Normativa UEMar. 28, 2012
UE: autoridad alimentaria modifica límites máximos de residuo para acibenzolar-S-methyl
According to Article 6 of Regulation (EC) No 396/2005, France received an application from Syngenta Agro S.A.S. to modify the existing MRLs for acibenzolar-S-methyl in lettuce and other salad plants including Brassicaceae. In order to accommodate for the intended use of acibenzolar-S-methyl in France under outdoor and indoor conditions, France proposed to raise the existing MRL in lettuce and other salad plants including Brassicaceae from 0.02* mg/kg to 0.3 mg/kg. France 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 11 July 2011.
EFSA derived the following conclusions based on the above mentioned evaluation report, the Draft Assessment Report (DAR) prepared by France under Directive 91/414/EEC, the review report and a previous EFSA reasoned opinion on the modification of the existing MRLs for acibenzolar-S-methyl in peaches and apricots.
The toxicological profile for acibenzolar-S-methyl was investigated in the peer review and data were sufficient to conclude on an ADI value of 0.1 mg/kg bw/day. No ARfD was established because of the low acute toxicity of the active substance.
Metabolism of acibenzolar-S-methyl in primary plants was investigated in the framework of the peer review on cereals (wheat), fruiting vegetables (tomatoes) and leafy vegetables (tobacco). An additional metabolism study on lettuce was evaluated and reported in the evaluation report prepared by France in support of a previous MRL application. The residue definition derived for risk assessment and enforcement for all categories of crops is acibenzolar-S-methyl (sum of acibenzolar-S-methyl and acibenzolar acid (CGA 210007), expressed as acibenzolar-S-methyl). The same residue definition for enforcement purposes has been established under Regulation (EC) No 396/2005.
In support to this MRL application, the applicant submitted eight residue trials performed on lettuce (Lactuca sativa) carried out under indoor conditions (three of the trials were performed on open leave varieties) as well as six and seven outdoor residue trials were conducted in Northern and Southern Europe, respectively. The residue trials on lettuce grown under indoor conditions generally showed higher residue levels than the outdoor trials. The residue concentrations on open leave varieties seem to be in the same range as the residue concentrations on head forming varieties. However, EFSA is of the opinion that a data set of three and five trials for open leave lettuce and head forming lettuce, respectively, is not sufficiently robust to conclude that the two sets of data represent the same population. Thus, an extrapolation to the whole crop group of lettuce and other salad plants including Brassicaceae is not recommended by EFSA. According to the current guidelines five additional trials on open leave varieties would be required for this extrapolation.
Acibenzolar-S-methyl is hydrolytically stable under the processing conditions representative of pasteurisation and baking/boiling/brewing while a significant degradation was observed under sterilisation processing conditions. Since the major degradation product acibenzolar acid (CGA 210007) was identified as a major plant metabolite, the same residue definition as for raw agricultural commodities (RAC) can be applied for the processed commodities.
Specific studies to assess the magnitude of acibenzolar-S-methyl residues during the processing of crops under consideration are not necessary as the total theoretical maximum daily intake (TMDI) accounted for less than 10 % of the ADI and thermal treatment is not considered as a relevant processing type for lettuce.
The possible occurrence of acibenzolar-S-methyl residues in rotational and/or succeeding crops was investigated; the residue levels in the edible parts of the rotational crops are not expected to exceed the trigger value of 0.01 mg/kg provided that the active substance is applied according to the proposed GAP.
Lettuce and other salad plants including Brassicaceae or any of their by-products are not part of the livestock diet. Therefore no further considerations are needed regarding residues in feed and their transfer into food of animal origin.
The chronic consumer risk assessment was performed with revision 2 of the EFSA PRIMo. For the calculation of the chronic exposure, EFSA used the median residue values as derived from the residue trials on lettuce as well as the median residue values for peaches and apricots from the previous EFSA reasoned opinion and also the median residue values for hazelnuts, bananas, mangoes, tomatoes and spinach from the residue database reported in the Pesticide Residue Overview File (PROFile) in order to refine the intake calculations. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annexes II and IIIB of Regulation (EC) No 396/2005 were used as input values.
No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values ranged from 0.3% to 1.9% of the ADI (WHO cluster diet B). The contribution of residues in lettuce to the total long-term exposure was insignificant (0.04% of the ADI).
An acute dietary risk assessment is not necessary because of the low acute toxicity of the active substance for which no ARfD has been considered as necessary.
EFSA concludes that the intended use of acibenzolar-S-methyl in lettuce only is acceptable with regard to the consumer exposure and the following MRL is recommended to be included in Annex II of Regulation (EC) No 396/2005.