Normativa UEAbr. 23, 2012
UE: autoridad alimentaria revisa límites máximos de residuos para butralin
A decision not to include butralin in Annex I to Directive 91/414/EEC entered into force on 18 November 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(1) of Regulation (EC) No 396/2005. Considering that the use of butralin is no longer authorised within the European Union and that no import tolerances were notified by the designated rapporteur Member State (RMS), EFSA based its assessment mainly on the conclusions derived by France in the framework of Directive 91/414/EEC.
On 29 November 2011 EFSA issued a draft reasoned opinion that was circulated to Member States’ 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 butralin was evaluated by France in the framework of Directive 91/414/EEC. Based on the available information, France proposed an ADI of 0.003 mg/kg bw/d and an ARfD of 0.003 mg/kg bw. EFSA emphasizes that these toxicological reference values have never been peer reviewed, neither by Member States, nor by EFSA.
Considering that the use of butralin is no longer authorised within the EU, that no CXLs are available for this active substance and that no uses authorised in third countries were notified to the RMS, residues of butralin are not expected to occur in any plant commodity or livestock. Nevertheless, primary crop metabolism of butralin has been investigated in tobacco. Butralin was found to be the principal component of the residue in fresh and cured leaves. Consequently, parent butralin is considered to be the only relevant residue for enforcement of a potential illegal use. There are indications that this residue may be enforced with a LOQ of 0.01 mg/kg in green tobacco and grass (high water commodities) and 0.1 mg/kg in other commodities of plant origin.
The nature of butralin residues in commodities of animal origin was also investigated in the lactating goats. Despite a high dosing rate, negligible residues were present in the edible tissues and milk and it can be concluded that butralin would be by default the only marker for enforcement of a potential illegal use. No validated analytical methods for enforcement of residues in product of animal origin are available (see also section 1).
A risk assessment is in principle not required considering that the use is no longer authorised in the EU and that no import tolerances have been notified but, using the ADI and ARfD proposed by the RMS, the default MRL of 0.01 mg/kg, as defined by Regulation (EC) No 396/2005, provides a satisfactory level of protection for the European consumer. Exceedances of both the ADI and ARfD were identified on the basis of the LOQ of 0.1 mg/kg.
Considering that the enforcement of potential illegal uses falls under the remit of risk managers, EFSA is not in a position to recommend whether the default MRL of 0.01 mg/kg, as defined by Regulation (EC) No 396/2005, should apply or whether the setting of a specific LOQ is necessary. However, the LOQ of 0.1 mg/kg is not expected to be sufficiently protective for European consumers. The default MRL of 0.01 mg/kg is sufficiently protective and might be enforced for plant commodities, although this was only demonstrated for green tobacco and grass (high water commodities).