In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences submitted a request to the competent national authority in Finland, to set an import tolerance for quizalofop-P-ethyl in grain from genetically modified maize containing aad-1 gene. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for quizalofop-P-ethyl maize grain. Adequate analytical methods for enforcement are available to control the residues of quizalofop-P-ethyl in maize grain. Based on the risk assessment results, EFSA concluded that the authorised use of quizalofop-P-ethyl on genetically modified maize containing aad-1 gene and the subsequent import of maize grain in Europe will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a risk to consumers' health. , 2018. Reasoned opinion on the setting of import tolerance for quizalofop-P-ethyl in genetically modified maize. EFSA Journal 2018;16(3):5250, 23 pp. https://doi.
SummaryIn accordance with Article 6 of Regulation (EC) No 396/2005, Dow AgroSciences submitted an application to the competent national authority in Finland (evaluating Member State, EMS), to set an import tolerance for the active substance quizalofop-P-ethyl in genetically modified (GM) maize (i.e. maize varieties expressing the AAD-1 protein that conveys resistance to 2,4-D, MCPA and aryloxyphenoxypropionate (AOPP) herbicides (R-isomers of dichlorprop, cyhalofop and quizalofop). The EMS drafted an evaluation report in accordance with Article quizalofop-P-ethyl, 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 25 January 2018. The EMS proposed to establish an maximum residue level (MRL) for GM maize imported from Canada, at the level of 0.02 mg/kg.EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation.Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the MRL Review under Article 12 of Regulation (EC) No 396/2005, and the new data submitted by the EMS in the MRL application, the following conclusions are derived.The metabolism of quizalofop-P-ethyl has been investigated following foliar applications in fruit crops, root crops and pulses/oilseeds. In the framework of the current application, a new metabolism study was submitted investigating the nature of quizalofop-P-ethyl in GM maize, containing the aryloxyalkanoate dioxygenase (aad-1) gene. At an application rate slightly above the authorised use rate, the total radioactive residue (TRR) in maize grain and cob was very low and thus not further characterised. European Food Safety Authority (EFSA) concludes that the metabolism of quizalofop-P-ethyl in GM maize grain is sufficiently investigated, indicating very low residues in GM maize grain when treated with quizalofop-P-ethyl at the rate tested. Additional metabolism studies are currently not...