Document ID: FDA-2017-C-6238-0007
Agency: fda
Document Type: Proposed Rule
Title: Colorcon, Inc.; Filing of Color Additive Petition
Posted Date: 2020-11-20T05:00Z

[Federal Register Volume 85, Number 225 (Friday, November 20, 2020)]
[Proposed Rules]
[Page 74304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25604]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2020-C-2131]

Ecoflora SAS; 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 Ecoflora SAS, proposing 
that the color additive regulations be amended to provide for the safe 
use of jagua (genipin-glycine) blue in various food categories at 
levels consistent with good manufacturing practice.

DATES: The color additive petition was filed on July 31, 2020.

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, 
240-402-7500.

FOR FURTHER INFORMATION CONTACT: Richard E. Bonnette, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1235.

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 0C0317), submitted by 
Ecoflora, SAS, c/o Exponent, Inc., 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 
jagua (genipin-glycine) blue derived from jagua fruit pulp (Genipa 
americana) as a color additive in: (1) Flavored milk; (2) dairy drinks 
and substitutes (milk shakes, milk substitutes, and other dairy 
drinks); (3) yogurt (dairy and non-dairy); (4) desserts (ice cream and 
frozen dairy and non-dairy desserts; pudding; gelatins, ices, and 
sorbets); (5) ready-to-eat cereals; (6) savory snacks (flavored potato 
chips; tortilla, corn, other chips); (7) candy and chewing gum; (8) 
non-alcoholic beverages (fruit drinks; nutritional beverages; 
smoothies); (9) flavored cream cheese-based spread; and (10) jams, 
syrups, icings, frostings, and fruit toppings and fillings, 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 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25604 Filed 11-19-20; 8:45 am]
BILLING CODE 4164-01-P