Peer review of the pesticide risk assessment of the active substance fosetyl

Abstract

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State France and co‐rapporteur Member State Estonia for the pesticide active substance fosetyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of fosetyl as a fungicide on grapes, citrus and pome fruits. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Evaluation of confirmatory data following the Article 12 MRL review for 1‐methylcyclopropene

“…EFSA has recently issued a conclusion on the peer review of the pesticide risk assessment of the active substance 1‐MCP under Regulation (EC) No 1107/2009 (EFSA, ) in which the toxicological reference values (TRVs) were increased compared to the previously agreed values (European Commission, ) which were used in the MRL review (EFSA, ). The new TRVs were formally adopted (European Commission, ).…”

“…EFSA based its assessment on the evaluation report submitted by the RMS (United Kingdom, ), the reasoned opinion on the MRL review according to Article 12 of Regulation (EC) No 396/2005 (EFSA, ) and the peer review of the pesticide risk assessment of the active substance 1‐MCP under Regulation (EC) No 1107/2009 (EFSA, ).…”

“…During the first and second peer review of 1‐MCP (EFSA, and EFSA, ) metabolism in apples, the only representative use was not investigated. Instead a laboratory‐scale study was presented mimicking the commercial practice by applying 1.2 ppm radiolabelled 1‐MCP to apples which is equivalent to 2.64 mg a.s./m 3 and corresponds to a 1.2N dose rate with respect to the proposed cGAP.…”

“…The previously derived residue definitions established in the peer‐review conclusion are still applicable (EFSA, ). The enforcement residue definition ‘1‐methylcyclopropene’ is the same as the one implemented in Regulation (EC) No 396/2005.…”

“…In the context of the renewal of the approval (EFSA, ), the TRVs have been revised; the new TRV were formally adopted by the European Commission (European Commission, ).…”