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, and in particular Article 10 thereof,
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).
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, and in particular Article 7 thereof,
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).
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, and in particular Article 4(1)(f) thereof,
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).
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; propyzamide by Commission Directive 2003/39/EC; and mecoprop and mecoprop-p by Commission Directive 2003/70/EC.
OJ L 101, 23.4.2003, p. 3.
OJ L 124, 20.5.2003, p. 30.
OJ L 184, 23.7.2003, p. 9.
(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.
OJ L 177, 16.7.2003, p. 12.
(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) and in Directives 86/362/EEC and 90/642/EEC for: propyzamide (Council Directives 96/32/EC and 96/33/EC). 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.
OJ L 211, 23.8.1993, p. 6.
OJ L 144, 18.6.1996, p. 12.
OJ L 144, 18.6.1996, p. 35.
(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 and the opinion of the Scientific Committee for Plants on the methodology employed. It is concluded that MRLs proposed will not lead to those ADIs or ARfD being exceeded.
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).
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).
(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
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)	0,05 CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals
Trifloxystrobin	0,3 Barley 0,05 Rye 0,05 Triticale, Wheat 0,02 other Cereals
Carfentrazone-ethyl (determined as carfentrazone and expressed as carfentrazone-ethyl)	0,05 CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals
Fenamidone	0,02 CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals
Mecoprop (sum of mecoprop-p and mecoprop expressed as mecoprop)	0,05 CEREALS Barley, Buckwheat, Maize, Millet, Oats, Rice, Rye, Sorghum, Triticale, Wheat, other Cereals
Maleic hydrazide	0,2 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	0,02 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)	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	0,05		0,01		0,05
(i) CITRUS FRUIT		0,3		0,02	
Grapefruit					
Lemons					
Limes					
Mandarins (including clementines and other hybrids)					
Oranges					
Pomelos					
Others					
(ii) TREE NUTS (shelled or unshelled)		0,02		0,02	
Almonds					
Brazil nuts					
Cashew nuts					
Chestnuts					
Coconuts					
Hazelnuts					
Macadamia					
Pecans					
Pine nuts					
Pistachios					
Walnuts					
Others					
(iii) POME FRUIT		0,5		0,02	
Apples					
Pears					
Quinces					
Others					
(iv) STONE FRUIT				0,02	
Apricots		1			
Cherries		1			
Peaches (including nectarines and similar hybrids)		1			
Plums					
Others		0,02			
(v) BERRIES AND SMALL FRUIT					
(a) Table and wine grapes		5		0,5	
Table grapes					
Wine grapes					
(b) Strawberries (other than wild)		0,02		0,02	
(c) Cane fruit (other than wild)		0,02		0,02	
Blackberries					
Dewberries					
Loganberries					
Raspberries					
Others					
(d) Other small fruit and berries (other than wild)				0,02	
Bilberries					
Cranberries					
Currants (red, black and white)		1			
Gooseberries		1			
Others		0,02			
(e) Wild berries and wild fruit		0,02		0,02	
(vi) MISCELLANEOUS				0,02	
Avocados					
Bananas		0,05			
Dates					
Figs					
Kiwi					
Kumquats					
Litchis					
Mangoes					
Olives					
Passion fruit					
Pineapples					
Papaya					
Others		0,02			
2. Vegetables, fresh or uncooked, frozen or dry	0,05		0,01		0,05
(i) ROOT AND TUBER VEGETABLES		0,02		0,02	
Beetroot					
Carrots					
Celeriac					
Horseradish					
Jerusalem artichokes					
Parsnips					
Parsley root					
Radishes					
Salsify					
Sweet potatoes					
Swedes					
Turnips					
Yam					
Others					
(ii) BULB VEGETABLES		0,02		0,02	
Garlic					
Onions					
Shallots					
Spring onions					
Others					
(iii) FRUITING VEGETABLES					
(a) Solanacea					
Tomatoes		0,5		0,5	
Peppers					
Aubergines					
Others		0,02		0,02	
(b) Cucurbits — edible peel		0,2		0,02	
Cucumbers					
Gherkins					
Courgettes					
Others					
(c) Cucurbits — inedible peel					
Melons		0,3		0,1	
Squashes					
Watermelons					
Others		0,02		0,02	
(d) Sweet corn		0,02		0,02	
(iv) BRASSICA VEGETABLES		0,02		0,02	
(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		0,02			
(a) Lettuce and similar				2	
Cress					
Lamb's lettuce					
Lettuce					
Scarole					
Others					
(b) Spinach and similar				0,02	
Spinach					
Beet leaves (chard)					
Others					
(c) Watercress				0,02	
(d) Witloof				0,02	
(e) Herbs				0,02	
Chervil					
Chives					
Parsley					
Celery leaves					
Others					
(vi) LEGUME VEGETABLES (fresh)		0,02		0,02	
Beans (with pods)					
Beans (without pods)					
Peas (with pods)					
Peas (without pods)					
Others					
(vii) STEM VEGETABLES (fresh)		0,02		0,02	
Asparagus					
Cardoons					
Celery					
Fennel					
Globe artichokes					
Leek					
Rhubarb					
Others					
(viii) FUNGI		0,02		0,02	
(a) Cultivated mushrooms					
(b) Wild mushrooms					
3. Pulses	0,05	0,02	0,01	0,02	0,05
Beans					
Lentils					
Peas					
Others					
4. Oil seed	0,1	0,05	0,02	0,05	0,05
Linseed					
Peanuts					
Poppy seeds					
Sesame seeds					
Sunflower seed					
Rape seed					
Soya bean					
Mustard seed					
Cotton seed					
Others					
5. Potatoes	0,05	0,02	0,01	0,02	0,05
Early potatoes					
Ware potatoes					
6. Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)	0,1	0,05	0,02	0,05	0,1
7. Hops (dried), including hop pellets and unconcentrated powder	0,1	30	0,02	0,05	0,1
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	0,02	0,2
(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	0,02	0,2
Beetroot		
Carrots		
Celeriac		
Horseradish		
Jerusalem artichokes		
Parsnips		
Parsley root		
Radishes		
Salsify		
Sweet potatoes		
Swedes		
Turnips		
Yam		
Others		
(ii) BULB VEGETABLES	0,02	
Garlic		15
Onions		15
Shallots		15
Spring onions		
Others		0,2
(iii) FRUITING VEGETABLES	0,02	0,2
(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	0,02	0,2
(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		0,2
(a) Lettuce and similar	1	
Cress		
Lamb's lettuce		
Lettuce		
Scarole		
Others		
(b) Spinach and similar	0,02	
Spinach		
Beet leaves (chard)		
Others		
(c) Watercress	0,02	
(d) Witloof	0,02	
(e) Herbs	1	
Chervil		
Chives		
Parsley		
Celery leaves		
Others		
(vi) LEGUME VEGETABLES (fresh)	0,02	0,2
Beans (with pods)		
Beans (without pods)		
Peas (with pods)		
Peas (without pods)		
Others		
(vii) STEM VEGETABLES (fresh)	0,02	0,2
Asparagus		
Cardoons		
Celery		
Fennel		
Globe artichokes		
Leek		
Rhubarb		
Others		
(viii) FUNGI	0,02	0,2
(a) Cultivated mushrooms		
(b) Wild mushrooms		
3. Pulses	0,02	0,2
Beans		
Lentils		
Peas		
Others		
4. Oil seed	0,05	0,5
Linseed		
Peanuts		
Poppy seeds		
Sesame seeds		
Sunflower seed		
Rape seed		
Soya bean		
Mustard seed		
Cotton seed		
Others		
5. Potatoes	0,02	50
Early potatoes		
Ware potatoes		
6. Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)	0,05	0,5
7. Hops (dried), including hop pellets and unconcentrated powder	0,05	0,5
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.		