Normativa UEAbr. 29, 2013
UE: revisan límites máximos de residuo para propamocarb
In order to assess the occurrence of propamocarb residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the 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. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.
European Food Safety Authority, 2013
Propamocarb was included in Annex I to Directive 91/414/EEC on 01 October 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 the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Ireland, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 20 April 2010 and, after having considered several comments made by EFSA, the RMS provided on 12 June 2012 a revised PROFile as well as an evaluation Report.
Based on the conclusions derived by EFSA 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 17 October 2012 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 21 December 2012 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of propamocarb was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.244 mg/kg bw per d and 0.84 mg/kg bw, respectively.
Primary crop metabolism of propamocarb was investigated in three different crop groups following foliar or soil applications. Based on these studies, EFSA proposes to define the residue for enforcement and risk assessment in all plant commodities as the sum of propamocarb and its salts, expressed as propamocarb. Validated analytical methods for enforcement of this residue definition are available with an LOQ of 0.01 mg/kg in high water content commodities.
Regarding the magnitude of residues in primary crops, at least one GAP is fully supported by data for most of the crops reported and the available residue data are considered acceptable to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for potatoes, peppers, cauliflower, salad plants (except lettuce) and fresh herbs where only tentative MRLs can be derived.
The nature of residues of propamocarb in processed commodities was not investigated. Studies investigating the magnitude of residues in several processed products of tomatoes and head cabbage, and for cooked spinach are available, which allowed EFSA to derive processing factors. Pending further investigation on the nature of the residues in processed commodities however, processing factors are indicative only and it cannot be excluded that additional processing studies may be required in order to derive robust processing factors for enforcement purposes.
The potential incorporation of soil residues into succeeding and rotational crops was investigated in lettuce, radish and wheat during the peer review. This study showed comparable metabolic patterns in primary and succeeding crops. Additional field trials also demonstrated that significant residues of parent propamocarb in rotational crops are not expected, provided that propamocarb is applied according to the GAPs supported in the framework of this review.
Based on the uses reported by the RMS, significant intakes were calculated for ruminants, poultry and pigs. Metabolism in lactating ruminants and poultry was sufficiently investigated and findings in ruminants can be extrapolated to pigs. The relevant residue definition for enforcement was defined as N-oxide propamocarb in milk, pig and ruminants tissues and as N-desmethyl propamocarb in poultry products. For risk assessment, the residue is defined in milk, pig and ruminant tissues as the sum of propamocarb, N-oxide propamocarb, oxazolidine-2-one propamocarb and 2-hydroxypropamocarb expressed as propamocarb; for poultry tissues, the residue is defined as the sum of propamocarb and N-desmethyl propamocarb, expressed as propamocarb. Fully validated analytical methods for enforcement of both residue definitions are not available and therefore still required.
The RMS also reported a livestock feeding study on lactating cows which was underdosed; no reliable conclusion can be drawn on the magnitude of residues in ruminants and pigs. A representative feeding study for ruminants is therefore required and tentative MRLs and risk assessment values were derived from the available metabolism study on cows. Regarding poultry, a feeding study in hens demonstrated that significant residues of propamocarb in edible matrices of poultry are expected but separate results for propamocarb and N-desmethyl propamocarb are still required; tentative MRLs and risk assessment values were derived.
Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. For spinach, lettuce and leek, an exceedance of the ARfD was identified representing 121, 119 and 105 % of the ARfD, respectively. Considering fall-back MRLs for spinach and for lettuce and excluding leek (no fall-back MRL available), the highest chronic exposure represented 2.9 % of the ADI (WHO Cluster Diet B) and the highest acute exposure amounted to 95 % of the ARfD (kale).
Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for propamocarb. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out and an exceedance of the ARfD was identified for the existing CXL in lettuce (275 %). Excluding this CXL from the calculation, the highest chronic exposure represented 4.3 % of the ADI (French toddlers) and the highest acute exposure amounted to 95 % of the ARfD (kale).
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 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, some tentative MRLs need to be confirmed by the following data:
· a fully validated analytical method, with its ILV and a confirmatory method, for enforcement of N-oxide propamocarb in milk, pig and ruminant tissues;
· a fully validated analytical method, with its ILV and a confirmatory method, for enforcement of N-desmethyl propamocarb in poultry products;
· 4 additional residue trials supporting the indoor GAP on cauliflower;
· 8 residue trials on lettuce (open leaves varieties) supporting the northern outdoor GAP on lamb’s lettuce, scarole and rocket;
· 8 residue trials on lettuce (open leaves varieties) supporting the southern outdoor GAP and 8 residue trials on lettuce (open leaves varieties) supporting the indoor GAP on salad plants (except lettuce);
· trials on fresh herbs or on any crop allowing extrapolation to fresh herbs supporting the indoor GAP;
· separate results for propamocarb and N-desmethyl propamocarb in the hen feeding study;
· a representative feeding study on ruminants supported by storage stability data.
Additionally, some of the MRLs derived 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 MRLs derived but which might have an impact on national authorisations:
· 4 additional residue trials supporting the southern outdoor GAP on potato;
· 8 residue trials supporting the southern outdoor GAP and 8 residue trials supporting the indoor GAP on pepper;
· 4 residue trials supporting the southern outdoor GAP on cucumber;
· 4 residue trials supporting the indoor GAP on gherkin;
· 4 residue trials supporting the northern outdoor GAP and 4 residue trials supporting the southern outdoor GAP on Chinese cabbage;
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. It is also highlighted that an exceedance of the ARfD was identified for the GAPs authorised on spinach and lettuce in the southern outdoor area and on leek in the northern outdoor area. Therefore, MSs concerned are in any case, regardless of the data gaps listed above, recommended to withdraw or modify those authorisations at national level. Moreover, as the indoor GAP reported by the Netherlands for lettuce may lead to an exceedance of the proposed MRL (based on the supported indoor GAP), the Netherlands are strongly recommended to reconsider their indoor GAPs as well in order not to have exceedances of the proposed MRL.
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. The following data are therefore considered desirable but not essential:
· residues trials supporting the indoor GAP on fresh beans with pods carried out with analytical methods achieving a LOQ of 0.01 mg/kg;
· a hydrolysis study investigating the effect of processing on the nature of the residues.