Normativa otros paísesMay. 30, 2014
UE: modifican límites máximos de residuo para ethephon en aceitunas y uvas
In order to accommodate for the intended uses of ethephon, France proposed to raise the existing MRLs from 0.7 mg/kg to 1.5 mg/kg for table grape and from 5 mg/kg to 7 mg/kg for table olive. France 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 08 January 2014.
EFSA bases its assessment on the evaluation report submitted by the EMS (France, 2013), the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC (The Netherlands, 2004), the conclusion on the peer review of the pesticide risk assessment of the active substance ethephon (EFSA, 2008), as well as the conclusions from previous EFSA opinion on ethephon (EFSA,2009).
The toxicological profile of ethephon was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.03 mg/kg bw per day and an ARfD of 0.05 mg/kg bw.
The metabolism of ethephon in primary crops was investigated in cereals and in the fruit crop group. From these studies the peer review concluded to establish the residue definition as ethephon for enforcement and sum ethephon and HEPA for risk assessment. Following the submission of additional toxicological data assessed during the MRL review, on the metabolite HEPA, the residues definition for monitoring and risk assessment was limited to ethephon only. For the uses on crops under consideration, EFSA concludes that the metabolism of ethephon in primary crops is sufficiently addressed and the proposed residue definitions are applicable.
EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals of 1.5 mg/kg for the proposed use on table grape and 7 mg/kg for the proposed use table olive. Adequate analytical enforcement methods are available to control the residues of ethephon in the commodities under consideration at the validated LOQ of 0.05 mg/kg.
Studies investigating the nature of residues in processed commodities were assessed in the peer review and showed that the compound is stable under processing conditions of pasteurisation but not boiling, brewing and sterilisation where degrades to ethylene. However, this compound was not included in residue definition due to its volatility and therefore, for processed commodities the same residue definition as for raw agricultural commodities (RAC) is applicable. During the MRL review, based on 4 studies, a processing factor of 9.8 was derived for dried grape (raisins). Under the current application, 4 studies were submitted for table olive brined, but not processing factor could be derived as the results were below the LOQ (0.05 mg/kg).
Since the proposed use of ethephon is on permanent crops, investigations of residues in rotational crops are not required.
Residues of ethephon in commodities of animal origin were not assessed in the framework of this application, since the table grape and table olive are normally 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 ethephon 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 ethephon at the EU level. EFSA updates this risk assessment with the median residue values for table grape and table olive derived from the submitted supervised residue trials.
No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake accounted for up to 19 % of the ADI (WHO Cluster diet B). The contribution of residues to the total consumer exposure accounted for a maximum of 0.9 % of the ADI (DE child diet) for table grape and 0.3 % of the ADI for table olives (WHO Cluster diet B).
No acute consumer risk was identified in relation to the MRL proposals for crops under consideration. The calculated maximum exposure in percentage of the ARfD was 73 % for table grape (related DE adult diet) and 29 % for table olives (BE adult diet).
EFSA concludes that the proposed use of ethephon on table grape and table olives will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.
Thus EFSA proposes to amend the existing MRL as reported in the summary table.