Commission Implementing Regulation (EU) 2026/287 of 6 February 2026 granting a Union authorisation for the biocidal product family Divodes FG Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
A Union authorisation with authorisation number EU-0034601-0000 is hereby granted to Diversey Europe Operations B.V. for the making available on the market and use of the biocidal product family ‘Divodes FG Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 1 March 2026 until 29 February 2036.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Summary of product characteristics for a biocidal product family
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)
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