According to EFSA the data are sufficient to derive MRL proposals of 0.15 mg/kg for the proposed uses on oilseed rape, linseed, poppy and mustard. However a data gap is identified for the stability of residues included in the plant risk assessment residue definition (other than prothioconazole-desthio) in plant samples, stored frozen, to be demonstrated. Adequate analytical enforcement methods are available to control the residues of prothioconazole in plant matrices at the validated LOQ of 0.02 mg/kg for prothioconazole-desthio as sum of isomers. Based on the risk assessment results, EFSA concludes that the proposed use of prothioconazole on oilseed rape, linseed, poppy and mustard 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, France, hereafter referred to as the evaluating Member State (EMS), received an application from Bayer CropScience to modify the existing MRLs for the active substance prothioconazole in rape seed, linseed, poppy seed and mustard seed. In order to accommodate the intended uses of prothioconazole, France proposed to raise the existing MRLs from the value of 0.1 mg/kg for rape seed and 0.05 mg/kg for the other three oilseeds to 0.15 mg/kg for these four oilseeds. France 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 29 February 2012.
EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) (and its addenda) prepared under Council Directive 91/414/EEC, the Commission Review Report on prothioconazole, the conclusion on the peer review of the pesticide risk assessment of the active substance prothioconazole, JMPR Evaluation reports as well as the conclusions from previous EFSA opinions on prothioconazole, difenoconazole and bixafen.
The toxicological profile of prothioconazole was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI for prothioconazole-desthio 50:50 racemate of 0.01 mg/kg bw per day and an ARfD of 0.01 mg/kg bw.
The metabolism of prothioconazole in primary crops was investigated in wheat (cereals), peanut (oilseeds) and sugar beet (root crops). From the studies on wheat and peanut the peer review concluded to establish the residue definition for enforcement as prothioconazole-desthio and for risk assessment as sum of prothioconazole desthio and all metabolites containing the 2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl-2H-1,2,4-triazole moiety expressed as prothioconazole-desthio. For the use on oilseed rape, linseed, poppy and mustard, EFSA concludes that the metabolism of prothioconazole in primary crops is sufficiently addressed and that the residue definition derived is applicable. It is noted that in practice these residue definitions are for sum of isomers (enantiomers) of unknown ratio, as chiral separation methods were not used in the available metabolism investigations. In the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 it should be considered to update the residue definition wording to explicitly state that the definitions are for the sum of isomers.
EFSA considers that the submitted supervised residue trials are sufficient to derive MRL proposals of 0.15 mg/kg for the proposed uses on oilseed rape, linseed, poppy and mustard. However a data gap is identified for the stability of residues included in the plant risk assessment residue definition (other than prothioconazole-desthio) in plant samples, stored frozen, to be demonstrated. Adequate analytical enforcement methods are available to control the residues of prothioconazole in plant matrices at the validated LOQ of 0.02 mg/kg for prothioconazole-desthio as sum of isomers.
Specific studies investigating the magnitude of prothioconazole residues in processed commodities are not available. It would be desirable to have data in this regard in relation to residues of prothioconazole-desthio and prothioconazole-desthio glucuronide conjugate with respect to processing factors for enforcement. For risk assessment, studies investigating the effect of processing on the nature and magnitude of all compounds containing the 2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl-2H-1,2,4-triazole moiety would be desirable.
The occurrence of prothioconazole related 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 of residues that retain the phenyl ring moiety, it was concluded that significant residue levels are unlikely to occur in rotational crops provided that the compound is used on oilseeds according to the proposed GAP (good agricultural practice). In relation to residues that contain just the triazole ring the assessment remains open.
Since oilseed rape seed, linseed and their by-products are used as feed products, a potential for carry-over into food of animal origin was assessed. The calculated livestock dietary burden exceeded the trigger value of 0.1 mg/kg (dry matter) for all relevant species but was mainly driven by the other crops for which uses of prothioconazole have been authorised (e.g. cereals and turnips). The impact of prothioconazole residues in the oilseeds being assessed, to the total livestock exposure was insignificant and therefore the modification of the MRLs for commodities of animal origin was not investigated further within the framework of the current application.
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 62.2 % of the ADI (French toddler diet). The contribution of residues in rape seed, linseed, poppy seed and mustard seed to the total consumer exposure accounted for a maximum of 0.31 % of the ADI (WHO cluster diet E). It is noted that there is some uncertainty in this risk characterisation as the toxicological reference values set are derived from studies where racemic test substance was dosed and the isomer ratio of residues at harvest and following storage of treated foodstuffs is unknown, (the analytical methods used only quantified sum of isomers (enantiomers)).
No acute consumer risk was identified in relation to the MRL proposals for rape seed, linseed, poppy seed and mustard seed. The calculated maximum exposure in percentage of the ARfD was 1.2 % for rape seed (German child diet).
EFSA concludes that the proposed use of prothioconazole on oilseed rape, linseed, poppy and mustard will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.
EFSA emphasises that the above assessment does not yet take into consideration triazole derivative metabolites (TDMs). Since these metabolites may be generated by several pesticides belonging to the group of triazole fungicides, EFSA recommends that a separate risk assessment should be performed for TDMs as soon as the confirmatory data requested for triazole compounds in the framework of Regulation (EC) No 1107/2009 have been evaluated and a general methodology on the risk assessment of triazole compounds and their triazole derivative metabolites is available.
Thus EFSA proposes to set temporary MRLs as reported in the summary table. It is noted that the GAP is associated with a product that also contains bixafen. The assessment of the use of bixafen according to the GAP related to this combination product has been assessed by EFSA in a recently issued opinion (EFSA, 2012), where it was concluded that the data available were insufficient to derive a MRL proposal for bixafen in these oilseeds.
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