Normativa UEOct. 2, 2013
UE: modifican límites máximos de residuos para cyazofamid en uvas
According to EFSA the data are sufficient to derive MRL proposals of 2 mg/kg for the proposed uses on table and wine grapes. Adequate analytical enforcement methods are available to control the residues of cyazofamid in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of cyazofamid on grapes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.
© European Food Safety Authority, 2013
In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State (EMS), received an application from the company ISK Biosciences Europe N.V to modify the existing MRLs for cyazofamid in table and wine grapes. In order to accommodate for the intended uses of cyazofamid, France proposed to raise the existing MRLs from the value of 0.5 mg/kg to 2 mg/kg. The EMS 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 EFSA on 5 March 2013.
EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, as well as the conclusions from previous EFSA opinions on cyazofamid.
The toxicological profile of cyazofamid was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.17 mg/kg bw per day. No ARfD was deemed necessary.
The metabolism of cyazofamid in primary crops was investigated in tomatoes, potatoes and grapes. In all three crops metabolic patterns were similar and the parent compound was the major residue in both fruits and foliage. The residue for enforcement and risk assessment in fruits and fruiting vegetables and root and tuber vegetables derived in the peer review was defined as cyazofamid only. EFSA concludes that the metabolism of cyazofamid in primary crops is sufficiently addressed and that the residue definitions derived are applicable.
The submitted supervised residue trials are sufficient to derive MRL proposals of 2 mg/kg for the proposed uses on table and wine grapes. Adequate analytical enforcement methods are available to control the residues of cyazofamid in the commodities under consideration at the validated LOQ of 0.01 mg/kg.
A limited number of data on the nature of residues over processing derived from the primary crop metabolism study for grapes were available in the framework of the Article 12 review (EFSA 2012b). According with these data some conversion of parent cyazofamid to metabolite CCIM was suggested. Additionally, some further information on levels on CCIM in wine confirms that CCIM is present in wine. Uncertainties remain on the similarity of the toxicity profile of CCIM compared to parent but this is not of major concern as the total chronic intake estimated on the basis of residues of cyazofamid in the raw agricultural commodities are <1% of the ADI. As the residues in wine are mainly composed of the metabolite CCIM, it is proposed that the residue definition for enforcement and risk assessment in wine should be defined as sum of cyazofamid and CCIM, expressed as cyazofamid. Based on the available information EFSA is of the opinion that the following processing factor should be included in Annex VI of Regulation (EC) No 396/2005.
Grapes to wine (white and red): 0.13
Since the proposed use of cyazofamid is on permanent crops, investigations of residues in rotational crops are not required.
No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The highest long-term exposure was calculated for DE child representing 0.3% of the ADI. Table grapes were the main contributor to the dietary burden accounting for a maximum of 0.2 % of the ADI (DE child); the contribution of wine grapes was insignificant (lower than 0.05% of the ADI).
No acute exposure calculation was necessary because of the low toxicity of cyazofamid.
EFSA concludes that the proposed use of cyazofamid on grapes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.