Notice - Notification of WTO Members: 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)
| WTO code |
G/SPS/N/EU/805 |
| Date notice |
09/01/2025 |
| Notice type |
Regular |
| Title |
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) |
| Summary |
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.
|
| Product |
Flufenacet (pesticide active substance) |
| Country |
European Union |
File attach:
NEU805.pdf
Orther Notice: