Setting of import tolerance for quizalofop‐P‐ethyl in genetically modified maize

Abstract

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...

Evaluation of confirmatory data following the Article 12 MRL review for quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop and modification of the existing maximum residue levels for quizalofop‐P‐tefuryl

“…6 The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed on all quizalofop‐P‐ester variants (quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop) (EFSA, 2017 ) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued two reasoned opinions on the modification of MRLs for quizalofop‐P‐ethyl (EFSA, 2018b , 2021 ). The proposals from these reasoned opinions have been considered in recent MRL regulations.…”

Modification of the existing maximum residue level for quizalofop (resulting from the use of quizalofop‐P‐ethyl) in caraway

“…The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed on all quizalofop‐P‐ester variants (quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop) (EFSA, 2017 ) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued one reasoned opinion on the modification of MRLs for quizalofop‐P‐ethyl (EFSA, 2018b ). The proposals from these reasoned opinions have been considered in recent MRL regulations.…”

“…EFSA based its assessment on the evaluation report submitted by the EMS (Finland, 2021 ), the DAR and its addendum (Finland, 2007 , 2008 ) prepared under Council Directive 91/414/EEC, the Commission review report on quizalofop‐P‐ethyl (European Commission, 2010c ), the conclusion on the peer review of the pesticide risk assessment of the active substance quizalofop‐P‐ethyl (EFSA, 2009 ), as well as the conclusions from the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 performed on all quizalofop‐P‐ester variants (quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop) (EFSA, 2017 ) and another EFSA opinion on quizalofop‐P‐ethyl (EFSA, 2018b ).…”

“…The metabolism of quizalofop‐P‐ethyl in primary crops belonging to the groups of fruit crops (tomatoes), root crops (sugar beets and potatoes) and pulses/oilseeds (cotton and soya beans) has been investigated in the framework of the EU pesticides peer review (EFSA, 2009 ) and the MRL review (EFSA, 2017 ). Additionally, a new metabolism study in cereals (GM maize, containing the aryloxyalkanoate dioxygenase (aad‐1) gene) was investigated in a subsequent MRL application (EFSA, 2018b ). No additional metabolism studies were submitted in the framework of this MRL application.…”

“…In the framework of the MRL review, a comprehensive long‐term exposure assessment was performed, taking into account the existing uses at EU level of all quizalofop‐P ester variants (EFSA, 2017 ). EFSA updated the calculation with the STMR value derived from the residue trials submitted in support of this MRL application for caraway and other STMRs derived in an EFSA opinion published after the MRL review (EFSA, 2018b ). The input values used in the exposure calculations are summarised in Appendix D.1 .…”