Avis juridique important

Commission Directive 87/552/EEC of 17 November 1987 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs Official Journal L 336 , 26/11/1987 P. 0034 - 0038 Finnish special edition: Chapter 3 Volume 24 P. 0193 Swedish special edition: Chapter 3 Volume 24 P. 0193

***** COMMISSION DIRECTIVE of 17 November 1987 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (87/552/EEC) 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 Directive 87/317/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 were consolidated by Commission Directive 85/429/EEC (3); Whereas the list of cases provided for in Annex I where bentonite/montmorillonite may, without interaction risk, be mixed with antibiotics, coccidiostats and other medicinal substances, should be supplemented; Whereas calcium sulphate dihydrate used as an anti-caking agent, as well as various additives belonging to the group of emulsifiers, comply, in every respect to the principles ruling the admission of additives; whereas it is desirable therefore to authorize their use throughout the Community; Whereas the investigation of various additives currently listed in Annex II and therefore authorizable at national level has not yet been completed; whereas, therefore, the period of authorization of these substances should be extended for a specific period; Whereas the use of various additives has been successfully tested in certain Member States; whereas these new uses should be provisionally authorized, at least at national level until such time as it is permitted at Community level; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for 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, by 30 November 1988 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1. They shall immediately inform the Commission thereof. Article 3 This Directive is addressed to the Member States. Done at Brussels, 17 November 1987. For the Commission Frans ANDRIESSEN Vice-President (1) OJ No L 270, 14. 12. 1970, p. 1. (2) OJ No L 160, 20. 6. 1987, p. 34. (3) OJ No L 245, 12. 9. 1985, p. 1. ANNEX 1. In Annex I: (a) under part E, 'Emulsifiers, stabilizers, thickeners and gelling agents', the following items are added: 1.2.3.4.5.6.7.8 // // // // // // // // // EEC No // Additives // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions 1.2.3.4.5.6,7.8 // // // // // // // // // // // // / / mg/kg of complete feedingstuff // // // // // // // // // 1.2.3.4.5.6.7.8 // 'E 432 E 433 E 434 E 435 E 436 // Polyoxyethylene(20)-sorbitan monolaurate Polyoxyethylene(20)-sorbitan mono-oleate Polyoxyethylene(20)-sorbitan monopalmitate Polyoxyethylene(20)-sorbitan monostearate Polyoxyethylene(20)-sorbitan tristearate // - - - - - // All species or categories of animals // - - - - - // - - - - - // 5 000 (alone or with the other Polysorbates) // Milk replacers only' // // // // // // // // (b) under part L, 'Binders, anti-caking agents and coagulants': (aa) the wording of EEC No E 558 'Bentonite/montmorillonite' is replaced by the following: 1.2.3.4.5.6.7.8 // // // // // // // // // EEC No // Additives // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions 1.2.3.4.5.6,7.8 // // // // // // // // // // // // / / mg/kg of complete feedingstuff // // // // // // // // // 1.2.3.4.5.6.7.8 // 'E 558 // Bentonite/montmorillonite // - // All species or categories of animals // - // - // 20 000 // All feedingstuffs Mixing with additives from the groups of ''antibiotics'', ''growth promoters'', ''coccidiostats and other medicanal substances'' is prohibited except in the case of: Tylosin, Monensin sodium, Narasin, Ipronidazole, Lasalocid sodium, Avoparcin, Flavophospholipol, Salinomycin sodium, Ronidazole and Virginiamycin Indication on the label of the specific name of the additive' // // // // // // // // (bb) the following item is added: 1.2.3.4.5.6.7.8 // // // // // // // // // EEC No // Additives // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions 1.2.3.4.5.6,7.8 // // // // // // // // // // // // / / mg/kg of complete feedingstuff // // // // // // // // // 1.2.3.4.5.6.7.8 // 'E 516 // Calcium sulphate dihydrate // CaSO4.2H2O // All species or categories of animals // - // - // 30 000 // All feedingstuffs' // // // // // // // // 2. In Annex II: (a) under part A, 'Antibiotics': (aa) the date '30. 11. 1987' in the column 'Period of authorization' is replaced by the date '30. 11. 1988' against the following items: No 21 'Virginiamycin'; No 26 'Flavophospholipol'; (bb) the following items are added: 1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // '27 // Salinomycin sodium // C42H69O11Na (Sodium salt of a polvether of monocarboxylic acids produced by Streptomyces albus) // Piglets Pigs // 4 months 6 months // 30 15 // 60 30 // Indicate in the instructions for use: ''Dangerous for Equines'' // 30. 11. 1988 30. 11. 1988 // 28 // Avilamycin // C57-62H82-90Cl1-2O31-32 (Mixtures of oligosaccharides of the orthosomycin group produced by Streptomyces viridochromogenes) // Piglets Pigs // 4 months 6 months // 20 10 // 40 20 // - - // 30. 11. 1988 30. 11. 1988' // // // // // // // // // (b) under part D, 'Coccidiostats and other medicinal substances': (aa) the text of item No 16 is completed as follows: 1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // // // // 'Rabbits // - // 220 // 220 // Use prohibited at least 5 days before slaughter // 30. 11. 1988' // // // // // // // // // (bb) the following item is added: 1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // '20 // Lasalocid sodium // C34H53O8Na (Sodium salt of a polyether of monocarboxylic acid produced by Streptomyces lasaliensis) // Turkeys // 12 weeks // 90 // 125 // Use prohibited at least 5 days before slaughter // 30. 11. 1988' // // // // // // // // // (c) Under part E, 'Emulsifiers, stabilizers, thickeners and gelling agents', the text of item No 29 'Polyoxyethylene (20) sorbitan trioleate' is replaced by the following: 1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // '29 // Polyoxyethylene (20)-sorbitan trioleate // - // All species or categories of animals // - // - // 5 000 (alone or with the other Polysorbates) // All feedingstuffs // 30. 11. 1988' // // // // // // // // // (d) under part F, 'Colouring matters including pigments': (aa) the text of item No 2, 'Canthaxanthin', is replaced by the following: 1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // '2 // Canthaxanthin // C40H52O2 // Salmon, trout // - // - // 100 (alone or together with Astaxanthin) // Use permitted from the age of 6 months onwards // 15. 5. 1988' // // // // // // // // // (bb) the following item is hereby added: 1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // '5 // Astaxanthin // C40H52O4 // Salmon, trout // - // - // 100 (alone or together with Canthaxanthin) // Use permitted from the age of 6 months onwards // 30. 11. 1988' // // // // // // // // // (e) under part G, 'Preservatives', the following item is added: 1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // '20 // Methylpropionic acid // C4H8O2 // All species or categories of animals with the exception of laying hens // - // 1 000 // 4 000 // - // 30. 11. 1988' // // // // // // // // // (f) under part J, 'Growth Promoters', the date '30. 11. 1987' in at the column 'Period of authorization' against Item No 1, 'Nitrovin', is replaced by the date 30. 6. 1988; (g) under part L, 'Binders, anti-caking agents and coagulants', the date '30. 11. 1987' in the column 'Period of authorization' against Item No 5, 'Perlite', is replaced by the date '30. 11. 1988'; (h) under part M, 'Acidity regulators', the date '30. 11. 1987' in the column 'Period of authorization' against all the additives listed under this part is replaced by the date '30. 11. 1988'.

*****

COMMISSION DIRECTIVE

of 17 November 1987

amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

(87/552/EEC)

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 Directive 87/317/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 were consolidated by Commission Directive 85/429/EEC (3);

Whereas the list of cases provided for in Annex I where bentonite/montmorillonite may, without interaction risk, be mixed with antibiotics, coccidiostats and other medicinal substances, should be supplemented;

Whereas calcium sulphate dihydrate used as an anti-caking agent, as well as various additives belonging to the group of emulsifiers, comply, in every respect to the principles ruling the admission of additives; whereas it is desirable therefore to authorize their use throughout the Community;

Whereas the investigation of various additives currently listed in Annex II and therefore authorizable at national level has not yet been completed; whereas, therefore, the period of authorization of these substances should be extended for a specific period;

Whereas the use of various additives has been successfully tested in certain Member States; whereas these new uses should be provisionally authorized, at least at national level until such time as it is permitted at Community level;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for 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, by 30 November 1988 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1. They shall immediately inform the Commission thereof.

Article 3

This Directive is addressed to the Member States.

Done at Brussels, 17 November 1987.

For the Commission

Frans ANDRIESSEN

Vice-President

(1) OJ No L 270, 14. 12. 1970, p. 1.

(2) OJ No L 160, 20. 6. 1987, p. 34.

(3) OJ No L 245, 12. 9. 1985, p. 1.

ANNEX

1. In Annex I:

(a) under part E, 'Emulsifiers, stabilizers, thickeners and gelling agents', the following items are added:

1.2.3.4.5.6.7.8 // // // // // // // // // EEC No // Additives // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions 1.2.3.4.5.6,7.8 // // // // // // // // // // // // / / mg/kg of complete feedingstuff // // // // // // // // // 1.2.3.4.5.6.7.8 // 'E 432 E 433 E 434 E 435 E 436 // Polyoxyethylene(20)-sorbitan monolaurate Polyoxyethylene(20)-sorbitan mono-oleate Polyoxyethylene(20)-sorbitan monopalmitate Polyoxyethylene(20)-sorbitan monostearate Polyoxyethylene(20)-sorbitan tristearate // - - - - - // All species or categories of animals // - - - - - // - - - - - // 5 000 (alone or with the other Polysorbates) // Milk replacers only' // // // // // // // //

(b) under part L, 'Binders, anti-caking agents and coagulants':

(aa) the wording of EEC No E 558 'Bentonite/montmorillonite' is replaced by the following:

1.2.3.4.5.6.7.8 // // // // // // // // // EEC No // Additives // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions 1.2.3.4.5.6,7.8 // // // // // // // // // // // // / / mg/kg of complete feedingstuff // // // // // // // // // 1.2.3.4.5.6.7.8 // 'E 558 // Bentonite/montmorillonite // - // All species or categories of animals // - // - // 20 000 // All feedingstuffs Mixing with additives from the groups of ''antibiotics'', ''growth promoters'', ''coccidiostats and other medicanal substances'' is prohibited except in the case of: Tylosin, Monensin sodium, Narasin, Ipronidazole, Lasalocid sodium, Avoparcin, Flavophospholipol, Salinomycin sodium, Ronidazole and Virginiamycin Indication on the label of the specific name of the additive' // // // // // // // //

(bb) the following item is added:

1.2.3.4.5.6.7.8 // // // // // // // // // EEC No // Additives // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions 1.2.3.4.5.6,7.8 // // // // // // // // // // // // / / mg/kg of complete feedingstuff // // // // // // // // // 1.2.3.4.5.6.7.8 // 'E 516 // Calcium sulphate dihydrate // CaSO4.2H2O // All species or categories of animals // - // - // 30 000 // All feedingstuffs' // // // // // // // //

2. In Annex II:

(a) under part A, 'Antibiotics':

(aa) the date '30. 11. 1987' in the column 'Period of authorization' is replaced by the date '30. 11. 1988' against the following items:

No 21 'Virginiamycin';

No 26 'Flavophospholipol';

(bb) the following items are added:

1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // '27 // Salinomycin sodium // C42H69O11Na (Sodium salt of a polvether of monocarboxylic acids produced by Streptomyces albus) // Piglets Pigs // 4 months 6 months // 30 15 // 60 30 // Indicate in the instructions for use: ''Dangerous for Equines'' // 30. 11. 1988 30. 11. 1988 // 28 // Avilamycin // C57-62H82-90Cl1-2O31-32 (Mixtures of oligosaccharides of the orthosomycin group produced by Streptomyces viridochromogenes) // Piglets Pigs // 4 months 6 months // 20 10 // 40 20 // - - // 30. 11. 1988 30. 11. 1988' // // // // // // // // //

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

(aa) the text of item No 16 is completed as follows:

1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // // // // 'Rabbits // - // 220 // 220 // Use prohibited at least 5 days before slaughter // 30. 11. 1988' // // // // // // // // //

(bb) the following item is added:

1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // '20 // Lasalocid sodium // C34H53O8Na (Sodium salt of a polyether of monocarboxylic acid produced by Streptomyces lasaliensis) // Turkeys // 12 weeks // 90 // 125 // Use prohibited at least 5 days before slaughter // 30. 11. 1988' // // // // // // // // //

(c) Under part E, 'Emulsifiers, stabilizers, thickeners and gelling agents', the text of item No 29 'Polyoxyethylene (20) sorbitan trioleate' is replaced by the following:

1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // '29 // Polyoxyethylene (20)-sorbitan trioleate // - // All species or categories of animals // - // - // 5 000 (alone or with the other Polysorbates) // All feedingstuffs // 30. 11. 1988' // // // // // // // // //

(d) under part F, 'Colouring matters including pigments':

(aa) the text of item No 2, 'Canthaxanthin', is replaced by the following:

1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // '2 // Canthaxanthin // C40H52O2 // Salmon, trout // - // - // 100 (alone or together with Astaxanthin) // Use permitted from the age of 6 months onwards // 15. 5. 1988' // // // // // // // // //

(bb) the following item is hereby added:

1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // '5 // Astaxanthin // C40H52O4 // Salmon, trout // - // - // 100 (alone or together with Canthaxanthin) // Use permitted from the age of 6 months onwards // 30. 11. 1988' // // // // // // // // //

(e) under part G, 'Preservatives', the following item is added:

1.2.3.4.5.6.7.8.9 // // // // // // // // // // No // Additive // Chemical formula, description // Species or category of animal // Maximum age // Minimum content // Maximum content // Other provisions // Period of authorization 1.2.3.4.5.6,7.8.9 // // // // // // // // // // // // // // mg/kg of complete feedingstuffs // // // // // // // // // // // 1.2.3.4.5.6.7.8.9 // '20 // Methylpropionic acid // C4H8O2 // All species or categories of animals with the exception of laying hens // - // 1 000 // 4 000 // - // 30. 11. 1988' // // // // // // // // //

(f) under part J, 'Growth Promoters', the date '30. 11. 1987' in at the column 'Period of authorization' against Item No 1, 'Nitrovin', is replaced by the date 30. 6. 1988;

(g) under part L, 'Binders, anti-caking agents and coagulants', the date '30. 11. 1987' in the column 'Period of authorization' against Item No 5, 'Perlite', is replaced by the date '30. 11. 1988';

(h) under part M, 'Acidity regulators', the date '30. 11. 1987' in the column 'Period of authorization' against all the additives listed under this part is replaced by the date '30. 11. 1988'.