CELEX: 51979PC0500
Language: en
Date: 1979-09-25
Title: Proposal for a COUNCIL DIRECTVE amending Council Directive 78/25/EEC on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (79) 500
Vol. 1979/0171
 ---pagebreak--- Disclaimer
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In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983
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Community and the European Atomic Energy Community (OJ L 43, 15.2.1983, p. 1), as
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                             COM ( 79 ) 500 final
                                             Brussels , 25 September 1979
                                    Proposal for a
                                   COUNCIL DIRECTVE
           amending Council Directive 78 / 25 / EEC on the approximation of
              the laws of the Member States relating to the colouring
                 matters which may be added to medicinal products
                   ( submitted to the Council by the Commission )
                                                            / -,
                                                                  . •_   ^ «y
 COM ( 79 ) 500 final
 ---pagebreak---                         I
                            Explanatory Memorandum
Council Directive 78 / 25 / EEC of 12 December 1977 relating to the colouring
matters which may be added to medicinal products refers to the list of
colouring matters authorised for use in foodstuffs intended for human
consumption ; this list makes a distinction between colouring matter for
both mass and surface colouring and colouring matter for surface colouring
only .
This distinction - which reduces the alternatives open to a pharmaceuticals
industry already subjected to severe technical constraints - is not justi­
fied from the point of view of the safeguarding of public health since
medicinal products are subjected to a number of prior tests before a marke­
ting authorization is granted .
It would therefore seem desirable to abolish this distinction for medicinal
products .
 ---pagebreak---                                    Proposal for a
                                  COUNCIL DIRECTVE
          amending Council Directive 78/ 25 / EEC on the approximation of
             the laws of the Member States relating to the colouring
                matters which may be added to medicinal products
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 ,
Having regard to the opinion of the Economic and Social Committee ,
                                                      (1 )
Whereas Article 1 of Council Directive 78/ 25 / EEC        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 Council Directive of 23 October 1962 on
the approximation of the rules of the Member States concerning the colouring
                                                                              (2)
matters authorized for use in foodstuffs intended for human consumption           ,
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 t.ie 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 :
                                                   »
 ( 1 ) 0J No L 11 , 14.1.1978 , p. 18
 ( 2 ) 0J No 115 , 11.11.1962, p. 2645 /62
 ---pagebreak---                                                    H
                                 Article 1
The following paragraph is 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
                                                   I i
This Directive is addressed to the Member States .