Commission Implementing Regulation (EU) 2025/2137 of 22 October 2025 amending Implementing Regulation (EU) 2024/1674 as regards administrative changes to the Union authorisation of the single biocidal product SANICALCO Q

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 13 June 2024, Commission Implementing Regulation (EU) 2024/1674 (2) granted a Union authorisation, under number EU-0029399-0000, to Carmeuse Europe SA for the making available on the market and use of the single biocidal product ‘SANICALCO Q’. The Annex to that Implementing Regulation provides the summary of product characteristics for that single biocidal product.

(2) On 26 May 2025, Carmeuse Europe SA submitted notification 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 single biocidal product ‘SANICALCO Q’, as referred to in Title 1 of the Annex to that Regulation. The notification was recorded in the Register for Biocidal Products (‘the Register’) under case number BC-JE106093-61. The notified proposed changes to that authorisation concern changes to the single biocidal product name and to the trade names.

(4) On 17 June 2025, the Agency submitted to the Commission in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, an opinion (4) on the notified administrative changes to the Union authorisation for the single biocidal product ‘SANICALCO Q’, together with a revised summary of the biocidal product characteristics. In the opinion, 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.

(5) On 17 June 2025, the Agency transmitted to the Commission a revised summary of the biocidal product characteristics of the Union authorisation for the single biocidal product ‘SANICALCO Q’ in all 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.

(6) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation for the single biocidal product ‘SANICALCO Q’ to introduce the administrative changes requested by Carmeuse Europe SA.

(7) Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of ‘SANICALCO Q’ as set out in the Annex to Implementing Regulation (EU) 2024/1674 remains unchanged.

(8) 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) 2024/1674 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 February2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes.

(9) Implementing Regulation (EU) 2024/1674 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2024/1674 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, 22 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) 2024/1674 of 13 June 2024 granting a Union authorisation for the single biocidal product ‘SANICALCO Q’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council. (OJ L, 2024/1674, 14.6.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/1674/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 N° UAD-C-1828576-13-00/F of 17 June 2025 on the administrative change of the Union authorisation of the single biocidal product ‘SANICALCO Q’, https://echa.europa.eu/opinions-on-union-authorisation.