Generally recognized as safe (GRAS): history and description

Burdock, George A; Carabin, Ioana G

doi:10.1016/j.toxlet.2003.07.004

Cited by 235Agricultural safety and regulationsFood Safety and HygieneHealthcare Regulation

Generally recognized as safe (GRAS): history and description

Burdock, George A, Carabin, Ioana G·2004·Toxicology Letters

DOI 10.1016/j.toxlet.2003.07.004

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Abstract

Generally recognized as safe (GRAS), a system for review and approval of ingredients for addition to food, was conceived at a time when the need for a less doctrinaire review of food ingredients was critical. The GRAS approval process for a food ingredient relies on the judgment of "...experts qualified by scientific training and experience to evaluate its safety..." the end product of which is no better or worse than that by FDA, but often more expeditious. The process and requirements for a successful GRAS determination are discussed and compared with that of the food additive petition (FAP) process. The future of the GRAS process is assured by its history of successful performance, bringing safe food ingredients to the consumer in a timely manner.

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In the United States, the FDA assigns GRAS status to substances whose safety for human consumption has been established through a history of use or sound scientific evidence.
“In the United States, the Food and Drug Administration (FDA) assigns Generally Recognized as Safe (GRAS) status to substances whose safety for human consumption has been established through a history of use or sound scientific evidence [2,239].”
From Navigating the potential of algal peptides: health effects, market applications, and scientific challenges (2026) · cites this paper as [239]

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Authors: Burdock, G. A., & Carabin, I. G.
Corresponding author: Burdock, George A
ORCID: Burdock, George A
Venue: Toxicology Letters
Publisher: Elsevier BV
Published: 2004-04
Volume: 150
Issue: 1
Pages: 3-18
ISSN: 0378-4274 (ISSN-L)
DOI: 10.1016/j.toxlet.2003.07.004
OpenAlex: W2050665337
Cited by: 235
References: 5
Citations by year: 2026: 25 · 2025: 22 · 2024: 26 · 2023: 21 · 2022: 27 · 2021: 16 · 2020: 11 · 2019: 14 · 2018: 14 · 2017: 7 · 2016: 11 · 2015: 4 · 2014: 8 · 2013: 8 · 2012: 3
FWCI: 3.13
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Toxicology Letters (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
Life Sciences › Agricultural and Biological Sciences › Food Science › Food Safety and Hygiene
Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
Keywords: GRAS, food ingredient safety, FDA regulatory process, food additive regulation
MeSH terms: Food, Food Additives, Humans, Legislation, Food, United States, United States Food and Drug Administration, History, 20th Century

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