Normativa UEJun. 18, 2012
UE: autoridad alimentaria revisa límites máximos de residuo para amitrole
Amitrole 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 the afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked France, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) The requested information was submitted to EFSA on 28 October 2008 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 December 2011 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 24 February were considered for finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of amitrole was already evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI being established at 0.001 mg/kg bw/d. An ARfD was not deemed necessary.
Primary crop metabolism was investigated for the fruit and fruiting vegetables crop grouping following spray application of amitrole to soil in apples. Apples were also studied in model studies (excised apple sprouts and cell suspension cultures). In the study representative of the proposed uses that was conducted at exaggerated use rates, parent amitrole was not detected in the mature fruits, and the major metabolite was triazolylalanine. This metabolite was also present as plant conjugates and is amongst the metabolite products named triazole derivative metabolites (TDMs). The only significant difference in the metabolism of amitrole in plants and animals (rat metabolism) is the occurrence of triazolylalanine in plants. EFSA concluded that the relevant residue for enforcement and risk assessment is amitrole only. However, as amitrole, similarly to other active substances belonging to the triazole class, is known to produce TDMs, EFSA is of the opinion that the residue definition may require to be revised pending a separate risk assessment for TDMs following a decision on the risk assessment methodology for all substances of the triazole chemical group. Analytical methods for enforcement of this residue definition are available. However primary validation data are not sufficient, and ILV data and confirmatory methods of analysis are not available for these methods and therefore further data are still required.
Regarding the magnitude of residues in primary crops, a sufficient number of supervised residue trials is available for the GAPs reported by the RMS, which allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities and to derive MRLs. These MRLs are currently regarded as tentative pending the data gaps identified on analytical methodology and since for table olives and olives for oil production (a level of 0.05* mg/kg based on residues being found below the LOQ in the trials), storage stability of residues data are not available for high oil content commodities.
As quantifiable residues of amitrole are not expected in the treated crops, there is no need to investigate the effect of industrial and/or household processing. However some limited studies are available, but since the residues in the raw agricultural commodities were less than the LOQ, robust processing factors could not be derived.
Crops evaluated in the framework of this MRL review are not expected to be grown in rotation. Further investigation of residues in rotational crops is therefore not required.
Studies on nature or magnitude of residues in commodities of animal origin are not available, or required. Following the estimation of the dietary burden arising from the authorised uses of amitrole, MRLs for livestock products are not required because livestock is not expected to be exposed to significant levels of amitrole residues.
Chronic consumer exposure resulting from the MRLs derived in the framework of this review was calculated using revision 2 of the EFSA PRIMo. Considering these crops, the highest chronic exposure represented 20.1% of the ADI (German child). 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 amitrole. Additional calculations of the consumer exposure, including these CXLs, were therefore carried out, the highest chronic exposure represented 21.3% of the ADI (German child).
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 are recommended for inclusion in Annex II because they require further consideration by risk managers (see table footnotes for details). In particular, tentative MRLs still need to be confirmed by the following data:
Primary method validation data, ILV data and confirmatory methods for enforcement of residues in all plant commodities;
a residues storage stability study for high oil content commodities to support the periods of storage of olives in the olives SEU trials data;
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.
EFSA emphasizes that the above assessment does not yet take into consideration triazole derivative metabolites (TDMs). Since these metabolites may be generated by several pesticides belonging to the group of triazole fungicides, EFSA recommends that a separate risk assessment should be performed for TDMs as soon as the confirmatory data requested for triazole compounds in the framework of Regulation (EC) No 1107/2009 have been evaluated and a general methodology on the risk assessment of triazole compounds and their triazole derivative metabolites is available.