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)
Date: 2010-04-09
Institutions: European Commission
Subjects: European standard, animal nutrition, animal product, crop production, food safety, foodstuff, foodstuffs legislation, pesticide, public health




L_2010094EN.01000101.xml










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 (ft)





110010 


Grapefruit


 




110020 


Oranges


 




110030 


Lemons


 




110040 


Limes


 




110050 


Mandarins


 




110990 


Others


 




120000 








(ii)


Tree nuts (shelled or unshelled)






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






0,05 (*1)





130010 


Apples


 




130020 


Pears


 




130030 


Quinces


 




130040 


Medlar


 




130050 


Loquat


 




130990 


Others


 




140000 








(iv)


Stone fruit






0,05 (*1)





140010 


Apricots


 




140020 


Cherries


 




140030 


Peaches


 




140040 


Plums


 




140990 


Others


 




150000 








(v)


Berries and small fruit






0,05 (*1)





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 (*1)





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 (*1)





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 (*1)





300010 


Beans


 




300020 


Lentils


 




300030 


Peas


 




300040 


Lupins


 




300990 


Others


 




400000 








4.


OILSEEDS AND OILFRUITS






 




401000 








(i)


Oilseeds






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






 




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






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






0,1 (*1)





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 (*1)





800000 








8.


SPICES






0,1 (*1)





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 (*1)





900010 


Sugar beet (root)


 




900020 


Sugar cane


 




900030 


Chicory roots


 




900990 


Others


 




1000000 








10.


PRODUCTS OF ANIMAL ORIGIN — TERRESTRIAL ANIMALS






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






 




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.

(*1)  Indicates lower limit of analytical determination.

(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.’