---
kind: "section"
citation: "21 C.F.R. § 1.601"
title: "21"
number: "1.601"
heading: "Who is subject to this subpart?"
url: "https://uscodex.org/cfr/21/1.601"
---

# §1.601. Who is subject to this subpart?

- (a) **Accreditation bodies.** Any accreditation body seeking recognition from FDA to accredit third-party certification bodies to conduct food safety audits and to issue food and facility certifications under this subpart.
- (b) **Third-party certification bodies.** Any third-party certification body seeking accreditation from a recognized accreditation body or direct accreditation by FDA for:
  - (1) Conducting food safety audits; and
  - (2) Issuing certifications that may be used in satisfying a condition of admissibility of an article of food under [section 801(q)](/cfr/21/801.md?p=q) of the FD&C Act; or issuing a facility certification for meeting the eligibility requirements for the Voluntary Qualified Importer Program under [section 806](/cfr/21/806.md) of the FD&C Act.
- (c) **Eligible entities.** Any eligible entity seeking a food safety audit or a food or facility certification from an accredited third-party certification body under this subpart.
- (d) **Limited exemptions from section 801(q) of the FD&C Act—**
  - (1) **Alcoholic beverages.**
    - (i) Any certification required under [section 801(q)](/cfr/21/801.md?p=q) of the FD&C Act does not apply with respect to alcoholic beverages from an eligible entity that is a facility that meets the following two conditions:
      - (A) 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 a foreign facility of a type that, if it were a domestic facility, would require obtaining a permit from, registering with, or obtaining approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States; and
      - (B) Under [section 415](/cfr/21/415.md) of the FD&C Act, the facility is required to register as a facility because it is engaged in manufacturing/processing one or more alcoholic beverages.
    - (ii) Any certification required under [section 801(q)](/cfr/21/801.md?p=q) of the FD&C Act does not apply with respect to food that is not an alcoholic beverage that is received and distributed by a facility described in [paragraph (d)(1)(i)](#d-1-i) of this section, provided such food:
      - (A) Is received and distributed in prepackaged form that prevents any direct human contact with such food; and
      - (B) Constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury.
    - (iii) Any certification required under [section 801(q)](/cfr/21/801.md?p=q) of the FD&C Act does not apply with respect to raw materials or other ingredients that are imported for use in alcoholic beverages provided that:
      - (A) The imported raw materials or other ingredients are used in the manufacturing/processing, packing, or holding of alcoholic beverages;
      - (B) Such manufacturing/processing, packing, or holding is performed by the importer;
      - (C) The importer is required to register under [section 415](/cfr/21/415.md) of the Federal Food, Drug, and Cosmetic Act; and
      - (D) The importer is exempt from the regulations in [part 117](/cfr/21/part117.md) of this chapter in accordance with [§ 117.5(i)](/cfr/21/117.5.md?p=i).
  - (2) **Certain meat, poultry, and egg products.** Any certification required under [section 801(q)](/cfr/21/801.md?p=q) of the FD&C Act does not apply with respect to:
    - (i) Meat food products that at the time of importation are subject to the requirements of the United States Department of Agriculture (USDA) under the Federal Meat Inspection Act ([21 U.S.C. 601](/usc/21/601.md) et seq.);
    - (ii) Poultry products that at the time of importation are subject to the requirements of the USDA under the Poultry Products Inspection Act ([21 U.S.C. 451](/usc/21/451.md) et seq.); and
    - (iii) Egg products that at the time of importation are subject to the requirements of the USDA under the Egg Products Inspection Act ([21 U.S.C. 1031](/usc/21/1031.md) et seq.).

## Notes

### Source

Source: 80 FR 74650, Nov. 27, 2015, unless otherwise noted.

### Authority

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

### Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.