Normativa UEJul. 18, 2012
UE: autoridad alimentaria revisa límites máximos de residuo para famoxadone
Famoxadone was included in Annex I to Directive 91/414/EEC on 01 October 2002, 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 (1) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked France, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 23 March 2009 and, after having considered several comments made by EFSA, the RMS provided on 10 December 2009 a revised PROFile.
Based on the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS, EFSA issued on 30 March 2012 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 06 April 2012 were considered for finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of famoxadone was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.012 mg/kg bw/d and an ARfD of 0.2 mg/kg bw/d.
Primary crop metabolism of famoxadone was investigated on three different crops using foliar application treatment. These crops are representative of cereals (wheat), root and tuber vegetables (potatoes) and fruit (grapes). Studies were performed with [14C-Phenoxyphenyl]-famoxadone and [14C-Phenylamino]-famoxadone. The studies indicated that famoxadone was the primary and only terminal residue which accounted for greater than 10 % of the total plant radiolabelled residues in all plant species. The residue definition for enforcement and risk assessment in all plant commodities is famoxadone. Validated analytical methods for enforcement of the residue definition are available with a LOQ of 0.01 mg/kg in dry, acidic, and high water containing commodities. An analytical method for enforcement of commodities with high oil content is not available.
Regarding the magnitude of residues in primary crops, a sufficient number of supervised residue trials are available for the GAPs reported by the RMS, which allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities and to derive MRLs. It is noted however that the MRL for rape seed can be derived on a tentative basis only since there is no validated analytical method reported for enforcement in this commodity.
The nature of residues in processed commodities indicated that famoxadone is susceptible to hydrolysis under conditions representative of sterilization (pH6, 120°C, 20 minutes) and baking, brewing or boiling (pH 5, 100°C, 60 minutes) processes but it is questionable whether the metabolites formed in this study will also occur in the presence of a substrate due to their high reactivity. Further investigation on the nature of residues in processed commodities is therefore desirable, for wine in particular as this is the main contributor to the chronic exposure. The magnitude of parent famoxadone in processed commodities of melons, grapes, tomatoes, barley and wheat was also investigated. Considering however that nature of residues still needs to be further clarified in processed commodities, only the processing factor of 0.03 for peeled melons can be recommended for enforcement and risk assessment purposes.
Occurrence of famoxadone residues in rotational crops was investigated during the peer review. A study showed the metabolism in primary and rotational crops is comparable and significant residues in rotational crops are not expected.
The nature of famoxadone residues in commodities of animal origin was investigated in the framework of Directive 91/414/EEC. Reported metabolism studies include one study in lactating goat and one study in laying hen using14C-Phenoxyphenyl labelled famoxadone and 14C-phenylamino labelled famoxadone. Based on these studies, the residue in all commodities of animal origin was defined as famoxadone both for enforcement and risk assessment. A livestock feeding study in lactating Holstein dairy cows was considered in the JMPR evaluation report for famoxadone which allowed EFSA to derive risk assessment values and MRLs for ruminants. For swine and poultry products, although no significant intake was identified, it was proposed to establish MRLs at or close to the LOQ (considering the fat solubility of famoxadone). There are indications that famoxadone can be enforced in food of animal origin with a LOQ of 0.01 mg/kg in muscle, fat and milk, 0.02 mg/kg in eggs and 0.05 mg/kg in liver and kidney but further validation of the method is still required. All MRL proposals for commodities of animal origin are therefore considered on a tentative basis only.
Chronic and acute consumer exposure resulting from the uses supported in the framework of this review was calculated using revision 2 of the EFSA PRIMo and compared with the toxicological reference values derived for famoxadone. The highest chronic exposure was calculated for FR all population representing 22.1 % of the ADI and the highest acute exposure was calculated for table grapes, representing 37.7 % of the ARfD.
Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for famoxadone. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out. The highest chronic exposure was calculated for FR all population representing 21.9 % of the ADI and the highest acute exposure was calculated for table grapes, representing 37.7 % of the ARfD.
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 were derived in compliance with the decision tree reported in Appendix D (see table below for a summary). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and 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 table for details). In particular, certain tentative MRLs still need to be confirmed by the following data:
• an analytical method for enforcement of famoxadone in high oil commodities.
• an analytical method for enforcement of famoxadone in commodities of animal origin.
Minor deficiencies were identified in the assessment but these deficiencies are not expected to impact either on the validity of the ‘Recommended’ MRLs or on the national authorisations. The following data are therefore considered desirable but not essential:
• residue trials on potatoes carried out with the current enforcement LOQ of 0.01 mg/kg;
• clarification on the origins of cereal grain and straw residues data;
• storage conditions of samples prior to analysis in the residue trials;
• a detailed evaluation report of the storage stability study in rape seed;
• a study investigating the nature of residues in wine;
• storage conditions of samples prior to analysis in the livestock feeding studies.