Commission Regulation (EU) 2024/1314of 15 May 2024amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for dithianon in or on certain products(Text with EEA relevance)

Commission Regulation (EU) 2024/1314 of 15 May 2024 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for dithianon 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) The maximum residue levels (MRLs) for dithianon are set out in Part A of Annex III to Regulation (EC) No 396/2005. (2) The Authority has submitted a reasoned opinion on the review of the existing MRLs for dithianon in accordance with Article 12(1) of Regulation (EC) No 396/2005 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for dithianon according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2023;21(1):7731. . The Authority noted that the mutagenicity potential of the metabolite 1,4-naphthoquinone remains uncertain, pending the submission of additional studies fulfilling the previously identified data gap European Food Safety Authority; Conclusion on the updated peer review of the pesticide risk assessment for the active substance dithianon in light of confirmatory data submitted. EFSA Journal 2020;18(9):6189. . Therefore, the values of the acceptable daily intake (ADI) and acute reference dose (ARfD) of 1,4-naphthoquinone are considered provisional and all MRLs for dithianon above the limits of determination (LODs) require further consideration by risk managers. As the missing data is to be submitted as part of the ongoing procedure for the renewal of the approval of dithianon, the MRLs should be reconsidered and revised by risk managers following the finalisation of that procedure. (3) Additionally, the Authority identified an exceedance of the ARfD of dithianon for apples and pears. The Authority consulted the Member States and requested them to report potential fall-back Good Agricultural Practices (GAPs) for apples and pears, authorised in Member States or third countries and already evaluated at Member State level, which would not lead to an unacceptable risk for consumers. Fall-back GAPs for apples and pears were identified that do not lead to exceedances of the ARfD of dithianon. It is therefore appropriate to lower the MRLs for dithianon on apples and pears to the values identified by the Authority in Part A of Annex III to Regulation (EC) No 396/2005. (4) The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs for dithianon. Those laboratories proposed product-specific LODs that are analytically achievable. (5) Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs for dithianon and their comments have been taken into account.

(6) Annex III to Regulation (EC) No 396/2005 should therefore be amended accordingly. (7) A reasonable period should be allowed to elapse before the new MRLs for dithianon become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to the requirements which result from the modification of the MRLs. (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

Part A of Annex III 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. It shall apply from 5 December 2024. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 15 May 2024. For the Commission The President Ursula von der Leyen

Annex

ANNEX In Part A of Annex III to Regulation (EC) No 396/2005, the column for dithianon 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 Pesticide-product combination for which a footnote exists. The list of footnotes is provided below. Dithianon The European Food Safety Authority identified some information on the metabolite 1,4-naphthoquinone as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted during the procedure for renewal of approval of the active substance dithianon, or, if that information is not submitted, the lack of it. 0110010 Grapefruits 0110020 Oranges 0110030 Lemons 0110040 Limes 0110050 Mandarins 0110990 Others (2) 0120010 Almonds 0120110 Walnuts 0130010 Apples 0130020 Pears 0130030 Quinces 0130040 Medlars 0130050 Loquats/Japanese medlars 0130990 Others (2) 0140010 Apricots 0140020 Cherries (sweet) 0140030 Peaches 0140040 Plums 0140990 Others (2) 0151000 (a) grapes 0151010 Table grapes 0151020 Wine grapes 0153010 Blackberries 0153020 Dewberries 0153030 Raspberries (red and yellow) 0154020 Cranberries 0154030 Currants (black, red and white) 0154040 Gooseberries (green, red and yellow) 0211000 (a) potatoes 0213020 Carrots 0231010 Tomatoes 0231020 Sweet peppers/bell peppers 0252010 Spinaches 0253000 (c) grape leaves and similar species 0260040 Peas (without pods) 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)

0500060 Rice 0500090 Wheat 0700000 HOPS Code numberGroups and examples of individual products to which the MRLs applyDithianon(1)(2)(3)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0110010Grapefruits10110020Oranges10110030Lemons10110040Limes10110050Mandarins30110990Others (2)10120000Tree nuts0120010Almonds0,050120020Brazil nuts0,010120030Cashew nuts0,010120040Chestnuts0,010120050Coconuts0,010120060Hazelnuts/cobnuts0,010120070Macadamias0,010120080Pecans0,010120090Pine nut kernels0,010120100Pistachios0,010120110Walnuts0,050120990Others (2)0,010130000Pome fruits0130010Apples1,50130020Pears1,50130030Quinces30130040Medlars30130050Loquats/Japanese medlars30130990Others (2)30140000Stone fruits0140010Apricots0,50140020Cherries (sweet)20140030Peaches0,5 0140040Plums0,50140990Others (2)20150000Berries and small fruits0151000 (a) grapes 30151010Table grapes0151020Wine grapes0152000 (b) strawberries 0,010153000 (c) cane fruits 0153010Blackberries0,50153020Dewberries0,50153030Raspberries (red and yellow)30153990Others (2)0,010154000 (d) other small fruits and berries 0154010Blueberries0,010154020Cranberries30154030Currants (black, red and white)30154040Gooseberries (green, red and yellow)30154050Rose hips0,010154060Mulberries (black and white)0,010154070Azaroles/Mediterranean medlars0,010154080Elderberries0,010154990Others (2)0,010160000Miscellaneous fruitswith0,010161000 (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 kaki 0162990Others (2)0163000 (c) inedible peel, large 0163010Avocados0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0211000 (a) potatoes 0,10212000 (b) tropical root and tuber vegetables 0,010212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)0213000 (c) other root and tuber vegetables except sugar beets 0213010Beetroots0,010213020Carrots0,050213030Celeriacs/turnip rooted celeries0,010213040Horseradishes0,010213050Jerusalem artichokes0,010213060Parsnips0,010213070Parsley roots/Hamburg roots parsley0,010213080Radishes0,010213090Salsifies0,010213100Swedes/rutabagas0,010213110Turnips0,010213990Others (2)0,010220000Bulb vegetables0,010220010Garlic0220020Onions 0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0231000 (a) Solanaceae and Malvaceae 0231010Tomatoes0,60231020Sweet peppers/bell peppers0,60231030Aubergines/eggplants0,010231040Okra/lady's fingers0,010231990Others (2)0,010232000 (b) cucurbits with edible peel

0,010232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)0233000 (c) cucurbits with inedible peel 0,010233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)0234000 (d) sweet corn 0,010239000 (e) other fruiting vegetables 0,010240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,010241000 (a) flowering brassica 0241010Broccoli0241020Cauliflowers0241990Others (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 0,010251010Lamb's lettuces/corn salads 0251020Lettuces0251030Escaroles/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 0252010Spinaches0,60252020Purslanes0,010252030Chards/beet leaves0,010252990Others (2)0,010253000 (c) grape leaves and similar species 0,10254000 (d) watercresses 0,010255000 (e) witloofs/Belgian endives 0,010256000 (f) herbs and edible flowers 0,010256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0260010Beans (with pods)0,010260020Beans (without pods)0,010260030Peas (with pods)0,010260040Peas (without pods)0,60260050Lentils0,010260990Others (2)0,010270000Stem vegetables0,010270010Asparagus0270020Cardoons0270030Celeries 0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010300000PULSES0,010300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0401000Oilseeds0,020401010Linseeds0401020Peanuts/groundnuts0401030Poppy seeds0401040Sesame seeds0401050Sunflower seeds0401060Rapeseeds/canola seeds0401070Soyabeans0401080Mustard seeds0401090Cotton seeds0401100Pumpkin seeds0401110Safflower seeds0401120Borage seeds0401130Gold of pleasure seeds0401140Hemp seeds0401150Castor beans0401990Others (2)0402000Oil fruits0,010402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits 0402040Kapok0402990Others (2)0500000CEREALS0500010Barley0,010500020Buckwheat and other pseudocereals0,010500030Maize/corn0,010500040Common millet/proso millet0,010500050Oat0,010500060Rice0,050500070Rye0,010500080Sorghum0,010500090Wheat0,050500990Others (2)0,010600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,010610000Teas0620000Coffee 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 breads0700000HOPS1000800000SPICES0810000Seed spices0,01 0810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,010820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,010830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,010840020Ginger (10)0840030Turmeric/curcuma0,010840040Horseradish (11)0840990Others (2)0,010850000Bud spices0,010850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,010860010Saffron0860990Others (2)0870000Aril spices0,010870010Mace0870990Others (2) 0900000SUGAR PLANTS0,010900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS0,011010000Commodities from1011000 (a) swine 1011010Muscle1011020Fat1011030Liver1011040Kidney1011050Edible offals (other than liver and kidney)1011990Others (2)1012000 (b) bovine 1012010Muscle1012020Fat1012030Liver1012040Kidney1012050Edible offals (other than liver and kidney)1012990Others (2)1013000 (c) sheep 1013010Muscle1013020Fat1013030Liver1013040Kidney1013050Edible offals (other than liver and kidney)1013990Others (2)1014000 d) goat 1014010Muscle1014020Fat1014030Liver1014040Kidney1014050Edible offals (other than liver and kidney)1014990Others (2)1015000 (e) equine 1015010Muscle1015020Fat1015030Liver 1015040Kidney1015050Edible offals (other than liver and kidney)1015990Others (2)1016000 (f) poultry 1016010Muscle1016020Fat1016030Liver1016040Kidney1016050Edible offals (other than liver and kidney)1016990Others (2)1017000 (g) other farmed terrestrial animals 1017010Muscle1017020Fat1017030Liver1017040Kidney1017050Edible offals (other than liver and kidney)1017990Others (2)1020000Milk1020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs1030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)1050000Amphibians and Reptiles1060000Terrestrial invertebrate animals1070000Wild terrestrial vertebrate animals1100000PRODUCTS 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)