ACTION
Final Rule.
SUMMARY
The Food and Drug Administration (FDA or we) is amending the color
additive regulations to provide for the safe use of spirulina extract as a color
additive in coating formulations applied to dietary supplement and drug tablets
and capsules. This action is in response to a petition filed by Colorcon, Inc.
(Colorcon).
TABLE OF CONTENTS
Back to Top
DATES:
ADDRESSES:
Electronic Submissions
Written Submissions
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Introduction
II. Background
III. Safety Evaluation
A. Determination of Safety
B. Safety of Petitioned Use of the Color Additive
IV. Conclusion
V. Public Disclosure
VI. Environmental Impact
VII. Paperwork Reduction Act of 1995
VIII. Section 301(ll) of the FD&C Act
IX. Objections
X. References
List of Subjects in 21 CFR Part 73
PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
Footnotes
DATES:
Back to Top
This rule is effective September 22, 2015. See section IX for information
on the filing of objections. Submit either electronic or written objections and
requests for a hearing by September 21, 2015.
ADDRESSES:
Back to Top
You may submit either electronic or written objections and requests for a
hearing, identified by Docket No. FDA-2014-C-1552, by any of the following
methods:
Electronic Submissions
Back to Top
Submit electronic objections in the following way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Back to Top
Submit written objections in the following ways:
Mail/Hand delivery/Courier (for paper submissions): Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
Instructions: All submissions received must include the Agency name and
Docket No. FDA-2014-C-1552 for this rulemaking. All objections received will be
posted without change to http://www.regulations.gov, including any personal
information provided. For detailed instructions on submitting objections, see
the “Objections” heading of the SUPPLEMENTARY INFORMATION section.
Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the docket
number, found in brackets in theheading of this document, into the “Search” box
and follow the prompts and/or go to the Division of Dockets Management, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Back to Top
Molly A. Harry, Center for Food Safety and Applied Nutrition (HFS-265),
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740-3835, 240-402-1075.
SUPPLEMENTARY INFORMATION:
Back to Top
I. Introduction
Back to Top
In a notice published in the Federal Register of October 22, 2014 (79 FR
63062), we announced that we had filed a color additive petition (CAP 4C0300),
submitted by Colorcon, Inc. (petitioner), 275 Ruth Rd., Harleysville, PA 19438.
The petition proposed to amend the color additive regulations in Title 21, Code
of Federal Regulations (CFR) part 73 Listing of Color Additives Exempt From
Certification to provide for the safe use of spirulina extract, prepared by the
filtered aqueous extraction of the dried biomass of Arthrospira platensis (A.
platensis), as a color additive in coating formulations applied to dietary
supplement and drug tablets and capsules.
II. Background
Back to Top
In the Federal Register of August 13, 2013 (78 FR 49117), we issued a
final rule in response to a color additive petition (CAP 2C0293) approving the
use of a filtered aqueous extract of the dried biomass of A. platensis as a
color additive in candy and chewing gum at levels consistent with good
manufacturing practice (GMP). We established spirulina extract as the common or
usual name for the color additive and listed it in § 73.530 (21 CFR 73.530). In
addition to the identity of the color additive, the regulation in § 73.530
includes specifications that must be met for lead, arsenic, mercury, and
microcystin toxin.
In the Federal Register of April 11, 2014 (79 FR 20095), we issued a
final rule in response to a color additive petition (CAP 2C0297) amending §
73.530 to include the use of spirulina extract as a color additive in
confections (including candy and chewing gum), frostings, ice cream and frozen
desserts, dessert coatings and toppings, beverage mixes and powders, yogurts,
custards, puddings, cottage cheese, gelatin, breadcrumbs, and ready-to-eat
cereals (excluding extruded cereals), at levels consistent with GMP.
The spirulina extract used for the purposes of CAP 4C0300 is a
blue-colored powder produced by the filtered aqueous extraction of the
spray-dried biomass of A. platensis (also known as Spirulina platensis), an
edible blue-green cyanobacterium. The color additive contains phycocyanins as
the principal coloring component. The maximum phycocyanin content of the color
additive is 28 percent. Based o