Normativa UEMay. 22, 2013
UE: revisan límites máximos de residuo para asulam
Considering that the use of asulam is no longer authorised within the European Union and that no import tolerances were notified by the designated rapporteur Member State (United Kingdom), EFSA based its assessment mainly on the conclusions derived by EFSA in the framework of Directive 91/414/EEC.
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.
Considering that the use of asulam 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 asulam are not expected to occur in any plant commodity. Nevertheless, primary crop metabolism of asulam was investigated for leafy vegetable (spinach). Parent remains the major residues in leafy crops, but is likely to conjugate into asulam malonyl (also during the storage of samples). Therefore, the most relevant residue for enforcement against a potential illegal use on plant (leafy crops) should be the sum of asulam and asulam malonyl, expressed as asulam. There are indications that asulam and asulam malonyl can be enforced with an LOQ of 0.05 mg/kg for each compound in plant commodities.
Residues of asulam are also not expected to occur in livestock. However, studies on the metabolism of asulam in lactating goat and laying hens indicated that parent asulam was a major component of the residue in most commodities. Another component, identified as acetyl sulphanilamide, would also be relevant if asulam would still be authorised and exposure to livestock was to be expected. Considering the active substance is no longer authorised, asulam is considered to be a sufficient indicator for enforcement against a potential illegal use. However, no validated analytical methods for enforcement of this residue in products of animal origin are available.
A risk assessment is in principle not required considering that the use of asulam is no longer authorised in the EU and that no import tolerances have been notified. Nevertheless, the reported LOQ value for plant commodities and the default MRL of 0.01 mg/kg for commodities of animal origin, as defined by Regulation (EC) No 396/2005, provide a satisfactory level of protection for the European consumer.
It is noted that the potential risk to consumer resulting from the occurrence of metabolite sulphanilamide was not assessed. No toxicological profile was available for this compound. Considering however that the use of asulam is no longer authorised within the EU, exposure to this metabolite could only occur in the exceptional case that asulam is used illegally. Also considering that this metabolite is only expected in rotational crops and that enforcement against illegal uses should preferably be carried out on the basis of the raw primary crop commodity, further consideration of this metabolite is no longer required.
Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005 but the existing EU MRLs in plants commodities, exceeding the value of 0.1 mg/kg (sum of LOQs for asulam and asulam malonyl) are in principle no longer required. Also 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 a specific LOQ is necessary. Available data indicate that 0.1 mg/kg (sum of LOQs for asulam and asulam malonyl) is sufficiently protective and could be enforced in practice, although this was not fully demonstrated.