21 CFR 70.40
§ 70.40 Safety factors to be considered.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 70.40, § 70.40 Safety factors to be considered, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83578
- Permanent ID
ys:prov:83578@1- SHA-256
0952493c3e4fcfefb0bfda3f904ad8ede2db70146a328f54a2bf94d731837b89
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
In accordance with section 721(b)(5)(A)(iii) of the act, the following safety factor will be applied in determining whether the proposed use of a color additive will be safe: Except where evidence is submitted which justifies use of a different safety factor, a safety factor of 100 to 1 will be used in applying animal experimentation data to man; that is, a color additive for use by man will not be granted a tolerance that will exceed 1/100th of the maximum no-effect level for the most susceptible experimental animals tested. The various species of experimental animals used in the tests shall conform to good pharmacological practice.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.