Commission Directive 2007/11/ECShow full title

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 cereals(1), 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(2), 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(3), 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(4), 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/EC(5).

(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/EC(6), imazosulfuron, methoxyfenozide, and S-metholachlor by Commission Directive 2005/3/EC(7), and milbemectin by Commission Directive 2005/58/EC(8).

(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 Organisation(9) and the opinion of the Scientific Committee for Plants(10) 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:

a Indicates lower limit of analytical determination.
b (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.’
Pesticide residues	Maximum levels in mg/kg
‘Acetamiprid	0,01a b Cereals
Imazosulfuron	0,01a b Cereals
Methoxyfenozide	0,05a b Cereals
Metholachlor including other mixtures of constituent isomers including S-metolachlor (Sum of isomers)	0,05a b Cereals
Milbemectin	0,05a b Cereals
Thiacloprid	0,02a b Cereals
Tribenuron — methyl	0,01a b Cereals

ANNEX II

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

a Indicates lower limit of analytical determination.
b (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.’
	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 0,05a b; liver 0,1b; kidney 0,2b; fat 0,05a b; others 0,05a b	0,05a b	0,05a b
Methoxyfenoxide	0,01a b	0,01a b	0,01a b
Thiacloprid	meat 0,05b; liver 0,3b; kidney 0,3b; fat 0,05b; others 0,01a b	0,03b	0,01a b

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:

a Indicates lower limit of analytical determination.
b (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.’
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		0,01a b			0,05a b		0,01a b
(i) CITRUS FRUIT	1b		1b	0,05a b		0,02a b
Grapefruit
Lemons
Limes
Mandarins (including clementines and other hybrids)
Oranges
Pomelos
Others
(ii) TREE NUTS (shelled or unshelled)	0,01a b		0,02a b	0,1a b		0,02a b
Almonds
Brazil nuts
Cashew nuts
Chestnuts
Coconuts
Hazelnuts
Macadamia
Pecans
Pine nuts
Pistachios
Walnuts
Others
(iii) POME FRUIT	0,1b		2b	0,05a b		0,3b
Apples
Pears
Quinces
Others
(iv) STONE FRUIT				0,05a b
Apricots	0,1b					0,3b
Cherries	0,2b					0,3b
Peaches (including nectarines and similar hybrids)	0,1b		0,3b			0,3b
Plums	0,02					0,1b
Others	0,01a b		0,02a b			0,02a b
(v) BERRIES AND SMALL FRUIT	0,01a b			0,05a b
(a) Table and wine grapes			1b			0,02a b
Table grapes
Wine grapes
(b) Strawberries (other than wild)			0,02a b			0,5b
(c) Cane fruit (other than wild)			0,02a b			1b
Blackberries
Dewberries
Loganberries
Raspberries
Others
(d) Other small fruit and berries (other than wild)			0,02a b			1b
Bilberries
Cranberries
Currants (red, black and white)
Gooseberries
Others
(e) Wild berries and wild fruit			0,02a b			0,02a b
(vi) MISCELLANEOUS	0,01a b			0,05a b		0,02a b
Avocados
Bananas
Dates
Figs
Kiwi			1b
Kumquats
Litchis
Mangoes
olives (table consumption)
olives (oil extraction)
Papaya
Passion fruit
Pineapples
Pomegranate
Others			0,02a b
2. Vegetables, fresh or uncooked, frozen or dry		0,01a b		0,05a b	0,05a b		0,01a b
(i) ROOT AND TUBER VEGETABLES	0,01a b		0,02a b			0,02a b
Beetroot
Carrots
Cassava
Celeriac
Horseradish
Jerusalem artichokes
Parsnips
Parsley root
Radishes
Salsify
Sweet potatoes
Swedes
Turnips
Yam
Others
(ii) BULB VEGETABLES	0,01a b		0,02a b			0,02a b
Garlic
Onions
Shallots
Spring onions
Others
(iii) FRUITING VEGETABLES
(a) Solanacea
Tomatoes	0,1b		2b			0,5b
Peppers	0,3b		1b			1b
Aubergines	0,1b		0,5b			0,5b
Okra
Others	0,01a b		0,02a b			0,02a b
(b) Cucurbits — edible peel	0,3b		0,02a b			0,3b
Cucumbers
Gherkins
Courgettes
Others
(c) Cucurbits — inedible peel	0,01a b		0,02a b
Melons						0,2b
Squashes
Watermelons						0,2b
Others						0,02a b
(d) Sweet corn	0,01a b		0,02a b			0,02a b
(iv) BRASSICA VEGETABLES	0,01a b		0,02a b			0,02a b
(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			0,02a b
(a) Lettuce and similar						2b
Cress
Lamb's lettuce	5
Lettuce	5
Scarole
Ruccola
Leaves and stems of brassica
Others	0,01a b
(b) Spinach and similar	0,01a b					0,02a b
Spinach
Beet leaves (chard)
Others
(c) Water cress	0,01a b					0,02a b
(d) Witloof	0,01a b					0,02a b
(e) Herbs	0,01a b					3b
Chervil
Chives
Parsley
Celery leaves
Others
(vi) LEGUME VEGETABLES (fresh)	0,01a b
Beans (with pods)			0,2b			1b
Beans (without pods)
Peas (with pods)
Peas (without pods)
Others			0,02a b			0,02a b
(vii) STEM VEGETABLES (fresh)	0,01a b		0,02a b			0,02a b
Asparagus
Cardoons
Celery
Fennel
Globe artichokes
Leek
Rhubarb
Others
(viii) FUNGI	0,01a b		0,02a b			0,02a b
(a) Cultivated mushrooms
(b) Wild mushrooms
3. Pulses	0,01a b	0,01a b	0,02a b	0,05a b	0,05a b	0,02a b	0,01a b
Beans
Lentils
Peas
Lupines
Others
4. Oilseed		0,01a b		0,1a b	0,1a b		0,01a b
Linseed
Peanuts
Poppy seeds
Sesame seeds
Sunflower seed
Rape seed						0,3b
Soya bean			2b
Mustard seed
Cotton seed	0,02		2b
Hemp seed
Others	0,01a b		0,05a b			0,05a b
5. Potatoes	0,01a b	0,01a b	0,02a b	0,05a b	0,05a b	0,02a b	0,01a b
Early potatoes
Ware potatoes
6. Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)	0,1a b	0,02a	0,05a b	0,1a b	0,1a b	0,05a b	0,02a
7. Hops (dried), including hop pellets and unconcentrated powder	0,1a b	0,02a	0,05a b	0,1a b	0,1a b	0,05a b	0,02a

(1)

OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2006/92/EC (OJ L 311, 10.11.2006, p. 31).

(2)

OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2006/62/EC (OJ L 206, 27.7.2006, p. 27).

(3)

OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2006/92/EC.

(4)

OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/136/EC (OJ L 349, 12.12.2006, p. 42).

(5)

JO L 244, 20.9.2005, p. 21.

(6)

OJ L 309, 6.10.2004, p. 6.

(7)

OJ L 20, 22.1.2005, p. 19.

(8)

OJ L 246, 22.9.2005, p. 17.

(9)

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).

(10)

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).