Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 73</CFR> <DEPDOC>[Docket No. FDA-2021-C-0522]</DEPDOC> <SUBJECT>Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final amendment; order. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc., on behalf of the Gardenia Blue Interest Group (GBIG). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This order is effective August 29, 2025. See section XI for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the order by August 14, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 14, 2025. Objections received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic objections in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2021-C-0522 for “Listing of Color Additives Exempt from Certification; Gardenia (genipin) blue.” Received objections, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Stephen DiFranco, Office of Pre-market Additive Safety, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2710; or Deirdre Jurand, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Introduction</HD> In a document published in the <E T="04">Federal Register</E> on June 30, 2021 (86 FR 34664), we announced that we filed a color additive petition (CAP 1C0319) submitted by GBIG, c/o Exponent, Inc., 1150 Connecticut Ave. NW, Suite 1100, Washington, DC 20036. The petition proposed to amend the color additive regulations in part 73 (21 CFR part 73), “Listing of Color Additives Exempt from Certification,” to provide for the safe use of gardenia (genipin) blue at levels consistent with GMP in (1) sport drinks, (2) flavored or enhanced non-carbonated water, (3) fruit drinks and ades, (4) ready-to-drink teas, (5) hard candy, and (6) soft candy. <HD SOURCE="HD1">II. Background</HD> Gardenia (genipin) blue is a dark purple or dark blue liquid or powder prepared by the polymerization of genipin obtained from the fruit of <E T="03">Gardenia jasminoides</E> Ellis with soy protein hydrolysate. Gardenia (genipin) blue is mainly composed of a genipin-peptide polymer (the principal coloring component), carriers (for powder form), and water (for liquid form). The color additive is manufactured by sourcing, drying, and crushing the mature fruit of <E T="03">Gardenia jasminoides</E> Ellis. The fruit is used to produce the raw material for manufacture of gardenia (genipin) blue because it contains iridoid glycosides, of which 3-8 percent is geniposide. The soluble components are extracted using a mixture of ethanol and water, and the solids are removed by filtration. The extract is further refined to obtain genipin, which is reacted with soy protein hydrolysate, followed by polymerization to produce the liquid form of the principal coloring component (genipin-peptide polymer). Optionally, the finished liquid may be mixed with a food-grade carrier (dextrin or maltodextrin) and the mixture heat-sterilized, spray-dried to powder, and sieved to produce the color additive as a powder (Ref. 1). The raw material for gardenia (genipin) blue contains carboxymethyl functional groups, which may hydrolyze into methanol under the aqueous conditions of the manufacturing process. Any methanol formed is likely to be removed along with ethanol during the concentration steps in the manufacturing process, as well as in the final drying step for the powder form. The petitioner proposed specifications for gardenia (genipin) blue of not more than 5 milligrams per kilogram (mg/kg) (5 parts per million (ppm)) of unreacted genipin, not more than 80 mg/kg (80 ppm) of geniposide, not more than 6 mg/kg (6 ppm) of methanol, not more than 2 mg/kg (2 ppm) of arsenic, not more than 1 mg/kg (1 ppm) of cadmium, not more than 2 mg/kg (2 ppm) of lead, and not more than 1 mg/kg (1 ppm) of mercury. <HD SOURCE="HD1">III. Safety Evaluation</HD> Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive may not be listed for a particular use unless the data and other information available to FDA establish that the color additive is safe for that use. Our color additive regulations, at 21 CFR 70.3(i), define “safe” to mean that there is convincing evidence establishing with reasonable certainty that no harm will result from the intended use of the color additive. To establish with reasonable certainty that a color additive intended for use in foods is not harmful under its intended conditions of use, we consider the projected human dietary exposure to the color additive, the additive's toxicological data, and other relevant information (such as published literature) available to us. We compare the estimated dietary exposure to the color additive from all dietary sources to an acceptable daily intake (ADI) that is established by toxicological data. The dietary exposure is determined by projections based on the amount of the color additive intend ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 29k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━