Commission Implementing Decision (EU) 2025/432 of 5 March 2025 postponing the expiry date of the approval of copper sulphate pentahydrate 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: 2025-03-05
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, health risk, market approval, marketing standard








L_202500432EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/432


6.3.2025







            COMMISSION IMPLEMENTING DECISION (EU) 2025/432
of 5 March 2025
         
postponing the expiry date of the approval of copper sulphate pentahydrate 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 14(5) thereof,


After consulting the Standing Committee on Biocidal Products,

Whereas:







(1)


Copper sulphate pentahydrate was approved as an active substance for use in biocidal products of product-type 2 by Commission Implementing Regulation (EU) No 1033/2013 (2) subject to the conditions set out in the Annex to that Regulation.












(2)


The approval of copper sulphate pentahydrate for use in biocidal products of product-type 2 (‘the approval’) is to expire on 30 June 2025. On 6 April 2023, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval (‘the application’).












(3)


On 17 September 2024, the evaluating competent authority of France informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.












(4)


The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.












(5)


Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.












(6)


Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to postpone the expiry date of the approval for a period of time sufficient to enable the examination of the application. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the European Chemicals Agency of its opinion and the time needed for the Commission to decide whether to renew the approval, the expiry date should be postponed to 31 December 2027.












(7)


After the postponement of the expiry date of the approval, copper sulphate pentahydrate remains approved for use in biocidal products of product-type 2 subject to the conditions set out in the Annex to Implementing Regulation (EU) No 1033/2013,





HAS ADOPTED THIS DECISION:



Article 1
The expiry date of the approval of copper sulphate pentahydrate for use in biocidal products of product-type 2 set out in the Annex to Implementing Regulation (EU) No 1033/2013 is postponed to 31 December 2027.


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, 5 March 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 Implementing Regulation (EU) No 1033/2013 of 24 October 2013 approving copper sulphate pentahydrate as an existing active substance for use in biocidal products for product-type 2 (OJ L 283, 25.10.2013, p. 25, ELI: http://data.europa.eu/eli/reg_impl/2013/1033/oj).


ELI: http://data.europa.eu/eli/dec_impl/2025/432/oj
ISSN 1977-0677 (electronic edition)