Annex II to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this Regulation.
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:
For the active substance acetamiprid, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.
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’.
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’).
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.
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.
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).
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.
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.
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.
On 30 November 2024, the Codex Alimentarius Commission adopted a new Codex maximum residue limit (CXL) for acetamiprid in soyabean(5).
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.
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.
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.
Regulation (EC) No 396/2005 should therefore be amended accordingly.
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
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
grapes
0,08
0151010
Table grapes
0151020
Wine grapes
0152000
strawberries
0,5
0153000
cane fruits
0153010
Blackberries
0,6
0153020
Dewberries
2
0153030
Raspberries (red and yellow)
0,6
0153990
Others (2)
2
0154000
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
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
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
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
potatoes
0212000
tropical root and tuber vegetables
0212010
Cassava roots/manioc
0212020
Sweet potatoes
0212030
Yams
0212040
Arrowroots
0212990
Others (2)
0213000
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
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
cucurbits with edible peel
0232010
Cucumbers
0,05 (+)
0232020
Gherkins
0,6
0232030
Courgettes
0,05 (+)
0232990
Others (2)
0,3
0233000
cucurbits with inedible peel
0233010
Melons
0,08
0233020
Pumpkins
0,08
0233030
Watermelons
0,08
0233990
Others (2)
0,2
0234000
sweet corn
0,01 (*)
0239000
other fruiting vegetables
0,2
0240000
Brassica vegetables(excluding brassica roots and brassica baby leaf crops)
0241000
flowering brassica
0241010
Broccoli
0,06
0241020
Cauliflowers
0,06
0241990
Others (2)
0,4
0242000
head brassica
0242010
Brussels sprouts
0,05
0242020
Head cabbages
0,03
0242990
Others (2)
0,01 (*)
0243000
leafy brassica
0,01 (*)
0243010
Chinese cabbages/pe-tsai
0243020
Kales
0243990
Others (2)
0244000
kohlrabies
0,01 (*)
0250000
Leaf vegetables, herbs and edible flowers
0251000
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
spinaches and similar leaves
0252010
Spinaches
0,01 (*)
0252020
Purslanes
0,6
0252030
Chards/beet leaves
0,01 (*)
0252990
Others (2)
0,6
0253000
grape leaves and similar species
0,01 (*)
0254000
watercresses
0,01 (*)
0255000
witloofs/Belgian endives
0,01 (*)
0256000
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
flowers
0631010
Chamomile
0631020
Hibiscus/roselle
0631030
Rose
0631040
Jasmine
0631050
Lime/linden
0631990
Others (2)
0632000
leaves and herbs
0632010
Strawberry
0632020
Rooibos
0632030
Mate/maté
0632990
Others (2)
0633000
roots
0633010
Valerian
0633020
Ginseng
0633990
Others (2)
0639000
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
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
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
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
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
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
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
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)