History of the Impurities Policy: Risk Assessment for Food and Color Additives

Abstract

The FDA impurities policy embodies a regulatory approach which distinguishes between a food or color additive as a whole and its constituents for the purpose of determining when the Delaney clause is triggered. Under the impurities policy, the Delaney clause does not apply to a carcinogenic impurity in a food or color additive unless there is a finding that the additive as a whole induces cancer. This interpretation of the Delaney clause enables the agency to use risk assessment to determine whether, under the general safety provisions for food and color additives, there is a reasonable certainty that no harm will result from the proposed use of an additive. The use of risk assessment in the implementation of the impurities policy permits the FDA to manage insignificant risk from low-level carcinogens consistent with the anti-cancer prohibitions of the Delaney clause.