Commission Implementing Regulation (EU) 2025/2218 of 31 October 2025 amending Implementing Regulation (EU) 2023/402 as regards administrative changes to the Union authorisation of the biocidal product family CMIT/MIT SOLVENT BASED and correcting that Regulation

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 February 2023, Commission Implementing Regulation (EU) 2023/402 (2) granted a Union authorisation, under number EU-0023657-0000, to Nutrition & Biosciences Netherlands B.V. for the making available on the market and use of the biocidal product family ‘CMIT/MIT SOLVENT BASED’. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.

(2) The company Nutrition & Biosciences Netherlands B.V. was acquired by the company MC (Netherlands) 1 B.V. before Implementing Regulation (EU) 2023/402 was adopted, and that Implementing Regulation should therefore have referred to ‘MC (Netherlands) 1 B.V’ in Article 1 thereof as being the authorisation holder, as was correctly done in the summary of the biocidal product characteristics (‘SPC’) for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in the Annex to that Implementing Regulation.

(3) On 17 November 2023, 17 July 2024, 13 January 2025 and 4 July 2025, MC (Netherlands) 1 B.V. 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 biocidal product family ‘CMIT/MIT SOLVENT BASED’, 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-FM090134-40, BC-FX098836-92, BC-KB102361-71 and BC-QG108678-28. The notified proposed changes to that authorisation concern the deletion and addition of trade names, the deletion of two biocidal product formulators and the addition of three biocidal product formulators, a change in the address of the authorisation holder and the addition of a manufacturer of the active substance.

(4) On 3 January 2024, 19 August 2024, 18 February 2025 and 24 July 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 ‘CMIT/MIT SOLVENT BASED’, 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, Section 1 and Title 1, Section 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.

(5) On 24 July 2025, the Agency transmitted to the Commission a revised SPC of the Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ 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 opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ to introduce the administrative changes requested by MC (Netherlands) 1 B.V.

(7) Except for the amendments regarding the proposed changes, all other information included in the SPC of ‘CMIT/MIT SOLVENT BASED’, as set out in the Annex to Implementing Regulation (EU) 2023/402, remains unchanged.

(8) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the SPC which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2023/402 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 SPC in that Annex should also include some minor editorial and layout changes.

(9) Implementing Regulation (EU) 2023/402 should therefore be amended accordingly.

(10) Implementing Regulation (EU) 2023/402 should therefore be corrected accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Article 1 , first paragraph, of Implementing Regulation (EU) 2023/402 is corrected as follows:

‘A Union authorisation with authorisation number EU-0023657-0000 is granted to MC (Netherlands) 1 B.V. for the making available on the market and use of the biocidal product family “CMIT/MIT SOLVENT BASED” in accordance with the summary of the biocidal product characteristics set out in the Annex.’

Article 2

The Annex to Implementing Regulation (EU) 2023/402 is replaced by the text in the Annex to this Regulation.

Article 3

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) 2023/402 of 22 February 2023 granting a Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 56, 23.2.2023, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2023/402/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 Nos UAD-C-1703145-38-00/F of 3 January 2024, UAD-C-1760130-45-00/F of 19 August 2024, UAD-C-1803042-40-00/F of 18 February 2025 and UAD-C-1843154-31-00/F of 24 July 2025 on the administrative change of the Union authorisation of the biocidal product family ‘CMIT/MIT SOLVENT BASED’, https://echa.europa.eu/opinions-on-union-authorisation.