``Ruby Chocolate'' Deviating From Identity Standard; Temporary Permit for Market Testing, 64541 [2019-25325]
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Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
Based on Agency data, we have
received no more than 50 submissions
since establishing the collection in
2017.
Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25364 Filed 11–21–19; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA or we) is
announcing that a temporary permit has
been issued to Barry Callebaut U.S.A.
LLC (the applicant) to market test a
product identified as ‘‘ruby chocolate’’
that deviates from the U.S. standards of
identity for chocolate products. The
temporary permit will allow the
applicant to evaluate commercial
viability of the product and to collect
data on consumer acceptance of the
product.
SUMMARY:
This permit is effective for 15
months, beginning on the date the
applicant introduces or causes
introduction of the test product into
interstate commerce, but not later than
February 20, 2020.
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.
SUPPLEMENTARY INFORMATION: We are
giving notice that we have issued a
temporary permit to Barry Callebaut
U.S.A. LLC. We are issuing the
temporary permit in accordance with 21
CFR 130.17, which addresses temporary
permits for interstate shipment of
experimental packs of food varying from
the requirements of definitions and
standards of identity issued under
section 401 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 341).
The permit covers the interstate
market testing of the product identified
as ‘‘ruby chocolate.’’ The test product
deviates from the U.S. standards of
identity for chocolates (21 CFR 163.111,
khammond on DSKJM1Z7X2PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
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 semiplastic
food prepared by mixing and grinding
cacao fat with one or more of the cacao
ingredients (namely, chocolate liquor,
breakfast cocoa, cocoa, and lowfat
cocoa), citric acid, one or more of
optional dairy ingredients, and one or
more optional nutritive carbohydrate
sweeteners. ‘‘Ruby chocolate’’ contains
not less than 1.5 percent nonfat cacao
solids, not less than 20 percent by
weight of cacao fat, 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 or 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 21 CFR part 163;
however, it deviates from the current
standards of identity for chocolate
products in terms of its final
composition, taste, and color.
The purpose of the temporary permit
is to allow the applicant to market test
the product throughout the United
States. The permit will allow the
applicant to evaluate commercial
viability of the product and to collect
data on consumer acceptance of the
product.
The permit provides for the temporary
marketing of approximately 60 million
pounds (27,215,540 kilograms) of the
test product. The test product will be
manufactured at the Barry Callebaut
facilities located at Aalstersestraat 122,
9280 Lebbeke, Belgium; 400 Industrial
Park Rd., St. Albans, VT 05478; and
1175 Commerce Blvd., American
Canyon, CA 94503.
Barry Callebaut U.S.A. LLC will
distribute the test product to various
manufacturers throughout the United
States for further manufacturing and
market testing. Each ingredient used in
the food must be declared on the label
as required by 21 CFR part 101. The
permit is effective for 15 months,
beginning on the date the applicant
introduces or causes the introduction of
the test product into interstate
commerce, but not later than February
20, 2020.
PO 00000
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64541
Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25325 Filed 11–21–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0319]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Dear Health Care
Provider Letters: Improving
Communication of Important Safety
Information
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing that a proposed
collection of information has been
submitted to the Office of Management
and Budget (OMB) for review and
clearance under the Paperwork
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Fax written comments on the
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To ensure that comments on
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OMB recommends that written
comments be faxed to the Office of
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In
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SUPPLEMENTARY INFORMATION:
E:\FR\FM\22NON1.SGM
22NON1
]]>Agencies
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Page 64541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25325]
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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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a temporary permit has been issued to Barry Callebaut U.S.A. LLC
(the applicant) to market test a product identified as ``ruby
chocolate'' that deviates from the U.S. standards of identity for
chocolate products. The temporary permit will allow the applicant to
evaluate commercial viability of the product and to collect data on
consumer acceptance of the product.
DATES: This permit is effective for 15 months, beginning on the date
the applicant introduces or causes introduction of the test product
into interstate commerce, but not later than February 20, 2020.
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.
SUPPLEMENTARY INFORMATION: We are giving notice that we have issued a
temporary permit to Barry Callebaut U.S.A. LLC. We are issuing the
temporary permit in accordance with 21 CFR 130.17, which addresses
temporary permits for interstate shipment of experimental packs of food
varying from the requirements of definitions and standards of identity
issued under section 401 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 341).
The permit covers the interstate market testing of the product
identified as ``ruby chocolate.'' The test product deviates from the
U.S. standards of identity for chocolates (21 CFR 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
semiplastic food prepared by mixing and grinding cacao fat with one or
more of the cacao ingredients (namely, chocolate liquor, breakfast
cocoa, cocoa, and lowfat cocoa), citric acid, one or more of optional
dairy ingredients, and one or more optional nutritive carbohydrate
sweeteners. ``Ruby chocolate'' contains not less than 1.5 percent
nonfat cacao solids, not less than 20 percent by weight of cacao fat,
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 or 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 21 CFR part 163;
however, it deviates from the current standards of identity for
chocolate products in terms of its final composition, taste, and color.
The purpose of the temporary permit is to allow the applicant to
market test the product throughout the United States. The permit will
allow the applicant to evaluate commercial viability of the product and
to collect data on consumer acceptance of the product.
The permit provides for the temporary marketing of approximately 60
million pounds (27,215,540 kilograms) of the test product. The test
product will be manufactured at the Barry Callebaut facilities located
at Aalstersestraat 122, 9280 Lebbeke, Belgium; 400 Industrial Park Rd.,
St. Albans, VT 05478; and 1175 Commerce Blvd., American Canyon, CA
94503.
Barry Callebaut U.S.A. LLC will distribute the test product to
various manufacturers throughout the United States for further
manufacturing and market testing. Each ingredient used in the food must
be declared on the label as required by 21 CFR part 101. The permit is
effective for 15 months, beginning on the date the applicant introduces
or causes the introduction of the test product into interstate
commerce, but not later than February 20, 2020.
Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25325 Filed 11-21-19; 8:45 am]
BILLING CODE 4164-01-P
