82 FR 30731 - Listing of Color Additives Exempt From Certification; Spirulina Extract

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 126 (July 3, 2017)

Page Range		30731-30734
FR Document		2017-13867

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) filed by McCormick & Company, Inc. (McCormick).

Federal Register, Volume 82 Issue 126 (Monday, July 3, 2017)

[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Rules and Regulations]
[Pages 30731-30734]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-13867]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2016-C-2570]

Listing of Color Additives Exempt From Certification; Spirulina
Extract

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is amending the
color additive regulations to provide for the expanded safe use of
spirulina extract to seasonally color hard-boiled shell eggs at levels
consistent with good manufacturing practice (GMP). This action is in
response to a color additive petition (CAP) filed by McCormick &
Company, Inc. (McCormick).

DATES: This rule is effective August 3, 2017. Submit either electronic
or written objections and requests for a hearing on the final rule by
August 2, 2017. See section IX for further information on the filing of
objections.

ADDRESSES: You may submit either electronic or written objections and
requests for a hearing as follows. Please note that late, untimely
filed objections will not be considered. Electronic objections must be
submitted on or before August 2, 2017. The https://www.regulations.gov
electronic filing

[[Page 30732]]

system will accept comments until midnight Eastern Time at the end of
August 2, 2017. Objections received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is 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-2016-C-2570 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.
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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 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: Molly A. Harry, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740-3835, 240-402-1075.

SUPPLEMENTARY INFORMATION:

I. Introduction

In a notice published in the Federal Register of September 16, 2016
(81 FR 63728), we announced that we filed a color additive petition
(CAP 6C0306) submitted by McCormick & Company, Inc., c/o Exponent, 1150
Connecticut Ave. NW., suite 1100, Washington, DC 20036. The petition
proposed to amend the color additive regulations in Sec. 73.530 (21
CFR 73.530) Spirulina extract to provide for the expanded safe use of
spirulina extract, prepared by the filtered aqueous extraction of the
dried biomass of Arthrospira platensis, to seasonally color the shells
of hard-boiled eggs. The color additive is intended to be sold as a
powder in a packet to consumers at levels consistent with GMP.

II. Background

Spirulina extract is currently 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), and coating formulations applied to dietary supplement
tablets and capsules, at levels consistent with GMP. Spirulina extract
also is currently approved under 21 CFR 73.1530 for coloring coating
formulations applied to drug tablets and capsules, at levels consistent
with GMP. Spirulina extract is exempt from certification under section
721(c) of the Federal Food, Drug, and Cosmetic Act (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 produced by the filtered aqueous extraction of the
dried biomass of A. platensis (also known as Spirulina platensis), an
edible blue-green cyanobacterium. The color additive contains
phycocyanins as the principal coloring components. 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-derived ingredients have also been the subject of four
notices submitted by firms to FDA informing us of their determinations
that certain uses of these substances in food are generally recognized
as safe (GRAS) (78 FR 49117 at 49118). Under section 201(s) of the FD&C
Act (21 U.S.C. 321(s)), 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 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)). One GRAS

[[Page 30733]]

notice (GRN 000424) pertains to the use of a spirulina-derived
substance that is similar in chemical composition to the color additive
that is the subject of this final rule, but the substance that was the
subject of GRN 000424 has a much higher phycocyanin content (Ref. 3).
Importantly, in our response to these GRAS notifications, we indicated
that if the substances that were the subject of these submissions
impart color to the food, they may be subject to regulation as a color
additive.

III. Safety Evaluation

A. Determination of Safety

Under section 721(b)(4) of the FD&C Act, 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 foods 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 an individual's estimated exposure, or estimated daily intake
(EDI), of the color 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 color additive
proposed for use in particular foods or drugs and on data regarding the
amount consumed from all ingested 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 exposure.

B. Safety of Petitioned Use of the Color Additive

During our safety review of this petition (CAP 6C0306), we
considered the projected human dietary exposure to spirulina extract
and to phycocyanins (the principal coloring components) from the
petitioned use and from currently permitted uses of spirulina extract
in foods and ingested drugs. McCormick submitted an exposure estimate
for spirulina extract and for phycocyanins for the petitioned use of
spirulina extract based on a worst-case scenario that presumed that
spirulina extract could potentially migrate from the outside of the egg
shell to the edible portion of the egg. McCormick estimated that the
petitioned use of spirulina extract to seasonally color the shells of
hard-boiled eggs would result in an exposure to spirulina extract of
8.8 milligrams per person per day (mg/p/d) at the 90th percentile for
the U.S. population aged 2 years and older (Ref. 2). McCormick also
estimated that the petitioned use of spirulina extract would result in
an exposure to phycocyanins of 1.9 mg/p/d at the 90th percentile for
the U.S. population aged 2 years and older (Ref. 2). Despite providing
this worst-case estimate, McCormick noted that egg shells are not
consumed and demonstrated that the spirulina extract applied to the
outside of an egg shell generally does not migrate through the shell
and the outer and inner membranes separating the shell from the edible
portion of the egg. For these reasons, McCormick asserted that the
amount of spirulina extract that would actually be found on the edible
portion of an egg would be negligible, resulting in a 0.17 percent
increase of the cumulative estimated daily intake (CEDI) for
phycocyanins (Ref. 2). The previously estimated upper bound CEDI for
phycocyanins from all GRAS-notified uses of spirulina extract in food
is 1,140 mg/p/day or 19 milligrams per kilogram body weight per day
(mg/kg bw/d) for a 60 kg individual based on uses addressed in GRN
000424 (Ref. 3). We agree that McCormick's exposure estimate is
sufficiently conservative. We conclude that the exposure to spirulina
extract and phycocyanins resulting from the petitioned use of spirulina
extract to seasonally color the shells of hard-boiled eggs is
negligible, and that the petitioned use would not result in a
significant contribution to the CEDI for phycocyanins (Ref. 2).
To support the safety of the proposed use of spirulina extract to
color the shells of hard-boiled eggs, McCormick referenced the safety
determinations made by FDA for CAPs 2C0293 (78 FR 49117, August 13,
2013), 2C0297 (79 FR 20095, April 11, 2014), and 4C0300 (80 FR 50762,
August 21, 2015). McCormick 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 were published between January 1, 2014, and July 20,
2016. McCormick submitted to us the published animal and human studies
that they identified as being relevant to their petition. We evaluated
the submitted safety information and additional studies that we
identified as relevant and concluded that this information does not
raise any safety concerns (Refs. 4 and 5).
In our previous evaluation of the use of spirulina extract as a
color additive in foods (80 FR 50762), we did not have any concerns
regarding the safety of the use of spirulina extract and its major
coloring components, phycocyanins. Taking into account all the
available safety information and the estimated exposure to phycocyanins
from the petitioned use, we conclude that the proposed use of spirulina
extract to seasonally color the shells of hard-boiled eggs 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). Based on the
comparison of the known amino acid sequences of phycocyanins with the
sequences of known protein allergens, we determined that there is a low
probability that phycocyanins are protein allergens. We therefore
concluded that the spirulina phycocyanins present an insignificant
allergy risk. Additionally, after a review of the literature relevant
to the potential allergenicity of spirulina phycocyanins, we have
determined that spirulina phycocyanins still present an insignificant
allergy risk (Refs. 4-7). 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 to seasonally color the shells of hard-boiled eggs 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 part 73 (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 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.

[[Page 30734]]

VI. Analysis of Environmental Impact

We previously considered the environmental effects of this rule, as
stated in the September 16, 2016, Federal Register notice of petition
for CAP 6C0306 (81 FR 63728). 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
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 (ll)(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 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.

X. References

The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. Memorandum from N. Belai, Color Technology Team, Office of
Cosmetics and Colors (OCAC), Center for Food Safety and Applied
Nutrition (CFSAN), FDA to M. Harry, Division of Petition Review,
Office of Food Additive Safety (OFAS), CFSAN, FDA, February 1, 2017.
2. Memorandum from H. Lee, Division of Petition Review, OFAS, CFSAN,
FDA to M. Harry, Division of Petition Review, OFAS, CFSAN, FDA,
February 1, 2017.
3. Letter from D. Keefe, OFAS, CFSAN, FDA to H. Newman, Desert Lake
Technologies, LLC, Agency Response Letter GRAS Notice 000424,
December 6, 2012, (http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm335743.htm).
4. Memorandum from L. Rosenfeld, Division of Petition Review, OFAS,
CFSAN, FDA to J. Park, Division of Petition Review, OFAS, CFSAN,
FDA, January 12, 2017.
5. Memorandum from J. Park, Division of Petition Review, OFAS,
CFSAN, FDA to M. Harry, Division of Petition Review, OFAS, CFSAN,
FDA, February 2, 2017.
6. Memorandum from J. Park, Division of Petition Review, OFAS,
CFSAN, FDA to M. Harry, Division of Petition Review, OFAS, CFSAN,
FDA, April 13, 2017.
7. Memorandum from J. Park, Division of Petition Review, OFAS,
CFSAN, FDA to M. Harry, Division of Petition Review, OFAS, CFSAN,
FDA, April 25, 2017.

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
authority delegated to the Commissioner of 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, 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 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: June 21, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13867 Filed 6-30-17; 8:45 am]
BILLING CODE 4164-01-P

30734 Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Rules and Regulations

VI. Analysis of Environmental Impact file with the Dockets Management Staff M. Harry, Division of Petition Review,
(see ADDRESSES) either electronic or OFAS, CFSAN, FDA, February 2, 2017.
We previously considered the
written objections. You must separately 6. Memorandum from J. Park, Division of
environmental effects of this rule, as
number each objection, and within each Petition Review, OFAS, CFSAN, FDA to
stated in the September 16, 2016,
numbered objection you must specify M. Harry, Division of Petition Review,
Federal Register notice of petition for
with particularity the provision(s) to OFAS, CFSAN, FDA, April 13, 2017.
CAP 6C0306 (81 FR 63728). We stated
which you object, and the grounds for 7. Memorandum from J. Park, Division of
that we had determined, under 21 CFR
your objection. Within each numbered Petition Review, OFAS, CFSAN, FDA to
25.32(r), that this action ‘‘is of a type
objection, you must specifically state M. Harry, Division of Petition Review,
that does not individually or
whether you are requesting a hearing on OFAS, CFSAN, FDA, April 25, 2017.
cumulatively have a significant effect on
the human environment’’ such that the particular provision that you specify
in that numbered objection. If you do List of Subjects in 21 CFR Part 73
neither an environmental assessment
nor an environmental impact statement not request a hearing for any particular
Color additives, Cosmetics, Drugs,
is required. We have not received any objection, you waive the right to a
Foods, Medical devices.
new information or comments that hearing on that objection. If you request
would affect our previous a hearing, your objection must include Therefore, under the Federal Food,
determination. a detailed description and analysis of Drug, and Cosmetic Act and under
the specific factual information you authority delegated to the Commissioner
VII. Paperwork Reduction Act of 1995 intend to present in support of the of Food and Drugs, 21 CFR part 73 is
This final rule contains no collection objection in the event that a hearing is amended as follows:
of information. Therefore, clearance by held. If you do not include such a
the Office of Management and Budget description and analysis for any PART 73—LISTING OF COLOR
under the Paperwork Reduction Act of particular objection, you waive the right ADDITIVES EXEMPT FROM
1995 is not required. to a hearing on the objection. CERTIFICATION
Any objections received in response
VIII. Section 301(ll) of the FD&C Act
to the regulation may be seen in the ■ 1. The authority citation for part 73
Our review of this petition was Dockets Management Staff between 9 continues to read as follows:
limited to section 721 of the FD&C Act. a.m. and 4 p.m., Monday through
This final rule is not a statement Friday, and will be posted to the docket Authority: 21 U.S.C. 321, 341, 342, 343,
regarding compliance with other at https://www.regulations.gov. We will 348, 351, 352, 355, 361, 362, 371, 379e.
sections of the FD&C Act. For example, publish notice of the objections that we
section 301(ll) of the FD&C Act ■ 2. Section 73.530 is amended by
have received or lack thereof in the
prohibits the introduction or delivery revising paragraph (c) to read as follows:
Federal Register.
for introduction into interstate § 73.530 Spirulina extract.
commerce of any food that contains a X. References
drug approved under section 505 of the The following references are on * * * * *
FD&C Act (21 U.S.C. 355), a biological display in the Dockets Management (c) Uses and restrictions. Spirulina
product licensed under section 351 of Staff (see ADDRESSES) and are available extract may be safely used for coloring
the Public Health Service Act (42 U.S.C. for viewing by interested persons confections (including candy and
262), or a drug or biological product for between 9 a.m. and 4 p.m., Monday chewing gum), frostings, ice cream and
which substantial clinical investigations through Friday; they are also available frozen desserts, dessert coatings and
have been instituted and their existence electronically at https:// toppings, beverage mixes and powders,
has been made public, unless one of the www.regulations.gov. FDA has verified yogurts, custards, puddings, cottage
exemptions in section 301(ll)(1) to (ll)(4) the Web site addresses, as of the date cheese, gelatin, breadcrumbs, ready-to-
of the FD&C Act applies. In our review this document publishes in the Federal eat cereals (excluding extruded cereals),
of this petition, we did not consider Register, but Web sites are subject to coating formulations applied to dietary
whether section 301(ll) of the FD&C Act change over time. supplement tablets and capsules, at
or any of its exemptions apply to food 1. Memorandum from N. Belai, Color
containing this color additive. levels consistent with good
Technology Team, Office of Cosmetics manufacturing practice, and to
Accordingly, this final rule should not and Colors (OCAC), Center for Food
be construed to be a statement that a Safety and Applied Nutrition (CFSAN),
seasonally color the shells of hard-
food containing this color additive, if FDA to M. Harry, Division of Petition boiled eggs, except that it may not be
introduced or delivered for introduction Review, Office of Food Additive Safety used to color foods for which standards
into interstate commerce, would not (OFAS), CFSAN, FDA, February 1, 2017. of identity have been issued under
violate section 301(ll) of the FD&C Act. 2. Memorandum from H. Lee, Division of section 401 of the Federal Food, Drug,
Petition Review, OFAS, CFSAN, FDA to and Cosmetic Act, unless the use of the
Furthermore, this language is included M. Harry, Division of Petition Review,
in all color additive final rules that OFAS, CFSAN, FDA, February 1, 2017. added color is authorized by such
pertain to food and therefore should not 3. Letter from D. Keefe, OFAS, CFSAN, FDA standards.
be construed to be a statement of the to H. Newman, Desert Lake * * * * *
likelihood that section 301(ll) of the Technologies, LLC, Agency Response
FD&C Act applies. Letter GRAS Notice 000424, December 6, Dated: June 21, 2017.
2012, (http://www.fda.gov/Food/ Anna K. Abram,
sradovich on DSK3GMQ082PROD with RULES

IX. Objections IngredientsPackagingLabeling/GRAS/
Deputy Commissioner for Policy, Planning,
This rule is effective as shown in the NoticeInventory/ucm335743.htm).
4. Memorandum from L. Rosenfeld, Division Legislation, and Analysis.
DATES section, except as to any [FR Doc. 2017–13867 Filed 6–30–17; 8:45 am]
of Petition Review, OFAS, CFSAN, FDA
provisions that may be stayed by the to J. Park, Division of Petition Review, BILLING CODE 4164–01–P
filing of proper objections. If you will be OFAS, CFSAN, FDA, January 12, 2017.
adversely affected by one or more 5. Memorandum from J. Park, Division of
provisions of this regulation, you may Petition Review, OFAS, CFSAN, FDA to

VerDate Sep<11>2014 17:08 Jun 30, 2017 Jkt 241001 PO 00000 Frm 00014 Fmt 4700 Sfmt 9990 E:\FR\FM\03JYR1.SGM 03JYR1

Document Created: 2018-11-14 10:19:47
Document Modified: 2018-11-14 10:19:47

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		Final rule.
Dates		This rule is effective August 3, 2017. Submit either electronic or written objections and requests for a hearing on the final rule by August 2, 2017. See section IX for further information on the filing of objections.
Contact		Molly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1075.
FR Citation		82 FR 30731
CFR Associated		Color Additives; Cosmetics; Drugs; Foods and Medical Devices

82 FR 30731 - Listing of Color Additives Exempt From Certification; Spirulina Extract

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 126 (July 3, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration