Proposed Rule2021-28162
Lallemand Inc.; Filing of Food Additive Petition
Primary source
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Published
December 29, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Lallemand Inc., proposing that the food additive regulations be amended to provide for the safe use of vitamin D<INF>2</INF> heat-killed ("inactive") baker's yeast as a source of vitamin D<INF>2</INF> in specific food categories.
Full Text
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<title>Federal Register, Volume 86 Issue 247 (Wednesday, December 29, 2021)</title>
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[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Proposed Rules]
[Page 74018]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28162]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2021-F-1157]
Lallemand Inc.; 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 Lallemand Inc., proposing
that the food additive regulations be amended to provide for the safe
use of vitamin D<INF>2</INF> heat-killed (``inactive'') baker's yeast
as a source of vitamin D<INF>2</INF> in specific food categories.
DATES: The food additive petition was filed on September 28, 2021.
ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Katie Overbey, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-7536.
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 1A4829), submitted by
Lallemand Inc., 1620 rue Prefontaine, Montreal, Quebec, H1W 2N8,
Canada. The petition proposes to amend the food additive regulations in
21 CFR part 172, Food additives permitted for direct addition to food
for human consumption, to allow for the safe use of vitamin
D<INF>2</INF> heat-killed bakers yeast as a nutrient supplement in
foods to which vitamin D<INF>2</INF> mushroom powder is currently
allowed to be added under Sec. 172.382 (21 CFR 172.382), at the
maximum level of vitamin D<INF>2</INF> authorized under Sec. 172.382.
The petitioner has claimed a categorical exclusion 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 at least 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.
Dated: December 21, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28162 Filed 12-28-21; 8:45 am]
BILLING CODE 4164-01-P
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