83 FR 56258 - Sensient Colors, LLC; Filing of Color Additive Petition
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 219 (November 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 219 (November 13, 2018)
| Page Range | 56258-56258 | |
| FR Document | 2018-24662 |
[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)] [Rules and Regulations] [Page 56258] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24662] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![56258 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Rules and Regulations
Item 15: Display proposes to amend the color additive enforcement period, entry into,
regulations in part 73 (21 CFR part 73), transiting, or anchoring in the safety
a. Does the NMS Stock ATS operate as
‘‘Listing of Color Additives Exempt zone is prohibited to all vessels not
an Electronic Communication Network
From Certification,’’ to provide for the registered with the sponsor as
as defined in Rule 600(b)(23) of
safe use of an aqueous extract of participants or official patrol vessels,
Regulation NMS?
butterfly pea flower (Clitoria ternatea) unless specifically authorized by the
Yes b No b as a color additive in: (1) Alcoholic Captain of the Port Marine Safety Unit
* * * * * beverages (liquor, liqueurs, and flavored Pittsburgh (COTP) or a designated
Dated: November 6, 2018. alcoholic beverages); (2) ready-to-drink representative.
non-alcoholic beverages; (3) liquid DATES: The regulations in 33 CFR
Eduardo A. Aleman,
coffee creamers (dairy and non-dairy); 165.801 Table 1, line 37 will be
Assistant Secretary.
(4) ice cream and frozen dairy desserts; enforced from 9 p.m. through 11:30 p.m.
[FR Doc. 2018–24549 Filed 11–9–18; 8:45 am] (5) fruit preparation in yogurt; (6) on November 16, 2018.
BILLING CODE 8011–01–P chewing gum; (7) coated nuts; (8) hard
FOR FURTHER INFORMATION CONTACT: If
candy; and (9) soft candy, at levels
you have questions about this notice of
consistent with good manufacturing
DEPARTMENT OF HEALTH AND enforcement, call or email Petty Officer
practice.
HUMAN SERVICES Jennifer Haggins, Marine Safety Unit
The petitioner has claimed that this
Pittsburgh, U.S. Coast Guard; telephone
action is categorically excluded under
Food and Drug Administration 412–221–0807, email
21 CFR 25.32(k) because the substance
Jennifer.L.Haggins@uscg.mil.
is intended to remain in food through
21 CFR Part 73 ingestion by consumers and is not SUPPLEMENTARY INFORMATION: The Coast
intended to replace macronutrients in Guard will enforce a temporary safety
[Docket No. FDA–2018–C–4117]
food. In addition, the petitioner has Zone for the Pittsburgh Downtown
Sensient Colors, LLC; Filing of Color stated that, to their knowledge, no Partnership/Light Up Night Fireworks
Additive Petition extraordinary circumstances exist. If in 33 CFR 165.801 Table 1 titled ‘‘Sector
FDA determines a categorical exclusion Ohio Valley Annual and Recurring
AGENCY: Food and Drug Administration, applies, neither an environmental Safety Zones’’, line 37 from 9 p.m.
HHS. assessment nor an environmental through 11:30 p.m. on November 16,
ACTION: Notification of petition. impact statement is required. If FDA 2018. This action is being taken to
determines a categorical exclusion does provide for the safety of persons,
SUMMARY: The Food and Drug vessels, and the marine environment on
not apply, we will request an
Administration (FDA or we) is the navigable waters of the Allegheny
environmental assessment and make it
announcing that we have filed a River during this event. Our regulation
available for public inspection.
petition, submitted by Sensient Colors, for marine events within the Eighth
LLC, proposing that the color additive Dated: November 6, 2018. Coast Guard District, § 165.801 specifies
regulations be amended to provide for Leslie Kux, the location of the regulated area for the
the safe use of an aqueous extract of Associate Commissioner for Policy. Pittsburgh Downtown Partnership/Light
butterfly pea flower (Clitoria ternatea) [FR Doc. 2018–24662 Filed 11–9–18; 8:45 am] Up Night Fireworks. Entry into the
as a color additive in various food BILLING CODE 4164–01–P safety zone is prohibited unless
categories, at levels consistent with authorized by the Captain of the Port
good manufacturing practice. Marine Safety Unit Pittsburgh (COTP) or
DATES: The color additive petition was DEPARTMENT OF HOMELAND a designated representative. Persons or
filed on October 4, 2018. SECURITY vessels desiring to enter into or passage
ADDRESSES: For access to the docket to through the safety zone must request
read background documents or Coast Guard permission from the COTP or a
comments received, go to https:// designated representative. They can be
www.regulations.gov and insert the 33 CFR Part 165 reached on VHF FM channel 16. If
docket number found in brackets in the [Docket No. USCG–2018–0964] permission is granted, all persons and
heading of this document into the vessels shall comply with the
‘‘Search’’ box and follow the prompts, Safety Zone; Allegheny River, Miles instructions of the COTP or designated
and/or go to the Dockets Management 0.0–1.0, Pittsburgh, PA representative.
Staff, 5630 Fishers Lane, Rm. 1061, In addition to this notice of
Rockville, MD 20852. AGENCY: Coast Guard, DHS. enforcement in the Federal Register, the
ACTION: Notice of enforcement of COTP or a designated representative
FOR FURTHER INFORMATION CONTACT:
regulation. will inform the public through
Stephen DiFranco, Center for Food
Safety and Applied Nutrition, Food and Broadcast Notices to Mariners (BNMs),
SUMMARY: The Coast Guard will enforce Local Notices to Mariners (LNMs),
Drug Administration, 5001 Campus Dr., the safety zone for the Pittsburgh
College Park, MD 20740, 240–402–2710. Marine Safety Information Bulletins
Downtown Partnership/Light Up Night (MSIBs), and/or through other means of
SUPPLEMENTARY INFORMATION: Under Fireworks to provide for the safety of public notice as appropriate at least 24
section 721(d)(1) of the Federal Food, persons, vessels, and the marine hours in advance of enforcement.
Drug, and Cosmetic Act (21 U.S.C. environment on the navigable waters of
amozie on DSK3GDR082PROD with RULES
379e(d)(1)), we are giving notice that we the Allegheny River, miles 0.0 to 1.0, Dated: October 29, 2018.
have filed a color additive petition (CAP extending the entire width of the river. A.W. Demo,
8C0313) submitted by Exponent, Inc. on Our regulation for marine events within Commander, U.S. Coast Guard, Captain of
behalf of Sensient Colors, LLC, 1150 the Eighth Coast Guard District the Port Marine Safety Unit Pittsburgh.
Connecticut Ave. NW, Suite 1100, identifies the regulated area for this [FR Doc. 2018–24624 Filed 11–9–18; 8:45 am]
Washington, DC 20036. The petition event in Pittsburgh, PA. During the BILLING CODE 9110–04–P
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Document Created: 2018-11-10 03:18:27
Document Modified: 2018-11-10 03:18:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notification of petition. | |
| Dates | The color additive petition was filed on October 4, 2018. | |
| Contact | Stephen DiFranco, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2710. | |
| FR Citation | 83 FR 56258 |
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