Commission Regulation (EU) No 304/2010

of 9 April 2010

amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 2-phenylphenol 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 Article 14(1) thereof,

Whereas:

(1) 2-phenylphenol is an active substance belonging to the fourth stage of the review programme of Council Directive 91/414/EEC [2] for which the assessment report was presented to the Commission on 19 December 2008 in the format of the EFSA Scientific Report for 2-phenylphenol [3]. That report includes the opinion of the European Food Safety Authority, hereinafter "the Authority", on the necessity of setting MRLs for that active substance in accordance with Article 12(1)(b) of Regulation (EC) No 396/2005, and a proposal for such MRLs.

(2) The Authority examined in particular the risks to consumers and animals. It evaluated the representative use as a post harvest fungicide on citrus and pears and concluded that, based on the available information, a maximum residue level (MRL) of 5 mg/kg should be set provisionally for the notified use on citrus fruit by drench application. In order to confirm the risk assessment, the Authority requested confirmation that the analytical method applied in the residue trials correctly quantifies the residues of 2-phenylphenol, 2-phenylhydroquinone and their conjugates. In addition, the Authority concluded that the notifier should submit two additional residue trials on citrus fruit and valid storage stability studies. As regards the notified use on pears, the Authority could not propose any MRL because the submitted residue data were not acceptable. In the absence of a specific MRL, the lowest limit of analytical determination should apply.

(3) The risk assessment carried out by the Authority took into account the most recent information on the toxicological properties of 2-phenylphenol. It showed that an MRL of 5 mg/kg for citrus fruit is acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The lifetime exposure assessment via consumption of all food products that may contain 2-phenylphenol showed that there is no risk that the acceptable daily intake (ADI) is exceeded. As an acute reference dose (ARfD) is not necessary for 2-phenylphenol, there was no need to evaluate the short term exposure.

(4) The Commission invited the notifier to submit its comments on the EFSA Scientific report for 2-phenylphenol, including the proposed MRLs. The notifier submitted its comments, which have been carefully examined.

(5) Based on the Scientific Report of the Authority and taking into account the factors relevant to the matter under consideration, the proposed 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,

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 1 January 2011.

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

Done at Brussels, 9 April 2010.

For the Commission

The President

José Manuel Barroso

[1] OJ L 70, 16.3.2005, p. 1.

[2] OJ L 230, 19.8.1991, p. 1.

[3] EFSA Scientific Report (2008) 217, Conclusion regarding the peer review of the pesticide risk assessment of the active substance 2-phenylphenol (finalised 19 December 2008).

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ANNEX

In Annex II to Regulation (EC) No 396/2005 the following column for 2-phenylphenol is added:

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

Code number | Groups and examples of individual products to which the MRLs apply [1] | Sum of 2-Phenylphenol, its salts and conjugates, expressed as 2-phenylphenol |

100000 | 1.FRUIT FRESH OR FROZEN; NUTS | |

110000 | (i)Citrus fruit | 5 [3] |

110010 | Grapefruit | |

110020 | Oranges | |

110030 | Lemons | |

110040 | Limes | |

110050 | Mandarins | |

110990 | Others | |

120000 | (ii)Tree nuts (shelled or unshelled) | 0,1 [2] |

120010 | Almonds | |

120020 | Brazil nuts | |

120030 | Cashew nuts | |

120040 | Chestnuts | |

120050 | Coconuts | |

120060 | Hazelnuts | |

120070 | Macadamia | |

120080 | Pecans | |

120090 | Pine nuts | |

120100 | Pistachios | |

120110 | Walnuts | |

120990 | Others | |

130000 | (iii)Pome fruit | 0,05 [2] |

130010 | Apples | |

130020 | Pears | |

130030 | Quinces | |

130040 | Medlar | |

130050 | Loquat | |

130990 | Others | |

140000 | (iv)Stone fruit | 0,05 [2] |

140010 | Apricots | |

140020 | Cherries | |

140030 | Peaches | |

140040 | Plums | |

140990 | Others | |

150000 | (v)Berries and small fruit | 0,05 [2] |

151000 | (a)Table and wine grapes | |

151010 | Table grapes | |

151020 | Wine grapes | |

152000 | (b)Strawberries | |

153000 | (c)Cane fruit | |

153010 | Blackberries | |

153020 | Dewberries | |

153030 | Raspberries | |

153990 | Others | |

154000 | (d)Other small fruit and berries | |

154010 | Blueberries | |

154020 | Cranberries | |

154030 | Currants (red, black and white) | |

154040 | Gooseberries | |

154050 | Rose hips | |

154060 | Mulberries | |

154070 | Azarole (Mediterranean medlar) | |

154080 | Elderberries | |

154990 | Others | |

160000 | (vi)Miscellaneous fruit | 0,05 [2] |

161000 | (a)Edible peel | |

161010 | Dates | |

161020 | Figs | |

161030 | Table olives | |

161040 | Kumquats | |

161050 | Carambola | |

161060 | Persimmon | |

161070 | Jambolan (java plum) | |

161990 | Others | |

162000 | (b)Inedible peel, small | |

162010 | Kiwi | |

162020 | Lychee (Litchi) | |

162030 | Passion fruit | |

162040 | Prickly pear (cactus fruit) | |

162050 | Star apple | |

162060 | American persimmon (Virginia kaki) | |

162990 | Others | |

163000 | (c)Inedible peel, large | |

163010 | Avocados | |

163020 | Bananas | |

163030 | Mangoes | |

163040 | Papaya | |

163050 | Pomegranate | |

163060 | Cherimoya (Custard apple, sugar apple (sweetsop), llama and other medium sized Annonaceae) | |

163070 | Guava | |

163080 | Pineapples | |

163090 | Bread fruit | |

163100 | Durian | |

163110 | Soursop (guanabana) | |

163990 | Others | |

200000 | 2.VEGETABLES FRESH OR FROZEN | 0,05 [2] |

210000 | (i)Root and tuber vegetables | |

211000 | (a)Potatoes | |

212000 | (b)Tropical root and tuber vegetables | |

212010 | Cassava | |

212020 | Sweet potatoes | |

212030 | Yams | |

212040 | Arrowroot | |

212990 | Others | |

213000 | (c)Other root and tuber vegetables except sugar beet | |

213010 | Beetroot | |

213020 | Carrots | |

213030 | Celeriac | |

213040 | Horseradish | |

213050 | Jerusalem artichokes | |

213060 | Parsnips | |

213070 | Parsley root | |

213080 | Radishes | |

213090 | Salsify | |

213100 | Swedes | |

213110 | Turnips | |

213990 | Others | |

220000 | (ii)Bulb vegetables | |

220010 | Garlic | |

220020 | Onions | |

220030 | Shallots | |

220040 | Spring onions | |

220990 | Others | |

230000 | (iii)Fruiting vegetables | |

231000 | (a)Solanacea | |

231010 | Tomatoes | |

231020 | Peppers | |

231030 | Aubergines | |

231040 | Okra, lady’s fingers | |

231990 | Others | |

232000 | (b)Cucurbits — edible peel | |

232010 | Cucumbers | |

232020 | Gherkins | |

232030 | Courgettes (Summer squash, marrow (patisson)) | |

232990 | Others | |

233000 | (c)Cucurbitsinedible peel | |

233010 | Melons | |

233020 | Pumpkins | |

233030 | Watermelons | |

233990 | Others | |

234000 | (d)Sweet corn | |

239000 | (e)Other fruiting vegetables | |

240000 | (iv)Brassica vegetables | |

241000 | (a)Flowering brassica | |

241010 | Broccoli | |

241020 | Cauliflower | |

241990 | Others | |

242000 | (b)Head brassica | |

242010 | Brussels sprouts | |

242020 | Head cabbage | |

242990 | Others | |

243000 | (c)Leafy brassica | |

243010 | Chinese cabbage | |

243020 | Kale | |

243990 | Others | |

244000 | (d)Kohlrabi | |

250000 | (v)Leaf vegetables and fresh herbs | |

251000 | (a)Lettuce and other salad plants including Brassicacea | |

251010 | Lamb’s lettuce | |

251020 | Lettuce | |

251030 | Scarole | |

251040 | Cress | |

251050 | Land cress | |

251060 | Rocket, Rucola | |

251070 | Red mustard | |

251080 | Leaves and sprouts of Brassica spp. | |

251990 | Others | |

252000 | (b)Spinach and similar (leaves) | |

252010 | Spinach | |

252020 | Purslane | |

252030 | Beet leaves (chard) | |

252990 | Others | |

253000 | (c)Vine leaves (grape leaves) | |

254000 | (d)Water cress | |

255000 | (e)Witloof | |

256000 | (f)Herbs | |

256010 | Chervil | |

256020 | Chives | |

256030 | Celery leaves | |

256040 | Parsley | |

256050 | Sage | |

256060 | Rosemary | |

256070 | Thyme | |

256080 | Basil | |

256090 | Bay leaves | |

256100 | Tarragon | |

256990 | Others | |

260000 | (vi)Legume vegetables (fresh) | |

260010 | Beans (with pods) | |

260020 | Beans (without pods) | |

260030 | Peas (with pods) | |

260040 | Peas (without pods) | |

260050 | Lentils | |

260990 | Others | |

270000 | (vii)Stem vegetables (fresh) | |

270010 | Asparagus | |

270020 | Cardoons | |

270030 | Celery | |

270040 | Fennel | |

270050 | Globe artichokes | |

270060 | Leek | |

270070 | Rhubarb | |

270080 | Bamboo shoots | |

270090 | Palm hearts | |

270990 | Others | |

280000 | (viii)Fungi | |

280010 | Cultivated | |

280020 | Wild | |

280990 | Others | |

290000 | (ix)Sea weeds | |

300000 | 3.PULSES, DRY | 0,05 [2] |

300010 | Beans | |

300020 | Lentils | |

300030 | Peas | |

300040 | Lupins | |

300990 | Others | |

400000 | 4.OILSEEDS AND OILFRUITS | |

401000 | (i)Oilseeds | 0,1 [2] |

401010 | Linseed | |

401020 | Peanuts | |

401030 | Poppy seed | |

401040 | Sesame seed | |

401050 | Sunflower seed | |

401060 | Rape seed | |

401070 | Soya bean | |

401080 | Mustard seed | |

401090 | Cotton seed | |

401100 | Pumpkin seeds | |

401110 | Safflower | |

401120 | Borage | |

401130 | Gold of pleasure | |

401140 | Hempseed | |

401150 | Castor bean | |

401990 | Others | |

402000 | (ii)Oilfruits | |

402010 | Olives for oil production | 0,05 [2] |

402020 | Palm nuts (palmoil kernels) | 0,1 [2] |

402030 | Palmfruit | 0,1 [2] |

402040 | Kapok | 0,1 [2] |

402990 | Others | 0,1 [2] |

500000 | 5.CEREALS | 0,05 [2] |

500010 | Barley | |

500020 | Buckwheat | |

500030 | Maize | |

500040 | Millet | |

500050 | Oats | |

500060 | Rice | |

500070 | Rye | |

500080 | Sorghum | |

500090 | Wheat | |

500990 | Others | |

600000 | 6.TEA, COFFEE, HERBAL INFUSIONS AND COCOA | 0,1 [2] |

610000 | (i)Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis) | |

620000 | (ii)Coffee beans | |

630000 | (iii)Herbal infusions (dried) | |

631000 | (a)Flowers | |

631010 | Camomille flowers | |

631020 | Hybiscus flowers | |

631030 | Rose petals | |

631040 | Jasmine flowers | |

631050 | Lime (linden) | |

631990 | Others | |

632000 | (b)Leaves | |

632010 | Strawberry leaves | |

632020 | Rooibos leaves | |

632030 | Maté | |

632990 | Others | |

633000 | (c)Roots | |

633010 | Valerian root | |

633020 | Ginseng root | |

633990 | Others | |

639000 | (d)Other herbal infusions | |

640000 | (iv)Cocoa (fermented beans) | |

650000 | (v)Carob (St Johns bread) | |

700000 | 7.HOPS (dried), including hop pellets and unconcentrated powder | 0,1 [2] |

800000 | 8.SPICES | 0,1 [2] |

810000 | (i)Seeds | |

810010 | Anise | |

810020 | Black caraway | |

810030 | Celery seed | |

810040 | Coriander seed | |

810050 | Cumin seed | |

810060 | Dill seed | |

810070 | Fennel seed | |

810080 | Fenugreek | |

810090 | Nutmeg | |

810990 | Others | |

820000 | (ii)Fruits and berries | |

820010 | Allspice | |

820020 | Anise pepper (Japan pepper) | |

820030 | Caraway | |

820040 | Cardamom | |

820050 | Juniper berries | |

820060 | Pepper, black and white | |

820070 | Vanilla pods | |

820080 | Tamarind | |

820990 | Others | |

830000 | (iii)Bark | |

830010 | Cinnamon | |

830990 | Others | |

840000 | (iv)Roots or rhizome | |

840010 | Liquorice | |

840020 | Ginger | |

840030 | Turmeric (Curcuma) | |

840040 | Horseradish | |

840990 | Others | |

850000 | (v)Buds | |

850010 | Cloves | |

850020 | Capers | |

850990 | Others | |

860000 | (vi)Flower stigma | |

860010 | Saffron | |

860990 | Others | |

870000 | (vii)Aril | |

870010 | Mace | |

870990 | Others | |

900000 | 9.SUGAR PLANTS | 0,05 [2] |

900010 | Sugar beet (root) | |

900020 | Sugar cane | |

900030 | Chicory roots | |

900990 | Others | |

1000000 | 10.PRODUCTS OF ANIMAL ORIGIN — TERRESTRIAL ANIMALS | 0,05 [2] |

1010000 | (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 | |

1011000 | (a)Swine | |

1011010 | Meat | |

1011020 | Fat free of lean meat | |

1011030 | Liver | |

1011040 | Kidney | |

1011050 | Edible offal | |

1011990 | Others | |

1012000 | (b)Bovine | |

1012010 | Meat | |

1012020 | Fat | |

1012030 | Liver | |

1012040 | Kidney | |

1012050 | Edible offal | |

1012990 | Others | |

1013000 | (c)Sheep | |

1013010 | Meat | |

1013020 | Fat | |

1013030 | Liver | |

1013040 | Kidney | |

1013050 | Edible offal | |

1013990 | Others | |

1014000 | (d)Goat | |

1014010 | Meat | |

1014020 | Fat | |

1014030 | Liver | |

1014040 | Kidney | |

1014050 | Edible offal | |

1014990 | Others | |

1015000 | (e)Horses, asses, mules or hinnies | |

1015010 | Meat | |

1015020 | Fat | |

1015030 | Liver | |

1015040 | Kidney | |

1015050 | Edible offal | |

1015990 | Others | |

1016000 | (f)Poultry — chicken, geese, duck, turkey and Guinea fowl-, ostrich, pigeon | |

1016010 | Meat | |

1016020 | Fat | |

1016030 | Liver | |

1016040 | Kidney | |

1016050 | Edible offal | |

1016990 | Others | |

1017000 | (g)Other farm animals | |

1017010 | Meat | |

1017020 | Fat | |

1017030 | Liver | |

1017040 | Kidney | |

1017050 | Edible offal | |

1017990 | Others | |

1020000 | (ii)Milk and cream, not concentrated, nor containing added sugar or sweetening matter, butter and other fats derived from milk, cheese and curd | |

1020010 | Cattle | |

1020020 | Sheep | |

1020030 | Goat | |

1020040 | Horse | |

1020990 | Others | |

1030000 | (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 | |

1030010 | Chicken | |

1030020 | Duck | |

1030030 | Goose | |

1030040 | Quail | |

1030990 | Others | |

1040000 | (iv)Honey | |

1050000 | (v)Amphibians and reptiles | |

1060000 | (vi)Snails | |

1070000 | (vii)Other terrestrial animal products | |

[1] 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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