---
kind: "section"
citation: "21 C.F.R. § 121.1"
title: "21"
number: "121.1"
heading: "Applicability."
url: "https://uscodex.org/cfr/21/121.1"
---

# §121.1. Applicability.


This part applies to the owner, operator or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the United States and is required to register under [section 415](/cfr/21/415.md) of the Federal Food, Drug, and Cosmetic Act, unless one of the exemptions in [§ 121.5](/cfr/21/121.5.md) applies.


## 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.