```

[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Rules and Regulations]
[Pages 5590-5594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01239]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2022-C-0098]

Listing of Color Additives Exempt From Certification; Myoglobin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
color additive regulations to provide for the safe use of myoglobin as 
a color additive in ground meat and ground poultry analogue products. 
We are taking this action in response to a color additive petition 
(CAP) submitted by Motif FoodWorks, Inc. (Motif FoodWorks or 
petitioner).

DATES: This order is effective February 19, 2025. See section X 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 February 18, 2025.

ADDRESSES: You may submit objections and requests for a hearing as 
follows.

[[Page 5591]]

Please note that late, untimely filed objections will not be 
considered. The https://www.regulations.gov electronic filing system 
will accept comments until 11:59 p.m. Eastern Time at the end of 
February 18, 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:
     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-2022-C-0098 for ``Listing of Color Additives Exempt From 
Certification; Myoglobin.'' 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 with the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections only as a written/paper submission. 
You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The 
Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management 
Staff. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Ellen Anderson, Office of Pre-market 
Additive Safety, Human Foods Program, Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740-3835, 240-402-1309 or Keronica 
Richardson, Office of Policy, Regulations, and Information, Human Foods 
Program, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1262.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a document published in the Federal Register of February 14, 
2022 (87 FR 8222), we announced that FDA filed a color additive 
petition (CAP 2C0322) submitted by Motif FoodWorks, Inc., 27 Drydock 
Ave., 2nd Floor, Boston, MA 02210. 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 myoglobin as a color additive in ground meat and ground poultry 
analogue products where the amount of myoglobin protein does not exceed 
2 percent by weight of the uncooked analogue product.
    The petition used the terms ``analogue'' and ``alternative'' 
interchangeably to describe the type of food products in which the 
color additive is intended for use. This order will use the phrase 
``ground meat and ground poultry analogue products,'' which refers to 
plant-based ground meat- and poultry-like food products, such as 
patties, sausages, links, and nuggets, subject to FDA regulation. (The 
petitioned use of this color additive does not include use in cell-
cultured meat and poultry products under regulatory authority of the 
United States Department of Agriculture.)
    The petition described myoglobin protein as the characterizing 
coloring component of a stabilized liquid mixture that imparts a red to 
pink coloration in uncooked ground meat and ground poultry analogue 
products to give an appearance similar to raw meat and poultry. The 
petition referred to the color additive as ``myoglobin'' or ``myoglobin 
preparation.'' For the purposes of this order, we refer to ``myoglobin 
preparation'' as the stabilized liquid mixture that contains myoglobin 
protein and note that ``myoglobin'' and ``myoglobin preparation'' are 
used interchangeably to refer to this color additive. We are 
establishing ``myoglobin'' as the common or usual name for this color 
additive.

II. Background

    The color additive that is the subject of this petition is the 
stabilized product of controlled fermentation of a non-pathogenic and 
non-toxicogenic strain of the yeast, Komagataella phaffii (K. phaffii), 
genetically engineered to express myoglobin protein, the principal 
coloring component. Although the organism is referred to as Pichia 
pastoris (P. pastoris) throughout the petition, we note that the 
nomenclature for P. pastoris was reassigned based on genetic typing to 
Komagataella phaffii. (Ref. 1). We are referring to the organism 
hereafter as K. phaffii to reflect the current taxonomic identity.
    The color additive is manufactured by the following steps: (1) 
construction of the K. phaffii production strain that is

[[Page 5592]]

genetically engineered to express a synthetic myoglobin gene from Bos 
taurus; (2) expression of myoglobin protein via submerged fed-batch 
fermentation by the K. phaffii production strain; (3) disruption of the 
K. phaffii cells by mechanical shearing to release myoglobin protein 
and removal of the K. phaffii cells by washing, lysing, centrifugation, 
and microfiltration; (4) ultrafiltration to concentrate the myoglobin 
protein; and (5) stabilization of the expressed protein as a liquid 
preparation. The gene that is inserted into the K. phaffii is generated 
by DNA synthesis and is not obtained directly from the DNA of Bos 
taurus. The amino acid sequence of the expressed myoglobin protein is 
identical to bovine myoglobin protein that has a history of being 
safely consumed.
    Based on information in the petition, the myoglobin preparation has 
a moisture content of >=92.5 percent, a myoglobin protein content of 
>=3 percent, and may contain stabilizers, preservatives, and 
antimicrobial agents such as sodium phosphate, sodium ascorbate, and 
sodium chloride. The color additive is stored as a frozen liquid. FDA 
concurs with the petitioner that the genetic modifications made to 
generate the non-toxigenic and non-pathogenic production strain are 
well-characterized and the production process conforms to good 
manufacturing practice (Ref. 2). We are requiring a specification for 
the minimum purity of myoglobin protein as a percent of the total 
protein in the color additive and a specification limit for lead. The 
petitioner provided analytical data from the analyses of five lots of 
myoglobin preparation showing that the color additive can be 
manufactured to meet these specifications.
    We have previously considered the safety of myoglobin preparation 
based on a submission from Motif FoodWorks, to which we had no 
questions, that the use of myoglobin preparation to impart flavor and 
aroma in ground meat and poultry analogue products is generally 
recognized as safe (GRAS). Under section 201(s) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(s)), a substance is 
GRAS if it is generally recognized, among experts qualified by 
scientific training and experience to evaluate its safety, as having 
been adequately shown through scientific procedures (or, in the case of 
a substance used in food before January 1, 1958, through either 
scientific procedures or experience based on common use in food) to be 
safe under the conditions of its intended use. Under section 201(s) of 
the FD&C Act, a substance that is GRAS for a particular use in food is 
not a food additive and may lawfully be utilized for that use without 
our review and approval. There is no GRAS exemption, however, to the 
definition of a 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)).
    A firm may voluntarily submit to FDA information supporting the 
firm's conclusion that a substance is GRAS for its intended use in food 
through our GRAS Notification Program (see 81 FR 54960, August 17, 
2016). Through this program, a GRAS conclusion was submitted by Motif 
FoodWorks and filed on June 28, 2021, as GRAS Notice 001001(GRN 
001001). This GRN informed FDA that Motif FoodWorks concluded that the 
use of myoglobin preparation at levels providing up to 2 percent 
myoglobin protein to impart flavor and aroma in ground meat and poultry 
analogue products was GRAS. Based on our evaluation of the information 
provided in GRN 001001, as well as other available information, we 
issued a response letter on December 3, 2021, to Motif FoodWorks 
stating that we had no questions regarding its conclusion that 
myoglobin preparation is GRAS for its intended conditions of use. In 
our response letter to Motif FoodWorks, we stated that because 
myoglobin preparation imparts a red coloration when exposed to oxygen 
in some food applications, its use may constitute a color additive use 
under section 201(t)(1) of the FD&C Act and FDA regulations in 21 CFR 
part 70. The specific use of myoglobin preparation to impart a reddish, 
meat-like color to ready-to-cook meat and poultry analogue products is 
important to the appearance and marketability of the analogue products. 
As such, this use of myoglobin preparation requires premarket approval 
as a color additive (see Sec.  70.3(g) (21 CFR 70.3(g))).

III. Safety Evaluation

    Under section 721(b)(4) of the 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 
information available to FDA establish that the color additive is safe 
for that use. Our color additive regulations at Sec.  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.

IV. Safety of Petitioned Use of the Color Additive

A. Dietary Exposure Estimate

    Myoglobin preparation is composed mainly of water, myoglobin 
protein, minor quantities of K. phaffii proteins, ash, fat, 
carbohydrates, and stabilizers and preservatives such as sodium 
phosphate, sodium ascorbate, and/or sodium chloride. During our safety 
review of this color additive petition, we evaluated the dietary 
exposure estimates for the myoglobin preparation, the myoglobin protein 
component, and selected nutrients of the preparation. The petitioner 
provided two sets of dietary exposure estimates. For one set of 
estimates, the petitioner used U.S. food consumption for meat and 
poultry analogue products (e.g., soy burgers, vegetarian hot dogs) from 
the combined 2013 to 2018 National Health and Nutrition Examination 
Survey (NHANES) and assumed these products contained myoglobin 
preparation at use levels that would result in myoglobin protein 
concentrations of 1 percent, 1.5 percent, and 2 percent in the food. 
The petitioner noted that typical use levels of myoglobin protein are 
expected to be 1 to 1.25 percent for most food categories. The 
petitioner estimated the eaters-only dietary exposure to myoglobin 
preparation at the maximum use level of 2 percent myoglobin protein for 
the U.S. population aged 2 years and older to be 43.7 grams/person/day 
(g/p/d) at the mean and 97.6 g/p/d at the 90th percentile. For the 
myoglobin protein, the eaters-only dietary exposure for the U.S. 
population aged 2 years and older was estimated to be 1.3 g/p/d at the 
mean and 2.9 g/p/d at the 90th percentile.
    The petitioner provided a second set of dietary exposure estimates 
based on a use level of 1 percent myoglobin protein and food 
consumption data for conventional ground meat and ground poultry 
products assuming a 1:1 substitution for ground meat and ground poultry 
analogue products. For these estimates, the petitioner selected NHANES 
food codes that represented the most common food applications in which 
myoglobin preparation is expected to be used (i.e., ground patties,

[[Page 5593]]

crumbles, links, bacon, sausage, and meatballs from beef, pork, or 
poultry). The petitioner estimated the mean and 90th percentile eaters-
only dietary exposures to myoglobin protein for the U.S. population 
aged 2 years and older to be 0.7 g/p/d and 1.5 g/p/d, respectively, and 
for ages 2 to 5 years to be 0.3 g/p/d and 0.7 g/p/d, respectively.
    FDA replicated and confirmed the petitioner's two sets of estimates 
of dietary exposure to myoglobin protein and myoglobin preparation. We 
also conducted a third analysis using 2021 per capita food availability 
data for retail beef and poultry in the United States (USDA Economic 
Research Service), the assumption of a 1:1 substitution with meat and 
poultry alternative products, and a use level that provides 2 percent 
myoglobin protein in the food. FDA estimated the dietary exposure to 
myoglobin protein and myoglobin preparation for U.S. consumers to be 
3.9 g/p/d and 129 g/p/d, respectively. We note that dietary exposures 
based on availability data typically overestimate per capita 
consumption because the data do not consider food loss and wastage 
(Ref. 2).
    The petitioner also estimated dietary exposures to iron from the 
petitioned use of the color additive using the first two methods 
described above. Based on NHANES consumption data for ground meat and 
ground poultry analogue products and the maximum intended use level of 
2 percent myoglobin protein, the petitioner estimated the mean and 90th 
percentile eaters-only dietary exposures to iron for the U.S. 
population aged 2 years and older to be 2.0 and 4.5 mg/p/d, 
respectively. Based on a use level of 1 percent myoglobin protein and 
food consumption data for conventional ground meat and ground poultry 
products assuming a 1:1 substitution for ground meat and ground poultry 
analogue products, the petitioner estimated the mean and 90th 
percentile eaters-only dietary exposures to iron for the U.S. 
population aged 2 years and older to be 1.0 and 2.0 mg/p/d, 
respectively, and for ages 2 to 5 years to be 0.5 and 1.0 mg/p/d, 
respectively.

B. Toxicological Considerations

    To establish that myoglobin preparation is safe for use as a color 
additive that provides up to 2 percent myoglobin protein in ground meat 
and ground poultry analogue products, the petitioner used a weight-of-
evidence approach based on the following: (1) the history of widespread 
and safe consumption of bovine myoglobin protein; (2) the safety of K. 
phaffii as a production organism; and (3) an allergenicity assessment 
of myoglobin and K. phaffii proteins.
    Based on our review of this petition (CAP 2C0322), we conclude that 
the proteins in the myoglobin preparation are well defined, nontoxic, 
and not likely to cause an allergenic response when consumed (Ref. 3). 
Because the myoglobin protein expressed in K. phaffii is 100 percent 
identical in amino acid sequence to bovine myoglobin protein, we 
conclude that the history of safe consumption of bovine myoglobin 
protein from ingestion of meat in the diet can be extended to the 
safety of Motif FoodWorks' myoglobin protein. Regarding the K. phaffii 
strain developed by the petitioner for the production of myoglobin 
preparation, we conclude that it is non-toxicogenic and non-pathogenic.
    We agree that the petitioned uses of the color additive are not 
expected to increase the dietary exposure to myoglobin protein and iron 
in the U.S. population, as the consumption of ground meat and poultry 
analogue products are substitutional for conventional ground meat and 
poultry products (Ref. 2). Furthermore, we note that the estimated 90th 
percentile eaters-only dietary exposures to K. phaffii-expressed 
myoglobin protein and iron are well below the Institute of Medicine's 
recommended dietary reference intakes for protein and iron for all age 
groups considered (Ref. 3).
    In its assessment of the allergenicity of myoglobin preparation, 
the petitioner examined the incidence of beef allergy in consumers and 
bioinformatic analyses to determine if the myoglobin and K. phaffii 
proteins found in the myoglobin preparation share significant sequence 
identity to known allergens. We agree that the weight of evidence 
demonstrates the safety of myoglobin protein consumption based on the 
absence of beef allergy case reports since 2004; the lack of the native 
Bos taurus glycosylation pattern in Motif FoodWorks's myoglobin 
protein, which makes the color additive less likely to trigger an 
allergic reaction; and a lack of immunologically meaningful sequence 
identity similarities between the myoglobin preparation proteins and 
known allergenic proteins. Furthermore, we conclude that myoglobin and 
K. phaffii proteins in the color additive are readily digested at 
acidic pH conditions found in the stomach and denatured at normal 
cooking temperatures. Therefore, FDA agrees with the conclusion that 
myoglobin protein produced in K. phaffii is not likely to pose a risk 
of allergenicity or toxicity upon consumption (Ref. 3).

V. Conclusion

    Based on the data and information in the petition and other 
available relevant information, we conclude that the petitioned use of 
myoglobin preparation as a color additive in ground meat and ground 
poultry analogue products is safe, provided the amount of myoglobin 
protein does not exceed 2 percent by weight of the uncooked product. 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 myoglobin, the established common or usual name for 
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 myoglobin is not necessary to protect the public health.

VI. Public Disclosure

    In accordance with Sec.  71.15(a) (21 CFR 71.15(a)), 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(b), we will delete from the documents any materials that are not 
available for public disclosure.

VII. Analysis of Environmental Impact

    We have 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. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. 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.

IX. Section 301(ll) of the FD&C Act

    Our review of this petition was limited to section 721 of the FD&C 
Act. This 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

[[Page 5594]]

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 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.

X. 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 https://www.regulations.gov. We will publish notice of the objections that we 
have received or lack thereof in the Federal Register.

XI. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. Although FDA 
verified the website addresses in this document, please note that 
websites are subject to change over time.

1. Kurtzman C.P., ``Biotechnological Strains of Komagataella 
(Pichia) Pastoris Are Komagataella Phaffii as Determined From 
Multigene Sequence Analysis,'' Journal of Industrial Microbiology 
and Biotechnology, 36(11):1435-1438, 2009. Doi: 10.1007/s10295-009-
0638-4. PMID: 19760441.
2. Memorandum from J. Mihalov, Chemistry Review Team, Division of 
Food Ingredients (DFI), Office of Food Additive Safety (OFAS), 
Center for Food Safety and Applied Nutrition (CFSAN), FDA to E. 
Anderson, DFI, OFAS, CFSAN, FDA, August 23, 2024.
3. Memorandum from S. Choudhuri, Toxicology Review Team, DFI, OFAS, 
CFSAN, FDA to E. Anderson, DFI, OFAS, CFSAN, FDA, August 23, 2024.

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.  73.297 to subpart A to read as follows:

Sec.  73.297   Myoglobin.

    (a) Identity. (1) The color additive myoglobin is a stabilized 
product of controlled fermentation of a non-pathogenic and non-
toxicogenic strain of the yeast, Komagataella phaffii, genetically 
engineered to express the myoglobin protein from Bos taurus. Myoglobin 
protein is the principal coloring component of the color additive and 
imparts a red color.
    (2) Color additive mixtures made with myoglobin 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. Myoglobin must conform to the following 
specifications and must be free from impurities, other than those 
named, to the extent that such impurities may be avoided by good 
manufacturing practice:
    (1) Myoglobin protein purity on protein basis (weight/weight), not 
less than 85 percent.
    (2) Lead, not more than 0.01 milligrams per kilogram (0.01 parts 
per million).
    (c) Uses and restrictions. Myoglobin may be safely used in ground 
meat and ground poultry analogue products (i.e., plant-based ground 
meat- and poultry-like food products subject to FDA regulation) where 
the amount of myoglobin protein does not exceed 2 percent by weight of 
the uncooked analogue product.
    (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 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: January 14, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-01239 Filed 1-16-25; 8:45 am]
BILLING CODE 4164-01-P
```