ABSTRACT
This chapter examines the procedures used to review the safety and specifications of a new food additive by the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA), the data requirements, and procedures used for the approval of a new food additive in the United States and the European Union (EU), to determine their use as a basis for evaluating the safety of new pharmaceutical excipients. In addition to the food additive petition process, the procedure whereby a substance can be recognized so Generally Recognized As Safe (GRAS) in the United States is discussed. This chapter deals only with food additives directly added to food (direct food additives) and not food additives indirectly added to food (food contact substances), secondary direct food additives, or prior sanction substances.
