COMMISSION REGULATION (EU) 2024/331

| Official Journal of the European Union | EN Series L ---|---|--- * * * | 2024/331 | 22.1.2024 ---|---|--- COMMISSION REGULATION (EU) 2024/331 of 19 January 2024 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for oxamyl 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 (1), and in particular Article 14(1), point (a) and Article 18(1), point (b), thereof, Whereas: (1) | For the active substance oxamyl, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. ---|--- (2) | The approval of the active substance oxamyl expired on 1 May 2023 (2). All authorisations for plant protection products containing that active substance will have been revoked by 1 November 2023. ---|--- (3) | In the context of the procedure for the renewal of the approval of that active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (3), the European Food Safety Authority (‘the Authority’) published a conclusion on the peer review of the risk assessment of that active substance (4), establishing a lower acceptable daily intake (ADI) and a lower acute reference dose (ARfD). ---|--- (4) | In accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to provide a reasoned opinion, assessing the risks that the current MRLs, including those based on Codex maximum residue limits (CXLs), for oxamyl, may pose to consumers in light of those lower ADI and ARfD. ---|--- (5) | In its reasoned opinion (5), the Authority identified unacceptable chronic exposure risks for a wide range of diets, as well as acute exposure risks for a wide range of commodities, including for melons and watermelons for which MRLs are set on the basis of CXLs. Therefore, no MRL can be maintained and MRLs for oxamyl in all products should be set at the respective limits of determination (LOD), which should be set in Annex V to Regulation (EC) No 396/2005 in accordance with Article 18(1), point (b) of that Regulation. Additionally, the footnotes indicating lack of information on storage stability, crop metabolism and residue trials should be deleted. ---|--- (6) | Additionally, the Authority identified that the default LOD value of 0,01* mg/kg does not provide a sufficient level of protection for consumers for most commodities, so that the LOD for these products should be set at lower, more protective levels. ---|--- (7) | The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs. 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) | Annex 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 Annexes II and V to Regulation (EC) No 396/2005 are 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 11 May 2024. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 19 January 2024. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 70, 16.3.2005, p. 1. (2) Commission Implementing Regulation (EU) 2023/741 of 5 April 2023 concerning the non-renewal of the approval of the active substance oxamyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 98, 11.4.2023, p. 1). (3) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 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). (4) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance oxamyl. EFSA Journal 2022;20(5):7296. (5) European Food Safety Authority; Statement on the risk assessment of maximum residue levels (MRLs) for oxamyl in view of consumer protection. EFSA Journal 2023;21(3):7823. * * * ANNEX Annexes II and V to Regulation (EC) No 396/2005 are amended as follows: (1) | in Annex II, the column for oxamyl is deleted; ---|--- (2) | in Annex V, the following column for oxamyl is added: ‘ Pesticide residues and maximum residue levels (mg/kg) | Code number | Groups and examples of individual products to which the MRLs apply (1) | Oxamyl ---|---|--- (1) | (2) | (3) 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | 0110000 | Citrus fruits | 0110010 | Grapefruits | 0,001 ((*)) 0110020 | Oranges | 0,002 ((*)) 0110030 | Lemons | 0,001 ((*)) 0110040 | Limes | 0,001 ((*)) 0110050 | Mandarins | 0,001 ((*)) 0110990 | Others (2) | 0,002 ((*)) 0120000 | Tree nuts | 0,01 ((*)) 0120010 | Almonds | 0120020 | Brazil nuts | 0120030 | Cashew nuts | 0120040 | Chestnuts | 0120050 | Coconuts | 0120060 | Hazelnuts/cobnuts | 0120070 | Macadamias | 0120080 | Pecans | 0120090 | Pine nut kernels | 0120100 | Pistachios | 0120110 | Walnuts | 0120990 | Others (2) | 0130000 | Pome fruits | 0,001 ((*)) 0130010 | Apples | 0130020 | Pears | 0130030 | Quinces | 0130040 | Medlars | 0130050 | Loquats/Japanese medlars | 0130990 | Others (2) | 0140000 | Stone fruits | 0,001 ((*)) 0140010 | Apricots | 0140020 | Cherries (sweet) | 0140030 | Peaches | 0140040 | Plums | 0140990 | Others (2) | 0150000 | Berries and small fruits | 0,001 ((*)) 0151000 | | (a) | grapes ---|--- 0151010 | Table grapes | 0151020 | Wine grapes | 0152000 | | (b) | strawberries ---|--- 0153000 | | (c) | cane fruits ---|--- 0153010 | Blackberries | 0153020 | Dewberries | 0153030 | Raspberries (red and yellow) | 0153990 | Others (2) | 0154000 | | (d) | other small fruits and berries ---|--- 0154010 | Blueberries | 0154020 | Cranberries | 0154030 | Currants (black, red and white) | 0154040 | Gooseberries (green, red and yellow) | 0154050 | Rose hips | 0154060 | Mulberries (black and white) | 0154070 | Azaroles/Mediterranean medlars | 0154080 | Elderberries | 0154990 | Others (2) | 0160000 | Miscellaneous fruitswith | 0161000 | | (a) | edible peel ---|--- 0161010 | Dates | 0,001 ((*)) 0161020 | Figs | 0,001 ((*)) 0161030 | Table olives | 0,01 ((*)) 0161040 | Kumquats | 0,001 ((*)) 0161050 | Carambolas | 0,001 ((*)) 0161060 | Kaki/Japanese persimmons | 0,001 ((*)) 0161070 | Jambuls/jambolans | 0,001 ((*)) 0161990 | Others (2) | 0,001 ((*)) 0162000 | | (b) | inedible peel, small ---|--- 0,001 ((*)) 0162010 | Kiwi fruits (green, red, yellow) | 0162020 | Litchis/lychees | 0162030 | Passionfruits/maracujas | 0162040 | Prickly pears/cactus fruits | 0162050 | Star apples/cainitos | 0162060 | American persimmons/Virginia kaki | 0162990 | Others (2) | 0163000 | | (c) | inedible peel, large ---|--- 0163010 | Avocados | 0,005 ((*)) 0163020 | Bananas | 0,001 ((*)) 0163030 | Mangoes | 0,001 ((*)) 0163040 | Papayas | 0,001 ((*)) 0163050 | Granate apples/pomegranates | 0,001 ((*)) 0163060 | Cherimoyas | 0,001 ((*)) 0163070 | Guavas | 0,001 ((*)) 0163080 | Pineapples | 0,001 ((*)) 0163090 | Breadfruits | 0,001 ((*)) 0163100 | Durians | 0,001 ((*)) 0163110 | Soursops/guanabanas | 0,001 ((*)) 0163990 | Others (2) | 0,001 ((*)) 0200000 | VEGETABLES, FRESH or FROZEN | 0210000 | Root and tuber vegetables | 0,001 ((*)) 0211000 | | (a) | potatoes ---|--- 0212000 | | (b) | tropical root and tuber vegetables ---|--- 0212010 | Cassava roots/manioc | 0212020 | Sweet potatoes | 0212030 | Yams | 0212040 | Arrowroots | 0212990 | Others (2) | 0213000 | | (c) | other root and tuber vegetables except sugar beets ---|--- 0213010 | Beetroots | 0213020 | Carrots | 0213030 | Celeriacs/turnip rooted celeries | 0213040 | Horseradishes | 0213050 | Jerusalem artichokes | 0213060 | Parsnips | 0213070 | Parsley roots/Hamburg roots parsley | 0213080 | Radishes | 0213090 | Salsifies | 0213100 | Swedes/rutabagas | 0213110 | Turnips | 0213990 | Others (2) | 0220000 | Bulb vegetables | 0,001 ((*)) 0220010 | Garlic | 0220020 | Onions | 0220030 | Shallots | 0220040 | Spring onions/green onions and Welsh onions | 0220990 | Others (2) | 0230000 | Fruiting vegetables | 0231000 | | (a) | Solanaceae and Malvaceae ---|--- 0231010 | Tomatoes | 0,002 ((*)) 0231020 | Sweet peppers/bell peppers | 0,001 ((*)) 0231030 | Aubergines/eggplants | 0,001 ((*)) 0231040 | Okra/lady's fingers | 0,001 ((*)) 0231990 | Others (2) | 0,002 ((*)) 0232000 | | (b) | cucurbits with edible peel ---|--- 0,001 ((*)) 0232010 | Cucumbers | 0232020 | Gherkins | 0232030 | Courgettes | 0232990 | Others (2) | 0233000 | | (c) | cucurbits with inedible peel ---|--- 0,001 ((*)) 0233010 | Melons | 0233020 | Pumpkins | 0233030 | Watermelons | 0233990 | Others (2) | 0234000 | | (d) | sweet corn ---|--- 0,001 ((*)) 0239000 | | (e) | other fruiting vegetables ---|--- 0,001 ((*)) 0240000 | Brassica vegetables(excluding brassica roots and brassica baby leaf crops) | 0,001 ((*)) 0241000 | | (a) | flowering brassica ---|--- 0241010 | Broccoli | 0241020 | Cauliflowers | 0241990 | Others (2) | 0242000 | | (b) | head brassica ---|--- 0242010 | Brussels sprouts | 0242020 | Head cabbages | 0242990 | Others (2) | 0243000 | | (c) | leafy brassica ---|--- 0243010 | Chinese cabbages/pe-tsai | 0243020 | Kales | 0243990 | Others (2) | 0244000 | | (d) | kohlrabies ---|--- 0250000 | Leaf vegetables, herbs and edible flowers | 0,001 ((*)) 0251000 | | (a) | lettuces and salad plants ---|--- 0251010 | Lamb's lettuces/corn salads | 0251020 | Lettuces | 0251030 | Escaroles/broad-leaved endives | 0251040 | Cresses and other sprouts and shoots | 0251050 | Land cresses | 0251060 | Roman rocket/rucola | 0251070 | Red mustards | 0251080 | Baby leaf crops (including brassica species) | 0251990 | Others (2) | 0252000 | | (b) | spinaches and similar leaves ---|--- 0252010 | Spinaches | 0252020 | Purslanes | 0252030 | Chards/beet leaves | 0252990 | Others (2) | 0253000 | | (c) | grape leaves and similar species ---|--- 0254000 | | (d) | watercresses ---|--- 0255000 | | (e) | witloofs/Belgian endives ---|--- 0256000 | | (f) | herbs and edible flowers ---|--- 0256010 | Chervil | 0256020 | Chives | 0256030 | Celery leaves | 0256040 | Parsley | 0256050 | Sage | 0256060 | Rosemary | 0256070 | Thyme | 0256080 | Basil and edible flowers | 0256090 | Laurel/bay leaves | 0256100 | Tarragon | 0256990 | Others (2) | 0260000 | Legume vegetables | 0,001 ((*)) 0260010 | Beans (with pods) | 0260020 | Beans (without pods) | 0260030 | Peas (with pods) | 0260040 | Peas (without pods) | 0260050 | Lentils | 0260990 | Others (2) | 0270000 | Stem vegetables | 0,001 ((*)) 0270010 | Asparagus | 0270020 | Cardoons | 0270030 | Celeries | 0270040 | Florence fennels | 0270050 | Globe artichokes | 0270060 | Leeks | 0270070 | Rhubarbs | 0270080 | Bamboo shoots | 0270090 | Palm hearts | 0270990 | Others (2) | 0280000 | Fungi, mosses and lichens | 0,001 ((*)) 0280010 | Cultivated fungi | 0280020 | Wild fungi | 0280990 | Mosses and lichens | 0290000 | Algae and prokaryotes organisms | 0,001 ((*)) 0300000 | PULSES | 0,01 ((*)) 0300010 | Beans | 0300020 | Lentils | 0300030 | Peas | 0300040 | Lupins/lupini beans | 0300990 | Others (2) | 0400000 | OILSEEDS AND OIL FRUITS | 0,01 ((*)) 0401000 | Oilseeds | 0401010 | Linseeds | 0401020 | Peanuts/groundnuts | 0401030 | Poppy seeds | 0401040 | Sesame seeds | 0401050 | Sunflower seeds | 0401060 | Rapeseeds/canola seeds | 0401070 | Soyabeans | 0401080 | Mustard seeds | 0401090 | Cotton seeds | 0401100 | Pumpkin seeds | 0401110 | Safflower seeds | 0401120 | Borage seeds | 0401130 | Gold of pleasure seeds | 0401140 | Hemp seeds | 0401150 | Castor beans | 0401990 | Others (2) | 0402000 | Oil fruits | 0402010 | Olives for oil production | 0402020 | Oil palms kernels | 0402030 | Oil palms fruits | 0402040 | Kapok | 0402990 | Others (2) | 0500000 | CEREALS | 0,005 ((*)) 0500010 | Barley | 0500020 | Buckwheat and other pseudocereals | 0500030 | Maize/corn | 0500040 | Common millet/proso millet | 0500050 | Oat | 0500060 | Rice | 0500070 | Rye | 0500080 | Sorghum | 0500090 | Wheat | 0500990 | Others (2) | 0600000 | TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS | 0610000 | Teas | 0,05 ((*)) 0620000 | Coffee beans | 0,05 ((*)) 0630000 | Herbal infusions from | 0,05 ((*)) 0631000 | | (a) | flowers ---|--- 0631010 | Chamomile | 0631020 | Hibiscus/roselle | 0631030 | Rose | 0631040 | Jasmine | 0631050 | Lime/linden | 0631990 | Others (2) | 0632000 | | (b) | leaves and herbs ---|--- 0632010 | Strawberry | 0632020 | Rooibos | 0632030 | Mate/maté | 0632990 | Others (2) | 0633000 | | (c) | roots ---|--- 0633010 | Valerian | 0633020 | Ginseng | 0633990 | Others (2) | 0639000 | | (d) | any other parts of the plant ---|--- 0640000 | Cocoa beans | 0,01 ((*)) 0650000 | Carobs/Saint John's breads | 0,05 ((*)) 0700000 | HOPS | 0,05 ((*)) 0800000 | SPICES | 0810000 | Seed spices | 0,05 ((*)) 0810010 | Anise/aniseed | 0810020 | Black caraway/black cumin | 0810030 | Celery | 0810040 | Coriander | 0810050 | Cumin | 0810060 | Dill | 0810070 | Fennel | 0810080 | Fenugreek | 0810090 | Nutmeg | 0810990 | Others (2) | 0820000 | Fruit spices | 0,05 ((*)) 0820010 | Allspice/pimento | 0820020 | Sichuan pepper | 0820030 | Caraway | 0820040 | Cardamom | 0820050 | Juniper berry | 0820060 | Peppercorn (black, green and white) | 0820070 | Vanilla | 0820080 | Tamarind | 0820990 | Others (2) | 0830000 | Bark spices | 0,05 ((*)) 0830010 | Cinnamon | 0830990 | Others (2) | 0840000 | Root and rhizome spices | 0840010 | Liquorice | 0,05 ((*)) 0840020 | Ginger (10) | 0840030 | Turmeric/curcuma | 0,05 ((*)) 0840040 | Horseradish (11) | 0840990 | Others (2) | 0,05 ((*)) 0850000 | Bud spices | 0,05 ((*)) 0850010 | Cloves | 0850020 | Capers | 0850990 | Others (2) | 0860000 | Flower pistil spices | 0,05 ((*)) 0860010 | Saffron | 0860990 | Others (2) | 0870000 | Aril spices | 0,05 ((*)) 0870010 | Mace | 0870990 | Others (2) | 0900000 | SUGAR PLANTS | 0,001 ((*)) 0900010 | Sugar beet roots | 0900020 | Sugar canes | 0900030 | Chicory roots | 0900990 | Others (2) | 1000000 | PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS | 1010000 | Commodities from | 1011000 | | (a) | swine ---|--- 1011010 | Muscle | 0,005 ((*)) 1011020 | Fat | 0,01 ((*)) 1011030 | Liver | 0,01 ((*)) 1011040 | Kidney | 0,01 ((*)) 1011050 | Edible offals (other than liver and kidney) | 0,01 ((*)) 1011990 | Others (2) | 0,01 ((*)) 1012000 | | (b) | bovine ---|--- 1012010 | Muscle | 0,005 ((*)) 1012020 | Fat | 0,01 ((*)) 1012030 | Liver | 0,01 ((*)) 1012040 | Kidney | 0,01 ((*)) 1012050 | Edible offals (other than liver and kidney) | 0,01 ((*)) 1012990 | Others (2) | 0,01 ((*)) 1013000 | | (c) | sheep ---|--- 1013010 | Muscle | 0,005 ((*)) 1013020 | Fat | 0,01 ((*)) 1013030 | Liver | 0,01 ((*)) 1013040 | Kidney | 0,01 ((*)) 1013050 | Edible offals (other than liver and kidney) | 0,01 ((*)) 1013990 | Others (2) | 0,01 ((*)) 1014000 | | d) | goat ---|--- 1014010 | Muscle | 0,005 ((*)) 1014020 | Fat | 0,01 ((*)) 1014030 | Liver | 0,01 ((*)) 1014040 | Kidney | 0,01 ((*)) 1014050 | Edible offals (other than liver and kidney) | 0,01 ((*)) 1014990 | Others (2) | 0,01 ((*)) 1015000 | | (e) | equine ---|--- 1015010 | Muscle | 0,005 ((*)) 1015020 | Fat | 0,01 ((*)) 1015030 | Liver | 0,01 ((*)) 1015040 | Kidney | 0,01 ((*)) 1015050 | Edible offals (other than liver and kidney) | 0,01 ((*)) 1015990 | Others (2) | 0,01 ((*)) 1016000 | | (f) | poultry ---|--- 1016010 | Muscle | 0,005 ((*)) 1016020 | Fat | 0,01 ((*)) 1016030 | Liver | 0,01 ((*)) 1016040 | Kidney | 0,01 ((*)) 1016050 | Edible offals (other than liver and kidney) | 0,01 ((*)) 1016990 | Others (2) | 0,01 ((*)) 1017000 | | (g) | other farmed terrestrial animals ---|--- 1017010 | Muscle | 0,005 ((*)) 1017020 | Fat | 0,01 ((*)) 1017030 | Liver | 0,01 ((*)) 1017040 | Kidney | 0,01 ((*)) 1017050 | Edible offals (other than liver and kidney) | 0,01 ((*)) 1017990 | Others (2) | 0,01 ((*)) 1020000 | Milk | 1020010 | Cattle | 0,001 ((*)) 1020020 | Sheep | 0,01 ((*)) 1020030 | Goat | 0,01 ((*)) 1020040 | Horse | 0,01 ((*)) 1020990 | Others (2) | 0,01 ((*)) 1030000 | Birds eggs | 0,005 ((*)) 1030010 | Chicken | 1030020 | Duck | 1030030 | Geese | 1030040 | Quail | 1030990 | Others (2) | 1040000 | Honey and other apiculture products (7) | 0,05 ((*)) 1050000 | Amphibians and Reptiles | 0,01 ((*)) 1060000 | Terrestrial invertebrate animals | 0,01 ((*)) 1070000 | Wild terrestrial vertebrate animals | 0,01 ((*)) 1100000 | PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8) | 1200000 | PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8) | 1300000 | PROCESSED FOOD PRODUCTS (9) | * * * ((*)) Indicates lower limit of analytical determination (1) For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I’ * * * ELI: http://data.europa.eu/eli/reg/2024/331/oj ISSN 1977-0677 (electronic edition) * * *