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Document 32024R0451

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

C/2024/633

OJ L, 2024/451, 06.02.2024, ELI: http://data.europa.eu/eli/reg/2024/451/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

In force

ELI: http://data.europa.eu/eli/reg/2024/451/oj

European flag

Official Journal
of the European Union

EN

Series L


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)


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