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
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.
Recommended Citation
Williams, G., Kobets, T., Iatropoulos, M., Duan, J., & Brunnemann, K. (2016). GRAS Determination Scientific Procedures and Possible Alternatives. Regulatory toxicology and pharmacology : RTP, 79 Suppl 2, 105-111. https://doi.org/https://doi.org/10.1016/j.yrtph.2016.06.015