(EU) 2015/1910：就双辛胍胺在某些产品中的最大残留限量，修订欧洲议会和理事会条例（EC）No 396/2005的附录III和V（amending Annexes III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for guazatine in or on certain products（�/h1>

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2015-11-05 09:54:09 来源９�a href="http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2015.280.01.0002.01.ENG" target="_blank" rel="nofollow">欧盟浏览次数９�span id="hits">3317

核心提示：据欧盟网站消息�?0�?4日欧盟发布（EU� 2015/1910号委员会条例，双辛胍胺（guazatine）在部分产品中的最大残留限量修订（EC� No 396/2005 号法规附� III � V、�/div>

发布单位	欧盟委员� 欧盟委员伙�/div>	发布文号	(EU) 2015/1910
发布日期	2015-10-24	生效日期	2015-11-13
有效性状�?/th>		废止日期	暂无
备注	2015�?0�?4日，欧盟发布委员会条�?EU) 2015/1910，修�?EC) No 396/2005附录中双辛胍胺在某些产品中的最大残留限量。具体修订如下： 删除附录III�?ldquo;双辛胍胺��一栎�/div> 增加以下内容至附录V中的��双辛胍胺�� 产品 双辛胍胺限量＇�/span>mg/kg（�/span> 新鲜或冷冻水果、树生坚枛�/span> 0.05 新鲜或冷冻蔬菛�/span> 0.05 豆类 0.05 油料种子与水枛�/span> 0.05 谷物 0.05 茶、咖啡、草茶、可可和角豆 0.05 啤酒芰�/span> 0.05 种子香料 0.05 水果香料 0.05 树皮香料 0.05 根茎类香料（干草、姜、姜黄等（�/span> 0.05 芽类香料 0.05 花蕊香料 0.05 假种皮香斘�/span> 0.05 糖类作物 0.05 肝脏、肾脏等动物组织 0.05 乳类 0.02 禽蛋 0.05 蜂蜜和其他蜂产品 0.05 两栖爬行动物 0.05 陆栖无脊椎动�?/span> 0.05 野生陆栖脊椎动物 0.05 ＇�/span>EC（�/span>No 396/2005号条例适用于在2016平�/span>5朇�/span>13日之前按要求生产的产品（葡萄柚和橙子除外）、�/span> 本法规自发布之日起第20天生效，并于2016平�/span>5朇�/span>13日实施、�/span>

　　COMMISSION REGULATION (EU) 2015/1910

　　of 21 October 2015

　　amending Annexes III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for guazatine 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 (1), and in particular Articles 14(1)(a) and 18(1)(b) and Article 49(2) thereof,

　　Whereas:

　　(1)

　　For guazatine, maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005.

　　(2)

　　The European Food Safety Authority, hereinafter ��the Authority��, submitted a reasoned opinion on the existing MRLs for guazatine in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). All existing authorisations for plant protection products containing the active substance guazatine have been revoked. Neither were import tolerances reported at Union level nor were Codex MRLs available. In the absence of information on specific good agricultural practices that could be used in a consumer risk assessment, the Authority concluded that a value of 0,05 mg/kg provides a satisfactory level of protection for the European consumers. It is therefore appropriate to set the MRLs at the specific limit of determination. It is also appropriate to change the residue definition.

　　(3)

　　Moreover, Belgium indicated that the existing MRLs for guazatine in grapefruit and oranges may raise concerns of consumer protection. In particular, an acute consumer risk could not be excluded even by a refined risk assessment, taking into account a processing factor for citrus fruit. The European Commission and the Member States represented in the Standing Committee on Plants, Animals, Food and Feed considered it an appropriate risk management decision to lower the MRLs to a level that has been demonstrated to be safe for European consumers.

　　(4)

　　In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was submitted for guazatine used on citrus fruits. In accordance with Article 8 of Regulation (EC) No 396/2005 this application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. The Authority assessed the application and the evaluation report, examining in particular the risks to the consumer and, where relevant, to animals and gave a reasoned opinion on the proposed MRLs (3). It forwarded this opinion to the Commission and the Member States and made it available to the public. It concluded in the opinion that it does not recommend setting the proposed MRLs since the available data were not sufficient to exclude a risk for European consumers.

　　(5)

　　The applicant requested an administrative review of the Authority's reasoned opinion according to Article 13 of Regulation (EC) No 396/2005. This review led to the conclusion that no substantial flaws and errors of assessment on the part of the Authority were identified.

　　(6)

　　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.

　　(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 lawfully produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained.

　　(9)

　　The transitional arrangement provided for by this Regulation should take the concerns of consumer protection with the existing MRLs for guazatine in grapefruit and oranges into account.

　　(10)

　　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.

　　(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)

　　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 III and V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

　　Article 2

　　As regards guazatine, Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to all products which were lawfully produced before 13 May 2016, except grapefruit and oranges.

　　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.

　　However, it shall apply from 13 May 2016.

　　This Regulation shall be binding in its entirety and directly applicable in all Member States.

　　Done at Brussels, 21 October 2015.

　　For the Commission

　　The President

　　Jean-Claude JUNCKER

　　(1) OJ L 70, 16.3.2005, p. 1.

　　(2) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels (MRLs) for guazatine according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2013;11(5):3239. [20 pp.].

　　(3) European Food Safety Authority; Reasoned opinion on the modification of the existing MRL for guazatine in citrus fruits. EFSA Journal 2014;12(8):3818. [29 pp.].

　　ANNEX

　　Annexes III and V to Regulation (EC) No 396/2005 are amended as follows:

　　(1)

　　in Annex III, the column for guazatine is deleted;

　　(2)

　　in Annex V, the following column for guazatine is added:

　　��Pesticide residues and maximum residue levels (mg/kg)

Code number	Groups and examples of individual products to which the MRLs apply(2)	Guazatine (guazatine acetate, sum of components)
(1)	(2)	(3)
0100000	FRUITS, FRESH or FROZEN; TREE NUTS	0,05(1)
0110000	Citrus fruits
0110010	Grapefruits
0110020	Oranges
0110030	Lemons
0110040	Limes
0110050	Mandarins
0110990	Others
0120000	Tree nuts
0120010	Almonds
0120020	Brazil nuts
0120030	Cashew nuts
0120040	Chestnuts
0120050	Coconuts
0120060	Hazelnuts/cobnuts
0120070	Macadamias
0120080	Pecans
0120090	Pine nut kernels
0120100	Pistachios
0120110	Walnuts
0120990	Others
0130000	Pome fruits
0130010	Apples
0130020	Pears
0130030	Quinces
0130040	Medlars
0130050	Loquats/Japanese medlars
0130990	Others
0140000	Stone fruits
0140010	Apricots
0140020	Cherries (sweet)
0140030	Peaches
0140040	Plums
0140990	Others
0150000	Berries and small fruits
0151000	(a) grapes
0151010	Table grapes
0151020	Wine grapes
0152000	(b) strawberries
0153000	(c) cane fruits
0153010	Blackberries
0153020	Dewberries
0153030	Raspberries (red and yellow)
0153990	Others
0154000	(d) other small fruits and berries
0154010	Blueberries
0154020	Cranberries
0154030	Currants (black, red and white)
0154040	Gooseberries (green, red and yellow)
0154050	Rose hips
0154060	Mulberries (black and white)
0154070	Azaroles/Mediterranean medlars
0154080	Elderberries
0154990	Others
0160000	Miscellaneous fruits with
0161000	(a) edible peel
0161010	Dates
0161020	Figs
0161030	Table olives
0161040	Kumquats
0161050	Carambolas
0161060	Kaki/Japanese persimmons
0161070	Jambuls/jambolans
0161990	Others
0162000	(b) inedible peel, small
0162010	Kiwi fruits (green, red, yellow)
0162020	Litchis/lychees
0162030	Passionfruits/maracujas
0162040	Prickly pears/cactus fruits
0162050	Star apples/cainitos
0162060	American persimmons/Virginia kaki
0162990	Others
0163000	(c) inedible peel, large
0163010	Avocados
0163020	Bananas
0163030	Mangoes
0163040	Papayas
0163050	Granate apples/pomegranates
0163060	Cherimoyas
0163070	Guavas
0163080	Pineapples
0163090	Breadfruits
0163100	Durians
0163110	Soursops/guanabanas
0163990	Others
0200000	VEGETABLES, FRESH or FROZEN	0,05(1)
0210000	Root and tuber vegetables
0211000	(a) potatoes
0212000	(b) tropical root and tuber vegetables
0212010	Cassava roots/manioc
0212020	Sweet potatoes
0212030	Yams
0212040	Arrowroots
0212990	Others
0213000	(c) other root and tuber vegetables except sugar beets
0213010	Beetroots
0213020	Carrots
0213030	Celeriacs/turnip rooted celeries
0213040	Horseradishes
0213050	Jerusalem artichokes
0213060	Parsnips
0213070	Parsley roots/Hamburg roots parsley
0213080	Radishes
0213090	Salsifies
0213100	Swedes/rutabagas
0213110	Turnips
0213990	Others
0220000	Bulb vegetables
0220010	Garlic
0220020	Onions
0220030	Shallots
0220040	Spring onions/green onions and Welsh onions
0220990	Others
0230000	Fruiting vegetables
0231000	(a) solanacea
0231010	Tomatoes
0231020	Sweet peppers/bell peppers
0231030	Aubergines/eggplants
0231040	Okra/lady's fingers
0231990	Others
0232000	(b) cucurbits with edible peel
0232010	Cucumbers
0232020	Gherkins
0232030	Courgettes
0232990	Others
0233000	(c) cucurbits with inedible peel
0233010	Melons
0233020	Pumpkins
0233030	Watermelons
0233990	Others
0234000	(d) sweet corn
0239000	(e) other fruiting vegetables
0240000	Brassica vegetables (excluding brassica roots and brassica baby leaf crops)
0241000	(a) flowering brassica
0241010	Broccoli
0241020	Cauliflowers
0241990	Others
0242000	(b) head brassica
0242010	Brussels sprouts
0242020	Head cabbages
0242990	Others
0243000	(c) leafy brassica
0243010	Chinese cabbages/pe-tsai
0243020	Kales
0243990	Others
0244000	(d) kohlrabies
0250000	Leaf vegetables, herbs and edible flowers
0251000	(a) lettuces and salad plants
0251010	Lamb's lettuces/corn salads
0251020	Lettuces
0251030	Escaroles/broad-leaved endives
0251040	Cresses and other sprouts and shoots
0251050	Land cresses
0251060	Roman rocket/rucola
0251070	Red mustards
0251080	Baby leaf crops (including brassica species)
0251990	Others
0252000	(b) spinaches and similar leaves
0252010	Spinaches
0252020	Purslanes
0252030	Chards/beet leaves
0252990	Others
0253000	(c) grape leaves and similar species
0254000	(d) watercresses
0255000	(e) witloofs/Belgian endives
0256000	(f) herbs and edible flowers
0256010	Chervil
0256020	Chives
0256030	Celery leaves
0256040	Parsley
0256050	Sage
0256060	Rosemary
0256070	Thyme
0256080	Basil and edible flowers
0256090	Laurel/bay leave
0256100	Tarragon
0256990	Others
0260000	Legume vegetables
0260010	Beans (with pods)
0260020	Beans (without pods)
0260030	Peas (with pods)
0260040	Peas (without pods)
0260050	Lentils
0260990	Others
0270000	Stem vegetables
0270010	Asparagus
0270020	Cardoons
0270030	Celeries
0270040	Florence fennels
0270050	Globe artichokes
0270060	Leeks
0270070	Rhubarbs
0270080	Bamboo shoots
0270090	Palm hearts
0270990	Others
0280000	Fungi, mosses and lichens
0280010	Cultivated fungi
0280020	Wild fungi
0280990	Mosses and lichens
0290000	Algae and prokaryotes organisms
0300000	PULSES	0,05(1)
0300010	Beans
0300020	Lentils
0300030	Peas
0300040	Lupins/lupini beans
0300990	Others
0400000	OILSEEDS AND OIL FRUITS	0,05(1)
0401000	Oilseeds
0401010	Linseeds
0401020	Peanuts/groundnuts
0401030	Poppy seeds
0401040	Sesame seeds
0401050	Sunflower seeds
0401060	Rapeseeds/canola seeds
0401070	Soyabeans
0401080	Mustard seeds
0401090	Cotton seeds
0401100	Pumpkin seeds
0401110	Safflower seeds
0401120	Borage seeds
0401130	Gold of pleasure seeds
0401140	Hemp seeds
0401150	Castor beans
0401990	Others
0402000	Oil fruits
0402010	Olives for oil production
0402020	Oil palms kernels
0402030	Oil palms fruits
0402040	Kapok
0402990	Others
0500000	CEREALS	0,05(1)
0500010	Barley
0500020	Buckwheat and other pseudo-cereals
0500030	Maize/corn
0500040	Common millet/proso millet
0500050	Oat
0500060	Rice
0500070	Rye
0500080	Sorghum
0500090	Wheat
0500990	Others
0600000	TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS	0,05(1)
0610000	Teas
0620000	Coffee beans
0630000	Herbal infusions from
0631000	(a) flowers
0631010	Chamomile
0631020	Hibiscus/roselle
0631030	Rose
0631040	Jasmine
0631050	Lime/linden
0631990	Others
0632000	(b) leaves and herbs
0632010	Strawberry
0632020	Rooibos
0632030	Mate/mat��
0632990	Others
0633000	(c) roots
0633010	Valerian
0633020	Ginseng
0633990	Others
0639000	(d) any other parts of the plant
0640000	Cocoa beans
0650000	Carobs/Saint John's breads
0700000	HOPS	0,05(1)
0800000	SPICES
0810000	Seed spices	0,05(1)
0810010	Anise/aniseed
0810020	Black caraway/black cumin
0810030	Celery
0810040	Coriander
0810050	Cumin
0810060	Dill
0810070	Fennel
0810080	Fenugreek
0810090	Nutmeg
0810990	Others
0820000	Fruit spices	0,05(1)
0820010	Allspice/pimento
0820020	Sichuan pepper
0820030	Caraway
0820040	Cardamom
0820050	Juniper berry
0820060	Peppercorn (black, green and white)
0820070	Vanilla
0820080	Tamarind
0820990	Others
0830000	Bark spices	0,05(1)
0830010	Cinnamon
0830990	Others
0840000	Root and rhizome spices
0840010	Liquorice	0,05(1)
0840020	Ginger	0,05(1)
0840030	Turmeric/curcuma	0,05(1)
0840040	Horseradish	(+)
0840990	Others	0,05(1)
0850000	Bud spices	0,05(1)
0850010	Cloves
0850020	Capers
0850990	Others
0860000	Flower pistil spices	0,05(1)
0860010	Saffron
0860990	Others
0870000	Aril spices	0,05(1)
0870010	Mace
0870990	Others
0900000	SUGAR PLANTS	0,05(1)
0900010	Sugar beet roots
0900020	Sugar canes
0900030	Chicory roots
0900990	Others
1000000	PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS
1010000	Tissues from	0,05(1)
1011000	(a) swine
1011010	Muscle
1011020	Fat tissue
1011030	Liver
1011040	Kidney
1011050	Edible offals (other than liver and kidney)
1011990	Others
1012000	(b) bovine
1012010	Muscle
1012020	Fat tissue
1012030	Liver
1012040	Kidney
1012050	Edible offals (other than liver and kidney)
1012990	Others
1013000	(c) sheep
1013010	Muscle
1013020	Fat tissue
1013030	Liver
1013040	Kidney
1013050	Edible offals (other than liver and kidney)
1013990	Others
1014000	d) goat
1014010	Muscle
1014020	Fat tissue
1014030	Liver
1014040	Kidney
1014050	Edible offals (other than liver and kidney)
1014990	Others
1015000	(e) equine
1015010	Muscle
1015020	Fat tissue
1015030	Liver
1015040	Kidney
1015050	Edible offals (other than liver and kidney)
1015990	Others
1016000	(f) poultry
1016010	Muscle
1016020	Fat tissue
1016030	Liver
1016040	Kidney
1016050	Edible offals (other than liver and kidney)
1016990	Others
1017000	(g) other farmed terrestrial animals
1017010	Muscle
1017020	Fat tissue
1017030	Liver
1017040	Kidney
1017050	Edible offals (other than liver and kidney)
1017990	Others
1020000	Milk	0,02(1)
1020010	Cattle
1020020	Sheep
1020030	Goat
1020040	Horse
1020990	Others
1030000	Birds eggs	0,05(1)
1030010	Chicken
1030020	Duck
1030030	Geese
1030040	Quail
1030990	Others
1040000	Honey and other apiculture products	0,05(1)
1050000	Amphibians and Reptiles	0,05(1)
1060000	Terrestrial invertebrate animals	0,05(1)
1070000	Wild terrestrial vertebrate animals	0,05(1)

　　(1) Indicates lower limit of analytical determination

　　(2) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

　　Guazatine (guazatine acetate, sum of components)

　　(+)

　　The applicable maximum residue level for horseradish (Armoracia rusticana) in the spice group (code 0840040) is the one set for horseradish (Armoracia rusticana) in the Vegetables category, root and tuber vegetables group (code 0213040) taking into account changes in the levels by processing (drying) according to Art. 20 (1) of Regulation (EC) No 396/2005.

　　0840040

　　Horseradish��

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