Commission Directive 2005/70/EC of 20 October 2005 amending Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for certain pesticides in and on cereals and certain products of animal and plant origin (Text with EEA relevance)
Commission Directive 2005/70/ECof 20 October 2005amending Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for certain pesticides in and on cereals and certain products of animal and plant origin(Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetablesOJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission Directive 2003/118/EC (OJ L 327, 16.12.2003, p. 25)., and in particular Article 5 thereof,Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cerealsOJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2005/48/EC (OJ L 219, 24.8.2005, p. 29)., 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 originOJ L 221, 7.8.1986, p. 43. Directive as last amended by Directive 2005/48/EC., 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 vegetablesOJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive 2005/48/EC., 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 marketOJ L 230, 19.8.1991, p. 1. Directive as last amended by Directive 2005/34/EC (OJ L 125, 18.5.2005, p. 5). 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: glyphosate by Commission Directive 2001/99/ECOJ L 304, 21.11.2001, p. 14., chlorpropham by Commission Directive 2004/20/ECOJ L 70, 9.3.2004, p. 32. and bromoxynil, and ioxinyl by Commission Directive 2004/58/ECOJ L 120, 24.4.2004, p. 26..(2)The following new active substances have been included in Annex I to Directive 91/414/EEC: dimethenamid-P and flurtamone by Commission Directive 2003/84/ECOJ L 247, 30.9.2003, p. 20. Directive as amended by Directive 2004/64/EC (OJ L 125, 28.4.2004, p. 42). propoxycarbazone and zoxamide by Commission Directive 2003/119/ECOJ L 325, 12.12.2003, p. 41., flazasulfuron and pyraclostrobin by Commission Directive 2004/30/ECOJ L 77, 13.3.2004, p. 50., quinoxyfen by Commission Directive 2004/60/ECOJ L 120, 24.4.2004, p. 39. Directive as amended by Directive 2004/97/EC (OJ L 301, 28.9.2004, p. 53). and mepanipyrim, by Commission Directive 2004/62/ECOJ L 125, 28.4.2004, p. 38..(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 their proposed use. Information relating to that 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)Community MRLs and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a number of Codex MRLs for chlorpropham, and glyphosate. There are already Community MRLs in Directive 76/895/EEC for chlorpropham (Council Directive 82/528/EECOJ L 234, 9.8.1982, p. 1.) and in Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for glyphosate (Council Directive 1998/82/ECOJ L 290, 29.10.1998, p. 25.). These have been taken into consideration 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 have 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.(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 substances concerned has been assessed in accordance with Community procedures. Account has also been taken of guidelines published by the World Health OrganisationGuidelines 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). and the opinion of the Scientific Committee for PlantsOpinion 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). on the methodology employed. It is concluded that 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 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.(8)It is therefore necessary to add or replace all of the MRLs arising from the use of these plant protection products to 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 modify them. Where MRLs have not been defined until now, it is appropriate to set them for the first time.(9)Glyphosate is used as ester or salt. In case of glyphosate trimesium salt, the residue of trimethylsulfonium cation is also of toxicological relevance. It is therefore necessary to set MRLs for that cation.(10)Provisions of Directive 76/895/EEC which set MRLs for chlorpropham should consequently be deleted.(11)Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly.(12)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 1In Annex II to Directive 76/895/EEC, the line for chlorpropham is deleted.
Article 2Directive 86/362/EEC is amended as follows:1.In Part A of Annex II, the lines for bromoxynil, chlorpropham, dimethenamid-P, flazasulfuron, flurtamone, ioxinyl, mepanipyrim, propoxycarbazone, pyraclostrobin, quinoxyfen, trimethylsulfonium cation and zoxamide as set out in Annex I to this Directive are added.2.In Part A of Annex II, the line for glyphosate is replaced by the text in Annex II to this Directive.
Article 3Directive 86/363/EEC is amended as follows:1.In Part A of Annex II, the lines for bromoxynil, chlorpropham, ioxinyl, pyraclostrobin, quinoxyfen and trimethylsulfonium cation, as set out in Annex III to this Directive, are added.2.In Part B of Annex II, the line for glyphosate is replaced by the text in Annex IV to this Directive.
Article 4Directive 90/642/EEC is amended as follows:1.In Annex II, the lines for bromoxynil, chlorpropham, dimethenamid-P, flazasulfuron, flurtamone, ioxinyl, mepanipyrim, propoxycarbazone, pyraclostrobin, quinoxyfen, trimethylsulfonium cation and zoxamide, as set out in Annex V to this Directive, are added.2.In Annex II, the line for glyphosate is replaced by the text in Annex VI to this Directive.
Article 51.Member States shall adopt and publish, by 21 April 2006 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 21 April 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 6This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.
Article 7This Directive is addressed to the Member States.
Done at Brussels, 20 October 2005.For the CommissionMarkos KyprianouMember of the CommissionANNEX I
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 10 November 2009.
Pesticide residuesMaximum levels in mg/kg (ppm)
Bromoxynil including its esters expressed as bromoxynil0,10 Maize0,05 Cereals others
Chlorpropham (chlorpropham and 3-chloroaniline, expressed as chlorpropham)0,02CEREALS
Dimethenamid-P including other mixtures of constituent isomers (sum of isomers)0,01CEREALS
Flazasulfuron0,02CEREALS
Flutarmone0,02CEREALS
Ioxynil, including its esters expressed as ioxynil0,05CEREALS
Mepanipyrim and its metabolite (2-anilino-4-(2-hydroxypropyl)-6-methylpyrimidine) expressed as mepanipyrim0,01CEREALS
Propoxycarbazone, its salts and 2-hydroxypropoxy-propoxycarbazone, calculated as propoxycarbazone0,02CEREALS
Pyraclostrobin0,1 Wheat0,3 Barley0,1 Rye0,3 Oats0,1 Triticale0,02 Cereals others
Quinoxyfen0,02 Wheat0,2 Barley0,02 Rye0,2 Oats0,02 Triticale0,02 Cereals others
Trimethylsulfonium cation, resulting from the use of glyphosate5 Wheat10 Barley5 Rye10 Oats5 Triticale0,05 Cereals others
Zoxamide0,02CEREALS
ANNEX II
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 10 November 2009.
Pesticide residuesMaximum levels in mg/kg (ppm)
Glyphosate10 Wheat20 Barley1 Maize10 Rye20 Oats20 Sorghum10 Triticale0,1 Cereals others
ANNEX III
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 10 November 2009.
Maximum levels in mg/kg (ppm)
Pesticide residuesof meat, including fat, preparations of meat, offal and animal fats listed in Annex I under headings Nos ex0201, 0202, 0203, 0204, 02050000, 0206, 0207, ex0208, 020900, 0210, 160100 and 1602for milk and milk products listed in Annex I under headings Nos 0401, 0402, 040500 and 0406of shelled fresh eggs, for bird's eggs and egg yolks listed in Annex I under headings Nos 040700 and 0408
Bromoxynil including its esters expressed as bromoxynilmeat 0,05; offals 0,200,01
Chlorpropham and 4’-hydroxychlorpropham-O-sulphonic acid (4-HSA), expressed as chlorpropham;meat 0,05; liver 0,05; kidney 0,20,2—
Ioxynil, including its esters expressed as ioxynilmeat 0,05 ; offals 0,200,01
Pyraclostrobin0,050,010,05
Quinoxyfen0,20,050,02
Trimethylsulfonium cation, resulting from the use of glyphosate0,2 kidney of cattle0,5 liver of cattle0,2 meat of cattle0,1 kidney of poultry0,05 others0,10,01
ANNEX IV
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 10 November 2009.
Maximum levels in mg/kg (ppm)
Pesticide residuesof meat, including fat, preparations of meat, offal and animal fats listed in Annex I under headings Nos ex0201, 0202, 0203, 0204, 02050000, 0206, 0207, ex0208, 020900, 0210, 160100 and 1602for milk and milk products listed in Annex I under headings Nos 0401, 0402, 040500 and 0406of shelled fresh eggs, for bird's eggs and egg yolks listed in Annex I under headings Nos 040700 and 0408
Glyphosate2 kidney of cattle0,2 liver of cattle0,5 kidney of pigs0,1 kidney of poultry0,05 others0,010,01
ANNEX V
Indicates lower limit of analytical determination.Residue definition in potatoes is chlorpropham only.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 10 November 2009.
Groups and examples of individual products to which the MRLs applyBromoxynil including its esters expressed as bromoxynilChlorpropham (chlorpropham and 3-chloroaniline, expressed as chlorpropham)Dimethenamid-P including other mixtures of constituent isomers (sum of isomers)FlazasulfuronFlurtamoneIoxynil, including its esters expressed as ioxynilMepanipyrim and its metabolite (2-anilino-4-(2-hydroxypropyl)-6-methylpyrimidine expressed as mepanipyrimPropoxycarbazone, its salts and 2-hydroxypropoxy-propoxycarbazone, calculated as propoxycarbazonePyraclostrobinQuinoxyfenTrimethylsulfonium cation resulting from the use of glyphosateZoxamide
1.Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts0,050,050,010,020,050,02
(i)CITRUS FRUIT0,020,0110,020,02
Grapefruit
Lemons
Limes
Mandarins (including clementines and other hybrids)0,05
Oranges0,5
Pomelos
Others0,05
(ii)TREE NUTS (shelled or unshelled)0,010,010,020,050,02
Almonds
Brazil nuts
Cashew nuts
Chestnuts
Coconuts
Hazelnuts
Macadamia
Pecans
Pine nuts
Pistachios1
Walnuts
Others0,02
(iii)POME FRUIT0,010,010,020,020,050,02
Apples
Pears
Quinces
Others
(iv)STONE FRUIT0,010,010,050,02
Apricots
Cherries0,20,3
Peaches (including nectarines and similar hybrids)
Plums
Others0,020,02
(v)BERRIES AND SMALL FRUIT0,05
(a)Table and wine grapes0,02315
Table grapes0,02
Wine grapes2
(b)Strawberries (other than wild)0,0120,50,30,02
(c)Cane fruit (other than wild)0,010,010,020,020,02
Blackberries
Dewberries
Loganberries
Raspberries
Others
(d)Other small fruit and berries (other than wild)0,010,010,0210,02
Bilberries
Cranberries
Currants (red, black and white)
Gooseberries
Others
(e)Wild berries and wild fruit0,010,010,020,020,02
(vi)MISCELLANEOUS0,010,020,02
Avocados
Bananas
Dates
Figs
Kiwi
Kumquats
Litchis
Mangoes0,05
Olives0,02
Olives (table consumption)————————————
Olives (oil extraction)——————————1—
Passion fruit
Pineapples
Papaya0,05
Others0,010,020,05
2.Vegetables, fresh or uncooked, frozen or dry0,050,050,010,010,020,02
(i)ROOT AND TUBER VEGETABLES0,010,020,020,050,02
Beetroot
Carrots0,2
Celeriac
Horseradish
Jerusalem artichokes
Parsnips0,2
Parsley root
Radishes
Salsify
Sweet potatoes
Swedes
Turnips
Yam
Others0,05
(ii)BULB VEGETABLES0,010,020,050,02
Garlic0,2
Onions0,20,2
Shallots0,2
Spring onions
Others0,050,02
(iii)FRUITING VEGETABLES0,050,020,05
(a)Solanacea0,02
Tomatoes10,5
Peppers
Aubergines
Others0,010,02
(b)Cucurbits — edible peel0,010,020,02
Cucumbers
Gherkins
Courgettes
Others
(c)Cucurbits — inedible peel0,010,050,02
Melons
Squashes
Watermelons
Others
(d)Sweet corn0,010,020,02
(iv)BRASSICA VEGETABLES0,050,010,020,020,050,02
(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 HERBS0,050,010,020,050,02
(a)Lettuce & similar2
Cress
Lamb's lettuce
Lettuce
Scarole
Others
(b)Spinach & similar0,02
Spinach
Beet leaves (chard)
Others
(c)Water cress0,02
(d)Witloof0,02
(e)Herbs0,02
Chervil
Chives
Parsley
Celery leaves
Others
(vi)LEGUME VEGETABLES (fresh)0,050,010,020,020,050,02
Beans (with pods)
Beans (without pods)
Peas (with pods)
Peas (without pods)
Others
(vii)STEM VEGETABLES (fresh)0,050,010,020,020,050,02
Asparagus
Cardoons
Celery
Fennel
Globe artichokes
Leek
Rhubarb
Others
(viii)FUNGI0,050,010,020,020,02
(a)Cultivated mushrooms0,05
(b)Wild mushrooms20
3.Pulses0,050,050,010,010,020,050,010,020,30,020,050,02
Beans
Lentils
Peas
Others
4.Oil seed0,10,10,020,020,050,10,020,020,020,050,05
Linseed
Peanuts
Poppy seeds
Sesame seeds
Sunflower seed
Rape seed
Soya bean10
Mustard seed
Cotton seed
Others0,05
5.Potatoes0,05100,010,010,020,050,010,020,020,020,050,02
Early potatoes
Ware potatoes
6.Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)0,10,10,020,020,050,10,020,050,050,050,050,05
7.Hops (dried), including hop pellets and unconcentrated powder0,10,10,020,020,050,10,020,050,050,50,050,05
ANNEX VI
Pesticide residues and MRLs (mg/kg)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 10 November 2009.1.Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts2.Vegetables, fresh or uncooked, frozen or dry3.Pulses4.Oil seed
Groups and examples of individual products to which the MRLs applyGlyphosate
(i)CITRUS FRUIT
Grapefruit0,1
Lemons0,1
Limes
Mandarins (including clementines and other hybrids)0,1
Oranges0,5
Pomelos
Others0,1
(ii)TREE NUTS (shelled or unshelled)0,1
Almonds
Brazil nuts
Cashew nuts
Chestnuts
Coconuts
Hazelnuts
Macadamia
Pecans
Pine nuts
Pistachios
Walnuts
Others
(iii)POME FRUIT0,1
Apples
Pears
Quinces
Others
(iv)STONE FRUIT0,1
Apricots
Cherries
Peaches (including nectarines and similar hybrids)
Plums
Others
(v)BERRIES AND SMALL FRUIT
(a)Table and wine grapes0,5
Table grapes
Wine grapes
(b)Strawberries (other than wild)0,1
(c)Cane fruit (other than wild)0,1
Blackberries
Dewberries
Loganberries
Raspberries
Others
(d)Other small fruit and berries (other than wild)0,1
Bilberries
Cranberries
Currants (red, black and white)
Gooseberries
Others
(e)Wild berries and wild fruit0,1
(vi)MISCELLANEOUS
Avocados
Bananas
Dates
Figs
Kiwi
Kumquats
Litchis
Mangoes
Olives
olives (table consuption)
olives (oil extraction)1
Passion fruit
Pineapples
Papaya
Others0,05
(i)ROOT AND TUBER VEGETABLES0,1
Beetroot
Carrots
Celeriac
Horseradish
Jerusalem artichokes
Parsnips
Parsley root
Radishes
Salsify
Sweet potatoes
Swedes
Turnips
Yam
Others
(ii)BULB VEGETABLES0,1
Garlic
Onions
Shallots
Spring onions
Others
(iii)FRUITING VEGETABLES0,1
(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 VEGETABLES0,1
(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 HERBS0,1
(a)Lettuce & similar
Cress
Lamb's lettuce
Lettuce
Scarole
Others
(b)Spinach and similar
Spinach
Beet leaves (chard)
Others
(c)Water cress
(d)Witloof
(e)Herbs
Chervil
Chives
Parsley
Celery leaves
Others
(vi)LEGUME VEGETABLES (fresh)0,1
Beans (with pods)
Beans (without pods)
Peas (with pods)
Peas (without pods)
Others
(vii)STEM VEGETABLES (fresh)0,1
Asparagus
Cardoons
Celery
Fennel
Globe artichokes
Leek
Rhubarb
Others
(viii)FUNGI
(a)Cultivated mushrooms0,1
(b)Wild mushrooms50
Beans2
Lentils
Peas10
Others0,1
Linseed10
Peanuts
Poppy seeds
Sesame seeds
Sunflower seed20
Rape seed10
Soya bean20
Mustard seed10
Cotton seed10
Others0,1
5.Potatoes0,5
Early potatoes
Ware potatoes
6.Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)2
7.Hops (dried), including hop pellets and unconcentrated powder0,1