Listing of Color Additives Exempt From Certification; Beetroot Red

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 73</CFR> <DEPDOC>[Docket No. FDA-2024-C-1085]</DEPDOC> <SUBJECT>Listing of Color Additives Exempt From Certification; Beetroot Red</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 beetroot red for the coloring of human foods generally, at levels consistent with current good manufacturing practice, except in products under the jurisdiction of the United States Department of Agriculture (USDA), infant formula, or foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), unless the use of the added color is authorized by such standards. We are taking this action in response to a color additive petition (CAP) submitted by Phytolon, Ltd. (Phytolon or petitioner). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This order is effective March 23, 2026. 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 March 9, 2026. </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 March 9, 2026. 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 comments 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-2024-C-1085 for “Listing of Color Additives Exempt From Certification; Beetroot Red.” 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 its 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> Christopher Kampmeyer, Office of Pre-Market Additive Safety, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1255; or Meadow Platt, Office of Policy and International Engagement, 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 the <E T="04">Federal Register</E> of March 12, 2024 (89 FR 17789), we announced that we filed a color additive petition (CAP 4C0326) submitted by Phytolon, Ltd., Ha-Tsmikha St, Yokne'am Illit, Israel. 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 beetroot red for the coloring of foods generally, in amounts consistent with current good manufacturing practice, except in products under the jurisdiction of the USDA, in infant formula, and foods for which standards of identity have been promulgated under section 401 of the FD&C Act unless added color is authorized by such standards. <HD SOURCE="HD1">II. Background</HD> Beetroot red is a reddish-purple liquid or powder produced by fermentation using a modified strain of the yeast, <E T="03">Saccharomyces cerevisiae</E> ( <E T="03">S. cerevisiae</E> ), expressing the genes for betanin biosynthesis from red beets ( <E T="03">Beta vulgaris</E> L. var. rubra). The principal coloring component in beetroot red is betanin (CAS Reg. No. 7659-95-2). Betanin is a type of betacyanin, which in turn is a type of betalain. Betalains are a class of water-soluble pigments present primarily in red beets and in plants belonging to the order, Caryophyllales ( <E T="03">e.g.,</E> quinoa, spinach, amaranths, and others). Betalains are divided into two subclasses: betacyanins (reddish to violet, including betanin) and betaxanthins (yellow to orange). Beetroot red contains a similar betacyanin pigment composition to dehydrated beets (21 CFR 73.40). The color additive is manufactured by the following steps: (1) construction of the <E T="03">S. cerevisiae</E> production strain that is genetically engineered to express the genes involved in the biosynthesis of betanin; (2) expression of betanin product via controlled fermentation by the <E T="03">S. cerevisiae</E> production strain; (3) removal of the production organism from the fermentation broth; and (4) water evaporation to produce the liquid form of the product and optional drying to produce a powder form of the product. The petitioner proposed the following specifications for beetroot red: total betacyanin, not less than 0.6 percent by weight; betanin purity, not less than 75 percent of the total betacyanin; total betacyanin other than betanin, not more than 20 percent; lead, not more than 0.15 milligram per kilogram (mg/kg); arsenic, not more than 0.05 mg/kg; mercury, not more than 0.01 mg/kg; cadmium, not more than 0.05 mg/kg. FDA concluded that the petitioner's proposed specifications for total betacyanin, betanin purity, and total betacyanin other than betanin are not needed in the codified regulation (Ref. 1). <HD SOURCE="HD1">III. Safety Evaluation</HD> Under section 721(b)(4) of the 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. As part of our safety evaluation to establish with reasonable certainty that a color additive is not harmful under its intended conditions of use, we consider the additive's manufacturing and stability, the projected dietary exposure to the additive and any impurities resulting ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 28k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━