Avis juridique important

Commission Directive 88/483/EEC of 14 July 1988 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs Official Journal L 237 , 27/08/1988 P. 0039 - 0043 Finnish special edition: Chapter 3 Volume 27 P. 0118 Swedish special edition: Chapter 3 Volume 27 P. 0118

***** COMMISSION DIRECTIVE of 14 July 1988 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (88/483/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 88/228/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 risk of interaction, be mixed with antibiotics, coccidiostats and other medicinal substances should be supplemented; Whereas perlite, used as an anticaking agent, complies in every respect with the principles governing the admission of additives; whereas it is desirable therefore to authorize its use throughout the Community; Whereas Commission Regulations (EEC) No 368/77 (4) and (EEC) No 443/77 (5), as last amended by Regulations (EEC) No 222/88 (6) and (EEC) No 1413/87 (7) respectively, provide for the use of certain iron and copper compounds for denaturing skimmed-milk powder used for the nutrition of animals with the exception of young calves; whereas it is necessary therefore to adapt Annex I to Directive 70/524/EEC; Whereas the investigation of the growth promotor 'Nitrovin' currently listed in Annex II and therefore authorizable at national level has not yet been completed; whereas, therefore, the period of authorization of this substance should be extended for a specific period; Whereas the use of a new coccidiostat, maduramicin ammonium, has been successfully tested in certain Member States; whereas this new additive should be provisionally authorized 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 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 June 1989 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof. Article 3 This Directive is addressed to the Member States. Done at Brussels, 14 July 1988. For the Commission Frans ANDRIESSEN Vice-President (1) OJ No L 270, 14. 12. 1970, p. 1. (2) OJ No L 101, 20. 4. 1988, p. 30. (3) OJ No L 245, 12. 9. 1985, p. 1. (4) OJ No L 52, 24. 2. 1977, p. 19. (5) OJ No L 58, 3. 3. 1977, p. 16. (6) OJ No L 28, 1. 2. 1988, p. 1. (7) OJ No L 133, 23. 5. 1987, p. 15. ANNEX 1. In Annex I: (a) the wording of part I, 'Trace elements' 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 // Other provisions // // // // // // // // // // // // // // 'I. Trace elements // // // // // E 1 // Iron-Fe // // // 1 250 (total) // // // // Ferrous carbonate // FeCO3 // // - // // // Ferrous chloride, tetrahydrate // FeCl2.4H2O // // - // // // Ferric chloride, hexahydrate // FeCl3.6H2O // // - // // // Ferrous citrate, hexahydrate // Fe3(C6H5O7)2.6H2O // // - // // // Ferrous fumarate // FeC4H2O4 // // - // // // Ferrous lactate, trihydrate // Fe(C3H5O3)2.3H2O // // - // // // Ferric oxide // Fe2O3 // // - // // // Ferrous sulphate monohydrate // FeSO4.H2O // // Permitted only for denaturing: - in skimmed-milk powder and - in compound feedingstuffs manufactured from denatured skimmed-milk powder // // // // // // Subject to the releyant provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77 // // // // // // Declaration of the amount of iron added, expressed as the element, on the label or package or container of denatured skimmed-milk powder // // // Ferrous sulphate, heptahydrate // FeSO4.7H2O // // Permitted: (i) in denatured skimmed-milk powder and in compound feedingstuffs manufactured from denatured skimmed-milk powder - Subject to the mandatory provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77 - Declaration of the amount of iron added, expressed as the element, on the label or package or container of denatured skimmed-milk powder (ii) in compound feedingstuffs other than those listed under (i) // // // // // // // EEC No // Element // Additive // Chemical formula // Maximum content of the element in mg/kg of the complete feedingstuff // Other provisions // // // // // // // // E 2 // Iodine - I // // // 40 (total) // // // // Calcium iodate, hexahydrate // Ca(IO3)2.6H2O // // - // // // Calcium iodate, anhydrous // Ca(IO3)2 // // - // // // Sodium iodite // NaI // // - // // // Potassium iodite // KI // // - // E 3 // Cobalt-Co // // // 10 (total) // // // // Cobaltous acetate, tetrahydrate // Co(CH3COO)2.4H2O // // - // // // Basic cobaltous carbonate // 2CoCO3.3Co(OH)2.H2O // // - // // // Cobaltous chloride, hexahydrate // CoCl2.6H2O // // - // // // Cobaltous sulphate, heptahydrate // CoSO47H2O // // - // // // Cobaltous sulphate, monohydrate // CoSO4.H2O // // - // // // Cobaltous nitrate, hexahydrate // Co(NO3)2.6H2O // // - // E 4 // Copper-Cu // Cupric acetate, monohydrate Basic cupric carbonate, monohydrate Cupric chloride, dihydrate Cupric methionate Cupric oxide Cupric sulphate, pentahydrate // Cu(CH3COO)2.H2O CuCo3.Cu(OH)2.H2O CuCl2.2H2O Cu(C3H10NO2S)2 CuO CuSO4.5H2O // Pigs for fattening: - 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 - 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 lower than 175 pigs per 100 ha of utilizable agricultural land - up to 16 weeks: 175 (total) - from 17th week up to six months: 100 (total) - over six months up to slaughter: 35 (total) Breeding pigs: 35 (total) Calves: - milk replacers: 30 (total) - other complete feedingstuffs: 50 (total) Ovines: 15 (total) Other species or categories of animals: 35 (total) // - - - - - - // // // // // // // EEC No // Element // Additive // Chemical formula // Maximum content of the element in mg/kg of the complete feedingstuff // Other provisions // // // // // // // // // // Cupric sulphate, monohydrate Cupric sulphate, pentahydrate // CuSO4.H2O CuSO4.5H2O // Pigs for fattening: - 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 - 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 lower than 175 pigs per 100 ha of utilizable agricultural land - up to 16 weeks: 175 (total) - from 17th week up to six months: 100 (total) - over six months up to slaughter: 35 (total) Breeding pigs: 35 (total) Ovines: 15 (total) Other species or categories of animals with the exception of calves: 35 (total) // Denatured skimmed-milk powder and compound feedingstuffs manufactured from denatured skimmed-milk powder - Subject to the relevant provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77 - Declaration of the amount of copper added, expressed as the element, on the label or package or the container of denatured skimmed-milk powder // E 5 // Manganese - Mn // // // 250 (total) // // // // Manganous carbonate // MnCO3 // // - // // // Manganous chloride, tetrahydrate // MnCl2.4H2O // // - // // // Manganous hydrogen phosphate, trihydrate // MnHPO4.3H2O // // - // // // Manganous oxide // MnO // // - // // // Manganic oxide // Mn2O3 // // - // // // Manganous sulphate, tetrahydrate // MnSO4.4H2O // // - // // // Manganous sulphate monohydrate // MnSO4.H2O // // - // E 6 // Zinc - Zn // // // 250 (total) // // // // Zinc lactate, trihydrate // Zn(C3H5O3)2.3H2O // // - // // // Zinc acetate, dihydrate // Zn(CH3.COO)2.2H2O // // - // // // Zinc carbonate // ZnCO3 // // - // // // Zinc chloride, monohydrate // ZnCl2.H2O // // - // // // Zinc oxide // ZnO // // - // // // Zinc sulphate, heptahydrate // ZnSO4.7H2O // // - // // // Zinc sulphate, monohydrate // ZnSO4.H2O // // - // E 7 // Molybdenum - Mo // // // 2,5 (total) // // // // Ammonium molybdate // (NH4)4Mo7O24.4 H2O // // - // // // Sodium molybdate // Na2MoO4.2 H2O // // - // E 8 // Selenium-Se // // // 0,5 (total) // // // // Sodium selenite // Na2Se O3 // // - // // // Sodium selenate // Na2Se O4 // // -' // // // // // // (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 // Additive // Chemical formule, 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 activities from the groups of "antibiotics" "growth promoters", "coccidiostats and other medicina substances" is prohibited except in the case of: Tylosin phosphate, Monensin sodium, Narasin, Ipronidazole, Lasalocid sodium, Avoparcin, Flavophospholipol, Salinomycin sodium, Ronidazole, Virginiamycin, Nicarbazine and Robenidine Indication on the label of the specific name of the additive' // // // // // // // // (bb) the following item is hereby added: 1.2.3.4.5.6.7.8 // // // // // // // // // EEC No // Additive // Chemical formule, 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 559 // Perlite // Natural silicate of sodium and aluminium, expanded by heating, free of asbestos // All species or categories of animals // - // - // - // All feedingstuffs' // // // // // // // // 2. In Annex II (a) under part D, 'Coccidiostats and other medicinal substances' the following item is added: 1.2.3.4.5.6.7.8.9 // // // // // // // // // // EEC No // Additive // Chemical fromula, 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 // // // // // // // // // // '21 // Maduramicin Amonium // C47H83O17N (Amonium salt of a polyether of monocarboxylic acid pproduced by Actinomadura) yumaensis // Chickens for fattening // - // 5 // 5 // Indicate in instructions for use: "- Use prohibited at least 7 days before slaughter - Dangerous for Equines" // 30.11.1989' // // // // // // // // // (b) under part J, 'Growth promotors' the date 30 June 1988 in colums 'period of authorization' of No 1 'Nitrovin' is replaced by the date 30 November 1988. _ 5 5 INDICATE IN INSTRUCTIONS FOR USE : "_ USE PROHIBITED AT LEAST 7 DAYS BEFORE SLAUGHTER _ DANGEROUS FOR EQUINES" 30.11.1989' // // // // // // // // // ( B ) UNDER PART J, "GROWTH PROMOTORS' THE DATE 30 JUNE 1988 IN COLUMS "PERIOD OF AUTHORIZATION' OF NO 1 "NITROVIN' IS REPLACED BY THE DATE 30 NOVEMBER 1988 .

*****

COMMISSION DIRECTIVE

of 14 July 1988

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

(88/483/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 88/228/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 risk of interaction, be mixed with antibiotics, coccidiostats and other medicinal substances should be supplemented;

Whereas perlite, used as an anticaking agent, complies in every respect with the principles governing the admission of additives; whereas it is desirable therefore to authorize its use throughout the Community;

Whereas Commission Regulations (EEC) No 368/77 (4) and (EEC) No 443/77 (5), as last amended by Regulations (EEC) No 222/88 (6) and (EEC) No 1413/87 (7) respectively, provide for the use of certain iron and copper compounds for denaturing skimmed-milk powder used for the nutrition of animals with the exception of young calves; whereas it is necessary therefore to adapt Annex I to Directive 70/524/EEC;

Whereas the investigation of the growth promotor 'Nitrovin' currently listed in Annex II and therefore authorizable at national level has not yet been completed; whereas, therefore, the period of authorization of this substance should be extended for a specific period;

Whereas the use of a new coccidiostat, maduramicin ammonium, has been successfully tested in certain Member States; whereas this new additive should be provisionally authorized 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 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 June 1989 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof.

Article 3

This Directive is addressed to the Member States.

Done at Brussels, 14 July 1988.

For the Commission

Frans ANDRIESSEN

Vice-President

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

(2) OJ No L 101, 20. 4. 1988, p. 30.

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

(4) OJ No L 52, 24. 2. 1977, p. 19.

(5) OJ No L 58, 3. 3. 1977, p. 16.

(6) OJ No L 28, 1. 2. 1988, p. 1.

(7) OJ No L 133, 23. 5. 1987, p. 15.

ANNEX

1. In Annex I:

(a) the wording of part I, 'Trace elements' 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 // Other provisions // // // // // // // // // // // // // // 'I. Trace elements // // // // // E 1 // Iron-Fe // // // 1 250 (total) // // // // Ferrous carbonate // FeCO3 // // - // // // Ferrous chloride, tetrahydrate // FeCl2.4H2O // // - // // // Ferric chloride, hexahydrate // FeCl3.6H2O // // - // // // Ferrous citrate, hexahydrate // Fe3(C6H5O7)2.6H2O // // - // // // Ferrous fumarate // FeC4H2O4 // // - // // // Ferrous lactate, trihydrate // Fe(C3H5O3)2.3H2O // // - // // // Ferric oxide // Fe2O3 // // - // // // Ferrous sulphate monohydrate // FeSO4.H2O // // Permitted only for denaturing: - in skimmed-milk powder and - in compound feedingstuffs manufactured from denatured skimmed-milk powder // // // // // // Subject to the releyant provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77 // // // // // // Declaration of the amount of iron added, expressed as the element, on the label or package or container of denatured skimmed-milk powder // // // Ferrous sulphate, heptahydrate // FeSO4.7H2O // // Permitted: (i) in denatured skimmed-milk powder and in compound feedingstuffs manufactured from denatured skimmed-milk powder - Subject to the mandatory provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77 - Declaration of the amount of iron added, expressed as the element, on the label or package or container of denatured skimmed-milk powder (ii) in compound feedingstuffs other than those listed under (i) // // // // // // // EEC No // Element // Additive // Chemical formula // Maximum content of the element in mg/kg of the complete feedingstuff // Other provisions // // // // // // // // E 2 // Iodine - I // // // 40 (total) // // // // Calcium iodate, hexahydrate // Ca(IO3)2.6H2O // // - // // // Calcium iodate, anhydrous // Ca(IO3)2 // // - // // // Sodium iodite // NaI // // - // // // Potassium iodite // KI // // - // E 3 // Cobalt-Co // // // 10 (total) // // // // Cobaltous acetate, tetrahydrate // Co(CH3COO)2.4H2O // // - // // // Basic cobaltous carbonate // 2CoCO3.3Co(OH)2.H2O // // - // // // Cobaltous chloride, hexahydrate // CoCl2.6H2O // // - // // // Cobaltous sulphate, heptahydrate // CoSO47H2O // // - // // // Cobaltous sulphate, monohydrate // CoSO4.H2O // // - // // // Cobaltous nitrate, hexahydrate // Co(NO3)2.6H2O // // - // E 4 // Copper-Cu // Cupric acetate, monohydrate Basic cupric carbonate, monohydrate Cupric chloride, dihydrate Cupric methionate Cupric oxide Cupric sulphate, pentahydrate // Cu(CH3COO)2.H2O CuCo3.Cu(OH)2.H2O CuCl2.2H2O Cu(C3H10NO2S)2 CuO CuSO4.5H2O // Pigs for fattening: - 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 - 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 lower than 175 pigs per 100 ha of utilizable agricultural land - up to 16 weeks: 175 (total) - from 17th week up to six months: 100 (total) - over six months up to slaughter: 35 (total) Breeding pigs: 35 (total) Calves: - milk replacers: 30 (total) - other complete feedingstuffs: 50 (total) Ovines: 15 (total) Other species or categories of animals: 35 (total) // - - - - - - // // // // // // // EEC No // Element // Additive // Chemical formula // Maximum content of the element in mg/kg of the complete feedingstuff // Other provisions // // // // // // // // // // Cupric sulphate, monohydrate Cupric sulphate, pentahydrate // CuSO4.H2O CuSO4.5H2O // Pigs for fattening: - 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 - 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 lower than 175 pigs per 100 ha of utilizable agricultural land - up to 16 weeks: 175 (total) - from 17th week up to six months: 100 (total) - over six months up to slaughter: 35 (total) Breeding pigs: 35 (total) Ovines: 15 (total) Other species or categories of animals with the exception of calves: 35 (total) // Denatured skimmed-milk powder and compound feedingstuffs manufactured from denatured skimmed-milk powder - Subject to the relevant provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77 - Declaration of the amount of copper added, expressed as the element, on the label or package or the container of denatured skimmed-milk powder // E 5 // Manganese - Mn // // // 250 (total) // // // // Manganous carbonate // MnCO3 // // - // // // Manganous chloride, tetrahydrate // MnCl2.4H2O // // - // // // Manganous hydrogen phosphate, trihydrate // MnHPO4.3H2O // // - // // // Manganous oxide // MnO // // - // // // Manganic oxide // Mn2O3 // // - // // // Manganous sulphate, tetrahydrate // MnSO4.4H2O // // - // // // Manganous sulphate monohydrate // MnSO4.H2O // // - // E 6 // Zinc - Zn // // // 250 (total) // // // // Zinc lactate, trihydrate // Zn(C3H5O3)2.3H2O // // - // // // Zinc acetate, dihydrate // Zn(CH3.COO)2.2H2O // // - // // // Zinc carbonate // ZnCO3 // // - // // // Zinc chloride, monohydrate // ZnCl2.H2O // // - // // // Zinc oxide // ZnO // // - // // // Zinc sulphate, heptahydrate // ZnSO4.7H2O // // - // // // Zinc sulphate, monohydrate // ZnSO4.H2O // // - // E 7 // Molybdenum - Mo // // // 2,5 (total) // // // // Ammonium molybdate // (NH4)4Mo7O24.4 H2O // // - // // // Sodium molybdate // Na2MoO4.2 H2O // // - // E 8 // Selenium-Se // // // 0,5 (total) // // // // Sodium selenite // Na2Se O3 // // - // // // Sodium selenate // Na2Se O4 // // -' // // // // // //

(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 // Additive // Chemical formule, 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 activities from the groups of "antibiotics" "growth promoters", "coccidiostats and other medicina substances" is prohibited except in the case of: Tylosin phosphate, Monensin sodium, Narasin, Ipronidazole, Lasalocid sodium, Avoparcin, Flavophospholipol, Salinomycin sodium, Ronidazole, Virginiamycin, Nicarbazine and Robenidine Indication on the label of the specific name of the additive' // // // // // // // //

(bb) the following item is hereby added:

1.2.3.4.5.6.7.8 // // // // // // // // // EEC No // Additive // Chemical formule, 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 559 // Perlite // Natural silicate of sodium and aluminium, expanded by heating, free of asbestos // All species or categories of animals // - // - // - // All feedingstuffs' // // // // // // // //

2. In Annex II

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

1.2.3.4.5.6.7.8.9 // // // // // // // // // // EEC No // Additive // Chemical fromula, 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 // // // // // // // // // // '21 // Maduramicin Amonium // C47H83O17N (Amonium salt of a polyether of monocarboxylic acid pproduced by Actinomadura) yumaensis // Chickens for fattening // - // 5 // 5 // Indicate in instructions for use: "- Use prohibited at least 7 days before slaughter - Dangerous for Equines" // 30.11.1989' // // // // // // // // //

(b) under part J, 'Growth promotors' the date 30 June 1988 in colums 'period of authorization' of No 1 'Nitrovin' is replaced by the date 30 November 1988.

_

5

5

INDICATE IN INSTRUCTIONS FOR USE : "_ USE PROHIBITED AT LEAST 7 DAYS BEFORE SLAUGHTER _ DANGEROUS FOR EQUINES"

30.11.1989' // // // // // // // // //

( B ) UNDER PART J, "GROWTH PROMOTORS' THE DATE 30 JUNE 1988 IN COLUMS "PERIOD OF AUTHORIZATION' OF NO 1 "NITROVIN' IS REPLACED BY THE DATE 30 NOVEMBER 1988 .