Fd&c Blue No. 2, Calcium Lake

FD&C Blue No. 2, Calcium Lake is a synthetic colorant derived from indigo carmine, a coal tar-based dye. The "lake" designation indicates that the dye has been precipitated onto a substrate (typically aluminum hydroxide or calcium carbonate) to create an insoluble, stable pigment. The calcium lake form uses calcium as the substrate material. This additive is identified by CAS Number 977011-14-5 and falls under the FD&C (Food, Drug, and Cosmetic Act) color additives permitted for use in the United States.

FD&C Blue No. 2, Calcium Lake is used primarily in foods where a stable, insoluble blue colorant is desired. Common applications include beverages, baked goods, confectionery products, and other processed foods. The lake form is particularly useful in products where oil-soluble or water-resistant coloring is needed, as it provides better stability and dispersibility in certain food matrices compared to the free acid form. The additive helps manufacturers achieve consistent color in products that may be exposed to light, heat, or varying pH conditions.

According to FDA records, there have been zero reported adverse events associated with FD&C Blue No. 2, Calcium Lake, and zero product recalls linked to this additive. While FD&C Blue No. 2, Calcium Lake does not have GRAS (Generally Recognized as Safe) status, it is approved as a certified color additive under FDA regulations for specific food uses. This approval is based on safety testing and regulatory evaluation prior to market authorization.

The parent compound, FD&C Blue No. 2 (Indigo Carmine), has been extensively studied. Historical safety assessments have not identified significant toxicological concerns at levels used in food coloring. The European Food Safety Authority (EFSA) has also evaluated similar indigo-based colorants. As with all synthetic colorants, regulatory bodies establish acceptable daily intake levels and permitted use levels to ensure consumer safety.

FD&C Blue No. 2, Calcium Lake is approved by the FDA as a certified color additive for use in foods. It is classified as a synthetic color and must be manufactured according to FDA specifications and purity standards. The "FD&C" designation indicates it has been approved for use in foods, drugs, and cosmetics under U.S. federal law. Manufacturers using this colorant must comply with labeling requirements and use limitations established by the FDA. In the European Union, equivalent indigo-based colorants are subject to different approval frameworks and may be listed under different nomenclature.

Safety evaluations of indigo carmine and its derivatives have been conducted over decades of use. The FDA's Color Additives Status List includes FD&C Blue No. 2 and its forms based on toxicological studies examining acute and chronic safety profiles. Research has generally supported the safety of this colorant at approved levels of use in food applications. While comprehensive published studies specifically on the calcium lake form are limited in public literature, the safety profile is supported by the parent compound's extensive history of use and regulatory approval across multiple jurisdictions.