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 vegetables1, 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 cereals2, 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 origin3, 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 vegetables4, 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 market5 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/EC6, chlorpropham by Commission Directive 2004/20/EC7 and bromoxynil, and ioxinyl by Commission Directive 2004/58/EC8.

(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/EC9 propoxycarbazone and zoxamide by Commission Directive 2003/119/EC10, flazasulfuron and pyraclostrobin by Commission Directive 2004/30/EC11, quinoxyfen by Commission Directive 2004/60/EC12 and mepanipyrim, by Commission Directive 2004/62/EC13.

(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/EEC14) and in Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for glyphosate (Council Directive 1998/82/EC15). 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 Organisation16 and the opinion of the Scientific Committee for Plants17 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. 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. 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. 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. 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. 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. 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

ANNEX I

Pesticide residues

Maximum levels in mg/kg (ppm)

Bromoxynil including its esters expressed as bromoxynil

0,1019 Maize

0,051819 Cereals others

Chlorpropham (chlorpropham and 3-chloroaniline, expressed as chlorpropham)

0,021819

CEREALS

Dimethenamid-P including other mixtures of constituent isomers (sum of isomers)

0,011819

CEREALS

Flazasulfuron

0,021819

CEREALS

Flutarmone

0,021819

CEREALS

Ioxynil, including its esters expressed as ioxynil

0,051819

CEREALS

Mepanipyrim and its metabolite (2-anilino-4-(2-hydroxypropyl)-6-methylpyrimidine) expressed as mepanipyrim

0,011819

CEREALS

Propoxycarbazone, its salts and 2-hydroxypropoxy-propoxycarbazone, calculated as propoxycarbazone

0,021819

CEREALS

Pyraclostrobin

0,119 Wheat

0,319 Barley

0,119 Rye

0,319 Oats

0,119 Triticale

0,021819 Cereals others

Quinoxyfen

0,021819 Wheat

0,219 Barley

0,021819 Rye

0,219 Oats

0,021819 Triticale

0,021819 Cereals others

Trimethylsulfonium cation, resulting from the use of glyphosate

519 Wheat

1019 Barley

519 Rye

1019 Oats

519 Triticale

0,051819 Cereals others

Zoxamide

0,021819

CEREALS

Indicates lower limit of analytical determination.

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

1021 Wheat

2021 Barley

121 Maize

1021 Rye

2021 Oats

2021 Sorghum

1021 Triticale

0,12021 Cereals others

Indicates lower limit of analytical determination.

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 ex 0201, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex 0208, 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 0,0523; offals 0,2023

0,012223

Chlorpropham and 4’-hydroxychlorpropham-O-sulphonic acid (4-HSA), expressed as chlorpropham;

meat 0,052223; liver 0,052223; kidney 0,223

0,223

Ioxynil, including its esters expressed as ioxynil

meat 0,0523 ; offals 0,2023

0,012223

Pyraclostrobin

0,052223

0,012223

0,052223

Quinoxyfen

0,223

0,0523

0,022223

Trimethylsulfonium cation, resulting from the use of glyphosate

0,223 kidney of cattle

0,523 liver of cattle

0,223 meat of cattle

0,123 kidney of poultry

0,052223 others

0,123

0,012223

Indicates lower limit of analytical determination.

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 ex 0201, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex 0208, 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

225 kidney of cattle

0,225 liver of cattle

0,525 kidney of pigs

0,125 kidney of poultry

0,052425 others

0,012425

0,012425

Indicates lower limit of analytical determination.

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

Groups and examples of individual products to which the MRLs apply

Bromoxynil including its esters expressed as bromoxynil

Chlorpropham (chlorpropham and 3-chloroaniline, expressed as chlorpropham)27

Dimethenamid-P including other mixtures of constituent isomers (sum of isomers)

Flazasulfuron

Flurtamone

Ioxynil, including its esters expressed as ioxynil

Mepanipyrim and its metabolite (2-anilino-4-(2-hydroxypropyl)-6-methylpyrimidine expressed as mepanipyrim

Propoxycarbazone, its salts and 2-hydroxypropoxy-propoxycarbazone, calculated as propoxycarbazone

Pyraclostrobin

Quinoxyfen

Trimethylsulfonium cation resulting from the use of glyphosate

Zoxamide

1.

Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts

0,052628

0,052628

0,012628

0,022628

0,052628

0,022628

(i)

CITRUS FRUIT

0,0228

0,012628

128

0,022628

0,022628

Grapefruit

Lemons

Limes

Mandarins (including clementines and other hybrids)

0,052628

Oranges

0,528

Pomelos

Others

0,052628

(ii)

TREE NUTS (shelled or unshelled)

0,012628

0,012628

0,022628

0,052628

0,022628

Almonds

Brazil nuts

Cashew nuts

Chestnuts

Coconuts

Hazelnuts

Macadamia

Pecans

Pine nuts

Pistachios

128

Walnuts

Others

0,022628

(iii)

POME FRUIT

0,012628

0,012628

0,022628

0,022628

0,052628

0,022628

Apples

Pears

Quinces

Others

(iv)

STONE FRUIT

0,012628

0,012628

0,052628

0,022628

Apricots

Cherries

0,228

0,328

Peaches (including nectarines and similar hybrids)

Plums

Others

0,022628

0,022628

(v)

BERRIES AND SMALL FRUIT

0,052628

(a)

Table and wine grapes

0,0228

328

128

528

Table grapes

0,022628

Wine grapes

228

(b)

Strawberries (other than wild)

0,012628

228

0,528

0,328

0,022628

(c)

Cane fruit (other than wild)

0,012628

0,012628

0,022628

0,022628

0,022628

Blackberries

Dewberries

Loganberries

Raspberries

Others

(d)

Other small fruit and berries (other than wild)

0,012628

0,012628

0,022628

128

0,022628

Bilberries

Cranberries

Currants (red, black and white)

Gooseberries

Others

(e)

Wild berries and wild fruit

0,012628

0,012628

0,022628

0,022628

0,022628

(vi)

MISCELLANEOUS

0,012628

0,022628

0,022628

Avocados

Bananas

Dates

Figs

Kiwi

Kumquats

Litchis

Mangoes

0,0528

Olives

0,0228

Olives (table consumption)

Olives (oil extraction)

128

Passion fruit

Pineapples

Papaya

0,0528

Others

0,012628

0,022628

0,052628

2.

Vegetables, fresh or uncooked, frozen or dry

0,052628

0,052628

0,012628

0,012628

0,022628

0,022628

(i)

ROOT AND TUBER VEGETABLES

0,012628

0,022628

0,022628

0,052628

0,022628

Beetroot

Carrots

0,228

Celeriac

Horseradish

Jerusalem artichokes

Parsnips

0,228

Parsley root

Radishes

Salsify

Sweet potatoes

Swedes

Turnips

Yam

Others

0,052628

(ii)

BULB VEGETABLES

0,012628

0,022628

0,052628

0,022628

Garlic

0,228

Onions

0,228

0,228

Shallots

0,228

Spring onions

Others

0,052628

0,022628

(iii)

FRUITING VEGETABLES

0,052628

0,022628

0,052628

(a)

Solanacea

0,022628

Tomatoes

128

0,528

Peppers

Aubergines

Others

0,012628

0,022628

(b)

Cucurbits — edible peel

0,012628

0,022628

0,022628

Cucumbers

Gherkins

Courgettes

Others

(c)

Cucurbits — inedible peel

0,012628

0,0528

0,022628

Melons

Squashes

Watermelons

Others

(d)

Sweet corn

0,012628

0,022628

0,022628

(iv)

BRASSICA VEGETABLES

0,052628

0,012628

0,022628

0,022628

0,052628

0,022628

(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

0,052628

0,012628

0,022628

0,052628

0,022628

(a)

Lettuce & similar

228

Cress

Lamb's lettuce

Lettuce

Scarole

Others

(b)

Spinach & similar

0,022628

Spinach

Beet leaves (chard)

Others

(c)

Water cress

0,022628

(d)

Witloof

0,022628

(e)

Herbs

0,022628

Chervil

Chives

Parsley

Celery leaves

Others

(vi)

LEGUME VEGETABLES (fresh)

0,052628

0,012628

0,022628

0,022628

0,052628

0,022628

Beans (with pods)

Beans (without pods)

Peas (with pods)

Peas (without pods)

Others

(vii)

STEM VEGETABLES (fresh)

0,052628

0,012628

0,022628

0,022628

0,052628

0,022628

Asparagus

Cardoons

Celery

Fennel

Globe artichokes

Leek

Rhubarb

Others

(viii)

FUNGI

0,052628

0,012628

0,022628

0,022628

0,022628

(a)

Cultivated mushrooms

0,052628

(b)

Wild mushrooms

2028

3.

Pulses

0,052628

0,052628

0,012628

0,012628

0,022628

0,052628

0,012628

0,022628

0,328

0,022628

0,052628

0,022628

Beans

Lentils

Peas

Others

4.

Oil seed

0,12628

0,12628

0,022628

0,022628

0,052628

0,12628

0,022628

0,022628

0,022628

0,052628

0,052628

Linseed

Peanuts

Poppy seeds

Sesame seeds

Sunflower seed

Rape seed

Soya bean

1028

Mustard seed

Cotton seed

Others

0,052628

5.

Potatoes

0,052628

102728

0,012628

0,012628

0,022628

0,052628

0,012628

0,022628

0,022628

0,022628

0,052628

0,022628

Early potatoes

Ware potatoes

6.

Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)

0,12628

0,12628

0,022628

0,022628

0,052628

0,12628

0,022628

0,052628

0,052628

0,052628

0,052628

0,052628

7.

Hops (dried), including hop pellets and unconcentrated powder

0,12628

0,12628

0,022628

0,022628

0,052628

0,12628

0,022628

0,052628

0,052628

0,52628

0,052628

0,052628

Indicates lower limit of analytical determination.

Residue definition in potatoes is chlorpropham only.

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

0,130

Lemons

0,130

Limes

Mandarins (including clementines and other hybrids)

0,130

Oranges

0,530

Pomelos

Others

0,12930

(ii)

TREE NUTS (shelled or unshelled)

0,12930

Almonds

Brazil nuts

Cashew nuts

Chestnuts

Coconuts

Hazelnuts

Macadamia

Pecans

Pine nuts

Pistachios

Walnuts

Others

(iii)

POME FRUIT

0,12930

Apples

Pears

Quinces

Others

(iv)

STONE FRUIT

0,12930

Apricots

Cherries

Peaches (including nectarines and similar hybrids)

Plums

Others

(v)

BERRIES AND SMALL FRUIT

(a)

Table and wine grapes

0,530

Table grapes

Wine grapes

(b)

Strawberries (other than wild)

0,12930

(c)

Cane fruit (other than wild)

0,12930

Blackberries

Dewberries

Loganberries

Raspberries

Others

(d)

Other small fruit and berries (other than wild)

0,12930

Bilberries

Cranberries

Currants (red, black and white)

Gooseberries

Others

(e)

Wild berries and wild fruit

0,12930

(vi)

MISCELLANEOUS

Avocados

Bananas

Dates

Figs

Kiwi

Kumquats

Litchis

Mangoes

Olives

olives (table consuption)

olives (oil extraction)

130

Passion fruit

Pineapples

Papaya

Others

0,052930

2. Vegetables, fresh or uncooked, frozen or dry

(i)

ROOT AND TUBER VEGETABLES

0,12930

Beetroot

Carrots

Celeriac

Horseradish

Jerusalem artichokes

Parsnips

Parsley root

Radishes

Salsify

Sweet potatoes

Swedes

Turnips

Yam

Others

(ii)

BULB VEGETABLES

0,12930

Garlic

Onions

Shallots

Spring onions

Others

(iii)

FRUITING VEGETABLES

0,12930

(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

0,12930

(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

0,12930

(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)

0,12930

Beans (with pods)

Beans (without pods)

Peas (with pods)

Peas (without pods)

Others

(vii)

STEM VEGETABLES (fresh)

0,12930

Asparagus

Cardoons

Celery

Fennel

Globe artichokes

Leek

Rhubarb

Others

(viii)

FUNGI

(a)

Cultivated mushrooms

0,12930

(b)

Wild mushrooms

5030

3. Pulses

Beans

230

Lentils

Peas

1030

Others

0,12930

4. Oil seed

Linseed

1030

Peanuts

Poppy seeds

Sesame seeds

Sunflower seed

2030

Rape seed

1030

Soya bean

2030

Mustard seed

1030

Cotton seed

1030

Others

0,12930

5.

Potatoes

0,530

Early potatoes

Ware potatoes

6.

Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)

230

7.

Hops (dried), including hop pellets and unconcentrated powder

0,12930

Indicates lower limit of analytical determination.

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.