Date: 2025-09-12Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2025/1778 of 11 September 2025 postponing the expiry date of the approval of copper pyrithione for use in biocidal products of product-type 21 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
Executive Summary:
Commission Implementing Decision EU 2025/1778 postpones the expiry date for the approval of copper pyrithione when used in biocidal products of product-type 21. This decision is in response to an application for renewal of approval submitted on June 27, 2024, which requires further evaluation. The new expiry date is set for June 30, 2028. The decision was made on September 11, 2025.
Key Points / Main Content:
* **Approval Extension:**
* The expiry date of the approval of copper pyrithione for use in biocidal products of product-type 21 is postponed.
* The new expiry date is June 30, 2028.
* **Background:**
* Copper pyrithione was initially approved under Implementing Regulation EU 2015/984.
* An application for renewal was submitted on June 27, 2024.
* A full evaluation of the renewal application is deemed necessary.
* **Evaluation Process:**
* Sweden, as the evaluating competent authority, will conduct a full evaluation within 365 days of validation, with possible suspension for data requests.
* The European Chemicals Agency (ECHA) will provide an opinion on the renewal within 270 days of receiving a recommendation from the evaluating authority.
* **Continued Approval:**
* Copper pyrithione remains approved under the conditions outlined in Implementing Regulation EU 2015/984 until the new expiry date.
Impact Analysis:
* **European Commission:**
* *Impact:* Responsible for making the decision on the renewal of approval after receiving the opinion from ECHA.
* *Action Required:* Decide whether to renew the approval of copper pyrithione based on ECHA’s opinion.
* **Evaluating Competent Authority (Sweden):**
* *Impact:* Responsible for the full evaluation of the application for renewal.
* *Action Required:* Perform a full evaluation of the application within 365 days (extendable under certain conditions).
* **European Chemicals Agency (ECHA):**
* *Impact:* Responsible for preparing and submitting an opinion to the Commission regarding the renewal of approval.
* *Action Required:* Prepare and submit an opinion to the Commission within 270 days of receiving the recommendation from the evaluating competent authority.
* **Applicants for Renewal:**
* *Impact:* Benefit from the extended expiry date, allowing continued marketing and use of products containing copper pyrithione while the renewal application is processed. May need to provide additional data if requested by the evaluating competent authority.
* *Action Required:* Continue to comply with the conditions set out in Implementing Regulation EU 2015/984. Provide any additional data requested by the evaluating competent authority.
* **Manufacturers and Suppliers of Biocidal Products (Product-Type 21) containing Copper Pyrithione:**
* *Impact:* Can continue to market and supply products containing copper pyrithione until June 30, 2028, subject to existing conditions.
* *Action Required:* Ensure continued compliance with Implementing Regulation EU 2015/984.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation EU No 528/2012: A regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
European Parliament: The parliamentary body of the European Union.
Council of the European Union: A legislative body of the European Union comprising ministers from member states.
copper pyrithione: An active substance used in biocidal products of product-type 21.
Commission Implementing Regulation EU 2015/984: A European Commission regulation approving copper pyrithione as an existing active substance for use in biocidal products for product-type 21.
Sweden: The evaluating competent authority that informed the Commission about the full evaluation of the application.
Official Journal EN
of the European Union L series
2025/1778 12.9.2025
COMMISSION IMPLEMENTING DECISION(EU) 2025/1778
of 11 September 2025
postponing the expiry date of the approval of copper pyrithione for use in biocidal products of
product-type 21 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 pyrithione was approved as an active substance for use in biocidal products of product-type 21 by
Commission Implementing Regulation (EU) 2015/984(2) subject to the conditions set out in the Annex to that
Regulation.
(2) The approval of copper pyrithione for use in biocidal products of product-type 21 (‘the approval’) is to expire on
31 December 2025. On 27 June 2024, 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 14 August 2024, the evaluating competent authority of Sweden 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 30 June 2028.
(7) After the postponement of the expiry date of the approval, copper pyrithione remains approved for use in biocidal
products of product-type 21 subject to the conditions set out in the Annex to Implementing Regulation
(EU) 2015/984,
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) 2015/984 of 24 June 2015 approving copper pyrithione as an existing active substance
for use in biocidal products for product-type 21 (OJ L 159, 25.6.2015, p. 43, ELI: http://data.europa.eu/eli/reg_impl/2015/984/oj).
ELI: http://data.europa.eu/eli/dec_impl/2025/1778/oj 1/2EN
OJ L, 12.9.2025
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of copper pyrithione for use in biocidal products of product-type 21 set out in the Annex to
Implementing Regulation (EU) 2015/984, is postponed to 30 June 2028.
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, 11 September 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/dec_impl/2025/1778/oj