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Document 32009L0035

Colouring matters for medicinal products

Date of last review:
19/05/2022
Initial creation date:
12/10/2009
Summarised document(s):
Author:
Publications Office of the European Union
Responsible entity(ies):
Directorate-General for Health and Food Safety

Colouring matters for medicinal products

 

SUMMARY OF:

Directive 2009/35/EC on the colouring matters which may be added to medicinal products

WHAT IS THE AIM OF THE DIRECTIVE?

  • The directive gives specifications on colouring matters for medicinal products.
  • It repeals Directive 78/25/EEC.

KEY POINTS

  • Only the colouring matters listed in Annex I to Directive 94/36/EC (which has been repealed and replaced by Regulation (EC) No 1333/2008) may be used to colour medicinal products for human and veterinary use.
  • The colouring matters referred to in Annex I must meet the specific purity criteria laid down in Annex I to Directive 95/45/EC (which has been replaced by Regulation (EU) No 231/2012). The methods of analysis needed to verify these criteria are set out in Directive 81/712/EEC (which has been repealed and replaced by Regulation (EC) No 1333/2008).
  • When a colouring matter is deleted from Annex V to Regulation (EC) No 1333/2008 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 European Commission may amend the duration of this additional period.
  • The Commission shall be assisted by a committee for the adjustment of the directives in line with technical progress, composed of representatives from Member States and chaired by a Commission representative.

FROM WHEN DO THE RULES APPLY?

Directive 2009/35/EC revises and replaces Directive 78/25/EEC. The original Directive 78/25/EEC had to be transposed into national law by 1979.

MAIN DOCUMENT

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) (OJ L 109, 30.4.2009, pp. 10–13).

last update 19.05.2022

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