In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Germany compiled an application to modify the existing maximum residue level (MRL) for the active substance thiacloprid in honey. In order to account for residues that could occur in honey, Germany proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.05 mg/kg to 0.2 mg/kg. Germany 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) prepared under Council Directive 91/414/EEC, the Commission review report on thiacloprid as well as the conclusions from the EFSA reasoned opinion on the MRL review for thiacloprid according to Article 12 of Regulation (EC) No 396/2005 (here after Article 12 MRL review). In addition, monitoring data from EU national control programmes conducted by several Member States in 2013 were considered by EFSA to propose alternative MRL values for thiacloprid in honey.
The toxicological profile of thiacloprid 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 0.01 mg/kg bw per day and an acute reference dose (ARfD) of 0.03 mg/kg bw.
The metabolism of thiacloprid in primary crops was investigated in the fruit, cereal/grass and pulses/oilseeds crop groups following foliar/soil applications. Based on these studies, the plant residue definition for enforcement and risk assessment was confirmed as thiacloprid during the Article 12 MRL review. Specific studies on the nature of the residues in honey are not available and EFSA proposes to apply to honey the residue definition set for plants. The QuEChERS method in combination with HPLC-MS/MS quantification was validated by the EURL for the determination of thiacloprid in honey at the LOQ of 0.02 mg/kg.
The EMS based the MRL proposal on a total of eight trials where honey was collected in hives positioned close to rapeseed plots treated with thiacloprid at the full bloom growth stage. Based on residue levels in honey collected 16 to 29 days after the last application, an MRL of 0.2 mg/kg was derived for thiacloprid in honey. However, an agreed guidance document on the setting of MRL in honey is not available at EU level and therefore, EFSA proposed alternative MRL values based on monitoring data. Honey was included by several EU member states in their 2013 national control programs. Based on a total of 562 samples from EU origin analysed for thiacloprid residues, MRL proposals of 0.15 and 0.2 mg/kg were derived by EFSA, considering the approaches recommended by the Food and Agriculture Organization (FAO). EFSA proposes to risk managers to decide which of these different approaches should be finally considered for the setting of an MRL in honey.
Specific studies to assess the magnitude of thiacloprid residues during the processing of honey were not provided and are not requested as the total theoretical maximum daily intake (TMDI) is less than 10 % of the ADI. The investigation of nature and magnitude of thiacloprid residues in rotational crops and in livestock commodities is of no relevance.
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 for thiacloprid, taking into account the existing uses at the EU level and the acceptable CXLs. EFSA updated this risk assessment with the median residue levels (STMR) in honey derived from the field trials. The acute exposure assessment was performed only with regard to honey and taking into account the highest MRL proposal of 0.2 mg/kg.
A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The highest chronic intake was estimated to be 33 % of the ADI (DE child), the contribution of residues in honey to the total consumer exposure representing less than 0.1 % of the ADI. An acute consumer risk was not identified in relation to the MRL proposals for honey as the highest acute intake was estimated to be 1 % of the ARfD.
EFSA concludes that the setting of an MRL of 0.15 or 0.2 mg/kg for thiacloprid in honey will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a concern for public health.