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Exhibit 558

Food Additives Amendment of 1958 (Public Law 85-929, 72 Stat. 1784)

Exhibit 558 ยท Statute

Food Additives Amendment of 1958 (Public Law 85-929, 72 Stat. 1784)

if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use

Section 2 adds the definition of 'food additive' to section 201 of the Federal Food, Drug, and Cosmetic Act and excludes any substance generally recognized as safe by qualified experts. Section 4 adds section 409, which deems an additive unsafe unless it is covered by a regulation or exemption, and lets any person petition for a regulation. The text does not say who the experts are, how they are chosen, or that the government must be told of their conclusion.

Source
U.S. Congress
Date
6 September 1958
Quoted from
72 Stat. 1784, sec. 2 (new paragraph (s) of section 201)
Grade
Primary record
Document
https://www.govinfo.gov/content/pkg/STATUTE-72/pdf/STATUTE-72-Pg1784.pdf
Accessed
2026-11-09
Cited by
Findings citing this exhibit
Note
Now codified at 21 U.S.C. 321(s).

Cited by

Finding AGR-1.1
Primary record The Food Additives Amendment of 1958 makes a food additive unsafe unless an FDA regulation or exemption covers it, and it excludes from the definition of food additive any substance generally recognized, among experts qualified by scientific training and experience, as safe for its intended use. The statute does not say who the experts are or that a company must tell FDA of its conclusion.