21 CFR 170.22
§ 170.22 Safety factors to be considered.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 170.22, § 170.22 Safety factors to be considered, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84879
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Full text
In accordance with section 409(c)(5)(C) of the Act, the following safety factors will be applied in determining whether the proposed use of a food additive will be safe: Except where evidence is submitted which justifies use of a different safety factor, a safety factor in applying animal experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be granted a tolerance that will exceed 1/100th of the maximum amount demonstrated to be without harm to experimental animals.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.