Date: 2025-09-12Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2025/1809 of 11 September 2025 postponing the expiry date of the approval of zineb 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 2025/1809 postpones the expiry date for the approval of zineb's use in biocidal products of product-type 21 from December 31, 2025, to June 30, 2028. This decision follows an application for renewal and a determination that a full evaluation is necessary. The decision was made on September 11, 2025, and will take effect twenty days after its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Zineb Approval:**
* Zineb is approved for use in biocidal products of product-type 21 under the conditions of Implementing Regulation EU No 922014.
* **Expiry Date Postponement:**
* The expiry date of zineb's approval is postponed from December 31, 2025, to June 30, 2028.
* This postponement is due to the pending decision on the renewal of its approval.
* **Application for Renewal:**
* An application for renewal was submitted on June 28, 2024, as per Article 131 of Regulation EU No 528/2012.
* A full evaluation of the application is deemed necessary according to Article 141 of Regulation EU No 528/2012.
* **Evaluation Process:**
* Ireland, as the evaluating competent authority, will perform a full evaluation within 365 days of validation, which may be suspended under certain conditions.
* The European Chemicals Agency will prepare and submit an opinion to the Commission within 270 days of receiving a recommendation from the evaluating competent authority.
* **Continued Approval:**
* Zineb remains approved for use in biocidal products of product-type 21, subject to the conditions in Implementing Regulation EU No 922014, until the new expiry date.
* **Entry into Force:**
* This decision enters into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
Stakeholder: Applicants for Zineb Renewal
Impact: The expiry date for zineb is extended giving more time for the application to be processed.
Action Required: Continue to cooperate with the evaluating competent authority and the European Chemicals Agency in the renewal process.
Stakeholder: Evaluating Competent Authority (Ireland)
Impact: Responsible for the full evaluation of the application for renewal.
Action Required: Conduct a full evaluation of the application within the stipulated timeframe, requesting data from the applicant as necessary.
Stakeholder: European Chemicals Agency
Impact: Tasked with preparing and submitting an opinion to the Commission regarding the renewal of zineb's approval.
Action Required: Prepare and submit an opinion to the Commission within 270 days of receiving a recommendation from the evaluating competent authority.
Stakeholder: European Commission
Impact: Responsible for making the final decision on the renewal of zineb's approval.
Action Required: Consider the opinion of the European Chemicals Agency and decide whether to renew the approval of zineb.
Stakeholder: Biocidal Product Manufacturers and Users
Impact: Can continue to use zineb in product-type 21 biocidal products until June 30, 2028, subject to existing conditions.
Action Required: Ensure continued compliance with the conditions set out in the Annex to Implementing Regulation EU No 922014.
Key Entities Referenced
Council of the European Union: A legislative body of the European Union comprising government ministers from each member state.
European Union: A political and economic union of member states located primarily in Europe.
Commission Implementing Decision (EU) 2025/1809: A decision by the European Commission regarding the expiry date of zineb approval.
Zineb: An active substance used in biocidal products of product type 21.
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: One of the legislative bodies of the European Union.
Commission Implementing Regulation (EU) No 92/2014: A regulation approving zineb as an existing active substance for use in biocidal products for product type 21.
European Chemicals Agency: An agency of the European Union that prepares and submits opinions on the renewal of active substance approvals.
Official Journal EN
of the European Union L series
2025/1809 12.9.2025
COMMISSION IMPLEMENTING DECISION(EU) 2025/1809
of 11 September 2025
postponing the expiry date of the approval of zineb 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) Zineb was approved as an active substance for use in biocidal products of product-type 21 by Commission
Implementing Regulation (EU) No 92/2014(2)subject to the conditions set out in the Annex to that Regulation.
(2) The approval of zineb for use in biocidal products of product-type 21 (‘the approval’) is to expire on 31 December
2025. On 28 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 5 December 2024, the evaluating competent authority of Ireland 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, zineb remains approved for use in biocidal products of
product-type 21 subject to the conditions set out in the Annex to Implementing Regulation (EU) No 92/2014,
(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 92/2014 of 31 January 2014 approving zineb as an existing active substance for use in
biocidal products for product-type 21 (OJ L 32, 1.2.2014, p. 16; ELI: http://data.europa.eu/eli/reg_impl/2014/92/oj).
ELI: http://data.europa.eu/eli/dec_impl/2025/1809/oj 1/2EN
OJ L, 12.9.2025
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of zineb for use in biocidal products of product-type 21 set out in the Annex to
Implementing Regulation (EU) No 92/2014, 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/2025/1809/oj