Commission Regulation (EU) 2023/1536 of 25 July 2023 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for nicotine in or on certain productsText with EEA relevance.

Commission Regulation (EU) 2023/1536 of 25 July 2023 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for nicotine 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. , and in particular Article 14(1), point (a), thereof, Whereas: (1) For nicotine, maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005. (2) The existing temporary MRL for nicotine in teas of 0,6 mg/kg was lowered by Commission Regulation (EU) 2023/377 Commission Regulation (EU) 2023/377 of 15 February 2023 amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benzalkonium chloride (BAC), chlorpropham, didecyldimethylammonium chloride (DDAC), flutriafol, metazachlor, nicotine, profenofos, quizalofop-P, sodium aluminium silicate, thiabendazole and triadimenol in or on certain products (OJ L 55, 22.2.2023, p. 1). to 0,5 mg/kg based on monitoring data which demonstrated that such a lower level is achievable. This level is to be further lowered to 0,4 mg/kg after 22 February 2026 unless modified further in light of new information provided by 30 June 2025. As the European Food Safety Authority (the Authority) had identified unacceptable risks for consumers from the existing MRL for teas European Food Safety Authority. Statement on the short-term (acute) dietary risk assessment for the temporary maximum residue levels for nicotine in rose hips, teas and capers. EFSA Journal 2022;20(9):7566. , Regulation (EU) 2023/377 did not provide for transitional arrangements for teas produced before the modification of the MRLs. (3) The Authority has received new information from Ireland pointing out that the Irish consumption data based on which the Authority identified unacceptable risks for consumers from the existing MRL for nicotine in teas did not accurately reflect exposure of Irish children and would lead to an overestimation of the risk. Based on this new information, the Authority performed a new acute (short-term) dietary risk assessment for nicotine in teas, excluding the previously considered Irish consumption data, and concluded that the current MRL of 0,6 mg/kg for nicotine in teas is safe for consumers European Food Safety Authority. Statement on the revised targeted risk assessment for certain maximum residue levels for nicotine. EFSA Journal 2023;21(3):7883. . Therefore, in order to allow for the normal marketing, processing and consumption of products, it is appropriate to provide for a transitional arrangement for teas that have been produced before the lowering of the MRL for nicotine in teas to 0,5 mg/kg, provided by Regulation (EU) 2023/377, as a high level of consumer protection is maintained.

(4) As regards nicotine in rose hips, for which the temporary MRL was lowered by Regulation (EU) 2023/377 from 0,3 mg/kg to 0,2 mg/kg, the Authority confirmed the previously identified unacceptable risks for consumers resulting from the existing MRL of 0,3 mg/kg. Therefore, no transitional arrangement can be allowed for rose hips which have been produced before the lowering of the MRL. (5) As regards nicotine in seed spices and fruit spices, temporary MRLs were set at 0,02 mg/kg by Regulation (EU) 2023/377 until 22 February 2030, pending the submission and evaluation of new data and information on the natural occurrence or formation of nicotine in those products. The Commission has received new information from the European Union Reference Laboratories noting that a limit of determination (LOD) of 0,05 mg/kg may be more appropriate for seed spices and fruit spices. Therefore, it is appropriate to establish the MRLs for these products at the LOD of 0,05 mg/kg. Those MRLs will be reviewed; the review will take into account the information available by 22 February 2030. (6) As regards nicotine in cinnamon, a temporary MRL was set at 0,07 mg/kg by Regulation (EU) 2023/377, based on a combined data set for bark spices, root and rhizome spices, bud spices, flower pistil spices and aril spices. Recently, specific monitoring data on cinnamon were submitted to the Commission, indicating that residues may occur in this product at higher levels than the temporary MRL established by Regulation (EU) 2023/377. Based on those more specific data, the temporary MRL should be set at a level of 0,2 mg/kg, corresponding to the 95th percentile of all the sample results. That MRL will be reviewed; the review will take into account additional monitoring data available by 22 February 2030. (7) Based on the relevant risk assessments of the Authority European Food Safety Authority. Reasoned Opinion on the setting of temporary MRLs for nicotine in tea, herbal infusions, spices, rose hips and fresh herbs. EFSA Journal 2011;9(3):2098. and taking into account the factors relevant to the matter under consideration, the proposed modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005. (8) For technical reasons, the amendments to the MRLs for seed spices, fruit spices and cinnamon should apply later than those of Regulation (EU) 2023/377, while the transitional provision for the new MRLs for teas as laid down in Regulation (EU) 2023/377 should apply at the same time as Regulation (EU) 2023/377, to prevent a gap in the transitional arrangement. (9) Regulation (EC) No 396/2005 should therefore be amended accordingly. (10) 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

Annex III to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this Regulation.

Article 2

Regulation (EC) No 396/2005 as it stood before being amended by Regulation (EU) 2023/377 shall continue to apply to teas which were produced in the Union or imported into the Union before 14 September 2023.

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 15 September 2023. However, Article 2 shall apply from 14 September 2023. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 25 July 2023. For the Commission The President Ursula von der Leyen

Annex

ANNEX In Part A of Annex III to Regulation (EC) No 396/2005 the column for Nicotine 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. Nicotine Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When reviewing the MRL, the Commission will take into account the information, if it is submitted by 22 February 2030, or, if that information is not submitted by that date, the lack of it. 0154050 Rose hips 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) 0630000 Herbal infusions from 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 0800000 SPICES 0810000 Seed spices 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 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 0830010 Cinnamon 0830990 Others (2) 0840000 Root and rhizome spices 0840010 Liquorice 0840030 Turmeric/curcuma 0840990 Others (2) 0850000 Bud spices 0850010 Cloves 0850020 Capers 0850990 Others (2) 0860000 Flower pistil spices 0860010 Saffron 0860990 Others (2) 0870000 Aril spices 0870010 Mace 0870990 Others (2) The following MRLs apply to dried wild mushrooms: 2,3 mg/kg for ceps, 1,2 mg/kg for dried wild mushrooms other than ceps. Recent monitoring data show that residues of nicotine occurs in dried ceps and dried wild mushrooms other than ceps. Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 25 July 2029, or, if that information is not submitted by that date, the lack of it.

0280020 Wild fungi Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. Temporary MRL valid until 22 February 2026. After this date the MRL will be 0,4 mg/kg unless further modified by a Regulation in light of new information provided by 30 June 2025 at the latest. 0610000 Teas Code numberGroups and examples of individual products to which the MRLs applyNicotine(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 fruits0151000 (a) grapes 0,010151010Table grapes0151020Wine grapes0152000 (b) strawberries 0,010153000 (c) cane fruits 0,010153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000 (d) other small fruits and berries 0154010Blueberries0,010154020Cranberries0,010154030Currants (black, red and white)0,01 0154040Gooseberries (green, red and yellow)0,010154050Rose hips0,2(+)0154060Mulberries (black and white)0,010154070Azaroles/Mediterranean medlars0,010154080Elderberries0,010154990Others (2)0,010160000Miscellaneous fruitswith0161000 (a) edible peel 0161010Dates0,010161020Figs0,010161030Table olives0,020161040Kumquats0,010161050Carambolas0,010161060Kaki/Japanese persimmons0,010161070Jambuls/jambolans0,010161990Others (2)0,010162000 (b) inedible peel, small 0,010162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)0163000 (c) inedible peel, large 0163010Avocados0,02 0163020Bananas0,010163030Mangoes0,010163040Papayas0,010163050Granate apples/pomegranates0,010163060Cherimoyas0,010163070Guavas0,010163080Pineapples0,010163090Breadfruits0,010163100Durians0,010163110Soursops/guanabanas0,010163990Others (2)0,010200000VEGETABLES, 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 artichokes0213060Parsnips 0213070Parsley 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 0233010Melons0233020Pumpkins 0233030Watermelons0233990Others (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/rucola 0251070Red 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 0,1(+)0256010Chervil(+)0256020Chives(+)0256030Celery leaves(+)0256040Parsley(+)0256050Sage(+)0256060Rosemary(+)0256070Thyme(+)0256080Basil and edible flowers(+)0256090Laurel/bay leaves(+)0256100Tarragon(+)0256990Others (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 lichens0280010Cultivated fungi0,010280020Wild fungi0,02(+)0280990Mosses and lichens0,010290000Algae and prokaryotes organisms0,010300000PULSES0,010300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,020401000Oilseeds 0401010Linseeds0401020Peanuts/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)0500000CEREALS0,020500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet 0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0610000Teas0,5(+)0620000Coffee beans0630000Herbal infusions from0,3(+)0631000

(a) flowers (+)0631010Chamomile(+)0631020Hibiscus/roselle(+)0631030Rose(+)0631040Jasmine(+)0631050Lime/linden(+)0631990Others (2)(+)0632000 (b) leaves and herbs (+)0632010Strawberry(+)0632020Rooibos(+)0632030Mate/maté(+)0632990Others (2)(+)0633000 (c) roots (+)0633010Valerian(+)0633020Ginseng(+)0633990Others (2)(+)0639000 (d) any other parts of the plant (+)0640000Cocoa beans0,05 0650000Carobs/Saint John's breads0,050700000HOPS0,050800000SPICES0810000Seed spices0,05(+)0810010Anise/aniseed(+)0810020Black caraway/black cumin(+)0810030Celery(+)0810040Coriander(+)0810050Cumin(+)0810060Dill(+)0810070Fennel(+)0810080Fenugreek(+)0810090Nutmeg(+)0810990Others (2)(+)0820000Fruit spices0,05(+)0820010Allspice/pimento(+)0820020Sichuan pepper(+)0820030Caraway(+)0820040Cardamom(+)0820050Juniper berry(+)0820060Peppercorn (black, green and white)(+)0820070Vanilla(+)0820080Tamarind(+)0820990Others (2)(+)0830000Bark spices0830010Cinnamon0,2(+)0830990Others (2)0,07(+) 0840000Root and rhizome spices(+)0840010Liquorice0,07(+)0840020Ginger (10)0840030Turmeric/curcuma0,07(+)0840040Horseradish (11)0840990Others (2)0,07(+)0850000Bud spices0,07(+)0850010Cloves(+)0850020Capers(+)0850990Others (2)(+)0860000Flower pistil spices0,07(+)0860010Saffron(+)0860990Others (2)(+)0870000Aril spices0,07(+)0870010Mace(+)0870990Others (2)(+)0900000SUGAR PLANTS0,010900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,011011000 (a) swine 1011010Muscle1011020Fat 1011030Liver1011040Kidney1011050Edible 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 1015010Muscle 1015020Fat1015030Liver1015040Kidney1015050Edible 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 eggs0,051030010Chicken1030020Duck 1030030Geese1030040Quail1030990Others (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)