Normativa UE
May. 25, 2012UE: autoridad alimentaria modifica límites máximos de residuos para dimetoato en aceitunas para consumo y producción de aceite
Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, Greece, herewith referred as the evaluating Member State (EMS), received an application from Cheminova A/S, on behalf of the Dimethoate Task Force, to modify the existing MRLs for the active substance dimethoate in olives for oil production and table olives. In order to accommodate for the intended use of dimethoate, Greece proposed to raise the existing MRLs in olives from the value of 2 mg/kg to 3 mg/kg. Greece 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. According to EFSA the data are sufficient to derive a MRL of 4 mg/kg on table olives and olives for oil production for the intended foliar use of dimethoate in Southern Europe according to the enforcement residue definition as sum of dimethoate and omethoate, expressed as dimethoate. Adequate analytical enforcement methods are available to control the residues of dimethoate and omethoate in olives at the validated LOQ of 0.01 mg/kg for each analyte. Based on the risk assessment results, EFSA concludes that the proposed use of dimethoate on olive trees for oil production and table olives will not result in a consumer exposure exceeding the toxicological reference values. However, the risk assessment in the framework of this opinion should be considered as provisional and may underestimate the actual consumer risk. The final evaluation of the toxicological relevance of metabolites III, XII and XX is still to be provided. To perform a more accurate calculation, the confirmation of the supported authorised use pattern and the results from residue trials conducted according to the final agreed residue definition for risk assessment are needed.
© European Food Safety Authority, 2012
Summary
In accordance with Article 6 of Regulation (EC) No 396/2005[1], Greece, herewith referred as the evaluating Member State (EMS), received an application from Cheminova A/S, on behalf of the Dimethoate Task Force, to modify the existing MRLs for the active substance dimethoate in olives for oil production and table olives. In order to accommodate for the intended use of dimethoate, Greece proposed to raise the existing MRLs in olives from the value of 2 mg/kg to 3 mg/kg. Greece 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 bases its assessment on the evaluation report, the Draft Assessment Report (DAR) and its addenda prepared by the United Kingdom under Council Directive 91/414/EEC[2], the Commission Review Report on dimethoate, EFSA conclusion on the peer review, the JMPR Evaluation reports, EFSA previous reasoned opinion on dimethoate as well as additional information submitted in the framework of Article 12 of Regulation (EC) No 396/2005.
The toxicological profile of dimethoate was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.001 mg/kg bw per day and an ARfD of 0.01 mg/kg bw. In addition separate toxicological reference values were set for omethoate, a metabolite considerably more toxic than dimethoate.
The metabolism of dimethoate in primary plants was investigated after foliar application in potatoes and wheat at time of the peer review and in olives under a previous MRL application. In the crop groups investigated dimethoate formed a wide range of metabolites, among which omethoate is the primary metabolism product. Even though omethoate is the more toxic metabolite, other metabolites, in particular (O-desmethyl omethoate carboxylic acid (metabolite XX), O-desmethyl iso-dimethoate (metabolite XII) and dimethoate carboxylic acid (metabolite III)), can potentially contribute to the toxicological burden given their presence in significant amounts. Therefore, further information to determine the toxicological relevance of these metabolites was requested as part of the response to the confirmatory data requirements. The peer review concluded on a residue definition for enforcement as dimethoate and omethoate to be determined separately. Since a change of the residue definition as established in Regulation (EC) No 396/2005 (dimethoate, sum of dimethoate and omethoate, expressed as dimethoate) would have had an impact on the existing MRLs for dimethoate, EFSA recommended to implement the change in the framework of the comprehensive MRL review for dimethoate under Article 12 of this Regulation. Pending the assessment of the data on the toxicity of metabolites XX, XII and III, a provisional residue definition for risk assessment was proposed as “sum of dimethoate and 6 times omethoate expressed as dimethoate (for acute risk assessment)” and “sum of dimethoate and 3 times omethoate expressed as dimethoate” (for chronic risk assessment), taking into account that both compounds share a common toxicological mode of action but with different potencies. EFSA concludes that the provisional residue definitions for enforcement and for risk assessment are applicable to the intended use on the crops under consideration.
EFSA considers that the submitted supervised residue trials are sufficient to derive a MRL of 4 mg/kg on table olives and olives for oil production for the intended foliar use of dimethoate in Southern Europe according to the enforcement residue definition as sum of dimethoate and omethoate, expressed as dimethoate. Adequate analytical enforcement methods are available to control the residues of dimethoate and omethoate in olives at the validated LOQ of 0.01 mg/kg for each analyte.
Studies investigating the nature of dimethoate residues in processed commodities were assessed in the framework of the peer review through hydrolysis studies simulating sterilisation, baking, brewing, boiling and pasteurization. The peer review concluded that the nature of residues was affected by processing to a certain extent only when severe conditions such as sterilisation are applied. However, no specific residue definition for processed commodities was set as the metabolism was similar to that observed in raw agricultural commodities (RAC). Specific studies investigating the magnitude of dimethoate and omethoate residues in olives processed to oil and canned olives were assessed during the peer review. EFSA is not recommending the inclusion of the derived processing factors in Annex VI of Regulation (EC) No 396/2005 as long as the residue definition (dimethoate and omethoate set separately) is not modified.
Since the proposed use of dimethoate is on permanent crops, investigations of residues in rotational crops are not required. Olives are also not usually fed to livestock, therefore the nature and magnitude of residues in commodities of animal origin resulting for the intended use of dimethoate in olive trees were not assessed.
A provisional consumer risk assessment was performed with revision 2 of the EFSA PRIMo. It is based on the assumption that metabolites XX, XII and III do not contribute to the overall toxicological burden taking into account the authorised uses of dimethoate as notified by the Member States for the Article 12 review and the existing acceptable CXLs. For the calculation of the chronic exposure, EFSA used the median residue values for dimethoate and omethoate as derived form the residue trials on olives, the median residue values for dimethoate and omethoate from previous reasoned opinions, the risk assessment input values reported by the rapporteur Member States, the United Kingdom, in the framework of Article 12 of Regulation (EC) No 396/2005 and the MRL values. The acute exposure assessment was performed only with regard to the commodities under consideration. The available processing factors were also applied to refine the calculation. The calculated exposure was then compared with the toxicological reference values as derived for dimethoate.
Taking into account the information available to EFSA, no long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values accounted for up to 79.4 % of the ADI (DE child diet). The contribution of residues in olives for oil production and table olives to the total consumer exposure accounted for a maximum of 8.8 % and 0.2 % of the ADI, respectively (WHO Cluster diet B). No acute consumer risk was identified in relation to the MRL proposal for olives for oil production and table olives. The calculated maximum exposure in percentage of the ARfD was 6.9 % for olives for oil production and 6.1 % for table olives.
EFSA concludes that the proposed use of dimethoate on olive trees for oil production and table olives will not result in a consumer exposure exceeding the toxicological reference values. However, the risk assessment in the framework of this opinion should be considered as provisional and may underestimate the actual consumer risk. The final evaluation of the toxicological relevance of metabolites III, XII and XX is still to be provided. To perform a more accurate calculation, the confirmation of the supported authorised use pattern and the results from residue trials conducted according to the final agreed residue definition for risk assessment are needed.