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)

L 187/6 EN Official Journal of the European Union 26.7.2023 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 2005on 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), 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(2)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(3), 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 (1) OJ L 70, 16.3.2005, p. 1. (2) 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). (3) 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):7566.26.7.2023 EN Official Journal of the European Union L 187/7 nicotine in teas is safe for consumers(4). 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(5)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. (4) European Food Safety Authority. Statement on the revised targeted risk assessment for certain maximum residue levels for nicotine. EFSA Journal 2023;21(3):7883. (5) 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.L 187/8 EN Official Journal of the European Union 26.7.2023 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 LEYENANNEX 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) Code number Groups and examples of individual products to which the MRLs apply** Nicotine (1) (2) (3) 0100000 FRUITS, FRESH or FROZEN; TREE NUTS 0110000 Citrus fruits 0,01* 0110010 Grapefruits 0110020 Oranges 0110030 Lemons 0110040 Limes 0110050 Mandarins 0110990 Others (2) 0120000 Tree nuts 0,02* 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) 26.7.2023 EN Official Journal of the European Union L 187/9(1) (2) (3) 0130000 Pome fruits 0,01* 0130010 Apples 0130020 Pears 0130030 Quinces 0130040 Medlars 0130050 Loquats/Japanese medlars 0130990 Others (2) 0140000 Stone fruits 0,01* 0140010 Apricots 0140020 Cherries (sweet) 0140030 Peaches 0140040 Plums 0140990 Others (2) 0150000 Berries and small fruits 0151000 (a) grapes 0,01* 0151010 Table grapes 0151020 Wine grapes 0152000 (b) strawberries 0,01* 0153000 (c) cane fruits 0,01* 0153010 Blackberries 0153020 Dewberries 0153030 Raspberries (red and yellow) 0153990 Others (2) 0154000 (d) other small fruits and berries 0154010 Blueberries 0,01* 0154020 Cranberries 0,01* 0154030 Currants (black, red and white) 0,01* L 187/10 EN Official Journal of the European Union 26.7.2023(1) (2) (3) 0154040 Gooseberries (green, red and yellow) 0,01* 0154050 Rose hips 0,2(+) 0154060 Mulberries (black and white) 0,01* 0154070 Azaroles/Mediterranean medlars 0,01* 0154080 Elderberries 0,01* 0154990 Others (2) 0,01* 0160000 Miscellaneous fruitswith 0161000 (a) edible peel 0161010 Dates 0,01* 0161020 Figs 0,01* 0161030 Table olives 0,02* 0161040 Kumquats 0,01* 0161050 Carambolas 0,01* 0161060 Kaki/Japanese persimmons 0,01* 0161070 Jambuls/jambolans 0,01* 0161990 Others (2) 0,01* 0162000 (b) inedible peel, small 0,01* 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 0,02* 26.7.2023 EN Official Journal of the European Union L 187/11(1) (2) (3) 0163020 Bananas 0,01* 0163030 Mangoes 0,01* 0163040 Papayas 0,01* 0163050 Granate apples/pomegranates 0,01* 0163060 Cherimoyas 0,01* 0163070 Guavas 0,01* 0163080 Pineapples 0,01* 0163090 Breadfruits 0,01* 0163100 Durians 0,01* 0163110 Soursops/guanabanas 0,01* 0163990 Others (2) 0,01* 0200000 VEGETABLES, FRESH or FROZEN 0210000 Root and tuber vegetables 0,01* 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 L 187/12 EN Official Journal of the European Union 26.7.2023(1) (2) (3) 0213070 Parsley roots/Hamburg roots parsley 0213080 Radishes 0213090 Salsifies 0213100 Swedes/rutabagas 0213110 Turnips 0213990 Others (2) 0220000 Bulb vegetables 0,01* 0220010 Garlic 0220020 Onions 0220030 Shallots 0220040 Spring onions/green onions and Welsh onions 0220990 Others (2) 0230000 Fruiting vegetables 0,01* 0231000 (a) Solanaceae and Malvaceae 0231010 Tomatoes 0231020 Sweet peppers/bell peppers 0231030 Aubergines/eggplants 0231040 Okra/lady's fingers 0231990 Others (2) 0232000 (b) cucurbits with edible peel 0232010 Cucumbers 0232020 Gherkins 0232030 Courgettes 0232990 Others (2) 0233000 (c) cucurbits with inedible peel 0233010 Melons 0233020 Pumpkins 26.7.2023 EN Official Journal of the European Union L 187/13(1) (2) (3) 0233030 Watermelons 0233990 Others (2) 0234000 (d) sweet corn 0239000 (e) other fruiting vegetables 0240000 Brassica vegetables(excluding brassica roots and brassica baby leaf crops) 0,01* 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 0251000 (a) lettuces and salad plants 0,01* 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 L 187/14 EN Official Journal of the European Union 26.7.2023(1) (2) (3) 0251070 Red mustards 0251080 Baby leaf crops (including brassica species) 0251990 Others (2) 0252000 (b) spinaches and similar leaves 0,01* 0252010 Spinaches 0252020 Purslanes 0252030 Chards/beet leaves 0252990 Others (2) 0253000 (c) grape leaves and similar species 0,01* 0254000 (d) watercresses 0,01* 0255000 (e) witloofs/Belgian endives 0,01* 0256000 (f) herbs and edible flowers 0,1(+) 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 0,01* 0260010 Beans (with pods) 0260020 Beans (without pods) 0260030 Peas (with pods) 26.7.2023 EN Official Journal of the European Union L 187/15(1) (2) (3) 0260040 Peas (without pods) 0260050 Lentils 0260990 Others (2) 0270000 Stem vegetables 0,01* 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 0280010 Cultivated fungi 0,01* 0280020 Wild fungi 0,02(+) 0280990 Mosses and lichens 0,01* 0290000 Algae and prokaryotes organisms 0,01* 0300000 PULSES 0,01* 0300010 Beans 0300020 Lentils 0300030 Peas 0300040 Lupins/lupini beans 0300990 Others (2) 0400000 OILSEEDS AND OIL FRUITS 0,02* 0401000 Oilseeds L 187/16 EN Official Journal of the European Union 26.7.2023(1) (2) (3) 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 0,02* 0500010 Barley 0500020 Buckwheat and other pseudocereals 0500030 Maize/corn 0500040 Common millet/proso millet 26.7.2023 EN Official Journal of the European Union L 187/17(1) (2) (3) 0500050 Oat 0500060 Rice 0500070 Rye 0500080 Sorghum 0500090 Wheat 0500990 Others (2) 0600000 TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS 0610000 Teas 0,5(+) 0620000 Coffee beans 0630000 Herbal infusions from 0,3(+) 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 0,05* L 187/18 EN Official Journal of the European Union 26.7.2023(1) (2) (3) 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 0830010 Cinnamon 0,2(+) 0830990 Others (2) 0,07(+) 26.7.2023 EN Official Journal of the European Union L 187/19(1) (2) (3) 0840000 Root and rhizome spices (+) 0840010 Liquorice 0,07(+) 0840020 Ginger (10) 0840030 Turmeric/curcuma 0,07(+) 0840040 Horseradish (11) 0840990 Others (2) 0,07(+) 0850000 Bud spices 0,07(+) 0850010 Cloves (+) 0850020 Capers (+) 0850990 Others (2) (+) 0860000 Flower pistil spices 0,07(+) 0860010 Saffron (+) 0860990 Others (2) (+) 0870000 Aril spices 0,07(+) 0870010 Mace (+) 0870990 Others (2) (+) 0900000 SUGAR PLANTS 0,01* 0900010 Sugar beet roots 0900020 Sugar canes 0900030 Chicory roots 0900990 Others (2) 1000000 PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS 1010000 Commodities from 0,01* 1011000 (a) swine 1011010 Muscle 1011020 Fat L 187/20 EN Official Journal of the European Union 26.7.2023(1) (2) (3) 1011030 Liver 1011040 Kidney 1011050 Edible offals (other than liver and kidney) 1011990 Others (2) 1012000 (b) bovine 1012010 Muscle 1012020 Fat 1012030 Liver 1012040 Kidney 1012050 Edible offals (other than liver and kidney) 1012990 Others (2) 1013000 (c) sheep 1013010 Muscle 1013020 Fat 1013030 Liver 1013040 Kidney 1013050 Edible offals (other than liver and kidney) 1013990 Others (2) 1014000 d) goat 1014010 Muscle 1014020 Fat 1014030 Liver 1014040 Kidney 1014050 Edible offals (other than liver and kidney) 1014990 Others (2) 1015000 (e) equine 1015010 Muscle 26.7.2023 EN Official Journal of the European Union L 187/21(1) (2) (3) 1015020 Fat 1015030 Liver 1015040 Kidney 1015050 Edible offals (other than liver and kidney) 1015990 Others (2) 1016000 (f) poultry 1016010 Muscle 1016020 Fat 1016030 Liver 1016040 Kidney 1016050 Edible offals (other than liver and kidney) 1016990 Others (2) 1017000 (g) other farmed terrestrial animals 1017010 Muscle 1017020 Fat 1017030 Liver 1017040 Kidney 1017050 Edible offals (other than liver and kidney) 1017990 Others (2) 1020000 Milk 0,01* 1020010 Cattle 1020020 Sheep 1020030 Goat 1020040 Horse 1020990 Others (2) 1030000 Birds eggs 0,05* 1030010 Chicken 1030020 Duck L 187/22 EN Official Journal of the European Union 26.7.2023(1) (2) (3) 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. **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 26.7.2023 EN Official Journal of the European Union L 187/230631000 (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 L 187/24 EN Official Journal of the European Union 26.7.20230820990 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 2025at the latest. 0610000 Teas’ 26.7.2023 EN Official Journal of the European Union L 187/25