Overview of FDA's redbook guidelines

Abstract

As part of its responsibility, the Food and Drug Administration provides guidance to industry and the public concerning the procedures and methods for safety assessment of food and color additives. The FDA published its guidelines in 1982 as the so‐called “Redbook” (“Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food”). The Center for Food Safety and Applied Nutrition of the FDA is now in the process of revising and updating the Redbook in light of developments in toxicological testing methods and comments from the scientific community and the public. The effort involves a number of center scientists who have special expertise in various areas of toxicology and food safety assessment. The goal is to make the revised Redbook more useful and practical and to address areas of safety assessment not covered in the 1982 edition. The several papers that follow deal with chapters that will be new to the Redbook.

Key words:

• food additives
• color additives
• safety assessment
• guidelines
• toxicity studies