LegalizeCommission Regulation (EC) No 1050/2009 of 28 October 2009 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 azoxystrobin, acetamiprid, clomazone, cyflufenamid, emamectin benzoate, famoxadone, fenbutatin oxide, flufenoxuron, fluopicolide, indoxacarb, ioxynil, mepanipyrim, prothioconazole, pyridalyl, thiacloprid and trifloxystrobin in or on certain products (Text with EEA relevance)
COMMISSION REGULATION (EC) No 1050/2009
of 28 October 2009
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 azoxystrobin, acetamiprid, clomazone, cyflufenamid, emamectin benzoate, famoxadone, fenbutatin oxide, flufenoxuron, fluopicolide, indoxacarb, ioxynil, mepanipyrim, prothioconazole, pyridalyl, thiacloprid and trifloxystrobin in or on certain products
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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,
(1) For azoxystrobin, acetamiprid, famoxadone, fenbutatin oxide, indoxacarb, ioxynil, mepanipyrim, thiacloprid and trifloxystrobin maximum residue levels (MRLs) were set in Annexes II and III to Regulation (EC) No 396/2005. For clomazone, cyflufenamid, flufenoxuron, fluopicolide and prothioconazole, MRLs were set in Annex III to Regulation (EC) No 396/2005. For emamectin benzoate and pyridalyl no specific MRLs were set nor were the substances included in Annex IV to Regulation (EC) No 396/2005.
(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 azoxystrobin on beet leaves and broccoli an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modifications of the existing MRLs.
(3) As regards acetamiprid, such an application was made for the use on cress, spinach and herbs, except parsley. As regards clomazone, such an application was made for the use on herbs. As regards cyflufenamid, such an application was made for the use on oats. In view of that application, it is also necessary to modify the existing MRLs for animal products, since this cereal is used as feed. As regards emamectin benzoate, such an application was made for the use on pome fruit, peaches and nectarines, table and wine grapes, strawberries, tomatoes, aubergines, pepper, cucurbits (edible and inedible peel), cauliflower, broccoli, head cabbage, lettuce and other salad plants, scarole, herbs, fresh beans (with and without pods), peas with pods and artichokes. As regards famoxadone, such an application was made for the use on flowers of herbal infusions. As regards fenbutatin oxide, such an application was made for the use on tomatoes. As regards indoxacarb, such an application was made for the use on small fruits and berries except gooseberries and currants. As regards ioxynil, such an application was made for the use on rye and triticale. In view of that application, it is also necessary to modify the existing MRLs for meat, liver, kidney and fat from bovines, sheep and goats, since those cereals are used in feed for these animals. As regards mepanipyrim, such an application was made for the use on courgette. As regards prothioconazole, such an application was made for the use on head cabbage and Brussels sprouts. As regards pyridalyl, such an application was made for the use on tomatoes, aubergines, peppers, cucurbits (inedible peel), lettuce and cotton seed. As regards thiacloprid, such an application was made for the use on leeks and spring onions. As regards trifloxystrobin, such an application was made for the use on head cabbage, celery, blue berries, lettuce, herbs, scarole and Brussels sprouts.
(4) In accordance with Article 6(2) of Regulation (EC) No 396/2005 applications were made for flufenoxuron on tea, fluopicolide on peppers and for trifloxystrobin on passion fruit. The authorised use of flufenoxuron on tea shrubs in Japan leads to higher residues than the present MRL in Annex III. To avoid trade barriers for the importation of Japanese tea, a higher MRL is necessary. The authorised use of fluopicolide on pepper plants in the USA leads to higher residues than the present MRL in Annex III. To avoid trade barriers for the importation of American peppers, a higher MRL is necessary. The authorised use of trifloxystrobin on passion fruit in Kenya leads to higher residues than the present MRL in Annex III. To avoid trade barriers for the importation of Kenyan passion fruits, a higher MRL is necessary.
(5) 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.
(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. Where the Authority recommended two MRL values for the same pesticide-product combination as two different ‘risk management options’, the Commission always opted for the lowest MRL in line with recital 5 of Regulation (EC) No 396/2005. In the case of flufenoxuron and tea, additional information provided by France about registered uses made it possible to conclude that the new MRL does not lead to a chronic health risk.
(8) Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the requested modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.
(9) Regulation (EC) No 396/2005 should therefore be amended accordingly.
(10) 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 azoxystrobin, acetamiprid, fenbutatin oxide, indoxacarb, ioxynil, mepanipyrim, thiacloprid and trifloxystrobin 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 () Acetamiprid (R) Azoxystrobin Fenbutatin oxide (F) Indoxacarb as sum of the isomers S and R (F) (1) Ioxynil, including its esters expressed as ioxynil (F) Mepanipyrim (Mepanipyrim and its metabolite (2-anilino-4-(2-hydroxypropyl)-6-methylpyrimidine) expressed as mepanipyrim) Thiacloprid (F) Trifloxystrobin (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 0100000 1. FRUIT FRESH OR FROZEN; NUTS
0,05 (3) 0110000 (i) Citrus fruit 1 1 5 0,02 (3)
0,01 (3) 0,02 (3) 0,3 0110010 Grapefruit 0110020 Oranges 0110030 Lemons 0110040 Limes 0110050 Mandarins 0110990 Others 0120000 (ii) Tree nuts (shelled or unshelled) 0,01 (3) 0,1 (3) 0,05 (3) 0,05 (3)
0,01 (3) 0,02 (3) 0,02 (3) 0120010 Almonds 0120020 Brazil nuts 0120030 Cashew nuts 0120040 Chestnuts 0120050 Coconuts 0120060 Hazelnuts 0120070 Macadamia 0120080 Pecans 0120090 Pine nuts 0120100 Pistachios 0120110 Walnuts 0120990 Others 0130000 (iii) Pome fruit 0,1 0,05 (3) 2
0,01 (3) 0,3 0,5 0130010 Apples
0,5 0130020 Pears
0,3 0130030 Quinces
0,3 0130040 Medlar (4) (4) (4) (4) (4) (4) (4) (4) 0130050 Loquat (4) (4) (4) (4) (4) (4) (4) (4) 0130990 Others
0,3 0140000 (iv) Stone fruit
0,05 (3) 0,05 (3)
0,01 (3) 0140010 Apricots 0,1
0,3
0,3 1 0140020 Cherries 0,2
0,02 (3)
0,3 1 0140030 Peaches 0,1
0,3
0,3 1 0140040 Plums 0,02
0,02 (3)
0,1 0,2 0140990 Others 0,01 (3)
0,02 (3)
0,02 (3) 0,02 (3) 0150000 (v) Berries & small fruit 0,01 (3) 0151000 (a) Table and wine grapes
2 2 2
3 0,02 (3) 5 0151010 Table grapes 0151020 Wine grapes 0152000 (b) Strawberries
2 1 0,02 (3)
2 0,5 0,5 0153000 (c) Cane fruit
0,01 (3)
0,02 (3) 0153010 Blackberries
3 5 0,5
3 0153020 Dewberries
0,05 (3) 0,05 (3) 0,02 (3)
1 0153030 Raspberries
3 5 0,5
3 0153990 Others
0,05 (3) 0,05 (3) 0,02 (3)
1 0154000 (d) Other small fruit & berries
0,05 (3) 0,05 (3) 1
0,01 (3) 1 0154010 Blueberries
2 0154020 Cranberries
0,02 (3) 0154030 Currants (red, black and white)
1 0154040 Gooseberries
1 0154050 Rose hips (4) (4) (4) (4) (4) (4) (4) (4) 0154060 Mulberries (4) (4) (4) (4) (4) (4) (4) (4) 0154070 Azarole (mediteranean medlar) (4) (4) (4) (4) (4) (4) (4) (4) 0154080 Elderberries (4) (4) (4) (4) (4) (4) (4) (4) 0154990 Others
0,02 (3) 0160000 (vi) Miscellaneous fruit 0,01 (3)
0,01 (3) 0161000 (a) Edible peel
0,05 (3) 0,05 (3) 0,02 (3)
0,02 (3) 0161010 Dates
0,02 (3) 0161020 Figs
0,02 (3) 0161030 Table olives
0,3 0161040 Kumquats
0,02 (3) 0161050 Carambola (4) (4) (4) (4) (4) (4) (4) (4) 0161060 Persimmon (4) (4) (4) (4) (4) (4) (4) (4) 0161070 Jambolan (java plum) (4) (4) (4) (4) (4) (4) (4) (4) 0161990 Others
0,02 (3) 0162000 (b) Inedible peel, small
0,05 (3) 0,02 (3)
0,02 (3) 0162010 Kiwi
0,05 (3)
0,02 (3) 0162020 Lychee (Litchi)
0,05 (3)
0,02 (3) 0162030 Passion fruit
4
4 0162040 Prickly pear (cactus fruit) (4) (4) (4) (4) (4) (4) (4) (4) 0162050 Star apple (4) (4) (4) (4) (4) (4) (4) (4) 0162060 American persimmon (Virginia kaki) (4) (4) (4) (4) (4) (4) (4) (4) 0162990 Others
0,05 (3)
0,02 (3) 0163000 (c) Inedible peel, large 0163010 Avocados
0,05 (3) 0,05 (3) 0,02 (3)
0,02 (3) 0,02 (3) 0163020 Bananas
2 3 0,2
0,02 (3) 0,05 0163030 Mangoes
0,2 0,05 (3) 0,02 (3)
0,02 (3) 0,5 0163040 Papaya
0,2 0,05 (3) 0,02 (3)
0,5 1 0163050 Pomegranate
0,05 (3) 0,05 (3) 0,02 (3)
0,02 (3) 0,02 (3) 0163060 Cherimoya (4) (4) (4) (4) (4) (4) (4) (4) 0163070 Guava (4) (4) (4) (4) (4) (4) (4) (4) 0163080 Pineapples
0,05 (3) 0,05 (3) 0,02 (3)
0,02 (3) 0,02 (3) 0163090 Bread fruit (4) (4) (4) (4) (4) (4) (4) (4) 0163100 Durian (4) (4) (4) (4) (4) (4) (4) (4) 0163110 Soursop (guanabana) (4) (4) (4) (4) (4) (4) (4) (4) 0163990 Others
0,05 (3) 0,05 (3) 0,02 (3)
0,02 (3) 0,02 (3) 0200000 2. VEGETABLES FRESH OR FROZEN 0210000 (i) Root and tuber vegetables 0,01 (3)
0,05 (3)
0,01 (3) 0211000 (a) Potatoes
0,05 (3)
0,02 (3) 0,05 (3)
0,02 (3) 0,02 (3) 0212000 (b) Tropical root and tuber vegetables
0,05 (3)
0,02 (3) 0,05 (3)
0,02 (3) 0,02 (3) 0212010 Cassava 0212020 Sweet potatoes 0212030 Yams 0212040 Arrowroot (4) (4) (4) (4) (4) (4) (4) (4) 0212990 Others 0213000 (c) Other root and tuber vegetables except sugar beet 0213010 Beetroot
0,05 (3)
0,02 (3) 0,05 (3)
0,02 (3) 0,02 (3) 0213020 Carrots
0,2
0,02 (3) 0,2
0,02 (3) 0,05 0213030 Celeriac
0,3
0,02 (3) 0,05 (3)
0,1 0,02 (3) 0213040 Horseradish
0,2
0,02 (3) 0,05 (3)
0,02 (3) 0,02 (3) 0213050 Jerusalem artichokes
0,05 (3)
0,02 (3) 0,05 (3)
0,02 (3) 0,02 (3) 0213060 Parsnips
0,2
0,02 (3) 0,2
0,02 (3) 0,02 (3) 0213070 Parsley root
0,2
0,02 (3) 0,05 (3)
0,02 (3) 0,02 (3) 0213080 Radishes
0,2
0,2 0,05 (3)
0,02 (3) 0,02 (3) 0213090 Salsify
0,2
0,02 (3) 0,05 (3)
0,02 (3) 0,02 (3) 0213100 Swedes
0,05 (3)
0,02 (3) 0,05 (3)
0,02 (3) 0,02 (3) 0213110 Turnips
0,2
0,02 (3) 0,05 (3)
0,02 (3) 0,02 (3) 0213990 Others
0,05 (3)
0,02 (3) 0,05 (3)
0,02 (3) 0,02 (3) 0220000 (ii) Bulb vegetables 0,01 (3)
0,05 (3) 0,02 (3)
0,01 (3)
0,02 (3) 0220010 Garlic
0,05 (3)
0,2
0,02 (3) 0220020 Onions
0,05 (3)
0,2
0,02 (3) 0220030 Shallots
0,05 (3)
0,2
0,02 (3) 0220040 Spring onions
2
3
0,1 0220990 Others
0,05 (3)
0,05 (3)
0,02 (3) 0230000 (iii) Fruiting vegetables
0,05 (3) 0231000 (a) Solanacea
2 0231010 Tomatoes 0,1
2 0,5
1 0,5 0,5 0231020 Peppers 0,3
1 0,3
0,01 (3) 1 0,3 0231030 Aubergines (egg plants) 0,1
1 0,5
1 0,5 0,02 (3) 0231040 Okra, lady’s fingers 0,01 (3)
1 0,02 (3)
0,01 (3) 0,02 (3) 0,02 (3) 0231990 Others 0,01 (3)
1 0,02 (3)
0,01 (3) 0,02 (3) 0,02 (3) 0232000 (b) Cucurbits — edible peel 0,3 1
0,2
0,3 0,2 0232010 Cucumbers
0,5
0,01 (3) 0232020 Gherkins
0,05 (3)
0,01 (3) 0232030 Courgettes
0,5
0,5 0232990 Others
0,05 (3)
0,01 (3) 0233000 (c) Cucurbits-inedible peel 0,01 (3) 0,5 0,05 (3) 0,1
0,01 (3) 0233010 Melons
0,2 0,3 0233020 Pumpkins
0,02 (3) 0,2 0233030 Watermelons
0,2 0,2 0233990 Others
0,02 (3) 0,02 (3) 0234000 (d) Sweet corn 0,01 (3) 0,05 (3) 0,05 (3) 0,02 (3)
0,01 (3) 0,1 0,02 (3) 0239000 (e) Other fruiting vegetables 0,01 (3) 0,05 (3) 0,05 (3) 0,02 (3)
0,01 (3) 0,02 (3) 0,02 (3) 0240000 (iv) Brassica vegetables
0,05 (3)
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