Normativa UEMay. 4, 2012
UE: autoridad alimentaria revisa límites máximos de residuo para thiophanate methyl y carbendazim
According to Article 6 of the Regulation (EC) No 396/2005, Sweden, hereafter referred to as the evaluating Member State (EMS), received an application from the company Nisso Chemical Europe GmbH to modify the existing MRLs for the active substances thiophanate-methyl and carbendazim in apples and pears. In order to accommodate for the intended use of thiophanate-methyl on apples and pears in Sweden, the EMS proposes to raise the existing MRLs both for thiophanate-methyl and carbendazim. The EMS Sweden 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 derives the following conclusions based on the submitted evaluation report prepared by Sweden, the Draft Assessment Report (DAR) prepared by the rapporteur Member State Germany under Directive 91/414/EEC, the EC review report on thiophanate-methyl and the previously issued EFSA reasoned opinion on the MRLs of concern for the active substances carbendazim and thiophanate-methyl.
The toxicological profiles of thiophanate-methyl and carbendazim were assessed in the framework of the peer review under Directive 91/414/EEC. For thiophanate-methyl the peer review proposed an ADI of 0.08 mg/kg bw/day and an ARfD of 0.2 mg/kg bw. For carbendazim an ADI value of 0.02 mg/kg bw/day and an ARfD of 0.02 mg/kg bw has been derived.
The metabolism of thiophanate-methyl in primary crops was investigated in fruits, root vegetables, cereals and pulses. From these studies the peer review concluded to establish the residue definition for risk assessment as the “sum of thiophanate-methyl and carbendazim, expressed as carbendazim”. The enforcement residue definition is established as parent thiophanate-methyl according to Regulation (EC) No 396/2005. For the use on the crops under consideration EFSA concludes that the metabolism of thiophanate-methyl is addressed and that the residue definitions derived by the peer review are applicable.
The proposed extrapolation of residue data from apples to pears is sufficiently supported by data. EFSA concludes that a MRL of 0.8 mg/kg for thiophanate-methyl and a MRL of 0.3 mg/kg for carbendazim would be required to support the intended use of thiophanate-methyl on apples and pears in Sweden. Analytical methods are available to control the compliance of carbendazim residues in the commodities under consideration at a validated LOQ of 0.01 mg/kg. An analytical enforcement method for the determination of thiophanate-methyl residues in apples and pears is available, but a validation of the method in an independent laboratory (ILV) is lacking.
The effects of processing on the nature of thiophanate-methyl have not been investigated and therefore adequate studies to address this data gap have to be provided. There is some evidence that degradation to carbendazim might occur but the possible formation of other degradation products needs to be further explored. According to the peer review, carbendazim is stable under standard hydrolysis studies simulating pasteurisation, baking or sterilisation. The effect of processing on the magnitude of thiophanate-methyl and carbendazim residues in apples was investigated in two studies submitted in the framework of the current application. Apples were processed into juice, puree and canned apple. Residues of thiophanate-methyl and carbendazim were determined in final processed products as well as in various intermediate products. Study results indicate a reduction of thiophanate-methyl residues in all processed products. A concentration of carbendazim residues is observed in wet and dry apple pomace. No study details have been provided as well as the number of studies is insufficient to propose the derived processing factors for enforcement purposes.
Since the proposed use of thiophanate-methyl is on permanent crops the investigation of residues in rotational crops/succeeding crops is not required.
Apple pomace can be fed to cattle and therefore the nature and magnitude of thiophanate-methyl and carbendazim residues in livestock and potential carry-over of residues in commodities of animal origin was investigated. The livestock dietary burden was calculated considering the livestock intake of thiophanate-methyl and carbendazim residues from the apple pomace as well as from all other potential feed crops for which the existing EU MRLs for thiophanate-methyl and carbendazim are set above the LOQ. The calculated dietary burden is exceeded for all livestock species, but the livestock intake is driven mainly by the existing uses of thiophanate-methyl and carbendazim and the contribution of the apple pomace to the total livestock exposure is low. Therefore the modification of the MRLs for commodities of animal origin was not further investigated in the framework of the current application.
Consumer intake calculation was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). Since both active substances share a common mechanism of toxicity, a combined consumer exposure assessment was performed considering the available residue data for carbendazim and thiophanate-methyl as well as the respective toxicological potencies of the active substances (calculation of the toxicologically adjusted sum of carbendazim and thiophanate-methyl). To calculate the chronic exposure for the crops under consideration, EFSA used the median residue value as derived from the residue trials on apples. The same input value was used for pears. For other commodities of plant and animal origin the toxicologically adjusted sum of the existing EU MRLs for thiophanate-methyl and carbendazim as established in Regulation (EC) No 396/2005 were used as input values in the chronic exposure calculation. For citrus fruit the risk assessment values from the previously issued EFSA reasoned opinion were available to refine the consumer exposure calculation.
The acute exposure assessment was performed only with regard to apples and pears, assuming the consumption of a large portion of the food item as reported in the national food surveys containing residues at the highest level as observed in supervised field trials. The estimated exposure was then compared with the toxicological reference values derived for carbendazim.
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 10- 49 % of the ADI (maximum for IE adult diet). The contribution of residues to the total consumer exposure (% of the ADI) accounted for a maximum of 9% for apples (DE child diet) and 0.5% of the ADI (DK child diet).
Using the internationally agreed standard methodology, based on the highest residue observed in residue trials, no acute consumer risk was identified. The calculated maximum exposure in percentage of the ARfD was 98% for apples and 91% for pears. Taking into account the uncertainties regarding the input values for the consumer risk assessment (see section 126.96.36.199) the result of the exposure assessment might underestimate the actual consumer exposure.
EFSA notes that in case apples and pears contain carbendazim residues at the proposed MRL of 0.3 mg/kg (not considering an additional contribution of thiophanate residues), the narrow margin of safety to the acute reference dose (for carbendazim) is not sufficient to exclude the consumer health risk in all cases (i.e. high consumption of unpeeled fruit and high variability (VF of 7) within a batch). Taking into account that the consumer group for which the highest exposure is estimated are infants, it is most likely that the fruits are consumed after peeling. However, since detailed consumption figures reporting separately the consumption of unpeeled, peeled and processed apples and pears and an accurate peeling factor are not available to EFSA, the estimation of the actual exposure for this sub-group of the population could not be further refined.
EFSA concludes that the intended use of thiophanate-methyl does not lead to a chronic consumer intake risk, but a potential acute exposure cannot be excluded for apples and pears containing residues of thiophanate-methyl and carbendazim at the level of the MRLs that would be required for the intended use.