Colorcon has petitioned for expansion of the use of calcium carbonate (CaCO3) as colour in dietary supplement tablets and capsules.
The Food and Drug Administration (FDA) is amending the colour additive regulations to provide for the safe use of calcium carbonate in dietary supplement tablets and capsules, including coatings and printing inks, in amounts consistent with good manufacturing practice (GMP). This amendment means the material can be used as an alternative colour additive in place of titanium dioxide (TiO2), which is banned for food use in the European Union.
Alexa Smith, Director - of Global Quality & Regulatory Services, said: “Colorcon submitted the petition to facilitate the expanded use of CaCO3 as a colour additive to support companies who want to formulate film coatings for dietary supplement tablets without the use of TiO2. Formulating without TiO2 is a particular issue in Europe, where legislation banning TiO2 (E171) use in foods is now in place; using CaCO3 as an alternative opacifier is now a viable option. In the USA, TiO2 is not banned in foods; however, some consumers would rather use products without, and this successful petition enables this.”
Nutafinish coatings are formulated to meet regulatory needs and appeal to consumers
Annabel Bordmann, General Manager of Film Coatings, said: “Colorcon leads the evolution in coating products for dietary supplements through Nutrafinish, Dietary Supplement Coatings and the expanded use of CaCO3 widens the choices for this market. Nutafinish coatings are formulated to meet regulatory needs and appeal to consumers."
Through the extensive portfolio of fully formulated coatings, Colorcon provides the scope for dietary supplement manufacturers to reduce complexity and time-to-market by delivering high-quality products with ingredients carefully selected from commonly used food ingredients and support label-friendly. This is backed by our superior, dedicated technical support and regulatory expertise.
