
COMMISSION DIRECTIVE 2005/48/EC of 23 August 2005 amending Council Directives 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 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,
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, 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, 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, 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: iprodione by Commission Directive 2003/31/EC; propiconazole by Commission Directive 2003/70/EC and molinate by Commission Directive 2003/81/EC.

(2) The following new active substances have been included in Annex I to Directive 91/414/EEC: mesotrione by Commission Directive 2003/68/EC and silthiofam, picoxystrobin, flufenacet, iodosulfuron-methyl-sodium and fosthiazate by Commission Directive 2003/84/EC.

(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) 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 iprodione and propiconazole. There are already Community MRLs set out in 86/362/EEC, 86/363/EEC and 90/642/EEC for: iprodione (Council Directive 93/58/EEC) and propiconazole (Council Directive 94/30/EC). These have been taken into account in 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 and the opinion of the Scientific Committee for Plants on the methodology employed. It has been 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 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.

(9) 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.

(10) Directives 86/362/EEC, 86/363/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:

Article1 
Directive 86/362/EEC is amended as follows:

1.. In Part A of Annex II, maximum residue levels are added for mesotrione, silthiofam, picoxystrobin, flufenacet, iodosulfuron-methyl-sodium, fosthiazate and molinate, as set out in Annex I to this Directive.
2.. In Part A of Annex II, the maximum residue levels for propiconazole and iprodione are replaced by those set out in Annex II to this Directive.
Article 2 
Directive 86/363/EEC is amended as follows:

1.. In Part A of Annex II, maximum residue levels are added for picoxystrobin, as set out in Annex III to this Directive.
2.. In Part B of Annex II, the maximum residue levels for propiconazole are replaced by those set out in Annex IV to this Directive.
Article 3 
Directive 90/642/EEC is amended as follows:

1.. In Annex II, maximum residue levels are added for mesotrione, silthiofam, picoxystrobin, flufenacet, iodosulfuron-methyl-sodium, fosthiazate and molinate, as set out in Annex V to this Directive.
2.. In Annex II, the maximum residue levels for propiconazole and iprodione, are replaced by those set out in Annex VI to this Directive.
Article 4 

1. Member States shall adopt and publish, by 24 February 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 24 February 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 twentieth 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, 23 August 2005.
For the Commission
Markos KYPRIANOU
Member of the Commission
ANNEX I

Maximum levels in mg/kg (ppm)
Pesticide residues Individual products to which the MRLs apply
Mesotrione ‘Sum of mesotrione and MNBA (4-methylsulfonyl-2-nitro benzoic acid), expressed as mesotrione’ 0,05CEREALS
Silthiofam 0,05CEREALS
Picoxystrobin 0,2 Barley0,2 Oats0,05 Cereals others
Flufenacet (Sum of all compounds containing the N fluorophenyl-N-isopropyl moiety expressed as flufenacet equivalent) 0,05CEREALS
Iodosulfuron-methyl sodium (iodosulfuron-methyl including salts, expressed as iodosulfuron-methyl) 0,02CEREALS
Fosthiazate 0,02CEREALS
Molinate 0,05CEREALS


ANNEX II

Maximum levels mg/kg
Pesticide residues Individual products to which the MRLs apply
Propiconazole 0,2 Barley0,2 Oats0,05 Cereals others
Iprodione 3 Rice0,5 Oats, barley and wheat0,02 Cereals others


ANNEX III

Maximum levels in mg/kg (ppm)
Pesticide residues of fat contained in meat, 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 cow's milk and whole cream cow's milk listed in Annex I under heading No 0401: for other foodstuffs in headings Nos 0401, 0402, 0405 00 and 0406 in accordance with of shelled fresh eggs, for bird's eggs and egg yolks listed in Annex I under headings Nos 0407 00 and 0408
Picoxystrobin 0,05 0,02 0,05






ANNEX IV

Maximum levels in mg/kg (ppm)
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
Propiconazole ruminant liver 0,1others products of animal origin 0,01 0,01 0,01


ANNEX V

Groups and examples of individual products to which the MRLs apply Mesotrione (Sum of mesotrione and MNBA (4-methylsulfonyl-2-nitro benzoic acid), expressed as mesotrione) Silthiofam Picoxystrobin Flufenacet (Sum of all compounds containing the N fluorophenyl-N-isopropyl moiety expressed as flufenacet) Iodosulfuron-methyl sodium (iodosulfuron-methyl including salts, expressed as iodosulfuron-methyl) Fosthiazate Molinate

1. Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts
 0,05 0,05 0,05 0,05 0,02  0,05

(i) CITRUS FRUIT
      0,02 
Grapefruit       
Lemons       
Limes       
Mandarins (including clementines and other hybrids)       
Oranges       
Pomelos       
Others       

(ii) TREE NUTS (shelled or unshelled)
      0,02 
Almonds       
Brazil nuts       
Cashew nuts       
Chestnuts       
Coconuts       
Hazelnuts       
Macadamia       
Pecans       
Pine nuts       
Pistachios       
Walnuts       
Others       

(iii) POME FRUIT
      0,02 
Apples       
Pears       
Quinces       
Others       

(iv) STONE FRUIT
      0,02 
Apricots       
Cherries       
Peaches (including nectarines and similar hybrids)       
Plums       
Others       

(v) BERRIES AND SMALL FRUIT
      0,02 

(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      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 0,05 0,05 0,05 0,02 0,02 0,05

(i) ROOT AND TUBER VEGETABLES
       
Beetroot       
Carrots       
Celeriac       
Horseradish       
Jerusalem artichokes       
Parsnips       
Parsley root       
Radishes       
Salsify       
Sweet potatoes       
Swedes       
Turnips       
Yam       
Others       

(ii) BULB VEGETABLES
       
Garlic       
Onions       
Shallots       
Spring onions       
Others       

(iii) FRUITING VEGETABLES
       

(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
       

(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
       

(a) Lettuce & similar
       
Cress       
Lamb's lettuce       
Lettuce       
Scarole       
Others       

(b) Spinach & similar
       
Spinach       
Beet leaves (chard)       
Others       

(c) Water cress
       

(d) Witloof
       

(e) Herbs
       
Chervil       
Chives       
Parsley       
Celery leaves       
Others       

(vi) LEGUME VEGETABLES (fresh)
       
Beans (with pods)       
Beans (without pods)       
Peas (with pods)       
Peas (without pods)       
Others       

(vii) STEM VEGETABLES (fresh)
       
Asparagus       
Cardoons       
Celery       
Fennel       
Globe artichokes       
Leek       
Rhubarb       
Others       

(viii) FUNGI
       

(a) Cultivated mushrooms
       

(b) Wild mushrooms
       

3. Pulses
 0,05 0,05 0,05 0,05 0,02 0,02 0,05
Beans       
Lentils       
Peas       
Others       

4. Oil seed
 0,05 0,05 0,05 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 0,05 0,05 0,1 0,02 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 0,1 0,1 0,05 0,05 0,05 0,1

7. Hops (dried), including hop pellets and unconcentrated powder
 0,1 0,1 0,1 0,05 0,05 0,05 0,1


ANNEX VI

Groups and examples of individual products to which the MRLs apply Propiconazole Iprodione
1. Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts

(i) CITRUS FRUIT
 0,05 
Grapefruit  
Lemons  5
Limes  
Mandarins (including clementines and other hybrids)  1
Oranges  
Pomelos  
Others  0,02

(ii) TREE NUTS (shelled or unshelled)
 0,05 
Almonds  
Brazil nuts  
Cashew nuts  
Chestnuts  
Coconuts  
Hazelnuts  0,2
Macadamia  
Pecans  
Pine nuts  
Pistachios  
Walnuts  
Others  0,02

(iii) POME FRUIT
 0,05 5
Apples  
Pears  
Quinces  
Others  

(iv) STONE FRUIT
  3
Apricots 0,2 
Cherries  
Peaches (including nectarines and similar hybrids) 0,2 
Plums  
Others 0,05 

(v) BERRIES AND SMALL FRUIT
 0,05 

(a) Table and wine grapes
  10
Table grapes  
Wine grapes  

(b) Strawberries (other than wild)
  15

(c) Cane fruit (other than wild)
  10
Blackberries  
Dewberries  
Loganberries  
Raspberries  
Others  

(d) Other small fruit and berries (other than wild)
  10
Bilberries  
Cranberries  
Currants (red, black and white)  
Gooseberries  
Others  

(e) Wild berries and wild fruit
  0,02

(vi) MISCELLANEOUS
  
Avocados  
Bananas 0,1 
Dates  
Figs  
Kiwi  5
Kumquats  
Litchis  
Mangoes  
Olives  
Passion-fruit  
Pineapples  
Papaya  
Others 0,05 0,02
2. Vegetables, fresh or uncooked, frozen or dry

(i) ROOT AND TUBER VEGETABLES
 0,05 
Beetroot  
Carrots  0,3
Celeriac  0,3
Horseradish  0,1
Jerusalem artichokes  
Parsnips  0,3
Parsley root  
Radishes  0,3
Salsify  
Sweet potatoes  
Swedes  
Turnips  
Yam  
Others  0,02

(ii) BULB VEGETABLES
 0,05 
Garlic  0,2
Onions  0,2
Shallots  0,2
Spring onions  3
Others  0,02

(iii) FRUITING VEGETABLES
 0,05 

(a) Solanacea
  5
Tomatoes  
Peppers  
Aubergines  
Others  

(b) Cucurbits — edible peel
  2
Cucumbers  
Gherkins  
Courgettes  
Others  

(c) Cucurbits — inedible peel
  1
Melons  
Squashes  
Watermelons  
Others  

(d) Sweet corn
  0,02

(iv) BRASSICA VEGETABLES
 0,05 

(a) Flowering brassica
  0,1
Broccoli  
Cauliflower  
Others  

(b) Head brassica
  
Brussels sprouts  0,5
Head cabbage  5
Others  0,02

(c) Leafy brassica
  
Chinese cabbage  5
Kale  
Others  0,02

(d) Kohlrabi
  0,02

(v) LEAF VEGETABLES AND FRESH HERBS
 0,05 

(a) Lettuce & similar
  10
Cress  
Lamb's lettuce  
Lettuce  
Scarole  
Others  

(b) Spinach and similar
  0,02
Spinach  
Beet leaves (chard)  
Others  

(c) Water cress
  0,02

(d) Witloof
  0,2

(e) Herbs
  10
Chervil  
Chives  
Parsley  
Celery leaves  
Others  

(vi) LEGUME VEGETABLES (fresh)
 0,05 
Beans (with pods)  5
Beans (without pods)  
Peas (with pods)  2
Peas (without pods)  0,3
Others  0,02

(vii) STEM VEGETABLES (fresh)
  
Asparagus  
Cardoons  
Celery  
Fennel  
Globe artichokes  
Leek 0,1 
Rhubarb  0,2
Others 0,05 0,02

(viii) FUNGI
 0,05 0,02

(a) Cultivated mushrooms
  

(b) Wild mushrooms
  

3. Pulses
 0,05 0,2
Beans  
Lentils  
Peas  
Others  
4. Oil seed
Linseed  0,5
Peanuts 0,2 
Poppy seeds  
Sesame seeds  
Sunflower seed  0,5
Rape seed  0,5
Soya bean  
Mustard seed  
Cotton seed  
Others 0,1 0,02

5. Potatoes
 0,05 0,02
Early potatoes  
Ware potatoes  

6. Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)
 0,1 0,1

7. Hops (dried), including hop pellets and unconcentrated powder
 0,1 0,1

