21 CFR § 170.22 - Safety factors to be considered.

---
identifier: "/us/cfr/t21/s170.22"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 170.22 - Safety factors to be considered."
title_number: 21
title_name: "Food and Drugs"
section_number: "170.22"
section_name: "Safety factors to be considered."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "170"
part_name: "FOOD ADDITIVES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 341, 342, 346a, 348, 371."
regulatory_source: "42 FR 14483, Mar. 15, 1977, unless otherwise noted."
cfr_part: "170"
---


# 170.22 Safety factors to be considered.

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.