Normativa UEJul. 3, 2013
UE: revisan límites máximos de residuo para propanil
On 05 April 2013 EFSA issued a draft reasoned opinion that was circulated to Member States’ experts for consultation. No comments were received by 07 June 2013 and the following conclusions are derived.
The toxicological profile of propanil was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.02 mg/kg bw per d and 0.07 mg/kg bw, respectively. It was also concluded that major metabolite 3,4-dichloroaniline (3,4-DCA) had a higher acute toxicity than propanil. Nevertheless, no toxicological reference values could be derived for this metabolite.
Considering that the use of propanil 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 propanil are not expected to occur in any plant commodity or livestock. Nevertheless, primary crop metabolism of propanil was investigated in cereals (rice). These data indicate that parent propanil is extensively metabolised and that metabolite 3,4-DCA is the principal component of the residue in consumable crop parts. Therefore, although parent compound propanil can be enforced in food of plant origin with an LOQ of 0.01 mg/kg in acidic and high water content commodities and an LOQ of 0.02 mg/kg in dry commodities, this compound would not be a good indicator for enforcement against a potential illegal use of propanil. However, enforcement of all compounds containing the 3,4-DCA moiety, free and conjugated, is also not considered to be the most appropriate because 3,4-DCA is a metabolite of other authorised compounds such as linuron and measurable levels of 3,4-DCA would not be specific to the illegal use of propanil. Moreover, there is not sufficient evidence that residues of compounds containing the 3,4-DCA moiety can be enforced in food of plant origin and no toxicological reference values are available for 3,4-DCA. Due to the limited data EFSA is not in a position to conclude on the most appropriate option.
The nature of propanil residues in commodities of animal origin was also investigated in lactating cows and laying hens. These data indicate that parent propanil is extensively metabolised to numerous conjugates of propanil and 3,4-DCA. As propanil was not found in plant commodities, animals will never be exposed to parent compound residues and propanil will not be present in livestock commodities. Therefore, although there are indications that propanil can be enforced in food of animal origin with an LOQ of 0.01 mg/kg in milk, meat, fat, liver, kidney and eggs, parent compound would not be a good indicator for enforcement against a potential illegal use of propanil in livestock commodities. However, enforcement of all compounds containing the 3,4-DCA moiety, free and conjugated, is also not considered to be the most appropriate due to the same considerations as for plant commodities and, also for commodities of animal origin, EFSA is not in a position to conclude on the most appropriate option.
A risk assessment is in principle not required considering that the use of propanil is no longer authorised within the EU, that no CXLs are available and that no import tolerances have been notified but a theoretical exposure calculation was carried out indicating that the LOQ values of 0.02 mg/kg and 0.01 mg/kg for plant and livestock commodities respectively provide a satisfactory level of protection for the European consumers regarding parent propanil. In case of illegal use, the occurrence of metabolites containing the 3,5-DCA moiety can not be excluded, even if parent residues levels remain below the LOQ. However, a calculation for these metabolites could not be carried out as no toxicological reference values were derived for 3,4-DCA.
Consequently the existing EU MRLs established for parent propanil are in principle no longer required. Nevertheless, it is noted that neither parent propanil nor metabolites containing the 3,4-DCA moiety can be considered as satisfactory markers for the enforcement against illegal use of propanil. Also considering that the enforcement against potential illegal uses falls under the remit of risk managers, EFSA is not in a position to recommend to recommend the most adequate enforcement measures. However, if propanil is chosen as residue definition for enforcement, available data indicate that LOQs of 0.02 mg/kg and 0.01 mg/kg for plant and livestock commodities respectively would be sufficiently protective for European consumers. If the sum of all compounds containing the 3,4-DCA moiety, free and conjugated, is chosen as residue definition for enforcement, EFSA recommends to await the review of MRLs for linuron according to Article 12 of Regulation (EC) No 396/2005 in order to set MRLs for the sum of compounds taking into consideration the residues generated by the use of linuron. Risk managers could then enforce against the potential illegal use of propanil without prejudice to 3,4-DCA residues resulting from the legal use of linuron.