GRAS determination scientific procedures and possible alternatives.
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.
Department of Pathology, New York Medical College, 40Sunshine Cottage Road, BSB # 413, Valhalla, NY, 10595, USA. Electronic address: gary_williams@nymc.edu.
Gary M
GM
Williams
Department of Pathology, New York Medical College, 40Sunshine Cottage Road, BSB # 413, Valhalla, NY, 10595, USA.
Tetyana
T
Kobets
Department of Pathology, New York Medical College, 40Sunshine Cottage Road, BSB # 413, Valhalla, NY, 10595, USA.
Michael J
MJ
Iatropoulos
Department of Pathology, New York Medical College, 40Sunshine Cottage Road, BSB # 413, Valhalla, NY, 10595, USA.
Jian-Dong
JD
Duan
Department of Pathology, New York Medical College, 40Sunshine Cottage Road, BSB # 413, Valhalla, NY, 10595, USA.
Klaus D
KD
Brunnemann
D000818:Animals; D015197:Carcinogenicity Tests; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards; D004305:Dose-Response Relationship, Drug; D005503:Food Additives / Q000009:adverse effects* / Q000592:standards; D019649:Food Industry / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D059022:Food Safety / Q000379:methods*; D033161:Government Regulation; D006291:Health Policy; D006801:Humans; D009753:Nutritive Value; D011050:Policy Making; D064167:Recommended Dietary Allowances; D018570:Risk Assessment; D018675:Toxicity Tests / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
D005503:Food Additives
Accelerated carcinogenicity bioassay(ACB); Alternatives; Carcinogenicity; GRAS determination scientific procedures; Generally Recognized as Safe (GRAS); In Ovo assay; Safety; Scientific procedures; Toxicity