Commission Regulation (EU) No 524/2011 of 26 May 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for biphenyl, deltamethrin, ethofumesate, isopyrazam, propiconazole, pymetrozine, pyrimethanil and tebuconazole in or on certain products Text with EEA relevance
COMMISSION REGULATION (EU) No 524/2011
of 26 May 2011
amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for biphenyl, deltamethrin, ethofumesate, isopyrazam, propiconazole, pymetrozine, pyrimethanil and tebuconazole 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)(a) thereof,
(1) For deltamethrin, ethofumesate, propiconazole, pymetrozine and pyrimethanil maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For tebuconazole, MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. For isopyrazam no MRLs were set before in any of the Annexes to Regulation (EC) No 396/2005, so the default value of 0.01 mg/kg applied. Up to now, for biphenyl no specific MRLs were set nor was the substance included in Annex IV to Regulation (EC) No 396/2005. Biphenyl was formerly used as a plant protection product. In accordance with Article 18(1)(b) Regulation (EC) No 396/2005 the default MRL of 0.01 mg/kg is to apply to all products listed in Annex I thereto.
(2) In the context of a procedure, in accordance with Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2), for the authorisation of the use of a plant protection product containing the active substance pymetrozine on spinach, purslane and beet leaves an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.
(3) As regards deltamethrin, such an application was made for the use on potatoes. As regards ethofumesate, such an application was made for the use in herbal infusions for leaves and flowers and thyme. As regards isopyrazam, such an application was made for the use on several cereals. As regards propiconazole, such an application was made for the use on table and wine grapes, and apples As regards pyrimethanil, such an application was made for the use on peas with pods. As regards tebuconazole, such an application was made for the use on various citrus fruit.
(4) In accordance with Article 8 of Regulation (EC) No 396/2005, these applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission.
(5) As Regards biphenyl, the Commission received information from Germany and business operators showing the presence of biphenyl on fresh herbs and herbal infusions containing pesticide residues higher than the default MRL. Germany submitted an evaluation report and informed that due to the ubiquitous presence of this substance from various sources it is impossible to produce herbs,tea rose hips, spices and herbal infusions containing residues of biphenyl complying with the MRL. Referring to the procedure described in Article 16(1) (a) of Regulation (EC) No 396/2005 Germany made an application for temporary MRLs to enable the placing on the market of the affected products.
(6) The European Food Safety Authority, hereinafter ‘the Authority’, assessed the applications and the evaluation reports, examining in particular the risks to the consumer and where relevant to animals and gave reasoned opinions on the proposed MRLs (3). It forwarded these opinions to the Commission and the Member States and made them available to the public.
(7) The Authority concluded in its reasoned opinions that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short term exposure due to extreme consumption of the relevant crops showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded.
(8) For biphenyl the Authority recommended only to raise the MRLs for which data demonstrated that this was necessary. It also advised that because of analytical problems in some cases it might not be possible to enforce the existing MRL and suggested that the lowest limit of analytical determination (LOD) for these crops might be raised. This was confirmed by information obtained from the EU reference laboratory.
(9) Based on the reasoned opinions and statement 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.
(10) Regulation (EC) No 396/2005 should therefore be amended accordingly.
(11) 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
Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:
(1)In Annex II, the columns for deltamethrin, ethofumesate, propiconazole, pymetrozine and pyrimethanil are replaced by the following:
‘Pesticide residues and maximum residue levels (mg/kg) Code number Groups and examples of individual products to which the MRLs apply () Deltamethrin (cis-deltamethrin) (F) Ethofumesate (sum of ethofumesate and the metabolite 2,3-dihydro-3,3-dimethyl-2-oxo-benzofuran-5-yl methane sulphonate expressed as ethofumesate) Propiconazole Pymetrozine Pyrimethanil (1) (2) (3) (4) (5) (6) (7) 0100000 1. FRUIT FRESH OR FROZEN; NUTS
0,05 (2) 0110000 (i) Citrus fruit 0,05 (2)
0,05 (2) 0,3 10 0110010 Grapefruit (Shaddocks, pomelos, sweeties, tangelo (except mineola), ugli and other hybrids) 0110020 Oranges (Bergamot, bitter orange, chinotto and other hybrids) 0110030 Lemons (Citron, lemon) 0110040 Limes 0110050 Mandarins (Clementine, tangerine, mineola and other hybrids) 0110990 Others 0120000 (ii) Tree nuts (shelled or unshelled) 0,05 (2)
0,05 (2) 0,02 (2) 0120010 Almonds
0,2 0120020 Brazil nuts
0,05 (2) 0120030 Cashew nuts
0,05 (2) 0120040 Chestnuts
0,05 (2) 0120050 Coconuts
0,05 (2) 0120060 Hazelnuts (Filbert)
0,05 (2) 0120070 Macadamia
0,05 (2) 0120080 Pecans
0,05 (2) 0120090 Pine nuts
0,05 (2) 0120100 Pistachios
0,2 0120110 Walnuts
0,05 (2) 0120990 Others
0,05 (2) 0130000 (iii) Pome fruit
0,02 (2) 5 0130010 Apples (Crab apple) 0,2
0,15 0130020 Pears (Oriental pear) 0,1
0,05 (2) 0130030 Quinces 0,1
0,05 (2) 0130040 Medlar (3) (3) (3) (3) (3) 0130050 Loquat (3) (3) (3) (3) (3) 0130990 Others 0,1
0,05 (2) 0140000 (iv) Stone fruit 0140010 Apricots 0,1
0,2 0,05 3 0140020 Cherries (sweet cherries, sour cherries) 0,2
0,05 (2) 0,02 (2) 0,05 (2) 0140030 Peaches (Nectarines and similar hybrids) 0,1
0,2 0,05 10 0140040 Plums (Damson, greengage, mirabelle, sloe) 0,1
0,05 (2) 0,02 (2) 3 0140990 Others 0,1
0,05 (2) 0,02 (2) 0,05 (2) 0150000 (v) Berries & small fruit 0151000 (a) Table and wine grapes 0,2
0,3 0,02 (2) 5 0151010 Table grapes 0151020 Wine grapes 0152000 (b) Strawberries 0,2
0,05 (2) 0,5 5 0153000 (c) Cane fruit
0,05 (2) 0153010 Blackberries 0,5
3 10 0153020 Dewberries (Loganberries, boysenberries, and cloudberries) 0,05 (2)
0,02 (2) 0,05 (2) 0153030 Raspberries (Wineberries, arctic bramble/raspberry, (Rubus arcticus), nectar raspberries (Rubus arcticus x idaeus)) 0,5
3 10 0153990 Others 0,05 (2)
0,02 (2) 0,05 (2) 0154000 (d) Other small fruit & berries
0,05 (2)
5 0154010 Blueberries (Bilberries) 0,05 (2)
0,02 (2) 0154020 Cranberries (Cowberries (red bilberries)) 0,05 (2)
0,02 (2) 0154030 Currants (red, black and white) 0,5
0,5 0154040 Gooseberries (Including hybrids with other ribes species) 0,2
0,5 0154050 Rose hips (3) (3) (3) (3) (3) 0154060 Mulberries (arbutus berry) (3) (3) (3) (3) (3) 0154070 Azarole (mediteranean medlar) (Kiwiberry (Actinidia arguta)) (3) (3) (3) (3) (3) 0154080 Elderberries (Black chokeberry (appleberry), mountain ash, buckthorn (sea sallowthorn), hawthorn, service berries, and other treeberries) (3) (3) (3) (3) (3) 0154990 Others 0,05 (2)
0,02 (2) 0160000 (vi) Miscellaneous fruit
0,02 (2) 0161000 (a) Edible peel
0,05 (2)
0,05 (2) 0161010 Dates 0,05 (2) 0161020 Figs 0,05 (2) 0161030 Table olives 1 0161040 Kumquats (Marumi kumquats, nagami kumquats, limequats (Citrus aurantifolia x Fortunella spp.)) 0,05 (2) 0161050 Carambola (Bilimbi) (3) (3) (3) (3) (3) 0161060 Persimmon (3) (3) (3) (3) (3) 0161070 Jambolan (java plum) (Java apple (water apple), pomerac, rose apple, Brazilean cherry Surinam cherry (grumichama Eugenia uniflora)) (3) (3) (3) (3) (3) 0161990 Others 0,05 (2) 0162000 (b) Inedible peel, small
0,05 (2)
0,05 (2) 0162010 Kiwi 0,2 0162020 Lychee (Litchi) (Pulasan, rambutan (hairy litchi), mangosteen) 0,05 (2) 0162030 Passion fruit 0,05 (2) 0162040 Prickly pear (cactus fruit) (3) (3) (3) (3) (3) 0162050 Star apple (3) (3) (3) (3) (3) 0162060 American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel (yellow sapote), and mammey sapote) (3) (3) (3) (3) (3) 0162990 Others 0,05 (2) 0163000 (c) Inedible peel, large 0,05 (2) 0163010 Avocados
0,05 (2)
0,05 (2) 0163020 Bananas (Dwarf banana, plantain, apple banana)
0,1
0,1 0163030 Mangoes
0,05 (2)
0,05 (2) 0163040 Papaya
0,05 (2)
0,05 (2) 0163050 Pomegranate
0,05 (2)
0,05 (2) 0163060 Cherimoya (Custard apple, sugar apple (sweetsop), llama and other medium sized Annonaceae) (3) (3) (3) (3) (3) 0163070 Guava (Red pitaya or dragon fruit (Hylocereus undatus)) (3) (3) (3) (3) (3) 0163080 Pineapples
0,05 (2)
0,05 (2) 0163090 Bread fruit (Jackfruit) (3) (3) (3) (3) (3) 0163100 Durian (3) (3) (3) (3) (3) 0163110 Soursop (guanabana) (3) (3) (3) (3) (3) 0163990 Others
0,05 (2)
0,05 (2) 0200000 2. VEGETABLES FRESH OR FROZEN 0210000 (i) Root and tuber vegetables
0,05 (2) 0,02 (2) 0211000 (a) Potatoes 0,2 0,05 (2)
0,05 (2) 0212000 (b) Tropical root and tuber vegetables 0,05 (2) 0,05 (2)
0,05 (2) 0212010 Cassava (Dasheen, eddoe (Japanese taro), tannia) 0212020 Sweet potatoes 0212030 Yams (Potato bean (yam bean), Mexican yam bean) 0212040 Arrowroot (3) (3) (3) (3) (3) 0212990 Others 0213000 (c) Other root and tuber vegetables except sugar beet 0,05 (2) 0213010 Beetroot
0,1
0,05 (2) 0213020 Carrots
0,05 (2)
1 0213030 Celeriac
0,05 (2)
0,05 (2) 0213040 Horseradish (Angelica roots, lovage roots, gentiana roots)
0,05 (2)
0,05 (2) 0213050 Jerusalem artichokes
0,05 (2)
0,05 (2) 0213060 Parsnips
0,05 (2)
0,05 (2) 0213070 Parsley root
0,05 (2)
0,05 (2) 0213080 Radishes (Black radish, Japanese radish, small radish and similar varieties, tiger nut (Cyperus esculentus))
0,05 (2)
0,05 (2) 0213090 Salsify (Scorzonera, Spanish salsify (Spanish oysterplant))
0,05 (2)
0,05 (2) 0213100 Swedes
0,05 (2)
0,05 (2) 0213110 Turnips
0,05 (2)
0,05 (2) 0213990 Others
0,05 (2)
0,05 (2) 0220000 (ii) Bulb vegetables
0,05 (2) 0,05 (2) 0,02 (2) 0220010 Garlic 0,1
0,05 (2) 0220020 Onions (Silverskin onions) 0,1
0,1 0220030 Shallots 0,1
0,05 (2) 0220040 Spring onions (Welsh onion and similar varieties) 0,1
0,05 (2) 0220990 Others 0,05 (2)
0,05 (2) 0230000 (iii) Fruiting vegetables
0,05 (2) 0,05 (2) 0231000 (a) Solanacea 0231010 Tomatoes (Cherry tomatoes, tree tomato, Physalis, gojiberry, wolfberry (Lycium barbarum and L. chinense)) 0,3
0,5 1 0231020 Peppers (Chilli peppers) 0,2
1 2 0231030 Aubergines (egg plants) (Pepino) 0,3
0,5 1 0231040 Okra, lady's fingers 0,3
1 0,05 (2) 0231990 Others 0,2
0,02 (2) 0,05 (2) 0232000 (b) Cucurbits - edible peel 0,2
0,5 1 0232010 Cucumbers 0232020 Gherkins 0232030 Courgettes (Summer squash, marrow (patisson)) 0232990 Others 0233000 (c) Cucurbits-inedible peel 0,2
0,2 0,05 (2) 0233010 Melons (Kiwano) 0233020 Pumpkins (Winter squash) 0233030 Watermelons 0233990 Others 0234000 (d) Sweet corn 0,05 (2)
0,02 (2) 0,05 (2) 0239000 (e) Other fruiting vegetables 0,05 (2)
0,02 (2) 0,05 (2) 0240000 (iv) Brassica vegetables
0,05 (2) 0,05 (2)
0,05 (2) 0241000 (a) Flowering brassica 0,1
0,02 (2) 0241010 Broccoli (Calabrese, Chinese broccoli, broccoli raab) 0241020 Cauliflower 0241990 Others 0242000 (b) Head brassica 0,1 0242010 Brussels sprouts
0,02 (2) 0242020 Head cabbage (Pointed head cabbage, red cabbage, savoy cabbage, white cabbage)
0,05 0242990 Others
0,02 (2) 0243000 (c) Leafy brassica 0,5
0,2 0243010 Chinese cabbage (Indian (Chinese) mustard, pak choi, Chinese flat cabbage (tai goo choi), choi sum, peking cabbage (pe-tsai)) 0243020 Kale (Borecole (curly kale), collards, Portuguese Kale, Portuguese cabbage, cow cabbage) 0243990 Others 0244000 (d) Kohlrabi 0,05 (2)
0,02 (2) 0250000 (v) Leaf vegetables & fresh herbs
0,05 (2) 0251000 (a) Lettuce and other salad plants including Brassicacea 0,5 0,05 (2)
2 0251010 Lamb's lettuce (Italian cornsalad)
0,05 (2) 0251020 Lettuce (Head lettuce, lollo rosso (cutting lettuce), iceberg lettuce, romaine (cos) lettuce)
10 0251030 Scarole (broad-leaf endive) (Wild chicory, red-leaved chicory, radicchio, curld leave endive, sugar loaf)
10 0251040 Cress
0,05 (2) 0251050 Land cress (3) (3) (3) (3) (3) 0251060 Rocket, Rucola (Wild rocket)
0,05 (2) 0251070 Red mustard (3) (3) (3) (3) (3) 0251080 Leaves and sprouts of Brassica spp (Mizuna, leaves of peas and radish and other babyleaf brassica crops (crops harvested up to 8 true leaf stage))
0,05 (2) 0251990 Others
0,05 (2) 0252000 (b) Spinach & similar (leaves) 0,5
0,05 (2) 0252010 Spinach (New Zealand spinach, amaranthus spinach)
0,05 (2)
0,4 0252020 Purslane (Winter purslane (miner’s lettuce), garden purslane, common purslane, sorrel, glassworth, Agretti (Salsola soda)) (3) (3) (3) (3) (3) 0252030 Beet leaves (chard) (Leaves of beetroot)
0,05 (2)
0,4 0252990 Others
0,05 (2)
0,02 (2) 0253000 (c) Vine leaves (grape leaves) (3) (3) (3) (3) (3) 0254000 (d) Water cress 0,05 (2) 0,05 (2)
0,02 (2) 0,05 (2) 0255000 (e) Witloof 0,05 (2) 0,05 (2)
0,02 (2) 0,05 (2) 0256000 (f) Herbs 0,5
3 0256010 Chervil
1
2 0256020 Chives
1
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