Normativa UEAbr. 29, 2013
UE: revisan límites máximos de residuo para el pesticida bifenox
In order to assess the occurrence of bifenox residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.
European Food Safety Authority, 2013
Bifenox was included in Annex I to Directive 91/414/EEC on 01 January 2009, which is after the entry into force of Regulation (EC) No 396/2005 on 02 September 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 afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Belgium, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The requested information was submitted to EFSA on 29 March 2010 and, after having considered several comments made by EFSA and the confirmatory data required in the framework of Directive 91/414/EEC (evaluation finalised in January 2012), the RMS provided on 19 March 2012 a revised PROFile and evaluation report.
Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the additional information provided by the RMS, EFSA issued on 12 December 2012 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 15 February 2013 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of bifenox was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at of 0.3 mg/kg bw per d and 0.5 mg/kg bw, respectively.
Primary crop metabolism of bifenox was investigated following early and late post-emergence application in wheat, barley and oil seed rape, hereby covering two different crop groups. Metabolic patterns in the different studies were shown to be similar. The relevant residue for enforcement and risk assessment in cereals and grass was defined as bifenox. With regard to pulses and oilseeds, the same residue definition was derived on a tentative basis as confirmation that bifenox acid will not occur in practice is still required. A validated analytical method for enforcement of the residue definition in foods of plant origin is available with an LOQ of 0.01 mg/kg in high water content, high oil content, dry and acidic commodities.
Regarding the magnitude of residues, the available residues data were considered sufficient to derive MRL proposals as well as risk assessment values for cereals. For rape seed and sunflower seed however, derived MRLs are only tentative in the absence of additional data on the possible occurrence of bifenox acid. Concerning grass, a tentative MRL was derived based on cereal forage data in order to improve as much as possible the estimation of the dietary burden calculation for livestock.
As residues of bifenox exceeding 0.1 mg/kg are not expected in the treated crops (for human consumption), and since the chronic exposure did not exceed 10% of the ADI, there was no need to investigate the effect of industrial and/or household processing.
Occurrence of bifenox residues in rotational crops was also investigated. It was concluded that no specific residue definition was needed ant that significant residues in rotational crops are not expected.
Based on the reported uses reported, significant intakes were calculated for ruminants and pigs. Metabolism in lactating ruminants was not sufficiently investigated because the available study does not cover the estimated exposures of ruminants; however, the study indicated that the presence of significant residues (mainly aminobifenox) is highly expected in livestock commodities. Therefore, it was concluded that a representative metabolism study on ruminants is still required and that the residue definition in commodities of animal origin should be reconsidered when such information is available. Meanwhile, EFSA was not able to conclude on a residue definition for enforcement and risk assessment in products of animal origin. Consequently, neither MRLs nor risk assessment values can be derived for the relevant commodities in ruminants and pigs. MRLs for poultry products are not required because poultry are normally not expected to be exposed to significant levels of bifenox residues.
Chronic and acute consumer exposure resulting from the authorisations reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. For commodities of animal origin where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. The highest chronic exposure represented 0.6 % of the ADI (Dutch child), and the highest acute exposure amounted to 1.2 % of the ARfD (milk).
Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005. MRL recommendations were derived in compliance with the decision tree reported in Appendix D of this reasoned opinion (see summary table). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see summary table footnotes for details). In particular, some tentative MRLs or existing EU MRLs need to be confirmed by submission of the following data:
· additional residue trials in oilseeds also demonstrating that residues of bifenox acid will not occur in practice (i.e. at least <0.01 mg/kg);
· 4 residues trials supporting the northern outdoor GAP on grass;
· an additional metabolism study covering the exposure of dairy and meat ruminant (also considering the possible impact of the additional residue trials on grass);
· an additional feeding study covering the exposure of dairy and meat ruminant (also considering the possible impact of the additional residue trials on grass) and with analysis of relevant residues (at least parent bifenox and aminobifenox, also depending on the outcome of the metabolism study).
If the above reported data gap is not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level.