Commission Regulation (EU) 2024/2711of 22 October 2024amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for thiacloprid in or on certain products(Text with EEA relevance)

Commission Regulation (EU) 2024/2711 of 22 October 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 thiacloprid 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/2005/396/2024-02-26. , 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 consumers EFSA (European Food Safety Authority), 2014. Reasoned opinion on the review of the existing maximum residue levels (MRLs) for thiacloprid according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2014;12(3):3617, https://doi:10.2903/j.efsa.2014.3617. . Commission Regulation (EU) 2015/1200 Commission Regulation (EU) 2015/1200 of 22 July 2015 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 amidosulfuron, fenhexamid, kresoxim-methyl, thiacloprid and trifloxystrobin in or on certain products (OJ L 195, 23.7.2015, p. 1, ELI: http://data.europa.eu/eli/reg/2015/1200/oj). included these MRLs in Annex II to Regulation (EC) No 396/2005. (2) In 2020, the approval of this active substance was not renewed Commission Implementing Regulation (EU) 2020/23 of 13 January 2020 concerning the non-renewal of the approval of the active substance thiacloprid, 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 the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 8, 14.1.2020, p. 8, ELI: http://data.europa.eu/eli/reg_impl/2020/23/oj). on the basis of 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 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, ELI: http://data.europa.eu/eli/reg/2009/1107/2022-11-21. , 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 thiacloprid EFSA (European Food Safety Authority), 2019. Conclusion on pesticides peer review. Peer review of the pesticide risk assessment of the active substance thiacloprid. EFSA Journal 2019;17(3): e05595, https://doi.org/10.2903/j.efsa.2019.5595.

and its classification, in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/2023-12-01). , 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 1107/2009 Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33, ELI: http://data.europa.eu/eli/reg/2018/605/2018-04-20). . The Authority noted, however, that thiacloprid was considered to meet the criteria for endocrine disrupting properties set out in 2013 EFSA (European Food Safety Authority) Scientific Committee, 2013. Scientific Opinion on the hazard assessment of endocrine disruptors: scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment. EFSA Journal 2013;11(3):3132.84, https://doi: 10.2903/j.efsa.2013.3132. and the WHO definition for endocrine disruptors WHO/IPCS (World Health Organization/International Programme on Chemical Safety), 2002. Global Assessment of the State-of-the-science of Endocrine Disruptors. WHO/PCS/EDC/02.2, https://iris.who.int/bitstream/handle/10665/67357/WHO_PCS_EDC_02.2.pdf?sequence=1. , 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 statement EFSA (European Food Safety Authority) 2023; Statement on the short-term (acute) dietary risk assessment and evaluation of confirmatory data for certain maximum residue levels (MRLs) for thiacloprid. EFSA Journal 2023;21(3):7888, https://doi.org/10.2903/j.efsa.2023.7888.

, 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 threshold EFSA (European Food Safety Authority) 2010; Scientific report of the Endocrine Active Substances Task Force. EFSA Journal 2010;8(11):1932, https://doi.org/10.2903/j.efsa.2010.1932. . 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 Authority

EFSA (European Food Safety Authority) 2024; The 2022 European Union report on pesticide residues in food. EFSA Journal 2024;22:e8753, https://doi.org/10.2903/j.efsa.2024.8753. . (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. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 22 October 2024. For the Commission The President Ursula von der Leyen

Annex

ANNEX Annexes II and V to Regulation (EC) No 396/2005 are amended as follows: (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) 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. Code numberGroups and examples of individual products to which the MRLs applyThiacloprid(1)(2)(3)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,010110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,020120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,010130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2) 0140000Stone fruits0,010140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0,010151000 (a) grapes 0151010Table grapes0151020Wine grapes0152000 (b) strawberries 0153000 (c) cane fruits 0153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000 (d) other small fruits and berries 0154010Blueberries0154020Cranberries0154030Currants (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/lychees0162030Passionfruits/maracujas 0162040Prickly 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 parsley0213080Radishes0213090Salsifies0213100Swedes/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 0232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (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 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 organisms0,010300000PULSES0,010300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,020401000Oilseeds0401010Linseeds0401020Peanuts/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 CAROBS0,050610000Teas0620000Coffee 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 breads 0700000HOPS0,050800000SPICES0810000Seed 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

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 1017010Muscle1017020Fat1017030Liver1017040Kidney1017050Edible offals (other than liver and kidney)1017990Others (2)1020000Milk0,011020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,021030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (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)