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), Article 18(1), and Article 49(2) thereof,Whereas:
(1)For the active substance thiacloprid, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. The European Food Safety Authority (the ‘Authority’) reviewed these MRLs in accordance with Article 12 of Regulation (EC) No 396/2005 and recommended MRLs which it found to be safe for consumersnote. Commission Regulation (EU) 2015/1200note included these MRLs in Annex II to Regulation (EC) No 396/2005.
(2)In 2020, the approval of this active substance was not renewednote on the basis of Regulation (EC) No 1107/2009 of the European Parliament and of the Councilnote, in view of the critical concerns identified by the Authority in the conclusions of the peer review in relation to the contamination of groundwater with potential carcinogenic metabolites of thiaclopridnote and its classification, in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Councilnote, as toxic for reproduction category 1B. Since the substance did not fulfil the approval criteria, the Authority did not consider it necessary to finalise the assessment of the possible endocrine disrupting properties of thiacloprid on the basis of the most recent criteria in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009note. The Authority noted, however, that thiacloprid was considered to meet the criteria for endocrine disrupting properties set out in 2013note and the WHO definition for endocrine disruptorsnote, since it causes adverse effects on the reproductive and endocrine system through an endocrine mode of action.
(3)All existing authorisations for plant protection products containing thiacloprid have been revoked. It is therefore appropriate to delete the existing MRLs set out for this active substance in Annex II of Regulation (EC) No 396/2005 in accordance with Article 17 of that Regulation in conjunction with Article 14(1), point (a) thereof. In view of the new toxicological reference values, in particular a lower acute reference dose, as proposed in the conclusion of the peer review, the Commission requested the Authority to provide a statement under Article 43 of Regulation (EC) No 396/2005 containing a short-term (acute) dietary risk assessment for the MRLs that are based on non-EU uses, being those that are based on import tolerance requests and those that are based on Codex maximum residue limits (‘CXLs’) set in 2007.
(4)In its statementnote, the Authority identified a risk for consumers concerning the CXLs for peaches and sweet peppers/bell peppers. It is therefore appropriate to lower the MRLs for those products to the product-specific limits of determination (‘LODs’). For the MRLs for papayas and tea, which were derived from import tolerances, and for the MRLs for quinces, medlars, loquats/Japanese medlars, apricots, cherries (sweet), plums, strawberries, ‘cane fruits’, ‘other small fruits and berries’, kiwis, potatoes, tomatoes, aubergines/eggplants, ‘cucurbits with edible peel’, melons, watermelons, rapeseeds/canola seeds, mustards seeds, rice, wheat, ‘animal (swine, bovine, sheep, horse, and other farm animals) products from tissues (muscle, liver, kidney and edible offal)’, poultry (muscle, liver and edible offal), milk and eggs, which are based on CXLs, the Authority did not identify an acute risk for the consumers but concluded that further consideration by risk managers was required.
(5)The risk assessment carried out by the Authority was based on existing toxicological reference values. These toxicological reference values do not necessarily reflect endocrine-related effects because they were not assessed according to the new EU criteria established in 2018 (8). Furthermore, endocrine-related effects frequently occur at low-dose levels and endocrine disruptor substances often do not have a safe thresholdnote. As a result, there remain reasonable grounds for concern that the MRLs that are based on non-EU uses have potentially harmful effects on human health and are inconsistent with the high level of consumer protection in the Union. The Commission has therefore requested the Authority to carry out an additional assessment for thiacloprid taking into account the most recent criteria for endocrine disruptors.
(6)Pending the conclusion of this additional risk assessment by the Authority, and given the available pertinent information with regard to potentially harmful effects on human health, it is appropriate to provisionally lower the MRLs that are based on non-EU uses. These MRLs will be reviewed once the assessment by the Authority is concluded.
(7)The Commission consulted the European Union reference laboratories for residues of thiacloprid as regards the need to adapt certain LODs. Those laboratories proposed product specific LODs that are analytically achievable for all products.
(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)Regulation (EC) No 396/2005 should therefore be amended accordingly.
(10)To allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products which have been placed on the market in the Union before the new MRLs become applicable, except for pears, peaches, raspberries (red and yellow), sweet peppers/bell peppers, Chinese cabbages/pe-tsai and lettuces for which an acute risk to consumers was identified. This transitional measure is justified and proportionate given the limited range of products for which such a period would effectively apply (mainly long shelf life products and not fresh perishable products) and the low exposure of consumers from such products, as evidenced by recent monitoring data representative for the market collected by the Authoritynote.
(11)A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs.
(12)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#
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 12 May 2025, except for pears, peaches, raspberries (red and yellow), sweet peppers/bell peppers, Chinese cabbages/pe-tsai and lettuces.
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 12 May 2025.
(1)in Annex II the column for thiacloprid is deleted.
(2)in Annex V the following column for thiacloprid is added:‘Pesticide residues and maximum residue levels (mg/kg)notenote(+)Pesticide-product combination for which a footnote exists. The list of footnotes is provided below.’Code numberGroups and examples of individual products to which the MRLs applynoteThiacloprid(1)(2)(3)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,01note0110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,02note0120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,01note0130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0,01note0140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0,01note0151000
(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 fruitswith0,01note01610000161010Dates0161020Figs0161030Table 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 vegetables0,01note021100002120000212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)02130000213010Beetroots0213020Carrots0213030Celeriacs/turnip rooted celeries0213040Horseradishes0213050Jerusalem artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0,01note0220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0,01note02310000231010Tomatoes0231020Sweet peppers/bell peppers0231030Aubergines/eggplants0231040Okra/lady's fingers0231990Others (2)02320000232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)02330000233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)023400002390000240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,01note02410000241010Broccoli0241020Cauliflowers0241990Others (2)02420000242010Brussels sprouts0242020Head cabbages0242990Others (2)02430000243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)02440000250000Leaf vegetables, herbs and edible flowers02510000,01note0251010Lamb's lettuces/corn salads0251020Lettuces0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2)02520000,01note0252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)02530000,01note02540000,01note02550000,01note02560000,02note0256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,01note0260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,01note0270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0,01note0280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,01note0300000PULSES0,01note0300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,02note0401000Oilseeds0401010Linseeds0401020Peanuts/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)0500000CEREALS0,01note0500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,05note0610000Teas0620000Coffee beans0630000Herbal infusions from06310000631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)06320000632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)06330000633010Valerian0633020Ginseng0633990Others (2)06390000640000Cocoa beans0650000Carobs/Saint John's breads0700000HOPS0,05note0800000SPICES0810000Seed 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 PLANTS0,01note0900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,01note10110001011010Muscle1011020Fat1011030Liver1011040Kidney1011050Edible 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)1020000Milk0,01note1020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,02note1030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (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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