Contents
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/EECnote, 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 addressednote. 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 addressednote, 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 addressednote, 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 addressednote, 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.
Annex II
Pesticide residues and maximum residue levels (mg/kg)
notenote2,4-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 applynote2,4-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 NUTS0,01note0,02note0110000Citrus fruits0,01note0,01note0110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,05note0,02note0120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,01note0,01note0130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0,01note0,01note0140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0,01note0,01note0151000
(a)grapes
(a)edible peel
(a)potatoes
(a)Solanaceae and Malvaceae
(a)flowering brassica
(a)lettuces and salad plants
(a)flowers
(a)swine
(b)strawberries
(b)inedible peel, small
(b)tropical root and tuber vegetables
(b)cucurbits with edible peel
(b)head brassica
(b)spinaches and similar leaves
(b)leaves and herbs
(b)bovine
(c)cane fruits
(c)inedible peel, large
(c)other root and tuber vegetables except sugar beets
(c)cucurbits with inedible peel
(c)leafy brassica
(c)grape leaves and similar species
(c)roots
(c)sheep
(d)other small fruits and berries
(d)sweet corn
(d)kohlrabies
(d)watercresses
(d)any other parts of the plant
d)goat
(e)other fruiting vegetables
(e)witloofs/Belgian endives
(e)equine
(f)herbs and edible flowers
(f)poultry
(g)other farmed terrestrial animals
0151010Table grapes0151020Wine grapes015200001530000153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)01540000154010Blueberries0154020Cranberries0154030Currants (black, red and white)0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruitswith0,01note0,01note01610000161010Dates0161020Figs0161030Table olives0161040Kumquats0161050Carambolas0161060Kaki/Japanese persimmons0161070Jambuls/jambolans0161990Others (2)01620000162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)01630000163010Avocados0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0,02note0210000Root and tuber vegetables0,01note0,01note0,01note021100002120000212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)02130000213010Beetroots0213020Carrots0213030Celeriacs/turnip rooted celeries0213040Horseradishes0213050Jerusalem artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0,01note0,01note0,01note0220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0,01note0,01note0,01note02310000231010Tomatoes0231020Sweet peppers/bell peppers0231030Aubergines/eggplants0231040Okra/lady's fingers0231990Others (2)02320000232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)02330000233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)023400002390000240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,01note0,01note0,01note02410000241010Broccoli0241020Cauliflowers0241990Others (2)02420000242010Brussels sprouts0242020Head cabbages0242990Others (2)02430000243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)02440000250000Leaf vegetables, herbs and edible flowers02510000,01note0,01note0,01note0251010Lamb's lettuces/corn salads0251020Lettuces0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2)02520000,01note0,01note0,01note0252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)02530000,01note0,01note0,01note02540000,01note0,01note0,01note02550000,01note0,01note0,01note02560000,02note0,02note0,02note0256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,01note0,01note0,01note0260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,01note0,01note0,01note0270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0,01note0,01note0,01note0280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,01note0,01note0,01note0300000PULSES0,01note0,01note0,01note0,02note0300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,05note0,02note0,02note0401000Oilseeds0401010Linseeds0,01note0401020Peanuts/groundnuts0,01note0401030Poppy seeds0,01note0401040Sesame seeds0,01note0401050Sunflower seeds0,01note0401060Rapeseeds/canola seeds0,01note0401070Soyabeans0,030401080Mustard seeds0,01note0401090Cotton seeds0,01note0401100Pumpkin seeds0,01note0401110Safflower seeds0,01note0401120Borage seeds0,01note0401130Gold of pleasure seeds0,01note0401140Hemp seeds0,01note0401150Castor beans0,01note0401990Others (2)0,01note0402000Oil fruits0,01note0402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0,01note0,01note0,02note0500010Barley0,050500020Buckwheat and other pseudocereals0,01note0500030Maize/corn0,01note0500040Common millet/proso millet0,01note0500050Oat0,050500060Rice0,01note0500070Rye0,050500080Sorghum0,01note0500090Wheat0,050500990Others (2)0,01note0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,05note0,05note0,05note0,1note0610000Teas0620000Coffee beans0630000Herbal infusions from06310000631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)06320000632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)06330000633010Valerian0633020Ginseng0633990Others (2)06390000640000Cocoa beans0650000Carobs/Saint John's breads0700000HOPS0,05note0,05note0,05note0,1note0800000SPICES0810000Seed spices0,05note0,05note0,05note0,1note0810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,05note0,05note0,05note0,1note0820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,05note0,05note0,05note0,1note0830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,05note0,05note0,05note0,1note0840020Ginger (10)0840030Turmeric/curcuma0,05note0,05note0,05note0,1note0840040Horseradish (11)0840990Others (2)0,05note0,05note0,05note0,1note0850000Bud spices0,05note0,05note0,05note0,1note0850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,05note0,05note0,05note0,1note0860010Saffron0860990Others (2)0870000Aril spices0,05note0,05note0,05note0,1note0870010Mace0870990Others (2)0900000SUGAR PLANTS0,01note0,01note0,01note0,02note0900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS0,05note1010000Commodities from0,02note0,01note0,02note10110001011010Muscle1011020Fat1011030Liver1011040Kidney1011050Edible offals (other than liver and kidney)1011990Others (2)10120001012010Muscle1012020Fat1012030Liver1012040Kidney1012050Edible offals (other than liver and kidney)1012990Others (2)10130001013010Muscle1013020Fat1013030Liver1013040Kidney1013050Edible offals (other than liver and kidney)1013990Others (2)10140001014010Muscle1014020Fat1014030Liver1014040Kidney1014050Edible offals (other than liver and kidney)1014990Others (2)10150001015010Muscle1015020Fat1015030Liver1015040Kidney1015050Edible offals (other than liver and kidney)1015990Others (2)10160001016010Muscle1016020Fat1016030Liver1016040Kidney1016050Edible offals (other than liver and kidney)1016990Others (2)10170001017010Muscle1017020Fat1017030Liver1017040Kidney1017050Edible offals (other than liver and kidney)1017990Others (2)1020000Milk0,02note0,01note0,02note1020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,02note0,01note0,02note1030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,05note0,05note0,05note1050000Amphibians and Reptiles0,02note0,01note0,02note1060000Terrestrial invertebrate animals0,02note0,01note0,02note1070000Wild terrestrial vertebrate animals0,02note0,01note0,02note1100000PRODUCTS 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)
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:
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