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 originText with EEA relevance

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) 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 vegetables OJ 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 cereals OJ 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 origin OJ 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 vegetables OJ 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 market OJ 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/EC OJ L 304, 21.11.2001, p. 14. , chlorpropham by Commission Directive 2004/20/EC OJ L 70, 9.3.2004, p. 32. and bromoxynil, and ioxinyl by Commission Directive 2004/58/EC OJ 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/EC OJ 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/EC OJ L 325, 12.12.2003, p. 41. , flazasulfuron and pyraclostrobin by Commission Directive 2004/30/EC OJ L 77, 13.3.2004, p. 50. , quinoxyfen by Commission Directive 2004/60/EC OJ 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/EC OJ 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/EEC OJ 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/EC OJ 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 Organisation 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). and the opinion of the Scientific Committee for Plants 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). 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 1

In Annex II to Directive 76/895/EEC, the line for chlorpropham is deleted.

Article 2

Directive 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 3

Directive 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 4

Directive 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 5

1. 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 6

This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

Article 7

This Directive is addressed to the Member States. Done at Brussels, 20 October 2005. For the Commission Markos Kyprianou Member of the Commission

Annex

ANNEX 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 bromoxynil 0,10 Maize 0,05 Cereals others Chlorpropham (chlorpropham and 3-chloroaniline, expressed as chlorpropham) 0,02 CEREALS Dimethenamid-P including other mixtures of constituent isomers (sum of isomers) 0,01 CEREALS Flazasulfuron 0,02 CEREALS Flutarmone 0,02 CEREALS Ioxynil, including its esters expressed as ioxynil 0,05 CEREALS Mepanipyrim and its metabolite (2-anilino-4-(2-hydroxypropyl)-6-methylpyrimidine) expressed as mepanipyrim 0,01 CEREALS Propoxycarbazone, its salts and 2-hydroxypropoxy-propoxycarbazone, calculated as propoxycarbazone 0,02 CEREALS Pyraclostrobin 0,1 Wheat 0,3 Barley 0,1 Rye 0,3 Oats 0,1 Triticale 0,02 Cereals others Quinoxyfen 0,02 Wheat 0,2 Barley 0,02 Rye 0,2 Oats 0,02 Triticale 0,02 Cereals others Trimethylsulfonium cation, resulting from the use of glyphosate 5 Wheat 10 Barley 5 Rye 10 Oats 5 Triticale 0,05 Cereals others Zoxamide 0,02 CEREALS

Annex

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)Glyphosate 10 Wheat 20 Barley 1 Maize 10 Rye 20 Oats 20 Sorghum 10 Triticale 0,1 Cereals others

Annex

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 0408Bromoxynil including its esters expressed as bromoxynilmeat 0,05; offals 0,200,01Chlorpropham 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 0,200,01Pyraclostrobin0,050,010,05Quinoxyfen0,20,050,02Trimethylsulfonium cation, resulting from the use of glyphosate 0,2 kidney of cattle 0,5 liver of cattle 0,2 meat of cattle 0,1 kidney of poultry 0,05 others 0,10,01

Annex

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 0408Glyphosate 2 kidney of cattle 0,2 liver of cattle 0,5 kidney of pigs 0,1 kidney of poultry 0,05 others 0,010,01

Annex

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; nuts 0,050,050,010,020,050,02 (i) CITRUS FRUIT 0,020,0110,020,02GrapefruitLemonsLimesMandarins (including clementines and other hybrids)0,05Oranges0,5PomelosOthers0,05 (ii) TREE NUTS (shelled or unshelled) 0,010,010,020,050,02AlmondsBrazil nutsCashew nutsChestnutsCoconutsHazelnutsMacadamiaPecansPine nutsPistachios1 WalnutsOthers0,02 (iii) POME FRUIT 0,010,010,020,020,050,02ApplesPearsQuincesOthers (iv) STONE FRUIT 0,010,010,050,02ApricotsCherries0,20,3Peaches (including nectarines and similar hybrids)PlumsOthers0,020,02 (v) BERRIES AND SMALL FRUIT 0,05 (a) Table and wine grapes 0,02315Table grapes0,02Wine grapes2 (b) Strawberries (other than wild) 0,0120,50,30,02 (c) Cane fruit (other than wild) 0,010,010,020,020,02BlackberriesDewberriesLoganberries RaspberriesOthers (d) Other small fruit and berries (other than wild) 0,010,010,0210,02BilberriesCranberriesCurrants (red, black and white)GooseberriesOthers (e) Wild berries and wild fruit 0,010,010,020,020,02 (vi) MISCELLANEOUS 0,010,020,02AvocadosBananasDatesFigsKiwiKumquatsLitchisMangoes0,05Olives0,02Olives (table consumption)————————————Olives (oil extraction)——————————1—Passion fruit PineapplesPapaya0,05Others0,010,020,05
2. Vegetables, fresh or uncooked, frozen or dry 0,050,050,010,010,020,02 (i) ROOT AND TUBER VEGETABLES 0,010,020,020,050,02BeetrootCarrots0,2CeleriacHorseradishJerusalem artichokesParsnips0,2Parsley rootRadishesSalsifySweet potatoesSwedesTurnipsYamOthers0,05

(ii) BULB VEGETABLES 0,010,020,050,02Garlic0,2Onions0,20,2 Shallots0,2Spring onionsOthers0,050,02 (iii) FRUITING VEGETABLES 0,050,020,05 (a) Solanacea 0,02Tomatoes10,5PeppersAuberginesOthers0,010,02 (b) Cucurbits — edible peel 0,010,020,02CucumbersGherkinsCourgettesOthers (c) Cucurbits — inedible peel 0,010,050,02MelonsSquashesWatermelonsOthers (d) Sweet corn 0,010,020,02 (iv) BRASSICA VEGETABLES 0,050,010,020,020,050,02 (a) Flowering brassica Broccoli CauliflowerOthers (b) Head brassica Brussels sproutsHead cabbageOthers (c) Leafy brassica Chinese cabbageKaleOthers (d) Kohlrabi (v) LEAF VEGETABLES AND FRESH HERBS 0,050,010,020,050,02 (a) Lettuce & similar 2CressLamb's lettuceLettuceScaroleOthers (b) Spinach & similar 0,02SpinachBeet leaves (chard)Others (c) Water cress 0,02 (d) Witloof 0,02 (e) Herbs 0,02ChervilChivesParsleyCelery leavesOthers (vi) LEGUME VEGETABLES (fresh) 0,050,010,020,020,050,02Beans (with pods)Beans (without pods)Peas (with pods)Peas (without pods)Others (vii) STEM VEGETABLES (fresh) 0,050,010,020,020,050,02AsparagusCardoonsCeleryFennelGlobe artichokesLeekRhubarbOthers (viii) FUNGI 0,050,010,020,020,02 (a) Cultivated mushrooms 0,05 (b) Wild mushrooms 20 3. Pulses 0,050,050,010,010,020,050,010,020,30,020,050,02BeansLentilsPeasOthers 4. Oil seed 0,10,10,020,020,050,10,020,020,020,050,05LinseedPeanutsPoppy seedsSesame seedsSunflower seedRape seedSoya bean10Mustard seedCotton seedOthers0,05 5. Potatoes 0,05100,010,010,020,050,010,020,020,020,050,02Early potatoesWare 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 powder 0,10,10,020,020,050,10,020,050,050,50,050,05

Annex

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. Groups and examples of individual products to which the MRLs applyGlyphosate

1. Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts (i) CITRUS FRUIT Grapefruit0,1Lemons0,1LimesMandarins (including clementines and other hybrids)0,1Oranges0,5PomelosOthers0,1 (ii) TREE NUTS (shelled or unshelled) 0,1AlmondsBrazil nutsCashew nutsChestnutsCoconutsHazelnutsMacadamiaPecansPine nutsPistachiosWalnutsOthers (iii) POME FRUIT 0,1ApplesPearsQuincesOthers (iv) STONE FRUIT 0,1ApricotsCherriesPeaches (including nectarines and similar hybrids)PlumsOthers (v) BERRIES AND SMALL FRUIT (a) Table and wine grapes 0,5Table grapesWine grapes (b) Strawberries (other than wild) 0,1 (c) Cane fruit (other than wild) 0,1BlackberriesDewberriesLoganberriesRaspberriesOthers (d) Other small fruit and berries (other than wild) 0,1BilberriesCranberriesCurrants (red, black and white)GooseberriesOthers (e) Wild berries and wild fruit

0,1 (vi) MISCELLANEOUS AvocadosBananasDatesFigsKiwiKumquatsLitchisMangoesOlivesolives (table consuption)olives (oil extraction)1Passion fruitPineapplesPapayaOthers0,05 2. Vegetables, fresh or uncooked, frozen or dry (i) ROOT AND TUBER VEGETABLES 0,1BeetrootCarrotsCeleriacHorseradishJerusalem artichokesParsnipsParsley rootRadishesSalsifySweet potatoesSwedesTurnipsYamOthers (ii) BULB VEGETABLES 0,1GarlicOnionsShallotsSpring onionsOthers (iii) FRUITING VEGETABLES 0,1 (a) Solanacea TomatoesPeppersAuberginesOthers (b) Cucurbits — edible peel CucumbersGherkinsCourgettesOthers (c) Cucurbits — inedible peel MelonsSquashesWatermelonsOthers (d) Sweet corn (iv) BRASSICA VEGETABLES 0,1 (a) Flowering brassica BroccoliCauliflowerOthers (b) Head brassica Brussels sproutsHead cabbageOthers (c) Leafy brassica Chinese cabbageKaleOthers (d) Kohlrabi (v) LEAF VEGETABLES AND FRESH HERBS 0,1 (a) Lettuce & similar CressLamb's lettuceLettuceScaroleOthers (b) Spinach and similar SpinachBeet leaves (chard)Others (c) Water cress (d) Witloof (e) Herbs ChervilChivesParsleyCelery leavesOthers (vi) LEGUME VEGETABLES (fresh) 0,1Beans (with pods)Beans (without pods)Peas (with pods)Peas (without pods)Others (vii) STEM VEGETABLES (fresh) 0,1AsparagusCardoonsCeleryFennelGlobe artichokesLeekRhubarbOthers (viii) FUNGI (a) Cultivated mushrooms 0,1 (b) Wild mushrooms 50 3. Pulses Beans2LentilsPeas10Others0,1 4. Oil seed Linseed10PeanutsPoppy seedsSesame seedsSunflower seed20Rape seed10Soya bean20Mustard seed10Cotton seed10Others0,1 5. Potatoes 0,5Early potatoesWare 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 powder 0,1