How Are Color Additives Approved for Use in Foods?
To market a new 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. Animal studies using large doses of the color additive for long periods are often necessary to show that the substance would not cause harmful effects at expected levels of human consumption. Studies of the color additive in humans also may be submitted to FDA. 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. Absolute safety of any substance can never be proven. Therefore, FDA must determine if there is a reasonable certainty of no harm from the color additive under its proposed conditions of use. If the color additive is approved, FDA issues regulations that may include the types of foods in which it can be used, the maximum
