Commission Implementing Regulation (EU) 2026/158 of 23 January 2026 granting a Union authorisation for the biocidal product family Hydrogen peroxide product family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Type Implementing Regulation
Publication 2026-01-26
State In force
Text As published
Department European Commission, SANTE
Source EUR-Lex
articles 2

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.

Reform history JSON API

see general directions for use of meta-SPC 5

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use of meta-SPC 5

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

see general directions for use of meta-SPC 5

4.2.   Use description

Table 2
Surface disinfection non-healthcare and food/feed areas, concentrate
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) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data
Field(s) of use indoor use Disinfection of hard non-porous surfaces in non-healthcare and food/feed areas
Application method(s) Method: manual application spraying Detailed description: Trigger spraying of diluted concentrate. Manual application by wiping with wipes. Manual application by mopping with mop bucket with wringer
Application rate(s) and frequency Application Rate: 40 ml/m2 Number and timing of application: Prepare the dilution manually or use automated dosing system Apply diluted product: Contact time: Bacteria, yeasts and fungi; 5 minutes Viruses; 15 minutes Dilution rate: 1% dilution of the biocidal product (corresponding to 0,5 % H2O2) for bacteria, yeasts and viruses. 10% dilution of the biocidal product (corresponding to 5 % H2O2) for fungi. Use frequency: up to 10 times a day
Category(ies) of users professional
Pack sizes and packaging material 10 litres, 20 litres, 50 litres, 200 and 1 000 litres High Density Polyethene (HDPE)containers
4.2.1.   Use-specific instructions for use

Prepare the required product dilution manually or use automated dosing system.

Application method:

  • — Spraying: Spray diluted product (trigger spray) evenly and make sure to wet surfaces completely.
  • — Wiping: soak the wipe with diluted product in a bucket or spray the diluted product on the wipe. Apply diluted product by wiping evenly and make sure to wet surfaces completely.
  • — Mopping: soak the mop with diluted product using a mop bucket with wringer. Apply diluted product by mopping evenly and make sure to wet surfaces completely.

Rinse surfaces after use.

For control of bacteria, yeasts and fungi: Allow to take effect for 5 minutes.

For control of viruses: Allow to take effect for 15 minutes.

Dilution rate:

1 % dilution of the biocidal product (corresponding to 0,5 % H2O2) for bacteria, yeast, and viruses (1 ml of product with 50 % H2O2, add up to 100 ml with water) and 10 % dilution of the biocidal product (corresponding to 5 % H2O2) for fungi.

4.2.2.   Use-specific risk mitigation measures

Unprotected persons are not allowed to be present during the application of the product. No access of third parties during application/treatment. Re-entry is only permitted once the air concentration has dropped below 0,9 ppm (1,25 mg/m3 ) or relevant lower national reference value.

For 1 % in use dilution:

During trigger spraying: Wear a respiratory protective equipment (RPE) aerosol and gas filter with an assigned protection factor of at least 4 (filter type (code letter, colour) and the standards to be specified by the authorisation holder within the product information). Wear protective gloves, clothes (coverall at least type 6) and goggles. Only for treatment of small surfaces (2 m2)

During manual application by mopping: Wear a respiratory protective equipment (RPE) aerosol and gas filter with an assigned protection factor of at least 10 (filter type (code letter, colour) and the standards to be specified by the authorisation holder within the product information)Wear protective gloves (EN374 or similar), goggles (EN 166 or similar), and coverall (EN 13034 or similar). A mop/brush with a long handle has to be used to apply the solution. Do not immerse hands in the solution.

During manual application by wiping: Wear a respiratory protective equipment (RPE) aerosol and gas filter with an assigned protection factor of at least 4 (filter type (code letter, colour) and the standards to be specified by the authorisation holder within the product information)Wear protective gloves (EN374 or similar), goggles (EN 166 or similar), and coverall (EN 13034 or similar). A mop/brush with a long handle has to be used to apply the solution. Do not immerse hands in the solution. Only for treatment of small surfaces (2 m2)

Wash hands after use.

For 10% in-use dilution

During trigger spraying: Wear a respiratory protective equipment (RPE) aerosol and gas filter with an assigned protection factor of at least 20 (filter type (code letter, colour) and the standards to be specified by the authorisation holder within the product information). Wear protective gloves (EN374 or similar), clothes (coverall at least type 6) and goggles (EN 166 or similar).Only for treatment of small surfaces (2 m2)

During manual application by mopping: Wear a respiratory protective equipment (RPE) aerosol and gas filter with an assigned protection factor of at least 40 (filter type (code letter, colour) and the standards to be specified by the authorisation holder within the product information). Wear protective gloves (EN374 or similar), goggles (EN 166 or similar), and coverall (EN 13034 or similar). A mop/brush with a long handle has to be used to apply the solution. Do not immerse hands in the solution. Ventilation rate minimum 1,5/h or with a window open.

During manual application by wiping: Wear a respiratory protective equipment (RPE) aerosol and gas filter with an assigned protection factor of at least 40 (filter type (code letter, colour) and the standards to be specified by the authorisation holder within the product information). Wear protective gloves (EN374 or similar), goggles (EN 166 or similar), and coverall (EN 13034 or similar). A mop/brush with a long handle has to be used to apply the solution. Do not immerse hands in the solution. Only for treatment of small surfaces (2 m2)

Wash hands after use.

The full references to the EN standards are available in Section 6.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

see general directions for use of meta-SPC 5

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use of meta-SPC 5

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

see general directions for use of meta-SPC 5

4.3.   Use description

Table 3
Disinfection of inner surfaces (incl. CIP and drinking water systems), concentrate
Product type PT04: Food and feed area
Where relevant, an exact description of the authorised use /
Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Scientific name: no data Common name: Legionella Development stage: no data
Field(s) of use indoor use Disinfection of inner-surfaces (hard non-porous surfaces) in food industry (incl. cleaning in place) and inner surfaces in veterinary and human drinking water systems
Application method(s) Method: closed system Detailed description: Filling the system with diluted concentrate.
Application rate(s) and frequency 1% dilution of the product (corresponding to 0,5 % H2O2) Number and timing of application: Prepare the dilution manually or use automated dosing system Use temperature: room temperature bacteria and yeasts; 1 % dilution of the product (corresponding to 0,5 % H2O2), contact time 5 minutes. fungi; 10 % dilution of the product (corresponding to 5 % H2O2), contact time 5 minutes. viruses; 1 % dilution of the product (corresponding to 0,5 % H2O2), contact time 15 minutes. Legionella, in drinking water systems; 1 % dilution of the product (corresponding to 0,5 % H2O2), contact time 30 minutes. Use frequency: up to 10 times a day
Category(ies) of users professional
Pack sizes and packaging material 10 litres, 20 litres, 50 litres, 200 litres and 1 000 litres High Density Polyethene (HDPE) containers
4.3.1.   Use-specific instructions for use

Disinfection of drinking water systems can only be performed during an out of service period.

Systems cannot be in use during disinfection.

Dilute the product in the installation or system until a dilution of 1 % is reached.

Prepare the dilution manually or use automated dosing system.

Dilution rate for bacteria, yeasts, viruses and Legionella: 1 % dilution of the biocidal product (corresponding to 0,5 % H2O2) (1 ml of product with 50 % H2O2, add up to 100 ml with water).

Dilution rate for fungi: 10 % dilution of the biocidal product (corresponding to 5 % H2O2)

For control of bacteria, yeasts and fungi: Allow to take effect for 5 minutes.

For control of viruses: Allow to take effect for 15 minutes.

For control of Legionella, in drinking water systems: Allow to take effect for 30 minutes.

Rinse the system vigorously after having allowed the product to take effect in order to remove loosened dirt. Use a measuring strip to measure the amount hydrogen peroxide in the rinsing water. Rinse the piping system with pure tap water until no more hydrogen peroxide is measured in the rinse water.

4.3.2.   Use-specific risk mitigation measures

see general directions for use of meta-SPC 5

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

see general directions for use of meta-SPC 5

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use of meta-SPC 5

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

see general directions for use of meta-SPC 5

4.4.   Use description

Table 4
Room disinfection by fogging, concentrate
Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use /
Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Tuberculosis bacilli Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data
Field(s) of use indoor use Disinfection of hard non-porous surfaces in healthcare.
Application method(s) Method: fogging Detailed description: Fogging of diluted concentrate
Application rate(s) and frequency Application Rate: 5 ml/m3 (corresponding to 2,5 ml H2O2/m3) 20 % dilution v/v of product (corresponding to 10 % H2O2) in fogging device Number and timing of application: Clean surfaces before disinfection treatment. Prepare the dilution manually or use automated dosing system 20 % dilution v/v of product (corresponding to 10 % H2O2) and add the diluted product to the fogging device Medibios basic; 5 ml/m3 (corresponding to 2,5 ml H2O2/m3) Room size 30-150 m3. Relative humidity: 40 - 80 % Particle size: lower than 1 - 5 μm The fogging time is regulated, the device will automatically stop. 2 hours contact time (at described conditions) Use temperature: room temperature Use frequency: up to 4 times a day
Category(ies) of users professional
Pack sizes and packaging material 10 litres, 20 litres, 50 litres, 200 litres and 1 000 litres High Density Polyethene (HDPE) containers
4.4.1.   Use-specific instructions for use

Clean and dry the surfaces before disinfection.

If present, switch off the air-conditioning system. Close all windows. Close doors and where necessary, seal door cracks with adhesive tape. Make sure that outside the room there is a warning sign to not enter the room.

The product is used in combination with the fogging device Medibios Basic.

Dilution rate: 20 % dilution of the product (corresponding to 10 % H2O2) (20 ml of product with 50 % H2O2, add up to 100 ml with water)

Prepare the dilution manually or with an automated dosing system. Add the 20 % dilution to the fogging device using the dosing bottle.

Verify that there are no persons or animals present in the room.

Start the fogging device Medibios basic after setting the dosage per cubic meter. A delayed start of 15 seconds allows the user to leave the room before the fogging starts.

The device will automatically stop fogging. Allow a contact time of 2 hours after the biocidal product is fully diffused into the room.

After fogging and contact time, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment. The warning sign should be removed after this waiting period so that the public knows that the room can be entered again. Re-entry is only permitted once the air concentration has dropped below 0,9 ppm (1,25 mg/m3) or the corresponding national reference value, if applicable (see section ‘other information’ for details).

The professional user may only enter the room in emergency situations or to reactivate the ventilation when the hydrogen peroxide level has dropped below 36 ppm (50 mg/m3), considering RPE with APF 40 against vapour (full mask; type of RPE, coverall and gloves to be specified by the authorisation holder within the product information).

Use a calibrated sensor to confirm the enclosure is below 0,9 ppm (1,25 mg/m3) or the corresponding national reference value prior to re-entry.

During emergency situations, the professional user is only allowed to enter during treatment when wearing suitable protective personal equipment and a self-contained breathing apparatus. See section below.

The user shall always carry out a microbiological and chemical 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.

4.4.2.   Use-specific risk mitigation measures

Make sure that outside the room there is a warning sign to not enter the room.

Leave the room within 15 seconds after starting the treatment and make sure that there are no persons or animals in the room.

2,5 hours after the end of the fogging, it is safe to enter the room again and to switch on the air-conditioning system. Remove the warning sign after this waiting period so that the public knows that the room can be entered again.

For re-entry in case of emergency: Wear a respiratory protective equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 40 (filter type (code letter, colour) to be specified by the authorisation holder within the product information).

Re-entry is only permitted once the air concentration has dropped below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value. Use a calibrated sensor to confirm the enclosure is below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value prior to re-entry.

The full references to the EN standards are available in Section 6.

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

see general directions for use of meta-SPC 5

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use of meta-SPC 5

4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

see general directions for use of meta-SPC 5

4.5.   Use description

Table 5

Equipment/instruments disinfection, concentrate

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) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data
Field(s) of use indoor use Disinfection of equipment in healthcare, non-healthcare and food industry.
Application method(s) Method: open system: immersion Detailed description: Immersion and filling
Application rate(s) and frequency Application Rate: Healthcare: 5 % H2O2; non-healthcare: 0,5 % H2O2 Food and/or feed areas bacteria and yeasts; 1 % dilution of the product (corresponding to 0,5 % H2O2) fungi; 10 % dilution of the product (corresponding to 5 % H2O2) Healthcare bacteria, yeasts, fungi and viruses; 10 % dilution of the product (corresponding to 5 % H2O2) Number and timing of application: Prepare the dilution manually or use automated dosing system Use temperature: room temperature Food and/or feed areas bacteria and yeasts; 1 % dilution of the product (corresponding to 0,5 % H2O2), contact time 5 minutes fungi; 10 % dilution of the product (corresponding to 5 % H2O2), contact time 5 minutes Healthcare bacteria, yeasts, fungi and viruses; 10% dilution of the product (corresponding to 5 % H2O2), contact time 15 minutes Use frequency: up to 30 times a day, max. 10 l per bath
Category(ies) of users professional
Pack sizes and packaging material 10 litres, 20 litres, 50 litres, 200 litres and 1 000 litres High Density Polyethene (HDPE) containers
4.5.1.   Use-specific instructions for use

Prepare the dilution manually or use automated dosing system.

Submerge the equipment or machinery to be treated in the dilution. Allow to take effect for:

Food and/or feed areas: 5 minutes (bacteria, yeasts and fungi).

Dilution rate for bacteria and yeasts: 1% dilution of the product (corresponding to 0,5 % H2O2) (1 ml of product with 50 % H2O2, add up to 100 ml with water)

Dilution rate for fungi: 10% dilution of the product (corresponding to 5 % H2O2) (10 ml of product with 50 % H2O2, add up to 100 ml with water)

Healthcare: 15 minutes (bacteria, yeasts, fungi and viruses).

Dilution rate: 10 % dilution of the product (corresponding to 5 % H2O2): 10 ml of product with 50 % H2O2, add up to 100 ml with water;

Product dilution can only be used once.

If the equipment or machinery may come into contact with foodstuffs after disinfection, rinse it with pure water after treatment.

4.5.2.   Use-specific risk mitigation measures
  • — During application in food/feed areas: Wear protective gloves (EN 374 or equivalent), wear protective goggles (EN ISO 16321 or equivalent). Wash hands after use.
  • — During application in healthcare areas: Wear a respiratory protective equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 10 (filter type (code letter, colour) to be specified by the authorisation holder within the product information). Wear protective gloves (EN 374 or equivalent), goggles (EN ISO 16321 or equivalent), and coverall classified under EN 13034 or equivalent.

The full references to the EN standards are available in Section 6

  • — Use a basket or another appropriate device for the dipping and retrieving of the equipment in the bath to avoid exposure.
  • — Do not immerse hands in the bath
  • — Wash hands after use.
  • — The bath can be used only once and should be emptied immediately after use.
4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

see general directions for use of meta-SPC 5

4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use of meta-SPC 5

4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

see general directions for use of meta-SPC 5

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5

5.1.   Instructions for use

see use-specific instructions for each use

5.2.   Risk mitigation measures

Keep out of reach of children.

  • — Manual mixing and loading: Wear a respiratory equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 4 (filter type (code letter, colour) to be specified by the authorisation holder within the product information. Wear protective clothes consistent with EN 13034 or equivalent, gloves classified under EN 374 or equivalent and goggles consistent with EN ISO16321 or equivalent. Wash hands after use.
  • — Automated mixing and loading: Wear protective clothes consistent with EN 13034 or equivalent, gloves classified under EN 374 or equivalent) and goggles consistent with EN ISO16321 or equivalent).

The full references to the EN standards are available in Section 6.

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 reference to this act.

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 or ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or 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 or ambulance for medical assistance.

Environmental precautions: Prevent soil and water pollution. Prevent spreading in sewers.

5.4.   Instructions for safe disposal of the product and its packaging

Dispose of this material and its container to hazardous or special waste collection point. Must not be disposed together with household garbage. Do not allow product to reach sewage system. Disposal should be in accordance with Local Authority Regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store in dry, dark and well-ventilated area. Protect from frost. Store below 30°C. Protect from direct sunlight. Keep container tightly closed. Must only be kept in original packaging. Shelf life is 24 months.

6. OTHER INFORMATION

Professionals (including industrial users) means trained professionals if this is required by national legislation.

The full titles of the EN standards referenced in sections 4.1.2, 4.2.2, 4.4.2, 4.5.2 and 5.2 ‘Risk mitigation measures’ are:

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

EN ISO 16321 - Eye and face protection for occupational use

EN 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)

EN 14387 - Respiratory Protective Devices

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).

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) HP-BPF-10 HP-BPF-10 Market area: EU Market area: EU Market area: EU
Authorisation number Authorisation number Authorisation number EU-0031657-0010 1-5 EU-0031657-0010 1-5 EU-0031657-0010 1-5
Common name IUPAC name Function Function CAS number CAS number EC number Content (%)
Hydrogen peroxide Active substance Active substance 7722-84-1 7722-84-1 231-765-0 49,5 % (w/w)

ELI: http://data.europa.eu/eli/reg_impl/2026/158/oj

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