Setting of import tolerances, modification of existing maximum residue levels and evaluation of confirmatory data following the Article 12 MRL review for flupyradifurone and DFA

Abstract

In accordance with Article 6 of Regulation ( EC ) No 396/2005, the applicants Bayer CropScience AG and Bayer SAS submitted two requests to the competent national authority in the Netherlands to set import tolerances and to modify existing EU maximum residue levels ( MRL s) for the active substance flupyradifurone and its metabolite difluoroacetic acid ( DFA ) in various crops. The application also included the request to evaluate the confirmatory data related to residues that were identified in the framework of the peer review of flupyradifurone under Regulation ( EC ) No 1107/2009 as not available. The data submitted in support of intended and authorised uses were found to be sufficient to derive MRL proposals for flupyradifurone and DFA in all crops under consideration except for prickly pear and hops; for grapefruit, pome fruits, grape leaves and witloof, further risk management discussion is recommended to decide on the appropriate MRL . Furthermore, EFSA recommended risk management discussion to examine different options to deal with DFA residues in crops that can be grown in crop rotation. The calculated livestock dietary burdens indicated that existing EU MRL s for flupyradifurone and DFA in animal commodities need to be modified. Adequate analytical methods for enforcement are available to control the residues of flupyradifurone and the DFA in plant and animal matrices. The submitted data are considered sufficient to address the data gaps related to residues which were identified in the framework of the EU pesticides peer review, and thus, the footnotes set for DFA and flupyradifurone MRL s in the Commission Regulation ( EU ) 2016/1902 can be deleted. Based on the consumer exposure assessment, acute consumer exposure concerns could not be excluded for tomatoes, melons, celery and processed escaroles. Hence, the raising of the existing MRL s for flupyradifurone in these crops is not recommended. For these four crops, MRL proposals for DFA were derived, which reflect the uptake of residues via soil resulting from previous use of flupyradifurone. For the remaining commodities of plant and animal origin, EFSA concludes that the intended EU uses and authorised US and Canadian uses of flupyradifurone and resulting residues of DFA will not result in chronic or acute consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health.

Modification of the existing maximum residue levels and setting of import tolerances for flupyradifurone and DFA in various crops and animal commodities

“…To calculate the livestock exposure to DFA residues, only the commodities which can reasonably enter EU livestock feed chain were considered and for the choice of input values, the following approaches were taken: –For feed crops under the present assessment on which the use of flupyradifurone is intended only in Europe (kale, sunflower, maize, wheat, barley), DFA residues in primary crop (reflecting the EU intended use, see Appendix B.1.2.1) were added to residue levels of DFA estimated in the respective rotational crop when grown in the soil with flupyradifurone residues at EU plateau level (see Table E.1, Appendix E). For barley, kale and wheat the derived risk assessment value was compared to the value derived in the previous assessment (EFSA, 2020a) and the highest value was used in the calculation of the livestock dietary burden. For processed feed commodities of wheat and barley grain the processing factors applied were as derived in the previous EFSA assessment (2020a). –For millet, oat and rye, for which an import tolerance was requested for USA uses and for which also EU uses are intended, the DFA residues in grain as primary crop (EU and USA use, respectively) were added to residue levels of DFA estimated in the respective rotational crop (barley grain or maize grain) when grown in the soil with flupyradifurone residues at EU or USA plateau levels (Table E.1, Appendix E).…”

“…For processed feed commodities of wheat and barley grain the processing factors applied were as derived in the previous EFSA assessment (2020a). –For millet, oat and rye, for which an import tolerance was requested for USA uses and for which also EU uses are intended, the DFA residues in grain as primary crop (EU and USA use, respectively) were added to residue levels of DFA estimated in the respective rotational crop (barley grain or maize grain) when grown in the soil with flupyradifurone residues at EU or USA plateau levels (Table E.1, Appendix E). The highest STMR and HR value (either EU or USA) was selected as input value. –For imported rye, oat and barley the data on straw and stover from authorised US uses were not considered in the dietary burden as it is not expected that these bulky commodities will be imported in the EU. –In the remaining feed commodities the input values were as reported in the previous EFSA outputs, considering also feed crops on which primary crop uses are not known, but residues might occur from the soil uptake only (EFSA, 2020a,b). …”

Modification of the existing maximum residue levels and setting import tolerances for flupyradifurone and difluoroacetic acid (DFA) in various crops

“…The data gaps identified by EFSA as well as new EU uses and authorised uses of flupyradifurone in third countries (import tolerance request) were assessed in an EFSA reasoned opinion (EFSA, 2020b ).…”

“…EFSA based its assessment on the evaluation report submitted by the EMS (Netherlands, 2023 ), the draft assessment report (DAR) and its addenda (Netherlands, 2014 , 2015 ) prepared under Regulation (EC) 1107/2009, the Commission review report on flupyradifurone (European Commission, 2015 ), the conclusion on the peer review of the pesticide risk assessment of the active substance flupyradifurone (EFSA, 2015a ), as well as the conclusions from previous EFSA opinions on flupyradifurone (EFSA, 2016 ; 2020a , 2020b , 2021 , 2023a , 2023b ).…”

“…The effect of processing on the nature of DFA has not been investigated. Considering the similarity of the structures between trifluoroacetic acid (TFA) and DFA, a read‐across for DFA endpoint was considered by using data from the same endpoint from TFA (EFSA, 2020b ). The TFA has been widely studied due to its wide use in the organic chemistry and is, due to its structure (complete fluoride ion substitution), very stable and thus has no potential for hydrolytic degradation.…”