2024-15892. Phytolon Ltd.; Filing of Color Additive Petition

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Department of Health and Human Services

Food and Drug Administration

1. 21 CFR Part 73
2. [Docket No. FDA-2024-C-3229]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of petition.

SUMMARY:

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Phytolon Ltd., proposing that the color additive regulations be amended to provide for the safe use of prickly pear yellow for the coloring of foods generally in amounts consistent with current good manufacturing practice.

DATES:

The color additive petition was filed on July 3, 2024.

ADDRESSES:

For access to the docket to read background documents or comments received, go to https://www.regulations.gov 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.

FOR FURTHER INFORMATION CONTACT:

Kaiping Deng, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 708-924-0622.

SUPPLEMENTARY INFORMATION:

Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 379e(d)(1)), we are giving notice that we have filed a color additive petition (CAP 4C0332), submitted by Phytolon Ltd., Ha-Tsmikha St, Yokne'am Illit, Israel. The petition proposes to amend the color additive regulations in 21 CFR part 73, “Listing of Color Additives Exempt From Certification,” to provide for the safe use of prickly pear yellow for the coloring of foods generally in amounts consistent with current good manufacturing practice.

The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(r), which applies to an action for substances which occur naturally in the environment, and for which the action does not significantly alter the concentration or distribution of the substance, its metabolites, or degradation products in the environment. In addition, the petitioner has stated that, to their knowledge, no extraordinary circumstances exist. If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection.

Dated: July 15, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.