Directive 1978/25 - Approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products - Main contents

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Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products

Official Journal L 011 , 14/01/1978 P. 0018 - 0020

Finnish special edition: Chapter 13 Volume 8 P. 0039

Greek special edition: Chapter 13 Volume 7 P. 0034

Swedish special edition: Chapter 13 Volume 8 P. 0039

Spanish special edition: Chapter 13 Volume 8 P. 0086

Portuguese special edition Chapter 13 Volume 8 P. 0086

COUNCIL DIRECTIVE of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products (78/25/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament (1),

Having regard to the opinion of the Economic and Social Committee (2),

Whereas the primary purpose of any laws concerning medicinal products must be to safeguard public health ; whereas, however, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community;

Whereas, although the Council Directive of 23 October 1962 (3), as last amended by Directive 76/399/EEC (4), established a single list of colouring matters authorized for use in foodstuffs intended for human consumption, the disparities between the laws of Member States concerning the colouring of medicinal products still exist ; whereas certain Member States apply the rules laid down for foodstuffs to medicinal products ; whereas others have separate lists of authorized colouring matters for medicinal products and for foodstuffs;

Whereas these disparities tend to hinder trade in medicinal products within the Community and trade in colouring matters which may be added to these products ; whereas such disparities therefore directly affect the establishment and functioning of the common market;

Whereas experience has shown that on health grounds there is no reason why the colouring matters authorized for use in foodstuffs intended for human consumption should not also be authorized for use in medicinal products ; whereas, consequently, Annexes I and III to the Directive of 23 October 1962, as they stand or as they subsequently may be amended, should also apply for medicinal products;

Whereas when the use of a colouring matter in foodstuffs and medicinal products is prohibited in order to safeguard public health, technological and economic disturbances should be avoided as far as is possible ; whereas to this end a procedure should be provided which establishes close cooperation between the Member States and the Commission within a Committee for the adjustment to technical progress of the Directives on the elimination of technical barriers to trade in the sector of colouring matters which may be added to medicinal products;

Whereas special consideration must be given to certain colouring matters hitherto permitted by certain Member States, in particular for colouring medicinal products for external use, (1)OJ No C 62, 30.5.1974, p. 23. (2)OJ No C 116, 30.9.1974, p. 24. (3)OJ No 115, 11.11.1962, p. 2645/62. (4)OJ No L 108, 26.4.1976, p. 19.

HAS ADOPTED THIS DIRECTIVE:

Article 1

Member States shall not authorize, for the colouring of medicinal products for human and veterinary use as defined in Article 1 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (1), any colouring matters other than those covered by Annex I, Sections I and II, to the Directive of 23 October 1962 as subsequently amended. Any transitional provisions laid down for certain of...

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