Commission Implementing Regulation (EU) 2025/2202 of 22 October 2025 amending Implementing Regulation (EU) 2022/1434 as regards administrative changes to the Union authorisation for the biocidal product family CMIT-MIT Aqueous 1.5-15, 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 July 2022, Commission Implementing Regulation (EU) 2022/1434 (2) granted a Union authorisation, under number EU-0025449-0000, to Nutrition & Biosciences Netherlands B.V. for the making available on the market and use of the biocidal product family ‘CMIT-MIT Aqueous 1.5-15’.

(2) The company ‘Nutrition & Biosciences Netherlands B.V.’ was acquired by the company ‘MC (Netherlands) 1 B.V.’ before Implementing Regulation (EU) 2022/1434 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 Aqueous 1.5-15’in the Annex to that Implementing Regulation.

(3) On 5 June 2024 and 14 January 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 Aqueous 1.5-15’. Those notifications were recorded in the register for biocidal products under case numbers BC-HX095612-07 and BC-HH102376-51. The notified proposed changes to that authorisation concern the addition of a manufacturer of the active substance, changes in the names of the manufacturers of the biocidal product, the addition of a manufacturer of the biocidal product, and changes to the address of the authorisation holder.

(4) On 11 July 2024 and 18 February 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 Aqueous 1.5-15’. 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 18 February 2025, the Agency transmitted to the Commission the revised SPCs of the Union authorisation for the biocidal product family ‘CMIT-MIT Aqueous 1.5-15’ 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.

(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 Aqueous 1.5-15’ to introduce the administrative changes requested by ‘MC (Netherlands) 1 B.V.’

(7) Apart from the amendments regarding the proposed changes, all other information included in the summary of the biocidal product characteristics of ‘CMIT-MIT Aqueous 1.5-15’, as set out in the Annex to Implementing Regulation (EU) 2022/1434, remain 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) 2022/1434 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.

(9) Implementing Regulation (EU) No 2022/1434 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Article 1 of Implementing Regulation (EU) 2022/1434 is replaced by the following:

‘A Union authorisation with authorisation number EU-0025449-0000 is granted to MC (Netherlands) 1 B.V. for the making available on the market and use of the biocidal product family “CMIT-MIT Aqueous 1.5-15” in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 20 September 2022 until 31 August 2032.’.

Article 2

The Annex to Implementing Regulation (EU) 2022/1434 is replaced by the text set out 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, 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) 2022/1434 of 22 July 2022 granting a Union authorisation for the biocidal product family ‘CMIT-MIT Aqueous 1.5-15’ (OJ L 226, 31.8.2022, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2022/1434/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 UAD-C-1750430-43-00/F of 11 July 2024 and UAD-C-1803043-39-00/F of 18 February 2025 on administrative changes of the Union authorisation of the biocidal product family ‘CMIT-MIT Aqueous 1.5-15’, https://echa.europa.eu/opinions-on-union-authorisation.