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
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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:
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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:
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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
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Submit electronic objections in the following way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
Written Submissions
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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:
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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:
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I. Introduction
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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
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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 on data and information provided in the petition on the identity, physical and chemical properties, manufacturing process, and composition of the color additive, we have determined that the color additive meets the specifications for spirulina extract in § 73.530 (Ref. 1).
Spirulina extract is intended to be used as a color additive in film coating formulations applied to dietary supplement and drug tablets and capsules in amounts consistent with GMP. The maximum GMP use level for spirulina extract in an individual coating will be determined by the desired coloring effect. Therefore, because the amount of the color additive used in these coatings is self-limiting, we have determined that there is no need for a specific upper limit on the percent by weight of spirulina extract in coating formulations applied to dietary supplement and drug tablets and capsules (Ref. 1).
III. Safety Evaluation
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A. Determination of Safety
Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (2