2023-22637. Kerry Inc.; Filing of Food Additive Petition

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 Kerry, Inc., proposing that the food additive regulations be amended to provide for the safe use of sodium alginate as a stabilizer and thickener in plant protein products at a level not to exceed 3 percent.

DATES:

The food additive petition was filed on August 9, 2023.

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:

Christopher Kampmeyer, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1255.

SUPPLEMENTARY INFORMATION:

Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that we have filed a food additive petition (FAP 3A4836), submitted on behalf of Kerry Inc., by ToxStrategies, LLC, 739 Thornapple Dr., Naperville, IL 60540. The petition proposes to amend the food additive regulations in part 172 (21 CFR part 172) “Food Additives Permitted for Direct Addition to Food for Human Consumption” to provide for the safe use of sodium alginate as a stabilizer and thickener in plant protein products (as defined in 21 CFR 170.3(n)(33)) at a level not to exceed 3 percent.

The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(k) because the substance is intended to remain in food through ingestion by consumers and that is not intended to replace macronutrients in food. 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: October 6, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.