Normativa UEJul. 17, 2013
UE: revisan límites máximos de residuo para acetochlor
A decision not to include acetochlor in Annex I to Directive 91/414/EEC entered into force on 31 December 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 acetochlor 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 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 acetochlor was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.0036 mg/kg bw per d and 1.5 mg/kg bw, respectively.
Considering that the use of acetochlor 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 neither uses authorised in third countries, nor derogations of use were notified to the RMS, residues of acetochlor are not expected to occur in any plant commodity. Nevertheless, primary crop metabolism of acetochlor was investigated in cereals. Parent acetochlor is extensively degraded, resulting in a large range of metabolites. No parent acetochlor was found in any crop part. Consequently, although there are indications that acetochlor can be enforced with an LOQ of 0.01 mg/kg in high water content, high oil content, acidic and dry commodities, EFSA considers that parent acetochlor is not the most appropriate indicator for enforcement against potential illegal uses. Another potential indicator for enforcement against potential illegal uses could be the sum of all compounds forming EMA and HEMA on hydrolysis, expressed as acetochlor. EFSA highlights however that EMA and HEMA are not specific to acetochlor. These moieties can also result from the hydrolysis of other chloroacetanilide compounds such as propisochlor and metolachlor. Moreover, although there are indications that this residue can be enforced in food of plant origin with a combined LOQ of 0.04 mg/kg in high water content and dry commodities and a combined LOQ of 0.02 mg/kg in high oil content commodities, the available analytical method includes hydrolytic steps and might be considered too cumbersome for enforcement of a compound that is anyhow no longer authorized for use. A third proposed indicator is t-sulfinyllactic acid, as it is a specific metabolite of acetochlor encountered in different crop parts. However, no validated analytical method is available for this compound. Due to the limitations for each proposal EFSA is not in a position to conclude on the most appropriate risk management option.
Residues of acetochlor are also not expected to occur in livestock and no analytical method is available for animal commodities. However, the metabolism data on ruminants and poultry show that a very low transfer of acetochlor plant residues to commodities of animal origin is expected. Therefore, EFSA considers that a suitable marker for acetochlor residues in commodities of animal origin is not relevant.
A risk assessment is in principle not required considering that the use of acetochlor is no longer authorised in the EU and that no import tolerances have been notified. Nevertheless, either the specific LOQ of 0.04 mg/kg for the sum of all compounds forming EMA and HEMA on hydrolysis, or the default MRL of 0.01 mg/kg, as defined by Regulation (EC) No 396/2005, for parent acetochlor or t-sulfinyllactic acid provide a satisfactory level of protection for the European consumer, noting however that, in case of illegal use, the occurrence of metabolites containing the EMA or HEMA moieties can not be excluded, even if parent residues levels remain below the default MRL.
Based on the above assessment, the existing EU MRLs in plants commodities and products for animal origin, exceeding the value of 0.01 mg/kg are in principle no longer required. Nevertheless, it is noted that several options were considered for the enforcement against illegal use of acetochlor, each of them having its specific disadvantages highlighted above. Also considering that the enforcement against potential illegal uses falls under the remit of risk managers, EFSA is not in a position to recommend the most adequate enforcement measures.