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Reasoned opinion on the modification of the existing MRLs for fosetyl in potato, kiwi and certain spices

EFSA Journal 2012;10(12):3019[43 pp.]. doi:10.2903/j.efsa.2012.3019
European Food Safety Authority Contact pesticides.mrl@efsa.europa.eu
Type: Reasoned Opinion On request from: European Commission Question number: EFSA-Q-2012-00406,EFSA-Q-2012-00476 ,EFSA-Q-2012-00867 Approved: 05 December 2012 Published: 06 December 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State France (EMS France), received an application from Bayer CropScience to modify the existing MRL for fosetyl-Al in kiwi. In order to accommodate the intended use in Italy, the EMS France proposed to raise the MRL in kiwi to 150 mg/kg. Spain (EMS Spain), received an application from Probelte S.A. to modify the existing MRL for fosetyl-Al in potatoes. In order to accommodate the intended use in the SEU and to account for resulting residues in animal commodities, the EMS Spain proposed to raise the MRL in potatoes to 70 mg/kg and in ruminant`s kidney to 0.6 mg/kg. Germany (EMS Germany) compiled an application to modify the existing MRL for fosetyl-Al in several spices. The EMS Germany proposed to raise the existing MRL for fosetyl in several seeds of spices and in caraway and cardamom to 300 mg/kg. The EMSs drafted evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive MRL proposals for the crops under consideration in support of the new intended uses for the residue definitions proposed in the Article 12 MRL review. Based on the risk assessment results, EFSA concludes that the proposed use of fosetyl-Al on kiwi and certain spices will not result in a consumer exposure exceeding the toxicological reference values for fosetyl and phosphonic acid and therefore is unlikely to pose a consumer health risk. The intended use on potatoes cannot be supported due to data gaps identified regarding the magnitude of phosphonic acid residues in livestock commodities. A new feeding study in ruminants is required to adequately estimate residues of phosphonic acid in food of animal origin.

© European Food Safety Authority,2012

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State France (EMS France), received an application from Bayer CropScience to modify the existing MRL for fosetyl-Al in kiwi. In order to accommodate the intended use in Italy, the EMS France proposed to raise the MRL in kiwi to 150 mg/kg. Spain (EMS Spain), received an application from Probelte S.A. to modify the existing MRL for fosetyl-Al in potatoes. In order to accommodate the intended use in the SEU and to account for resulting residues in animal commodities, the EMS Spain proposed to raise the MRL in potatoes to 70 mg/kg and in ruminant`s kidney to 0.6 mg/kg. Germany (EMS Germany) compiled an application to modify the existing MRL for fosetyl-Al in several spices. The EMS Germany proposed to raise the existing MRL for fosetyl in several seeds of spices and in caraway and cardamom to 300 mg/kg. The EMSs drafted evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA on 21 March 2012, 3 April 2012 and 1 October 2012.

EFSA bases its assessment on the evaluation reports submitted by France, Spain and Germany, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC by rapporteur Member State (RMS) France, the conclusion on the peer review of the pesticide risk assessment of the active substance fosetyl and the conclusions from the EFSA reasoned opinion on the review of the existing MRLs for fosetyl according to Article 12 of Regulation (EC) No 396/2005 (hereafter -Article 12 MRL review). Since all MRL applications refer to the same active substance, for reasons of efficiency EFSA assessed them in one reasoned opinion.

The toxicological profile of fosetyl-Al was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 3 mg/kg bw per day and 3.9 mg/kg bw per day being set for fosetyl-Al and phosphonic acid respectively. It was concluded that fosetyl and phosphonic acid have the same mechanism of toxicity and that an ARfD was not necessary for either compound. The ADI of 2.8 mg/kg bw per day for fosetyl has been calculated by EFSA by molecular weight conversion from the ADI of fosetyl-Al.

Primary crop metabolism of fosetyl-Al was investigated for foliar applications on fruits and fruiting vegetables. Based on the elementary nature of fosetyl and the similar metabolic pattern found in all fruits and their leafy parts, during the peer review it was concluded that the metabolic pattern would be expected to be similar in all crop groups. Thus, for the uses on the crops under consideration, EFSA concludes that the metabolism of fosetyl-Al is sufficiently addressed. The residue definition for the risk assessment and enforcement was proposed by the peer review as “the sum of fosetyl, phosphorous acid and their salts, expressed as fosetyl”. The metabolism studies were reassessed in the framework of the Article 12 MRL review and the experts concluded that the residue definition for both risk assessment and monitoring should be set as phosphonic acid and that risk managers should consider if a separate residue definition for fosetyl should be established to enforce residues that are specific to the use of fosetyl-Al. A validated analytical method for enforcement of both residue definitions in food of plant origin is available.

EFSA concludes that the submitted supervised residue trials data are sufficient to derive MRL proposals for the crops under consideration in support of the new intended uses for the residue definitions proposed in the Article 12 MRL review.

In processed commodities fosetyl-Al and phosphonic acid were found to be hydrolytically stable during pasteurisation, cooking, boiling/brewing/baking and sterilisation and no formation of toxicologically relevant metabolites occurred. Specific studies to assess the magnitude of fosetyl and phosphonic acid residues during the processing of the crops under consideration have not been submitted and such studies are not necessary since the total theoretical maximum daily intake (TMDI) amounts to less than 10% of the ADI.

Potatoes and spices crops can be grown in rotation and therefore the possible occurrence of residues in rotational/succeeding crops was assessed. Phosphonic acid is the main soil metabolite of fosetyl-Al and its nature in rotational crops was investigated by the peer review. The same residue definition as in primary plants was proposed. EFSA concludes that significant residues of phosphonic acid will not occur in rotational/succeeding crops, provided that fosetyl-Al is used on the primary crops under consideration in compliance with the intended GAPs and that a pre-planting interval of 30 days is observed.

Potatoes can be fed to livestock and thus a potential carry-over of residues into food of animal origin was assessed. In the Article 12 MRL review the livestock dietary burden was calculated separately for fosetyl and phosphonic acid. That calculation is now updated with residues in potatoes from the intended use of fosetyl-Al in Spain. The calculated dietary burden for fosetyl indicates that the new use on potatoes would not affect the current livestock exposure. The calculated dietary burden for phosphonic acid indicates that residues in potatoes resulting from the intended use contribute significantly to the dietary burdens for all livestock species.

Metabolism of fosetyl-Al in lactating ruminants was sufficiently investigated and, considering the elementary nature of fosetyl, the peer review concluded that findings can be extrapolated to pigs and poultry. The residue definition derived by the peer review is “the sum of fosetyl, phosphorous acid and their salts expressed as fosetyl”. The Article 12 MRL review proposed that the residue definition for enforcement and risk assessment is defined as phosphonic acid only. The calculated dietary burdens and results from the feeding studies with phosphonic acid were used to estimate potential residues of phosphonic acid in commodities of animal origin from the intake of potatoes. Results indicate no need to modify the MRLs proposed in the Article 12 MRL review in milk and poultry products. However, as the calculated maximum dietary burdens for meat ruminants and pigs were significantly higher than the highest feeding level investigated in the feeding study, the study cannot be used to extrapolate the residue concentrations of phosphonic acid in animal matrices at the expected dietary burden. EFSA concludes that a new feeding study in ruminants with higher feeding levels is required to adequately estimate residues in food of animal origin. The intended use on potatoes thus cannot be supported.

The consumer exposure assessment was performed separately for fosetyl and phosphonic acid residues in the framework of the Article 12 MRL review, using the revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). This consumer exposure assessment now updates the assessment performed under Article 12 MRL review with the median residue values as observed in the residue trials on kiwi and seeds of spices. For potatoes the MRL proposal derived for the intended use was not considered in the exposure calculation because data gaps linked to the GAP on potatoes were identified regarding livestock exposure.

No acute consumer exposure was performed due to the low acute toxicity of the active substance. The estimated exposures were then compared with the toxicological reference values derived for fosetyl and phosphonic acid.

No long-term consumer intake concerns were identified for phosphonic acid for any of the European diets incorporated in the EFSA PRIMo, taking into account the proposals derived for the current MRL applications and the MRL proposals derived in the framework of the Article 12 MRL review. The total calculated intake values accounted for up to 7.1% of the ADI (DE child diet). The contribution of residues in the crops under consideration to the total consumer exposure was insignificant and for kiwi it accounted for a maximum of 0.16% of the ADI (DE child diet) and for spices seeds, where consumption data were available, for 0.012% of the ADI.

No long-term consumer intake concerns were identified for fosetyl for any of the European diets incorporated in the EFSA PRIMo, taking into account the proposals derived for the current MRL applications and the MRL proposals derived in the framework of the Article 12 MRL review. The total calculated intake values accounted for up to 0.3% of the ADI (WHO Cluster diet B). The contribution of residues in the crops under consideration to the total consumer exposure was insignificant (below 0.01% of the ADI).

EFSA concludes that the proposed use of fosetyl-Al on kiwi and certain spices will not result in a consumer exposure exceeding the toxicological reference values for fosetyl and phosphonic acid and therefore is unlikely to pose a consumer health risk. The intended use on potatoes cannot be supported due to data gaps identified regarding the magnitude of phosphonic acid residues in livestock commodities. A new feeding study in ruminants is required to adequately estimate residues of phosphonic acid in food of animal origin.

Thus EFSA proposes to amend the existing MRL as reported in the summary table.
 

Keywords

Fosetyl and phosphorous acid, potato, kiwi, spices, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, organophosphorous fungicide.