Normativa UESep. 21, 2012
UE: autoridad alimentaria revisa límites máximos de residuo para benthiavalicarb
According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance benthiavalicarb. In order to assess the occurrence of benthiavalicarb residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as European authorisations reported by Member States (incl. the supporting residues data).Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and one MRL proposal derived by EFSA still requires further consideration by risk managers.
© European Food Safety Authority, 2012
Benthiavalicarb was included in Annex I to Directive 91/414/EEC on 01 August 2008, which is before the entry into force of Regulation (EC) No 396/2005 on 02 September 2008. EFSA is therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(2) of afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Belgium, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 23 February 2009 and, after having considered several comments made by EFSA, the RMS provided on 21 October 2009 a revised PROFile.
Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the additional information provided by the RMS, EFSA issued on 03 April 2012 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 08 June 2012 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of benthiavalicarb-isopropyl was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI being established at 0.1 mg/kg bw per d. An ARfD was not deemed necessary.
Primary crop metabolism of benthiavalicarb-isopropyl was investigated following foliar applications in grapes, tomatoes and potatoes and also following a post-emergence application in potatoes, hereby covering two different crop groups. Metabolic patterns in the different studies were shown to be similar and the relevant residue for enforcement and risk assessment in fruits/fruiting vegetables and root/tuber vegetables could be defined as the sum of benthiavalicarb-isopropyl (KIF 230 R-L) and its enantiomer (KIF 230 S-D) and its diastereomers (KIF 230 S-L and KIF 230 R-D), expressed as benthiavalicarb-isopropyl. A validated analytical method for enforcement of the residue definition in foods of plant origin is available with an LOQ of 0.02 mg/kg in high water content and acidic commodities.
Regarding the magnitude of residues in most crops reported by the RMS, at least one GAP was supported by a sufficient number of supervised residue trials. This allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities and to derive appropriate MRLs For cucumbers, no residues trials were available. EFSA was therefore not able to derive a reliable MRL proposal for this crop and further residue trials are required.
In processed commodities, benthiavalicarb-isopropyl was shown to be stable during pasteurisation, baking, boiling, brewing and sterilisation. The relevant residue for enforcement and risk assessment in processed commodities is therefore expected to be the same as for primary crops. Magnitude of residues in processed commodities was also investigated and robust processing factors were derived for raisins, grape juice, must, red and white wine. Further processing studies are not required because they are not expected to affect the outcome of the risk assessment. However, if there would be the intention from risk managers to derive more processing factors for enforcement purposes, additional processing studies might be required.
The possible occurrence of benthiavalicarb-isopropyl and toxicologically relevant M1, M4 and M5 metabolites residues in rotational crops has been investigated. No parent compound or metabolites was observed. Benthiavalicarb residues, including toxicologically relevant metabolites M1, M4 and M5, are therefore not expected to exceed 0.01 mg/kg in rotational commodities. Specific plant-back restrictions related to the use of benthiavalicarb are also not required, provided that benthiavalicarb is applied in compliance with the GAPs reported in Appendix A
Based on the uses reported by the RMS, no significant intake was calculated for any type of livestock. The setting of MRLs in commodities of animal origin is therefore not required.
Chronic consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. For cucumbers where data were insufficient to derive an MRL, EFSA considered the existing EU MRL (rounded up to the appropriate LOQ for enforcement purposes) for an indicative calculation. The highest chronic exposure represented 0.5 % of the ADI (WHO Cluster diet B). Acute exposure calculations were not carried out because an ARfD was not deemed necessary for this active substance.
Although the active substance approved at EU level is referred to as benthiavalicarb, EFSA highlights that the above assessment is based on data for the variant benthiavalicarb-isopropyl. Considering that hydrolysis of benthiavalicarb-isopropyl to benthiavalicarb (acid compound) was not observed, the above assessment is only relevant to benthiavalicarb-isopropyl. If the use of other variants of benthiavalicarb would be supported in the future, these variants will require a specific assessment.
Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005. MRL recommendations for benthiavalicarb-isopropyl were derived in compliance with the decision tree reported in Appendix D of the reasoned opinion (see summary table). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see summary table footnotes for details). In particular, one existing EU MRL still needs to be confirmed by the following data:
• 8 residue trials supporting the northern outdoor GAP on cucumbers.
If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorizations at national level.