Directive 2009/35/EC of the European Parliament and of the CouncilShow full title

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)

Article 2

Member States shall take all measures necessary to ensure that the colouring matters covered by Annex I to Directive 94/36/EC satisfy the general specifications for aluminium lakes of colours and the specific criteria of purity laid down in the Annex to Directive 95/45/EC.