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)
See general directions for use of meta SPC 7.
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 7.
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 7.
4.4. Use description
Table 4
Disinfection of large non-food contact surfaces in institutional/commercial buildings by spraying using wall- mounted device
| 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 with a wall-mounted device Detailed description: Routine disinfection of large surfaces in large non-food and food areas. 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). |
| Application rate(s) and frequency | Application rate: Application rate: 180 ml/m2 Dilution (%): 7,5-15 Number and timing of application: Application frequency: 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 |
4.4.1. Use-specific instructions
Apply product via wall-mounted device. When used under clean conditions: clean surface before applying the product. Rinse after application.
4.4.2. Use-specific risk mitigation measures
Do not breathe vapours/spray.
Ensure technical ventilation with at least 15 air exchanges/hour.
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 7.
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 7.
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 7.
4.5. Use description
Table 5
Disinfection of large food contact surfaces in institutional/commercial buildings 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: Routine disinfection of large surfaces in large food areas (e.g. kitchens). Contact time for spraying at 20oC in clean conditions: — 5 minutes for bacteria and yeasts (10 % dilution);w — 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: 10 ml/m2 Dilution (%): 7,5-15 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 |
4.5.1. 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 diluted product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Do not rinse after use. Used wipes must be disposed of in a closed container.
4.5.2. Use-specific risk mitigation measures
Do not breathe vapours/spray.
Keep food, feed or beverages away from treated surfaces until dried. Do not use directly on or near food, feed or drinks.
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.
4.5.3. 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 7.
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 7.
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 7.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 7
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 use on surfaces sensitive to oxidative agents such as marble, copper or brass.
Dilution instruction (7,5%): to produce 1 L of diluted surface disinfectant, add 75 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 L with distilled water or water of equal quality.
Dilution instruction (10%): to produce 1 L of diluted surface disinfectant, add 100 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 L with distilled water or water of equal quality.
Dilution instruction (15%): to produce 1 L of diluted surface disinfectant, add 150 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 L with distilled water or water of equal quality.
5.2. Risk mitigation measures
Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).
The use of eye protection while handling 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: Wash off immediately with plenty of water for at least 15 minutes. Use a mild soap if available. Wash clothing before reuse. Thoroughly clean shoes before reuse. Seek medical attention immediately.
If swallowed: Rinse mouth with water. Do NOT induce vomiting. Never give anything by mouth to an unconscious person. Seek medical attention immediately.
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.
Storage temperature: 0-25 °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 7
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Incidin OxyConcentrate | Incidin OxyConcentrate | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | UltraSan Floor | UltraSan Floor | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0008 1-7 | EU-0024303-0008 1-7 | EU-0024303-0008 1-7 | ||
| 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 | 4,95 % (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 | Non-Active substance | 53563-70-5 | 53563-70-5 | 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 | Non-Active substance | 105391-15-9 | 105391-15-9 | 0,62 % (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) | KitchenPro Oxy Des Super Concentrate | KitchenPro Oxy Des Super Concentrate | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Incidin OxyConcentrate FF | Incidin OxyConcentrate FF | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | CidalSan Large Area | CidalSan Large Area | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0009 1-7 | EU-0024303-0009 1-7 | EU-0024303-0009 1-7 | ||
| 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 | 4,95 % (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 | Non-Active substance | 53563-70-5 | 53563-70-5 | 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 | Non-Active substance | 105391-15-9 | 105391-15-9 | 0,62 % (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 (%) |
|---|---|---|---|---|---|
| Hydrogen peroxide | active substance | 7722-84-1 | 231-765-0 | 1 - 1 % (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 | |
| Precautionary statements |
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 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: Wiping using impregnated RTU wipes Detailed description: Disinfection of surfaces in industry (e.g. dining areas, bathrooms). Contact time for wiping at 10oC in dirty conditions: — 5 minutes for bacteria and yeasts. Contact times for wiping at 20oC in dirty conditions: — 2 minutes for bacteria; — 5 minutes for yeasts; — 15 minutes for fungi; — 60 minutes for mycobacteria. |
| 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 PP Bucket with 10-5000 impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 mm or 200x200 mm). Light precluding PP Pouch with 10-5000 impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 mm or 200x200 mm). |
4.1.1. Use-specific instructions
See general directions for use of meta SPC 8.
4.1.2. Use-specific risk mitigation measures
-
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 8.
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 8.
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 8.
4.2. Use description
Table 2
Disinfection of small 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 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: Wiping using impregnated RTU wipes Detailed description: Disinfection of small surfaces in food processing plant. Contact time for wiping at 10oC in dirty conditions: — 5 minutes for bacteria and yeasts. Contact times for wiping at 20oC in dirty conditions: — 2 minutes for bacteria; — 5 minutes for yeasts; — 15 minutes for fungi; — 60 minutes for mycobacteria. |
| 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 PP Bucket with 10-5000 impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 mm or 200x200 mm). Light precluding PP Pouch with 10-5000 impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 mm or 200x200 mm). |
4.2.1. Use-specific instructions
See general directions for use of meta SPC 8.
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 8.
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 8.
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 8.
4.3. Use description
Table 3
Disinfection of small non-food contact surfaces in healthcare 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 |
| 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 time for wiping at 10oC in dirty conditions: — 5 minutes for bacteria and yeasts. Contact times for wiping at 20oC in dirty conditions: — 15 minutes for bacteria, yeasts and fungi; — 60 minutes for mycobacteria. |
| 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 twice per day per room |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Light precluding PP Bucket with 10-5000 impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 mm or 200x200 mm). Light precluding PP Pouch with 10-5000 impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 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 8.
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 8.
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 8.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 8
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. 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
-
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 8
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | DrySan Oxy Wipes | DrySan Oxy Wipes | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | IncidinOxyWipe | IncidinOxyWipe | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0010 1-8 | EU-0024303-0010 1-8 | EU-0024303-0010 1-8 | ||
| 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 % (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 (%) |
|---|---|---|---|---|---|
| Hydrogen peroxide | active substance | 7722-84-1 | 231-765-0 | 7 - 7,7 % (w/w) | |
| Phosphoric acid | Orthophosphoric acid | Non-Active substance | 7664-38-2 | 231-633-2 | 1,5 - 1,5 % (w/w) |
| Nitric acid | Nitric acid | Non-Active substance | 7697-37-2 | 231-714-2 | 3,71 - 3,71 % (w/w) |
| Alcohol EO phosphate ester | Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, mono-C8-10-alkyl ethers, phosphates | Non-Active substance | 68130-47-2 | 14,625 - 14,625 % (w/w) | |
| Alkylpolyglycoside C8-C10 | (3R,4S,5S,6R)-2-decoxy-6-(hydroxymethyl)oxane-3,4,5-triol | Non-Active substance | 68515-73-1 | 500-220-1 | 6,35 - 6,35 % (w/w) |
| Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980) | Alcohols, C10-C16 ethoxylated propoxylated | Non-Active substance | 69227-22-1 | 3 - 3 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 9
| Formulation type(s) | SL Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9
| Hazard statements | H290: May be corrosive to metals. H314: Causes severe skin burns and eye damage. |
| Precautionary statements | P234: Keep only in original packaging. P264: Wash hands thoroughly after handling. P260: Do not breathe vapours. P260: Do not breathe spray. P280: Wear face protection. P280: Wear protective gloves. P280: Wear eye protection. 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 doctor. P310: Immediately call a POISON CENTER. 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. P390: Absorb spillage to prevent material damage. P406: Store in a a corrosion-resistant container with a resistant inner liner. 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 small 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: Viruses Common name: Viruses Development stage: no data |
| Field(s) of use | indoor use |
| Application method(s) | Method: Wiping using cloth/wipe and bucket Detailed description: Routine and non-routine disinfection of smaller surfaces in hospital rooms and medical practices that are frequently touched by people and that are not frequently touched by people. Contact times for wiping at 20oC in dirty conditions: — 5 minutes for bacteria (5 % dilution); — 5 minutes for yeasts (3 % dilution); — 5 minutes for fungi (4 % dilution); — 50 minutes for viruses (5 % dilution). |
| Application rate(s) and frequency | Application rate: Application rate: 10 ml/m2 Dilution (%): 3-5 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 Jug, 0,5-5 L Light precluding HDPE Pouch, 0,01-1 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. Pour diluted product into a clean bucket and distribute across surface using a single-use cloth/wipe, wipe the surface with a clean cloth/wipe and let air dry. 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.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 9.
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 9.
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 9.
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 9.
4.2. Use description
Table 2
Disinfection of large 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 Scientific name: Fungi Common name: fungi 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 flat mop and bucket Detailed description: Routine and non-routine disinfection of larger surfaces 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 dirty conditions: — 5 minutes for bacteria (5 % dilution); — 5 minutes for yeasts (3 % dilution); — 5 minutes for fungi (4 % dilution); — 50 minutes for viruses (5 % dilution). |
| Application rate(s) and frequency | Application rate: Application rate: 20 ml/m2 Dilution (%): Dilution (%): 3-5 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 Jug, 0,5-5 L Light precluding HDPE Pouch, 0,01-1 L |
4.2.1. 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. Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with a clean, dry mop and let air dry. Do not rinse after use.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 9.
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 9.
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 9.
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 9.
4.3. Use description
Table 3
Disinfection of small and/or large non-food contact surfaces in institutional/commercial buildings by spraying using trigger sprayer and dry wipe or by wiping using single-use cloth and bucket, and/or floors 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 Scientific name: Fungi Common name: fungi 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: Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms). Contact times for spraying and wiping at 20oC in dirty conditions: — 5 minutes for bacteria (5% dilution); — 5 minutes for yeasts (3% dilution); — 5 minutes for fungi (4% dilution); — 50 minutes for viruses (5% dilution). Method: Wiping using single-use cloth/wipe and bucket Detailed description: Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms). Contact times for wiping at 20oC in dirty conditions: — 5 minutes for bacteria (5% dilution); — 5 minutes for yeasts (3% dilution); — 5 minutes for fungi (4% dilution); — 50 minutes for viruses (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 dirty conditions: — 5 minutes for bacteria (5% dilution); — 5 minutes for yeasts (3% dilution); — 5 minutes for fungi (4% dilution); — 50 minutes for viruses (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 wiping, mopping at 20oC in dirty conditions: — 5 minutes for bacteria (5% dilution); — 5 minutes for yeasts (3% dilution); — 5 minutes for fungi (4% dilution); — 50 minutes for viruses (5% dilution). Method: Wiping using cloth/wipe and bucket 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 wiping and mopping at 20oC in dirty conditions: — 5 minutes for bacteria (5% dilution); — 5 minutes for yeasts (3% dilution); — 5 minutes for fungi (4% dilution); — 50 minutes for viruses (5% dilution). |
| Application rate(s) and frequency | Application rate: Application rate for spraying: 10 ml/m2 Dilution (%): Dilution (%): 3-5 Number and timing of application: Application frequency for trigger spraying: up to 10 times per day per room Application rate: Application rate for wiping: 10 ml/m2 Dilution (%): 3-5 Number and timing of application: Application frequency for wiping: up to 10 times per day per room Application rate for mopping: 20 ml/m2 Dilution (%): 3-5 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 (%): 3-5 Number and timing of application: Application frequency for combined trigger spraying and mopping: once per day per room. Application rate: Application rate for wiping: 10 ml/m2; Application rate for mopping: 20 ml/m2 Dilution (%): 3-5 Number and timing of application: Application frequency for combined wiping 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 Jug, 0,5-5 L Light precluding HDPE Pouch, 0,01-1 L |
4.3.1. Use-specific instructions
Do not rinse after use.
Spraying: For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the diluted product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray the diluted product onto the surface, wipe the surface with a clean, dry wipe or let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
Wiping: Pour diluted product into a clean bucket and distribute across surface using single-use cloth/wipe, wipe the surface with a clean cloth/wipe and let air dry. Used wipes must be disposed of in a closed container.
Mopping: Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with a clean, dry mop and let air dry.
4.3.2. Use-specific risk mitigation measures
Do not breathe vapours/spray.
For spraying: 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.
4.3.3. 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 9.
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 9.
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 9.
4.4. Use description
Table 4
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 Scientific name: Fungi Common name: fungi 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 flat mop and bucket Detailed description: Routine disinfection of large surfaces in large non-food areas. Contact times for mopping at 20oC in dirty conditions: — 5 minutes for bacteria (5% dilution); — 5 minutes for yeasts (3% dilution); — 5 minutes for fungi (4% dilution); — 50 minutes for viruses (5% dilution). |
| Application rate(s) and frequency | Application rate: Application rate: 20 ml/m2 Dilution (%): 3-5 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 Jug, 0,5-5 L Light precluding HDPE Pouch, 0,01-1 L |
4.4.1. Use-specific instructions
Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with a clean, dry mop and let air dry. Do not rinse after use.
4.4.2. Use-specific risk mitigation measures
Ensure technical ventilation with at least 15 air exchanges/hour.
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 9.
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 9.
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 9.
4.5. Use description
Table 5
Disinfection of large non-food contact surfaces in institutional/commercial buildings by spraying using wall- mounted device
| 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 with a wall- mounted device Detailed description: Routine disinfection of large surfaces in large non-food and food areas. Contact time for spraying at 20oC in dirty conditions: — 5 minutes for bacteria and yeasts (3% dilution). Contact times for spraying at 20oC in clean conditions: — 5 minutes for bacteria (1,5 % dilution); — 15 minutes for yeasts (2% dilution). |
| Application rate(s) and frequency | Application rate: Application rate: 180 ml/m2 Dilution (%): Dilution (%): 1,5-3 Number and timing of application: Application frequency: 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 Jug, 0,5-5 L Light precluding HDPE Pouch, 0,01-1 L |
4.5.1. Use-specific instructions
When used under clean conditions: clean surface before applying the product. Apply product via wall-mounted device. Rinse after application.
4.5.2. Use-specific risk mitigation measures
Do not breathe vapours/spray.
Ensure technical ventilation with at least 15 air exchanges/hour.
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 9.
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 9.
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 9.
4.6. Use description
Table 6
Disinfection of large 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: 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 |
| Field(s) of use | indoor use |
| Application method(s) | Method: Spraying using trigger spray and dry wipe Detailed description: Routine disinfection of large surfaces in large food areas (e.g. kitchens). Contact times for spraying and wiping at 20oC in dirty conditions: — 5 minutes for bacteria (5% dilution); — 5 minutes for yeasts (3% dilution); — 5 minutes for fungi (4% dilution); — 50 minutes for viruses (5% dilution). |
| Application rate(s) and frequency | Application rate: Application rate: 10 ml/m2 Dilution (%): Dilution (%): 3-5 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 Jug, 0,5-5 L Light precluding HDPE Pouch, 0,01-1 L |
4.6.1. Use-specific instructions
For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the diluted product onto a dry wipe and wipe small surfaces such as worktops and equipment or 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. Do not rinse after use. Used wipes must be disposed of in a closed container.
4.6.2. Use-specific risk mitigation measures
Do not breathe vapours/spray.
Keep food, feed or beverages away from treated surface until dried. Do not use directly on or near food, feed or drinks.
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.
4.6.3. 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 9.
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 9.
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 9.
4.7. Use description
Table 7
Disinfection of large food contact surfaces in institutional/commercial buildings by wiping using single-use cloth and bucket
| 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: Viruses Common name: Viruses Development stage: no data |
| Field(s) of use | indoor use |
| Application method(s) | Method: Wiping using single-use cloth/wipe and bucket Detailed description: Routine disinfection of large surfaces in large food areas (e.g. kitchens). Contact times for wiping at 20oC in dirty conditions: — 5 minutes for bacteria (5% dilution); — 5 minutes for yeasts (3% dilution); — 5 minutes for fungi (4% dilution); — 50 minutes for viruses (5% dilution). |
| Application rate(s) and frequency | Application rate: 10 ml/m2 Dilution (%): 3-5 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 Jug, 0,5-5 L Light precluding HDPE Pouch, 0,01-1 L |
4.7.1. Use-specific instructions
Pour diluted product into a clean bucket and distribute across surface using single-use cloth/wipe, wipe the surface with a clean cloth/wipe and let air dry. Do not rinse after use. Used wipes must be disposed of in a closed container.
4.7.2. 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.
4.7.3. 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 9.
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 9.
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 9.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 9
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 use on surfaces sensitive to oxidative agents such as marble, copper or brass.
Dilution instruction (1,5 %): to produce 1 L of diluted surface disinfectant, add 15 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 L with distilled water or water of equal quality.
Dilution instruction (2%): to produce 1 L of diluted surface disinfectant, add 20 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 L with distilled water or water of equal quality.
Dilution instruction (3%): to produce 1 L of diluted surface disinfectant, add 30 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 L with distilled water or water of equal quality.
Dilution instruction (4%): to produce 1 L of diluted surface disinfectant, add 40 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 L with distilled water or water of equal quality.
Dilution instruction (5%): to produce 1 L of diluted surface disinfectant, add 50 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 L with distilled water or water of equal quality.
5.2. Risk mitigation measures
Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).
The use of eye protection while handling 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: Wash off immediately with plenty of water for at least 15 minutes. Use a mild soap if available. Wash contaminated clothing before reuse. Thoroughly clean shoes before reuse. Seek medical attention immediately.
If swallowed: Rinse mouth with water. Do NOT induce vomiting. Never give anything by mouth to an unconscious person. Seek medical attention immediately.
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.
Storage temperature: 0-25 °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 9
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | KitchenPro Oxy Des Concentrate | KitchenPro Oxy Des Concentrate | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Incidin OxyPro | Incidin OxyPro | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sirafan Oxy Conc | Sirafan Oxy Conc | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0011 1-9 | EU-0024303-0011 1-9 | EU-0024303-0011 1-9 | ||
| 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 | 7 % (w/w) | |
| Phosphoric acid | Orthophosphoric acid | Non-Active substance | Non-Active substance | 7664-38-2 | 7664-38-2 | 231-633-2 | 1,5 % (w/w) |
| Nitric acid | Nitric acid | Non-Active substance | Non-Active substance | 7697-37-2 | 7697-37-2 | 231-714-2 | 3,71 % (w/w) |
| Alcohol EO phosphate ester | Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, mono-C8-10-alkyl ethers, phosphates | Non-Active substance | Non-Active substance | 68130-47-2 | 68130-47-2 | 14,625 % (w/w) | |
| Alkylpolyglycoside C8-C10 | (3R,4S,5S,6R)-2-decoxy-6-(hydroxymethyl)oxane-3,4,5-triol | Non-Active substance | Non-Active substance | 68515-73-1 | 68515-73-1 | 500-220-1 | 6,35 % (w/w) |
| Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980) | Alcohols, C10-C16 ethoxylated propoxylated | Non-Active substance | Non-Active substance | 69227-22-1 | 69227-22-1 | 3 % (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) | Oasis Pro Oxy Des | Oasis Pro Oxy Des | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Maxx Oxy Des 2 | Maxx Oxy Des 2 | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0012 1-9 | EU-0024303-0012 1-9 | EU-0024303-0012 1-9 | ||
| 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 | 7 % (w/w) | |
| Phosphoric acid | Orthophosphoric acid | Non-Active substance | Non-Active substance | 7664-38-2 | 7664-38-2 | 231-633-2 | 1,5 % (w/w) |
| Nitric acid | Nitric acid | Non-Active substance | Non-Active substance | 7697-37-2 | 7697-37-2 | 231-714-2 | 3,71 % (w/w) |
| Alcohol EO phosphate ester | Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, mono-C8-10-alkyl ethers, phosphates | Non-Active substance | Non-Active substance | 68130-47-2 | 68130-47-2 | 14,625 % (w/w) | |
| Alkylpolyglycoside C8-C10 | (3R,4S,5S,6R)-2-decoxy-6-(hydroxymethyl)oxane-3,4,5-triol | Non-Active substance | Non-Active substance | 68515-73-1 | 68515-73-1 | 500-220-1 | 6,35 % (w/w) |
| Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980) | Alcohols, C10-C16 ethoxylated propoxylated | Non-Active substance | Non-Active substance | 69227-22-1 | 69227-22-1 | 3 % (w/w) |
1. META SPC 10 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 10 identifier
| Identifier | Meta SPC: META SPC 10 |
1.2. Suffix to the authorisation number
| Number | 1-10 |
1.3. Product type(s)
| Product type(s) | PT01: Human hygiene |
2. META SPC 10 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 10
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Hydrogen peroxide | Active substance | 7722-84-1 | 231-765-0 | 1,4 - 1,61 % (w/w) | |
| Citric acid monohydrate | 2-hydroxypropane -1,2,3-tricarboxylic acid | Non-Active substance | 5949-29-1 | 201-069-1 | 0,9 - 0,9 % (w/w) |
| Phenoxyethanol | 2-Phenoxyethanol | Non-Active substance | 122-99-6 | 204-589-7 | 0,9 - 0,9 % (w/w) |
| Sodium lauryl Sulphate | Sodium dodecyl sulphate | Non-Active substance | 151-21-3 | 205-788-1 | 3,88 - 3,88 % (w/w) |
| L-Glutamic acid, N-coco acyl derivs., monosodium salts | Sodium;(4S)-4-amino-5-hydroxy-5-oxopentanoate | Non-Active substance | 68187-32-6 | 269-087-2 | 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 | 90583-11-2 | 292-209-0 | 1,12 - 1,12 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 10
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10
| Hazard statements | H290: May be corrosive to metals. H319: Causes serious eye irritation. |
| Precautionary statements | P234: Keep only in original packaging. P264: Wash hands thoroughly after handling. P280: Wear eye protection. P280: Wear face protection. P390: Absorb spillage to prevent material damage. P406: Store in a a corrosion-resistant container with a resistant inner liner. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337+P313: If eye irritation persists: Get medical attention. P337+P313: If eye irritation persists: Get medical advice. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Hygienic hand wash
| Product type | PT01: Human 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: Direct application onto skin Detailed description: Antimicrobial hand soap, intended only as hygienic hand wash for food and beverage industry. Contact time at 20oC in dirty conditions: — 60 seconds for bacteria and yeasts. |
| Application rate(s) and frequency | Application rate: Application rate: 3 ml of product per application Dilution (%): RTU product Number and timing of application: Application frequency: 1-10 times/day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | Light precluding HDPE Jug, 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 Pouch, 0,5-100 L |
4.1.1. Use-specific instructions
See general directions for use of meta SPC 10.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 10.
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 10.
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 10.
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 10.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 10
5.1. Instructions for use
Apply approximately 3 ml of product to wet hands and rub for 60 seconds. Rinse thoroughly with running tap water for about 30 seconds.
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 with water.
In case of skin contact: Rinse with 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 10
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Manosan Oxy | Manosan Oxy | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0024303-0013 1-10 | EU-0024303-0013 1-10 | EU-0024303-0013 1-10 | ||
| 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 | 1,4 % (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 11 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 11 identifier
| Identifier | Meta SPC: META SPC 11 |
1.2. Suffix to the authorisation number
| Number | 1-11 |
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 11 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 11
| 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 11
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11
| Hazard statements | |
| Precautionary statements |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Disinfection of life sciences cleanrooms 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: 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: Wiping using impregnated RTU wipes Detailed description: Disinfection of small surfaces, materials and equipment in life sciences cleanrooms and supporting environments (e.g. pharmaceutical industry) and transfer disinfection. 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: 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) |
4.1.1. Use-specific instructions
See general directions for use of meta SPC 11.
4.1.2. Use-specific risk mitigation measures
-
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 11.
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 11.
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 11.
4.2. Use description
Table 2
Disinfection of life sciences cleanrooms by mopping using impregnated RTU mop wipes
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