Normativa UEJul. 25, 2014
UE: revisan límites máximos de residuo para boscalid
Boscalid 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 the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Germany, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 28 September 2009 and, after having considered several comments made by EFSA, the RMS provided on 10 August 2011 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 16 December 2013 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 14 February 2014 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological assessment of boscalid was peer reviewed under Directive 91/414/EEC, which resulted in an ADI of 0.04 mg/kg bw per day. An ARfD was not deemed necessary.
Metabolism of boscalid was investigated for foliar application on grapes, beans and lettuce, hereby covering three different crop groups. The relevant residue for enforcement and risk assessment in plants is defined as parent boscalid only. Validated analytical methods for enforcement of the proposed residue definition are available with an LOQ of 0.01 mg/kg in high water content, high oil content, acidic commodities, and dry commodities. Validated methods for enforcement of boscalid in hops, spices and herbal infusions are however still required.
Regarding the magnitude of residues in primary crops, a sufficient number of supervised residue trials is available for most of the GAPs reported by the RMS, which allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities. Appropriate MRL and risk assessment values were derived for all commodities under evaluation, except for Jerusalem artichokes, beet leaves and fresh lentils, where available data were insufficient to derive a tentative MRL, and for apricots, cauliflowers, fresh beans without pods, celery and fennel where data were sufficient to derive tentative MRLs only. The MRLs for hops, spices and herbal infusions are also considered as tentative because a validated analytical method for enforcement of boscalid in these crops is not available.
In processed commodities, boscalid residues were shown to be stable during processing by pasteurisation, baking/brewing/boiling and sterilisation. Magnitude of residues in processed commodities was also investigated and robust processing factors for enforcement and risk assessment were derived for several commodities. Further processing studies are not required for the time being as they are not expected to affect the outcome of the risk assessment. However, if more robust processing factors were to be required by risk managers, in particular for enforcement purposes, additional processing studies would be required.
Occurrence of boscalid residues in rotational crops was already investigated during the peer review. It is concluded that metabolic patterns in primary and succeeding crops are similar and that a potential for accumulation of boscalid residues in crops grown in rotation is expected. EFSA is aware that instead of defining risk mitigating measures, risk managers may have the interest to establish MRLs accommodating for the uptake of residues from previously treated soils, EFSA therefore re-calculated the MRL proposals to take into account such residues. However, these MRLs are subject to a higher degree of uncertainty; Member States may therefore also consider the establishment of appropriate risk mitigation measures in order to prevent the presence of residues in rotational crops. Furthermore, residue trials after repeated application in permanent crops would be desirable as well.
Based on the uses reported by the RMS, significant intakes were calculated for all groups of livestock. Metabolism in ruminants was sufficiently investigated and findings can be extrapolated to pigs as well. The relevant residue for both enforcement and risk assessment is defined as boscalid in muscle, fat, milk and eggs and as the sum of boscalid and its hydroxy metabolite M510F01 (free and conjugated), expressed as boscalid, in liver and kidney. In addition, in ruminant and pig liver, the bound residues (measured as M510F53 and M510F52, but expressed as boscalid) should be considered for risk assessment as well. Additional data are necessary to include these compounds in the risk assessment for poultry liver. Considering the lack of data regarding the fate of the pyridine moiety in ruminants and poultry liver, the residue definition should be considered tentative in these commodities. Livestock feeding studies were also reported on lactating cows and laying hens, which allowed EFSA to estimate the magnitude of residues in poultry, ruminants and pig products and to derive MRLs in these commodities. MRLs considering both primary crop use and incorporation of residues from previously treated soil were derived. MRLs in liver should however be considered on a tentative basis only because the residue definition for risk assessment in these commodities is tentative only and MRLs accounting for the incorporation of residues from previously treated soil are also tentative, due to the uncertainties regarding the estimated uptake in rotational crops.
Chronic consumer exposure resulting from the uses supported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. The highest chronic exposure represented 39.6 % of the ADI (German children) considering residue levels in primary crops only, and 42.9 % of the ADI (WHO Cluster diet B) considering both primary crop use and incorporation of residues from previously treated soil. 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 boscalid. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out. The highest chronic exposure represented 53.0 % of the ADI (Irish adult). According to EFSA, most CXLs for boscalid are not adequate because the extrapolations applied by JMPR were very wide and not in compliance with EU guidance. They should therefore be considered on a tentative basis only.
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, considering three different options (see also summary table):
MRL proposals reflecting the primary crop use at European level
MRL proposals reflecting the primary crop use at European level including the possible incorporation of residues from previously treated soils
MRL proposals reflecting the primary crop use at European level and MRLs established by the Codex Alimentarius Commission, including the possible incorporation of residues from previously treated soils
These options are presented in order to facilitate decision by risk managers but, although option 3 is favoured by the RMS Germany, EFSA highlights that options 2 and 3 are subject to a higher degree of uncertainty compared to option 1 because the accumulation of boscalid residues was not fully addressed according to EFSA. Indeed, MRLs accommodating for the incorporation of residues from previously treated soils would need to be confirmed by at least the following data:
further data to confirm the plateau level in soil that served as a basis for performing the rotational crop field trials;
further rotational crop field trials to address residues in strawberries, fruiting vegetables, stem vegetables, leafy vegetables, etc.;
residue trials after repeated application in permanent crops;
MRL values listed in the table according to option 1 are sufficiently supported by data and therefore proposed for inclusion in Annex II to the Regulation, except for apricots, Jerusalem artichokes, cauliflower, beet leaves, fresh beans without pods, fresh lentils, celery, fennel, hops, herbal infusions, liver and kidney. Indeed, MRL values for these commodities are not recommended for inclusion in Annex II because they still need to be confirmed by the following data:
a validated analytical method for enforcement of boscalid in hops, spices and herbal infusions;
additional residues trials supporting authorisations on apricots, Jerusalem artichokes, cauliflower, beet leaves, fresh beans without pods, fresh lentils, celery and fennel;
further investigation on the fate of the pyridine moiety in ruminants and poultry liver;
additional data on the nature and magnitude of the bound residues in poultry liver;
In addition, it is highlighted that some of the MRLs derived according to option 1 result from a GAP in one climatic zone only or from an import tolerance, while other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the need for additional residue trials supporting the authorisations on plums, strawberries, carrots, garlic, tomatoes, cucurbits with inedible peel, Brussels sprouts, Chinese cabbage, kale, kohlrabi, asparagus, dry beans, rape seed, wheat and rye. These data gaps are not expected to impact on the validity of the MRLs derived but might have an impact on national authorisations.
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.
Minor deficiencies were also identified in the assessment but these deficiencies are not expected to impact either on the validity of the MRLs derived or on the national authorisations. A validation of the hydrolytic step dissociating the conjugates of metabolite M510F01 for the GC-ECD method and additional residues trials supporting authorisations on cherries, plums, table and wine grapes, strawberries, cane fruit, other small fruits and berries, tomatoes, aubergines, peppers, cucurbits with inedible peel, head cabbage, lettuce and other salads, spinach, fresh herbs, fresh beans with pods, dry beans, dry peas and sunflower seed are therefore considered desirable but not essential.
It is noted by EFSA that residue trials on beet leaves, fresh beans with pods, fresh peas without pods, asparagus, beans and peas (dry) were conducted by BASF, the main applicant for the active substance; they were however not yet available to the RMS or EFSA. The RMS also stated that residue trials on apricots, strawberries, Jerusalem artichokes, Brussels sprouts, kale, kohlrabi, lentils, rape seed and sunflower are already planned by BASF and that supplementary trials will soon be planned on cherries, table and wine grapes, dewberries, tomatoes, melons and fresh beans without pods.