Flufenacet: BVL refrains from withdrawals pre-empting EU decision

With a technical announcement of 4 February 2025, the BVL has made its decision public as to whether Flufenacet containing plant protection products are withdrawn ex officio at short notice. The Federal Office of Consumer Protection and Food Safety (BVL) has decided against a withdrawal with regard to the pending renewal procedure for the active substance approval at European level, which is just before its conclusion.

In October 2024, the BVL had informed all holders of authorisations for plant protection products containing Flufenacet that a withdrawal was intended. The reasons for the BVL were findings from the active substance renewal process at the European level (endocrine disrupting properties) and new findings on the metabolite triflour acetate (TFA). Authorisation holders had the opportunity to comment on the hearing letter from BVL. KOOF Lawyers has successfully assisted on this matter.

The BVL now considers the reasons for its intention to withdraw the authorisations ex officio sufficiently taken into account in the ongoing active substance renewal process, which is very likely to result in a non-renewal. The Commission has already submitted a draft regulation declining the renewal to the competent committee of the representatives of the Member States (SCoPAFF) at the beginning of December 2024. Accordingly, the approval of the active substance would not be renewed and therefore expire. The SCoPAFF will finally decide on the implementing regulation at its meeting in March 2025.

The BVL now decided to wait for this. It considers it very likely that the active substance approval will not be renewed. In the consequence, authorisations will have to be withdrawn at national level within the framework of the European transitional periods.

The decision not to withdraw authorisations in advance ex officio is to be welcomed. Otherwise, a crucial active substance in Germany would no longer have been available earlier than in most of the other Member States in the European market. At the moment, the agricultural sector does not see comparable alternatives to control pests such as blackgrass (Alopecurus myosuroides) in Germany.

The withdrawal ex officio was particularly requested by environmental organisations.