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Commission Regulation (EU) 2025/1212 of 24 June 2025 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid in or on certain products

Commission Regulation (EU) 2025/1212 of 24 June 2025 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid in or on certain products

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 the active substance acetamiprid, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.

  2. Applications pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting modifications of the existing MRLs for acetamiprid were submitted for plums, linseeds, poppy seeds, mustard seeds, gold of pleasure seeds, and ‘honey and other apiculture products’.

  3. In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, those applications were evaluated by the Member State concerned and the evaluation reports were forwarded to the Commission. The Commission forwarded the applications, the evaluation reports and the supporting dossiers to the European Food Safety Authority (the ‘Authority’).

  4. In accordance with Article 10 of Regulation (EC) No 396/2005, the Authority assessed the applications and the evaluation reports, examining in particular the risks to consumers and, where relevant, to animals, and gave reasoned opinions on the requested MRLs(2). It forwarded those reasoned opinions to the applicants, the Commission and the Member States and made them available to the public.

  5. The Authority concluded that, for plums, linseeds, poppy seeds, mustard seeds, gold of pleasure seeds, and ‘honey and other apiculture products’, the requested modifications to the MRLs were acceptable with regard to consumer safety.

  6. Furthermore, to ensure that the assessment of acetamiprid would reflect the current scientific knowledge, the Commission requested the Authority to provide a statement on the toxicological properties and MRLs of acetamiprid and its metabolites, on the basis of Article 31 of Regulation (EC) No 178/2002 of the European Parliament and of the Council(3).

  7. In its statement(4), the Authority established a lower acceptable daily intake (‘ADI’) and a lower acute reference dose (‘ARfD’) for acetamiprid and included the metabolite IM-2-1 in the residue definition for the risk assessment of acetamiprid in fruit and leafy crops.

  8. The Authority concluded that the requested modifications to the MRLs for plums, linseeds, poppy seeds, mustard seeds, gold of pleasure seeds, and ‘honey and other apiculture products’, were acceptable with regard to consumer safety taking into account the new ARfD, ADI and residue definition for risk assessment. Neither the lifetime exposure to acetamiprid via consumption of all food products that may contain it nor the short-term exposure due to high consumption of the relevant products showed a risk that the ADI or the ARfD is exceeded.

  9. Based on the opinion of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, it is concluded that the requested modifications to the MRLs for plums, linseeds, poppy seeds, mustard seeds, gold of pleasure seeds, and ‘honey and other apiculture products’ are acceptable.

  10. On 30 November 2024, the Codex Alimentarius Commission adopted a new Codex maximum residue limit (CXL) for acetamiprid in soyabean(5).

  11. In accordance with Article 5(3) of Regulation (EC) No 178/2002 where international standards exist or their completion is imminent, they are to be taken into consideration in the development or adaptation of food law, except where such standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of the Union food law or where there is a scientific justification, or where they would result in a different level of protection from the one determined as appropriate in the Union. Moreover, in accordance with Article 13, point (e), of that Regulation, the Union is to promote consistency between international technical standards and food law while ensuring that the high level of protection adopted in the Union is not reduced.

  12. The Authority assessed the risks to consumers and produced a scientific report(6). It confirmed that the CXL for acetamiprid in soyabean is safe for consumers in the Union.

  13. Based on the scientific report of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, it is concluded that the MRL for acetamiprid in soyabean, previously set at 0,01*mg/kg as a Limit of Determination, should be set at the level of the CXL of 0,01 mg/kg in Annex II to that Regulation.

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

  15. 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 II 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, 24 June 2025.

For the Commission

The President

Ursula von der Leyen

ANNEX

In Annex II to Regulation (EC) No 396/2005, the column for acetamiprid is replaced by the following:

ANNEX II

Pesticide residues and maximum residue levels (mg/kg)

Code number

Groups and examples of individual products to which the MRLs apply(2)

Acetamiprid (R)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0110000

Citrus fruits

0,9

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others (2)

0120000

Tree nuts

0,07

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

0130010

Apples

0,07 (+)

0130020

Pears

0,07 (+)

0130030

Quinces

0,15 (+)

0130040

Medlars

0,3

0130050

Loquats/Japanese medlars

0,8

0130990

Others (2)

0,8

0140000

Stone fruits

0140010

Apricots

0,08 (+)

0140020

Cherries (sweet)

0,8

0140030

Peaches

0,08

0140040

Plums

0,04

0140990

Others (2)

0,01 (*)

0150000

Berries and small fruits

0151000

  1. grapes

0,08

0151010

Table grapes

0151020

Wine grapes

0152000

  1. strawberries

0,5

0153000

  1. cane fruits

0153010

Blackberries

0,6

0153020

Dewberries

2

0153030

Raspberries (red and yellow)

0,6

0153990

Others (2)

2

0154000

  1. other small fruits and berries

0154010

Blueberries

0,7

0154020

Cranberries

0,7

0154030

Currants (black, red and white)

0,01 (*)

0154040

Gooseberries (green, red and yellow)

0,7

0154050

Rose hips

2

0154060

Mulberries (black and white)

2

0154070

Azaroles/Mediterranean medlars

0,01 (*)

0154080

Elderberries

0,5

0154990

Others (2)

0,01 (*)

0160000

Miscellaneous fruitswith

0161000

  1. edible peel

0161010

Dates

0,01 (*)

0161020

Figs

0,03

0161030

Table olives

0,9

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

  1. 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

  1. inedible peel, large

0,01 (*)

0163010

Avocados

0163020

Bananas

0163030

Mangoes

0163040

Papayas

0163050

Granate apples/pomegranates

0163060

Cherimoyas

0163070

Guavas

0163080

Pineapples

0163090

Breadfruits

0163100

Durians

0163110

Soursops/guanabanas

0163990

Others (2)

0200000

VEGETABLES, FRESH or FROZEN

0210000

Root and tuber vegetables

0,01 (*)

0211000

  1. potatoes

0212000

  1. tropical root and tuber vegetables

0212010

Cassava roots/manioc

0212020

Sweet potatoes

0212030

Yams

0212040

Arrowroots

0212990

Others (2)

0213000

  1. 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

0220010

Garlic

0,02

0220020

Onions

0,02

0220030

Shallots

0,01 (*)

0220040

Spring onions/green onions and Welsh onions

0,01 (*)

0220990

Others (2)

0,01 (*)

0230000

Fruiting vegetables

0231000

  1. Solanaceae and Malvaceae

0231010

Tomatoes

0,06

0231020

Sweet peppers/bell peppers

0,09 (+)

0231030

Aubergines/eggplants

0,2

0231040

Okra/lady's fingers

0,2

0231990

Others (2)

0,2

0232000

  1. cucurbits with edible peel

0232010

Cucumbers

0,05 (+)

0232020

Gherkins

0,6

0232030

Courgettes

0,05 (+)

0232990

Others (2)

0,3

0233000

  1. cucurbits with inedible peel

0233010

Melons

0,08

0233020

Pumpkins

0,08

0233030

Watermelons

0,08

0233990

Others (2)

0,2

0234000

  1. sweet corn

0,01 (*)

0239000

  1. other fruiting vegetables

0,2

0240000

Brassica vegetables(excluding brassica roots and brassica baby leaf crops)

0241000

  1. flowering brassica

0241010

Broccoli

0,06

0241020

Cauliflowers

0,06

0241990

Others (2)

0,4

0242000

  1. head brassica

0242010

Brussels sprouts

0,05

0242020

Head cabbages

0,03

0242990

Others (2)

0,01 (*)

0243000

  1. leafy brassica

0,01 (*)

0243010

Chinese cabbages/pe-tsai

0243020

Kales

0243990

Others (2)

0244000

  1. kohlrabies

0,01 (*)

0250000

Leaf vegetables, herbs and edible flowers

0251000

  1. lettuces and salad plants

0251010

Lamb's lettuces/corn salads

1,5

0251020

Lettuces

0,01 (*)

0251030

Escaroles/broad-leaved endives

0,01 (*)

0251040

Cresses and other sprouts and shoots

3

0251050

Land cresses

3

0251060

Roman rocket/rucola

1,5

0251070

Red mustards

0,9

0251080

Baby leaf crops (including brassica species)

3

0251990

Others (2)

0,01 (*)

0252000

  1. spinaches and similar leaves

0252010

Spinaches

0,01 (*)

0252020

Purslanes

0,6

0252030

Chards/beet leaves

0,01 (*)

0252990

Others (2)

0,6

0253000

  1. grape leaves and similar species

0,01 (*)

0254000

  1. watercresses

0,01 (*)

0255000

  1. witloofs/Belgian endives

0,01 (*)

0256000

  1. herbs and edible flowers

3

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

0260010

Beans (with pods)

0,6

0260020

Beans (without pods)

0,3

0260030

Peas (with pods)

0,6

0260040

Peas (without pods)

0,3

0260050

Lentils

0,01 (*)

0260990

Others (2)

0,01 (*)

0270000

Stem vegetables

0270010

Asparagus

0,01 (*)

0270020

Cardoons

0,01 (*)

0270030

Celeries

0,01 (*)

0270040

Florence fennels

0,01 (*)

0270050

Globe artichokes

0,7

0270060

Leeks

0,01 (*)

0270070

Rhubarbs

0,01 (*)

0270080

Bamboo shoots

0,01 (*)

0270090

Palm hearts

0,01 (*)

0270990

Others (2)

0,01 (*)

0280000

Fungi, mosses and lichens

0,01 (*)

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0,01 (*)

0300000

PULSES

0,15

0300010

Beans

0300020

Lentils

0300030

Peas

0300040

Lupins/lupini beans

0300990

Others (2)

0400000

OILSEEDS AND OIL FRUITS

0401000

Oilseeds

0401010

Linseeds

0,06

0401020

Peanuts/groundnuts

0,01 (*)

0401030

Poppy seeds

0,3

0401040

Sesame seeds

0,01 (*)

0401050

Sunflower seeds

0,01 (*)

0401060

Rapeseeds/canola seeds

0,4

0401070

Soyabeans

0,01

0401080

Mustard seeds

0,15

0401090

Cotton seeds

0,7

0401100

Pumpkin seeds

0,01 (*)

0401110

Safflower seeds

0,01 (*)

0401120

Borage seeds

0,01 (*)

0401130

Gold of pleasure seeds

0,06

0401140

Hemp seeds

0,01 (*)

0401150

Castor beans

0,01 (*)

0401990

Others (2)

0,01 (*)

0402000

Oil fruits

0402010

Olives for oil production

3

0402020

Oil palms kernels

0,01 (*)

0402030

Oil palms fruits

0,01 (*)

0402040

Kapok

0,01 (*)

0402990

Others (2)

0,01 (*)

0500000

CEREALS

0500010

Barley

0,05

0500020

Buckwheat and other pseudocereals

0,01 (*)

0500030

Maize/corn

0,01 (*)

0500040

Common millet/proso millet

0,01 (*)

0500050

Oat

0,05

0500060

Rice

0,01 (*)

0500070

Rye

0,01 (*)

0500080

Sorghum

0,01 (*)

0500090

Wheat

0,1

0500990

Others (2)

0,01 (*)

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0,05 (*)

0610000

Teas

0620000

Coffee beans

0630000

Herbal infusions from

0631000

  1. flowers

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others (2)

0632000

  1. leaves and herbs

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others (2)

0633000

  1. roots

0633010

Valerian

0633020

Ginseng

0633990

Others (2)

0639000

  1. any other parts of the plant

0640000

Cocoa beans

0650000

Carobs/Saint John's breads

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

0820010

Allspice/pimento

0,05 (*)

0820020

Sichuan pepper

0,05 (*)

0820030

Caraway

0,05 (*)

0820040

Cardamom

0,1

0820050

Juniper berry

0,05 (*)

0820060

Peppercorn (black, green and white)

0,1

0820070

Vanilla

0,05 (*)

0820080

Tamarind

0,05 (*)

0820990

Others (2)

0,05 (*)

0830000

Bark spices

0,05 (*)

0830010

Cinnamon

0830990

Others (2)

0840000

Root and rhizome spices

0840010

Liquorice

0,05 (*)

0840020

Ginger (10)

0840030

Turmeric/curcuma

0,05 (*)

0840040

Horseradish (11)

0840990

Others (2)

0,05 (*)

0850000

Bud spices

0,05 (*)

0850010

Cloves

0850020

Capers

0850990

Others (2)

0860000

Flower pistil spices

0,05 (*)

0860010

Saffron

0860990

Others (2)

0870000

Aril spices

0,05 (*)

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

1011000

  1. swine

1011010

Muscle

0,5

1011020

Fat

0,3

1011030

Liver

1

1011040

Kidney

1

1011050

Edible offals (other than liver and kidney)

1

1011990

Others (2)

0,02 (*)

1012000

  1. bovine

1012010

Muscle

0,5

1012020

Fat

0,3

1012030

Liver

0,03

1012040

Kidney

1

1012050

Edible offals (other than liver and kidney)

0,05

1012990

Others (2)

0,02 (*)

1013000

  1. sheep

1013010

Muscle

0,5

1013020

Fat

0,3

1013030

Liver

1

1013040

Kidney

1

1013050

Edible offals (other than liver and kidney)

1

1013990

Others (2)

0,02 (*)

1014000

  1. goat

1014010

Muscle

0,5

1014020

Fat

0,3

1014030

Liver

1

1014040

Kidney

1

1014050

Edible offals (other than liver and kidney)

1

1014990

Others (2)

0,02 (*)

1015000

  1. equine

1015010

Muscle

0,5

1015020

Fat

0,3

1015030

Liver

1

1015040

Kidney

1

1015050

Edible offals (other than liver and kidney)

1

1015990

Others (2)

0,02 (*)

1016000

  1. poultry

1016010

Muscle

0,02 (*)

1016020

Fat

0,02 (*)

1016030

Liver

0,1 (*)

1016040

Kidney

0,1 (*)

1016050

Edible offals (other than liver and kidney)

0,02 (*)

1016990

Others (2)

0,02 (*)

1017000

  1. other farmed terrestrial animals

1017010

Muscle

0,5

1017020

Fat

0,3

1017030

Liver

1

1017040

Kidney

1

1017050

Edible offals (other than liver and kidney)

1

1017990

Others (2)

0,02 (*)

1020000

Milk

0,2

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others (2)

1030000

Birds eggs

0,02 (*)

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others (2)2

1040000

Honey and other apiculture products (7)

0,3

1050000

Amphibians and Reptiles

0,02 (*)

1060000

Terrestrial invertebrate animals

0,02 (*)

1070000

Wild terrestrial vertebrate animals

0,02 (*)

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)

ANNEX II