[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.

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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


