Description
Section 409 of the Federal Food, Drug, and Cosmetic Act provides that a substance added to food is unsafe unless the substance conforms to the terms of an exemption for investigational use, or unless the substance is in conformance with a regulation describing the conditions under which the substance may be safely used or unless the substance is generally recognized as safe (GRAS). Although it is impractical to list all substances that are GRAS, FDA has identified numerous substances which, when used for their specified uses and in accordance with good manufacturing practice, are GRAS. See 21 CFR Part 182, 184 and 186. According to 21 CFR 182.1(b), the following good manufacturing practices are applicable to GRAS substances:
Scope & Applicability
Product Classes
1Safety Assessment of Direct Food Additives
Stakeholders
2The issuing office for this Compliance Policy Guide.
Program involved in data standards
Regulatory Context
Attributes
2Constraints on the use or amount of a GRAS substance
Substances intended for use in food must be of appropriate quality
Related CFR Sections (1)
- 21CFR182.1§ 182.1 Substances that are generally recognized as safe.
(a) It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, vinegar, baking powder, and monosodium glutamate as safe for their intended use. This pRead full regulation →
See Also (8)
- Guidance for Industry: Antimicrobial Food Additives (Status: Final)
- Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry (Status: Final)
- Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives (Status: Final)
- Small Entity Compliance Guide: Revocation of Uses of Partially Hydrogenated Oils in Foods (Status: Final)
- CPG Sec 562.550 Safety and Labeling of Waxed (Coated) Fruits and Vegetables (Status: Final)
- Guidance for Industry: Estimating Dietary Intake of Substances in Food (Status: Final)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (Status: Final)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices for Enzyme Preparations (Status: Final)