In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Denmark, received an application from Sumitomo Chemical Agro Europe S.A.S to modify the existing maximum residue levels (MRLs) for the active substance tebuconazole in rye and wheat (triticale). In order to accommodate for the intended EU uses of tebuconazole, Denmark proposed to raise the existing MRLs from 0.1 mg/kg to 0.3 mg/kg for rye and wheat. Denmark 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 3 June 2015.
EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) (and its addendum) prepared under Council Directive 91/414/EEC, the Commission review report on tebuconazole, the conclusion on the peer review of the pesticide risk assessment of the active substance tebuconazole, the JMPR Evaluation report as well as the conclusions from previous EFSA opinions on tebuconazole.
The toxicological profile of tebuconazole 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) value of 0.03 mg/kg bw per day and an acute reference dose (ARfD) of 0.03 mg/kg bw.
The metabolism of tebuconazole in primary crops was investigated in the fruit (grape), cereal (wheat), and pulses/oilseeds (peanut) crop groups. Residue definitions for monitoring and risk assessment in plant products were provisionally proposed as tebuconazole (sum of enantiomers), pending the submission of additional information on the triazole derivative metabolites (TDMs). The peer review concluded that a separate risk assessments have to be performed for triazole compounds and TDMs once a global risk assessment approach for TMDs is developed.
EFSA concludes that the submitted residue trials on wheat are sufficient to derive a MRL proposal of 0.3 mg/kg for tebuconazole in wheat extrapolated to rye. Data on the magnitude of TDMs were not provided. Adequate analytical enforcement methods are available to monitor the residues of tebuconazole in cereals at the validated LOQ of 0.02 mg/kg.
Studies investigating the nature of tebuconazole residues under standard hydrolysis conditions were assessed during peer review and showed the active substance to be hydrolytically stable. New processing studies have not been submitted under the current application and are not requested.
The occurrence of tebuconazole residues in rotational crops was investigated in the framework of the peer review. The metabolites identified in rotational crops were in accordance with the metabolic pathway observed in primary crops and it was concluded that the uptake by plants is not expected to lead to residues of tebuconazole in rotational crops above the LOQ. In contrast, triazole derivative metabolites might be of concern in rotational crops and this situation will be reconsidered as soon as a global approach on TDMs will be defined.
The supported uses of tebuconazole on wheat and rye do not result in a change of the livestock dietary intakes estimated in framework of the Article 12 MRL review. Thus, EFSA concluded that a modification of the current MRL values is not required.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). The risk assessment performed in the last issued reasoned opinion of EFSA was now updated with the median (STMR) and highest (HR) residue levels derived from the residue trials conducted on wheat according to the supported GAP.
No chronic or acute intake concern was identified for the consumers, since the highest long-term intake was calculated to be 14 % of the ADI (WHO Cluster B) and the highest acute intake was calculated to be 8 % of the ARfD for wheat.
EFSA concludes that the intended use of tebuconazole on wheat and rye in Europe will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a health risk to consumers.
However, EFSA emphasises that the above assessment does not yet take into consideration triazole derivative metabolites. Since these metabolites may be generated by several pesticides belonging to the group of triazole fungicides, EFSA recommends that a separate risk assessment is 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.
The Evaluation Report is available in the Register of Questions