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.
Use 7.1: 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.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 6
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 6
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | PEROXAL 25 TNB | PEROXAL 25 TNB | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0017 1-6 | EU-0035039-0017 1-6 | EU-0035039-0017 1-6 | ||
| 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 7 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 7 identifier
| Identifier | Meta SPC: 8 |
1.2. Suffix to the authorisation number
| Number | 1-7 |
1.3. Product type(s)
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
2. META SPC 7 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 7
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| hydrogen peroxide | hydrogen peroxide | Active substance | 7722-84-1 | 231-765-0 | >=35–<=35 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 7
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
| Hazard statements | H272: May intensify fire; oxidiser. H302: Harmful if swallowed. H315: Causes skin irritation. H318: Causes serious eye damage. H335: May cause respiratory irritation. 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. P271: Use only outdoors or in a well-ventilated area. 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. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P330: Rinse mouth. P332+P313: If skin irritation occurs: Get medical advice. P332+P313: If skin irritation occurs: Get medical attention. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P405: Store locked up. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use 8.9: Disinfection of internal surfaces of pharmaceutical/medical isolators
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| Target organism(s) (including development stage) | Common name: Bacterial spores Common name: fungi Common name: bacteria Common name: yeasts |
| Field(s) of use | indoor use Professional disinfection of inner surfaces of isolators (leak-proof enclosures where operators manipulate sterile products without direct contact) by vaporized hydrogen peroxide. |
| Application method(s) | Method: closed system Detailed description: Vaporisation of hydrogen peroxide |
| Application rate(s) and frequency | Number and timing of application: The product is a 35 % w/w hydrogen peroxide solution and is ready-to-use. Volume: 0,04–0,61 m3 Application rate (recommended): 230–390 g product /m3 Contact time: 8 to 60 minutes Temperature: 20 °C Recommended humidity: up to 50 % Aeration time: suitable to reach a 1 ppm residual H2O2 content in the enclosure Frequency: maximum 3 times per day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 1L and 5L 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. Install biological and chemical indicators to validate the disinfection cycle.
The vaporiser unit is fed by connecting a 1l bottle of hydrogen peroxide solution.
The decontamination process starts with a dehumidification phase in which the machine removes water from the atmosphere.
In the disinfection phase, the machine injects vaporised hydrogen peroxide into the sealed area for decontamination to get the hydrogen peroxide concentration up to the effective level. During this phase, hydrogen peroxide vapour 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 a defined value.
Biological and chemical indicators can then be collected to confirm the efficacy of the decontamination cycle. No one will actually enter the isolator after disinfection. No re-entry requirement is therefore necessary.
Application rates may vary from one equipment to the other. It is possible to use the product with different decontamination devices or for isolators with different volumes. The user shall always carry out a microbiological validation of the disinfection in the isolator to be disinfected with the devices to be used after which a protocol for disinfection of these isolators can be made and used thereafter.
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.
Insert the sealed cartridge as delivered by the manufacturer into the VHP 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.
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.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 7
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 7
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | HYDROCYDE | HYDROCYDE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | RAIDOX | RAIDOX | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0018 1-7 | EU-0035039-0018 1-7 | EU-0035039-0018 1-7 | ||
| 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) | RAIDOX | RAIDOX | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0035039-0019 1-7 | EU-0035039-0019 1-7 | EU-0035039-0019 1-7 | ||
| 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) |
ELI: http://data.europa.eu/eli/reg_impl/2026/277/oj
ISSN 1977-0677 (electronic edition)
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