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), 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 2023note. All authorisations for plant protection products containing that active substance will have been revoked by 1 November 2023.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 Councilnote, the European Food Safety Authority (‘the Authority’) published a conclusion on the peer review of the risk assessment of that active substancenote, 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 opinionnote, 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.
(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)notenoteCode numberGroups and examples of individual products to which the MRLs applynoteOxamyl(1)(2)(3)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0110010Grapefruits0,001note0110020Oranges0,002note0110030Lemons0,001note0110040Limes0,001note0110050Mandarins0,001note0110990Others (2)0,002note0120000Tree nuts0,01note0120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,001note0130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0,001note0140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0,001note0151000
(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 fruitswith01610000161010Dates0,001note0161020Figs0,001note0161030Table olives0,01note0161040Kumquats0,001note0161050Carambolas0,001note0161060Kaki/Japanese persimmons0,001note0161070Jambuls/jambolans0,001note0161990Others (2)0,001note01620000,001note0162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)01630000163010Avocados0,005note0163020Bananas0,001note0163030Mangoes0,001note0163040Papayas0,001note0163050Granate apples/pomegranates0,001note0163060Cherimoyas0,001note0163070Guavas0,001note0163080Pineapples0,001note0163090Breadfruits0,001note0163100Durians0,001note0163110Soursops/guanabanas0,001note0163990Others (2)0,001note0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0,001note021100002120000212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)02130000213010Beetroots0213020Carrots0213030Celeriacs/turnip rooted celeries0213040Horseradishes0213050Jerusalem artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0,001note0220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables02310000231010Tomatoes0,002note0231020Sweet peppers/bell peppers0,001note0231030Aubergines/eggplants0,001note0231040Okra/lady's fingers0,001note0231990Others (2)0,002note02320000,001note0232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)02330000,001note0233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)02340000,001note02390000,001note0240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,001note02410000241010Broccoli0241020Cauliflowers0241990Others (2)02420000242010Brussels sprouts0242020Head cabbages0242990Others (2)02430000243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)02440000250000Leaf vegetables, herbs and edible flowers0,001note02510000251010Lamb's lettuces/corn salads0251020Lettuces0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2)02520000252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)02530000254000025500002560000256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,001note0260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,001note0270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0,001note0280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,001note0300000PULSES0,01note0300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,01note0401000Oilseeds0401010Linseeds0401020Peanuts/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)0500000CEREALS0,005note0500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0610000Teas0,05note0620000Coffee beans0,05note0630000Herbal infusions from0,05note06310000631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)06320000632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)06330000633010Valerian0633020Ginseng0633990Others (2)06390000640000Cocoa beans0,01note0650000Carobs/Saint John's breads0,05note0700000HOPS0,05note0800000SPICES0810000Seed spices0,05note0810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,05note0820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,05note0830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,05note0840020Ginger (10)0840030Turmeric/curcuma0,05note0840040Horseradish (11)0840990Others (2)0,05note0850000Bud spices0,05note0850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,05note0860010Saffron0860990Others (2)0870000Aril spices0,05note0870010Mace0870990Others (2)0900000SUGAR PLANTS0,001note0900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from10110001011010Muscle0,005note1011020Fat0,01note1011030Liver0,01note1011040Kidney0,01note1011050Edible offals (other than liver and kidney)0,01note1011990Others (2)0,01note10120001012010Muscle0,005note1012020Fat0,01note1012030Liver0,01note1012040Kidney0,01note1012050Edible offals (other than liver and kidney)0,01note1012990Others (2)0,01note10130001013010Muscle0,005note1013020Fat0,01note1013030Liver0,01note1013040Kidney0,01note1013050Edible offals (other than liver and kidney)0,01note1013990Others (2)0,01note10140001014010Muscle0,005note1014020Fat0,01note1014030Liver0,01note1014040Kidney0,01note1014050Edible offals (other than liver and kidney)0,01note1014990Others (2)0,01note10150001015010Muscle0,005note1015020Fat0,01note1015030Liver0,01note1015040Kidney0,01note1015050Edible offals (other than liver and kidney)0,01note1015990Others (2)0,01note10160001016010Muscle0,005note1016020Fat0,01note1016030Liver0,01note1016040Kidney0,01note1016050Edible offals (other than liver and kidney)0,01note1016990Others (2)0,01note10170001017010Muscle0,005note1017020Fat0,01note1017030Liver0,01note1017040Kidney0,01note1017050Edible offals (other than liver and kidney)0,01note1017990Others (2)0,01note1020000Milk1020010Cattle0,001note1020020Sheep0,01note1020030Goat0,01note1020040Horse0,01note1020990Others (2)0,01note1030000Birds eggs0,005note1030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,05note1050000Amphibians and Reptiles0,01note1060000Terrestrial invertebrate animals0,01note1070000Wild terrestrial vertebrate animals0,01note1100000PRODUCTS 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)
Annexes II and V to Regulation (EC) No 396/2005 are amended as follows:
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