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Colouring matters for medicinal products (recast)

In the light of the many disparities between Member States’ legislation on colouring matters for medicinal products, the European Commission considered it necessary to recast Directive 78/25/EC. It is important not to hamper the development of the pharmaceutical industry or trade in medicinal products within the Community.


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).


This Directive gives specifications on colouring matters for medicinal products.

Only the colouring matters listed in Annex I to Directive 94/36/EC may be used to colour medicinal products for human and veterinary use.

The colouring matters referred to in Annex I must meet the general specifications for aluminium lakes of colours and the specific criteria of purity laid down in Annex I to Directive 95/45/EC. The methods of analysis needed to verify these criteria are framed by Directive 81/712/EC.

When a colouring matter is deleted from Annex I to Directive 94/36/EC, but the marketing of foodstuffs containing this colouring matter is permitted to continue for a limited period, this additional period of use also extends to medicinal products. However, the Commission may amend the duration of this additional period.

The Commission shall be assisted by a committee for the adjustment to technical progress of the Directives composed of representatives from Member States and chaired by a Commission representative.

This Directive repeals Directive 78/25/EC.


ActEntry into forceDeadline for transposition in the Member StatesOfficial Journal
Directive 2009/35/EC



OJ L109 of 30.4.2009

This summary is for information only. It is not designed to interpret or replace the reference document, which remains the only binding legal text.

Last updated: 12.10.2009
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