Description
Commercial processors who manufacture, process, or pack AF and LACF are subject to the registration requirements of 21 CFR 108.25(c)(1) (for AF) and 21 CFR 108.35(c)(1) (for LACF), as well as the process filing requirements of 21 CFR 108.25(c)(2) (for AF) and 21 CFR 108.35(c)(2) (for LACF). These provisions require two basic types of submissions:
Scope & Applicability
Product Classes
5Specific food category discussed in Chapter 16; low-acid foods to which acid(s) or acid food(s) are added; Primary product category discussed; Subject of the guidance chapter; Foods with finished equilibrium pH of 4.6 or lower; Subject of Chapter 16 and Part 114 regulations; Specific category of food with additional recordkeeping requirements; Specific food category subject to 21 CFR 108 and 114.
Thermally processed foods in hermetically sealed containers.
AF products subject to registration and filing; Category of food requiring establishment registration and process filing.
LACF products subject to registration and filing
Category of food requiring establishment registration and process filing.
Stakeholders
6Entities subject to registration and process filing requirements.; Entity required to register and file processes
Person designated to oversee REMS implementation and compliance for a health care setting; Individual responsible for pharmacy/setting compliance and enrollment
Authorized official for the establishment; Individual with authority to grant access to the establishment's process filing information.
Role authorized to perform registration updates and process filings.
Role with view-only access to the electronic AF/LACF system.
Specific role within CFSAN for handling registrations
Related CFR Sections (4)
- 21CFR108.25§ 108.25 Acidified foods.
(a) Inadequate or improper manufacture, processing, or packing of acidified foods may result in the distribution in interstate commerce of processed foods that may be injurious to health. The harmful nature of such foods cannot be adequately determined after these foods have entered into interstate Read full regulation →
- 21CFR108.35§ 108.35 Thermal processing of low-acid foods packaged in hermetically sealed containers.
(a) Inadequate or improper manufacture, processing, or packing of thermally processed low-acid foods in hermetically sealed containers may result in the distribution in interstate commerce of processed foods that may be injurious to health. The harmful nature of such foods cannot be adequately deterRead full regulation →
- 21CFR114.3§ 114.3 Definitions.
For the purposes of this part, the following definitions apply.Read full regulation →
- 21CFR1.234§ 1.234 How and when do you update your facility's registration information?
(a) Update requirements. You must update a facility's registration within 60 calendar days of any change to any of the information previously submitted under § 1.232 (e.g., change of operator, agent in charge, or U.S. agent), except a change of the owner. You may authorize an individual to update a Read full regulation →
Related Warning Letters (10)
- 2025-06-17
Foreign Supplier Verification Program (FSVP)
Zest US Wholesale Inc.
- 2024-11-26
Acidified Foods/Emergency Permit Control/Adulterated
Tova Industries, LLC
- 2024-09-24
Acidified Foods/Emergency Permit Control/Adulterated
Brewing Market Coffee
- 2024-09-03
Foreign Supplier Verification Program (FSVP)
Dasada Group LLC
- 2024-07-09
Acidified Foods/Emergency Permit Control/Adulterated
Choo's Enterprises Ltd
- 2024-04-16
Foreign Supplier Verification Program (FSVP)
La Sucursal Produce Inc.
- 2024-04-02
Acidified Foods/Emergency Permit Control/Adulterated
Kitchen Garden Foods, LTD
- 2023-10-03
Foreign Supplier Verification Program (FSVP)
Apollo Import Export, Inc.
- 2023-07-18
Foreign Supplier Verification Program (FSVP)
Ocalsa Transport & Logistics, LLC
- 2022-09-27
Foreign Supplier Verification Program (FSVP)
El Salvador Products Inc
See Also (6)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition) (Status: Final)
- Guidance for Industry and FDA Staff: Model Accreditation Standards for Third-Party Certification Body Accreditation for Food Safety Audits (Status: Final)
- Guidance for Industry: Frequently Asked Questions About Medical Foods - Third Edition (Status: Final)
- Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods (Status: Draft)
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) (Status: Final)