: EU
clean comfort wipes
Market area: EU
disinfecting wipes
Market area: EU
Authorisation number
EU-0023656-0006 1-6
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
META SPC 7
1.    META SPC 7 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 7 identifier
Identifier
meta SPC 7 AntiLy SD
1.2.    Suffix to the authorisation number
Number
1-7
1.3.    Product type(s)
Product type(s)
PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
63,1
2.2.    Type(s) of formulation of the meta SPC 7
Formulation(s)
Any other liquid (AL), ready-to-use
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Keep container tightly closed.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.
4.    AUTHORISED USE(S) OF THE META SPC 7
4.1.    Use description
Table 17
Use # 1 – Disinfection of surfaces - spraying
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
Application method(s)
Method: Spraying
Detailed description:
Product will be sprayed directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use. Do not apply more than 25 ml/m 2 .
Dilution (%): -
Number and timing of application:
-
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 125-1000 ml
packaging material: HDPE
Clack cap material: PP; Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel); Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
4.1.1.    Use-specific instructions for use
Spray ready-to-use product onto the surfaces and allow to take effect for at least 1 minute at room temperature (20±2 °C).
4.1.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
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
See general directions for use.
4.2.    Use description
Table 18
Use # 2 – Disinfection of surfaces - wiping
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
Application method(s)
Method: Wiping
Detailed description:
Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping).
Application rate(s) and frequency
Application Rate: Ready-to-use. Do not apply more than 25 ml/m 2 .
Dilution (%): -
Number and timing of application:
-
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 125-1000 ml
packaging material: HDPE
Clack cap material: PP
Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel);
Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
Canister: 5-30 litre
packaging material: HDPE
closure material: HDPE
4.2.1.    Use-specific instructions for use
Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20±2 °C).
4.2.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
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
See general directions for use.
4.3.    Use description
Table 19
Use # 3 – Disinfection of surfaces with food and feed contact - spraying
Product type
PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)
Method: Spraying
Detailed description:
Product will be sprayed directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use. Do not apply more than 25 ml/m 2 .
Dilution (%): -
Number and timing of application:
-
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 125-1000 ml
packaging material: HDPE
Clack cap material: PP
Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
4.3.1.    Use-specific instructions for use
Spray ready-to-use product onto the surface and allow to take effect at room temperature (20 ± 2 °C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).
4.3.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
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
See general directions for use.
4.4.    Use description
Table 20
Use # 4 – Disinfection of surfaces with food and feed contact - wiping
Product type
PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)
Method: Wiping
Detailed description:
Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping).
Application rate(s) and frequency
Application Rate: Ready-to-use. Do not apply more than 25 ml/m 2 .
Dilution (%): -
Number and timing of application:
-
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Bottle: 125-1000 ml
packaging material: HDPE
Clack cap material: PP
Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
Canister: 5-30 litre
packaging material: HDPE
closure material: HDPE
4.4.1.    Use-specific instructions for use
Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20 ±2°C).
4.4.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
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
See general directions for use.
5.    GENERAL DIRECTIONS FOR USE   ( 7 )
OF THE META SPC 7
5.1.    Instructions for use
Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Do not apply more than 25 ml/m 2 .
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.    Risk mitigation measures
The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Apply a funnel for refilling.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.    Instructions for safe disposal of the product and its packaging
-
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 36 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.    OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
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)
AntiLy 5
Market area: EU
Authorisation number
EU-0023656-0007 1-7
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
AntiLy 6
Market area: EU
Authorisation number
EU-0023656-0008 1-7
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
META SPC 8
1.    META SPC 8 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 8 identifier
Identifier
meta SPC 8 AntiLy SD wipes
1.2.    Suffix to the authorisation number
Number
1-8
1.3.    Product type(s)
Product type(s)
PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
63,1
2.2.    Type(s) of formulation of the meta SPC 8
Formulation(s)
Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Keep container tightly closed.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.
4.    AUTHORISED USE(S) OF THE META SPC 8
4.1.    Use description
Table 21
Use # 1 – Disinfection of surfaces - wiping
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
Application method(s)
Method: Wiping
Detailed description:
Product will be wiped directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
-
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Can: 100-150 wipes
Packaging: HDPE
Closure material: HDPE
Pack: 100-150 wipes
Packaging: PET/PE
4.1.1.    Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
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
See general directions for use.
4.2.    Use description
Table 22
Use # 2 – Disinfection of surfaces with food and feed contact - wiping
Product type
PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)
Method: Wiping
Detailed description:
Product will be wiped directly on the surface.
Application rate(s) and frequency
Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
-
Category(ies) of users
Industrial
Professional
Pack sizes and packaging material
Can: 100-150 wipes
Packaging: HDPE
Closure material: HDPE
Pack: 100-150 wipes
Packaging: PET/PE
4.2.1.    Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.2.2.    Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
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
See general directions for use.
5.    GENERAL DIRECTIONS FOR USE   ( 8 )
OF THE META SPC 8
5.1.    Instructions for use
Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.    Risk mitigation measures
The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.    Instructions for safe disposal of the product and its packaging
-
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.    OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
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)
AntiLy 5 wipes
Market area: EU
Authorisation number
EU-0023656-0009 1-8
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
AntiLy 6 wipes
Market area: EU
Authorisation number
EU-0023656-0010 1-8
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.
( 2 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.
( 3 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.
( 4 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.
( 5 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.
( 6 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.
( 7 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.
( 8 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.
Commission Implementing Regulation (EU) 2024/2194 of 4 September 2024 amending Implementing Regulation (EU) 2020/1991 as regards administrative and minor changes to the Union authorisation for the biocidal product family perform-IPA

Schedules & Appendices

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