NYMC Faculty Publications

GRAS Determination Scientific Procedures and Possible Alternatives

DOI

https://doi.org/10.1016/j.yrtph.2016.06.015

Journal Title

Regulatory toxicology and pharmacology : RTP

First Page

105

Last Page

111

Document Type

Article

Publication Date

8-2016

Department

Pathology, Microbiology and Immunology

Second Department

Pathology, Microbiology and Immunology

Keywords

Animals, Carcinogenicity Tests, Consumer Product Safety, Dose-Response Relationship, Drug, Food Additives, Food Industry, Food Safety, Government Regulation, Health Policy, Humans, Nutritive Value, Policy Making, Recommended Dietary Allowances, Risk Assessment, Toxicity Tests, United States, United States Food and Drug Administration

Disciplines

Medicine and Health Sciences

Abstract

The use of a food substance is Generally Recognized as Safe (GRAS) through scientific procedures or experience based on common use in food. The pivotal data used for GRAS determination must be of common knowledge and should include evidence for safety under the conditions of intended use of the substance. Such evidence includes data on the identity and specifications of the substance, its properties of absorption, distribution, metabolism and excretion, and depending on the level of concern, data on genotoxicity, acute and subchronic toxicity, reproductive and developmental toxicity and carcinogenicity. Several alternative procedures can be used as the replacement for standard scientific procedures in order to improve the GRAS process.

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