Normativa UEAgo. 7, 2012
UE: autoridad alimentaria revisa límites máximos de residuo para bromoxynil
According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance bromoxynil. In order to assess the occurrence of bromoxynil 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 one MRL proposal derived by EFSA still requires further consideration by risk managers.
© European Food Safety Authority, 2012
Bromoxynil was included in Annex I to Directive 91/414/EEC on 01 March 2005, which is before 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(2) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked France, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 03 November 2008 and, after having considered several comments made by EFSA, the RMS provided on 20 November 2009 a revised PROFile.
Based on the conclusions derived in the framework of Directive 91/414/EEC and the additional information provided by the RMS, EFSA issued on 28 February 2012 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 04 May 2012 were considered for finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of bromoxynil was already evaluated in the framework of Directive 91/414/EEC. The ADI and the ARfD were established at 0.01 mg/kg bw per d and 0.04 mg/kg bw respectively.
Primary crop metabolism of bromoxynil was investigated for foliar application on cereals (wheat and maize) and pulses and oilseeds (cotton and alfalfa). Alfalfa was considered sufficient to cover a third crop group (it is normally in this case considered to be more representative for the ‘leafy vegetables’ group) and therefore it was possible to propose a general residue definition for all plant commodities. The relevant residue for enforcement and risk assessment is defined as bromoxynil phenol. A validated analytical method for enforcement of this residue definition is available, with an LOQ of 0.01 mg/kg in high water and high fat content, acidic and dry commodities but a validated analytical method is still required for enforcement of residues in hops. Considering that the use of bromoxynil on genetically modified crops (bromoxynil resistant) is currently not authorized within Europe, EFSA highlights that the present assessment only relates to the use of bromoxynil on conventional crops and inclusion of 3,5-dibromo-4-hydroxybenzoic acid in the residue definition is in principle not required. However, if risk managers would also have the intention to enforce the possible illegal use of bromoxynil in such crops it would be necessary to include this metabolite in the residue definition and modify the analytical method.
Regarding the magnitude of residues in primary crops, a sufficient number of supervised residue trials is available for most of the GAPs reported by the RMS, which allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities and to derive appropriate MRLs. It is noted that for onions, leek, small grain cereals (southern use only) and maize grain (northern use only) insufficient residues trials are available however, in this case, this is considered acceptable because all results were below the LOQ.
As significant residues of bromoxynil are not expected in the treated crops there is no need to investigate the effect of industrial and/or household processing. In addition, the chronic exposure does not exceed 10 % of the ADI.
All crops under consideration, except permanent crops (hops), may be grown in rotation. Based on soil degradation studies evaluated in the framework of the peer review the DT90 value of bromoxynil is expected to be lower than 27 days which is far below the trigger value of 100 days.
The soil metabolites 3,5-dibromo-4-hydroxy-benzamide and 3,5-dibromo-4-hydroxybenzoic acid have maximum DT90 values of 18 days and <2 days, respectively (assuming single first order kinetics, as reported). Further investigation of residues in rotational crops is therefore not required and relevant residues in rotational crops are not expected.
Based on the uses reported by the RMS, significant intakes were calculated for ruminants and pigs. Metabolism in lactating ruminants was sufficiently investigated and findings can be extrapolated to pigs as well. The relevant residue definition for enforcement and risk assessment was defined as the bromoxynil phenol. A validated analytical method for enforcement of this residue definition is available, with an LOQ of 0.05 mg/kg in meat, fat, liver, kidney and eggs and an LOQ of 0.01 mg/kg in milk. In addition, the RMS reported a livestock feeding study on lactating cows, which allowed EFSA to tentatively estimate the magnitude of residues in ruminant and pig products and to derive tentative MRLs in these commodities. MRLs for poultry products are not required because poultry is not expected to be exposed to significant levels of bromoxynil residues.
Chronic and acute consumer exposure resulting from the uses supported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. The calculated exposures were compared with the toxicological reference values derived for bromoxynil; the highest chronic exposure was calculated for WHO Cluster Diet B, representing 7.5 % of the ADI, and the highest acute exposure was calculated for sweet corn, representing 7.3 % of the ARfD.
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 (see summary table). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and 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, one tentative MRL still needs to be confirmed by the following data:
• an analytical method for enforcement of residues in hops (including ILV and confirmatory method.
It is highlighted that some of the MRLs derived result from a GAP in one climatic zone only, while other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the following data gap which is not expected to impact on the validity of the MRLs derived but which might have an impact on national authorisations:
• 6 additional trials on maize forage complying with the southern outdoor GAP;
If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level.
Minor deficiencies were also identified in the assessment but these deficiencies are not expected to impact either on the validity of the MRLs derived or on the national authorisations. The following data are therefore considered desirable but not essential:
• residues trials on small grain cereals and sorghum carried out with the current enforcement LOQ of 0.01 mg/kg;
• a ruminant livestock feeding study representative for the exposure to bromoxynil phenol.