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

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(7):4203 [49 pp.].
doi
10.2903/j.efsa.2015.4203
Type
Reasoned Opinion
On request from
EFSA
Question Number
EFSA-Q-2009-00031
Approved
14 July 2015
Published
22 July 2015
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 acrinathrin. In order to assess the occurrence of acrinathrin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009 as well as the European authorisations reported by Member States (incl uding the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Furthermore, only few authorisations reported by Member States were compliant with the current approval restrictions of acrinathrin. Hence, the consumer risk assessment is considered indicative only, all MRL proposal s derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

Summary

Acrinathrin was approved on 1 January 2012 under Regulation (EC) No 1107/2009, which repealed Directive 91/414/EEC. Since acrinathrin was approved after the entry into force of Regulation (EC) No 396/2005 on 02 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 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 11 April 2014 and, after having considered several comments made by EFSA, the RMS provided on 27 June 2014 a revised PROFile.

Based on the conclusions derived by EFSA in the framework of Regulation (EC) No 1107/2009 and the additional information provided by the RMS, EFSA issued on 1 December 2014 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 6 February 2015 were discussed in a meeting of experts, which took place on 24 April 2015 , and the outcome of that meeting was considered in the finalisation of this reasoned opinion. The following conclusions are derived.

The toxicological profile of acrinathrin was evaluated in the framework of Regulation (EC) No 1107/2009, which resulted in an ADI and an ARfD being established at 0.01 mg/kg bw per d and 0.01 mg/kg bw, respectively.

The metabolism of acrinathrin was investigated for foliar application on fruits and fruiting vegetables (grapes and oranges). Metabolism studies were also performed on leafy vegetables (cabbages) and fruits and fruiting vegetables (cucumber and apples) however these studies were invalid or deficient and therefore could not be considered. Based on the grape metabolism study EFSA already concluded that following foliar application the residue definition proposed for risk assessment is parent and all isomers (as long as the toxicity of the individual isomers including enantiomers has not been addressed by eligible data) and for monitoring is parent and its enantiomer. A conversion factor of 1.1 was derived on the basis of the grape metabolism study. In the absence of adequate metabolism studies covering authorisations on crops other than fruits and fruiting vegetables, the proposed residue definitions and conversion factor have been tentatively applied to all crops. Validated analytical methods for enforcement of the proposed residue definition are available (see also Section 1.1), except for high oil content commodities.

Regarding the magnitude of residues, the available residues data are only considered sufficient to derive MRL proposals and risk assessment values for pome fruit, table and wine grapes, tomatoes, aubergines, cucumbers, gherkins, courgettes, lettuces and salad plants (except land cresses and baby leaf crops) and beans with pods, noting that all MRLs are tentative. Whilst the MRLs for cucumbers, gherkins and courgettes are fully supported by data the MRLs are tentative as the GAPs are not compliant with the approval restrictions. For the remaining crops, data were insufficient to derive a tentative MRL.

Residues of acrinathrin exceeding 0.1 mg/kg are not expected in any of the treated crops except beans with pods. A hydrolysis study investigating the effect of processing is therefore required.

The metabolism of acrinathrin in rotational crops was investigated during the peer review. Three confined rotational crop studies investigating the nature of residues following different plant-back intervals were performed. Based on these studies EFSA already concluded that translocation of residues in crops growing in the following season is not expected to be significant (total residue less than 0.01 mg/kg) for the representative uses and this conclusion is considered to be valid for the uses considered as part of this MRL review. A specific residue definition for rotational crops is not deemed necessary due to the very low residue levels expected.

Based on the uses reported by the RMS, significant exposure to acrinathrin is expected for meat ruminants. The nature of acrinathrin residues in commodities of animal origin was however not investigated and further investigation on the nature and magnitude of residues in meat ruminants should therefore be carried out in order to establish appropriate residue definitions and MRLs. Furthermore, validated analytical methods for enforcement of the proposed residue definition in food derived from meat ruminants are not available. MRLs for food derived from dairy ruminants, poultry and swine are not required because they are not expected to be exposed to significant levels of acrinathrin residues.

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. For bananas, melons, peppers, watermelons, peaches and apricots an exceedance of the ARfD was identified representing 460 %, 167 %, 139 %, 135 %, 131 % and 102 % of the ARfD, respectively. A second exposure calculation was therefore performed, excluding these crops. According to the results of this second calculation the highest chronic exposure represented 9 % of the ADI (German children) and the highest acute exposure amounted to 75 % of the ARfD (apples).

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). None of the MRL values listed in the table are recommended for inclusion in Annex II to the Regulation as they are not sufficiently supported by data (see summary table footnotes for details). In particular, some tentative MRLs and existing EU MRLs need to be confirmed by the following data:

  • a storage stability study in high acid and high oil content commodities;
  • a fully validated analytical method for enforcement in high oil content commodities;
  • a fully validated analytical method for enforcement in food derived from ruminants;
  • appropriate metabolism studies on root and tuber vegetables, leafy vegetables and pulses and oilseeds following foliar treatment analysing the levels of the single isomers. Considering that application up to a PHI of 50 days is authorised in soya bean, a metabolism study (on pulses and oilseeds) reporting isomerisation at longer PHIs is strongly recommended;
  • a metabolism study on ruminant and a livestock feeding study depending on the results from the ruminant metabolism;
  • additional residue trials supporting authorisations on pome fruit, cherries, plums, strawberries, garlic, onions, tomatoes, aubergines, okra, pumpkins, lamb’s lettuce, scarole, cress, rocket (rucola), red mustard, fresh beans with pods and soya beans;
  • a hydrolysis study investigating the effect of processing.

Furthermore, the GAPs on pome fruit, cherries, apricots, peaches, plums, strawberries, bananas, garlic, onions, tomatoes, aubergines, peppers, okra, cucurbits edible and inedible peel, lettuce, beans (with pods) and soya bean are not yet compliant with the approval restrictions for acrinathrin, and Member States were not able to provide alternative GAPs compliant with the approval restrictions. MRL proposals for these crops are therefore in any case tentative and, in case the current approval restrictions for acinathrin remain in place, additional residue trials supporting authorisations in tomatoes, aubergines, cucurbits with edible peel and lettuce would be required. EFSA was also informed of more critical GAPs on table and wine grapes in northern and southern Europe that are not compliant with the approval restrictions. If these GAPs were to be supported in the future (i.e. if the approval restrictions are removed), residue trials data would be needed to support them.

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. Considering that a risk to consumers could not be excluded for the existing EU MRLs on apricots, peaches, bananas, peppers, melons and watermelons, Member States are in any case recommended to withdraw or modify authorisations for these crops.

In view of the potential for transformation of acrinathrin leading to the occurrence of an analytical artefact during routine monitoring, EFSA recommends that laboratories check for potential transformation prior to analysis and, whenever significant transformation is observed, to change the GC liner. If minimal transformation occurs then it is acceptable to measure the acrinathrin peak only however, if transformation persists, it is acceptable to measure the acrinathrin peak as well as the peak of the artefact for calibration standards and samples and to express the result as total acrinathrin including its enantiomer.

EFSA also emphasises that some uncertainties remain regarding the toxicological properties of acrinathrin isomers. However, since guidance on the consideration of isomer ratios in the consumer risk assessment is not yet available, EFSA recommends that this issue is reconsidered when such guidance is available.

Keywords
acrinathrin, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, pyrethroid, insecticide, acaricide
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49