Draft Commission Implementing Regulation on Non-Renewal of Approval of Active Substance Oxamyl

The European Commission has released a draft implementing regulation regarding the non-renewal of the approval of the active substance oxamyl in accordance with Regulation (EC) No 1107/2009. The decision to not renew the approval of oxamyl 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, which demonstrated that the substance does not meet the approval criteria outlined in the regulation.

As a result of this decision, EU member states must withdraw authorizations for plant protection products containing oxamyl as an active substance. Existing authorizations will need to be withdrawn within six months of the regulation's entry into force, with a grace period of 12 months for the final season of use. After the grace period expires, separate action may be taken on Maximum Residue Limits and a separate notification will be made in accordance with SPS procedures.

The concerns and areas that could not be finalized in the evaluation of oxamyl were outlined in the conclusion of the European Food Safety Authority (EFSA), which indicated that exposure to the operators is unacceptable and that there is a large exceedance of the acute reference dose for consumers, even when oxamyl residues at the limit of quantification of 0.01mg/kg were considered.

This draft Commission Implementing Regulation has been notified under the TBT Agreement in notice G/TBT/N/EU/945 and is also included in the notification G/SPS/N/EU/613. The objective of the regulation is to ensure the protection of food safety, plant protection, animal health, and to protect the territory from other damage from pests.