ANNEX
Summary of product characteristics for a biocidal product family
Divodes FG family
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
Authorisation number: EU-0034601-0000
R4BP asset number: EU-0034601-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
Name
Divodes FG family
1.2. Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
1.3. Authorisation holder
Name and address of the authorisation holder
Name
Diversey Europe Operations B.V.
Address
De Corridor 4 (Regulatory team) 3621 ZB Breukelen NL
Authorisation number
EU-0034601-0000
R4BP asset number
EU-0034601-0000
Date of the authorisation
1 March 2026
Expiry date of the authorisation
29 February 2036
1.4. Manufacturer(s) of the product
Name of manufacturer
Diversey Europe Operations B.V.
Address of manufacturer
De Corridor 4 (Regulatory team) 3621 ZB Breukelen Netherlands (the)
Location of manufacturing sites
Diversey Europe Operations B.V. site 1 Diversey España Production S.L.U., Avenida Conde Duque 5, 7 y 9, Poligono Industrial La Postura 28343 Valdemoro (Madrid) Spain
Diversey Europe Operations B.V. site 2 Diversey Italy Production Srl, Strada Statale 235 I - 26010 Bagnolo Cremasco (CR) Italy
Diversey Europe Operations B.V. site 3 Diversey UK Production Limited, Cotes Park Industrial Estate DE55 4PA Somercotes, Alfreton United Kingdom of Great Britain and Northern Ireland (the)
Diversey Europe Operations B.V. site 4 Diversey Netherlands Production BV, Rembrandtlaan 414 7545 ZW Enschede Netherlands (the)
Diversey Europe Operations B.V. site 5 Diversey Germany Production OHG, Morschheimer Strasse 12 D-67292 Kirchheimbolanden Germany
Name of manufacturer
Orvema B.V.
Address of manufacturer
Westkanaaldijk 26-I 3606 AM Maarssen Netherlands (the)
Location of manufacturing sites
Orvema B.V. site 1 Westkanaaldijk 26-I 3606 AM Maarssen Netherlands (the)
Name of manufacturer
Brenntag GmbH
Address of manufacturer
Am Röhrenwerk 46 47259 Duisburg Germany
Location of manufacturing sites
Brenntag GmbH site 1 Am Röhrenwerk 46 47259 Duisburg Germany
Name of manufacturer
Brenntag SA
Address of manufacturer
Zone d' Activités les Sauzets 07340 Andance France
Location of manufacturing sites
Brenntag SA site 1 Zone d’Activités les Sauzets 07340 Andance France
Name of manufacturer
Brenntag Nederland B.V.
Address of manufacturer
Chemieweg 9, Havennummer 4208 3197 KC Botlek Rotterdam Netherlands (the)
Location of manufacturing sites
Brenntag Nederland B.V. site 1 Chemieweg 9, Havennummer 4208 3197 KC Botlek Rotterdam Netherlands (the)
Name of manufacturer
Brenntag Schweizerhall AG
Address of manufacturer
Elsässerstrasse 229/245 4056 Basel Switzerland
Location of manufacturing sites
Brenntag Schweizerhall AG site 1 Elsässerstrasse 229/245 4056 Basel Switzerland
Name of manufacturer
Cheport spol s.r.o.
Address of manufacturer
Lhotsko 93 76312 Vizovice Czechia
Location of manufacturing sites
Cheport spol s.r.o. site 1 Lhotsko 93 76312 Vizovice Czechia
Name of manufacturer
Ionic Products Ltd
Address of manufacturer
Blaris Industrial Estate, Altona Road BT27 5QB Lisburn, Northern Ireland United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
Ionic Products Ltd site 1 Blaris Industrial Estate, Altona Road BT27 5QB Lisburn, Northern Ireland United Kingdom of Great Britain and Northern Ireland (the)
Name of manufacturer
Multifill B.V.
Address of manufacturer
Constructieweg 25a, P.O. Box 367 3640 AJ Mijdrecht Netherlands (the)
Location of manufacturing sites
Multifill B.V. site 1 Constructieweg 25a, P.O. Box 367 3640 AJ Mijdrecht Netherlands (the)
Name of manufacturer
Pluswipes Ltd
Address of manufacturer
Pywell Road, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
Pluswipes Ltd site 1 Pywell Road, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)
1.5. Manufacturer(s) of the active substance(s)
Active substance
Propan-1-ol
Name of manufacturer
BASF SE
Address of manufacturer
Carl-Bosch-Str. 38 67056 Ludwigshafen Germany
Location of manufacturing sites
BASF SE site 1 Carl-Bosch-Str. 38 67056 Ludwigshafen Germany
Active substance
Propan-1-ol
Name of manufacturer
OXEA Corporation
Address of manufacturer
2001 FM 3057 TX 77414 Bay City United States (the)
Location of manufacturing sites
OXEA Corporation site 1 2001 FM 3057 TX 77414 Bay City United States (the)
Active substance
Propan-2-ol
Name of manufacturer
SASOL Solvents Germany GmbH
Address of manufacturer
Anckelmannsplatz D-20537 Hamburg Germany
Location of manufacturing sites
SASOL Solvents Germany GmbH site 1 Shamrockstrasse 88 D-44623 Herne Germany
SASOL Solvents Germany GmbH site 2 Römerstr. 733 D-47443 Moers Germany
Active substance
Propan-2-ol
Name of manufacturer
Shell Chemicals Europe B.V.
Address of manufacturer
Postbus 2334 3000 CH Rotterdam Netherlands (the)
Location of manufacturing sites
Shell Chemicals Europe B.V. site 1 Shell Nederland Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the)
Active substance
Propan-2-ol
Name of manufacturer
Exxon Mobil Chemicals
Address of manufacturer
Hermeslaan 2 1831 Machelen Belgium
Location of manufacturing sites
Exxon Mobil Chemicals site 1 ExxonMobil’s Baton Rouge Refinery and Chemical Plant, 4045 Scenic Hwy LA 70805 Baton Rouge United States (the)
Exxon Mobil Chemicals site 2 Esso Refinery Fawley SO45 1TX Southampton United Kingdom of Great Britain and Northern Ireland (the)
Active substance
Propan-2-ol
Name of manufacturer
Novapex
Address of manufacturer
21 Chemin de la Sauvegarde - 21 Ecully Parc - CS 33167 69134 Écully Cedex France
Location of manufacturing sites
Novapex site 1 Novapex SAS Usine de Rousillon, Rue Gaston Monmousseau, Saint Maurice l’Exil 38556 Cédex France
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-1-ol
Active substance
71-23-8
200-746-9
52,2 - 52,2 % (w/w)
Propan-2-ol
Active substance
67-63-0
200-661-7
17,5 - 17,5 % (w/w)
2.2. Type(s) of formulation
Formulation type(s)
AL Any other liquid
XX Impregnated wipes
PART II
SECOND INFORMATION LEVEL META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
Identifier
Meta SPC: Meta 1: Divodes FG VT29
1.2. Suffix to the authorisation number
Number
1-1
1.3. Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-1-ol
Active substance
71-23-8
200-746-9
52,2 - 52,2 % (w/w)
Propan-2-ol
Active substance
67-63-0
200-661-7
17,5 - 17,5 % (w/w)
2.2. Type(s) of formulation of the meta SPC 1
Formulation type(s)
AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
H226: Flammable liquid and vapour.
H318: Causes serious eye damage.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye/face protection.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a poison centre or doctor/physician.
P312: Call a POISON CENTER if you feel unwell.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents a hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container a hazardous waste disposal service in accordance with the statutory regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use # 1 – Small scale disinfection - Trigger spray - PT 2 - Industrial and healthcare (clean)
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Fungi
Common name: Viruses (limited spectrum virucidal activity)
Field(s) of use
indoor use
Ready to use disinfectant for clean hard non-porous surfaces in industrial areas (e.g. laboratories, pharmaceutical and cosmetic industries) and healthcare.
Application method(s)
Method: spraying
Detailed description:
Disinfection using a trigger spray: Ready to use for spraying on cleaned surfaces.
Application rate(s) and frequency
Application Rate: 25 ml/m 2 No dilution required
Number and timing of application:
Use frequencies:
Laboratories: Up to 10 times per day
Cleanrooms (ventilation rate 8 per h): Up to 20 times per day
Cleanrooms (ventilation rate 20 per h): Up to 40 times per day
Pharmaceutical and cosmetic: Up to 80 times per day
Healthcare (e.g. hospitals and medical practices): Up to 8 times per day
Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms)
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.
Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.
4.1.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Spray on cleaned surface (25 ml/m 2 ) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (See contact times below). Let air dry.
Contact times
Pre-cleaned surface at room temperature:
Bacteria and yeasts: 30 seconds
Fungi and viruses (limited spectrum virucidal activity): 5 minutes
Pre-cleaned surface in cosmetic industry and healthcare at room temperature:
Bacteria and yeasts: 30 seconds
Fungi and viruses (limited spectrum virucidal activity): 5 minutes
Pre-cleaned surface at 4 °C:
Bacteria and yeasts: 30 seconds
4.1.2. Use-specific risk mitigation measures
In laboratories, cleanrooms and pharmaceutical and cosmetic industries and hospitals:
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
—
Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)
In medical practices:
—
Ensure that the application is carried out in areas with a minimum ventilation of 5 air changes per hour. (N-29)
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
—
Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
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
Not applicable
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.2. Use description
Table 2
Use # 2 – Small scale disinfection - Trigger spray – PT 2 – Institutional and public areas – Professional use (clean)
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Fungi
Common name: Viruses (limited spectrum virucidal activity)
Field(s) of use
indoor use
Ready to use disinfectant for clean hard non-porous surfaces in institutional (e.g. educational institutions) and public areas.
Application method(s)
Method: spraying
Detailed description:
Disinfection using a trigger spray: Ready to use for spraying on cleaned surfaces.
Application rate(s) and frequency
Application Rate: 25 ml/m 2 No dilution required
Number and timing of application:
Use up to 10 times per day
Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms)
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.
Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.
4.2.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Spray on cleaned surface (25 ml/m 2 ) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (See contact times below). Let air dry.
Contact times
Pre-cleaned surface at room temperature:
Bacteria and yeasts: 30 seconds
Fungi and viruses (limited spectrum virucidal activity): 5 minutes
Pre-cleaned surface at 4 °C:
Bacteria and yeasts: 30 seconds
4.2.2. Use-specific risk mitigation measures
In institutional and public areas:
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)
—
Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
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
Not applicable
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.3. Use description
Table 3
Use # 3 – Small scale disinfection - Trigger spray - PT 4 - Food and beverage industry (clean)
Product type
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Fungi
Common name: Viruses
Field(s) of use
indoor use
Ready to use disinfectant for clean hard non-porous surfaces (including indirect food contact) in the food and beverage industries (including kitchens, beverage, meat industries).
Application method(s)
Method: spraying
Detailed description:
Disinfection using a trigger spray: Ready to use for spraying on cleaned surfaces.
Application rate(s) and frequency
Application Rate: 25 ml/m 2 No dilution required
Number and timing of application:
Use up to 10 times per day
Can be used in areas at room temperature or at low temperature of 4°C (cold storage rooms)
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.
Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.
4.3.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Spray on cleaned surface (25 ml/m 2 ) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.
Contact times
Pre-cleaned surface in food and beverage industry at room temperature:
Bacteria and yeasts: 30 seconds
Fungi and viruses: 5 minutes
Pre-cleaned surface at 4 °C:
Bacteria and yeasts: 30 seconds
4.3.2. Use-specific risk mitigation measures
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
—
Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
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
Not applicable
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.4. Use description
Table 4
Use # 4 – Small scale disinfection - Trigger spray - PT 2 - Industrial and healthcare
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Field(s) of use
indoor use
Ready to use disinfectant for hard non-porous surfaces in industrial areas (e.g. laboratories, pharmaceutical and cosmetic industries) and healthcare.
Application method(s)
Method: spraying
Detailed description:
Disinfection using a trigger spray: Ready to use for spraying on surfaces.
Application rate(s) and frequency
Application Rate: 25 mL/m 2 No dilution required
Number and timing of application:
Use frequencies:
Laboratories: Up to 10 times per day
Cleanrooms (ventilation rate 8 per h): Up to 20 times per day
Cleanrooms (ventilation rate 20 per h): Up to 40 times per day
Pharmaceutical and cosmetic: Up to 80 times per day
Healthcare (e.g. hospitals and medical practices): Up to 8 times per day
Use at room temperature
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.
Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.
4.4.1. Use-specific instructions for use
Spray on surface (25 ml/m 2 ) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.
Contact times
Surface (industrial including cosmetics industry and healthcare):
Bacteria and yeasts: 30 seconds
4.4.2. Use-specific risk mitigation measures
In laboratories, cleanrooms and pharmaceutical and cosmetic industries and hospitals:
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
—
Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)
In medical practices:
—
Ensure that the application is carried out in areas with a minimum ventilation of 5 air changes per hour. (N-29)
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
—
Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
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
Not applicable
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.5. Use description
Table 5
Use # 5 – Small scale disinfection - Trigger spray - PT 2 - Institutional and public - Professional use
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Field(s) of use
indoor use
Ready to use disinfectant for hard non-porous surfaces in institutional (e.g. educational institutions) and public areas
Application method(s)
Method: spraying
Detailed description:
Disinfection using a trigger spray: Ready to use for spraying on surfaces.
Application rate(s) and frequency
Application Rate: 25 ml/m 2 No dilution required
Number and timing of application:
Use up to 10 times per day
Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms)
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.
Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.
4.5.1. Use-specific instructions for use
Spray on surface (25 ml/m 2 ) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.
Contact times
Surface at room temperature:
Bacteria and yeasts: 30 seconds
Surface at 4 °C:
Bacteria and yeasts: 30 seconds
4.5.2. Use-specific risk mitigation measures
In institutional and public areas:
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)
—
Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Not applicable
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.6. Use description
Table 6
Use # 6 – Small scale disinfection - Trigger spray - PT 4 - Food industry
Product type
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Field(s) of use
indoor use
Ready to use disinfectant for hard non-porous surfaces (e.g. kitchens)
Application method(s)
Method: spraying
Detailed description:
Disinfection using a trigger spray: Ready to use for spraying on surfaces.
Application rate(s) and frequency
Application Rate: 25 ml/m 2 No dilution required
Number and timing of application:
Use up to 10 times per day
Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms)
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.
Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.
4.6.1. Use-specific instructions for use
Spray on surface (25 ml/m 2 ) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.
Contact times
Surface (generic) at room temperature:
Bacteria and yeasts: 30 seconds
Surface at 4 °C:
Bacteria and yeasts: 30 seconds
4.6.2. Use-specific risk mitigation measures
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
—
Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Not applicable
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.7. Use description
Table 7
Use # 7 – Small scale disinfection - Trigger spray - PT 4 - Food and beverage industry (specific claims)
Product type
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Fungi
Field(s) of use
indoor use
Ready to use disinfectant for hard non-porous surfaces (e.g. kitchens, dairies, and food and beverage industries).
Application method(s)
Method: spraying
Detailed description:
Disinfection using a trigger spray: Ready to use for spraying on surfaces.
Application rate(s) and frequency
Application Rate: 25 ml/m 2 No dilution required
Number and timing of application:
Use up to 10 times per day
Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms)
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.
Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.
4.7.1. Use-specific instructions for use
Spray on surface (25 ml/m 2 ) and make sure to wet surfaces completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.
Contact times
Surface in beverage industry at room temperature:
Bacteria and yeasts: 30 seconds
Fungi: 5 minutes
Surface in meat industry at room temperature:
Bacteria and yeasts: 30 seconds
Surface in dairy industry at room temperature:
Bacteria and yeasts: 5 minutes
Surface in meat industry at 4 °C:
Bacteria and yeasts: 30 seconds
4.7.2. Use-specific risk mitigation measures
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
—
Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Not applicable
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.8. Use description
Table 8
Use # 8 – Pressurised spraying - PT 4
Product type
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Fungi
Common name: Viruses
Field(s) of use
indoor use
Ready to use disinfectant for hard non-porous surfaces in dairy, beverage and processed food industries.
Application method(s)
Method: spraying
Detailed description:
Disinfection using pressurised spraying: Ready to use for spraying on surfaces.
Application rate(s) and frequency
Application Rate: 50 ml/m 2 No dilution required
Number and timing of application:
Use frequency:
End of shift disinfection: Once per day
Mid-shift disinfection: Up to 3 times per day
Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms).
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (screw cap) (HDPE): 0,75, 1, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L
4.8.1. Use-specific instructions for use
Pre-cleaned surface:
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Spray on cleaned surface (50 ml/m 2 ) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.
Contact times
Pre-cleaned surface in food and beverage industry at room temperature:
Bacteria and yeasts: 30 seconds
Fungi and viruses: 5 minutes
Pre-cleaned surface at 4 °C:
Bacteria and yeasts: 30 seconds
Dirty surface:
Spray on surface (50 ml/m 2 ) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.
Contact times
Dirty surface (generic) at room temperature:
Bacteria and yeasts: 30 seconds
Dirty surface in beverage industry at room temperature:
Bacteria and yeasts: 30 seconds
Fungi: 5 minutes
Dirty surface in meat industry at room temperature:
Bacteria and yeasts: 30 seconds
Fungi: 5 minutes
Dirty surface in dairy industry at room temperature:
Bacteria and yeasts: 5 minutes
Dirty surface in meat industry at 4 °C:
Bacteria and yeasts: 30 seconds
4.8.2. Use-specific risk mitigation measures
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
—
Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Not applicable
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.9. Use description
Table 9
Use # 9 – Pressurised spraying - PT 2
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Fungi
Common name: Viruses (limited spectrum virucidal activity)
Field(s) of use
indoor use
Ready to use disinfectant for hard non-porous surfaces in industrial areas (e.g. laboratories and pharmaceutical and cosmetic industries).
Application method(s)
Method: spraying
Detailed description:
Disinfection using pressurised spraying: Ready to use for spraying on surfaces.
Application rate(s) and frequency
Application Rate: 50 ml/m 2 No dilution required
Number and timing of application:
Use frequency:
End of shift disinfection: Once per day
Mid-shift disinfection: Up to 3 times per day
Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms).
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (screw cap) (HDPE): 0,75, 1, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L
4.9.1. Use-specific instructions for use
Pre-cleaned surface:
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Spray on cleaned surface (50 ml/m 2 ) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.
Contact times
Pre-cleaned surface (including cosmetics industry):
Bacteria and yeasts: 30 seconds
Fungi and viruses (limited spectrum virucidal activity): 5 minutes
Pre-cleaned surface at 4 °C:
Bacteria and yeasts: 30 sec
Dirty surface:
Spray on surface (50 ml/m 2 ) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.
Contact times
Dirty surface (including cosmetics industry):
Bacteria and yeasts: 30 seconds
Dirty surface at 4 °C:
Bacteria and yeasts: 30 seconds
4.9.2. Use-specific risk mitigation measures
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
—
Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Not applicable
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.10. Use description
Table 10
Use # 10 – Container opening disinfection - PT 4
Product type
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Fungi
Common name: Viruses
Field(s) of use
indoor use
Ready to use disinfectant for container openings with a valve in the food and beverage industry.
Application method(s)
Method: spraying
Detailed description:
Disinfection using automated spraying equipment: Ready to use for spraying container openings.
Application rate(s) and frequency
Application Rate: 1 - 10 ml/ container opening No dilution required
Number and timing of application:
Use frequency: Up to 600 containers per hour
Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms).
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (screw cap) (HDPE): 0,75, 1, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L
4.10.1. Use-specific instructions for use
Automated spraying on container opening with valve (1 - 10 ml/ container opening). Make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.
Contact times
Pre-cleaned surface in food and beverage industry at room temperature:
Bacteria and yeasts: 30 seconds
Fungi and viruses: 5 minutes
Pre-cleaned surface at 4 °C:
Bacteria and yeasts: 30 seconds
Dirty surface (generic) at room temperature:
Bacteria and yeasts: 30 seconds
Dirty surface in beverage industry at room temperature:
Bacteria and yeasts: 30 seconds
Fungi: 5 minutes
Dirty surface in meat industry at room temperature:
Bacteria and yeasts: 30 seconds
Dirty surface in dairy industry at room temperature:
Bacteria and yeasts: 5 minutes
Dirty surface in meat industry at 4 °C:
Bacteria and yeasts: 30 seconds
4.10.2. Use-specific risk mitigation measures
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent) (N-70)
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
—
Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Not applicable
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.11. Use description
Table 11
Use # 12 – Glove disinfection - PT 2 & PT 4
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Field(s) of use
indoor use
Ready to use disinfectant for non-porous gloves worn by professional workers in healthcare institutions, laboratories and the pharmaceutical, cosmetic, dairy, beverage and processed food industries.
Application method(s)
Method: spraying
Detailed description:
Ready to use disinfectant for clean non-porous gloves.
Application rate(s) and frequency
Application Rate: 3 ml (both hands) No dilution required
Number and timing of application:
Use up to 10 times per day.
Use temperature: room temperature
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.
Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.
4.11.1. Use-specific instructions for use
Apply directly onto clean non-porous gloves, distribute evenly and allow to take effect for 30 seconds to be effective for bacteria and yeasts. Make sure to wet the surface completely.
Do not use for disinfection of medical gloves falling under Regulation (EU) 2017/745
4.11.2. Use-specific risk mitigation measures
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Not applicable
4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.12. Use description
Table 12
Use # 13 – Small scale disinfection - Trigger spray – PT 2 – Veterinary practices
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Field(s) of use
indoor use
Ready to use disinfectant for general hard non-porous surfaces in veterinary practices.
Application method(s)
Method: spraying
Detailed description:
Disinfection using a trigger spray: Ready to use for spraying on surfaces.
Application rate(s) and frequency
Application Rate: 25 ml/m 2 No dilution required
Number and timing of application:
Use up to 10 times per day
Use at room temperature
Category(ies) of users
professional
Pack sizes and packaging material
Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.
Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.
4.12.1. Use-specific instructions for use
Spray on surface (25 ml/m 2 ) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (See contact times below). Let air dry.
Contact times
Surface:
Bacteria and yeasts: 5 minutes
4.12.2. Use-specific risk mitigation measures
—
Ensure that the application is carried out in areas with a minimum ventilation of 5 air changes per hour. (N-29)
—
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
—
Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Not applicable
4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1. Instructions for use
See use specific instructions in the individual uses.
5.2. Risk mitigation measures
See specific risk mitigation measures in the individual use.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
Stability and Reactivity
Reactivity: No reactivity hazards known under normal storage and use conditions.
Chemical stability: Stable under normal storage and use conditions.
Possibility of hazardous reactions: No hazardous reactions known under normal storage and use conditions.
Conditions to avoid: None known under normal storage and use conditions.
Incompatible materials: None known under normal use conditions.
Hazardous decomposition products: None known under normal storage and use conditions.
Environmental precautions
The product shall not reach sewage water or drainage ditch undiluted or unneutralised.
Do not allow to enter drainage system, surface or groundwater. Dilute with plenty of water.
Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, universal binders, sawdust).
5.4. Instructions for safe disposal of the product and its packaging
Dispose according to national or local regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
36 months shelf life.
Store below 30 °C.
6. OTHER INFORMATION
The full titles of the EN standards referenced in sections ‘Use-specific risk mitigation measures’ are:
EN 374 – Protective gloves against dangerous chemicals and micro-organisms
EN 166 – Personal Eye Protection - Specifications
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ).
With respect to the ‘Category (ies) of users’ note: ‘Professionals (including industrial users)’ means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Suma Quicksan D4.3
Market area: EU
Suma Quicksan
Market area: EU
HORECA Select DESINFEKTIONSSPRAY
Market area: EU
Divodes FG
Market area: EU
Divodes FG VT 29
Market area: EU
ClearKlens Divodes FG
Market area: EU
ClearKlens FG
Market area: EU
DOMESTOS QuickGuard
Market area: EU
GLORIX QuickGuard
Market area: EU
KLINEX QuickGuard
Market area: EU
LYSOFORM QuickGuard
Market area: EU
SAVO QuickGuard
Market area: EU
CIF QuickGuard
Market area: EU
VISS QuickGuard
Market area: EU
JIF QuickGuard
Market area: EU
FLORASZEPT QuickGuard
Market area: EU
ANDY QuickGuard
Market area: EU
SUPERANDY QuickGuard
Market area: EU
ANDYSAN QuickGuard
Market area: EU
Authorisation number
EU-0034601-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-1-ol
Active substance
71-23-8
200-746-9
52,2 % (w/w)
Propan-2-ol
Active substance
67-63-0
200-661-7
17,5 % (w/w)
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
Identifier
Meta SPC: Meta 2: Divodes FG Wipes
1.2. Suffix to the authorisation number
Number
1-2
1.3. Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-1-ol
Active substance
71-23-8
200-746-9
52,2 - 52,2 % (w/w)
Propan-2-ol
Active substance
67-63-0
200-661-7
17,5 - 17,5 % (w/w)
2.2. Type(s) of formulation of the meta SPC 2
Formulation type(s)
Impregnated wipes
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements
H226: Flammable liquid and vapour.
H318: Causes serious eye damage.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye/face protection.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a poison centre or doctor/physician.
P312: Call a POISON CENTER if you feel unwell.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents a hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container a hazardous waste disposal service in accordance with the statutory regulations.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use # 1 – Small scale disinfection - Wipes - PT 2 Industrial and healthcare - Professional use
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Fungi
Common name: Viruses (limited spectrum virucidal activity)
Field(s) of use
indoor use
Ready to use wipe for clean hard non-porous surfaces in industrial areas (e.g. laboratories and cosmetics and pharmaceutical industries) and healthcare.
Application method(s)
Method: wiping
Detailed description:
Ready to use wipe for clean hard non-porous surfaces
Application rate(s) and frequency
Application Rate: For wipes with size 133 × 200 mm: use 1 wipe per m 2 ; For wipes with size 200 × 195 mm: use 1 wipe per 1,75 m 2 ; For wipes with size 200 × 390 mm: use 1 wipe per 2,5 m 2 No dilution required
Number and timing of application:
Use up to 20 times per day.
Use at room temperature.
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (snap top cap with/without Aluminium induction seal or PET induction seal) (PP): 150, 200, 500, 1 000 wipes
4.1.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Open the lid, take a single wipe, close the lid. Only use wet wipes. Wipe the surface and allow to take effect for the appropriate contact time (see contact times below). Make sure to wet the surface completely. Let air dry. No rinsing.
Contact times
Pre-cleaned surface:
Bacteria and yeasts: 30 seconds
Fungi and viruses (limited spectrum virucidal activity): 5 minutes
Pre-cleaned surface in cosmetic industry and healthcare:
Bacteria and yeasts: 30 seconds
Fungi and viruses (limited spectrum virucidal activity): 5 minutes
4.1.2. Use-specific risk mitigation measures
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
—
Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
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
Not applicable
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.2. Use description
Table 2
Use # 2 – Small scale disinfection - Wipes - PT 2 Institutional and public areas - Professional use
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Fungi
Common name: Viruses (limited spectrum virucidal activity)
Field(s) of use
indoor use
Ready to use wipe for clean hard non- porous surfaces in institutional (e.g. educational institutions) and public areas.
Application method(s)
Method: wiping
Detailed description:
Ready to use wipe for clean hard non-porous surfaces
Application rate(s) and frequency
Application Rate: For wipes with size 133 × 200 mm: use 1 wipe per m 2 ; For wipes with size 200 × 195 mm: use 1 wipe per 1,75 m 2 ; For wipes with size 200 × 390 mm: use 1 wipe per 2,5 m 2 No dilution required
Number and timing of application:
Use up to 10 times per day.
Use at room temperature.
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (snap top cap with/without Aluminium induction seal or PET induction seal) (PP): 150, 200, 500, 1 000 wipes
4.2.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Open the lid, take a single wipe, close the lid. Only use wet wipes. Wipe the surface and allow to take effect for the appropriate contact time (see contact times below). Make sure to wet the surface completely. Let air dry. No rinsing.
Contact times
Pre-cleaned surface:
Bacteria and yeasts: 30 seconds
Fungi and viruses (limited spectrum virucidal activity): 5 minutes
4.2.2. Use-specific risk mitigation measures
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
—
Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
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
Not applicable
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.3. Use description
Table 3
Use # 3 – Small scale disinfection - Wipes - PT 2 & PT 4 Institutional and public areas - General public (Non-professional use)
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Fungi
Common name: Viruses (limited spectrum virucidal activity for PT2)
Field(s) of use
indoor use
Ready to use wipe for clean hard non-porous surfaces in institutional (e.g. educational institutions) and public areas. Ready to use wipe for clean hard non-porous surfaces in kitchens and the food and beverage industry. Not for domestic use
Application method(s)
Method: wiping
Detailed description:
Ready to use wipe for clean hard non-porous surfaces.
Application rate(s) and frequency
Application Rate: For wipes with size 133 × 200 mm: use 1 wipe per m 2 .
For wipes with size 200 × 195 mm: use 1 wipe per 1,75 m 2 .
No dilution required
Number and timing of application:
Use up to 5 times per day.
Use at room temperature.
Category(ies) of users
general public (non-professional)
Pack sizes and packaging material
Rigid container (snap top cap with/without Aluminium induction seal or PET induction seal) (PP): 150, 200, 500, 1 000 wipes
4.3.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Open the lid, take a single wipe, close the lid. Only use wet wipes. Wipe the surface and allow to take effect for the appropriate contact time (see contact times below). Make sure to wet the surface completely. Let air dry. No rinsing.
Contact times
Pre-cleaned surface:
Bacteria and yeasts: 30 seconds
Fungi and viruses (limited spectrum virucidal activity): 5 minutes
Comply with the instructions for use. (N-359)
4.3.2. Use-specific risk mitigation measures
Do not touch treated surfaces until completely dry.
Avoid contact with eyes. (N-317)
Only to be used by adults. (N-327)
The product information (i.e. label and/or leaflet) shall clearly show that: the product shall not be supplied to the general public (e.g. ‘for professionals only’).
Keep out of reach of children and non-target animals/pets. (N-316)
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
If medical advice is needed, have product container or label at hand. (N-360)
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.4. Use description
Table 4
Use # 4 – Small scale disinfection - Wipes - PT 4 - Professional use
Product type
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Fungi
Common name: Viruses
Field(s) of use
indoor use
Ready to use wipe.
Application method(s)
Method: wiping
Detailed description:
Ready to use wipe for clean hard non-porous surfaces in kitchens and the food and beverage industry.
Application rate(s) and frequency
Application Rate: For wipes with size 133 × 200 mm: use 1 wipe per m 2 ; For wipes with size 200 × 195 mm: use 1 wipe per 1,75 m 2 ; For wipes with size 200 × 390 mm: use 1 wipe per 2,5 m 2 No dilution required
Number and timing of application:
Use up to 20 times per day.
Use at room temperature.
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (snap top cap with/without Aluminium induction seal or PET induction seal) (PP): 150, 200, 500, 1 000 wipes
4.4.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Open the lid, take a single wipe, close the lid. Only use wet wipes. Wipe the surface and allow to take effect for the appropriate contact time (see contact times below). Make sure to wet the surface completely. Let it air dry. No rinsing.
Contact times
Pre-cleaned surface in food and beverage industry at room temperature:
Bacteria and yeasts: 30 seconds
Fungi and viruses: 5 minutes
4.4.2. Use-specific risk mitigation measures
—
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
—
Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)
The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
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
Not applicable
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
4.5. Use description
Table 5
Use # 5 – Glove disinfection - PT 2 & PT 4 - Professional use
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Field(s) of use
indoor use
Ready to use wipe
Application method(s)
Method: wiping
Detailed description:
Ready to use wipe on clean non-porous gloves worn by professional workers in hospitals and other healthcare institutions, laboratories and the pharmaceutical, cosmetic, dairy, beverage and processed food industries.
Application rate(s) and frequency
Application Rate: 1 wipe (both hands) No dilution required
Number and timing of application:
Use up to 10 times per day.
Use at room temperature
Category(ies) of users
industrial
professional
Pack sizes and packaging material
Rigid container (snap top cap with/without Aluminium induction seal or PET induction seal) (PP): 150, 200, 500, 1 000 wipes
4.5.1. Use-specific instructions for use
Use only on clean non-porous gloves. Open the lid, take a single wipe, close the lid. Only use wet wipes. Wipe the gloves and allow to take effect for 30 seconds for bacteria and yeasts. Let it air dry. Make sure to wet the surface completely. No rinsing.
Do not use for disinfection of medical gloves falling under Regulation (EU) 2017/745
4.5.2. Use-specific risk mitigation measures
The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Not applicable
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Not applicable
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Not applicable
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1. Instructions for use
See use specific instructions in the individual use.
5.2. Risk mitigation measures
See specific risk mitigation measures in the individual use.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
Stability and Reactivity
Reactivity: No reactivity hazards known under normal storage and use conditions.
Chemical stability: Stable under normal storage and use conditions.
Possibility of hazardous reactions: No hazardous reactions known under normal storage and use conditions.
Conditions to avoid: Take action to prevent static discharges.
Incompatible materials: None known under normal use conditions.
Hazardous decomposition products: None known under normal storage and use conditions.
Environmental precautions
The product shall not reach sewage water or drainage ditch undiluted or unneutralised.
Do not allow to enter drainage system, surface or groundwater. Dilute with plenty of water.
Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, universal binders, sawdust).
5.4. Instructions for safe disposal of the product and its packaging
Dispose according to national or local regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
24 months shelf life. Store below 30 °C.
6. OTHER INFORMATION
The full titles of the EN standards referenced in sections ‘Use-specific risk mitigation measures’ are:
EN 374 – Protective gloves against dangerous chemicals and micro-organisms
EN 166 – Personal Eye Protection – Specifications
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ).
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ( OJ L 117, 5.5.2017, p. 1–175 ).
With respect to the ‘Category (ies) of users’ note: ‘Professionals (including industrial users)’ means trained professionals if this is required by national legislation.
For packaging containing:
—
500 - 1 000 wipes per container:
Wipe material: 100 % Polypropylene or 60 % Viscose/40 % Polypropylene
Wipe area/ pack: 39 m 2
Approximate volume of liquid/ wipe: 2,69 g/wipe (1 000 pc); 5,48 g/wipe (500 pc)
—
150 - 200 wipes per container:
Wipe material: 100 % Polypropylene or 60 % Viscose/40 % Polypropylene
Wipe area/ pack: 4 m 2 (150 pc); 5,3 m 2 (200 pc)
Approximate volume of liquid/ wipe: 2,27 g/wipe
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)
Divodes FG Wipes VT75
Market area: EU
Divodes FG Wipes
Market area: EU
Suma Disinfection Wipes
Market area: EU
Suma Disinfection Wipes XL
Market area: EU
Suma Disinfection Wipes XXL
Market area: EU
Suma Quicksan Wipes
Market area: EU
Suma Quicksan Wipes XL
Market area: EU
Suma Quicksan Wipes XXL
Market area: EU
DOMESTOS QuickGuard Wipes
Market area: EU
GLORIX QuickGuard Wipes
Market area: EU
KLINEX QuickGuard Wipes
Market area: EU
LYSOFORM QuickGuard Wipes
Market area: EU
SAVO QuickGuard Wipes
Market area: EU
CIF QuickGuard Wipes
Market area: EU
VISS QuickGuard Wipes
Market area: EU
JIF QuickGuard Wipes
Market area: EU
FLORASZEPT QuickGuard Wipes
Market area: EU
ANDY QuickGuard Wipes
Market area: EU
SUPERANDY QuickGuard Wipes
Market area: EU
ANDYSAN QuickGuard Wipes
Market area: EU
Authorisation number
EU-0034601-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-1-ol
Active substance
71-23-8
200-746-9
52,2 % (w/w)
Propan-2-ol
Active substance
67-63-0
200-661-7
17,5 % (w/w)