Commission Implementing Regulation (EU) 2025/534 of 21 March 2025 amending Implementing Regulation (EU) 2022/1226 as regards administrative changes to the Union authorisation for the single biocidal product Bioquell HPV-AQ

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 14 July 2022, Commission Implementing Regulation (EU) 2022/1226 (2) granted a Union authorisation, under number EU-0027469-0000, to Ecolab Deutschland GmbH for the making available on the market and use of the single biocidal product ‘Bioquell HPV-AQ’. The Annex to that Implementing Regulation provides the summary of product characteristics (‘SPC’) for that single biocidal product.

(2) On 24 January 2023 and 24 April 2024, Ecolab Deutschland GmbH submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), notifications of administrative changes to the Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’, recorded in the register for biocidal products under case numbers BC-EE084020-66 and BC-VW094451-98. The notified proposed changes concern the addition of active substance manufacturers and formulators of biocidal products, a change of the manufacturer name from ‘Ecolab SNC’ to ‘Ecolab Europe GmbH’ to align with other Ecolab biocidal product authorisations and the addition of one packaging size within the packaging range assessed during the evaluation.

(3) On 10 March 2023 and 20 May 2024 (4), the Agency submitted to the Commission in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions on the notified administrative changes to the Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’. 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, Section 1, 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 29 April 2024, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’ in all official languages of the Union, covering all 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 single biocidal product ‘Bioquell HPV-AQ’ 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 ‘Bioquell HPV-AQ’ as set out in the Annex to Implementing Regulation (EU) 2022/1226 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, the Annex to Implementing Regulation (EU) 2022/1226 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 2024, the summary of biocidal product characteristics in that Annex, should also include some minor editorial and layout changes.

(8) Implementing Regulation (EU) 2022/1226 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2022/1226 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, 21 March 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) 2022/1226 of 14 July 2022 granting a Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’ (OJ L 189, 18.7.2022, p. 3, ELI: http://data.europa.eu/eli/reg_impl/2022/1226/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 Opinion No UAD-C-1650176-34-00/F and UAD-C-1732722-38-00/F of 10/03/2023 and 20/05/2024 on the administrative change of the Union authorisation of the single biocidal product ‘Bioquell HPV-AQ’, https://echa.europa.eu/opinions-on-applications-for-union-authorisation.