Commission Regulation (EU) 2020/192 of 12 February 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 prochloraz in or on certain productsText with EEA relevance.

Commission Regulation (EU) 2020/192 of 12 February 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 prochloraz 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 prochloraz, maximum residue limits (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. (2) For that active substance, 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; Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2018; 16(8):5401. . The Authority proposed to change the residue definition to the sum of prochloraz, BTS 44595 (M201-04) and BTS 44596 (M201-03), expressed as prochloraz. The Authority identified a risk for consumers concerning the MRLs for citrus fruits, kiwi, bananas, mangoes, pineapples and bovine liver. It is therefore appropriate to lower these MRLs to the Limit of Determination (LOD) or the level identified by the Authority. The Authority recommended lowering the MRLs for garlic, shallots, lettuces and salad plants, purslanes, herbs and edible flowers, peas, linseeds, sunflower seeds, rapeseeds/canola seeds, barley, oat, rice, rye, wheat, coffee beans, herbal infusions from flowers, leaves and herbs and roots, spices, sugar beet roots, bovine (fat, kidney), equine fat and poultry liver. 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 level identified by the Authority. The Authority concluded that concerning the Codex maximum residue levels (CXLs) for kumquats, litchis/lychees, passionfruits/maracujas, prickly pears/cactus fruits, star apples/cainitos, American persimmons/Virginia kaki, avocados, papayas, Granate apples/pomegranates, cherimoyas, guavas, breadfruits, durians and soursops/guanabanas, some information was not available in relation to the new residue definition 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 level of the existing CXLs. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. (3) As regards products on which the use of the plant protection products concerned is not authorised, and for which no import tolerances or CXLs exist, MRLs should be set at the specific limit of determination or the default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) No 396/2005.

(4) 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. (5) 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. (6) 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. (7) Regulation (EC) No 396/2005 should therefore be amended accordingly. (8) 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. (9) 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. (10) 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

As regards the active substance prochloraz in and on all products except citrus fruits, kiwi, bananas, mangoes, pineapples and bovine liver, 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 4 September 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 4 September 2020. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 12 February 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 column for prochloraz is replaced by the following: () 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 Prochloraz (sum of prochloraz, BTS 44595 (M201-04) and BTS 44596 (M201-03), expressed as prochloraz) (F) (+) The European Food Safety Authority identified some information on residue trials in relation with the new residue definition 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 [Office of Publication: please insert date 2 years after publication], or, if that information is not submitted by that date, the lack of it.

0161040 Kumquats 0162020 Litchis/lychees 0162030 Passionfruits/maracujas 0162040 Prickly pears/cactus fruits 0162050 Star apples/cainitos 0162060 American persimmons/Virginia kaki 0163010 Avocados 0163040 Papayas 0163050 Granate apples/pomegranates 0163060 Cherimoyas 0163070 Guavas 0163090 Breadfruits 0163100 Durians 0163110 Soursops/guanabanas (+) The European Food Safety Authority identified some information on feeding studies analysing both enforcement and risk assessment residue definitions 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 [Office of Publication: please insert date 2 years after publication], or, if that information is not submitted by that date, the lack of it. 1011030 Liver 1011040 Kidney 1012020 Fat 1012030 Liver 1012040 Kidney 1013020 Fat 1013030 Liver 1013040 Kidney 1014020 Fat 1014030 Liver 1014040 Kidney 1015020 Fat 1015030 Liver 1015040 Kidney 1016010 Muscle 1016020 Fat 1016030 Liver 1016040 Kidney 1016050 Edible offals (other than liver and kidney) 1016990 Others (2) 1030010 Chicken 1030020 Duck 1030030 Geese 1030040 Quail Code numberGroups and examples of individual products to which the MRLs apply (a)Prochloraz (sum of prochloraz, BTS 44595 (M201-04) and BTS 44596 (M201-03), expressed as prochloraz) (F)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0.030110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0.030120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0.030130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0.030140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2) 0150000Berries and small fruits0.030151000 (a) grapes 0151010Table grapes0151020Wine grapes0152000 (b) strawberries 0153000 (c) cane fruits 0153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000 (d) other small fruits and berries 0154010Blueberries0154020Cranberries0154030Currants (black, red and white)0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruits with0161000 (a) edible peel 0161010Dates0.030161020Figs0.030161030Table olives0.030161040Kumquats10 (+)0161050Carambolas0.030161060Kaki/Japanese persimmons0.030161070Jambuls/jambolans0.030161990Others (2)0.030162000 (b) inedible peel, small 0162010Kiwi fruits (green, red, yellow)0.030162020Litchis/lychees7 (+)0162030Passionfruits/maracujas7 (+)0162040Prickly pears/cactus fruits7 (+)0162050Star apples/cainitos7 (+)0162060American persimmons/Virginia kaki7 (+) 0162990Others (2)0.030163000 (c) inedible peel, large

0163010Avocados7 (+)0163020Bananas0.030163030Mangoes0.030163040Papayas7 (+)0163050Granate apples/pomegranates7 (+)0163060Cherimoyas7 (+)0163070Guavas7 (+)0163080Pineapples0.030163090Breadfruits7 (+)0163100Durians7 (+)0163110Soursops/guanabanas7 (+)0163990Others (2)0.030200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0.030211000 (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 vegetables0.030220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0.030231000 (a) Solanaceae and Malvaceae 0231010Tomatoes0231020Sweet peppers/bell peppers0231030Aubergines/eggplants0231040Okra/lady's fingers0231990Others (2)0232000 (b) cucurbits with edible peel 0232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)0233000 (c) cucurbits with inedible peel 0233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)0234000 (d) sweet corn 0239000 (e) other fruiting vegetables 0240000Brassica vegetables (excluding brassica roots and brassica baby leaf crops)0.030241000 (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 0.030251010Lamb'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 0.030252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0.030254000 (d) watercresses 0.030255000 (e) witloofs/Belgian endives 0.030256000 (f) herbs and edible flowers 0.060256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2) 0260000Legume vegetables0.030260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0.030270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0280010Cultivated fungi30280020Wild fungi0.030280990Mosses and lichens0.030290000Algae and prokaryotes organisms0.030300000PULSES0.030300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0401000Oilseeds0401010Linseeds0.30401020Peanuts/groundnuts0.030401030Poppy seeds0.30401040Sesame seeds0.030401050Sunflower seeds0.30401060Rapeseeds/canola seeds0.3

0401070Soyabeans0.030401080Mustard seeds0.030401090Cotton seeds0.030401100Pumpkin seeds0.030401110Safflower seeds0.030401120Borage seeds0.030401130Gold of pleasure seeds0.030401140Hemp seeds0.030401150Castor beans0.030401990Others (2)0.030402000Oil fruits0.030402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0500010Barley0.030500020Buckwheat and other pseudocereals0.030500030Maize/corn0.030500040Common millet/proso millet0.030500050Oat0.030500060Rice0.030500070Rye0.20500080Sorghum0.030500090Wheat0.20500990Others (2)0.030600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0.150610000Teas0620000Coffee beans0630000Herbal infusions from0631000 (a) flowers 0631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden 0631990Others (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 breads0700000HOPS0.150800000SPICES0810000Seed spices0.150810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0.150820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2) 0830000Bark spices0.150830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0.150840020Ginger (10)0.150840030Turmeric/curcuma0.150840040Horseradish (11)0840990Others (2)0.150850000Bud spices0.150850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0.150860010Saffron0860990Others (2)0870000Aril spices0.150870010Mace0870990Others (2)0900000SUGAR PLANTS0.030900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from1011000 (a) swine 1011010Muscle0.031011020Fat0.031011030Liver0.3 (+)1011040Kidney0.05 (+)1011050Edible offals (other than liver and kidney)0.031011990Others (2)0.031012000 (b) bovine 1012010Muscle0.031012020Fat0.07 (+)1012030Liver1 (+) 1012040Kidney0.2 (+)1012050Edible offals (other than liver and kidney)0.031012990Others (2)0.031013000 (c) sheep 1013010Muscle0.031013020Fat0.15 (+)1013030Liver3 (+)1013040Kidney0.5 (+)1013050Edible offals (other than liver and kidney)0.031013990Others (2)0.031014000 d) goat 1014010Muscle0.031014020Fat0.15 (+)1014030Liver3 (+)1014040Kidney0.5 (+)1014050Edible offals (other than liver and kidney)0.031014990Others (2)0.031015000 (e) equine 1015010Muscle0.031015020Fat0.07 (+)1015030Liver1 (+)1015040Kidney0.2 (+)1015050Edible offals (other than liver and kidney)0.031015990Others (2)0.031016000 (f) poultry 1016010Muscle0.03 (+)1016020Fat0.03 (+)1016030Liver0.04 (+)1016040Kidney0.03 (+)1016050Edible offals (other than liver and kidney)0.03 (+)1016990Others (2)0.03 (+)1017000

(g) other farmed terrestrial animals 0.031017010Muscle1017020Fat1017030Liver1017040Kidney1017050Edible offals (other than liver and kidney) 1017990Others (2)1020000Milk0.031020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0.11030010Chicken(+)1030020Duck(+)1030030Geese(+)1030040Quail(+)1030990Others (2)1040000Honey and other apiculture products (7)0.151050000Amphibians and Reptiles0.031060000Terrestrial invertebrate animals0.031070000Wild terrestrial vertebrate animals0.031100000PRODUCTS 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 B of Annex III the column for prochloraz is deleted.