Review of the existing maximum residue levels for fenpyroximate according to Article 12 of Regulation (EC) No 396/2005

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2016;14(1):4382 [48 pp.].
doi
10.2903/j.efsa.2016.4382
Acknowledgements

EFSA wishes to thank the rapporteur Member State Germany for the preparatory work on this scientific output.

Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2009-00129
Approved
15 December 2015
Published
15 January 2016
Last Updated
21 March 2016. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenpyroximate. In order to assess the occurrence of fenpyroximate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission, as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers.

Summary

Fenpyroximate was included in Annex I to Directive 91/414/EEC on 1 May 2009 by Commission Directive 2008/107/EC, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. As the active substance was approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, EFSA is required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(1) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Germany, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report provided by the RMS were made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period which was initiated by EFSA on 17 February 2015 and finalised on 17 April 2015. After having considered all the information provided, EFSA prepared a completeness check report which was made available to Member States on 20 May 2015.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS and Member States, EFSA prepared in September 2015 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 6 October 2015 were considered during the finalisation of this reasoned opinion. The following conclusions are derived.

The primary crop metabolism of fenpyroximate was investigated for foliar treatment in fruit crops (tangerine, grapes and apples) and in pulses and oilseeds (beans). However, an additional metabolism study addressing primary crop metabolism in a third crop group is still required (to cover authorisations in celeriac and hops in particular) and studies investigating the nature of the residues in rotational crops and in processed commodities were also not available. In the absence of these data, the residue definition for monitoring in plants is tentatively defined as the parent compound E‑isomer, while for risk assessment the residue definition is tentatively proposed as the sum of fenpyroximate and its Z-isomer, expressed as fenpyroximate. A validated analytical method for enforcement of the proposed residue definition is available for acidic and high water content commodities, but further validation in hops is still required.

Regarding the magnitude of residues, the available data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for celeriac and pumpkins where the available data were insufficient to derive MRLs. Furthermore, it is noted that all MRL proposals are considered tentative due to the data gaps identified on nature of residues in primary crops, rotational crops and processed commodities, and due to the missing residue trials identified for several crops.

Fenpyroximate is authorised for use on crops that might be fed to livestock and the livestock dietary burden calculated was found to exceed the trigger value of 0.1 mg/kg dry matter (DM) only for meat ruminants. Metabolism of fenpyroximate was investigated in lactating goats. A livestock feeding study on lactating cow is also available. Based on livestock metabolism and animal feeding studies, parent residues are not expected in any tissues but metabolite M-3 can be present at levels above the limit of quantification (LOQ) in kidney and liver. Therefore, the residue definition for enforcement in animal commodities was proposed as metabolite M-3, expressed as fenpyroximate. It is noted that an analytical method for the enforcement of the proposed residue definition is not available. Consequently, the default LOQ of 0.01 mg/kg is tentatively proposed for enforcement. For risk assessment the residue definition is proposed as the sum of fenpyroximate, Fen-OH, M-3 and their Z-isomers, expressed as fenpyroximate. The available livestock feeding study also allowed EFSA to derive MRL and risk assessment values for ruminant tissues and milk. However, considering that a fully validated analytical method for enforcement of the proposed residue definition in animal commodities is still required and the data gaps identified for plant commodities (resulting in a tentative livestock dietary burden calculation), these MRLs are tentative only.

Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL multiplied for the CF of 1.3 derived from the available metabolism studies for an indicative calculation. The highest chronic exposure was calculated for German children, representing 16% of the ADI, and the highest acute exposure was calculated for peaches, representing 73% of the ARfD.

Keywords
fenpyroximate, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, pyrazole acaricides
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Number of Pages
48