Commission Implementing Regulation (EU) 2024/1767 of 26 June 2024 granting a Union authorisation for the biocidal product family Sure Lactic Family 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, Diversey Europe Operations B.V submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘Sure Lactic Family’, of product-types 2, 3 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-EM051406-41 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ later authorised by Commission Implementing Regulation (EU) 2023/1758 (3), recorded in the Register under case number BC-HC051278-51.

(2) The same biocidal product family ‘Sure Lactic Family’ contains L-(+)-lactic acid as the 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, 3 and 4.

(3) On 19 September 2022, the Agency submitted to the Commission its opinion (4) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Sure Lactic Family’ in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013.

(4) In its opinion, the Agency concludes that the proposed differences between ‘Sure Lactic Family’ and the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ are limited to information which can be the subject of an administrative change in accordance with Article 11 of Commission Implementing Regulation (EU) No 354/2013 (5), and that based on the assessment of the related reference biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ and subject to compliance with the draft SPC, ‘Sure Lactic Family’ meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.

(5) On 16 November 2023, the Agency transmitted to the Commission the revised SPCs of ‘Sure Lactic Family’ in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(6) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family ‘Sure Lactic Family’.

(7) The expiry date of this authorisation is aligned to the expiry date of the authorisation of the related reference biocidal product family ‘SALVECO SALVESAFE PRODUCTS’.

(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-0029485-0000 is hereby granted to Diversey Europe Operations B.V for the making available on the market and use of the same biocidal product family ‘Sure Lactic Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 17 July 2024 until 30 September 2033.

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, 26 June 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) Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj).

(3) Commission Implementing Regulation (EU) 2023/1758 of 11 September 2023 granting a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 224, 12.9.2023, p. 34, ELI: http://data.europa.eu/eli/reg_impl/2023/1758/oj).

(4) ECHA opinion of 19.9.2022 on the Union authorisation of the same biocidal product family ‘Sure Lactic Family’, https://echa.europa.eu/opinions-on-union-authorisation.

(5) 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).