Commission Regulation (EU) 2023/127 of 18 January 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acequinocyl in or on certain productsText with EEA relevance.

Commission Regulation (EU) 2023/127 of 18 January 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acequinocyl 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. , and in particular Article 14(1), point (a), thereof, Whereas: (1) For acequinocyl, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. (2) In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance acequinocyl on sweet peppers/bell peppers, an application pursuant to Article 6(1) of Regulation (EC) No 396/2005, requesting a modification of the existing MRL, was submitted. (3) In accordance with Article 8 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. (4) The European Food Safety Authority (the Authority) assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRL Reasoned Opinion on the modification of the existing maximum residue level for acequinocyl in sweet peppers/bell peppers. EFSA Journal 2022;20(3):7175. EFSA scientific reports available online: http://www.efsa.europa.eu . It forwarded that opinion to the applicant, the Commission and the Member States and made it available to the public. (5) The Authority concluded that all requirements with respect to completeness of data submission were met and that the modification to the MRL requested by the applicant was acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. In so concluding, the Authority took into account the most recent information on the toxicological properties of the substance. Neither the lifetime exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded. (6) An application pursuant to Article 6(1) of Regulation (EC) No 396/2005, requesting a modification of the existing MRL for acequinocyl in kaki/Japanese persimmons, was submitted. (7) As regards this application, a Member State made a request to use the fast-track procedure, foreseen in the Technical Guidelines on the MRL setting procedure Technical guidelines MRL setting procedure in accordance with Articles 6 to 11 of Regulation (EC) No 396/2005 and Article 8 of Regulation (EC) No 1107/2009 (SANTE/2015/10595 Rev. 6.1).

, to set an MRL based on residue trials on apples. (8) The Authority has recently assessed residue trials on apples in the framework of the review of the existing MRLs for acequinocyl, and gave a reasoned opinion on the proposed MRL Reasoned Opinion on the review of the existing maximum residue levels for acequinocyl according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020;18(1):5983. EFSA scientific reports available online: http://www.efsa.europa.eu . This opinion from the Authority relies on the current scientific and technical knowledge on the subject. As it is appropriate to extrapolate from the residue trials on apples to kaki/Japanese persimmons, as confirmed by the existing Union guidelines on extrapolation of MRLs Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolation of residue data on products from plant and animal origin (SANTE/2019/12752 – 23 November 2020). , it is unnecessary to request the Authority to provide a reasoned opinion on kaki/Japanese persimmons. (9) It is therefore appropriate to set the MRL for kaki/Japanese persimmons at 0,05 mg/kg on the basis of the residue trials performed on apples. (10) Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the proposed modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005. (11) Regulation (EC) No 396/2005 should therefore be amended accordingly. (12) 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. It shall apply from 23 February 2023 as regards all proposed MRLs. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 18 January 2023. For the Commission The President Ursula von der Leyen

Annex

ANNEX In Annex II to Regulation (EC) No 396/2005, the column for acequinocyl is replaced by the following: 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 Acequinocyl (F) (F) Fat soluble The European Food Safety Authority identified some information on analytical methods and storage stability 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 2 August 2024, or, if that information is not submitted by that date, the lack of it. 0120060 Hazelnuts/cobnuts The European Food Safety Authority identified some information on analytical methods 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 2 August 2024, or, if that information is not submitted by that date, the lack of it.

1011010 Muscle 1011020 Fat 1011030 Liver 1011040 Kidney 1012010 Muscle 1012020 Fat 1012030 Liver 1012040 Kidney 1015010 Muscle 1015020 Fat 1015030 Liver 1015040 Kidney 1020010 Cattle 1020040 Horse The European Food Safety Authority identified some information on hydrolysis studies simulating pasteurisation, boiling and sterilisation 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 2 August 2024, or, if that information is not submitted by that date, the lack of it. 0110000 Citrus fruits 0110010 Grapefruits 0110020 Oranges 0110030 Lemons 0110040 Limes 0110050 Mandarins 0130000 Pome fruits 0130010 Apples 0130020 Pears 0130030 Quinces 0130040 Medlars 0130050 Loquats/Japanese medlars 0151010 Table grapes 0151020 Wine grapes 0231010 Tomatoes 0231030 Aubergines/eggplants The European Food Safety Authority identified some information on storage stability and hydrolysis studies simulating pasteurisation, boiling and sterilisation 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 2 August 2024, or, if that information is not submitted by that date, the lack of it. 0700000 HOPS Code numberGroups and examples of individual products to which the MRLs applyAcequinocyl (F)(1)(2)(3)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,6(+)0110010Grapefruits(+)0110020Oranges(+)0110030Lemons(+)0110040Limes(+)0110050Mandarins(+)0110990Others (2)0120000Tree nuts0,010120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts(+)0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,4(+)0130010Apples(+)0130020Pears(+)0130030Quinces(+)0130040Medlars(+)0130050Loquats/Japanese medlars(+)0130990Others (2) 0140000Stone fruits0140010Apricots0,010140020Cherries (sweet)0,10140030Peaches0,10140040Plums0,030140990Others (2)0,010150000Berries and small fruits0151000 (a) grapes 0,80151010Table grapes(+)0151020Wine grapes(+)0152000 (b) strawberries 0,010153000 (c) cane fruits 0,010153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000 (d) other small fruits and berries 0,010154010Blueberries0154020Cranberries0154030Currants (black, red and white)0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruitswith0161000 (a) edible peel 0161010Dates0,010161020Figs0,010161030Table olives0,010161040Kumquats0,010161050Carambolas0,010161060Kaki/Japanese persimmons0,050161070Jambuls/jambolans0,010161990Others (2)0,010162000 (b) inedible peel, small 0,010162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees 0162030Passionfruits/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 parsley0213080Radishes0213090Salsifies 0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0,010220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0231000 (a) Solanaceae and Malvaceae 0231010Tomatoes0,3(+)0231020Sweet peppers/bell peppers0,30231030Aubergines/eggplants0,3(+)0231040Okra/lady's fingers0,010231990Others (2)0,010232000 (b) cucurbits with edible peel 0232010Cucumbers0,080232020Gherkins0,040232030Courgettes0,080232990Others (2)0,010233000 (c) cucurbits with inedible peel 0,010233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)0234000 (d) sweet corn 0,010239000 (e) other fruiting vegetables 0,010240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,010241000 (a) flowering brassica 0241010Broccoli0241020Cauliflowers0241990Others (2)0242000 (b) head brassica 0242010Brussels sprouts0242020Head cabbages0242990Others (2) 0243000 (c) leafy brassica 0243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)0244000 (d) kohlrabies 0250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants 0,010251010Lamb's lettuces/corn salads0251020Lettuces0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2)0252000 (b) spinaches and similar leaves 0,010252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0,010254000 (d) watercresses 0,010255000 (e) witloofs/Belgian endives 0,010256000 (f) herbs and edible flowers 0,020256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,010260010Beans (with pods)0260020Beans (without pods) 0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,010270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010300000PULSES0,010300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,010401000Oilseeds0401010Linseeds0401020Peanuts/groundnuts0401030Poppy seeds0401040Sesame seeds0401050Sunflower seeds0401060Rapeseeds/canola seeds0401070Soyabeans0401080Mustard seeds0401090Cotton seeds0401100Pumpkin seeds

0401110Safflower seeds0401120Borage seeds0401130Gold of pleasure seeds0401140Hemp seeds0401150Castor beans0401990Others (2)0402000Oil fruits0402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0,010500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, 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 breads0700000HOPS20(+)0800000SPICES0810000Seed spices0,050810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,050820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,050830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,050840020Ginger (10)0840030Turmeric/curcuma0,050840040Horseradish (11)0840990Others (2)0,05 0850000Bud 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 from0,011011000 (a) swine 1011010Muscle(+)1011020Fat(+)1011030Liver(+)1011040Kidney(+)1011050Edible offals (other than liver and kidney)1011990Others (2)1012000 (b) bovine 1012010Muscle(+)1012020Fat(+)1012030Liver(+)1012040Kidney(+)1012050Edible offals (other than liver and kidney)1012990Others (2)1013000 (c) sheep 1013010Muscle1013020Fat1013030Liver1013040Kidney1013050Edible offals (other than liver and kidney)1013990Others (2) 1014000 d) goat 1014010Muscle1014020Fat1014030Liver1014040Kidney1014050Edible offals (other than liver and kidney)1014990Others (2)1015000 (e) equine 1015010Muscle(+)1015020Fat(+)1015030Liver(+)1015040Kidney(+)1015050Edible offals (other than liver and kidney)1015990Others (2)1016000 (f) poultry 1016010Muscle1016020Fat1016030Liver1016040Kidney1016050Edible offals (other than liver and kidney)1016990Others (2)1017000 (g) other farmed terrestrial animals 1017010Muscle1017020Fat1017030Liver1017040Kidney1017050Edible offals (other than liver and kidney)1017990Others (2)1020000Milk0,011020010Cattle(+)1020020Sheep1020030Goat1020040Horse(+)1020990Others (2)1030000Birds eggs0,011030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)