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 cereals1, 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 vegetables2, 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 market3, 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/EC4; propyzamide by Commission Directive 2003/39/EC5; and mecoprop and mecoprop-p by Commission Directive 2003/70/EC6.

(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/EC7.

(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/EC9 and 96/33/EC10). 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 Organisation11 and the opinion of the Scientific Committee for Plants12 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:

  1. (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;

  2. (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:

  1. (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.

  2. (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

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)13

0,051415

CEREALS

Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals

Trifloxystrobin

0,315 Barley

0,0515 Rye

0,0515 Triticale, Wheat

0,021415 other Cereals

Carfentrazone-ethyl (determined as carfentrazone and expressed as carfentrazone-ethyl)

0,051415

CEREALS

Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals

Fenamidone

0,021415

CEREALS

Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals

Mecoprop (sum of mecoprop-p and mecoprop expressed as mecoprop)

0,051415

CEREALS

Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals

Maleic hydrazide

0,21415

CEREALS

Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals

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

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 24 June 2009.

ANNEX II

Maximum levels mg/kg

Pesticide residues

Individual products to which the MRLs apply

Propyzamide

0,021617

CEREALS

Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other 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 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)18

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

0,051920

0,011920

0,051920

(i)

CITRUS FRUIT

0,320

0,021920

Grapefruit

Lemons

Limes

Mandarins (including clementines and other hybrids)

Oranges

Pomelos

Others

(ii)

TREE NUTS (shelled or unshelled)

0,021920

0,021920

Almonds

Brazil nuts

Cashew nuts

Chestnuts

Coconuts

Hazelnuts

Macadamia

Pecans

Pine nuts

Pistachios

Walnuts

Others

(iii)

POME FRUIT

0,520

0,021920

Apples

Pears

Quinces

Others

(iv)

STONE FRUIT

0,021920

Apricots

120

Cherries

120

Peaches (including nectarines and similar hybrids)

120

Plums

Others

0,021920

(v)

BERRIES AND SMALL FRUIT

(a)

Table and wine grapes

520

0,520

Table grapes

Wine grapes

(b)

Strawberries (other than wild)

0,021920

0,021920

(c)

Cane fruit (other than wild)

0,021920

0,021920

Blackberries

Dewberries

Loganberries

Raspberries

Others

(d)

Other small fruit and berries (other than wild)

0,021920

Bilberries

Cranberries

Currants (red, black and white)

120

Gooseberries

120

Others

0,021920

(e)

Wild berries and wild fruit

0,021920

0,021920

(vi)

MISCELLANEOUS

0,021920

Avocados

Bananas

0,0520

Dates

Figs

Kiwi

Kumquats

Litchis

Mangoes

Olives

Passion fruit

Pineapples

Papaya

Others

0,021920

2.

Vegetables, fresh or uncooked, frozen or dry

0,051920

0,011920

0,051920

(i)

ROOT AND TUBER VEGETABLES

0,021920

0,021920

Beetroot

Carrots

Celeriac

Horseradish

Jerusalem artichokes

Parsnips

Parsley root

Radishes

Salsify

Sweet potatoes

Swedes

Turnips

Yam

Others

(ii)

BULB VEGETABLES

0,021920

0,021920

Garlic

Onions

Shallots

Spring onions

Others

(iii)

FRUITING VEGETABLES

(a)

Solanacea

Tomatoes

0,520

0,520

Peppers

Aubergines

Others

0,021920

0,021920

(b)

Cucurbits — edible peel

0,220

0,021920

Cucumbers

Gherkins

Courgettes

Others

(c)

Cucurbits — inedible peel

Melons

0,320

0,120

Squashes

Watermelons

Others

0,021920

0,021920

(d)

Sweet corn

0,021920

0,021920

(iv)

BRASSICA VEGETABLES

0,021920

0,021920

(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

0,021920

(a)

Lettuce and similar

220

Cress

Lamb's lettuce

Lettuce

Scarole

Others

(b)

Spinach and similar

0,021920

Spinach

Beet leaves (chard)

Others

(c)

Watercress

0,021920

(d)

Witloof

0,021920

(e)

Herbs

0,021920

Chervil

Chives

Parsley

Celery leaves

Others

(vi)

LEGUME VEGETABLES (fresh)

0,021920

0,021920

Beans (with pods)

Beans (without pods)

Peas (with pods)

Peas (without pods)

Others

(vii)

STEM VEGETABLES (fresh)

0,021920

0,021920

Asparagus

Cardoons

Celery

Fennel

Globe artichokes

Leek

Rhubarb

Others

(viii)

FUNGI

0,021920

0,021920

(a)

Cultivated mushrooms

(b)

Wild mushrooms

3.

Pulses

0,051920

0,021920

0,011920

0,021920

0,051920

Beans

Lentils

Peas

Others

4.

Oil seed

0,11920

0,051920

0,021920

0,051920

0,051920

Linseed

Peanuts

Poppy seeds

Sesame seeds

Sunflower seed

Rape seed

Soya bean

Mustard seed

Cotton seed

Others

5.

Potatoes

0,051920

0,021920

0,011920

0,021920

0,051920

Early potatoes

Ware potatoes

6.

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

0,11920

0,051920

0,021920

0,051920

0,11920

7.

Hops (dried), including hop pellets and unconcentrated powder

0,11920

3020

0,021920

0,051920

0,11920

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

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 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

0,022122

0,22122

(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

0,022122

0,22122

Beetroot

Carrots

Celeriac

Horseradish

Jerusalem artichokes

Parsnips

Parsley root

Radishes

Salsify

Sweet potatoes

Swedes

Turnips

Yam

Others

(ii)

BULB VEGETABLES

0,022122

Garlic

1522

Onions

1522

Shallots

1522

Spring onions

Others

0,22122

(iii)

FRUITING VEGETABLES

0,022122

0,22122

(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

0,022122

0,22122

(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

0,22122

(a)

Lettuce and similar

122

Cress

Lamb's lettuce

Lettuce

Scarole

Others

(b)

Spinach and similar

0,022122

Spinach

Beet leaves (chard)

Others

(c)

Watercress

0,022122

(d)

Witloof

0,022122

(e)

Herbs

122

Chervil

Chives

Parsley

Celery leaves

Others

(vi)

LEGUME VEGETABLES (fresh)

0,022122

0,22122

Beans (with pods)

Beans (without pods)

Peas (with pods)

Peas (without pods)

Others

(vii)

STEM VEGETABLES (fresh)

0,022122

0,22122

Asparagus

Cardoons

Celery

Fennel

Globe artichokes

Leek

Rhubarb

Others

(viii)

FUNGI

0,022122

0,22122

(a)

Cultivated mushrooms

(b)

Wild mushrooms

3.

Pulses

0,022122

0,22122

Beans

Lentils

Peas

Others

4.

Oil seed

0,052122

0,52122

Linseed

Peanuts

Poppy seeds

Sesame seeds

Sunflower seed

Rape seed

Soya bean

Mustard seed

Cotton seed

Others

5.

Potatoes

0,022122

5023

Early potatoes

Ware potatoes

6.

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

0,052122

0,52122

7.

Hops (dried), including hop pellets and unconcentrated powder

0,052122

0,52122

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 24 June 2009.

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