How are additives approved for use in foods?

To market a new food or color additive, a manufacturer must first petition FDA for its approval. Approximately 100 new food and color additives petitions are submitted to FDA annually. Most of these petitions are for indirect additives such as packaging materials.

A food or color additive petition must provide convincing evidence that the proposed additive performs as it is intended. Animal studies using large doses of the 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 additive in humans also may be submitted to FDA.

In deciding whether an 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 the additive is safe under the proposed conditions of use, based on the best scientific knowledge available.

If an additive is approved, FDA issues regulations that may include the types of foods in which it can be used, the maximum amounts to be used, and how it should be identified on food labels. Additives proposed for use in meat and poultry products also must receive specific authorization by USDA. Federal officials then carefully monitor the extent of Americans' consumption of the new additive and results of any new research on its safety to assure its use continues to be within safe limits.

In addition, FDA operates an Adverse Reaction Monitoring System (ARMS) to help serve as an ongoing safety check of all additives. The system monitors and investigates all complaints by individuals or their physicians that are believed to be related to specific foods; food and color additives; or vitamin and mineral supplements. The ARMS computerized database helps officials decide whether reported adverse reactions represent a real public health hazard associated with food, so that appropriate action can be taken.