Normativa UEMar. 21, 2012
UE: autoridad alimentaria revisa límites máximos de residuo para spinosad
Spinosad was included in Annex I to Directive 91/414/EEC on 01 February 2007, 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 The Netherlands, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 06 February 2009 and, after having considered several comments made by EFSA, the RMS provided on 27 October 2009 a revised PROFile.
Based on the conclusions derived in the framework of Directive 91/414/EEC under the supervision of the European Commission, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS, EFSA issued on 13 July 2011 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 16 September 2011 were discussed in a meeting of experts, which took place on 02 December 2011, and the outcome of that meeting was considered for finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of spinosad was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.024 mg/kg bw/d. No ARfD value was deemed necessary for spinosad.
Primary crop metabolism of spinosad was investigated following foliar application in grapes, apples, tomatoes, cabbage, turnips and cotton, hereby covering four different crop groups. Results of these studies were discussed during an expert meeting. Although metabolic patterns in the different studies were not shown to be similar – results on leafy vegetables (cabbage, turnip leaves) were not in line with the ones obtained on fruits (apples, grapes) and fruiting vegetables (tomatoes) – these contradictions were considered not to have any consequence on the outcome of the risk assessment. Also high amounts of unknown metabolites were reported at longer sampling intervals. However, since it is very likely that these unknown metabolites are incorporated into natural plant components, data on uncharacterised radioactivity was only considered desirable. Consequently, the relevant residue for both enforcement and risk assessment in all plant commodities is defined as spinosad, sum of spinosyn A and spinosyn D. Validated analytical methods for enforcement of the residue definition are available, with a combined LOQ of 0.02 mg/kg in commodities with high water content, acidic, dry and high oil content commodities. No representative metabolism studies are available for seed treatment on radishes and post-harvest application on cereals. However, considering that radish is a minor crop and that the metabolism for post-harvest application on cereals can be covered by studies with short sampling intervals on fruits, cabbage and turnips, the proposed residue definition for both enforcement and risk assessment in all plant commodities is therefore applicable for radishes and cereals. In case future seed treatment or post-harvest uses of spinosad would be requested, a representative metabolism study would be required.
Regarding the magnitude of residues, a sufficient number of supervised residues trials is available to support the GAPs for most of the crops reported by the RMS, which allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities. For flowering brassica, scarole, cress, rocket (rucola) and globe artichokes, residues trials data were only sufficient to derive tentative MRLs. For dewberries and swedes/turnips, the number of residues trials was not sufficient to derive tentative MRL proposals and further residues trials are required.
The nature of spinosad in processed commodities was not investigated. However, such studies are necessary; spinach and cereal grains in particular, the main contributors to the exposure calculation, are usually processed before consumption. Studies investigating the magnitude of residues in processed commodities of wine grapes and tomatoes are available, but no robust processing factors could be derived, due to the lack of a study about the effect of processing on the nature of spinosad. Furthermore, for tomato, the processing factors are not sufficiently supported by studies; a minimum of 3 processing studies is normally required. Currently, further processing studies on the magnitude of residues are not required in this case as they are not expected to affect the outcome of the risk assessment. If there would be the intention to derive more robust processing factors, in particular for enforcement purposes, additional processing studies would be required.
Following the assessment of the confined rotational crop study during the peer review of spinosad, it was concluded that the metabolic pattern in rotational crops is similar to primary crops and that no significant residue levels are expected in rotational crops. This conclusion also applies to the GAPs of spinosad supported in the framework of this review.
Based on the uses reported by the RMS, significant intakes were calculated for all groups of livestock. Metabolism in lactating ruminants and poultry was sufficiently investigated and findings can be extrapolated to pigs as well. The relevant residue definition for both enforcement and risk assessment in all commodities of animal origin was therefore defined as spinosad, sum of spinosyn A and spinosyn D;except for poultry liver and eggs, where the residue definition for risk assessment is proposed as the sum of spinosyn A, spinosyn D, O-demethylated spinosyn D and N-demethylated spinosyn D. Tentative conversion factors for risk assessment of 4 and 1.5, respectively, can be derived from the metabolism studies. A validated analytical method for enforcement of this residue definition in foods of animal origin is available, with a combined LOQ of 0.02 mg/kg in milk, liver, kidney, fat, muscle and eggs. Available cow feeding studies demonstrated that residues of spinosad were found in significant amounts and MRLs in pigs and ruminants commodities were derived. No livestock feeding study was reported for poultry and no MRLs could be derived for this group of livestock. As there is significant exposure of poultry to spinosad residues, MRLs have to be established, and a feeding study is still required.
Chronic consumer exposure resulting from the MRLs proposed in the framework of this review was calculated. The highest chronic exposure represented 57.5 % of ADI (WHO Cluster diet B). Acute exposure calculations were not carried out because an ARfD was not deemed necessary for this active substance.
Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for spinosad. Additional calculations of the consumer exposure, including these CXLs, were therefore performed and an exceedance of the ADI was identified for Dutch children, representing 120.1 % of the ADI. Excluding the dermal application of dairy ruminants which leads to this high chronic exposure, a fall-back CXL on milk could be derived. Considering this fall-back CXL, the chronic exposure decreased to an acceptable level. Indeed, the highest chronic exposure declined to 56.9 % of the ADI for the WHO Cluster diet B.
Finally, it should be noted, that in the EU, spinosad is also authorised for the use as a biocide. There are currently no indications that the biocide use of spinosad within the EU would lead to higher residues in commodities of animal origin than the pesticide use. In case information indicating a possible exceedance of the proposed MRLs would be made available in the future, modification of the proposed MRLs might be required.
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 footnotes for details). In particular, certain tentative MRLs and existing EU MRLs still need to be confirmed by submission of the following data:
• 4 additional residues trials on raspberries supporting the southern outdoor GAP on cane fruits and 4 additional residues trials on raspberries supporting the indoor GAP on cane fruits;
• 4 residue trials supporting the indoor GAP on swedes and/or turnips;
• 2 additional residues trials performed on cauliflower supporting the southern outdoor GAP on cauliflower and broccoli;
• 4 residue trials supporting the northern outdoor GAP on globe artichoke;
• Studies about the nature of residues in processed commodities. It should be noted, that such studies are necessary for spinach and cereal grains in particular which are the main contributors to the exposure calculation and usually processed before consumption;
• A poultry feeding study in order to derive appropriate MRLs and conversion factors for this group of livestock.
It is highlighted, however, that some of the ‘Recommended’ MRLs result from a CXL or from a GAP in one climatic zone only, while other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the following data gaps which are not expected to impact on the validity of the recommended MRLs but which might have an impact on national authorisations:
• 8 residue trials supporting the indoor GAP on wine and table grapes;
• 8 residue trials supporting the northern outdoor GAP on strawberry;
• 4 residue trials supporting the indoor use on garlic;
• 8 residue trials supporting the southern outdoor GAP on cucumbers and courgettes;
• 8 residue trials on melon supporting the southern outdoor GAP on inedible peel cucurbits;
• 4 residue trials supporting the indoor GAP on lamb’s lettuce;
• 8 residue trials supporting the northern outdoor GAP on lettuce;
• 2 additional residue trials supporting the southern outdoor GAP on lettuce;
• 8 residues trials supporting the northern outdoor GAP on scarole, rucola and herbs;
• 8 residues trials supporting the southern outdoor GAP on scarole;
• 4 additional residues trials (carried out on open leaf varieties of lettuce or spinach) supporting the indoor GAP on scarole, cress, rucola, leaves and sprouts of brassica spp., spinach, beet leaves and herbs (other than parsley).
If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level. For the indoor GAP on leafy vegetables in particular (except parsley and lettuce), EFSA strongly recommends Member States to reconsider their authorisations because based on the results of residue trials on parlsey with a less critical GAP exceedances of the MRL proposals are very likely.
Minor deficiencies were also 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:
• a metabolism study representative for seed-treatment use on roots and tuber vegetables;
• further clarifications on the nature of uncharacterised residues in primary crops;
• 4 trials on open nuts variety complying with the GAP on tree nuts (resulting from the new extrapolation rules);
• a confirmation on the country of origin for the import tolerance on apples;
• 4 residue trials supporting the southern outdoor use on apricots to accept the extrapolation from peaches (resulting from the new extrapolation rules);
• 4 residue trials supporting the southern outdoor use on plums (resulting from the new classification as a major crop);
• 1 additional trial supporting the southern use on strawberry;
• new residues trials on Brussels sprouts and lamb’s lettuce with a lower LOQ of 0.02 mg/kg;
• information on the exact storage conditions of the residues trials samples where the information was not reported.