Normativa UEMay. 8, 2013
UE: autoridad alimentaria revisa límites máximos de residuos para picolinafen
Picolinafen was included in Annex I to Directive 91/414/EEC on 01 October 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 aforementioned 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 13 August 2009 and, after having considered several comments made by EFSA, the RMS provided on 04 May 2012 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 09 January 2013 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 08 March 2013 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of picolinafen was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.014 mg/kg bw per d and 0.05 mg/kg bw, respectively.
Primary crop metabolism of picolinafen was investigated in wheat following foliar applications, hereby covering the cereal crop group. The relevant residue for both enforcement and risk assessment for cereals was proposed as picolinafen only. Analytical methods for enforcement of the residue definition in foods of plant origin are available with an LOQ of 0.05 mg/kg in dry commodities and straw but an ILV is still required.
Regarding the magnitude of residues in all crops reported by the RMS, GAPs were supported by a sufficient number of supervised residue trials, which allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities. However, data were only sufficient to derive tentative MRLs on cereals because analytical methods for enforcement are not yet fully validated.
Quantifiable residues of picolinafen are not expected in crops 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. Specific processing factors for enforcement of processed commodities are therefore not proposed.
Occurrence of picolinafen residues in rotational crops was already investigated during the peer review. It was concluded that no significant residues of picolinafen are expected in rotational crops. These conclusions also apply to the GAPs of picolinafen supported in the framework of this review.
Based on the uses reported by the RMS, significant intakes were calculated for ruminants. Metabolism in lactating ruminants was sufficiently investigated. The relevant residue definition for enforcement and risk assessment was defined as the sum of picolinafen and 6-(3-trifluoromethylphenoxy)-pyridine-2-carboxylic acid, expressed as picolinafen. A validated analytical method for enforcement of the residue definition is however not available. The available metabolism study also demonstrated that residues are not expected in significant amounts in milk, fat, muscle and liver. Consequently, MRLs in these ruminant commodities can tentatively be set at the default LOQ of 0.01 mg/kg. Nevertheless, as significant residues are expected in kidney, a ruminant feeding study is required while an MRL was tentatively proposed for kidney base on the metabolism study. MRLs are not required for all poultry and pig products because they are not expected to be exposed to significant levels of picolinafen residues.
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. The highest chronic exposure represented 4 % of the ADI (Dutch children) and the highest acute exposure amounted to 2.5 % of the ARfD (milk).
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). 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 (see summary table footnotes for details). In particular, all tentative MRLs still need to be confirmed by the following data:
· an ILV for enforcement of the residue in dry commodities and straw (in process of evaluation for the renewal of the approval of picolinafen under Regulation (EC) No 1107/2009);
· a validated analytical method (with confirmatory method and ILV) for enforcement of the residue in ruminants matrices (in process of evaluation for the renewal of the approval of picolinafen under Regulation (EC) No 1107/2009);
· further investigation on the magnitude of residues in ruminants (ruminant feeding study).
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.