Commission Directive 2007/11/EC

of 21 February 2007

amending certain Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for acetamiprid, thiacloprid, imazosulfuron, methoxyfenozide, S-metholachlor, milbemectin and tribenuron

(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 existing active substance tribenuron has been included in Annex I to Directive 91/414/EEC by Commission Directive 2005/54/EC5.

(2)

The following new active substances have been included in Annex I to Directive 91/414/EEC: acetamiprid and thiacloprid by Commission Directive 2004/99/EC6, imazosulfuron, methoxyfenozide, and S-metholachlor by Commission Directive 2005/3/EC7, and milbemectin by Commission Directive 2005/58/EC8.

(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)

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 substance concerned has been assessed and evaluated in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation9 and the opinion of the Scientific Committee for Plants10 on the methodology employed. It has been concluded that the 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 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.

(8)

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.

(9)

Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly.

(10)

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 in accordance with Annex I to this Directive.

Article 2

Directive 86/363/EEC is amended in accordance with Annex II to this Directive.

Article 3

Directive 90/642/EEC is amended in accordance with Annex III to this Directive.

Article 4

1

Member States shall adopt and publish, by 1 September 2007 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 2 September 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 20th 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, 21 February 2007.

For the Commission

Markos Kyprianou

Member of the Commission

ANNEX I

In Part A of Annex II to Directive 86/362/EEC, the following lines for acetamiprid, thiacloprid, imazosulfuron, methoxyfenozide, S-metholachlor, milbemectin, thiacloprid and tribenuron are added:

Pesticide residues

Maximum levels in mg/kg

‘Acetamiprid

0,011112

Cereals

Imazosulfuron

0,011112

Cereals

Methoxyfenozide

0,051112

Cereals

Metholachlor including other mixtures of constituent isomers including S-metolachlor (Sum of isomers)

0,051112

Cereals

Milbemectin

0,051112

Cereals

Thiacloprid

0,021112

Cereals

Tribenuron — methyl

0,011112

Cereals

Indicates lower limit of analytical determination.

  1. (p)

    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 21 March 2011.’

ANNEX II

In Part A of Annex II to Directive 86/363/EEC, the following lines for acetamiprid, methoxyfenozide and thiachloprid are added:

Maximum levels in mg/kg

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

‘Acetamiprid and IM-2-1 metabolite

meat 0,051314; liver 0,114; kidney 0,214; fat 0,051314; others 0,051314

0,051314

0,051314

Methoxyfenoxide

0,011314

0,011314

0,011314

Thiacloprid

meat 0,0514; liver 0,314; kidney 0,314; fat 0,0514; others 0,011314

0,0314

0,011314

Indicates lower limit of analytical determination.

  1. (p)

    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 21 March 2011.’

ANNEX III

In Part A of Annex II to Directive 90/642/EEC, the following lines for acetamiprid, thiacloprid, imazosulfuron, methoxyfenozide, S-metholachlor, milbemectin, and tribenuron are added:

Pesticide residue and maximum residue level (mg/kg)

Groups and examples of individual products to which the MRLs apply

Acetamiprid

Imazosulfuron

Methoxyfenozide

Sum of MA4 + 8,9Z-MA4, expressed as milbemectin

Metholachlor including other mixtures of constituent isomers including S-metolachlor (Sum of isomers)

Thiacloprid

Tribenuron — methyl

‘1.

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

0,011516

0,051516

0,011516

(i)

CITRUS FRUIT

116

116

0,051516

0,021516

Grapefruit

Lemons

Limes

Mandarins (including clementines and other hybrids)

Oranges

Pomelos

Others

(ii)

TREE NUTS (shelled or unshelled)

0,011516

0,021516

0,11516

0,021516

Almonds

Brazil nuts

Cashew nuts

Chestnuts

Coconuts

Hazelnuts

Macadamia

Pecans

Pine nuts

Pistachios

Walnuts

Others

(iii)

POME FRUIT

0,116

216

0,051516

0,316

Apples

Pears

Quinces

Others

(iv)

STONE FRUIT

0,051516

Apricots

0,116

0,316

Cherries

0,216

0,316

Peaches (including nectarines and similar hybrids)

0,116

0,316

0,316

Plums

0,02

0,116

Others

0,011516

0,021516

0,021516

(v)

BERRIES AND SMALL FRUIT

0,011516

0,051516

(a)

Table and wine grapes

116

0,021516

Table grapes

Wine grapes

(b)

Strawberries (other than wild)

0,021516

0,516

(c)

Cane fruit (other than wild)

0,021516

116

Blackberries

Dewberries

Loganberries

Raspberries

Others

(d)

Other small fruit and berries (other than wild)

0,021516

116

Bilberries

Cranberries

Currants (red, black and white)

Gooseberries

Others

(e)

Wild berries and wild fruit

0,021516

0,021516

(vi)

MISCELLANEOUS

0,011516

0,051516

0,021516

Avocados

Bananas

Dates

Figs

Kiwi

116

Kumquats

Litchis

Mangoes

olives (table consumption)

olives (oil extraction)

Papaya

Passion fruit

Pineapples

Pomegranate

Others

0,021516

2.

Vegetables, fresh or uncooked, frozen or dry

0,011516

0,051516

0,051516

0,011516

(i)

ROOT AND TUBER VEGETABLES

0,011516

0,021516

0,021516

Beetroot

Carrots

Cassava

Celeriac

Horseradish

Jerusalem artichokes

Parsnips

Parsley root

Radishes

Salsify

Sweet potatoes

Swedes

Turnips

Yam

Others

(ii)

BULB VEGETABLES

0,011516

0,021516

0,021516

Garlic

Onions

Shallots

Spring onions

Others

(iii)

FRUITING VEGETABLES

(a)

Solanacea

Tomatoes

0,116

216

0,516

Peppers

0,316

116

116

Aubergines

0,116

0,516

0,516

Okra

Others

0,011516

0,021516

0,021516

(b)

Cucurbits — edible peel

0,316

0,021516

0,316

Cucumbers

Gherkins

Courgettes

Others

(c)

Cucurbits — inedible peel

0,011516

0,021516

Melons

0,216

Squashes

Watermelons

0,216

Others

0,021516

(d)

Sweet corn

0,011516

0,021516

0,021516

(iv)

BRASSICA VEGETABLES

0,011516

0,021516

0,021516

(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

0,021516

(a)

Lettuce and similar

216

Cress

Lamb's lettuce

5

Lettuce

5

Scarole

Ruccola

Leaves and stems of brassica

Others

0,011516

(b)

Spinach and similar

0,011516

0,021516

Spinach

Beet leaves (chard)

Others

(c)

Water cress

0,011516

0,021516

(d)

Witloof

0,011516

0,021516

(e)

Herbs

0,011516

316

Chervil

Chives

Parsley

Celery leaves

Others

(vi)

LEGUME VEGETABLES (fresh)

0,011516

Beans (with pods)

0,216

116

Beans (without pods)

Peas (with pods)

Peas (without pods)

Others

0,021516

0,021516

(vii)

STEM VEGETABLES (fresh)

0,011516

0,021516

0,021516

Asparagus

Cardoons

Celery

Fennel

Globe artichokes

Leek

Rhubarb

Others

(viii)

FUNGI

0,011516

0,021516

0,021516

(a)

Cultivated mushrooms

(b)

Wild mushrooms

3.

Pulses

0,011516

0,011516

0,021516

0,051516

0,051516

0,021516

0,011516

Beans

Lentils

Peas

Lupines

Others

4.

Oilseed

0,011516

0,11516

0,11516

0,011516

Linseed

Peanuts

Poppy seeds

Sesame seeds

Sunflower seed

Rape seed

0,316

Soya bean

216

Mustard seed

Cotton seed

0,02

216

Hemp seed

Others

0,011516

0,051516

0,051516

5.

Potatoes

0,011516

0,011516

0,021516

0,051516

0,051516

0,021516

0,011516

Early potatoes

Ware potatoes

6.

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

0,11516

0,0215

0,051516

0,11516

0,11516

0,051516

0,0215

7.

Hops (dried), including hop pellets and unconcentrated powder

0,11516

0,0215

0,051516

0,11516

0,11516

0,051516

0,0215

Indicates lower limit of analytical determination.

  1. (p)

    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 21 March 2011.’