[Federal Register Volume 87, Number 217 (Thursday, November 10, 2022)]
[Rules and Regulations]
[Pages 67785-67789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24429]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2020-C-1309]
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 expanded safe use of
spirulina (Arthrospira platensis) extract
[[Page 67786]]
as a color additive in alcoholic beverages with less than 20 percent
alcohol-by-volume content, non-alcoholic beverages, condiments and
sauces, dips, dairy product alternatives (identified as non-dairy
yogurt alternatives, non-dairy frozen desserts, and non-dairy
puddings), salad dressings, and seasoning mixes (unheated). This action
is in response to a color additive petition (CAP) filed by GNT USA,
Inc. (GNT).
DATES: This rule is effective December 13, 2022. See section X for
further information on the filing of objections. Either electronic or
written objections and requests for a hearing on the final rule must be
submitted by December 12, 2022.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of
December 12, 2022. Objections received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
received on or before that date.
Electronic Submissions
Submit electronic objections in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your objection, that information will be
posted on https://www.regulations.gov.
If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper objections submitted to the Dockets
Management Staff, FDA will post your objection, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2020-C-1309 for ``Listing of Color Additives Exempt from
Certification; Spirulina Extract.'' Received objections, those filed in
a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We
will review this copy, including the claimed confidential information,
in our consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper 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: Stephanie A. Hice, Center for Food
Safety and Applied Nutrition, Food and Drug Administration (HFS-255),
5001 Campus Dr., College Park, MD 20740, 301-348-1740; or Philip L.
Chao, Center for Food Safety and Applied Nutrition, Office of
Regulations and Policy (HFS-024), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Introduction
In a document published in the Federal Register of May 8, 2020 (85
FR 27340), we announced that we filed a color additive petition (CAP
0C0316) submitted on behalf of GNT by Hogan Lovells US LLP, 555 13th
St. NW, Washington, DC 20004. The petition proposed to amend the color
additive regulations in Sec. 73.530 Spirulina extract (21 CFR 73.530)
to provide for the expanded safe use of spirulina extract, prepared
from the filtered aqueous extraction of the dried biomass of A.
platensis, as a color additive in alcoholic beverages with less than 20
percent alcohol-by-volume content (the proposed scope was subsequently
amended to include beer), non-alcoholic beverages, condiments and
sauces, dips, dairy product alternatives (identified as non-dairy
yogurt alternatives, non-dairy frozen desserts, and non-dairy
puddings), salad dressings, and seasoning mixes (unheated) at levels
consistent with good manufacturing practice (GMP).
II. Background
Spirulina extract is approved under Sec. 73.530 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), coating
formulations applied to dietary supplement tablets and capsules, at
levels consistent with GMP, and to seasonally color the shells of hard-
boiled eggs, 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 (FD&C Act) (21 U.S.C. 341), unless the use
of the added color is authorized by such standards. Spirulina extract
also is approved under 21 CFR 73.1530 for coloring coating formulations
applied to drug tablets and capsules, at levels consistent with GMP.
[[Page 67787]]
Spirulina extract is exempt from certification under section 721(c) of
the FD&C Act (21 U.S.C. 379e(c)) because we previously determined that
certification was not necessary for the protection of public health (78
FR 49117 at 49119, August 13, 2013).
The spirulina extract that is the subject of this final rule is a
blue-colored powder or liquid prepared by the water extraction and
filtration of the dried biomass of A. platensis (also known as
Spirulina platensis), an edible blue-green cyanobacterium. The
extraction and filtration remove oil, oil soluble substances, and
fibers. The color additive contains phycocyanins as the principal
coloring components, and consists of proteins, carbohydrates, and
minerals. 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
(Refs. 1 and 2).
Spirulina-based ingredients have been the subject of four generally
recognized as safe (GRAS) notices (GRNs) filed by FDA (78 FR 49117 at
49118). Under section 201(s) of the FD&C Act (21 U.S.C. 321(s)), a
substance is GRAS if it is generally recognized, among experts
qualified by scientific training and experience to evaluate its safety,
as having been adequately shown through scientific procedures (or, in
the case of a substance used in food before January 1, 1958, through
either scientific procedures or experience based on common use in food)
to be safe under the conditions of its intended use. Under section
201(s) of the FD&C Act, a substance that is GRAS for a particular use
in food is not a food additive and may lawfully be utilized for that
use without our review and approval. There is no GRAS exemption,
however, to the definition of color additive in section 201(t) of the
FD&C Act. Therefore, we must approve the intended use of a color
additive in food before it is marketed; otherwise, the food containing
the color additive is adulterated under section 402(c) of the FD&C Act
(21 U.S.C. 342(c)). Importantly, in our response to these GRNs, we
indicated that if the substance imparts color to the food, it may be
subject to regulation as a color additive (78 FR 49117 at 49118).
III. Safety Evaluation
A. Determination of Safety
Under section 721(b)(4) of the FD&C Act, a color additive cannot 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 in 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 color
additive, the additive's toxicological data, and other relevant
information (such as published literature) available to us. We compare
the estimated daily intake (EDI) of the color additive from all sources
to an acceptable daily intake (ADI) level established by toxicological
data. The EDI is calculated based on the amount of the color additive
proposed for use in particular foods or drugs and on data regarding the
amount consumed from all sources of the color additive. We commonly use
the EDI for the 90th percentile consumer of a color additive as a
measure of high chronic dietary exposure.
B. Safety of Petitioned Use of the Color Additive
During our safety review of this petition (CAP 0C0316), we
considered the estimated dietary exposure to spirulina extract and c-
phycocyanin (the main coloring component) from the petitioned uses of
the subject color additive. GNT provided the eaters-only 90th
percentile estimates of dietary exposure for spirulina extract and c-
phycocyanin for the petitioned uses for the U.S. population aged 2
years and older, and various subpopulations. Upon further clarification
of the proposed uses to include beer (Ref. 3), we amended GNT's dietary
exposure estimate to include additional food codes for beer (Ref. 2).
We estimated that the petitioned uses of the subject color additive
would result in dietary exposures to spirulina extract and c-
phycocyanins of 31 grams/person/day (g/p/d) and 0.6 g/p/d,
respectively, at the 90th percentile for the U.S. population aged 2
years and older (Ref. 2). GNT cited a cumulative estimated daily intake
(CEDI) to phycocyanins of 1.14 g/p/d (Ref. 2). This value has been
cited in previous reviews of spirulina extract as an upper bound CEDI
for phycocyanins from GRAS-notified uses of spirulina extract in food
and is based on uses described in GRN 000424 (see 80 FR 50762 at 50763,
August 21, 2015, and Ref. 4). GRN 000424 pertains to the use of a
spirulina-based substance similar in chemical composition to the
subject color additive but with a higher phycocyanin content and
included use in all foods (except infant formula and foods under the
U.S. Department of Agriculture's jurisdiction) at levels consistent
with GMP (Refs. 2 and 4).
The highest 90th percentile estimate of dietary exposure to
phycocyanins (0.7 g/p/d for adults 19 years or older) from the
petitioned uses is below the upper-bound CEDI of 1.14 g/p/d
phycocyanins from the notified GRAS uses described in GRN 000424 and
from the uses approved under Sec. 73.530 (Ref. 2). GNT indicated that,
given the high phycocyanin content of the spirulina-based substance
described in GRN 000424 (42 to 47 percent) relative to the subject
color additive (2 percent) and the multiple uses of spirulina extract
addressed previously in GRN 000424, the cited upper-bound CEDI
encompasses current and previously petitioned uses of spirulina
extract. Based on the data and information reviewed by FDA, the
petitioned uses of spirulina extract are not expected to increase the
estimated CEDI to phycocyanins in the U.S. diet (Ref. 2).
To support the safety of the petitioned uses of spirulina extract,
GNT referenced the safety determinations made by FDA for CAPs 2C0293
(78 FR 49117), 2C0297 (79 FR 20095, April 11, 2014), 4C0300 (80 FR
50762), and 6C0306 (82 FR 30731, July 3, 2017). GNT also conducted an
updated search of the peer-reviewed scientific literature on spirulina
and submitted the published studies that they identified as being
relevant to their petition. GNT concluded that these publications did
not reveal any significant new toxicological effects and should not
alter the conclusions of FDA's previous reviews on spirulina. Of the
publications submitted by the petitioner, some studies had been
previously reviewed by FDA. Our review of the new information, the
information submitted in previously reviewed publications, as well as
our own independent literature search and review of spirulina and
phycocyanins, did not reveal any safety concerns relating to spirulina
or phycocyanin, nor did it identify any information or data that would
change the ADI of 1.0-1.8 g/p/d for phycocyanins (Refs. 5 and 6).
In our most recent evaluation of the use of spirulina extract as a
color additive to seasonally color hard-boiled shell eggs (82 FR
30731), we did not have any concerns regarding the safety of the use of
spirulina extract and its principal coloring components, phycocyanins.
Considering all available safety information and the estimated dietary
exposure to phycocyanins from
[[Page 67788]]
the petitioned uses, we conclude that the petitioned use of spirulina
extract as a color additive is safe (Ref. 5).
We discussed the potential allergenicity of spirulina phycocyanins
in our final rule for the use of spirulina extract as a color additive
in candy and chewing gum (78 FR 49117 at 49119). We stated that, based
on our review of a comparison of the known amino acid sequences of
phycocyanins with the sequences of known protein allergens, there is a
low probability that the spirulina phycocyanins are protein allergens.
Therefore, we concluded that spirulina phycocyanins present an
insignificant allergy risk to consumers of the color additive.
Additionally, after a review of the literature relevant to the
potential allergenicity of spirulina, we have determined that spirulina
extract as a color additive for both current uses and the petitioned
uses in food still presents an insignificant allergy risk for the
general population (Ref. 6). We are not aware of any new information
that would cause us to change this conclusion.
IV. Comment to the Petition and FDA Response
We received one comment on the petition. The comment asked us to
clarify that we interpret ``malted beverages'' to apply to ``what is
commonly known in the alcoholic beverage industry and amongst the
general public as `beer.''' GNT included a table of proposed uses in
the petition. Under the alcoholic beverages category, GNT included
ciders, cocktails and liqueur, ready-to-drink (e.g., daiquiris,
schnapps) with less than 20 percent alcohol-by-volume content, malt
beverages, wine, and wine coolers. In the proposed amendment to Sec.
73.530 Spirulina extract, GNT proposed that the intended uses include
alcoholic beverages (with less than 20 percent alcohol-by-volume
content, excluding beer).
As we noted in section I of this document, GNT subsequently
expanded the scope of its petition to include beer. Therefore, we
consider beer to be within the scope of the amended regulation as an
alcoholic beverage with less than 20 percent alcohol-by-volume content.
V. Conclusion
Based on the data and information in the petition and other
relevant material, we conclude that the petitioned use of spirulina
extract as a color additive in alcoholic beverages with less than 20
percent alcohol-by-volume content, non-alcoholic beverages, condiments
and sauces, dips, dairy product alternatives (identified as non-dairy
yogurt alternatives, non-dairy frozen desserts, and non-dairy
puddings), salad dressings, and seasoning mixes (unheated) is safe. We
further conclude that the color additive will achieve its intended
technical effect and is suitable for the petitioned use. Consequently,
we are amending the color additive regulations in 21 CFR part 73 as set
forth in this document. In addition, based upon the factors listed in
21 CFR 71.20(b), we continue to conclude that certification of
spirulina extract is not necessary for the protection of public health.
VI. 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.
VII. Analysis of Environmental Impact
We previously considered the environmental effects of this rule, as
stated in the May 8, 2020, Federal Register notice of petition for CAP
0C0316 (85 FR 27340). We stated that we had determined, under 21 CFR
25.32(k), 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.
VIII. 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.
IX. 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) through (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.
X. 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 Dockets Management Staff (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) 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.
Any objections received in response to the regulation may be seen
in the Dockets Management Staff 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.
XI. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through
[[Page 67789]]
Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
1. Memorandum from N. Belai, Color Technology Branch, Division of
Color Certification and Technology, Office of Cosmetics and Colors
(OCAC), CFSAN, FDA to S. Hice, Regulatory Review Branch (RRB),
Division of Food Ingredients (DFI), Office of Food Additive Safety
(OFAS), CFSAN, FDA, September 30, 2022.
2. Memorandum from M. Swain, Chemistry Review Branch, DFI, OFAS,
CFSAN, FDA to S. Hice, RRB, DFI, OFAS, CFSAN, FDA, October 7, 2022.
3. Memorandum of Telephone Conversation from S. Hice, RRB, DFI,
OFAS, CFSAN, FDA, January 26, 2022.
4. Letter from D. Keefe, OFAS, CFSAN, FDA to H. Newman, Desert Lake
Technologies, LLC, Agency Response Letter GRAS Notice 000424,
December 6, 2012, (https://wayback.archive-it.org/7993/20171031010129/https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm335743.htm).
5. Memorandum from D. DeGroot, Toxicology Review Branch (TRB), DFI,
OFAS, CFSAN, FDA to S. Hice, RRB, DFI, OFAS, CFSAN, FDA, October 8,
2022.
6. Memorandum from D. DeGroot, TRB, DFI, OFAS, CFSAN, FDA to S.
Hice, RRB, DFI, OFAS, CFSAN, FDA, October 8, 2022.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Foods, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of the Food and Drugs, 21
CFR part 73 is amended as follows:
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
0
1. The authority citation for 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 (including non-dairy frozen dessert), dessert
coatings and toppings, beverage mixes and powders, yogurts (including
non-dairy yogurt alternatives), custards, puddings (including non-dairy
puddings), cottage cheese, gelatin, breadcrumbs, ready-to-eat cereals
(excluding extruded cereals), alcoholic beverages with less than 20
percent alcohol-by-volume content, non-alcoholic beverages, seasoning
mixes (unheated), salad dressings, condiments and sauces, dips, coating
formulations applied to dietary supplement tablets and capsules, at
levels consistent with good manufacturing practice, and to seasonally
color the shells of hard-boiled eggs, 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.
* * * * *
Dated: November 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24429 Filed 11-9-22; 8:45 am]
BILLING CODE 4164-01-P