Normativa UEJul. 17, 2013
UE: revisan límites máximos de residuo para Ácido 2-naftiloxiacético
A decision not to include 2-naphthyloxyacetic acid in Annex I to Directive 91/414/EEC entered into force on 16 February 2009. 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 2-naphthyloxyacetic acid is no longer authorised within the European Union and that no import tolerances were notified by the designated rapporteur Member State (Italy), EFSA based its assessment mainly on the conclusions derived by EFSA in the framework of Directive 91/414/EEC.
On 24 April 2013 EFSA issued a draft reasoned opinion that was circulated to Member States’ experts for consultation. No comments were received by 28 June 2013 and the following conclusions are derived.
The toxicological profile of 2-naphthyloxyacetic acid (2-NOA) was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.01 mg/kg bw per d and 0.6 mg/kg bw, respectively. The toxicity of the main two metabolites M1 and M4 could not be assessed during the peer review. Later information from the applicant indicated that M4 was found in rat urine and that the toxicity of M1 and M4 was covered by parent. However, this information could not be confirmed by EFSA.
Considering that the use of 2-NOA 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 2-NOA are not expected to occur in any plant commodity or livestock. Nevertheless, primary crop metabolism of 2-NOA was investigated for foliar application on fruiting vegetables (tomatoes). These data indicate that M1 and M4 are the principal component of the residue in consumable crop parts but, although in lower amounts, measurable levels of parent compound 2-NOA were also identified on the fruit surface. As parent 2-NOA can be used as a tracer compound and can be enforced in most plant commodities, EFSA concludes that parent compound 2-NOA would be the most relevant residue for enforcement against a potential illegal use of 2-NOA. 2-NOA can be enforced in food of plant origin with an LOQ of 0.01 mg/kg in high water content, acidic and dry commodities. For risk assessment calculations, EFSA proposes to consider the sum of 2-naphthyloxyacetic acid, M1 and M4, expressed as parent, because both metabolites are also expected to be present in significant amounts in case of misuse and, in the absence of a more accurate assessment, these metabolites should be considered to have at least the same toxicological burden as the parent compound. A conversion factor of 5 was calculated from the metabolism study, on the basis of results on mature tomato samples (considering entire fruit and surface wash).
No data about the nature of 2-NOA residues in commodities of animal origin were investigated in the framework of Directive 91/414/EEC. Furthermore, there is no evidence that residues of parent 2-naphtyloxyacetic acid can be enforced in food of animal origin.
A risk assessment is in principle not required considering that the use of 2-NOA is no longer authorised within the EU, that no CXLs are available and that no import tolerances have been notified but the default MRL of 0.01 mg/kg for products of plant and animal origin provides a satisfactory level of protection for the European consumer.
Consequently, considering 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 the specific LOQ for plant commodities is necessary. Although this was not adequately demonstrated, available data indicate that the default MRL of 0.01 mg/kg for parent 2-NOA can be achieved in routine enforcement and provides a valid and protective indicator against potential illegal uses.