How Are Additives Approved for Use in Foods?

Today, food and color additives are more strictly studied, regulated and monitored than at any other time in history. FDA has the primary legal responsibility for determining their safe use. To market a new food or color additive (or before using an additive already approved for one use in another manner not yet approved), a manufacturer or other sponsor must first petition FDA for its approval. These petitions must provide evidence that the substance is safe for the ways in which it will be used. As a result of recent legislation, since 1999, indirect additives have been approved via a premarket notification process requiring the same data as was previously required by petition.
When evaluating the safety of a substance and whether it should be approved, FDA considers: 1) the composition and properties of the substance, 2) the amount that would typically be consumed, 3) immediate and long-term health effects, and 4) various safety factors. The evaluation determines an appropriate level of use that includes a built-in safety margin - a factor that allows for uncertainty about the levels of consumption that are expected to be harmless. In other words, the levels of use that gain approval are much lower than what would be expected to have any adverse effect.
Because of inherent limitations of science, FDA can never be absolutely certain of the absence of any risk from the use of any substance. Therefore, FDA must determine - based on the best science available - if there is a reasonable certainty of no harm to consumers when an additive is used as proposed.
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. In 1999, procedures changed so that FDA now consults with USDA during the review process for ingredients that are proposed for use in meat and poultry products. Federal officials then monitor the extent of Americans' consumption of the new additive and results of any new research on its safety to ensure its use continues to be within safe limits.
If new evidence suggests that a product already in use may be unsafe, or if consumption levels have changed enough to require another look, federal authorities may prohibit its use or conduct further studies to determine if the use can still be considered safe.

Regulations known as Good Manufacturing Practices (GMP) limit the amount of food ingredients used in foods to the amount necessary to achieve the desired effect.