Draft Commission Implementing Regulation renewing the approval of the active substance etoxazole as a candidate for substitution in accordance with Regulation (EC) No 1107/2009 on plant protection products
Title of document
Draft Commission Implementing Regulation renewing the approval of the active substance etoxazole as a candidate for substitution 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; 3 page(s), in English)
This draft Commission Implementing Regulation provides that the approval of the active substance etoxazole is renewed as a candidate for substitution in accordance with Regulation (EC) No 1107/2009. It is however, necessary to include certain conditions and restrictions. In particular, only use on ornamental plants in permanent greenhouses can be approved.
Existing authorised plant protection products containing etoxazole will be reviewed in accordance with the restrictions. The restriction 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 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 action will likely be taken on MRLs and a separate notification will be made in accordance with SPS procedures.
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) which must be met to enable approval.
During the evaluation and peer-review of etoxazole, 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).
EFSA concluded high risk to non-target arthropods and the consumer dietary risk assessment could not been finalised considering the outstanding data to conclude on the residue definition for risk assessment for processed commodities.
These concerns mean that etoxazole meets the approval criteria as outlined in Regulation (EC) No 1107/2009 only if the approval is restricted to use on ornamental plants in permanent greenhouses.
Existing authorisations will need to be amended or withdrawn following renewal of authorisation in accordance with Article 43 of Regulation (EC) No 1107/2009.
- Submission: 14/08/2020
- Reception: 17/08/2020
- Distribution: 17/08/2020
- Final date for comments: 16/10/2020
- Proposed date of adoption: N/A