Commission Regulation (EU) 2024/1077of 15 April 2024amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 2,4-DB, iodosulfuron-methyl, mesotrione and pyraflufen-ethyl in or on certain products(Text with EEA relevance)

Commission Regulation (EU) 2024/1077 of 15 April 2024 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 2,4-DB, iodosulfuron-methyl, mesotrione and pyraflufen-ethyl 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) and Article 49(2) thereof, Whereas: (1) For 2,4-DB, iodosulfuron-methyl, mesotrione and pyraflufen-ethyl, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. (2) During the review of those MRLs pursuant to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (the Authority) identified some information as unavailable for certain products. The available information was sufficient for the Authority to propose MRLs that are safe for consumers. Data gaps were indicated in Annex II to that Regulation specifying the date by which the missing information was to be submitted to the Authority by the applicant in support of the proposed MRLs. (3) For 2,4-DB, the missing information concerning its metabolism and analytical methods for barley, oats, rye and wheat was submitted by the applicant and the Authority concluded that the data gap indicated in Annex II to Regulation (EC) No 396/2005 was sufficiently addressed European Food Safety Authority; Lack of confirmatory data following Article 12 MRL reviews for 2,4-DB, iodosulfuron-methyl, mesotrione, methoxyfenozide and pyraflufen-ethyl, EFSA Journal, 2023;21(5):8013. . Therefore, for these products, the existing MRLs in Annex II to Regulation (EC) No 396/2005 should be maintained, and the footnote requiring the submission of additional information should be deleted from that Annex. For swine (muscle, fat, liver, kidney), bovine (muscle, fat, liver, kidney, edible offals), sheep (muscle, fat, liver, kidney, edible offals), goat (muscle, fat, liver, kidney, edible offals), equine (muscle, fat, liver, kidney, edible offals), other farmed terrestrial animals (muscle, fat, liver, kidney, edible offals) and milk (cattle, sheep, goat, horse), although information on analytical methods was submitted by the applicant, a feeding study for ruminants is still missing. The Authority concluded that this information was not sufficient to address the data gap previously identified and recommended that risk managers consider lowering the MRLs for those products to the limit of determination (LOD)2. Therefore, it is appropriate to set the MRLs for those products in Annex II to Regulation (EC) No 396/2005 at the product-specific LOD, and to delete the footnote indicating a request for a submission additional information from that Annex.

(4) For iodosulfuron-methyl, the missing information concerning storage stability, crop metabolism and residue trials for linseeds and residue trials for maize/corn was not submitted by the applicant. The Authority therefore concluded that the data gap previously identified was not addressed European Food Safety Authority; Lack of confirmatory data following Article 12 MRL reviews for 2,4-DB, iodosulfuron-methyl, mesotrione, methoxyfenozide and pyraflufen-ethyl, EFSA Journal, 2023;21(5):8013. , and recommended that risk managers consider lowering those MRLs to the LOD. Therefore, for these products, it is appropriate to set the MRLs in Annex II to Regulation (EC) No 396/2005 at the product-specific LOD, and to delete the [footnote indicating a] request for the submission of additional information from that Annex. (5) For mesotrione, the missing information on residue trials investigating residue levels of that substance and its metabolite AMBA (free and conjugate) for sugar canes was not submitted by the applicant. The Authority therefore concluded that the data gap previously identified was not addressed European Food Safety Authority; Lack of confirmatory data following Article 12 MRL reviews for 2,4-DB, iodosulfuron-methyl, mesotrione, methoxyfenozide and pyraflufen-ethyl, EFSA Journal, 2023;21(5):8013. , and recommended that risk managers consider lowering that MRL to the LOD. Therefore, for sugar canes, it is appropriate to set the MRL in Annex II to Regulation (EC) No 396/2005 at the product-specific LOD, and to delete the requirement to submit additional information from that Annex. (6) For pyraflufen-ethyl, the missing information concerning analytical methods for hops was not submitted by the applicant. The Authority therefore concluded that the data gap previously identified was not addressed European Food Safety Authority; Lack of confirmatory data following Article 12 MRL reviews for 2,4-DB, iodosulfuron-methyl, mesotrione, methoxyfenozide and pyraflufen-ethyl, EFSA Journal, 2023;21(5):8013. , and recommended that risk managers consider lowering that MRL to the LOD. Therefore, for hops, it is appropriate to set the MRL in Annex II to Regulation (EC) No 396/2005 at the product-specific LOD, and to delete the requirement to submit additional information from that Annex. (7) The Commission consulted the European Union reference laboratories as regards the need to adapt certain LODs. Those laboratories concluded that for certain products technical developments permit the setting of lower LODs. (8) Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. (9) Regulation (EC) No 396/2005 should therefore be amended accordingly. (10) In order to allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products, which have been placed on the market before the new MRLs become applicable and for which a high level of consumer protection is maintained.

(11) A reasonable period should be allowed to elapse before the modified MRLs 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. (12) 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

Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which have been placed on the market in the Union before 6 November 2024.

Article 3

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 6 November 2024. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 15 April 2024. For the Commission The President Ursula von der Leyen

Annex

ANNEX In Annex II to Regulation (EC) No 396/2005, the columns for 2,4-DB, iodosulfuron-methyl, mesotrione and pyraflufen-ethyl are replaced by the following:

Annex

Annex II-1 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 2,4-DB (sum of 2,4-DB, its salts, its esters and its conjugates, expressed as 2,4-DB) (R) (R) The residue definition differs for the following combinations pesticide-code number: 2,4-DB-code 1000000 except 1040000: sum of 2,4-DB and its conjugates, expressed as 2,4-DB. Code numberGroups and examples of individual products to which the MRLs apply2,4-DB (sum of 2,4-DB, its salts, its esters and its conjugates, expressed as 2,4-DB) (R)Iodosulfuron-methyl (sum of iodosulfuron-methyl and its salts, expressed as iodosulfuron-methyl)MesotrionePyraflufen-ethyl (Sum of pyraflufen-ethyl and pyraflufen, expressed as pyraflufen-ethyl)0100000FRUITS, FRESH or FROZEN; TREE NUTS0,010,020110000Citrus fruits0,010,010110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,050,020120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts 0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,010,010130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0,010,010140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0,010,010151000 (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 fruitswith0,010,010161000 (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 FROZEN0,020210000Root and tuber vegetables0,010,010,010211000 (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 artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley 0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0,010,010,010220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0,010,010,010231000 (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)0,010,010,010241000 (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 0,010,010,010251010Lamb'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 0,010,010,010252010Spinaches0252020Purslanes 0252030Chards/beet leaves0252990Others (2)0253000

(c) grape leaves and similar species 0,010,010,010254000 (d) watercresses 0,010,010,010255000 (e) witloofs/Belgian endives 0,010,010,010256000 (f) herbs and edible flowers 0,020,020,020256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,010,010,010260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,010,010,010270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels 0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0,010,010,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010,010,010300000PULSES0,010,010,010,020300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,050,020,020401000Oilseeds0401010Linseeds0,010401020Peanuts/groundnuts0,010401030Poppy seeds0,010401040Sesame seeds0,010401050Sunflower seeds0,010401060Rapeseeds/canola seeds0,010401070Soyabeans0,030401080Mustard seeds0,010401090Cotton seeds0,010401100Pumpkin seeds0,01 0401110Safflower seeds0,010401120Borage seeds0,010401130Gold of pleasure seeds0,010401140Hemp seeds0,010401150Castor beans0,010401990Others (2)0,010402000Oil fruits0,010402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0,010,010,020500010Barley0,050500020Buckwheat and other pseudocereals0,010500030Maize/corn0,010500040Common millet/proso millet0,010500050Oat0,050500060Rice0,010500070Rye0,050500080Sorghum0,010500090Wheat0,050500990Others (2)0,010600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,050,050,050,10610000Teas0620000Coffee beans0630000Herbal infusions from0631000 (a) flowers 0631010Chamomile 0631020Hibiscus/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 breads0700000HOPS0,050,050,050,10800000SPICES0810000Seed spices0,050,050,050,10810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg 0810990Others (2)0820000Fruit spices0,050,050,050,10820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,050,050,050,10830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,050,050,050,10840020Ginger (10)0840030Turmeric/curcuma0,050,050,050,10840040Horseradish (11)0840990Others (2)0,050,050,050,10850000Bud spices0,050,050,050,10850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,050,050,050,10860010Saffron0860990Others (2)0870000Aril spices0,050,050,050,10870010Mace

0870990Others (2)0900000SUGAR PLANTS0,010,010,010,020900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS0,051010000Commodities from0,020,010,021011000 (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 1015010Muscle1015020Fat1015030Liver1015040Kidney1015050Edible 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)1020000Milk0,020,010,02 1020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,020,010,021030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,050,050,051050000Amphibians and Reptiles0,020,010,021060000Terrestrial invertebrate animals0,020,010,021070000Wild terrestrial vertebrate animals0,020,010,021100000PRODUCTS 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)