LegalizeCommission Implementing Regulation (EU) 2026/277 of 5 February 2026 granting a Union authorisation for the biocidal product family Hydrogen Peroxide Group in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
- — Wear coverall (EN 13034 or equivalent)
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.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See General directions for use.
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.
4.3. Use description
Table 3
Use 2.6: Disinfection of hard surface by spraying for veterinary purpose
| Product type | PT03: Veterinary hygiene |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses |
| Field(s) of use | indoor use outdoor use Porous and non-porous hard surfaces in animal husbandry (animal houses, pens), including tables, floors, walls, machinery, hard furniture and equipment, excluding outer surfaces of animal transportation. |
| Application method(s) | Method: open system: spray treatment Detailed description: Surfaces must be cleaned before disinfection. Disinfection of equipment by spraying (medium pressure); A portable spraying equipment (volume ~ 20 Litres, medium pressure, hand held) is filled with the product dilution and then used for disinfection. Manual dilution (jerry can): Product dilution to the in-use concentration is achieved by an operator in a bucket or spray reservoir. Surfaces must kept wet during disinfection. |
| Application rate(s) and frequency | Number and timing of application: Prior to use, the product shall be diluted to (all concentrations are expressed as active substance content % w/w): — 2 % for porous surfaces in animal husbandry — 1,5 % for non-porous surfaces in animal husbandry Application rate: 300 ml/m2. The minimum contact time is: — 30 minutes for porous and non-porous surfaces in animal husbandry Frequency: once a week for porous and non-porous surfaces in animal husbandry. |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 30 kilogram (kg) and 65 kg high-density polyethylene (HDPE) jerrycans |
4.3.1. Use-specific instructions for use
Clean surfaces before use.
Dose the concentrate in the reservoir of the pressure cleaner to obtain an in-use concentration of:
- — 2 % for porous surfaces in animal husbandry
- — 1,5 % for non-porous surfaces in animal husbandry
Use a pressure washer or other mechanical sprayer to apply the diluted solution at an application rate of 300 ml spray /m2. The disinfection solution shall remain in contact with the surface to be disinfected for at least:
30 minutes for porous and non-porous surfaces in animal husbandry
4.3.2. Use-specific risk mitigation measures
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
Mixing and loading (automated):
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 4 is mandatory.
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
- — Wear coverall (EN 13034 or equivalent)
Mixing and loading (manual):
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 10 is mandatory.
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
- — Wear coverall (EN 13034 or equivalent)
Spraying, hard surfaces:
- — Ensure that application is carried out in areas with a minimum ventilation of 4 air changes per hour.
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 20 is mandatory.
- — Animals are not allowed to be present during treatment
- — Do not allow re-entry of animals to the disinfected facilities before 15 minutes after disinfection.
- — Leave the room directly after application.
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.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See General directions for use.
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.
4.4. Use description
Table 4
Use 2.10: Disinfection of hard surfaces by medium pressure spraying
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: fungi |
| Field(s) of use | indoor use outdoor use Non-porous hard surfaces (e.g. floors, walls, work surfaces including food contact surfaces) in industry, institutions and health care facilities. |
| Application method(s) | Method: open system: spray treatment Detailed description: Surfaces must be cleaned before disinfection. Disinfection of equipment by spraying (medium pressure); A portable spraying equipment (volume ~ 20 Liters, medium pressure, hand held) is filled with the product dilution and then used for disinfection. |
| Application rate(s) and frequency | Number and timing of application: For bacteria and yeasts and fungi, the product shall be diluted to 1,5 % (active substance % w/w) prior to use. The minimum contact time is: — 5 minutes for bacteria and yeasts — 15 minutes for fungi. Application rate: 300 ml/m2 Apply the product at room temperature Frequency: once a day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 220 L HDPE Drum 600 litre (L) and 1 000 L HDPE intermediate bulk container (IBC) 30 kilogram (kg) and 65 kg high-density polyethylene (HDPE) jerrycans |
4.4.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection.
Dose the concentrate in the reservoir of the pressure cleaner to obtain a suitable in-use concentration of the active substance (see application rate section).
Automatic dilution (IBC, drum): The product is pumped into the reservoir of the pressure cleaner where it is mixed with water to the required dose. There is no manual dilution step.
Manual dilution (jerry can): Product dilution to the in-use concentration is achieved by an operator in a bucket or spray reservoir.
Surfaces must kept wet during disinfection.
Use a pressure washer or other mechanical sprayer to apply the diluted solution at an application rate of 300 ml/m2. The disinfection solution shall remain in contact with the surface to be disinfected 5 minutes for removal of bacteria and yeasts, and 15 minutes to remove fungi.
Premises shall be well-ventilated before re-entry
4.4.2. Use-specific risk mitigation measures
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
Mixing and loading (automated):
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 4 is mandatory.
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
Mixing and loading (manual):
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 10 is mandatory.
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
Spraying of hard surfaces:
- — Ensure that application is carried out in areas with a minimum ventilation of 4 air changes per hour.
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 20 is mandatory.
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
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.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See General directions for use.
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.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1. Instructions for use
Unless otherwise stated on the label, products must be diluted for use.
Follow the label instructions for use dilutions and application volumes according to the use required.
Surfaces shall be cleaned before disinfection.
See Use-specific instructions for use per use
5.2. Risk mitigation measures
- — No access of third parties during application/treatment/maintenance, unless the required personal protective equipment as prescribed for the professional user is worn.
- — Re-entry is only permitted once the air concentration for hydrogen peroxide has dropped below 0,9 ppm (1,25 mg/m3 ) or relevant lower national reference value
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First-Aid measures
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid
Fire-fighting measures
Extinguishing media:
Suitable extinguishing media: In case of fire involving the product: Water spray Unsuitable extinguishing media: All other extinguishants.
Special hazards arising from the substance or mixture: Contact with combustible material may cause fire. Thermal decomposition gives: Oxygen, that can enhance sites of combustion. Hazards of over-pressurization in containers exposed to heat: explosion risk.
Precautions for fire-fighters: Specific methods: Keep upwind and operate from safe distance. In case of fire, remove exposed containers. Containers/tanks should be cooled with water spray.
Special protective actions for fire-fighters: Wear self-contained breathing apparatus and protective suit.
Accidental release measures
Personal precautions, protective equipment and emergency procedures:
Evacuate non-essential staff and those not equipped with individual protection apparatus. Prohibit contact with eyes. Avoid contact with skin. Avoid inhalation of vapours. Prohibit all sources of sparks and ignition - Do not smoke. If safe to do so, plug or seal off leak. Remove all incompatible substances.
Environmental precautions: Dam up with sand or inert earth (do not use combustible materials). Dilute with large quantities of water before discharging into sewers or into the environment
Methods and materials for containment and cleaning up:
Recovery: Soak up with inert absorbent material. Never reintroduce the spilled product in another container. Risk of decomposition.
Neutralisation: Dilute with water.
Elimination: Dispose of rinse water as waste water.
5.4. Instructions for safe disposal of the product and its packaging
Waste treatment:
Disposal of product: Dilute with water.
Disposal of packaging: Clean container with water. Recycle or incinerate at an approved waste disposal site. In accordance with local and national regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life of 1 year.
The product should be stored in the original packaging.
Protect from light.
Store below 54 °C.
6. OTHER INFORMATION
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
Professionals (including industrial, professionals) mean trained professional if this is required by national legislation.
Please be aware of the European reference value of 1,25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product (please be aware that relevant lower national limit values may apply).
The full titles of the EN standards referenced in the Risk mitigation measures are:
- — EN 13832 – Footwear protecting against chemicals
- — EN 374 – Protective gloves against dangerous chemicals and micro-organisms
- — EN 405 – Respiratory protective devices
- — EN 166 – Eye protection against chemicals
- — EN 13034 – Protective coverall against liquid chemicals – type 6
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | OXMAVI | OXMAVI | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0004 1-3 | EU-0035039-0004 1-3 | EU-0035039-0004 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 35 % (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) | A CID HIS | A CID HIS | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0005 1-3 | EU-0035039-0005 1-3 | EU-0035039-0005 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 35 % (w/w) |
7.3. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | HD 20 OXYGERMS | HD 20 OXYGERMS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 20S OXY GERMS SPRAY | HD 20S OXY GERMS SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 22 AGRI GERMS | HD 22 AGRI GERMS | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0006 1-3 | EU-0035039-0006 1-3 | EU-0035039-0006 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 35 % (w/w) |
7.4. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Hydrosan | Hydrosan | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0007 1-3 | EU-0035039-0007 1-3 | EU-0035039-0007 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 35 % (w/w) |
7.5. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | 162 Combitartre | 162 Combitartre | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0008 1-3 | EU-0035039-0008 1-3 | EU-0035039-0008 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 35 % (w/w) |
7.6. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Antisept WO 35 | Antisept WO 35 | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0009 1-3 | EU-0035039-0009 1-3 | EU-0035039-0009 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 35 % (w/w) |
7.7. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 35 AHS | PEROXAL 35 AHS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 35 DS | PEROXAL 35 DS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 35 PG | PEROXAL 35 PG | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 35 HSD | PEROXAL 35 HSD | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 35 SD | PEROXAL 35 SD | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ALBONE 35 S | ALBONE 35 S | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 35 CIP | PEROXAL 35 CIP | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0010 1-3 | EU-0035039-0010 1-3 | EU-0035039-0010 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 35 % (w/w) |
7.8. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Antisept WO 50 | Antisept WO 50 | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0011 1-3 | EU-0035039-0011 1-3 | EU-0035039-0011 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 49,9 % (w/w) |
7.9. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 50 AHS | PEROXAL 50 AHS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ALBONE 50 | ALBONE 50 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 50 HSD | PEROXAL 50 HSD | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 50 SD | PEROXAL 50 SD | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0012 1-3 | EU-0035039-0012 1-3 | EU-0035039-0012 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 49,9 % (w/w) |
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
| Identifier | Meta SPC: 4 |
1.2. Suffix to the authorisation number
| Number | 1-4 |
1.3. Product type(s)
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT03: Veterinary hygiene |
2. META SPC 4 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 4
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| hydrogen peroxide | hydrogen peroxide | Active substance | 7722-84-1 | 231-765-0 | >=30–<=30 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 4
| Formulation type(s) | SL Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
| Hazard statements | H272: May intensify fire; oxidiser. H302: Harmful if swallowed. H318: Causes serious eye damage. H412: Harmful to aquatic life with long lasting effects. |
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P273: Avoid release to the environment. P280: Wear eye protection. P280: Wear face protection. P301+P312: IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P330: Rinse mouth. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use 4.2: Hard surface disinfection
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: fungi |
| Field(s) of use | indoor use outdoor use Disinfection of non-porous hard surfaces (tables, floors, walls, hard furniture, equipment), by wiping, mopping or using a hand held trigger spray in: — Hospitals, health care facilities, industries, institutions … (PT2) — Food and feed industry, kitchens, restaurants, abattoirs… (PT4) |
| Application method(s) | Method: manual application Detailed description: Wiping or mopping with a soaked cloth, or spraying with a trigger sprayer. |
| Application rate(s) and frequency | Number and timing of application: For bacteria, yeasts and fungi: the product shall be diluted to 1,5 % (expressed as active substance content in % w/w) prior to use. Application rate: 300 ml/m2. The minimum contact time is: — 5 minutes for bacteria and yeasts — 15 minutes for fungi. Frequency: once a day Apply the product at room temperature. |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 30 kilogram (kg) and 65 kg high-density polyethylene (HDPE) jerrycans 1 L and 5 L HDPE bottle |
4.1.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate.
Manual dilution (jerry can, bottle): Product dilution to the in-use concentration of 1,5 % hydrogen peroxide (w/w) is achieved by an operator in a bucket or small intermediate reservoir.
Wiping and mopping
Soak the wipe or mop with product until completely soaked and then wipe or mop the surface to be disinfected. Make sure to wet the surfaces completely.
Spraying
Fill a hand held sprayer with the diluted solution. Make sure to wet surfaces completely by spraying the product onto the surface to be disinfected.
Allow to take effect for at least the required contact time.
4.1.2. Use-specific risk mitigation measures
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
Mixing and loading (manual):
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 10 is mandatory.
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
Wiping and trigger spray application:
- — Ensure that application is carried out in areas with a minimum ventilation of 4 air changes per hour.
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 4 is mandatory.
- — Leave the room directly after application.
Mopping application:
- — Ensure that application is carried out in areas with a minimum ventilation of 4 air changes per hour.
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 10 is mandatory.
- — Leave the room directly after application.
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.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See General directions for use.
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.
4.2. Use description
Table 2
Use 4.3: Disinfection of equipment by filling or immersion
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: fungi |
| Field(s) of use | indoor use outdoor use Disinfection of equipments (e.g. pipes, tanks, fillers, mixers, boxes …) by filling with solution (disinfection of inner surfaces), or immersion in a solution (inner/outer disinfection) in industrial (e.g. cosmetics, chemical synthesis …), institutional, food and feed areas. |
| Application method(s) | Method: open system: immersion Detailed description: Filling or Immersion. Equipment surfaces must be cleaned before disinfection. |
| Application rate(s) and frequency | Number and timing of application: The product shall be diluted to 10 % (active substance w/w) prior to use. The contact time is 5 minutes for bacteria, yeasts, and fungi. The diluted solution should be at room temperature. Frequency: once a day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 600 litre (L) and 1 000 L HDPE intermediate bulk container (IBC) 220 L HDPE Drum 30 kilogram (kg) and 65 kg high-density polyethylene (HDPE) jerrycans |
4.2.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection.
The product is diluted manually or automatic to 10 % hydrogen peroxide by professionals for application.
Automatic dilution (IBC, drum): The product is pumped into an intermediate reservoir where it is mixed with water to the required dose. There is no manual dilution step.
Manual dilution (jerry can): Product dilution to the in-use concentration is achieved by an operator in a bucket or intermediate small reservoir.
The diluted solution is then either used in a bath (disinfection by immersion) or poured into the equipment to be disinfected (disinfection by filling).
Rinse treated [surfaces/equipment/pipes/machinery] with drinking water after application.
Solutions shall be disposed of after a single use
4.2.2. Use-specific risk mitigation measures
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
Mixing and loading (automated):
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 4 is mandatory.
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
- — Wear coverall (EN 13034 or equivalent)
Mixing and loading (manual):
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 10 is mandatory.
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
- — Wear coverall (EN 13034 or equivalent)
Disinfection of equipment by filling or immersion:
- — Ensure that application is carried out in areas with a minimum ventilation of 4 air changes per hour.
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 20 is mandatory.
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
- — The bath must be emptied directly after the contact time and removal of equipment.
- — Leave the room directly after application.
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.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See General directions for use.
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.
4.3. Use description
Table 3
Use 4.6: Disinfection of hard surface by spraying for veterinary purpose
| Product type | PT03: Veterinary hygiene |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses |
| Field(s) of use | indoor use outdoor use Porous and non-porous hard surfaces in animal husbandry (animal houses, pens), including tables, floors, walls, machinery, hard furniture and equipment, excluding outer surfaces of animal transportation. |
| Application method(s) | Method: open system: spray treatment Detailed description: Surfaces must be cleaned before disinfection. Disinfection of equipment by spraying (medium pressure); A portable spraying equipment (volume ~ 20 Litres, medium pressure, hand held) is filled with the product dilution and then used for disinfection. Manual dilution (jerry can): Product dilution to the in-use concentration is achieved by an operator in a bucket or spray reservoir. Surfaces must kept wet during disinfection. |
| Application rate(s) and frequency | Number and timing of application: Prior to use, the product shall be diluted to (all concentrations are expressed as active substance content % w/w): — 2 % for porous surfaces in animal husbandry — 1,5 % for non-porous surfaces in animal husbandry Application rate: 300 ml/m2. The minimum contact time is: — 30 minutes for porous and non-porous surfaces in animal husbandry Frequency: once a week for porous and non-porous surfaces in animal husbandry. |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 30 kilogram (kg) and 65 kg high-density polyethylene (HDPE) jerrycans |
4.3.1. Use-specific instructions for use
Clean surfaces before use.
Dose the concentrate in the reservoir of the pressure cleaner to obtain an in-use concentration of:
- — 2 % for porous surfaces in animal husbandry
- — 1,5 % for non-porous surfaces in animal husbandry
Use a pressure washer or other mechanical sprayer to apply the diluted solution at an application rate of 300 ml spray /m2. The disinfection solution shall remain in contact with the surface to be disinfected for at least:
30 minutes for porous and non-porous surfaces in animal husbandry
4.3.2. Use-specific risk mitigation measures
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
Mixing and loading (automated):
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 4 is mandatory.
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
- — Wear coverall (EN 13034 or equivalent)
Mixing and loading (manual):
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 10 is mandatory.
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
- — Wear coverall (EN 13034 or equivalent)
Spraying, hard surfaces:
- — Ensure that application is carried out in areas with a minimum ventilation of 4 air changes per hour.
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 20 is mandatory.
- — Animals are not allowed to be present during treatment
- — Do not allow re-entry of animals to the disinfected facilities before 15 minutes after disinfection.
- — Leave the room directly after application.
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.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See General directions for use.
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.
4.4. Use description
Table 4
Use 4.10: Disinfection of hard surfaces by medium pressure spraying
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: fungi |
| Field(s) of use | indoor use outdoor use Non-porous hard surfaces (e.g. floors, walls, work surfaces including food contact surfaces) in industry, institutions and health care facilities. |
| Application method(s) | Method: open system: spray treatment Detailed description: Surfaces must be cleaned before disinfection. Disinfection of equipment by spraying (medium pressure); A portable spraying equipment (volume ~ 20 Liters, medium pressure, hand held) is filled with the product dilution and then used for disinfection. |
| Application rate(s) and frequency | Number and timing of application: For bacteria and yeasts and fungi, the product shall be diluted to 1,5 % (active substance % w/w) prior to use. The minimum contact time is: — 5 minutes for bacteria and yeasts — 15 minutes for fungi. Application rate: 300 ml/m2 Apply the product at room temperature Frequency: once a day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 220 L HDPE Drum 600 litre (L) and 1 000 L HDPE intermediate bulk container (IBC) 30 kilogram (kg) and 65 kg high-density polyethylene (HDPE) jerrycans |
4.4.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection.
Dose the concentrate in the reservoir of the pressure cleaner to obtain a suitable in-use concentration of the active substance (see application rate section).
Automatic dilution (IBC, drum): The product is pumped into the reservoir of the pressure cleaner where it is mixed with water to the required dose. There is no manual dilution step.
Manual dilution (jerry can): Product dilution to the in-use concentration is achieved by an operator in a bucket or spray reservoir.
Surfaces must kept wet during disinfection.
Use a pressure washer or other mechanical sprayer to apply the diluted solution at an application rate of 300 ml/m2. The disinfection solution shall remain in contact with the surface to be disinfected 5 minutes for removal of bacteria and yeasts, and 15 minutes to remove fungi.
Premises shall be well-ventilated before re-entry
4.4.2. Use-specific risk mitigation measures
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
Mixing and loading (automated):
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 4 is mandatory.
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
Mixing and loading (manual):
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 10 is mandatory.
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
Spraying of hard surfaces:
- — Ensure that application is carried out in areas with a minimum ventilation of 4 air changes per hour.
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 20 is mandatory.
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
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.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See General directions for use.
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.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
5.1. Instructions for use
Unless otherwise stated on the label, products must be diluted for use.
Follow the label instructions for use dilutions and application volumes according to the use required.
Surfaces shall be cleaned before disinfection.
See Use-specific instructions for use per use
5.2. Risk mitigation measures
- — No access of third parties during application/treatment/maintenance, unless the required personal protective equipment as prescribed for the professional user is worn.
- — Re-entry is only permitted once the air concentration for hydrogen peroxide has dropped below 0,9 ppm (1,25 mg/m3 ) or relevant lower national reference value
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First-Aid measures
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
Protection of first-aiders: In case of insufficient ventilation, wear suitable respiratory equipment. Protective suit
Fire-fighting measures
Extinguishing media:
Suitable extinguishing media: In case of fire involving the product: Water spray. Unsuitable extinguishing media: All other extinguishants
Special hazards arising from the substance or mixture: Contact with combustible material may cause fire. Thermal decomposition gives: Oxygen, that can enhance sites of combustion. Hazards of over-pressurization in containers exposed to heat: explosion risk.
Precautions for fire-fighters: Specific methods: Keep upwind and operate from safe distance. In case of fire, remove exposed containers. Containers/tanks should be cooled with water spray.
Special protective actions for fire-fighters: Wear self-contained breathing apparatus and protective suit.
Accidental release measures
Personal precautions, protective equipment and emergency procedures:
Evacuate non-essential staff and those not equipped with individual protection apparatus. Prohibit contact with eyes. Avoid contact with skin. Avoid inhalation of vapours. Prohibit all sources of sparks and ignition - Do not smoke. If safe to do so, plug or seal off leak. Remove all incompatible substances.
Environmental precautions: Dam up with sand or inert earth (do not use combustible materials). Dilute with large quantities of water before discharging into sewers or into the environment
Methods and materials for containment and cleaning up:
Recovery: Soak up with inert absorbent material. Never reintroduce the spilled product in another container. Risk of decomposition.
Neutralisation: Dilute with water.
Elimination: Dispose of rinse water as waste water.
5.4. Instructions for safe disposal of the product and its packaging
Waste treatment
Disposal of product: Dilute with water.
Disposal of packaging: Clean container with water. Recycle or incinerate at an approved waste disposal site. In accordance with local and national regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life of 1 year.
The product should be stored in the original packaging.
Protect from light.
Store below 54 °C.
6. OTHER INFORMATION
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
Professionals (including industrial, professionals) mean trained professional if this is required by national legislation.
Please be aware of the European reference value of 1,25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product (please be aware that relevant lower national limit values may apply).
The full titles of the EN standards referenced in the Risk mitigation measures are:
- — EN 13832 – Footwear protecting against chemicals
- — EN 374 – Protective gloves against dangerous chemicals and micro-organisms
- — EN 405 – Respiratory protective devices
- — EN 166 – Eye protection against chemicals
- — EN 13034 – Protective coverall against liquid chemicals – type 6
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) | Antisept WO 30 | Antisept WO 30 | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0013 1-4 | EU-0035039-0013 1-4 | EU-0035039-0013 1-4 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 30 % (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) | PEROXAL 30 AHS | PEROXAL 30 AHS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ALBONE 30 | ALBONE 30 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 30 HSD | PEROXAL 30 HSD | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 30 SD | PEROXAL 30 SD | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 30 ED | PEROXAL 30 ED | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0014 1-4 | EU-0035039-0014 1-4 | EU-0035039-0014 1-4 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 30 % (w/w) |
7.3. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | ELIGERM PSA | ELIGERM PSA | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ELIGERM PEROX | ELIGERM PEROX | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0015 1-4 | EU-0035039-0015 1-4 | EU-0035039-0015 1-4 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 30 % (w/w) |
1. META SPC 5 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 5 identifier
| Identifier | Meta SPC: 6 |
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 | hydrogen peroxide | Active substance | 7722-84-1 | 231-765-0 | >=25 –<=25 % (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 | H272: May intensify fire; oxidiser. H302: Harmful if swallowed. H318: Causes serious eye damage. H412: Harmful to aquatic life with long lasting effects. |
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P273: Avoid release to the environment. P280: Wear eye protection. P280: Wear face protection. P301+P312: IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P330: Rinse mouth. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use 6.1: Room disinfection with Nebulized Hydrogen Peroxide
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: fungi |
| Field(s) of use | indoor use Disinfection of dry surfaces in closed rooms and enclosed spaces by Nebulized hydrogen peroxide, e.g. laboratory equipment, hospital rooms, emergency vehicles, food and feed areas. |
| Application method(s) | Method: - Nebulization Detailed description: Nebulization to disinfect hard non-porous surfaces. |
| Application rate(s) and frequency | Number and timing of application: The product is a 25 % w/w hydrogen peroxide solution and is ready-to-use. Room volume: 30–150 m3 Diffusion rate: Bacteria and yeast: 10 ml/m3 product Fungi: 11,4 ml/m3 product Diffusion time: Dependant upon the room volume. Temperature: room temperature Recommended relative humidity: 40 to 80 % Contact time: 3 hours Frequency: maximum 3 times per 24 hour period. |
| Category(ies) of users | professional |
| Pack sizes and packaging material | Sealed 1L HDPE cartridges. |
4.1.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate install biological and chemical indicators to validate the disinfection cycle.
The nebulizer devices are fed by connecting a drum of hydrogen peroxide solution (automated transfer and dosing) or by inserting a sealed cartridge. Professionals seal the enclosed space or room and initiate the decontamination cycle.
During this step, exposure to hydrogen peroxide is not possible as access to the fog-treated area is denied. The decontamination process starts with a dehumidification phase in which the machine removes water from the atmosphere.
In the disinfection phase, the machine injects nebulized hydrogen peroxide, depending on the device, into the sealed area for decontamination to get the hydrogen peroxide concentration up to the effective levels.
The succeeding disinfection phase lasts 3 hours during which the hydrogen peroxide fog disinfects the surfaces inside the sealed space.
After finishing the decontamination phase, the aeration cycle starts. This step has variable durations since it is complete when sensors inform that the hydrogen peroxide level is below 1,25 mg/m3. Biological and chemical indicators can then be collected to confirm the efficacy of the decontamination cycle
The user shall always carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable “standard room”, if applicable) with the devices to be used after which a protocol for disinfection of these rooms can be made and used thereafter.
Access to the treated area is denied during the disinfection process.
4.1.2. Use-specific risk mitigation measures
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
All surfaces must be cleaned before disinfection
- — Insert the sealed cartridge as delivered by the manufacturer into the machine. See equipment user’s manual for proper equipment preparation and set-up
- — The applicator must placard or post all entrances to the treatment enclosure with signs bearing:
- — The signal word ‘DANGER’ in red. ‘Area under treatment, DO NOT ENTER/NO ENTRY.’
- — The statement ‘This sign may only be removed 1 hour after the treatment enclosure has been aerated to hydrogen peroxide levels less than or equal to 1,25 mg/m3 ’.
- — Identification of hydrogen peroxide as a hazard associated with the treatment process.
- — Contact information for the applicator.
The following PPE are required if emergency re-entry is required before the air concentration has dropped below the AEC:
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC
- — The use of eye protection (chemical goggles/face shield) (EN166 or equivalent) during handling of the product is mandatory.
- — Wear a protective coverall (at least type 6, EN 13034 or equivalent) (coverall material to be specified by the authorisation holder within the product information).
- — Wear chemical resistant boots (EN 13832 or equivalent)
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 40 is mandatory.
- — During exposure time, the treated room may only be entered wearing suitable personal protective equipment
For other instructions see General directions of use.
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.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See General directions for use.
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.
4.2. Use description
Table 2
Use 6.4b: Disinfection of food packaging by aseptic technology (spray/vapour)
| Product type | PT04: Food and feed area |
| Target organism(s) (including development stage) | Common name: bacteria Common name: Bacterial spores Common name: yeasts |
| Field(s) of use | indoor use Disinfection of cardboard or plastic packaging (e.g. bricks, bottles, cups, pouches …) before filling with sensitive food products to be stored at room temperature for a long period |
| Application method(s) | Method: closed system Detailed description: Surfaces must be cleaned before disinfection. ‘spray technology’: the packaging material (preformed cardboard containers, plastic bottles and plastic preforms) is exposed to hydrogen peroxide vapor generated from a 25 % hydrogen peroxide solution which is sprayed and then vaporized, ensuring the complete sterilization of the inner surface of the packaging. Further hot sterile air removes hydrogen peroxide residual in the brick or bottle. The sterile packaging is then filled with sterile food products and sealed. The disinfection machines are closed systems with no access to professionals during operation. In case of maintenance, the machine is stopped, hydrogen peroxide is removed (vapour extraction). |
| Application rate(s) and frequency | Number and timing of application: Validated food processing systems that have control over the contaminant load on food packaging surfaces or food processing equipment prior to fill may vary concentration, temperature, and/or contact time to achieve the required level of disinfection. Container volume range (generally from 100 to 2 000 ml) may also influence operating parameters. The biocidal product is 25 % w/w hydrogen peroxide solutions and is ready-to-use. Spray technology: Application rate: 20–30 g H2O2/m3 Contact time: 12 seconds Temperature: 130 °C |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 600 litre (L) and 1 000 L HDPE intermediate bulk container (IBC) 30 kilogram (kg) and 65 kg high-density polyethylene (HDPE) jerrycans |
4.2.1. Use-specific instructions for use
All surfaces must be cleaned before disinfection.
The user shall always carry out a microbiological validation of the disinfection process in the machine to be used with the devices to be used after which a protocol for disinfection of these machine can be made and used thereafter.
4.2.2. Use-specific risk mitigation measures
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
Mixing and loading (automated) or maintenance of the machine:
-
- Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 4 is mandatory.
-
- Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, polyvinyl chloride (PVC).
-
- The use of eye protection (chemical goggles/face shield) (EN 166 or equivalent) during handling of the product is mandatory.
-
- Wear coverall (EN 13034 or equivalent)
Mixing and loading (manual):
- — Use of respiratory protective equipment (RPE) (EN 405 or equivalent) with APF 10 is mandatory.
- — Wear protective chemical resistant gloves (EN 374 or equivalent) during product handling phase. Examples of preferred materials for insulating gloves: neoprene, PVC.
- — The use of eye protection (chemical goggles/face shield) (EN 166 or equivalent) during handling of the product is mandatory.
During use of the machine the following risk mitigation measures (RMMs) apply:
- — All surfaces must be cleaned before disinfection.
- — Machines to be operated in areas where local exhaust ventilation (LEV) or forced ventilation is operational.
- — Wear coverall (EN 13034 or equivalent)
For other instructions, see General directions for use.
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.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See General directions for use.
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.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
5.1. Instructions for use
Unless otherwise stated on the label, products must be diluted for use.
Follow the label instructions for use dilutions and application volumes according to the use required.
Surfaces shall be cleaned before disinfection.
See Use-specific instructions for use per use
5.2. Risk mitigation measures
- — No access of third parties during application/treatment/maintenance, unless the required personal protective equipment as prescribed for the professional user is worn.
- — Re-entry is only permitted once the air concentration for hydrogen peroxide has dropped below 0,9 ppm (1,25 mg/m3 ) or relevant lower national reference value
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First-Aid measures
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
Protection of first-aiders: In case of insufficient ventilation, wear suitable respiratory equipment. Protective suit
Fire-fighting measures
Extinguishing media:
Suitable extinguishing media: In case of fire involving the product: Water spray. Unsuitable extinguishing media: All other extinguishants
Special hazards arising from the substance or mixture: Contact with combustible material may cause fire. Thermal decomposition gives: Oxygen, that can enhance sites of combustion. Hazards of over-pressurization in containers exposed to heat: explosion risk.
Precautions for fire-fighters: Specific methods: Keep upwind and operate from safe distance. In case of fire, remove exposed containers. Containers/tanks should be cooled with water spray.
Special protective actions for fire-fighters: Wear self-contained breathing apparatus and protective suit.
Accidental release measures
Personal precautions, protective equipment and emergency procedures:
Evacuate non-essential staff and those not equipped with individual protection apparatus. Prohibit contact with eyes. Avoid contact with skin. Avoid inhalation of vapours. Prohibit all sources of sparks and ignition - Do not smoke. If safe to do so, plug or seal off leak. Remove all incompatible substances.
Environmental precautions: Dam up with sand or inert earth (do not use combustible materials). Dilute with large quantities of water before discharging into sewers or into the environment
Methods and materials for containment and cleaning up:
Recovery: Soak up with inert absorbent material. Never reintroduce the spilled product in another container. Risk of decomposition.
Neutralisation: Dilute with water.
Elimination: Dispose of rinse water as waste water.
5.4. Instructions for safe disposal of the product and its packaging
Waste treatment
Disposal of product: Dilute with water.
Disposal of packaging: Clean container with water. Recycle or incinerate at an approved waste disposal site. In accordance with local and national regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life of 1 year.
The product should be stored in the original packaging.
Protect from light.
Store below 54 °C.
6. OTHER INFORMATION
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
Professionals (including industrial, professionals) mean trained professional if this is required by national legislation.
Please be aware of the European reference value of 1,25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product (please be aware that relevant lower national limit values may apply).
The full titles of the EN standards referenced in the Risk mitigation measures are:
- — EN 13832 – Footwear protecting against chemicals
- — EN 374 – Protective gloves against dangerous chemicals and micro-organisms
- — EN 405 – Respiratory protective devices
- — EN 166 – Eye protection against chemicals
- — EN 13034 – Protective coverall against liquid chemicals – type 6
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) | VALSTERANE 25 SHP | VALSTERANE 25 SHP | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0016 1-5 | EU-0035039-0016 1-5 | EU-0035039-0016 1-5 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| hydrogen peroxide | hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 25 % (w/w) |
1. META SPC 6 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 6 identifier
| Identifier | Meta SPC: 7 |
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 | hydrogen peroxide | Active substance | 7722-84-1 | 231-765-0 | >=25–<=25 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 6
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
| Hazard statements | H272: May intensify fire; oxidiser. H302: Harmful if swallowed. H318: Causes serious eye damage. H412: Harmful to aquatic life with long lasting effects. |
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P273: Avoid release to the environment. P280: Wear eye protection. P280: Wear face protection. P301+P312: IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P330: Rinse mouth. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
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