Normativa UEJul. 13, 2012
UE: autoridad alimentaria revisa límite máximo de residuo para bentazone
Bentazone was included in Annex I to Directive 91/414/EEC on 01 August 2001, 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 afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Germany, 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 20 October 2008 and, after having considered several comments made by EFSA, the RMS provided on 27 October 2009 a revised PROFile.
Based on the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS, EFSA issued on 23 January 2012 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 30 March 2012 were considered for finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of bentazone was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.1 mg/kg bw/d and an ARfD of 0.25 mg/kg bw.
Primary crop metabolism of bentazone was investigated following foliar application on root and tuber vegetables (potatoes), pulses and oilseeds (green beans, soya beans) and cereals (maize, rice). Metabolic patterns in the different studies were shown to be similar and the relevant residue for enforcement and risk assessment in all plant commodities could be defined as the sum of bentazone and the conjugates of metabolites 6-hydroxy bentazone and 8-hydroxy bentazone, expressed as bentazone. Metabolism studies showed that 8-hydroxy bentazone is not found in most crops and might be disregarded from this residue definition, provided sufficiently detailed residue data were available to EFSA. A validated analytical method for enforcement of the residue definition is also available, with a combined LOQ of 0.03 mg/kg in high water content, high oil content, acidic and dry commodities. A validated analytical method in herbal infusions is not available and is therefore required.
Regarding the magnitude of residues in all crops reported by the RMS, a sufficient number of supervised residue trials is available for some 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, except for potato, leeks, maize and herbal infusions where data were sufficient to derive a tentative MRL only. For spring onions, cucumber, poppy seed, soya bean, rice, alfalfa and clover, no residue trials were available. EFSA was therefore not able to derive MRL proposals for the above mentioned crops and further residue trials are required.
The effect of processing on the nature of bentazone was not investigated. Although quantifiable residues of bentazone are expected in several crops which can be processed, such studies are currently not necessary, as the chronic exposure is far below the ADI. Studies investigating the magnitude of residues in processed rice are available but they only allowed EFSA to derive indicative processing factors for rice. Further processing studies are not required because they are not expected to affect the outcome of the risk assessment. However, if there would be the intention from risk managers to derive more robust processing factors for enforcement purposes, additional processing studies might be required.
The potential incorporation of soil residues into succeeding and rotational crops was investigated in Swiss chard, radish, turnip, sorghum and wheat. These studies showed a comparable metabolism to the primary crops and significant residues in rotational crops are not expected, provided that bentazone is applied according to the GAPs supported in the framework of this review.
Based on the uses reported by the RMS, significant exposures to bentazone and conjugates of 6-hydroxy bentazone are expected for dairy ruminants, meat ruminants, poultry and pigs. Metabolism in lactating ruminants and poultry was sufficiently investigated and findings can be extrapolated to pigs as well. The relevant residue definition for both enforcement and risk assessment in commodities of animal origin is proposed as the sum of bentazone and the metabolite 6-hydroxy bentazone (free and conjugated), expressed as bentazone. A validated analytical method for enforcement of the proposed residue definition is available with an LOQ of 0.02 mg/kg for meat, milk, liver and eggs, but a validated method is still required for fat. Based on the metabolism study on laying hens, it was concluded that residues of bentazone are not expected in poultry tissues nor in eggs, and that MRLs in these commodities can be set at the LOQ. A feeding study on lactating ruminants also demonstrated that residues of bentazone and its metabolite are not expected in significant amounts in milk and that the MRL in this commodity can be set at the LOQ, noting that storage stability data are in principle still required. Considering that this feeding study did not investigate residues in any other commodity than milk, tentative MRLs for ruminant and pig tissues were proposed based on an extrapolation from the metabolism study, but a feeding study is still required.
Chronic and acute consumer exposures resulting from the MRLs derived in the framework of this review were calculated using revision 2 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. The highest chronic exposure represented 1.6 % of the ADI (Dutch child) and the highest acute exposure amounted to 17.7 % of the ARfD (celery leaves).
Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for bentazone. Additional calculations of the consumer exposure, including these CXLs for products of plant origin, were therefore carried out. The highest chronic exposure represented also 1.6 % of the ADI (Dutch child) and the highest acute exposure amounted to 17.7 % of the ARfD (celery leaves).
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 table below for a summary). 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 table footnotes for details). In particular, certain tentative MRLs and existing EU MRLs still need to be confirmed by the following data:
• 2 additional residue trials supporting the northern outdoor GAP and 4 additional residue trials supporting the southern outdoor GAP on potatoes;
• 4 residue trials supporting the northern outdoor GAP on spring onions;
• 8 residue trials supporting the northern outdoor GAP on cucumbers;
• 4 additional residue trials supporting the northern outdoor GAP on leeks;
• 4 residue trials supporting the northern outdoor GAP on poppy seed;
• 8 residue trials supporting the northern outdoor GAP and 8 residue trials supporting the southern outdoor GAP on soya bean;
• a confirmation on the validity of the existing CXL for rye;
• further clarification of the GAP of herbal infusions;
• a validated analytical method (with confirmatory method and ILV) for enforcement of the proposed residue definition in herbal infusion;
• an analytical method (with confirmatory method and ILV) for the enforcement of the residue in fat;
• a livestock feeding study for meat ruminant;
• storage stability data for bentazone and 6-hydroxy bentazone in livestock tissues and milk.
It is highlighted that some of the ‘Recommended’ MRLs resulted 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 gaps which are not expected to impact on the validity of the recommended MRLs but which might have an impact on national authorisations:
• 1 additional trial on beans with pods and 2 additional trials on peas without pods complying with the northern outdoor GAP;
• 8 residue trials supporting the northern outdoor GAP on barley and oats;
• 8 residue trials supporting the southern outdoor GAP on rice;
• 8 residue trials supporting the northern outdoor GAP on wheat and rye;
• 8 residue trials supporting the northern outdoor GAP and 8 residue trials supporting the southern outdoor GAP on maize;
• 4 additional residue trials supporting the northern outdoor GAP and 4 additional residue trials supporting the southern outdoor GAP on maize forage;
• 4 residue trials supporting the northern outdoor GAP and 4 residue trials supporting the southern outdoor GAP on alfalfa and clover.
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 ‘Recommended’ MRLs or on the national authorisations. The following data are therefore considered desirable but not essential:
• elaboration of residue trials with an LOQ of 0.03 mg/kg;
• residue data in plants combining bentazone and 6-hydroxybentazone only;
• confirmation that all residues trials samples were stored in compliance with demonstrated storage stability;
• validation data on the hydrolysis step for enforcement of the proposed residue definition in food of animal origin.