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Reasoned opinion on the modification of the existing MRLs for epoxiconazole in products of animal origin

EFSA Journal 2012;10(6):2795 [34 pp.]. doi:10.2903/j.efsa.2012.2795
European Food Safety Authority Contact pesticides.mrl@efsa.europa.eu
Type: Reasoned Opinion On request from: European Commission Question number: EFSA-Q-2011-01259 Approved: 22 June 2012 Published: 27 June 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, herewith referred as the evaluating Member State (EMS), received an application from BASF SE to modify the existing MRLs for the active substance epoxiconazole in products of animal origin considering residue levels in feed items derived from maize. In order to accommodate the intended use of epoxiconazole in Germany, France, Bulgaria, Spain, Greece and Portugal on maize, it proposed to raise the existing MRL for milk from 0.002 mg/kg to 0.003 mg/kg and that for ruminant kidney from the limit of quantification to 0.015 mg/kg. However since this proposal from the RMS was submitted, the MRL for ruminant kidney was raised to the higher level of 0.02mg/kg.  Germany drafted an evaluation report according to 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 MRL proposals. However, the existing MRLs for maize ruminant kidney and milk are considered sufficient to cover the intended uses requested so no modification is necessary. Adequate analytical enforcement methods are available to control the residues of epoxiconazole in the commodities under consideration at the validated LOQ of 0.01 mg/kg and 0.001mg/kg in milk. Based on the risk assessment results, EFSA concludes thatthat the proposed use of epoxiconazole on maize under consideration will not result in a consumer exposure exceeding the toxicological reference values set for parent epoxiconazole and therefore is unlikely to pose a consumer health risk. However the residue definition for risk assessment was set on a provisional basis, pending additional data on the presence of the triazole derivative metabolites (TDMs) being available and a methodology for assessing the consumer exposure to TDMs becoming available.

© European Food Safety Authority, 2012

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, herewith referred as the evaluating Member State (EMS), received an application from BASF SE to modify the existing MRLs for the active substance epoxiconazole in products of animal origin considering residue levels in feed items derived from maize. In order to accommodate the intended use of epoxiconazole in Germany, France, Bulgaria, Spain, Greece and Portugal on maize, it proposed to raise the existing MRL for milk from 0.002 mg/kg to 0.003 mg/kg and that for ruminant kidney from the limit of quantification to 0.015 mg/kg. However since this proposal from the RMS was submitted, the MRL for ruminant kidney was raised to the higher level of 0.02mg/kg.  Germany drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 29 November 2011.

EFSA bases its assessment on the evaluation report submitted by the EMS (Germany, 2011), the Draft Assessment Report (DAR) (and its addendum) prepared under Council Directive 91/414/EEC (Germany, 2005 and 2008), the Commission Review Report on epoxiconazole (EC, 2010), the conclusion regarding the peer review of the pesticide risk assessment of the active substance epoxiconazole (EFSA, 2008), as well as the conclusion from a previous EFSA opinion on epoxiconazole (EFSA, 2011).

The toxicological profile of epoxiconazole was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.008 mg/kg bw per day and an ARfD of 0.023 mg/kg bw.

The metabolism of epoxiconazole in primary crops was investigated in wheat, bananas, coffee beans and sugar beets after foliar application. From these studies the peer review proposed to define the residue definition for enforcement and for risk assessment as epoxiconazole. The same definition is established in Regulation (EC) no 396/2005.  The residue definition for risk assessment, however, was set on a provisional basis pending additional data on the presence of triazole derivative metabolites (TDMs) in primary crops. TDMs are common metabolites of other active substances belonging to the chemical class of triazoles. Currently at EU level the methodology for assessing the consumer exposure to TDMs is still under development. Pending the available data on the TDMs, for the crops under consideration the same residue definitions as proposed by the peer review are applicable.

EFSA considers that the submitted supervised residue trials and available livestock feeding studies are sufficient to derive an MRL proposal for maize. However, the existing MRL for maize is considered sufficient to cover the intended uses requested. For maize silage a MRL proposal was derived by the EMS, should the legal framework be extended to cover MRLS for animal feed items in the future. Adequate analytical enforcement methods are available to control the residues of epoxiconazole in the commodities under consideration at the validated LOQ of 0.01 mg/kg and 0.001mg/kg in milk.

The occurrence of epoxiconazole residues in rotational crops was investigated in the framework of the peer review. Based on the available information on the nature and magnitude of residues in succeeding crops, it was concluded that significant residue levels are unlikely to occur in rotational crops provided that the compound is used on maize according to the intended pattern of use.  However the issue of TDMs in rotational crops remains open.

The calculated livestock dietary burden exceeded the trigger value of 0.1 mg/kg (dry matter) for all relevant species from the livestock intake of the feed products (primarily cereal straw and sugar beet leaves). The contribution of maize and maize silage to the total expected livestock dietary intake however is considered insignificant. The possible occurrence of epoxiconazole residues in commodities of animal origin was investigated in a previously issued EFSA opinion. Taking into account the new intended use on maize, EFSA concludes that the MRLs and risk assessment values for food of animal origin do not need to be revised. The other conclusions in the previous EFSA opinion that the enforcement residue definition should be parent epoxiconazole and that the risk assessment residue definition as parent epoxiconazole should be considered provisional remain unchanged. The issue whether TDMs need to be included in the risk assessment residue definition for food of animal origin remains open.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values accounted for up to 46.5 % of the ADI (UK toddler diet). The contribution of residues in products of ruminant origin to the total long term consumer exposure accounted for a maximum of <0.5% of the ADI (French toddler diet).

No acute consumer risk was identified in relation to the MRLs for ruminant kidney and milk. The calculated maximum exposure in percentage of the ARfD was 7 % for ruminant liver (UK infant diet). No acute consumer risk was identified in relation to the existing MRL in place for maize which only accounted for 2.9 % of the ARfD (UK infant diet).

EFSA concludes that the intended use of epoxiconazole on maize and residues of parent epoxiconazole in products of animal origin, will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health concern.

EFSA concludes that the existing MRLs accommodate the intended use that was requested on maize.  Consequently there is no need to amend any MRLs including those for ruminant kidney and milk that the EMS had proposed to change.

Keywords

Epoxiconazole, maize, milk, liver, kidney, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, triazole fungicide, triazole derivative metabolites, triazole alanine, triazole acetic acid, triazole lactic acid