Reasoned opinion on the review of the existing maximum residue levels (MRLs) for flonicamid according to Article 12 of Regulation (EC) No 396/2005

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(6):3740 [49 pp.].
doi
10.2903/j.efsa.2014.3740
Acknowledgements

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

Type
Reasoned Opinion
On request from
EFSA
Question Number
EFSA-Q-2010-01072
Approved
17 June 2014
Published
18 June 2014
Last Updated
27 November 2014. 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 flonicamid. In order to assess the occurrence of flonicamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC 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 found to be missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Summary

Flonicamid was included in Annex I to Directive 91/414/EEC on 01 September 2010, which is after the entry into force of Regulation (EC) No 396/2005 on 02 September 2008. EFSA is therefore 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 France, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The requested information was submitted to EFSA on 31 July 2013 and, after having considered several comments made by EFSA, the RMS provided on 02 October 2013 a revised PROFile.

Based on the conclusions derived by EFSA, in the framework of Directive 91/414/EEC and the additional information provided by the RMS, EFSA issued on 24 January 2014 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 28 March 2014 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.

The toxicological profile of flonicamid was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.025 mg/kg bw per d and 0.025 mg/kg bw, respectively.

Metabolism of flonicamid was investigated for foliar application on cereals (wheat), on fruits and fruiting vegetables (peach, pepper) and on root and tuber vegetables (potato), using 3-14C-phenyl labelled flonicamid. The flonicamid metabolic pathway is similar in wheat, potato, peach and pepper which involves hydrolysis of the cyano and amide functional groups leading to two major metabolites TFNA and TFNG. Quantitative variations in the metabolite profile did occur in the crops considered; however parent flonicamid, TFNG and TFNA constituted the most significant components of the residue. It was concluded that the residue definition for all the considered uses for both risk assessment and enforcement should be established as the sum of flonicamid, TFNG and TFNA expressed as flonicamid. Validated analytical methods for enforcement of this residue definition in food of plant origin are available with a combined LOQ of 0.03 mg/kg in high water content, high fat content, acidic and dry commodities. For hops, a matrix which is considered difficult to analyse, no validated method is available; this is required.

Regarding the magnitude of residues in primary crops, a sufficient number of supervised residue trials are available for the majority of the GAPs reported by the RMS, which allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities and to derive appropriate MRL proposals, except for cherries, plum, tomato, aubergine, courgette and cucurbits with inedible peel where trial data were only sufficient to derive tentative MRLs, and apricot, barley and oats where the available data were insufficient to derive tentative MRLs. The MRL proposal and risk assessment values for citrus fruits and hops are also tentative considering that storage stability data are still required for acidic matrices and no validated enforcement method is available for the determination of residues in hops.

Residue data on the nature of residues over processing in the form of a radiolabelled hydrolysis study were presented and indicates that flonicamid remained stable and that no breakdown or reaction products were formed. Considering however the high contribution of wheat to the overall chronic exposure, a hydrolysis study addressing the effects of processing on the flonicamid metabolites TFNG and TFNA is still required. Studies investigating the effect of processing on the magnitude of residues of flonicamid and its metabolites TFNG, TFNA and TFNA-AM in processed commodities of wheat, peach and plum and tomato were available to enable the proposal of indicative processing factors (in the absence of data on nature of residues in these crops). For melons however a robust peeling factor of 0.38 could be derived from the supervised residue trials as it does not involve heating and used to refine the risk assessment for cucurbits with inedible peel.

According to the soil degradation studies evaluated in the framework of the peer review, DT90 values of flonicamid and its metabolites in the soil (TFNG, TFNA-OH and TFNG-AM) are all expected to range between 1.5 – 8.7 days which is far below the trigger value of 100 days. Further investigation of residues in rotational crops is not required and relevant residues in rotational crops are not expected.

The nature of flonicamid residues in commodities of animal origin was investigated in lactating goats and laying hens using 3-[14C-phenyl] labelled flonicamid. The metabolism studies on both ruminant and poultry show that the metabolite TFNA-AM is the main component of the residue in animal tissues and products and the low levels of parent flonicamid indicate extensive metabolism involving hydrolysis of -CN and -CONH functional groups of flonicamid. The general metabolic pathways in rodents and ruminants were found to be comparable; the findings in ruminants can therefore be extrapolated to pigs. A residue definition for enforcement and risk assessment is proposed as the sum of flonicamid and TFNA-AM expressed as flonicamid. A validated method of analysis is available for the determination of flonicamid and TFNA-AM in food of animal origin with a combined LOQ of 0.02 mg/kg. Based on the feeding studies performed with a mixture 1/1 of flonicamid/TFNG significant residues in edible matrices of hens and ruminant and pig (liver, kidney and muscle) are expected and MRLs for these commodities can be proposed. Significant residues in milk and fat of ruminants and muscle and fat of pigs, are not expected and MRLs for these commodities can be established at the LOQ.

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 for an indicative calculation. The highest chronic exposure represented 18 % of the ADI (Danish child) and the highest acute exposure amounted to 80 % of the ARfD (cucumber).

Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005. MRL recommendations were derived in compliance with the decision tree reported in Appendix D of the reasoned opinion (see summary table). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see summary table footnotes for details). In particular, tentative MRLs or existing EU MRLs need to be confirmed by the following data:

  • fully validated method of analysis for enforcement of flonicamid and its metabolites TFNG and TFNA in hops;
  • storage stability studies of flonicamid and its metabolites TFNG and TFNA in acidic commodities;
  • 4 residue trials supporting the northern outdoor GAP on apricots;
  • 4 additional residue trials supporting the northern outdoor GAP on cherries;
  • 3 additional residue trials supporting the southern outdoor GAP on plum;
  • 8 residue trials supporting the southern outdoor GAP and 8 residue trials supporting the EU indoor GAP on tomato and aubergine;
  • 8 trials supporting the EU indoor GAP on courgette;
  • 4 residue trials supporting the southern GAP and 8 residue trials supporting the EU indoor GAP on cucurbits with inedible peel;
  • 8 residue trials on barley supporting the northern outdoor GAP on barley and oats;
  • a hydrolysis study on the flonicamid metabolites TFNG and TFNA investigating the nature of residues in processed commodities, in particular for wheat and rye which are the main contributors to the chronic exposure.

It is highlighted, however, that some of the MRLs derived result from a GAP in one climatic zone only, while other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the following data gaps which are not expected to impact on the validity of the MRLs derived but which might have an impact on national authorisations:

  • 4 residue trials supporting the northern outdoor GAP on peach;
  • 8 residue trials supporting the northern outdoor GAP on peppers;
  • 8 residue trials supporting the northern outdoor GAP and 8 residue trials supporting the southern outdoor GAP on cucurbits with edible peel.

If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level.

Minor deficiencies were also identified in the assessment but these deficiencies are not expected to impact either on the validity of the MRLs derived or on the national authorisations. The following data are therefore considered desirable but not essential:

  • 1 residue trial supporting the southern outdoor GAP on oranges and 2 residue trials supporting the southern outdoor GAP on mandarin;
  • clarification as to whether the TFNA metabolite could be a common metabolite to other active substances.
Keywords
flonicamid, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, insecticide
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Number of Pages
49