Commission Regulation (EU) 2024/451 of 5 February 2024 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
Date: 2024-02-05
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: aromatic plant, consumer protection, food inspection, food safety, foodstuff, pesticide, pesticide residue




L_202400451EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/451


6.2.2024







            COMMISSION REGULATION (EU) 2024/451
of 5 February 2024
         
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 (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)


As regards nicotine in bark spices, root and rhizome, bud spices, flower pistil spices and aril spices, temporary MRLs were set by Commission Regulation (EU) 2023/377 (2) at 0,07 mg/kg 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.












(3)


As regards nicotine in seed spices and fruit spices, temporary MRLs were set by Commission Regulation (EU) 2023/1536 (3) at 0,05 mg/kg 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. That Regulation also set a temporary MRL for nicotine in cinnamon at 0,2 mg/kg, until 22 February 2030, pending the submission of the same information.












(4)


Recently, food business operators submitted to the Commission specific monitoring data on spices, indicating that residues may occur in this product at higher levels than the temporary MRL established by Regulations (EU) 2023/377 and (EU) 2023/1536. Based on this more specific data, the Commission proposed the setting of temporary MRLs at a level of 0,3 mg/kg for all spices, corresponding to the 95th percentile of all the sample results.












(5)


Based on this new information, the European Food Safety Authority (‘the Authority’) performed a new acute (short-term) dietary risk assessment for nicotine in spices and a new chronic (long-term) exposure assessment for European consumers. The Authority examined the risks to consumers and, where relevant, to animals, and gave a statement on the proposed MRLs (4). It concluded that the modifications to the MRLs for nicotine in spices were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The Authority took into account the most recent information on the toxicological properties of nicotine. Neither the long-term (chronic) exposure to that substance via consumption of all food products that may contain it nor the short-term (acute) exposure due to high consumption of relevant products show that there is any risk that the acceptable daily intake or the acute reference dose is exceeded.












(6)


Based on the relevant risk assessments of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the proposed modifications to the MRLs are acceptable.












(7)


Regulation (EC) No 396/2005 should therefore be amended accordingly.












(8)


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
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 February 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(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)  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 (OJ L 187, 26.7.2023, p. 6).

(4)  European Food Safety Authority, 2023. Targeted risk assessment for maximum residue levels for nicotine in spices. EFSA Journal, 21(10), 1–12. https://doi.org/10.2903/j.efsa.2023.8372




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)









Code number




Groups and examples of individual products to which the MRLs apply
 (1)




Nicotine





(1)


(2)


(3)




0100000 



FRUITS, FRESH or FROZEN; TREE NUTS



 




0110000 



Citrus fruits



0,01  (*1)





0110010 


Grapefruits


 




0110020 


Oranges


 




0110030 


Lemons


 




0110040 


Limes


 




0110050 


Mandarins


 




0110990 


Others (2)


 




0120000 



Tree nuts



0,02  (*1)





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)


 




0130000 



Pome fruits



0,01  (*1)





0130010 


Apples


 




0130020 


Pears


 




0130030 


Quinces


 




0130040 


Medlars


 




0130050 


Loquats/Japanese medlars


 




0130990 


Others (2)


 




0140000 



Stone fruits



0,01  (*1)





0140010 


Apricots


 




0140020 


Cherries (sweet)


 




0140030 


Peaches


 




0140040 


Plums


 




0140990 


Others (2)


 




0150000 



Berries and small fruits



 




0151000 








(a)



grapes







0,01  (*1)





0151010 


Table grapes


 




0151020 


Wine grapes


 




0152000 








(b)



strawberries







0,01  (*1)





0153000 








(c)



cane fruits







0,01  (*1)





0153010 


Blackberries


 




0153020 


Dewberries


 




0153030 


Raspberries (red and yellow)


 




0153990 


Others (2)


 




0154000 








(d)



other small fruits and berries







 




0154010 


Blueberries


0,01  (*1)





0154020 


Cranberries


0,01  (*1)





0154030 


Currants (black, red and white)


0,01  (*1)





0154040 


Gooseberries (green, red and yellow)


0,01  (*1)





0154050 


Rose hips


0,2  ((+))





0154060 


Mulberries (black and white)


0,01  (*1)





0154070 


Azaroles/Mediterranean medlars


0,01  (*1)





0154080 


Elderberries


0,01  (*1)





0154990 


Others (2)


0,01  (*1)





0160000 



Miscellaneous fruitswith



 




0161000 








(a)



edible peel







 




0161010 


Dates


0,01  (*1)





0161020 


Figs


0,01  (*1)





0161030 


Table olives


0,02  (*1)





0161040 


Kumquats


0,01  (*1)





0161050 


Carambolas


0,01  (*1)





0161060 


Kaki/Japanese persimmons


0,01  (*1)





0161070 


Jambuls/jambolans


0,01  (*1)





0161990 


Others (2)


0,01  (*1)





0162000 








(b)



inedible peel, small







0,01  (*1)





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  (*1)





0163020 


Bananas


0,01  (*1)





0163030 


Mangoes


0,01  (*1)





0163040 


Papayas


0,01  (*1)





0163050 


Granate apples/pomegranates


0,01  (*1)





0163060 


Cherimoyas


0,01  (*1)





0163070 


Guavas


0,01  (*1)





0163080 


Pineapples


0,01  (*1)





0163090 


Breadfruits


0,01  (*1)





0163100 


Durians


0,01  (*1)





0163110 


Soursops/guanabanas


0,01  (*1)





0163990 


Others (2)


0,01  (*1)





0200000 



VEGETABLES, FRESH or FROZEN



 




0210000 



Root and tuber vegetables



0,01  (*1)





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


 




0213070 


Parsley roots/Hamburg roots parsley


 




0213080 


Radishes


 




0213090 


Salsifies


 




0213100 


Swedes/rutabagas


 




0213110 


Turnips


 




0213990 


Others (2)


 




0220000 



Bulb vegetables



0,01  (*1)





0220010 


Garlic


 




0220020 


Onions


 




0220030 


Shallots


 




0220040 


Spring onions/green onions and Welsh onions


 




0220990 


Others (2)


 




0230000 



Fruiting vegetables



0,01  (*1)





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


 




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  (*1)





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  (*1)





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


 




0251070 


Red mustards


 




0251080 


Baby leaf crops (including brassica species)


 




0251990 


Others (2)


 




0252000 








(b)



spinaches and similar leaves







0,01  (*1)





0252010 


Spinaches


 




0252020 


Purslanes


 




0252030 


Chards/beet leaves


 




0252990 


Others (2)


 




0253000 








(c)



grape leaves and similar species







0,01  (*1)





0254000 








(d)



watercresses







0,01  (*1)





0255000 








(e)



witloofs/Belgian endives







0,01  (*1)





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  (*1)





0260010 


Beans (with pods)


 




0260020 


Beans (without pods)


 




0260030 


Peas (with pods)


 




0260040 


Peas (without pods)


 




0260050 


Lentils


 




0260990 


Others (2)


 




0270000 



Stem vegetables



0,01  (*1)





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  (*1)





0280020 


Wild fungi


0,02  ((+))





0280990 


Mosses and lichens


0,01  (*1)





0290000 



Algae and prokaryotes organisms



0,01  (*1)





0300000 



PULSES



0,01  (*1)





0300010 


Beans


 




0300020 


Lentils


 




0300030 


Peas


 




0300040 


Lupins/lupini beans


 




0300990 


Others (2)


 




0400000 



OILSEEDS AND OIL FRUITS



0,02  (*1)





0401000 



Oilseeds



 




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  (*1)





0500010 


Barley


 




0500020 


Buckwheat and other pseudocereals


 




0500030 


Maize/corn


 




0500040 


Common millet/proso millet


 




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  (*1)





0650000 



Carobs/Saint John's breads



0,05  (*1)





0700000 



HOPS



0,05  (*1)





0800000 



SPICES




 ((+))





0810000 



Seed spices




0,3 
 ((+))





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




0,3 
 ((+))





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




0,3 
 ((+))





0830010 


Cinnamon



 ((+))





0830990 


Others (2)



 ((+))





0840000 



Root and rhizome spices




 ((+))





0840010 


Liquorice



0,3 
 ((+))





0840020 


Ginger (10)


 




0840030 


Turmeric/curcuma



0,3 
 ((+))





0840040 


Horseradish (11)


 




0840990 


Others (2)



0,3 
 ((+))





0850000 



Bud spices




0,3 
 ((+))





0850010 


Cloves



 ((+))





0850020 


Capers



 ((+))





0850990 


Others (2)



 ((+))





0860000 



Flower pistil spices




0,3 
 ((+))





0860010 


Saffron



 ((+))





0860990 


Others (2)



 ((+))





0870000 



Aril spices




0,3 
 ((+))





0870010 


Mace



 ((+))





0870990 


Others (2)



 ((+))





0900000 



SUGAR PLANTS



0,01  (*1)





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  (*1)





1011000 








(a)



swine







 




1011010 


Muscle


 




1011020 


Fat


 




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


 




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  (*1)





1020010 


Cattle


 




1020020 


Sheep


 




1020030 


Goat


 




1020040 


Horse


 




1020990 


Others (2)


 




1030000 



Birds eggs



0,05  (*1)





1030010 


Chicken


 




1030020 


Duck


 




1030030 


Geese


 




1030040 


Quail


 




1030990 


Others (2)


 




1040000 



Honey and other apiculture products (7)



0,05  (*1)





1050000 



Amphibians and Reptiles



0,01  (*1)





1060000 



Terrestrial invertebrate animals



0,01  (*1)





1070000 



Wild terrestrial vertebrate animals



0,01  (*1)





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)



 





Nicotine

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 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’







(*1)  Indicates lower limit of analytical determination

(1)  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.



ELI: http://data.europa.eu/eli/reg/2024/451/oj
ISSN 1977-0677 (electronic edition)