EN Official Journal of the European Union L 141/10

COMMISSION DIRECTIVE 2005/37/EC

of 3 June 2005

amending Council Directives 86/362/EEC and 90/642/EEC as regards the maximum levels for certain pesticide residues in and on cereals and certain products of plant origin, including fruit and vegetables

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 10 thereof,

Having regard to Council Directive 90/642/EEC of 27 November 1990 on fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables (2), and in particular Article 7 thereof,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), and in particular Article 4(1)(f) thereof,

Whereas:

(1) The following existing active substances have been included in Annex I to Directive 91/414/EEC: maleic hydrazide by Commission Directive 2003/31/EC (4); propyzamide by Commission Directive 2003/39/EC (5); and mecoprop and mecoprop-p by Commission Directive 2003/70/EC (6).

(2) The new active substances isoxaflutole, trifloxystrobin, carfentrazone-ethyl and fenamidone were included in Annex I to Directive 91/414/EEC by Commission Directive 2003/68/EC (7).

(3) The inclusion in Annex I to Directive 91/414/EEC of the active substances concerned was based on the assessment of the information submitted concerning the proposed use. Information relating to this use has been submitted by certain Member States in accordance with Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to allow certain maximum residue levels (MRLs) to be fixed.

(4) Where no Community MRL or provisional MRL exists, Member States are to establish a national provisional MRL in accordance with Article 4(1)(f) of Directive 91/414/EEC before plant protection products containing these active substances may be authorised.

(5) Community MRLs and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a limited number of Codex MRLs for maleic hydrazide. There are already Community MRLs in Directive 90/642/EEC for: maleic hydrazide, (Council Directive 93/58/EC) (8) and in Directives 86/362/EEC and 90/642/EEC for: propyzamide (Council Directives 96/32/EC (9) and 96/33/EC (10)). These have been considered when setting the MRLs concerned by the adaptations made by this Directive. Codex MRLs that will be recommended for withdrawal in the near future were not taken into account. The MRLs based on Codex MRLs having been evaluated in the light of the risks for the consumers. No risk was established when using the toxicological end points based on the studies available to the Commission.

(6) With respect to the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, the related technical and scientific evaluations were finalised in the form of Commission review reports. The assessment reports for those substances mentioned were finalised on the dates as mentioned in the Commission Directives cited in Recitals 1 and 2. These reports fixed the acceptable daily intake (ADI) and if necessary, the acute reference dose (ARfD) for the substances concerned. The exposure of consumers of food products treated with the active substance concerned has been assessed and evaluated in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation (11) and the opinion of the Scientific Committee for Plants (12) on the methodology employed. It is concluded that MRLs proposed will not lead to those ADIs or ARfD being exceeded.

(7) In order to ensure that the consumer is adequately protected from exposure to residues resulting from unauthorised uses of plant protection products, provisional MRLs should be set for the relevant product/pesticide combinations at the lower limit of analytical determination.

(8) The setting at Community level of such provisional MRLs does not prevent the Member States from establishing provisional MRLs for the substances concerned in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of the active substance concerned. The provisional MRL should then become definitive.

(9) It is therefore necessary to add or replace, all of the pesticide residues arising from the use of these plant protection products to the Annexes to Directives 86/362/EEC and 90/642/EEC to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer. Where MRLs have already been defined in the annexes to those directives it is appropriate to modify them. Where MRLs have not been defined until now, it is appropriate to set them for the first time.

(10) Directives 86/362/EEC and 90/642/EEC should therefore be amended accordingly.

(11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 86/362/EEC is amended as follows:

(a) in Part A of Annex II the maximum pesticide residue levels for isoxaflutole, trifloxystrobin, carfentrazone-ethyl, mecoprop, mecoprop-p, maleic hydrazide and fenamidone as shown in Annex I to this Directive are added;

(b) in Part A of Annex II the maximum pesticide residue levels for propyzamide are replaced by those as shown in Annex II to this Directive.

Article 2

Directive 90/642/EEC is amended as follows:

(a) in Annex II the maximum pesticide residue levels for isoxaflutole, trifloxystrobin, carfentrazone-ethyl, mecoprop, mecoprop-p and fenamidone as shown in Annex III to this Directive are added.

(b) in Annex II the maximum pesticide residue levels for propyzamide and maleic hydrazide are replaced by those as shown in Annex IV to this Directive.

Article 3

1. Member States shall adopt and publish, by 4 December 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 4 December 2006.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 4

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

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 3 June 2005. For the Commission Markos KYPRIANOU Member of the Commission

(1) OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2004/61/EC (OJ L 127, 29.4.2004, p. 81).

(2) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2004/115/EC (OJ L 374, 22.12.2004, p. 64).

(3) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2005/34/EC (OJ L 125, 18.5.2005, p. 5).

(4) OJ L 101, 23.4.2003, p. 3.

(5) OJ L 124, 20.5.2003, p. 30.

(6) OJ L 184, 23.7.2003, p. 9.

(7) OJ L 177, 16.7.2003, p. 12.

(8) OJ L 211, 23.8.1993, p. 6.

(9) OJ L 144, 18.6.1996, p. 12.

(10) OJ L 144, 18.6.1996, p. 35.

(11) Guidelines for predicting dietary intake of pesticide residues (revised), prepared by the GEMS/Food Programme in collaboration with the Codex Committee on Pesticide Residues, published by the World Health Organisation 1997 (WHO/FSF/FOS/97.7).

(12) Opinion of the Scientific Committee on Plants regarding questions relating to amending the annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC (Opinion expressed by the Scientific Committee on Plants, 14 July 1998) (http://europa.eu.int/comm/food/fs/sc/index_en.html).

ANNEX I

Maximum levels (mg/kg) Pesticide residues Individual products to which the MRLs apply Isoxaflutole (sum of isoxaflutole, RPA 202248 and RPA 203328, expressed as isoxaflutole) (1) 0,05 (2) (3) CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals Trifloxystrobin 0,3 (3) Barley 0,05 (3) Rye 0,05 (3) Triticale, Wheat 0,02 (2) (3) other Cereals Carfentrazone-ethyl (determined as carfentrazone and expressed as carfentrazone-ethyl) 0,05 (2) (3) CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals Fenamidone 0,02 (2) (3) CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals Mecoprop (sum of mecoprop-p and mecoprop expressed as mecoprop) 0,05 (2) (3) CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals Maleic hydrazide 0,2 (2) (3) CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals

(1) RPA 202248 is 2-cyano-3-cyclopropyl-1-(2-methylsulfonyl-4-trifluoromethylphenyl) propane-1,3-dione. RPA 203328 is 2-methanesulfonyl-4-trifluoromethylbenzoic acid.

(2) Indicates lower limit of analytical determination.

(3) Indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level will become definitive with effect from 24 June 2009.

ANNEX II

Maximum levels mg/kg Pesticide residues Individual products to which the MRLs apply Propyzamide 0,02 (1) (2) CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals

(1) Indicates lower limit of analytical determination.

(2) Indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level will become definitive with effect from 24 June 2009.

ANNEX III

Pesticide residues and maximum residue levels (mg/kg) Groups and examples of individual products to which the MRLs apply Isoxaflutole (sum of isoxaflutole, RPA 202248 and RPA 203328, expressed as isoxaflutole) (1) Trifloxystrobin Carfentrazone-ethyl (determined as carfentrazone and expressed as carfentrazone-ethyl) Fenamidone Mecoprop (sum of mecoprop-p and mecoprop expressed as mecoprop) 1. Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts 0,05 (2) (3) 0,01 (2) (3) 0,05 (2) (3) (i) CITRUS FRUIT 0,3 (3) 0,02 (2) (3) Grapefruit Lemons Limes Mandarins (including clementines and other hybrids) Oranges Pomelos Others (ii) TREE NUTS (shelled or unshelled) 0,02 (2) (3) 0,02 (2) (3) Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (iii) POME FRUIT 0,5 (3) 0,02 (2) (3) Apples Pears Quinces Others (iv) STONE FRUIT 0,02 (2) (3) Apricots 1 (3) Cherries 1 (3) Peaches (including nectarines and similar hybrids) 1 (3) Plums Others 0,02 (2) (3) (v) BERRIES AND SMALL FRUIT (a) Table and wine grapes 5 (3) 0,5 (3) Table grapes Wine grapes (b) Strawberries (other than wild) 0,02 (2) (3) 0,02 (2) (3) (c) Cane fruit (other than wild) 0,02 (2) (3) 0,02 (2) (3) Blackberries Dewberries Loganberries Raspberries Others (d) Other small fruit and berries (other than wild) 0,02 (2) (3) Bilberries Cranberries Currants (red, black and white) 1 (3) Gooseberries 1 (3) Others 0,02 (2) (3) (e) Wild berries and wild fruit 0,02 (2) (3) 0,02 (2) (3) (vi) MISCELLANEOUS 0,02 (2) (3) Avocados Bananas 0,05 (3) Dates Figs Kiwi Kumquats Litchis Mangoes Olives Passion fruit Pineapples Papaya Others 0,02 (2) (3) 2. Vegetables, fresh or uncooked, frozen or dry 0,05 (2) (3) 0,01 (2) (3) 0,05 (2) (3) (i) ROOT AND TUBER VEGETABLES 0,02 (2) (3) 0,02 (2) (3) Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnips Parsley root Radishes Salsify Sweet potatoes Swedes Turnips Yam Others (ii) BULB VEGETABLES 0,02 (2) (3) 0,02 (2) (3) Garlic Onions Shallots Spring onions Others (iii) FRUITING VEGETABLES (a) Solanacea Tomatoes 0,5 (3) 0,5 (3) Peppers Aubergines Others 0,02 (2) (3) 0,02 (2) (3) (b) Cucurbits — edible peel 0,2 (3) 0,02 (2) (3) Cucumbers Gherkins Courgettes Others (c) Cucurbits — inedible peel Melons 0,3 (3) 0,1 (3) Squashes Watermelons Others 0,02 (2) (3) 0,02 (2) (3) (d) Sweet corn 0,02 (2) (3) 0,02 (2) (3) (iv) BRASSICA VEGETABLES 0,02 (2) (3) 0,02 (2) (3) (a) Flowering brassica Broccoli Cauliflower Others (b) Head brassica Brussels sprouts Head cabbage Others (c) Leafy brassica Chinese cabbage Kale Others (d) Kohlrabi (v) LEAF VEGETABLES AND FRESH HERBS 0,02 (2) (3) (a) Lettuce and similar 2 (3) Cress Lamb's lettuce Lettuce Scarole Others (b) Spinach and similar 0,02 (2) (3) Spinach Beet leaves (chard) Others (c) Watercress 0,02 (2) (3) (d) Witloof 0,02 (2) (3) (e) Herbs 0,02 (2) (3) Chervil Chives Parsley Celery leaves Others (vi) LEGUME VEGETABLES (fresh) 0,02 (2) (3) 0,02 (2) (3) Beans (with pods) Beans (without pods) Peas (with pods) Peas (without pods) Others (vii) STEM VEGETABLES (fresh) 0,02 (2) (3) 0,02 (2) (3) Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Others (viii) FUNGI 0,02 (2) (3) 0,02 (2) (3) (a) Cultivated mushrooms (b) Wild mushrooms 3. Pulses 0,05 (2) (3) 0,02 (2) (3) 0,01 (2) (3) 0,02 (2) (3) 0,05 (2) (3) Beans Lentils Peas Others 4. Oil seed 0,1 (2) (3) 0,05 (2) (3) 0,02 (2) (3) 0,05 (2) (3) 0,05 (2) (3) Linseed Peanuts Poppy seeds Sesame seeds Sunflower seed Rape seed Soya bean Mustard seed Cotton seed Others 5. Potatoes 0,05 (2) (3) 0,02 (2) (3) 0,01 (2) (3) 0,02 (2) (3) 0,05 (2) (3) Early potatoes Ware potatoes 6. Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis ) 0,1 (2) (3) 0,05 (2) (3) 0,02 (2) (3) 0,05 (2) (3) 0,1 (2) (3) 7. Hops (dried), including hop pellets and unconcentrated powder 0,1 (2) (3) 30 (3) 0,02 (2) (3) 0,05 (2) (3) 0,1 (2) (3)

(1) RPA 202248 is 2-cyano-3-cyclopropyl-1-(2-methylsulfonyl-4-trifluoromethylphenyl) propane-1,3-dione. RPA 203328 is 2-methanesulfonyl-4-trifluoromethylbenzoic acid.

(2) Indicates lower limit of analytical determination.

(3) Indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level will become definitive with effect from 24 June 2009.

ANNEX IV

Groups and examples of individual products to which the MRLs apply Propyzamide Maleic hydrazide 1. Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts 0,02 (1) (2) 0,2 (1) (2) (i) CITRUS FRUIT Grapefruit Lemons Limes Mandarins (including clementines and other hybrids) Oranges Pomelos Others (ii) TREE NUTS (shelled or unshelled) Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (iii) POME FRUIT Apples Pears Quinces Others (iv) STONE FRUIT Apricots Cherries Peaches (including nectarines and similar hybrids) Plums Others (v) BERRIES AND SMALL FRUIT (a) Table and wine grapes Table grapes Wine grapes (b) Strawberries (other than wild) (c) Cane fruit (other than wild) Blackberries Dewberries Loganberries Raspberries Others (d) Other small fruit and berries (other than wild) Bilberries Cranberries Currants (red, black and white) Gooseberries Others (e) Wild berries and wild fruit (vi) MISCELLANEOUS Avocados Bananas Dates Figs Kiwi Kumquats Litchis Mangoes Olives Passion fruit Pineapples Papaya Others 2. Vegetables, fresh or uncooked, frozen or dry (i) ROOT AND TUBER VEGETABLES 0,02 (1) (2) 0,2 (1) (2) Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnips Parsley root Radishes Salsify Sweet potatoes Swedes Turnips Yam Others (ii) BULB VEGETABLES 0,02 (1) (2) Garlic 15 (2) Onions 15 (2) Shallots 15 (2) Spring onions Others 0,2 (1) (2) (iii) FRUITING VEGETABLES 0,02 (1) (2) 0,2 (1) (2) (a) Solanacea Tomatoes Peppers Aubergines Others (b) Cucurbits — edible peel Cucumbers Gherkins Courgettes Others (c) Cucurbits — inedible peel Melons Squashes Watermelons Others (d) Sweet corn (iv) BRASSICA VEGETABLES 0,02 (1) (2) 0,2 (1) (2) (a) Flowering brassica Broccoli Cauliflower Others (b) Head brassica Brussels sprouts Head cabbage Others (c) Leafy brassica Chinese cabbage Kale Others (d) Kohlrabi (v) LEAF VEGETABLES AND FRESH HERBS 0,2 (1) (2) (a) Lettuce and similar 1 (2) Cress Lamb's lettuce Lettuce Scarole Others (b) Spinach and similar 0,02 (1) (2) Spinach Beet leaves (chard) Others (c) Watercress 0,02 (1) (2) (d) Witloof 0,02 (1) (2) (e) Herbs 1 (2) Chervil Chives Parsley Celery leaves Others (vi) LEGUME VEGETABLES (fresh) 0,02 (1) (2) 0,2 (1) (2) Beans (with pods) Beans (without pods) Peas (with pods) Peas (without pods) Others (vii) STEM VEGETABLES (fresh) 0,02 (1) (2) 0,2 (1) (2) Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Others (viii) FUNGI 0,02 (1) (2) 0,2 (1) (2) (a) Cultivated mushrooms (b) Wild mushrooms 3. Pulses 0,02 (1) (2) 0,2 (1) (2) Beans Lentils Peas Others 4. Oil seed 0,05 (1) (2) 0,5 (1) (2) Linseed Peanuts Poppy seeds Sesame seeds Sunflower seed Rape seed Soya bean Mustard seed Cotton seed Others 5. Potatoes 0,02 (1) (2) 50 (3) Early potatoes Ware potatoes 6. Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis ) 0,05 (1) (2) 0,5 (1) (2) 7. Hops (dried), including hop pellets and unconcentrated powder 0,05 (1) (2) 0,5 (1) (2)

(1) Indicates lower limit of analytical determination.

(2) Indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level will become definitive with effect from 24 June 2009.

(3) Potato MRL subject to review of outstanding data requirements 18 months from the date of publication.