Spanish special edition: Chapter 13 Volume 011 P. 209 - 209
Portuguese special edition: Chapter 13 Volume 011 P. 209 - 209
Special edition in Finnish: Chapter 13 Volume 011 P. 146 - 146
Special edition in Swedish: Chapter 13 Volume 011 P. 146 - 146
Special edition in Czech: Chapter 13 Volume 006 P. 168 - 168
Special edition in Estonian: Chapter 13 Volume 006 P. 168 - 168
Special edition in Latvian: Chapter 13 Volume 006 P. 168 - 168
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Document 31981L0464
Council Directive 81/464/EEC of 24 June 1981 amending 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
Council Directive 81/464/EEC of 24 June 1981 amending 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
Council Directive 81/464/EEC of 24 June 1981 amending 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
OJ L 183, 4.7.1981, p. 33–33
(DA, DE, EL, EN, FR, IT, NL) This document has been published in a special edition(s)
(ES, PT, FI, SV, CS, ET, LV, LT, HU, MT, PL, SK, SL, BG, RO)
No longer in force, Date of end of validity: 20/05/2009
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31981L0464
Council Directive 81/464/EEC of 24 June 1981 amending 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
Official Journal L 183 , 04/07/1981 P. 0033 - 0033
Finnish special edition: Chapter 13 Volume 11 P. 0146
Spanish special edition: Chapter 13 Volume 11 P. 0209
Swedish special edition: Chapter 13 Volume 11 P. 0146
Portuguese special edition Chapter 13 Volume 11 P. 0209
COUNCIL DIRECTIVE of 24 June 1981 amending 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) 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 Article 1 of Directive 78/25/EEC (3) stipulates that Member States shall not authorize, for the colouring of medicinal products for human and veterinary use, any colouring matters other than those covered by Annex I, Sections I and II, of the Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorized for use in foodstuffs intended for human consumption (4); Whereas Section I of the abovementioned Annex covers colouring matter for both mass and surface colouring, and Section II covers colouring matter for surface colouring only; Whereas there is no justification on public health grounds for maintaining, in the case of medicinal products, the distinction made in the case of foodstuffs intended for human consumption between colouring matter for both mass and surface colouring and colouring matter for surface colouring only; Whereas Directive 78/25/EEC should therefore be amended accordingly, HAS ADOPTED THIS DIRECTIVE: Article 1 The following paragraph shall be added to Article 1 of Directive 78/25/EEC: "However, in the case of medicinal products, no distinction shall be made between colouring matter for both mass and surface colouring and colouring matter for surface colouring only." Article 2 Member States shall take the measures necessary to comply with this Directive before 1 October 1981 and shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States. Done at Luxembourg, 24 June 1981. For the Council The President G.M.V. van AARDENNE (1) OJ No C 4, 7.1.1980, p. 46. (2) OJ No C 113, 7.5.1980, p. 36. (3) OJ No L 11, 14.1.1978, p. 18. (4) OJ No 115, 11.11.1962, p. 2645/62.