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Reasoned opinion on the modification of the existing MRLs for bixafen in rape seed, linseed, poppy seed and mustard seed

EFSA Journal 2013;11(2):3127[28 pp.]. doi:10.2903/j.efsa.2013.3127
European Food Safety Authority Contact pesticides.mrl@efsa.europa.eu
Type: Reasoned Opinion On request from: European Commission Question number: EFSA-Q-2012-00918 Approved: 27 February 2013 Published: 28 February 2013 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an application from Bayer CropSciences AG to modify the existing MRL for the active substance bixafen in rape seed. The submitted residue data support the intended use of bixafen in rape seed, linseed, poppy seed and mustard seed in France as well. In order to accommodate for the intended use of bixafen, the United Kingdom proposed to raise the existing MRL from 0.015 mg/kg to 0.1 mg/kg. The United Kingdom 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 0.07 mg/kg for the proposed use on rape seed, linseed, poppy seed and mustard seed. An adequate analytical enforcement method is available to control the residues of bixafen in oilseeds. Based on the risk assessment results, EFSA concludes that the proposed use of bixafen on rape seed, linseed, poppy seed and mustard seed will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. This risk assessment has to be regarded as provisional since the residue definition for enforcement and risk assessment in oilseeds are provisional and pending the need for MRLs in rotational crops and the definitive MRLs in animal origin commodities.

© European Food Safety Authority,2013

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an application from Bayer CropSciences AG to modify the existing MRL for the active substance bixafen in rape seed. The submitted residue data support the intended use of bixafen in rape seed, linseed, poppy seed and mustard seed in France as well. In order to accommodate for the intended use of bixafen, the United Kingdom proposed to raise the existing MRL from 0.015 mg/kg to 0.1 mg/kg. The United Kingdom 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 31 October 2012.

EFSA bases its assessment on the evaluation report, the Draft Assessment Report prepared for the approval under Regulation (EC) No 1107/2009, the conclusion on the peer review of the pesticide risk assessment of the active substance bixafen as well as the conclusions from previous EFSA opinions on bixafen.

The toxicological profile of bixafen was assessed in the framework of the peer review for the approval of the active substance and the data were sufficient to derive an ADI of 0.02 mg/kg bw per day and an ARfD of 0.2 mg/kg bw.

The metabolism of bixafen in primary crops after foliar applications was investigated in wheat (cereals) and soybean (pulses and oilseeds). From these studies the peer review concluded to establish the residue definition for enforcement as bixafen and for risk assessment as sum of bixafen and desmethyl-bixafen (M21) expressed as bixafen in cereals only. No conclusion could be reached on the residue definition for pulses and oilseeds. EFSA considered the data on soybean as not adequate to fully elucidate the metabolism of bixafen. For the use on the oilseeds being assessed in this opinion EFSA proposes to use the residue definition for enforcement and risk assessment derived for cereals on a provisional basis. The residue definition for risk assessment in pulses and oilseeds and in rotational crops should be reconsidered in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005.

EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.07 mg/kg for the proposed use on rape seed, linseed, poppy seed and mustard seed. An adequate analytical enforcement method is available to control the residues of bixafen in oilseeds at the validated LOQ of 0.01 mg/kg.

Under processing conditions simulating pasteurisation, baking/brewing/boiling and sterilisation bixafen residues showed to be stable. Specific studies investigating the magnitude of bixafen residues in processed commodities are not required as the residues in raw agricultural commodities are expected to be low and the total theoretical maximum daily intake (TMDI) is below the trigger value of 10 % of the ADI.

The occurrence of bixafen 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, EFSA could not conclude on a suitable residue definition for rotational crops and on the relevant metabolites to be included. For the crops under consideration EFSA concludes that residues of bixafen and its metabolites in rotational crops resulting from the use according to the proposed GAP (Good Agricultural Practice) can not be excluded and plant-back restrictions should be considered when granting an authorisation at national level.

The contribution of the intended use on the oilseeds under evaluation to the total livestock exposure is irrelevant. Thus, a modification of the provisional MRLs for the commodities of animal origin was not further investigated in the framework of the current application.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residue Intake Model (PRIMo). For the calculation of the chronic exposure EFSA used the median residue value as derived from the residue trials on rape seed for rape seed, linseed, poppy seed and mustard seed and reported in previously issued EFSA reasoned opinion for barley, wheat, oats and rye. 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 median residue values and the MRLs for ruminant products were multiplied by the conversion factor for enforcement to risk assessment residue definition. The acute exposure assessment was performed only with regard to the commodities under consideration.

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 less than 10 % of the ADI (NL child diet). The contribution of residues in oilseeds to the total consumer exposure accounted for a maximum of 0.06 % of the ADI for rape seed.

No acute consumer risk was identified in relation to the MRL proposal for the oilseeds under assessment. The calculated maximum exposure in percentage of the ARfD was 0.01 % for rape seed, linseed and poppy seed and lower for mustard seed.

EFSA concludes that the proposed use of bixafen on rape seed, linseed, poppy seed and mustard seed will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. This risk assessment has to be regarded as provisional since the residue definition for enforcement and risk assessment in oilseeds are provisional and pending the need for MRLs in rotational crops and the definitive MRLs in animal origin commodities.

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

Keywords

Bixafen, oilseeds, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, pyrazole fungicide, dsesmethyl-bixafen (M21)