Contents
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/EECnote, and in particular Article 14(1), point (a), thereof,Whereas:
(1)For the active substance prothioconazole, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.
(2)An application requesting a modification of the existing MRLs for prothioconazole in sugar beet roots and chicory roots was submitted to the Member State concerned pursuant to Article 6(1) of Regulation (EC) No 396/2005.
(3)In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. The Commission forwarded the application, the evaluation report, and the supporting dossier to the European Food Safety Authority (the ‘Authority’).
(4)The Authority assessed the application and the evaluation report. It examined in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRLsnote. It forwarded its reasoned opinion to the applicant, the Commission and the Member States and made it available to the public.
(5)As regards the modifications to the MRLs for prothioconazole in sugar beet roots and chicory roots requested by the applicant, the Authority concluded that all the data requirements had been met and that the modifications to the MRLs requested by the applicant were 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 data on the toxicological properties of prothioconazole. Neither the long-term exposure to that substance via consumption of all food products that may contain it nor the short-term exposure due to high consumption of relevant products show a risk that the acceptable daily intake or the acute reference dose is exceeded.
(6)Based on the reasoned opinion of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, it is concluded that the proposed modifications to the MRLs fulfil the requirements of that Article.
(7)Regulation (EC) No 396/2005 should therefore be amended accordingly.
(8)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.
In Annex II to Regulation (EC) No 396/2005, the column for prothioconazole is replaced by the following:
‘Pesticide residues and maximum residue levels (mg/kg)notenoteCode numberGroups and examples of individual products to which the MRLs applynoteProthioconazole: prothioconazole-desthio (sum of isomers) (F)(1)(2)(3)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,01note0110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,02note0120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,01note0130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0,01note0140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0151000
(a)grapes
(a)edible peel
(a)potatoes
(a)Solanaceae and Malvaceae
(a)flowering brassica
(a)lettuces and salad plants
(a)flowers
(a)swine
(b)strawberries
(b)inedible peel, small
(b)tropical root and tuber vegetables
(b)cucurbits with edible peel
(b)head brassica
(b)spinaches and similar leaves
(b)leaves and herbs
(b)bovine
(c)cane fruits
(c)inedible peel, large
(c)other root and tuber vegetables except sugar beets
(c)cucurbits with inedible peel
(c)leafy brassica
(c)grape leaves and similar species
(c)roots
(c)sheep
(d)other small fruits and berries
(d)sweet corn
(d)kohlrabies
(d)watercresses
(d)any other parts of the plant
d)goat
(e)other fruiting vegetables
(e)witloofs/Belgian endives
(e)equine
(f)herbs and edible flowers
(f)poultry
(g)other farmed terrestrial animals
0,01note0151010Table grapes0151020Wine grapes01520000,01note01530000,01note0153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)01540000154010Blueberries0,01note0154020Cranberries0,150154030Currants (black, red and white)0,01note0154040Gooseberries (green, red and yellow)0,01note0154050Rose hips0,01note0154060Mulberries (black and white)0,01note0154070Azaroles/Mediterranean medlars0,01note0154080Elderberries0,01note0154990Others (2)0,01note0160000Miscellaneous fruitswith0,01note01610000161010Dates0161020Figs0161030Table olives0161040Kumquats0161050Carambolas0161060Kaki/Japanese persimmons0161070Jambuls/jambolans0161990Others (2)01620000162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)01630000163010Avocados0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables02110000,02note02120000,01note0212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)02130000213010Beetroots0,1(+)0213020Carrots0,1(+)0213030Celeriacs/turnip rooted celeries0,01note0213040Horseradishes0,1(+)0213050Jerusalem artichokes0,01note0213060Parsnips0,1(+)0213070Parsley roots/Hamburg roots parsley0,1(+)0213080Radishes0,01note0213090Salsifies0,1(+)0213100Swedes/rutabagas0,1(+)0213110Turnips0,1(+)0213990Others (2)0,01note0220000Bulb vegetables0220010Garlic0,01note0220020Onions0,05(+)0220030Shallots0,05(+)0220040Spring onions/green onions and Welsh onions0,01note0220990Others (2)0,01note0230000Fruiting vegetables02310000,01note0231010Tomatoes0231020Sweet peppers/bell peppers0231030Aubergines/eggplants0231040Okra/lady's fingers0231990Others (2)02320000,01note0232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)02330000,01note0233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)02340000,0202390000,01note0240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)02410000,05(+)0241010Broccoli(+)0241020Cauliflowers(+)0241990Others (2)(+)02420000242010Brussels sprouts0,1(+)0242020Head cabbages0,09(+)0242990Others (2)0,01note02430000,01note0243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)02440000,01note0250000Leaf vegetables, herbs and edible flowers02510000,01note0251010Lamb's lettuces/corn salads0251020Lettuces0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2)02520000,01note0252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)02530000,01note02540000,01note02550000,01note02560000,02note0256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,01note0260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0270010Asparagus0,01note0270020Cardoons0,01note0270030Celeries0,01note0270040Florence fennels0,01note0270050Globe artichokes0,01note0270060Leeks0,06(+)0270070Rhubarbs0,01note0270080Bamboo shoots0,01note0270090Palm hearts0,01note0270990Others (2)0,01note0280000Fungi, mosses and lichens0,01note0280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,01note0300000PULSES0300010Beans0,05(+)0300020Lentils1(+)0300030Peas1(+)0300040Lupins/lupini beans1(+)0300990Others (2)0,01note0400000OILSEEDS AND OIL FRUITS0401000Oilseeds0401010Linseeds0,09(+)0401020Peanuts/groundnuts0,02note(+)0401030Poppy seeds0,09(+)0401040Sesame seeds0,02note0401050Sunflower seeds0,20401060Rapeseeds/canola seeds0,15(+)0401070Soyabeans0,20401080Mustard seeds0,09(+)0401090Cotton seeds0,30401100Pumpkin seeds0,02note0401110Safflower seeds0,02note0401120Borage seeds0,02note0401130Gold of pleasure seeds0,04(+)0401140Hemp seeds0,02note0401150Castor beans0,02note0401990Others (2)0,02note0402000Oil fruits0,02note0402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0500010Barley0,2(+)0500020Buckwheat and other pseudocereals0,01note0500030Maize/corn0,10500040Common millet/proso millet0,01note0500050Oat0,05(+)0500060Rice0,01note0500070Rye0,05(+)0500080Sorghum0,01note0500090Wheat0,1(+)0500990Others (2)0,01note0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,05note0610000Teas0620000Coffee beans0630000Herbal infusions from06310000631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)06320000632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)06330000633010Valerian0633020Ginseng0633990Others (2)06390000640000Cocoa beans0650000Carobs/Saint John's breads0700000HOPS0,05note0800000SPICES0810000Seed spices0,05note0810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,05note0820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,05note0830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,05note0840020Ginger (10)0840030Turmeric/curcuma0,05note0840040Horseradish (11)0840990Others (2)0,05note0850000Bud spices0,05note0850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,05note0860010Saffron0860990Others (2)0870000Aril spices0,05note0870010Mace0870990Others (2)0900000SUGAR PLANTS0900010Sugar beet roots0,030900020Sugar canes0,01note0900030Chicory roots0,030900990Others (2)0,01note1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from10110001011010Muscle0,011011020Fat0,021011030Liver0,5(+)1011040Kidney0,5(+)1011050Edible offals (other than liver and kidney)0,5(+)1011990Others (2)0,5(+)10120001012010Muscle0,011012020Fat0,021012030Liver0,5(+)1012040Kidney0,5(+)1012050Edible offals (other than liver and kidney)0,5(+)1012990Others (2)0,5(+)10130001013010Muscle0,011013020Fat0,021013030Liver0,5(+)1013040Kidney0,5(+)1013050Edible offals (other than liver and kidney)0,5(+)1013990Others (2)0,5(+)10140001014010Muscle0,011014020Fat0,021014030Liver0,5(+)1014040Kidney0,5(+)1014050Edible offals (other than liver and kidney)0,5(+)1014990Others (2)0,5(+)10150001015010Muscle0,011015020Fat0,021015030Liver0,5(+)1015040Kidney0,5(+)1015050Edible offals (other than liver and kidney)0,5(+)1015990Others (2)0,5(+)10160001016010Muscle0,01note1016020Fat0,01note1016030Liver0,11016040Kidney0,11016050Edible offals (other than liver and kidney)0,11016990Others (2)0,01note10170001017010Muscle0,011017020Fat0,021017030Liver0,5(+)1017040Kidney0,5(+)1017050Edible offals (other than liver and kidney)0,5(+)1017990Others (2)0,5(+)1020000Milk0,01note(+)1020010Cattle(+)1020020Sheep(+)1020030Goat(+)1020040Horse(+)1020990Others (2)(+)1030000Birds eggs0,01note1030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,05note1050000Amphibians and Reptiles0,01note1060000Terrestrial invertebrate animals0,01note1070000Wild terrestrial vertebrate animals0,011100000PRODUCTS 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)(+)Pesticide-product combination for which a footnote exists. The list of footnotes is provided below.Prothioconazole: prothioconazole-desthio (sum of isomers) (F)(F)Fat solubleThe European Food Safety Authority identified some information on residue trials and storage stability data complying with the proposed 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 27 January 2018, or, if that information is not submitted by that date, the lack of it.0213010 Beetroots0213020 Carrots0213040 Horseradishes0213060 Parsnips0213070 Parsley roots/Hamburg roots parsley0213090 Salsifies0213100 Swedes/rutabagas0213110 Turnips0220020 Onions0241000 (a) flowering brassica0241010 Broccoli0241020 Cauliflowers0241990 Others (2)0242010 Brussels sprouts0242020 Head cabbages0270060 Leeks0300010 Beans0300020 Lentils0300030 Peas0300040 Lupins/lupini beans0401010 Linseeds0401020 Peanuts/groundnuts0401030 Poppy seeds0401060 Rapeseeds/canola seeds0401080 Mustard seeds0401130 Gold of pleasure seeds0500010 Barley0500050 Oat0500070 Rye0500090 WheatThe European Food Safety Authority identified some information on analytical methods and storage stability data complying with the proposed 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 27 January 2018, or, if that information is not submitted by that date, the lack of it.0220030 ShallotsThe European Food Safety Authority identified some information on residue trials on grass (major component of the livestock dietary burden), 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 27 January 2018, or, if that information is not submitted by that date, the lack of it.1011030 Liver1011040 Kidney1011050 Edible offals (other than liver and kidney)1011990 Others (2)1012030 Liver1012040 Kidney1012050 Edible offals (other than liver and kidney)1012990 Others (2)1013030 Liver1013040 Kidney1013050 Edible offals (other than liver and kidney)1013990 Others (2)1014030 Liver1014040 Kidney1014050 Edible offals (other than liver and kidney)1014990 Others (2)1015030 Liver1015040 Kidney1015050 Edible offals (other than liver and kidney)1015990 Others (2)1017030 Liver1017040 Kidney1017050 Edible offals (other than liver and kidney)1017990 Others (2)1020000 Milk1020010 Cattle1020020 Sheep1020030 Goat1020040 Horse1020990 Others (2)’
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