Commission Regulation (EU) 2015/603 of 13 April 2015 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 2-naphthyloxyacetic acid, acetochlor, chloropicrin, diflufenican, flurprimidol, flutolanil and spinosad in or on certain products Text with EEA relevance

COMMISSION REGULATION (EU) 2015/603

of 13 April 2015

amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 2-naphthyloxyacetic acid, acetochlor, chloropicrin, diflufenican, flurprimidol, flutolanil and spinosad 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 Articles 14(1)(a) and 18(1)(b) and Article 49(2) thereof,

(1) For acetochlor, chloropicrin, diflufenican, flurprimidol, flutolanil and spinosad, maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005. For 2-naphthyloxyacetic acid no MRLs are set in Regulation (EC) No 396/2005, and as that active substance is not included in Annex IV to that Regulation, the default value of 0,01 mg/kg laid down in Article 18(1)(b) of that Regulation applies.

(2) The non-inclusion of 2-naphthyloxyacetic acid in Annex I to Directive 91/414/EEC is provided for in Commission Implementing Regulation (EU) No 1127/2011 (²). All existing authorisations for plant protection products containing the active substance 2-naphthyloxyacetic acid have been revoked. It is therefore appropriate to set the MRLs at the specific limit of determination or at the default MRL as set out in Article 18(1)(b) of Regulation (EC) No 396/2005.

(3) The non-inclusion of acetochlor in Annex I to Directive 91/414/EEC is provided for in Commission Implementing Regulation (EU) No 1372/2011 (³). All existing authorisations for plant protection products containing the active substance acetochlor have been revoked. In accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1)(a) thereof the MRLs set out for that active substance in Annex III should therefore be deleted.

(4) The non-inclusion of chloropicrin in Annex I to Directive 91/414/EEC is provided for in Commission Implementing Regulation (EU) No 1381/2011 (⁴). All existing authorisations for plant protection products containing the active substance chloropicrin have been revoked. In accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1)(a) thereof the MRLs set out for that active substance in Annex III should therefore be deleted.

(5) For diflufenican, the European Food Safety Authority, hereinafter ‘the Authority’, submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (⁵). It recommended lowering the MRLs for table olives, barley grain, oats grain, rye grain and wheat grain. For another product it recommended raising the existing MRL. It concluded that concerning the MRLs for citrus fruit, almonds, walnuts, pome fruit, stone fruit, table grapes, wine grapes, kiwi, bovine muscle, fat, liver and kidney, sheep muscle, fat, liver and kidney, goat muscle, fat, liver and kidney and cattle, sheep and goat milk some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. The Authority concluded that concerning the MRLs for strawberries, cane fruits, other small fruits and berries, peas (with pods), peas (without pods), peas (dry) and millet grain no information was available and that further consideration by risk managers was required. The MRLs for these products should be set at the specific limit of determination or at the default MRL as set out in Article 18(1)(b) of Regulation (EC) No 396/2005.

(6) The non-inclusion of flurprimidol in Annex I to Directive 91/414/EEC is provided for in Commission Implementing Decision No 2011/328/EU (⁶). All existing authorisations for plant protection products containing the active substance flurprimidol have been revoked. In accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1)(a) thereof the MRLs set out for that active substance in Annex III should therefore be deleted.

(7) For flutolanil, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (⁷). It proposed to change the residue definition. It recommended lowering the MRL for potatoes. For another product it recommended keeping the existing MRL. It concluded that concerning the MRLs for peppers, beans (fresh, with pods), globe artichokes, swine muscle, fat, liver and kidney, bovine muscle, fat, liver and kidney, sheep muscle, fat, liver and kidney, goat muscle, fat, liver and kidney, poultry muscle, fat and liver, cattle, sheep and goat milk and birds' eggs some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for these products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.

(8) For spinosad, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (⁸). It recommended lowering the MRLs for almonds, brazil nuts, cashew nuts, chestnuts, coconuts, hazelnuts, macadamia, pecans, pine nuts, pistachios, walnuts, apples, pears, quinces, medlar, loquat, apricots, cherries, peaches, plums, kiwi, garlic, onions, shallots, tomatoes, aubergines (egg plants), cucumbers, beans (fresh, with pods), peas (fresh, with pods), and leek. For other products it recommended keeping or raising the existing MRLs. It concluded that concerning the MRLs for flowering brassica, spinach, globe artichokes, cereals grain, poultry muscle, fat and liver and birds eggs some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for these products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. The Authority concluded that concerning the MRLs for swedes and turnips no information was available and that further consideration by risk managers was required. The MRLs for these products should be set at the specific limit of determination or at the default MRL as set out in Article 18(1)(b) of Regulation (EC) No 396/2005. As regards blackberries, raspberries, other small fruit and berries, celery, fennel, swine muscle and liver, bovine muscle, sheep muscle, fat and liver, goat muscle, fat and liver and poultry muscle, after submitting the opinion referred to in the first sentence, the Authority submitted further opinions concerning the MRLs (⁹) (¹⁰) (¹¹). It is appropriate to take those opinions into account. As regards tree nuts, dewberries, passion fruit and spring onions, after the Authority submitted the opinion referred to in the first sentence, by Commission Regulation (EU) No 293/2013 (¹²), CXLs were included as MRLs in Regulation (EC) No 396/2005. It is appropriate to take those MRLs into account.

(9) As regards products of plant and animal origin for which neither relevant authorisations or import tolerances were reported at Union level nor CXLs were available, the Authority concluded that further consideration by risk managers was required. Taking into account the current scientific and technical knowledge, MRLs for those products should be set at the specific limit of determination or at the default MRL in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005.

(10) The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain limits of determination. As regards several substances, those laboratories concluded that for certain commodities technical development requires the setting of specific limits of determination.

(11) Based on the reasoned opinions 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.

(12) Regulation (EC) No 396/2005 should therefore be amended accordingly.

(13) In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been lawfully produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained.

(14) A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs.

(15) Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account.

(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes II, III and V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

Article 2

Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were lawfully produced before  7 November 2015.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from  7 November 2015.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

Annexes II, III and V to Regulation (EC) No 396/2005 are amended as follows:

(1)in Annex II, the columns for diflufenican, flutolanil and spinosad are added:

‘Pesticide residues and maximum residue levels (mg/kg) Code number Groups and examples of individual products to which the MRLs apply () Diflufenican (F) Flutolanil (R) Spinosad (spinosad, sum of spinosyn A and spinosyn D) (F) (1) (2) (3) (4) (5) 0100000 1. FRUIT FRESH OR FROZEN NUTS 0,01 (¹) 0,01 (¹) 0110000 (i) Citrus fruit (+)

0,3 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, Buddha's hand (Citrus medica var. sarcodactylis)) 0110040 Limes 0110050 Mandarins (Clementine, tangerine, mineola and other hybrids tangor (Citrus reticulata × sinensis)) 0110990 Others 0120000 (ii) Tree nuts

0,07 0120010 Almonds (+) 0120020 Brazil nuts 0120030 Cashew nuts 0120040 Chestnuts 0120050 Coconuts 0120060 Hazelnuts (Filbert) 0120070 Macadamia 0120080 Pecans 0120090 Pine nuts 0120100 Pistachios 0120110 Walnuts (+) 0120990 Others 0130000 (iii) Pome fruit (+)

0,3 0130010 Apples (Crab apple) 0130020 Pears (Oriental pear) 0130030 Quinces 0130040 Medlar 0130050 Loquat 0130990 Others 0140000 (iv) Stone fruit (+) 0140010 Apricots

0,6 0140020 Cherries (Sweet cherries, sour cherries)

0,2 0140030 Peaches (Nectarines and similar hybrids)

0,6 0140040 Plums (Damson, greengage, mirabelle, sloe, red date/Chinese date/Chinese jujube (Ziziphus zizyphus))

0,2 0140990 Others

0,02 (¹) 0150000 (v) Berries & small fruit 0151000 (a) Table and wine grapes (+)

0,5 0151010 Table grapes 0151020 Wine grapes 0152000 (b) Strawberries

0,3 0153000 (c) Cane fruit 0153010 Blackberries

1,5 0153020 Dewberries (Loganberries, tayberries, boysenberries, cloudberries and other Rubus hybrids)

1 0153030 Raspberries (Wineberries, arctic bramble/raspberry, (Rubus arcticus), nectar raspberries (Rubus arcticus × Rubus idaeus))

1,5 0153990 Others

0,02 (¹) 0154000 (d) Other small fruit & berries

1,5 0154010 Blueberries (Bilberries) 0154020 Cranberries (Cowberries/red bilberries (V. vitis-idaea)) 0154030 Currants (red, black and white) 0154040 Gooseberries (Including hybrids with other Ribes species) 0154050 Rose hips 0154060 Mulberries (Arbutus berry) 0154070 Azarole (mediteranean medlar) (Kiwiberry (Actinidia arguta)) 0154080 Elderberries (Black chokeberry/appleberry, mountain ash, buckthorn/sea sallowthorn, hawthorn, serviceberries, and other treeberries) 0154990 Others 0160000 (vi) Miscellaneous fruit 0161000 (a) Edible peel

0,02 (¹) 0161010 Dates 0161020 Figs 0161030 Table olives 0161040 Kumquats (Marumi kumquats, nagami kumquats, limequats (Citrus aurantifolia × Fortunella spp.)) 0161050 Carambola (Bilimbi) 0161060 Persimmon 0161070 Jambolan (java plum) (Java apple/water apple, pomerac, rose apple, Brazilean cherry, Surinam cherry/grumichama (Eugenia uniflora)) 0161990 Others 0162000 (b) Inedible peel, small 0162010 Kiwi (+)

0,05 0162020 Lychee (Litchi) (Pulasan, rambutan/hairy litchi, longan, mangosteen, langsat, salak)

0,02 (¹) 0162030 Passion fruit

0,7 0162040 Prickly pear (cactus fruit)

0,02 (¹) 0162050 Star apple

0,02 (¹) 0162060 American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel/yellow sapote, mammey sapote)

0,02 (¹) 0162990 Others

0,02 (¹) 0163000 (c) Inedible peel, large 0163010 Avocados

0,02 (¹) 0163020 Bananas (Dwarf banana, plantain, apple banana)

2 0163030 Mangoes

0,02 (¹) 0163040 Papaya

0,5 0163050 Pomegranate

0,02 (¹) 0163060 Cherimoya (Custard apple, sugar apple/sweetsop, ilama (Annona diversifolia) and other medium sized Annonaceae fruits)

0,02 (¹) 0163070 Guava (Red pitaya/dragon fruit (Hylocereus undatus))

0,02 (¹) 0163080 Pineapples

0,02 (¹) 0163090 Bread fruit (Jackfruit)

0,02 (¹) 0163100 Durian

0,02 (¹) 0163110 Soursop (guanabana)

0,02 (¹) 0163990 Others

0,02 (¹) 0200000 2. VEGETABLES FRESH OR FROZEN 0210000 (i) Root and tuber vegetables 0,01 (¹) 0211000 (a) Potatoes

0,1 0,02 (¹) 0212000 (b) Tropical root and tuber vegetables

0,01 (¹) 0,02 (¹) 0212010 Cassava (Dasheen, eddoe/Japanese taro, tannia) 0212020 Sweet potatoes 0212030 Yams (Potato bean/yam bean, Mexican yam bean) 0212040 Arrowroot 0212990 Others 0213000 (c) Other root and tuber vegetables except sugar beet

0,01 (¹) 0213010 Beetroot

0,02 (¹) 0213020 Carrots

0,02 (¹) 0213030 Celeriac

0,02 (¹) 0213040 Horseradish (Angelica roots, lovage roots, gentiana roots)

0,02 (¹) 0213050 Jerusalem artichokes (Crosne)

0,02 (¹) 0213060 Parsnips

0,02 (¹) 0213070 Parsley root

0,02 (¹) 0213080 Radishes (Black radish, Japanese radish, small radish and similar varieties, tiger nut (Cyperus esculentus))

0,3 0213090 Salsify (Scorzonera, Spanish salsify/Spanish oysterplant, edible burdock)

0,02 (¹) 0213100 Swedes

0,02 (¹) 0213110 Turnips

0,02 (¹) 0213990 Others

0,02 (¹) 0220000 (ii) Bulb vegetables 0,01 (¹) 0,01 (¹) 0220010 Garlic

0,07 0220020 Onions (Other bulb onions, silverskin onions)

0,07 0220030 Shallots

0,07 0220040 Spring onions and welsh onions (Other green onions and similar varieties)

4 0220990 Others

0,02 (¹) 0230000 (iii) Fruiting vegetables 0,01 (¹) 0,01 (¹) 0231000 (a) Solanacea 0231010 Tomatoes (Cherry tomatoes, Physalis spp., gojiberry, wolfberry (Lycium barbarum and L. chinense), tree tomato)

0,7 0231020 Peppers (Chilli peppers)

(+) 2 0231030 Aubergines (egg plants) (Pepino, antroewa/white eggplant (S. macrocarpon))

0,7 0231040 Okra (lady's fingers)

0,02 (¹) 0231990 Others

0,02 (¹) 0232000 (b) Cucurbits — edible peel

0,3 0232010 Cucumbers 0232020 Gherkins 0232030 Courgettes (Summer squash, marrow (patisson), lauki (Lagenaria siceraria), chayote, sopropo/bitter melon, snake gourd, angled luffa/teroi) 0232990 Others 0233000 (c) Cucurbits-inedible peel

1 0233010 Melons (Kiwano) 0233020 Pumpkins (Winter squash, marrow (late variety)) 0233030 Watermelons 0233990 Others 0234000 (d) Sweet corn (Baby corn)

0,02 (¹) 0239000 (e) Other fruiting vegetables

0,02 (¹) 0240000 (iv) Brassica vegetables 0,01 (¹) 0,01 (¹) 2 0241000 (a) Flowering brassica