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Commission Directive 85/520/EEC of 11 November 1985 amending Commission Directive 85/429/EEC, amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs Official Journal L 323 , 04/12/1985 P. 0012 - 0016 Spanish special edition: Chapter 03 Volume 39 P. 0088 Portuguese special edition Chapter 03 Volume 39 P. 0088 Finnish special edition: Chapter 3 Volume 19 P. 0223 Swedish special edition: Chapter 3 Volume 19 P. 0223

***** COMMISSCOMMISSION DIRECTIVE of 11 November 1985 amending Commission Directive 85/429/EEC, amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (85/520/EEC) THETHE 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 85/429/EEC (2), and in particular Article 7 thereof, Whereas Directive 70/524/EEC provides for regular adaptation of the content of its Annexes to the evolution of scientific and technical knowledge; Whereas certain additives of the antibiotics, coccidiostats, emulsifers or preservatives groups, hitherto authorized for certain uses at national level, have been widely tested, whereas the studies carried out and experience gained indicate that these additives may be authorized throughout the Community for the uses specified; Whereas Directive 70/524/EEC authorizes, under certain conditions, the use of copper in feedingstuffs and fixes, in particular, maximum levels for copper for different types of feedingstuffs for pigs; Whereas there is evidence that pig slurry could contain certain risks for the environment in Member States with very intensive pig rearing and little surface for the spreading of slurry; whereas the copper contribution by slurry could lead to a not negligible increase of the copper level in soils and cause phytotoxic effects in more or less long terms; Whereas taking account of the particular situation of these Member States, it is therefore appropriate beyond a specific threshold of total number of pigs to provide for the fixing of maximum levels for copper lower than those actually fixed by Directive 70/524/EEC for fattening pigs; it is also indicated to adapt the levels intended for other categories or species of animals to their real physiological need (requirements); 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 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 of Directive 70/524/EEC shall be amended as set out in the Annex hereto. Article 2 Member States shall, by 3 December 1986, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1, and shall immedialety inform the Commission thereof. Article 3 This Directive is addressed to the Member States. Done at Brussels, 11 November 1985. For the Commission Frans ANDRIESSEN Vice-President ((1) OJ No L 270, 14. 12. 1970, p. 1. (2) OJ No L 245, 12. 9. 1985, p. 1. ANNEX 1. In Annex I (a) under part A 'Antibiotics' item EEC No E 715 is completed as follows: 1.2.3.4.5.6.7.8 // // // // // // // // // 'EEC No // Additive // 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 // // // / / Calves // 6 months // 15 // 40 // - // // // // Cattle for fattening // - // 15 // 30 // Indicate in the instructions for use: // // // // // // // // '- for supplementary feedingstuffs, the maximum dose in the daily ration must not exceed: // // // // // // // // - for 100 kg bodyweight: 110 mg; // // // // // // // // - above 100 kg: add 5 mg for each additional 10 kg bodyweight' // // // // // // // // (b) under part D 'Coccidiostats and other medicinal substances', the item EEC No E 761 'Meticlorpindol/methylbenzoquate: (mixture of 100 parts of (a) meticlorpindol and 8,35 parts of (b) methylbenzoquate)' is completed as follows: 1.2.3.4.5.6.7.8 // // // // // // // // // 'EEC No // Additive // 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 // // // / / Turkeys // 12 weeks // 110 // 110 // Use prohibited at least 5 days before slaughter' // // // // // // // // (c) under part E 'Emulsifiers, stabilizers, thickeners and gelling agents', the following item is added: 1.2.3.4.5.6.7.8 // // // // // // // // // 'EEC No // Additive // 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 498 // Partial polyglycerol esters of polycondensed fatty acids of castor oil // - // Dogs // - // - // - // All feedingstuffs' // // // // // // // // (d) under part G 'Preservatives' aa) the following item is added: 1.2.3.4.5.6.7.8 // // // // // // // // // 'EEC No // Additive // 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 250 // Sodium nitrite // NaNO2 // Dogs, cats // - // - // 100 // Canned feedingstuffs only' // // // // // // // // bb) item EEC No E 490 'Propane-1,2-diol' is completed as follows: 1.2.3.4.5.6.7.8 // // // // // // // // // 'EEC No // Additive // 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 // // // / / Cats // - // - // 75 000 // All feedingstuffs' // // // // // // // // (e) under part I 'Trace elements' the text of item EEC No E 4 'Copper-Cu' is replaced by the following: 1.2.3.4.5,6 // // // // // // 'EEC No // Element // Additive // Chemical formula // Maximum content of the element in mg/kg of the complete feedingstuff // 1.2.3.4.5.6 // // // // // // // E4 // Copper-Cu // Cupric acetate, monohydrate Cupric methionate // Cu(CH3COO)2.H2O Cu(C5H10NO2S)2 // Pigs for fattening: - up to 16 weeks: 175 (total) - from 17th week up to slaughter: 35 (total) // In Member States where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilizable agricultural land // // // Basic cupric carbonate, monohydrate Cupric chloride, dihydrate Cupric oxide Cupric sulphate, pentahydrate // CuCO3.Cu(OH)2.H2O CuC12.2H2O CuO CuSO4.5H2O // Pigs for fattening: - up to 16 weeks: 175 (total) - from 17th week up to 6 months: 100 (total) - over 6 months up to slaughter: 35 (total) Breeding pigs: 35 (total) Calves: - milk replacers: 30 (total) - other complete feedingstuffs: 50 (total) Ovines: 20 (total) Other species or categories of animals: 35 (total) // In Member States where the mean density of the porcine population is lower than 175 pigs per 100 ha of utilizable agricultural land' // // // // // // 2. In Annex II: (a) under part A 'Antibiotics' aa) the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items: No 21 Virginiamycin No 22 Avoparcin No 25 Nosiheptide; bb) under item No 22 'Avoparcin' aaa) in the column 'Maximum content' the figure 45 is replaced by the figure 30 with respect to cattle for fattening; bbb) in the column 'Other provisions' - first indent: the figure 155 is replaced by the figure 110; - second indent: the figure 6,5 is replaced by the figure 5; (b) under part D 'Coccidiostats and other medicinal substances' aa) the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items: No 6 Nicarbazine No 16 Meticlorpindol/methylbenzoquate (mixture of 100 parts of (a) meticlorpindol and 8,35 parts of (b) methylbenzoquate) No 19 Nifursol; bb) under item No 6 'Nicarbazine' the term '7 days' in the column headed 'Other provisions' is replaced by the term '9 days'; cc) under item No 19 'Nifursol', the indications in the column headed 'Other provisions' are completed as follows: 'Indicate in the instructions for use: "Avoid inhalation and contact with the skin" '; (c) under part E 'Emulsifiers, stabilizers, thickeners and gelling agents' aa) the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items: No 8 Partial polyglycerol ersters of polycondensed fatty acids of castor oil No 12 Polyoxyethylene (20) sorbitan monolaurate No 13 Polyoxyethylene (20) sorbitan monopalmitate No 14 Polyoxyethylene (20) sorbitan monostearate No 15 Polyoxyethylene (20) sorbitan tristearate No 16 Polyoxyethylene (20) sorbitan mono-oleate No 29 Polyoxyethylene (20) sorbitan trioleate (synonym: polysorbate 85); bb) under item No 8 'Partial polyglycerol esters of polycondensed fatty accids of castor oil' the word 'Dogs' is added in the column headed 'Species or category of animal'; (d) under part F 'Colouring matters including pigments' the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1985 for item No 2 'Canthaxanthin'; (e) under part G 'Preservatives' aa) the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items: No 3 Hydrochloric acid No 4 Sulphuric acid No 5 Formaldehyde No 16 Sodium nitrite (E 250) No 19 Propane-1,2-diol; bb) under item No 16 'Sodium nitrite (E 250)' in the column headed 'Other provisions' the words 'except canned feedingstuffs' are added after 'All feedingstuffs'; (f) under part J 'Growth promoters' the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items: No 1 Nitrovin No 2 Carbadox No 3 Olaquindox; (g) under part L 'Binders, anti-caking agents and coagulants' the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items: No 1 Bentonite and montmorillonite No 4 Natural mixtures of steatite and chlorite free of asbestos, other than the mixture E 560 No 5 Perlite.

*****

COMMISSCOMMISSION DIRECTIVE

of 11 November 1985

amending Commission Directive 85/429/EEC, amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

(85/520/EEC)

THETHE 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 85/429/EEC (2), and in particular Article 7 thereof,

Whereas Directive 70/524/EEC provides for regular adaptation of the content of its Annexes to the evolution of scientific and technical knowledge;

Whereas certain additives of the antibiotics, coccidiostats, emulsifers or preservatives groups, hitherto authorized for certain uses at national level, have been widely tested, whereas the studies carried out and experience gained indicate that these additives may be authorized throughout the Community for the uses specified;

Whereas Directive 70/524/EEC authorizes, under certain conditions, the use of copper in feedingstuffs and fixes, in particular, maximum levels for copper for different types of feedingstuffs for pigs;

Whereas there is evidence that pig slurry could contain certain risks for the environment in Member States with very intensive pig rearing and little surface for the spreading of slurry; whereas the copper contribution by slurry could lead to a not negligible increase of the copper level in soils and cause phytotoxic effects in more or less long terms;

Whereas taking account of the particular situation of these Member States, it is therefore appropriate beyond a specific threshold of total number of pigs to provide for the fixing of maximum levels for copper lower than those actually fixed by Directive 70/524/EEC for fattening pigs; it is also indicated to adapt the levels intended for other categories or species of animals to their real physiological need (requirements);

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

HAS ADOPTED THIS DIRECTIVE:

The Annexes of Directive 70/524/EEC shall be amended as set out in the Annex hereto.

Article 2

Member States shall, by 3 December 1986, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1, and shall immedialety inform the Commission thereof.

Article 3

This Directive is addressed to the Member States.

Done at Brussels, 11 November 1985.

For the Commission

Frans ANDRIESSEN

Vice-President

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

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

ANNEX

1. In Annex I

(a) under part A 'Antibiotics' item EEC No E 715 is completed as follows:

1.2.3.4.5.6.7.8 // // // // // // // // // 'EEC No // Additive // 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 // // // / / Calves // 6 months // 15 // 40 // - // // // // Cattle for fattening // - // 15 // 30 // Indicate in the instructions for use: // // // // // // // // '- for supplementary feedingstuffs, the maximum dose in the daily ration must not exceed: // // // // // // // // - for 100 kg bodyweight: 110 mg; // // // // // // // // - above 100 kg: add 5 mg for each additional 10 kg bodyweight' // // // // // // // //

(b) under part D 'Coccidiostats and other medicinal substances', the item EEC No E 761 'Meticlorpindol/methylbenzoquate: (mixture of 100 parts of (a) meticlorpindol and 8,35 parts of (b) methylbenzoquate)' is completed as follows:

1.2.3.4.5.6.7.8 // // // // // // // // // 'EEC No // Additive // 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 // // // / / Turkeys // 12 weeks // 110 // 110 // Use prohibited at least 5 days before slaughter' // // // // // // // //

(c) under part E 'Emulsifiers, stabilizers, thickeners and gelling agents', the following item is added:

1.2.3.4.5.6.7.8 // // // // // // // // // 'EEC No // Additive // 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 498 // Partial polyglycerol esters of polycondensed fatty acids of castor oil // - // Dogs // - // - // - // All feedingstuffs' // // // // // // // //

(d) under part G 'Preservatives'

aa) the following item is added:

1.2.3.4.5.6.7.8 // // // // // // // // // 'EEC No // Additive // 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 250 // Sodium nitrite // NaNO2 // Dogs, cats // - // - // 100 // Canned feedingstuffs only' // // // // // // // //

bb) item EEC No E 490 'Propane-1,2-diol' is completed as follows:

1.2.3.4.5.6.7.8 // // // // // // // // // 'EEC No // Additive // 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 // // // / / Cats // - // - // 75 000 // All feedingstuffs' // // // // // // // //

(e) under part I 'Trace elements' the text of item EEC No E 4 'Copper-Cu' is replaced by the following:

1.2.3.4.5,6 // // // // // // 'EEC No // Element // Additive // Chemical formula // Maximum content of the element in mg/kg of the complete feedingstuff // 1.2.3.4.5.6 // // // // // // // E4 // Copper-Cu // Cupric acetate, monohydrate Cupric methionate // Cu(CH3COO)2.H2O Cu(C5H10NO2S)2 // Pigs for fattening: - up to 16 weeks: 175 (total) - from 17th week up to slaughter: 35 (total) // In Member States where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilizable agricultural land // // // Basic cupric carbonate, monohydrate Cupric chloride, dihydrate Cupric oxide Cupric sulphate, pentahydrate // CuCO3.Cu(OH)2.H2O CuC12.2H2O CuO CuSO4.5H2O // Pigs for fattening: - up to 16 weeks: 175 (total) - from 17th week up to 6 months: 100 (total) - over 6 months up to slaughter: 35 (total) Breeding pigs: 35 (total) Calves: - milk replacers: 30 (total) - other complete feedingstuffs: 50 (total) Ovines: 20 (total) Other species or categories of animals: 35 (total) // In Member States where the mean density of the porcine population is lower than 175 pigs per 100 ha of utilizable agricultural land' // // // // // //

2. In Annex II:

(a) under part A 'Antibiotics'

aa) the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items:

No 21 Virginiamycin

No 22 Avoparcin

No 25 Nosiheptide;

bb) under item No 22 'Avoparcin'

aaa) in the column 'Maximum content' the figure 45 is replaced by the figure 30 with respect to cattle for fattening;

bbb) in the column 'Other provisions'

- first indent: the figure 155 is replaced by the figure 110;

- second indent: the figure 6,5 is replaced by the figure 5;

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

aa) the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items:

No 6 Nicarbazine

No 16 Meticlorpindol/methylbenzoquate (mixture of 100 parts of (a) meticlorpindol and 8,35 parts of (b) methylbenzoquate)

No 19 Nifursol;

bb) under item No 6 'Nicarbazine' the term '7 days' in the column headed 'Other provisions' is replaced by the term '9 days';

cc) under item No 19 'Nifursol', the indications in the column headed 'Other provisions' are completed as follows: 'Indicate in the instructions for use: "Avoid inhalation and contact with the skin" ';

(c) under part E 'Emulsifiers, stabilizers, thickeners and gelling agents'

aa) the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items:

No 8 Partial polyglycerol ersters of polycondensed fatty acids of castor oil

No 12 Polyoxyethylene (20) sorbitan monolaurate

No 13 Polyoxyethylene (20) sorbitan monopalmitate

No 14 Polyoxyethylene (20) sorbitan monostearate

No 15 Polyoxyethylene (20) sorbitan tristearate

No 16 Polyoxyethylene (20) sorbitan mono-oleate

No 29 Polyoxyethylene (20) sorbitan trioleate (synonym: polysorbate 85);

bb) under item No 8 'Partial polyglycerol esters of polycondensed fatty accids of castor oil' the word 'Dogs' is added in the column headed 'Species or category of animal';

(d) under part F 'Colouring matters including pigments' the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1985 for item No 2 'Canthaxanthin';

(e) under part G 'Preservatives'

aa) the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items:

No 3 Hydrochloric acid

No 4 Sulphuric acid

No 5 Formaldehyde

No 16 Sodium nitrite (E 250)

No 19 Propane-1,2-diol;

bb) under item No 16 'Sodium nitrite (E 250)' in the column headed 'Other provisions' the words 'except canned feedingstuffs' are added after 'All feedingstuffs'; (f) under part J 'Growth promoters' the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items:

No 1 Nitrovin

No 2 Carbadox

No 3 Olaquindox;

(g) under part L 'Binders, anti-caking agents and coagulants' the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items:

No 1 Bentonite and montmorillonite

No 4 Natural mixtures of steatite and chlorite free of asbestos, other than the mixture E 560

No 5 Perlite.