Normativa UEMay. 8, 2013
UE autoridad alimentaria revisa límites máximos de residuo para 1,3-dicloropropeno
A decision not to include 1,3-dichloropropene in Annex I to Directive 91/414/EEC entered into force on 10 February 2011. 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 1,3-dichloropropene is no longer authorised within the European Union and that no import tolerances were notified by the designated rapporteur Member State (Spain), EFSA based its assessment mainly on the conclusions derived by EFSA in the framework of Directive 91/414/EEC.
On 19 February 2013 EFSA issued a draft reasoned opinion that was circulated to Member States’ experts for consultation. No comments were received by 26 April 2013 and the following conclusions are derived.
The toxicological profile of 1,3-dichloropropene was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.025 mg/kg bw per d and 0.2 mg/kg bw, respectively.
Considering that the use of 1,3-dichloropropene is no longer authorised within the EU (authorisations for emergency situations in plant protection granted in application of Article 53 of Regulation (EC) No 1107/2009 are not considered in the context of this Reasoned Opinion), that no CXLs are available for this active substance and that no uses authorised in third countries were notified to the RMS, residues of 1,3-dichloropropene are not expected to occur in any plant commodity. Nevertheless, primary crop metabolism of 1,3-dichloropropene was investigated for three different crop groups (fruits and fruiting vegetables, root and tuber vegetables, pulses and oilseeds). 1,3-dichloropropene residues are expected to be incorporated into natural plant constituents because naturally occurring plant constituents represented the majority of the radioactive residue in tomatoes, oranges, sugar beets and soybeans. Consequently, parent 1,3-dichloropropene is considered to be the only relevant residue for enforcement against a potential illegal use in plants. Parent 1,3-dichloropropene can be enforced with a LOQ of 0.01 mg/kg in acidic, high oil content and high water content commodities. No confirmatory method is available for the determination in dry commodities.
Residues of 1,3-dichloropropene are also not expected to occur in livestock. Moreover, studies on the metabolism of 1,3-dichloropropene in lactating cow and laying hens demonstrated that negligible residues are present in the edible tissues, eggs and milk. In eggs and hens tissues, parent compound and its cysteine conjugate are the most relevant indicators for enforcement against a potential illegal use on crops. However, no validated analytical methods for enforcement of residues in product of animal origin are available.
A risk assessment is in principle not required considering that the use of 1,3-dichloropropene is no longer authorised in the EU and that no import tolerances have been notified. Nevertheless, 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.
Based on the above assessment, the existing EU MRLs in plants commodities, exceeding the value 0.01 mg/kg are in principle no longer required. Considering however that the enforcement against 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. Available data indicate that the default MRL of 0.01 mg/kg is sufficiently protective and could be enforced in practice, although this was not fully demonstrated in dry commodities.