Directive 2009/35/EC of the European Parliament and of the Council

of 23 April 2009

on the colouring matters which may be added to medicinal products

(recast)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee1,
Acting in accordance with the procedure laid down in Article 251 of the Treaty2,

Whereas:

(1)
Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products3 has been substantially amended several times4. Since further amendments are to be made, it should be recast in the interests of clarity.
(2)

The primary purpose of any laws concerning medicinal products must be to safeguard public health. However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.

(3)
Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs5 established a single list of colouring matters authorised for use in foodstuffs, but disparities between the laws of Member States concerning the colouring of medicinal products still exist.
(4)

Those disparities tend to hinder trade in medicinal products within the Community and trade in colouring matters which may be added to those products. Such disparities therefore directly affect the functioning of the internal market.

(5)
Experience has shown that there is no reason, on health grounds, why the colouring matters authorised for use in foodstuffs should not also be authorised for use in medicinal products. Consequently, Annex I to Directive 94/36/EC as well as the Annex to Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs6 should also apply for medicinal products.
(6)

However, 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. To this end a procedure should be provided for which establishes 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 to trade in the sector of colouring matters which may be added to medicinal products.

(7)
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission7.
(8)

In particular, the Commission should be empowered to amend the limited period of use of medicinal products. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(9)

The new elements introduced into this Directive only concern the committee procedures. They therefore do not need to be transposed by the Member States.

(10)

This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex I, Part B,

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