Description
You may submit written or electronic comments regarding this document at any time. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments tohttp://www.regulations.gov.
Scope & Applicability
Product Classes
2Cosmetic products with limited exemption from regulation
Substances used to impart color, generally excepted from food additive definition.; Substances used to impart color, generally not eligible for GRAS
Stakeholders
1Party submitting a citizen petition; party evaluating whether a food allergen is of public health importance; Party recommended to conduct systematic reviews and evidence scoring.
Regulatory Context
Attributes
1Minimum percentage assay required in specifications
Identified Hazards
Hazards
1Impurities of specific toxicological concern
Related CFR Sections (4)
- 21CFR82.51§ 82.51 Lakes (FD&C).
- 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 →
- 21CFR71.15§ 71.15 Confidentiality of data and information in color additive petitions.
(a) The following data and information in a color additive petition are available for public disclosure, unless extraordinary circumstances are shown, after the notice of filing of the petition is published in the Federal Register or, if the petition is not promptly filed because of deficiencies in Read full regulation →
- 21CFR70.42§ 70.42 Criteria for evaluating the safety of color additives.
(a) In deciding whether a petition is complete and suitable for filing and in reaching a decision on any petition filed, the Commissioner will apply the “safe-for-use” principle. This will require the presentation of all needed scientific data in support of a proposed listing to assure that each lisRead full regulation →
See Also (8)
- Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives (Status: Final)
- Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process (Status: Final)
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (Status: Draft)
- 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: Colored Sea Salt (Status: Final)
- CPG Sec 500.425 Use of Color Additives in Paper and Paperboard Intended for Use with Food (Status: Final)
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance (Status: Final)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (Status: Final)