Normativa UEAbr. 10, 2013
UE: autoridad alimentaria revisa límites máximos de residuo para propoxycarbazone
According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance propoxycarbazone. In order to assess the occurrence of propoxycarbazone residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC 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. No information required by the regulatory framework was found to be missing and no risk to consumers was identified.
© European Food Safety Authority, 2013
Propoxycarbazone was included in Annex I to Directive 91/414/EEC on 01 April 2004, 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 Germany, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 19 December 2008 and, after having considered several comments made by EFSA, the RMS provided on 28 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 and the additional information provided by the RMS, EFSA issued on 20 September 2012 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 30 November 2012 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of propoxycarbazone was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI being established at 0.4 mg/kg bw per d. An ARfD was not deemed necessary.
Primary crop metabolism of propoxycarbazone was investigated following foliar application on spring and winter wheat. Metabolic patterns in the different studies were shown to be similar and the relevant residue for enforcement and risk assessment in cereal crops supported in the framework of this review could be defined as the sum of propoxycarbazone, its salts and 2-hydroxy-propoxycarbazone, expressed as propoxycarbazone. Analytical methods for enforcement of the proposed residue definition are available with a combined LOQ of 0.02 mg/kg in dry and high water content commodities and straw.
Regarding the magnitude of residues in primary crops, a sufficient number of supervised residue trials is available. The GAPs reported by the RMS and the available residue data are considered acceptable to derive MRL proposals as well as risk assessment values for all commodities under evaluation.
Quantifiable residues of propoxycarbazone are not expected in cereal grains and as the chronic exposure does not exceed 10 % of the ADI, there was no need to investigate the effect of industrial and/or household processing.
The potential incorporation of soil residues into succeeding and rotational crops was investigated in wheat, kale and turnips. Available rotational crop studies are considered sufficient to conclude that the residue levels in food will be below 0.01 mg/kg and that low residue levels identified in cereal straw and forage will be without impact on the dietary burden of livestock, provided that propoxycarbazone is applied in compliance with the GAPs reported in Appendix A.
Based on the uses reported by the RMS, dietary burden was calculated for each type of livestock. As all the calculated intakes represented less than 0.1 mg/kg DM, further investigation of residues in livestock is in principle not necessary. Although not required, metabolism in ruminants was investigated. Nevertheless, the available data do not allow EFSA to propose a residue definition in animal commodities. If livestock would be exposed to significant residues of propoxycarbazone due to new uses in the future, data on the nature and magnitude of residues in livestock exposed to the metabolite 2-hydroxy-propoxycarbazone could be required in order to establish appropriate residue definitions and MRLs. In that case, analytical methods for enforcement in accordance with the future residue definitions would also be required. For the time being however further investigation of residues as well as the setting of MRLs in commodities of animal origin is not necessary because, according to uses supported in the framework of this review, significant intake of residues by livestock is not expected.
Chronic consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. The highest chronic exposure represented 0.05 % of ADI (Danish 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 of the reasoned opinion (see summary table). All MRL values listed in the table are sufficiently supported by data and therefore proposed for inclusion in Annex II to the Regulation.