Colouring Matters in Medicinal Products Directive
Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the colouring matters which may be added to medicinal products (Recast)
- Stage
- In force, reached 30 Apr 2009
- In force
- In force since 20 May 2009 · CELEX 32009L0035
- Transposition deadline
- 15 Jun 1979
- Procedure
- Directive · Ordinary legislative procedure
- Last activity
- 20 May 2009
Documents
Newest first. Each opens at its source.
- Text adopted · OJ L 109 30.04.2009, p. 0010Commission · 30 Apr 2009
- Text adopted · Directive 2009/0035Commission · 23 Apr 2009
- Report · A6-0280/2008Parliament
- Committee opinion · PE404.618Parliament
- Report · PE407.752Parliament
- Text adopted · SP(2008)6073Parliament
- Text adopted · T6-0431/2008Parliament
Summary
GeneratedDirective 2009/35/EC limits the coloring matters Member States may authorize in human and veterinary medicinal products to those listed in Annex I to Directive 94/36/EC on food colors. Purity criteria and analysis methods for food colors also apply. It entered into force 20 days after its 30 April 2009 publication, recasting Directive 78/25/EEC.
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Sources: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 12 Oct 2026. Something wrong on this page? Report an error.
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