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Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition
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 it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach or have any questions regarding this document contact Adejoke Ogungbesan at FDA's Office of Food Additive Safety, 5001 Campus Drive, College Park, Maryland, 20740-3835, 240-402-1229.
The reader is advised that the use of the word "should" in the text of Agency guidance documents means that something is suggested or recommended, but not required.
The Food and Drug Administration (FDA) is making available nine templates related to the submission of toxicology data. Templates for: 1) Subchronic Toxicity Study in Rodents, 2) Subchronic Toxicity Study in Dogs, 3) Genetic Toxicity Study: in vitro Bacterial Reverse Mutation (Ames) Test, 4) Genetic Toxicity Study: in vitro Mouse Lymphoma Thymidine Kinase Gene Mutation Assay, 5) Genetic Toxicity Study: Mammalian Erythrocyte Micronucleus Test, 6)Genetic Toxicity Study: in vitro Mammalian Chromosomal Aberration Test, 7) Chronic Toxicity Study with an in utero phase, 8) Chronic (1 year) Dog Toxicity Study, and 9) Two-Generation Reproduction Toxicity Study. These templates provide optional tools for industry in submitting summary toxicology data from the respective studies in support of petitions and notifications for safe use of food and color additives. The purpose of this guidance is to assist industry in preparing toxicology reports using standardized formats and vocabularies that are consistent with current Agency recommendations for toxicological information. Their use will expedite the evaluation process of toxicology information by the Agency since data will be presented in a consistent, predictable, format for evaluation. An Experimental Study Calculation Guide has also been provided for convenience of industry.
This guidance explains FDA's current thinking and recommendations that the Agency considers appropriate in submitting toxicology reports in support of petitions and notifications for food and color additives. However, these toxicology data templates are not substitutes for the Federal Food, Drug, and Cosmetic Act (FFDCA) or the Code of Federal Regulations (CFR). FDA will consider the information adequate if it is submitted in accordance with applicable statutes and regulations. Requirements for toxicity data and information in support of food and color additives can be found in 21 CFR Parts 71, 170, and 171. The Agency also has provided guidances on toxicology recommendations for specific product categories such as food contact substances, direct food additives, color additives, and GRAS notifications. These are available on the Agency's Internet site at Food Ingredients and Packaging Guidance Documents.
Other templates may be made available in the future as the Agency continues to develop templates for other types of toxicity studies.
These templates are available in accessible HTML or Microsoft Word documents. The accessible HTML versions are for use with a screen reader for the visually impaired.
|Accessible HTML Document
|Word 2000 Template
|1. Subchronic Toxicity Study in Rodents
|2. Subchronic Toxicity Study in Dogs
|3. Genetic Toxicity Study: in vitro Bacterial Reverse Mutation (Ames) Test
|template (250 KB)
|4. Genetic Toxicity Study: in vitro Mouse Lymphoma Thymidine Kinase Gene Mutation Assay
|5. Genetic Toxicity Study: Mammalian Erythrocyte Micronucleus Test
|6. Genetic Toxicity Study: in vitro Mammalian Chromosomal Aberration Test
|7. Chronic Toxicity Study with an in utero phase
|8. Chronic (1 Year) Dog Toxicity Study Template
|9. Two-Generation Reproduction Toxicity Study
|Also available: Experimental Study Calculation Guide
Available as a Excel spreadsheet (86KB).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1941.