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

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(10):3405 [43 pp.].
doi
10.2903/j.efsa.2013.3405
Acknowledgements

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

Type
Reasoned Opinion
On request from
EFSA
Question Number
EFSA-Q-2008-494
Approved
7 October 2013
Published
8 October 2013
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 benalaxyl. In order to assess the occurrence of benalaxyl 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 found to be missing and the consumer risk assessment for benalaxyl is considered indicative only. Moreover, residues of benalaxyl may also be generated by the use of benalaxyl-M, which is the purified R-enantiomer of benalaxyl and which is currently stioll under assessment at EU level. Considering that EFSA was not yet in a position to include the use of benalaxyl-M in the above assessment and that most of the uses of benalaxyl evaluated in the framework of this review do not seem to require the setting of MRLs higher than those currently listed in Annexes II and III of Regulation (EC) No 396/2005 EFSA recommends that the existing EU MRLs for benalaxyl (benalaxyl including other mixtures of constituent isomers including benalaxyl-M (sum of isomers)), except for table grapes, are maintained until the review of MRLs for benalaxyl-M can be finalised. For table grapes, EFSA recommends to increase the existing EU MRL of 0.3 mg/kg to 0.6 mg/kg to cover the authorised use of benalaxyl on table grapes which is adequately supported by data and for which no risk to consumers was identified.

Summary

Benalaxyl was included in Annex I to Directive 91/414/EEC on 01 March 2005, 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 afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Portugal, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 10 October 2008 and, after having considered several comments made by EFSA, the RMS provided on 22 June 2011 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 19 April 2013 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 21 June 2013 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.

The toxicological profile of benalaxyl was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.04 mg/kg bw/d. An ARfD was not deemed necessary. The ADI was established for benalaxyl, but it was concluded that benalaxyl-M (the purified R-enantiomer of benalaxyl) has a similar pattern of toxicity, toxicokinetics and metabolism as benalaxyl and the same ADI was established for both active substances.

Metabolism of benalaxyl was investigated in three different crop groups following foliar application. Metabolic patterns in the different studies were shown to be similar and the residue definition could be extended to all plants. The relevant residue for enforcement and risk assessment in plants could be defined as benalaxyl including other mixtures of constituent isomers including benalaxyl-M (sum of isomers). A validated analytical method for enforcement of the proposed residue definition is also available, with an LOQ of 0.01 mg/kg in acidic, dry, high water and high oil content commodities.

Regarding the magnitude of residues, a sufficient number of supervised residues trials is available for most 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 MRLs, except for pepper and rape seed. In these two crops, no residue trials were available and no MRL or risk assessment values could be derived.

As the chronic exposure to benalaxyl does not exceed 10 % of the ADI, investigations on processed products are in principle not necessary. A study on the magnitude of residues was performed in grapes and tomatoes but the processing factors derived can only be considered as indicative as the nature of residues in processed commodities was not investigated. Further processing studies are not required because they are not expected to affect the outcome of the risk assessment. However, if there would be the intention from risk managers to derive more processing factors for enforcement purposes, additional processing studies might be required.

Occurrence of benalaxyl residues in rotational crops was already investigated during the peer review of benalaxyl. On the basis of the reported data and considering the GAPs of benalaxyl reported in the framework of this review, it is concluded that significant residues of benalaxyl are not expected in rotational crops.

Based on the uses reported by the RMS, no significant intakes were calculated for all groups of livestock. However, metabolism studies on goats and hens were performed. These studies show that even if the compound is highly excreted, the remaining radioactivity consists mainly of hydroxymethyl metabolites, rather than of parent compound.

Chronic consumer exposure resulting from the MRLs derived 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 2 % 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.

However, residues of benalaxyl may also be generated by the use of benalaxyl-M, which is the purified R-enantiomer of benalaxyl. Considering that benalaxyl-M is currently under assessment at European level, and that no information supporting the review of MRLs for benalaxyl-M has been provided to EFSA so far, EFSA is not yet in a position to include the uses of benalaxyl-M in the current assessment. EFSA therefore assessed by means of a second calculation whether the existing EU MRLs for benalaxyl (including benalaxyl-M) might be of concern for European consumers. Noting that none of the MRLs derived in the framework of this review exceeds the existing EU MRLs for benalaxyl-M, except the one for table grapes, and assuming that current authorised uses of benalaxyl-M are also covered by the existing EU MRLs, this approach is expected to provide a tentative and conservative estimate of the combined exposure of European consumers to benalaxyl and benalaxyl-M residues, provided that the higher MRL proposal for table grapes is also included in the calculation. Based on this calculation, the highest chronic exposure represented 12.3 % of the ADI (WHO cluster diet B).

As the use of benalaxyl was previously assess by JMPR (FAO, 2009a), the CXLs resulting from this assessment should in principle also be taken into account for the intake calculation. However, these CXLs were already implemented at EU level by means of Regulation (EU) No 520/2011. Consequently, consumer exposure due to CXLs is already taken into account in the second intake calculation and no additional calculation is necessary.

Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005. Considering that EFSA was not yet in a position to include the use of benalaxyl-M in the above assessment and that most of the uses of benalaxyl evaluated in the framework of this review do not seem to require the setting of MRLs higher than those currently listed in Annexes II and III of Regulation (EC) no 396/2005 EFSA recommends that the existing EU MRLs for benalaxyl (benalaxyl including other mixtures of constituent isomers including benalaxyl-M (sum of isomers)), except for table grapes, are maintained until the review of MRLs for benalaxyl-M can be finalised. For table grapes, EFSA recommends to increase the existing EU MRL of 0.3 mg/kg to 0.6 mg/kg to cover the authorised use of benalaxyl on table grapes which is adequately supported by data and for which no risk to consumers was identified.

It is noted however that during the assessment of benalaxyl the following data gaps have been identified for other crops:

  • 8 residue trials supporting the northern outdoor GAP on wine grapes;
  • 8 residue trials supporting the northern outdoor GAP tomatoes;
  • 8 residue trials supporting the southern outdoor GAP and 8 residue trials supporting the indoor GAP on peppers;
  • 6 additional residue trials supporting the indoor GAP on melon and watermelon;
  • 8 residue trials supporting the northern outdoor GAP and 8 residue trials supporting the indoor GAPs on lettuce;
  • 8 residue trials supporting the northern outdoor GAP on rapeseed;
  • Storage stability data on high oil content commodities.

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. Regardless of the data gaps identified, Member States are in any case strongly recommended to reconsider any indoor GAP on melons and watermelons in order not to have exceedances of the EU MRL.

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

  • 1 additional residue trial supporting the southern outdoor GAP on melon and watermelon.
Keywords
benalaxyl, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, phenylamide, fungicide, benalaxyl M
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Number of Pages
43