Notice - Notification of WTO Members: Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance metribuzin, 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.
| WTO code |
G/SPS/N/EU/789 |
| Date notice |
01/08/2024 |
| Notice type |
Regular |
| Title |
Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance metribuzin, 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. |
| Summary |
This draft Commission Implementing Regulation provides that the approval of the active substance metribuzin is not renewed in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorizations for plant protection products containing metribuzin 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 European Union 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 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 metribuzin, 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). Metribuzin meets the criteria in point 3.6.5 of Annex II to Regulation (EC) No 1107/2009 to be identified as an endocrine disruptor for the thyroid (T)-modality for humans and it has not been demonstrated that the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use, is negligible. Bystander and resident exposure estimates exceed the established A(AOEL) value for all representative uses evaluated. The available higher tier studies for bees were not sufficient to exclude a high risk to bees. These concerns mean that metribuzin does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009.
Existing authorizations will need to be withdrawn; EU member States must withdraw existing plant protection products containing metribuzin at the latest by six months from the date of entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 is allowed for and shall expire at the latest 12 months from the entry into force (allowing for a final season of use); Protection of human health or safety; Protection of animal or plant life or health; Protection of the environment 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 Reg
|
| Product |
Metribuzin (pesticide active substance) |
| Country |
European Union |
File attach:
NEU789.pdf
Orther Notice: