Commission Implementing Regulation (EU) 2025/2221 of 31 October 2025 amending Implementing Regulation (EU) 2023/364 as regards administrative changes to the Union authorisation of the biocidal product family IPA 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 16 February 2023, Commission Implementing Regulation (EU) 2023/364 (2) granted a Union authorisation, under number EU-0028425-0000, to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘IPA Family 1’. Annex II to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.

(2) On 30 November 2023 and 17 December 2024, Ecolab Deutschland GmbH submitted notifications to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), of administrative changes to the Union authorisation for the biocidal product family ‘IPA Family 1’, as referred to in Title 1 of the Annex to that Regulation. The notifications were recorded in the Register for Biocidal Products (‘the Register’) under case numbers BC-KE090454-43 and BC-JF101949-39. The notified proposed changes to that authorisation concern a clarification of the instructions for use for all products in the family, the addition of new trade names, the removal and addition of the biocidal product formulators and the addition of active substance manufacturers.

(3) On 24 January 2024 and 16 January 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions (4) on the notified administrative changes to the Union authorisation for the biocidal product family ‘IPA Family 1’, together with a revised summary of the biocidal product characteristics. In the opinions, the Agency concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Sections 1 and 2, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

(4) On 23 January 2025, the Agency transmitted to the Commission a revised summary of the biocidal product characteristics of the Union authorisation for the biocidal product family ‘IPA Family 1’ in all the official languages of the Union, covering all the administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.

(5) The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘IPA Family 1’ to introduce the administrative changes requested by Ecolab Deutschland GmbH.

(6) Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of ‘IPA Family 1’ as set out in Annex II to Implementing Regulation (EU) 2023/364 remains unchanged.

(7) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, Annex II to Implementing Regulation (EU) 2023/364 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 in February 2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes.

(8) Implementing Regulation (EU) No 2023/364 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Implementing Regulation (EU) No 2023/364 is replaced by the text 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, 31 October 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) 2023/364 of 16 February 2023 granting a Union authorisation for the biocidal product family ‘IPA Family 1’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 50, 17.2.2023, p. 28, ELI: http://data.europa.eu/eli/reg_impl/2023/364/oj).

(3) 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).

(4) ECHA Opinions Nos UAD-C-1706275-25-00/F of 24 January 2024 and UAD-C-1790252-35-00/F of 16 January 2025 on the administrative change of the Union authorisation of the biocidal product family ‘IPA Family 1’, https://echa.europa.eu/opinions-on-union-authorisation.