Setting import tolerances for fenpyrazamine in blueberries and cane fruits

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2016;14(2):4384 [20 pp.].
doi
10.2903/j.efsa.2016.4384
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2015-00574
Approved
15 January 2016
Published
5 February 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) Austria received an application from the company Sumitomo Chemical Agro Europa S.A.S. to set maximum residue limits (MRLs) for fenpyrazamine in blueberries and cane fruits in support of the import of these berries from the United States. Austria 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 submitted supervised residue trials are sufficient to derive a MRL proposal of 4 mg/kg in blueberries. From a combined residue data set on blackberries and raspberries a MRL of 5 mg/kg is derived for the whole group of cane fruits. Adequate analytical enforcement methods are available. Based on the risk assessment results, EFSA concludes that the authorized use of fenpyrazamine in the United States on blueberries and cane fruits 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) Austria received from the company Sumitomo Chemical Agro Europa S.A.S. an application to set import tolerances for the active substance fenpyrazamine in blueberries and cane fruits. Austria 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 6 October 2015.

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

The toxicological profile of fenpyrazamine was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.13 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.3 mg/kg bw.

The metabolism of fenpyrazamine in primary crops was investigated in the fruit, leafy and pulses/oilseeds crop groups. The peer review concluded that the definition for monitoring is `fenpyrazamine´. The risk assessment residue definition was established as the `sum of fenpyrazamine and S-2188-DC, expressed as fenpyrazamine`. For the uses on the berries under consideration, EFSA concludes that the metabolism of fenpyrazamine is sufficiently addressed and the residue definitions derived are applicable.

EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 4 mg/kg in blueberries. From a combined residue data set on blackberries and raspberries a MRL of 5 mg/kg is derived for the whole group of cane fruits. Based on a limited data set where samples were analysed for fenpyrazamine and metabolite S-2188-DC, an overall conversion factor of 2 is proposed for berries. Adequate analytical enforcement methods are available, achieving a limit of quantification (LOQ) of 0.01 mg/kg.

Studies investigating the nature of fenpyrazamine residues under standard hydrolysis conditions were assessed during the peer review and showed fenpyrazamine to be stable under pasteurisation and boiling, but slightly degrading to metabolite S-2188-DC under sterilisation. Thus, for raw and processed commodities the same enforcement and risk assessment residue definitions are applicable. New studies on effect of processing on the magnitude of fenpyrazamine residues in processed blueberries or cane fruits have not been submitted and are not necessary.

The residues of fenpyrazamine in rotational crops are of no relevance for the import tolerance application. Berries are not fed to livestock and therefore the nature and magnitude of fenpyrazamine residues in livestock was not assessed.

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 derived from the residue trials conducted on blueberries, raspberries and blackberries. For several crops the risk assessment values were available to refine the exposure calculation. For the remaining commodities of plant and animal origin, the existing MRLs as established in Regulation (EU) No 2015/401 were used as input values. The acute exposure assessment was performed only with regard to blueberries and cane fruits.  

The total calculated chronic intake accounted for up to 5% of the ADI (WHO Cluster B). The contribution of residues in the berries under consideration to the total consumer exposure accounted individually for less than 0.2% of the ADI. An acute consumer risk was not identified in relation to residues in the berries under consideration.

EFSA concludes that the import tolerances for blueberries and cane fruits will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a concern for public health.

Keywords
fenpyrazamine, blueberries, cane fruits, MRL application, consumer risk assessment
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Number of Pages
20