Normativa UEMay. 22, 2013
UE: revisan límites máximos de residuo para ethoxyquin
A decision not to include ethoxyquin in Annex I to Directive 91/414/EEC entered into force on 02 January 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 ethoxyquin is no longer authorised within the European Union (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) and that no import tolerances were notified by the designated rapporteur Member State (Germany), EFSA based its assessment mainly on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the MRL on pears established by the Codex Alimentarius Commission.
On 08 March 2013 EFSA issued a draft reasoned opinion that was circulated to Member States’ experts for consultation. No comments were received by 10 May 2013 and the following conclusions are derived.
The toxicological profile of ethoxyquin was not sufficiently elucidated in the framework of Directive 91/414/EEC. An ADI and an ARfD being established at 0.005 mg/kg bw per d and 0.5 mg/kg bw, respectively, were derived by JMPR but EFSA cannot confirm the validity of these values.
Primary crop metabolism of ethoxyquin was investigated following post harvest application on pears, hereby covering group of fruits and fruiting vegetables. Parent compound was rapidly converted to a dimeric structure, which becomes the main component of the residues 8 weeks after application. However, identification of metabolites was considered insufficient by EFSA. Consequently, no residue definition could be proposed. Although there are indications that parent ethoxyquin can be enforced in food of plant origin with an LOQ of 0.01 mg/kg in acidic commodities and 0.25 mg/kg in high water content commodities, the methods are not fully validated and the enforcement residue definition as derived by JMPR (parent compound) is not deemed appropriate by EFSA. Also for risk assessment purposes, further investigation of the unidentified metabolites and their toxicity would be needed in order to confirm the residue definition derived by JMPR (sum of ethoxyquin, methyl-ethoxyquin, dihydro-ethoxyquin and dehydromethyl ethoxyquin, expressed as ethoxyquin).
A metabolic pathway of ethoxyquin in livestock was not established, but, as no CXLs are set for ethoxyquin on crops that might be fed to livestock, investigation of residues in commodities of animal origin is not considered relevant.
As ethoxyquin is no longer registered in EU and no import tolerances were reported by the RMS, only the CXL on pears was considered in the calculations of the consumer exposure. Chronic and acute consumer exposure resulting from this CXL were calculated, on a tentative basis only, using revision 2 of the EFSA PRIMo and assuming the toxicological reference values and the risk assessment residue definition proposed by the JMPR. The highest chronic exposure represented 67.7 % of the ADI (Danish children) and an exceedance of the ARfD was identified for the existing CXLs in pears (109 % of the ARfD).
Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005. EFSA also does not recommend inclusion of the existing CXL for ethoxyquin in Annex II to Regulation (EC) No 396/2005. Furthermore, considering that EFSA was not able to define an appropriate indicator compound for the pesticide use of ethoxyquin and that the toxicity of ethoxyquin was not adequately addressed, EFSA is not in a position to recommend any enforcement measure against the potential illegal phytosanitary use of ethoxyquin.
It is also highlighted that exposure to ethoxyquin may result from its other uses as a EU approved feed additive (E324, antioxidant) or as a formulant in medicinal and cosmetic products. Risk managers should therefore ensure that any enforcement measure will not conflict with other specific legislations regulating the use of ethoxyquin.