S.L. 458.41 Art. 2Permitted colouring matters.

(1) The only colouring matters that shall be permitted for the colouring of medicinal products for human use shall be those under Annex I, Sections I and II, to the Directive of the 23rd October, 1962, as subsequently amended, as long as such colouring matters satisfy the general and specific criteria of purity laid down under Annex III to the Directive of the 23rd October, 1962.

(2) No distinction shall be made between colouring matter for both mass and surface colouring, and colouring matter for surface colouring only.

(3) The Licensing Authority shall adopt methods of analysis to verify that the general and specific criteria of purity under Annex III to Directive of the 23rd October, 1962 are satisfied.