The Lacuna Project

lacuna (n.) a gap in a record where something should be

Independent research. Not affiliated with any government, agency, or company.

Exhibit 567

21 CFR 170.30, Eligibility for classification as generally recognized as safe (GRAS)

Exhibit 567 ยท Regulation

21 CFR 170.30, Eligibility for classification as generally recognized as safe (GRAS)

General recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive.

FDA's regulation on what general recognition of safety requires: the views of qualified experts based on scientific procedures or, for pre-1958 substances, common use in food, and 'common knowledge throughout the scientific community' that there is reasonable certainty of no harm.

Source
U.S. Food and Drug Administration
Date
In force 1 November 2026 (eCFR)
Quoted from
21 CFR 170.30(b)
Grade
Primary record
Document
https://www.ecfr.gov/current/title-21/section-170.30
Accessed
2026-11-09
Cited by
Findings citing this exhibit

Cited by

Finding AGR-1.8
Primary record FDA's regulation says general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as an additive approval. FDA removed cyclamate salts from the GRAS list in 1969, and in 2010 it sent warning letters to makers of caffeinated alcoholic beverages that had made no GRAS determination.