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 | PT03: Veterinary hygiene |
| 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: Manual dipping using a dip/foam cup (pre-milking disinfection) Detailed description: Pre-milking teat disinfection by manual dipping using a dip/foam cup. Contact time for dipping at 30oC in clean conditions: — 60 seconds for bacteria and yeasts. |
| Application rate(s) and frequency | Application rate: Application rate: 4 ml of product per application (i.e. 1 ml per teat therefore 4 ml product for animals with four teats) Dilution (%): RTU product Number and timing of application: Application frequency: up to twice per day |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Light precluding HDPE Jugs, 1-100 L Light precluding HDPE Jerry can, 1-100 L Light precluding HDPE IBC, 600-1000 L Light precluding HDPE Drum, 60-220 L Light precluding HDPE Bottle, 0,1-5 L Light precluding HDPE; PE Pouch, 0,5-100 L |
4.1.1. Use-specific instructions
See general directions for use of meta SPC 4.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 4.
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 4.
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 4.
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 4.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
5.1. Instructions for use
Always read the label or leaflet before use and follow all the instructions. The product should be applied pre-milking by use of a dipping or foam cup. The product must be brought to room temperature before use.
Clean teat with a dry wipe, fill foam cup with product and press foam cup until foam is generated. Dip teat into the cup. Apply foam for 60 seconds on the teat. Wipe the product away with a clean towel. Do not rinse after use.
5.2. Risk mitigation measures
Avoid splashes and spills.
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.
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: 0-25°C
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 4
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | OxyFoamPlus | OxyFoamPlus | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | MEPA Foampro D | MEPA Foampro D | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Predip PLUS | Predip PLUS | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0004 1-4 | EU-0024303-0004 1-4 | EU-0024303-0004 1-4 | ||
| Common name | UPAC 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 | 1,4 % (w/w) | |
| Citric acid monohydrate | 2-hydroxypropane -1,2,3-tricarboxylic acid | Non-Active substance | Non-Active substance | 5949-29-1 | 5949-29-1 | 201-069-1 | 0,9 % (w/w) |
| Phenoxyethanol | 2-Phenoxyethanol | Non-Active substance | Non-Active substance | 122-99-6 | 122-99-6 | 204-589-7 | 0,9 % (w/w) |
| Sodium lauryl Sulphate | Sodium dodecyl sulphate | Non-Active substance | Non-Active substance | 151-21-3 | 151-21-3 | 205-788-1 | 3,88 % (w/w) |
| L-Glutamic acid, N-coco acyl derivs., monosodium salts | Sodium;(4S)-4-amino-5-hydroxy-5-oxopentanoate | Non-Active substance | Non-Active substance | 68187-32-6 | 68187-32-6 | 269-087-2 | 2 % (w/w) |
| Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts (Texapon ALS) | Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts | Non-Active substance | Non-Active substance | 90583-11-2 | 90583-11-2 | 292-209-0 | 1,12 % (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 (%) |
|---|---|---|---|---|---|
| Hydrogen peroxide | active substance | 7722-84-1 | 231-765-0 | 1,5 - 1,5 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 5
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
| Hazard statements | |
| Precautionary statements |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Disinfection of life sciences cleanrooms by spraying using trigger sprayer and dry wipe
| 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: Mycobacteria Common name: Mycobacteria 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: 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: Spraying using trigger sprayer and dry wipe Detailed description: Disinfection of surfaces, materials and equipment in life sciences cleanrooms A - D and supporting environments (e.g. pharmaceutical industry). Transfer disinfection or disinfection of small surfaces. Contact times for spraying and wiping at 20oC in dirty conditions: — 1 minute for bacteria and yeasts; — 5 minutes for fungi and mycobacteria; — 60 minutes for bacterial spores; — 30 minutes for viruses. Contact times for spraying and wiping at 20oC in clean conditions: — 5 minutes for Clostridium difficile spores; — 30 minutes for bacterial spores. Contact times for spraying at 20oC in clean conditions: — 5 minutes for bacteria, yeasts and fungi; — 30 minutes for viruses and bacterial spores. |
| Application rate(s) and frequency | Application rate: Application rate: 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 Polyethylene terephthalate (PET) Spray bottle, 0.25-1 L Light precluding Polypropylene and Polyethylene (PP+PE) Spray bottle, 0.25-1 L Light precluding High Density Poly Ethylene (HDPE) or Poly Ethylene (PE) Bottle, 1-5 L |
4.1.1. Use-specific instructions
When used under clean conditions: clean surface before applying the product. For optimum results, hold the bottle upright and spray from a distance of 10 cm to 20 cm. Spray the product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray the product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 5.
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 5
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 5.
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 5
4.2. Use description
Table 2
Disinfection of life sciences cleanrooms by mopping using flat mop and bucket
| 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: Mycobacteria Common name: Mycobacteria 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: 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 |
| Application method(s) | Method: Mopping using a flat mop and bucket Detailed description: Disinfection of floors in life sciences cleanrooms and supporting environments (e.g. pharmaceutical industry). Contact times for mopping at 20oC in dirty conditions: — 1 minute for bacteria and yeasts; — 5 minutes for fungi and mycobacteria; — 60 minutes for bacterial spores; — 30 minutes for viruses. Contact times for mopping at 20oC in clean conditions: — 5 minutes for Clostridium difficile spores; — 30 minutes for bacterial spores. |
| Application rate(s) and frequency | Application rate: Application rate: 20 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 HDPE or PE Bottle, 1-5 L |
4.2.1. Use-specific instructions
When used under clean conditions: clean surface before applying the product. Apply to surfaces by mopping.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 5.
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 5
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 5
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 5
4.3. Use description
Table 3
Disinfection of small and/or large non-food contact surfaces in healthcare applications by spraying using trigger sprayer and dry wipe
| 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 |
| Field(s) of use | indoor use |
| Application method(s) | Method: Spraying using trigger spray and dry wipe Detailed description: Routine and non-routine disinfection of small and large surfaces in hospital rooms and medical practices. Contact times for spraying at 20oC in dirty conditions: — 1 minute for bacteria and yeasts; — 5 minutes for fungi; — 15 minutes for mycobacteria. |
| Application rate(s) and frequency | Application rate: Application rate: 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 Spray bottle, 0,25-1 L Light precluding HDPE Jerry can, 1-5 L |
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.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto the surface, then wipe surface with a clean, dry wipe and leave to dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
4.3.2. Use-specific risk mitigation measures
The area of the surfaces to be disinfected (in m2) must not be larger than 1/10 of the room volume (in m3) e.g. in a room of 120 m3 volume, the maximum surface to be disinfected is 12 m2.
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 5.
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 5.
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 5.
4.4. Use description
Table 4
Disinfection of small and/or large non-food contact surfaces in healthcare applications by spraying using trigger sprayer and dry wipe
| 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: Mycobacteria Common name: Mycobacteria 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: 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 |
| Application method(s) | Method: Spraying using trigger spray and dry wipe Detailed description: Routine and non-routine disinfection of small and large surfaces in hospital rooms and medical practices. Contact times for spraying and wiping at 20oC in dirty conditions: — 1 minute for bacteria and yeasts; — 5 minutes for fungi and mycobacteria; — 30 minutes for viruses. Contact times for spraying and wiping at 20oC in clean conditions: — 60 minutes for Clostridium difficile spores; — 60 minutes for bacterial spores. Contact times for spraying at 20oC in clean conditions: — 5 minutes for bacteria, yeasts and fungi; — 30 minutes for viruses; — 60 minutes for bacterial spores. |
| Application rate(s) and frequency | Application rate: Application rate: 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 HDPE Bottle, 1-5 L Light precluding PET Spray bottle, 0,25-1 L Light precluding HDPE Jerry can, 1-5 L |
4.4.1. 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.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product. For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray product onto the surface, then wipe surface with a clean, dry wipe and leave to dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
4.4.2. Use-specific risk mitigation measures
The area of the surface to be disinfected (in m2) must not be larger than 1/10 of the room volume (in m3) e.g. in a room of 120 m3 volume, the maximum surface to be disinfected is 12 m2.
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 5
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 5
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 5
4.5. Use description
Table 5
Disinfection of small and/or large non-food contact surfaces in healthcare applications by wiping using clean single-use cloth/wipe and bucket
| 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 |
| Field(s) of use | Indoor |
| Application method(s) | Method: Wiping using cloth/wipe and bucket Detailed description: Routine and non-routine disinfection of small and large surfaces in hospital rooms and medical practices. Contact times for wiping at 20oC in dirty conditions: — 1 minute for bacteria and yeasts; — 5 minutes for fungi; — 15 minutes for mycobacteria. |
| Application rate(s) and frequency | Application rate: Application rate: 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 HDPE Jerry can, 1-5 L |
4.5.1. 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.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. Pour product into a clean bucket and distribute across surface using single-use cloth/wipe and let air dry. Used wipes must be disposed of in a closed container.
4.5.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 5.
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 5.
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 5.
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 5.
4.6. Use description
Table 6
Disinfection of small and/or large non-food contact surfaces in healthcare applications by wiping using clean single-use cloth/wipe and bucket
| 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: Mycobacteria Common name: Mycobacteria 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: 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 |
| Application method(s) | Method: Wiping using cloth/wipe and bucket Detailed description: Routine and non-routine disinfection of small and large surfaces in hospital rooms and medical practices. Contact times for wiping at 20oC in dirty conditions: — 1 minute for bacteria and yeasts; — 5 minutes for fungi and mycobacteria ; — 30 minutes for viruses. Contact times for wiping at 20oC in clean conditions: — 60 minutes for Clostridium difficile spores; — 60 minutes for bacterial spores. |
| Application rate(s) and frequency | Application rate: Application rate: 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 HDPE Bottle, 1-5 L Light precluding HDPE Jerry can, 1-5 L |
4.6.1. 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.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product. Pour product into a clean bucket and distribute across surface using single-use cloth/wipe and let air dry. Used wipes must be disposed of in a closed container.
4.6.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 5.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 5
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 5.
4.6.5. 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 5
4.7. Use description
Table 7
Disinfection of large non-food contact surfaces in healthcare applications by mopping using mop and bucket
| 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: Mycobacteria Common name: Mycobacteria 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: 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: Mopping using mop and bucket Detailed description: Non-routine disinfection of larger surfaces in hospital room. Contact times for mopping at 20oC in dirty conditions: — 1 minute for bacteria and yeasts; — 5 minutes for fungi and mycobacteria; — 30 minutes for viruses. Contact times for mopping at 20oC in clean conditions: — 60 minutes for Clostridium difficile spores; — 60 minutes for bacterial spores. |
| Application rate(s) and frequency | Application rate: Application rate: 20 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 HDPE Bottle, 1-5 L Light precluding HDPE Jerry can, 1-5 L |
4.7.1. Use-specific instructions
Non routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product. Fill the bucket with ready to use product and distribute across floor using mop and let air dry.
4.7.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 5.
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 5
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 5
4.7.5. 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 5
4.8. Use description
Table 8
Disinfection of large non-food contact surfaces in healthcare applications by mopping using mop and bucket
| 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: Mycobacteria Common name: Mycobacteria 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: 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: Mopping using mop and bucket Detailed description: Non-routine disinfection of larger surfaces in medical practices. Contact times for mopping at 20oC in dirty conditions: — 1 minute for bacteria and yeasts; — 5 minutes for fungi and mycobacteria; — 30 minutes for viruses. Contact times for mopping at 20oC in clean conditions: — 60 minutes for Clostridium difficile spores; — 60 minutes for bacterial spores. |
| Application rate(s) and frequency | Application rate: Application rate: 20 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 HDPE Bottle, 1-5 L Light precluding HDPE Jerry can, 1-5 L |
4.8.1. Use-specific instructions
Non routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product. Fill the bucket with ready to use product and distribute across floor using mop, wipe the surface with a clean, dry mop and let air dry.
4.8.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 5.
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 5.
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 5
4.8.5. 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 5
4.9. Use description
Table 9
Disinfection of small and/or large non-food contact surfaces in healthcare applications by spraying the surface and then wiping with a clean cloth/wipe or spraying liquid onto a wipe and then wiping the surface, or by having the disinfectant in a bucket and wiping with a single-use clean cloth/wipe, and non-routine disinfection of larger surfaces by mopping using mop and bucket
| 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: Mycobacteria Common name: Mycobacteria 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: 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: Spraying using trigger sprayer and dry wipe and mopping using mop and bucket Detailed description: Non-routine disinfection of smaller and larger surfaces in hospital rooms and medical practices. Contact times for spraying and wiping, mopping at 20oC in dirty conditions: — 1 minute for bacteria and yeasts; — 5 minutes for fungi and mycobacteria; — 30 minutes for viruses. Contact times for spraying and wiping, mopping at 20oC in clean conditions: — 60 minutes for Clostridium difficile spores; — 60 minutes for bacterial spores. Contact times for spraying at 20oC in clean conditions: — 5 minutes for bacteria, yeasts and fungi; — 30 minutes for viruses; — 60 minutes for bacterial spores. Method: Wiping using cloth/wipe and bucket and mopping using mop and bucket Detailed description: Non-routine disinfection of smaller and larger surfaces in hospital rooms and medical practices. Contact times for wiping and mopping at 20oC in dirty conditions: — 1 minute for bacteria and yeasts; — 5 minutes for fungi and mycobacteria; — 30 minutes for viruses. Contact times for wiping and mopping at 20oC in clean conditions: — 60 minutes for Clostridium difficile spores; — 60 minutes for bacterial spores. |
| Application rate(s) and frequency | Application rate: Application rate for spraying: 10 ml/m2; Application rate for mopping: 20 ml/m2 Dilution (%): RTU product Number and timing of application: Application frequency for combined trigger spraying and mopping: up to twice per day per room Application rate: Application rate for wiping: 10 ml/m2; Application rate for mopping: 20 ml/m2 Dilution (%): RTU product Number and timing of application: Application frequency for combined wiping and mopping: up to twice per day per room |
| Category(ies) of users | professional |
| Pack sizes and packaging material | Light precluding HDPE Bottle, 1-5 L Light precluding PET Spray bottle, 0,25-1 L Light precluding HDPE Jerry can, 1-5 L |
4.9.1. Use-specific instructions
The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
Spraying using trigger sprayer and wiping using a dry wipe: For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray the product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
Mopping using mop and bucket: Fill the bucket with ready to use product and distribute across floor using mop, wipe the surface with a clean, dry mop and let air dry.
Wiping using cloth/wipe and bucket: Pour product into a clean bucket and distribute across surface using single-use cloth/wipe, wipe the surface with clean cloth/wipe and let air dry. Used wipes must be disposed of in a closed container.
4.9.2. Use-specific risk mitigation measures
For spraying: The area of the surfaces to be disinfected (in m2) must not be larger than 1/10 of the room volume (in m3) e.g. in a room of 120 m3 volume, the maximum surface to be disinfected is 12 m2.
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 5
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 5.
4.9.5. 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 5
4.10. Use description
Table 10
Disinfection of small non-food contact surfaces in institutional/commercial buildings by spraying using trigger sprayer and dry wipe
| 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: Mycobacteria Common name: Mycobacteria 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: 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: Spraying using trigger spray and dry wipe Detailed description: Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms). Contact times for spraying and wiping at 20oC in dirty conditions: — 1 minute for bacteria and yeasts; — 5 minutes for fungi and mycobacteria; — 60 minutes for bacterial spores; — 30 minutes for viruses. Contact times for spraying and wiping at 20oC in clean conditions: — 5 minutes for Clostridium difficile spores; — 30 minutes for bacterial spores. Contact times for spraying at 20oC in clean conditions: — 5 minutes for bacteria, yeasts and fungi; — 30 minutes for viruses and bacterial spores. |
| Application rate(s) and frequency | Application rate: 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 HDPE Bottle, 1-5 L Light precluding PET Spray bottle, 0,25-1 L |
4.10.1. Use-specific instructions
When used under clean conditions: clean surface before applying the product. For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray the product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
4.10.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 5.
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 5
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 5.
4.10.5. 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 5
4.11. Use description
Table 11
Disinfection of small food contact surfaces in institutional/commercial buildings by spraying using trigger sprayer and dry wipe
| 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: Mycobacteria Common name: Mycobacteria 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: 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: Spraying using trigger spray and dry wipe Detailed description: Routine disinfection of small surfaces in small food areas (e.g. kitchens). Contact times for spraying and wiping at 20oC in dirty conditions: — 1 minute for bacteria and yeasts; — 5 minutes for fungi and mycobacteria; — 60 minutes for bacterial spores; — 30 minutes for viruses. Contact times for spraying and wiping at 20oC in clean conditions: — 5 minutes for Clostridium difficile spores; — 30 minutes for bacterial spores. Contact times spraying at 20oC in clean conditions: — 5 minutes for bacteria, yeasts and fungi; — 30 minutes for viruses and bacterial spores. |
| Application rate(s) and frequency | Application rate: Application rate: 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 HDPE Bottle, 1-5 L Light precluding PET Spray bottle, 0,25-1 L |
4.11.1. Use-specific instructions
When used under clean conditions: clean surface before applying the product. For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray the product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
4.11.2. 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.
4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 5.
4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 5.
4.11.5. 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 5.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
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. Do not rinse after use. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass.
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 5
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Incidin OxyFoam | Incidin OxyFoam | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0005 1-5 | EU-0024303-0005 1-5 | EU-0024303-0005 1-5 | ||
| 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 OxyFoam S | Incidin OxyFoam S | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Klercide Sporicidal Enhanced Peroxide | Klercide Sporicidal Enhanced Peroxide | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | KitchenPro Oxy Foam S | KitchenPro Oxy Foam S | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Anios Low Peroxide IP sterile | Anios Low Peroxide IP sterile | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sirafan Oxy | Sirafan Oxy | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0006 1-5 | EU-0024303-0006 1-5 | EU-0024303-0006 1-5 | ||
| 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 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 (%) |
|---|---|---|---|---|---|
| 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 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. |
| 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 doctor. P310: Immediately call a POISON CENTER. 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 small surfaces in industry (e.g. dining areas, bathrooms) by spraying using trigger sprayer
| 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: Spraying using trigger sprayer and dry wipe Detailed description: Disinfection of small surfaces in industry (e.g. dining areas, bathrooms).Contact time for spraying at 10oC and 20oC in dirty conditions: — 5 minutes for bacteria and yeasts. Contact time for spraying at 10oC in clean conditions: — 1 minute for bacteria and yeasts. |
| Application rate(s) and frequency | Application rate: Application rate: 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 HDPE Container, 1-100 L Light precluding HDPE Jerry can, 1-100 L Light precluding HDPE IBC, 600-1000 L Light precluding HDPE Drum, 60-220 L Light precluding HDPE Bottle, 0,1-5 L Light precluding HDPE Spray bottle, up to 1 L |
4.1.1. Use-specific instructions
See general directions of use of meta SPC 6.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 6.
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 6.
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 6.
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 6.
4.2. Use description
Table 2
Disinfection of food contact surfaces in food and beverage industry by spraying using trigger sprayer
| 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: Spraying using trigger sprayer and dry wipe Detailed description: Disinfection of small surfaces in food processing plants. Contact time for spraying at 10oC and 20oC in dirty conditions: — 5 minutes for bacteria and yeasts. Contact time for spraying at 10oC in clean conditions: — 1 minute for bacteria and yeasts. |
| Application rate(s) and frequency | Application rate: Application rate: 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 HDPE Container, 1-100 L Light precluding HDPE Jerry can, 1-100 L Light precluding HDPE IBC, 600-1000 L Light precluding HDPE Drum, 60-220 L Light precluding HDPE Bottle, 0,1-5 L Light precluding HDPE Spray bottle, up to 1 L |
4.2.1. Use-specific instructions
See general directions for use of meta SPC 6.
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 6.
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 6.
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 6.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 6
5.1. Instructions for use
Always read the label or leaflet before use and follow all the instructions. When used under clean conditions: clean surface before applying the product. The product should be applied to a dry surface. For optimum results, hold the bottle upright and spray from a distance of 10 cm to 20 cm. Spray the product onto the surface, wipe the surface with a clean, dry wipe or let air dry. Always close the nozzle after use. Wet surface completely using the product. Do not rinse after use. 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
The use of eye protection while handling of the product is mandatory.
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: 24 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 6
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | OxyDes Rapid | OxyDes Rapid | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0007 1-6 | EU-0024303-0007 1-6 | EU-0024303-0007 1-6 | ||
| 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) |
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 (%) |
|---|---|---|---|---|---|
| Hydrogen peroxide | active substance | 7722-84-1 | 231-765-0 | 4,95 - 5,45 % (w/w) | |
| Capryleth-9 Carboxylic acid (mixture of alkyl ether carboxylic acid) | Poly(oxy-1,2-ethanediyl), .alpha.-(carboxymethyl)-.omega.-(octyloxy)- (4-11 EO) | Non-Active substance | 53563-70-5 | 2,15 - 2,15 % (w/w) | |
| Hexeth-4 Carboxylic Acid (mixture of alkyl ether carboxylic acid) | Poly(oxy-1,2-ethanediyl), .alpha.-(carboxymethyl)-.omega.-(hexyloxy)- (3 EO) | Non-Active substance | 105391-15-9 | 0,62 - 0,62 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 7
| Formulation type(s) | SL Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
| Hazard statements | H314: Causes severe skin burns and eye damage. |
| Precautionary statements | P260: Do not breathe spray. P260: Do not breathe vapours. P264: Wash hands thoroughly after handling. P280: Wear eye protection. P280: Wear face protection. P280: Wear protective gloves. P280: Wear protective clothing. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P310: Immediately call a POISON CENTER. P310: Immediately call a doctor. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P321: Specific treatment (see first aid instruction on this label). P363: Wash contaminated clothing before reuse. P405: Store locked up. 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 non-food contact surfaces in healthcare applications by mopping using flat mop and bucket
| 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: Mopping using flat mop and bucket Detailed description: Routine and non-routine disinfection of floors in hospital rooms and medical practices that are frequently touched by people and that are not frequently touched by people. Contact times for mopping at 20oC in clean conditions: — 5 minutes for bacteria and yeasts (10 % dilution); — 15 minutes for bacteria (7,5 % dilution). |
| Application rate(s) and frequency | Application rate: Application rate: 20 ml/m2 Dilution (%): Dilution (%): 7,5-10 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 HDPE Bottle, 0,5-5 L Light precluding HDPE Canister, 1-100 L Light precluding HDPE Pouch, 0,01-1 L Light precluding HDPE Jug, 0,5-5 L |
4.1.1. 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.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. Clean surface before applying the product. Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with clean, dry floor mop and let air dry. Do not rinse after use.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 7.
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 7.
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 7.
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 7.
4.2. Use description
Table 2
Disinfection of small and/or large non-food contact surfaces in institutional/commercial buildings by spraying using trigger sprayer and dry wipe and/or by mopping using flat mop and bucket
| 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: Spraying using trigger sprayer and dry wipe Detailed description: Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms). Contact times for spraying at 20oC in clean conditions: — 5 minutes for bacteria and yeasts (10 % dilution); — 15 minutes for bacteria (7,5 % dilution). Contact times for spraying at 20oC in dirty conditions: — 5 minutes for bacteria (10 % dilution); — 5 minutes for yeasts (15 % dilution); — 15 minutes for bacteria (7,5 % dilution). Method: Mopping using flat mop and bucket Detailed description: Routine disinfection of large surfaces in small non-food areas (e.g. bathrooms).Contact times for mopping at 20oC in clean conditions: — 5 minutes for bacteria and yeasts (10 % dilution); — 15 minutes for bacteria (7,5 % dilution). Method: Spraying using trigger sprayer and dry wipe and mopping using flat mop and bucket Detailed description: Routine disinfection of small and large surfaces in small non-food areas (e.g. bathrooms). Contact times for spraying and mopping at 20oC in clean conditions: — 5 minutes for bacteria and yeasts (10 % dilution); — 15 minutes for bacteria (7,5 % dilution).Contact times for spraying at 20oC in dirty conditions: — 5 minutes for bacteria (10 % dilution); — 5 minutes for yeasts (15 % dilution); — 15 minutes for bacteria (7,5 % dilution). |
| Application rate(s) and frequency | Application rate: Application rate for spraying: 10 ml/m2 Dilution (%): Dilution (%): 7,5-15 Number and timing of application: Application frequency for trigger spraying: up to 10 times per day per room Application rate: Application rate for mopping: 20 ml/m2 Dilution (%): Dilution (%): 7,5-10 Number and timing of application: Application frequency for mopping: up to twice per day per room Application rate: Application rate for spraying: 10 ml/m2; Application rate for mopping: 20 ml/m2 Dilution (%): Dilution (%): 7,5-15 Number and timing of application: Application frequency for combined trigger spraying and mopping: once per day per room. |
| Category(ies) of users | professional |
| Pack sizes and packaging material | Light precluding HDPE Bottle, 0,5-5 L Light precluding HDPE Canister, 1-100 L Light precluding HDPE Pouch, 0,01-1 L Light precluding HDPE jug, 0,5-5 L |
4.2.1. Use-specific instructions
Do not rinse after use.
Spraying: When used under clean conditions: clean surface before applying the product. For optimum results, hold the bottle upright and spray from a distance of 10 cm to 20 cm. Spray the diluted product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
Mopping: The product is intended for one-step cleaning and disinfection. Clean surface before applying the product. Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with clean, dry mop and let air dry.
4.2.2. Use-specific risk mitigation measures
Do not breathe vapours/spray.
For spraying: The area of the surfaces to be disinfected (in m2) must not be larger than 1/10 of the room volume (in m3) e.g. in a room of 120 m3 volume, the maximum surface to be disinfected is 12 m2.
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 7.
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 7.
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 7.
4.3. Use description
Table 3
Disinfection of large non-food contact surfaces in institutional/commercial buildings by mopping using flat mop and bucket
| 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: Mopping using flat mop and bucket Detailed description: Routine disinfection of large surfaces in large non-food areas. Contact time for mopping at 20oC in clean conditions: — 5 minutes for bacteria and yeasts (10 % dilution); — 15 minutes for bacteria (7,5 % dilution). |
| Application rate(s) and frequency | Application rate: Application rate: 20 ml/m2 Dilution (%): Dilution (%): 7,5-10 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 HDPE Bottle, 0,5-5 L Light precluding HDPE Canister, 1-100 L Light precluding HDPE Pouch, 0,01-1 L Light precluding HDPE Jug, 0,5-5 L |
4.3.1. Use-specific instructions
The product is intended for one-step cleaning and disinfection. Clean surface before applying the product. Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with a clean, dry floor mop and let air dry. Do not rinse after use.
4.3.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 7.
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
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