Prováděcí nařízení Komise (EU) 2026/158 ze dne 23. ledna 2026 o udělení povolení Unie pro kategorii biocidních přípravků Hydrogen peroxide product family v souladu s nařízením Evropského parlamentu a Rady (EU) č. 528/2012

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 productsOJ L 167, 27.6.2012, p. 1 , ELI: http://data.europa.eu/eli/reg/2012/528/oj. , and in particular Article 44(5), first subparagraph, thereof,

A Union authorisation with authorisation number EU-0031657-0000 is hereby granted to Arche Consortia for the making available on the market and use of the biocidal product family Hydrogen peroxide product family in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 15 February 2026 until 31 January 2036 .

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

(1) On 19 January 2017 , Arche Consortia submitted an application to the European Chemicals Agency (the Agency) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named Hydrogen peroxide product family of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-FN029041-50 in the Register for Biocidal Products.

(2) Hydrogen peroxide 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 8 March 2023 , the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

(4) On 20 June 2023 , the ECHA Efficacy Working Group (WG-II-2023) discussed the application for Union authorisation of the biocidal product family Hydrogen peroxide product family and concluded that the hydrogen peroxide concentration of products in use #2 of meta SPC 5 (summary of the biocidal product characteristics) would have to be raised from 0,5 % H2 O2 to 5 % H2 O2 to ensure their efficacy against fungi.

(5) On 5 October 2023 , the Agency submitted to the Commission its opinionECHA opinion of 13 September 2023 on the Union authorisation of Hydrogen peroxide product family (ECHA/BPC/392/2023), https://echa.europa.eu/opinions-on-union-authorisation. , the draft summary of the biocidal product characteristics (SPC) of Hydrogen peroxide product family and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012. However, the opinion of the Agency, including the draft SPC, omitted to take into account the increase of the concentration to 5 % H2 O2 for the risk to human health.

(6) On 23 October 2023 , the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7) The Commission, after discussion in the Standing Committee on Biocidal Products on 21 June 2024 84th meeting of the Standing Committee on Biocidal Products of 21 June 2024 . , requested the Agency to provide a revised opinion, including a revised draft SPC, identifying adequate use conditions for products in use #2 of meta SPC 5 in accordance with Article 75(1), point (g), of Regulation (EU) No 528/2012 taking into account the concentration of 5 % H2 O2 of products in use #2 of meta SPC 5.

(8) On 28 May 2025 , the Agency transmitted to the Commission its revised opinionECHA opinion of 16 May 2025 on the Union authorisation of Hydrogen peroxide product family (ECHA/BPC/482/2025), https://echa.europa.eu/opinions-on-union-authorisation. , including a revised draft SPC, as well as an updated assessment report, including a new assessment of the risks for products containing 5 % H2 O2 for use #2 against fungi in meta SPC 5 and a recommendation for adequate risk mitigations measures. The revised draft SPC also included a better and consistent description of the uses #1, #2 and #3 of meta SPC 5.The revised opinion concludes that Hydrogen peroxide product family is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(6) of that Regulation.

(9) The Commission concurs with the revised Agency opinion and considers it therefore appropriate to grant a Union authorisation for the biocidal product family Hydrogen peroxide product family.

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

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

ECHA opinion of 13 September 2023 on the Union authorisation of Hydrogen peroxide product family (ECHA/BPC/392/2023), https://echa.europa.eu/opinions-on-union-authorisation.

Article 1 Article 1

Article 2 Article 2

84th meeting of the Standing Committee on Biocidal Products of 21 June 2024 .

ECHA opinion of 16 May 2025 on the Union authorisation of Hydrogen peroxide product family (ECHA/BPC/482/2025), https://echa.europa.eu/opinions-on-union-authorisation.

HAS ADOPTED THIS REGULATION: