# L_2010094EN.01000101.xml

| 15.4.2010 | EN | Official Journal of the European Union | L 94/1 |
| --- | --- | --- | --- |

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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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, |
| --- | --- |

(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.

1

(2)  
  OJ L 230, 19.8.1991, p. 1.

2

(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).

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 |

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.

110000

| (i) | Citrus fruit |
| --- | --- |

(i)

5 (ft)

110010

Grapefruit

110020

Oranges

110030

Lemons

110040

Limes

110050

Mandarins

110990

Others

120000

| (ii) | Tree nuts (shelled or unshelled) |
| --- | --- |

(ii)

0,1 (*1)

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 |
| --- | --- |

(iii)

0,05 (*1)

130010

Apples

130020

Pears

130030

Quinces

130040

Medlar

130050

Loquat

130990

Others

140000

| (iv) | Stone fruit |
| --- | --- |

(iv)

0,05 (*1)

140010

Apricots

140020

Cherries

140030

Peaches

140040

Plums

140990

Others

150000

| (v) | Berries and small fruit |
| --- | --- |

(v)

0,05 (*1)

151000

| (a) | Table and wine grapes |
| --- | --- |

(a)

151010

Table grapes

151020

Wine grapes

152000

| (b) | Strawberries |
| --- | --- |

(b)

153000

| (c) | Cane fruit |
| --- | --- |

(c)

153010

Blackberries

153020

Dewberries

153030

Raspberries

153990

Others

154000

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

(d)

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 |
| --- | --- |

(vi)

0,05 (*1)

161000

| (a) | Edible peel |
| --- | --- |

(a)

161010

Dates

161020

Figs

161030

Table olives

161040

Kumquats

161050

Carambola

161060

Persimmon

161070

Jambolan (java plum)

161990

Others

162000

| (b) | Inedible peel, small |
| --- | --- |

(b)

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 |
| --- | --- |

(c)

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 |
| --- | --- |

2.

0,05 (*1)

210000

| (i) | Root and tuber vegetables |
| --- | --- |

(i)

211000

| (a) | Potatoes |
| --- | --- |

(a)

212000

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

(b)

212010

Cassava

212020

Sweet potatoes

212030

Yams

212040

Arrowroot

212990

Others

213000

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

(c)

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 |
| --- | --- |

(ii)

220010

Garlic

220020

Onions

220030

Shallots

220040

Spring onions

220990

Others

230000

| (iii) | Fruiting vegetables |
| --- | --- |

(iii)

231000

| (a) | Solanacea |
| --- | --- |

(a)

231010

Tomatoes

231020

Peppers

231030

Aubergines

231040

Okra, lady’s fingers

231990

Others

232000

| (b) | Cucurbits — edible peel |
| --- | --- |

(b)

232010

Cucumbers

232020

Gherkins

232030

Courgettes (Summer squash, marrow (patisson))

232990

Others

233000

| (c) | Cucurbitsinedible peel |
| --- | --- |

(c)

233010

Melons

233020

Pumpkins

233030

Watermelons

233990

Others

234000

| (d) | Sweet corn |
| --- | --- |

(d)

239000

| (e) | Other fruiting vegetables |
| --- | --- |

(e)

240000

| (iv) | Brassica vegetables |
| --- | --- |

(iv)

241000

| (a) | Flowering brassica |
| --- | --- |

(a)

241010

Broccoli

241020

Cauliflower

241990

Others

242000

| (b) | Head brassica |
| --- | --- |

(b)

242010

Brussels sprouts

242020

Head cabbage

242990

Others

243000

| (c) | Leafy brassica |
| --- | --- |

(c)

243010

Chinese cabbage

243020

Kale

243990

Others

244000

| (d) | Kohlrabi |
| --- | --- |

(d)

250000

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

(v)

251000

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

(a)

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) |
| --- | --- |

(b)

252010

Spinach

252020

Purslane

252030

Beet leaves (chard)

252990

Others

253000

| (c) | Vine leaves (grape leaves) |
| --- | --- |

(c)

254000

| (d) | Water cress |
| --- | --- |

(d)

255000

| (e) | Witloof |
| --- | --- |

(e)

256000

| (f) | Herbs |
| --- | --- |

(f)

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) |
| --- | --- |

(vi)

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) |
| --- | --- |

(vii)

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 |
| --- | --- |

(viii)

280010

Cultivated

280020

Wild

280990

Others

290000

| (ix) | Sea weeds |
| --- | --- |

(ix)

300000

| 3. | PULSES, DRY |
| --- | --- |

3.

0,05 (*1)

300010

Beans

300020

Lentils

300030

Peas

300040

Lupins

300990

Others

400000

| 4. | OILSEEDS AND OILFRUITS |
| --- | --- |

4.

401000

| (i) | Oilseeds |
| --- | --- |

(i)

0,1 (*1)

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 |
| --- | --- |

(ii)

402010

Olives for oil production

0,05 (*1)

402020

Palm nuts (palmoil kernels)

0,1 (*1)

402030

Palmfruit

0,1 (*1)

402040

Kapok

0,1 (*1)

402990

Others

0,1 (*1)

500000

| 5. | CEREALS |
| --- | --- |

5.

0,05 (*1)

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 |
| --- | --- |

6.

0,1 (*1)

610000

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

(i)

620000

| (ii) | Coffee beans |
| --- | --- |

(ii)

630000

| (iii) | Herbal infusions (dried) |
| --- | --- |

(iii)

631000

| (a) | Flowers |
| --- | --- |

(a)

631010

Camomille flowers

631020

Hybiscus flowers

631030

Rose petals

631040

Jasmine flowers

631050

Lime (linden)

631990

Others

632000

| (b) | Leaves |
| --- | --- |

(b)

632010

Strawberry leaves

632020

Rooibos leaves

632030

Maté

632990

Others

633000

| (c) | Roots |
| --- | --- |

(c)

633010

Valerian root

633020

Ginseng root

633990

Others

639000

| (d) | Other herbal infusions |
| --- | --- |

(d)

640000

| (iv) | Cocoa (fermented beans) |
| --- | --- |

(iv)

650000

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

(v)

700000

| 7. | HOPS (dried), including hop pellets and unconcentrated powder |
| --- | --- |

7.

0,1 (*1)

800000

| 8. | SPICES |
| --- | --- |

8.

0,1 (*1)

810000

| (i) | Seeds |
| --- | --- |

(i)

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 |
| --- | --- |

(ii)

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 |
| --- | --- |

(iii)

830010

Cinnamon

830990

Others

840000

| (iv) | Roots or rhizome |
| --- | --- |

(iv)

840010

Liquorice

840020

Ginger

840030

Turmeric (Curcuma)

840040

Horseradish

840990

Others

850000

| (v) | Buds |
| --- | --- |

(v)

850010

Cloves

850020

Capers

850990

Others

860000

| (vi) | Flower stigma |
| --- | --- |

(vi)

860010

Saffron

860990

Others

870000

| (vii) | Aril |
| --- | --- |

(vii)

870010

Mace

870990

Others

900000

| 9. | SUGAR PLANTS |
| --- | --- |

9.

0,05 (*1)

900010

Sugar beet (root)

900020

Sugar cane

900030

Chicory roots

900990

Others

1000000

| 10. | PRODUCTS OF ANIMAL ORIGIN — TERRESTRIAL ANIMALS |
| --- | --- |

10.

0,05 (*1)

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 |
| --- | --- |

(i)

1011000

| (a) | Swine |
| --- | --- |

(a)

1011010

Meat

1011020

Fat free of lean meat

1011030

Liver

1011040

Kidney

1011050

Edible offal

1011990

Others

1012000

| (b) | Bovine |
| --- | --- |

(b)

1012010

Meat

1012020

Fat

1012030

Liver

1012040

Kidney

1012050

Edible offal

1012990

Others

1013000

| (c) | Sheep |
| --- | --- |

(c)

1013010

Meat

1013020

Fat

1013030

Liver

1013040

Kidney

1013050

Edible offal

1013990

Others

1014000

| (d) | Goat |
| --- | --- |

(d)

1014010

Meat

1014020

Fat

1014030

Liver

1014040

Kidney

1014050

Edible offal

1014990

Others

1015000

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

(e)

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 |
| --- | --- |

(f)

1016010

Meat

1016020

Fat

1016030

Liver

1016040

Kidney

1016050

Edible offal

1016990

Others

1017000

| (g) | Other farm animals |
| --- | --- |

(g)

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 |
| --- | --- |

(ii)

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 |
| --- | --- |

(iii)

1030010

Chicken

1030020

Duck

1030030

Goose

1030040

Quail

1030990

Others

1040000

| (iv) | Honey |
| --- | --- |

(iv)

1050000

| (v) | Amphibians and reptiles |
| --- | --- |

(v)

1060000

| (vi) | Snails |
| --- | --- |

(vi)

1070000

| (vii) | Other terrestrial animal products |
| --- | --- |

(vii)

---

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

1

(*1)  Indicates lower limit of analytical determination.

*1

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

ft

---