Commission Regulation (EU) 2022/1264 of 20 July 2022 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fludioxonil in or on certain productsText with EEA relevance.

Commission Regulation (EU) 2022/1264 of 20 July 2022 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fludioxonil in or on certain products (Text with EEA relevance) 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/EEC OJ L 70, 16.3.2005, p. 1. , and in particular Article 14(1)(a) thereof, Whereas: (1) For fludioxonil maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. (2) An application for import tolerances pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005 for fludioxonil used in the United States on sugar beet roots, and in Guatemala, Honduras and Colombia on bananas was submitted. The applicant states that the authorised uses of that substance on such crops in those countries lead to residues exceeding the MRLs provided for in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops. (3) In accordance with Article 8 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. (4) The European Food Safety Authority (the Authority) assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRLs Reasoned opinion on the setting of import tolerances for fludioxonil in sugar beet roots and bananas. EFSA Journal 2021;19(11):6919. EFSA scientific reports available online: http://www.efsa.europa.eu. . It forwarded that opinion to the applicant, the Commission and the Member States and made it available to the public. (5) The Authority concluded that all requirements with respect to completeness of data submission were met and that the modifications to the MRLs requested by the applicant were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. In so concluding, the Authority took into account the most recent information on the toxicological properties of the substance. The lifetime exposure to the substance via consumption of all food products that may contain it showed that there is no risk that the acceptable daily intake is exceeded. Moreover, the Authority concluded that the establishment of an acute reference dose is not necessary on the basis of the low acute toxicity profile of the active substance. (6) Based on the reasoned opinion of the Authority and taking into account the factors relevant to the matter under consideration, the proposed modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.

(7) 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

Annex II to Regulation (EC) No 396/2005 is 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. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 July 2022. For the Commission The President Ursula von der Leyen

Annex

ANNEX In Annex II to Regulation (EC) No 396/2005, the column for fludioxonil is replaced by the following: Pesticide residues and maximum residue levels (mg/kg) Indicates lower limit of analytical determination For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I Fludioxonil (R) (F) (R) The residue definition differs for the following combinations pesticide-code number: Fludioxonil - code 1000000 except 1040000 : sum of fludioxonil and its metabolites oxidized to metabolite 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid, expressed as fludioxonil (F) Fat soluble Code numberGroups and examples of individual products to which the MRLs applyFludioxonil (R) (F)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits100110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0120010Almonds0,010120020Brazil nuts0,010120030Cashew nuts0,010120040Chestnuts0,010120050Coconuts0,010120060Hazelnuts/cobnuts0,010120070Macadamias0,010120080Pecans0,010120090Pine nut kernels0,010120100Pistachios0,20120110Walnuts0,010120990Others (2)0,010130000Pome fruits50130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits 0140010Apricots50140020Cherries (sweet)50140030Peaches100140040Plums50140990Others (2)0,010150000Berries and small fruits0151000 (a) grapes 0151010Table grapes50151020Wine grapes40152000 (b) strawberries 40153000 (c) cane fruits 50153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000 (d) other small fruits and berries 0154010Blueberries40154020Cranberries40154030Currants (black, red and white)40154040Gooseberries (green, red and yellow)40154050Rose hips0,010154060Mulberries (black and white)0,010154070Azaroles/Mediterranean medlars0,010154080Elderberries40154990Others (2)0,010160000Miscellaneous fruitswith0161000 (a) edible peel 0,010161010Dates0161020Figs0161030Table olives0161040Kumquats0161050Carambolas0161060Kaki/Japanese persimmons0161070Jambuls/jambolans0161990Others (2)0162000 (b) inedible peel, small 0162010Kiwi fruits (green, red, yellow)150162020Litchis/lychees0,01 0162030Passionfruits/maracujas0,010162040Prickly pears/cactus fruits0,010162050Star apples/cainitos0,010162060American persimmons/Virginia kaki0,010162990Others (2)0,010163000

(c) inedible peel, large 0163010Avocados1,50163020Bananas20163030Mangoes20163040Papayas0,010163050Granate apples/pomegranates30163060Cherimoyas0,010163070Guavas0,50163080Pineapples70163090Breadfruits0,010163100Durians0,010163110Soursops/guanabanas0,010163990Others (2)0,010200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0211000 (a) potatoes 50212000 (b) tropical root and tuber vegetables 0212010Cassava roots/manioc0,010212020Sweet potatoes100212030Yams100212040Arrowroots0,010212990Others (2)0,010213000 (c) other root and tuber vegetables except sugar beets 0213010Beetroots10213020Carrots10213030Celeriacs/turnip rooted celeries0,20213040Horseradishes10213050Jerusalem artichokes0,010213060Parsnips10213070Parsley roots/Hamburg roots parsley10213080Radishes0,30213090Salsifies1 0213100Swedes/rutabagas0,010213110Turnips0,010213990Others (2)0,010220000Bulb vegetables0220010Garlic0,50220020Onions0,50220030Shallots0,50220040Spring onions/green onions and Welsh onions50220990Others (2)0,50230000Fruiting vegetables0231000 (a) Solanaceae and Malvaceae 0231010Tomatoes30231020Sweet peppers/bell peppers10231030Aubergines/eggplants0,40231040Okra/lady's fingers0,010231990Others (2)0,010232000 (b) cucurbits with edible peel 0,40232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)0233000 (c) cucurbits with inedible peel 0,30233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)0234000 (d) sweet corn 0,010239000 (e) other fruiting vegetables 0,010240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0241000 (a) flowering brassica 0241010Broccoli0,70241020Cauliflowers0,010241990Others (2)0,010242000 (b) head brassica 0242010Brussels sprouts0,010242020Head cabbages20242990Others (2)0,01 0243000 (c) leafy brassica 0243010Chinese cabbages/pe-tsai100243020Kales0,010243990Others (2)0,010244000 (d) kohlrabies 0,010250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants 0251010Lamb's lettuces/corn salads200251020Lettuces400251030Escaroles/broad-leaved endives200251040Cresses and other sprouts and shoots200251050Land cresses200251060Roman rocket/rucola200251070Red mustards200251080Baby leaf crops (including brassica species)200251990Others (2)200252000 (b) spinaches and similar leaves 0252010Spinaches300252020Purslanes200252030Chards/beet leaves200252990Others (2)200253000 (c) grape leaves and similar species 0,010254000 (d) watercresses 100255000 (e) witloofs/Belgian endives 0,020256000 (f) herbs and edible flowers 200256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables 0260010Beans (with pods)10260020Beans (without pods)0,40260030Peas (with pods)10260040Peas (without pods)0,30260050Lentils0,050260990Others (2)0,010270000Stem vegetables0270010Asparagus0,010270020Cardoons0,010270030Celeries1,50270040Florence fennels1,50270050Globe artichokes0,010270060Leeks0,010270070Rhubarbs0,70270080Bamboo shoots0,010270090Palm hearts0,010270990Others (2)0,010280000Fungi, mosses and lichens0,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010300000PULSES0300010Beans0,50300020Lentils0,40300030Peas0,40300040Lupins/lupini beans0,40300990Others (2)0,40400000OILSEEDS AND OIL FRUITS0401000Oilseeds0401010Linseeds0,30401020Peanuts/groundnuts0,010401030Poppy seeds0,010401040Sesame seeds0,30401050Sunflower seeds0,010401060Rapeseeds/canola seeds0,3

0401070Soyabeans0,20401080Mustard seeds0,30401090Cotton seeds0,010401100Pumpkin seeds0,010401110Safflower seeds0,010401120Borage seeds0,30401130Gold of pleasure seeds0,30401140Hemp seeds0,30401150Castor beans0,010401990Others (2)0,010402000Oil fruits0,010402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0,010500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0610000Teas0,050620000Coffee beans0,050630000Herbal infusions from0631000 (a) flowers 0,050631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden 0631990Others (2)0632000 (b) leaves and herbs 0,050632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)0633000 (c) roots 0633010Valerian10633020Ginseng40633990Others (2)10639000 (d) any other parts of the plant 0,050640000Cocoa beans0,050650000Carobs/Saint John's breads0,050700000HOPS0,050800000SPICES0810000Seed spices0,050810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,050820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,05 0830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice10840020Ginger (10)0840030Turmeric/curcuma10840040Horseradish (11)0840990Others (2)10850000Bud spices0,050850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,050860010Saffron0860990Others (2)0870000Aril spices0,050870010Mace0870990Others (2)0900000SUGAR PLANTS0900010Sugar beet roots40900020Sugar canes0,010900030Chicory roots0,010900990Others (2)0,011000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from1011000 (a) swine 1011010Muscle0,021011020Fat0,021011030Liver0,11011040Kidney0,11011050Edible offals (other than liver and kidney)0,11011990Others (2)0,021012000 (b) bovine 1012010Muscle0,021012020Fat0,021012030Liver0,11012040Kidney0,1 1012050Edible offals (other than liver and kidney)0,11012990Others (2)0,021013000 (c) sheep 1013010Muscle0,021013020Fat0,021013030Liver0,11013040Kidney0,11013050Edible offals (other than liver and kidney)0,11013990Others (2)0,021014000 (d) goat 1014010Muscle0,021014020Fat0,021014030Liver0,11014040Kidney0,11014050Edible offals (other than liver and kidney)0,11014990Others (2)0,021015000 (e) equine 1015010Muscle0,021015020Fat0,021015030Liver0,11015040Kidney0,11015050Edible offals (other than liver and kidney)0,11015990Others (2)0,021016000 (f) poultry 1016010Muscle0,011016020Fat0,011016030Liver0,11016040Kidney0,11016050Edible offals (other than liver and kidney)0,11016990Others (2)0,011017000 (g) other farmed terrestrial animals

1017010Muscle0,021017020Fat0,021017030Liver0,11017040Kidney0,11017050Edible offals (other than liver and kidney)0,11017990Others (2)0,02 1020000Milk0,041020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,021030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,051050000Amphibians and Reptiles0,011060000Terrestrial invertebrate animals0,011070000Wild terrestrial vertebrate animals0,021100000PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)1200000PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)1300000PROCESSED FOOD PRODUCTS (9)