Rule2022-10025
Listing of Color Additives Exempt From Certification; Antarctic Krill Meal
Primary source
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Published
May 10, 2022
Effective
June 10, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of Antarctic krill meal, composed of the ground and dried tissue of Euphausia superba, with or without the lipid fraction, for use in the feed of salmonid fish, to enhance the color of their flesh. We are taking this action in response to a color additive petition (CAP) submitted by Aker BioMarine Antarctic AS (Aker BioMarine or petitioner).
Full Text
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<title>Federal Register, Volume 87 Issue 90 (Tuesday, May 10, 2022)</title>
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[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Rules and Regulations]
[Pages 27931-27936]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10025]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2018-C-1007]
Listing of Color Additives Exempt From Certification; Antarctic
Krill Meal
AGENCY: Food and Drug Administration, Department of Health and Human
Services (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 Antarctic
krill meal, composed of the ground and dried tissue of Euphausia
superba, with or without the lipid fraction, for use in the feed of
salmonid fish, to enhance the color of their flesh. We are taking this
action in response to a color additive petition (CAP) submitted by Aker
BioMarine Antarctic AS (Aker BioMarine or petitioner).
DATES: This rule is effective June 10, 2022. Submit either electronic
or written objections and requests for a hearing on the final rule by
June 9, 2022. See section XI for further information on the filing of
objections.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of June
9, 2022. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
[[Page 27932]]
information, or other information that identifies you in the body of
your objection, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2018-C-1007 for ``Listing of Color Additives Exempt From
Certification; Antarctic Krill Meal.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Stephen DiFranco, Office of Food
Additive Safety (HFS-255), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740-3835, 240-402-2710; or Alexandra Jurewitz, Office of
Regulations and Policy (HFS-024), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Introduction
In a notification published in the Federal Register of April 9,
2018 (83 FR 15089), we announced that we filed a color additive
petition (CAP 5C0303) submitted by Aker BioMarine Antarctic AS (Aker
BioMarine), c/o Intertek Scientific & Regulatory Consultancy, Rm. 1036,
Bldg. A8 Cody Technology Park, Ively Rd., Farnborough, Hampshire, GU14
0LX, United Kingdom. The petition proposed to amend the color additive
regulations in part 73 (21 CFR part 73), Listing of Color Additives
Exempt from Certification, to provide for the safe use of Antarctic
krill meal, composed of the ground and dried tissue of Euphausia
superba, with or without removal of the lipid fraction, for use in the
feed of salmonid fish, to enhance the color of their flesh. Aker
BioMarine proposed use levels not to exceed 4 percent (weight/weight or
w/w) in feed for freshwater salmonids and 12 percent (w/w) in feed for
marine salmonids. Antarctic krill meal is primarily intended for use as
a nutrient source, partially replacing other meals (especially fish
meal) used in the diet of salmonids. Antarctic krill meal is a natural
source of astaxanthin, and it has been established that astaxanthin can
impart color to the edible tissues of the salmonids.
Antarctic krill meal is not intended to be the sole source of
pigmentation in salmonid feed, and other permitted color additives--
including other permitted sources of astaxanthin--may be added to
achieve the desired level of coloration in the fish flesh. In the
Federal Register of April 13, 1995 (60 FR 18736), we published a final
rule that listed astaxanthin in Sec. 73.35 (21 CFR 73.35) for use in
the feed of salmonid fish. In that final rule, we concluded that 80
milligrams (mg) of astaxanthin per kilogram (kg) of finished feed may
be safely used to enhance pigmentation of the flesh of salmonid fish,
and we limited the astaxanthin content of the finished feed to not more
than 80 mg/kg in Sec. 73.35(c)(2). In the Federal Register of July 6,
2000 (65 FR 41581 and 65 FR 41584), we published final rules that
listed haematococcus algae meal in 21 CFR 73.185 and phaffia yeast in
21 CFR 73.355 as additional sources of astaxanthin permitted for use in
the feed of salmonid fish, provided that the quantity of astaxanthin in
finished feed from either color additive--when used alone or in
combination with other astaxanthin color additive sources listed in
part 73--results in no more than 80 mg/kg of astaxanthin in the
finished feed. In the Federal Register of November 5, 2009 (74 FR
57248), and November 16, 2009 (74 FR 58845), we published final rules
that listed astaxanthin dimethyldisuccinate (21 CFR 73.37) and
paracoccus pigment (21 CFR 73.352), respectively, as color additive
astaxanthin sources permitted in salmonid fish feed with the limitation
that they impart no more than 80 mg/kg of astaxanthin when used alone
or in combination with other astaxanthin sources listed in part 73 as a
condition of use.
Consistent with these regulations, the petitioner proposed that the
quantity of astaxanthin in the finished feed contributed by Antarctic
krill meal when used under the intended conditions of use, alone or in
combination with other permitted sources of astaxanthin, should not
exceed 80 mg/kg astaxanthin in the finished feed.
This final rule covers only the intended use of Antarctic krill
meal as a color additive in the feed of salmonid fish, as the target
animal. Under 21 CFR 70.42, we apply a ``safe-for-use'' principle when
evaluating a color additive petition. This approach ensures that each
listed color additive will be safe for its intended use or uses in or
on food, drugs, or cosmetics. In reviewing this color additive petition
for the proposed intended use of Antarctic krill
[[Page 27933]]
meal in the feed of salmonid fish, we evaluated the safety of the
petitioned use of the additive in the diet of both the target animal
and humans. A discussion of this evaluation can be found in sections
III and IV of this document. Approvals for other potential uses, such
as in non-target animal food, were not the subject of this petition and
therefore are not discussed below. However, such approvals may be
subject to the provisions of section 409(b) or 721(b) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(b) or 21 U.S.C.
379e(b)) and 21 CFR 570.30 or 71.1.
II. Background
Antarctic krill meal is a brownish-orange powder composed of the
cooked, dried, and ground tissue of Euphausia superba. To obtain the
color additive, Antarctic krill are harvested from Antarctic waters and
processed by cooking, drying, and milling to yield whole Antarctic
krill meal. The manufacture of defatted Antarctic krill meal includes
an additional step of lipid extraction with ethanol. Residual ethanol
in the krill biomass is removed by evaporation, yielding defatted
Antarctic krill meal. The petition requests approval of the whole
Antarctic krill meal and the defatted form of Antarctic krill meal for
use as a color additive in salmonid feed.
The primary coloring component in Antarctic krill meal is
astaxanthin. Astaxanthin is an oxygenated carotenoid (xanthophyll) with
the chemical name 3,3'-dihydroxy-[beta], [beta]-carotene-4,4'-dione and
may consist of cis, trans, and optical isomers. Astaxanthin is found as
the mono- and di-astaxanthin esters and as free astaxanthin.
Astaxanthin is present at levels of 80 to 170 mg/kg in the whole
Antarctic krill meal and 10 to 90 mg/kg in the defatted Antarctic krill
meal, calculated as free astaxanthin (Ref. 1).
Ethoxyquin, an additive approved for use in animal feed, may be
added as a stabilizer to whole Antarctic krill meal. Under Sec.
573.380 (21 CFR 573.380), ethoxyquin may be safely used in fish feeds
as a chemical preservative to retard the oxidation of xanthophylls at a
level not to exceed 150 parts per million (150 ppm) in the treated
article. The petition proposes the optional addition of ethoxyquin into
whole Antarctic krill meal at levels up to 250 mg/kg (250 ppm). When
the whole krill meal is formulated with other fish feed ingredients up
to a maximum level of 12 percent by weight in feed for marine salmonids
and 4 percent by weight in feed for freshwater salmonids to produce a
finished feed, the concentration of ethoxyquin from the whole krill
meal in the finished feed would be no more than 30 ppm and 10 ppm,
respectively.
III. Safety Evaluation
Under section 721(b)(4) of the FD&C Act, a color additive may not
be listed for a proposed 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 establishing with reasonable
certainty that no harm will result from the intended use of the color
additive. As part of our safety evaluation to establish with reasonable
certainty that a color additive is not harmful under its intended
conditions of use, we consider the additive's manufacturing and
stability; the projected human dietary exposure to the additive and any
impurities resulting from the petitioned use of the additive; the
additive's toxicological data; and other relevant information (such as
published literature) available to us.
Because consumers are not directly exposed to Antarctic krill meal,
FDA focused its review on the safety of the substances present in
Antarctic krill meal that are deposited in the consumable portions of
the fish. We considered the safety of astaxanthin, which is already
approved for use in the feed of salmonid fish, as well as the safety of
other components found in Antarctic krill meal at levels higher than
that in other fish meals, for which Antarctic krill meal is intended to
serve as a replacement in salmonid feed. Target animal safety was also
evaluated for the salmonids consuming the Antarctic krill meal. Our
review was based on the petitioned use in salmonid feed and on human
consumption of the consumable portions of these salmonids.
IV. Safety of Petitioned Use of the Color Additive
A. Exposure Estimate
Astaxanthin is found in wild salmonids and is the principal pigment
that imparts the pink or red coloring characteristic of the flesh of
these fish. As referenced above, astaxanthin is currently approved for
use as a color additive in the feed of salmonid fish at levels not to
exceed 80 mg/kg of the finished feed. Antarctic krill meal is not
intended to be the sole source of pigmentation in salmonid feed, and
other permitted sources of astaxanthin may be added in order to achieve
the desired level of coloration in the fish flesh. The quantity of
astaxanthin in the finished feed contributed by Antarctic krill meal
when used under the intended conditions of use, alone or in combination
with other permitted sources of astaxanthin, is not to exceed 80 mg/kg
astaxanthin. Therefore, the exposure to astaxanthin from the petitioned
use of Antarctic krill meal is substitutional for the currently
approved uses of astaxanthin, and there would be no increase in human
exposure to astaxanthin from this use (Ref. 2).
Additionally, we considered the exposure to astaxanthin from the
consumption of wild salmon and the exposure to astaxanthin from the
consumption of farm-raised salmonid fish that have been fed approved
color additive sources of these carotenoids to be comparable. We
conclude that the petitioned use of Antarctic krill meal will not
increase the exposure to astaxanthin (Ref. 3).
The petition notes that Antarctic krill meal contains higher levels
of fluoride than are present in the fish meal it is intended to
partially replace. The petitioner indicated that salmonids that consume
a relatively high dietary concentration of fluoride from the petitioned
use of Antarctic krill meal may exhibit elevated levels of fluoride in
the kidney and bones, but no significant accumulation in the edible
tissues (muscle meat and skin) is anticipated. The petitioner indicated
that canned salmon may contain bones from the fish that could be
consumed by humans. Therefore, we considered fluoride exposure to
humans from the consumption of canned salmon (Ref. 2).
B. Toxicological Considerations
To support the safety of the petitioned use of the subject color
additive, including astaxanthin, the petitioner noted that
synthetically produced and naturally derived astaxanthin has been
previously approved for safe use as a color additive in salmonid feed.
The petitioner noted that the astaxanthin in Antarctic krill meal
occurs in the same optical isomer distribution as is found in wild
salmon and in the naturally occurring astaxanthin coloring additives
currently permitted for use in salmonid feed. In previous safety
evaluations of other sources of astaxanthin, FDA concluded that the
esterified forms of astaxanthin that are present in Antarctic krill
meal present no additional safety concerns as compared to free
astaxanthin because they are converted to the free form during
digestion in the fish (Refs. 4 and 5).
The petitioner noted that Antarctic krill meal contains a higher
level of
[[Page 27934]]
fluoride than is typically present in the fish meal it is intended to
partially replace. The petitioner indicated that salmonids that consume
an increased dietary concentration of fluoride from the petitioned use
of Antarctic krill meal may exhibit elevated levels of fluoride in the
kidney and bones. However, no significant accumulation of fluoride in
the edible tissues (muscle meat and skin) is anticipated. FDA
considered a possible increase in human fluoride exposure due to the
consumption of fish fed a diet containing Antarctic krill meal. We
concluded that we have no safety concerns regarding the level of
fluoride when humans are consuming the flesh of salmonids fed feed
containing Antarctic krill meal or when humans are consuming canned
salmon made from these fish (Ref. 4).
Regarding the target animal safety of the Antarctic krill meal, the
petitioner included data and literature references addressing
nutrition, astaxanthin content, and fluoride content of Antarctic krill
meal when fed to salmonids. These studies did not reveal any toxicity
to the target fish species (Ref. 3).
Based on the substitutional exposure to astaxanthin, the safety of
astaxanthin to humans and the target fish species, and our
consideration of the fluoride content of the additive, we conclude
there is a reasonable certainty of no harm to humans or to the target
fish species from the proposed use of Antarctic krill meal.
V. Labeling Requirements
In accordance with Sec. 70.25 (21 CFR 70.25), all color additives
must be labeled with sufficient information to assure their safe use
and to allow a determination of compliance with any limitations imposed
by FDA in other applicable regulations. Therefore, the labeling of the
color additive, Antarctic krill meal, and any mixture prepared
therefrom, is subject to the requirements of Sec. 70.25.
Under Sec. 70.25(a)(4), an expiration date for a color additive
must be stated on its label if stability data require it. The
petitioner determined the stability of astaxanthin as a color additive
in the product to be approximately 12 months. Although the effect of
imparting color may be attenuated after 12 months, the degradation of
the astaxanthin-based coloring components does not form any new
substances of toxicological concern. FDA finds that because of the
potential impact on the stability of astaxanthin in Antarctic krill
meal after 12 months, an expiration date must be stated on the label of
sealed and open containers, in accordance with Sec. 70.25(a)(4).
In addition to the requirements for labeling the color additive or
color additive mixture, the ingredient list on fish feed, to which
Antarctic krill meal is added, must identify the presence of the color
additive under Sec. 501.4 (21 CFR 501.4). The new regulation, Sec.
73.32(d)(2) (21 CFR 73.32(d)(2)), references Sec. 501.4 to ensure that
the presence of Antarctic krill meal as a color additive in the fish
feed will be declared on the ingredient label.
The presence of the color additive must be declared on the label of
any food. This is to include a declaration on the label of salmonid
fish fed feed containing added Antarctic krill meal and on the label of
food containing such salmonid fish as an ingredient. Our regulations,
at Sec. 101.22(b) (21 CFR 101.22(b)), require a food that bears or
contains artificial coloring, such as salmon artificially colored with
Antarctic krill meal, to bear labeling even though such food is not in
package form. Section 101.22(c) requires that label statements of
artificial coloring be likely to be read by the ordinary person under
customary conditions of purchase and use of such food. Furthermore,
Sec. 101.22(k)(2) requires, in the statement of ingredients for a food
to which any coloring has been added, and for which the coloring is not
subject to certification, a declaration that makes it clear that a
color additive has been used in the food. In addition, the presence of
a color additive in a food received in a bulk container that is held at
a retail establishment must be declared on the labeling of the bulk
container or on a counter card or other similar device under Sec.
101.100(a)(2) (21 CFR 101.100(a)(2)). The ingredient label would alert
the consumer that the fish is artificially colored. Without such
ingredient labeling, food comprising salmonid fish fed feed with added
Antarctic krill meal would be deemed to be misbranded under section
403(k) of the FD&C Act (21 U.S.C. 343(k)), which states that a food
shall be deemed to be misbranded if it bears or contains any artificial
flavoring, artificial coloring, or chemical preservative, unless it
bears labeling stating that fact.
Therefore, in accordance with Sec. Sec. 101.22(b), (c), and (k)(2)
and 101.100(a)(2), labeling on any salmonid fish fed feed with added
Antarctic krill meal is required to declare the presence of the color
additive or color additive mixture. The new regulation, at Sec.
73.32(d)(3), references Sec. Sec. 101.22(b), (c), and (k)(2) and
101.100(a)(2) to ensure that, at the retail level, the presence of
Antarctic krill meal as a color additive in the fish will be declared,
and that the labeling of the bulk fish container, including a list of
ingredients, will be displayed on the container or on a counter card
with similar information.
VI. Conclusion
Based on the data and information in the petition and other
available relevant information, we conclude that the petitioned use of
Antarctic krill meal, for use as a color additive is safe to the target
fish species and to humans who consume this fish, at levels not to
exceed 4 percent (w/w) in feed for freshwater salmonids and 12 percent
(w/w) in feed for marine salmonids. We further conclude that this color
additive will achieve its intended technical effect and is suitable for
the petitioned use. Therefore, we are amending the color additive
regulations in part 73 to provide for the safe use of this color
additive as set forth in this document. In addition, based on the
factors in 21 CFR 71.20(b), we conclude that batch certification of
Antarctic krill meal is not necessary to protect the public health.
VII. 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.
VIII. Analysis of Environmental Impact
We have carefully considered the potential environmental effects of
this action. FDA has concluded that the action will not have a
significant impact on the human environment and that an environmental
impact statement is not required (Ref. 6). FDA's finding of no
significant impact and the evidence supporting that finding, contained
in an environmental assessment, may be seen in the Dockets Management
Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
IX. 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.
X. 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
[[Page 27935]]
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.
XI. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. We will publish notice of the objections that we
have received or lack thereof in the Federal Register.
XII. 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 Friday; they are also
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
1. Memorandum from E. Miranda-Bermudez, Color Technology Branch,
Division of Color Certification and Technology (DCCT), Office of
Cosmetics and Colors (OCAC), Center for Food Safety and Applied
Nutrition (CFSAN), FDA to S. DiFranco, Division of Food Ingredients
(DFI), Office of Food Additive Safety (OFAS), CFSAN, FDA, March 14,
2020.
2. Memorandum from D. Doell, Chemistry Review Team, DFI, OFAS,
CFSAN, FDA to S. DiFranco, DFI, OFAS, CFSAN, FDA, March 11, 2020.
3. Memorandum from L. Post, Target Animal Review, Division of
Animal Feeds, Office of Surveillance and Compliance, Center for
Veterinary Medicine, FDA to S. DiFranco, DFI, OFAS, CFSAN, FDA, July
30, 2019.
4. Memorandum from T. Thurmond, Toxicology Review Team, DFI,
OFAS, CFSAN, FDA to S. DiFranco, DFI, OFAS, CFSAN, FDA, March 14,
2020.
5. Memorandum from T. Thurmond, Toxicology Review Team, Division
of Petition Review (DPR), OFAS, CFSAN, FDA to F. Ellison, DPR, OFAS,
CFSAN, FDA, February 3, 2009.
6. Memorandum from M. Pfeil, Environmental Review Team, Division
of Science and Technology, OFAS, CFSAN, FDA to S. DiFranco, DFI,
OFAS, CFSAN, FDA, March 23, 2020.
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. Add Sec. 73.32 to read as follows:
Sec. 73.32 Antarctic krill meal.
(a) Identity. (1) The color additive Antarctic krill meal consists
of the cooked, dried, and ground biomass of whole Euphausia superba
(Antarctic krill), with or without removal of the lipid fraction. The
lipid fraction may be fully or partially extracted with ethanol,
followed by removal of residual ethanol, to produce defatted Antarctic
krill meal. Whole Antarctic krill meal, produced when the lipid
fraction is not removed, may contain ethoxyquin as a preservative.
(2) Color additive mixtures for fish feed use made with Antarctic
krill meal may contain only those diluents that are suitable and are
listed in this subpart as safe for use in color additive mixtures for
coloring foods.
(b) Specifications. Antarctic krill meal 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) Physical state, solid.
(2) Ethoxyquin, not more than 250 milligrams per kilogram (mg/kg)
(250 parts per million (ppm)) in whole Antarctic krill meal.
(3) Lead, not more than 2 mg/kg (2 ppm).
(4) Arsenic, not more than 5 mg/kg (5 ppm).
(5) Mercury, not more than 1 mg/kg (1 ppm).
(6) Cadmium, not more than 2 mg/kg (2 ppm).
(7) Fluoride, not more than 2,500 mg/kg (2,500 ppm).
(8) Astaxanthin, not more than 170 mg/kg (170 ppm) in whole
Antarctic krill meal; not more than 90 mg/kg (90 ppm) in defatted
Antarctic krill meal.
(c) Uses and restrictions. Antarctic krill meal may be safely used
in salmonid feed in accordance with the following prescribed
conditions:
(1) The color additive is used to enhance the pink to orange-red
color of the flesh of salmonid fish;
(2) The color additive may be used at levels not to exceed 4
percent by weight in freshwater salmonid feed and 12 percent by weight
in marine salmonid feed;
(3) The quantity of the color additive incorporated in the feed is
such that the finished feed meets the tolerance limitation for
ethoxyquin in animal feed prescribed in Sec. 573.380 of this chapter;
and
(4) The quantity of astaxanthin in the finished feed, from
Antarctic krill meal when used alone or in combination with other
astaxanthin color additive sources listed in this part, must not exceed
80 mg/kg astaxanthin (72 grams per ton) in the finished feed.
(d) Labeling requirements. (1) The labeling of the color additive
and any
[[Page 27936]]
premixes prepared therefrom must bear expiration dates for the sealed
and open container (established through generally accepted stability
testing methods), other information required by Sec. 70.25 of this
chapter, a statement of the concentration of ethoxyquin contained
therein (whole Antarctic krill meal only), and adequate directions to
prepare a final product complying with the limitations prescribed in
paragraph (c) of this section.
(2) The presence of the color additive in finished fish feed
prepared according to paragraph (c) of this section must be declared in
accordance with Sec. 501.4 of this chapter.
(3) The presence of the color additive in salmonid fish that have
been fed feeds containing Antarctic krill meal must be declared in
accordance with Sec. Sec. 101.22(b), (c), and (k)(2) and 101.100(a)(2)
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: May 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10025 Filed 5-9-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on May 10, 2022.
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