Commission Directive 2005/37/ECShow full title

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 cereals(1), 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 vegetables(2), 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(3), 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/EC(4); propyzamide by Commission Directive 2003/39/EC(5); and mecoprop and mecoprop-p by Commission Directive 2003/70/EC(6).

(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/EC(7).

(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/EC(9) and 96/33/EC(10)). 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 Organisation(11) and the opinion of the Scientific Committee for Plants(12) 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:

(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;

(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:

(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.

(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

a RPA 202248 is 2-cyano-3-cyclopropyl-1-(2-methylsulfonyl-4-trifluoromethylphenyl) propane-1,3-dione. RPA 203328 is 2-methanesulfonyl-4-trifluoromethylbenzoic acid.
b Indicates lower limit of analytical determination.
c 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.
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)a	0,05b c CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals
Trifloxystrobin	0,3c Barley 0,05c Rye 0,05c Triticale, Wheat 0,02b c other Cereals
Carfentrazone-ethyl (determined as carfentrazone and expressed as carfentrazone-ethyl)	0,05b c CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals
Fenamidone	0,02b c CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals
Mecoprop (sum of mecoprop-p and mecoprop expressed as mecoprop)	0,05b c CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals
Maleic hydrazide	0,2b c CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals

ANNEX II

a Indicates lower limit of analytical determination.
b 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.
Maximum levels mg/kg
Pesticide residues	Individual products to which the MRLs apply
Propyzamide	0,02a b CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals

ANNEX III

a RPA 202248 is 2-cyano-3-cyclopropyl-1-(2-methylsulfonyl-4-trifluoromethylphenyl) propane-1,3-dione. RPA 203328 is 2-methanesulfonyl-4-trifluoromethylbenzoic acid.
b Indicates lower limit of analytical determination.
c 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.
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)a	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	0,05b c		0,01b c		0,05b c
(i) CITRUS FRUIT		0,3c		0,02b c
Grapefruit
Lemons
Limes
Mandarins (including clementines and other hybrids)
Oranges
Pomelos
Others
(ii) TREE NUTS (shelled or unshelled)		0,02b c		0,02b c
Almonds
Brazil nuts
Cashew nuts
Chestnuts
Coconuts
Hazelnuts
Macadamia
Pecans
Pine nuts
Pistachios
Walnuts
Others
(iii) POME FRUIT		0,5c		0,02b c
Apples
Pears
Quinces
Others
(iv) STONE FRUIT				0,02b c
Apricots		1c
Cherries		1c
Peaches (including nectarines and similar hybrids)		1c
Plums
Others		0,02b c
(v) BERRIES AND SMALL FRUIT
(a) Table and wine grapes		5c		0,5c
Table grapes
Wine grapes
(b) Strawberries (other than wild)		0,02b c		0,02b c
(c) Cane fruit (other than wild)		0,02b c		0,02b c
Blackberries
Dewberries
Loganberries
Raspberries
Others
(d) Other small fruit and berries (other than wild)				0,02b c
Bilberries
Cranberries
Currants (red, black and white)		1c
Gooseberries		1c
Others		0,02b c
(e) Wild berries and wild fruit		0,02b c		0,02b c
(vi) MISCELLANEOUS				0,02b c
Avocados
Bananas		0,05c
Dates
Figs
Kiwi
Kumquats
Litchis
Mangoes
Olives
Passion fruit
Pineapples
Papaya
Others		0,02b c
2. Vegetables, fresh or uncooked, frozen or dry	0,05b c		0,01b c		0,05b c
(i) ROOT AND TUBER VEGETABLES		0,02b c		0,02b c
Beetroot
Carrots
Celeriac
Horseradish
Jerusalem artichokes
Parsnips
Parsley root
Radishes
Salsify
Sweet potatoes
Swedes
Turnips
Yam
Others
(ii) BULB VEGETABLES		0,02b c		0,02b c
Garlic
Onions
Shallots
Spring onions
Others
(iii) FRUITING VEGETABLES
(a) Solanacea
Tomatoes		0,5c		0,5c
Peppers
Aubergines
Others		0,02b c		0,02b c
(b) Cucurbits — edible peel		0,2c		0,02b c
Cucumbers
Gherkins
Courgettes
Others
(c) Cucurbits — inedible peel
Melons		0,3c		0,1c
Squashes
Watermelons
Others		0,02b c		0,02b c
(d) Sweet corn		0,02b c		0,02b c
(iv) BRASSICA VEGETABLES		0,02b c		0,02b c
(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		0,02b c
(a) Lettuce and similar				2c
Cress
Lamb's lettuce
Lettuce
Scarole
Others
(b) Spinach and similar				0,02b c
Spinach
Beet leaves (chard)
Others
(c) Watercress				0,02b c
(d) Witloof				0,02b c
(e) Herbs				0,02b c
Chervil
Chives
Parsley
Celery leaves
Others
(vi) LEGUME VEGETABLES (fresh)		0,02b c		0,02b c
Beans (with pods)
Beans (without pods)
Peas (with pods)
Peas (without pods)
Others
(vii) STEM VEGETABLES (fresh)		0,02b c		0,02b c
Asparagus
Cardoons
Celery
Fennel
Globe artichokes
Leek
Rhubarb
Others
(viii) FUNGI		0,02b c		0,02b c
(a) Cultivated mushrooms
(b) Wild mushrooms
3. Pulses	0,05b c	0,02b c	0,01b c	0,02b c	0,05b c
Beans
Lentils
Peas
Others
4. Oil seed	0,1b c	0,05b c	0,02b c	0,05b c	0,05b c
Linseed
Peanuts
Poppy seeds
Sesame seeds
Sunflower seed
Rape seed
Soya bean
Mustard seed
Cotton seed
Others
5. Potatoes	0,05b c	0,02b c	0,01b c	0,02b c	0,05b c
Early potatoes
Ware potatoes
6. Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)	0,1b c	0,05b c	0,02b c	0,05b c	0,1b c
7. Hops (dried), including hop pellets and unconcentrated powder	0,1b c	30c	0,02b c	0,05b c	0,1b c

ANNEX IV

a Indicates lower limit of analytical determination.
b 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.
c Potato MRL subject to review of outstanding data requirements 18 months from the date of publication.
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	0,02a b	0,2a b
(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	0,02a b	0,2a b
Beetroot
Carrots
Celeriac
Horseradish
Jerusalem artichokes
Parsnips
Parsley root
Radishes
Salsify
Sweet potatoes
Swedes
Turnips
Yam
Others
(ii) BULB VEGETABLES	0,02a b
Garlic		15b
Onions		15b
Shallots		15b
Spring onions
Others		0,2a b
(iii) FRUITING VEGETABLES	0,02a b	0,2a b
(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	0,02a b	0,2a 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		0,2a b
(a) Lettuce and similar	1b
Cress
Lamb's lettuce
Lettuce
Scarole
Others
(b) Spinach and similar	0,02a b
Spinach
Beet leaves (chard)
Others
(c) Watercress	0,02a b
(d) Witloof	0,02a b
(e) Herbs	1b
Chervil
Chives
Parsley
Celery leaves
Others
(vi) LEGUME VEGETABLES (fresh)	0,02a b	0,2a b
Beans (with pods)
Beans (without pods)
Peas (with pods)
Peas (without pods)
Others
(vii) STEM VEGETABLES (fresh)	0,02a b	0,2a b
Asparagus
Cardoons
Celery
Fennel
Globe artichokes
Leek
Rhubarb
Others
(viii) FUNGI	0,02a b	0,2a b
(a) Cultivated mushrooms
(b) Wild mushrooms
3. Pulses	0,02a b	0,2a b
Beans
Lentils
Peas
Others
4. Oil seed	0,05a b	0,5a b
Linseed
Peanuts
Poppy seeds
Sesame seeds
Sunflower seed
Rape seed
Soya bean
Mustard seed
Cotton seed
Others
5. Potatoes	0,02a b	50c
Early potatoes
Ware potatoes
6. Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)	0,05a b	0,5a b
7. Hops (dried), including hop pellets and unconcentrated powder	0,05a b	0,5a b

(1)

OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2004/61/EC (OJ L 127, 29.4.2004, p. 81).

(2)

OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2004/115/EC (OJ L 374, 22.12.2004, p. 64).

(3)

OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2005/34/EC (OJ L 125, 18.5.2005, p. 5).

(4)

OJ L 101, 23.4.2003, p. 3.

(5)

OJ L 124, 20.5.2003, p. 30.

(6)

OJ L 184, 23.7.2003, p. 9.

(7)

OJ L 177, 16.7.2003, p. 12.

(8)

OJ L 211, 23.8.1993, p. 6.

(9)

OJ L 144, 18.6.1996, p. 12.

(10)

OJ L 144, 18.6.1996, p. 35.

(11)

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).

(12)

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).