1978L0025 — EN — 01.01.1986 — 003.001 — 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
Amended by:
►A1Act of Accession of Greece L 291 17 19.11.1979
►A2Act of Accession of Spain and 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),
Whereasthe primary purpos e of any lawsconcerning 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 productswithin the Community;
Whereas, although the Council Directive of 23 October 1962(
3), aslas t
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
certain Member Statesapply the ruleslaid down for foods tuffsto
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 matterswhich may be
added to these products; whereas such disparities therefore directlyaffect the establishment and functioning of the common market;
Whereasexperience hass hown that on health groundsthere isno
reason why the colouring matters authorized for use in foodstuffs
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 productsisprohibited in order to s afeguard public health,technological and economic disturbances should be avoided as far asis possible; whereas to this end a procedure should be provided whichestablishes 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 totrade in the sector of colouring matters which may be added to medic-inal products;
Whereas special consideration must be given to certain colouring
mattershitherto permitted by certain Member States , in particular forcolouring medicinal productsfor external us e,1978L0025 — EN — 01.01.1986 — 003.001 — 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 Statess hall not authorize, for the colouring of medicinal
productsfor human and veterinary us e asdefined in Article 1 ofCouncil Directive 65/65/EEC of 26 January 1965 on the approximationof 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 Directive
of 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 matterscovered by Annex I, SectionsI 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 isdeleted from Annex I to the Directive of
23 October 1962 but the marketing of foodstuffs containing thiscolouring matter ispermitted to continue for a limited period, this
provision shall also apply to medicinal products. This limited period
of use may however be amended for medicinal products according tothe procedure laid down in Article 6.
Article 5
1. A committee for the adaptation to technical progress of the Direc-
tiveson the elimination of technical barriersto trade in the s ector ofcolouring matterswhich 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 theCommission as chairman.
2. The Committee shall draw up its own rules of procedure.
Article 6
1. Where the procedure laid down in thisArticle isto be followed,
matterss hall be referred to the Committee by the chairman, either onhis own initiative or at the request of the representative of a MemberState.
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 tothe urgency of the matter. Opinionss hall be delivered by a majorityof►
A2fifty-four ◄votes, the votes of the Member States being
weighted asprovided in Article 148 (2) of the Treaty. The chairmanshall not vote.1978L0025 — EN — 01.01.1986 — 003.001 — 3
(1) OJ No 22, 9. 2. 1965, p. 369/65.▼M1
▼B
▼B
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 doesnot deliver an opinion, the
Commission shall forthwith submit to the Council a proposal regardingthe measures to be adopted.
The Council shall act by a qualified majority.If the Council hasnot taken a decis ion within three monthsof the
matter being referred to it, the Commission shall adopt the proposedmeasures.
Article 7
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directivewithin 18 monthsof itsnotification and s hall forthwith inform the
Commission thereof.
2. However, any Member State may permit, on itsown territory,
until the end of a period of four yearsfrom the notification of thisDirective, the marketing of medicinal productscontaining colouringmatterswhich do not comply with the requirementsof thisDirectiveso long as these colouring 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 ofthisDirective a propos al for amendment of the Directive to allow theuse of:
— the colouring matters:
= Brilliant Blue FCF CI 42090,
= Red 2G CI 18050,
— other colouring mattersfor medicinal productsfor external us e
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 thisDirective.
Article 8
This Directive is addressed to the Member States.1978L0025 — EN — 01.01.1986 — 003.001 — 4