---
kind: "section"
citation: "21 C.F.R. § 121.5"
title: "21"
number: "121.5"
heading: "Exemptions."
url: "https://uscodex.org/cfr/21/121.5"
---

# §121.5. Exemptions.

- (a) This part does not apply to a very small business, except that a very small business must, upon request, provide for official review documentation sufficient to show that the facility meets this exemption. Such documentation must be retained for 2 years.
- (b) **This part does not apply to the holding of food, except the holding of food in liquid storage tanks.**
- (c) This part does not apply to the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact.
- (d) This part does not apply to activities of a farm that are subject to [section 419](/cfr/21/419.md) of the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety).
- (e)
  - (1) This part does not apply with respect to alcoholic beverages at a facility that meets the following two conditions:
    - (i) Under the Federal Alcohol Administration Act ([27 U.S.C. 201](/usc/27/201.md) et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 ([26 U.S.C. 5001](/usc/26/5001.md) et seq.) the facility is required to obtain a permit from, register with, or obtain approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States, or is a foreign facility of a type that would require such a permit, registration, or approval if it were a domestic facility; and
    - (ii) Under [section 415](/cfr/21/415.md) of the Federal Food, Drug, and Cosmetic Act the facility is required to register as a facility because it is engaged in manufacturing, processing, packing, or holding one or more alcoholic beverages.
  - (2) This part does not apply with respect to food that is not an alcoholic beverage at a facility described in [paragraph (e)(1)](#e-1) of this section, provided such food:
    - (i) Is in prepackaged form that prevents any direct human contact with such food; and
    - (ii) Constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury.
- (f) This part does not apply to the manufacturing, processing, packing, or holding of food for animals other than man.
- (g) This part does not apply to on-farm manufacturing, processing, packing, or holding of the following foods on a farm mixed-type facility, when conducted by a small or very small business if such activities are the only activities conducted by the business subject to [section 418](/cfr/21/418.md) of the Federal Food, Drug, and Cosmetic Act.
  - (1) Eggs (in-shell, other than raw agricultural commodities, e.g., pasteurized); and
  - (2) **Game meats (whole or cut, not ground or shredded, without secondary ingredients).**

## Notes

### Authority

Authority: 21 U.S.C. 331, 342, 350g, 350(i), 371, 374.

### Source

Source: 81 FR 34219, May 27, 2016, unless otherwise noted.