Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance bromoxynil
Title of document
Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance bromoxynil, 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)
This draft Commission Implementing Regulation provides that the approval of the active substance bromoxynil is not renewed in accordance with Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant protection products containing bromoxynil 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 may 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 bromoxynil, 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 conclusion of the Authority indicates that, during the peer review, experts from Member States and the Authority suggested that bromoxynil, currently subject to harmonised classification and labelling in accordance with Regulation (EC) No 1272/2008 as toxic for reproduction category 2, should be classified as toxic for reproduction category 1B in accordance with the criteria laid down in that Regulation. The Commission therefore requested the Authority to consider whether negligible exposure in accordance with Point 3.6.4 of Annex II to Regulation (EC) No 1107/2009 could be demonstrated. On 8 November 2018, the Authority communicated to the Commission its conclusion (EFSA Journal 2018;16 (12):5490, 15 pp.) that, for the representative uses considered, non-dietary exposure to bromoxynil cannot be considered negligible. In that conclusion, the Authority identified a risk to child residents from the representative uses of bromoxynil even when taking into account available mitigation measures.
In its conclusion from 2017, the Authority also identified a high risk to wild mammals from dietary exposure to bromoxynil. Furthermore, the Authority concluded that the consumer risk assessment for products of animal origin and the risk assessment for aquatic organisms could not be finalised.
Derogation in accordance with Article 4(7) of Regulation (EC) No 1107/2009 does not apply for the reasons set out in the draft Regulation.
These concerns mean that bromoxynil 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 bromoxynil 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: 16/04/2020
- Reception: 16/04/2020
- Distribution: 17/04/2020
- Final date for comments: 16/06/2020
- Proposed date of adoption: N/A