Commission Regulation (EU) 2019/1559 of 16 September 2019 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 cyflufenamid, fenbuconazole, fluquinconazole and tembotrione in or on certain productsText with EEA relevance.

Commission Regulation (EU) 2019/1559 of 16 September 2019 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 cyflufenamid, fenbuconazole, fluquinconazole and tembotrione 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 cyflufenamid, fenbuconazole, fluquinconazole and tembotrione maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005. (2) For cyflufenamid the European Food Safety Authority (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 cyflufenamid according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2018;16(10):5416. . It proposed to change the residue definition for commodities of animal origin. It recommended lowering the MRLs for gherkins and rye. For other products, it recommended raising or keeping the existing MRLs. It concluded that concerning the MRLs for maize/corn, common millet/proso millet, rice, sorghum, wheat, poultry (muscle, fat, liver) and birds' eggs some information was not available and that further consideration by risk managers was required. 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. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. (3) For fenbuconazole 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 fenbuconazole according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2018;16(8):5399. . It proposed to change the residue definition. It recommended lowering the MRLs for grapefruit, oranges, almonds, Brazil nuts, cashew nuts, chestnuts, coconuts, hazelnuts/cobnuts, macadamias, pecans, pine nut kernels, pistachios, walnuts and blueberries. For other products, the Authority recommended raising or keeping the existing MRLs. It concluded that concerning the MRLs for apricots, peaches, plums, cucumbers, gherkins, courgettes, melons, pumpkins and watermelons some information was not available and that further consideration by risk managers was required. 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. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. (4) For fluquinconazole 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 fluquinconazole according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2018;16(9):5409. . The Authority concluded that no uses or import tolerances are currently authorised for fluquinconazole in the Union and no codex maximum residue limits (CXLs) are available for that active substance. Residues of fluquinconazole are therefore not expected to occur in any plant commodity or in any animal product. As there is no risk for consumers, the MRLs for fluquinconazole should be set in Annex II to Regulation (EC) No 396/2005 at the specific limit of determination (LOD). (5) For tembotrione 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 tembotrione according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2018;16(9):5417. . It recommended lowering the MRLs for swine (liver, kidney), bovine (liver, kidney) and equine (liver, kidney). For other products, the Authority recommended raising or keeping the existing MRLs. It concluded that concerning the MRLs for sweet corn and fruit spices some information was not available and that further consideration by risk managers was required. 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. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. (6) As regards products on which the use of the plant protection product concerned is not authorised, and for which no import tolerances or 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. (7) 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. (8) 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. (9) 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.

(10) Regulation (EC) No 396/2005 should therefore be amended accordingly. (11) 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. (12) 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. (13) 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 7 April 2020,

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 7 April 2020, This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 16 September 2019. For the Commission The President Jean-Claude Juncker

Annex

ANNEX Annexes II and III to Regulation (EC) No 396/2005 are amended as follows: (1) In Annex II the following columns for cyflufenamid, fenbuconazole, fluquinconazole and tembotrione are added: Pesticide residues and maximum residue levels (mg/kg) 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. (F)Fat soluble Cyflufenamid (sum of cyflufenamid (Z-isomer) and its E-isomer, expressed as cyflufenamid) (A) (R) (A) The EU reference labs identified the reference standards for the E-isomer and for metabolite 149-F1 as commercially not available. When re-viewing the MRL, the Commission will take into account the commercial availability of the reference standards referred to in the first sentence by 17 September 2020, 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: Cyflufenamid - code 1000000 except 1040000: sum of cyflufenamid (Z-isomer), its E-isomer and metabolite 149-F1, expressed as cyflufenamid (+) The European Food Safety Authority identified some information on feeding studies for poultry 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 17 September 2021, or, if that information is not submitted by that date, the lack of it.

0500090Wheat Fenbuconazole (sum of constituent enantiomers) (+) The European Food Safety Authority identified some information relating to triazole derivative metabolites (TDMs) 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 17 September 2021, or, if that information is not submitted by that date, the lack of it. 0110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars (+) The European Food Safety Authority identified some information on residue trials, including data relating to triazole derivative metabolites (TDMs), 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 17 September 2021, or, if that information is not submitted by that date, the lack of it. 0140010Apricots (+) The European Food Safety Authority identified some information relating to triazole derivative metabolites (TDMs) 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 17 September 2021, or, if that information is not submitted by that date, the lack of it. 0140020Cherries (sweet) (+) The European Food Safety Authority identified some information on residue trials, including data relating to triazole derivative metabolites (TDMs), 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 17 September 2021, or, if that information is not submitted by that date, the lack of it. 0140030Peaches0140040Plums (+) The European Food Safety Authority identified some information relating to triazole derivative metabolites (TDMs) 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 17 September 2021, or, if that information is not submitted by that date, the lack of it. 0151010Table grapes0151020Wine grapes0154010Blueberries0154020Cranberries0163020Bananas0231020Sweet peppers/bell peppers (+) The European Food Safety Authority identified some information on residue trials, including data relating to triazole derivative metabolites (TDMs), 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 17 September 2021, or, if that information is not submitted by that date, the lack of it. 0232010Cucumbers0232020Gherkins0232030Courgettes0233010Melons0233020Pumpkins0233030Watermelons (+) The European Food Safety Authority identified some information relating to triazole derivative metabolites (TDMs) 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 17 September 2021, or, if that information is not submitted by that date, the lack of it.

0401020Peanuts/groundnuts0401050Sunflower seeds0401060Rapeseeds/canola seeds0500010Barley0500070Rye0500090Wheat1011030Liver1011040Kidney1011050Edible offals (other than liver and kidney)1012030Liver1012040Kidney1012050Edible offals (other than liver and kidney)1013030Liver1013040Kidney1013050Edible offals (other than liver and kidney)1014030Liver1014040Kidney1014050Edible offals (other than liver and kidney)1015030Liver1015040Kidney1015050Edible offals (other than liver and kidney)1017030Liver1017040Kidney1017050Edible offals (other than liver and kidney) Tembotrione (Sum of parent tembotrione (AE 0172747) and its metabolite M5 (4,6-dihydroxy tembotrione), expressed as tembotrione) (R) (R) The residue definition differs for the following combinations pesticide-code number: Tembotrione - code 1000000 except 1040000: Metabolite M5 (Dihydroxy-tembotrione) (+) 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 17 September 2021, or, if that information is not submitted by that date, the lack of it. 0234000 (d) sweet corn Code numberGroups and examples of individual products to which the MRLs applyCyflufenamid (sum of cyflufenamid (Z-isomer) and its E-isomer, expressed as cyflufenamid) (A) (R)Fenbuconazole (sum of constituent enantiomers)Fluquinconazole (F)Tembotrione (Sum of parent tembotrione (AE 0172747) and its metabolite M5 (4,6-dihydroxy tembotrione), expressed as tembotrione) (R)(1)(2)(3)(4)(5)(6)0100000FRUITS, FRESH or FROZEN; TREE NUTS0,010,020110000Citrus fruits0,010110010Grapefruits0,7 (+)0110020Oranges0,9 (+)0110030Lemons1 (+)0110040Limes1 (+)0110050Mandarins0,5 (+)0110990Others (2)0,50120000Tree nuts0,010,010120010Almonds (+)0120020Brazil nuts (+)0120030Cashew nuts (+)0120040Chestnuts (+)0120050Coconuts (+)0120060Hazelnuts/cobnuts (+)0120070Macadamias (+)0120080Pecans (+)0120090Pine nut kernels (+)0120100Pistachios (+)0120110Walnuts (+)0120990Others (2)0130000Pome fruits0,060,50130010Apples (+)0130020Pears (+)0130030Quinces (+)0130040Medlars (+)0130050Loquats/Japanese medlars (+)0130990Others (2) 0140000Stone fruits0140010Apricots0,060,6 (+)0140020Cherries (sweet)0,11 (+)0140030Peaches0,060,6 (+)0140040Plums0,070,6 (+)0140990Others (2)0,060,60150000Berries and small fruits0151000 (a) grapes 0,21,50151010Table grapes (+)0151020Wine grapes (+)0152000 (b) strawberries 0,040,010153000 (c) cane fruits 0,010,010153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000 (d) other small fruits and berries 0,010154010Blueberries0,5 (+)0154020Cranberries1 (+)0154030Currants (black, red and white)0,010154040Gooseberries (green, red and yellow)0,010154050Rose hips0,010154060Mulberries (black and white)0,010154070Azaroles/Mediterranean medlars0,010154080Elderberries0,010154990Others (2)0,010160000Miscellaneous fruits with0,010161000 (a) edible peel

0,010161010Dates0161020Figs0161030Table olives0161040Kumquats0161050Carambolas0161060Kaki/Japanese persimmons0161070Jambuls/jambolans0161990Others (2)0162000 (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 0163010Avocados0,010163020Bananas0,05 (+)0163030Mangoes0,010163040Papayas0,010163050Granate apples/pomegranates0,010163060Cherimoyas0,010163070Guavas0,010163080Pineapples0,010163090Breadfruits0,010163100Durians0,010163110Soursops/guanabanas0,010163990Others (2)0,010200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0,010,010,010,020211000 (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 vegetables0,010,010,010,020220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0,010231000 (a) Solanaceae and Malvaceae 0,020231010Tomatoes0,040,010231020Sweet peppers/bell peppers0,060,6 (+) 0231030Aubergines/eggplants0,020,010231040Okra/lady's fingers0,010,010231990Others (2)0,010,010232000 (b) cucurbits with edible peel 0,050,30,020232010Cucumbers (+)0232020Gherkins (+)0232030Courgettes (+)0232990Others (2)0233000 (c) cucurbits with inedible peel 0,050,30,020233010Melons (+)0233020Pumpkins (+)0233030Watermelons (+)0233990Others (2)0234000 (d) sweet corn 0,010,010,05 (+)0239000 (e) other fruiting vegetables 0,010,010,020240000Brassica vegetables (excluding brassica roots and brassica baby leaf crops)0,010,010,010,020241000 (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 0,010,010,010,020251010Lamb'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 0,010,010,010,020252010Spinaches0252020Purslanes 0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0,010,010,010,020254000 (d) watercresses 0,010,010,010,020255000 (e) witloofs/Belgian endives 0,010,010,010,020256000

(f) herbs and edible flowers 0,020,020,020,040256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,010,010,010,020260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,010,010,020270010Asparagus0,010270020Cardoons0,010270030Celeries0,010270040Florence fennels0,010270050Globe artichokes0,040270060Leeks0,010270070Rhubarbs0,010270080Bamboo shoots0,010270090Palm hearts0,010270990Others (2)0,010280000Fungi, mosses and lichens0,010,010,010,020280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010,010,010,020300000PULSES0,010,010,010,020300010Beans0300020Lentils0300030Peas 0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,010,010,020401000Oilseeds0401010Linseeds0,010401020Peanuts/groundnuts0,1 (+)0401030Poppy seeds0,010401040Sesame seeds0,010401050Sunflower seeds0,05 (+)0401060Rapeseeds/canola seeds0,05 (+)0401070Soyabeans0,010401080Mustard seeds0,010401090Cotton seeds0,010401100Pumpkin seeds0,010401110Safflower seeds0,010401120Borage seeds0,010401130Gold of pleasure seeds0,010401140Hemp seeds0,010401150Castor beans0,010401990Others (2)0,010402000Oil fruits0,010402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0,010,020500010Barley0,10,2 (+)0500020Buckwheat and other pseudocereals0,10,010500030Maize/corn0,010,010500040Common millet/proso millet0,010,010500050Oat0,10,010500060Rice0,010,010500070Rye0,040,1 (+)0500080Sorghum0,010,010500090Wheat0,04 (+)0,1 (+)0500990Others (2)0,010,010600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,050,050,050,10610000Teas0620000Coffee beans0630000Herbal infusions from0631000 (a) flowers 0631010Chamomile0631020Hibiscus/roselle0631030Rose 0631040Jasmine0631050Lime/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 breads0700000HOPS0,050,050,050,10800000SPICES0810000Seed spices0,050,050,050,10810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,050,050,050,10820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,050,050,050,10830010Cinnamon0830990Others (2) 0840000Root and rhizome spices0840010Liquorice0,050,050,050,10840020Ginger (10)0,050,050,050,10840030Turmeric/curcuma0,050,050,050,10840040Horseradish (11)0840990Others (2)0,050,050,050,10850000Bud spices0,050,050,050,10850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,050,050,050,10860010Saffron0860990Others (2)0870000Aril spices0,050,050,050,10870010Mace0870990Others (2)0900000SUGAR PLANTS0,010,010,010,020900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,020,011011000

(a) swine 1011010Muscle0,050,011011020Fat0,050,011011030Liver0,1 (+)0,0151011040Kidney0,1 (+)0,0151011050Edible offals (other than liver and kidney)0,1 (+)0,0151011990Others (2)0,050,011012000 (b) bovine 1012010Muscle0,050,011012020Fat0,050,011012030Liver0,1 (+)0,051012040Kidney0,1 (+)0,021012050Edible offals (other than liver and kidney)0,1 (+)0,051012990Others (2)0,050,011013000 (c) sheep 0,011013010Muscle0,051013020Fat0,051013030Liver0,1 (+) 1013040Kidney0,1 (+)1013050Edible offals (other than liver and kidney)0,1 (+)1013990Others (2)0,051014000 (d) goat 0,011014010Muscle0,051014020Fat0,051014030Liver0,1 (+)1014040Kidney0,1 (+)1014050Edible offals (other than liver and kidney)0,1 (+)1014990Others (2)0,051015000 (e) equine 1015010Muscle0,050,011015020Fat0,050,011015030Liver0,1 (+)0,051015040Kidney0,1 (+)0,021015050Edible offals (other than liver and kidney)0,1 (+)0,051015990Others (2)0,050,011016000 (f) poultry 0,050,011016010Muscle1016020Fat1016030Liver1016040Kidney1016050Edible offals (other than liver and kidney)1016990Others (2)1017000 (g) other farmed terrestrial animals 0,011017010Muscle0,051017020Fat0,051017030Liver0,1 (+)1017040Kidney0,1 (+)1017050Edible offals (other than liver and kidney)0,1 (+)1017990Others (2)0,051020000Milk0,020,050,010,011020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,020,050,010,011030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2) 1040000Honey and other apiculture products (7)0,050,050,050,051050000Amphibians and Reptiles0,020,050,010,011060000Terrestrial invertebrate animals0,020,050,010,011070000Wild terrestrial vertebrate animals0,020,050,010,011100000PRODUCTS 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 cyflufenamid, fenbuconazole, fluquinconazole and tembotrione are deleted.