Setting of import tolerances for fluxapyroxad in various crops

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2016;14(3):4404 [28 pp.].
doi
10.2903/j.efsa.2016.4404
Type
Reasoned Opinion
Question Number
EFSA-Q-2015-00712
Approved
5 February 2016
Published
3 March 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Netherlands received an application from the company BASF to set import tolerances for the active substance fluxapyroxad in a wide range of crops from the USA, Brazil, Colombia, Ecuador and Honduras. The Netherlands drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive import tolerances for most of the crops under consideration, except for root and tuber vegetables (except radishes). The setting of an import tolerance on banana is not recommended, as long as evidence of the authorisation and MRL in place in the exporting countries has not been provided. For mangoes a MRL at the level of the tolerance established in the exporting country is proposed although trials would suggest a higher value. Based on the risk assessment results, EFSA concludes that the proposed use of fluxapyroxad on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Netherlands received an application from BASF to set import tolerances for the active substance fluxapyroxad in a wide range of crops. The Netherlands drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 3 November 2015.

EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) prepared under Council Directive 91/414/EEC, the conclusion on the peer review of the pesticide risk assessment of the active substance fluxapyroxad as well as the conclusions from previous EFSA opinions on fluxapyroxad.

The toxicological profile of fluxapyroxad was assessed in the framework of the peer review and the data were sufficient to derive an acceptable daily intake (ADI) of 0.02 mg/kg bw per day and an acute reference dose (ARfD) of 0.25 mg/kg bw.  

The metabolism of fluxapyroxad in primary crops was investigated in the fruit, pulses/oilseeds and cereals/grass crop groups following foliar application and in cereals/grass crop group after seed treatment. The residue definition for enforcement and risk assessment has been agreed as parent fluxapyroxad. For the uses on the crops under consideration the metabolism of fluxapyroxad in primary crops has been sufficiently addressed and the residue definitions derived are applicable.

EFSA concludes that the submitted supervised residue trials are sufficient to derive import tolerances for most of the crops under consideration, except for root and tuber vegetables crop group (except radishes) for which insufficient number of residue trials has been submitted. In addition, the setting of an import tolerance on banana is not recommended, as long as evidence of the authorisation and MRL in place in the exporting countries has not been provided. For mangoes, although residue trials would suggest a higher MRL, EFSA proposed a MRL at the level of the tolerance established in the exporting country. Adequate analytical enforcement methods are available to monitor fluxapyroxad residues in the crops under consideration at the validated LOQ of 0.01 mg/kg.

Studies investigating the nature of fluxapyroxad residues under standard hydrolysis conditions were assessed during peer review and showed the active substance to be hydrolytically stable under standard processing conditions. Therefore for processed commodities the same residue definition as for raw commodities is applicable. Processing studies with grapes, rice and sugar cane were provided and the data were sufficient to derive the following processing factors (PF), which are recommended to be included in Annex VI of Regulation (EC) No 396/2005:

– Grape/pasteurized juice:   0.3                               – Rice/hulls:                       4

– Grape/raisins:                   2.9                               – Rice/bran:                        0.9

– Grape/red wine:               0.2                              

For other processed commodities of rice and sugar cane additional processing studies are required.

The residues of fluxapyroxad in rotational crops and livestock are of no relevance for the assessment of import tolerance requests.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). To calculate the chronic exposure, EFSA used median residue values (STMR) derived from the residue trials conducted on the crops under consideration and the STMR values reported in previous EFSA reasoned opinions. For the crops for which no MRL proposals were made under the current application and for the remaining commodities of plant and animal origin, the existing MRLs as established in Regulation (EU) No 491/2014 were used as input values. Acute exposure assessment was performed only for the crops under consideration.

A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated chronic intake accounted for up to 81 % of the ADI (DE child). The individual contribution of residues in the crops under consideration to the total consumer exposure was below 3 % of the ADI, except for wine grapes (5 % ADI; FR all population).

An acute consumer risk was not identified in relation to the import tolerance proposals for the crops under consideration. The highest acute consumer exposure was calculated to be 95 % of the ARfD for celery, 77 % ARfD for rhubarb, 54 % ARfD for banana and was below 50 % ARfD for other crops under consideration.

EFSA concludes that the authorized uses of fluxapyroxad on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a health risk to consumers. It is noted that all proposed MRLs are at the same or lower level than the tolerances established in the exporting countries. 

Keywords
fluxapyroxad, various crops, MRL application, consumer risk assessment
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Number of Pages
28