[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Rules and Regulations]
[Page 56258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2018-C-4117]


Sensient Colors, 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 Sensient Colors, LLC, 
proposing that the color additive regulations be amended to provide for 
the safe use of an aqueous extract of butterfly pea flower (Clitoria 
ternatea) as a color additive in various food categories, at levels 
consistent with good manufacturing practice.

DATES: The color additive petition was filed on October 4, 2018.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov 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 8C0313) submitted by 
Exponent, Inc. on behalf of Sensient Colors, LLC, 1150 Connecticut Ave. 
NW, Suite 1100, Washington, DC 20036. The petition proposes to amend 
the color additive regulations in part 73 (21 CFR part 73), ``Listing 
of Color Additives Exempt From Certification,'' to provide for the safe 
use of an aqueous extract of butterfly pea flower (Clitoria ternatea) 
as a color additive in: (1) Alcoholic beverages (liquor, liqueurs, and 
flavored alcoholic beverages); (2) ready-to-drink non-alcoholic 
beverages; (3) liquid coffee creamers (dairy and non[hyphen]dairy); (4) 
ice cream and frozen dairy desserts; (5) fruit preparation in yogurt; 
(6) chewing gum; (7) coated nuts; (8) hard candy; and (9) soft candy, 
at levels consistent with good manufacturing practice.
    The petitioner has claimed 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 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.

    Dated: November 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24662 Filed 11-9-18; 8:45 am]
 BILLING CODE 4164-01-P


