Redbook 2000 Home > Food > Guidance, Compliance & Regulatory Information > Guidance Documents Food Redbook 2000 July 2000; Revised July 2007 Guidance for Industry and Other Stakeholders Toxicological Principles for the Safety Assessment of Food Ingredients Redbook 2000 Additional copies are available from: Office of Food Additive Safety, HFS-200 Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20740 (Tel)301-436-1200 http://www.cfsan.fda.gov/guidance.html U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition July 2000; Updated July 2007 Note to reader: Individual chapters/sections of this internet version of "Redbook" are available as linked documents via the Table of Contents. The date of revision for each chapter and /or chapter section is provided in the Table of Contents and the individual documents. These revisions supersede previous versions of Redbook Table of Contents I Introduction 1 (July 2007) II. Agency Review of Toxicology Information Submitted in Support of the Safety Assessment of Food Ingredients (available in 1993 Draft "Redbook II" 2) III Recommended Toxicity Studies 3 (July 2007) IV. Guidelines for Toxicity Studies A. Introduction 4 (November 2003) B. General Recommendations for Toxicity Studies 000001 3/3/2010 Page 1 of 4 Redbook 2000 1. General Guidelines for Designing and Conducting Toxicity Studies 5 (November 2003) 2. Guidelines for Reporting Results of Toxicity Studies 6 (November 2003) 3. Pathology Considerations in Toxicity Studies 7 (July 2000) 4. Statistical Considerations in Toxicity Studies 8 (July 2000) 5. Diets for Toxicity Studies (available in 1993 Draft "Redbook II" 9) C. Guidelines for Specific Toxicity Studies 1. Short-Term Tests for Genetic Toxicity 10 (July 2000) a. Bacterial Reverse Mutation Test 11 (July 2000) b. In vitro Mammalian Chromosomal Aberration Test 12 (November 2003) c. In vitro Mouse Lymphoma TK 13 +/- Gene Mutation Assay 14 (April 2006) d. In vivo Mammalian Erythrocyte Micronucleus Test 15 (July 2000) 2. Acute Oral Toxicity Tests (available in 1993 Draft "Redbook II" 16) 3. Short Term Toxicity Studies a. Short-Term Toxicity Studies with Rodents 17 (November 2003) b. Short-Term Toxicity Studies with Non-Rodents 18 (November 2003) 4. Subchronic Toxicity Studies a. Subchronic Toxicity Studies with Rodents 19 (November 2003) b. Subchronic Toxicity Studies with Non-Rodents 20 (November 2003) 5. Chronic Toxicity Studies a. Chronic Toxicity Studies with Rodents 21 (July 2007) b. One-Year Toxicity Studies with Non-Rodents 22 (November 2003) 6. Carcinogenicity Studies with Rodents 23 (January 2006) 7. Combined Chronic Toxicity/Carcinogenicity Studies with Rodents 24 (July 2007) 8. In Utero Exposure Phase for Addition to Carcinogenicity Studies with Rodents 25 (July 2007) 9. Reproduction and Developmental Toxicity Studies a. Guidelines for Reproduction Studies 26 (July 2000) b. Guidelines for Developmental Toxicity Studies 27 (July 2000) 10. Neurotoxicity Studies 28 (July 2000) V. Additional Studies (available in 1993 Draft "Redbook II" 29) A. Introduction B. Metabolism and Pharmacokinetic Studies C. Immunotoxicity Studies VI. Human Studies 000002 3/3/2010 Page 2 of 4 Redbook 2000 A. Clinical Evaluation of Food Ingredients (available in 1993 Draft "Redbook II" 30) B. Epidemiology Studies 31 (October 2001) VII Glossary: Acronyms and Definitions 32 (April 2004) 1This guidance has been prepared by the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 2Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food (also known as Redbook I), U.S. Food and Drug Administration, Bureau of Foods (now CFSAN), 1982. May be purchased from: National Technical Information Services (NTIS), 5285 Port Royal Road, Springfield, VA 22161, Telephone (703) 605-6000, NTIS Order Number PB83-170696. 3Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food 1993 Draft "Redbook II" Table of Contents 33 Links on this page: 1. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078044.htm 2. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078717.htm 3. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078310.htm 4. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078311.htm 5. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078315.htm 6. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078409.htm 7. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078318.htm 8. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078320.htm 9. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078717.htm 10. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078321.htm 11. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078330.htm 12. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078332.htm 000003 3/3/2010 Page 3 of 4 Redbook 2000 13. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078336.htm 14. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078336.htm 15. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078338.htm 16. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078717.htm 17. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078339.htm 18. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078342.htm 19. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078345.htm 20. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078346.htm 21. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078349.htm 22. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078348.htm 23. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078388.htm 24. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078393.htm 25. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078394.htm 26. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078396.htm 27. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078399.htm 28. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078323.htm 29. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078717.htm 30. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078717.htm 31. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078401.htm 32. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078404.htm 33. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredie ntsandPackaging/Redbook/ucm078717.htm 000004 3/3/2010 Page 4 of 4 Redbook 2000: I Introduction Home > Food > Guidance, Compliance & Regulatory Information > Guidance Documents Food Redbook 2000: I Introduction July 2007 Toxicological Principles for the Safety Assessment of Food Ingredients Redbook 2000 Chapter I. Introduction Return to Redbook 2000 table of contents 1 This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the