1978L0025 — EN — 01.01.1981 — 001.001 — 1
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►B COUNCIL DIRECTIVE
of 12December 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)
(OJ L 11, 14.1.1978, p. 18)
Amended by:
Official Journal
No page date
►A1Act of Accession of Greece L 291 17 19.11.1979
▼B
COUNCIL DIRECTIVE
of 12December 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 publichealth; whereas, however, this objec tivemust be attained by means which will not hinder the development of thepharmaceutical industry or trade in medicinal products within theCommunity;
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; whereascertain Member States apply the rules laid down for foodstuffs tomedicinal products; whereas others have separate lists of authorizedcolouring 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 beadded to these products; whereas such disparities therefore directlyaffect 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 forhuman consumption should not also be authorized for use in medicinalproducts; whereas, consequently, Annexes I and III to the Directive of23 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 establishesclose cooperation between the Member States and the Commissionwithin a Committee for the adjustment to technical progress of theDirectives on the elimination of technical barriers to trade in the sectorof 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 forcolouring medicinal products for external use,
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 CouncilDirective 65/65/EEC of 26 January 1965 on the approximation of1978L0025 — EN — 01.01.1981 — 001.001 — 2
(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.
▼B
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 these colouring matters shall also apply.
Article 2
Member States shall take all measures necessary to ensure that the
colouring matters covered by Annex I, Sections I and II, to the Directive
of 23 October 1962 satisfy the general and specific criteria of purity laid
down in Annex III to that Directive.
Article 3
The methods of analysis needed to verify that the general and specific
criteria of purity adopted pursuant to the Directive of 23 October 1962
are satisfied shall also apply for the purpose of this Directive.
Article 4
Where a colouring matter is deleted from Annex I to the Directive of 23
October 1962 but the marketing of foodstuffs containing this colouringmatter is permitted to continue for a limited period, this provision shallalso apply to medicinal products. This limited period of use may
however be amended for medicinal products according to the procedure
laid down in Article 6.
Article 5
1. A committee for the adaptation 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,
hereinafter called the ‘Committee’, is hereby set up and shall consist ofrepresentatives of the Member States with a representative of theCommission as chairman.
2. The Committee shall draw up its own rules of procedure.
Article 6
1. Where the procedure laid down in this Article is to be followed,
matters shall be referred to the Committee by the chairman, either on his
own initiative or at the request of the representative of a Member State.
2. The Commission representative shall submit a draft of the
measures to be adopted. The Committee shall deliver its opinion on
such measures within a time limit set by the chairman according to theurgency of the matter. Opinions shall be delivered by a majority of►
A1forty-five ◄votes, the votes of the Member States being
weighted as provided in Article 148 (2) of the Treaty. The chairmanshall not vote.
3. The Commission shall adopt the proposed measures where they are
in accordance with the opinion of the Committee.
If these measures are not in accordance with the opinion of the
Committee, or if the Committee does not deliver an opinion, theCommission shall forthwith submit to the Council a proposal regarding
the measures to be adopted.
The Council shall act by a qualified majority.
If the Council has not taken a decision within three months of the matter
being referred to it, the Commission shall adopt the proposed measures.1978L0025 — EN — 01.01.1981 — 001.001 — 3
(1) OJ No 22, 9. 2. 1965, p. 369/65.
▼B
Article 7
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive within
18 months of its notification and shall forthwith inform the Commission
thereof.
2. However, any Member State may permit, on its own territory, until
the end of a period of four years from the notification of this Directive,the marketing of medicinal products containing colouring matters whichdo not comply with the requirements of this Directive so long as thesecolouring matters were authorized in that Member State before the
adoption of the Directive.
3. Depending on the opinion of the Scientific Committee for Food
and of the Committee referred to in Article 5 the Commission shall ifappropriate submit to the Council within two years of the adoption ofthis Directive a proposal for amendment of the Directive to allow the useof:
— the colouring matters:
=Brilliant Blue FCF CI 42090,
=Red 2G CI 18050,
— other colouring matters for medicinal products for external use only.
The Council shall take a decision on the Commission proposal no later
than two years after its submission.
4. Member States shall communicate to the Commission the text of
the main provisions of national law which they adopt in the field
covered by this Directive.
Article 8
This Directive is addressed to the Member States.1978L0025 — EN — 01.01.1981 — 001.001 — 4