Commission Implementing Decision (EU) 2025/1262 of 27 June 2025 on the non-approval of certain active substances for use in biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2025-06-27
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval, marketing standard, preservative








L_202501262EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1262


1.7.2025







            COMMISSION IMPLEMENTING DECISION (EU) 2025/1262
of 27 June 2025
         
on the non-approval of certain active substances for use in biocidal products 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 in its Annex II a list of active substance/product-type combinations included in the review programme of existing active substances in biocidal products.












(2)


For a number of active substance/product-type combinations included in that list, all the participants have withdrawn or are considered to have withdrawn their support in a timely manner.












(3)


In accordance with Article 14(1) of Delegated Regulation (EU) No 1062/2014, the European Chemicals Agency (‘the Agency’) published an open invitation to take over the role of participant for those active substance/product-type combinations for which the role of participant had not previously been taken over. For those combinations no notification has been submitted to the Agency within the time limit provided for by Article 14(2) of Delegated Regulation (EU) No 1062/2014. Therefore, those active substance/product-type combinations, in accordance with Article 20, first paragraph, point (b), of that Delegated Regulation, should not be approved for use in biocidal products. Those active substance/product-type combinations are the following:






(a)


pyrithione zinc (product-types 2, 10);










(b)


reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with bromine and chlorine (DCDMH) (product-type 11);










(c)


reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with chlorine (DCEMH) (product-type 11).
















(4)


In addition, in accordance with Article 12(3) of Delegated Regulation (EU) No 1062/2014, the Agency informed the Commission of those active substance/product-type combinations for which all participants have withdrawn or are considered to have withdrawn their support in a timely manner, and for which the role of participant had previously been taken over. Those active substance/product-type combinations which, in accordance with Article 20, first paragraph, point (a), of that Delegated Regulation, should not be approved for use in biocidal products are the following:






(a)


1,2-benzisothiazol-3(2H)-one (BIT) (product-type 2);










(b)


chlorine dioxide (product-type 12).
















(5)


The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS DECISION:



Article 1
The active substances listed in the Annex are not approved for the product-types indicated therein.


Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




Done at Brussels, 27 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).




ANNEX
Active substance/product-type combinations not approved:











Entry Number in Annex II to Regulation (EU) No 1062/2014




Substance name




Rapporteur Member State




EC number




CAS number




Product-type(s)





339


1,2-Benzisothiazol-3(2H)- one (BIT)


ES


220-120-9


2634-33-5


2




491


Chlorine dioxide


DE


233-162-8


10049-04-4


12




522


Pyrithione zinc


SE


236-671-3


13463-41-7


2, 10




152


Reaction products of 5,5- dimethylhydantoin, 5-ethyl-5- methylhydantoin with bromine and chlorine (DCDMH)


NL


Not available


Not available


11




777


Reaction products of 5,5- dimethylhydantoin, 5-ethyl-5- methylhydantoin with chlorine (DCEMH)


NL


Not available


Not available


11







ELI: http://data.europa.eu/eli/dec_impl/2025/1262/oj
ISSN 1977-0677 (electronic edition)