Commission Regulation (EU) 2020/785 of 9 June 2020 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 chromafenozide, fluometuron, pencycuron, sedaxane, tau-fluvalinate and triazoxide in or on certain productsText with EEA relevance.

Commission Regulation (EU) 2020/785 of 9 June 2020 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 chromafenozide, fluometuron, pencycuron, sedaxane, tau-fluvalinate and triazoxide 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 chromafenozide, fluometuron, pencycuron, sedaxane and tau-fluvalinate maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005. For triazoxide no MRLs were set in Regulation (EC) No 396/2005 and as this active substance is not included in Annex IV to that Regulation, the default value of 0,01 mg/kg laid down in Article 18(1)(b) of that Regulation applies. (2) For chromafenozide the European Food Safety Authority (the Authority), submitted a reasoned opinion on the review of the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for chromafenozide according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2019;17(1):5533. . No uses are authorised and no import tolerances exist for chromafenozide in the Union. The Authority concluded that setting the MRL at the Limit of Determination (LOD) would provide a satisfactory level of protection for consumers in the Union. Therefore, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the specific LOD. (3) For fluometuron the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2019;17(1):5560. . It recommended keeping the existing MRL for cotton seeds. No other authorisations exist for this substance. As there is no risk for consumers, the MRL for that product should be set in Annex II to Regulation (EC) No 396/2005 at the existing level. (4) For pencycuron the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2018;16(12):5518. . It proposed to change the residue definition and concluded that concerning the MRLs for all commodities some information was not available and that further consideration by risk managers was required. As a risk for consumers cannot be excluded, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the specific LOD.

(5) For sedaxane the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2019;17(1):5544. . It proposed to change the residue definition and recommended keeping the existing MRLs. As there is no risk for consumers, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the existing level. (6) For tau-fluvalinate the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for tau-fluvalinate according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2018;16(11):5475. . It proposed to change the residue definition and recommended lowering the MRLs for cherries (sweet), strawberries, beetroots, carrots, broccoli, beans (without pods), peas (without pods), sesame seeds, rapeseeds/canola seeds, cotton seeds, barley, oats, swine (muscle, fat, kidney), kidney (bovine, sheep, goat, equine), milk (cattle, sheep, goat, horse). For other products, the Authority recommended raising or keeping the existing MRLs. As there is no risk for consumers, the MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. It concluded that concerning the MRLs for cucumbers, poultry fat and poultry edible offals (other than liver and kidney) some information was not available and that further consideration by risk managers was required. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. (7) For triazoxide the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2019;17(1):5525. . It recommended lowering the MRLs for barley, oats, rye and wheat. No other authorisations exist for this substance. As there is no risk for consumers, the MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the specific LOD or the level identified by the Authority. (8) As regards products on which the use of the plant protection product concerned is not authorised, and for which no import tolerances or Codex maximum residue limits (CXLs) exist, MRLs should be set at the specific LOD or the default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) No 396/2005. (9) The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain limits of determination. As regards several substances, those laboratories concluded that for certain commodities technical development requires the setting of specific limits of determination.

(10) Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005. (11) 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. (12) Regulation (EC) No 396/2005 should therefore be amended accordingly. (13) In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement 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. (14) 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. (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

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 products which were produced in the Union or imported into the Union before 6 January 2021.

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 6 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 9 June 2020. 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 chromafenozide, fluometuron, pencycuron, sedaxane, tau-fluvalinate and triazoxide are added: Pesticide residues and maximum residue levels (mg/kg) () Limit of analytical determination (a) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I. (F) = Fat soluble Pencycuron (sum of pencycuron and pencycuron-PB-amine, expressed as pencycuron) (F) (R) (A) (A) The EU reference labs identified the reference standard for the pencycuron-PB-amine as commercially not available. When re-viewing the MRL, the Commission will take into account the commercial availability of the reference standard referred to in the first sentence by 16 June 2021, or, if that reference standard is not commercially available by that date, the unavailability of it. (R) = The residue definition differs for the following combinations pesticide-code number: Pencycuron - code 1000000: pencycuron (F)

Fluvalinate (sum of isomers) (F) resulting from the use of tau-fluvalinate (+) 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 16 June 2022, or, if that information is not submitted by that date, the lack of it. 0232010 Cucumbers (+) The European Food Safety Authority identified some information on livestock metabolism and feeding studies 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 16 June 2022, or, if that information is not submitted by that date, the lack of it. 1016020 Fat 1016050 Edible offals (other than liver and kidney) Code numberGroups and examples of individual products to which the MRLs apply (a)ChromafenozideFluometuronPencycuron (sum of pencycuron and pencycuron-PB-amine, expressed as pencycuron) (F) (R) (A)Sedaxane (sum of isomers)Fluvalinate (sum of isomers) (F) resulting from the use of tau-fluvalinateTriazoxide(1)(2)(3)(4)(5)(6)(7)(8)0100000FRUITS, FRESH or FROZEN; TREE NUTS0,01()0,01()0,02()0,01()0110000Citrus fruits0,40,001()0110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,01()0,005()0120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios 0120110Walnuts0120990Others (2)0130000Pome fruits0,30,001()0130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0,001()0140010Apricots0,30140020Cherries (sweet)0,40140030Peaches0,30140040Plums0,01()0140990Others (2)0,01()0150000Berries and small fruits0,001()0151000(a) grapes10151010Table grapes0151020Wine grapes0152000(b) strawberries0,30153000(c) cane fruits0,01()0153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000(d) other small fruits and berries0,01()0154010Blueberries0154020Cranberries 0154030Currants (black, red and white)0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruitswith0,01()0161000(a) edible peel0161010Dates0,001()0161020Figs0,001()0161030Table olives0,005()0161040Kumquats0,001()0161050Carambolas0,001()0161060Kaki/Japanese persimmons0,001()0161070Jambuls/jambolans0,001()0161990Others (2)0,001()0162000(b) inedible peel, small0,001()0162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2) 0163000(c) inedible peel, large0163010Avocados0,005()0163020Bananas0,001()0163030Mangoes0,001()0163040Papayas0,001()0163050Granate apples/pomegranates0,001()0163060Cherimoyas0,001()0163070Guavas0,001()0163080Pineapples0,001()0163090Breadfruits0,001()0163100Durians0,001()0163110Soursops/guanabanas0,001()0163990Others (2)0,001()0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0,01()0,01()0,02()0,01()0,001()0211000(a) potatoes0,020212000(b) tropical root and tuber vegetables0,01()0212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)0213000(c) other root and tuber vegetables except sugar beets0,01()0213010Beetroots0213020Carrots0213030Celeriacs/turnip rooted celeries0213040Horseradishes

0213050Jerusalem artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0,01()0,01()0,02()0,01()0,01()0,001()0220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0,01()0,01()0,02()0,01()0,001()0231000(a) Solanaceae and Malvaceae0231010Tomatoes0,01()0231020Sweet peppers/bell peppers0,01()0231030Aubergines/eggplants0,150231040Okra/lady's fingers0,01()0231990Others (2)0,01()0232000(b) cucurbits with edible peel0,020232010Cucumbers(+)0232020Gherkins0232030Courgettes0232990Others (2) 0233000(c) cucurbits with inedible peel0233010Melons0,090233020Pumpkins0,01()0233030Watermelons0,090233990Others (2)0,01()0234000(d) sweet corn0,01()0239000(e) other fruiting vegetables0,01()0240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,01()0,01()0,02()0,01()0,001()0241000(a) flowering brassica0,30241010Broccoli0241020Cauliflowers0241990Others (2)0242000(b) head brassica0242010Brussels sprouts0,150242020Head cabbages0,30242990Others (2)0,01()0243000(c) leafy brassica0,01()0243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)0244000(d) kohlrabies0,080250000Leaf vegetables, herbs and edible flowers0251000(a) lettuces and salad plants0,01()0,01()0,02()0,01()0,70,001()0251010Lamb's lettuces/corn salads0251020Lettuces 0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2)0252000(b) spinaches and similar leaves0,01()0,01()0,02()0,01()0,01()0,001()0252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)0253000(c) grape leaves and similar species0,01()0,01()0,02()0,01()0,01()0,001()0254000(d) watercresses0,01()0,01()0,02()0,01()0,01()0,001()0255000(e) witloofs/Belgian endives0,01()0,01()0,02()0,01()0,01()0,001()0256000(f) herbs and edible flowers0,02()0,02()0,04()0,02()0,02()0,002()0256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves 0256100Tarragon0256990Others (2)0260000Legume vegetables0,01()0,01()0,02()0,01()0,001()0260010Beans (with pods)0,60260020Beans (without pods)0,050260030Peas (with pods)0,60260040Peas (without pods)0,050260050Lentils0,01()0260990Others (2)0,01()0270000Stem vegetables0,01()0,01()0,02()0,01()0,001()0270010Asparagus0,01()0270020Cardoons0,01()0270030Celeries0,01()0270040Florence fennels0,01()0270050Globe artichokes0,80270060Leeks0,01()0270070Rhubarbs0,01()0270080Bamboo shoots0,01()0270090Palm hearts0,01()0270990Others (2)0,01()0280000Fungi, mosses and lichens0,01()0,01()0,02()0,01()0,01()0,001()0280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,01()0,01()0,02()0,01()0,01()0,001()0300000PULSES0,01()0,005()0,02()0,01()0,01()0,003()0300010Beans0300020Lentils0300030Peas

0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,01()0,01()0,02()0,01()0,005()0401000Oilseeds0401010Linseeds0,020401020Peanuts/groundnuts0,01()0401030Poppy seeds0,01()0401040Sesame seeds0,01()0401050Sunflower seeds0,01()0401060Rapeseeds/canola seeds0,020401070Soyabeans0,01()0401080Mustard seeds0,020401090Cotton seeds0,090401100Pumpkin seeds0,020401110Safflower seeds0,020401120Borage seeds0,020401130Gold of pleasure seeds0,020401140Hemp seeds0,020401150Castor beans0,01()0401990Others (2)0,01()0402000Oil fruits0,01()0402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0,01()0,005()0,02()0,01()0,003()0500010Barley0,4 0500020Buckwheat and other pseudocereals0,01()0500030Maize/corn0,01()0500040Common millet/proso millet0,01()0500050Oat0,40500060Rice0,01()0500070Rye0,050500080Sorghum0,01()0500090Wheat0,050500990Others (2)0,01()0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,05()0,05()0,1()0,05()0,05()0,005()0610000Teas0620000Coffee beans0630000Herbal infusions from0631000(a) flowers0631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)0632000(b) leaves and herbs0632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)0633000(c) roots0633010Valerian0633020Ginseng 0633990Others (2)0639000(d) any other parts of the plant0640000Cocoa beans0650000Carobs/Saint John's breads0700000HOPS0,05()0,05()0,1()0,05()0,05()0,005()0800000SPICES0810000Seed spices0,05()0,05()0,1()0,05()0,05()0,005()0810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,05()0,05()0,1()0,05()0,05()0,005()0820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,05()0,05()0,1()0,05()0,05()0,005() 0830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,05()0,05()0,1()0,05()0,05()0,005()0840020Ginger (10)0840030Turmeric/curcuma0,05()0,05()0,1()0,05()0,05()0,005()0840040Horseradish (11)0840990Others (2)0,05()0,05()0,1()0,05()0,05()0,005()0850000Bud spices0,05()0,05()0,1()0,05()0,05()0,005()0850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,05()0,05()0,1()0,05()0,05()0,005()0860010Saffron0860990Others (2)0870000Aril spices0,05()0,05()0,1()0,05()0,05()0,005()0870010Mace0870990Others (2)0900000SUGAR PLANTS0,01()0,01()0,02()0,01()0,01()0,001()0900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,01()0,005()0,01()0,01()0,01()1011000(a) swine1011010Muscle0,0151011020Fat0,05 1011030Liver0,01()1011040Kidney0,01()1011050Edible offals (other than liver and kidney)0,051011990Others (2)0,01()1012000(b) bovine1012010Muscle0,051012020Fat0,31012030Liver0,01()1012040Kidney0,0151012050Edible offals (other than liver and kidney)0,31012990Others (2)0,01()1013000(c) sheep1013010Muscle0,051013020Fat0,31013030Liver0,01()1013040Kidney0,0151013050Edible offals (other than liver and kidney)0,31013990Others (2)0,01()1014000d) goat1014010Muscle0,051014020Fat0,31014030Liver0,01()1014040Kidney0,0151014050Edible offals (other than liver and kidney)0,31014990Others (2)0,01()

1015000(e) equine1015010Muscle0,051015020Fat0,31015030Liver0,01()1015040Kidney0,0151015050Edible offals (other than liver and kidney)0,31015990Others (2)0,01()1016000(f) poultry1016010Muscle0,01()1016020Fat0,03 (+)1016030Liver0,01()1016040Kidney0,01()1016050Edible offals (other than liver and kidney)0,03 (+)1016990Others (2)0,01()1017000(g) other farmed terrestrial animals1017010Muscle0,051017020Fat0,31017030Liver0,01()1017040Kidney0,0151017050Edible offals (other than liver and kidney)0,31017990Others (2)0,01()1020000Milk0,01()0,005()0,01()0,01()0,01()1020010Cattle0,031020020Sheep0,021020030Goat0,021020040Horse0,03 1020990Others (2)0,021030000Birds eggs0,01()0,005()0,01()0,01()0,01()0,01()1030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,05()0,05()0,05()0,05()0,05()0,05()1050000Amphibians and Reptiles0,01()0,005()0,01()0,01()0,01()0,01()1060000Terrestrial invertebrate animals0,01()0,005()0,01()0,01()0,01()0,01()1070000Wild terrestrial vertebrate animals0,01()0,005()0,01()0,01()0,01()0,01()1100000PRODUCTS 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) (2) in Part A of Annex III, the columns for chromafenozide, fluometuron, pencycuron, sedaxane and tau-fluvalinate are deleted.