Commission Regulation (EU) 2025/1212of 24 June 2025amending 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(Text with EEA relevance)

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 (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 OJ L 70, 16.3.2005, p. 1, ELI: http://data.europa.eu/eli/reg/2005/396/oj. , 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 European Food Safety Authority; Reasoned opinion on the modification of the existing maximum residue level for acetamiprid in various crops. EFSA Journal, 2021;19(9):6830. European Food Safety Authority; Reasoned opinion on the modification of the existing maximum residue levels for acetamiprid in honey and various oilseed crops; EFSA Journal, 2022;20(8):7535. . 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 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1, ELI: http://data.europa.eu/eli/reg/2002/178/oj).

. (7) In its statement European Food Safety Authority; Statement on the toxicological properties and maximum residue levels of acetamiprid and its metabolites; EFSA Journal, 2024;22:e8759. , 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 Joint FAO/WHO Food Standards Programme Codex Alimentarius Commission, Forty-seventh Session, CICG, Geneva, Switzerland, 25-30 November 2024. https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-701-47%252FFINAL%2BREPORT%252FREP24_CACe.pdf. . (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 European Food Safety Authority; Scientific support for preparing an EU position in the 55th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal, 2024;22:e8841. . 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 0,01mg/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

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

Annex

ANNEX II Pesticide residues and maximum residue levels (mg/kg) 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 (+) Pesticide-product combination for which a footnote exists. The list of footnotes is provided below. Acetamiprid (R) (R) The residue definition differs for the following combinations pesticide-code number: Acetamiprid - code 1000000 except 1040000: Sum of acetamiprid and N-desmethyl-acetamiprid (IM-2-1), expressed as acetamiprid The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 19 February 2027, or, if that information is not submitted by that date, the lack of it. 0130010 Apples 0130020 Pears 0130030 Quinces 0140010 Apricots 0231020 Sweet peppers/bell peppers 0232010 Cucumbers 0232030 Courgettes Code numberGroups and examples of individual products to which the MRLs applyAcetamiprid (R)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,90110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,070120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0130010Apples0,07(+)0130020Pears0,07(+)0130030Quinces0,15(+)0130040Medlars0,30130050Loquats/Japanese medlars0,80130990Others (2)0,8 0140000Stone fruits0140010Apricots0,08(+)0140020Cherries (sweet)0,80140030Peaches0,080140040Plums0,040140990Others (2)0,010150000Berries and small fruits0151000 (a) grapes 0,080151010Table grapes0151020Wine grapes0152000 (b) strawberries 0,50153000 (c) cane fruits 0153010Blackberries0,60153020Dewberries20153030Raspberries (red and yellow)0,60153990Others (2)20154000 (d) other small fruits and berries 0154010Blueberries0,70154020Cranberries0,70154030Currants (black, red and white)0,010154040Gooseberries (green, red and yellow)0,70154050Rose hips20154060Mulberries (black and white)20154070Azaroles/Mediterranean medlars0,010154080Elderberries0,50154990Others (2)0,010160000Miscellaneous fruitswith0161000

(a) edible peel 0161010Dates0,010161020Figs0,030161030Table olives0,90161040Kumquats0,010161050Carambolas0,010161060Kaki/Japanese persimmons0,01 0161070Jambuls/jambolans0,010161990Others (2)0,010162000 (b) inedible peel, small 0,010162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)0163000 (c) inedible peel, large 0,010163010Avocados0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0,010211000 (a) potatoes 0212000 (b) tropical root and tuber vegetables 0212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2) 0213000 (c) other root and tuber vegetables except sugar beets 0213010Beetroots0213020Carrots0213030Celeriacs/turnip rooted celeries0213040Horseradishes0213050Jerusalem artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0220010Garlic0,020220020Onions0,020220030Shallots0,010220040Spring onions/green onions and Welsh onions0,010220990Others (2)0,010230000Fruiting vegetables0231000 (a) Solanaceae and Malvaceae 0231010Tomatoes0,060231020Sweet peppers/bell peppers0,09(+)0231030Aubergines/eggplants0,20231040Okra/lady's fingers0,20231990Others (2)0,20232000 (b) cucurbits with edible peel 0232010Cucumbers0,05(+)0232020Gherkins0,60232030Courgettes0,05(+)0232990Others (2)0,3 0233000 (c) cucurbits with inedible peel 0233010Melons0,080233020Pumpkins0,080233030Watermelons0,080233990Others (2)0,20234000 (d) sweet corn 0,010239000 (e) other fruiting vegetables 0,20240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0241000 (a) flowering brassica 0241010Broccoli0,060241020Cauliflowers0,060241990Others (2)0,40242000 (b) head brassica 0242010Brussels sprouts0,050242020Head cabbages0,030242990Others (2)0,010243000 (c) leafy brassica 0,010243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)0244000 (d) kohlrabies 0,010250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants 0251010Lamb's lettuces/corn salads1,50251020Lettuces0,010251030Escaroles/broad-leaved endives0,010251040Cresses and other sprouts and shoots30251050Land cresses30251060Roman rocket/rucola1,50251070Red mustards0,90251080Baby leaf crops (including brassica species)30251990Others (2)0,01 0252000 (b) spinaches and similar leaves 0252010Spinaches0,010252020Purslanes0,60252030Chards/beet leaves0,010252990Others (2)0,60253000 (c) grape leaves and similar species 0,010254000 (d) watercresses 0,010255000 (e) witloofs/Belgian endives 0,010256000 (f) herbs and edible flowers 30256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0260010Beans (with pods)0,60260020Beans (without pods)0,30260030Peas (with pods)0,60260040Peas (without pods)0,30260050Lentils0,010260990Others (2)0,010270000Stem vegetables0270010Asparagus0,010270020Cardoons0,010270030Celeries0,010270040Florence fennels0,010270050Globe artichokes0,70270060Leeks0,010270070Rhubarbs0,01

0270080Bamboo shoots0,010270090Palm hearts0,010270990Others (2)0,010280000Fungi, mosses and lichens0,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010300000PULSES0,150300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0401000Oilseeds0401010Linseeds0,060401020Peanuts/groundnuts0,010401030Poppy seeds0,30401040Sesame seeds0,010401050Sunflower seeds0,010401060Rapeseeds/canola seeds0,40401070Soyabeans0,010401080Mustard seeds0,150401090Cotton seeds0,70401100Pumpkin seeds0,010401110Safflower seeds0,010401120Borage seeds0,010401130Gold of pleasure seeds0,060401140Hemp seeds0,010401150Castor beans0,010401990Others (2)0,01 0402000Oil fruits0402010Olives for oil production30402020Oil palms kernels0,010402030Oil palms fruits0,010402040Kapok0,010402990Others (2)0,010500000CEREALS0500010Barley0,050500020Buckwheat and other pseudocereals0,010500030Maize/corn0,010500040Common millet/proso millet0,010500050Oat0,050500060Rice0,010500070Rye0,010500080Sorghum0,010500090Wheat0,10500990Others (2)0,010600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,050610000Teas0620000Coffee beans0630000Herbal infusions from0631000 (a) flowers 0631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)0632000 (b) leaves and herbs 0632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2) 0633000 (c) roots 0633010Valerian0633020Ginseng0633990Others (2)0639000 (d) any other parts of the plant 0640000Cocoa beans0650000Carobs/Saint John's breads0700000HOPS0,050800000SPICES0810000Seed spices0,050810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0820010Allspice/pimento0,050820020Sichuan pepper0,050820030Caraway0,050820040Cardamom0,10820050Juniper berry0,050820060Peppercorn (black, green and white)0,10820070Vanilla0,050820080Tamarind0,050820990Others (2)0,05 0830000Bark spices0,050830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,050840020Ginger (10)0840030Turmeric/curcuma0,050840040Horseradish (11)0840990Others (2)0,050850000Bud spices0,050850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,050860010Saffron0860990Others (2)0870000Aril spices0,050870010Mace0870990Others (2)0900000SUGAR PLANTS0,010900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from1011000 (a) swine 1011010Muscle0,51011020Fat0,31011030Liver11011040Kidney11011050Edible offals (other than liver and kidney)11011990Others (2)0,02 1012000 (b) bovine 1012010Muscle0,51012020Fat0,31012030Liver0,031012040Kidney11012050Edible offals (other than liver and kidney)0,051012990Others (2)0,021013000 (c) sheep 1013010Muscle0,51013020Fat0,31013030Liver11013040Kidney11013050Edible offals (other than liver and kidney)11013990Others (2)0,021014000

d) goat 1014010Muscle0,51014020Fat0,31014030Liver11014040Kidney11014050Edible offals (other than liver and kidney)11014990Others (2)0,021015000 (e) equine 1015010Muscle0,51015020Fat0,31015030Liver11015040Kidney11015050Edible offals (other than liver and kidney)11015990Others (2)0,021016000 (f) poultry 1016010Muscle0,021016020Fat0,021016030Liver0,1 1016040Kidney0,11016050Edible offals (other than liver and kidney)0,021016990Others (2)0,021017000 (g) other farmed terrestrial animals 1017010Muscle0,51017020Fat0,31017030Liver11017040Kidney11017050Edible offals (other than liver and kidney)11017990Others (2)0,021020000Milk0,21020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,021030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)21040000Honey and other apiculture products (7)0,31050000Amphibians and Reptiles0,021060000Terrestrial invertebrate animals0,021070000Wild terrestrial vertebrate animals0,021100000PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8) 1200000PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)1300000PROCESSED FOOD PRODUCTS (9)