Listing of Color Additives Exempt From Certification; Spirulina Extract, 50762-50765 [2015-20676]
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Federal Register / Vol. 80, No. 162 / Friday, August 21, 2015 / Rules and Regulations
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to the list of countries with which DOD
has such arrangements. The list is
informational only and does not affect
any right, duty or prohibition that
applies to any person under the DPAS
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request priority delivery in countries
with which it has security of supply
arrangements and persons in the United
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assistance from DOD in obtaining
priority delivery even if the list did not
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With the addition of Spain, the list
will read: Australia, Finland, Italy, The
Netherlands, Spain, Sweden and the
United Kingdom.
Rulemaking Requirements
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direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
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2. Notwithstanding any other
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to respond to, nor shall any person be
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with, a collection of information subject
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et seq.), unless that collection of
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3. This rule does not contain policies
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4. BIS finds good cause under 5 U.S.C.
553(b)(B) to waive prior notice of
proposed rulemaking and the
opportunity for public comment
because it is unnecessary. This rule
merely updates the list of countries with
which the DOD has entered into
security of supply arrangements and
thus may seek prioritization of contracts
in those countries. Persons in the
United States who need such
prioritization may request DOD
assistance to obtain it. The lists are in
the DPAS regulations to inform persons
whose need for contract prioritization
may extend beyond the United States of
where they may be able to obtain
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assistance. DOD may seek such
prioritization and persons in the United
States may request DOD assistance
regardless whether or not the countries
with which DOD has entered into
security of supply arrangements are
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Listing these countries in the DPAS
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List of Subjects in 15 CFR Part 700
Administrative practice and
procedure, Business and industry,
Government contracts, National defense,
Reporting and recordkeeping
requirements, Strategic and critical
materials.
For the reasons set forth in the
preamble, the Defense Priorities and
Allocations System Regulations (15 CFR
part 700) are amended as follows:
PART 700—[AMENDED]
1. The authority citation for 15 CFR
part 700 continues to read as follows:
■
Authority: 50 U.S.C. App. 2061, et seq.; 42
U.S.C. 5195, et seq.; 50 U.S.C. App 468; 10
U.S.C. 2538; 50 U.S.C. 82; E.O. 12656, 53 FR
226, 3 CFR, 1988, Comp. 585; E.O. 12742, 56
FR 1079, 3 CFR, 1991 Comp. 309; E.O. 13603,
77 FR 16651, 3 CFR, 2012 Comp., p. 225.
§ 700.57
[Amended]
2. Section 700.57 is amended by
adding ‘‘Spain’’ after ‘‘The
Netherlands,’’ in:
■ a. The last sentence of paragraph (a);
■ b. The italicized heading of paragraph
(c);
■ c. Paragraph (c)(1); and
■ d. The first and second sentences of
paragraph (c)(2).
■
Dated: August 17, 2015.
Kevin J. Wolf,
Assistant Secretary for Export
Administration.
[FR Doc. 2015–20704 Filed 8–20–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA–2014–C–1552]
Listing of Color Additives Exempt
From Certification; Spirulina Extract
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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).
SUMMARY:
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: 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:
DATES:
Electronic Submissions
Submit electronic objections in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
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 https://
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 https://
www.regulations.gov and insert the
docket number, found in brackets in the
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Federal Register / Vol. 80, No. 162 / Friday, August 21, 2015 / Rules and Regulations
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.
aqueous extraction of the spray-dried
biomass of A. platensis (also known as
Spirulina platensis), an edible bluegreen 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).
II. Background
III. Safety Evaluation
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 bluecolored powder produced by the filtered
A. Determination of Safety
Under section 721(b)(4) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 379e(b)(4)), a color
additive may not be listed for a
particular use unless the data and
information available to FDA establish
that the color additive is safe for that
use. Our color additive regulations at 21
CFR 70.3(i) define ‘‘safe’’ to mean that
there is convincing evidence that
establishes with reasonable certainty
that no harm will result from the
intended use of the color additive. To
establish with reasonable certainty that
a color additive intended for use in food
is not harmful under its intended
conditions of use, we consider the
projected human dietary exposure to the
additive, the additive’s toxicological
data, and other relevant information
(such as published literature) available
to us. We compare an individual’s
estimated exposure, or estimated daily
intake (EDI), of the additive from all
food sources to an acceptable daily
intake level established by toxicological
data. The EDI is determined by
projections based on the amount of the
additive proposed for use in particular
foods or drugs and on data regarding the
amount consumed from all ingested
sources of the additive. We commonly
use the EDI for the 90th percentile
heading 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:
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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consumer of a color additive as a
measure of high chronic exposure.
B. Safety of Petitioned Use of the Color
Additive
To support the safety of the petitioned
use of spirulina extract as a color
additive in coating formulations applied
to dietary supplement and drug tablets
and capsules, Colorcon submitted an
exposure estimate for phycocyanins (the
principal coloring component).
Colorcon estimated that the petitioned
use of spirulina extract in coating
formulations applied to dietary
supplement and drug tablets and
capsules will result in an exposure to
phycocyanins of 20.9 milligrams/
person/day (mg/p/d) for the 90th
percentile consumer (Ref. 2). We agree
with Colorcon’s exposure estimate for
phycocyanins and conclude that it is
sufficiently conservative (Ref. 2).1
Regarding cumulative exposure
(cumulative EDI, or CEDI) to
phycocyanins from spirulina and
spirulina-derived substances, FDA
discussed in the final rule for use of
spirulina extract as a color additive in
candy and chewing gum that spirulina
and spirulina-derived substances have
been the subject of four notices
submitted by firms to FDA informing us
of their determinations that certain uses
of spirulina-derived substances are
generally recognized as safe (GRAS) (78
FR 49117 at 49118). One of the GRAS
notices (GRN 000424) pertains to the
use of a spirulina-derived substance
similar in chemical composition to the
subject color additive but with a much
higher phycocyanin content ranging
from 42 to 47 percent, and included use
in all foods (except infant formula and
foods under U.S. Department of
Agriculture’s jurisdiction) at levels
consistent with GMP. The upper bound
CEDI for phycocyanins resulting from
the notified uses of spirulina extract was
estimated to be 1,140 mg/p/d in GRN
000424 based on conservative
assumptions (Ref. 3). This exposure
estimate does not appear to include
exposure to phycocyanins from use of
spirulina extract in dietary
supplements. Colorcon estimated that
the use of spirulina extract in coating
formulations applied to dietary
supplement and drug tablets and
capsules would increase the previously
estimated upper bound CEDI of
phycocyanins by 1.8 percent. We agree
that Colorcon’s estimate is conservative,
and that the petitioned use of spirulina
1 The petition referred to both ‘‘drug tablets and
capsules’’ and ‘‘pharmaceutical tablets and
capsules.’’ The term ‘‘pharmaceutical tablets and
capsules’’ was used regarding the exposure
assessment (Ref. 2).
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extract would not contribute
significantly to the previously estimated
upper bound CEDI of 1,140 mg/p/d for
phycocyanins (Ref. 2).
In support of safety of the use of
spirulina extract as a color additive in
coating formulations applied to dietary
supplement and drug tablets and
capsules in the subject petition,
Colorcon referenced the safety
determinations made by FDA for CAP
2C0293 (78 FR 49117) and CAP 2C0297
(79 FR 20095). The petitioner also
conducted a search of the peer-reviewed
scientific literature for animal and
human oral consumption studies that
tested spirulina, spirulina-derived
ingredients, and phycocyanins that have
been published since 2011. The
petitioner submitted the published
animal and human studies that they had
identified as being relevant to their
petition. We reviewed the relevant
studies and determined that these
publications did not raise any safety
concerns.
In our previous evaluations of the use
of spirulina extract as a color additive
in food, we had selected as the pivotal
safety study a 21-month chronic feeding
study that tested spirulina powder in
rats at dietary concentrations of 10, 20,
or 30 percent (equivalent to 5,000,
10,000, or 15,000 milligrams per
kilogram bodyweight per day (mg/kg
bw/d)). The results of this study showed
that prolonged oral consumption of
spirulina powder up to a dietary
concentration of 15,000 mg/kg bw/d was
without adverse effects. Therefore, we
concluded that the no-observed-effect
level (NOEL) for spirulina is 15,000 mg/
kg bw/d (900,000 mg/p/d for a 60 kg
person) based on the absence of
treatment-related adverse effects at the
highest concentration tested in this
study. We had also determined the
NOEL for phycocyanins for humans to
be between 108,000 and 184,500 mg/p/
d (78 FR 49117 at 49119). Taking into
account all the available safety
information, the estimated exposure to
phycocyanins from the petitioned use of
the spirulina extract, and the margin of
safety between the CEDI for
phycocyanin (1,140 mg/p/d) and the
NOEL for phycocyanin (108,000 to
184,500 mg/p/d), we conclude that the
petitioned use of spirulina extract as a
color additive in coating formulations
applied to dietary supplement and drug
tablets and capsules is safe (Ref. 4).
The potential allergenicity of
spirulina phycocyanins was discussed
in the final rule for the use of spirulina
extract as a color additive in candy and
chewing gum (78 FR 49117 at 49119).
Based on our review of a comparison of
the known amino acid sequences of
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phycocyanins with the sequences of
known protein allergens, we had
determined that there is a low
probability that phycocyanins are
protein allergens. We therefore
concluded that the spirulina
phycocyanins present an insignificant
allergy risk to consumers of the color
additive. We are not aware of any new
information that would cause us to
change this conclusion.
IV. Conclusion
Based on the data and information in
the petition and other relevant material,
we conclude that the petitioned use of
spirulina extract in coating formulations
applied to dietary supplement and drug
tablets and capsules is safe. We further
conclude that the additive will achieve
its intended technical effect and is
suitable for the petitioned use.
Consequently, we are amending the
color additive regulations in part 73 as
set forth in this document. In addition,
based upon the factors listed in 21 CFR
71.20(b), we conclude that certification
of spirulina extract is not necessary for
the protection of the public health.
V. Public Disclosure
In accordance with § 71.15 (21 CFR
71.15), the petition and the documents
that we considered and relied upon in
reaching our decision to approve the
petition will be made available for
public disclosure (see FOR FURTHER
INFORMATION CONTACT). As provided in
§ 71.15, we will delete from the
documents any materials that are not
available for public disclosure.
VI. Environmental Impact
We previously considered the
environmental effects of this rule, as
stated in the October 22, 2014, notice of
filing for CAP 4C0300. We stated that
we had determined, under 21 CFR
25.32(r), that this action ‘‘is of a type
that does not individually or
cumulatively have a significant effect on
the human environment’’ such that
neither an environmental assessment
nor an environmental impact statement
is required. We have not received any
new information or comments that
would affect our previous
determination.
VII. Paperwork Reduction Act of 1995
This final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
VIII. Section 301(ll) of the FD&C Act
Our review of this petition was
limited to section 721 of the FD&C Act.
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This final rule is not a statement
regarding compliance with other
sections of the FD&C Act. For example,
section 301(ll) of the FD&C Act (21
U.S.C. 331(ll) prohibits the introduction
or delivery for introduction into
interstate commerce of any food that
contains a drug approved under section
505 of the FD&C Act (21 U.S.C. 355), a
biological product licensed under
section 351 of the Public Health Service
Act (42 U.S.C. 262), or a drug or
biological product for which substantial
clinical investigations have been
instituted and their existence has been
made public, unless one of the
exemptions in section 301(ll)(1) to (4) of
the FD&C Act applies. In our review of
this petition, we did not consider
whether section 301(ll) of the FD&C Act
or any of its exemptions apply to food
containing this color additive.
Accordingly, this final rule should not
be construed to be a statement that a
food containing this color additive, if
introduced or delivered for introduction
into interstate commerce, would not
violate section 301(ll) of the FD&C Act.
Furthermore, this language is included
in all color additive final rules that
pertain to food and therefore should not
be construed to be a statement of the
likelihood that section 301(ll) of the
FD&C Act applies.
IX. Objections
This rule is effective as shown in the
DATES section except as to any
provisions that may be stayed by the
filing of proper objections. If you will be
adversely affected by one or more
provisions of this regulation, you may
file with the Division of Dockets
Management (see ADDRESSES) either
electronic or written objections. You
must separately number each objection,
and within each numbered objection
you must specify with particularity the
provision(s) of the regulation to which
you object, and the grounds for your
objection. Within each numbered
objection, you must specifically state
whether you are requesting a hearing on
the particular provision that you specify
in that numbered objection. If you do
not request a hearing for any particular
objection, you waive the right to a
hearing on that objection. If you request
a hearing, your objection must include
a detailed description and analysis of
the specific factual information you
intend to present in support of the
objection in the event that a hearing is
held. If you do not include such a
description and analysis for any
particular objection, you waive the right
to a hearing on the objection.
It is only necessary to send one set of
documents. Identify documents with the
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docket number found in brackets in the
heading of this document. Any
objections received in response to the
regulation may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov. We will publish
notice of the objections that we have
received or lack thereof in the Federal
Register.
X. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site address in this reference
section, but FDA is not responsible for
any subsequent changes to the Web site
after this document publishes in the
Federal Register).
1. Memorandum from N. Belai, Color
Technology Team, OCAC, CFSAN, FDA
to M. Harry, Division of Petition Review,
OFAS, CFSAN, FDA, March 19, 2015.
2. Memorandum from H. Lee, Division of
Petition Review, OFAS, CFSAN, FDA to
M. Harry, Division of Petition Review,
OFAS, CFSAN, FDA, January 30, 2015.
3. Letter from D. Keefe, Office of Food
Additive Safety, CFSAN, FDA to H.
Newman, Desert Lake Technologies,
LLC, Agency Response Letter GRAS
Notice 000424, December 6, 2012,
(https://www.fda.gov/Food/
IngredientsPackagingLabeling/GRAS/
NoticeInventory/ucm335743.htm).
4. Memorandum from T. Walker, Division of
Petition Review, OFAS, CFSAN, FDA to
M. Harry, Division of Petition Review,
OFAS, CFSAN, FDA, April 2, 2015.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs,
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and re-delegated to
the Director, Center for Food Safety and
Applied Nutrition, 21 CFR part 73 is
amended as follows:
PART 73—LISTING OF COLOR
ADDITIVES EXEMPT FROM
CERTIFICATION
1. The authority citation for 21 CFR
part 73 continues to read as follows:
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■
Authority: 21 U.S.C. 321, 341, 342, 343,
348, 351, 352, 355, 361, 362, 371, 379e.
2. Section 73.530 is amended by
revising paragraph (c) to read as follows:
■
§ 73.530
*
*
Spirulina extract.
*
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(c) Uses and restrictions. Spirulina
extract may be safely used for coloring
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, ready-toeat cereals (excluding extruded cereals),
and coating formulations applied to
dietary supplement tablets and
capsules, at levels consistent with good
manufacturing practice, except that it
may not be used to color foods for
which standards of identity have been
issued under section 401 of the Federal
Food, Drug, and Cosmetic Act, unless
the use of the added color is authorized
by such standards.
*
*
*
*
*
■ 3. Section 73.1530 is added to subpart
B to read as follows:
Dated: August 14, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and
Social Sciences, Center for Food Safety and
Applied Nutrition.
§ 73.1530
AGENCY:
Spirulina extract.
(a) Identity. (1) The color additive
spirulina extract is prepared by the
filtered aqueous extraction of the dried
biomass of Arthrospira platensis. The
color additive contains phycocyanins as
the principal coloring components.
(2) Color additive mixtures for drug
use made with spirulina extract may
contain only those diluents that are
suitable and are listed in this subpart as
safe for use in color additive mixtures
for coloring ingested drugs.
(b) Specifications. Spirulina extract
must conform to the following
specifications and must be free from
impurities, other than those named, to
the extent that such other impurities
may be avoided by good manufacturing
practice:
(1) Lead, not more than 2 milligrams
per kilogram (mg/kg) (2 parts per
million (ppm));
(2) Arsenic, not more than 2 mg/kg (2
ppm);
(3) Mercury, not more than 1 mg/kg (1
ppm); and
(4) Negative for microcystin toxin.
(c) Uses and restrictions. Spirulina
extract may be safely used for coloring
coating formulations applied to drug
tablets and capsules, at levels consistent
with good manufacturing practice.
(d) Labeling requirements. The label
of the color additive and any mixture
prepared therefrom intended solely or
in part for coloring purposes shall
conform to the requirements of § 70.25
of this chapter.
(e) Exemption from certification.
Certification of this color additive is not
necessary for the protection of the
public health, and therefore batches
thereof are exempt from the certification
requirements of section 721(c) of the
Federal Food, Drug, and Cosmetic Act.
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[FR Doc. 2015–20676 Filed 8–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket Number USCG–2015–0216]
RIN 1625–AA08
Special Local Regulation; Suncoast
Super Boat Grand Prix; Gulf of Mexico,
Sarasota, FL
ACTION:
Coast Guard, DHS.
Final rule.
The Coast Guard is amending
a special local regulation for the
Suncoast Super Boat Grand Prix that
occurs on the waters of the Gulf of
Mexico near Sarasota, Florida. The
event is scheduled to take place
annually on the first Friday, Saturday,
and Sunday of July from 10 a.m. to 5
p.m. The amendment is needed in order
to protect the safety of race participants,
participant vessels, spectators, and the
general public on the navigable waters
of the United States. The amended
special local regulation will restrict
vessel traffic on the waters near the
event by establishing the following three
areas: A race area, where all persons and
vessels, except those persons and
vessels participating in the high speed
boat races, are prohibited from entering,
transiting through, anchoring in, or
remaining within; a spectator area,
where all vessels must be anchored or
operate at No Wake Speed; and an
enforcement area where designated
representatives may control vessel
traffic as determined by prevailing
conditions.
SUMMARY:
This rule is effective September
21, 2015.
ADDRESSES: Documents mentioned in
this preamble are part of docket USCG–
2015–0216. To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type the docket
number in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rulemaking. You may also visit the
Docket Management Facility in Room
W12–140 on the ground floor of the
DATES:
E:\FR\FM\21AUR1.SGM
21AUR1
]]>Agencies
[Federal Register Volume 80, Number 162 (Friday, August 21, 2015)]
[Rules and Regulations]
[Pages 50762-50765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20676]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2014-C-1552]
Listing of Color Additives Exempt From Certification; Spirulina
Extract
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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).
DATES: 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: 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
Submit electronic objections in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
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 https://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 https://www.regulations.gov and insert the
docket number, found in brackets in the
[[Page 50763]]
heading 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: 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:
I. Introduction
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
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 Sec. 73.530 (21 CFR 73.530). In addition to the
identity of the color additive, the regulation in Sec. 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 Sec. 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 Sec. 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
A. Determination of Safety
Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive may not be
listed for a particular use unless the data and information available
to FDA establish that the color additive is safe for that use. Our
color additive regulations at 21 CFR 70.3(i) define ``safe'' to mean
that there is convincing evidence that establishes with reasonable
certainty that no harm will result from the intended use of the color
additive. To establish with reasonable certainty that a color additive
intended for use in food is not harmful under its intended conditions
of use, we consider the projected human dietary exposure to the
additive, the additive's toxicological data, and other relevant
information (such as published literature) available to us. We compare
an individual's estimated exposure, or estimated daily intake (EDI), of
the additive from all food sources to an acceptable daily intake level
established by toxicological data. The EDI is determined by projections
based on the amount of the additive proposed for use in particular
foods or drugs and on data regarding the amount consumed from all
ingested sources of the additive. We commonly use the EDI for the 90th
percentile consumer of a color additive as a measure of high chronic
exposure.
B. Safety of Petitioned Use of the Color Additive
To support the safety of the petitioned use of spirulina extract as
a color additive in coating formulations applied to dietary supplement
and drug tablets and capsules, Colorcon submitted an exposure estimate
for phycocyanins (the principal coloring component). Colorcon estimated
that the petitioned use of spirulina extract in coating formulations
applied to dietary supplement and drug tablets and capsules will result
in an exposure to phycocyanins of 20.9 milligrams/person/day (mg/p/d)
for the 90th percentile consumer (Ref. 2). We agree with Colorcon's
exposure estimate for phycocyanins and conclude that it is sufficiently
conservative (Ref. 2).\1\
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\1\ The petition referred to both ``drug tablets and capsules''
and ``pharmaceutical tablets and capsules.'' The term
``pharmaceutical tablets and capsules'' was used regarding the
exposure assessment (Ref. 2).
---------------------------------------------------------------------------
Regarding cumulative exposure (cumulative EDI, or CEDI) to
phycocyanins from spirulina and spirulina-derived substances, FDA
discussed in the final rule for use of spirulina extract as a color
additive in candy and chewing gum that spirulina and spirulina-derived
substances have been the subject of four notices submitted by firms to
FDA informing us of their determinations that certain uses of
spirulina-derived substances are generally recognized as safe (GRAS)
(78 FR 49117 at 49118). One of the GRAS notices (GRN 000424) pertains
to the use of a spirulina-derived substance similar in chemical
composition to the subject color additive but with a much higher
phycocyanin content ranging from 42 to 47 percent, and included use in
all foods (except infant formula and foods under U.S. Department of
Agriculture's jurisdiction) at levels consistent with GMP. The upper
bound CEDI for phycocyanins resulting from the notified uses of
spirulina extract was estimated to be 1,140 mg/p/d in GRN 000424 based
on conservative assumptions (Ref. 3). This exposure estimate does not
appear to include exposure to phycocyanins from use of spirulina
extract in dietary supplements. Colorcon estimated that the use of
spirulina extract in coating formulations applied to dietary supplement
and drug tablets and capsules would increase the previously estimated
upper bound CEDI of phycocyanins by 1.8 percent. We agree that
Colorcon's estimate is conservative, and that the petitioned use of
spirulina
[[Page 50764]]
extract would not contribute significantly to the previously estimated
upper bound CEDI of 1,140 mg/p/d for phycocyanins (Ref. 2).
In support of safety of the use of spirulina extract as a color
additive in coating formulations applied to dietary supplement and drug
tablets and capsules in the subject petition, Colorcon referenced the
safety determinations made by FDA for CAP 2C0293 (78 FR 49117) and CAP
2C0297 (79 FR 20095). The petitioner also conducted a search of the
peer-reviewed scientific literature for animal and human oral
consumption studies that tested spirulina, spirulina-derived
ingredients, and phycocyanins that have been published since 2011. The
petitioner submitted the published animal and human studies that they
had identified as being relevant to their petition. We reviewed the
relevant studies and determined that these publications did not raise
any safety concerns.
In our previous evaluations of the use of spirulina extract as a
color additive in food, we had selected as the pivotal safety study a
21-month chronic feeding study that tested spirulina powder in rats at
dietary concentrations of 10, 20, or 30 percent (equivalent to 5,000,
10,000, or 15,000 milligrams per kilogram bodyweight per day (mg/kg bw/
d)). The results of this study showed that prolonged oral consumption
of spirulina powder up to a dietary concentration of 15,000 mg/kg bw/d
was without adverse effects. Therefore, we concluded that the no-
observed-effect level (NOEL) for spirulina is 15,000 mg/kg bw/d
(900,000 mg/p/d for a 60 kg person) based on the absence of treatment-
related adverse effects at the highest concentration tested in this
study. We had also determined the NOEL for phycocyanins for humans to
be between 108,000 and 184,500 mg/p/d (78 FR 49117 at 49119). Taking
into account all the available safety information, the estimated
exposure to phycocyanins from the petitioned use of the spirulina
extract, and the margin of safety between the CEDI for phycocyanin
(1,140 mg/p/d) and the NOEL for phycocyanin (108,000 to 184,500 mg/p/
d), we conclude that the petitioned use of spirulina extract as a color
additive in coating formulations applied to dietary supplement and drug
tablets and capsules is safe (Ref. 4).
The potential allergenicity of spirulina phycocyanins was discussed
in the final rule for the use of spirulina extract as a color additive
in candy and chewing gum (78 FR 49117 at 49119). Based on our review of
a comparison of the known amino acid sequences of phycocyanins with the
sequences of known protein allergens, we had determined that there is a
low probability that phycocyanins are protein allergens. We therefore
concluded that the spirulina phycocyanins present an insignificant
allergy risk to consumers of the color additive. We are not aware of
any new information that would cause us to change this conclusion.
IV. Conclusion
Based on the data and information in the petition and other
relevant material, we conclude that the petitioned use of spirulina
extract in coating formulations applied to dietary supplement and drug
tablets and capsules is safe. We further conclude that the additive
will achieve its intended technical effect and is suitable for the
petitioned use. Consequently, we are amending the color additive
regulations in part 73 as set forth in this document. In addition,
based upon the factors listed in 21 CFR 71.20(b), we conclude that
certification of spirulina extract is not necessary for the protection
of the public health.
V. Public Disclosure
In accordance with Sec. 71.15 (21 CFR 71.15), the petition and the
documents that we considered and relied upon in reaching our decision
to approve the petition will be made available for public disclosure
(see FOR FURTHER INFORMATION CONTACT). As provided in Sec. 71.15, we
will delete from the documents any materials that are not available for
public disclosure.
VI. Environmental Impact
We previously considered the environmental effects of this rule, as
stated in the October 22, 2014, notice of filing for CAP 4C0300. We
stated that we had determined, under 21 CFR 25.32(r), that this action
``is of a type that does not individually or cumulatively have a
significant effect on the human environment'' such that neither an
environmental assessment nor an environmental impact statement is
required. We have not received any new information or comments that
would affect our previous determination.
VII. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VIII. Section 301(ll) of the FD&C Act
Our review of this petition was limited to section 721 of the FD&C
Act. This final rule is not a statement regarding compliance with other
sections of the FD&C Act. For example, section 301(ll) of the FD&C Act
(21 U.S.C. 331(ll) prohibits the introduction or delivery for
introduction into interstate commerce of any food that contains a drug
approved under section 505 of the FD&C Act (21 U.S.C. 355), a
biological product licensed under section 351 of the Public Health
Service Act (42 U.S.C. 262), or a drug or biological product for which
substantial clinical investigations have been instituted and their
existence has been made public, unless one of the exemptions in section
301(ll)(1) to (4) of the FD&C Act applies. In our review of this
petition, we did not consider whether section 301(ll) of the FD&C Act
or any of its exemptions apply to food containing this color additive.
Accordingly, this final rule should not be construed to be a statement
that a food containing this color additive, if introduced or delivered
for introduction into interstate commerce, would not violate section
301(ll) of the FD&C Act. Furthermore, this language is included in all
color additive final rules that pertain to food and therefore should
not be construed to be a statement of the likelihood that section
301(ll) of the FD&C Act applies.
IX. Objections
This rule is effective as shown in the DATES section except as to
any provisions that may be stayed by the filing of proper objections.
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Division of Dockets Management (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) of the regulation to which
you object, and the grounds for your objection. Within each numbered
objection, you must specifically state whether you are requesting a
hearing on the particular provision that you specify in that numbered
objection. If you do not request a hearing for any particular
objection, you waive the right to a hearing on that objection. If you
request a hearing, your objection must include a detailed description
and analysis of the specific factual information you intend to present
in support of the objection in the event that a hearing is held. If you
do not include such a description and analysis for any particular
objection, you waive the right to a hearing on the objection.
It is only necessary to send one set of documents. Identify
documents with the
[[Page 50765]]
docket number found in brackets in the heading of this document. Any
objections received in response to the regulation may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we
have received or lack thereof in the Federal Register.
X. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov. (FDA
has verified the Web site address in this reference section, but FDA is
not responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register).
1. Memorandum from N. Belai, Color Technology Team, OCAC, CFSAN, FDA
to M. Harry, Division of Petition Review, OFAS, CFSAN, FDA, March
19, 2015.
2. Memorandum from H. Lee, Division of Petition Review, OFAS, CFSAN,
FDA to M. Harry, Division of Petition Review, OFAS, CFSAN, FDA,
January 30, 2015.
3. Letter from D. Keefe, Office of Food Additive Safety, CFSAN, FDA
to H. Newman, Desert Lake Technologies, LLC, Agency Response Letter
GRAS Notice 000424, December 6, 2012, (https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm335743.htm).
4. Memorandum from T. Walker, Division of Petition Review, OFAS,
CFSAN, FDA to M. Harry, Division of Petition Review, OFAS, CFSAN,
FDA, April 2, 2015.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and re-
delegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 73 is amended as follows:
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
0
1. The authority citation for 21 CFR part 73 continues to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.
0
2. Section 73.530 is amended by revising paragraph (c) to read as
follows:
Sec. 73.530 Spirulina extract.
* * * * *
(c) Uses and restrictions. Spirulina extract may be safely used for
coloring 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, ready-to-eat cereals (excluding extruded
cereals), and coating formulations applied to dietary supplement
tablets and capsules, at levels consistent with good manufacturing
practice, except that it may not be used to color foods for which
standards of identity have been issued under section 401 of the Federal
Food, Drug, and Cosmetic Act, unless the use of the added color is
authorized by such standards.
* * * * *
0
3. Section 73.1530 is added to subpart B to read as follows:
Sec. 73.1530 Spirulina extract.
(a) Identity. (1) The color additive spirulina extract is prepared
by the filtered aqueous extraction of the dried biomass of Arthrospira
platensis. The color additive contains phycocyanins as the principal
coloring components.
(2) Color additive mixtures for drug use made with spirulina
extract may contain only those diluents that are suitable and are
listed in this subpart as safe for use in color additive mixtures for
coloring ingested drugs.
(b) Specifications. Spirulina extract must conform to the following
specifications and must be free from impurities, other than those
named, to the extent that such other impurities may be avoided by good
manufacturing practice:
(1) Lead, not more than 2 milligrams per kilogram (mg/kg) (2 parts
per million (ppm));
(2) Arsenic, not more than 2 mg/kg (2 ppm);
(3) Mercury, not more than 1 mg/kg (1 ppm); and
(4) Negative for microcystin toxin.
(c) Uses and restrictions. Spirulina extract may be safely used for
coloring coating formulations applied to drug tablets and capsules, at
levels consistent with good manufacturing practice.
(d) Labeling requirements. The label of the color additive and any
mixture prepared therefrom intended solely or in part for coloring
purposes shall conform to the requirements of Sec. 70.25 of this
chapter.
(e) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health, and
therefore batches thereof are exempt from the certification
requirements of section 721(c) of the Federal Food, Drug, and Cosmetic
Act.
Dated: August 14, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2015-20676 Filed 8-20-15; 8:45 am]
BILLING CODE 4164-01-P
