In accordance with Article 6 of Regulation (EC) No 396/2005 , the Netherlands, herewith referred as the evaluating Member State (EMS), received an application from Bayer S.A.S-Bayer CropScience to modify the existing MRLs for spirodiclofen in strawberries and bananas and set import tolerances for papaya, avocado and mango to accommodate imports from the USA. The Netherlands proposed to decrease the existing MRL for strawberries from 2 mg/kg to 0.02 mg/kg to take into account, the modification of the GAP in the Netherlands. In order to accommodate for the intended use of spirodiclofen, the Netherlands proposed to increase the MRL for banana from the limit of quantification 0.02* mg/kg to 0.3mg/kg. In order to accommodate the import of produce, the Netherlands proposed to set the MRL for papaya, mangos and avocados at 1.0 mg/kg. The Netherlands drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 29 November 2011.
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 spirodiclofen, the conclusion on the peer review of the pesticide risk assessment of the active substance spirodiclofen and the JMPR evaluation.
The toxicological profile of spirodiclofen was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.015 mg/kg bw per day. The setting of an ARfD was deemed unnecessary.
The metabolism of spirodiclofen in primary crops was investigated in apples, grapes, oranges and lemons (covering fruits and fruiting vegetables). In addition a translocation study in grapefruit was performed. From these studies the peer review concluded that the residue definition for enforcement and risk assessment be established as spirodiclofen (for the uses assessed in the context of the peer review). For the uses assessed in the framework of this application, EFSA concludes that the metabolism of spirodiclofen in primary crops is sufficiently addressed and that the same residue definitions are applicable.
EFSA considers that the submitted supervised residue trials are sufficient to derive MRL proposals of 0.3 mg/kg for the proposed use in banana and 1.5 mg/kg to accommodate the reported use in the USA on avocado, noting that the MRL in the country of origin is set at the level of 1 mg/kg. EFSA has some reservations regarding the proposal that the residue trial results for avocado might be extrapolated to propose MRLs to accommodate the reported uses in the USA on papaya and mango. This should be considered further by risk managers. The intended use on strawberries is not adequately supported by residue data. Though the EMS made the case that the use of the active substance before flowering and after harvest represents a no residue situation, EFSA does not accept this case. The case does not address the potential for residues from mulch / soil that will be incurred from application before flowering, being transferred to developing fruit via contact. Also before considering lowering the existing strawberry MRL to the limit of quantification, Member States need to confirm that no other authorised GAPs in the EU or in third countries, requires the existing MRL of 2 mg/kg to be maintained.
Studies investigating the nature of spirodiclofen residues in processed commodities were assessed in the peer review. These studies showed that the compound is essentially stable under the conditions of pasteurisation but that it is hydrolysed to spirodiclofen-enol under the processing conditions representative of boiling/cooking and sterilisation. On a provisional basis the residue definitions for processed commodities is defined as parent compound, but should be reconsidered in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005. The available data for processing strawberries were insufficient to derive processing factors, to be included in Annex VI of Regulation (EC) No 396/2005. From field trials on bananas where pulp residues were reported, a peeling factor of 0.1 was derived.
Based on the available information on the nature and rate of decline of residues in soil considered in the framework of the peer review, it was concluded that significant residue levels are unlikely to occur in rotational crops, when the compound is used on strawberries according to the use pattern assessed in FAO, 2009 or the intended use proposed by the EMS.
Residues of spirodiclofen in commodities of animal origin were not assessed in the framework of this application, since the fruit crops under consideration, are not normally fed to livestock.
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 dietary exposure accounted for up to 54.2 % of the ADI (German child) when there is no change to the existing MRL for strawberries. The contribution of residues in strawberry, banana, avocado, papaya and mango to the total consumer exposure accounted for a maximum of 0.43 % of the ADI (Irish adult). A calculation of acute consumer exposure was not performed, due to the low acute toxicity of the active substance.
EFSA concludes that the proposed use of spirodiclofen on strawberry, banana, avocado, mango and papaya will not result in consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.