Date: 6-Mar-2025Category: Not ApplicableState: Union GovernmentCountry: Europe
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
Issued by European Commission
· Directorate-General for Health and Food Safety
Commission Implementing Decision (EU) 2025/432 postpones the expiry date of the approval of copper sulphate pentahydrate for use in biocidal products of product-type 2. This decision is based on Regulation (EU) No 528/2012.
Key Changes
The expiry date of the approval of copper sulphate pentahydrate for use in biocidal products of product-type 2, initially set to expire on 30 June 2025, is postponed to 31 December 2027.
The postponement is due to the need for a full evaluation of the application for renewal of the approval, which could not be completed before the original expiry date.
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.
Impact Analysis
Biocidal Product Manufacturers/Suppliers
Action Item: Monitor the progress of the application for renewal of the approval of copper sulphate pentahydrate and prepare for potential changes in regulations after 31 December 2027.
Users of Biocidal Products
Action Item: Continue to use the products in accordance with the instructions and safety guidelines provided.
Evaluating Competent Authority (France)
Action Item: Continue the evaluation process, ensuring sufficient data is collected and analyzed within the extended timeframe.
European Chemicals Agency (ECHA)
Action Item: Prepare to evaluate the recommendation from the evaluating competent authority and develop an opinion for the Commission within the stipulated timeframe.
European Commission
Action Item: Consider the opinion from ECHA and decide whether to renew the approval before 31 December 2027.
Key Entities Referenced
European Commission: The executive branch of the European Union, responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
European Parliament: The directly elected parliamentary body of the European Union with legislative, supervisory, and budgetary responsibilities.
Council of the European Union: A body representing the governments of the EU member states, sharing legislative power with the European Parliament.
European Chemicals Agency (ECHA): An agency of the European Union which manages the technical, scientific and administrative aspects of the implementation of REACH and other EU legislation related to chemicals.
Regulation (EU) No 528/2012: Regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
Commission Implementing Regulation (EU) No 1033/2013: Commission Implementing Regulation approving copper sulphate pentahydrate as an existing active substance for use in biocidal products for product-type 2.
Copper sulphate pentahydrate: An active substance used in biocidal products of product-type 2.
Standing Committee on Biocidal Products: A committee that the European Commission consults with regarding biocidal products.
Official Journal EN
of the European Union 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 2012concerning
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,
(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 1/2EN
OJ L, 6.3.2025
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
2/2 ELI: http://data.europa.eu/eli/dec_impl/2025/432/oj