21 CFR § 172.5 - General provisions for direct food additives.

---
identifier: "/us/cfr/t21/s172.5"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 172.5 - General provisions for direct food additives."
title_number: 21
title_name: "Food and Drugs"
section_number: "172.5"
section_name: "General provisions for direct food additives."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "172"
part_name: "FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION"
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, 348, 371, 379e."
regulatory_source: "42 FR 14491, Mar. 15, 1977, unless otherwise noted."
cfr_part: "172"
---


# 172.5 General provisions for direct food additives.

(a) Regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice. For the purposes of this part, good manufacturing practice shall be defined to include the following restrictions.

(1) The quantity of the substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food.

(2) Any substance intended for use in or on food is of appropriate food grade and is prepared and handled as a food ingredient.

(b) The existence of a regulation prescribing safe conditions of use for a food additive shall not be construed to relieve the use of the substance from compliance with any other provision of the Act.

(c) The existence of any regulation prescribing safe conditions of use for a nutrient substance does not constitute a finding that the substance is useful or required as a supplement to the diet of humans.