Commission Regulation (EU) 2024/376of 24 January 2024amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for indoxacarb in or on certain products(Text with EEA relevance)

Commission Regulation (EU) 2024/376 of 24 January 2024 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for indoxacarb 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), 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 Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309 24.11.2009, p. 1). , the European Food Safety Authority (the Authority) published a conclusion on the peer review of the risk assessment of that active substance European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance indoxacarb. EFSA Journal 2018;16(1):5140. , 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 Commission Implementing Regulation (EU) 2021/2081 of 26 November 2021 concerning the non-renewal of approval of the active substance indoxacarb, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 426, 29.11.2021, p. 28). . All authorisations for plant protection products containing that active substance have been revoked.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 European Food Safety Authority; Targeted review of maximum residues levels (MRLs) for indoxacarb. EFSA Journal 2022;20(8):7527. , 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 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance indoxacarb. EFSA Journal 2018;16(1):5140. 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. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 January 2024. For the Commission The President Ursula von der Leyen

Annex

ANNEX 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) 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 Indoxacarb (sum of indoxacarb and its R enantiomer) (F) (F) Fat soluble Code numberGroups and examples of individual products to which the MRLs applyIndoxacarb (sum of indoxacarb and its R enantiomer)(F)(1)(2)(3)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,010110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,010120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine 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 0154010Blueberries0,010154020Cranberries10154030Currants (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 vegetables0,010211000 (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 vegetables0,010220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0,010231000 (a) Solanaceae and Malvaceae 0231010Tomatoes0231020Sweet peppers/bell peppers0231030Aubergines/eggplants0231040Okra/lady's fingers0231990Others (2)0232000 (b) cucurbits with edible peel 0232010Cucumbers0232020Gherkins0232030Courgettes0232990 Others (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)0,010241000 (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 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 0,010252010Spinaches0252020Purslanes0252030Chards/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 flowers 0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,010260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,010270010Asparagus0270020Cardoons0270030Celeries0270040Florence 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 FRUITS0,010401000Oilseeds0401010Linseeds0401020Peanuts/groundnuts0401030Poppy seeds0401040Sesame seeds 0401050Sunflower seeds0401060Rapeseeds/canola seeds0401070Soyabeans0401080Mustard seeds0401090Cotton seeds0401100Pumpkin seeds0401110Safflower seeds0401120Borage seeds0401130Gold of pleasure seeds0401140Hemp seeds0401150Castor beans0401990Others (2)0402000Oil fruits0402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0,010500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0610000Teas50620000Coffee beans0,050630000Herbal infusions from0,050631000

(a) flowers 0631010Chamomile0631020Hibiscus/roselle0631030Rose 0631040Jasmine0631050Lime/linden0631990Others (2)0632000 (b) leaves and herbs 0632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)0633000 (c) roots 0633010Valerian0633020Ginseng0633990Others (2)0639000 (d) any other parts of the plant 0640000Cocoa beans0,050650000Carobs/Saint John's breads0,050700000HOPS0,050800000SPICES0810000Seed spices0,050810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,050820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla 0820080Tamarind0820990Others (2)0830000Bark spices0,050830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,050840020Ginger (10)0840030Turmeric/curcuma0,050840040Horseradish (11)0840990Others (2)0,050850000Bud spices0,050850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,050860010Saffron0860990Others (2)0870000Aril spices0,050870010Mace0870990Others (2)0900000SUGAR PLANTS0,010900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,011011000 (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 1017010Muscle1017020Fat 1017030Liver1017040Kidney1017050Edible offals (other than liver and kidney)1017990Others (2)1020000Milk0,011020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (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)