Commission Regulation (EU) 2025/146of 29 January 2025amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for zoxamide in or on certain products(Text with EEA relevance)

Commission Regulation (EU) 2025/146 of 29 January 2025 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for zoxamide 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), and Article 49(2) thereof, Whereas: (1) For the active substance zoxamide, maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. (2) The European Food Safety Authority (the Authority) submitted a reasoned opinion on the review of the existing MRLs for zoxamide in accordance with Article 12(1) of Regulation (EC) No 396/2005 and on the setting of an import tolerance for onions, garlic and shallots European Food Safety Authority; Review of the existing maximum residue levels for zoxamide according to Article 12 of Regulation (EC) No 396/2005 and setting of an import tolerance for onions, garlic and shallots; EFSA Journal 2023; 21(12):e8427. https://doi.org/10.2903/j.efsa.2023.8427. . (3) In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005, an application for import tolerance was submitted for zoxamide in onions, garlic and shallots. (4) In accordance with Article 8 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and in accordance with Article 9 of that Regulation, the evaluation report was forwarded to the Commission. (5) The Authority assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals and forwarded its reasoned opinion to the applicant, the Commission and the Member States, and made it available to the public. (6) The Authority concluded that all data requirements were met and that the modification to the MRLs requested by the applicant was acceptable on the basis of a consumer exposure assessment showing that the short-term and long-term intake of residues resulting from the use of zoxamide according to the agricultural practices on onions, garlic and shallots is unlikely to present a risk to consumer health. (7) The Authority recommended setting MRLs for potatoes, tomatoes, cucumbers, gherkins, courgettes, melons, pumpkins and watermelons, for which sufficient supporting data on good agricultural practices were submitted and assessed. As there is no risk for consumers, it is appropriate to set the MRLs for those products in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. (8) The Authority concluded that concerning the MRLs for aubergines/eggplants some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for this product should be maintained in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.

(9) For all other products, it is appropriate to set the MRLs to the product specific LOD in accordance with Article 14(1), point (a), of Regulation (EC) No 396/2005, in conjunction with Article 17 of that Regulation. (10) The Commission consulted the European Union reference laboratories for residues of zoxamide as regards the need to adapt certain LODs. Those laboratories proposed product-specific LODs that are analytically achievable for all products. (11) 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. (12) Regulation (EC) No 396/2005 should therefore be amended accordingly. (13) To allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products which have been produced and placed on the market before the new MRLs for zoxamide become applicable and for which a high level of consumer protection is maintained. This is the case for all products. (14) 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. (15) 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

Annexes II and III to Regulation (EC) No 396/2005 are 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 were placed on the market in the Union before 19 August 2025.

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 19 August 2025. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 29 January 2025. For the Commission The President Ursula von der Leyen

Annex

ANNEX Annexes II and III to Regulation (EC) No 396/2005 are amended as follows: (1) in Annex II, the column for zoxamide 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 Pesticide-product combination for which a footnote exists. The list of footnotes is provided below. Zoxamide (sum of constituent isomers) The European Food Safety Authority identified some information on residue trials 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 30 january 2027, or, if that information is not submitted by that date, the lack of it. 0231030 Aubergines/eggplants

Code numberGroups and examples of individual products to which the MRLs applyZoxamide (sum of constituent isomers)(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 50151010Table grapes0151020Wine grapes0152000 (b) strawberries 0,010153000 (c) cane fruits 0,010153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000 (d) other small fruits and berries 0,010154010Blueberries0154020Cranberries0154030Currants (black, red and white)0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruitswith0,010161000 (a) edible peel 0161010Dates0161020Figs0161030Table olives0161040Kumquats0161050Carambolas0161060Kaki/Japanese persimmons0161070Jambuls/jambolans0161990Others (2)0162000 (b) inedible peel, small 0162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees 0162030Passionfruits/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 0,010213010Beetroots0213020Carrots0213030Celeriacs/turnip rooted celeries0213040Horseradishes0213050Jerusalem artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2) 0220000Bulb vegetables0220010Garlic0,70220020Onions0,70220030Shallots0,70220040Spring onions/green onions and Welsh onions0,010220990Others (2)0,010230000Fruiting vegetables0231000 (a) Solanaceae and Malvaceae 0231010Tomatoes20231020Sweet peppers/bell peppers0,010231030Aubergines/eggplants0,50231040Okra/lady's fingers0,010231990Others (2)0,010232000 (b) cucurbits with edible peel 20232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)0233000 (c) cucurbits with inedible peel 20233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)0234000

(d) sweet corn 0,010239000 (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 flowers0,010251000 (a) lettuces and salad plants 0251010Lamb'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 0252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0254000 (d) watercresses 0255000 (e) witloofs/Belgian endives 0256000 (f) herbs and edible flowers 0256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/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 organisms0300000PULSES0,010300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,010401000Oilseeds0401010Linseeds0401020Peanuts/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)0500000CEREALS0,010500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,010610000Teas0620000Coffee beans0630000Herbal infusions from0631000 (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 cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (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 spices0,050860010Saffron0860990Others (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 1014010Muscle1014020Fat1014030Liver 1014040Kidney1014050Edible 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)1020000Milk0,011020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,011030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2) 1040000Honey and other apiculture products (7)0,21050000Amphibians 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) (2) in Part A of Annex III, the column for zoxamide is deleted.