European Union | Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance indoxacarb
Title of document
Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance indoxacarb, 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 Implementing Regulation (EU) No 540/2011 (5 page(s), in English)
This draft Commission Implementing Regulation provides that the approval of the active substance indoxacarb is not renewed in accordance with Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant protection products containing indoxacarb 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.
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.
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.
uring the evaluation and peer-review of indoxacarb, 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).
The EFSA identified a critical concern in relation to the high long-term risk to wild mammals for all representative uses and, additionally, a high risk to consumers and workers for the representative use in lettuce and a high risk to bees for the representative use in maize, sweet corn and lettuce for seed production. Furthermore, there are several areas of the risk assessment not finalised due to lack of data in the dossier.
These concerns mean that indoxacarb does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and cannot be approved currently.
Existing authorisations will need to be withdrawn; EU Member States must withdraw existing plant protection products containing indoxacarb at the latest by 3 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 6 months from the entry into force.
- Submission: 30/07/2021
- Reception: 02/08/2021
- Distribution: 02/08/2021
- Final date for comments: 01/10/2021
- Proposed date of adoption: N/A