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Commission Directive 91/508/EEC of 9 September 1991 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs Official Journal L 271 , 27/09/1991 P. 0067 - 0069 Finnish special edition: Chapter 3 Volume 39 P. 0096 Swedish special edition: Chapter 3 Volume 39 P. 0096

COMMISSION DIRECTIVE of 9 September 1991 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (91/508/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 Commission Directive 91/336/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 a new use of the antibiotic 'salinomycin sodium', the sweetener 'neohesperidine dihydrochalcone', the vitamin D3 and the trace element 'iron', in the form of a ferrous chelate of amino acids hydrate has been successfully 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 certain studies have cast doubt on the effectiveness of the carotenoid 'violaxanthin', whereas it is advisable to ban the use of this colourant; Whereas the use of a new coccidiostat has been successfully tested in certain Member States; whereas it is suitable provisionally to authorize this new use at national level while waiting for it 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, by 30 November 1992 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1. They shall inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 3 This Directive is addressed to the Member States. Done at Brussels, 9 September 1991. For the Commission Ray MAC SHARRY Member of the Commission (1) OJ No L 270, 14. 12. 1970, p. 1. (2) OJ No L 185, 11. 7. 1991, p. 31. (3) OJ No L 124, 18. 5. 1991, p. 1. ANNEX 1. In Annex I: (a) In part A 'Antibiotics', (aa) item E 714 'Monensin-sodium', the following is added in the column 'Other provisions' after the word 'equines': 'This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated'; (bb) the following item is added: EEC No Additives Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content mg/kg of complete feedingstuff Other provisions E 716 Salinomycin sodium C42H69O11Na (sodium salt of a polyether monocarboxylic acid produced by Streptomyces albus) Piglets Pigs 4 months 6 months 30 15 60 30 Indicate in the instructions for use: - 'Dangerous for equines'; - 'This feedingstuff contains on ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated.' (b) In part C 'Aromatic and appetizing substances', point 2, the following item is inserted: EEC No Additives Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content mg/kg of complete feedingstuff Other provisions E 959 Neohesperidine dihydrochalcone C28H36O15 Piglets Dogs 4 months - - - 35 35 - - (c) in part D 'Coccidiostats and other medicinal substances': (aa) item E 757 'Monensin-sodium', the following sentence is added in the column 'Other provisions' after the word 'equines': 'This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated'; (bb) item E 763 'Lasalocid-sodium', the following sentence is added in the column 'Other provisions': 'Indicate in the instructions for use: "This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contra indicated"'; (cc) item E 765 'Narasin', the following sentence is added in the column 'Other provisions' after the word 'equines': 'This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated'; (dd) item E 766 'Salinomycin-sodium' the following sentence is added in the column 'Other provisions' after the word 'equines': 'This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated'; (d) in part F 'Colouring matters including pigments', point 1 'Carotenoids and xanthopylls', item E 161e 'Violaxanthin' is deleted; (e) in part H 'Vitamins, provitamins and chemically well-defined substances having similar effect': (aa) item E 670 'Vitamin D2', in the column 'Species or category of animal' the indication 'Other species or categories of animals with the exception of poultry' is replaced by the indication 'Other species or categories of animals with the exception of poultry and fish'; (bb) item E 671 'Vitamin D3', the following indications are inserted after those concerning the category 'Other poultry': EEC No Additive Chemical formula, description Specie or categorie of animal Maximum age Maximum content iu/kg of complete feedingstuff or of the daily ration Other provisions Fish - 3 000 Simultaneous use of vitamin D2 prohibited (f) In part I 'Trace elements', the wording of item E 1 'Iron-Fe' is completed as follows: EEC No Element Additive Chemical formula Maximum content of the element in mg/kg of the complete feedingstuff Other provisions Ferrous chelate of amino acids hydrate Fe(x)1-3.nH2O (where x equals an anion of any amino acids derived from hydrolyzed soya protein) molecular weight not exceeding 1 500 - - 2. In Annex II in part D 'Coccidiostats and other medicinal substances': (a) item 20 'Lasalocid sodium', the following sentence is added in the column 'Other provisions': 'Indicate in the instructions for use: "This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contra indicated"'; (b) item 21 'Maduramicin ammonium', the following sentence is added in the column 'Other provisions' after the word 'equines': 'This feeedingstuff contains an ionophore; simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated'; (c) item 23 'Narasin/Nicarbazin' the following sentence is added in the column 'Other provisions' after the word 'equines': 'This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated', (d) the following item is added: EEC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content mg/kg of complete feedingstuff Other provisions Period of authorization 24 Diclazuril (+)-4-chlorphenyl[2,6-dichloro- 4-(2,3,4,5-tetrohydro-3,5-dioxo- 1,2,4-triazin-2-yl)phenyl] acetonitrile Chickens for fattening - 1 1 Use prohibited at least 5 days before slaughter 30. 11. 1992

COMMISSION DIRECTIVE of 9 September 1991 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (91/508/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 Commission Directive 91/336/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 a new use of the antibiotic 'salinomycin sodium', the sweetener 'neohesperidine dihydrochalcone', the vitamin D3 and the trace element 'iron', in the form of a ferrous chelate of amino acids hydrate has been successfully 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 certain studies have cast doubt on the effectiveness of the carotenoid 'violaxanthin', whereas it is advisable to ban the use of this colourant;

Whereas the use of a new coccidiostat has been successfully tested in certain Member States; whereas it is suitable provisionally to authorize this new use at national level while waiting for it 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, by 30 November 1992 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1. They shall inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.

Article 3

This Directive is addressed to the Member States. Done at Brussels, 9 September 1991. For the Commission

Ray MAC SHARRY

Member of the Commission

(1) OJ No L 270, 14. 12. 1970, p. 1. (2) OJ No L 185, 11. 7. 1991, p. 31. (3) OJ No L 124, 18. 5. 1991, p. 1.

ANNEX

1. In Annex I:

(a) In part A 'Antibiotics',

(aa) item E 714 'Monensin-sodium', the following is added in the column 'Other provisions' after the word 'equines':

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

(bb) the following item is added:

EEC

No Additives Chemical formula,

description Species or category

of animal Maximum

age Minimum

content Maximum

content mg/kg of complete

feedingstuff Other provisions E 716 Salinomycin sodium C42H69O11Na (sodium salt of a polyether monocarboxylic acid produced by Streptomyces albus) Piglets

Pigs 4 months

6 months 30

15 60

30 Indicate in the instructions for use:

- 'Dangerous for equines';

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

(b) In part C 'Aromatic and appetizing substances', point 2, the following item is inserted:

EEC

No Additives Chemical formula,

description Species or category

of animal Maximum

age Minimum

content Maximum

content mg/kg of complete

feedingstuff Other provisions E 959 Neohesperidine dihydrochalcone C28H36O15 Piglets

Dogs 4 months

- -

- 35

35 -

-

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

(aa) item E 757 'Monensin-sodium', the following sentence is added in the column 'Other provisions' after the word 'equines':

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

(bb) item E 763 'Lasalocid-sodium', the following sentence is added in the column 'Other provisions':

'Indicate in the instructions for use:

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

(cc) item E 765 'Narasin', the following sentence is added in the column 'Other provisions' after the word 'equines':

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

(dd) item E 766 'Salinomycin-sodium' the following sentence is added in the column 'Other provisions' after the word 'equines':

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

(d) in part F 'Colouring matters including pigments', point 1 'Carotenoids and xanthopylls', item E 161e 'Violaxanthin' is deleted;

(e) in part H 'Vitamins, provitamins and chemically well-defined substances having similar effect':

(aa) item E 670 'Vitamin D2', in the column 'Species or category of animal' the indication 'Other species or categories of animals with the exception of poultry' is replaced by the indication 'Other species or categories of animals with the exception of poultry and fish';

(bb) item E 671 'Vitamin D3', the following indications are inserted after those concerning the category 'Other poultry':

EEC No Additive Chemical formula, description Specie or categorie of animal Maximum age Maximum content iu/kg of complete feedingstuff or of the daily ration Other provisions Fish - 3 000 Simultaneous use of vitamin D2 prohibited

(f) In part I 'Trace elements', the wording of item E 1 'Iron-Fe' is completed as follows:

EEC No Element Additive Chemical formula Maximum content of the element in mg/kg of the complete feedingstuff Other provisions Ferrous chelate of amino acids hydrate Fe(x)1-3.nH2O (where x equals an anion of any amino acids derived from hydrolyzed soya protein) molecular weight not exceeding 1 500 - -

2. In Annex II in part D 'Coccidiostats and other medicinal substances':

(a) item 20 'Lasalocid sodium', the following sentence is added in the column 'Other provisions':

'Indicate in the instructions for use:

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

(b) item 21 'Maduramicin ammonium', the following sentence is added in the column 'Other provisions' after the word 'equines':

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

(c) item 23 'Narasin/Nicarbazin' the following sentence is added in the column 'Other provisions' after the word 'equines':

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

(d) the following item is added:

EEC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content mg/kg of complete feedingstuff Other provisions Period of authorization 24 Diclazuril (+)-4-chlorphenyl[2,6-dichloro-

4-(2,3,4,5-tetrohydro-3,5-dioxo-

1,2,4-triazin-2-yl)phenyl]

acetonitrile Chickens for

fattening - 1 1 Use prohibited at least 5 days before slaughter 30. 11. 1992