Listing of Color Additives Exempt From Certification; Spirulina Extract

<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-3384]</DEPDOC> <SUBJECT>Listing of Color Additives Exempt From Certification; Spirulina Extract</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 expanded use of spirulina ( <E T="03">Arthrospira platensis</E> ) extract as a color additive in human foods generally (except for infant formula, certain foods subject to regulation by the U.S. Department of Agriculture, and foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards) at levels consistent with good manufacturing practice (GMP), to lower the heavy metal specifications for lead, arsenic, and mercury, and to add a specification for cadmium. We are taking this action in response to a color additive petition (CAP) submitted by GNT USA, LLC (GNT or petitioner). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This order is effective March 23, 2026 See section IX of this document for further information on the filing of objections. Either electronic or written objections and requests for a hearing on the order must be submitted 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 objections 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 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-2024-C-3384 for “Listing of Color Additives Exempt from Certification; Spirulina Extract.” 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:// </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> Marissa Santos, Office of Pre-Market Additive Safety, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-8160 or Meridith L. Kelsch, 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 the <E T="04">Federal Register</E> of August 5, 2024 (89 FR 63330), FDA announced that we filed a color additive petition (CAP 4C0334) submitted on behalf of GNT by Exponent, 1150 Connecticut Ave. NW, Suite 1100, Washington, DC 20036. The petition proposed that FDA amend the color additive regulations in part 73 (21 CFR 73.530), “Listing of Color Additives Exempt from Certification,” to provide for the expanded safe use of spirulina extract as a color additive at levels consistent with GMP in human foods generally, excluding infant formula and certain foods subject to regulation by the U.S. Department of Agriculture (USDA). <HD SOURCE="HD1">II. Background</HD> Spirulina extract is approved under § 73.530 for coloring confections (including candy and chewing gum), frostings, ice cream and frozen desserts (including non-dairy frozen dessert), dessert coatings and toppings, beverage mixes and powders, yogurts (including non-dairy yogurt alternatives), custards, puddings (including non-dairy puddings), cottage cheese, gelatin, breadcrumbs, ready-to-eat cereals (excluding extruded cereals), alcoholic beverages with less than 20 percent alcohol-by-volume content, non-alcoholic beverages, seasoning mixes (unheated), salad dressings, condiments and sauces, dips, coating formulations applied to dietary supplement tablets and capsules, at levels consistent with GMP, and to seasonally color the shells of hard-boiled eggs, except that it may not be used to color foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341), unless the use of the added color is authorized by such standards. Spirulina extract is exempt from certification under section 721(c) of the FD&C Act (21 U.S.C. 379e(c)) because we previously determined that certification was not necessary for the protection of public health (78 FR 49117 at 49119, August 13, 2013). The spirulina extract that is the subject of this final order is a blue-colored powder or liquid prepared by the water extraction and filtration of the dried biomass of <E T="03">A. platensis</E> (also known as <E T="03">Spirulina platensis</E> ), an edible blue-green cyanobacterium. The extraction and filtration remove oil, oil soluble substances, and fibers. The color additive contains phycocyanins as the principal coloring components, and consists of proteins, carbohydrates, and minerals. Based on data and information provided in the petition on the identity, physical and chemical properties, manufacturing process, and composition of the color additive, we have determined that the color additive meets the current specifications for spirulina extract in § 73.530 (Refs. 1 and 2). During the review of the petition, FDA noted that the specifications for heavy metals could be lowered based on the results of the petitioner's batch analyses, and a specification for cadmium should be added. These modifications to the heavy metal specifications would align with FDA's work to reduce dietary exposure to contaminants. Therefore, in addition to expanding the use of spirulina extract, the petitioner proposed to lower the heavy metal specifications for lead (≤0.2 mg/kg), arsenic (≤0.3 mg/kg), and mercury (≤0.1 mg/kg) that are currently in the regulation, and to add a specification for cadmium (≤0.3 mg/kg). 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