Commission Implementing Regulation (EU) 2023/2089 of 28 September 2023 approving reaction mass of N,N-didecyl-N-(2-hydroxyethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-hydroxyethoxy)ethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-(2-hydroxyethoxy)ethoxy)ethyl)-N-methylammonium propionate as an active substance for use in biocidal products of product-types 2 and 4 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 89(1), third subparagraph, thereof,

Whereas:

(1) Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes didecylmethylpoly(oxyethyl)ammonium propionate.

(2) Didecylmethylpoly(oxyethyl)ammonium propionate has been evaluated for use in biocidal products of product-type 2, private area and public health area disinfectants and other biocidal products, and product-type 4, food and feed area disinfectants, as described in Annex V to Directive 98/8/EC of the European Parliament and of the Council (3), which correspond to product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, and product-type 4, food and feed area disinfectants, as described in Annex V to Regulation (EU) No 528/2012.

(3) Italy was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment reports together with its conclusions to the Commission on 27 July 2010. After the submission of the assessment reports, discussions took place in technical meetings organised by the Commission and, after 1 September 2013, by the European Chemicals Agency (the ‘Agency’).

(4) It follows from Article 90(2) of Regulation (EU) No 528/2012 that substances for which the Member States’ evaluation has been completed by 1 September 2013 are to be assessed under the evaluation criteria of Directive 98/8/EC.

(5) During the examination of didecylmethylpoly(oxyethyl)ammonium propionate, the identity of this active substance has been redefined in accordance with Article 13 of Delegated Regulation (EU) No 1062/2014 to reaction mass of N,N-didecyl-N-(2-hydroxyethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-hydroxyethoxy)ethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-(2-hydroxyethoxy)ethoxy)ethyl)-N-methylammonium propionate (‘DMPAP’).

(6) In accordance with Article 75(1), second subparagraph, point (a), of Regulation (EU) No 528/2012, the Biocidal Products Committee prepares the opinion of the Agency regarding the applications for approval of active substances. In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the Biocidal Products Committee adopted the opinions of the Agency ECHA/BPC/363/2022 (4) and ECHA/BPC/364/2022 (5) on 22 November 2022, having regard to the conclusions of the evaluating competent authority.

(7) According to those opinions, biocidal products of product-types 2 and 4 containing DMPAP may be expected to satisfy the requirements corresponding to those laid down in Article 5(1), points (b), (c) and (d), of Directive 98/8/EC, provided that certain requirements concerning their use are complied with.

(8) Taking into account the opinions of the Agency, it is appropriate to approve DMPAP as an active substance for use in biocidal products of product-types 2 and 4 subject to compliance with certain conditions.

(9) A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

(10) 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

Reaction mass of N,N-didecyl-N-(2-hydroxyethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-hydroxyethoxy)ethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-(2-hydroxyethoxy)ethoxy)ethyl)-N-methylammonium propionate is approved as an active substance for use in biocidal products of product-types 2 and 4 subject to the conditions set out in the Annex.

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 September 2023.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 167, 27.6.2012, p. 1.

(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

(3) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

(4) Biocidal Products Committee Opinion on the application for approval of the active substance reaction mass of N,N-didecyl-N-(2-hydroxyethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-hydroxyethoxy)ethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-(2-hydroxyethoxy)ethoxy)ethyl)-N-methylammonium propionate; Product-type 2; ECHA/BPC/363/2022.

(5) Biocidal Products Committee Opinion on the application for approval of the active substance reaction mass of N,N-didecyl-N-(2-hydroxyethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-hydroxyethoxy)ethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-(2-hydroxyethoxy)ethoxy)ethyl)-N-methylammonium propionate; Product-type 4; ECHA/BPC/364/2022.