Commission Regulation (EU) 2024/1318of 15 May 2024amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels prothioconazole in or on certain products(Text with EEA relevance)

Commission Regulation (EU) 2024/1318 of 15 May 2024 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels prothioconazole 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, ELI: http://data.europa.eu/eli/reg/2005/396/oj. , and in particular Article 14(1), point (a), thereof, Whereas: (1) For the active substance prothioconazole, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. (2) An application requesting a modification of the existing MRLs for prothioconazole in sugar beet roots and chicory roots was submitted to the Member State concerned pursuant to Article 6(1) of Regulation (EC) No 396/2005. (3) In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. The Commission forwarded the application, the evaluation report, and the supporting dossier to the European Food Safety Authority (the Authority). (4) 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 EFSA 2023. Reasoned Opinion on the modification of the existing maximum residue levels for prothioconazole in sugar beet and chicory roots. EFSA Journal, 21(8), 1–49. https://doi.org/10.2903/j.efsa.2023.8198. . It forwarded its reasoned opinion to the applicant, the Commission and the Member States and made it available to the public. (5) As regards the modifications to the MRLs for prothioconazole in sugar beet roots and chicory roots requested by the applicant, the Authority concluded that all the data requirements had been 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 data on the toxicological properties of prothioconazole. Neither the long-term exposure to that substance via consumption of all food products that may contain it nor the short-term exposure due to high consumption of 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 modifications to the MRLs fulfil the requirements of that Article. (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, 15 May 2024. For the Commission The President Ursula von der Leyen

Annex

ANNEX In Annex II to Regulation (EC) No 396/2005, the column for prothioconazole 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 Code numberGroups and examples of individual products to which the MRLs applyProthioconazole: prothioconazole-desthio (sum of isomers) (F)(1)(2)(3)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,010110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,020120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts 0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,010130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0,010140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0151000 (a) grapes 0,010151010Table grapes0151020Wine grapes0152000 (b) strawberries 0,010153000 (c) cane fruits 0,010153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2) 0154000 (d) other small fruits and berries 0154010Blueberries0,010154020Cranberries0,150154030Currants (black, red and white)0,010154040Gooseberries (green, red and yellow)0,010154050Rose 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 kaki0162990Others (2) 0163000 (c) inedible peel, large 0163010Avocados0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0211000

(a) potatoes 0,020212000 (b) tropical root and tuber vegetables 0,010212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)0213000 (c) other root and tuber vegetables except sugar beets 0213010Beetroots0,1(+)0213020Carrots0,1(+)0213030Celeriacs/turnip rooted celeries0,010213040Horseradishes0,1(+)0213050Jerusalem artichokes0,010213060Parsnips0,1(+) 0213070Parsley roots/Hamburg roots parsley0,1(+)0213080Radishes0,010213090Salsifies0,1(+)0213100Swedes/rutabagas0,1(+)0213110Turnips0,1(+)0213990Others (2)0,010220000Bulb vegetables0220010Garlic0,010220020Onions0,05(+)0220030Shallots0,05(+)0220040Spring onions/green onions and Welsh onions0,010220990Others (2)0,010230000Fruiting vegetables0231000 (a) Solanaceae and Malvaceae 0,010231010Tomatoes0231020Sweet peppers/bell peppers0231030Aubergines/eggplants0231040Okra/lady's fingers0231990Others (2)0232000 (b) cucurbits with edible peel 0,010232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)0233000 (c) cucurbits with inedible peel 0,010233010Melons0233020Pumpkins0233030Watermelons0233990Others (2) 0234000 (d) sweet corn 0,020239000 (e) other fruiting vegetables 0,010240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0241000 (a) flowering brassica 0,05(+)0241010Broccoli(+)0241020Cauliflowers(+)0241990Others (2)(+)0242000 (b) head brassica 0242010Brussels sprouts0,1(+)0242020Head cabbages0,09(+)0242990Others (2)0,010243000 (c) leafy brassica 0,010243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)0244000 (d) kohlrabies 0,010250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants 0,010251010Lamb'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 0,010252010Spinaches 0252020Purslanes0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0,010254000 (d) watercresses 0,010255000 (e) witloofs/Belgian endives 0,010256000 (f) herbs and edible flowers 0,020256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,010260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0270010Asparagus0,010270020Cardoons0,010270030Celeries0,01 0270040Florence fennels0,010270050Globe artichokes0,010270060Leeks0,06(+)0270070Rhubarbs0,010270080Bamboo shoots0,010270090Palm hearts0,010270990Others (2)0,010280000Fungi, mosses and lichens0,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010300000PULSES0300010Beans0,05(+)0300020Lentils1(+)0300030Peas1(+)0300040Lupins/lupini beans1(+)0300990Others (2)0,010400000OILSEEDS AND OIL FRUITS0401000Oilseeds0401010Linseeds0,09(+)0401020Peanuts/groundnuts0,02(+)0401030Poppy seeds0,09(+)0401040Sesame seeds0,020401050Sunflower seeds0,20401060Rapeseeds/canola seeds0,15(+)0401070Soyabeans0,20401080Mustard seeds0,09(+)0401090Cotton seeds0,3

0401100Pumpkin seeds0,020401110Safflower seeds0,020401120Borage seeds0,020401130Gold of pleasure seeds0,04(+)0401140Hemp seeds0,020401150Castor beans0,020401990Others (2)0,020402000Oil fruits0,020402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0500010Barley0,2(+)0500020Buckwheat and other pseudocereals0,010500030Maize/corn0,10500040Common millet/proso millet0,010500050Oat0,05(+)0500060Rice0,010500070Rye0,05(+)0500080Sorghum0,010500090Wheat0,1(+)0500990Others (2)0,010600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,050610000Teas0620000Coffee beans0630000Herbal infusions from 0631000 (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 breads0700000HOPS0,050800000SPICES0810000Seed spices0,050810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel 0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,050820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,050830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,050840020Ginger (10)0840030Turmeric/curcuma0,050840040Horseradish (11)0840990Others (2)0,050850000Bud spices0,050850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,050860010Saffron 0860990Others (2)0870000Aril spices0,050870010Mace0870990Others (2)0900000SUGAR PLANTS0900010Sugar beet roots0,030900020Sugar canes0,010900030Chicory roots0,030900990Others (2)0,011000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from1011000 (a) swine 1011010Muscle0,011011020Fat0,021011030Liver0,5(+)1011040Kidney0,5(+)1011050Edible offals (other than liver and kidney)0,5(+)1011990Others (2)0,5(+)1012000 (b) bovine 1012010Muscle0,011012020Fat0,021012030Liver0,5(+)1012040Kidney0,5(+)1012050Edible offals (other than liver and kidney)0,5(+)1012990Others (2)0,5(+)1013000 (c) sheep 1013010Muscle0,011013020Fat0,021013030Liver0,5(+) 1013040Kidney0,5(+)1013050Edible offals (other than liver and kidney)0,5(+)1013990Others (2)0,5(+)1014000 d) goat 1014010Muscle0,011014020Fat0,021014030Liver0,5(+)1014040Kidney0,5(+)1014050Edible offals (other than liver and kidney)0,5(+)1014990Others (2)0,5(+)1015000 (e) equine 1015010Muscle0,011015020Fat0,021015030Liver0,5(+)1015040Kidney0,5(+)1015050Edible offals (other than liver and kidney)0,5(+)1015990Others (2)0,5(+)1016000 (f) poultry 1016010Muscle0,011016020Fat0,011016030Liver0,11016040Kidney0,11016050Edible offals (other than liver and kidney)0,11016990Others (2)0,011017000 (g) other farmed terrestrial animals

1017010Muscle0,011017020Fat0,021017030Liver0,5(+)1017040Kidney0,5(+) 1017050Edible offals (other than liver and kidney)0,5(+)1017990Others (2)0,5(+)1020000Milk0,01(+)1020010Cattle(+)1020020Sheep(+)1020030Goat(+)1020040Horse(+)1020990Others (2)(+)1030000Birds eggs0,011030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,051050000Amphibians and Reptiles0,011060000Terrestrial invertebrate animals0,011070000Wild terrestrial vertebrate animals0,011100000PRODUCTS 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) (+) Pesticide-product combination for which a footnote exists. The list of footnotes is provided below. Prothioconazole: prothioconazole-desthio (sum of isomers) (F) (F) Fat soluble The European Food Safety Authority identified some information on residue trials and storage stability data complying with the proposed residue definition 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 by 27 January 2018, or, if that information is not submitted by that date, the lack of it. 0213010 Beetroots 0213020 Carrots 0213040 Horseradishes 0213060 Parsnips 0213070 Parsley roots/Hamburg roots parsley 0213090 Salsifies 0213100 Swedes/rutabagas 0213110 Turnips 0220020 Onions 0241000 (a) flowering brassica 0241010 Broccoli 0241020 Cauliflowers 0241990 Others (2) 0242010 Brussels sprouts 0242020 Head cabbages 0270060 Leeks 0300010 Beans 0300020 Lentils 0300030 Peas 0300040 Lupins/lupini beans 0401010 Linseeds 0401020 Peanuts/groundnuts 0401030 Poppy seeds 0401060 Rapeseeds/canola seeds 0401080 Mustard seeds 0401130 Gold of pleasure seeds 0500010 Barley 0500050 Oat 0500070 Rye 0500090 Wheat The European Food Safety Authority identified some information on analytical methods and storage stability data complying with the proposed residue definition 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 by 27 January 2018, or, if that information is not submitted by that date, the lack of it. 0220030 Shallots The European Food Safety Authority identified some information on residue trials on grass (major component of the livestock dietary burden), 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 by 27 January 2018, or, if that information is not submitted by that date, the lack of it. 1011030 Liver 1011040 Kidney 1011050 Edible offals (other than liver and kidney) 1011990 Others (2) 1012030 Liver 1012040 Kidney 1012050 Edible offals (other than liver and kidney) 1012990 Others (2) 1013030 Liver 1013040 Kidney 1013050 Edible offals (other than liver and kidney) 1013990 Others (2)

1014030 Liver 1014040 Kidney 1014050 Edible offals (other than liver and kidney) 1014990 Others (2) 1015030 Liver 1015040 Kidney 1015050 Edible offals (other than liver and kidney) 1015990 Others (2) 1017030 Liver 1017040 Kidney 1017050 Edible offals (other than liver and kidney) 1017990 Others (2) 1020000 Milk 1020010 Cattle 1020020 Sheep 1020030 Goat 1020040 Horse 1020990 Others (2)