LegalizeCommission 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
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
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 m2/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 m2.
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 m2/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 m2.
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/m3 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) | Trade name(s) | Trade name(s) | Bacillol pure Tissues | Bacillol pure Tissues | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0034602-0006 1-5 | EU-0034602-0006 1-5 | EU-0034602-0006 1-5 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-1-ol | Active substance | Active substance | 71-23-8 | 71-23-8 | 200-746-9 | 30 % (w/w) | |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 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/m2; Industrial area: 18 - 50 ml/m2. 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/m2) on the surface.
Spraying (500 – 1000ml bottle): 15 pump strokes per m2.
Spraying (50ml bottle): 12 pump strokes per 0,1m2.
For industrial area:
Pouring: Invert the bottle and pour (8 - 22 sec/m2) on the surface.
Spraying (500 – 1000ml bottle): 15 - 41 pump strokes per m2.
Spraying (50ml bottle): at least 12 pump strokes per 0,1m2.
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/m2. 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/m2) 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/m2; Industrial area: 18 - 50 ml/m2. 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/m2) on the surface.
Spraying (500 – 1000ml bottle): 15 pump strokes per m2.
Spraying (50ml bottle): 12 pump strokes per 0,1m2.
For industrial area:
Pouring: Invert the bottle and pour (8 - 22 sec/m2) on the surface.
Spraying (500 – 1000ml bottle): 15 - 41 pump strokes per m2.
Spraying (50ml bottle): at least 12 pump strokes per 0,1m2.
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/m2 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/m2) 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/m3 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) | Trade name(s) | Trade name(s) | Bacillol AF pro | Bacillol AF pro | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0034602-0007 1-6 | EU-0034602-0007 1-6 | EU-0034602-0007 1-6 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-1-ol | Active substance | Active substance | 71-23-8 | 71-23-8 | 200-746-9 | 45 % (w/w) | |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 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 m2/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 m2.
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 m2/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 m2.
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 m2/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 m2.
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 m2/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 m2.
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/m3 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) | Trade name(s) | Trade name(s) | Bacillol AF pro Tissues | Bacillol AF pro Tissues | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0034602-0008 1-7 | EU-0034602-0008 1-7 | EU-0034602-0008 1-7 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-1-ol | Active substance | Active substance | 71-23-8 | 71-23-8 | 200-746-9 | 45 % (w/w) | |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 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/m2; Industrial area: 18 - 50 ml/m2. 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/m2) on the surface.
Spraying (500 – 1000ml bottle): 15 pump strokes per m2.
Spraying (50ml bottle): 12 pump strokes per 0,1m2.
For industrial area:
Pouring: Invert the bottle and pour (8 - 22 sec/m2) on the surface.
Spraying (500 – 1000ml bottle): 15 - 41 pump strokes per m2.
Spraying (50ml bottle): at least 12 pump strokes per 0,1m2.
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/m2 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/m2) 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/m2; Industrial area: 18 - 50 ml/m2 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/m2) on the surface.
Spraying (500 – 1000ml bottle): 15 pump strokes per m2.
Spraying (50ml bottle): 12 pump strokes per 0,1m2.
For industrial area:
Pouring: Invert the bottle and pour (8 - 22 sec/m2) on the surface.
Spraying (500 – 1000ml bottle): 15 - 41 pump strokes per m2.
Spraying (50ml bottle): at least 12 pump strokes per 0,1m2.
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/m2. 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/m2) 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/m3 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) | Trade name(s) | Trade name(s) | Bacillol AF classic | Bacillol AF classic | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0034602-0009 1-8 | EU-0034602-0009 1-8 | EU-0034602-0009 1-8 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-1-ol | Active substance | Active substance | 71-23-8 | 71-23-8 | 200-746-9 | 45 % (w/w) | |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 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 m2/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 m2.
Bacillol AF classic Tissues: Use 2 - 3 wipes per m2.
Bacillol classic Wipes: Use ca. 1 wipe per m2.
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 m2/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 m2.
Bacillol AF classic Tissues: Use 2 - 3 wipes per m2.
Bacillol classic Wipes: Use ca. 1 wipe per m2.
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 m2/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 m2.
Bacillol AF classic Tissues: Use 2 - 3 wipes per m2.
Bacillol classic Wipes: Use ca. 1 wipe per m2.
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 m2/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 m2.
Bacillol AF classic Tissues: Use 2 - 3 wipes per m2.
Bacillol classic Wipes: Use ca. 1 wipe per m2.
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
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