Normativa UEMay. 4, 2012
UE: autoridad alimentaria revisa límites máximos de residuo para pyridate (2)
Pyridate was included in Annex I to Directive 91/414/EEC on 01 January 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(2) of afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Austria, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 07 October 2008 and, after having considered several comments made by EFSA, the RMS provided on 23 October 2009 a revised PROFile.
Based on the conclusions derived in the framework of Directive 91/414/EEC and the additional information provided by the RMS, EFSA issued on 29 November 2011 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 10 February 2012 were considered for finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of pyridate was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.036 mg/kg bw/d. An ARfD was not deemed necessary for this active substance.
Metabolism of pyridate was investigated in three different crop groups following foliar application. Metabolic patterns in the different studies were shown to be similar and the relevant residue for enforcement and risk assessment could be defined as the sum of pyridate, its hydrolysis product 6-chloro-4-hydroxy-3-phenylpyridazin and hydrolysable conjugates of 6-chloro-4-hydroxy-3-phenylpyridazin, expressed as pyridate. A validated analytical method for enforcement of this residue definition in food of plant origin (including difficult commodities such as herbal infusions and spices) is not available and is required.
Regarding the magnitude of residues in all crops reported by the RMS, a sufficient number of supervised residues 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 and to derive tentative MRLs. For globe artichokes, barley grain, rice grain and wheat grain, no residues trials were available. EFSA was therefore not able to derive MRL proposals and risk assessment values and further residues trials are required. Moreover, as validated analytical methods are not available, all proposed MRLs are considered tentative. In the absence of validated LOQ, the existing LOQ of 0.05* mg/kg, as established by Regulation (EC) No 396/2005, is proposed for MRL setting in the plant commodities under assessment.
As residues of pyridate are in most cases below 0.1 mg/kg and contribution of these residues to chronic consumer exposure is generally low, investigating the effect of industrial and/or household processing was not considered necessary. Studies investigating the magnitude of residues in some processed products were submitted but were not appropriate for derive processing factors for enforcement purposes. With regard to the risk assessment, 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.
Occurrence of pyridate residues in rotational crops was also investigated and it was concluded that metabolic patterns in primary and succeeding crops are similar and that significant residues in rotational crops are not expected. These conclusions apply to the GAPs of pyridate supported in the framework of this review.
Based on the uses reported by the RMS, significant intakes were calculated for ruminants, pigs and laying hens. Metabolism in lactating ruminants was sufficiently investigated and findings can be extrapolated to pigs as well. The relevant residue definition for both enforcement and risk assessment in pigs, ruminants and poultry was therefore defined as sum of pyridate, its hydrolysis product 6-chloro-4-hydroxy-3-phenylpyridazin and hydrolysable conjugates of 6-chloro-4-hydroxy-3-phenylpyridazin, expressed as pyridate. Available studies also demonstrated that residues of pyridate are not expected in significant amounts and MRLs can be set at the LOQ, except in livers and kidneys from both ruminants and pigs. However, all the MRLs derived are tentative considering the data gaps regarding the storage stability and the analytical method. Based on the available methods (even if not adequate), a tentative LOQ of 0.05 mg/kg is derived.
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 5.7 % of the ADI (Dutch children). Acute exposure calculations were not carried out because an ARfD was not deemed necessary for this active substance.
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). None of the MRL values listed in the table is sufficiently supported by data and further consideration by risk managers is required (see table footnotes for details). In particular, all tentative MRLs and existing EU MRLs still need to be confirmed by the following data:
• 4 residue trials supporting the northern outdoor GAP on globe artichokes;
• 8 residue trials supporting the southern outdoor GAPs on barley, rice and wheat (8 trials each);
• a validated analytical method for enforcement of the proposed residue definition in food of plant origin;
• a validated analytical method for enforcement of the proposed residue definition in animal commodities;
• a storage stability study on products of animal origin;
• storage conditions of the feeding studies samples.
It is highlighted that some of the MRLs derived result from a GAP in one climatic zone only, while other GAPs reported by the RMS were also not fully supported by data. EFSA therefore identified the following data gaps which are not expected to impact on the validity of the tentative MRLs derived but which might have an impact on national authorisations:
• 8 residue trials supporting the southern outdoor GAP on cauliflower and broccoli (4 on cauliflower, 4 on broccoli);
• 4 residue trials supporting the southern outdoor GAP on head cabbage;
• 4 residue trials supporting the southern outdoor GAP on kale;
• 8 residue trials on rape seed supporting the southern outdoor GAP on rape seed and poppy seed;
• 8 residue trials supporting the southern outdoor GAP on maize forage;
• 8 residue trials supporting the southern outdoor GAP on rape forage;
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. The following data are therefore considered desirable but not essential:
• European residue trials supporting the northern outdoor and indoor use on asparagus.