Final Rules: Food Additives and Color Additives
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Petition(s): CAP 1C0319
Listing of Color Additives Exempt from Certification; Gardenia (Genipin) Blue
| Petitioner: | Gardenia Blue Interest Group |
|---|---|
| Docket number (legacy and/or former docket number(s)): | FDA-2021-C-0522 |
| Subject additive and intended use: | amending the color additive regulations to provide for the safe use of gardenia (genipin) blue in various food categories at levels consistent with good manufacturing practice. |
| 21 CFR* affected: | 73.168; Gardenia (Genipin) Blue |
| Substance(s)*, (CAS Registry® No.): |
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| Federal Register publication history: | Jun 20, 2021; 86 FR 34664; Notification of petition. |
| Jul 15, 2025; 90 FR 31586; Final amendment; order.; Effective date: Aug 29, 2025 | |
| Oct 1, 2025; 90 FR 47229; Final amendment; order; confirmation of effective date.; Effective date: Aug 29, 2025 |
*Definitions
- CAS Reg. No. (or other ID): Chemical Abstract Service (CAS) Registry Number© for the substance or a numerical code (other ID) assigned by CFSAN to those substances that do not have a CAS Registry Number (977nnn-nn-n or 809777nnn-nn-n series).
- Substance: A name of the additive or impurity as recognized by CFSAN.
- Calculation/Update Date: The date on which the CEDI was calculated or re-evaluated.
- CDC: Cumulative Dietary Concentration (CDC, parts-per-billion, ppb)
- CEDI: Cumulative Estimated Daily Intake (micrograms/kilogram body weight/person/day, µg/kg bw/d)
- 21 CFR: The Code of Federal Regulations, Title 21 is the preferred reference to determine the regulatory status of Indirect Food Additives. Substances whose names appear in 21 CFR, parts 175-178 are authorized for specified intended users and conditions of use as stated in the regulation. Note that substances may appear in more than one regulation, or several times in the same regulation. Note that if a substance is mentioned in 21 CFR parts 175-178 and thus, is listed above, any other citations for the same substance in other sections of 21 CFR dealing with food additives (parts 1-199 inclusive) may also be cited.
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