---
kind: "section"
citation: "21 C.F.R. § 70.40"
title: "21"
number: "70.40"
heading: "Safety factors to be considered."
url: "https://uscodex.org/cfr/21/70.40"
---

# §70.40. Safety factors to be considered.


In accordance with [section 721(b)(5)(A)(iii)](/cfr/21/721.md?p=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.


## Notes

### Authority

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 360b, 361, 371, 379e.

### Source

Source: 42 FR 15636, Mar. 22, 1977, unless otherwise noted.