Draft Commission Implementing Regulation concerning the approval of the active substance abamectin
Title of document
Draft Commission Implementing Regulation concerning the approval of the active substance abamectin, 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 (4 page(s), in English; 3 page(s), in English)
This draft Commission Implementing Regulation provides that the approval of the active substance abamectin is renewed with restriction to uses in permanent greenhouses, as defined by Art 3(27) of Regulation (EC) No 1107/2009. EU Member States shall amend/withdraw authorisations for plant protection products containing abamectin as an active substance. The restricted 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. Separate action is likely to 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.
During the evaluation and peer-review of abamectin, 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) and reported here after:
Risk to wild non-target terrestrial vertebrates
Risk to wild non-target terrestrial organisms other than vertebrates
Risk to aquatic organisms
These concerns and areas that could not be finalised mean that not all abamectin’s uses meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and only uses restricted to greenhouses as defined in Art 3(27) of Regulation (EC) No 1107/2009 can be currently approved.
Existing authorisations will need to be amended or withdrawn; EU Member States must withdraw existing plant protection products containing abamectin for in-field uses at the latest by 6 months from the date of entry into force of this draft measure. In line with Article 46 of Regulation 1107/2009, there is a period of grace, which shall expire at the latest 12 months from the date of entry into force of the draft measure (allowing for a final season of use).
- Submission: 11/03/2021
- Reception: 12/03/2021
- Distribution: 15/03/2021
- Final date for comments: 14/05/2021
- Proposed date of adoption: N/A