Normativa UEAbr. 24, 2013
UE: autoridad alimentaria modifica límites máximos de residuo para tricyclazole en arroz
In accordance with Article 6 of Regulation (EC) No 396/2005 , Italy, herewith referred to as the evaluating Member State (EMS), received an application from Dow AgroScience to set an import tolerance for tricyclazole in rice to accommodate the authorized use in Brazil. Tricyclazole is a non-included active substance and no EU uses are currently authorized. Thus, the existing EU MRL of 1 mg/kg in rice should be lowered to the LOQ. The applicant requested to maintain the existing EU MRL to allow the import of rice treated with tricyclazole from third countries. The EMS confirmed that the MRL should be set provisionally at the level 1 mg/kg to accommodate the Brazilian GAP. The EMS drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 3 April 2012.
On 17 April 2012 some data requirements were identified, which prevented EFSA to conclude on the legal validity of the submitted application. An updated evaluation report was submitted by the EMS on 24 September 2012. On 15 February 2013 the draft of the reasoned opinion was submitted for the Member State consultation. By the end of the commenting period, the comments were received from France and Italy and were further considered by EFSA for the finalisation of this reasoned opinion.
EFSA bases its assessment on the updated evaluation report submitted by the EMS Italy, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC by the rapporteur Member State France and the Commission Review Report on tricyclazole.
The toxicological profile of tricyclazole was assessed by the RMS France in the framework of the peer review. The available data were insufficient to derive toxicological reference values. Because of these data gaps a decision on non-inclusion of tricyclazole in Annex I of Directive 91/414/EEC was taken. In a meanwhile, new toxicological studies have become available which were assessed by the EMS Italy in the framework of the current application. The EMS proposed an ADI of 0.05 mg/kg bw per day and an ARfD of 0.05 mg/kg bw, based on the rat developmental toxicity study. EFSA is of the opinion that on the basis of the currently available studies the setting of toxicological reference values is not appropriate since the genotoxic potential could not be totally disregarded. In addition, EFSA identified uncertainties regarding the carcinogenic potential of tricyclazole in rats where liver tumours were observed from the lowest dose level tested (4.2 mg/kg bw per day). In case the genotoxic potential of tricyclazole can be disproved, EFSA would propose to set the ADI at the level of 0.0042 mg/kg bw per day on the basis of the LOAEL of 4.2 mg/kg bw per day with an uncertainty factor (UF) of 1000; regarding the ARfD, EFSA would agree with the ARfD proposed by the EMS (0.05 mg/kg bw based on the NOAEL of 5 mg/kg bw per day observed in the rat developmental toxicity study (UF of 100)).
The metabolism of tricyclazole was evaluated in rice in the framework of the peer review using tricyclazole radiolabelled in the phenyl ring of the molecule. The compounds identified in rice grain, hulls and straw were parent tricyclazole and its alcohol metabolite. The major part of the radioactivity in grain was associated with glucose. The RMS provisionally proposed a residue definition for the risk assessment and enforcement as “tricyclazole and its alcohol metabolite”. The enforcement residue definition in Regulation (EC) No 396/2005 is set as parent tricyclazole only. Taking into account the fact that the metabolism study labelled in the phenyl ring provided evidence of an extensive metabolism in rice, EFSA is of the opinion that an additional metabolism study in which tricyclazole is labelled in a second position of the molecule is indispensable to elucidate the metabolic behaviour in rice. EFSA concludes that the available rice metabolism studies are not sufficient to derive residue definitions for enforcement and risk assessment purposes.
Adequate analytical enforcement methods are available to control the residues of tricyclazole and tricyclazole alcohol metabolite in rice.
The submitted residue trials data were found to be insufficient to derive an MRL proposal which accommodates the use of tricyclazole on rice in Brazil because the number of trials was not in line with the data requirements and because lacking information on the analytical method used and the storage period of samples prior to analysis does not allow to conclude on the validity of the residue trials.
The effect of processing on the nature of tricyclazole was investigated in a hydrolysis study. The results indicate that tricyclazole is stable under conditions representative for pasteurisation, boiling and sterilisation. Processing studies with rice demonstrated that the magnitude of tricyclazole residues is reduced in husked rice, polished rice and in rice bran. An increased residue concentration is only expected in husks.
The residues of tricyclazole in rotational crops are of no relevance for the import tolerance application.
Since rice and its by-products are not normally fed to livestock according to EU livestock diet, the nature and magnitude of tricyclazole residues in livestock was not assessed in the framework of this application.
EFSA was not able to perform the consumer risk assessment for tricyclazole as the available data did not allow to conclude on the following issues:
· residue definition for risk assessment
· mean residue concentration according to risk assessment residue definition derived from sufficient number of valid residue trials reflecting the critical GAP
· toxicological reference values
EFSA concludes that the import tolerance request for tricyclazole in rice is not sufficiently supported by data which would justify maintaining the existing EU MRL of 1 mg/kg in rice.