REASONED OPINION OF EFSA. Modification of the existing MRLs for tebufenpyrad in raspberries and blackberries 1

Transcription

1 EFSA Scientific Report (2009) 321, 1-20 REASONED OPINION OF EFSA Modification of the existing MRLs for tebufenpyrad in raspberries and blackberries 1 Prepared by the Pesticides Unit (PRAPeR) (Question No EFSA-Q ) Issued on 29 June 2009 SUMMARY The United Kingdom received an application from the Horticultural Development Council to modify the existing MRLs for tebufenpyrad in raspberries and blackberries. In order to accommodate for a new use of tebufenpyrad on these crops, the applicant proposes to raise the existing MRL of 0.05 mg/kg (equivalent to the LOQ) to 0.5 mg/kg. The United Kingdom as the Evaluating Member State (EMS) drafted an Evaluation Report according to Article 9 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA on 14 January. On 17 March 2009 data requirements were identified by EFSA regarding supervised residue trials, which prevented EFSA from deriving the MRL proposal and performing the consumer risk assessment. In reply to this request on 4 June 2009 EFSA received the notice of the EMS that no further data are available. Consequently EFSA derived the following conclusions regarding the application, based on the above mentioned Evaluation Report and the Draft Assessment Report prepared by Germany. Metabolism of tebufenpyrad in fruits and fruiting vegetables was sufficiently addressed in the framework of the peer review and for these crops a risk assessment and enforcement residue definition was established as parent tebufenpyrad only. For the determination of tebufenpyrad in high acid content matrices a multi-residue method DFG S19 is sufficiently validated at the LOQ of 0.01 mg/kg. The applicant submitted two indoor and two outdoor supervised residue trials on raspberries. An extrapolation to blackberries was envisaged. EFSA is of the opinion that the of submitted supervised residue trials is insufficient for deriving an MRL proposal for tebufenpyrad in raspberries and blackberries since at least four trials should be performed reflecting each proposed GAP. Two trials for each use are not sufficiently representative for 1 For citation purposes: Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for tebufenpyrad in raspberries and blackberries. EFSA Scientific Report (2009) 321, 1-20 European Food Safety Authority, 2009

2 concluding whether indoor and outdoor data sets are comparable. A complete data set is essential because extrapolation of supervised residue trials data is requested. Taking into account the above mentioned, EFSA concludes that the intended use is not supported by residue data as requested in the EU Guidance documents, therefore no MRL proposal could be derived for tebufenpyrad in raspberries and blackberries and no consumer intake assessment could be performed. Overview of the proposed EC MRLs Commodity Existing EC MRL (mg/kg) Proposed EC MRL (mg/kg) Justification for the proposal Raspberries, blackberries 0.05* - No MRL proposal could be derived since it is not sufficiently supported by residue data. (*): Indicates that the MRL is set at the limit of analytical quantification. Key words: tebufenpyrad, blackberries, raspberries, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, pyrazole insecticide, acaricide EFSA Scientific Report (2009) 321, 2-20

3 TABLE OF CONTENTS Background... 4 Terms of reference... 4 The active substance and its use pattern... 5 Assessment Methods of analysis Methods for enforcement of residues in food of plant origin Methods for enforcement of residues in food of animal origin Mammalian toxicology Residues Nature and magnitude of residues in plant Primary crops Nature of residues Magnitude of residues Effect of industrial processing and/or household preparation Rotational crops Nature and magnitude of residues in livestock Consumer risk assessment... 9 Conclusions and recommendations Documentation provided to EFSA References Appendix A Good Agricultural Practices (GAPs) Appendix B Existing EC MRLs Glossary / Abbreviations EFSA Scientific Report (2009) 321, 3-20

4 BACKGROUND Regulation (EC) No 396/2005 establishes the rules governing the setting of pesticide MRLs at Community level. Article 6 of that regulation lays down that a party requesting an authorisation for the use of a plant protection product in accordance with Directive 91/414/EEC, shall submit to a Member State, when appropriate, an application to set or modify an MRL in accordance with the provisions of Article 7 of that regulation. The United Kingdom hereafter referred to as the Evaluating Member State (EMS), received an application from the Horticultural Development Council 2 to modify the existing MRL for tebufenpyrad in raspberries and blackberries. This application was notified to the European Commission and EFSA and subsequently evaluated by the EMS in accordance with Article 8 of the Regulation. After completion, the evaluation report of the EMS was submitted to the European Commission, who forwarded the application, the evaluation report and the supporting dossier to EFSA on 14 January, The application was included in the EFSA Register of Question with the reference EFSA-Q and the following subject: - Application to modify the existing MRL for tebufenpyrad in raspberries from 0.05* mg/kg to 0.5 mg/kg and in blackberries from 0.05* mg/kg to 0.5 mg/kg EFSA then proceeded with the assessment of the application as required by Article 10 of the Regulation. On 17 March 2009 some data requirements were identified, which prevented EFSA to conclude on the consumer risk assessment. In reply to this request EFSA received the notice of the EMS on 4 June 2009 that no further data are available and that EFSA should continue the assessment with the available data. This information was taken into consideration by EFSA for finalization of this reasoned opinion. TERMS OF REFERENCE According to Article 10 of Regulation (EC) No 396/2005, EFSA shall, based on the evaluation report provided by the Evaluating Member State, provide a reasoned opinion on the risks to the consumer associated with the application. According to Article 11 of that Regulation, the reasoned opinion shall be provided as soon as possible and at the latest within 3 months from the date of receipt of the application. Where EFSA requests supplementary information, the time limit laid down shall be suspended until that information has been provided. In this particular case the calculated deadline for providing the reasoned opinion is 2 July Horticultural Development Council, Bradbourne House, East Mailing, Kent, ME 196DZ, The United Kingdom EFSA Scientific Report (2009) 321, 4-20

5 THE ACTIVE SUBSTANCE AND ITS USE PATTERN is the ISO common name for N-(4-tert-butylbenzyl)-4-chloro-3-ethyl-1- methylpyrazole-5-carboxamide (IUPAC). The chemical structure of tebufenpyrad is the following: belongs to the group of pyrazole insecticides and acaricides. It is a nonsystemic substance, active by contact and ingestion routes. has a broad spectrum of activity on a wide variety of mite pests and on all developmental stages of mites (eggs, larvae, nymph and adults). There is no evidence that the active substance tebufenpyrad is translocated in plants. acts by inhibiting mitochondrial respiration. It is used to control all stages of Tetranychus, Panonychus, Oligoncyhus, Eotetrancyhus spp. on fruit, wines, citrus, vegetables, hops, ornamentals, melons and cotton. was peer reviewed under Directive 91/414/EEC with Germany being the designated Rapporteur Member State. It will be included in Annex I of this Directive by Directive 2009/11/EC following its entry into force on 1 November The Annex I inclusion is restricted to the uses as insecticide and acaricide only. The representative use supported in the peer review refers to the outdoor foliar application of tebufenpyrad on pome fruit at an application rate 1 x 100 g a.s./ha. In the European Community currently temporary MRLs for tebufenpyrad are established in Annex IIIA of Regulation (EC) No 396/2005 (Appendix B). The current MRLs for blackberries and raspberries are set at the LOQ of 0.05 mg/kg. x Alimentarius has not established CXLs for tebufenpyrad. The applicant Horticultural Development Council applied for an authorization of the use of tebufenpyrad on blackberries and raspberries in The United Kingdom. The GAP for which an authorization is requested refers to a field and glasshouse use of tebufenpyrad once at the growth stage of BBCH at an application rate of 100 g a.s./ha. The minimum waiting period is 7 days. EFSA Scientific Report (2009) 321, 5-20

6 ASSESSMENT 1. Methods of analysis 1.1. Methods for enforcement of residues in food of plant origin The analytical methods for the determination of tebufenpyrad in the foodstuffs of plant origin were evaluated in the framework of the peer review of Directive 91/414/EEC (Germany, 2007). For the determination of tebufenpyrad in high acid content matrices, where berries belong to, a multi-residue method DFG S19 (GC-MS) is applicable with the validate LOQ of 0.01 mg/kg. The method has been validated for matrices with high acid (grapes) and high water (apples) content. An adequate analytical method is available for the enforcement of the MRLs Methods for enforcement of residues in food of animal origin Since blackberries and raspberries are not used as a livestock feed, analytical methods for the products of animal origin are not of relevance. 2. Mammalian toxicology The toxicological reference values for tebufenpyrad were derived in the peer review process of Directive 91/414/EEC (EFSA, 2008) and are compiled in Table 2-1. Table 2-1. Overview of the toxicological reference values Source Year Value Study relied upon Safety factor ADI EFSA mg/kg bw/d 2 yr and 90 day rat 100 ARfD EFSA mg/kg bw Acute clinical signs in dog studies 3. Residues 3.1. Nature and magnitude of residues in plant Primary crops Nature of residues During the peer review of Directive 91/414/EEC the metabolism of tebufenpyrad was investigated in apples and pears, covering the crop category of fruits and fruiting vegetables (Germany, 2007). The metabolism studies were performed with either phenyl- or pyrazole labelled tebufenpyrad. The radiolabelled tebufenpyrad was applied on apple trees at a total application rate of 2.22 kg a.s./ha. was metabolised in apples to a minor degree, with fractions of metabolites below 2%. It was concluded that the only relevant component in apples treated with both types of radiolabelled tebufenpyrad is the parent compound 100 EFSA Scientific Report (2009) 321, 6-20

7 tebufenpyrad. The residue definition for enforcement and risk assessment in fruits and fruiting vegetables was set as the parent tebufenpyrad only. Taking into account that raspberries and blackberries belong to the crop category of fruits, it can be concluded that metabolism of tebufenpyrad in these berries proceeds according to a similar pattern than in apples and no additional metabolism studies are required Magnitude of residues The applicant submitted two indoor and two outdoor trials on raspberries. An extrapolation to blackberries was envisaged. Two trials were designed as residue decline studies. Supervised residues field trials data are summarized in Table 3-1. EFSA is of the opinion that the of submitted supervised residue trials is insufficient for deriving an MRL proposal for tebufenpyrad in raspberries and blackberries. At least four trials should be performed reflecting each proposed GAP. Two trials for each use are not sufficiently representative for concluding whether indoor and outdoor data sets are comparable. A complete data set is essential because extrapolation of supervised residue trials data is requested. In addition, no supplementing information on growth and cultivation conditions of berries with regard to indoor use is available to EFSA that could possibly be used for supporting the MRL proposal submitted by the EMS. EFSA Scientific Report (2009) 321, 7-20

8 Table 3-1. Overview of the available residues trials data Commodity Region (a) Outdoor /Indoor Individual trial results (mg/kg) Enforcement Risk assessment STMR (mg/kg) (b) HR (mg/kg) (c) MRL proposal (mg/kg) Median CF (d) Raspberries, blackberries NEU Outdoor 0.116; ; EU Indoor 0.110; ; (a): NEU, SEU, EU or Import (country code). In the case of indoor uses there is no necessity to differentiate between NEU and SEU. (b): Median value of the individual trial results according to the enforcement residue definition. (c): Highest value of the individual trial results according to the enforcement residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial. Comments No MRL proposal could be derived. EFSA Scientific Report (2009) 321, 8-20

9 Effect of industrial processing and/or household preparation Under the peer review the effect of processing on the nature of tebufenpyrad was investigated in hydrolysis study (Germany, 2007), simulating pasteurisation (90 C, 20 min.), baking, brewing, boiling (100 C, 60 min.) and sterilisation (120 C, 20 min.). was concluded to be stable under the simulated processing conditions and no formation of toxicologically significant metabolites was observed. is the only relevant residue in processed commodities Rotational crops Raspberries and blackberries are not f relevance for raspberries and blackberries since they are not normally grown in rotation Nature and magnitude of residues in livestock Raspberries and blackberries are not used as livestock feed therefore studies on nature and magnitude of residues in livestock are not of relevance regarding the current MRL application. 4. Consumer risk assessment Consumer intake risk assessment was not performed since MRL proposal could not be derived with regard to tebufenpyrad residues in raspberries and blackberries. EFSA Scientific Report (2009) 321, 9-20

10 CONCLUSIONS AND RECOMMENDATIONS The United Kingdom received an application from the Horticultural Development Council to modify the existing MRLs for tebufenpyrad in raspberries and blackberries. In order to accommodate for a new use of tebufenpyrad on these crops, the applicant proposes to raise the existing MRL of 0.05 mg/kg (equivalent to the LOQ) to 0.5 mg/kg. The United Kingdom as the Evaluating Member State (EMS) drafted an Evaluation Report according to Article 9 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA on 14 January. On 17 March 2009 data requirements were identified by EFSA regarding supervised residue trials, which prevented EFSA from deriving the MRL proposal and performing the consumer risk assessment. In reply to this request on 4 June 2009 EFSA received the notice of the EMS that no further data are available. Consequently EFSA derived the following conclusions regarding the application, based on the above mentioned Evaluation Report and the Draft Assessment Report prepared by Germany. Metabolism of tebufenpyrad in fruits and fruiting vegetables was sufficiently addressed in the framework of the peer review and for these crops a risk assessment and enforcement residue definition was established as parent tebufenpyrad only. For the determination of tebufenpyrad in high acid content matrices a multi-residue method DFG S19 is sufficiently validated at the LOQ of 0.01 mg/kg. The applicant submitted two indoor and two outdoor supervised residue trials on raspberries. An extrapolation to blackberries was envisaged. EFSA is of the opinion that the of submitted supervised residue trials is insufficient for deriving an MRL proposal for tebufenpyrad in raspberries and blackberries since at least four trials should be performed reflecting each proposed GAP. Two trials for each use are not sufficiently representative for concluding whether indoor and outdoor data sets are comparable. A complete data set is essential because extrapolation of supervised residue trials data is requested. Taking into account the above mentioned, EFSA concludes that the intended use is not supported by residue data as requested in the EU Guidance documents, therefore no MRL proposal could be derived for tebufenpyrad in raspberries and blackberries and no consumer intake assessment could be performed. Overview of the proposed EC MRLs Commodity Existing EC MRL (mg/kg) Proposed EC MRL (mg/kg) Justification for the proposal Raspberries, blackberries 0.05* - No MRL proposal could be derived since it is not sufficiently supported by residue data. (*): Indicates that the MRL is set at the limit of analytical quantification. EFSA Scientific Report (2009) 321, 10-20

11 DOCUMENTATION PROVIDED TO EFSA 1. Evaluation report on the modification of the existing MRL for tebufenpyrad in raspberry and blackberry prepared by the United Kingdom under Regulation (EC) No 396/2005. Submitted to EFSA on 14 January REFERENCES EFSA, Conclusion of EFSA prepared by PRAPeR on the peer review of pesticide risk assessment of the active substance tebufenpyrad. EFSA Scientific Report (2008) 192, Germany, Draft Assessment Report on tebufenpyrad prepared by Germany under Directive 91/414/EEC. February, EFSA Scientific Report (2009) 321, 11-20

12 APPENDIX A GOOD AGRICULTURAL PRACTICES (GAPS) Crop and/or situation (a) Raspberry, blackberry F or G (b) F and G Pest or group of pests controlled (c) Formulation rate per treatment Type (d-f) Conc. of as (i) acaricide WP 20 % w/w Application method, kind, if other than spray (f-h) Spray growth stage (j) BBCH (range) Application rate per treatment kg as/hl, where appropriate water l/ha g as/ha, where appropriate PHI (days) (k) Remarks: (l) e.g. minimum realistic PHI (a) For crops, the EU and x classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure). (b) Outdoor or field use, glasshouse application (G) or indoor application. (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds. (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR). (e) GCPF s GIFAP Technical Monograph No 2, (f) All abbreviations used must be explained. (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench. (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant - type of equipment used must be indicated. (i) g/kg or g/l. (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application. (k) Indicate the minimum and maximum of application possible under practical conditions of use. (l) PHI minimum pre-harvest interval. (m) Remarks may include: extent of use/economic importance/restrictions. EFSA Scientific Report (2009) 321, 12-20

13 APPENDIX B EXISTING EC MRLS FRUIT FRESH OR FROZEN; NUTS (i) Citrus fruit 0, Grapefruit (Shaddocks, pomelos, sweeties, tangelo, ugli and other hybrids) 0, Oranges (Bergamot, bitter orange, chinotto and other hybrids) 0, Lemons 0,5 (Citron, lemon ) Limes 0, Mandarins 0,5 (Clementine, tangerine and other hybrids) Others 0, (ii) Tree nuts (shelled or unshelled) Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts (Filbert) Macadamia Pecans Pine nuts Pistachios Walnuts Others (iii) Pome fruit 0, Apples (Crab apple) 0, Pears (Oriental pear) 0, Quinces 0, Medlar 0, Loquat 0, Others 0, (iv) Stone fruit Apricots 0, Cherries (sweet cherries, sour cherries) 0, Peaches (Nectarines 0,3 and similar hybrids) Plums (Damson, 0,5 greengage, mirabelle) Others 0, (v) Berries & small fruit (a) Table and 0,5 wine grapes Table grapes 0, Wine grapes 0, (b) Strawberries 0, (c) Cane fruit Blackberries Dewberries (Loganberries, Boysenberries, and cloudberries) Raspberries (Wineberries ) Others (d) Other small 1 fruit & berries Blueberries (Bilberries cowberries (red bilberries)) Cranberries Currants (red, black 1 and white) Gooseberries 1 (Including hybrids with other ribes species) Rose hips Mulberries (arbutus 1 berry) Azarole 1 (mediteranean medlar) Elderberries (Black 1 chokeberry (appleberry), mountain ash, azarole, buckthorn (sea sallowthorn), hawthorn, service berries, and other treeberries) Others (vi) Miscellaneous fruit EFSA Scientific Report (2009) 321, 13-20

14 (a) Edible peel Dates Figs Table olives Kumquats (Marumi kumquats, nagami kumquats) Carambola (Bilimbi) Persimmon Jambolan (java plum) (Java apple (water apple), pomerac, rose apple, Brazilean cherry (grumichama), Surinam cherry) Others (b) Inedible peel, small Kiwi Lychee (Litchi) (Pulasan, rambutan (hairy litchi)) Passion fruit Prickly pear (cactus fruit) Star apple American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel (yellow sapote), and mammey sapote) Others (c) Inedible peel, large Avocados Bananas (Dwarf banana, plantain, apple banana) Mangoes Papaya Pomegranate Cherimoya (Custard apple, sugar apple (sweetsop), llama and other medium sized Annonaceae) Guava Pineapples Bread fruit (Jackfruit) Durian Soursop (guanabana) Others VEGETABLES FRESH OR FROZEN (i) Root and tuber vegetables (a) Potatoes (b) Tropical root and tuber vegetables Cassava (Dasheen, eddoe (Japanese taro), tannia) Sweet potatoes Yams (Potato bean (yam bean), Mexican yam bean) Arrowroot Others (c) Other root and tuber vegetables except sugar beet Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnips Parsley root Radishes (Black radish, Japanese radish, small radish and similar varieties) Salsify (Scorzonera, Spanish salsify (Spanish oysterplant)) Swedes Turnips Others (ii) Bulb vegetables Garlic Onions (Silverskin onions) Shallots EFSA Scientific Report (2009) 321, 14-20

15 Spring onions (Welsh onion and similar varieties) Others (iii) Fruiting vegetables (a) Solanacea Tomatoes 0,5 (Cherry tomatoes, ) Peppers (Chilli 0,5 peppers) Aubergines (egg 0,5 plants) (Pepino) Okra, lady s fingers Others (b) Cucurbits - edible peel Cucumbers 0, Gherkins 0, Courgettes (Summer squash, marrow (patisson)) 0, Others 0, (c) Cucurbits-inedible peel Melons (Kiwano ) 0, Pumpkins (Winter squash) Watermelons 0, Others (d) Sweet corn (e) Other fruiting vegetables (iv) Brassica vegetables (a) Flowering brassica Broccoli (Calabrese, Chinese broccoli, Broccoli raab) Cauliflower Others (b) Head brassica Brussels sprouts Head cabbage (Pointed head cabbage, red cabbage, savoy cabbage, white cabbage) Others (c) Leafy brassica Chinese cabbage (Indian (Chinese) mustard, pak choi, Chinese flat cabbage (tai goo choi), peking cabbage (pe-tsai), cow cabbage) Kale (Borecole (curly kale), collards) Others (d) Kohlrabi (v) Leaf vegetables & fresh herbs (a) Lettuce and other salad plants including Brassicacea Lamb s lettuce (Italian cornsalad) Lettuce (Head lettuce, lollo rosso (cutting lettuce), iceberg lettuce, romaine (cos) lettuce) Scarole (broad-leaf endive) (Wild chicory, red-leaved chicory, radicchio, curld leave endive, sugar loaf) Cress Land cress Rocket, Rucola (Wild rocket) Red mustard Leaves and sprouts of Brassica spp (Mizuna) Others (b) Spinach & similar (leaves) Spinach (New Zealand spinach, turnip greens (turnip tops)) Purslane (Winter purslane (miner s lettuce), garden purslane, common EFSA Scientific Report (2009) 321, 15-20

16 purslane, sorrel, glassworth) Beet leaves (chard) (Leaves of beetroot) Others (c) Vine leaves (grape leaves) (d) Water cress (e) Witloof (f) Herbs Chervil Chives Celery leaves (fennel leaves, Coriander leaves, dill leaves, Caraway leaves, lovage, angelica, sweet cisely and other Apiacea) Parsley Sage (Winter savory, summer savory, ) Rosemary Thyme ( marjoram, oregano) Basil (Balm leaves, mint, peppermint) Bay leaves (laurel) Tarragon (Hyssop) Others (vi) Legume vegetables (fresh) Beans (with pods) (Green bean (french beans, snap beans), scarlet runner bean, slicing bean, yardlong beans) Beans (without pods) (Broad beans, Flageolets, jack bean, lima bean, cowpea) Peas (with pods) (Mangetout (sugar peas)) Peas (without pods) (Garden pea, green pea, chickpea) Lentils Others (vii) Stem vegetables (fresh) Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Bamboo shoots Palm hearts Others (viii) Fungi Cultivated (Common mushroom, Oyster mushroom, Shi-take) Wild (Chanterelle, Truffle, Morel) Others (ix) Sea weeds PULSES, DRY Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas) Lentils Peas (Chickpeas, field peas, chickling vetch) Lupins Others OILSEEDS AND OILFRUITS (i) Oilseeds Linseed Peanuts Poppy seed Sesame seed Sunflower seed Rape seed (Bird rapeseed, turnip rape) Soya bean Mustard seed Cotton seed Pumpkin seeds Safflower Borage Gold of pleasure Hempseed EFSA Scientific Report (2009) 321, 16-20

17 Castor bean Others (ii) Oilfruits Olives for oil production Palm nuts (palmoil kernels) Palmfruit Kapok Others CEREALS Barley Buckwheat Maize Millet (Foxtail millet, teff) Oats Rice Rye Sorghum Wheat (Spelt Triticale) Others TEA, COFFEE, 0,1 HERBAL INFUSIONS AND COCOA (i) Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis) 0, (ii) Coffee beans 0, (iii) Herbal 0,1 infusions (dried) (a) Flowers 0, Camomille flowers 0, Hybiscus flowers 0, Rose petals 0, Jasmine flowers 0, Lime (linden) 0, Others 0, (b) Leaves 0, Strawberry leaves 0, Rooibos leaves 0, Maté 0, Others 0, (c) Roots 0, Valerian root 0, Ginseng root 0, Others 0, (d) Other herbal 0,1 infusions (iv) Cocoa 0,1 (fermented beans) (v) Carob (st johns 0,1 bread) HOPS (dried), including hop pellets and unconcentrated powder 0, SPICES 0, (i) Seeds 0, Anise 0, Black caraway 0, Celery seed (Lovage 0,1 seed) Coriander seed 0, Cumin seed 0, Dill seed 0, Fennel seed 0, Fenugreek 0, Nutmeg 0, Others 0, (ii) Fruits and 0,1 berries Allspice 0, Anise pepper (Japan 0,1 pepper) Caraway 0, Cardamom 0, Juniper berries 0, Pepper, black and white (Long pepper, pink pepper) 0, Vanilla pods 0, Tamarind 0, Others 0, (iii) Bark 0, Cinnamon (Cassia ) 0, Others 0, (iv) Roots or 0,1 rhizome Liquorice 0, Ginger 0, Turmeric (Curcuma) 0, Horseradish 0,1 EFSA Scientific Report (2009) 321, 17-20

18 Others 0, (v) Buds 0, Cloves 0, Capers 0, Others 0, (vi) Flower stigma 0, Saffron 0, Others 0, (vii) Aril 0, Mace 0, Others 0, SUGAR PLANTS Sugar beet (root) Sugar cane Chicory roots Others PRODUCTS OF ANIMAL ORIGIN- TERRESTRIAL ANIMALS (i) Meat, preparations of meat, offals, blood, animal fats fresh chilled or frozen, salted, in brine, dried or smoked or processed as flours or meals other processed products such as sausages and food preparations based on these (a) Swine Meat Fat free of lean meat Liver Kidney Edible offal Others (b) Bovine Meat Fat Liver Kidney Edible offal Others (c) Sheep Meat Fat Liver Kidney Edible offal Others (d) Goat Meat Fat Liver Kidney Edible offal Others (e) Horses, asses, mules or hinnies Meat Fat Liver Kidney Edible offal Others (f) Poultry - chicken, geese, duck, turkey and Guinea fowl-, ostrich, pigeon Meat Fat Liver Kidney Edible offal Others (g) Other farm animals (Rabbit, Kangaroo) Meat Fat Liver Kidney Edible offal Others (ii) Milk and cream, not concentrated, nor containing added sugar or sweetening matter, butter and other fats derived from milk, cheese and curd Cattle EFSA Scientific Report (2009) 321, 18-20

19 Sheep Goat Horse Others (iii) Birds eggs, fresh preserved or cooked Shelled eggs and egg yolks fresh, dried, cooked by steaming or boiling in water, moulded, frozen or otherwise preserved whether or not containing added sugar or sweetening matter Chicken Duck Goose Quail Others (iv) Honey (Royal jelly, pollen) (v) Amphibians and reptiles (Frog legs, crocodiles) (vi) Snails (vii) Other terrestrial animal products * - Indicates lower limit of analytical determination EFSA Scientific Report (2009) 321, 19-20

20 GLOSSARY / ABBREVIATIONS a.s. ADI ARfD BBCH bw CAC CXL d DAR EC EFSA EMS EU GAP ha hl HPLC HR IUPAC L LOQ MRL MS active substance acceptable daily intake acute reference dose Federal Biological Research Centre for Agriculture and Forestry (Germany) body weight x Alimentarius Commission codex maximum residue limit day Draft Assessment Report (prepared under Directive 91/414/eec) European Community European Food Safety Authority Evaluating Member State European Union good agricultural practice hectare hectolitre high performance liquid chromatography highest residue International Union of Pure and Applied Chemistry litre limit of quantification maximum residue limit Member States NEU Northern European Union PHI pre harvest interval ppm parts per million (10-6 ) PRIMo Pesticide Residues Intake Model RMS Rapporteur Member State STMR supervised trials median residue TRR total radioactive residue WP wettable powder EFSA Scientific Report (2009) 321, 20-20