Commission Implementing Regulation (EU) 2025/1878 of 16 September 2025 granting a Union authorisation for the biocidal product family BPF Propanol in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Summary of product characteristics for a biocidal product family

ANNEXSupplementary provisions

ANNEX Summary of product characteristics for a biocidal product family BPF Propanol Product type(s) PT01: Human hygiene PT04: Food and feed area PT02: Disinfectants and algaecides not intended for direct application to humans or animals Authorisation number EU-0034602-0000 R4BP asset number EU-0034602-0000 PART I FIRST INFORMATION LEVEL 1. ADMINISTRATIVE INFORMATION 1.1. Family name Name BPF Propanol 1.2. Product type(s) Product type(s) PT01: Human hygiene PT04: Food and feed area PT02: Disinfectants and algaecides not intended for direct application to humans or animals 1.3. Authorisation holder Name and address of the authorisation holder Name BODE Chemie GmbH Address Melanchthonstr. 27 22525 Hamburg DE Authorisation number EU-0034602-0000 R4BP asset number EU-0034602-0000 Date of the authorisation 7 October 2025 Expiry date of the authorisation 30 September 2035 1.4. Manufacturer(s) of the product Name of manufacturer Bode Chemie GmbH Address of manufacturer Melanchthonstrasse 27 22525 Hamburg Germany Location of manufacturing sites BODE Chemie GmbH site 1 Melanchthonstraße 27 22525 Hamburg Germany 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-2-ol Name of manufacturer INEOS Solvents Germany GmbH Address of manufacturer Römerstr. 733 47443 Moers Germany Location of manufacturing sites INEOS Solvents Germany GmbH site 1 Römerstr. 733 47443 Moers Germany 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 30 - 45 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 25 - 45 % (w/w) 1-Tetradecanol - Non-active substance 112-72-1 204-000-3 0 - 1 % (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 SPC 1 1.2. Suffix to the authorisation number Number 1-1 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 30 - 30 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 45 - 45 % (w/w) 1-Tetradecanol - Non-active substance 112-72-1 204-000-3 0,25 - 1 % (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. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H412: Harmful to aquatic life with long lasting effects. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear eye protection. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a doctor if you feel unwell. P312: Call a POISON CENTER if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local/ regional/national/international regulations. P501: Dispose of container in accordance with local/ regional/national/international regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Hygienic handrub, PT1, professional and industrial user - meta SPC 1 Product type PT01: Human hygiene Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hygienic handrub for use in industrial, institutional, health care and domestic areas. Application method(s) Method: Hygienic handrub Detailed description: Application rate(s) and frequency Application Rate: 3 ml per application Number and timing of application: Product is used as required which may be multiple times per day (frequency: 25 per day) Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 30 seconds Limited spectrum virucidal activity – 60 seconds Category(ies) of users industrial professional Pack sizes and packaging material HDPE bottle 50 - 1000 ml HDPE container 5 l 4.1.1. Use-specific instructions for use Rub 3 ml into the dry and visibly clean hands and keep moist for the required contact time. 4.1.2. Use-specific risk mitigation measures The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied: The use of eye protection during refilling of the application bottles is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.2. Use description Table 2 Hygienic handrub, PT1, general public - meta SPC 1 Product type PT01: Human hygiene Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hygienic handrub for use in institutional, health care and domestic areas. Application method(s) Method: Hygienic handrub Detailed description: Application rate(s) and frequency Application Rate: 3 ml (the amount of liquid should resemble the size of a large-sized coin) Number and timing of application: Product is used as required, for adults and children older than 2 years up to 10 times per day, for toddlers up to 8 times per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 30 seconds Limited spectrum virucidal activity – 60 seconds Category(ies) of users general public (non-professional) Pack sizes and packaging material HDPE bottle 50 - 1000 ml 4.2.1. Use-specific instructions for use Comply with the instructions for use. Rub 3 ml into the dry and visibly clean hands and keep moist for the required contact time. 4.2.2. Use-specific risk mitigation measures Do not use more than the specified number of applications per day The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Use for children only under supervision of an adult. Apply the amount for the child/toddler on your own hand first and rub the product on child’s/toddler’s hand. Make sure that the child/toddler does not touch eyes or mouth before the product has dried. Avoid contact with eyes. Avoid unnecessary contact to skin. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.3. Use description Table 3 Surgical hand disinfection / residential bacterial skin flora, PT1, professional user - meta SPC 1 Product type PT01: Human hygiene Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Field(s) of use indoor use Surgical hand disinfection / resident bacterial skin flora. The product is a ready-to-use alcoholic disinfectant for use in health care areas / hospital sector. Application method(s) Method: Surgical handrub Detailed description: Application rate(s) and frequency Application Rate: 2 times 3 ml per application Number and timing of application: Product is used as required which may be multiple times per day (frequency: 4 times per day). Contact time: 90 seconds Category(ies) of users professional Pack sizes and packaging material HDPE bottle 50 - 1000 ml HDPE container 5 l 4.3.1. Use-specific instructions for use Rub 2 times 3 ml into dry and visibly clean hands and forearms for 1,5 minutes, keeping the skin moist during the application time. Any decanting or refilling may only be carried out under aseptic conditions. 4.3.2. Use-specific risk mitigation measures The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied: The use of eye protection during refilling of the application bottles is mandatory. Eye protection according to the European Standard EN ISO16321-1 or equivalent. 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1. Instructions for use see use-specific instructions 5.2. Risk mitigation measures Keep out of reach of children and pets or non-target animals. Ensure adequate ventilation during the application. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTER or a doctor. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTER or a doctor. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. 5.4. Instructions for safe disposal of the product and its packaging Avoid release to the environment. Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 36 months. Store at temperatures not exceeding 40 °C. Protect from direct light. 6. OTHER INFORMATION Please be aware of the European reference values of 129,28 mg/m 3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product. The full title of the EN standard referenced in the Risk mitigation measures are: the European Standard EN ISO 16321 - Eye and face protection for occupational use. 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) Sterillium pure Market area: EU Authorisation number EU-0034602-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 30 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 45 % (w/w) 1-Tetradecanol - Non-active substance 112-72-1 204-000-3 0,95 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Sterillium classic blue Market area: EU Authorisation number EU-0034602-0002 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 30 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 45 % (w/w) 1-Tetradecanol - Non-active substance 112-72-1 204-000-3 0,95 % (w/w) 1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier Meta SPC: meta SPC 2 1.2. Suffix to the authorisation number Number 1-2 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 30 - 30 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 45 - 45 % (w/w) 2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements H226: Flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a doctor if you feel unwell. P312: Call a POISON CENTER if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local/ regional/national/international regulations. P501: Dispose of container in accordance with local/ regional/national/international regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Hygienic handrub, PT1, professional and industrial user - meta SPC 2 Product type PT01: Human hygiene Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hygienic handrub for use in industrial, institutional, health care and domestic areas. Application method(s) Method: Hygienic handrub Detailed description: Application rate(s) and frequency Application Rate: 3 ml per application Number and timing of application: Product is used as required which may be multiple times per day (frequency: 25 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 30 seconds Limited spectrum virucidal activity – 60 seconds Category(ies) of users industrial professional Pack sizes and packaging material HDPE bottle 50 - 1000 ml HDPE container 5 l 4.1.1. Use-specific instructions for use Rub 3 ml into the dry and visibly clean hands and keep moist for the required contact time. 4.1.2. Use-specific risk mitigation measures The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied: The use of eye protection during refilling of the application bottles is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.2. Use description Table 2 Hygienic handrub, PT1, general public - meta SPC 2 Product type PT01: Human hygiene Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hygienic handrub for use in institutional, health care and domestic areas. Application method(s) Method: Hygienic handrub Detailed description: Application rate(s) and frequency Application Rate: 3 ml (the amount of liquid should resemble the size of a large-sized coin) Number and timing of application: Product is used as required, for adults and children older than 2 years up to 10 times per day, for toddlers up to 8 times per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 30 seconds Limited spectrum virucidal activity – 60 seconds Category(ies) of users general public (non-professional) Pack sizes and packaging material HDPE bottle 50 - 1000 ml 4.2.1. Use-specific instructions for use Comply with the instructions for use. Rub 3 ml into the dry and visibly clean hands and keep moist for the required contact time. 4.2.2. Use-specific risk mitigation measures Do not use more than the specified number of applications per day. The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Use for children only under supervision of an adult. Apply the amount for the child/toddler on your own hand first and rub the product on child’s/toddler’s hand. Make sure that the child/toddler does not touch eyes or mouth before the product has dried. Avoid contact with eyes. Avoid unnecessary contact to skin. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.3. Use description Table 3 Surgical hand disinfection / residential bacterial skin flora, PT1, professional user Product type PT01: Human hygiene Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Field(s) of use indoor use Surgical hand disinfection / resident bacterial skin flora. The product is a ready-to-use alcoholic disinfectant for use in health care areas / hospital sector. Application method(s) Method: surgical handrub Detailed description: Application rate(s) and frequency Application Rate: 2 times 3 ml per application Number and timing of application: Product is used as required which may be multiple times per a day (frequency: 4 per day). Contact time: 90 seconds Category(ies) of users professional Pack sizes and packaging material HDPE bottle 50 - 1000 ml HDPE container 5 l 4.3.1. Use-specific instructions for use Rub 2 times 3 ml into dry and visibly clean hands and forearms for 1.5 minutes, keeping the skin moist during the application time. Any decanting or refilling may only be carried out under aseptic conditions. 4.3.2. Use-specific risk mitigation measures The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied: The use of eye protection during refilling of the application bottles is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent. 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1. Instructions for use see use-specific instructions for use 5.2. Risk mitigation measures Keep out of reach of children and pets or non-target animals. Ensure adequate ventilation during the application. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. 5.4. Instructions for safe disposal of the product and its packaging Avoid release to the environment. Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 36 months Store at temperatures not exceeding 40 °C. Protect from direct light. 6. OTHER INFORMATION Please be aware of the European reference values of 129,28 mg/m 3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product. The full title of the EN standard referenced in the Risk mitigation measures are: the European Standard EN ISO 16321 - Eye and face protection for occupational use. With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Sterillium pure IPM Market area: EU Authorisation number EU-0034602-0003 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 30 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 45 % (w/w) 1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifier Meta SPC: meta SPC 3 1.2. Suffix to the authorisation number Number 1-3 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 3 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 3 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 30 - 30 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 45 - 45 % (w/w) 2.2. Type(s) of formulation of the meta SPC 3 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements H226: Flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of container in accordance with local/ regional/national/international regulations. P501: Dispose of contents in accordance with local/ regional/national/international regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Hygienic handrub, PT1, professional and industrial user Product type PT01: Human hygiene Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hygienic handrub for use in industrial, institutional, health care and domestic areas. Application method(s) Method: Hygienic handrub Detailed description: Application rate(s) and frequency Application Rate: 3 ml per application Number and timing of application: Product is used as required which may be multiple times per day (frequency: 25 per day). Contact time: 30 seconds Category(ies) of users industrial professional Pack sizes and packaging material HDPE bottle 50 - 1000 ml HDPE bottle 35 - 100 ml HDPE container 5 l 4.1.1. Use-specific instructions for use Rub 3 ml into the dry and visibly clean hands and keep moist for the required contact time. 4.1.2. Use-specific risk mitigation measures The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied: The use of eye protection during refilling of the application bottles is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.2. Use description Table 2 Hygienic handrub, PT1, general public Product type PT01: Human hygiene Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hygienic handrub for use in institutional, health care and domestic areas. Application method(s) Method: Hygienic handrub Detailed description: Application rate(s) and frequency Application Rate: 3 ml (the amount of liquid should resemble the size of a large-sized coin) Number and timing of application: Product is used as required, for adults and children older than 2 years up to 10 times per day, for toddlers up to 8 times per day. Contact time: 30 seconds Category(ies) of users general public (non-professional) Pack sizes and packaging material HDPE bottle 50 - 1000 ml HDPE bottle 35 - 100 ml 4.2.1. Use-specific instructions for use Comply with the instructions for use. Rub 3 ml into the dry and visibly clean hands and keep moist for the required contact time. 4.2.2. Use-specific risk mitigation measures Do not use more than the specified number of applications per day. The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Use for children only under supervision of an adult. Apply the amount for the child/toddler on your own hand first and rub the product on child’s/toddler’s hand. Make sure that the child/toddler does not touch eyes or mouth before the product has dried. Avoid contact with eyes. Avoid unnecessary contact to skin. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.3. Use description Table 3 Surgical hand disinfection / residential bacterial skin flora, PT1, professional user Product type PT01: Human hygiene Target organism(s) (including development stage) Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Enveloped viruses Field(s) of use indoor use Surgical hand disinfection / resident bacterial skin flora. The product is a ready-to-use alcoholic disinfectant for use in health care areas / hospital sector. Application method(s) Method: surgical handrub Detailed description: Application rate(s) and frequency Application Rate: At least 3 ml per application Number and timing of application: Product is used as required which may be multiple times per day (frequency: 4 per day). Contact time: 90 seconds Category(ies) of users professional Pack sizes and packaging material HDPE bottle 35 - 100 ml HDPE bottle 50 - 1000 ml HDPE container 5 l 4.3.1. Use-specific instructions for use Rub at least 3 ml into dry and visibly clean hands and forearms for 1,5 minutes, keeping the skin moist during the application time. Any decanting or refilling may only be carried out under aseptic conditions. 4.3.2. Use-specific risk mitigation measures The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied: The use of eye protection during refilling of the application bottles is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent. 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3 5.1. Instructions for use see use-specific instructions for use 5.2. Risk mitigation measures Keep out of reach of children and pets or non-target animals. Ensure adequate ventilation during the application. Make sure that product is applied and completely dried before entering the room or area where people will stay for a longer period. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. 5.4. Instructions for safe disposal of the product and its packaging Avoid release to the environment. Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 36 months. Store at temperatures not exceeding 40 °C. 6. OTHER INFORMATION Please be aware of the European reference values of 129,28 mg/m 3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product. The full title of the EN standard referenced in the Risk mitigation measures are: the European Standard EN ISO 16321 - Eye and face protection for occupational use. With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Sterillium Gel PRO Market area: EU Authorisation number EU-0034602-0004 1-3 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 30 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 45 % (w/w) 1. META SPC 4 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 4 identifier Identifier Meta SPC: meta SPC 4 1.2. Suffix to the authorisation number Number 1-4 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 4 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 4 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 30 - 30 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 45 - 45 % (w/w) 2.2. Type(s) of formulation of the meta SPC 4 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 Hazard statements H226: Flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye 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. P312: Call a doctor if you feel unwell. P312: Call a POISON CENTER if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of container in accordance with local/ regional/national/international regulations. P501: Dispose of contents in accordance with local/ regional/national/international regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Small surface disinfection, PT2, professional and industrial user - meta SPC 4 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: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in industrial, institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area. Application method(s) Method: Spraying or pouring followed by wiping Detailed description: Application rate(s) and frequency Application Rate: Institutional, health care and domestic area: 18 ml/m 2 ; Industrial area: 18 - 50 ml/m 2 . Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes Category(ies) of users industrial professional Pack sizes and packaging material HDPE bottle 50 - 1000 ml HDPE container 5 l 4.1.1. Use-specific instructions for use For institutional, health care and domestic area: Pouring: Invert the bottle and pour (8 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 pump strokes per m 2 . Spraying (50ml bottle): 12 pump strokes per 0,1m 2 . For industrial area: Pouring: Invert the bottle and pour (8 - 22 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 - 41 pump strokes per m 2 . Spraying (50ml bottle): at least 12 pump strokes per 0,1m 2 . 4.1.2. Use-specific risk mitigation measures The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied: The use of eye protection during refilling of the application bottles of the product is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.2. Use description Table 2 Small surface disinfection, PT2, general public - meta SPC 4 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: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area. Application method(s) Method: Spraying or pouring followed by wiping Detailed description: Application rate(s) and frequency Application Rate: 18 ml/m 2 . Number and timing of application: maximum 5 applications per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes Category(ies) of users general public (non-professional) Pack sizes and packaging material HDPE bottle 50 - 1000 ml 4.2.1. Use-specific instructions for use Comply with the instructions for use. Pouring: Invert the bottle and pour (8 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 pump strokes per m 2 . Spraying (50ml bottle): 12 pump strokes per 0,1m 2 . 4.2.2. Use-specific risk mitigation measures The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Avoid contact with eyes. Avoid unnecessary contact to skin. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.3. Use description Table 3 Small surface disinfection, PT4, professional and industrial user - meta SPC 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: Mycobacteria Common name: Viruses Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in industrial, institutional, health care and domestic area. Application method(s) Method: Spraying or pouring followed by wiping Detailed description: Application rate(s) and frequency Application Rate: Institutional, health care and domestic area: 18ml/m 2 ; Industrial area: 18 - 50 ml/m 2 . Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes Category(ies) of users industrial professional Pack sizes and packaging material HDPE bottle 50 - 1000 ml HDPE container 5 l 4.3.1. Use-specific instructions for use For institutional, health care and domestic area: Pouring: Invert the bottle and pour (8 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 pump strokes per m 2 . Spraying (50ml bottle): 12 pump strokes per 0,1m 2 . For industrial area: Pouring: Invert the bottle and pour (8 - 22 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 - 41 pump strokes per m 2 . Spraying (50ml bottle): at least 12 pump strokes per 0,1m 2 . 4.3.2. Use-specific risk mitigation measures The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied: The use of eye protection during refilling of the application bottles of the product is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent. 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.4. Use description Table 4 Small surface disinfection, PT4, general public - meta SPC 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: Mycobacteria Common name: Viruses Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in institutional, health care and domestic area. Application method(s) Method: Spraying or pouring followed by wiping Detailed description: Application rate(s) and frequency Application Rate: 18 ml/m 2 Number and timing of application: maximum 1 application per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes Category(ies) of users general public (non-professional) Pack sizes and packaging material HDPE bottle 50 - 1000 ml 4.4.1. Use-specific instructions for use Comply with the instructions for use. Pouring: Invert the bottle and pour (8 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 pump strokes per m 2 . Spraying (50ml bottle): 12 pump strokes per 0,1m 2 . 4.4.2. Use-specific risk mitigation measures The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Avoid contact with eyes. Avoid unnecessary contact to skin. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4 5.1. Instructions for use Spray or pour a sufficient amount of the product on the surface to be disinfected, if needed wipe to ensure complete coverage and allow to act for the required contact time. For use at room temperature. 5.2. Risk mitigation measures Ensure adequate ventilation (e. g. by opening windows or by mechanical ventilation) during application. In small rooms avoid presence of toddlers and pets for 15 min before re-entry. Keep out of reach of children and non-target animals or pets. Used wipes must be disposed in a closed container. 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 SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTER or a doctor. 5.4. Instructions for safe disposal of the product and its packaging Avoid release to the environment. Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 36 months. Store at temperatures not exceeding 40 °C. 6. OTHER INFORMATION Please be aware of the European reference values of 129,28 mg/m 3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product. The full title of the EN standard referenced in the Risk mitigation measures are: the European Standard EN ISO 16321 - Eye and face protection for occupational use. With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Bacillol pure Market area: EU Authorisation number EU-0034602-0005 1-4 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 30 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 45 % (w/w) 1. META SPC 5 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 5 identifier Identifier Meta SPC: meta SPC 5 1.2. Suffix to the authorisation number Number 1-5 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 5 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 5 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 30 - 30 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 45 - 45 % (w/w) 2.2. Type(s) of formulation of the meta SPC 5 Formulation type(s) XX Impregnated wipes 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 Hazard statements H226: Flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye 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. P312: Call a doctor if you feel unwell. P312: Call a POISON CENTER if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local/ regional/national/international regulations. P501: Dispose of container in accordance with local/ regional/national/international regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Small surface disinfection, PT2, professional and industrial user - meta SPC 5 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: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in industrial, institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area. Application method(s) Method: Wiping Detailed description: Application rate(s) and frequency Application Rate: 0,2 - 0,5 m 2 /wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes Category(ies) of users industrial professional Pack sizes and packaging material PET tissues/wipes in a PET/PE flowpack or PET/PE sachet. 4.1.1. Use-specific instructions for use Wipe the surface with a tissue/wipe ensuring the complete coverage with the product. Use 2 - 3 wipes per m 2 . 4.1.2. Use-specific risk mitigation measures see general section 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.2. Use description Table 2 Small surface disinfection, PT2, general public - meta SPC 5 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: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area. Application method(s) Method: Wiping Detailed description: Application rate(s) and frequency Application Rate: 0,2 - 0,5 m 2 /wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: maximum 5 applications per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes Category(ies) of users general public (non-professional) Pack sizes and packaging material PET tissues/wipes in a PET/PE flowpack or PET/PE sachet. 4.2.1. Use-specific instructions for use Comply with the instructions for use. Wipe the surface with a tissue/wipe ensuring the complete coverage with the product. Use 2 - 3 wipes per m 2 . 4.2.2. Use-specific risk mitigation measures The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Provide adequate ventilation (e.g. by opening windows or by mechanical ventilation) for 15 min before re-entry. Avoid contact with eyes. Avoid unnecessary contact to skin. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.3. Use description Table 3 Small surface disinfection, PT4, professional and industrial user - meta SPC 5 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: Mycobacteria Common name: Viruses Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in industrial, institutional, health care and domestic area. Application method(s) Method: Wiping Detailed description: Application rate(s) and frequency Application Rate: 0,2 - 0,5 m 2 /wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes Category(ies) of users industrial professional Pack sizes and packaging material PET tissues/wipes in a PET/PE flowpack or PET/PE sachet. 4.3.1. Use-specific instructions for use Wipe the surface with a tissue/wipe ensuring the complete coverage with the product. Use 2 - 3 wipes per m 2 . 4.3.2. Use-specific risk mitigation measures see general section 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.4. Use description Table 4 Small surface disinfection, PT4, general public - meta SPC 5 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: Mycobacteria Common name: Viruses Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in institutional, health care and domestic area. Application method(s) Method: Wiping Detailed description: Application rate(s) and frequency Application Rate: 0,2 - 0,5 m 2 /wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: maximum 1 application per day Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes Category(ies) of users general public (non-professional) Pack sizes and packaging material PET tissues/wipes in a PET/PE flowpack or PET/PE sachet. 4.4.1. Use-specific instructions for use Comply with the instructions for use. Wipe the surface with a tissue/wipe ensuring the complete coverage with the product. Use 2 - 3 wipes per m 2 . 4.4.2. Use-specific risk mitigation measures The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Avoid contact with eyes. Avoid unnecessary contact to skin. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5 5.1. Instructions for use Wipe the surface with a tissue/wipe ensuring the complete coverage with the product and allow to act for the required contact time. Dispose tissue after use. Only use wet wipes. For use at room temperature. Close the package after opening. 5.2. Risk mitigation measures Used wipes must be disposed in a closed container. Ensure adequate ventilation (e. g. by opening windows or by mechanical ventilation) during application. In small rooms avoid presence of toddlers and pets for 15 min before re-entry. Keep out of reach of children and non-target animals or pets. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. 5.4. Instructions for safe disposal of the product and its packaging Avoid release to the environment. Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 36 months Store at temperatures not exceeding 40 °C. 6. OTHER INFORMATION Please be aware of the European reference values of 129,28 mg/m 3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product. With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Bacillol pure Tissues Market area: EU Authorisation number EU-0034602-0006 1-5 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 30 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 45 % (w/w) 1. META SPC 6 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 6 identifier Identifier Meta SPC: meta SPC 6 1.2. Suffix to the authorisation number Number 1-6 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 6 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 6 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 45 - 45 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 25 - 25 % (w/w) 2.2. Type(s) of formulation of the meta SPC 6 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6 Hazard statements 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. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye 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 CENTER. P310: Immediately call a doctor. P312: Call a doctor if you feel unwell. P312: Call a POISON CENTER if you feel unwell. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of container in accordance with local/ regional/national/international regulations. P501: Dispose of contents in accordance with local/ regional/national/international regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Small surface disinfection, PT2, professional and industrial user - meta SPC 6 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: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in industrial, institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area. Application method(s) Method: Spraying or pouring followed by wiping Detailed description: Application rate(s) and frequency Application Rate: Institutional, health care and domestic area: 18 ml/m 2 ; Industrial area: 18 - 50 ml/m 2 . Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes Category(ies) of users industrial professional Pack sizes and packaging material HDPE bottle 50 - 1000 ml HDPE container 5 l 4.1.1. Use-specific instructions for use Spray or pour a sufficient amount of the product on the surface to be disinfected, if needed wipe to ensure complete coverage and allow to act for the required contact time. For institutional, health care and domestic area: Pouring: Invert the bottle and pour (8 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 pump strokes per m 2 . Spraying (50ml bottle): 12 pump strokes per 0,1m 2 . For industrial area: Pouring: Invert the bottle and pour (8 - 22 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 - 41 pump strokes per m 2 . Spraying (50ml bottle): at least 12 pump strokes per 0,1m 2 . 4.1.2. Use-specific risk mitigation measures The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied: The use of eye protection during refilling of the application bottles and handling of the product is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.2. Use description Table 2 Small surface disinfection, PT2, general public - meta SPC 6 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: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area. Application method(s) Method: Pouring followed by wiping Detailed description: Application rate(s) and frequency Application Rate: 18 ml/m 2 . Number and timing of application: maximum 5 applications per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes Category(ies) of users general public (non-professional) Pack sizes and packaging material HDPE bottle 50 - 1000 ml 4.2.1. Use-specific instructions for use Pour a sufficient amount of the product on the surface to be disinfected, if needed wipe to ensure complete coverage and allow to act for the required contact time. Pouring: Invert the bottle and pour (8 sec/m 2 ) on the surface. Comply with the instructions for use. 4.2.2. Use-specific risk mitigation measures The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Avoid contact with eyes. Avoid unnecessary contact to skin. Avoid splashes. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.3. Use description Table 3 Small surface disinfection, PT4, professional and industrial user - meta SPC 6 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: Mycobacteria Common name: Viruses Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in industrial, institutional, health care and domestic area. Application method(s) Method: Spraying or pouring followed by wiping Detailed description: Application rate(s) and frequency Application Rate: Institutional, health care and domestic area: 18ml/m 2 ; Industrial area: 18 - 50 ml/m 2 . Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes Category(ies) of users industrial professional Pack sizes and packaging material HDPE bottle 50 - 1000 ml HDPE container 5 l 4.3.1. Use-specific instructions for use Spray or pour a sufficient amount of the product on the surface to be disinfected, if needed wipe to ensure complete coverage and allow to act for the required contact time. For institutional, health care and domestic area: Pouring: Invert the bottle and pour (8 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 pump strokes per m 2 . Spraying (50ml bottle): 12 pump strokes per 0,1m 2 . For industrial area: Pouring: Invert the bottle and pour (8 - 22 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 - 41 pump strokes per m 2 . Spraying (50ml bottle): at least 12 pump strokes per 0,1m 2 . 4.3.2. Use-specific risk mitigation measures The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied: The use of eye protection during refilling of the application bottles and handling of the product is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent. 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.4. Use description Table 4 Small surface disinfection, PT4, general public - meta SPC 6 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: Mycobacteria Common name: Viruses Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in institutional, health care and domestic area. Application method(s) Method: Pouring followed by wiping Detailed description: Application rate(s) and frequency Application Rate: 18 ml/m 2 Number and timing of application: maximum 1 application per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes Category(ies) of users general public (non-professional) Pack sizes and packaging material HDPE bottle 50 - 1000 ml 4.4.1. Use-specific instructions for use Pour a sufficient amount of the product on the surface to be disinfected, if needed wipe to ensure complete coverage and allow to act for the required contact time. Comply with the instructions for use. Pouring: Invert the bottle and pour (8 sec/m 2 ) on the surface. 4.4.2. Use-specific risk mitigation measures The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Avoid contact with eyes. Avoid unnecessary contact to skin. Avoid splashes. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 6 5.1. Instructions for use For use at room temperature. 5.2. Risk mitigation measures Ensure adequate ventilation (e. g. by opening windows or by mechanical ventilation) during application. In small rooms avoid presence of toddlers and pets for 15 min before re-entry. Keep out of reach of children and non-target animals or pets. Used wipes must be disposed in a closed container. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. 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 or an ambulance for medical assistance. Information to Healthcare personnel or doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. 5.4. Instructions for safe disposal of the product and its packaging Avoid release to the environment. Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 36 months Store at temperatures not exceeding 40 °C. 6. OTHER INFORMATION Please be aware of the European reference values of 129,28 mg/m 3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product. The full title of the EN standard referenced in the Risk mitigation measures are: the European Standard EN ISO 16321 - Eye and face protection for occupational use. With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Bacillol AF pro Market area: EU Authorisation number EU-0034602-0007 1-6 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 45 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 25 % (w/w) 1. META SPC 7 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 7 identifier Identifier Meta SPC: meta SPC 7 1.2. Suffix to the authorisation number Number 1-7 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 7 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 7 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 45 - 45 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 25 - 25 % (w/w) 2.2. Type(s) of formulation of the meta SPC 7 Formulation type(s) XX Impregnated wipes 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7 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. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye 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 doctor. P312: Call a doctor if you feel unwell. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local/ regional/national/international regulations. P501: Dispose of container in accordance with local/ regional/national/international regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Small surface disinfection, PT2, professional and industrial user - meta SPC 7 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: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in industrial, institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area. Application method(s) Method: Wiping Detailed description: Application rate(s) and frequency Application Rate: 0,2 - 0,5 m 2 /wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes Category(ies) of users industrial professional Pack sizes and packaging material PET tissues/wipes in PET/PE flowpack or PET/PE sachet 4.1.1. Use-specific instructions for use Wipe the surface with a tissue/wipe ensuring the complete coverage with the product. Use 2 - 3 wipes per m 2 . 4.1.2. Use-specific risk mitigation measures see general section 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.2. Use description Table 2 Small surface disinfection, PT2, general public - meta SPC 7 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: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area. Application method(s) Method: Wiping Detailed description: Application rate(s) and frequency Application Rate: 0,2 - 0,5 m 2 /wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: maximum 5 applications per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes Category(ies) of users general public (non-professional) Pack sizes and packaging material PET tissues/wipes in PET/PE flowpack or PET/PE sachet 4.2.1. Use-specific instructions for use Comply with the instructions for use. Wipe the surface with a tissue/wipe ensuring the complete coverage with the product. Use 2 - 3 wipes per m 2 . 4.2.2. Use-specific risk mitigation measures The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Avoid contact with eyes. Avoid unnecessary contact to skin. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.3. Use description Table 3 Small surface disinfection, PT4, professional and industrial user - meta SPC 7 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: Mycobacteria Common name: Viruses Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in industrial, institutional, health care and domestic area. Application method(s) Method: Wiping Detailed description: Application rate(s) and frequency Application Rate: 0,2 - 0,5 m 2 /wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes Category(ies) of users industrial professional Pack sizes and packaging material PET tissues/wipes in PET/PE flowpack or PET/PE sachet 4.3.1. Use-specific instructions for use Wipe the surface with a tissue/wipe ensuring the complete coverage with the product. Use 2 - 3 wipes per m 2 . 4.3.2. Use-specific risk mitigation measures see general section 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.4. Use description Table 4 Small surface disinfection, PT4, general public - meta SPC 7 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: Mycobacteria Common name: Viruses Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in institutional, health care and domestic area. Application method(s) Method: Wiping Detailed description: Application rate(s) and frequency Application Rate: 0,2 - 0,5 m 2 /wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: maximum 1 application per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes Category(ies) of users general public (non-professional) Pack sizes and packaging material PET tissues/wipes in PET/PE flowpack or PET/PE sachet 4.4.1. Use-specific instructions for use Comply with the instructions for use. Wipe the surface with a tissue/wipe ensuring the complete coverage with the product. Use 2 - 3 wipes per m 2 . 4.4.2. Use-specific risk mitigation measures The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Avoid contact with eyes. Avoid unnecessary contact to skin. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 7 5.1. Instructions for use Wipe the surface with a tissue/wipe ensuring the complete coverage with the product and allow to act for the required contact time. Dispose tissue after use. Only use wet wipes. For use at room temperature. Close the package after opening. 5.2. Risk mitigation measures Ensure adequate ventilation (e. g. by opening windows or by mechanical ventilation) during application. In small rooms avoid presence of toddlers and pets for 15 min before re-entry. Keep out of reach of children and non-target animals or pets. Used wipes must be disposed in a closed container. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: 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 or an ambulance for medical assistance. Information to Healthcare personnel or doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid 5.4. Instructions for safe disposal of the product and its packaging Avoid release to the environment. Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 36 months. Store at temperatures not exceeding 40 °C. 6. OTHER INFORMATION Please be aware of the European reference values of 129,28 mg/m 3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product. With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Bacillol AF pro Tissues Market area: EU Authorisation number EU-0034602-0008 1-7 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 45 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 25 % (w/w) 1. META SPC 8 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 8 identifier Identifier Meta SPC: meta SPC 8 1.2. Suffix to the authorisation number Number 1-8 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 8 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 8 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 45 - 45 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 25 - 25 % (w/w) 2.2. Type(s) of formulation of the meta SPC 8 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8 Hazard statements 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. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye 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 doctor. P312: Call a doctor if you feel unwell. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local/ regional/national/international regulations. P501: Dispose of container in accordance with local/ regional/national/international regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Small surface disinfection, PT2, professional and industrial user - meta SPC 8 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: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in industrial, institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area. Application method(s) Method: Spraying or pouring followed by wiping Detailed description: Application rate(s) and frequency Application Rate: Institutional, health care and domestic area: 18 ml/m 2 ; Industrial area: 18 - 50 ml/m 2 . Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes Category(ies) of users industrial professional Pack sizes and packaging material HDPE bottle 50 - 1000 ml HDPE container 5 l 4.1.1. Use-specific instructions for use Spray or pour a sufficient amount of the product on the surface to be disinfected, if needed wipe to ensure complete coverage and allow to act for the required contact time. For use at room temperature. For institutional, health care and domestic area: Pouring: Invert the bottle and pour (8 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 pump strokes per m 2 . Spraying (50ml bottle): 12 pump strokes per 0,1m 2 . For industrial area: Pouring: Invert the bottle and pour (8 - 22 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 - 41 pump strokes per m 2 . Spraying (50ml bottle): at least 12 pump strokes per 0,1m 2 . 4.1.2. Use-specific risk mitigation measures The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied: The use of eye protection during refilling of the application bottles and handling of the product is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.2. Use description Table 2 Small surface disinfection, PT2, general public - meta SPC 8 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: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area. Application method(s) Method: Pouring followed by wiping Detailed description: Application rate(s) and frequency Application Rate: 18 ml/m 2 Number and timing of application: maximum 5 applications per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes Category(ies) of users general public (non-professional) Pack sizes and packaging material HDPE bottle 50 - 1000 ml 4.2.1. Use-specific instructions for use Pour a sufficient amount of the product on the surface to be disinfected, if needed wipe to ensure complete coverage and allow to act for the required contact time. Pouring: Invert the bottle and pour (8 sec/m 2 ) on the surface. For use at room temperature. Comply with the instructions for use. 4.2.2. Use-specific risk mitigation measures The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Avoid contact with eyes. Avoid unnecessary contact to skin. Avoid splashes. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.3. Use description Table 3 Small surface disinfection, PT4, professional and industrial user - meta SPC 8 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: Mycobacteria Common name: Viruses Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in industrial, institutional, health care and domestic area. Application method(s) Method: Spraying or pouring followed by wiping Detailed description: Application rate(s) and frequency Application Rate: Institutional, health care and domestic area: 18ml/m 2 ; Industrial area: 18 - 50 ml/m 2 Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes Category(ies) of users industrial professional Pack sizes and packaging material HDPE bottle 50 - 1000 ml HDPE container 5 l 4.3.1. Use-specific instructions for use Spray or pour a sufficient amount of the product on the surface to be disinfected, if needed wipe to ensure complete coverage and allow to act for the required contact time. For bactericidal and yeasticidal efficacy: For use at 4°C up to room temperature. For efficacy against other target organisms: For use at room temperature. For institutional, health care and domestic area: Pouring: Invert the bottle and pour (8 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 pump strokes per m 2 . Spraying (50ml bottle): 12 pump strokes per 0,1m 2 . For industrial area: Pouring: Invert the bottle and pour (8 - 22 sec/m 2 ) on the surface. Spraying (500 – 1000ml bottle): 15 - 41 pump strokes per m 2 . Spraying (50ml bottle): at least 12 pump strokes per 0,1m 2 . 4.3.2. Use-specific risk mitigation measures The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied: The use of eye protection during refilling of the application bottles and handling of the product is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent. 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.4. Use description Table 4 Small surface disinfection, PT4, general public - meta SPC 8 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: Mycobacteria Common name: Viruses Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in institutional, health care and domestic area. Application method(s) Method: Pouring followed by wiping Detailed description: Application rate(s) and frequency Application Rate: 18 ml/m 2 . Number and timing of application: maximum 1 application per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes Category(ies) of users general public (non-professional) Pack sizes and packaging material HDPE bottle 50 - 1000 ml 4.4.1. Use-specific instructions for use Pour a sufficient amount of the product on the surface to be disinfected, if needed wipe to ensure complete coverage and allow to act for the required contact time. For bactericidal and yeasticidal efficacy: For use at 4°C up to room temperature. For efficacy against other target organisms: For use at room temperature. Comply with the instructions for use. Pouring: Invert the bottle and pour (8 sec/m 2 ) on the surface. 4.4.2. Use-specific risk mitigation measures The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Avoid contact with eyes. Avoid unnecessary contact to skin. Avoid splashes. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 8 5.1. Instructions for use 5.2. Risk mitigation measures Ensure adequate ventilation (e. g. by opening windows or by mechanical ventilation) during application. In small rooms avoid presence of toddlers and pets for 15 min before re-entry. Keep out of reach of children and non-target animals or pets. Used wipes must be disposed in a closed container. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: 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 or an ambulance for medical assistance. Information to Healthcare personnel or doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. 5.4. Instructions for safe disposal of the product and its packaging Avoid release to the environment. Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 36 months Store at temperatures not exceeding 40 °C. 6. OTHER INFORMATION Please be aware of the European reference values of 129,28 mg/m 3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product. The full title of the EN standard referenced in the Risk mitigation measures are: the European Standard EN ISO 16321 - Eye and face protection for occupational use. With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Bacillol AF classic Market area: EU Authorisation number EU-0034602-0009 1-8 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 45 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 25 % (w/w) 1. META SPC 9 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 9 identifier Identifier Meta SPC: meta SPC 9 1.2. Suffix to the authorisation number Number 1-9 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 9 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 9 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 45 - 45 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 25 - 25 % (w/w) 2.2. Type(s) of formulation of the meta SPC 9 Formulation type(s) XX Impregnated wipes 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9 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. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye 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 doctor. P310: Immediately call a POISON CENTER. P312: Call a doctor if you feel unwell. P312: Call a POISON CENTER if you feel unwell. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local/ regional/national/international regulations. P501: Dispose of container in accordance with local/ regional/national/international regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Small surface disinfection, PT2, professional and industrial user - meta SPC 9 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: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in industrial, institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area. Application method(s) Method: Wiping Detailed description: Application rate(s) and frequency Application Rate: 0,2 - 0,5 m 2 /wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: 1) For Bacillol AF classic Tissues and Bacillol classic Wipes: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes 2) For Bacillol classic Tissues: 5 minutes, with 2 tissues one above the other Category(ies) of users industrial professional Pack sizes and packaging material PET tissues/wipes in PET/PE flowpack or PET/PE sachet PET/Cellulose tissues/wipes in HDPE dispenser or PET/PE sachet 4.1.1. Use-specific instructions for use For use at room temperature. Wipe the surface with a tissue/wipe ensuring the complete coverage with the product. Bacillol classic Tissues: Use 5 - 8 wipes per m 2 . Bacillol AF classic Tissues: Use 2 - 3 wipes per m 2 . Bacillol classic Wipes: Use ca. 1 wipe per m 2 . 4.1.2. Use-specific risk mitigation measures see general section 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.2. Use description Table 2 Small surface disinfection, PT2, general public - meta SPC 9 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: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area. Application method(s) Method: Wiping Detailed description: Application rate(s) and frequency Application Rate: 0,2 - 0,5 m 2 /wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: maximum 5 applications per day. Contact times: 1) For Bacillol AF classic Tissues and Bacillol classic Wipes: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes 2) For Bacillol classic Tissues: 5 minutes, with 2 tissues one above the other Category(ies) of users general public (non-professional) Pack sizes and packaging material PET tissues/wipes in PET/PE flowpack or PET/PE sachet PET/Cellulose tissues/wipes in HDPE dispenser or PET/PE sachet 4.2.1. Use-specific instructions for use For use at room temperature. Comply with the instructions for use. Wipe the surface with a tissue/wipe ensuring the complete coverage with the product. Bacillol classic Tissues: Use 5 - 8 wipe per m 2 . Bacillol AF classic Tissues: Use 2 - 3 wipes per m 2 . Bacillol classic Wipes: Use ca. 1 wipe per m 2 . 4.2.2. Use-specific risk mitigation measures The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Avoid contact with eyes. Avoid unnecessary contact to skin. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.3. Use description Table 3 Small surface disinfection, PT4, professional and industrial user - meta SPC 9 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: Mycobacteria Common name: Viruses Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in industrial, institutional, health care and domestic area. Application method(s) Method: Wiping Detailed description: Application rate(s) and frequency Application Rate: 0,2 - 0,5 m 2 /wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: 1) For Bacillol AF classic Tissues and Bacillol classic Wipes: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes 2) For Bacillol classic Tissues: 5 minutes, with 2 tissues one above the other Category(ies) of users industrial professional Pack sizes and packaging material PET tissues/wipes in PET/PE flowpack or PET/PE sachet PET/Cellulose tissues/wipes in HDPE dispenser or PET/PE sachet 4.3.1. Use-specific instructions for use For bactericidal and yeasticidal efficacy: For use at 4°C up to room temperature. For efficacy against other target organisms: For use at room temperature. Wipe the surface with a tissue/wipe ensuring the complete coverage with the product. Bacillol classic Tissues: Use 5 - 8 wipes per m 2 . Bacillol AF classic Tissues: Use 2 - 3 wipes per m 2 . Bacillol classic Wipes: Use ca. 1 wipe per m 2 . 4.3.2. Use-specific risk mitigation measures see general section 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment see general section 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 4.4. Use description Table 4 Small surface disinfection, PT4, general public - meta SPC 9 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: Mycobacteria Common name: Viruses Common name: Enveloped viruses Field(s) of use indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in institutional, health care and domestic area. Application method(s) Method: Wiping Detailed description: Application rate(s) and frequency Application Rate: 0,2 - 0,5 m 2 /wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: maximum 1 application per day. Contact times: 1) For Bacillol AF classic Tissues and Bacillol classic Wipes: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes 2) For Bacillol classic Tissues: 5 minutes, with 2 tissues one above the other Category(ies) of users general public (non-professional) Pack sizes and packaging material PET tissues/wipes in PET/PE flowpack or PET/PE sachet PET/Cellulose tissues/wipes in HDPE dispenser or PET/PE sachet 4.4.1. Use-specific instructions for use For bactericidal and yeasticidal efficacy: For use at 4°C up to room temperature. For efficacy against other target organisms: For use at room temperature. Comply with the instructions for use. Wipe the surface with a tissue/wipe ensuring the complete coverage with the product. Bacillol classic Tissues: Use 5 - 8 wipes per m 2 . Bacillol AF classic Tissues: Use 2 - 3 wipes per m 2 . Bacillol classic Wipes: Use ca. 1 wipe per m 2 . 4.4.2. Use-specific risk mitigation measures The authorisation holder shall specify the application rate in a simple, easily understandable form on the label. Avoid contact with eyes. Avoid unnecessary contact to skin. In case of skin dryness, use appropriate skin care lotion. 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 If medical advice is needed, have product container or label at hand. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general section 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage see general section 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 9 5.1. Instructions for use Wipe the surface with a tissue/wipe ensuring the complete coverage with the product and allow to act for the required contact time. Only use wet wipes. Close the package after opening. 5.2. Risk mitigation measures Ensure adequate ventilation (e. g. by opening windows or by mechanical ventilation) during application. In small rooms avoid presence of toddlers and pets for 15 min before re-entry. Keep out of reach of children and non-target animals or pets. Used wipes must be disposed in a closed container. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. 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 or an ambulance for medical assistance. Information to Healthcare personnel or doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. 5.4. Instructions for safe disposal of the product and its packaging Avoid release to the environment. Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 36 months Store at temperatures not exceeding 40 °C. 6. OTHER INFORMATION Please be aware of the European reference values of 129,28 mg/m 3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product. With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Bacillol AF classic Tissues Market area: EU Authorisation number EU-0034602-0010 1-9 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 45 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 25 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Bacillol classic Tissues Market area: EU Authorisation number EU-0034602-0011 1-9 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 45 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 25 % (w/w) 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Bacillol classic Wipes Market area: EU Authorisation number EU-0034602-0012 1-9 Common name IUPAC name Function CAS number EC number Content (%) Propan-1-ol Active substance 71-23-8 200-746-9 45 % (w/w) Propan-2-ol Active substance 67-63-0 200-661-7 25 % (w/w)

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Article 2

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