Commission Implementing Regulation (EU) 2024/2863 of 12 November 2024 granting a Union authorisation for the biocidal product family Teat disinfectants L-(+)-lactic acid based biocidal product family of Novadan 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 30 April 2019, ITW Novadan ApS 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 ‘Teat disinfectants L-(+)-lactic acid based biocidal product family of Novadan’ of product-type 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Denmark had agreed to evaluate the application. The application was recorded under case number BC-DB051458-55 in the Register for Biocidal Products.

(2) ‘Teat disinfectants L-(+)-lactic acid based biocidal product family of Novadan’ contains L-(+)-lactic acid as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 3.

(3) On 30 June 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 20 March 2024, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Teat disinfectants L-(+)-lactic acid based biocidal product family of Novadan’ 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 ‘Teat disinfectants L-(+)-lactic acid based biocidal product family of Novadan’ 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) On 2 April 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.

(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘Teat disinfectants L-(+)-lactic acid based biocidal product family of Novadan’.

(8) 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-0032465-0000 is hereby granted to ITW Novadan ApS for the making available on the market and use of the biocidal product family ‘Teat disinfectants L-(+)-lactic acid-based biocidal product family of Novadan’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 3 December 2024 until 30 November 2034.

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, 12 November 2024.

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 27 February 2024 on the Union authorisation of ‘Teat disinfectants L-(+)-lactic acid based biocidal product family of Novadan’ (ECHA/BPC/413/2024) (https://echa.europa.eu/opinions-on-union-authorisation).