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
Modified by
Actconcerning the conditions of accession of the Hellenic Republic and the adjustments to the Treaties, 11979H, November 19, 1979
Council Directiveof 24 June 1981amending Council Directive 78/25/EEC on the approximation of the rules of the Member States relating to the colouring matters which may be added to medicinal products(81/464/EEC), 31981L0464, July 4, 1981
Actconcerning the conditions of accession of the Kingdom of Spain and the Portuguese Republic and the adjustments to the Treaties, 11985I, November 15, 1985
Council Regulation (EC) No 807/2003of 14 April 2003adapting to Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in Council instruments adopted in accordance with the consultation procedure (unanimity), 32003R0807, May 16, 2003
Directive 2009/35/EC of the European Parliament and of the Councilof 23 April 2009on the colouring matters which may be added to medicinal products(recast)(Text with EEA relevance), 32009L0035, April 30, 2009
Council Directiveof 12 December 1977on 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 ParliamentOJ No C 62, 30. 5. 1974, p. 23.,Having regard to the opinion of the Economic and Social CommitteeOJ No C 116, 30. 9. 1974, p. 24.,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 1962OJ No 115, 11. 11. 1962, p. 2645/62., as last amended by Directive 76/399/EECOJ No L 108, 26. 4. 1976, p. 19., 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,HAS ADOPTED THIS DIRECTIVE: