Description
Because of Congress’s explicit statutory authorization to effectuate certain binding requirements related to food product categories in food facility registrations based on findings in guidance, this document is not subject to the usual restrictions in FDA’s good guidance practice (GGP) regulations, such as the requirements that guidances not establish legally enforceable responsibilities and that they prominently display a statement of the document's nonbinding effect. See 21 CFR 10.115(d) and (i). This guidance contains findings that serve as the predicates for binding requirements on industry.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
5Finished pet food requires registration.
Includes Fin Fish, Shellfish, and RTE products.
Includes Proteins, Amino Acids, Fats and Lipid Substances.
Additional food product category for human consumption.
AF products subject to registration and filing; Category of food requiring establishment registration and process filing.
Stakeholders
2Person or entity responsible for reporting establishment information
Entities required to submit registration information
Regulatory Context
Regulatory Activities
1Requirement for food facilities
Identified Hazards
Hazards
2Safety incidents requiring rapid communication with facilities
Potential threat requiring quick response via registration data
Related CFR Sections (5)
- 21CFR113.3§ 113.3 Definitions.
For the purposes of this part, the following definitions apply:Read full regulation →
- 21CFR114.3§ 114.3 Definitions.
For the purposes of this part, the following definitions apply.Read full regulation →
- 21CFR1.232§ 1.232 What information is required in the registration?
(a) For a domestic and foreign facility, the following information is required:Read full regulation →
- 21CFR170.3§ 170.3 Definitions.
For the purposes of this subchapter, the following definitions apply:Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
Enforcement Impact
Deficiencies cited in Warning Letters referencing the same regulations
Related Warning Letters (3)
See Also (8)
- Guidance for Industry: Submitting Forms for Food Canning Establishment Registration and Food Process Filing to FDA in Electronic or Paper Format (Status: Final)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) (Status: Final)
- Small Entity Compliance Guide: Registration of Food Facilities (Status: Final)
- Draft Guidance for Industry: Questions and Answers on the Accredited Third-Party Certification Program (Status: Draft)
- Redbook 2000: IV.C.9.a.Guidelines for Reproduction Studies (Status: Final)
- Redbook 2000: I Introduction (Status: Final)
- Redbook 2000: III Recommended Toxicity Studies (Status: Final)