Statement on the testing strategy and timelines for the assessment of developmental neurotoxicity and endocrine disruption properties of acetamiprid in the context of the review of the approval of the active substance

Abstract

On 29 January 2021, the EFSA Panel on Plant Protection Products and their Residues adopted a Statement on acetamiprid in response to a mandate from the Commission following a notification under Article 69 of Regulation (EC) No 1107/2009 in which, among others, it was recommended to conduct an assessment of the endocrine disrupting (ED) properties of acetamiprid in line with the criteria established by Commission Regulation (EU) No 2018/605. On 27 March 2024, EFSA issued a Statement on the toxicological properties and maximum residue levels of acetamiprid and its metabolites, following a mandate from the Commission pursuant to Article 31 of Regulation (EC) No 178/2002. EFSA concluded that there are data gaps in the in vivo body of evidence, including the lack of an acceptable measurement of learning and memory, motor activity and morphometric evaluation in the available developmental neurotoxicity (DNT) studies. To account for the identified gaps, EFSA proposed to include an additional uncertainty factor of 5 in the derivation of the Health-Based Guidance Values: as a consequence, it could not be fully established that acetamiprid still meets the approval criteria laid down in Article 4 of Regulation (EC) No 1107/2009 with respect to its DNT, as well as for the ED properties for which an assessment is not available. Therefore, the European Commission decided to launch a review of the existing approval in accordance with Article 21 of that Regulation and invited the applicant to submit a comprehensive list of existing or planned studies, along with any relevant information, for re-assessing the ED and DNT properties of acetamiprid. On 21 May 2025, pursuant to Article 21(2) of Regulation (EC) No 1107/2009, the Commission requested EFSA to assess the proposal, as submitted by the applicant, on the testing strategy and associated timelines for the generation of additional data for the assessment of the DNT and ED properties of acetamiprid. The current statement contains EFSA's considerations whether the proposed studies are considered sufficient and realistic to complete the assessment of the ED properties of the active substance in line with Commission Regulation (EU) 2018/605 and to conduct an evaluation of DNT properties in line with the recommendations given in the EFSA statement issued in 2024.