Commission Regulation (EU) 2021/1842 of 20 October 2021 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for flupyradifurone and difluoroacetic acid in or on certain productsText with EEA relevance.

Commission Regulation (EU) 2021/1842 of 20 October 2021 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for flupyradifurone and difluoroacetic acid 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)(a) and Article 49(2) thereof, Whereas: (1) For flupyradifurone and difluoroacetic acid, maximum residue levels (MRLs) were set in Part A of Annex III 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 flupyradifurone on strawberries, table olives, okra/lady’s fingers, cauliflowers, broccoli, Brussels sprouts, head cabbages, kales, kohlrabies, lettuces and salad plants, spinaches and similar (leaves), herbs and edible flowers, beans, peas, rapeseeds/canola seeds, mustard seeds and olives for oil production, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs for flupyradifurone and its main metabolite difluoroacetic acid. (3) In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application for import tolerances was submitted for flupyradifurone used in the United States on citrus fruits, prickly pears/cactus fruits, cotton seeds, sweet corn, barley, maize/corn, sorghum and wheat, in the United States and Canada on tree nuts, pome fruits, grapes, blueberries, root and tuber vegetables, tomatoes, sweet peppers/bell peppers, aubergines/eggplants, melons, celeries, pulses, peanuts, soyabeans and hops, in Brazil on coffee beans, and in Ghana and Ivory Coast on cocoa beans. The applicants state that the authorised uses of that substance on such crops in those countries lead to residues exceeding the MRLs contained in Regulation (EC) No 396/2005 for flupyradifurone and difluoroacetic acid and that higher MRLs are necessary to avoid trade barriers for the import of those crops. (4) In the context of these applications, the applicant submitted to the Rapporteur Member State, the Netherlands, the additional rotational crop field studies and livestock feeding studies within the deadline set under Commission Regulation (EU) 2016/486 Commission Regulation (EU) 2016/486 of 29 March 2016 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cyazofamid, cycloxydim, difluoroacetic acid, fenoxycarb, flumetralin, fluopicolide, flupyradifurone, fluxapyroxad, kresoxim-methyl, mandestrobin, mepanipyrim, metalaxyl-M, pendimethalin and tefluthrin in or on certain products (OJ L 90, 6.4.2016, p. 1).

. (5) In accordance with Article 8 of Regulation (EC) No 396/2005, those applications were evaluated by the Netherlands, and the evaluation reports were forwarded to the Commission. (6) The European Food Safety Authority (the Authority) assessed the applications and the evaluation reports, examining in particular the risks to the consumer and, where relevant, to animals and gave reasoned opinions on the proposed MRLs EFSA scientific reports available online: http://www.efsa.europa.eu: Reasoned opinion on the setting of import tolerances, modification of existing maximum residue levels and evaluation of confirmatory data following the Article 12 MRL review for flupyradifurone and DFA. EFSA Journal 2020;18(6):6133. Reasoned opinion on the modification of the existing maximum residue levels for flupyradifurone and DFA in rapeseeds/canola seeds and mustard seeds. EFSA Journal 2020;18(11):6298. Reasoned opinion on the modification of the existing maximum residue levels for flupyradifurone and DFA in okra/lady’s finger. EFSA Journal 2021;19(5):6581. . It forwarded those opinions to the applicants, the Commission and the Member States and made them available to the public. (7) As regards flupyradifurone in prickly pear/cactus fruit, melons, tomatoes and hops, the Authority concluded that the submitted data was insufficient to set new MRLs. As regards flupyradifurone in celeries, an acute intake concern could not be excluded. As regards all other applications, the Authority concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain them, 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. (8) Following the assessment of the additional rotational crop field studies and livestock feeding studies, the Authority recommended raising, lowering or keeping the existing MRLs for flupyradifurone and difluoroacetic acid in rotational crops and products of animal origin. In particular, the Authority suggested lowering the MRLs for flupyradifurone in grape leaves and difluoroacetic acid in maize, cocoa beans and swine liver. These MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the existing levels or the levels identified by the Authority. (9) Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the respective modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005. (10) Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account.

(11) Regulation (EC) No 396/2005 should therefore be amended accordingly. (12) In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional measure for products which have been produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained. (13) A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs. (14) 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

Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

Article 2

Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to flupyradifurone in grape leaves and difluoroacetic acid in maize, cocoa beans and swine liver, for products which were produced in the Union or imported into the Union before 10 May 2022.

Article 3

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 10 May 2022 as regards the MRLs for flupyradifurone in grape leaves and difluoroacetic acid in maize, cocoa beans and swine liver. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 October 2021. For the Commission The President Ursula von der Leyen

Annex

ANNEX Annexes II and III to Regulation (EC) No 396/2005 are amended as follows: (1) in Annex II, the following columns for difluoroacetic acid and flupyradifurone are added: 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 MRLs apply, reference should be made to Annex I Code numberGroups and examples of individual products to which the MRLs applyDifluoroacetic acid (DFA)Flupyradifurone(1)(2)(3)(4)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0110010Grapefruits0,0530110020Oranges0,0530110030Lemons0,051,50110040Limes0,051,50110050Mandarins0,051,50110990Others (2)0,020,010120000Tree nuts0,040,020120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,20,60130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2) 0140000Stone fruits0,020,010140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0151000 (a) grapes 0,1530151010Table grapes0151020Wine grapes0152000

(b) strawberries 0,30,40153000 (c) cane fruits 0153010Blackberries0,071,50153020Dewberries0,020,010153030Raspberries (red and yellow)0,071,50153990Others (2)0,020,010154000 (d) other small fruits and berries 0154010Blueberries0,0540154020Cranberries0,020,010154030Currants (black, red and white)0,020,010154040Gooseberries (green, red and yellow)0,020,010154050Rose hips0,020,010154060Mulberries (black and white)0,020,010154070Azaroles/Mediterranean medlars0,020,010154080Elderberries0,020,010154990Others (2)0,020,010160000Miscellaneous fruitswith0161000 (a) edible peel 0161010Dates0,020,010161020Figs0,020,010161030Table olives0,1550161040Kumquats0,020,010161050Carambolas0,020,010161060Kaki/Japanese persimmons0,020,010161070Jambuls/jambolans0,020,010161990Others (2)0,020,010162000 (b) inedible peel, small 0,020,010162010Kiwi fruits (green, red, yellow) 0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)0163000 (c) inedible peel, large 0,020,010163010Avocados0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0211000 (a) potatoes 0,20,050212000 (b) tropical root and tuber vegetables 0,20,050212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)0213000 (c) other root and tuber vegetables except sugar beets 0,40,90213010Beetroots0213020Carrots0213030Celeriacs/turnip rooted celeries0213040Horseradishes0213050Jerusalem artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes 0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0,150,010220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0231000 (a) Solanaceae and Malvaceae 0231010Tomatoes0,40,70231020Sweet peppers/bell peppers0,90,90231030Aubergines/eggplants0,910231040Okra/lady's fingers0,40,90231990Others (2)0,150,010232000 (b) cucurbits with edible peel 0,70,60232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)0233000 (c) cucurbits with inedible peel 0233010Melons0,30,010233020Pumpkins0,30,010233030Watermelons0,150,150233990Others (2)0,150,010234000 (d) sweet corn 0,20,050239000 (e) other fruiting vegetables 0,150,010240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0241000 (a) flowering brassica 0,70,60241010Broccoli0241020Cauliflowers0241990Others (2)0242000 (b) head brassica 0242010Brussels sprouts0,40,090242020Head cabbages0,40,3 0242990Others (2)0,020,010243000 (c) leafy brassica 0243010Chinese cabbages/pe-tsai0,020,010243020Kales0,650243990Others (2)0,020,010244000 (d) kohlrabies 0,40,090250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants

0251010Lamb's lettuces/corn salads0,360251020Lettuces0,260251030Escaroles/broad-leaved endives0,080,070251040Cresses and other sprouts and shoots0,360251050Land cresses0,360251060Roman rocket/rucola0,360251070Red mustards0,360251080Baby leaf crops (including brassica species)0,360251990Others (2)0,360252000 (b) spinaches and similar leaves 0,360252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0,040,010254000 (d) watercresses 0,080,070255000 (e) witloofs/Belgian endives 0,080,070256000 (f) herbs and edible flowers 0,360256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2) 0260000Legume vegetables0260010Beans (with pods)0,90,50260020Beans (without pods)10,40260030Peas (with pods)0,90,50260040Peas (without pods)10,40260050Lentils10,40260990Others (2)0,40,010270000Stem vegetables0,20,010270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0,020,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,020,010300000PULSES330300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0401000Oilseeds0401010Linseeds0,050,010401020Peanuts/groundnuts0,060,040401030Poppy seeds0,050,010401040Sesame seeds0,050,010401050Sunflower seeds0,050,010401060Rapeseeds/canola seeds0,30,30401070Soyabeans0,71,5 0401080Mustard seeds0,30,30401090Cotton seeds0,080,80401100Pumpkin seeds0,050,010401110Safflower seeds0,050,010401120Borage seeds0,050,010401130Gold of pleasure seeds0,050,010401140Hemp seeds0,050,010401150Castor beans0,050,010401990Others (2)0,050,010402000Oil fruits0402010Olives for oil production0,1550402020Oil palms kernels0,020,010402030Oil palms fruits0,020,010402040Kapok0,020,010402990Others (2)0,020,010500000CEREALS0500010Barley0,830500020Buckwheat and other pseudocereals0,30,010500030Maize/corn0,10,020500040Common millet/proso millet0,30,010500050Oat0,30,010500060Rice0,30,010500070Rye0,30,010500080Sorghum0,330500090Wheat1,510500990Others (2)0,30,010600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0610000Teas0,10,050620000Coffee beans0,210630000Herbal infusions from0,050631000 (a) flowers 0,10631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2) 0632000 (b) leaves and herbs 0,10632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)0633000 (c) roots 0,10633010Valerian0633020Ginseng0633990Others (2)0639000 (d) any other parts of the plant 0640000Cocoa beans0,060,050650000Carobs/Saint John's breads0,10,050700000HOPS0,340800000SPICES0810000Seed spices0,10,050810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,10,050820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,10,050830010Cinnamon0830990Others (2)

0840000Root and rhizome spices0840010Liquorice0,10,050840020Ginger (10)0840030Turmeric/curcuma0,10,050840040Horseradish (11)0840990Others (2)0,10,050850000Bud spices0,10,050850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,10,050860010Saffron0860990Others (2)0870000Aril spices0,10,050870010Mace0870990Others (2)0900000SUGAR PLANTS0,020,010900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from1011000 (a) swine 1011010Muscle0,150,031011020Fat0,10,0151011030Liver0,090,081011040Kidney0,20,091011050Edible offals (other than liver and kidney)0,20,091011990Others (2)0,20,091012000 (b) bovine 1012010Muscle0,40,31012020Fat0,50,21012030Liver0,411012040Kidney0,511012050Edible offals (other than liver and kidney)0,511012990Others (2)0,51 1013000 (c) sheep 1013010Muscle0,20,31013020Fat0,150,21013030Liver0,1511013040Kidney0,311013050Edible offals (other than liver and kidney)0,311013990Others (2)0,311014000 (d) goat 1014010Muscle0,20,31014020Fat0,150,21014030Liver0,1511014040Kidney0,311014050Edible offals (other than liver and kidney)0,311014990Others (2)0,311015000 (e) equine 1015010Muscle0,40,31015020Fat0,50,21015030Liver0,411015040Kidney0,511015050Edible offals (other than liver and kidney)0,511015990Others (2)0,511016000 (f) poultry 0,011016010Muscle0,151016020Fat0,031016030Liver0,31016040Kidney0,021016050Edible offals (other than liver and kidney)0,021016990Others (2)0,021017000 (g) other farmed terrestrial animals 1017010Muscle0,40,31017020Fat0,50,21017030Liver0,411017040Kidney0,511017050Edible offals (other than liver and kidney)0,511017990Others (2)0,511020000Milk1020010Cattle0,070,151020020Sheep0,030,15 1020030Goat0,030,151020040Horse0,030,011020990Others (2)0,030,011030000Birds eggs0,10,011030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,050,051050000Amphibians and Reptiles0,020,011060000Terrestrial invertebrate animals0,020,011070000Wild terrestrial vertebrate animals0,020,011100000PRODUCTS OF ANIMAL ORIGIN - FISH, FISH PRODUCTS 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) (2) in Part A of Annex III, the columns for difluoroacetic acid and flupyradifurone are deleted.