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
Date: 2025-06-26
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval, pharmaceutical product








L_202501260EN.000101.fmx.xml












Official Journal of the European Union


EN
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.












(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
            





(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.




ANNEX











Common Name


IUPAC Name
Identification Numbers


Minimum degree of purity of the active substance (1)



Date of approval


Expiry date of approval


Product type


Specific conditions




Peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide


IUPAC name: Ethaneperoxoic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide
EC No: not available
CAS No: not available


The specification of peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide is based on the precursors triacetin and hydrogen peroxide.
For triacetin the minimum purity is set to 88,3 % w/w.
For hydrogen peroxide, a 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 February 2027


31 January 2037


2








(1)


The authorisation of biocidal products containing peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide as an active substance is subject to the following conditions:






(a)


the product assessment pays particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level assessment of the active substance;










(b)


the product assessment pays particular attention to industrial and professional users.














(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
ISSN 1977-0677 (electronic edition)