In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Hungary received an application from Bayer Crop Science to modify the existing maximum residue level (MRL) for the active substance prothioconazole in sunflower seeds in order to accommodate the intended southern Europe (SEU) and northern Europe (NEU) uses. Hungary 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 the European Food Safety Authority (EFSA) on 7 July 2015.
EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) (and its addendum) prepared under Directive 91/414/EEC, the conclusion on the peer review of the pesticide risk assessment of the active substance prothioconazole, as well as the conclusions from previous EFSA reasoned opinions on prothioconazole, including the opinion on the review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (here after Article 12 MRL review).
The toxicological profile of prothioconazole and prothioconazole-desthio was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.05 and 0.01 mg/kg (body weight) bw per day, respectively, and an acute reference dose (ARfD) of 0.2 and 0.01 mg/kg bw, respectively.
The metabolism of prothioconazole was investigated by foliar application on the root, pulses/oilseeds and cereal/grass crop groups. Based on these studies, the residue definition for enforcement was set as ‘prothioconazole-desthio’ in the conclusion of the peer review and confirmed during the Article 12 MRL review. The residue for risk assessment was defined as ‘the 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 (sum of isomers)’. Adequate analytical enforcement methods are available.
EFSA concludes that the submitted supervised residue trials on sunflower are sufficient to derive a MRL proposal of 0.2 mg/kg for prothioconazole in sunflower seeds. As residue trials indicated no presence of the five hydroxy metabolites analysed for, EFSA suggests for risk assessment to use the conversion factor of 2 derived from the metabolism studies and proposed under the Article 12 MRL review. New studies on the storage stability of prothioconazole-hydroxy-desthio metabolites were assessed in the framework of this MRL application and confirm the stability of these components under frozen storage conditions for 24 months in high water, high starch-, high acid- and high oil content matrices. This study addresses the data requirement raised by the Article 12 MRL review.
Prothioconazole and prothioconazole-desthio were shown to be stable under standard hydrolysis conditions. Therefore for processed commodities the same residue definitions as for primary crops are applicable. New processing studies with sunflower seed have not been submitted and are not necessary considering that the total theoretical maximum daily intake (TMDI) amounts to less than 10% of the ADI
The metabolism of prothioconazole in primary and rotational crops was found to be similar and a specific residue definition for rotational crops is not deemed necessary. Considering the application rates of prothioconazole on sunflower, it can be concluded that prothioconazole residue levels in rotational crops are expected to be covered by the residue levels in primary crops and no risk mitigation measures need to be proposed.
Sunflower seeds and their by-products can be fed to livestock and therefore a potential carry-over of residues into food of animal origin was assessed. The dietary burdens for livestock were recently calculated under Article 12 MRL review and were now updated with residues in sunflower seed and meal, resulting from the intended use. Since residues in sunflower seed do not affect the calculated dietary burdens, a modification of the MRLs proposed for animal commodities under Article 12 MRL review is not necessary. The EMS submitted validation data (and independent laboratory validation (ILV)) for the analytical method for the determination of prothioconazole-desthio in animal matrices, including eggs. The method was considered sufficiently validated and thus the data requirement raised by the Article 12 MRL review on a need for a fully validated analytical method for the determination of prothioconazole-desthio in eggs is considered addressed.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). In the framework of the Article 12 MRL review a comprehensive long-term exposure assessment was performed which was now updated with the median residue levels in sunflower seeds. The acute exposure assessment was performed only with regard to sunflower seed. A conversion factor (CF) of 2 which was established during the peer review and tentatively supported by Article 12 MRL review, was applied to consider all metabolites included in the residue definition for risk assessment.
Under the assumption that the MRLs will be amended as proposed in the Article 12 MRL review, long-term consumer intake concerns were not identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated chronic intake accounted for up to 6% of the ADI (WHO Cluster diet B). The contribution of residues in sunflower seed to the total consumer exposure accounted for a maximum of 0.15% of the ADI (WHO Cluster B).
An acute consumer risk was not identified in relation to the MRL proposal for sunflower seed (8% of the ARfD).
EFSA concludes that the intended use of prothioconazole on sunflower will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a health risk to consumer.
EFSA emphasises that the above assessment does not take into consideration triazole derivative metabolites (TDMs). As 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 TDMs is available.