LegalizeCommission Implementing Regulation (EU) 2022/1423 of 22 July 2022 granting a Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’ (Text with EEA relevance)
| 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) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Fungi Common name: fungi Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data Scientific name: Bacterial spores Common name: Bacterial spores Development stage: no data Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: no data Scientific name: Mycobacteria Common name: Mycobacteria Development stage: no data |
| Field(s) of use | indoor use |
| Application method(s) | Method: Mopping using impregnated RTU mop wipes Detailed description: Disinfection of floors in life sciences cleanrooms and supporting environments (e.g. pharmaceutical industry).Contact times for wiping at 20oC in dirty conditions: — 5 minutes for bacteria, yeasts, fungi and mycobacteria; — 30 minutes for viruses; — 60 minutes for bacterial spores. Contact times for wiping at 20oC in clean conditions: — 5 minutes for Clostridium difficile spores; — 30 minutes for bacterial spores. |
| Application rate(s) and frequency | Application rate: 1 wipe per m2 (corresponding to 10 ml/m2) Dilution (%): RTU product Number and timing of application: Application frequency: up to twice per day per room |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Light precluding PET or PE Bucket with 10-5000 impregnated 45% polyester / 55% cellulose blend wipes (wipe size: 420x250 mm or 200x200 mm) Light precluding PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 45% polyester / 55% cellulose blend wipes (wipe size: 420x250 mm or 200x200 mm) |
4.2.1. Use-specific instructions
See general directions for use of meta SPC 11.
4.2.2. Use-specific risk mitigation measures
-
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 11.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 11.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use of meta SPC 11.
4.3. Use description
Table 3
Disinfection of small non-food contact surfaces in health care applications by wiping using impregnated RTU wipes
| 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) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: No data Scientific name: Fungi Common name: fungi Development stage: no data Scientific name: Mycobacteria Common name: Mycobacteria Development stage: no data Scientific name: Bacterial spores Common name: Bacterial spores Development stage: no data Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
| Field(s) of use | indoor use |
| Application method(s) | Method: Wiping using impregnated RTU wipes Detailed description: Routine disinfection of smaller surfaces in hospital rooms and medical practices that are not frequently touched by people. Contact times for wiping at 20oC in clean conditions: — 15 minutes for Clostridium difficile; — 30 minutes for bacterial spores, mycobacteria and viruses. Contact times for wiping at 20oC in dirty conditions: — 15 minutes for bacteria and yeasts; — 30 minutes for fungi, mycobacteria and viruses. |
| Application rate(s) and frequency | Application rate: 1 wipe per m2 (corresponding to 10 ml/m2) Dilution (%): RTU product Number and timing of application: Application frequency: up to twice per day per room |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Light precluding pre-printed pouch with 10-100 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm). Light precluding PET canister with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm). Light precluding PET bucket with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm). Light precluding PET pouch with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm). |
4.3.1. Use-specific instructions
Routine disinfection: Disinfection of surfaces, which might be contaminated with pathogens during medical or nursing processes, on a regular basis to reduce the risk of transmission of such organisms via surfaces.
4.3.2. Use-specific risk mitigation measures
-
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 11.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 11.
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use of meta SPC 11.
4.4. Use description
Table 4
Disinfection of small non-food contact surfaces in institutional/commercial buildings by wiping using impregnated RTU wipes
| 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) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: No data Scientific name: Fungi Common name: fungi Development stage: no data Scientific name: Mycobacteria Common name: Mycobacteria Development stage: no data Scientific name: Bacterial spores Common name: Bacterial spores Development stage: no data Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
| Field(s) of use | indoor use |
| Application method(s) | Method: Wiping using impregnated RTU wipes Detailed description: Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms). Contact times for wiping at 20oC in clean conditions: — 15 minutes for Clostridium difficile spores; — 30 minutes for bacterial spores, mycobacteria and viruses. Contact times for wiping at 20oC in dirty conditions: — 2 minutes for bacteria; — 15 minutes for yeasts; — 30 minutes for fungi, mycobacteria and viruses. |
| Application rate(s) and frequency | Application rate: Application rate: 1 wipe per m2 (corresponding to 10 ml/m2) Dilution (%): RTU product Number and timing of application: Application frequency: up to 10 times per day per room |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Light precluding pre-printed pouch with 10-100 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm). Light precluding PET canister with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm). Light precluding PET bucket with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm). Light precluding PET pouch with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm). |
4.4.1. Use-specific instructions
See general directions for use of meta SPC 11.
4.4.2. Use-specific risk mitigation measures
-
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 11.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 11.
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use of meta SPC 11.
4.5. Use description
Table 5
Disinfection of small food contact surfaces in institutional/commercial buildings by wiping using impregnated RTU wipes
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: No data Scientific name: Fungi Common name: fungi Development stage: no data Scientific name: Mycobacteria Common name: Mycobacteria Development stage: no data Scientific name: Bacterial spores Common name: Bacterial spores Development stage: no data Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
| Field(s) of use | indoor use |
| Application method(s) | Method: Wiping using impregnated RTU wipes Detailed description: Routine disinfection of small surfaces in small food areas (e.g. kitchens). Contact times for wiping at 20oC in clean conditions: — 15 minutes for Clostridium difficile spores; — 30 minutes for bacterial spores, mycobacteria and viruses. Contact time for wiping at 20oC in dirty conditions: — 2 minutes for bacteria; — 15 minutes for yeasts; — 30 minutes for fungi, mycobacteria and viruses. |
| Application rate(s) and frequency | Application rate: Application rate: 1 wipe per m2 (corresponding to 10 ml/m2) Dilution (%): RTU product Number and timing of application: Application frequency: up to 10 times per day per room |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Light precluding pre-printed pouch with 10-100 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm). Light precluding PET canister with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm). Light precluding PET bucket with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm). Light precluding PET pouch with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm). |
4.5.1. Use-specific instructions
See general directions for use of meta SPC 11.
4.5.2. Use-specific risk mitigation measures
Keep food, feed or beverages away from treated surface until dried. Do not use directly on or near food, feed or drinks.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 11.
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 11.
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use of meta SPC 11.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 11
5.1. Instructions for use
The product is intended for one-step cleaning and disinfection. Always read the label or leaflet before use and follow all the instructions. When used under clean conditions: clean surface before applying the product. Apply product to a dry surface. Wet surface completely using the product. Allow surface to air dry. Do not rinse after use. Close container when not in use. Do not use wipes which have become dehydrated. Dispose of the container when empty. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass. Used wipes must be disposed of in a closed container.
5.2. Risk mitigation measures
-
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
FIRST AID MEASURES
In case of eye contact: Rinse with plenty of water.
In case of skin contact: Rinse with plenty of water.
If swallowed: Rinse mouth. Seek medical attention if symptoms occur.
If inhaled: Seek medical attention if symptoms occur.
ENVIRONMENTAL EMERGENCY MEASURES
Do not allow contact with soil, surface or ground water.
Consider the provision of containment around storage vessels.
5.4. Instructions for safe disposal of the product and its packaging
Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.
Contaminated packaging: Dispose of container in accordance with national regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.
Storage temperature: 0-35 °C. Protect from frost.
Shelf life: 18 months
6. OTHER INFORMATION
The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Klerwipe Sporicidal Enhanced Peroxide | Klerwipe Sporicidal Enhanced Peroxide | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Anios Low Peroxide IP sterile wipes | Anios Low Peroxide IP sterile wipes | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0014 1-11 | EU-0024303-0014 1-11 | EU-0024303-0014 1-11 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Hydrogen peroxide | active substance | active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 1,5 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Incidin OxyWipe S | Incidin OxyWipe S | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | KitchenPro Oxy Wipes S | KitchenPro Oxy Wipes S | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sirafan Oxy Wipes | Sirafan Oxy Wipes | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0015 1-11 | EU-0024303-0015 1-11 | EU-0024303-0015 1-11 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 1,5 % (w/w) |
1. META SPC 12 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 12 identifier
| Identifier | Meta SPC: META SPC 12 |
1.2. Suffix to the authorisation number
| Number | 1-12 |
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 12 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 12
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Hydrogen peroxide | active substance | 7722-84-1 | 231-765-0 | 2 - 2,3 % (w/w) | |
| N-propanol | Propan-1-ol | Non-Active substance | 71-23-8 | 200-746-9 | 17,5 - 17,5 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 12
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12
| Hazard statements | H226: Flammable liquid and vapour. H318: Causes serious eye damage. |
| Precautionary statements | 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 ventilating equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P280: Wear eye protection. P280: Wear face protection. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. 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. P370+P378: In case of fire: Use water to extinguish. P403+P235: Store in a well-ventilated place. Keep cool. P501: Dispose of contents to in accordance with national regulations. P501: Dispose of container to in accordance with national regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Disinfection of surfaces in industry (e.g. dining areas, bathrooms) by wiping using impregnated RTU wipes
| 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) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data |
| Field(s) of use | indoor use |
| Application method(s) | Method: Wiping using impregnated RTU wipes Detailed description: Disinfection of surfaces in industry (e.g. dining areas, bathrooms). Contact time for wiping at 10oC and 20oC in dirty conditions: — 5 minutes for bacteria and yeasts. |
| Application rate(s) and frequency | Application rate: Application rate: 1 wipe per m2 (corresponding to 10 ml/m2) Dilution (%): RTU product Number and timing of application: Application frequency: up to 3 times per day |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Light precluding PP Bucket with 10-5000 impregnated non-woven, 100% polypropylene wipes (wipe size: 200x250 mm). Light precluding PE Pouch with 10-5000 impregnated non-woven, 100% polypropylene wipes (wipe size: 200x250 mm). |
4.1.1. Use-specific instructions
See general directions for use of meta SPC 12.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 12.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 12.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 12.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use of meta SPC 12.
4.2. Use description
Table 2
Disinfection of food contact surfaces in food and beverage industry by wiping using impregnated RTU wipes
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data |
| Field(s) of use | indoor use |
| Application method(s) | Method: Wiping using impregnated RTU wipes Detailed description: Disinfection of small surfaces in food processing plants. Contact time for wiping at 10oC and 20oC in dirty conditions: — 5 minutes for bacteria and yeasts. |
| Application rate(s) and frequency | Application rate: Application rate: 1 wipe per m2 (corresponding to 10 ml/m2) Dilution (%): RTU product Number and timing of application: Application frequency: up to 4 times per day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | Light precluding PP Bucket with 10-5000 impregnated non-woven, 100% polypropylene wipes (wipe size: 200x250 mm). Light precluding PE Pouch with 10-5000 impregnated non-woven, 100% polypropylene wipes (wipe size: 200x250 mm). |
4.2.1. Use-specific instructions
See general directions for use of meta SPC 12.
4.2.2. Use-specific risk mitigation measures
Keep food, feed or beverages away from treated surface until dried. Do not use directly on or near food, feed or drinks.
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 12.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 12.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use of meta SPC 12.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 12
5.1. Instructions for use
Always read the label or leaflet before use and follow all the instructions. The product should be applied to a dry surface. Wet surface completely using the product. Allow surface to air dry after using the product. Do not rinse after use. Close container when not in use. Do not use wipes which have become dehydrated. Dispose of the container when empty. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass. Used wipes must be disposed of in closed container.
5.2. Risk mitigation measures
Avoid hand to eye transfer.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
FIRST AID MEASURES
In case of eye contact: Rinse immediately with plenty of water, including under the eyelids, for at least 15 minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Seek medical attention immediately.
In case of skin contact: Rinse with plenty of water.
If swallowed: Rinse mouth. Seek medical attention if symptoms occur.
If inhaled: Remove person to fresh air. Treat symptomatically. Seek medical attention if symptoms occur.
ENVIRONMENTAL EMERGENCY MEASURES
Do not allow contact with soil, surface or ground water.
Consider the provision of containment around storage vessels
5.4. Instructions for safe disposal of the product and its packaging
Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.
Contaminated packaging: Dispose of container in accordance with national regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers. Keep away from heat and sources of ignition. Keep in a cool, well-ventilated place. Keep away from oxidizing agents.
Storage temperature: 0-30°C.
Shelf life: 12 months
6. OTHER INFORMATION
The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 12
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | OxyDes Maxi Wipes | OxyDes Maxi Wipes | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0016 1-12 | EU-0024303-0016 1-12 | EU-0024303-0016 1-12 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 2 % (w/w) | |
| N-propanol | Propan-1-ol | Non-Active substance | Non-Active substance | 71-23-8 | 71-23-8 | 200-746-9 | 17,5 % (w/w) |
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