[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49548-49549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19096]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4844]
``Ruby Chocolate'' Deviating From Identity Standard; Temporary
Permit for Market Testing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
extension of a temporary permit issued to Barry Callebaut U.S.A. LLC
(the applicant) to market test products (designated as ``ruby
chocolate'') that deviate from the U.S. standards of identity for cacao
products. The extension allows the applicant to continue to evaluate
commercial viability of the product and to collect data on consumer
acceptance of the product in support of a petition to establish a
standard of identity for ``ruby chocolate.'' We also invite other
interested parties to participate in the market test.
DATES: The new expiration date of the permit will be either the
effective date of a final rule establishing a standard of identity for
``ruby chocolate'' that may result from the petition or 30 days after
denial of the petition.
FOR FURTHER INFORMATION CONTACT: Marjan Morravej, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, 240-402-2371; or Carrol
Bascus, Center for Food Safety and Applied Nutrition, Office of
Regulations and Policy (HFS-024), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION: In accordance with Sec. 130.17 (21 CFR
130.17), we issued a temporary permit to Barry Callebaut U.S.A. LLC,
600 West Chicago Ave, Suite 860, Chicago, IL 60654, to market test
products identified as ``ruby chocolate'' that deviate from the
requirements of the standards of identity for cacao products in part
163 (21 CFR part 163) (84 FR 64541, November 22, 2019). We issued the
permit to facilitate market testing of products that deviate from the
requirements of the standard of identity for cacao products issued
under section 401 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 341). The permit covers limited interstate marketing tests of
products identified as ``ruby chocolate.'' These test products deviate
from the U.S. standards of identity for cacao products (Sec. Sec.
163.111, 163.123, 163.124, 163.130, 163.135, 163.140, and 163.145).
For the purpose of this permit, ``ruby chocolate'' is the solid or
semi-plastic food prepared by mixing and grinding cacao fat with one or
more of the cacao ingredients (namely, chocolate liquor, breakfast
cocoa, cocoa, and low-fat cocoa), citric acid, one or more of optional
nutritive carbohydrate sweeteners. ``Ruby chocolate'' contains not less
than 1.5 percent nonfat cacao solids, not less than 2.5 percent by
weight of milk fat, not less than 12 percent by weight of total milk
solids, not more than 1.5 percent of emulsifying agents, and not more
than 5 percent of whey or whey products. It may also contain other
ingredients such as antioxidants approved for food use, spices, natural
and artificial flavorings, and other seasonings. However, these other
ingredients cannot imitate the flavor of chocolate, milk, butter,
berry, or another fruit. Additionally, ``ruby chocolate'' contains no
added coloring. The test product ``ruby chocolate'' contains the
principal ingredients used in most of the current standards for cacao
products under part 163; however, it deviates from the current standard
of identify for chocolate products in terms of its final composition,
taste, and color.
On February 19, 2021, the applicant asked us to extend the
temporary permit so the applicant could have more time to market test
the ``ruby chocolate'' and gain additional consumer acceptance in
support of the petition to establish a standard for ``ruby chocolate.''
We find that it is in the interest of consumers to extend the permit
for continued market testing of ``ruby chocolate'' to gain additional
information on consumer expectations and acceptance. Therefore, under
Sec. 130.17(i), we are extending the temporary permit granted to Barry
Callebaut U.S.A. LLC for temporary marketing of approximately 60
million pounds (27,215,540 kilograms) of ``ruby chocolate'' to provide
continued market testing of the specified amount of product for the
applicant on an annual basis. The test products will bear the name
``ruby chocolate.'' The new expiration date of the permit will be
either the effective date of a final rule establishing a standard of
identity for ``ruby chocolate'' that may result from the petition or 30
days after denial of the petition. All other conditions and terms of
this permit remain the same.
In addition, we invite interested persons to participate in the
market test under the conditions of the permit, except for the
designated area of distribution. Any person who wishes to participate
in the extended market test should notify, in writing, the Branch
Chief, Product Evaluation Labeling Branch, Division of Food Labeling
and Standards, Office of Nutrition and Food Labeling, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740. The notification must describe
the amount to be distributed, the area of distribution, and include the
labeling that will be used for the test product (see Sec. 130.17(i)).
For information on what to include in the notification to FDA, see
Sec. 130.17(c). Test products must be labeled in accordance with 21
CFR part 101.
[[Page 49549]]
Dated: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy
[FR Doc. 2021-19096 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P