Reasoned opinion on the modification of the existing MRLs for phosmet in citrus fruits, pome fruits and rape seed

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(12):3510 [33 pp.].
doi
10.2903/j.efsa.2013.3510
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2013-00841
Approved
11 December 2013
Published
13 December 2013
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, Spain, hereafter referred to as the evaluating Member State (EMS), received an application from Gowan Comércio Internacional e Serviços Ltda to modify the existing MRLs for the active substance phosmet in citrus fruits, pome fruits and rape seed. In order to accommodate for the intended uses of phosmet, Spain proposed to raise the existing MRLs to 0.4 mg/kg in oranges and grapefruits and 0.6 mg/kg in the other fruits of the citrus group, to 0.5 mg/kg in pome fruits and to lower the existing MRL to 0.04 mg/kg in rape seed. Spain 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 a MRL proposal of 0.5 mg/kg for the proposed uses on citrus fruits and pome fruits. No modification of the existing MRL is proposed for rape seed. Adequate analytical enforcement methods are available to control the residues of phosmet and phosmet oxon in the commodities under consideration. Based on the risk assessment results, EFSA concludes that according to the internationally agreed methodology for estimation of the consumer exposure, the intended uses of phosmet in citrus fruits, pome fruits and rape seed will not result in an exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health concern.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, hereafter referred to as the evaluating Member State (EMS), received an application from Gowan Comércio Internacional e Serviços Ltda to modify the existing MRLs for the active substance phosmet in citrus fruits, pome fruits and rape seed. In order to accommodate for the intended uses of phosmet, Spain proposed to raise the existing MRLs to 0.4 mg/kg in oranges and grapefruits and 0.6 mg/kg in the other fruits of the citrus group, to 0.5 mg/kg in pome fruits and to lower the existing MRL to 0.04 mg/kg in rape seed. Spain 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 on 24 October 2013.

EFSA bases its assessment on the evaluation report, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, the Commission Review Report on phosmet, the conclusion on the peer review of the pesticide risk assessment of the active substance phosmet as well as the conclusions from a previous EFSA opinion on phosmet.

The toxicological profile of phosmet was assessed in the framework of the peer and the data were sufficient to derive an ADI of 0.01 mg/kg bw per day and an ARfD of 0.045 mg/kg bw.

The metabolism of phosmet in primary crops was investigated in cherries (fruits and fruiting vegetables), potatoes (toot and tuber vegetables) and maize (cereals) following foliar applications. Since phosmet oxon was detected in the metabolism study on cherries but no specific information on the toxicological relevance of this compound was available, the peer review considered phosmet oxon to be at least as toxic as the parent compound phosmet and included it in the residue definition for enforcement and risk assessment. Thus, the residue definition for enforcement and risk assessment is phosmet and phosmet oxon, expressed as phosmet. For the use on citrus fruits, pome fruits and rape seed EFSA concludes that the metabolism of phosmet in primary crops is sufficiently addressed and that the residue definitions derived are applicable.

EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.5 mg/kg for the proposed uses on citrus fruits and pome fruits. A change of the existing MRL is not necessary to support the intended uses on rape seed. Adequate analytical enforcement methods are available to control the residues of phosmet and phosmet oxon in the commodities under consideration at the validated combined LOQ of 0.02 mg/kg.

Studies investigating the nature of phosmet residues in processed commodities demonstrated that under boiling and sterilization conditions the parent compound progressively degraded to various metabolites, including phthalimide in relevant concentrations. Since phthalimide is included in the risk assessment and enforcement residue definitions of the active substance folpet both for raw and processed commodities, in the processed commodities the residues of phthalimide could occur both from the degradation of phosmet and folpet. Thus EFSA proposes to reconsider the residue definitions for phosmet and folpet with regard to the common metabolite phthalimide in the framework of Article 12 of Regulation (EC) No 396/2005.

In the framework of the current application the applicant submitted studies investigating the effect of processing on the magnitude of phosmet and phosmet oxon residues in pasteurised orange juice, canned oranges and orange marmalade. A reduction of residues was observed, however due to lacking details reported in the studies, the definitive processing factor cannot be derived. The data were sufficient and adequate to derive the following processing factor which is recommended to be included in Annex VI of Regulation (EC) No 396/2005:

  • Orange, juice: 0.15

Studies on succeeding/rotational crops after the use on rape seed are not required due to a fast degradation of phosmet in the soil.

Since the fruit pomace and rape seed by-products are used as feed products, a potential carry-over into food of animal origin was assessed. The calculated livestock dietary burdens exceeded the trigger value of 0.1 mg/kg (dry matter) for the ruminant species and were driven by the livestock intake of orange pomace. The peer review established the residue definition for monitoring and risk assessment as phosmet. Based the results of the metabolism study, which were conducted at a significantly higher dose (about 15 times) compared to the expected maximum dietary burden in ruminants, EFSA concludes that an amendment of the existing MRLs for animal commodities is not necessary in the framework of the current MRL application.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For the calculation of the chronic exposure, EFSA used the median residue values as derived from the residue trials on oranges, mandarins, apples and rape seed and the median residue values for peaches, olives and potatoes used in a previously issued EFSA reasoned opinion. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annex IIIA of Regulation (EC) No 396/2005 were used as input values. The acute exposure assessment was performed only with regard to the commodities under consideration. The input values for citrus fruits were multiplied by the peeling factor derived based on the data on the distribution of residues in the peel and the pulp.

No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake accounted for up to 53 % of the ADI (DE child diet). Only the contribution of residues in apples to the total consumer exposure was relevant, accounting for a maximum of 22 % of the ADI (DE child diet); the contribution of the remaining commodities under consideration accounted for less than 2 % of the ADI.

No acute consumer risk was identified in relation to the intended uses on citrus fruits, pome fruits and rape seed. The calculated maximum exposure in percentage of the ARfD was less than 57 % for apples, 53 % for pears, 18 % for oranges, 12 % for grapefruits and less than 10 % for the remaining commodities under consideration. EFSA notes that the short term exposure related to apples and pears exceeds the ARfD if the fruits contain residues at the proposed MRL of 0.5 mg/kg, taking into account the variability factor of 7. In case a variability factor of 5 or 3 is used, the acute exposure accounts for less than 100 % of the ARfD, for the respective MRL proposals.

EFSA concludes that, according to the internationally agreed methodology for estimation of the consumer exposure, the intended uses of phosmet in citrus fruits, pome fruits and rape seed will not result in an exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health concern.

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

Keywords
phosmet, citrus and pome fruits, rape seed, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, organopohosphate insecticide, phosmet oxon
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Number of Pages
33