Commission Implementing Regulation (EU) 2025/1260 of 26 June 2025 approving peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide as an existing active substance for use in biocidal products of product-type 2 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Official Journal EN of the European Union L series 2025/1260 27.6.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1260 of 26 June 2025 approving peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide as an existing active substance for use in biocidal products of product-type 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 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 peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide for product-type 2.

(2) Peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide has been evaluated for use in biocidal products of product-type 2 (disinfectants and algaecides not intended for direct application to humans or animals), as described in Annex V to Regulation (EU) No 528/2012.

(3) Austria was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the European Chemicals Agency (‘the Agency’) on 8 March 2024.

(4) 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 read in conjunction with Article 75(1) and (4) of Regulation (EU) No 528/2012, the Biocidal Products Committee adopted the opinion of the Agency on 27 November 2024(3), having regard to the conclusions of the evaluating competent authority.

(5) In its opinion, the Agency concluded that biocidal products of product-type 2 containing peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide may be expected to satisfy the criteria laid down in Article 19(1), point (b), of Regulation (EU) No 528/2012, provided that certain conditions concerning their use are complied with.

(6) Taking into account the opinion of the Agency, it is therefore appropriate to approve peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide as an active substance for use in biocidal products of product-type 2 subject to compliance with certain conditions.

(7) A reasonable period should elapse before the date of approval of the active substance in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(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, ELI: http://data.europa.eu/eli/reg_del/2014/1062/oj).

(3) Biocidal Products Committee Opinion on the application for approval of the active substance peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide; Product-type: 2; ECHA/BPC/451/2024, adopted on 27 November 2024.

ELI: http://data.europa.eu/eli/reg_impl/2025/1260/oj 1/3EN OJ L, 27.6.2025

(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 Peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide is approved as an active substance for use in biocidal products of product-type 2, 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, 26 June 2025.

For the Commission The President Ursula VON DER LEYEN 2/3 ELI: http://data.europa.eu/eli/reg_impl/2025/1260/ojANNEX IUPAC Name Minimum degree of purity of Date of Expiry date of Common Name Product type Specific conditions Identification Numbers the active substance(1) approval approval

Peracetic acid IUPAC name: The specification of 1 February 31 January 2 (1) The authorisation of biocidal products containing generated from Ethaneperoxoic acid peracetic acid generated 2027 2037 peracetic acid generated from 1,3-diacetyloxypropan- 1,3-diacetyloxy­ generated from from 1,3-diacetyloxypropan- 2-yl acetate and hydrogen peroxide as an active propan-2-yl 1,3-diacetyloxypro­ 2-yl acetate and hydrogen substance is subject to the following conditions:

acetate and pan-2-yl acetate and peroxide is based on the (a) the product assessment pays particular attention to hydrogen hydrogen peroxide precursors triacetin and the exposures, the risks and the efficacy linked to peroxide hydrogen peroxide. any uses covered by an application for

EC No: not available authorisation, but not addressed in the Union level For triacetin the minimum assessment of the active substance;

CAS No: not purity is set to 88,3 % w/w.

(b) the product assessment pays particular attention to available For hydrogen peroxide, a industrial and professional users. minimum purity is not applicable, as hydrogen peroxide is always directly produced as an aqueous solution, which is then used as precursor.

The range for the pure active substance was set as the global composition. The minimum peracetic acid content is 0,011 % w/w and the maximum peracetic acid content is 4,39 % w/w.

(1) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

ELI:

http://data.europa.eu/eli/reg_impl/2025/1260/oj 3/3 OJ L,

27.6.2025 EN