Kerry Ingredients and Flavours Ltd.; Filing of Food Additive Petition, 70918-70919 [2023-22613]

Download as PDF 70918 Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Proposed Rules significant economic impact on a substantial number of small entities, but excludes rules that previously have 17 CFR Chapter II been reviewed, rules that have been substantially changed since adoption, [Release Nos. 33–11252; 34–98699; IA– rules that are minor amendments to 6454; IC–35030; File No. S7–17–23] previously adopted rules, and rules that List of Rules To Be Reviewed Pursuant are ministerial, procedural, or technical in nature. Based upon an analysis of the to the Regulatory Flexibility Act rules adopted by the Commission in AGENCY: Securities and Exchange 2014, the Commission has determined Commission. that no such rules are required to be ACTION: Publication of list of rules reviewed pursuant to the RFA during scheduled for review. the succeeding 12 months. Accordingly, the agency is publishing a list that SUMMARY: The Regulatory Flexibility Act reflects that there are no rules to be (‘‘RFA’’) requires an agency to publish reviewed pursuant to the RFA during in the Federal Register, each year, a list the succeeding 12 months. of rules that are to be reviewed in By the Commission. accordance with the RFA during the Dated: October 6, 2023. succeeding 12 months. Based upon its J. Lynn Taylor, review of rules potentially subject to review under the RFA during the Assistant Secretary. succeeding 12 months, the Securities [FR Doc. 2023–22605 Filed 10–12–23; 8:45 am] and Exchange Commission BILLING CODE 8011–01–P (‘‘Commission’’) has determined that no such rules are required to be reviewed. Accordingly, the agency is not DEPARTMENT OF HEALTH AND publishing a list of rules to be reviewed HUMAN SERVICES pursuant to the RFA during the succeeding 12 months. Food and Drug Administration DATES: October 13, 2023. 21 CFR Part 172 FOR FURTHER INFORMATION CONTACT: Sandra Sojka, General Attorney, Office [Docket No. FDA–2023–F–4332] of the General Counsel, 202–551–4928. Kerry Ingredients and Flavours Ltd.; SUPPLEMENTARY INFORMATION: The Filing of Food Additive Petition Regulatory Flexibility Act (‘‘RFA’’), codified at 5 U.S.C. 601 through 612, AGENCY: Food and Drug Administration, requires an agency to review its rules HHS. that have a significant economic impact ACTION : Notification of petition. upon a substantial number of small entities within 10 years of the SUMMARY: The Food and Drug publication of such rules as final rules. Administration (FDA or we) is 5 U.S.C. 610(a). The purpose of the announcing that we have filed a review is ‘‘to determine whether such petition, submitted by Kerry Ingredients rules should be continued without and Flavours Ltd., proposing that the change, or should be amended or food additive regulations be amended to rescinded . . . to minimize any provide for the safe use of vitamin D3 as significant economic impact of the rules a nutrient supplement in powdered upon a substantial number of such small drink mixes added to water or entities.’’ 5 U.S.C. 610(a). carbonated water, excluding drinks or The RFA further requires an agency to drink mixes that are specially publish in the Federal Register, each formulated or processed for infants. year, a list of the rules that are to be DATES: The food additive petition was reviewed in accordance with the RFA filed on April 26, 2023. during the succeeding 12 months. 5 ADDRESSES : For access to the docket to U.S.C. 610(c). In determining which read background documents or rules to include in each year’s rule comments received, go to https:// review list, the Commission analyzes rules adopted in the ninth calendar year www.regulations.gov and insert the docket number found in brackets in the prior to the year the rule review list is heading of this document into the published, and those rules included in ‘‘Search’’ box and follow the prompts, the rule review list are reviewed in and/or go to the Dockets Management accordance with the RFA during the calendar year following the year the rule Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. review list is published. The Commission includes in its rule review FOR FURTHER INFORMATION CONTACT: lists any rules that may have a Lane A. Highbarger, Center for Food lotter on DSK11XQN23PROD with PROPOSALS1 SECURITIES AND EXCHANGE COMMISSION VerDate Sep<11>2014 16:00 Oct 12, 2023 Jkt 262001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1204. 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 2A4834), submitted on behalf of Kerry Ingredients and Flavours Ltd. by Hogan Lovells US LLP, Columbia Square, 555 13th Street NW, Washington, DC 20004. The petition proposes to amend the food additive regulations in 21 CFR 172.380 ‘‘Vitamin D3,’’ to provide for the safe use of vitamin D3 as a nutrient supplement in powdered drink mixes added to water or carbonated water at levels not to exceed 180 international units per 360 milliliters (mL) as consumed, excluding drinks or drink mixes that are specially formulated or processed for infants (Refs. 1 and 2). If calcium is added, calcium is present at levels greater than or equal to 150 milligrams of calcium per 360 mL as consumed (Refs. 1 and 2). 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 is not intended to replace macronutrients in food. In addition, the petitioner has stated that, to their knowledge, no extraordinary circumstances exist that would warrant an environmental assessment (see 21 CFR 25.21). 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. SUPPLEMENTARY INFORMATION: References The following references are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https:// www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. Emails from M. Gradison, to L. Highbarger, March 8, 2023, and March 30, 2023. 2. FDA Memorandum from L. Highbarger, Regulatory Review Branch, March 30, 2023. E:\FR\FM\13OCP1.SGM 13OCP1 Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Proposed Rules Dated: October 6, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–22613 Filed 10–12–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 172 [Docket No. FDA–2003–F–0321] Kerry Inc.; Filing of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notification of petition. 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 lotter on DSK11XQN23PROD with PROPOSALS1 SUMMARY: VerDate Sep<11>2014 16:00 Oct 12, 2023 Jkt 262001 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 PO 00000 Frm 00009 Fmt 4702 Sfmt 9990 70919 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. [FR Doc. 2023–22637 Filed 10–12–23; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\13OCP1.SGM 13OCP1

Agencies

[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Proposed Rules]
[Pages 70918-70919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22613]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2023-F-4332]


Kerry Ingredients and Flavours Ltd.; Filing of Food Additive 
Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Kerry Ingredients and 
Flavours Ltd., proposing that the food additive regulations be amended 
to provide for the safe use of vitamin D3 as a nutrient 
supplement in powdered drink mixes added to water or carbonated water, 
excluding drinks or drink mixes that are specially formulated or 
processed for infants.

DATES: The food additive petition was filed on April 26, 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: Lane A. Highbarger, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1204.

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 2A4834), submitted on 
behalf of Kerry Ingredients and Flavours Ltd. by Hogan Lovells US LLP, 
Columbia Square, 555 13th Street NW, Washington, DC 20004. The petition 
proposes to amend the food additive regulations in 21 CFR 172.380 
``Vitamin D3,'' to provide for the safe use of vitamin 
D3 as a nutrient supplement in powdered drink mixes added to 
water or carbonated water at levels not to exceed 180 international 
units per 360 milliliters (mL) as consumed, excluding drinks or drink 
mixes that are specially formulated or processed for infants (Refs. 1 
and 2). If calcium is added, calcium is present at levels greater than 
or equal to 150 milligrams of calcium per 360 mL as consumed (Refs. 1 
and 2).
    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 is not intended to 
replace macronutrients in food. In addition, the petitioner has stated 
that, to their knowledge, no extraordinary circumstances exist that 
would warrant an environmental assessment (see 21 CFR 25.21). 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.

References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. Emails from M. Gradison, to L. Highbarger, March 8, 2023, and 
March 30, 2023.
2. FDA Memorandum from L. Highbarger, Regulatory Review Branch, 
March 30, 2023.


[[Page 70919]]


    Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22613 Filed 10-12-23; 8:45 am]
BILLING CODE 4164-01-P

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