EN Official Journal of the European Union L 276/35

COMMISSION DIRECTIVE 2005/70/EC

of 20 October 2005

amending Council Directives 76/895/EEC, 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 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (1), and in particular Article 5 thereof,

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 (2), 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 (3), 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 (4), 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 (5) 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: glyphosate by Commission Directive 2001/99/EC (6), chlorpropham by Commission Directive 2004/20/EC (7) and bromoxynil, and ioxinyl by Commission Directive 2004/58/EC (8).

(2) The following new active substances have been included in Annex I to Directive 91/414/EEC: dimethenamid-P and flurtamone by Commission Directive 2003/84/EC (9) propoxycarbazone and zoxamide by Commission Directive 2003/119/EC (10), flazasulfuron and pyraclostrobin by Commission Directive 2004/30/EC (11), quinoxyfen by Commission Directive 2004/60/EC (12) and mepanipyrim, by Commission Directive 2004/62/EC (13).

(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 their proposed use. Information relating to that 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) Community MRLs and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a number of Codex MRLs for chlorpropham, and glyphosate. There are already Community MRLs in Directive 76/895/EEC for chlorpropham (Council Directive 82/528/EEC (14)) and in Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for glyphosate (Council Directive 1998/82/EC (15)). These have been taken into consideration 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 have 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.

(5) The Commission review reports which were prepared for the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned fixed the Acceptable Daily Intake (ADI) and, if necessary, the Acute Reference Dose (ARfD) for those substances. The exposure of consumers of food products treated with the active substances concerned has been assessed in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation (16) and the opinion of the Scientific Committee for Plants (17) on the methodology employed. It is concluded that MRLs proposed will not lead to those ADIs or ARfD being exceeded.

(6) 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.

(7) 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.

(8) It is therefore necessary to add or replace all of the MRLs arising from the use of these plant protection products to 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 modify them. Where MRLs have not been defined until now, it is appropriate to set them for the first time.

(9) Glyphosate is used as ester or salt. In case of glyphosate trimesium salt, the residue of trimethylsulfonium cation is also of toxicological relevance. It is therefore necessary to set MRLs for that cation.

(10) Provisions of Directive 76/895/EEC which set MRLs for chlorpropham should consequently be deleted.

(11) Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly.

(12) 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

In Annex II to Directive 76/895/EEC, the line for chlorpropham is deleted.

Article 2

Directive 86/362/EEC is amended as follows:

1. In Part A of Annex II, the lines for bromoxynil, chlorpropham, dimethenamid-P, flazasulfuron, flurtamone, ioxinyl, mepanipyrim, propoxycarbazone, pyraclostrobin, quinoxyfen, trimethylsulfonium cation and zoxamide as set out in Annex I to this Directive are added.

2. In Part A of Annex II, the line for glyphosate is replaced by the text in Annex II to this Directive.

Article 3

Directive 86/363/EEC is amended as follows:

1. In Part A of Annex II, the lines for bromoxynil, chlorpropham, ioxinyl, pyraclostrobin, quinoxyfen and trimethylsulfonium cation, as set out in Annex III to this Directive, are added.

2. In Part B of Annex II, the line for glyphosate is replaced by the text in Annex IV to this Directive.

Article 4

Directive 90/642/EEC is amended as follows:

1. In Annex II, the lines for bromoxynil, chlorpropham, dimethenamid-P, flazasulfuron, flurtamone, ioxinyl, mepanipyrim, propoxycarbazone, pyraclostrobin, quinoxyfen, trimethylsulfonium cation and zoxamide, as set out in Annex V to this Directive, are added.

2. In Annex II, the line for glyphosate is replaced by the text in Annex VI to this Directive.

Article 5

1. Member States shall adopt and publish, by 21 April 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 21 April 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 6

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

Article 7

This Directive is addressed to the Member States.

Done at Brussels, 20 October 2005. For the Commission Markos KYPRIANOU Member of the Commission

(1) OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission Directive 2003/118/EC (OJ L 327, 16.12.2003, p. 25).

(2) OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2005/48/EC (OJ L 219, 24.8.2005, p. 29).

(3) OJ L 221, 7.8.1986, p. 43. Directive as last amended by Directive 2005/48/EC.

(4) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive 2005/48/EC.

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

(6) OJ L 304, 21.11.2001, p. 14.

(7) OJ L 70, 9.3.2004, p. 32.

(8) OJ L 120, 24.4.2004, p. 26.

(9) OJ L 247, 30.9.2003, p. 20. Directive as amended by Directive 2004/64/EC (OJ L 125, 28.4.2004, p. 42).

(10) OJ L 325, 12.12.2003, p. 41.

(11) OJ L 77, 13.3.2004, p. 50.

(12) OJ L 120, 24.4.2004, p. 39. Directive as amended by Directive 2004/97/EC (OJ L 301, 28.9.2004, p. 53).

(13) OJ L 125, 28.4.2004, p. 38.

(14) OJ L 234, 9.8.1982, p. 1.

(15) OJ L 290, 29.10.1998, p. 25.

(16) 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).

(17) 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

Pesticide residues Maximum levels in mg/kg (ppm) Bromoxynil including its esters expressed as bromoxynil 0,10 (2) Maize 0,05 (1) (2) Cereals others Chlorpropham (chlorpropham and 3-chloroaniline, expressed as chlorpropham) 0,02 (1) (2) CEREALS Dimethenamid-P including other mixtures of constituent isomers (sum of isomers) 0,01 (1) (2) CEREALS Flazasulfuron 0,02 (1) (2) CEREALS Flutarmone 0,02 (1) (2) CEREALS Ioxynil, including its esters expressed as ioxynil 0,05 (1) (2) CEREALS Mepanipyrim and its metabolite (2-anilino-4-(2-hydroxypropyl)-6-methylpyrimidine) expressed as mepanipyrim 0,01 (1) (2) CEREALS Propoxycarbazone, its salts and 2-hydroxypropoxy-propoxycarbazone, calculated as propoxycarbazone 0,02 (1) (2) CEREALS Pyraclostrobin 0,1 (2) Wheat 0,3 (2) Barley 0,1 (2) Rye 0,3 (2) Oats 0,1 (2) Triticale 0,02 (1) (2) Cereals others Quinoxyfen 0,02 (1) (2) Wheat 0,2 (2) Barley 0,02 (1) (2) Rye 0,2 (2) Oats 0,02 (1) (2) Triticale 0,02 (1) (2) Cereals others Trimethylsulfonium cation, resulting from the use of glyphosate 5 (2) Wheat 10 (2) Barley 5 (2) Rye 10 (2) Oats 5 (2) Triticale 0,05 (1) (2) Cereals others Zoxamide 0,02 (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 10 November 2009.

ANNEX II

Pesticide residues Maximum levels in mg/kg (ppm) Glyphosate 10 (2) Wheat 20 (2) Barley 1 (2) Maize 10 (2) Rye 20 (2) Oats 20 (2) Sorghum 10 (2) Triticale 0,1 (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 10 November 2009.

ANNEX III

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 Bromoxynil including its esters expressed as bromoxynil meat 0,05 (2); offals 0,20 (2) 0,01 (1) (2) Chlorpropham and 4’-hydroxychlorpropham-O-sulphonic acid (4-HSA), expressed as chlorpropham; meat 0,05 (1) (2); liver 0,05 (1) (2); kidney 0,2 (2) 0,2 (2) — Ioxynil, including its esters expressed as ioxynil meat 0,05 (2) ; offals 0,20 (2) 0,01 (1) (2) Pyraclostrobin 0,05 (1) (2) 0,01 (1) (2) 0,05 (1) (2) Quinoxyfen 0,2 (2) 0,05 (2) 0,02 (1) (2) Trimethylsulfonium cation, resulting from the use of glyphosate 0,2 (2) kidney of cattle 0,5 (2) liver of cattle 0,2 (2) meat of cattle 0,1 (2) kidney of poultry 0,05 (1) (2) others 0,1 (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 10 November 2009.

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 Glyphosate 2 (2) kidney of cattle 0,2 (2) liver of cattle 0,5 (2) kidney of pigs 0,1 (2) kidney of poultry 0,05 (1) (2) others 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 10 November 2009.

ANNEX V

(1) Indicates lower limit of analytical determination.

(2) Residue definition in potatoes is chlorpropham only.

(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 10 November 2009.

ANNEX VI

Pesticide residues and MRLs (mg/kg)

Groups and examples of individual products to which the MRLs apply Glyphosate 1. Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts (i) CITRUS FRUIT Grapefruit 0,1 (2) Lemons 0,1 (2) Limes Mandarins (including clementines and other hybrids) 0,1 (2) Oranges 0,5 (2) Pomelos Others 0,1 (1) (2) (ii) TREE NUTS (shelled or unshelled) 0,1 (1) (2) Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (iii) POME FRUIT 0,1 (1) (2) Apples Pears Quinces Others (iv) STONE FRUIT 0,1 (1) (2) Apricots Cherries Peaches (including nectarines and similar hybrids) Plums Others (v) BERRIES AND SMALL FRUIT (a) Table and wine grapes 0,5 (2) Table grapes Wine grapes (b) Strawberries (other than wild) 0,1 (1) (2) (c) Cane fruit (other than wild) 0,1 (1) (2) Blackberries Dewberries Loganberries Raspberries Others (d) Other small fruit and berries (other than wild) 0,1 (1) (2) Bilberries Cranberries Currants (red, black and white) Gooseberries Others (e) Wild berries and wild fruit 0,1 (1) (2) (vi) MISCELLANEOUS Avocados Bananas Dates Figs Kiwi Kumquats Litchis Mangoes Olives olives (table consuption) olives (oil extraction) 1 (2) Passion fruit Pineapples Papaya Others 0,05 (1) (2) 2. Vegetables, fresh or uncooked, frozen or dry (i) ROOT AND TUBER VEGETABLES 0,1 (1) (2) Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnips Parsley root Radishes Salsify Sweet potatoes Swedes Turnips Yam Others (ii) BULB VEGETABLES 0,1 (1) (2) Garlic Onions Shallots Spring onions Others (iii) FRUITING VEGETABLES 0,1 (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 0,1 (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 0,1 (1) (2) (a) Lettuce & similar Cress Lamb's lettuce Lettuce Scarole Others (b) Spinach and similar Spinach Beet leaves (chard) Others (c) Water cress (d) Witloof (e) Herbs Chervil Chives Parsley Celery leaves Others (vi) LEGUME VEGETABLES (fresh) 0,1 (1) (2) Beans (with pods) Beans (without pods) Peas (with pods) Peas (without pods) Others (vii) STEM VEGETABLES (fresh) 0,1 (1) (2) Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Others (viii) FUNGI (a) Cultivated mushrooms 0,1 (1) (2) (b) Wild mushrooms 50 (2) 3. Pulses Beans 2 (2) Lentils Peas 10 (2) Others 0,1 (1) (2) 4. Oil seed Linseed 10 (2) Peanuts Poppy seeds Sesame seeds Sunflower seed 20 (2) Rape seed 10 (2) Soya bean 20 (2) Mustard seed 10 (2) Cotton seed 10 (2) Others 0,1 (1) (2) 5. Potatoes 0,5 (2) Early potatoes Ware potatoes 6. Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis ) 2 (2) 7. Hops (dried), including hop pellets and unconcentrated powder 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 10 November 2009.