Commission Regulation (EU) 2024/376

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/EEC^note, and in particular Article 14(1), point (a), and Article 18(1), point (b) thereof,Whereas:

(1)For the active substance indoxacarb, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.

(2)In the context of the procedure for the renewal of the approval of indoxacarb in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council^note, the European Food Safety Authority (‘the Authority’) published a conclusion on the peer review of the risk assessment of that active substance^note, establishing a lower acceptable daily intake (‘ADI’) and a lower acute reference dose (‘ARfD’).

(3)The approval of the active substance indoxacarb expired on 19 December 2021 and was non-renewed^note. All authorisations for plant protection products containing that active substance have been revoked.

(4)In accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to provide a reasoned opinion on the risks that the current MRLs for indoxacarb based on import tolerances and Codex maximum residue limits (‘CXLs’) may pose to consumers in light of the lower ADI and ARfD. In its reasoned opinion^note, the Authority identified unacceptable risks concerning the current MRLs based on CXLs for apples, pears, apricots, cherries, peaches, plums, table and wine grapes, tomatoes, peppers, aubergines, cucumbers, gherkins, courgettes, melons, pumpkins, watermelons, broccoli, cauliflower and lettuce. Therefore, MRLs for these products should be lowered to the relevant limit of determination (LOD) in Annex II to Regulation (EC) No 396/2005.

(5)Furthermore, in its conclusion^note on the peer review published in the context of the procedure for the renewal of the approval of indoxacarb, the Authority explained that, due to insufficient data on the toxicity and genotoxicity of various metabolites and degradation products formed during processing at high temperature, risks for human health could not be excluded. Therefore, further decision by risk managers was needed. For products that are usually processed at high temperature, the MRLs based on CXLs cannot be confirmed as being safe for consumers. This concerns the MRLs for basil, potatoes, sweet corn, beans (dry), peas (dry), peanuts, soya beans, cotton seeds, as well as for fat, liver, kidney and edible offal of swine, bovine, sheep, goat and equine, for poultry tissues, milks and eggs. Therefore, MRLs for these products should be lowered to the relevant LOD in Annex II to Regulation (EC) No 396/2005 in accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1), point (a), thereof. For products that are usually not processed at high temperature, and thus for which those metabolites and degradation products would not be formed, existing MRLs based on CXLs can be maintained. This concerns the MRLs for cranberries and teas. Therefore, the MRLs for cranberries and teas should be maintained in Annex II to Regulation (EC) No 396/2005. Additionally, as the MRLs on apples, broccoli, cauliflowers, rucola, baby leaf crops, poultry tissues and eggs are set at the product specific LODs, there is no longer a need for confirmatory data. Therefore, all footnotes containing requests for confirmatory data should be deleted.

(6)As regards products for which no import tolerances or CXLs exist, MRLs should be set at the product specific LOD or the default MRL should apply, as provided for in Article 18(1), point (b), of Regulation (EC) No 396/2005.

(7)The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs. For all the active substances covered by this Regulation, those laboratories proposed product specific LODs that are analytically achievable.

(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)Annexes II and V to Regulation (EC) No 396/2005 should therefore be amended accordingly.

(10)A reasonable period should be allowed to elapse before the new 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.

(11)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.It shall apply from 14 August 2024.

In Annex II to Regulation (EC) No 396/2005, the column for indoxacarb is replaced by the following:

‘Pesticide residues and maximum residue levels (mg/kg)^note^noteIndoxacarb (sum of indoxacarb and its R enantiomer) (F)(F)Fat soluble’Code numberGroups and examples of individual products to which the MRLs apply^noteIndoxacarb (sum of indoxacarb and its R enantiomer)(F)(1)(2)(3)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,01^note0110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,01^note0120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,01^note0130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0,01^note0140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0151000

(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

Others (2)

0,01^note0151010Table grapes0151020Wine grapes01520000,01^note01530000,01^note0153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)01540000154010Blueberries0,01^note0154020Cranberries10154030Currants (black, red and white)0,01^note0154040Gooseberries (green, red and yellow)0,01^note0154050Rose hips0,01^note0154060Mulberries (black and white)0,01^note0154070Azaroles/Mediterranean medlars0,01^note0154080Elderberries0,01^note0154990Others (2)0,01^note0160000Miscellaneous fruitswith0,01^note01610000161010Dates0161020Figs0161030Table 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 FROZEN0210000Root and tuber vegetables0,01^note021100002120000212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)02130000213010Beetroots0213020Carrots0213030Celeriacs/turnip rooted celeries0213040Horseradishes0213050Jerusalem artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0,01^note0220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0,01^note02310000231010Tomatoes0231020Sweet peppers/bell peppers0231030Aubergines/eggplants0231040Okra/lady's fingers0231990Others (2)02320000232010Cucumbers0232020Gherkins0232030Courgettes023299002330000233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)023400002390000240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,01^note02410000241010Broccoli0241020Cauliflowers0241990Others (2)02420000242010Brussels sprouts0242020Head cabbages0242990Others (2)02430000243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)02440000250000Leaf vegetables, herbs and edible flowers02510000,01^note0251010Lamb's lettuces/corn salads0251020Lettuces0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2)02520000,01^note0252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)02530000,01^note02540000,01^note02550000,01^note02560000,02^note0256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,01^note0260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,01^note0270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0,01^note0280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,01^note0300000PULSES0,01^note0300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,01^note0401000Oilseeds0401010Linseeds0401020Peanuts/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)0500000CEREALS0,01^note0500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0610000Teas50620000Coffee beans0,05^note0630000Herbal infusions from0,05^note06310000631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)06320000632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)06330000633010Valerian0633020Ginseng0633990Others (2)06390000640000Cocoa beans0,05^note0650000Carobs/Saint John's breads0,05^note0700000HOPS0,05^note0800000SPICES0810000Seed spices0,05^note0810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,05^note0820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,05^note0830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,05^note0840020Ginger (10)0840030Turmeric/curcuma0,05^note0840040Horseradish (11)0840990Others (2)0,05^note0850000Bud spices0,05^note0850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,05^note0860010Saffron0860990Others (2)0870000Aril spices0,05^note0870010Mace0870990Others (2)0900000SUGAR PLANTS0,01^note0900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,01^note10110001011010Muscle1011020Fat1011030Liver1011040Kidney1011050Edible 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)1020000Milk0,01^note1020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,01^note1030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,05^note1050000Amphibians and Reptiles0,01^note1060000Terrestrial invertebrate animals0,01^note1070000Wild terrestrial vertebrate animals0,01^note1100000PRODUCTS 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)

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