Commission Implementing Regulation (EU) 2026/2050 of 11 September 2026 granting a Union authorisation for the biocidal product family Hydrogen peroxide biocidal product family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

of 11 September 2026

granting a Union authorisation for the biocidal product family ‘Hydrogen peroxide biocidal product family’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(Text with EEA relevance)

Preamble

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ¹ , and in particular Article 44(5), first subparagraph, thereof,

Whereas:

(1) On 25 January 2017, MELLERUD CHEMIE GMBH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 ² for Union authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘Hydrogen peroxide biocidal product family’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-JT029241-30 in the Register for Biocidal Products. The application referred to the biocidal product family ‘Hydrogen peroxide product family’ authorised by Commission Implementing Regulation (EU) 2026/158 ³ , with authorisation number EU-0031657-0000.

(2) The biocidal product family ‘Hydrogen peroxide biocidal product family’ contains hydrogen peroxide as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.

(3) On 7 May 2024, the Agency submitted to the Commission its opinion ⁴ and the draft summary of product characteristics (‘SPC’) of ‘Hydrogen peroxide biocidal product family’, in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.

(4) In the opinion, the Agency concludes that the proposed differences between the biocidal product family ‘Hydrogen peroxide biocidal product family’ and the related reference biocidal product family ‘Hydrogen peroxide product family’ are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 ⁵ , and that based on the assessment of the related reference biocidal product family ‘Hydrogen peroxide product family’ and subject to compliance with the draft SPC, the same biocidal product family ‘Hydrogen peroxide biocidal product family’ meets the conditions laid down in Article 19(6) of Regulation (EU) No 528/2012.

(5) Following the authorisation of the reference biocidal product family ‘Hydrogen peroxide product family’ on 23 January 2026, the Agency transmitted to the Commission, on 5 March 2026, the revised draft SPC of the same biocidal product family ‘Hydrogen peroxide biocidal product family’ in all the official languages of the Union, in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(6) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family ‘Hydrogen peroxide biocidal product family’.

(7) The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference biocidal product family ‘Hydrogen peroxide product family’.

(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0032675-0000 is hereby granted to MELLERUD CHEMIE GMBH for the making available on the market and use of the same biocidal product family ‘Hydrogen peroxide biocidal product family’ in accordance with the summary of the product characteristics set out in the Annex.

The Union authorisation is valid from 4 October 2026 until 31 January 2036.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Final provisions

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 11 September 2026. For the Commission The President Ursula VON DER LEYEN

¹ OJ L 167, 27.6.2012, p. 1 , ELI: http://data.europa.eu/eli/reg/2012/528/oj .

² Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council ( OJ L 125, 7.5.2013, p. 4 , ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj ).

³ 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. OJ L, 2026/158, 26.1.2026, ELI: http://data.europa.eu/eli/reg_impl/2026/158/oj ).

⁴ European Chemicals Agency opinion of 7 May 2024 on the Union authorisation of the same biocidal product family ‘Hydrogen peroxide biocidal product family’ UBP-C-1729529-06-00/F https://echa.europa.eu/fr/opinions-on-applications-for-union-authorisation .

⁵ Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council ( OJ L 109, 19.4.2013, p. 4 , ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj ).

Hydrogen peroxide biocidal product family

Product type(s)

PT02: Disinfectants and algaecides not intended for direct application to humans or animals

PT04: Food and feed area

Authorisation number EU-0032675-0000

R4BP asset number EU-0032675-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name

1.2. Product type(s)

1.3. Authorisation holder

1.4. Manufacturer(s) of the product

1.5. Manufacturer(s) of the active substance(s)

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1. Qualitative and quantitative information on the composition of the family

2.2. Type(s) of formulation

PART II

SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 1 identifier

1.2. Suffix to the authorisation number

1.3. Product type(s)

2. META SPC 1 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 1

2.2. Type(s) of formulation of the meta SPC 1

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description

Table 1

Surface disinfection healthcare, RTU

4.1.1. Use-specific instructions for use

Spray evenly and make sure to wet surfaces completely.

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

For control of bacteria, yeasts, fungi and viruses: Allow to take effect for 15 minutes.

Rinse surfaces after use.

4.1.2. Use-specific risk mitigation measures

see general directions of use for meta-SPC 1

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 of use for meta-SPC 1

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

see general directions of use for meta-SPC 1

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 of use for meta-SPC 1

4.2. Use description

Table 2

Surface disinfection non-healthcare and food/feed areas, RTU

4.2.1. Use-specific instructions for use

Spray evenly and make sure to wet surfaces completely.

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.

Rinse surfaces after use.

4.2.2. Use-specific risk mitigation measures

see general directions of use for meta-SPC 1

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 of use for meta-SPC 1

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

see general directions of use for meta-SPC 1

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 of use for meta-SPC 1

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1. Instructions for use

see use-specific instructions for each use

5.2. Risk mitigation measures

Keep out of reach of children.

Re-entry is only permitted once the air concentration has dropped below 0,9 ppm (1,25 mg/m 3 ) or relevant lower national reference value. Use a calibrated sensor to confirm the enclosure is below 0,9 ppm (1,25 mg/m 3 ) or the corresponding national reference value prior to re-entry.

No access of third parties during application/treatment.

Do not use for cleaning toilets or in a cleaning toilets routine.

Professional user:

— During loading: Wear protective gloves classified under EN 374 or equivalent and goggles consistent with EN ISO 16321 or equivalent. Wash hands after use.

— During application: Wear a respiratory protective equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 20 (filter type (code letter, colour) to be specified by the authorisation holder within the product information). Wear protective gloves against chemicals classified under EN 374 or equivalent and protective 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.

Wash hands after use. Always spray away from user. Only for treatment of small surfaces (2 m 2 )

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.

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.

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:

Do not allow product to reach sewage system or water bodies.

Dilute spillages with much water.

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 36 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 section 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 14387 - Respiratory Protective Devices – Gas filter

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 1

7.1. Trade name(s), authorisation number and specific composition of each individual product

7.2. Trade name(s), authorisation number and specific composition of each individual product

7.3. Trade name(s), authorisation number and specific composition of each individual product

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 2 identifier

1.2. Suffix to the authorisation number

1.3. Product type(s)

2. META SPC 2 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 2

2.2. Type(s) of formulation of the meta SPC 2

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description

Table 1

Surface disinfection healthcare, RTU

4.1.1. Use-specific instructions for use

Spray evenly and make sure to wet surfaces completely.

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

For control of bacteria, yeasts, fungi and viruses: Allow to take effect for 15 mins.

Rinse surfaces after use.

4.1.2. Use-specific risk mitigation measures

see general directions for use of meta-SPC 2

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

see general directions for use of meta-SPC 2

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 2

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 2

4.2. Use description

Table 2

Surface disinfection non-healthcare and food/feed areas, RTU

4.2.1. Use-specific instructions for use

Spray evenly and make sure to wet surfaces completely.

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

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

Rinse surfaces after use.

4.2.2. Use-specific risk mitigation measures

see general directions for use of meta-SPC 2

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 2

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 2

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 2

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1. Instructions for use

see use-specific instructions for each use

5.2. Risk mitigation measures

Keep out of reach of children.

Re-entry is only permitted once the air concentration has dropped below 0,9 ppm (1,25 mg/m 3 ) or relevant lower national reference value.

Use a calibrated sensor to confirm the enclosure is below 0,9 ppm (1,25 mg/m 3 ) or the corresponding national reference value prior to re-entry.

Unprotected persons are not allowed to be present during the application of the product. No access of third parties during application/treatment.

Do not use for cleaning toilets or in a cleaning toilets routine.

During application and 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).

During application: Wear protective gloves classified under EN 374 or equivalent and goggles consistent with EN ISO 16321 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

Wash hands after use.

Always spray away from the user. Only for treatment of small surfaces (2 m 2 ).

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.

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.

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:

Do not allow product to reach sewage system or water bodies.

Dilute spillages with much water.

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 36 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 section 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 14387 - Respiratory Protective Devices – Gas filter

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 2

7.1. Trade name(s), authorisation number and specific composition of each individual product

7.2. Trade name(s), authorisation number and specific composition of each individual product

Footnotes

1. , ELI: . ↩ ↩²

2. Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (, ELI: ). ↩ ↩²

3. 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. ). ↩ ↩²

4. European Chemicals Agency opinion of 7 May 2024 on the Union authorisation of the same biocidal product family ‘Hydrogen peroxide biocidal product family’ UBP-C-1729529-06-00/F . ↩ ↩²

5. Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (, ELI: ). ↩ ↩²