Reasoned Opinion on the review of the existing maximum residue levels (MRLs) for trifloxystrobin 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(2):3592 [81 pp.].
doi
10.2903/j.efsa.2014.3592
Acknowledgements

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

Type
Reasoned Opinion
On request from
EFSA
Question Number
EFSA-Q-2008-644
Approved
26 February 2014
Published
27 February 2014
Last Updated
9 April 2015. 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 trifloxystrobin. In order to assess the occurrence of trifloxystrobin 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 import tolerances and 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

Trifloxystrobin was included in Annex I to Directive 91/414/EEC on 01 October 2003, which is before 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(2) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked United Kingdom, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 21 July 2011 and, after having considered several comments made by EFSA, the RMS provided on 02 November 2012 a revised PROFile.

Based on the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS, EFSA issued on 20 August 2013 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 18 October 2013 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.

The toxicological profile of trifloxystrobin was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI being established at 0.1 mg/kg bw per d. An ARfD was not deemed necessary.

Primary crop metabolism of trifloxystrobin was investigated in three different crop groups following foliar applications. Based on these studies, EFSA proposes to define the residue for enforcement in all plant commodities as parent trifloxystrobin while for risk assessment the relevant residue is defined as the sum of trifloxystrobin and CGA321113, expressed as trifloxystrobin. Validated analytical methods for enforcement of this residue definition are available with an LOQ of 0.01 mg/kg.

Regarding the magnitude of residues in primary crops, at least one GAP is fully supported by data for most of the crops reported and the available residue data were considered acceptable to derive MRL proposals as well as risk assessment, except for cherry, apricot, peach, currants, gooseberries, passion fruit, pepper, cucurbits with edible peel, leafy brassica, scarole, herbs, beans (fresh, with pods), leek, barley and oats where additional data are required (residue trials compliant with GAP) and only tentative MRLs are derived. For blackberries, raspberries, pumpkins, witloof, peas (fresh, with pods), olives for oil production and chicory roots, the available data were insufficient to derive tentative MRLs.

The hydrolysis studies demonstrated that under pasteurisation, baking/boiling/brewing and sterilisation conditions, trifloxystrobin remained stable in processed commodities. Consequently, the residue definitions proposed for enforcement and risk assessment of raw commodities also apply to processed commodities. Studies investigating the magnitude of residues in processed commodities of apple and wines were also reported. As data on trifloxystrobin and CGA 321113 residue levels in raw and processed commodities were not reported, it was not possible to derive processing factors according to the proposed residue definitions.

The potential incorporation of soil residues into succeeding and rotational crops was investigated in lettuce, radish and wheat during the peer review and the residue definition set for the primary crops also applies to the rotational crops. Trifloxystrobin residue levels are also not expected to exceed 0.01 mg/kg in rotational commodities, provided that trifloxystrobin is applied in compliance with the GAPs reported in Appendix A.

Based on the uses reported by the RMS, significant intakes were calculated for ruminants, poultry and pigs. Metabolism in lactating ruminants and poultry was sufficiently investigated and findings in ruminants can be extrapolated to pigs. The relevant residue definition for enforcement in all commodities of animal origin was defined as sum of trifloxystrobin and CGA321113, expressed as trifloxystrobin. For risk assessment, the residue definition is the same, except in ruminant liver and kidney, where EFSA proposes to define the residue as the sum of trifloxystrobin, CGA321113 and its conjugates, expressed as trifloxystrobin. Fully validated analytical methods for enforcement of the residue definition are not available and they are therefore still required. Feeding studies also allowed to derive MRLs in ruminants and pigs. Considering however that no fully validated analytical method is available, these MRLs are tentative.

Chronic 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 5.9 % of the ADI (WHO Cluster diet B). Acute exposure calculations were not carried out because an ARfD was not deemed necessary for this active substance.

Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for trifloxystrobin. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out. The highest chronic exposure represented 6.1 % of the ADI (WHO Cluster diet B).

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, some tentative MRLs and existing EU MRLs need to be confirmed by the following data:

  • an analytical method fully validated and its ILV for the determination of trifloxystrobin and its metabolite CGA 321113 in animal commodities;
  • 4 residue trials on raspberry complying with the northern GAP on blackberry and raspberry;
  • 6 residue trials on currants complying with the northern GAP on currants and gooseberries and including results in accordance with the residue definition for risk assessment;
  • 4 residue trials complying with the import tolerance on passion fruit;
  • 8 trials complying with the southern GAP and 3 additional trials complying with the indoor GAP on pepper;
  • 8 residue trials on cucumbers complying with the northern GAP on cucurbits with edible peel and 8 residue trials complying with the indoor GAP on cucumber;
  • 2 additional trials on kale complying with the northern GAP on leafy brassica, including residue data in accordance with the residue definition for risk assessment;
  • 4 trials on lettuce (open leaves variety) complying with the indoor GAP and 4 trials on lettuce (open leaves variety) complying with the northern GAP on scarole and herbs;
  • 4 residue trials complying with the northern GAP on witloof;
  • 8 trials complying with the indoor GAP and 6 additional trials complying with the northern GAP on beans (fresh, with pods) (including residue data in accordance with the residue definition for risk assessment);
  • 8 residue trials complying with the indoor GAP on peas (fresh, with pods);
  • 8 residue trials complying with the southern GAP on olives for oil production;
  • 8 residue trials complying with the northern GAP on oats;
  • 4 residue trials complying with the northern GAP on chicory roots.

It is highlighted, however, that some of the MRLs derived result from a CXL or 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:

  • 7 additional residue trials (with a minimum of 4 trials on apricots) complying with the northern outdoor GAP on apricot and peaches and 8 residue trials (with a minimum of 4 trials on apricots) complying with the southern outdoor GAP on apricot and peaches;
  • 8 residue trials on cherries complying with the northern GAP, 1 additional trial on cherries complying with the southern GAP and 4 residue trials on cherries complying with the indoor GAP;
  • 8 residue trials on grapes complying with the indoor GAP;
  • 6 additional residue trials on strawberries complying with the northern GAP and 8 trials complying with the southern GAP;
  • 8 residue trials complying with the southern GAP on tomato;
  • 4 additional residue trials complying with the southern GAP on courgettes;
  • 8 residue trials complying with the northern GAP on melons;
  • 4 residue trials complying with the northern GAP and 4 residue trials complying with the indoor GAP on pumpkin;
  • 2 additional residue trials complying with the southern GAP on watermelon;
  • 8 residue trials complying with the northern GAP and 6 additional residue trials complying with the southern GAP on leek (including residue data in accordance with the residue definition for risk assessment);
  • 2 additional residue trials on wheat complying with the southern GAP on wheat and rye;
  • 2 additional residue trials complying with the southern GAP on barley;
  • 4 residue trials complying with the northern GAP on grass.

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:

  • data on the toxicological relevance and magnitude of the compound SA04271 in cereal grain;
  • a detailed evaluation report of the latest storage stability studies as well as the storage conditions of the residues trials samples for which storage conditions were not yet reported;
  • 1 additional residue trial on plum complying with the northern GAP;
  • 1 additional residue trial on melon complying with the southern GAP;
  • 1 additional residue trial on barley supporting the northern GAP;
  • 1 additional residue trial on wheat complying with the northern GAP on wheat and rye;
  • information on the storage conditions of the samples from livestock feeding studies.
Keywords
trifloxystrobin, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, strobilurins, fungicide
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