Proposed Rule2026-19658
Filing of Color Additive Petition From Doehler GmbH; Request To Amend the Color Additive Regulations To Provide for the Safe Use of Calcium Sulfate in Various Foods at Levels Consistent With Good Manufacturing Practice
Primary source
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Published
September 25, 2026
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 color additive petition, submitted by Doehler GmbH, c/o Hogan Lovells Cadwalader, proposing that we amend our color additive regulations to provide for the safe use of calcium sulfate in various foods at levels consistent with good manufacturing practice.
Full Text
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<title>Federal Register, Volume 91 Issue 185 (Friday, September 25, 2026)</title>
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[Federal Register Volume 91, Number 185 (Friday, September 25, 2026)]
[Proposed Rules]
[Page 60911]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19658]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2026-C-10597]
Filing of Color Additive Petition From Doehler GmbH; Request To
Amend the Color Additive Regulations To Provide for the Safe Use of
Calcium Sulfate in Various Foods at Levels Consistent With Good
Manufacturing Practice
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 color additive petition, submitted by Doehler
GmbH, c/o Hogan Lovells Cadwalader, proposing that we amend our color
additive regulations to provide for the safe use of calcium sulfate in
various foods at levels consistent with good manufacturing practice.
DATES: The color additive petition was filed on September 10, 2026.
ADDRESSES: For access to the docket to read background documents, 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, Office of Food
Chemical Safety, Dietary Supplements, and Innovation, Human Foods
Program, 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 6C0342), submitted by
Doehler GmbH, c/o Hogan Lovells Cadwalader, 555 13th Street NW,
Washington DC, 20004. The petition proposes that we amend our color
additive regulations in 21 CFR part 73 Listing of Color Additives
Exempt from Certification to provide for the safe use of calcium
sulfate at levels consistent with good manufacturing practice in: (1)
coated candies; (2) dry milk; (3) whey products; (4) powdered creamers;
and (5) icings and baked good fillings.
The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(k) because granting of this petition would
authorize the use of a substance intended to remain in food through
ingestion by consumers and is not intended to replace macronutrients in
food. The petitioner has also claimed that this action is categorically
excluded under 21 CFR 25.32(r) because granting of this petition would
authorize the use of a substance that occurs naturally in the
environment and the proposed uses do not alter significantly 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19658 Filed 9-24-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on September 25, 2026.
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