Commission Implementing Regulation (EU) 2022/2253 of 14 November 2022 granting a Union authorisation for the biocidal product family ‘Colgate-Palmolive Lactic acid PT 2’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

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 29 January 2019, Colgate Palmolive Sp. Z.o.o submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Colgate-Palmolive_Lactic acid_PT 2’ of product-type 2, 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-HK051319-37 in the Register for Biocidal Products.

(2) ‘Colgate-Palmolive Lactic acid PT 2’ 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 2.

(3) On 25 August 2021, 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 23 March 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Colgate-Palmolive Lactic acid PT 2’ 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 ‘Colgate Palmolive Lactic acid PT 2’ 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(1) and (6) of that Regulation.

(6) On 12 April 2022, 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 ‘Colgate-Palmolive Lactic acid PT 2’.

(8) In its opinion, the Agency recommends that the authorisation holder conducts a differential scanning calorimetry test for representative products of all meta-SPCs of ‘Colgate-Palmolive Lactic acid PT 2’ as a condition in the authorisation. That test should confirm that representative products of those meta-SPCs are not to be classified as self-reactive mixture. The Commission agrees with that recommendation and considers that the submission of the results of that test should be a condition relating to the making available on the market and use of the biocidal product family ‘Colgate Palmolive Lactic acid PT 2’ in all meta SPCs pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on existing data.

(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-0028421-0000 is hereby granted to Colgate Palmolive Sp. Z.o.o for the making available on the market and use of the biocidal product family ‘Colgate-Palmolive Lactic acid PT 2’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.

The Union authorisation is valid from 5 December 2022 to 30 November 2032.

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, 14 November 2022.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 167, 27.6.2012, p. 1.

(2) ECHA opinion of 2 March 2022 on the Union authorisation of ‘Colgate-Palmolive Lactic acid PT2’ (ECHA/BPC/317/2022), https://echa.europa.eu/bpc-opinions-on-union-authorisation