Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients (Redbook)
"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"). Major changes in this revised guidance are presented later in this chapter. This document provides guidance to industry and other stakeholders (e.g. 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. It is a guidance document that is intended to assist petitioners and notifiers in:
- determining the need for toxicity studies
- designing, conducting, and reporting the results of toxicity studies
- conducting statistical analyses of data
- the review of histological data
- the submission of this information to the FDA as part of the safety assessment of food ingredients.
The term "food ingredients", as used in this guidance, includes food additives and color additives used in food, and those substances which are classified as food contact substances (formerly known as indirect food additives), and those substances which are classified as generally recognized as safe (GRAS). The toxicity studies included in this guidance document can also be used in the safety assessment of constituent residues.
Petitioners and notifiers are encouraged to become familiar with the information in this guidance document as well as other toxicology related guidance information available via the following internet links when considering the submission of a petition or notification:
Additionally, sponsors are encouraged to discuss with the appropriate regulatory divisions in the OFAS the extent and types of toxicity testing they are considering and the type of petition or notification they intend to submit. FDA consistently has taken the position that various types of scientifically valid information may be used to support a determination that the proposed use of an ingredient is safe. Sponsors should consult with the FDA to discuss the use of alternative information to support a determination of safety for the food ingredient prior to the submission of a petition or notification.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.