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 cereals1, 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 origin2, 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 vegetables3, 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 market4, 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/EC5; propiconazole by Commission Directive 2003/70/EC6 and molinate by Commission Directive 2003/81/EC7.

(2)

The following new active substances have been included in Annex I to Directive 91/414/EEC: mesotrione by Commission Directive 2003/68/EC8 and silthiofam, picoxystrobin, flufenacet, iodosulfuron-methyl-sodium and fosthiazate by Commission Directive 2003/84/EC9.

(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 Organisation12 and the opinion of the Scientific Committee for Plants13 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. 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. 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. 1.

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

  2. 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. 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. 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

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’

0,051415

CEREALS

Silthiofam

0,051415

CEREALS

Picoxystrobin

0,215 Barley

0,215 Oats

0,051415 Cereals others

Flufenacet (Sum of all compounds containing the N fluorophenyl-N-isopropyl moiety expressed as flufenacet equivalent)

0,051415

CEREALS

Iodosulfuron-methyl sodium (iodosulfuron-methyl including salts, expressed as iodosulfuron-methyl)

0,021415

CEREALS

Fosthiazate

0,021415

CEREALS

Molinate

0,051415

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 13 September 2009.

ANNEX II

Maximum levels mg/kg

Pesticide residues

Individual products to which the MRLs apply

Propiconazole

0,217 Barley

0,217 Oats

0,051617 Cereals others

Iprodione

317 Rice

0,517 Oats, barley and wheat

0,021617 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 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 ex 0201, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex 0208, 0209 00, 0210, 1601 00 and 16022023

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 with2123

of shelled fresh eggs, for bird's eggs and egg yolks listed in Annex I under headings Nos 0407 00 and 04082223

Picoxystrobin

0,051819

0,021819

0,051819

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 13 September 2009.

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.

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.

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.

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 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

Propiconazole

ruminant liver 0,125

others products of animal origin 0,012425

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 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

0,052627

0,052627

0,052627

0,052627

0,022627

0,052627

(i)

CITRUS FRUIT

0,022627

Grapefruit

Lemons

Limes

Mandarins (including clementines and other hybrids)

Oranges

Pomelos

Others

(ii)

TREE NUTS (shelled or unshelled)

0,022627

Almonds

Brazil nuts

Cashew nuts

Chestnuts

Coconuts

Hazelnuts

Macadamia

Pecans

Pine nuts

Pistachios

Walnuts

Others

(iii)

POME FRUIT

0,022627

Apples

Pears

Quinces

Others

(iv)

STONE FRUIT

0,022627

Apricots

Cherries

Peaches (including nectarines and similar hybrids)

Plums

Others

(v)

BERRIES AND SMALL FRUIT

0,022627

(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

0,0527

Dates

Figs

Kiwi

Kumquats

Litchis

Mangoes

Olives

Passion fruit

Pineapples

Papaya

Others

0,022627

2.

Vegetables, fresh or uncooked, frozen or dry

0,052627

0,052627

0,052627

0,052627

0,022627

0,022627

0,052627

(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

0,052627

0,052627

0,052627

0,052627

0,022627

0,022627

0,052627

Beans

Lentils

Peas

Others

4.

Oil seed

0,052627

0,052627

0,052627

0,052627

0,022627

0,052627

0,052627

Linseed

Peanuts

Poppy seeds

Sesame seeds

Sunflower seed

Rape seed

Soya bean

Mustard seed

Cotton seed

Others

5.

Potatoes

0,052627

0,052627

0,052627

0,127

0,022627

0,022627

0,052627

Early potatoes

Ware potatoes

6.

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

0,12627

0,12627

0,12627

0,052627

0,052627

0,052627

0,12627

7.

Hops (dried), including hop pellets and unconcentrated powder

0,12627

0,12627

0,12627

0,052627

0,052627

0,052627

0,12627

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 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

0,052829

Grapefruit

Lemons

529

Limes

Mandarins (including clementines and other hybrids)

129

Oranges

Pomelos

Others

0,022829

(ii)

TREE NUTS (shelled or unshelled)

0,052829

Almonds

Brazil nuts

Cashew nuts

Chestnuts

Coconuts

Hazelnuts

0,229

Macadamia

Pecans

Pine nuts

Pistachios

Walnuts

Others

0,022829

(iii)

POME FRUIT

0,052829

529

Apples

Pears

Quinces

Others

(iv)

STONE FRUIT

329

Apricots

0,229

Cherries

Peaches (including nectarines and similar hybrids)

0,229

Plums

Others

0,052829

(v)

BERRIES AND SMALL FRUIT

0,052829

(a)

Table and wine grapes

1029

Table grapes

Wine grapes

(b)

Strawberries (other than wild)

1529

(c)

Cane fruit (other than wild)

1029

Blackberries

Dewberries

Loganberries

Raspberries

Others

(d)

Other small fruit and berries (other than wild)

1029

Bilberries

Cranberries

Currants (red, black and white)

Gooseberries

Others

(e)

Wild berries and wild fruit

0,022829

(vi)

MISCELLANEOUS

Avocados

Bananas

0,129

Dates

Figs

Kiwi

529

Kumquats

Litchis

Mangoes

Olives

Passion-fruit

Pineapples

Papaya

Others

0,052829

0,022829

2. Vegetables, fresh or uncooked, frozen or dry

(i)

ROOT AND TUBER VEGETABLES

0,052829

Beetroot

Carrots

0,329

Celeriac

0,329

Horseradish

0,129

Jerusalem artichokes

Parsnips

0,329

Parsley root

Radishes

0,329

Salsify

Sweet potatoes

Swedes

Turnips

Yam

Others

0,022829

(ii)

BULB VEGETABLES

0,052829

Garlic

0,229

Onions

0,229

Shallots

0,229

Spring onions

329

Others

0,022829

(iii)

FRUITING VEGETABLES

0,052829

(a)

Solanacea

529

Tomatoes

Peppers

Aubergines

Others

(b)

Cucurbits — edible peel

229

Cucumbers

Gherkins

Courgettes

Others

(c)

Cucurbits — inedible peel

129

Melons

Squashes

Watermelons

Others

(d)

Sweet corn

0,022829

(iv)

BRASSICA VEGETABLES

0,052829

(a)

Flowering brassica

0,129

Broccoli

Cauliflower

Others

(b)

Head brassica

Brussels sprouts

0,529

Head cabbage

529

Others

0,022829

(c)

Leafy brassica

Chinese cabbage

529

Kale

Others

0,022829

(d)

Kohlrabi

0,022829

(v)

LEAF VEGETABLES AND FRESH HERBS

0,052829

(a)

Lettuce & similar

1029

Cress

Lamb's lettuce

Lettuce

Scarole

Others

(b)

Spinach and similar

0,022829

Spinach

Beet leaves (chard)

Others

(c)

Water cress

0,022829

(d)

Witloof

0,229

(e)

Herbs

1029

Chervil

Chives

Parsley

Celery leaves

Others

(vi)

LEGUME VEGETABLES (fresh)

0,052829

Beans (with pods)

529

Beans (without pods)

Peas (with pods)

229

Peas (without pods)

0,329

Others

0,022829

(vii)

STEM VEGETABLES (fresh)

Asparagus

Cardoons

Celery

Fennel

Globe artichokes

Leek

0,129

Rhubarb

0,229

Others

0,052829

0,022829

(viii)

FUNGI

0,052829

0,022829

(a)

Cultivated mushrooms

(b)

Wild mushrooms

3.

Pulses

0,052829

0,229

Beans

Lentils

Peas

Others

4. Oil seed

Linseed

0,529

Peanuts

0,229

Poppy seeds

Sesame seeds

Sunflower seed

0,529

Rape seed

0,529

Soya bean

Mustard seed

Cotton seed

Others

0,12829

0,022829

5.

Potatoes

0,052829

0,022829

Early potatoes

Ware potatoes

6.

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

0,12829

0,12829

7.

Hops (dried), including hop pellets and unconcentrated powder

0,12829

0,12829

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 13 September 2009.