Proposed Rule2024-10888
Lonza Greenwood LLC; Filing of Color Additive Petition
Primary source
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Published
May 17, 2024
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 Lonza Greenwood LLC, proposing that the color additive regulations be amended to provide for the safe use of sodium copper chlorophyllin in dietary supplement capsules in an amount ranging from 0.08 to 0.4 percent of the weight of the capsule, and to add fescue grass (Festuca arundinacea) as a permitted source of the color additive.
Full Text
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<title>Federal Register, Volume 89 Issue 97 (Friday, May 17, 2024)</title>
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[Federal Register Volume 89, Number 97 (Friday, May 17, 2024)]
[Proposed Rules]
[Page 43349]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-10888]
[[Page 43349]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2024-C-2295]
Lonza Greenwood LLC; Filing of Color 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 Lonza Greenwood LLC,
proposing that the color additive regulations be amended to provide for
the safe use of sodium copper chlorophyllin in dietary supplement
capsules in an amount ranging from 0.08 to 0.4 percent of the weight of
the capsule, and to add fescue grass (Festuca arundinacea) as a
permitted source of the color additive.
DATES: The color additive petition was filed on March 26, 2024.
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: Stephen DiFranco, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-2710.
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 4C0330), submitted by
Intertek Health Sciences, Inc. on behalf of Lonza Greenwood LLC, 2233
Argentia Rd., Suite 201, Mississauga, ON, Canada L5N 2X7. The petition
proposes to amend the color additive regulations in 21 CFR 73.125,
Listing of Color Additives Exempt from Certification: Sodium copper
chlorophyllin to provide for the safe use of sodium copper
chlorophyllin in dietary supplement capsules in an amount ranging from
0.08 to 0.4 percent of the weight of the capsule, and to add fescue
grass (Festuca arundinacea) as a permitted source of the color
additive.
The petitioner claims 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 states 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: May 14, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10888 Filed 5-16-24; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on May 17, 2024.
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