Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EECnote, and in particular Article 14(1), point (a), thereof,Whereas:
(1)For the active substance fipronil, maximum residue levels (‘MRLs’) were set at the relevant limit of determination (‘LOD’) in Annex V to Regulation (EC) No 396/2005 by Commission Regulation (EU) 2019/1792note following the expiry of the approval of that active substance.
(2)Pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005, an application was submitted for import tolerances for fipronil used on sugar canes in Brazil and on potatoes in Brazil, the United States and Ukraine. The applicant stated that the uses of fipronil on such crops that are authorised in those countries would lead to residues that exceed the MRLs provided for in Regulation (EC) No 396/2005 and that higher MRLs would be needed to avoid trade barriers when importing those crops. As sugar canes and potatoes can be fed to animals, the applicant also proposed raising some of the existing MRLs for fipronil in animal commodities.
(3)In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, the Member State concerned evaluated this application and forwarded the evaluation report to the Commission. In the evaluation report, the Member State assessed the livestock dietary burden taking into account the livestock intake of commodities produced from those crops, and proposed raising some of the existing MRLs for fipronil in animal commodities.
(4)The European Food Safety Authority (‘the Authority’) assessed the application and the evaluation report. It examined in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRLsnote. It forwarded its reasoned opinion to the applicant, the Commission and the Member States and made it available to the public.
(5)In its reasoned opinion, the Authority concluded that the data submitted by the applicant concerning fipronil in potatoes was insufficient to set a new MRL. As regards the modification to the MRL for fipronil in sugar canes, bovine fat, sheep fat and goat fat requested by the applicant, the Authority concluded that all data requirements had been met and that such modifications were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The Authority took into account the most recent information on the toxicological properties of the substance. Neither the lifetime exposure to this substance via consumption of all food products that may contain it nor the short-term exposure due to high consumption of the relevant products show a risk that the acceptable daily intake or the acute reference dose is exceeded.
(6)Based on the reasoned opinion of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, it is concluded that the proposed modification to the MRL is acceptable.
(7)Annexes II and V to Regulation (EC) No 396/2005 should therefore be amended accordingly.
(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1#
Annexes II and V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Annex II
Pesticide residues and maximum residue levels (mg/kg)
| Code number | Groups and examples of individual products to which the MRLs applynote | Fipronil (sum fipronilnote sulfone metabolite (MB46136) expressed as fipronil) (F) |
|---|---|---|
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | 0,005note |
| 0110000 | Citrus fruits | |
| 0110010 | Grapefruits | |
| 0110020 | Oranges | |
| 0110030 | Lemons | |
| 0110040 | Limes | |
| 0110050 | Mandarins | |
| 0110990 | Others (2) | |
| 0120000 | Tree nuts | |
| 0120010 | Almonds | |
| 0120020 | Brazil nuts | |
| 0120030 | Cashew nuts | |
| 0120040 | Chestnuts | |
| 0120050 | Coconuts | |
| 0120060 | Hazelnuts/cobnuts | |
| 0120070 | Macadamias | |
| 0120080 | Pecans | |
| 0120090 | Pine nut kernels | |
| 0120100 | Pistachios | |
| 0120110 | Walnuts | |
| 0120990 | Others (2) | |
| 0130000 | Pome fruits | |
| 0130010 | Apples | |
| 0130020 | Pears | |
| 0130030 | Quinces | |
| 0130040 | Medlars | |
| 0130050 | Loquats/Japanese medlars | |
| 0130990 | Others (2) | |
| 0140000 | Stone fruits | |
| 0140010 | Apricots | |
| 0140020 | Cherries (sweet) | |
| 0140030 | Peaches | |
| 0140040 | Plums | |
| 0140990 | Others (2) | |
| 0150000 | Berries and small fruits | |
| 0151000 | (a) grapes | |
| 0151010 | Table grapes | |
| 0151020 | Wine grapes | |
| 0152000 | (b) strawberries | |
| 0153000 | (c) cane fruits | |
| 0153010 | Blackberries | |
| 0153020 | Dewberries | |
| 0153030 | Raspberries (red and yellow) | |
| 0153990 | Others (2) | |
| 0154000 | (d) other small fruits and berries | |
| 0154010 | Blueberries | |
| 0154020 | Cranberries | |
| 0154030 | Currants (black, red and white) | |
| 0154040 | Gooseberries (green, red and yellow) | |
| 0154050 | Rose hips | |
| 0154060 | Mulberries (black and white) | |
| 0154070 | Azaroles/Mediterranean medlars | |
| 0154080 | Elderberries | |
| 0154990 | Others (2) | |
| 0160000 | Miscellaneous fruitswith | |
| 0161000 | (a) edible peel | |
| 0161010 | Dates | |
| 0161020 | Figs | |
| 0161030 | Table olives | |
| 0161040 | Kumquats | |
| 0161050 | Carambolas | |
| 0161060 | Kaki/Japanese persimmons | |
| 0161070 | Jambuls/jambolans | |
| 0161990 | Others (2) | |
| 0162000 | (b) inedible peel, small | |
| 0162010 | Kiwi fruits (green, red, yellow) | |
| 0162020 | Litchis/lychees | |
| 0162030 | Passionfruits/maracujas | |
| 0162040 | Prickly pears/cactus fruits | |
| 0162050 | Star apples/cainitos | |
| 0162060 | American persimmons/Virginia kaki | |
| 0162990 | Others (2) | |
| 0163000 | (c) inedible peel, large | |
| 0163010 | Avocados | |
| 0163020 | Bananas | |
| 0163030 | Mangoes | |
| 0163040 | Papayas | |
| 0163050 | Granate apples/pomegranates | |
| 0163060 | Cherimoyas | |
| 0163070 | Guavas | |
| 0163080 | Pineapples | |
| 0163090 | Breadfruits | |
| 0163100 | Durians | |
| 0163110 | Soursops/guanabanas | |
| 0163990 | Others (2) | |
| 0200000 | VEGETABLES, FRESH or FROZEN | 0,005note |
| 0210000 | Root and tuber vegetables | |
| 0211000 | (a) potatoes | |
| 0212000 | (b) tropical root and tuber vegetables | |
| 0212010 | Cassava roots/manioc | |
| 0212020 | Sweet potatoes | |
| 0212030 | Yams | |
| 0212040 | Arrowroots | |
| 0212990 | Others (2) | |
| 0213000 | (c) other root and tuber vegetables except sugar beets | |
| 0213010 | Beetroots | |
| 0213020 | Carrots | |
| 0213030 | Celeriacs/turnip rooted celeries | |
| 0213040 | Horseradishes | |
| 0213050 | Jerusalem artichokes | |
| 0213060 | Parsnips | |
| 0213070 | Parsley roots/Hamburg roots parsley | |
| 0213080 | Radishes | |
| 0213090 | Salsifies | |
| 0213100 | Swedes/rutabagas | |
| 0213110 | Turnips | |
| 0213990 | Others (2) | |
| 0220000 | Bulb vegetables | |
| 0220010 | Garlic | |
| 0220020 | Onions | |
| 0220030 | Shallots | |
| 0220040 | Spring onions/green onions and Welsh onions | |
| 0220990 | Others (2) | |
| 0230000 | Fruiting vegetables | |
| 0231000 | (a) Solanaceae and Malvaceae | |
| 0231010 | Tomatoes | |
| 0231020 | Sweet peppers/bell peppers | |
| 0231030 | Aubergines/eggplants | |
| 0231040 | Okra/lady's fingers | |
| 0231990 | Others (2) | |
| 0232000 | (b) cucurbits with edible peel | |
| 0232010 | Cucumbers | |
| 0232020 | Gherkins | |
| 0232030 | Courgettes | |
| 0232990 | Others (2) | |
| 0233000 | (c) cucurbits with inedible peel | |
| 0233010 | Melons | |
| 0233020 | Pumpkins | |
| 0233030 | Watermelons | |
| 0233990 | Others (2) | |
| 0234000 | (d) sweet corn | |
| 0239000 | (e) other fruiting vegetables | |
| 0240000 | Brassica vegetables(excluding brassica roots and brassica baby leaf crops) | |
| 0241000 | (a) flowering brassica | |
| 0241010 | Broccoli | |
| 0241020 | Cauliflowers | |
| 0241990 | Others (2) | |
| 0242000 | (b) head brassica | |
| 0242010 | Brussels sprouts | |
| 0242020 | Head cabbages | |
| 0242990 | Others (2) | |
| 0243000 | (c) leafy brassica | |
| 0243010 | Chinese cabbages/pe-tsai | |
| 0243020 | Kales | |
| 0243990 | Others (2) | |
| 0244000 | (d) kohlrabies | |
| 0250000 | Leaf vegetables, herbs and edible flowers | |
| 0251000 | (a) lettuces and salad plants | |
| 0251010 | Lamb's lettuces/corn salads | |
| 0251020 | Lettuces | |
| 0251030 | Escaroles/broad-leaved endives | |
| 0251040 | Cresses and other sprouts and shoots | |
| 0251050 | Land cresses | |
| 0251060 | Roman rocket/rucola | |
| 0251070 | Red mustards | |
| 0251080 | Baby leaf crops (including brassica species) | |
| 0251990 | Others (2) | |
| 0252000 | (b) spinaches and similar leaves | |
| 0252010 | Spinaches | |
| 0252020 | Purslanes | |
| 0252030 | Chards/beet leaves | |
| 0252990 | Others (2) | |
| 0253000 | (c) grape leaves and similar species | |
| 0254000 | (d) watercresses | |
| 0255000 | (e) witloofs/Belgian endives | |
| 0256000 | (f) herbs and edible flowers | |
| 0256010 | Chervil | |
| 0256020 | Chives | |
| 0256030 | Celery leaves | |
| 0256040 | Parsley | |
| 0256050 | Sage | |
| 0256060 | Rosemary | |
| 0256070 | Thyme | |
| 0256080 | Basil and edible flowers | |
| 0256090 | Laurel/bay leaves | |
| 0256100 | Tarragon | |
| 0256990 | Others (2) | |
| 0260000 | Legume vegetables | |
| 0260010 | Beans (with pods) | |
| 0260020 | Beans (without pods) | |
| 0260030 | Peas (with pods) | |
| 0260040 | Peas (without pods) | |
| 0260050 | Lentils | |
| 0260990 | Others (2) | |
| 0270000 | Stem vegetables | |
| 0270010 | Asparagus | |
| 0270020 | Cardoons | |
| 0270030 | Celeries | |
| 0270040 | Florence fennels | |
| 0270050 | Globe artichokes | |
| 0270060 | Leeks | |
| 0270070 | Rhubarbs | |
| 0270080 | Bamboo shoots | |
| 0270090 | Palm hearts | |
| 0270990 | Others (2) | |
| 0280000 | Fungi, mosses and lichens | |
| 0280010 | Cultivated fungi | |
| 0280020 | Wild fungi | |
| 0280990 | Mosses and lichens | |
| 0290000 | Algae and prokaryotes organisms | |
| 0300000 | PULSES | 0,005note |
| 0300010 | Beans | |
| 0300020 | Lentils | |
| 0300030 | Peas | |
| 0300040 | Lupins/lupini beans | |
| 0300990 | Others (2) | |
| 0400000 | OILSEEDS AND OIL FRUITS | 0,005note |
| 0401000 | Oilseeds | |
| 0401010 | Linseeds | |
| 0401020 | Peanuts/groundnuts | |
| 0401030 | Poppy seeds | |
| 0401040 | Sesame seeds | |
| 0401050 | Sunflower seeds | |
| 0401060 | Rapeseeds/canola seeds | |
| 0401070 | Soyabeans | |
| 0401080 | Mustard seeds | |
| 0401090 | Cotton seeds | |
| 0401100 | Pumpkin seeds | |
| 0401110 | Safflower seeds | |
| 0401120 | Borage seeds | |
| 0401130 | Gold of pleasure seeds | |
| 0401140 | Hemp seeds | |
| 0401150 | Castor beans | |
| 0401990 | Others (2) | |
| 0402000 | Oil fruits | |
| 0402010 | Olives for oil production | |
| 0402020 | Oil palms kernels | |
| 0402030 | Oil palms fruits | |
| 0402040 | Kapok | |
| 0402990 | Others (2) | |
| 0500000 | CEREALS | 0,005note |
| 0500010 | Barley | |
| 0500020 | Buckwheat and other pseudocereals | |
| 0500030 | Maize/corn | |
| 0500040 | Common millet/proso millet | |
| 0500050 | Oat | |
| 0500060 | Rice | |
| 0500070 | Rye | |
| 0500080 | Sorghum | |
| 0500090 | Wheat | |
| 0500990 | Others (2) | |
| 0600000 | TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS | 0,005note |
| 0610000 | Teas | |
| 0620000 | Coffee beans | |
| 0630000 | Herbal infusions from | |
| 0631000 | (a) flowers | |
| 0631010 | Chamomile | |
| 0631020 | Hibiscus/roselle | |
| 0631030 | Rose | |
| 0631040 | Jasmine | |
| 0631050 | Lime/linden | |
| 0631990 | Others (2) | |
| 0632000 | (b) leaves and herbs | |
| 0632010 | Strawberry | |
| 0632020 | Rooibos | |
| 0632030 | Mate/maté | |
| 0632990 | Others (2) | |
| 0633000 | (c) roots | |
| 0633010 | Valerian | |
| 0633020 | Ginseng | |
| 0633990 | Others (2) | |
| 0639000 | (d) any other parts of the plant | |
| 0640000 | Cocoa beans | |
| 0650000 | Carobs/Saint John's breads | |
| 0700000 | HOPS | 0,005note |
| 0800000 | SPICES | |
| 0810000 | Seed spices | 0,005note |
| 0810010 | Anise/aniseed | |
| 0810020 | Black caraway/black cumin | |
| 0810030 | Celery | |
| 0810040 | Coriander | |
| 0810050 | Cumin | |
| 0810060 | Dill | |
| 0810070 | Fennel | |
| 0810080 | Fenugreek | |
| 0810090 | Nutmeg | |
| 0810990 | Others (2) | |
| 0820000 | Fruit spices | 0,005note |
| 0820010 | Allspice/pimento | |
| 0820020 | Sichuan pepper | |
| 0820030 | Caraway | |
| 0820040 | Cardamom | |
| 0820050 | Juniper berry | |
| 0820060 | Peppercorn (black, green and white) | |
| 0820070 | Vanilla | |
| 0820080 | Tamarind | |
| 0820990 | Others (2) | |
| 0830000 | Bark spices | 0,005note |
| 0830010 | Cinnamon | |
| 0830990 | Others (2) | |
| 0840000 | Root and rhizome spices | |
| 0840010 | Liquorice | 0,005note |
| 0840020 | Ginger (10) | |
| 0840030 | Turmeric/curcuma | 0,005note |
| 0840040 | Horseradish (11) | |
| 0840990 | Others (2) | 0,005note |
| 0850000 | Bud spices | 0,005note |
| 0850010 | Cloves | |
| 0850020 | Capers | |
| 0850990 | Others (2) | |
| 0860000 | Flower pistil spices | 0,005note |
| 0860010 | Saffron | |
| 0860990 | Others (2) | |
| 0870000 | Aril spices | 0,005note |
| 0870010 | Mace | |
| 0870990 | Others (2) | |
| 0900000 | SUGAR PLANTS | |
| 0900010 | Sugar beet roots | 0,005note |
| 0900020 | Sugar canes | 0,01 |
| 0900030 | Chicory roots | 0,005note |
| 0900990 | Others (2) | 0,005note |
| 1000000 | PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS | |
| 1010000 | Commodities from | |
| 1011000 | (a) swine | 0,005note |
| 1011010 | Muscle | |
| 1011020 | Fat | |
| 1011030 | Liver | |
| 1011040 | Kidney | |
| 1011050 | Edible offals (other than liver and kidney) | |
| 1011990 | Others (2) | |
| 1012000 | (b) bovine | |
| 1012010 | Muscle | 0,005note |
| 1012020 | Fat | 0,03 |
| 1012030 | Liver | 0,005note |
| 1012040 | Kidney | 0,005note |
| 1012050 | Edible offals (other than liver and kidney) | 0,005note |
| 1012990 | Others (2) | 0,005note |
| 1013000 | (c) sheep | |
| 1013010 | Muscle | 0,005note |
| 1013020 | Fat | 0,015 |
| 1013030 | Liver | 0,005note |
| 1013040 | Kidney | 0,005note |
| 1013050 | Edible offals (other than liver and kidney) | 0,005note |
| 1013990 | Others (2) | 0,005note |
| 1014000 | d) goat | |
| 1014010 | Muscle | 0,005note |
| 1014020 | Fat | 0,015 |
| 1014030 | Liver | 0,005note |
| 1014040 | Kidney | 0,005note |
| 1014050 | Edible offals (other than liver and kidney) | 0,005note |
| 1014990 | Others (2) | 0,005note |
| 1015000 | (e) equine | 0,005note |
| 1015010 | Muscle | |
| 1015020 | Fat | |
| 1015030 | Liver | |
| 1015040 | Kidney | |
| 1015050 | Edible offals (other than liver and kidney) | |
| 1015990 | Others (2) | |
| 1016000 | (f) poultry | 0,005note |
| 1016010 | Muscle | |
| 1016020 | Fat | |
| 1016030 | Liver | |
| 1016040 | Kidney | |
| 1016050 | Edible offals (other than liver and kidney) | |
| 1016990 | Others (2) | |
| 1017000 | (g) other farmed terrestrial animals | 0,005note |
| 1017010 | Muscle | |
| 1017020 | Fat | |
| 1017030 | Liver | |
| 1017040 | Kidney | |
| 1017050 | Edible offals (other than liver and kidney) | |
| 1017990 | Others (2) | |
| 1020000 | Milk | 0,005note |
| 1020010 | Cattle | |
| 1020020 | Sheep | |
| 1020030 | Goat | |
| 1020040 | Horse | |
| 1020990 | Others (2) | |
| 1030000 | Birds eggs | 0,005note |
| 1030010 | Chicken | |
| 1030020 | Duck | |
| 1030030 | Geese | |
| 1030040 | Quail | |
| 1030990 | Others (2) | |
| 1040000 | Honey and other apiculture products (7) | 0,005note |
| 1050000 | Amphibians and Reptiles | 0,005note |
| 1060000 | Terrestrial invertebrate animals | 0,005note |
| 1070000 | Wild terrestrial vertebrate animals | 0,005note |
| 1100000 | PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8) | |
| 1200000 | PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8) | |
| 1300000 | PROCESSED FOOD PRODUCTS (9) |
Fipronil (sum fipronil + sulfone metabolite (MB46136) expressed as fipronil) (F)(F)Fat soluble
(1)in Annex II, the column for fipronil is added:‘’
(2)in Annex V, the column for fipronil is deleted.
Annexes II and V to Regulation (EC) No 396/2005 are amended as follows:
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