academia, other regulatory groups) regarding toxicological information submitted to the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Additive Safety (OFAS) regarding food ingredients. This document provides guidance to industry and other stakeholders (e.g. Major changes in this revised guidance are presented later in this chapter. " Toxicological Principles for the Safety Assessment of Food Ingredients" ("Redbook 2000") is the new name for Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food" that was originally published in 1982 ("Redbook I") and a draft revision was published in 1993 ( "Redbook II"). If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.
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