European Union | Draft Commission Implementing Regulation renewing the approval of the active substance bifenazate
Title of document
Draft Commission Implementing Regulation renewing the approval of the active substance bifenazate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (5 page(s), in English; 4 page(s), in English)
This draft Commission Implementing Regulation provides that the approval of the active substance bifenazate is renewed in accordance with Regulation (EC) No 1107/2009. It is however, necessary to include certain conditions and restrictions, i.e. to restrict the use of plant protection products containing bifenazate to non-edible crops in permanent greenhouses and to require further confirmatory information.
Existing authorised plant protection products containing bifenazate will be reviewed in accordance with the conditions and restrictions set in this act. The conditions and restrictions are 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 approved under Directive 91/414/EEC.
This decision only concerns the placing on the market of this substance. Following restriction of the approval and the consequent expiry of all grace periods for stocks of products, separate legal action may be taken on Maximum Residue Levels and a separate notification will be made in accordance with SPS procedures in due time.
Notifying member: European Union
Protection of human health or safety; Protection of animal or plant life or health; Protection of the environment
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 bifenazate, a number of concerns and areas that could not be finalised were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA).
This means that bifenazate meets the approval criteria as outlined in Regulation (EC) No 1107/2009 only if its use is restricted to non-edible crops in permanent greenhouses. The restriction to use on non-edible crops will exclude dietary exposure of consumers and is required since the consumer risk assessment could not be finalised. As a high risk was identified to birds via long term exposure to bifenazate, a restriction to use in greenhouses as defined in Article 3 of Regulation (EC) No 1107/2009 will ensure that birds are not exposed to bifenazate.
Existing authorisations will need to be amended or withdrawn following renewal of authorisation in accordance with Article 43 of Regulation (EC) No 1107/2009.
Agency responsibleEuropean Commission
- Submission: 21/01/2022
- Reception: 24/01/2022
- Distribution: 24/01/2022
- Final date for comments: 25/03/2022
- Proposed date of adoption: N/A