Notice - Notification of WTO Members: Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance oxamyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of
||Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance oxamyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of
This draft Commission Implementing Regulation provides that the approval of the active substance oxamyl is not renewed in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorisations for plant protection products containing oxamyl 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 European Union under Regulation (EC) No 1107/2009. The substance was formerly assessed and approved under Directive 91/414/ EEC.
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 oxamyl, a number of concerns and areas that could not be finalised finalized were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA) and reported here after: The operators' exposure is unacceptable (min 112% of the AEOL and min 389% of the AAOEL) even when the use of PPE is considered; The preliminary consumer dietary risk assessment did indicate a large exceedance of the acute reference dose (ARfD) for all the representative uses: 1,538% (potatoes, children), 1,223% (watermelons, children), 656% (cucumbers, children) and 581% (tomatoes, children) even when oxamyl residues at the LOQ of 0.01mg/kg were considered. These concerns and areas that could not be finalised mean that oxamyl does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and its approval cannot be renewed. Existing authorisations will need to be withdrawn. EU member States must withdraw existing plant protection products containing oxamyl at the latest by six months from the date of entry into force. A period of grace in line with Article 46 of Regulation No 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).
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 Maximum Residue Limits and a separate notification will be made in accordance with SPS procedures.
||Oxamyl (pesticide active substance)