Normativa UEJul. 31, 2014
UE: revisan límite máximo de residuos para desmedipham
Desmedipham was included in Annex I to Directive 91/414/EEC on 01 March 2005, 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 Finland, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 25 January 2010 and, after having considered several comments made by EFSA, the RMS provided on 06 September 2011 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 17 February 2014 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 18 April 2014 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of desmedipham was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.03 mg/kg bw per d and 0.1 mg/kg bw, respectively.
Primary crop metabolism of desmedipham was investigated following foliar application in sugar beet, hereby covering the root and tuber vegetables crop group. However, these studies are not fully reliable and new metabolism data are necessary in order to elucidate the metabolism of desmedipham in root and tuber vegetables. Moreover, the use of desmedipham by foliar application is also authorised on beet leaves, which do not belong to the aforementioned group. In order to cover all crops supported in the framework of this review, an additional metabolism study following foliar application on crops representing leafy vegetables is also required. According to the RMS, a new sugar beet metabolism study will be submitted in the framework of the renewal of the approval of the active substance under Regulation (EC) No 1107/2009 (January 2015). Meanwhile, a tentative residue definition for enforcement and risk assessment in plant commodities is defined as desmedipham only. Validated analytical methods for enforcement of the proposed residue definition are available with an LOQ of 0.01 mg/kg in commodities with high water content.
Regarding the magnitude of residues in primary crops, the available residues data were considered sufficient to derive MRL proposals as well as risk assessment values for sugar beet (root), beetroot and beet leaves (chard). However, as data on plants metabolism are insufficient, only tentative MRLs can be derived. Tentative MRLs were derived for feed crops (fodder beet (root and tops) and sugar beet (tops)) in view of the future need to set MRLs in feed items.
The nature of residues during processing was not investigated. Nevertheless, as quantifiable residues of desmedipham are not expected in the treated crops and the chronic exposure does not exceed 10 % of the ADI, there is no need to investigate the effect of industrial and/or household processing. If robust processing factors were to be required by risk managers, in particular for enforcement purposes, processing studies would be needed.
Occurrence of desmedipham residues in rotational crops was investigated during the peer review. It can be concluded that significant residues in rotational crops are not expected (provided that desmedipham is applied in compliance with the authorised European uses) and that a specific residue definition for rotational crops is not necessary.
Based on the uses reported by the RMS, significant intakes were calculated for dairy ruminants, meat ruminants and pigs. Metabolism studies in lactating ruminants suffered of many deficiencies. Nevertheless, the presence of many metabolites indicates extensive metabolism of parent desmedipham, involving hydrolysis and conjugation. Based on the extraction profiles, it can be assumed that metabolism fate of desmedipham in ruminants is similar to the one in rat and findings in ruminants can be extrapolated to pigs. As, according to the available metabolism studies, residue levels in ruminant and pig commodities are expected to be negligible, a default residue definition for enforcement and risk assessment in ruminant and pig matrices can be proposed as parent desmedipham only. Validated analytical methods for enforcement of the proposed residue definition are available with an LOQ of 0.05 mg/kg but a confirmatory method is still required. Furthermore, MRLs and risk assessment values for the relevant commodities in ruminants and pigs can be established at the LOQ level. These MRLs can only be tentatively derived but, considering the low residue expected in animal tissue, for the time being new ruminant metabolism studies are desirable only. Nevertheless, EFSA highlights that, if in the future new uses leading to residues above the LOQ in animal commodities will be granted, the proposed formal residue definition will need to be reconsidered and more data on animal metabolism will be required. For poultry matrices, neither a residue definition, nor MRLs or risk assessment values are necessary, as there is no significant exposure of poultry to desmedipham residues.
Chronic and acute consumer exposure resulting from the MRLs derived in the framework of this review was calculated using revision 2 of the EFSA PRIMo. The highest chronic exposure represented 8.2 % of the ADI (British children) and the highest acute exposure amounted to 6.2 % of the ARfD (milk and milk products).
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 summary table). None of the MRL values listed in the table are recommended for inclusion in Annex II to the Regulation as they are not sufficiently supported by data; they therefore require further consideration by risk managers (see summary table footnotes for details). In particular, certain tentative MRLs or existing EU MRLs still need to be confirmed by the following data:
a confirmatory method for the determination of desmedipham in fat, meat, liver and kidney (a new method will be provided in the framework of the AIR – January 2015);
a new representative study investigating primary crop metabolism in root and tuber vegetables (a new study will be provided in the framework of the AIR – January 2015);
a representative study investigating primary crop metabolism in leafy vegetables.
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 they 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:
at least two trials in each zone complying with the northern and southern outdoor GAPs on sugar beet root, fodder beet root and beetroot, where residues are analysed according to the enforcement LOQ (0.01 mg/kg) (new trials will be provided in the framework of the AIR – January 2015);
at least two trials in each zone complying with the northern and southern outdoor GAPs on sugar beet tops, fodder beet tops and beet leaves (chard), where residues are analysed according to the enforcement LOQ (0.01 mg/kg) (new trials will be provided in the framework of the AIR – January 2015);
the missing information on the storage conditions of the samples from the concerned residue trials (this information will be provided in the framework of the AIR – January 2015);
new appropriate ruminant metabolism studies.