15.4.2010   

EN

Official Journal of the European Union

L 94/1


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).


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.

(2)  Indicates lower limit of analytical determination.

(3)  MRL valid until 30 September 2012 pending the submission and evaluation of two additional residue trials on citrus fruit and valid storage stability studies.’