Commission Implementing Regulation (EU) 2025/2048 of 10 October 2025 granting a Union authorisation for the biocidal product family 3025 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 14 July 2017, Schuelke & Mayr 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 biocidal product family named ‘3025’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-NX032401-23 in the Register for Biocidal Products.

(2) ‘3025’ 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 2 and 4.

(3) On 11 September 2024, 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 19 March 2025, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘3025’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that ‘3025’ is a biocidal product family within the meaning of Article 3(1), point (s), 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(6) 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 family in accordance with Article 23(1) of that Regulation. In that comparative assessment no alternative could be identified as the chemical diversity was considered insufficient to substitute ‘3025’. Therefore, the biocidal product family should be authorised for a period not exceeding 5 years in accordance with Article 23(6) of Regulation (EU) No 528/2012.

(7) On 8 April 2025, 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 biocidal product family ‘3025’.

(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-0034603-0000 is hereby granted to Schuelke & Mayr GmbH for the making available on the market and use of the biocidal product family ‘3025’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 5 November 2025 until 30 September 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, 10 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) Opinion of 27 February 2025 on the Union authorisation of the biocidal product family ‘3025’ (ECHA/BPC/464/2025), 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).