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Regul. Toxicol. Pharmacol. · Aug 2016
ReviewGRAS determination scientific procedures and possible alternatives.
- Gary M Williams, Tetyana Kobets, Michael J Iatropoulos, Jian-Dong Duan, and Klaus D Brunnemann.
- Department of Pathology, New York Medical College, 40Sunshine Cottage Road, BSB # 413, Valhalla, NY, 10595, USA. Electronic address: gary_williams@nymc.edu.
- Regul. Toxicol. Pharmacol. 2016 Aug 1; 79 Suppl 2: S105-11.
AbstractThe 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. Copyright © 2016 Elsevier Inc. All rights reserved.
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