On 25 May 2012 the evaluation report was forwarded to EFSA. Based on the available information and the use pattern, EFSA derives the MRL value of 0.9 mg/kg and concludes that the emergency indoor use of spinosad on raspberries granted in France is not likely to result in a consumer exposure exceeding the toxicological reference value and therefore is not expected to pose a public health concern.
In accordance with Article 53 of Regulation (EC) No 1107/2009, France has granted an authorisation for the use of spinosad on raspberries for the period from 4 May 2012 to 4 September 2012 to control a pest that has been recently introduced in France, Drosophila suzuki. In order to accommodate for the emergency use of spinosad France proposed to raise the existing MRL for raspberries from 0.3 mg/kg to 1.5 mg/kg. In accordance with Article 8 of Regulation (EC) No 396/2005, France submitted to the European Commission an evaluation report and performed a consumer risk assessment demonstrating that the proposed temporary MRL is safe. On 25 May 2012 the evaluation report was forwarded to EFSA requesting a statement on the safety of spinosad MRL in raspberries proposed by France with a view of setting temporary MRLs in line with Article 16(1)(a) and 18(4) of Regulation (EC) No 396/2005.
EFSA bases its assessment on the evaluation report submitted by France, the Draft Assessment Report (DAR) and its addenda prepared under Council Directive 91/414/EEC, an additional evaluation report prepared by the United Kingdom, the JMPR Evaluation reports as well as the conclusions from previous EFSA opinions, including the EFSA reasoned opinion on the review of the existing MRLs for spinosad according to Article 12 of Regulation (EC) No 396/2005.
The toxicological profile of spinosad was evaluated in the framework of Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.024 mg/kg bw per day. No ARfD value was deemed necessary for spinosad.
The metabolism of spinosad in primary crops was investigated in grapes, apples, tomatoes, cabbage, turnips and cotton, covering four different crop groups. The review of the existing MRLs for spinosad performed under Article 12 of Regulation (EC) No 396/2005 confirmed the conclusion of the peer review that the relevant residue for enforcement and risk assessment in all plant commodities treated by foliar application is spinosad (sum of spinosyn A and spinosyn D). However, EFSA proposed to delete the indication that the residues should be expressed in spinosad equivalents reported in Regulation (EC) No 396/2005. For the emergency use on raspberries, EFSA concludes that the metabolism of spinosad is sufficiently addressed and that the residue definitions as proposed in the previous EFSA reasoned opinion are adequate.
The supervised residue trials are sufficient and adequate to derive the MRL value of 0.9 mg/kg for the emergency use of spinosad on protected raspberries granted in France. There are adequate analytical methods available to monitor spinosad (sum of spinosyn A and spinosyn D) residues in the crop under consideration at the validated combined LOQ of 0.02 mg/kg.
Studies on the nature of spinosad in processed commodities are not available. EFSA is of the opinion that such studies would be desirable, but considering that the use of spinosad is for a limited period of time and raspberries are minor contributors to the overall exposure calculation, the chronic consumer risk assessment performed in the framework of this temporary MRL application is not expected to by significantly affected.
Since the emergency use of spinosad is on a permanent/semi-permanent crop only for a limited time period, investigations of residues in rotational crops are not required. Nature and magnitude of spinosad residues in livestock was not assessed since the crop under consideration is not fed to livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). In the framework of the review of the existing MRLs for spinosad according to Article 12 of Regulation (EC) No 396/2005, a comprehensive long-term exposure assessment was performed taking into account the existing uses of spinosad at EU level supported by data and the existing acceptable CXLs. EFSA now updates this risk assessment with the median residue value as derived from the supervised residue trials on raspberries. No acute consumer risk assessment was performed because of the low acute toxicity of spinosad.
It is noted that the long-term consumer exposure calculation is based on the conclusions and recommendations derived in the review of the existing MRLs for spinosad under Article 12 of Regulation (EC) No 396/2005. Under the assumption that the MRLs will be amended as proposed in the Article 12 review, the total calculated intake accounted for 57 % of the ADI (WHO cluster diet B). The contribution of residues in raspberries to the total consumer exposure was found to be insignificant, accounting for a maximum of 0.1 % of the ADI.
The consumer risk assessment demonstrates that the safety margin in the chronic exposure calculation is wide enough to conclude that the emergency use of spinosad on raspberries granted in France is not likely to result in a consumer exposure exceeding the toxicological reference value and therefore is not expected to pose a public health concern.
