Under the current US regulatory system, FDA is responsible for ensuring the safety of new food additives, including new color additive approval.
There is no “generally recognized as safe” exemption to the definition of a color additive. To market a new color additive or new use of an existing color additive, a manufacturer must first petition FDA for its approval. The petition must provide convincing evidence that the proposed color additive performs as it is intended via submission of a battery of studies to demonstrate that the substance would not cause harmful effects at expected levels of human consumption. In deciding whether a color additive should be approved, the agency considers the composition and properties of the substance, the amount likely to be consumed, its probable long-term effects and various safety factors. If the color additive is approved, FDA issues regulations that may include the types of foods in which it can be used, t he maximum amounts to be used and how it should be identified on food labels. Federal officials then carefully monitor the extent of Americans’ consumption of the new color additive and results of any new research on its safety.
US requirements for color additive petitions have created substantial safety data for many colors. This data has also been reviewed by WHO/FAO Joint Expert Committee on Food Additives (JECFA) to establish acceptable daily intakes (ADIs). These studies confirm the safety of FDA approved colors, and as a result various color additives have been approved for use in food, beverage, and other products in the US, EU and elsewhere.