EN Official Journal of the European Union L 219/29

COMMISSION DIRECTIVE 2005/48/EC

of 23 August 2005

amending Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for certain pesticides in and on cereals and certain products of animal and plant origin

(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 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (2), and in particular Article 10 thereof,

Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (3), 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 (4), 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: iprodione by Commission Directive 2003/31/EC (5); propiconazole by Commission Directive 2003/70/EC (6) and molinate by Commission Directive 2003/81/EC (7).

(2) The following new active substances have been included in Annex I to Directive 91/414/EEC: mesotrione by Commission Directive 2003/68/EC (8) and silthiofam, picoxystrobin, flufenacet, iodosulfuron-methyl-sodium and fosthiazate by Commission Directive 2003/84/EC (9).

(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 that Directive. 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 iprodione and propiconazole. There are already Community MRLs set out in 86/362/EEC, 86/363/EEC and 90/642/EEC for: iprodione (Council Directive 93/58/EEC) (10) and propiconazole (Council Directive 94/30/EC) (11). These have been taken into account in 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 (12) and the opinion of the Scientific Committee for Plants (13) on the methodology employed. It has been 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 to that Directive. It is considered that a period of four years is sufficient to permit the development of further uses of the active substance concerned. The provisional MRL should then become definitive.

(9) It is therefore necessary to modify the MRLs set out in the Annexes to Directives 86/362/EEC, 86/363/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 amend them. Where MRLs have not already been defined, it is appropriate to set them for the first time.

(10) Directives 86/362/EEC, 86/363/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:

Article1

Directive 86/362/EEC is amended as follows:

1. In Part A of Annex II, maximum residue levels are added for mesotrione, silthiofam, picoxystrobin, flufenacet, iodosulfuron-methyl-sodium, fosthiazate and molinate, as set out in Annex I to this Directive.

2. In Part A of Annex II, the maximum residue levels for propiconazole and iprodione are replaced by those set out in Annex II to this Directive.

Article 2

Directive 86/363/EEC is amended as follows:

1. In Part A of Annex II, maximum residue levels are added for picoxystrobin, as set out in Annex III to this Directive.

2. In Part B of Annex II, the maximum residue levels for propiconazole are replaced by those set out in Annex IV to this Directive.

Article 3

Directive 90/642/EEC is amended as follows:

1. In Annex II, maximum residue levels are added for mesotrione, silthiofam, picoxystrobin, flufenacet, iodosulfuron-methyl-sodium, fosthiazate and molinate, as set out in Annex V to this Directive.

2. In Annex II, the maximum residue levels for propiconazole and iprodione, are replaced by those set out in Annex VI to this Directive.

Article 4

1. Member States shall adopt and publish, by 24 February 2006 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 24 February 2007.

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 5

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

Article 6

This Directive is addressed to the Member States.

Done at Brussels, 23 August 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 2005/46/EC (OJ L 177, 9.7.2005, p. 35).

(2) OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2005/46/EC.

(3) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2005/46/EC.

(4) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council (OJ L 70, 16.3.2005, p. 1).

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

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

(7) OJ L 224, 6.9.2003, p. 29.

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

(9) OJ L 247, 30.9.2003, p. 20.

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

(11) OJ L 189, 23.7.1994, p. 70.

(12) 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).

(13) 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 in mg/kg (ppm) Pesticide residues Individual products to which the MRLs apply Mesotrione ‘Sum of mesotrione and MNBA (4-methylsulfonyl-2-nitro benzoic acid), expressed as mesotrione’ 0,05 (1) (2) CEREALS Silthiofam 0,05 (1) (2) CEREALS Picoxystrobin 0,2 (2) Barley 0,2 (2) Oats 0,05 (1) (2) Cereals others Flufenacet (Sum of all compounds containing the N fluorophenyl-N-isopropyl moiety expressed as flufenacet equivalent) 0,05 (1) (2) CEREALS Iodosulfuron-methyl sodium (iodosulfuron-methyl including salts, expressed as iodosulfuron-methyl) 0,02 (1) (2) CEREALS Fosthiazate 0,02 (1) (2) CEREALS Molinate 0,05 (1) (2) 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 13 September 2009.

ANNEX II

Maximum levels mg/kg Pesticide residues Individual products to which the MRLs apply Propiconazole 0,2 (2) Barley 0,2 (2) Oats 0,05 (1) (2) Cereals others Iprodione 3 (2) Rice 0,5 (2) Oats, barley and wheat 0,02 (1) (2) Cereals others

(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 13 September 2009.

ANNEX III

Maximum levels in mg/kg (ppm) Pesticide residues of fat contained in meat, preparations of meat, offal and animal fats listed in Annex I under headings Nos ex02 01, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex02 08, 0209 00, 0210, 1601 00 and 1602 (3) (6) for cow's milk and whole cream cow's milk listed in Annex I under heading No 0401: for other foodstuffs in headings Nos 0401, 0402, 0405 00 and 0406 in accordance with (4) (6) of shelled fresh eggs, for bird's eggs and egg yolks listed in Annex I under headings Nos 0407 00 and 0408 (5) (6) Picoxystrobin 0,05 (1) (2) 0,02 (1) (2) 0,05 (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 13 September 2009.

(3) In the case of foodstuffs with a fat content of 10 % or less by weight, the residue is related to the total weight of the boned foodstuff. In such cases, the maximum level is one-tenth of the value related to fat content, but must be no less than 0,01 mg/kg.

(4) In determining the residues in raw cow's milk and whole cream cow's milk, a fat content of 4 % by weight should be taken as a basis. For raw milk and whole cream milk of another animal origin the residues are expressed on the basis of the fat.

For the other foodstuffs listed in Annex I under heading Nos 0401, 0402, 0405 00, and 0406:

— with a fat content of less than 2 % by weight, the maximum level is taken as half that set for raw milk and whole cream milk,

— with a fat content of 2 % or more by weight, the maximum level is expressed in mg/kg of fat. In such cases, the maximum level is 25 times that set for raw milk and whole cream milk.

(5) For eggs and egg products with a fat content higher than 10 %, the maximum level is expressed in mg/kg fat. In this case, the maximum level is 10 times higher than the maximum level for fresh eggs.

(6) Footnotes (1), (2) and (3) do not apply in cases where the lower limit of analytical determination is indicated.

ANNEX IV

Maximum levels in mg/kg (ppm) Pesticide residues of meat, including fat, preparations of meat, offal and animal fats listed in Annex I under headings Nos ex02 01, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex02 08, 0209 00, 0210, 1601 00 and 1602 for milk and milk products listed in Annex I under headings Nos 0401, 0402, 0405 00 and 0406 of shelled fresh eggs, for bird's eggs and egg yolks listed in Annex I under headings Nos 0407 00 and 0408 Propiconazole ruminant liver 0,1 (2) others products of animal origin 0,01 (1) (2) 0,01 (1) (2) 0,01 (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 13 September 2009.

ANNEX V

Groups and examples of individual products to which the MRLs apply Mesotrione (Sum of mesotrione and MNBA (4-methylsulfonyl-2-nitro benzoic acid), expressed as mesotrione) Silthiofam Picoxystrobin Flufenacet (Sum of all compounds containing the N fluorophenyl-N-isopropyl moiety expressed as flufenacet) Iodosulfuron-methyl sodium (iodosulfuron-methyl including salts, expressed as iodosulfuron-methyl) Fosthiazate Molinate 1. Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts 0,05 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,02 (1) (2) 0,05 (1) (2) (i) CITRUS FRUIT 0,02 (1) (2) Grapefruit Lemons Limes Mandarins (including clementines and other hybrids) Oranges Pomelos Others (ii) TREE NUTS (shelled or unshelled) 0,02 (1) (2) Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (iii) POME FRUIT 0,02 (1) (2) Apples Pears Quinces Others (iv) STONE FRUIT 0,02 (1) (2) Apricots Cherries Peaches (including nectarines and similar hybrids) Plums Others (v) BERRIES AND SMALL FRUIT 0,02 (1) (2) (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 0,05 (2) Dates Figs Kiwi Kumquats Litchis Mangoes Olives Passion fruit Pineapples Papaya Others 0,02 (1) (2) 2. Vegetables, fresh or uncooked, frozen or dry 0,05 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,02 (1) (2) 0,02 (1) (2) 0,05 (1) (2) (i) ROOT AND TUBER VEGETABLES Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnips Parsley root Radishes Salsify Sweet potatoes Swedes Turnips Yam Others (ii) BULB VEGETABLES Garlic Onions Shallots Spring onions Others (iii) FRUITING VEGETABLES (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 (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 (a) Lettuce & similar Cress Lamb's lettuce Lettuce Scarole Others (b) Spinach & similar Spinach Beet leaves (chard) Others (c) Water cress (d) Witloof (e) Herbs Chervil Chives Parsley Celery leaves Others (vi) LEGUME VEGETABLES (fresh) Beans (with pods) Beans (without pods) Peas (with pods) Peas (without pods) Others (vii) STEM VEGETABLES (fresh) Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Others (viii) FUNGI (a) Cultivated mushrooms (b) Wild mushrooms 3. Pulses 0,05 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,02 (1) (2) 0,02 (1) (2) 0,05 (1) (2) Beans Lentils Peas Others 4. Oil seed 0,05 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,02 (1) (2) 0,05 (1) (2) 0,05 (1) (2) Linseed Peanuts Poppy seeds Sesame seeds Sunflower seed Rape seed Soya bean Mustard seed Cotton seed Others 5. Potatoes 0,05 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,1 (2) 0,02 (1) (2) 0,02 (1) (2) 0,05 (1) (2) Early potatoes Ware potatoes 6. Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis ) 0,1 (1) (2) 0,1 (1) (2) 0,1 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,1 (1) (2) 7. Hops (dried), including hop pellets and unconcentrated powder 0,1 (1) (2) 0,1 (1) (2) 0,1 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,05 (1) (2) 0,1 (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 13 September 2009.

ANNEX VI

Groups and examples of individual products to which the MRLs apply Propiconazole Iprodione 1. Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts (i) CITRUS FRUIT 0,05 (1) (2) Grapefruit Lemons 5 (2) Limes Mandarins (including clementines and other hybrids) 1 (2) Oranges Pomelos Others 0,02 (1) (2) (ii) TREE NUTS (shelled or unshelled) 0,05 (1) (2) Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts 0,2 (2) Macadamia Pecans Pine nuts Pistachios Walnuts Others 0,02 (1) (2) (iii) POME FRUIT 0,05 (1) (2) 5 (2) Apples Pears Quinces Others (iv) STONE FRUIT 3 (2) Apricots 0,2 (2) Cherries Peaches (including nectarines and similar hybrids) 0,2 (2) Plums Others 0,05 (1) (2) (v) BERRIES AND SMALL FRUIT 0,05 (1) (2) (a) Table and wine grapes 10 (2) Table grapes Wine grapes (b) Strawberries (other than wild) 15 (2) (c) Cane fruit (other than wild) 10 (2) Blackberries Dewberries Loganberries Raspberries Others (d) Other small fruit and berries (other than wild) 10 (2) Bilberries Cranberries Currants (red, black and white) Gooseberries Others (e) Wild berries and wild fruit 0,02 (1) (2) (vi) MISCELLANEOUS Avocados Bananas 0,1 (2) Dates Figs Kiwi 5 (2) Kumquats Litchis Mangoes Olives Passion-fruit Pineapples Papaya Others 0,05 (1) (2) 0,02 (1) (2) 2. Vegetables, fresh or uncooked, frozen or dry (i) ROOT AND TUBER VEGETABLES 0,05 (1) (2) Beetroot Carrots 0,3 (2) Celeriac 0,3 (2) Horseradish 0,1 (2) Jerusalem artichokes Parsnips 0,3 (2) Parsley root Radishes 0,3 (2) Salsify Sweet potatoes Swedes Turnips Yam Others 0,02 (1) (2) (ii) BULB VEGETABLES 0,05 (1) (2) Garlic 0,2 (2) Onions 0,2 (2) Shallots 0,2 (2) Spring onions 3 (2) Others 0,02 (1) (2) (iii) FRUITING VEGETABLES 0,05 (1) (2) (a) Solanacea 5 (2) Tomatoes Peppers Aubergines Others (b) Cucurbits — edible peel 2 (2) Cucumbers Gherkins Courgettes Others (c) Cucurbits — inedible peel 1 (2) Melons Squashes Watermelons Others (d) Sweet corn 0,02 (1) (2) (iv) BRASSICA VEGETABLES 0,05 (1) (2) (a) Flowering brassica 0,1 (2) Broccoli Cauliflower Others (b) Head brassica Brussels sprouts 0,5 (2) Head cabbage 5 (2) Others 0,02 (1) (2) (c) Leafy brassica Chinese cabbage 5 (2) Kale Others 0,02 (1) (2) (d) Kohlrabi 0,02 (1) (2) (v) LEAF VEGETABLES AND FRESH HERBS 0,05 (1) (2) (a) Lettuce & similar 10 (2) Cress Lamb's lettuce Lettuce Scarole Others (b) Spinach and similar 0,02 (1) (2) Spinach Beet leaves (chard) Others (c) Water cress 0,02 (1) (2) (d) Witloof 0,2 (2) (e) Herbs 10 (2) Chervil Chives Parsley Celery leaves Others (vi) LEGUME VEGETABLES (fresh) 0,05 (1) (2) Beans (with pods) 5 (2) Beans (without pods) Peas (with pods) 2 (2) Peas (without pods) 0,3 (2) Others 0,02 (1) (2) (vii) STEM VEGETABLES (fresh) Asparagus Cardoons Celery Fennel Globe artichokes Leek 0,1 (2) Rhubarb 0,2 (2) Others 0,05 (1) (2) 0,02 (1) (2) (viii) FUNGI 0,05 (1) (2) 0,02 (1) (2) (a) Cultivated mushrooms (b) Wild mushrooms 3. Pulses 0,05 (1) (2) 0,2 (2) Beans Lentils Peas Others 4. Oil seed Linseed 0,5 (2) Peanuts 0,2 (2) Poppy seeds Sesame seeds Sunflower seed 0,5 (2) Rape seed 0,5 (2) Soya bean Mustard seed Cotton seed Others 0,1 (1) (2) 0,02 (1) (2) 5. Potatoes 0,05 (1) (2) 0,02 (1) (2) Early potatoes Ware potatoes 6. Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis ) 0,1 (1) (2) 0,1 (1) (2) 7. Hops (dried), including hop pellets and unconcentrated powder 0,1 (1) (2) 0,1 (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 13 September 2009.