Official Journal of the European Union L 81/3
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1 Official Journal of the European Union L 81/3 COMMISSION REGULATION (EC) No 256/2009 of 23 March 2009 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 azoxystrobin and fludioxonil in or on certain products (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, 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 ( 1 ), and in particular Article 14 (1) (a) thereof, (4) The Authority concluded in its reasoned opinions that all requirements with respect to data were met and that the two 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 both substances via consumption of all food products that may contain the two substances, nor the short-term exposure due to extreme consumption of turnips or pomegranates showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded. Whereas: (1) For azoxystrobin and fludioxonil maximum residue levels (MRLs) were set in Annexes II and III to Regulation (EC) No 396/2005 respectively. As regards azoxystrobin, in the context of a new authorisation in accordance with Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ( 2 ) for use of that plant protection product on turnips, an application has been made for a modification of the existing MRL in accordance with Article 6(1) of that Regulation. As regards fludioxonil an application for an import tolerance MRL in accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 was made by an applicant in a third country (the United States) in which the authorised use of that plant protection product leads to residues exceeding the MRL for pomegranates, as set out in Annex III to that Regulation. (5) Based on the reasoned opinion of the Authority and taking into account the factors relevant to the matter under consideration, the requested modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005. (6) Regulation (EC) No 396/2005 should therefore be amended accordingly. (7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them, (2) Both applications were evaluated in accordance with Article 8 of that Regulation and Portugal and Denmark forwarded evaluation reports to the Commission. HAS ADOPTED THIS REGULATION: (3) The European Food Safety Authority, hereinafter the Authority, assessed the safety of the proposed MRLs taking into account the information in the applications and the evaluation reports and gave reasoned opinions. It forwarded these opinions [in accordance with Article 10 of the Regulation] to the Commission and the Member States and made them available to the public ( 3 ). ( 1 ) OJ L 70, , p. 1. ( 2 ) OJ L 230, , p. 1. ( 3 ) EFSA scientific reports (2008) 199 and 200 on Article 1 Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation. Article 2 This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
2 L 81/4 Official Journal of the European Union This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 23 March For the Commission Androulla VASSILIOU Member of the Commission
3 Official Journal of the European Union L 81/5 ANNEX Annexes II and III to Regulation (EC) No 396/2005 are amended as follows: (1) Annex II is amended as follows: The lines for azoxystrobin are replaced by the following: Pesticide residues and maximum residue levels (mg/kg) FRUIT FRESH OR FROZEN; NUTS (i) Citrus fruit Grapefruit Oranges Lemons Limes Mandarins Others (ii) Tree nuts (shelled or unshelled) 0,1 (*) Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (iii) Pome fruit Apples Pears Quinces Medlar (**) Loquat (**) Others (iv) Stone fruit Apricots Cherries Peaches Plums Others (v) Berries & small fruit (a) Table and wine grapes Table grapes Wine grapes (b) Strawberries (c) Cane fruit Blackberries Dewberries Raspberries Others (d) Other small fruit & berries Blueberries Cranberries Currants Gooseberries Rose hips (**) Mulberries (**) Azarole (**) Elderberries (**) Others (vi) Miscellaneous fruit (a) Edible peel Dates Figs Table olives Kumquats Carambola (**) Persimmon (**) Jambolan (**) Others
4 L 81/6 Official Journal of the European Union (b) Inedible peel, small Kiwi Lychee Passion fruit Prickly pear (**) Star apple (**) American persimmon (**) Others (c) Inedible peel, large Avocados Bananas Mangoes 0, Papaya 0, Pomegranate Cherimoya (**) Guava (**) Pineapples Breadfruit (**) Durian (**) Soursop (**) Others VEGETABLES FRESH OR FROZEN (i) Root and tuber vegetables (a) Potatoes (b) Tropical root and tuber vegetables Cassava Sweet potatoes Yams Arrowroot (**) Others (c) Other root and tuber vegetables except sugar beet Beetroot Carrots 0, Celeriac 0, Horseradish 0, Jerusalem artichokes Parsnips 0, Parsley root 0, Radishes 0, Salsify 0, Swedes Turnips 0, Others (ii) Bulb vegetables Garlic Onions Shallots Spring onions Others (iii) Fruiting vegetables (a) Solanacea Tomatoes Peppers Aubergines Okra, lady's fingers Others (b) Cucurbits edible peel Cucumbers Gherkins Courgettes Others (c) Cucurbits inedible peel 0, Melons Pumpkins Watermelons Others (d) Sweetcorn (e) Other fruiting vegetables (iv) Brassica vegetables (a) Flowering brassica 0, Broccoli Cauliflower Others (b) Head brassica 0, Brussels sprouts Head cabbage Others (c) Leafy brassica Chinese cabbage Kale, collards) Others (d) Kohlrabi 0,2
5 Official Journal of the European Union L 81/ (v) Leaf vegetables & fresh herbs (a) Lettuce and other salad plants including Brassicacea Lamb's lettuce Lettuce Scarole Cress Land cress (**) Rocket, Rucola Red mustard (**) Leaves and sprouts of Brassica spp Others (b) Spinach & similar (leaves) Spinach Purslane (**) Beet leaves Others (c) Vine leaves (**) (d) Watercress (e) Witloof 0, (f) Herbs Chervil Chives Celery leaves Parsley Sage (**) Rosemary (**) Thyme (**) Basil (**) Bay leaves (**) Tarragon (**) Others (vi) Legume vegetables (fresh) Beans Beans 0, Peas 0, Peas 0, Lentils Others (vii) Stem vegetables (fresh) Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Bamboo shoots (**) Palm hearts (**) Others (viii) Fungi Cultivated Wild Others (**) (ix) Seaweeds PULSES, DRY 0, Beans Lentils Peas Lupins Others OILSEEDS AND OILFRUITS (i) Oilseeds Linseed Peanuts Poppy seed Sesame seed Sunflower seed Rapeseed 0, Soya bean 0, Mustard seed Cotton seed Pumpkin seeds Safflower (**) Borage (**) Gold of pleasure (**) Hempseed Castor bean (**) Others (ii) Oilfruits Olives for oil production Palm nuts (**) Palmfruit (**) Kapok (**) Others
6 L 81/8 Official Journal of the European Union CEREALS Barley 0, Buckwheat Maize Millet Oats 0, Rice Rye 0, Sorghum Wheat 0, Others TEA, COFFEE, HERBAL INFUSIONS AND COCOA (i) Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis) 0,1 (*) (ii) Coffee beans (**) (iii) Herbal infusions (dried) (**) (a) Flowers (**) Camomille flowers (**) Hybiscus flowers (**) Rose petals (**) Jasmine flowers (**) Lime (**) Others (**) (b) Leaves (**) Strawberry leaves (**) Rooibos leaves (**) Maté (**) Others (**) (c) Roots (**) Valerian root (**) Ginseng root (**) Others (**) (d) Other herbal infusions (**) (iv) Cocoa (fermented beans) (**) (v) Carob (St Johns bread) (**) HOPS (DRIED), INCLUDING HOP PELLETS AND UNCONCEN TRATED POWDER SPICES (**) (i) Seeds (**) Anise (**) Black caraway (**) Celery seed (**) Coriander seed (**) Cumin seed (**) Dill seed (**) Fennel seed (**) Fenugreek (**) Nutmeg (**) Others (**) (ii) Fruits and berries (**) Allspice (**) Anise pepper (**) Caraway (**) Cardamom (**) Juniper berries (**) Pepper, black and white (**) Vanilla pods (**) Tamarind (**) Others (**) (iii) Bark (**) Cinnamon (**) Others (**) (iv) Roots or rhizome (**) Liquorice (**) Ginger (**) Turmeric (**) Horseradish (**) Others (**) (v) Buds (**) Cloves (**) Capers (**) Others (**) (vi) Flower stigma (**) Saffron (**) Others (**) (vii) Aril (**) Mace (**) Others (**) SUGAR PLANTS (**) Sugar beet (**) Sugar cane (**) Chicory roots (**) Others (**)
7 Official Journal of the European Union L 81/ PRODUCTS OF ANIMAL ORIGIN- TERRESTRIAL ANIMALS (i) Meat, preparations of meat, offals, blood, animal fats fresh chilled or frozen, salted, in brine, dried or smoked or processed as flours or meals other processed products such as sausages and food preparations based on these (a) Swine Meat Fat-free or lean meat Liver Kidney Edible offal Others (b) Bovine Meat Fat Liver Kidney Edible offal Others (c) Sheep Meat Fat Liver Kidney Edible offal Others (d) Goat Meat Fat Liver Kidney Edible offal Others (e) Horses, asses, mules or hinnies (**) Meat (**) Fat (**) Liver (**) Kidney (**) Edible offal (**) Others (**) (f) Poultry - chicken, geese, duck, turkey and Guineafowl, ostrich, pigeon Meat Fat Liver Kidney Edible offal Others (g) Other farm animals (Rabbit, Kangaroo) Meat (**) Fat (**) Liver (**) Kidney (**) Edible offal (**) Others (**) (ii) Milk and cream, not concentrated, nor containing added sugar or sweetening matter, butter and other fats derived from milk, cheese and curd Cattle Sheep Goat Horse Others (iii) Birds' eggs, fresh preserved or cooked Shelled eggs and egg yolks fresh, dried, cooked by steaming or boiling in water, moulded, frozen or otherwise preserved whether or not containing added sugar or sweetening matter (**) 0,01 (*) Chicken (**) Duck (**) Goose (**) Quail (**) Others (**) (iv) Honey (Royal jelly, pollen) (**) (v) Amphibians and reptiles (Frog legs, crocodiles) (vi) Snails (**) (vii) Other terrestrial animal products (a) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I. (*) Indicates lower limit of analytical determination. (**) Pesticide-code combination for which the MRL as set in Annex III Part B applies. (**) (**)
8 L 81/10 Official Journal of the European Union (2) Annex III is amended as follows: The lines for fludioxonil are replaced by the following: Pesticide residues and maximum residue levels (mg/kg) FRUIT FRESH OR FROZEN; NUTS (i) Citrus fruit Grapefruit Oranges Lemons Limes Mandarins Others (ii) Tree nuts (shelled or unshelled) Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (iii) Pome fruit Apples Pears Quinces Medlar Loquat Others (iv) Stone fruit Apricots Cherries Peaches Plums 0, Others (v) Berries & small fruit (a) Table and wine grapes Table grapes Wine grapes (b) Strawberries (c) Cane fruit Blackberries Dewberries Raspberries Others (d) Other small fruit & berries Blueberries Cranberries Currants Gooseberries Rose hips Mulberries Azarole Elderberries Others (vi) Miscellaneous fruit (a) Edible peel Dates Figs Table olives Kumquats Carambola Persimmon Jambolan Others
9 Official Journal of the European Union L 81/ (b) Inedible peel, small Kiwi Lychee Passion fruit Prickly pear Star apple American persimmon Others (c) Inedible peel, large Avocados Bananas Mangoes Papaya Pomegranate Cherimoya Guava Pineapples Breadfruit Durian Soursop Others VEGETABLES FRESH OR FROZEN (i) Root and tuber vegetables (a) Potatoes (b) Tropical root and tuber vegetables Cassava Sweet potatoes Yams Arrowroot Others (c) Other root and tuber vegetables except sugar beet Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnips Parsley root Radishes Salsify Swedes Turnips Others (ii) Bulb vegetables Garlic Onions 0, Shallots Spring onions 0, Others (iii) Fruiting vegetables (a) Solanacea Tomatoes Peppers Aubergines Okra, lady's fingers 0, Others 0, (b) Cucurbits edible peel Cucumbers Gherkins 0, Courgettes Others 0, (c) Cucurbits inedible peel Melons Pumpkins Watermelons Others (d) Sweetcorn (e) Other fruiting vegetables (iv) Brassica vegetables (a) Flowering brassica Broccoli Cauliflower Others (b) Head brassica Brussels sprouts Head cabbage Others (c) Leafy brassica Chinese cabbage Kale, collards) Others (d) Kohlrabi
10 L 81/12 Official Journal of the European Union (v) Leaf vegetables & fresh herbs (a) Lettuce and other salad plants including Brassicacea Lamb's lettuce Lettuce Scarole Cress Land cress Rocket, Rucola Red mustard Leaves and sprouts of Brassica spp Others (b) Spinach & similar (leaves) Spinach Purslane Beet leaves Others (c) Vine leaves (d) Watercress (e) Witloof (f) Herbs Chervil Chives Celery leaves Parsley Sage Rosemary Thyme Basil Bay leaves Tarragon Others (vi) Legume vegetables (fresh) Beans Beans 0, Peas 0, Peas Lentils Others (vii) Stem vegetables (fresh) Asparagus Cardoons Celery Fennel 0, Globe artichokes Leek Rhubarb Bamboo shoots Palm hearts Others (viii) Fungi Cultivated Wild Others (ix) Seaweeds PULSES, DRY Beans Lentils Peas Lupins Others OILSEEDS AND OILFRUITS (i) Oilseeds Linseed Peanuts Poppy seed Sesame seed Sunflower seed Rapeseed Soya bean Mustard seed Cotton seed Pumpkin seeds Safflower Borage Gold of pleasure Hempseed Castor bean Others (ii) Oilfruits Olives for oil production Palm nuts Palmfruit Kapok Others
11 Official Journal of the European Union L 81/ CEREALS Barley Buckwheat Maize 0, Millet Oats Rice Rye Sorghum Wheat 0, Others TEA, COFFEE, HERBAL INFUSIONS AND COCOA (i) Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis) (ii) Coffee beans (iii) Herbal infusions (dried) (a) Flowers Camomille flowers Hybiscus flowers Rose petals Jasmine flowers Lime Others (b) Leaves Strawberry leaves Rooibos leaves Maté Others (c) Roots Valerian root Ginseng root Others (d) Other herbal infusions (iv) Cocoa (fermented beans) (v) Carob (St Johns bread) HOPS (DRIED), INCLUDING HOP PELLETS AND UNCONCEN TRATED POWDER SPICES (i) Seeds Anise Black caraway Celery seed Coriander seed Cumin seed Dill seed Fennel seed Fenugreek Nutmeg Others (ii) Fruits and berries Allspice Anise pepper Caraway Cardamom Juniper berries Pepper, black and white Vanilla pods Tamarind Others (iii) Bark Cinnamon Others (iv) Roots or rhizome Liquorice Ginger Turmeric Horseradish Others (v) Buds Cloves Capers Others (vi) Flower stigma Saffron Others (vii) Aril Mace Others SUGAR PLANTS Sugar beet Sugar cane Chicory roots Others
12 L 81/14 Official Journal of the European Union PRODUCTS OF ANIMAL ORIGIN- TERRESTRIAL ANIMALS (i) Meat, preparations of meat, offals, blood, animal fats fresh chilled or frozen, salted, in brine, dried or smoked or processed as flours or meals other processed products such as sausages and food preparations based on these (a) Swine Meat Fat-free or lean meat Liver Kidney Edible offal Others (b) Bovine Meat Fat Liver Kidney Edible offal Others (c) Sheep Meat Fat Liver Kidney Edible offal Others (d) Goat Meat Fat Liver Kidney Edible offal Others (e) Horses, asses, mules or hinnies Meat Fat Liver Kidney Edible offal Others (f) Poultry - chicken, geese, duck, turkey and Guineafowl, ostrich, pigeon Meat Fat Liver Kidney Edible offal Others (g) Other farm animals (Rabbit, Kangaroo) Meat Fat Liver Kidney Edible offal Others (ii) Milk and cream, not concentrated, nor containing added sugar or sweetening matter, butter and other fats derived from milk, cheese and curd Cattle Sheep Goat Horse Others (iii) Birds' eggs, fresh preserved or cooked Shelled eggs and egg yolks fresh, dried, cooked by steaming or boiling in water, moulded, frozen or otherwise preserved whether or not containing added sugar or sweetening matter Chicken Duck Goose Quail Others (iv) Honey (Royal jelly, pollen) (v) Amphibians and reptiles (Frog legs, crocodiles) (vi) Snails (vii) Other terrestrial animal products (a) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I. (*) Indicates lower limit of analytical determination.
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