Draft Commission Implementing Regulation withdrawing the approval of the active substance alpha-cypermethrin
Title of document
Draft Commission Implementing Regulation withdrawing the approval of the active substance alpha-cypermethrin 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 Commission Implementing Regulation (EU) No 540/2011 (4 page(s), in English)
This draft Commission Implementing Regulation provides that the approval of the active substance alpha-cypermethrin is withdrawn in accordance with Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant protection products containing alpha-cypermethrin as an active substance.
This decision only concerns the placing on the market of this substance and plant protection products containing it. Following withdrawal 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.
Commission Implementing Regulation (EU) 2019/1690 renewed the approval of the active substance alpha-cypermethrin as candidate for substitution under the conditions that the applicant shall submit to the Commission, the EU Member States and the Authority confirmatory information as regards the toxicological profile of certain metabolites by 30 October 2020. In addition, confirmatory information had been required for three other points by other deadlines.
On 14 October 2020, the applicant informed the Commission, the rapporteur Member State and EFSA that it would not submit any confirmatory data, therefore, as the information required in accordance with Article 6(f) was not submitted, the approval for alpha-cypermethrin has to be withdrawn according to Article 21(3) of Regulation (EC) No 1107/2009.
Existing authorisations will need to be withdrawn; EU Member States must withdraw existing plant protection products containing alpha-cypermethrin at the latest by 6 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).
- Submission: 21/01/2021
- Reception: 22/01/2021
- Distribution: 22/01/2021
- Final date for comments: 23/03/2021
- Proposed date of adoption: N/A