Normativa UEFeb. 14, 2014
UE: autoridad alimentaria modifica límites máximos de residuo de chromafenozide en uvas
In accordance with Article 6 of Regulation (EC) No 396/2005, Hungary, hereafter referred to as the evaluating Member State (EMS), received an application from Arysta LifeScience on behalf of Nippon Kayaku Co. Ltd to modify the existing MRLs for the active substance chromafenozide in pome fruits and grapes. In order to accommodate for the intended uses of chromafenozide, Hungary proposed to raise the existing MRLs from the limit of quantification (LOQ) of 0.01 mg/kg in grapes and pome fruits except apples and from 0.3 mg/kg in apples to 1.5 mg/kg in grapes, 0.4 mg/kg in apples and 0.5 mg/kg in the other pome fruits. Hungary 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 3 April 2012. EFSA identified some data requirements, which prevented EFSA to conclude on the consumer risk assessment. On 20 December 2013 the EMS provided the reply in a revised evaluation report, which replaces the previous document.
EFSA bases its assessment on the revised evaluation report, the Draft Assessment Report (DAR) and its final addendum prepared under Council Directive 91/414/EEC and the EFSA conclusion on the peer review of the active substance chromafenozide.
The toxicological profile of chromafenozide was assessed during the peer review and the data were sufficient to propose an ADI of 0.27 mg/kg bw per day. No ARfD was deemed necessary.
Based on the results from the metabolism study on apples after foliar applications, the peer review proposed the parent chromafenozide as residue definition for enforcement and risk assessment in the fruits and fruiting vegetables. For the uses on pome fruits and grapes, EFSA concludes that the metabolism of chromafenozide is sufficiently addressed and the residue definitions for enforcement and risk assessment proposed during the peer review are applicable.
EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals of 0.6 mg/kg and 1.5 mg/kg for the intended uses on pome fruits and grapes, respectively. As alternative option, risk managers may consider the MRL of 0.5 mg/kg for the group of pome fruits. An analytical enforcement method is available to control the residues of chromafenozide on the commodities under consideration at the validated LOQ of 0.01 mg/kg. EFSA confirms the data gap identified in the peer review regarding the lack of information demonstrating the efficiency of the extraction step involved in the sample preparation. However, this data gap is considered as being of minor relevance and should be addressed in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005.
Specific studies investigating the nature of chromafenozide residues in processed commodities are not available. Although desirable, such studies are not required as the total theoretical maximum daily intake (TMDI) is below the trigger value of 10 % of the ADI. The results of the processing studies on grape processed products submitted in the framework of the current MRL application give evidence that a reduction of chromafenozide residues in grape juice, must and wine occurs. EFSA does not recommend the inclusion of the derived processing factors in Annex VI of Regulation (EC) No 396/2005 due to the uncertainties (high variability of results, limited number of studies) of the processing studies.
Since the proposed uses of chromafenozide are on permanent crops, investigations of residues in rotational crops are not required.
Apple pomace is used as feed product in the ruminant diet, therefore a potential carry-over into food of animal origin should be considered. According to the results of the metabolism study in lactating goats, significant residue levels of chromafenozide are not expected in food of animal origin at the calculated dietary burdens. Therefore, the setting of MRLs in commodities of animal origin is not required in the framework of the current application.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For the calculation of the chronic exposure EFSA used the median residue values as derived from the residue trials on apples, pears and grapes and the existing MRLs for the other commodities of plant origin. 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 less than 1 % of the ADI (German child diet). Wine grapes and apples were the main contributors to the dietary burden accounting for a maximum of 0.6 % and 0.5 % of the ADI, respectively. No acute exposure calculation was necessary because of the low acute toxicity of chromafenozide.
EFSA concludes that the proposed uses of chromafenozide on pome fruits and table and wine grapes will not result in a consumer exposure exceeding the toxicological reference value and therefore are unlikely to pose a consumer health risk.
Since a decision concerning the approval of the active substance chromafenozide in accordance with Regulation (EC) No 1107/2009 has not been made, the conclusions reported in this reasoned opinion should be taken as provisional and might need to be reconsidered in the light of the outcome of the regulatory procedure.
EFSA proposes to amend the existing MRLs as reported in the summary table.