Commission Implementing Regulation (EU) 2025/807 of 28 April 2025 granting a Union authorisation for the single biocidal product C(M)IT/MIT & Glutaraldehyde Formulations in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

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 44(5), first subparagraph, thereof,

Whereas:

(1) On 1 February 2020, Solenis Switzerland GmbH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a single biocidal product named ‘C(M)IT/MIT & Glutaraldehyde Formulations’ of product-types 6, 11 and 12 as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-JP057170-35 in the Register for Biocidal Products.

(2) ‘C(M)IT/MIT & Glutaraldehyde Formulations’ contains C(M)IT/MIT (3:1) and glutaraldehyde as active substances, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 6, 11 and 12.

(3) On 1 December 2023, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

(4) On 27 June 2024, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘C(M)IT/MIT & Glutaraldehyde Formulations’ and the final assessment report on the single biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that ‘C(M)IT/MIT & Glutaraldehyde Formulations’ is a single biocidal product within the meaning of Article 3(1), point (r), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.

(6) The active substance glutaraldehyde meets the criteria for classification as a substance that can lead to respiratory sensitisation as defined in section 3.4.1.1 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3). Therefore, that active substance meets the conditions for being considered a candidate for substitution in accordance with Article 10(1), point (b), of Regulation (EU) No 528/2012 and the evaluating competent authority performed a comparative assessment of the biocidal product in accordance with Article 23(1) of that Regulation. In the comparative assessment no alternative could be identified as the chemical diversity was considered insufficient to substitute ‘C(M)IT/MIT & Glutaraldehyde Formulations’. Therefore, the biocidal product should be authorised for a period not exceeding 5 years in accordance with Article 23(6) of Regulation (EU) No 528/2012.

(7) On 16 July 2024, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(8) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the single biocidal product ‘C(M)IT/MIT & Glutaraldehyde Formulations’ for 5 years.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0032888-0000 is hereby granted to Solenis Switzerland GmbH for the making available on the market and use of the single biocidal product ‘C(M)IT/MIT & Glutaraldehyde Formulations’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 19 May 2025 until 30 April 2030.

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, 28 April 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) ECHA opinion of 30 May 2024 on the Union authorisation of ‘C(M)IT/MIT & Glutaraldehyde Formulations’ (ECHA/BPC/435/2024), https://echa.europa.eu/opinions-on-union-authorisation.

(3) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).