1978L0025 — EN — 05.06.2003 — 004.001 — 1
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►B COUNCILDIRECTIVE
of12December 1977
on the approximation of the laws of the Member States relating to the colouring matters which
maybeaddedtomedicinal products
(78/25/EEC)
(OJ L 11, 14.1.1978, p. 18)
Amended by:
Official Journal
No page date
►M1Council Directive 81/464/EEC of 24 June 1981 L 183 33 4.7.1981
►M2Council Regulation (EC) No 807/2003 of 14 April 2003 L 122 36 16.5.2003
Amended by:
►A1Act of Accessionof Greece L 291 17 19.11.1979
►A2Act of Accessionof Spainan d Portugal L 302 23 15.11.1985
▼B
COUNCILDIRECTIVE
of12December 1977
on the approximationof the lawsofthe Member States relating to
thecolouringmatterswhichmaybeaddedtomedicinal 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, thisobjective must be attained by means which will not hinder the develop-ment of the pharmaceutical industry or trade in medicinal productswithinthe Commun ity;
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 humanconsumption, the disparities between the laws of Member Statesconcerning the colouring of medicinal products still exist; whereas
certainMember States apply the rules laid downfor foodstuffs to
medicinal 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 be
added 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
reasonwhy the colourin g matters authorized for use infoodstuffs
intended for human consumption should not also be authorized for usein medicinal products; whereas, consequently, Annexes I and III to theDirective of 23 October 1962, as they stand or as they subsequentlymay be amended, should also apply for medicinal products;
Whereas when the use of a colouring matter in foodstuffs and medic-
inal products is prohibited in order to safeguard public health,technological and economic disturbances should be avoided as far asis possible; whereas to this end a procedure should be provided whichestablishes close cooperationbetweenthe Member States an d the
Commission within a Committee for the adjustment to technical
progress of the Directives on the elimination of technical barriers totrade inthe sector of colourin g matters which may be added to medic-inal products;
Whereas special consideration must be given to certain colouring
matters hitherto permitted by certainMember States, inparticular forcolouring medicinal products for external use,1978L0025 — EN — 05.06.2003 — 004.001 — 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
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 actionrelating to proprietary medicinal products (
1), any colouring matters
other than those covered by Annex I, Sections I and II, to the Directiveof 23 October 1962 as subsequently amended. Any transitional provi-sions laid down for certain of these colouring matters shall also apply.
However, in the case of medicinal products, no distinction shall be
made between colouring matter for both mass and surface colouringand colouring matter for surface colouring only.
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 Direc-
tive of 23 October 1962 satisfy the general and specific criteria ofpurity 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 1962are 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
colouring matter is permitted to continue for a limited period, thisprovisionshall also apply to medicin al products. This limited periodof use may however be amended for medicinal products according tothe procedure laid downinArticle 6.
Article 5
1. A committee for the adaptationto techn ical progress of the Direc-
tives on the elimination of technical barriers to trade in the sector of
colouring matters which may be added to medicinal products, herein-
after called the ‘Committee’, is hereby set up and shall consist ofrepresentatives of the Member States with a representative of theCommissionas chairman .
Article 6
1. The Commissionshall be assisted by the committee for the adap-
tation to technical progress of the Directives on the elimination oftechnical barriers to trade in the sector of colouring matters whichmay be added to medicinal products.
2. Where reference is made to this Article, Articles 5 and 7 of Deci-
sion1999/468/EC (
2) shall apply.
The period laid downinArticle 5(6) of Decision1999/468/EC shall be
set at three months.
3. The committee shall adopt its rules of procedure.1978L0025 — EN — 05.06.2003 — 004.001 — 3
(1) OJ No 22, 9. 2. 1965, p. 369/65.
(2) OJ L 184, 17.7.1999, p. 23.▼M1
▼B
▼M2
▼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
Commissionthereof.
2. However, any Member State may permit, on its own territory,
until the end of a period of four years from the notification of thisDirective, the marketing of medicinal products containing colouringmatters which do not comply with the requirements of this Directiveso long as these colouring matters were authorized in that Member
State before the adoptionof 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 theuse of:
— 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
thantwo 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 — 05.06.2003 — 004.001 — 4