Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance benalaxyl

Title of document
Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance benalaxyl, 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)

Description
This draft Commission Implementing Regulation provides that the approval of the active substance benalaxyl is not renewed in accordance with Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant protection products containing benalaxyl 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

Notification: G/TBT/N/EU/721

Objective tag
Protection of human health or safety; Protection of animal or plant life or health; Protection of the environment

Objective
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 benalaxyl, 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). In Particular, the Authority could not exclude the potential groundwater contamination by relevant metabolites and identified as a critical area of concern a long-term risk to birds and earthworm-eating birds from secondary poisoning from benalaxyl. Additionally, the Authority identified concerns in relation to the risk to in-field and off-field non-target arthropods for all representative uses. Finally, following the request by the Authority for additional information, the applicant confirmed that no additional studies would be performed or submitted. Consequently, the assessment of the endocrine disrupting potential of benalaxyl could not be finalised and it could not be concluded that the substance has no endocrine disrupting properties. These concerns mean that benalaxyl 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 benalaxyl 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).

Documents

• 20_3204_00_e.pdf

Agency responsible
European Commission

Timing:

• Submission: 13/05/2020
• Reception: 13/05/2020
• Distribution: 14/05/2020
• Final date for comments: 13/07/2020
• Proposed date of adoption: N/A