Commission Implementing Regulation (EU) 2025/1800 of 10 September 2025 amending Implementing Regulation (EU) 2023/753 as regards administrative changes to the Union authorisation for the biocidal product family C(M)IT/MIT formulations

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 12 April 2023, Commission Implementing Regulation (EU) 2023/753 (2) granted a Union authorisation, under number EU-0025678-0000, to Solenis Switzerland GmbH for the making available on the market and use of the biocidal product family ‘C(M)IT/MIT formulations’. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.

(2) On 1 October 2024, Solenis Switzerland GmbH submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), a notification of administrative change to the Union authorisation for the biocidal product family ‘C(M)IT/MIT formulations’, recorded in the register for biocidal products under case number BC-TG100256-47. The notified proposed change concerns the addition of formulators of the biocidal product.

(3) On 6 November 2024 (4), the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, an opinion on the notified administrative change to the Union authorisation for the biocidal product family ‘C(M)IT/MIT formulations’. In the opinion, the Agency concludes that the proposed change is an administrative change as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 2, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the change, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

(4) On 6 November 2024, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the biocidal product family ‘C(M)IT/MIT formulations’ in all official languages of the Union, covering the administrative change applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.

(5) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘C(M)IT/MIT formulations’ to introduce the administrative change requested by Solenis Switzerland GmbH.

(6) Except for the amendments regarding the administrative change, all other information included in the summary of the biocidal product characteristics of ‘C(M)IT/MIT formulations’ as set out in Annex to Implementing Regulation (EU) 2023/753 remain 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) 2023/753 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.

(8) Implementing Regulation (EU) 2023/753 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2023/753 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, 10 September 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) 2023/753 of 12 April 2023 granting a Union authorisation for the biocidal product family “C(M)IT/MIT formulations” (OJ L 100, 13.4.2023, p. 48, ELI: http://data.europa.eu/eli/reg_impl/2023/753/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 UAD-C-1777770-16-00/F of 6 November 2024 on administrative changes of the Union authorisation of the biocidal product family ‘C(M)IT/MIT formulations’, https://echa.europa.eu/opinions-on-union-authorisation.