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Commission Directive 92/64/EEC of 13 July 1992 amending Council Directive 70/524/EEC concerning additives in feedingstuffs Official Journal L 221 , 06/08/1992 P. 0051 - 0053 Finnish special edition: Chapter 3 Volume 44 P. 0115 Swedish special edition: Chapter 3 Volume 44 P. 0115

COMMISSION DIRECTIVE 92/64/EEC of 13 July 1992 amending Council Directive 70/524/EEC concerning additives in feedingstuffs THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 91/620/EEC (2), and in particular Article 7 thereof, Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge; whereas the Annexes have been codified by Commission Directive 91/248/EEC (3); Whereas the use of the antibiotic 'Avilamycin', of the coccidiostats 'Lasalocid sodium' and 'Maduramicin ammonium', as well as of the binder 'synthetic calcium aluminates' has been widely tested in certain Member States; whereas, on the basis of experience gained, it appears that these new uses can be authorized throughout the Community; Whereas the additive 'zinc oxide' can, according to its origins, contain significant quantities of lead and whereas it is appropriate to limit the content of this substance in order to prevent undesirable effects on health; Whereas new uses of the coccidiostat 'halofuginone' and of the binder 'synthetic calcium aluminates' have been successfully tested in certain Member States; whereas it is appropriate to authorize these new uses provisionally at national level, while waiting for them to be authorized at Community level; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, HAS ADOPTED THIS DIRECTIVE: Article 1 The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex hereto. Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 31 March 1993 at the latest. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States. Done at Brussels, 13 July 1992. For the Commission Ray MAC SHARRY Member of the Commission (1) OJ No L 270, 14. 12. 1970, p. 1. (2) OJ No L 334, 5. 12. 1991, p. 62. (3) OJ No L 124, 18. 5. 1991, p. 1. ANNEX 1. In Annex I: (a) in part A 'Antibiotica', the following item is added: EEC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions mg/kg of complete feedingstuff E 717 Avilamycin C57-62H82-90CI1-2O31-32 (Mixture of oligosaccharides of the orthosomycin group produced by Strepomyces viridochromogenes ) Piglets Pigs 4 months 6 months 20 10 40 20 - - (b) in part D 'Coccidiostats and other medicinal substances': (aa) the wording of item E 763 'Lasalocid sodium' is completed as follows: EEC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions mg/kg of complete feedingstuff Turkeys 12 weeks 90 125 Use prohibited at least five days before slaughter Indicate in the instructions for use: 'This feedingstuff contains an ionophore; simultaneous use with certain medicinal substances can be contra-indicated' (bb) the following item is added: EEC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions mg/kg of complete feedingstuff E 770 Maduramicin ammonium C47H83O17N (ammonium salt of a polyether monocarboxylic acid produced by Actinomadura yumaensis ) Chickens for fattening - 5 5 Indicate in the instructions for use: '- Use prohibited at least five days before slaughter - Dangerous for Equidae' 'This feedingstuff contains an ionophore; simultaneous use with certain medicinal substances (e. g. tiamulin) can be contra-indicated' (c) in part I 'Trace elements' item E 6 'Zinc - Zn', the provision 'Maximum content of lead: 600 mg/kg', is indicated in the column 'Other provisions' for the additive 'Zinc oxide'. (d) in part L 'Binders, anti-caking agents and coagulants': (aa) item E 558 'Bentonite montmorillonite' in the column 'Other provisions', the words 'and Robenidine' are replaced by the words 'Robenidine, maduramicin ammonium' (bb) the following item is added: EEC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions mg/kg of complete feedingstuff E 598 Synthetic calcium aluminates Mixture of calcium aluminates containing between 35 and 51 % of AI2O3 Maximum molybdenum content of 20 mg/kg Poultry, rabbits and pigs - - 20 000 All feedingstuffs 2. In Annex II: (a) in part D 'Coccidiostats and other medicinal substances', the following item is added: No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions Period of authorization mg/kg of complete feedingstuff 25 Halofuginone di-trans-7-bromo-6-chloro-3- [3-(3-hydroxy-2-piperidyl) acetonyl] quinazolin-4(3H)-one hydrobromide Chickens reared for laying 16 weeks 3 3 - 30. 11. 1993 (b) in part L 'Binders, anti-caking agents and coagulants', the wording of the item No 1 'Synthetic calcium aluminates' is completed as follows: No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions Period of authorization mg/kg of complete feedingstuff Dairy cows Cattle for fattening calves, lambs, kids - - 8 000 All feedingstuffs 30. 11. 1993

COMMISSION DIRECTIVE 92/64/EEC of 13 July 1992 amending Council Directive 70/524/EEC concerning additives in feedingstuffs

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 91/620/EEC (2), and in particular Article 7 thereof,

Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge; whereas the Annexes have been codified by Commission Directive 91/248/EEC (3);

Whereas the use of the antibiotic 'Avilamycin', of the coccidiostats 'Lasalocid sodium' and 'Maduramicin ammonium', as well as of the binder 'synthetic calcium aluminates' has been widely tested in certain Member States; whereas, on the basis of experience gained, it appears that these new uses can be authorized throughout the Community;

Whereas the additive 'zinc oxide' can, according to its origins, contain significant quantities of lead and whereas it is appropriate to limit the content of this substance in order to prevent undesirable effects on health;

Whereas new uses of the coccidiostat 'halofuginone' and of the binder 'synthetic calcium aluminates' have been successfully tested in certain Member States; whereas it is appropriate to authorize these new uses provisionally at national level, while waiting for them to be authorized at Community level;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex hereto.

Article 2

Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 31 March 1993 at the latest. They shall immediately inform the Commission thereof.

When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

Article 3

This Directive is addressed to the Member States. Done at Brussels, 13 July 1992. For the Commission

Ray MAC SHARRY

Member of the Commission

(1) OJ No L 270, 14. 12. 1970, p. 1. (2) OJ No L 334, 5. 12. 1991, p. 62. (3) OJ No L 124, 18. 5. 1991, p. 1.

ANNEX

1. In Annex I:

(a) in part A 'Antibiotica', the following item is added:

EEC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions mg/kg of complete feedingstuff E 717 Avilamycin C57-62H82-90CI1-2O31-32 (Mixture of oligosaccharides of the orthosomycin group produced by Strepomyces viridochromogenes ) Piglets

Pigs 4 months

6 months 20

10 40

20 -

-

(b) in part D 'Coccidiostats and other medicinal substances':

(aa) the wording of item E 763 'Lasalocid sodium' is completed as follows:

EEC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions mg/kg of complete feedingstuff Turkeys 12 weeks 90 125 Use prohibited at least five days before slaughter

Indicate in the instructions for use:

'This feedingstuff contains an ionophore; simultaneous use with certain medicinal substances can be contra-indicated'

(bb) the following item is added:

EEC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions mg/kg of complete feedingstuff E 770 Maduramicin ammonium C47H83O17N (ammonium salt of a polyether monocarboxylic acid produced by Actinomadura yumaensis ) Chickens for fattening - 5 5 Indicate in the instructions for use:

'- Use prohibited at least five days before slaughter

- Dangerous for Equidae'

'This feedingstuff contains an ionophore; simultaneous use with certain medicinal substances (e. g. tiamulin) can be contra-indicated'

(c) in part I 'Trace elements' item E 6 'Zinc - Zn', the provision 'Maximum content of lead: 600 mg/kg', is indicated in the column 'Other provisions' for the additive 'Zinc oxide'.

(d) in part L 'Binders, anti-caking agents and coagulants':

(aa) item E 558 'Bentonite montmorillonite' in the column 'Other provisions', the words 'and Robenidine' are replaced by the words 'Robenidine, maduramicin ammonium'

(bb) the following item is added:

EEC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions mg/kg of complete feedingstuff E 598 Synthetic calcium aluminates Mixture of calcium aluminates containing between 35 and 51 % of AI2O3

Maximum molybdenum content of 20 mg/kg Poultry, rabbits and pigs - - 20 000 All feedingstuffs

2. In Annex II:

(a) in part D 'Coccidiostats and other medicinal substances', the following item is added:

No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions Period of authorization mg/kg of complete feedingstuff 25 Halofuginone di-trans-7-bromo-6-chloro-3- [3-(3-hydroxy-2-piperidyl) acetonyl] quinazolin-4(3H)-one hydrobromide Chickens reared for laying 16 weeks 3 3 - 30. 11. 1993

(b) in part L 'Binders, anti-caking agents and coagulants', the wording of the item No 1 'Synthetic calcium aluminates' is completed as follows:

No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions Period of authorization mg/kg of complete feedingstuff Dairy cows

Cattle for fattening calves, lambs, kids - - 8 000 All feedingstuffs 30. 11. 1993