European Chemicals Agency: Sumitomo Chemical Agro Europe Appeals Decision

The European Chemicals Agency has announced an appeal, Case A-010-2023, filed by Sumitomo Chemical Agro Europe SAS, based in France. The appeal, which was received on September 4, 2023, concerns a decision made by the European Chemicals Agency under Article 54(4) of the Biocidal Products Regulation.

The subject matter of the case revolves around the technical equivalence assessment of two strains of micro-organisms, Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 ('BTI AM65-52'), manufactured by Sumitomo Chemical Agro Europe SAS, and Bacillus thuringiensis subsp. israelensis Strain BMP 144 ('BTI BMP 144') manufactured by another company. The Competent Authority of France, Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), had previously given a positive technical equivalence decision for BTI BMP 144, and Sumitomo Chemical Agro Europe SAS sought a similar decision for BTI AM65-52.

On June 6, 2023, the European Chemicals Agency adopted a Contested Decision, rejecting Sumitomo Chemical Agro Europe SAS's request for technical equivalence between BTI AM65-52 and BTI BMP 144. The Agency argued that there was no legal necessity for Sumitomo to obtain a technical equivalence decision as a condition for authorizing a biocidal product under Article 19(1)(c). They also noted that ANSES had already carried out the technical equivalence assessment for these strains.

Sumitomo Chemical Agro Europe SAS has appealed this decision, seeking to annul it and requesting a refund of the appeal fee. They present several arguments, claiming that the Agency erred in interpreting Article 54, misunderstood the necessity of a technical equivalence decision, and failed to consider that ANSES was not competent to assess technical equivalence post-BPR implementation.

Sumitomo Chemical Agro Europe SAS also contends that the Agency deviated from its own guidelines regarding the assessment of applications for technical equivalence of active micro-organisms. They argue that two distinct applications should have been submitted for the renewal of BTI AM65-52 and BTI BMP 144 approval.