2.

Agency responsible: European Commission, Health and Food Safety Directorate-General

3.

Products covered (provide tariff item number(s) as specified in national schedules deposited with the WTO; ICS numbers should be provided in addition, where applicable): Flufenacet (pesticide active substance)

4.

Regions or countries likely to be affected, to the extent relevant or practicable:

[X] All trading partners

[ ] Specific regions or countries:

5.

Title of the notified document: Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance flufenacet, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 and Commission Implementing Regulation (EU) 2015/408 (Text with EEA relevance). Language(s): English. Number of pages: 6

https://members.wto.org/crnattachments/2025/SPS/EEC/25_00450_00_e.pdf

6.

Description of content: This draft Commission Implementing Regulation provides that the approval of the active substance flufenacet is not renewed in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorizations for plant protection products containing flufenacet as an active substance. The non-renewal of approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly assessed and approved under Directive 91/414/ EEC.

In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on G/TBT/N/EU/1105 - 2 - the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II thereto) which must be met to enable approval.

During the evaluation and peer-review of flufenacet, a number of concerns and areas that could not be finalized were identified. These are detailed in the statement of the European Food Safety Authority (EFSA).

Flufenacet meets the criteria in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 to be identified as an endocrine disruptor for the thyroid (T)-modality for humans and non-target organisms and it has not been demonstrated that the exposure of humans and non-target organisms to that active substance in a plant protection product, under realistic proposed conditions of use, is negligible.

High potential for contamination of ground water with trifluoroacetic acid was identified and that metabolite is considered to be to toxicologically relevant.

The risk assessment could not be finalized with respect to the non-relevance assessment of groundwater metabolites and the risks for the consumers.

These concerns mean that flufenacet does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009.

This decision only concerns the placing on the market of this substance and plant protection products containing it. Following non-approval and the expiry of all grace periods for stocks of products containing this substance, separate action will likely be taken on MRLs and a separate notification will be made in accordance with SPS procedures.

This draft Commission Implementing Regulation was also notified under the TBT Agreement in notice G/TBT/N/EU/1105.

7.

Objective and rationale: [X] food safety, [X] animal health, [X] plant protection, [X] protect humans from animal/plant pest or disease, [X] protect territory from other damage from pests.

8.

Is there a relevant international standard? If so, identify the standard:

[ ] Codex Alimentarius Commission (e.g. title or serial number of Codex standard or related text):

[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic Animal Health Code, chapter number):

[ ] International Plant Protection Convention (e.g. ISPM number):

[X] None

Does this proposed regulation conform to the relevant international standard?

[ ] Yes   [ ] No

If no, describe, whenever possible, how and why it deviates from the international standard:

9.

Other relevant documents and language(s) in which these are available:

        Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC

https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32009R1107

        Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11 June 2011, p. 1–186)

https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32011R0540

        Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (OJ L 67, 12 March 2015, p. 18–22)

https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32015R0408

        EFSA (European Food Safety Authority), 2024. Peer review of the pesticide risk assessment of the active substance flufenacet. EFSA Journal 2024; 22(9): e08997

https://doi.org/10.2903/j.efsa.2024.8997

10.

Proposed date of adoption (dd/mm/yy): April 2025

Proposed date of publication (dd/mm/yy): May 2025

11.

Proposed date of entry into force: [ ] Six months from date of publication, and/or (dd/mm/yy): 20 days following publication in the Official Journal of the European Union.

[ ] Trade facilitating measure

12.

Final date for comments: [ ] Sixty days from the date of circulation of the notification and/or (dd/mm/yy): Not applicable. Comments are only welcomed on TBT related issues and to be addressed to the TBT Enquiry Point on notice G/TBT/N/EU/1105.

Agency or authority designated to handle comments: [X] National Notification Authority, [X] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:

European Commission

EU-TBT Enquiry Point

Fax: +(32) 2 299 80 43

E-mail: grow-eu-tbt@ec.europa.eu

13.

Text(s) available from: [X] National Notification Authority, [X] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:

European Commission

EU-TBT Enquiry Point

Fax: +(32) 2 299 80 43

E-mail: grow-eu-tbt@ec.europa.eu