Date: 2025-09-11Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2025/1791 of 10 September 2025 postponing the expiry date of the approval of imidacloprid for use in biocidal products of product-type 18 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 2025/1791 postpones the expiry date of the approval of imidacloprid for use in biocidal products of product type 18. This decision is in response to delays in the evaluation of the renewal applications. The new expiry date is set to December 31, 2027.
Key Points / Main Content:
* **Approval Postponement:**
* The expiry date for the approval of imidacloprid's use in biocidal products of product type 18 is postponed.
* The new expiry date is December 31, 2027.
* **Reason for Postponement:**
* The evaluation of the renewal applications for imidacloprid is delayed.
* Additional time is needed to complete the assessment of endocrine-disrupting properties.
* **Continued Approval Conditions:**
* Imidacloprid remains approved under the conditions outlined in Annex I to Directive 98/8/EC.
* **Entry into Force:**
* This decision takes effect twenty days after its publication in the Official Journal of the European Union.
Impact Analysis:
**Applicants for Renewal of Imidacloprid Approval:**
* *Impact:* The expiry date for imidacloprid approval is extended, allowing continued use while the renewal assessment is completed.
* *Action Required:* Await the outcome of the renewal assessment report, expected in the first half of 2026.
**Evaluating Competent Authority of Germany:**
* *Impact:* Additional time is granted to complete the evaluation of imidacloprid's endocrine-disrupting properties.
* *Action Required:* Submit the renewal assessment report to the European Chemicals Agency (ECHA) in the first half of 2026.
**European Chemicals Agency (the Agency):**
* *Impact:* The Agency will receive the renewal assessment report at a later date.
* *Action Required:* Prepare and submit an opinion to the Commission on the renewal of the approval of imidacloprid within 270 days of receiving the assessment report.
**European Commission:**
* *Impact:* The Commission is responsible for making a decision on the renewal of imidacloprid's approval based on the Agency's opinion.
* *Action Required:* Decide whether to renew the approval of imidacloprid for use in biocidal products of product type 18, taking into account the evaluation and opinion provided.
**Users of Biocidal Products of Product Type 18 Containing Imidacloprid:**
* *Impact:* Continued access to and use of products containing imidacloprid for biocidal purposes (product type 18) is permitted until December 31, 2027, subject to existing conditions.
* *Action Required:* Continue to adhere to the conditions set out in Annex I to Directive 98/8/EC when using products containing imidacloprid.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
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 council of ministers representing the governments of EU member states.
imidacloprid: An active substance used in biocidal products of product type 18, the expiry date of whose approval is being postponed.
Directive 98/8/EC: A directive of the European Parliament and of the Council concerning the placing of biocidal products on the market.
Commission Implementing Decision EU 2023/460: A Commission Implementing Decision postponing the expiry date of the approval of imidacloprid for use in biocidal products of product type 18.
European Chemicals Agency: An agency of the European Union that prepares and submits to the Commission an opinion on renewal of the approval of the active substance.
Official Journal EN
of the European Union L series
2025/1791 11.9.2025
COMMISSION IMPLEMENTING DECISION(EU) 2025/1791
of 10 September 2025
postponing the expiry date of the approval of imidacloprid for use in biocidal products of product-
type 18 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) Imidacloprid was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council(2)as an
active substance for use in biocidal products of product-type 18. Pursuant to Article 86 of Regulation (EU)
No 528/2012, it was therefore considered approved until 30 June 2023 under that Regulation subject to the
conditions set out in Annex I to Directive 98/8/EC.
(2) On 23 and 24 December 2021, two applications were submitted in accordance with Article 13(1) of Regulation (EU)
No 528/2012 for the renewal of the approval of imidacloprid for use in biocidal products of product-type 18 (‘the
applications’).
(3) On 27 April 2022, the evaluating competent authority of Germany informed the Commission that it had decided,
pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the applications 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 (‘the 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) Commission Implementing Decision (EU) 2023/460(3)postponed the expiry date of the approval of imidacloprid for
use in biocidal products of product-type 18 to 31 December 2025, in order to allow sufficient time for the
examination of the applications.
(7) On 26 February 2025, the evaluating competent authority informed the Commission that the evaluation is delayed
due to the need for additional time to complete the assessment of endocrine-disrupting properties. The evaluating
competent authority expects to submit the renewal assessment report to the Agency in the first half of 2026.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1, ELI: http://data.europa.eu/eli/dir/1998/8/oj).
(3) Commission Implementing Decision (EU) 2023/460 of 2 March 2023 postponing the expiry date of the approval of imidacloprid for
use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the
Council (OJ L 67, 3.3.2023, p. 58; ELI: http://data.europa.eu/eli/dec_impl/2023/460/oj).
ELI: http://data.europa.eu/eli/dec_impl/2025/1791/oj 1/2EN
OJ L, 11.9.2025
(8) Consequently, for reasons beyond the control of the applicants, the approval is likely to expire before a decision has
been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period
of time sufficient to enable the examination of the applications. Taking into account the time-limits for evaluation by
the evaluating competent authority, for preparation and submission by the Agency of its opinion and the time needed
for the Commission to decide whether to renew the approval of imidacloprid for use in biocidal products of product-
type 18, the expiry date should be postponed to 31 December 2027.
(9) After the further postponement of the expiry date of the approval, imidacloprid remains approved for use in biocidal
products of product-type 18 subject to the conditions set out in Annex I to Directive 98/8/EC,
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of imidacloprid for use in biocidal products of product-type 18 set out in Implementing
Decision (EU) 2023/460 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, 10 September 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/dec_impl/2025/1791/oj