: EFSA Journal 2011;9(6):2196 REASONED OPINION Setting of new MRLs for fluxapyroxad (BAS 700 F) in various commodities of plant and animal origin 1 European Food Safety Authority 2 European Food Safety Authority (EFSA), Parma, Italy SUMMARY In accordance with Article 6 of Regulation (EC) No 396/2005, The United Kingdom, herewith referred as the evaluating Member State (EMS), received an application from BASF SE to set import tolerances for the active substance fluxapyroxad (BAS 700 F) in pome fruit (at 0.7 mg/kg), cherries (2.0 mg/kg), peaches, plums, apricots and nectarines (1.5 mg/kg), root and tuber vegetables including sugar beets (0.2 mg/kg), bulb vegetables (0.2 mg/kg), brassica vegetables (0.1 mg/kg), leafy vegetables and fresh herbs (0.1 mg/kg), sweet corn (0.1 mg/kg), pulses (0.3 mg/kg), peanuts (0.02 mg/kg), sunflower seeds (0.3 mg/kg), rape seed (0.9 mg/kg), soya bean (0.2 mg/kg), cotton (0.02 mg/kg), minor oilseeds (1.0 mg/kg), wheat, triticale and rye (0.3 mg/kg), barley and oats (2.0 mg/kg), maize (0.02 mg/kg) and sorghum (0.8 mg/kg) from The United States, Canada and Brazil. The United Kingdom 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 1 December 2010. It is noted that fluxapyroxad is a new active substance for which the peer review process under Directive 91/414/EEC is not yet finalised. EFSA bases its assessment on the evaluation report and the Draft Assessment Report (DAR) prepared by the rapporteur Member State (RMS) The United Kingdom under Council Directive 91/414/EEC. The toxicological profile of Fluxapyroxad was assessed under Directive 91/414/EEC by the RMS who proposed an ADI of 0.02 mg/kg bw/day and an ARfD of 0.09 mg/kg bw. The metabolism of fluxapyroxad in primary crops was investigated in tomato, soybean and wheat after foliar spray. The RMS proposed to set a general residue definition for enforcement as parent fluxapyroxad. For risk assessment RMS proposed to set the residue definition for pulses and oilseeds as sum of fluxapyroxad and its metabolite M700F048 expressed as fluxapyroxad parent and for all the other crops as fluxapyroxad parent only. No information was provided regarding fluxapyroxad metabolism in plants after seed treatment. For the uses on the crops under consideration, EFSA concludes that the metabolism of fluxapyroxad is sufficiently addressed, except for the seed treatment on cotton. For the remaining crops EFSA is of the opinion that the residue definitions as proposed by the RMS are provisionally applicable. 1 On request from the European Commission, Question No EFSA-Q-2010-01476, issued on 30 May 2011. 2 Correspondence: praper.mrl@efsa.europa.eu Suggested citation: European Food Safety Authority; Setting of new MRLs for fluxapyroxad (BAS 700 F) in various commodities of plant and animal origin. EFSA Journal 2011;9(6):2196. [68 pp.] doi:10.2903/j.efsa.2011.2196. Available online: www.efsa.europa.eu/efsajournal European Food Safety Authority, 2011
The supervised residue trials are sufficient and adequate to derive MRL proposals for the intended import tolerances on pome fruit, apricots, peaches, nectarines, plums, potatoes, sugar beets, sweet corn, flowering brassicas, fresh beans and fresh peas with and without pods, pulses, peanuts, sunflower seeds, rape seed, soya bean, minor oilseeds, barley, maize, oats, wheat, triticale, sorghum and rye from USA and Canada. The data on cherries and cotton seeds were not sufficient for deriving MRL proposals. As all the supervised residue trial samples were stored longer than the demonstrated storage stability time for metabolite M700F048 relevant for pulses and oilseeds, it is concluded that the validity of the results for this metabolite needs to be demonstrated by providing storage stability studies for up to 24 months. Analytical methods are available to enforce the proposed MRLs on the commodities under consideration. Studies investigating the nature of residues in processed commodities were assessed in the DAR and it was concluded that fluxapyroxad is stable under the representative processing conditions. Thus, for processed commodities the same residue definition as for raw agricultural commodities is applicable. Studies investigating the effect of processing on the magnitude of fluxapyroxad residues in processed wheat and barley were assessed in the DAR prepared under Directive 91/414/EEC. Additionally under the framework of this application, the applicant submitted balance processing studies performed on apples, plums, potatoes, sugar beets, tomatoes and peanuts and a processing study on oilseed rape and sunflowers. EFSA proposes to include the following processing factors derived for food commodities which are relevant for trade, in Annex VI of Regulation (EC) No 396/2005: Wheat, bran: 3.09 Wheat, flour: 0.24 Wheat, germ: 1.46 Wheat bread (white): 0.17 Wheat, whole meal: 1.05 Wheat, bread whole meal: 0.71 Barley, bran: 2.08 Barley, flour: 0.23 Barley, brewing malt: 0.01 Apples juice: 0.21 Apples, wet pomace: 4.60 Apples, sauce: 0.24 Apples, canned: 0.22 Apples, dried: 0.54 Plums, puree: 0.83 Plums, jam: 0.41 Plums, dried: 2.80 Potatoes, flakes: <0.67 Potatoes, chips: <0.67 Potatoes: peeled: <0.67 Tomatoes, canned: 0.22 Tomatoes, paste: 0.71 Tomatoes, peeled: 0.14 Tomatoes, puree: 0.41 Tomatoes, raw juice: 0.19 Peanuts, nutmeat: <0.12 Peanuts, meal: <0.12 Peanuts, butter: <0.12 Peanuts, refined oil (expeller): 0.24 Peanuts, crude oil (expeller): 0.35 Peanuts, crude oil (solvent): 0.35 Peanuts, refined oil (solvent): 0.17 EFSA Journal 2011;9(6):2196 2
Setting of new MRLs for fluxapyroxad (BAS 700 F) in various commodities The occurrence of fluxapyroxad residues in rotational crops was investigated in the DAR. The data on metabolism and distribution of fluxapyroxad in succeeding crops (spinach, white radish and wheat) demonstrate that the metabolism of the active substance in rotational crops is similar to the pathway observed in primary crops, thus the same residue definition as for primary crops applies. Based on the available information on the magnitude of residues in succeeding crops, it was concluded that under crop rotations at the proposed GAP there is the potential for residues occurring in carrots, lettuce and flowering brassica harvested at immature stages for consumption. The applicant proposed an MRL of 0.2 mg/kg to be set for bulb vegetables and root and tuber vegetables including potatoes and sugar beets and an MRL of 0.1 mg/kg for leafy and brassica vegetables. Lacking clear rules for the extrapolation, EFSA proposed to establish MRLs of 0.03, 0.1 and 0.07 mg/kg for lettuce, carrots and flowering brassicas, respectively. Since many of the crops under consideration and their by-products are used as feed products, a potential carry-over into food of animal origin was assessed. The calculated livestock dietary burden exceeded the trigger value of 0.1 mg/kg (dry matter) for all relevant animal species and was mainly driven by the livestock intake of sugar beet leaves. Therefore the possible occurrence of fluxapyroxad residues in commodities of animal origin was investigated. The nature of fluxapyroxad residues in livestock has been sufficiently investigated to propose an enforcement residue definition as fluxapyroxad parent only and the risk assessment residue definition as sum of fluxapyroxad and its metabolite M00F008 expressed as fluxapyroxad parent. The calculated dietary burdens and the results of livestock feeding studies were used to derive the MRL proposals for ruminants fat, ruminants liver, milk and eggs at the level of 0.05, 0.03, 0.005 and 0.003 mg/kg, respectively. The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For the calculation of the chronic exposure, EFSA used the median residue values (where relevant multiplied by the conversion factor for risk assessment as derived from the residue trials) for the crops and animal products under consideration including the MRL proposals for carrots, lettuce and flowering brassica derived from the rotational crop studies. For the remaining commodities of plant and animal origin, the default MRL of 0.01 mg/kg was used as input value. The acute exposure assessment was performed only with regard to the commodities under consideration. The estimated exposure was then compared with the toxicological reference values derived for fluxapyroxad. No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values ranged from 2.5 to 23.7% of the ADI. The maximum contribution of fluxapyroxad residues to the total consumer exposure was given by apples accounting for 15.7% of the ADI (Germany, child diet). No acute consumer risk was identified in relation to the MRL proposals for the crops under consideration. The calculated maximum exposure in percentage of the ARfD was 51.2% for apples, 47.6% for pears, 41.5% for peaches, 34.7% for plums and 21.7% for apricots. Additionally, EFSA performed the calculation of the background exposure linked to the presence of fluxapyroxad residues in rotational crops: in Scenario 1 the MRLs proposed by EFSA for carrots, lettuce and flowering brassica were used as input values; in Scenario 2 the MRLs extrapolated from the rotational crops studies on lettuce, carrots, broccoli and cauliflowers to the whole groups of root and tuber vegetables (including potatoes), bulb vegetables, brassica vegetables and leafy vegetables and fresh herbs, as proposed by the applicant, were used as input values. The chronic and acute background exposure linked to the consumption of commodities from crops not directly treated with fluxapyroxad but grown in rotation, calculated according to scenario 1 accounted for a maximum of 1.5% of the ADI and 7% of the ARfD, respectively. When the extrapolation proposed by the applicant is considered for the calculation (scenario 2) the background chronic and acute exposure accounted for a maximum of 4.5% of the ADI and 17.1% of the ARfD, respectively. EFSA Journal 2011;9(6):2196
Consequently EFSA concludes that the occurrence of residues at the proposed MRLs on imported crops will not result in a consumer exposure posing a consumer health risk. Thus EFSA proposes to amend the current MRLs as proposed in the table below: Code Commodity Existing number (a) EU MRL Proposed EU MRL Justification for the proposal 0130000 Pome fruit 0.01* 0.7 The MRL proposal is 0140010 Apricots 0.01* 1.5 The MRL proposal is 0140020 Cherries (sweet, sour) 0.01* 0.01* Number of trials is not sufficient for deriving an MRL proposal. 0140030 Peaches and Nectarines 0.01* 1.5 The MRL proposal is 0140040 Plums 0.01* 1.5 The MRL proposal is 0211000 Potatoes 0.01* 0.01 The MRL proposal is 0213020 Carrots 0.01* 0.1 The MRL proposal is based on rotational crops studies. No risk for consumers was identified for the proposed MRL. Extrapolation of results of rotational crop study in carrots to other root and tuber vegetables may be considered by risk managers. 0220000 Bulb vegetables 0.01* 0.01* No specific studies in primary or rotational crops are available. However, extrapolation of results of rotational crops study in carrots to bulb vegetables may be considered by risk managers. 0234000 Sweet corn 0.01* 0.1 The MRL proposal is 0241000 Flowering brassicas 0.01* 0.07 The MRL proposal is based on rotational crops studies in EFSA Journal 2011;9(6):2196 4
Code Commodity Existing number (a) EU MRL Proposed EU MRL Justification for the proposal cauliflowers and broccoli. No identified for the proposed MRL. Extrapolation of results of rotational crops study in cauliflowers and broccoli to brassica vegetables may be considered by risk managers. 0251020 Lettuce 0.01* 0.03 The MRL proposal is based on rotational crops studies. No risk for consumers was identified for the MRL proposal. Extrapolation of results of rotational crops study in lettuce to other leafy vegetables may be considered by risk managers. 0260010 Beans (with pods) 0.01* 1.5 The MRL proposals are 0260020 Beans (without pods) 0.01* 0.08 0260030 Peas (with pods) 0.01* 1.5 0260040 Peas (without pods) 0.01* 0.08 import tolerances. 0300000 Pulses, dry 0.01* 0.3 The MRL proposals are 0401010 Linseed 0.01* 0.9 0401020 Peanuts 0.01* 0.01 0401030 Poppy seed 0.01* 0.9 0401040 Sesame seed 0.01* 0.9 The storage stability of 0401050 Sunflower seed 0.01* 0.3 metabolite M700F048, included in the residue definition for risk 0401060 Rape seed (canola) 0.01* 0.9 assessment, should be 0401070 Soya bean 0.01* 0.15 demonstrated by providing 0401080 Mustard seed 0.01* 0.9 storage stability studies for up to 24 month. 0401090 Cotton 0.01* 0.01* Since plant metabolism studies for seed treatment are not available it is not possible to derive an MRL proposal. 0401110 Pumpkin seeds 0.01* 0.9 The MRL proposals are 0401120 Safflower 0.01* 0.9 0401120 Borage 0.01* 0.9 0401130 Gold of pleasure 0.01* 0.9 0401140 Hempseed 0.01* 0.9 0401150 Castor bean 0.01* 0.9 0401990 Other oilseeds 0.01* 0.9 The storage stability of metabolite M700F048, included in the residue definition for risk assessment, should be demonstrated by providing storage stability studies for up to 24 month. 0500010 Barley grain 0.01* 2 The MRL proposals are 0500030 Maize grain 0.01* 0.01 0500050 Oat grain 0.01* 2 0500070 Rye grain 0.01* 0.4 import tolerances. 0500080 Sorghum grain 0.01* 0.8 The MRL proposals are EFSA Journal 2011;9(6):2196 5
Code Commodity Existing number (a) EU MRL Proposed EU MRL Justification for the proposal The EMS needs to confirm that the GAP for sorghum is identical to the GAP for wheat authorised in USA. 0500090 Wheat and triticale grain 0.01* 0.4 The MRL proposals are 0900010 Sugar beet (root) 0.01* 0.15 MRL proposal is based on supervised residue trials. No 1012020 1013020 Bovine, sheep, goat: fat 0.01* 0.05 1014020 1012030 1013030 1014030 Bovine, goat, sheep: liver 0.01* 0.03 1020000 Milk 0.01* 0.005 1030000 Eggs 0.01* 0.003 (a): According to Annex I of Regulation (EC) No 396/2005. (*): Indicates that the MRL is set by default at the limit of analytical quantification. The MRL proposals are identified. Since the peer review under Directive 91/414/EEC has not yet been finalised, the conclusions reached in this reasoned opinion should be taken as provisional and might need to be reconsidered in the light of the outcome of the peer review. EFSA Journal 2011;9(6):2196 6