Listing of Color Additive Exempt From Certification; Beetroot Red; Delay of Effective Date

Listing of Color Additive Exempt From Certification; Beetroot Red; Delay of Effective Date

SUPPLEMENTARY INFORMATION:

In the Federal Register of February 6, 2026 (91 FR 5295), FDA issued a final order, Listing of Color Additives Exempt from Certification; Beetroot Red, 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 USDA, infant formula, or foods for which standards of identity have been issued under section 401 of the FD&C Act, unless the use of the added color is authorized by such standards. Specifically, the final order added a new § 73.39, titled "Beetroot red," (21 CFR 73.39). We issued the final order in response to a color additive petition submitted by Phytolon, Ltd. We gave interested persons until March 9, 2026, to file objections and requests for a hearing on the final order.

We received a submission from GMO/Toxin Free USA containing objections that meet the conditions set forth in 21 CFR 12.22 to initiate a stay of the effective date of the final order. See Submission from GMO/Toxin Free USA, to the Dockets Management Staff, Food and Drug Administration, dated March 5, 2026, at pages 1-6. In addition to the objections submitted by GMO/Toxin Free USA, we received other comments that opposed the final order, but none of them appear to be an objection under 21 CFR 12.22 nor do any of them request a hearing. We plan to address the objections in a future document.

Under sections 701(e)(2) and 721(d) of the FD&C Act (21 U.S.C. 371(e)(2) and 379e(d)), within 30 days after publication of an order relating to a color additive regulation, any person adversely affected by such an order may file objections, specifying with particularity the provisions of the order deemed objectionable, stating the grounds therefor, and requesting a public hearing upon such objections. The filing of the objections operates to delay the effective date of the final order until we take final action on the objections. ⁽¹⁾ Our announcement of the delay of the effective date of the final order does not reflect a change in our determination that there is a reasonable certainty of no harm from the use of this color additive under the proposed conditions of its intended use. In addition, this notification does not constitute a determination that all of the issues raised in the submission constitute objections or that a hearing is justified on any submissions that have been filed.

For access to the docket to read the objections received, go to https://www.regulations.gov and insert the docket number FDA-2024-C-1085 into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

⁽¹⁾  Although the statute uses the word "stay," this delay effectuates the same result.