Commission Regulation (EU) 2024/347of 22 January 2024amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fipronil in or on certain products(Text with EEA relevance)

Commission Regulation (EU) 2024/347 of 22 January 2024 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fipronil 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), 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) 2019/1792 Commission Regulation (EU) 2019/1792 of 17 October 2019 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for amitrole, fipronil, flupyrsulfuron-methyl, imazosulfuron, isoproturon, orthosulfamuron and triasulfuron in or on certain products (OJ L 277, 29.10.2019, p. 66). 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 MRLs Reasoned opinion on the setting of import tolerances for fipronil in potatoes, sugar canes and commodities of animal origin. EFSA Journal 2023;21(4):7931. . 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. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 22 January 2024. For the Commission The President Ursula von der Leyen

Annex

ANNEX Annexes II and V to Regulation (EC) No 396/2005 are amended as follows: (1) in Annex II, the column for fipronil is added: (2) in Annex V, the column for fipronil is deleted.

Annex

ANNEX II 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 Pesticide-product combination for which a footnote exists. The list of footnotes is provided below. Code numberGroups and examples of individual products to which the MRLs applyFipronil (sum fipronil sulfone metabolite (MB46136) expressed as fipronil) (F)0100000FRUITS, FRESH or FROZEN; TREE NUTS0,0050110000Citrus fruits0110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2) 0140000Stone fruits0140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0151000 (a) grapes 0151010Table grapes0151020Wine grapes0152000 (b) strawberries 0153000 (c) cane fruits 0153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000 (d) other small fruits and berries 0154010Blueberries0154020Cranberries0154030Currants (black, red and white)0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruitswith0161000 (a) edible peel 0161010Dates0161020Figs0161030Table olives0161040Kumquats0161050Carambolas0161060Kaki/Japanese persimmons0161070Jambuls/jambolans0161990Others (2) 0162000 (b) inedible peel, small 0162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)0163000

(c) inedible peel, large 0163010Avocados0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0,0050210000Root and tuber vegetables0211000 (a) potatoes 0212000 (b) tropical root and tuber vegetables 0212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)0213000 (c) other root and tuber vegetables except sugar beets 0213010Beetroots0213020Carrots0213030Celeriacs/turnip rooted celeries0213040Horseradishes0213050Jerusalem artichokes 0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0231000 (a) Solanaceae and Malvaceae 0231010Tomatoes0231020Sweet peppers/bell peppers0231030Aubergines/eggplants0231040Okra/lady's fingers0231990Others (2)0232000 (b) cucurbits with edible peel 0232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)0233000 (c) cucurbits with inedible peel 0233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)0234000 (d) sweet corn 0239000 (e) other fruiting vegetables 0240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0241000 (a) flowering brassica 0241010Broccoli 0241020Cauliflowers0241990Others (2)0242000 (b) head brassica 0242010Brussels sprouts0242020Head cabbages0242990Others (2)0243000 (c) leafy brassica 0243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)0244000 (d) kohlrabies 0250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants 0251010Lamb's lettuces/corn salads0251020Lettuces0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2)0252000 (b) spinaches and similar leaves 0252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0254000 (d) watercresses 0255000 (e) witloofs/Belgian endives 0256000 (f) herbs and edible flowers 0256010Chervil0256020Chives0256030Celery leaves0256040Parsley 0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0300000PULSES0,0050300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)

0400000OILSEEDS AND OIL FRUITS0,0050401000Oilseeds0401010Linseeds0401020Peanuts/groundnuts0401030Poppy seeds0401040Sesame seeds0401050Sunflower seeds0401060Rapeseeds/canola seeds0401070Soyabeans0401080Mustard seeds0401090Cotton seeds0401100Pumpkin seeds0401110Safflower seeds0401120Borage seeds0401130Gold of pleasure seeds0401140Hemp seeds0401150Castor beans0401990Others (2)0402000Oil fruits0402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0,0050500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2) 0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,0050610000Teas0620000Coffee beans0630000Herbal infusions from0631000 (a) flowers 0631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)0632000 (b) leaves and herbs 0632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)0633000 (c) roots 0633010Valerian0633020Ginseng0633990Others (2)0639000 (d) any other parts of the plant 0640000Cocoa beans0650000Carobs/Saint John's breads0700000HOPS0,0050800000SPICES0810000Seed spices0,0050810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2) 0820000Fruit spices0,0050820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,0050830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,0050840020Ginger (10)0840030Turmeric/curcuma0,0050840040Horseradish (11)0840990Others (2)0,0050850000Bud spices0,0050850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,0050860010Saffron0860990Others (2)0870000Aril spices0,0050870010Mace0870990Others (2)0900000SUGAR PLANTS0900010Sugar beet roots0,0050900020Sugar canes0,010900030Chicory roots0,0050900990Others (2)0,005 1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from1011000 (a) swine 0,0051011010Muscle1011020Fat1011030Liver1011040Kidney1011050Edible offals (other than liver and kidney)1011990Others (2)1012000 (b) bovine 1012010Muscle0,0051012020Fat0,031012030Liver0,0051012040Kidney0,0051012050Edible offals (other than liver and kidney)0,0051012990Others (2)0,0051013000 (c) sheep 1013010Muscle0,0051013020Fat0,0151013030Liver0,0051013040Kidney0,0051013050Edible offals (other than liver and kidney)0,0051013990Others (2)0,0051014000 d) goat 1014010Muscle0,0051014020Fat0,0151014030Liver0,0051014040Kidney0,0051014050Edible offals (other than liver and kidney)0,0051014990Others (2)0,0051015000 (e) equine 0,0051015010Muscle1015020Fat1015030Liver 1015040Kidney1015050Edible offals (other than liver and kidney)1015990Others (2)1016000 (f) poultry 0,0051016010Muscle1016020Fat1016030Liver1016040Kidney1016050Edible offals (other than liver and kidney)1016990Others (2)1017000

(g) other farmed terrestrial animals 0,0051017010Muscle1017020Fat1017030Liver1017040Kidney1017050Edible offals (other than liver and kidney)1017990Others (2)1020000Milk0,0051020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,0051030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,0051050000Amphibians and Reptiles0,0051060000Terrestrial invertebrate animals0,0051070000Wild terrestrial vertebrate animals0,005 1100000PRODUCTS 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) Fipronil (sum fipronil + sulfone metabolite (MB46136) expressed as fipronil) (F) (F) Fat soluble