Description
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Scope & Applicability
Product Classes
5Foods resulting from biotechnology
Substances generally recognized as safe for intended use.
Substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food; referred to as FCS throughout the guidance; The potential for genetic toxicity is an important consideration in the safety evaluation of FCSs.; toxicological recommendations for FCS
Substances used to impart color, generally excepted from food additive definition.; Substances used to impart color, generally not eligible for GRAS
Substance added directly to food; Subject of the petition guidance
Stakeholders
2Entity responsible for submitting NDINs
Entity responsible for submitting NDINs
Regulatory Context
Attributes
1Standard for marketing food ingredients in the US
Related CFR Sections (2)
- 21CFR170.3§ 170.3 Definitions.
For the purposes of this subchapter, the following definitions apply:Read full regulation →
- 21CFR70.3§ 70.3 Definitions.
(a) Secretary means the Secretary of Health and Human Services.Read full regulation →
See Also (7)
- Redbook 2000: IV.C.9.a.Guidelines for Reproduction Studies (Status: Final)
- Redbook 2000: I Introduction (Status: Final)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (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)
- 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: Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal Food (Status: Final)
- Guidance for Industry: Colored Sea Salt (Status: Final)