Scope & Applicability
Product Classes
2Substances used to impart color, generally excepted from food additive definition.; Substances used to impart color, generally not eligible for GRAS
Approved substances for direct addition to food
Stakeholders
2GLP Regulations also require the use of a Quality Assurance Unit (QAU)
individual responsible for the overall conduct of a nonclinical laboratory study; Responsible for consulting with veterinarian and explaining outcomes; Individual responsible for the final study report and amendments; Responsible for reporting inspections and ensuring the report details the source of animals.
Regulatory Context
Attributes
1specifications for the purity, strength, and composition of dietary supplements
Related CFR Sections (9)
- 21CFR58.195§ 58.195 Retention of records.
(a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this chapter.Read full regulation →
- 21CFR58.190§ 58.190 Storage and retrieval of records and data.
(a) All raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids) generated as a result of a nonclinical laboratory study shall be retained.Read full regulation →
- 21CFR58.120§ 58.120 Protocol.
(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following information:Read full regulation →
- 21CFR58.35§ 58.35 Quality assurance unit.
(a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. For any given study, the quaRead full regulation →
- 21CFR170.101§ 170.101 Information in a premarket notification for a food contact substance (FCN).
An FCN must contain the following:Read full regulation →
- 21CFR170.35§ 170.35 Affirmation of generally recognized as safe (GRAS) status.
(a) The Commissioner, on his own initiative, may affirm that a substance that directly or indirectly becomes a component of food is GRAS under the conditions of its intended use.Read full regulation →
- 21CFR71.1§ 71.1 Petitions.
(a) Any interested person may propose the listing of a color additive for use in or on any food, drug, or cosmetic or for coloring the human body. Such proposal shall be made in a petition in the form prescribed in paragraph (c) of this section. The petition shall be submitted in triplicate (quadrupRead full regulation →
- 21CFR171.1§ 171.1 Petitions.
(a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the Federal Food, Drug, and Cosmetic Act (the act) shall be submitted in triplicate (quadruplicate, if intended uses include use in meat, meat food product, or poultry product). If any part of the material submRead full regulation →
- 21CFR58.185§ 58.185 Reporting of nonclinical laboratory study results.
(a) A final report shall be prepared for each nonclinical laboratory study and shall include, but not necessarily be limited to, the following:Read full regulation →
Related Warning Letters (1)
- 2020-05-05
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
University of Kentucky
See Also (4)
- Good Laboratory Practice Regulations Questions and Answers (Status: Final)
- General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission (Status: Final)