Commission Implementing Regulation (EU) 2025/223 of 6 February 2025 amending Implementing Regulation (EU) 2022/1423 as regards minor changes to the Union authorisation for the biocidal product family Hydrogen Peroxide Family 1

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 50(2) thereof,

Whereas:

(1) On 22 July 2022, Commission Implementing Regulation (EU) 2022/1423 (2) granted a Union authorisation, under number EU-0024303-0000, to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘Hydrogen Peroxide Family 1’. That Regulation was later amended by Commission Implementing Regulation (EU) 2024/2209 (3), which introduced administrative and minor changes to the authorisation.

(2) Commission Implementing Regulation (EU) No 354/2013 (4) lays down the procedural rules for the different categories of changes referred to in Article 50(3) of Regulation (EU) No 528/2012. Upon receipt of an opinion from the European Chemicals Agency (‘the Agency’) on an application from an authorisation holder of a Union authorisation seeking to change any of the information submitted for the initial application for authorisation, the Commission is to decide whether the conditions of Article 19 or, where relevant, Article 25 of Regulation (EU) No 528/2012, are still met and whether the terms and conditions of the authorisation need to be amended.

(3) On 24 April 2024, Ecolab Deutschland GmbH submitted an application to the Agency, in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, for minor changes to the Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’, as referred to in Title 2 of the Annex to that Regulation. Ecolab Deutschland GmbH applied for the following changes, concerning five uses of the products in meta summary of biocidal product characteristics 5: (i) amending the contact time from 30 minutes to 60 minutes for bacterial spores in clean conditions; (ii) amending the contact time from 5 min to 60 min for Clostridium difficile spores in clean conditions; and (iii) removing the claim of 60 minutes for bacterial spores in dirty conditions. The application was recorded in the register for biocidal products under case number BC-AJ094453-41.

(4) On 20 September 2024, the Agency submitted to the Commission an opinion of the Biocidal Products Committee (5) on the application for minor changes, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, together with a revised summary of the biocidal product characteristics and a revised assessment report. In the opinion, the Agency concludes that after the implementation of the changes sought by the authorisation holder, the conditions of Article 19 of Regulation (EU) No 528/2012 are still met.

(5) On 11 October 2024, the Agency transmitted to the Commission the revised summary of biocidal product characteristics of the Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’ in all official languages of the Union covering the minor changes applied for, in accordance with Article 12(6) of Implementing Regulation (EU) No 354/2013.

(6) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’ to introduce the minor changes requested by Ecolab Deutschland GmbH.

(7) Except for the amendments regarding the minor changes, all other information included in the summary of the biocidal product characteristics of ‘Hydrogen Peroxide Family 1’ as set out in the Annex to Implementing Regulation (EU) 2022/1423 remains unchanged.

(8) In order to enhance clarity and to ease the access of users and interested parties to the final consolidated version of the summary of biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2022/1423 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the register for biocidal products in February 2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes.

(9) Implementing Regulation (EU) 2022/1423 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2022/1423 is replaced by the text set out in the Annex to this Regulation.

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 6 February 2025.

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) 2022/1423 of 22 July 2022 granting a Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’ (OJ L 222, 26.8.2022, p. 1; ELI: http://data.europa.eu/eli/reg_impl/2022/1423/oj).

(3) Commission Implementing Regulation (EU) 2024/2209 of 5 September 2024 amending Implementing Regulation (EU) 2022/1423 as regards administrative and minor changes to the Union authorisation for the biocidal product family Hydrogen Peroxide Family 1 (OJ L, 2024/2209, 11.9.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2209/oj).

(4) 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).

(5) Opinion of the Biocidal Products Committee (BPC) of 19 September 2024 on the minor change of the Union authorisation of the biocidal product family Hydrogen Peroxide Family 1, ECHA/BPC/445/2024, https://echa.europa.eu/documents/10162/79839763/hydrogen_peroxide_fam_1_ua-mic_bc-AJ094453-41_final_bpc_opinion_en.pdf/e7a69440-c1e0-bcc4-0ca8-88138895fef0?t=1726819953228.