Rule2025-08250
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 12, 2025
Effective
June 26, 2025
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 galdieria extract blue, derived from unicellular red algae (Galdieria sulphuraria), in various food categories at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Fermentalg (Fermentalg or petitioner).
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<title>Federal Register, Volume 90 Issue 90 (Monday, May 12, 2025)</title>
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[Federal Register Volume 90, Number 90 (Monday, May 12, 2025)]
[Rules and Regulations]
[Pages 20104-20108]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08250]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2021-C-0925]
Listing of Color Additives Exempt From Certification; Galdieria
Extract Blue
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; order.
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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 galdieria
extract blue, derived from unicellular red algae (Galdieria
sulphuraria), in various food categories at levels consistent with good
manufacturing practice (GMP). We are taking this action in response to
a color additive petition (CAP) submitted by Fermentalg (Fermentalg or
petitioner).
DATES: This order is effective June 26, 2025. See section XI of this
document for further information on the filing of objections. Either
electronic or written objections and requests for a hearing on the
order must be submitted by June 11, 2025.
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 objections until 11:59 p.m. Eastern Time at the end of June
11, 2025. 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:
<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 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-2021-C-0925 for ``Listing of Color Additives Exempt from
Certification; Galdieria Extract Blue.'' 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
[[Page 20105]]
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: Stephanie A. Hice, Office of Food
Chemical Safety, Dietary Supplements, and Innovation, Human Foods
Program, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 301-348-1740 or Keronica Richardson, Office of Policy,
Regulations, and Information, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Introduction
In the Federal Register of September 9, 2021 (86 FR 50495), FDA
announced that we filed a color additive petition (CAP 1C0320)
submitted by Fermentalg, 4 Rue Rivi[egrave]re, 33500 Libourne, France.
The petition proposed that FDA 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 galdieria extract blue
as a color additive at levels consistent with GMP in: non-alcoholic
beverages and beverage bases, fruit drinks, fruit smoothies, fruit
juices, vegetable juices, dairy-based smoothies, milk shakes and
flavored milks, yogurt drinks, milk-based meal replacement and
nutritional beverages, breakfast cereal coatings, hard candy, soft
candy and chewing gum, flavored frostings, ice cream and frozen dairy
desserts, frozen fruits, water ices and popsicles, gelatin desserts,
puddings and custards, whipped cream, yogurt, frozen or liquid creamers
(including non-dairy alternatives), and whipped toppings (including
non-dairy alternatives). (In the filing notice for CAP 1C0320, the
color additive was called ``blue galdieria extract.'' After the filing
notice was published, the name was changed to ``galdieria extract
blue.'')
II. Background
Galdieria extract blue is a blue liquid or powder prepared from the
aqueous extraction of the dried biomass of Galdieria sulphuraria, a
naturally occurring species of red microalgae. Galdieria extract blue
contains C-phycocyanin, the principal coloring component, and may
contain authorized food-grade carriers and antioxidants to standardize
the color intensity and stabilize the color additive.
Production of the G. sulphuraria biomass is carried out by
heterotrophic fermentation with no reported instances of pathogenicity
or toxigenicity. The petitioner states that the production strain was
deposited in the Culture Collection of Algae and Protozoa, Scottish
Marine Institute, in Dunbeg, Oban, Scotland. Using a fed-batch or
continuous process for providing the fermentation medium, the
production strain is contained in an enclosed fermentation vessel,
which avoids potential contamination by bacteria, cyanobacteria, fungi,
or environmental contaminants such as heavy metals and pesticides that
could otherwise be encountered in open ponds.
The finished biomass is concentrated, washed with water to remove
the majority of culture medium and antifoam agent, mechanically lysed,
and subjected to extraction with water, which results in a crude
extract. The crude extract consists of a mixture of C-phycocyanin and
other water-soluble proteins, minerals, and carbohydrates, which is
then treated with a carbohydrase enzyme that digests the carbohydrates.
The resulting extract is purified with consecutive filtrations and can
be in a liquid form, or in a powdered form using spray-drying or other
drying technologies (Ref. 1).
The petitioner proposed the following specifications for galdieria
extract blue: lead, not more than 0.5 milligram/kilogram (mg/kg) (0.5
part per million (ppm)); cadmium, not more than 1 mg/kg (1 ppm);
arsenic, not more than 0.5 mg/kg (0.5 ppm); mercury, not more than 0.05
mg/kg (0.05 ppm). FDA has determined that the petitioner's data support
that lead, cadmium, and arsenic should all have a specification of not
more than 0.5 mg/kg. The petitioner's data support a specification of
not more than 0.05 mg/kg for mercury (Ref. 1).
III. Safety Evaluation
Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive may not be listed
for a proposed use unless the data and other 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.
To determine whether a color additive is safe under the general
safety clause, the FD&C Act requires FDA to conduct a fair evaluation
of the available data and consider, among other relevant factors: (1)
probable consumption of, or other relevant exposure from, the additive
and of any substance formed in or on food, drugs, devices, or cosmetics
because of the use of the additive; (2) cumulative effect, if any, of
such additive in the diet of man or animals, taking into account
chemically or pharmacologically related substance or substances in such
diet; and (3) safety factors recognized by experts as appropriate for
the use of animal experimentation data (see section 721(b)(5)(A)(i)
through (iii) of the FD&C Act).
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.
IV. Safety of the Petitioned Use of the Color Additive
A. Dietary Exposure Estimate
The petitioner provided information on the proposed food categories
and the corresponding maximum use levels of galdieria extract blue as a
color additive that represent levels consistent with GMP for each
proposed food category (Ref. 2). The petitioner used food consumption
data from the 2017-2018 National Health and Nutrition Examination
Survey (NHANES) to
[[Page 20106]]
estimate the dietary exposure to galdieria extract blue from the
petitioned uses. The petitioner estimated the eaters-only (i.e., only
those individuals in the population that consume the foods of interest)
dietary exposure to galdieria extract blue to be 273 mg/person/day (mg/
p/d) at the mean and 630 mg/p/d at the 90th percentile for the U.S.
population aged 2 years and older; and 261 mg/p/d at the mean and 575
mg/p/d at the 90th percentile for children aged 2-5 years (Ref. 2).
The petitioner indicated that the typical level of C-phycocyanin in
galdieria extract blue is 34 percent. FDA estimated the dietary
exposure to C-phycocyanin by multiplying the dietary exposure to
galdieria extract blue by the typical C-phycocyanin level of 34
percent, resulting in an estimated eaters-only dietary exposure to the
principal coloring component from the petitioned uses to be 93 mg/p/d
at the mean and 214 mg/p/d at the 90th percentile for the U.S.
population aged 2 years and older; and 89 mg/p/d at the mean and 196
mg/p/d at the 90th percentile for children aged 2-5 years (Ref. 2).
The petitioner stated that galdieria extract blue will likely be
used in the petitioned food categories as a substitute for spirulina
extract, a related C-phycocyanin-based color additive derived from
Arthrospira platensis. Given that galdieria extract blue will likely be
used in the petitioned food categories as a substitute for spirulina
extract, and given the structural similarity of the phycocyanobilin
chromophores in these two sources, we would not expect an increase in
the current upper-bound cumulative estimated daily intake (CEDI) for C-
phycocyanin of 1140 mg/p/d in the U.S. diet from the petitioned uses of
galdieria extract blue. Therefore, the current upper-bound CEDI of C-
phycocyanin encompasses the petitioned uses of galdieria extract blue
(Ref. 2).
B. Toxicological Considerations
To support the safety of the petitioned use of galdieria extract
blue, the petitioner provided peer-reviewed studies, data derived from
publicly available databases, and referenced previously submitted color
additive petitions. The data and information provided included: (1) the
results of a subchronic (90-day rat) toxicology study on the G.
sulphuraria C-phycocyanin extract and the G. sulphuraria biomass, (2)
two genotoxicity assays (bacterial reverse mutation test and in vitro
micronucleus test), (3) a safety narrative that discusses the results
of their safety assessment of the color additive, (4) a narrative that
discusses the current published literature that supports the safe use
of the color additive, and (5) a discussion on FDA's previous reviews
of color additive petitions regarding the safety of C-phycocyanin (78
FR 49117, August 13, 2013; 79 FR 20095, April 11, 2014; 82 FR 30731,
July 3, 2017). The petitioner also addressed the potential for
allergenicity associated with the color additive (Ref. 3).
The petitioner included data from a 90-day subchronic study that
used multiple doses of galdieria extract blue. The study also included
a post-treatment recovery period of 28 days to facilitate evaluation of
the persistence, reversibility, or delayed occurrence of toxic effects.
C-phycocyanin extract derived from Spirulina platensis (reclassified as
A. platensis) was used as a reference test item, for a period of 90
days with the same dosing procedure as for galdieria extract blue. The
petitioner reported no instances of mortality among the animals treated
with galdieria extract blue or C-phycocyanin extract derived from A.
platensis throughout the study. All control animals and treated animals
survived during the treatment period of 90 days and during the 28-day
recovery period. No gross treatment-related changes were observed at
necropsy. FDA identified no major deficiencies that would invalidate
the study results for its intended purpose, and no results from this
study suggest that galdieria extract blue produces adverse effects for
any of the parameters evaluated during the study. The petitioner
concluded that under the test conditions, the no observed adverse
effect level (NOAEL) for galdieria extract blue was the highest dose
tested, 4000 mg/kg body weight (bw)/d (Ref. 3).
The petitioner also included data from a 90-day subchronic study
that used multiple doses of the G. sulphuraria biomass. Following
completion of the study, the petitioner stated that the G. sulphuraria
biomass was well-tolerated at all dose levels with no mortality or
toxicity observed. The petitioner concluded that under the test
conditions, the NOAEL for the G. sulphuraria biomass was the highest
dose tested, 5000 mg/kg bw/d (Ref. 3).
An Ames test (bacterial reverse mutation test) and an in vitro
micronucleus test were also conducted on both galdieria extract blue
and the G. sulphuraria biomass. Following completion of the studies,
the petitioner concluded that the test items did not show any mutagenic
activity in the Ames test, and that the in vitro micronucleus test
demonstrated no statistically significant increase in micronucleated
cells. Based on the data submitted by the petitioner, FDA agrees with
the petitioner's findings that galdieria extract blue was not a mutagen
in the Ames test under the conditions of the assay, nor did it induce
chromosomal damage under the conditions of the micronucleus test.
The petitioner's discussion of the potential allergenicity of C-
phycocyanin included a pepsin gastric simulation assay, a
bioinformatics analysis of potential proteins encoded in the genome DNA
of G. sulphuraria that could be associated with allergenicity, and the
results of petitioner's literature search. The results of the pepsin
gastric simulation assay indicated that C-phycocyanin derived from G.
sulphuraria is likely to undergo rapid degradation under normal
digestive conditions, suggesting that it may be non-allergenic. The
results of the bioinformatic analysis only identified sequences from
highly conserved gene families, and these sequences demonstrated lower
similarity to G. sulphuraria proteins than to members of the same gene
family in common foodstuffs. Therefore, the color additive is proposed
to have low allergenic risk. The petitioner's literature search
identified one case report of an atopic person having an anaphylactic
reaction to C-phycocyanin derived from A. platensis. The petitioner
considered the response to be idiosyncratic; no other reports of a
similar reaction to C-phycocyanin were identified. Given the results of
the pepsin gastric simulation assay, the bioinformatic analysis, and
the search of the literature, we concur with the petitioner's
conclusion that galdieria extract blue is unlikely to produce an
allergic reaction and find no additional data suggesting galdieria
extract blue is associated with allergic or hypersensitivity reactions
(Ref. 3).
The petitioner's safety narrative included a structural comparison
of C-phycocyanin from G. sulphuraria and C-phycocyanin from A.
platensis, noting that C-phycocyanins from G. sulphuraria and A.
platensis belong to the same C-phycocyanin family and stated that their
primary sequences of the protein backbone are highly similar, with no
significant differences between their 3-dimensional organizations. The
petitioner stated that, despite amino acid differences between the two
C-phycocyanins, the differences did not seem to affect any of the
molecular recognition properties of the C-phycocyanins, neither in
their structural organization nor in the chromophore binding, and
therefore, the functional properties are likely to be similar (Ref. 3).
[[Page 20107]]
Based on our review of the safety data provided by the petitioner,
and our independent review of the current published literature, which
do not present evidence of safety concerns for galdieria extract blue
at the expected dietary exposures, and given that the estimated 90th
percentile dietary exposure for the color additive for the U.S.
population aged 2 years and older (630 mg/p/d) does not exceed the
NOAEL of 4000 mg/kg bw/d, we conclude that galdieria extract blue is
safe for the petitioned uses.
VI. Conclusion
Based on the data and information in the petition and other
available relevant information, we conclude that the petitioned use of
galdieria extract blue as a color additive in non-alcoholic beverages
and beverage bases, fruit drinks, fruit smoothies, fruit juices,
vegetable juices, dairy-based smoothies, milk shakes and flavored
milks, yogurt drinks, milk-based meal replacement and nutritional
beverages, breakfast cereal coatings, hard candy, soft candy and
chewing gum, flavored frostings, ice cream and frozen dairy desserts,
frozen fruits, water ices and popsicles, gelatin desserts, puddings and
custards, whipped cream, yogurt, frozen or liquid creamers (including
non-dairy alternatives), and whipped toppings (including non-dairy
alternatives) is safe, provided the amount of galdieria extract blue
does not exceed levels consistent with GMP.
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 galdieria extract blue is not
necessary to protect the public health.
This final order is expected to result in expanded production
options and is considered an E.O. 14192 deregulatory action.
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
As we stated in the September 9, 2021, Federal Register
notification of petition for CAP 1C0320 (86 FR 50495 at 50495 to
50496), the petitioner claimed that this action is categorically
excluded under Sec. 25.32(r) (21 CFR 25.32(r)) because the substance
occurs naturally in the environment, and the proposed action does not
significantly alter the concentration or distribution of the substance,
its metabolites, or degradation products in the environment, and that,
to their knowledge, no extraordinary circumstances exist that would
warrant at least an environmental assessment (see Sec. 25.21 (21 CFR
25.21)). We did not receive any new information or comments regarding
this claim of categorical exclusion. We considered the petitioner's
claim of categorical exclusion and determined that this action is
categorically excluded under Sec. 25.32(r). Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IX. Paperwork Reduction Act of 1995
This order 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 (21 U.S.C. 379e). This order is not a statement regarding
compliance with other sections of the FD&C Act. For example, section
301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction
or delivery for introduction into interstate commerce of any food that
contains a drug approved under section 505 of the FD&C Act (21 U.S.C.
355), a biological product licensed under section 351 of the Public
Health Service Act (42 U.S.C. 262), or a drug or biological product for
which substantial clinical investigations have been instituted and
their existence has been made public, unless one of the exemptions in
section 301(ll)(1) to (4) of the FD&C Act applies. In our review of
this petition, we did not consider whether section 301(ll) of the FD&C
Act or any of its exemptions apply to food containing this color
additive. Accordingly, this order 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 orders 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 order 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>. 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,
Office of the Chief Scientist, FDA to S. Hice, Innovative Foods
Staff (IFS), Office of Food Chemical Safety, Dietary Supplements,
and Innovation (OFCSDSI), Human Foods Program (HFP), FDA, April 28,
2025.
[[Page 20108]]
2. Memorandum from H. Lee, Chemistry Evaluation Branch, DFI, Office
of Pre-Market Additive Safety (OPMAS), OFCSDSI, HFP, FDA to S. Hice,
IFS, OFCSDSI, HFP, FDA, April 28, 2025.
3. Memorandum from S. Thurmond, Toxicology Review Branch, DFI,
OPMAS, OFCSDSI, HFP, FDA to S. Hice, IFS, OFCSDSI, HFP, FDA, April
28, 2025.
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 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. 73.167 to subpart A to read as follows:
Sec. 73.167 Galdieria extract blue.
(a) Identity. (1) The color additive galdieria extract blue is a
liquid or powder prepared by the filtered aqueous extraction of the
dried biomass of a non-pathogenic and non-toxigenic strain of Galdieria
sulphuraria. The biomass is prepared by heterotrophic fermentation of
G. sulphuraria. The color additive contains C-phycocyanin as the
principal coloring component.
(2) Color additive mixtures for food use made with galdieria
extract blue 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. Galdieria extract blue must conform to the
following specifications and must be free from impurities, other than
those named, to the extent that such other impurities may be avoided by
good manufacturing practice:
(1) Lead, not more than 0.5 milligram/kilogram (mg/kg) (0.5 parts
per million (ppm)).
(2) Arsenic, not more than 0.5 mg/kg (0.5 ppm).
(3) Mercury, not more than 0.05 mg/kg (0.05 ppm).
(4) Cadmium, not more than 0.5 mg/kg (0.5 ppm).
(c) Uses and restrictions. Galdieria extract blue may be safely
used for coloring non-alcoholic beverages and beverage bases, fruit
drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based
smoothies, milk shakes and flavored milks, yogurt drinks, milk-based
meal replacement and nutritional beverages, breakfast cereal coatings,
hard candy, soft candy and chewing gum, flavored frostings, ice cream
and frozen dairy desserts, frozen fruits, water ices and popsicles,
gelatin desserts, puddings and custards, whipped cream, yogurt, frozen
or liquid creamers (including non-dairy alternatives), and whipped
toppings (including non-dairy alternatives), at levels consistent with
good manufacturing practice, except that it may not be used to color
foods for which standards of identity have been issued under section
401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the
added color is authorized by such standards.
(d) Labeling. The label of the color additive and of any mixture
prepared therefrom intended solely or in part for coloring purposes
must conform to the requirements of Sec. 70.25 of this chapter.
(e) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health, and
therefore batches thereof are exempt from the certification
requirements of section 721(c) of the Federal Food, Drug, and Cosmetic
Act.
Dated: May 6, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08250 Filed 5-9-25; 8:45 am]
BILLING CODE 4164-01-P
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