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331
Chapter Six
Feed Terms and Ingredient Definitions
Editor—Richard Ten Eyck, OR
New and Modified Ingredient Definitions

A Guide to Submitting New Ingredient Definitions to AAFCO
Section Editor – Jennifer Roland, FASS
To assist in development of new feed definitions the following guide is offered. The
roles of each party are described below.
The definitions should be non-proprietary as not to favor one ingredient producer
over another.
Materials to be used as feed ingredients should have the following attributes:
They should be consistent batch to batch. The material should not be a combination of
other ingredients. The intended use should not be to mitigate, treat, or diagnose a disease,
but rather to provide nutrition, color, taste, or aroma for the animal or provide a technical
effect in the feed. It is the manufacturer’s responsibility to produce a safe ingredient for
its intended purpose.
The Requester
A requester (industry, public, regulatory official, etc.) should make the request to
the appropriate investigator (See the AAFCO Official Publication or website for current
listing) in writing that contains the information described below.
The following information should be provided, if pertinent, in the request so there
is sufficient information for the decision process:
(1) Firm and contact person.
(2) Summary of the request, including name of the ingredient, intended use, and
rationale for the request.
(3) Proposed definition.
(4) Description of the ingredient.
(5) Prior Sanctioned use (common use in United States pre 1958) and/or historical
regulation of the ingredient.
(6) General Description of the Manufacturing processes.
(7) The purpose of the ingredient.
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(8) Use limitations, if any.

(9) Data and observations to support intended use. Data may include controlled
feeding trials, if necessary.
(10) Summary of safety assessment. The safety assessment should include
A. Reports of available safety studies such as target animal safety, toxicity,
carcinogenicity, mutagenicity, and chronic effects.
B. For microbial enzymes, information to demonstrate that they are produced
from nonpathogenic and nontoxigenic strains.
C. Levels of known impurities and/or potential contaminants and explanation
of how to assure the safety of the ingredient.
D. Statement of risk for Target Animals.
E. Statement of risk related to Human Food.
F. Statement of environmental safety.
(11) List of Cited Literature.
(12) Proposed labeling (can be generic).
2020 Official Publication

332 Feed Terms and Ingredient Definitions
It is imperative that the requester provides all information that is available to support
their request. Proprietary information should be clearly identified in the request. It may
be advisable to put proprietary information in a separate document that can be sent, if
needed, only to the FDA during the scientific review. Materials that are of a proprietary
nature should not be disseminated in by an investigator without requester’s knowledge;
also see Section 13f, AAFCO Model Bill or applicable governing state laws.
It is encouraged that protocols supporting the ingredient definitions (especially long-
term feeding trials and other significant research studies) be submitted to FDA for review
prior to conducting the studies.
Some ingredients may have human health concerns; these ingredients are not
appropriate for review by AAFCO but need to be submitted through the Food Additive
Process to FDA. Food additive petition issues will be addressed by the Director, Division
of Animal Feeds, Center for Veterinary Medicine, Food and Drug Administration,
7500 Standish Place, Rockville, MD 20855.
A requester wanting approval pursuant to the Canadian Feeds Act and Regulations is
required to file a formal application with the Canadian Food Inspection Agency. Inquiries
should be addressed to Director, Animal Feed Division, Canadian Food Inspection
Agency, 59 Camelot Drive, Ottawa, Ontario, Canada K1A 0Y9.
Once a request has been submitted the firm should wait to market the ingredient
until the definition has been reviewed and voted on by the AAFCO Ingredient Definitions
Committee, Board, and General Membership. Marketing prior to the board and membership
vote is at the firm’s discretion. Some states require an ingredient definition to be accepted
for publication in the Official Publication prior to distributing feed containing the ingredient.
The requester may contact the investigator to determine if the request has been
submitted to FDA for their review at the 30-day mark and every 30 days after that time.
The Investigator
As an AAFCO Investigator you are a one-person committee and may have to make
decisions on data/specifications without counsel in your area of concern. One of the
goals is to develop official feed definitions and standards that are just and equitable in
cooperation with the members of the industry producing the product. A second goal is
to assure that the production, sale, and use of ingredients will result in safe and effective
feeds. The definitions should be non-proprietary as not to favor one producer over another.
The investigator may initiate a definition modification based upon knowledge of
the affected industry and not on a specific request from a sponsor. It is the responsibility
of the investigator to acquire sufficient documentation to support their actions, as it is
industry’s responsibility to provide sufficient documentation to support their request.
Upon receipt of the request for an AAFCO definition, the investigator must decide
(1) Is the ingredient in their area of concern? If not, then it should be referred to the
appropriate investigator or to the chair of the Ingredients Definition Committee
and the requesting party be notified of referral.
(2) Does the proposed ingredient fully meet an existing AAFCO definition? (Notify
the requester of such).
(3) If in the initial contact with the requester it appears that the proposed ingredient
may have human safety concerns causing it to be a “food additive,” then the
requester should be referred directly to Director, Division of Animal Feeds,
Center for Veterinary Medicine, Food and Drug Administration. If FDA
issues a food additive regulation for the ingredient, the investigator may
proceed with the writing of a new AAFCO definition.
(4) Is the request a modification of an existing definition?
(5) Is this a request for a new definition?

Official Feed Terms 333
In the process of writing the definition based on the requesters proposal, the
investigator will have to consider several components:
(1) Correct nomenclature (common and usual name and appropriate scientific name).
(2) Origin of the ingredient.
(3) Ingredient processing or the process derived from.
(4) Use restrictions.
(5) Physical/chemical properties.
(6) Impurities.
Upon receiving a complete request for a new AAFCO definition, the expected
administrative review time for the AAFCO investigator is 30 calendar days. If the
investigator expects their review to take longer than 30 days they may request the chair of
the Ingredient Definitions Committee to assign the definition to another investigator.
Once the administrative review is complete the investigator will ask the requester
to send 2 hard copies (or one hard copy and one electronic copy) of the request to
Director, Division of Animal Feeds, Center for Veterinary Medicine, Food and Drug
Administration. The investigator will e-mail a request to the Director to review the
request for a definition on behalf of AAFCO. FDA acts in a consulting role to evaluate the
safety and efficacy of the ingredient. AAFCO investigators should send review requests
directed to: Director, Division of Animal Feeds, Center for Veterinary Medicine, Food
and Drug Administration, 7500 Standish Place, Rockville, MD 20855.
Materials that are of a proprietary nature should not be disseminated by an
investigator without knowledge of the requestor also see Section 13f, AAFCO Model Bill
or applicable governing state laws.
The expected time for FDA to complete their safety and efficacy review is 90
calendar days. When FDA has finished their review the investigator will prepare and
forward an “Investigators Report” form to the chair of the Ingredient Definitions
Committee. These reports will be added to the agenda of the next committee meeting and
are open for public viewing and comments.
The Investigator will respond to the submitter’s request for update on the status
of the submission when the requests for updates are reasonably timed. Typically after
a review request has been at FDA for 90 days, the investigator may need to contact the
FDA reviewer to determine the status.
When the FDA provides a written response to the investigator regarding the request
for definition, the investigator will contact the requestor and relay the FDA response.
If the FDA does not believe that the new definition has been fully supported they
will notify the investigator. The investigator will then work with the requester to obtain
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more information.
The Expert Panel

A panel of experts may be consulted at any time if the investigator so deems it
necessary to assist in the decision making process. If AAFCO has not identified any
experts in specific fields, then the investigator is free to make their own selection. The
experts are not limited to academia but should not have corporate financial interest for or
against, the proposal.
The FDA
Since the Food and Drug Administration (FDA) recognizes AAFCO definitions,
it is imperative that FDA does not disagree with AAFCO’s investigators findings and
recommendations on definitions and therefore critical that investigators submit all
materials in the request to FDA for its review. If in the initial contact with the requester

it appears that the proposed ingredient may have human safety concerns causing it to
be a “food additive,” then the requester should be referred directly to FDA. Upon the
completion of FDA’s review, which may result in a publication of a 21 CFR regulation,
the investigator may proceed with the writing of a new AAFCO definition.
AAFCO investigators should send review requests directed to: Director, Division
of Animal Feeds, Center for Veterinary Medicine, Food and Drug Administration,
7500 Standish Place, Rockville, MD 20855.
It typically takes 3 months depending on complexity of the request and workload for
FDA’s review. The AAFCO investigator can contact the FDA reviewer every 30 days to
inquire as to the progress of reviewing the request.
If FDA considers the request incomplete, but the needed information to be likely
quickly available from the requester, FDA may contact the requester directly for that
information (keeping the investigator informed of all communications). Should the FDA
reviewer believe significant information is required to complete the request, FDA will
notify the AAFCO investigator, who will inform the requestor that AAFCO will need
additional information to proceed. If needed to support their scientific review, FDA may
directly request proprietary information from the requester.
FDA will provide a written response to the investigator with the conclusions of their
review.
Canadian Food Inspection Agency

The Chair of the IDC will share all investigator proposals with Canadian officials
for their information when the information is forwarded to the Ingredient Definitions
Committee.
A requester wanting approval pursuant to the Canadian Feeds Act and Regulations is
required to file a formal application with the Canadian Food Inspection Agency. Inquiries
should be addressed to: Director, Animal Feed Division, Canadian Food Inspection
Agency, 59 Camelot Drive, Ottawa, Ontario, Canada K1A 0Y9.
The Association
Once reviewed by the investigator and FDA the proposed definition is submitted,
by the investigator, to the Chair of the Ingredient Definitions Committee (IDC) by
December 1 or June 15 of each year. The IDC is the clearinghouse for all new or
modified definitions by acting as a peer review panel for the investigator to assure that
definitions are acceptable and consistent with AAFCO policies and existing definitions.
Membership of the committee is drawn from the ranks of AAFCO members. The
deadline is necessary to allow ample time for committee review, corresponding with
the investigator, and referral to the AAFCO Board of Directors for consideration by the
general membership at the Annual Meeting or Mid Year meeting.
Once a new ingredient definition is approved by the Ingredient Definitions
Committee they forward a recommendation to the AAFCO Board to place the definition
in the Official Publication in tentative status. The Board will vote on this recommendation
before the next membership meeting so members can vote on the recommendation
during the annual or midyear meetings. Once approved by the membership the ingredient
definition will be published in the next Official Publication. The fastest this step happens
is one year.
Firms may use the ingredient definition once the AAFCO membership vote has
occurred affirming the recommended definition to appear in the OP. Prior to publication
in the Official Publication the next year, firms wanting to manufacture feed with the

ingredient may use committee minutes and general session minutes to document the
completion of the process. These are typically posted on the AAFCO website.
If deletion of an ingredient definition from the Official Publication is proposed, the
investigator shall follow the same dateline as if proposing any other ingredient definition
change. This will allow the IDC the opportunity to review and discuss the proposed
deletion.
Animal Food Additives Approved by FDA

Animal food additives approved by FDA are listed in 21 CFR 573. The food
additive regulation specifies the requirements for safe use of the food additive and
establishes the common or usual name for the new ingredient. To ensure that the
AAFCO OP listing of defined feed ingredients is complete, the approved food additive,
as specified in the published final rule, will be incorporated in the AAFCO OP’s Official
Common and Usual Names and Definition of Feed Ingredients section.
The designated FDA representative to the IDC will provide the appropriate
investigator with the food additive regulation. The investigator will prepare a
recommendation form and forward it to the Chair of the Ingredient Definitions
Committee for consideration at the next committee meeting.
Since the ingredient has gone through the formal FDA approval process, once the
AAFCO IDC, and the AAFCO Board, and AAFCO Membership have approved the
definition, the entry will be incorporated in the AAFCO OP as Official.
CHAPTER SIX

Feed Terms and Definitions

Investigator and Section Editor—Ali Kashani, WA
Official Feed Terms

Note: Suggestions for changes should be addressed to the Feed Terms Investigator.
Official feed terms are listed in the following section to define nouns and/or processes to
provide uniformity and clear understanding of words used when describing ingredients.
It is acceptable to use a combination of a “process” feed term and a defined ingredient or
common or usual name when describing an ingredient in the ingredient statement as long
as the ingredient is not nutritionally altered from the original. If the ingredient has gone
through a recognized review process the name may include a “part” feed term.
Additive. An ingredient or combination of ingredients added to the basic feed mix or

parts thereof to fulfill a specific need. Usually used in micro quantities and requires
careful handling and mixing.
(Note: A “Food Additive” is defined by federal laws as any substance which becomes
a component of or affects the characteristics of a feed or food if such substance is not
generally recognized among experts qualified by scientific training and experience to
evaluate its safety as having been adequately shown through scientific procedures to be safe
under the conditions of its intended use. Excepted are substances having “prior sanction”
and pesticide chemicals under certain conditions. See Public Law 65-929 for details.)
Aerial parts. (Part) The above ground parts of plants.

Air ashed. (Process) Reduced by combustion in air to a mineral residue.
Ammoniated, ammoniating. (Process) Combined with or impregnated with ammonia or
an ammonium compound.
Animal food. See feed.
Animal waste. Means a material composed of excreta, with or without bedding materials,
and collected from poultry, ruminants or other animals except humans.
Antibiotics. A class of drug. They are usually synthesized by a living microorganism and
in proper concentration inhibit the growth of other microorganisms.
Artificially dried. (Process) Moisture having been removed by other than natural means.
Aspic. A solid or semi-solid dressing produced by mixing a gelling agent(s) with
broth or water, and/or common seasonings or flavor enhancer(s). If the aspic or gel is
characterized as a meat, poultry, or fish aspic or gel, it must contain an extract or essence
of meat, poultry, or fish in an amount sufficient to characterize it as such.
Aspirated, aspirating. Having removed chaff, dust, or other light materials by use of air.
Bagasse. (Part) Pulp from sugar cane. (See pulp.)
Balanced. A term that may be applied to a diet, ration, or feed having all known required
nutrients in proper amount and proportion based upon recommendations of recognized
authorities in the field of animal nutrition, such as the National Research Council, for a
given set of physiological animal requirements. The species for which it is intended and
the functions such as maintenance or maintenance plus production (growth, fetus, fat,
milk, eggs, wool, feathers, or work) shall be specified.
Barn-cured. (Process) Forage material dried with forced ventilation in an enclosure.
Beans. Seed of leguminous plants especially of the genera Phaseolus, Dolichos, and Vigna.
Biscuits. (Physical form) Shaped and baked dough.

Blending. (Process) To mingle or combine two or more ingredients of feed. It does not
imply a uniformity of dispersion.
Blocked, blocking. (Process) Having agglomerated individual ingredients or mixtures in
to a large mass.
Blocks. (Physical form) Agglomerated feed compressed into a solid mass cohesive enough
to hold its form and weighing over two pounds, and generally weighing 30-50 pounds.
Blood. (Part) Vascular fluid of animals.
Blood albumin. (Part) One of the blood proteins.
Blowings. (Part) See mill dust.
Bolls. (Part) The pods or capsules of certain plants, especially flax or cotton.
Bolted, bolting. (Process) Separated by means of a bolting cloth as flour from bran.
Bone. (Part) Skeletal parts of vertebrates.
Boneless. (Process) The flesh resulting from removal of bone from accompanying flesh
by means of knife separation.
Bran. (Part) Pericarp of grain.
Brand name. Any word, name, symbol or device or any combination thereof identifying
the commercial feed of a distributor and distinguishing it from that of others.
Bricks. (Physical form) Agglomerated feed, other than pellets, compressed into a solid
mass cohesive enough to hold its form and weighing less than two pounds. (See blocks.)
Browse. (Part) Small stems, leaves and/or flowers and fruits of shrubs, trees or woody
vines.
Buttermilk. (Part) All residue from churning cream.
By-product. (Part) Secondary products produced in addition to the principal product.
Cake. (Physical form) The mass resulting from the pressing of seeds, meat, or fish in
order to remove oils, fats, or other liquids.
Calcined, calcining. (Process) Treated at high temperature in the presence of air.
Canned. (Process) A term applied to animal feed that has been processed, commercially
sterilized, and sealed according to 21 CFR part 113 in hermetically sealed containers such
as but not limited to cans, pouches, tubs, and trays.
Cannery residue. (Part) Residue suitable for feeding obtained in preparing a product for
canning.
Carcass meat trimmings. (Part) Clean flesh obtained from slaughtered animals. It is
limited to striate, skeletal, and cardiac muscles, but may include the accompanying and
overlaying fat and the portion of skin, sinew, nerve, and blood vessels which normally
accompany the flesh.
Carcass residue, mammals. (Part) Residues from animal tissues including bones and
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exclusive of hair, hoofs, horns, and contents of the digestive tract.

Carriers. An edible material to which ingredients (such as but not limited to vitamins and
minerals) are added to facilitate uniform incorporation of the latter into feeds. The active
substances are absorbed, impregnated, or coated into or onto the edible materials in such
a way as to physically carry the active ingredient.
Chaff. (Part) Glumes, husks, or other seed covering together with other plant parts
separated from seed in threshing or processing.
Chipped, chipping. (Process) Cut or broken into fragments; also meaning prepared into
small thin slices.
Chopped, chopping. (Process) Reduced in particle size by cutting with knives or other
edged instruments.
Cleaned, cleaning. (Process) Removal of material by such methods as scalping,
aspirating, magnetic separation, or by any other method.
Cleanings. (Part) Chaff, weed seeds, dust, and other foreign matter removed from cereal
grains.

Cobs with grain. (Part) The ears of maize without the husks, but consisting of the entire
cobs and adhering grain.
Cobs with husks. (Part) Kernel-free fibrous inner portion of the ear of maize with
enveloping leaves.
Commercial feed. See AAFCO Model Bill.
Complete feed. A nutritionally adequate feed for animals other than man; by specific
formula is compounded to be fed as the sole ration and is capable of maintaining life and/
or promoting production without any additional substance being consumed except water.
Concentrate. A feed used with another to improve the nutritive balance of the total and
intended to be further diluted and mixed to produce a supplement or a complete feed.
Condensed, condensing. (Process) Reduced to denser form by removal of moisture.
Conditioned, conditioning. (Process) Having achieved pre-determined moisture
characteristics and/or temperature of ingredients or a mixture of ingredients prior to
further processing.
Cooked, cooking. (Process) Heated in the presence of moisture to alter chemical and/or
physical characteristics or to sterilize.
Cracked, cracking. (Process) Particle size reduced by a combined breaking and crushing
action.
Cracklings. (Part) Residue after removal of fat from adipose tissue or skin of animals by
dry heat.
Crimped, crimping. (Process) Rolled by use of corrugated rollers. It may curtail
tempering or conditioning and cooling.
Crumbled, crumbling. (Process) Pellets reduced to granular form.
Crumbles. (Physical form) Pelleted feed reduced to granular form.
Crushed, crushing. (Process) See rolled, rolling.
Cubes. (Physical form) See pellets.
Cubes, range. (Physical form) See pellets and range cubes.
Cull. Material rejected as inferior to the process of grading or separating.
Culture. Nutrient medium inoculated with specific microorganisms which may be in a
live or dormant condition.
Cultured, culturing. (Process) Biological material multiplied or produced in a nutrient
media.
Cure, curing, cured. (Process) To prepare for keeping for use, or to use, or to preserve.
The process may be by drying, use of chemical preservatives, smoking, salting, or by use
of other processes and/or materials for preserving.
Customer-formula feed. Consists of a mixture of commercial feeds and/or feed
ingredients each batch of which is manufactured according to the specific instructions of
the final purchaser.
Cut, cutting. (Process) See chopped, chopping.
D-activated, D-activating. Plant or animal sterol fractions which have been vitamin D
activated by ultra-violet light or by other means.
Deboned. (Process) The flesh resulting from removal of bones from accompanying flesh
by mechanical deboning.
Decharacterize, decharacterized. (Process) Use of approved color additives to make a
substance clearly distinguishable from the same substance for human consumption.
Defluorinated, defluorinating. (Process) Having had fluorine removed.
Degermed. (Process) Having had the embryo of seeds wholly or partially separated from
the starch endosperm.
Dehulled, dehulling. (Process) Having removed the outer covering from grains or other
seeds.
Dehydrating, dehydrated. (Process) Having been freed of moisture by thermal means.

Dextrose Equivalent (D.E.). is the reducing power calculated as dextrose, expressed

as a percentage of the dry substance. It is used in conjunction with sugars and starch
hydrolysates.
Diet. Feed ingredients or mixture of ingredients including water, which is consumed by
animals.
Dietary starch. (Nutrient) An alpha-linked-glucose carbohydrate of or derived from
plants, animals and/or microbes from which glucose is released through the hydrolytic
actions of purified alpha-amylases and amyloglucosidases that are specifically active only
on alpha-(1-4) and alpha-(1-6) linkages in samples that have been gelatinized in heated,
mildly acidic buffer. Its concentration in feed is determined by enzymatically converting
the alpha-linked-glucose carbohydrate to glucose and then measuring the liberated
glucose. This definition encompasses plant starch, glycogen, maltooligosaccharides and
maltose/isomaltose. (Proposed 2009)
Digested, digesting. (Process) Subjected to prolonged heat and moisture, or to chemicals
or enzymes with a resultant change of decomposition of the physical or chemical nature.
Diluent. An edible substance used to mix with and reduce the concentrate of nutrients
and/or additives to make them more acceptable to animals, safer to use, and more capable
of being mixed uniformly in a feed. (It may also be a carrier.)
Distillation solubles. (Part) Stillage filtrate.
Dressed, dressing. (Process) Made uniform in texture by breaking or screening of lumps
from feed and/or the application of liquid(s).
Dried, drying. (Process) Materials from which water or other liquid has been removed.
Drug. (as defined by FDA as applied to feed) A substance (a) intended for use in the
diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals or
(b) a substance other than food intended to affect the structure or any function of the body
of man or other animals.
Dry-milled. (Process) Tempered with a small amount of water or steam to facilitate the
separation of the various component parts of the kernel in the absence of any significant
amount of free water.
Dry-rendered, dry-rendering. Dry rendered (Process) Residues of animal tissue cooked
in open steam-jacketed vessels until the water has evaporated. Fat is removed by draining
and pressing the solid residue.
Dust. (Part) Fine, dry pulverized particles of matter usually resulting from the cleaning or
grinding of grain.
Ears. (Part) Fruiting heads of Zea maize, including only the cob and grain.
Egg albumin. (Part) Whites of eggs of poultry.
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Emulsifier. A material capable of causing fat or oils to remain in liquid suspension.

Endosperm. (Part) Starchy portion of seed.
Ensiled. (Process) Aerial parts of plants which have been preserved by ensiling.
Normally the original material is finely cut and blown into an airtight chamber as a silo,
where it is pressed to exclude air and where it undergoes an acid fermentation that retards
spoilage.
Environmental nutrition. The role of nutritional factors in altering animal impacts on
the environment.
Enzymatic activity. The catalytic activity required to convert a given amount of assay
substrate to a given amount of product per unit time under the standard conditions set
forth in the assay procedure.
Enzyme. A protein made up of amino acids or their derivatives, which catalyzes a
defined chemical reaction. Required cofactors should be considered an integral part of the
enzyme.
Enzyme product. A processed, standardized enzyme-containing material which has been
produced with the intention of being sold for use in animal feed and feed ingredients.

Etiolated. (Process) A material grown in the absence of sunlight, blanched, bleached,

colorless or pale.
Evaporated, evaporating. (Process) Reduced to a denser form; concentrated as by
evaporation or distillation.
Eviscerated. (Process) Having had all the organs in the great cavity of the body removed.
Expanded, expanding. (Process) Subjected to moisture, pressure, and temperature
to gelatinize the starch portion. When extruded, its volume is increased, due to abrupt
reduction in pressure.
Extracted, mechanical. (Process) Having removed fat or oil from materials by heat and
mechanical pressure. Similar terms: expeller extracted, hydraulic extracted, “old process.”
Extracted, solvent. (Process) Having removed fat or oil from materials by organic
solvents. Similar term: “new process.”
Extruded. (Process) A process by which feed has been pressed, pushed, or protruded
through orifices under pressure.
Fat. (Part) A substance composed chiefly of triglycerides of fatty acids, and solid or
plastic at room temperature.
Fatty acids. (Part) Aliphatic monobasic acids containing only the elements carbon,
hydrogen, and oxygen.
Feathers. (Part) The light, horny epidermal outgrowths that form the external coverings
of birds.
Feed. Material consumed or intended to be consumed by animals other than humans that
contributes nutrition, taste, or aroma or has a technical effect on the consumed material.
This includes raw materials, ingredients, and finished product.
Feed grade. Material that has been determined to be safe, functional, and suitable for
its intended use in animal food, is handled and labeled appropriately, and conforms to
the Federal Food, Drug, and Cosmetic Act unless otherwise expressly permitted by the
appropriate state or federal agency (suitable for use in animal feed).
Feed mixture. See formula feed.
Feedstuff. See feed(s).
Fermentation aid. A substance added to assist in providing proper conditions which
results in action by yeasts, molds or bacteria in a controlled aerobic or anaerobic process
used for the manufacture of certain products.
Fermented, fermenting. (Process) Acted upon by yeasts, molds, or bacteria in a
controlled aerobic or anaerobic process in the manufacture of such products as alcohols,
acids, vitamins of the B-complex group, or antibiotics.
Fiber. (Nutrient) Any of a large class of plant carbohydrates that resist digestion hydrolysis.
Fines. (Physical form) Any materials which will pass through a screen whose openings
are immediately smaller than the specified minimum crumble size or pellet diameter.
Flaked, flaking. (Process) See rolled.
Flakes. (Physical form) An ingredient rolled or cut into flat pieces with or without prior
steam conditioning.
Flour. (Part) Soft, finely ground and bolted meal obtained from the milling of cereal
grains, other seeds, or products. It consists essentially of the starch and gluten of the
endosperm.
Fodder. (Part) The green or cured plant, containing all the ears or seed heads, if any,
grown primarily for forage. (It has been applied more specifically to corn and sorghum.)
Food(s). When used in reference to animals, is synonymous with feed(s). See feed(s).
Formula feed. Two or more ingredients proportioned, mixed, and processed according to
specifications.
Free choice. A feeding system by which animals are given unlimited access to the
separate components or groups of components constituting the diet.

Fresh. (Process) Ingredient(s) having not been subject to freezing, to treatment by

cooking, drying, rendering, hydrolysis, or similar process, to the addition of salt, curing
agents, natural or synthetic chemical preservatives or other processing aids, or to
preservation by means other than refrigeration.
Fructans. (Nutrient) – Polysaccharides and oligosaccharides in which fructose is the
major constituent and glucose is the minor constituent. Glucose content is 33% or less.
Fused, fusing. (Process) Melted by heat.
Gel. See Aspic.
Gelatinized, gelatinizing. (Process) Having had the starch granules completely ruptured by
a combination of moisture, heat and pressure, and in some instances, by mechanical shear.
Germ. (Part) The embryo found in seeds and frequently separated from the bran and
starch endosperm during the milling.
Gluten. (Part) The tough, viscid nitrogenous substance remaining when the flour of
wheat or other grain is washed to remove the starch.
Gossypol. (Part) A phenolic pigment in cottonseed that is toxic to some animals.
Grain. (Part) Seed from cereal plants.
GRAS. Abbreviation for the phase “Generally Recognized as Safe.” A substance which
is generally recognized as safe by experts qualified to evaluate the safety of the substance
for its intended use.
Gravy. A multiple component fluid dressing or topping consisting of a combination of
one or more ingredients imparting special characteristics or flavors. It may be formulated
separately and added to another ingredient or combination of ingredients. If the gravy
is characterized as a meat, poultry or fish gravy it must contain an extract or essence of
meat, poultry or fish in an amount sufficient to characterize it as such.
Grease. Animal fats with a titer below 40o C
Grit. Course ground, insoluble, non-nutritive material (e.g. granite rock) for the in vivo
mechanical grinding of feed by avian species.)
Grits. (Part) Coarsely ground grain from which the bran and germ have been removed,
usually screened to uniform particle size.
Groats. (Part) Grain from which the hulls have been removed.
Ground, grinding. (Process) Reduced in particle size by impact, shearing, or attrition.
Hay. (Part) The aerial portion of grass or herbage especially cut and cured for animal feeding.
Heads. (Part) The seed or grain-containing portions of a plant.
Heat-processed, heat-processing. (Process) Subjected to a method of preparation
involving the use of elevated temperatures with or without pressure.
Heat-rendered, heat rendering. (Process) Melted, extracted, or clarified through use of
CHAPTER SIX
heat. Usually, water and fat are removed.

Homogenized, homogenizing. (Process) Particles broken down into evenly distributed
globules small enough to remain emulsified for long periods of time.
Hulls. (Part) Outer covering of grain or other seed.
Human grade. Every ingredient and the resulting product are stored, handled, processed,
and transported in a manner that is consistent and compliant with regulations for current
good manufacturing practices (cGMPs) for human edible foods as specified in 21 CFR
Part 117.
Husks. (Part) Leaves enveloping an ear of maize; or the outer coverings of kernels or
seeds, especially when dry and membranous.
Hydrolyzed, hydrolyzing. (Process) Complex molecules having been split to simpler
units by chemical reaction with water, usually by catalysis.
Iodinated. (Process) Treated with iodine.
Iodize, iodized. (Process) To treat with iodine or an iodide.
Irradiated, irradiating. (Process) Treated, prepared, or altered by exposure to a specific
radiation.

Juice. (Part) The aqueous substance obtainable from biological tissue by pressing or
filtering with or without addition of water.
Kernel. (Part) A whole grain. For other species, dehulled seed.
Kibbled, kibbling. (Process) Cracked or crushed baked dough, or extruded feed that has
been cooked prior to or during the extrusion process.
Laboratory method. A technique or procedure of conducting scientific experiment, test,
investigation or observation according to a definite established logical or systematic plan.
Lard. (Part) Rendered fat of swine.
Leached. (Process) The condition of a product following subjection of the material to the
action of percolating water or other liquid.
Leaves. (Part) Lateral outgrowths of stems that constitute part of the foliage of a plant,
typically a flattened green blade, and primarily functions in photosynthesis.
Lecithin. (Part) A specific phospholipid. The principal constituent of crude phosphatides
derived from oil-bearing seeds.
Liver. (Part) The hepatic gland.
Malt. (Part) Sprouted and steamed whole grain from which the radicle has been removed.
Malted, malting. (Process) Converted into malt or treated with malt or malt extract.
Mash. (Physical form) A mixture of ingredients in meal form. Similar term: mash feed.
Meal. (Physical form) An ingredient which has been ground or otherwise reduced in
particle size.
Medicated feed. Any feed which contains drug ingredients intended or presented for
the cure, mitigation, treatment, or prevention of diseases of animals other than man or
which contains drug ingredients intended to affect the structure or any function of the
body of animals other than man. Antibiotics included in a feed growth promotion and/or
efficiency levels are drug additives and feeds containing such antibiotics are included in
the foregoing definition of “Medicated Feed.”
Micro-ingredients. Vitamins, minerals, antibiotics, drugs, and other materials normally
required in small amounts and measured in milligrams, micrograms or parts per million (ppm).
Middlings. (Part) A by-product of flour milling comprising several grades of granular
particles containing different proportions of endosperm, bran, germ, each of which
contains different levels of crude fiber.
Milk. Total lacteal secretion from the mammary gland.
Mill by-product. (Part) A secondary product obtained in addition to the principal product
in milling practice.
Mill dust. (Part) Fine feed particles of undetermined origin resulting from handling and
processing feed and feed ingredients.
Mill run. (Part) The state in which a material comes from the mill, ungraded and usually
uninspected.
Mineralize, mineralized. (Process) To supply, impregnate, or add inorganic mineral
compounds to a feed ingredient or mixture.
Mixing. (Process) To combine by agitation two or more materials to a specific degree of
dispersion.
Molasses. (Part) The thick, viscous by-product resulting from refined sugar production or
the concentrated, partially dehydrated juices from fruits.
Natural. A feed or ingredient derived solely from plant, animal or mined sources, either
in its unprocessed state or having been subject to physical processing, heat processing,
rendering, purification, extraction, hydrolysis, enzymolysis or fermentation, but not
having been produced by or subject to a chemically synthetic process and not containing
any additives or processing aids that are chemically synthetic except in amounts as might
occur unavoidably in good manufacturing practices.

Nutrient. A feed constituent in a form and at a level that will help support the life of an
animal. The chief classes of feed nutrients are proteins, fats, carbohydrates, minerals and
vitamins.
Offal. (Part) Material left as a by-product from the preparation of some specific product,
less valuable portions and the by-products of milling.
Oil. (Part) A substance composed chiefly of triglycerides of fatty acids, and liquid at
room temperature.
Organic. (Process) A formula feed or a specific ingredient within a formula feed that has
been produced and handled in compliance with the requirements of the USDA National
Organic Program (7 CFR Part 205).
Parboiling. A Hydrothermal process in which the crystalline form of starch is changed
into the amorphous form, due to the irreversible swelling and fusion of starch. This is
accomplished by soaking, steaming, drying and milling to produce physical and chemical
modifications.
Part. A subcomponent of an original material. A “part” feed term can be used in an
ingredient name if the ingredient part has gone through a recognized review process.
Pearled, pearling. (Process) Dehulled grains reduced by machine brushing into smaller
smooth particles.
Peel. (Part) See skin.
Pelleted, pelleting. (Process) Having agglomerated feed by compaction and forced
through die openings.
Pellets. (Physical form) Agglomerated feed formed by compacting and forcing through
die openings by a mechanical process. Similar terms: pelleted feed, hard pellet.
Pellets, soft. (Physical form) Similar term: High Molasses Pellets. Pellets containing
sufficient liquid to require immediate dusting and cooling.
Physical form. Shape, appearance or structure of a feed based on size, texture, particle
size, density, hardness, moisture/dryness or other physical characteristics. Physical form
may be used to further describe an ingredient name.
Polished, polishing. (Process) Having a smooth surface produced by mechanical process
usually by friction.
Pomace. (Part) Pulp from fruit or vegetables. See pulp.
Popped, puffed. (Process) To expand whole or cracked processed grains or non-grains
by heat with or without high pressure. Examples of grains are corn, rice, wheat, millet,
barley, buckwheat. Example of non-grain is soybean.
Powder, powdered. (Process) Pulverizing a feed or feed ingredient into fine or very
small particle size or atomization and drying of liquids.
CHAPTER SIX
Precipitated, precipitating. (Process) Separated from suspension or a solution as a result

of some chemical or physical change brought about by a chemical reaction, by cold or by
any other means.
Premix. A uniform mixture of one or more micro-ingredients with diluent and/or carrier.
Premixes are used to facilitate uniform dispersion of the micro-ingredients in a large mix.
Premixing. (Process) The preliminary mixing of ingredients with diluents and/or carriers.
Preservative. A substance added to protect, prevent or retard decay, discoloration or
spoilage under conditions of use or storage.
Pressed, pressing. (Process) Compacted or molded by pressure; also meaning having fat,
oil, or juices extracted under pressure.
Presswater. The aqueous extract of fish or meat free from the fats and/or oils. Presswater
is the result of hydraulic pressing of the fishing or meat followed by separation of the oil
either by centrifuging or other means.
Process. A method used to prepare, treat, convert or transform materials into feeds or
feed ingredients. A “process” feed term can be used to further describe an ingredient
name as long as the ingredient is not nutritionally altered from the original.

Processed animal waste. Animal waste that has been artificially dried, dry stacked,
ensiled, oxidized, chemically treated, micro-biologically digested, chemically or
physically fractionated, or otherwise treated to render the material suitable for feeding.
Product. (Part) A substance produced from one or more other substances as a result of
chemical or physical change.
Protein. (Nutrient) Any of a large class of naturally occurring complex combinations of
amino acids.
Pulp. (Part) The solid residue remaining after extraction of juices from fruits, roots, or
stems. Similar terms: Bagasse and Pomace.
Pulverized, pulverizing. (Process) See ground, grinding.
Range cake. (Physical form) See cake.
Range cubes. (Physical form) Large pellets designed to be fed on the ground. Similar
term: range wafer.
Ration. The amount of the total feed which is provided to one animal over a 24-hour period.
Raw. Food in its natural or crude state not having been subjected to heat in the course of
preparation as food.
Refuse. (Part) Damaged, defective, or superfluous edible material produced during or left
over from a manufacturing or industrial process.
Rendered, rendering. (Process) A cooking and separating process in which conditions
such as time and temperature, with or without pressure, are sufficient to remove water,
kill pathogenic microorganisms, and separate fats and oils from other components.
Residue. Part remaining after the removal of a portion of its original constituents.
Rolled, rolling. (Process) Having changed the shape and/or size of particles by
compressing between rollers. It may entail tempering or conditioning.
Roasted. (Process) Cooked, dried or browned by exposure to heat.
Roots. (Part) Subterranean parts of plants.
Rumen contents. Contents of the first two compartments of the stomach of a ruminant.
Rumen inert. Refers to a nutrient(s) that does not result in a change in rumen
fermentation parameters yet is available to the animal in the intestine.
Rumen protected. Refers to a nutrient(s) fed in such a form that provides an increase in
the flow of that nutrient(s), unchanged, to the abomasum, yet is available to the animal in
the intestine.
Sauce. A multiple component fluid dressing or topping consisting of a combination of
one or more ingredients imparting special characteristics or flavors. It may be formulated
separately and added to another ingredient or combination of ingredients.
Scalped, scalping. (Process) Having removed larger material by screening.
Scratch. (Physical form) Whole, cracked, or coarsely cut grain. Similar terms: scratch
grain, scratch feed.
Screened, screening. (Process) Having separated various sized particles by passing over
and/or through screens.
Seed. (Part) The fertilized and ripened ovule of a plant.
Self fed. A feeding system where animals have continuous free access to some or all
component(s) of a ration, either individually or as mixtures.
Separating. (Process) Classification of particles by size, shape, and/or density.
Separating, magnetic. (Process) Removing ferrous material by magnetic attraction.
Shells. (Part) The hard, fibrous, or calcareous covering of a plant or animal product, i.e.,
nut, egg, oyster.
Shoots. (Part) The immature aerial parts of plants, stems with leaves and other
appendages in contrast to the roots.
Shorts. (Part) Fine particles of bran, germ, flour, or offal from the tail of the mill from
commercial flour milling.

Sifted. (Process) Materials that have been passed through wire sieves to separate particles
in different sizes. The separation of finer materials than would be done by screening.
Sizing. (Process) See screened, screening.
Skimmed. (Process) Material from which floating solid material has been removed. It is
also applied to milk from which fat has been removed by centrifuging.
Skin. (Part) Outer coverings of fruits or seeds, as the rinds, husks, or peels. May also
apply to dermal tissue of animals.
Sludge. The suspended or dissolved solid matter resulting from the processing of animal
or plant tissue for human food.
Solubles. Liquid containing dissolved substances obtained from processing animal or
plant materials. It may contain some fine suspended solids.
Solvent extracted. (Process) A product from which oil has been removed by solvents.
Spent. Exhausted of active or effective properties, i.e., absorbing activity.
Spray dehydrated. (Process) Material which has been dried by spraying on the surface
of a heated drum. It is recovered by scraping from the drum.
Spray dried. Material which has been dried by spraying or atomizing into a draft of
heated dry air.
_______ Stabilized. (Process) To retard degradation of ingredients. (The process used to
be specified)
Stalk(s). (Part) The main stem of a herbaceous plant often with its dependent parts as
leaves, twigs and fruit.
Starch. (Part) A white, granular polymer of plant origin. The principal part of seed
endosperm.
Steamed, steaming. (Process) Having treated ingredients with steam to alter physical
and/or chemical properties. Similar terms: steam cooked, steam rendered, tanked.
Steep-extracted, steep-extracting. (Process) Soaked in water or other liquid (as in the
wet milling of corn) to remove soluble materials.
Steepwater. Water containing soluble materials extracted by steep-extraction, i.e., by
soaking in water or other liquid (as in the wet milling of corn).
Stem. (Part) The coarse, aerial parts of plants which serve as supporting structures for
leaves, buds, fruit, etc.
Sterols. (Part) Solid cyclic alcohols which are the major constituents of the unsaponfiable
portion of animal and vegetable fats and oils.
Stick. See stickwater and presswater.
Stickwater, fish. (Part) The aqueous extract of cooked fish free from the oil. Stickwater
contains the aqueous cell solutions of the fish and any water used in processing.
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Stickwater, meat. (Part) The aqueous extract of meat free from the fat. Meat stickwater
is the result of the wet rendering of meat products and contains the aqueous cell solution,
the soluble glue proteins, and the water condensed from steam used in wet rendering.
Stillage. (Part) The mash from fermentation of grains after removal of alcohol by distillation.
Stover. (Part) The stalks and leaves of corn after the ears, or sorghum after the heads
have been harvested.
Straw. (Part) The plant residue remaining after separation of the seeds in threshing. It
includes chaff.
Sugars. (Nutrient) The sum of all free disaccharides and monosaccharides such as:
sucrose, lactose, maltose, glucose, fructose and galactose or others digestible by enzymes
found in an animal’s digestive tract.
Suitable for use in animal feed. See feed grade.
Sun-cured. (Process) Material dried by exposure in open air to the direct rays of the sun.

Supplement. A feed used with another to improve the nutritive balance or performance
of the total and intended to be:
(1) Fed undiluted as a supplement to other feeds: or,
(2) Offered free choice with other parts of the ration separately available; or
(3) Further diluted and mixed to produce a complete feed.
Syrup. (Part) Concentrated juice of a fruit or plant.
Tallow. (Part) Animal fats with titer above 40°C.
Tankage. (Part) See carcass residue.
Tempered, tempering. (Process) See conditioned, conditioning.
Titer. A property of fat determined by the solidification point of the fatty acids liberated
by hydrolysis.
Toasted. (Process) Browned, dried, or parched by exposure to a fire, or to gas or electric
heat.
Trace minerals. Mineral nutrients required by animals in micro amounts only (measured
in milligrams per pound or smaller units.)
Tracer. (Part) A harmless substance present at insignificant levels in an animal food to
assure the presence of and thorough mixing of a component (ingredient/premix) of that
food.
Tubers. (Part) Short, thickened fleshy stems or terminal portions of stems or rhizomes
that are usually formed underground, bear minute scaled leaves, each with a bud capable
under suitable conditions of developing into a new plant, and constitutes the resting stage
of various plants.
Twigs. (Part) Small shoots or branches, usually without leaves, portions of stems of
variable length or size.
Type A medicated article is intended solely for use in the manufacture of another Type
A medicated article or a Type B or Type C medicated feed. It consists of a new animal
drug(s), with or without carrier (e.g., calcium carbonate, rice hull, corn gluten) with or
without inactive ingredients. The manufacture of a Type A medicated article requires an
application approved under 21 CFR 514.105.
Type B medicated feed is intended solely for the manufacture of other medicated feeds
(Type B or Type C). It contains a substantial quantity of nutrients including vitamins
and/or minerals and/or other nutritional ingredients in an amount not less than 25% of
the weight. It is manufactured by diluting a Type A medicated article or another Type B
medicated feed. The maximum concentration of animal drug(s) in a Type B medicated
feed is 200 times the highest continuous use level for Category I drugs and 100 times
the highest continuous use level for Category II drugs. The term “highest continuous use
level” means the highest dosage at which the drug is approved for continuous use (14
days or more), or, if the drug is not approved for continuous use, it means the highest
level used for disease prevention or control. If the drug is approved for multiple species at
different use levels, the highest approved level of use would govern under this definition.
The manufacture of a Type B medicated feed from a Category II, Type A medicated
article requires a medicated feed mill license application approved under 21 CFR 515.20.
Type C medicated feed is intended as the complete feed for the animal or may be fed
“top dressed” (added on top of usual ration) or offered “free choice” (e.g., supplement)
in conjunction with other animal feed. It contains a substantial quantity of nutrients
including vitamins, minerals, and/or other nutritional ingredients. It is manufactured by
diluting a Type A medicated article or a Type B medicated feed. A Type C medicated feed
may be further diluted to produce another Type C medicated feed. The manufacture of a
Type C medicated feed from a Category II, Type A medicated article requires a medicated
feed mill license application approved under 21 CFR 515.20.
Uncleaned. (Physical form) Containing foreign material.

Unsaponifiable matter. (Part) Ether soluble material extractable after complete reaction
with strong alkali.
Vines. (Part) Any plant whose stems require support, or lie on the ground.
Viscera. (Part) All the organs in the great cavity of the body, excluding contents of the
intestinal tract.
Viscera, fish. (Part) All organs in the great cavity of the body; it includes the gills, heart,
liver, spleen, stomach, and intestines.
Viscera, mammals. (Part) All organs in the great cavity of the body; it includes the
esophagus, heart, liver, spleen, stomach, and intestines, but excludes the contents of the
intestinal tract.
Viscera, poultry. (Part) All organs in the great cavity of the body; it includes the
esophagus, heart, liver, spleen, stomach, crop, gizzard, undeveloped eggs, and intestines.
Vitaminize, vitaminized. (Process) To provide or supplement with vitamins.
Vitamins. Organic compounds that function as parts of enzyme systems essential for the
transmission of energy and the regulation of metabolisms of the body.
Wafered, wafering. (Process) Having agglomerated a feed of a fibrous nature by
compressing into a form usually having a diameter or cross section measurement greater
than its length.
Wafers. (Physical form) A form of agglomerated feed based on fibrous ingredients in
which the finished form usually has a diameter or cross section measurement greater than
its length.
Waste. (Part) See refuse.
Water extract. The aqueous phase containing dissolved materials resulting from the
treatment (e.g. by mixing or boiling) of a solid with water. All or part of the solid matrix
may be dissolved in the extract.
Weathered. (Process) A material which has been subjected to the action of the elements.
Wet. (Physical form) Material containing liquid or which has been soaked or moistened
with water or other liquid.
Wet-milled. (Process) Steeped in water with or without sulfur dioxide to soften the
kernel in order to facilitate the separation of the various component parts.
Wet-rendered, wet-rendering. (Process) Cooked with steam under pressure in closed tanks.
Whey. (Part) The watery part of milk separated from the curd.
Whey solids. (Part) The solids of whey (proteins, fats, lactose, ash, and lactic acid)
Whole. (Physical form) Complete, entire.
Whole pressed, whole pressing. (Process) Having the entire seed to remove oil.
Wilted. (Physical form) A product without turgor as a result of water loss.
Wort. (Part) The liquid portion of malted grain. It is a solution of malt sugar and other
CHAPTER SIX
water-soluble extracts from malted mash.
Deleted Feed Terms

The membership has voted to remove the following feed terms from use:
1. Ingredient, Feed Ingredient (2009)
2. Charcoal (2010)

Official Common or Usual Names

and Definitions of Feed Ingredients
Official Ingredient Definitions
As Established By The Association Of American Feed Control Officials
The bold print name and international feed name (IFN) are both acceptable as
ingredient names, unless designated otherwise in the definition.
Occasionally an item may be suggested as an ingredient in a mixed feed that is
not listed in this publication. When this happens, the appropriate investigator should be
contacted, a term developed, and the product defined. Some ingredients, e.g. sugar, are so
common there is no need to define them.
3. Alfalfa Products
Investigator and Section Editor—Erin Bubb, PA
Official
3.1 Suncured Alfalfa Meal, or Pellets or Ground Alfalfa Hay is the aerial portion
of the alfalfa plant, reasonably free of other crop plants, weeds, and mold, which has
been dried by solar means, stored as bales or stacks, and finely or coarsely ground. If it
is chopped instead of ground, it must be designated as “Suncured Chopped Alfalfa” or
“Chopped Alfalfa Hay.” (Adopted prior to 1928, Amended 1937, 1965, 2004.)
IFN 1-00-104 Alfalfa hay sun-cured chopped
IFN 1-00-090 Alfalfa hay sun-cured 13% Protein
IFN 1-00-111 Alfalfa hay sun-cured ground
IFN 1-00-112 Alfalfa hay sun-cured ground 13% Protein
3.2 Dehydrated Alfalfa Meal or Pellets is the aerial portion of the alfalfa plant,
reasonably free of other crop plants, weeds, and mold, which has been finely ground and dried
by thermal means under controlled conditions. (Adopted 1928, Amended 1965, 1995, 2004.)
IFN 1-00-025 Alfalfa Meal dehydrated
IFN 1-00-021 Alfalfa Meal dehydrated 13% Protein
NOTE 1: The following guarantees are recommended for the various grades of
alfalfa meal and ground alfalfa hay:
For 15% Crude Protein, Crude Fiber not more than 30%

Official Names and Definitions of Feed Ingredients 349
NOTE 2: A guarantee of the beta carotene content of alfalfa products expressed in

milligrams per pound, and accompanied by an expiration date may be included on the
label if the distributor so desires.
Guarantees made on the label (including the invoice), on the delivery ticket, on a
“certificate of analysis,” or other document associated with the distribution of an alfalfa
product are to be in terms of milligrams per pound of beta carotene without reference to
quantity of Vitamin A which may be derived therefrom by the animal.
Example: Beta carotene 60 milligrams per pound (a source of Vitamin A) (Adopted
1941, Amended 1945 and 1966.)
NOTE 3: Brand names, such as “Doe’s ______ % Alfalfa Meal with Animal Fat
or Vegetable Oil,” must be used to show that the product is a mixture and not simply
alfalfa meal. The chemical name of the antioxidant or antioxidants must be listed in the
ingredient statement. (Adopted 1963)
3.3 Alfalfa Nutrient Concentrate is the product obtained from the extracted juice
of freshly cut alfalfa, by coagulation, separation from the alfalfa solubles and subsequent
dehydration. The product should express both protein and Xanthophyll guarantees.
(Proposed 1982, Adopted 1983)
IFN 4-16-026 Alfalfa nutrient concentrate dehydrated
3.4 Concentrated Alfalfa Solubles is the product obtained by the concentration of
the liquid remaining after the separation of Alfalfa Nutrient Concentrate from the juice of
freshly cut alfalfa. The moisture level should not exceed 50%. (Proposed 1982. Adopted
1983)
IFN 4-16-027 Alfalfa solubles condensed
3.5 Direct Dehydrated Alfalfa Meal or Pellet is the aerial portion of the alfalfa
plant, reasonably free of other crop plants, weeds, and mold, that has not been stored in
bales or in stacks as sun-cured alfalfa hay prior to being ground and dried by thermal
means under controlled conditions. (Proposed 2016 rev. 1, Adopted 2018)
Tentative
T3.1 Suncured Alfalfa Meal, or Pellets, or Ground Alfalfa Hay is the aerial
portion of the alfalfa plant, reasonably free of other crop plants, weeds, and mold, which
has been dried by solar means, stored as bales or stacks, and finely or coarsely ground.
If it is chopped instead of ground, it must be designated as “Suncured Chopped Alfalfa”
or “Chopped Alfalfa Hay.” If the ingredient is further dehydrated by thermal means after
being ground, it must be designated as “Dehydrated Suncured Alfalfa Meal, or Pellets.”
(Proposed 2020)
CHAPTER SIX
6. Amino Acids and Related Products

Investigator and Section Editor—Richard Ten Eyck, OR
Official
6.1 DL-Methionine Hydroxy Analogue Calcium is a product that contains a
minimum of 97% racemic 2-hydroxy-4-(methylthio)butanoic acid calcium salt. The
percentage of DL-Methionine Hydroxy Analogue Calcium must be guaranteed. (Adopted
1959, Amended 1974, 1978, 1989, 2005, 2009, Adopted 2011). 21 CFR 582.5477
IFN 5-03-087 DL-Methionine Hydroxy Analogue Calcium
6.2 DL-Methionine is a product containing a minimum of 99% racemic 2-amino-
4-(methylthio)butanoic acid. The percentage of DL-Methionine must be guaranteed.
(Adopted 1957, Amended 1975, 1978, 1989, 2005, 2009, Adopted 2011). 21 CFR
582.5475
IFN 5-03-086 DL-Methionine

6.3 Glycine is a product which contains a minimum of 97% amino acetic acid. The
percentage of glycine must be guaranteed. (Adopted 1957.) 21 CFR 582.5049
IFN 5-02-127 Glycine
6.4 L-Lysine is a product which contains a minimum of 95% L-2,6-
diaminohexanoic acid. The percentage of L-lysine must be guaranteed. (Proposed 1966,
Adopted 1969, Amended 1975) 21 CFR 582.5411
IFN 5-08-022 L-Lysine
6.5 L-Threonine is a product which contains a minimum of 95% L-2-amino-3-
hydroxybutanoic acid. The percentage of L-threonine must be guaranteed. (Proposed
1967, Adopted 1969, Amended 1975, Amended 2010, Adopted 2012) 21 CFR 582.5881
IFN 5-08-092 L-Threonine
6.6 DL-Tryptophan is a product which contains a minimum of 97% racemic
2-amino-3-(3-indolyl)-propionic acid. The percentage of DL-tryptophan must
be guaranteed. Excessive tryptophan consumption in cattle (in excess of 0.17g
tryptophan/100 pounds bodyweight/day) is associated with bovine pulmonary
emphysema. (Proposed 1967, Adopted 1969, Amended 1975, Amended 2001, Adopted
2003.) 21 CFR 582.5915
IFN 5-08-093 DL-Tryptophan
6.7 DL-Methionine Hydroxyl Analogue Isopropyl Ester is a product containing
a minimum of 90% racemic 2-hydroxy-4(methylthio)butanoic acid isopropyl ester
monomer for use as a source of methionine activity in cattle diets. The percentage of DL-
methionine hydroxyl analogue isopropyl ester monomer must be guaranteed. (Adopted
2008, Amended 2009, Adopted 2011)
6.8 DL-Methionine Hydroxy Analogue is a product containing a minimum of
88% racemic 2-hydroxy-4-(methylthio)butanoic acid. The percentage of DL-Methionine
Hydroxy Analogue must be guaranteed. (Proposed 1980, Adopted 1985, Amended 1989,
2005, 2009, Adopted 2011). 21 CFR 582.5477
IFN 5-30-281 DL-Methionine Hydroxy Analogue
6.9 DL-Methionine Sodium is a product containing a minimum of 45.9% racemic
2-amino-(methylthio)butanoic acid sodium salt. The percentage of DL-methionine must
be guaranteed. (Proposed 1983, Amended 1989, Adopted 1990, Amended 2005, Amended
2009, Adopted 2011)
IFN 5-16-730 DL-Methionine Sodium
6.10 L-Tryptophan is a product which contains a minimum of 97% L-2-amino-
3-(3’indolyl)-propionic acid. The percentage of L-tryptophan must be guaranteed.
Excessive tryptophan consumption in cattle (in excess of 0.17g tryptophan/100 pounds
bodyweight/day) is associated with bovine pulmonary emphysema (Proposed 1985,
Adopted 1987, Amended 2001, Adopted 2003) 21 CFR 582.5915
IFN 5-18-776 L-Tryptophan
6.11 L-Lysine Monohydrochloride is a product which contains a minimum of 95%
L-2, 6-diaminohexanoic acid monohydrochloride. The percentage of L-lysine must be
guaranteed. (Adopted 1989)
IFN 5-19-118 L-Lysine Monohydrochloride
6.12 Taurine is a product that contains a minimum of 97% 2-aminoethanesulfonic
acid. The percentage of taurine must be guaranteed. It is used as a nutritional supplement
in cat foods, dog foods, and fish foods. Taurine may also be added to the feed of growing
chickens; when added to complete chicken feed, the total taurine content shall not exceed
0.054% of the feed (21 CFR 573.980). (Proposed 2017 rev. 1, Adopted 2019 rev. 1)
IFN 5-09-821 Taurine

6.13 L-Arginine is a product which contains a minimum of 98% L-2-amino-

5-guanidyl-valeric acid. The percentage of L-Arginine must be guaranteed. 21 CFR
582.5145 (Adopted 1990)
IFN 5-32-043 L-Arginine
6.14 DL-Arginine is a product which contains a minimum of 98% racemic 2-amino-
5-guanidyl-valeric acid. The percentage of DL-Arginine must be guaranteed. 21 CFR
582.5145 (Adopted 1990)
IFN 5-32-044 DL-Arginine
6.15 L-Tyrosine is a product which contains a minimum of 98% L-2-amino-3-(4-
hydroxyphenyl) propionic acid. The percentage of L-Tyrosine must be guaranteed. 21
CFR 582.5920 (Adopted 1990)
IFN 5-32-045 L-Tyrosine
6.16 L-Lysine Liquid is a product that contains a minimum of 50% L-2,
6-diaminohexanoic acid by weight in a water solution. The L-lysine content must not be
less than 85% on a moisture-free basis. The percentage of L-lysine must be guaranteed.
21 CFR 582.5411 (Proposed 1999, Adopted 2001)
6.17 L-Methionine is a product containing a minimum of 98.5% L-isomer of
2-amino-4-(methylthio)butanoic acid. L-Methionine is produced by Escherichia coli
K12 fermentation followed by enzymatic conversion to L-methionine. The percentage of
L-methionine must be guaranteed. (Proposed 2015, Adopted 2017 rev. 1)
Note 1. Guarantees for amino acids should be expressed as percent on feed labels.
Note 2. Unless indicated otherwise, the amino acids defined above can be added to
animal feed for nutritional purposes in accord with good manufacturing or feeding practices.
9. Animal Products
Investigator and Section Editor—Brett Boswell, MN
Official
*Use of this ingredient, from mammalian origins, is restricted to non-ruminant feeds
unless specifically exempted by 21 CFR 589.2000. Feeds containing prohibited material
must bear the following label statement: “Do not feed to cattle or other ruminants.”
*9.2 Meat is the clean flesh derived from slaughtered mammals and is limited to
that part of the striate muscle which is skeletal or that which is found in the tongue, in
the diaphragm, in the heart, or in the esophagus; with or without the accompanying and
CHAPTER SIX
overlying fat and the portions of the skin, sinew, nerve, and blood vessels which normally
accompany the flesh. It shall be suitable for use in animal food. If it bears a name
descriptive of its kind, it must correspond thereto. (Adopted 1938, Amended 1939, 1963)
IFN 5-00-394 Animal meat fresh
*9.3 Meat By-Products is the non-rendered, clean parts, other than meat, derived
from slaughtered mammals. It includes, but is not limited to, lungs, spleen, kidneys,
brain, livers, blood, bone, partially defatted low temperature fatty tissue, and stomachs
and intestines freed of their contents. It does not include hair, horns, teeth and hoofs. It
shall be suitable for use in animal food. If it bears name descriptive of its kind, it must
correspond thereto. (Proposed 1973, Adopted 1974, Amended 1978)
IFN 5-00-395 Animal meat by-products fresh
*9.7 Animal Liver if it bears a name descriptive of its kind, it must correspond
thereto. Meal is obtained by drying and grinding liver from slaughtered animals.
(Adopted 1954, Amended 2006)
IFN 5-00-389 Animal livers meal

9.10 Poultry By-Product Meal consists of the ground, rendered, clean parts of the
carcass of poultry, such as necks, feet, undeveloped eggs, viscera, and whole carcasses,
exclusive of added feathers, except in such amounts as might occur unavoidably in good
processing practices. The label shall include guarantees for minimum crude protein,
minimum crude fat, maximum calcium (Ca), and minimum phosphorus (P). The calcium
(Ca) level shall not exceed the actual level of phosphorus (P) by more than 2.2 times. If
the product bears a name descriptive of its kind, the name must correspond thereto. It
shall be suitable for use in animal food. (Proposed 1985, Adopted 1990, Amended 2000,
Proposed 2016 rev. 1, Adopted 2018 rev. 1)
IFN 5-03-798 Poultry by-product meal rendered
9.11 Poultry Hatchery By-Product is a mixture of eggshells, infertile and
unhatched eggs, and culled chicks which have been cooked, dried, and ground, with or
without removal of part of the fat. (Adopted 1957)
IFN 5-03-796 Poultry hatchery by-product meal
*9.12 Dried Meat Solubles is obtained by drying the defatted water extract of
the clean, wholesome parts of slaughtered animals prepared by steaming or hot water
extraction. It must be designated according to its crude protein content which shall be no
less than 70%. (Proposed 1961, Adopted 1962, Amended 1964,1967)
IFN 5-00-393 Animal meat solubles dehydrated
9.14 Poultry By-Products consists of nonrendered clean parts of poultry, such as
heads, feet, viscera, and whole carcasses, free from foreign matter except in such trace
amounts as might occur unavoidably in good processing practices. If the product bears a
name descriptive of its kind, the name must correspond thereto. It shall be suitable for use
in animal food. (Proposed 1963, Adopted 1964, Amended 2000, Proposed 2016 rev. 1,
Adopted 2018 rev. 1)
IFN 5-03-800 Poultry by-product fresh
9.15 Hydrolyzed Poultry Feathers is the product resulting from the treatment
under pressure of clean, undecomposed feathers from slaughtered poultry, free of
additives, and/or accelerators. Not less than 75% of its crude protein content must be
digestible by the pepsin digestibility method.** (Proposed 1961, Adopted 1965)
IFN 5-03-795 Poultry feathers meal hydrolyzed
*9.16 Fleshings Hydrolysate is obtained by acid hydrolysis of the flesh from fresh
or salted hides. It is defatted, strained, and neutralized. If evaporated to 50% solids, it
shall be designated “Condensed Fleshings Hydrolysate.” It must have a minimum crude
protein and maximum salt guarantee. (Proposed 1967, Adopted 1968) Reg. 573.200
IFN 5-08-094 Animal skin fleshings hydrolyzed rendered
9.20 Animal Serum is the product obtained by removing the fibrin from liquid
animal plasma by chemical and mechanical processes. The serum protein portion of this
product is primarily albumin and globulin proteins. The minimum percent crude protein,
maximum percent ash, minimum albumin content, and the minimum globulin content
must be guaranteed on the label. The minimum albumin content is 42% (as a percent of
total protein) determined by colorimetric assay (Doumas, B. T., Watson, W. A., Biggs,
H. G., Clin. Chim Acta. 1971) and the minimum globulin content is 20% (as a percent of
total protein) as measured by an assay method such as the Becker titer analysis (Becker,
W. 1969 Immunochemistry 6: 539-546). If the product bears a name descriptive of its
kind, origin or composition, it must correspond thereto. (Proposed 1996, Adopted 2000)
9.21 Serum Albumin is the product obtained by removing the fibrin and globulin
proteins from liquid animal plasma by chemical and mechanical processes. The resultant
product will be greater than 60% albumin (as a percent of total protein) as measured by
colorimetric assay (Doumas, B. T., Watson, W. A., Biggs, H. G., Clin Chim Acta. 1971). The
minimum percent crude protein and the maximum percent ash must be guaranteed on the

label as well as the minimum albumin concentration. If the product bears a name descriptive
of its kind, origin or composition, it must correspond thereto. (Proposed 1996, Adopted 2000)
9.22 Serum Globulin is the product obtained by removing the fibrin and albumin
proteins from liquid animal plasma by chemical and mechanical processes. The resultant
product will be greater than 40% globulin (as a percent of total protein) as measured by
an assay method such as the Becker titer analysis (Becker, W. 1969 Immunochemistry
6: 539-546). The minimum percent crude protein and the maximum percent ash must be
guaranteed on the label as well as the minimum globulin concentration. If the product
bears a name descriptive of its kind, origin or composition, it must correspond thereto.
9.24 Spray Dried Animal Blood Cells is the product obtained by spray drying
red and white blood cells which have been separated from the plasma of clean, fresh,
whole animal blood with only such amounts of plasma as might occur unavoidably in
good processing practices. The blood cells are dried by spraying into a draft of warm,
dry air which reduces the blood to finely divided particles. The guaranteed analysis
is: a maximum moisture of 8%; a minimum crude protein of 90%; and a minimum
solubility in water of 75%. If the product bears a name descriptive of its kind, origin, or
composition, it must correspond thereto. (Proposed 1996, Adopted 1998)
*9.40 Meat Meal is the rendered product from mammal tissues, exclusive of any added
blood, hair, hoof, horn, hide trimmings, manure, stomach and rumen contents except in such
amounts as may occur unavoidably in good processing practices. It shall not contain added
extraneous materials not provided for by this definition. The Calcium (Ca) level shall not
exceed the actual level of Phosphorus (P) by more than 2.2 times. It shall not contain more than
12% Pepsin indigestible residue** and not more than 9% of the crude protein in the product
shall be pepsin indigestible**. The label shall include guarantees for minimum crude protein,
minimum crude fat, maximum crude fiber, minimum Phosphorus (P) and minimum and maxi-
mum Calcium (Ca). If the product bears a name descriptive of its kind, composition or origin,
it must correspond thereto. (Proposed 1971, Adopted 1972, Amended 1985, Adopted 1993)
IFN 5-00-385 Animal meat meal rendered
*9.41 Meat and Bone Meal is the rendered product from mammal tissues, including
bone, exclusive of any added blood, hair, hoof, horn, hide trimmings, manure, stomach
and rumen contents, except in such amounts as may occur unavoidably in good processing
practices. It shall not contain added extraneous materials not provided for in this definition.
It shall contain a minimum of 4.0% Phosphorus (P) and the Calcium (Ca) level shall not
be more than 2.2 times the actual Phosphorus (P) level. It shall not contain more than 12%
pepsin indigestible residue** and not more than 9% of the crude protein in the product
CHAPTER SIX
shall be pepsin indigestible**. The label shall include guarantees for minimum crude
protein, minimum crude fat, maximum crude fiber, minimum Phosphorus (P) and minimum
and maximum Calcium (Ca). If it bears a name description of its kind, composition or
origin it must correspond thereto. (Proposed 1985, Amended 1992, Adopted 1994)
IFN 5-00-388 Animal meat with bone rendered
*9.42 Animal By-Product Meal is the rendered product from animal tissues, exclusive
of any added hair, hoof, horn, hide trimmings, manure, stomach and rumen contents, except
in such amounts as may occur unavoidably in good processing practices. It shall not contain
added extraneous materials not provided for by this definition. This ingredient definition
is intended to cover those individual rendered animal tissue products that cannot meet the
criteria as set forth elsewhere in this section. This ingredient is not intended to be used to
label a mixture of animal tissue products. (Proposed 1985, Amended 1992, Adopted 1993)
IFN 5-08-786
*9.50 Meat Meal Tankage is the rendered product from mammal tissues, exclusive
of any added hair, hoof, horn, hide trimmings, manure, stomach and rumen contents, except
in such amounts as may occur unavoidably in processing factory practices. It may contain

added blood or blood meal, however, it shall not contain any other added extraneous
materials not provided for by this definition. The Calcium (Ca) level shall not exceed the
actual level of Phosphorus (P) by more than 2.2 times. It shall not contain more than 12%
pepsin indigestible residue** and not more than 9% of the crude protein in the product shall
be pepsin indigestible**. The label shall include guarantees for minimum crude protein,
minimum crude fat, maximum crude fiber, minimum Phosphorus (P) and minimum and
maximum Calcium (Ca). If the product bears a name descriptive of its kind, composition or
origin it must correspond thereto. (Proposed 1985, Amended 1992, Adopted 1994)
IFN 5-00-386 Animal tankage meal rendered
*9.51 Meat and Bone Meal Tankage is the rendered product from mammal tissues,
including bone, exclusive of any added hair, hoof, horn, hide trimmings, manure, stomach and
rumen contents except in such amounts as may occur unavoidably in good processing practices.
It may contain added blood or blood meal, however, it shall not contain any added extraneous
materials not provided for in this definition. . It shall contain a minimum of 4.0% Phosphorus
(P) and the Calcium (Ca) level shall not be more than 2.2 times the actual Phosphorus (P) level.
It shall not contain more than 12% pepsin indigestible residue** and not more than 9% of the
crude protein in the product shall be pepsin indigestible**. The label shall include guarantees
for minimum crude protein, minimum crude fat, maximum crude fiber, minimum Phosphorus
(P) and minimum and maximum Calcium (Ca). If the product bears a name descriptive of
its kind, composition or origin it must correspond thereto. (Proposed 1985, Adopted 1994)
IFN 5-00-387 Animal tankage with bone rendered
*9.54 Hydrolyzed Hair is a product prepared from clean, undecomposed hair, by
heat and pressure to produce a product suitable for animal feeding. Not less than 80% of
its crude protein must be digestible by the pepsin digestibility method** (Proposed 1968,
Adopted 1970)
IFN 5-08-997 Animal hair hydrolyzed
*9.55 Hydrolyzed Leather Meal is produced from leather scrap that is treated with
steam for not less than 33 minutes at a pressure not less than 125 pounds per square inch
and further processed to contain not more than 10% moisture, not less than 60% crude
protein, not more than 6% crude fiber, not more than 2.75% chromium, and with not less
than 80% of its crude protein digestible by the pepsin digestibility method**. Hydrolyzed
leather meal may be utilized in livestock feeds as provided in food additive regulation
573.540 (Proposed 1968, Adopted 1970)
IFN 5-08-998 Animal leather meal hydrolyzed
9.56 Spray Dried Animal Blood is produced from clean, fresh animal blood,
exclusive of all extraneous material such as hair, stomach belching, urine, except in such
traces as might occur unavoidably in good factory practice. Moisture is removed from
the blood by a low temperature, evaporator under vacuum until it contains approximately
30% solids. It is then dried by spraying into a draft of warm, dry air which reduces
the blood to finely divided particles with a maximum moisture of 8% and a minimum
crude protein of 85%. It must be designated according to its minimum water solubility.
(Proposed 1972, Amended 1976, Adopted 1978)
IFN 5-00-381 Animal blood spray dehydrated
9.57 Poultry is the clean combination of flesh and skin with or without
accompanying bone, derived from the parts or whole carcasses of slaughtered poultry,
or a combination thereof, exclusive of feathers, heads, feet, and viscera. If it bears a
name descriptive of its kind, it must correspond thereto. If the bone has been removed,
the process may be so designated by use of the appropriate feed term. It shall be suitable
for use in animal food. (Proposed 1978, Adopted 1979, Amended 1995, Amended 1997,
Proposed 2016 rev. 1, Adopted 2018 rev. 1)
9.58 Hydrolyzed Whole Poultry is the product resulting from the hydrolyzation
of whole carcasses of culled or dead, undecomposed, poultry including feathers, heads,

feet, entrails, undeveloped eggs, blood and any other specific portions of the carcass. The
product must be consistent with the actual proportions of whole poultry and must be free
of added parts; including, but not limited to entrails, blood or feathers. The poultry may
be fermented as a part of the manufacturing process. The product shall be processed in
such a fashion as to make it suitable for animal food, including heating (boiling at 212°F,
or 100°C at sea level, for 30 minutes; dry extrusion at a minimum temperature of 284°F
or 140°C for 30 seconds with a pressure differential of approximately 40 atmospheres as
the product exits the extruder; or their equivalents) and agitating (except in steam cooking
equipment). The product may, if acid or alkaline treated, be subsequently neutralized.
If the product bears a name descriptive of its kind, the name must correspond thereto.
(Proposed 1995, Adopted 1997, Amended 2000, Adopted 2003)
9.59 Hydrolyzed Poultry By-Products Aggregate is the product resulting from
hydrolyzation, heat treatment, or a combination thereof, of all by-products of slaughter
poultry, clean and undecomposed, including such parts as heads, feet, undeveloped eggs,
intestines, feathers and blood. The parts may be fermented as a part of the manufacturing
process. The product shall be processed in such a fashion as to make it suitable for animal
food, including heating (boiling at 212°F, or 100°C at sea level for 30 minutes, or its
equivalent, and agitated, except in steam cooking equipment). It may, if acid treated, be
subsequently neutralized. If the product bears a name descriptive of its kind, the name
must correspond thereto. (Proposed 1978, Adopted 1980 Amended 1995, Adopted 1997)
9.60 Egg Shell Meal is a mixture of eggshells, shell membranes and egg content
obtained by drying the residue from an egg breaking plant in a dehydrator to an end
product temperature of 180°F. It must be designated according to its protein and calcium
content. (Proposed 1975, Adopted 1982)
IFN 6-26-004 Poultry egg shells meal
9.61 Blood Meal ____________ is produced from clean, fresh animal blood,
exclusive of all extraneous materials such as hair, stomach belchings and urine, except as
might occur unavoidably in good processing practices. The process used must be listed
as a part of the product name such as conventional cooker dried, steamed or hydrolyzed.
The product usually has a dark black like color and is rather insoluble in water. (Proposed
1975, Adopted 1979, Amended 1991, Adopted 1993)
IFN 5-26-005 Animal blood meal conventional cooker dehydrated
IFN Number ______ Animal blood meal steamed dehydrated
IFN Number ______ Animal blood meal hydrolyzed dehydrated
9.62 Blood Meal, Flash Dried is produced from clean, fresh animal blood,
exclusive of all extraneous material such as hair, stomach belchings and urine except
CHAPTER SIX
as might occur unavoidably in good manufacturing processes. A large portion of

the moisture (water) is usually removed by a mechanical dewatering process or
by condensing by cooking to a semi-solid state. The semi-solid blood mass is then
transferred to a rapid drying facility where the more tightly bound water is rapidly
removed. The minimum biological activity of lysine shall be 80%. (Proposed 1975,
Adopted 1980)
IFN 5-26-006 Animal blood meal flash dehydrated
9.63 Blood Protein is produced by quick freezing and/or transporting in a chilled
state, clean, fresh, whole or dewatered animal blood exclusive of all extraneous material
such as hair, stomach belchings and urine except as might occur unavoidably in good
manufacturing processes. If the product bears a name descriptive of its kind, composition
or origin, it must correspond thereto. (Proposed 1975, Amended 1980, Adopted 1982,
Amended 1993, Adopted 1994)
IFN 5-25-007 Animal blood fresh
*9.65 Glandular Meal and Extracted Glandular Meal is obtained by drying liver
and other glandular tissues from slaughtered mammals. When a significant portion of the

water-soluble material has been removed, it may be called Extracted Glandular Meal.
IFN 5-12-247 Animal glands meal
IFN 5-30-080 Animal glands meal water extracted
*9.67 Unborn Calf Carcasses is the product obtained from whole unborn carcasses
taken from slaughtered cows at government inspected slaughter plants. The product is
produced by grinding the whole unborn carcass, exclusive of calf hides. The product is
denatured, fresh frozen and shall be suitable for use as an animal feed. (Proposed 1979,
Adopted 1980)
IFN 5-30-081 Cattle fetus carcass without skin fresh 
*9.68 Animal Digest is a material which results from chemical and/or enzymatic
hydrolysis of clean and undecomposed animal tissue. The animal tissues used shall be
exclusive of hair, horns, teeth, hooves and feathers, except in such trace amounts as might
occur unavoidably in good factory practice and shall be suitable for animal feed. If it
bears a name descriptive of its kind or flavor(s), it must correspond thereto. (Proposed
IFN 5-06-935 Animal Digest Condensed
*9.69 Cooked Bone Marrow is the soft material coming from the center of large
bones, such as leg bones. This material, which is predominantly fat with some protein,
must be separated from the bone material by cooking with steam. It shall not contain
added extraneous materials not provided for by this definition except for small amount
of tissue which may adhere to the bone unavoidably in good processing practice. The
labeling of this product shall include, but is not limited to, guarantees for minimum crude
protein and minimum crude fat. (Proposed 1988, Adopted 1992)
*9.70 Mechanically Separated Bone Marrow is the soft material coming from
the center of large bones, such as leg bones. This material, which is predominantly fat
with some protein, must be separated from the bone material by mechanical separation.
It shall not contain added extraneous materials not provided for by this definition except
for small amount of tissue which may adhere to the bone unavoidably in good processing
practice. The labeling of this product shall include, but is not limited to, guarantees for
minimum crude protein and minimum crude fat. (Proposed 1988, Adopted 1992)
9.71 Poultry Meal is the wet rendered or dry rendered product from a combination
of clean flesh and skin with or without accompanying bone, derived from the parts of
whole carcasses of slaughtered poultry, or a combination thereof, exclusive of feathers,
heads, feet, and viscera. The label shall include guarantees for minimum crude protein,
minimum crude fat, maximum calcium (Ca), and minimum phosphorus (P). The calcium
(Ca) level shall not exceed the actual level of phosphorus (P) by more than 2.2 times. If
it bears a name descriptive of its kind, it must correspond thereto. It shall be suitable for
use in animal food. (Proposed 1988, Adopted 1992, Proposed 2016 rev. 1, Adopted 2018
rev. 1)
9.72 Animal Plasma is the product obtained by spray drying plasma which has been
separated away from the cellular matter (red and white blood cells) of fresh whole blood
by chemical and mechanical processing. The protein portion of this product is primarily
albumin, globulin, and fibrinogen type proteins. The minimum percent crude protein and
the maximum percent ash must be guaranteed on the label. If it bears a name descriptive
of its kind, composition, or origin, it must correspond thereto. (Proposed 1990, Adopted
1993)
9.73 Ensiled Paunch is a product composed of the contents of rumen of cattle
slaughtered at USDA inspected facilities. The moisture level is reduced to 50-68%. The
product is then packed into an airtight environment, such as a silo, where it undergoes an
acid fermentation that retards spoilage. The ensiled product will have a pH of 4.0 or less.

9.74 Egg Product is product obtained from egg graders, egg breakers and/or
hatchery operations that is dehydrated, handled as liquid, or frozen. These sources shall
be labeled as per USDA regulations governing eggs and egg products (9CFR, 590). This
product shall be free of shells or other non-egg materials except in such amounts which
might occur unavoidably in good processing practices, and contain a maximum ash
content of 6% on a dry matter basis. (Proposed 1991, Adopted 1996, Amended 2008)
9.75 Leather Hydrolysate is obtained from chromium tanned unfinished leather
shavings, trimmings, and/or lime fleshings that may or may not be pressure cooked
with the addition of steam, sodium hydroxide, lime or magnesium oxide. Chromium is
precipitated and separated so that only trivalent chromium at less than 1000 ppm on a dry
matter basis remains in the hydrolysate. This product is available as a liquid ingredient
or as a spray dried powder. In either form, the analysis on a solids basis will not be less
than 75% crude protein and not less than 85% of the protein shall be pepsin digestible**.
(Adopted 1993, Amended 1999, Adopted 2001)
*9.77 _____ Stock/Broth is obtained by cooking mammalian or poultry bones,
parts, and/or muscle tissue. The crude protein content of stock/broth must be no less than
90% on a dry matter basis. In order for the stock/broth to be labeled as such, the moisture
to crude protein ratio must not exceed 135:1 (135 parts water to 1 part crude protein). The
product must bear a name descriptive of its kind, composition or origin, such as, but not
limited to, meat, beef, pork, poultry, chicken, turkey: and may be called either stock or
broth. (Proposed 1997, Amended 2001, Adopted 2002)
*9.78 Meat Protein Isolate is produced by separating meat protein from fresh,
clean, unadulterated bones by heat processing followed by low temperature drying to
preserve function and nutrition. This product is characterized by a fresh meaty aroma, a
90% minimum protein level, 1% maximum fat and 2% maximum ash. (Proposed 1993,
Adopted 1994)
**Determined by AOAC method listed in the Check Sample Reference for
Analytical Variations.
9.79 Air Dried Animal Blood Cells (Air Swept Tubular Drying) is obtained by
drying red and white blood cells which have been separated from the plasma of clean,
fresh, whole animal blood with only such amounts of plasma as might occur unavoidably
in good processing methods. The blood cells are dried by exposing the cells to a heated
air stream and retaining them in the maximum moisture of 11%; and a minimum protein
of 90%. If the product bears a name descriptive of its kind, origin, or composition it must
correspond thereto. (Proposed 2008, Adopted 2010)
9.80 Hydrolyzed Whole Swine is the product resulting from the hydrolyzation of
CHAPTER SIX
whole carcasses of culled or dead, undecomposed, swine, including heads, feet, viscera,
blood and any other specific portions of the carcass. The product must be consistent
with the actual proportions of whole swine and must be free of added parts; including,
but not limited to viscera, blood or hair. The swine may be fermented as a part of the
manufacturing process. The product shall be processed in such a fashion as to make it
suitable for animal food, including heating (boiling at 212° F or 100° C at sea level for 30
minutes; dry extrusion at a minimum temperature of 284° F or 140°C for 30 seconds with
a pressure differential of approximately 40 atmospheres as the product exits the extruder;
or their equivalent) and agitating (except in steam cooking equipment). The product
may, if acid or alkaline treated, be subsequently neutralized. If the product bears a name
descriptive of its kind, the name must correspond thereto. (Proposed 2007, Adopted 2010)

12. Barley Products

Investigator and Section Editor—Dan King, MN
Official
12.1 Barley Hulls consist of the outer covering of the barley. (Adopted prior to 1928)
IFN 1-00-496 Barley hulls
12.3 Pearl Barley By-Product is the entire by-product resulting from the
manufacture of pearl barley from clean barley. (Proposed 1961, Adopted 1962)
IFN 5-00-548 Barley pearl by-product
12.4 Barley Mill By-Product is the entire residue from the milling of barley flour
from clean barley and is composed of barley hulls and barley middlings. (Proposed 1961,
Adopted 1962)
IFN 4-00-523 Barley mill run
12.6 Barley Distillers Protein Concentrate is the dried protein fraction of barley
prepared by enzymatic hydrolysis and Saccharomyces cerevisiae yeast fermentation of
starch, beta glucans and fiber. The ingredient is prepared from high quality, sound, cleaned
dehulled or hulless barley. It must contain not less than 54% protein (primarily from
barley) on a dry basis and with a moisture content of less than 10%. The crude protein
equivalent from added non-protein nitrogen must be declared on the label. It is to be used
in the feed of fish as a source of protein. If a conditioning or dust control agent is used, the
agent must be shown as an added ingredient. (Tentative 2012, Adopted 2014 rev. 1)
15. Brewers Products

Investigator and Section Editor—Nathan Price, ID
Official
15.1 Brewers Dried Grains is the dried extracted residue of barley malt alone or
in mixture with other cereal grain or grain products resulting from the manufacture of
wort or beer and may contain pulverized dried spent hops in an amount not to exceed 3%,
evenly distributed. (Adopted 1965, Amended 1972)
IFN 5-00-516 Barley brewers grains dehydrated
15.2 Malt Sprouts is obtained from malted barley by the removal of the rootlets
and sprouts which may include some of the malt hulls, other parts of malt and foreign
material unavoidably present. It must contain not less than 24% crude protein. The term
malt sprouts when applied to a corresponding portion of other malted cereals must be
used in qualified form: i.e., “Rye Malt Sprouts,” “Wheat Malt Sprouts,” etc. (Adopted
1942, Amended 1964, 1980)
IFN 5-00-545 Barley malt sprouts dehydrated
IFN 5-04-048 Rye malt sprouts dehydrated
IFN 5-29-796 Wheat malt sprouts dehydrated
15.3 Malt Cleanings is obtained from the cleaning of malted barley or from the
recleaning of malt which does not meet the minimum crude protein standard of malt sprouts.
It must be designated and sold according to its crude protein content. (Adopted 1942)
IFN 5-00-544 Barley malt cleanings dehydrated
15.4 Malt Hulls consists almost entirely of hulls as obtained in the cleaning of
malted barley. (Adopted 1942)
IFN 1-00-497 Barley malt hulls
15.5 Dried Spent Hops is obtained by drying the material filtered from hopped
wort. (Adopted 1944)
IFN 5-02-396 Hop common fruit (hops) spent dehydrated
15.6 Brewers Wet Grains is the extracted residue resulting from the manufacture
of wort from barley malt alone or in mixture with other cereal grains or grain products.

The guaranteed analysis shall include the maximum moisture. (Proposed 1971,
Adopted 1974)
IFN 5-00-517 Barley brewers grains wet
15.7 Brewers Condensed Solubles is obtained by condensing liquids resulting as
by-products from manufacturing beer or wort. It must contain not less than 20% total
solids, 70% carbohydrates on a dry matter basis and the guaranteed analysis shall include
maximum moisture. (Proposed 1975)
IFN 5-12-239 Barley brewers soluble condensed
18. Preservatives
Official
18.1 Chemical Preservatives

When using any of these materials, a statement of the fact that a preservative has
been added must be shown. Examples: BHA (a preservative), or preserved with BHT, or
sorbic acid added to retard mold growth.
Classification
Under Food
FDA Additives Limitations or
Name Regulations Amendment Restrictions
Ascorbic acid Reg. 582.3013 Chemical Nonea
preservative
IFN 7-00-433
Ascorbyl palmitate Reg. 582.3149 Chemical Nonea
preservative
IFN 8-26-245
Benzoic acid Reg. 582.3021 Chemical Not to exceed 0.1%
preservative
IFN 8-26-244
Butylated hydroxy Reg. 582.3169 Chemical Total content of
anisole (BHA)b preservative preservatives not more than
0.02% of fat or oil content
including essential (volatile)
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oil content of food

Butylated Reg. 582.3173 Chemical Total content of
hydroxytoluene preservative preservatives not more than
(BHT)b 0.02% of fat or oil content
IFN 8-01-045 oil content of food
Calcium ascorbate Reg. 582.3189 Chemical Nonea
preservative
IFN 8-26-246
Calcium propionate Reg. 582.3221 Chemical Nonea
IFN 8-01-085 preservative
(continued)

Classification
Under Food
Calcium sorbate Reg. 582.3225 Chemical Nonea
preservative
IFN 8-01-086
Citric acid Reg. 582.6033, Chemical Nonea
21 CFR 582.1033 preservative
IFN 8-01-233
Dilauryl Reg. 582.3280 Chemical Total content of
thiodipropionate preservative preservatives not more than
Distearyl Chemical Total content of
thiodipropionate preservative preservatives not more than
Erythorbic acid Reg. 582.3041 Chemical Nonea
preservative
IFN 8-09-823
Ethoxyquin Reg. 573.380 Chemical 0.015% in or on feed (a) it
preservative is intended for use only: (1)
as a chemical preservative
for retarding oxidation of
carotene, xanthophylls, and
vitamins A and E in animal
feed and fish feed, and (2)
as an aid in preventing the
development of organic
IFN 8-01-841 peroxides in canned pet food.
Gum guaiac Reg. 582.3336 Chemical 0.1% (equivalent
preservative preservative activity 0.01%)
IFN 8-03-909 only in edible fats or oils
Methylparaben Reg. 582.3490 Chemical 0.1%
preservative
IFN 8-03-088
Potassium bisulfite Reg. 582.3616 Chemical Not for use in meats or
preservative vitamin B1 sources
IFN 8-26-302
Potassium Reg. 582.3637 Chemical Not for use in meats or
metabisulfite preservative vitamin B1 sources
IFN 8-26-203
Potassium sorbate Reg. 582.3640 Chemical Nonea
preservative
IFN 8-03-761
(continued)
Classification
Under Food
Propionic acid Reg. 582.3081 Chemical Nonea
preservative
IFN 8-02-807
Propyl gallate Reg. 582.3660 Chemical Total content of
preservative preservatives not more than
Propylparaben Reg. 582.3670 Chemical 0.1%
preservative
IFN 8-03-810
Sodium ascorbate Reg. 582.3731 Chemical Nonea
preservative
IFN 8-26-304
Sodium benzoate Reg. 582.3733 Chemical 0.1%
preservative
IFN 8-04-271
Sodium bisulfite Reg. 582.3739 Chemical Not for use in meats or
preservative vitamin B1 sources
IFN 8-26-305
Sodium Reg. 582.3766 Chemical Not for use in meats or
metabisulfite preservative vitamin B1 sources
IFN 8-26-306
Sodium nitrite Reg. 573.700 Preservative and 20 ppm
color fixative (0.002%)
in canned pet
food containing
fish, meat, fish
by-products,
CHAPTER SIX
or meat
IFN 8-04-283 by-products
Sodium propionate Reg. 582.3784 Chemical Nonea
Sodium sorbate Reg. 582.3795 Chemical Nonea
Sodium sulfite Reg. 582.3798 Chemical Not for use in meats or
IFN 8-26-307 preservative vitamin B1 sources
Sorbic acid Reg. 582.3089 Chemical Nonea
Stannous chloride Reg. 582.3845 Chemical Not to exceed 0.0015%
IFN 8-26-308 preservative as tin
(continued)

Classification
Under Food
Sulfur dioxide Reg. 582.3862 Chemical Not for use in meats or
IFN 8-26-309 preservative vitamin B1 sources
Tertiary butyl I.R.P.c Chemical Total content of
hydroquinone Preservative preservatives not more than
(TBHQ) 0.02% of fat or oil content
Thiodipropionic Reg. 582.3109 Chemical Total content of
acid preservative preservatives not more than
Tocopherols Reg. 582.3890 Chemical Nonea
preservative
IFN 7-05-038
aNone = no quantitative restrictions, although use must conform to good manufacturing
practices.
NOTE: When using any of the above materials, a statement of the fact that a chemical
preservative has been added must be shown. Examples: BHA (a preservative), or
preserved with BHT, or sorbic acid added to retard mold growth, etc.
NOTE: International feed name and AAFCO name are identical for the above chemical
preservatives.
bFor BHA and BHT either the name or the abbreviation may be used.
cI.R.P. = informal review process.
21. Citrus Products

Investigator and Section Editor—Michael Davidson, CA
Official
21.1 Dried Citrus Pulp is the ground peel, residue of the inside portions, and
occasional cull fruits of the citrus family which have been dried, producing a coarse, flaky
product. It may contain dried citrus meal or pellets and whole citrus seeds. If calcium
oxide or calcium hydroxide is added as an aid in processing, the maximum percentage
present, expressed as calcium (Ca), must be shown. If it bears a name descriptive of its
kind or origin, it must correspond thereto. (Adopted 1958, Amended 1965)
IFN 4-01-237 Citrus pomace without fines dehydrated (pulp)
21.2 Dried Citrus Meal is the finer particles obtained by screening dried citrus pulp.
IFN 4-01-235 Citrus pomace fines dehydrated (pulp)
21.3 Citrus Seed Meal, Mechanical Extracted, is the seed or seed meats of orange
and grapefruit from which most of the oil has been removed by means of pressure. It
is composed mostly of the kernel with such portions of the hull and pulp as cannot be
avoided in the manufacture of Citrus Seed Oil. It may be designated and sold according
to its crude protein content. (Adopted 1958, Amended 1965)
IFN 5-01-239 Citrus seeds meal mechanical extracted.

22. Collective Terms

Investigator and Section Editor—Jacob Fleig, MO
Official
Collective terms recognize a general classification of ingredient origin, which
perform a similar function, but do not imply equivalent nutritional values.
When a collective term is used, individual ingredients within that group cannot be
listed on the label.
The control official shall be provided, upon request, the ingredients that are being
used within each collective term by the manufacturer using collective terms.
22.1 Animal Protein Products may include one or more of the following:
9.61 Blood Meal _______ 9.51a Meat and Bone Meal Tankage
9.42 a Animal By-Product Meal 9.40a Meat Meal
54.2 Buttermilk, Condensed 9.50a Meat Meal Tankage
54.1 Buttermilk, Dried 9.12a Meat Solubles, Dried
54.16 Casein 54.18 Lactalbumin, Dried
54.21 Casein, Dried Hydrolyzed 54.19 Milk, Dried Feed Grade
54.17 Cheese Rind 54.20 Milk Protein, Dried
51.4 Crab Meal 9.14 Poultry By-Products
54.31 Dried Cheese 9.10 Poultry By-Product Meal
54.32 Dried Cheese Product 9.11 Poultry Hatchery By-Product
51.10 Fish By-Products 51.5 Shrimp Meal
51.34 Fish Liver and Glandular Meal 54.4 Skimmed Milk, Condensed
51.14 Fish Meal 54.6 Skimmed Milk, Condensed Cultured
51.9 Fish Protein Concentrate 54.3 Skimmed Milk, Dried
51.24 Fish Residue Meal 54.5 Skim Milk, Dried Cultured
51.6 Fish Solubles, Condensed 54.8 Whey, Condensed
51.7 Fish Solubles, Dried 54.15 Whey, Condensed Cultured
9.16a Fleshings Hydrolysate 54.12 Whey, Condensed Hydrolyzed
9.54a Hydrolyzed Hair 54.7 Whey, Dried
9.55a Hydrolyzed Leather Meal 54.11 Whey, Dried Hydrolyzed
9.59 Hydrolyzed Poultry By-Product 54.13 Whey Product, Condensed
Aggregate
CHAPTER SIX
9.15 Hydrolyzed Poultry Feathers 54.14 Whey Product, Dried

9.58 Hydrolyzed Whole Poultry 54.10 Whey Solubles, Condensed
9.75 Leather Hydrolysate 54.9 Whey Solubles, Dried
9.41a Meat and Bone Meal
aUse of this ingredient, from mammalian origins, is restricted to non-ruminant feeds
22.2 Forage Products may include one or more of the following:
3.2 Alfalfa Meal, Dehydrated or Pellets 71.3 Flax Plant Product
3.1 Alfalfa Hay, Ground 60.11 Ground Grass
3.1 Alfalfa Meal, Suncured or Pellets 45.1 Lespedeza Meal
60.27 Coastal Bermudagrass Hay 45.2 Lespedeza Stem Meal
48.20 Corn Plant, Dehydrated 84.2 Soybean Hay, Ground

60. Dehydrated Silage (Ensilage Pellets)
22.3 Grain Products—In any of the normal forms such as whole, ground,
cracked, screen cracked, flaked, kibbled, toasted, or heat processed:
a Barley a Wheat
48.3, 48.4, 48.5, 48.6 Corn 75.5 Brown Rice, Ground
48.11, 48.12, 48.19 (corn) 75.2 Rough Rice, Ground or Ground Paddy
42.1, 42.6 Grain Sorghum 75.4 Broken, or Chipped Rice
69.6 Mixed Feed Oats 75.4 Rice, Brewers
a Oats a Rye
a Triticale
aNo official definition for the grain product.
22.4 Plant Protein Products may include one or more of the following:
60.34 Beans, Dried 84.7, 84.60, Soybean Meal
71.77 Canola Meal 84.61
71.60, 71.61 Coconut Meal 84.71 Soybean Meal, Dehulled,
24.30, 24.31 Cottonseed Flakes Mechanical Extracted
24.2 Cottonseed Cake 84.13 Soybean Meal, Kibbled
24.10, 24.12 Cottonseed Meal 84.11 Soybeans Heat Processed
24.50, 24.51 Cottonseed Meal, Low 84.15 Whole Soybeans, Ground
Gossypol Extruded
24.4 Cottonseed, Whole 84.51 Soy Flour
Pressed 84.5 Soy Grits
60.18 Guar Meal 84.62 Soy Protein Isolate
84.63 Hydrolyzed Soy Protein 71.220, Sunflower Meal
60.19 Kelp, Dried 71.221
71.1, 71.11 Linseed Meal 71.210, Sunflower Meal, Dehulled
71.9 Peanut Meal 71.211
a Peas 84.64 Textured Soy Protein Product
60.94 Potato Protein 96.2 Yeast, Active Dry
84.16 _____ Protein Modified 96.4 Yeast, Brewers Dried
60.76 Seaweed Meal, Dried 96.8 Yeast, Culture
71.130, Safflower Meal 96.1 Yeast, Dried
71.131 96.1 Yeast, Primary Dried
84.12 Soy Protein Concentrate 96.7 Yeast, Torula Dried or Candida
84.4 Soybean Feed Dried
84.1 Soybeans, Ground
aNo official definition for the plant protein product.
22.5 Processed Grain By-Products may include one or more of the following:
60.43 Aspirated Grain Fractions 48.16, 48.26 Hominy Feed
15.1 Brewers Dried Grains 15.2 Malt Sprouts
60.6 Buckwheat Middlings 69.1 Oat Groats
27.7 Condensed Distillers Solubles 69.3 Oat Meal, Feeding

48.24 Condensed Fermented Corn 42.10 Grain Sorghum Mill Feed

Extractives 12.3 Pearl Barley By-Product
48.2 Corn Bran 71.21 Peanut Skins
48.8 Corn Flour 75.3, 75.7 Rice Bran
48.22, Corn Germ Meal 75.1 Rice Polishings
48.23 78.2 Rye Middlings
48.13 Corn Gluten Feed 42.8 Sorghum Grain Flour, Gelatinized
48.14 Corn Gluten Meal 42.9 Sorghum Grain Flour, Partially
Aspirated
48.7 Corn Grits 93.1 Wheat Bran
27.5 _____ Distillers Dried Grains 93.2 Wheat Flour
27.6 _____ Distillers Dried Grains 93.6 Wheat Shorts
With Solubles
27.4 _____ Distillers Dried Solubles 93.3 Wheat Germ Meal
a _____ Flour 93.8 Wheat Germ Meal, Defatted
42.4 Grain Sorghum Germ Cake 93.5 Wheat Middlings
42.4 Grain Sorghum Germ Meal 93.4 Wheat Mill Run
42.7 Grain Sorghum Grits 93.7 Wheat Red Dog
22.6 Roughage Products may include one or more of the following:

60.7 Almond Hulls 60.84 Psyllium Seed Husk
60.2 Apple Pectin Pulp, Dried 15.4 Malt Hulls
60.1 Apple Pomace, Dried 69.4 Clipped Oat By-Product
63.26 Bagasse 69.2 Oat Hulls
12.1 Barley Hulls 69.7 Oat Mill By-Product
12.4 Barley Mill By-Product 71.6 Peanut Hulls
63.36 Beet Pulp, Dried, Plain 75.6 Rice Hulls
60.17 Buckwheat Hulls 75.8 Rice Mill By-Product
21.2 Citrus Meal, Dried 78.1 Rye Mill Run
21.1 Citrus Pulp, Dried 84.3 Soybean Hulls
21.3 Citrus Seed Meal 84.8 Soybean Mill Feed
48.1 Corn Cob Fractions 84.9 Soybean Mill Run
CHAPTER SIX
24.6 Cottonseed Hulls 71.23 Sunflower Hulls

71.4 Flax Straw By-Product 60.10 Straw, Ground
48.21 Corn Cob, Ground 60.8 Tomato Pomace, Dried
22.7a Molasses Products may include one or more of the following:

63.1 Beet Molasses 36.10 Condensed Molasses Fermentation
Solubles
63.39 Beet Molasses, Dried Product 63.6 Starch Molasses
63.37 Beet Pulp, Dried, Molasses 27.2 Molasses Distillers Cond. Solubles
63.7 Cane Molasses 27.1 Molasses Distillers Dried Solubles
63.3 Citrus Molasses
63.81 Concentrated Separator By- 96.9 Molasses Yeast Condensed
Product Solubles
aThe molasses collective term is not recognized by the FDA (21 CFR 501.110).

24. Cottonseed Products

Investigator and Section Editor—Michael Davidson, CA
Official
24.14 Ammoniated Cottonseed Meal is obtained by the treatment of cottonseed
meal with anhydrous ammonia until a pressure of 50 pounds per square inch gauge is
reached. It is to be used in the feed of ruminants as a source of protein and/or as the sole
source of non-protein nitrogen in an amount not to exceed 20% of the total ration.
The label of the additive and of any feed additive supplement, feed additive
concentrate, or feed additive premix prepared therefrom, must contain the following
information in addition to any other required information:
(1) The name of the additive.
(2) The maximum percentage of equivalent crude protein from non-protein
nitrogen.
(3) Directions for use to provide not more than 20% of the additive in the total
ration and a prominent statement: “Warning--This feed should be used only
in accordance with the directions furnished on the label.” (Reg. 573.140)
(Proposed 1969, Adopted 1970.)
IFN 5-09-352 Cotton seeds meal solvent extracted ammoniated
24.10 Cottonseed Meal, Mechanical Extracted, is the product obtained by finely
grinding the cake, which remains after removal of most of the oil from cottonseed by
a mechanical extraction process. It must contain not less than 36% crude protein. It
may contain an inert, non-toxic conditioning agent either nutritive or non-nutritive or
any combination thereof, to reduce caking and improve flowability in an amount not
to exceed that necessary to accomplish its intended effect and in no case exceed 0.5%.
The name of the conditioning agent must be shown as an added ingredient. The words
“mechanical extracted” are not required when listing as an ingredient in a manufactured
feed. (Proposed 1984, Adopted 2002)
IFN 5-01-625 Cotton seeds meal mechanical extracted 36% protein
24.12 Cottonseed Meal, Solvent Extracted, is the product obtained by finely
grinding the flakes, which remain after removal of most of the oil from cottonseed by
a solvent extraction process. It must contain not less then 36% crude protein. It may
contain an inert, non-toxic conditioning agent either nutritive or non-nutritive or any
combination thereof, to reduce caking and improve flowability in an amount not to
exceed that necessary to accomplish its intended effect and in no case exceed 0.5%.
The name of the conditioning agent must be shown as an added ingredient. The words
“solvent extracted” are not required when listing as an ingredient in a manufactured feed.
IFN 5-01-632 Cotton seeds meal solvent extracted 36% protein
24.2 Cottonseed Cake, Mechanical Extracted, is the unground product composed
of the kernel and such portions of the lint, hull, and oil as remain after removal of most of
the oil from cottonseed by a mechanical process. It must contain not less than 36% crude
protein. The words “mechanical extracted” are not required when listing as an ingredient
in a manufactured feed. (Proposed 1964, Adopted 1966, Amended 1968)
IFN 5-01-623 Cotton seeds mechanical extracted caked 36% protein
24.30 Cottonseed Flakes, Mechanical Extracted, is the unground product,
composed of the kernel and such portions of the lint, hull, and oil as remain after
removal of the oil from cottonseed by a mechanical extraction process. It must contain
not less than 36% crude protein. The words “mechanical extracted” are not required
when listing as an ingredient in a manufactured feed. (Proposed 1964, Adopted 1966,
Amended 1968)
IFN 5-08-820 Cotton seeds mechanical extracted flaked 36% protein

24.31 Cottonseed Flakes, Solvent Extracted, is the unground product, composed

of the kernel and such portions of the lint, hull, and oil as remain after removal of the oil
from cottonseed by a solvent extraction process. It must contain not less than 36% crude
protein. The words “solvent extracted” are not required when listing as an ingredient in a
manufactured feed. (Proposed 1964, Adopted 1966, Amended 1968)
IFN 5-01-629 Cotton seeds solvent extracted flaked 36% protein
NOTE: The following levels of minimum crude fat and maximum crude fiber are
adopted for cottonseed meals, cake, or flakes, of respective grade.
Crude Fat
Crude Protein Mechanical Solvent Crude Fiber
36% 2.0% 0.5% 17%
41% 2.0% 0.5% 14%
43% 2.0% 0.5% 13%

This product (when sold or distributed singly) may be additionally labeled with the
following bold face terms when the requirements thereinafter are met;
________, Prime Quality must be free of mold, excess lint, and sour, musty, or
burnt odors.
________, Off Quality shall be that which does not meet the prime quality requirements.
24.4 Whole-Pressed Cottonseed, Mechanical Extracted, is composed of sound,
mature, clean, delinted, and unhulled cottonseed, from which most of the oil has been
removed by mechanical pressure. It must be designated and sold by its crude protein
content. If ground, it must be so designated. The words “mechanical extracted” are not
required when listing as an ingredient in a manufactured feed. (Proposed 1964, Adopted
1966, Amended 1968)
IFN 5-01-609 Cotton seeds meal mechanical extracted
24.50 Low Gossypol Cottonseed Meal, Mechanical Extracted, is a meal in which
the gossypol is not more than 0.04% free gossypol. The words “mechanical extracted”
are not required when listing as an ingredient in a manufactured feed. (Proposed 1964,
Adopted 1966, Amended 1968)
CHAPTER SIX
IFN 5-09-002 Cotton seeds low gossypol meal mechanical extracted

24.51 Low Gossypol Cottonseed Meal, Solvent Extracted, is a meal in which the
gossypol is not more than 0.04% free gossypol. The words “solvent extracted” are not
1966, Amended 1968)
IFN 5-01-633 Cotton seeds low gossypol meal solvent extracted
24.6 Cottonseed Hulls consist primarily of the outer covering of the cottonseed.
IFN 1-01-599 Cotton hulls
24.7 Cottonseed Screenings is obtained in the commercial delinting and processing
of cottonseeds for planting purposes. It consists of lint, stems, leaves, small and immature
seeds, sand and/or dirt. It must contain a minimum of 12% crude protein and not more than
30% crude fiber. It must be labeled with minimum guarantees for crude protein and crude
fat and maximum guarantees for crude fiber and ash. If it contains more than 6.5% ash, the
words “sand” and/or “dirt” must appear in the product name. (Proposed 1980, Adopted 1983)
IFN 4-12-023 Cotton seed screenings

24.8 Cotton Plant By-Product is the residue from the ginning of cotton. It consists
of cotton burrs, leaves, stems, lint, immature seeds, and sand and/or dirt. It shall not
contain more than 38% crude fiber, nor more than 15% ash. It must be labeled with
minimum guarantees for crude protein and crude fat and maximum guarantees for crude
fiber and ash. If it contains more than 15.0% ash, the words “sand and/or dirt” must
appear in the product name. (Proposed 1980, Adopted 1983, Amended 1984)
IFN 1-08-413 Cotton gin by-product
27. Distillers Products

Investigator and Section Editor—Steve Gramlich, NE
Official
27.1 Molasses Distillers Dried Solubles is obtained by drying the residue from the
yeast fermentation of molasses after the removal of the alcohol by distillation. (Adopted
1943, Amended 1944)
IFN 4-04-698 Sugarcane molasses distillers solubles dehydrated
27.2 Molasses Distillers Condensed Solubles is obtained by condensing to a
syrupy consistency the residue from the yeast fermentation of molasses after the removal
of the alcohol by distillation. (Adopted 1946)
IFN 4-04-697 Sugarcane molasses distillers solubles condensed
27.3 Potato Distillers Dried Residue is the dried product obtained after the
manufacture of alcohol and distilled liquors from potatoes or from a mixture in which
potatoes predominate. (Adopted 1947)
IFN 5-03-773 Potato distillers residue dehydrated
27.4 ____________Distillers Dried Solubles is obtained after the removal of
ethyl alcohol by distillation from the yeast fermentation of a grain or a grain mixture
by condensing the thin stillage fraction and drying it by methods employed in the grain
distilling industry. The predominating grain must be declared as the first word in the
name. (Proposed 1963, Adopted 1964)
IFN 5-00-520 Barley distillers solubles dehydrated
IFN 5-02-147 Cereals distillers solubles dehydrated
IFN 5-02-844 Maize distillers solubles dehydrated
IFN 5-04-026 Rye distillers solubles dehydrated
IFN 5-04-376 Sorghum distillers solubles dehydrated
IFN 5-05-195 Wheat distillers solubles dehydrated
27.5 ____________ Distillers Dried Grains is obtained after the removal of
ethyl alcohol by distillation from the yeast fermentation of a grain or a grain mixture
by separating the resultant coarse grain fraction of the whole stillage and drying it by
methods employed in the grain distilling industry. The predominating grain shall be
declared as the first word in the name. (Proposed 1963, Adopted 1964)
IFN 5-00-518 Barley distillers grains dehydrated
IFN 5-02-144 Cereals distillers grains dehydrated
IFN 5-02-842 Maize distillers grains dehydrated
IFN 5-04-023 Rye distillers grains dehydrated
IFN 5-04-374 Sorghum distillers grains dehydrated
IFN 5-05-193 Wheat distillers grains dehydrated
27.6 ____________ Distillers Dried Grains with Solubles is the product obtained
after the removal of ethyl alcohol by distillation from the yeast fermentation of a grain or
a grain mixture by condensing and drying at least 3/4 of the solids of the resultant whole
stillage by methods employed in the grain distilling industry. The predominating grain
shall be declared as the first word in the name. (Proposed 1963, Adopted 1964)

IFN 5-12-185 Barley distillers grains with solubles dehydrated

IFN 5-07-987 Cereals distillers grains with solubles dehydrated
IFN 5-02-843 Maize distillers grains with solubles dehydrated
IFN 5-04-024 Rye distillers grains with solubles dehydrated
IFN 5-04-375 Sorghum distillers grains with solubles dehydrated
IFN 5-05-194 Wheat distillers grains with solubles dehydrated
27.7 ____________ Condensed Distillers Solubles is obtained after the removal
of ethyl alcohol by distillation from the yeast fermentation of a grain or a grain mixture
by condensing the thin stillage fraction to a semi-solid. The predominating grain must be
declared as the first word in the name. (Proposed 1969, Adopted 1970)
IFN 5-12-210 Barley distillers solubles condensed
IFN 5-02-146 Cereals distillers solubles condensed
IFN 5-12-211 Maize distillers solubles condensed
IFN 5-12-212 Rye distillers solubles condensed
IFN 5-12-231 Sorghum distillers solubles condensed
IFN 5-12-213 Wheat distillers solubles condensed
27.8 ____________Distillers Wet Grains is the product obtained after the removal of
ethyl alcohol by distillation from the yeast fermentation of a grain or a grain mixture. The
guaranteed analysis shall include the maximum moisture. The predominating grain must be
declared as the first word in the name. (Proposed 1981, Adopted 1982, Amended 2007)
IFN 5-16-149 Cereals distillers grains wet
27.9 Deoiled Corn Distillers Dried Grains with Solubles, Solvent Extracted, is
the product resulting from the solvent extraction of oil from corn distillers dried grains
with solubles (DDGS) to result in a crude fat content of less than 3% on an as fed basis. It
is intended as a source of protein. The label shall include a guarantee for minimum crude
protein and maximum sulfur. The words “solvent extracted” are not required when listing
as an ingredient in a manufactured feed. (Proposed 2015, Adopted 2017 rev. 1)
Drugs and Medicated Feeds

Investigator and Section Editor—Dragan Momcilovic, FDA
(See Medicated Feed Section)
30. Enzymes
*See the “Enzyme Marketing Coordination” document which appears on page 376.
CHAPTER SIX
The immediate following pages contain Table 30.1, Enzymes/Source Organisms

Acceptable for Use in Animal Feeds. The purpose statement of a product label shall
include a statement of enzyme functionality (“Function” and/or “Supported Use” as
stated in Table 30.1) if enzymatic activity is represented in any manner.
For enzymes obtained from microorganisms, ingredient names shall use one of
the applicable definitions, 36.6, 36.7, 36.11, or 36.12, from Section 36, Fermentation
Products, using the source organism that produced the specific enzyme. For example, the
name Dried Aspergillus niger Fermentation Extract may be used for a dry alpha-amylase
enzyme product because in Table 30.1, Aspergillus niger is an accepted source organism
for alpha-amylase. Enzymes obtained from plants or animals shall use an appropriate
common or usual name that accurately describes the ingredient obtained from the Table
30.1 source organism, such as dried pineapple stem for bromelain, fig extract for ficin, or
dried pork stomach mucosa powder for pepsin. For more information about the labeling
of enzyme products, see the labeling section in the Enzyme Marketing Coordination
document.

30.1 Enzymes/Source Organisms Acceptable for Use in Animal Feeds

In the case of microbial enzymes, it is understood that they are produced from
nonpathogenic and nontoxigenic strains.
Classification/ Typical Supported
Name Source Organism Substratea Function Useb
Carbohydrases
alpha-Amylase Animal pancreatic Corn Hydrolyzes
tissue silage, starch
Aspergillus niger, var. corn, corn
Aspergillus oryzae, var. feed meal,
Bacillus amyloliquefaciens corn gluten
Bacillus lentus feed,
Bacillus licheniformis soybean
Bacillus licheniformis meal,
containing a Bacillus wheat,
stearothermophilus wheat
gene for alpha-amylase middlings,
Bacillus barley,
stearothermophilus grain
Bacillus subtilis sorghum,
containing a Bacillus pea, oat,
megaterium gene for tapioca,
alpha-amylase millet, rice
Bacillus subtilis
containing a Bacillus
stearothermophilus
gene for alpha-
amylase
Bacillus subtilis, var.
Barley malt
Paenibacillus lentus
Rhizopus niveus
Rhizopus oryzae, var.
Maltogenic Bacillus subtilis See alpha- Hydrolyzes
alpha-amylase containing a Bacillus amylase starch with
stearothermophilus production of
gene for maltogenic maltose
alpha-amylase
beta-Amylase Barley malt See alpha- Hydrolyzes
amylase starch with
production of
maltose
Cellulase Aspergillus niger, var. Corn, Breaks down
Humicola insolens barley, cellulose
Trichoderma wheat,
longibrachiatum wheat,
(also known as T. bran, rye,
reesei or T. viride) grain
sorghum
(continued)


alpha-Galactosidase Aspergillus niger, var. Sweet Hydrolyzes
Morteirella vinaceae lupin, oligosaccharides
var. raffinoseutilizer soybean
Saccharomyces sp. meal
beta-Glucanase Aspergillus niger, var. Wheat, Hydrolyzes Reduction
Aspergillus aculeatus barley, beta-glucans, of digesta
Bacillus lentus canola a type of viscosity with
Bacillus subtilis, var. meal, non-starch barley-based
Humicola insolens wheat polysaccharide poultry diets,
Paenibacillus lentus by-product, reduces soluble
Talaromyces funiculosus oat groats, non-starch
Talaromyces versatilis rye, polysaccharides
overexpressing triticale, in digesta
glucanase grain
Trichoderma sorghum
longibrachiatum
(also known as T.
reesei or T. viride)
beta-Glucosidase Aspergillus niger, var. Plant Hydrolyzes
cell wall cellulose
constituents degradation
products to
glucose
Glucoamylase Aspergillus niger, var. See alpha- Hydrolyzes
(amyloglucosidase) Aspergillus oryzae, var. amylase starch with
Rhizopus niveus production of
Rhizopus oryzae, var. glucose
Hemicellulase Aspergillus aculeatus Corn, Breaks down Reduction
Aspergillus niger, var. soybean hemicellulose in stickiness
Bacillus lentus meal, guar of excreta in
Bacillus subtilis, var. meal, poultry fed
Humicola insolens barley, guar meal
CHAPTER SIX
Paenibacillus lentus rye, grain

Trichoderma sorghum,
longibrachiatum wheat, oats,
(also known as T. peas, lentils
Invertase Aspergillus niger, var. Sucrose Hydrolyzes
Saccharomyces sp. containing sucrose to
products glucose and
and fructose
by-products
(continued)


Lactase Aspergillus niger, var. Lactose Hydrolyzes
Aspergillus oryzae, var. containing lactose to
Candida pseudotropicalis products glucose and
Kluyveromyces and galactose
marxianis var. by-products
lactis (formerly
Saccharomyces sp.)
beta-Mannanase Aspergillus niger, var. Corn, Hydrolyzes Reduction
Bacillus lentus soybean beta- in stickiness
Paenibacillus lentus meal, guar mannans, a of excreta in
Trichoderma meal, copra component of poultry fed
longibrachiatum meal hemicellulose guar meal
(also known as T.
Bacillus subtilis, var. Distillers Hydrolyzes Reduction
dried beta- of digesta
grains with mannans, a viscosity with
solubles component of swine diets
hemicellulose
Pectinase Aspergillus aculeatus Corn, Breaks down
Aspergillus niger, var. wheat pectin
Rhizopus oryzae
Pullulanase Bacillus See alpha- Hydrolyzes
acidopullulyticus amylase starch
Bacillus licheniformis
containing a Bacillus
deramificans gene
for pullulanase
Xylanase Aspergillus niger, var. Corn, Hydrolyzes Reduction
Aspergillus oryzae barley, xylans, a of digesta
expressing a rye, wheat, component of viscosity with
Thermomyces grain hemicellulose poultry diets
lanuginosus sorghum,
xylanase gene triticale,
Bacillus lentus oats
Humicola insolens
Paenibacillus lentus
Talaromyces funiculosus
Talaromyces versatilis
overexpressing
xylanase
Trichoderma
longibrachiatum
(also known as T.
(continued)


Lipases
Lipase Animal pancreatic Plant and Hydrolyzes
tissue animal triglycerides
Aspergillus niger, var. sources of
Aspergillus oryzae, var. fats and
Candida rugosa oils
(formerly
cylindracea)
Edible forestomach of
calves, kids, and
lambs
Rhizomucor (Mucor-)
miehei
Rhizopus oryzae
Proteases
Bromelain Pineapples—stem, fruit Plant and Hydrolyzes

animal proteins
proteins
Ficin Figs Plant and Hydrolyzes
animal proteins
proteins
Keratinase Bacillus licheniformis Plant and Hydrolyzes
animal proteins
proteins
Papain Papaya Plant and Hydrolyzes
animal proteins
proteins
Pepsin Porcine or other animal Plant and Hydrolyzes
stomachs animal proteins
proteins
(continued)
CHAPTER SIX


Protease Aspergillus niger, var. Plant and Hydrolyzes
(general) Aspergillus oryzae, var. animal proteins
Bacillus proteins
amyloliquefaciens
Bacillus licheniformis Plant Hydrolyzes Increases the
expressing serine proteins proteins digestibility
protease genes from of protein in
Nocardiopsis corn-soybean
prasina meal based
diets
Bacillus subtilis Plant Hydrolyzes
containing a Bacillus proteins proteins
amyloliquefaciens
gene for protease
Trypsin Animal pancreas Plant and Hydrolyzes
animal proteins
proteins
Oxidoreductases
Catalase Aspergillus niger, var. Hydrogen Produces
Micrococcus peroxide water and
lysodeikticus oxygen from
hydrogen
peroxide
Glucose oxidase Aspergillus niger, var. Glucose Degrades
glucose to
hydrogen
peroxide and
gluconic acid
(continued)


Phosphatases
Phytase Aspergillus niger, var. Corn, Hydrolyzes Increases the
Aspergillus oryzae, var. soybean phytate digestibility of
Aspergillus oryzae meal, phytin-bound
expressing the sunflower phosphorus
Peniophora lycii meal, in poultry and
phytase gene hominy, swine diets
Phytase canola tapioca,
(Brassica napus plant
expressing the by-products
Aspergillus niger
phytase gene)
Pichia pastoris
expressing a phytase
gene from a Risk
Group 1 Escherichia
coli
Schizosaccharomyces
pombe expressing an
Excherichia coli
strain B phytase
gene
Trichoderma reesei
expressing an
altered phytase gene
from a Risk Group 1
Escherichia coli
Trichoderma reesei
expressing an altered
phytase gene from a
Buttiauxella sp.
Talaromyces funiculosus Hydrolyzes Increases the
phytate digestibility of
CHAPTER SIX
phytin-bound
phosphorus in
poultry diets
(Recombinant DNA risk groups are defined by the US National Institutes of Health.)
aThis list is to provide guidance and is not all-inclusive.
bThe Supported Use column references additional enzyme functionality beyond that in
the Function column, and does not limit the enzyme functionality statement to specific
animal species.

Enzyme Marketing Coordination

Section Editor—Mika Alewynse
NOTE: Sponsors of new enzyme/source organisms shall fully

comply with this document by January 1, 1998.
Background
Enzymes are organic catalysts that affect the rate at which chemical reactions occur
for specific substrates, including foods. AAFCO Policy Statement 7 describes the current
sources of enzymes permitted in animal feeds. Rennet and papain are listed as GRAS
under 21 CFR 582. All other enzyme materials to be used in animal feeds require a Food
Additive regulation unless they are determined to be GRAS. The Center for Food Safety
and Applied Nutrition (CFSAN) has published regulations for some enzyme preparations
for use in human nutrition as secondary direct food additives under 21 CFR 173 and
as GRAS food substances in 21 CFR 184. However, these applications are not directly
transferable to animal use.
Definitions
The terms presented below are to clarify this document and do not represent
nomenclature utilized by all enzyme manufacturers.
Enzyme. A protein made up of amino acids or their derivatives, which catalyzes a
defined chemical reaction. Required cofactors should be considered an integral part of the
enzyme.
Note: All other organic catalysts are excluded from consideration under this
marketing coordination scheme.
Source organism. The organism that actually produces the enzyme(s).
Manufacturer. The firm or individual that actually produces the enzyme from the
source organism.
Sponsor. The firm or individual that proposes adding an enzyme/source organism to
the list published in the AAFCO Official Publication (Official Publication).
Enzyme preparation. A partially purified, unstandardized mixture of the enzyme(s)
of interest and residues from the source organism. Enzyme preparations are not intended
for sale or distribution for direct use on animal feed products without undergoing further
processing.
Enzyme containing material. A material which is manufactured from the enzyme
preparation, but is not necessarily, the final enzyme product. This material, if used in
product development trials, must be substantially similar to the proposed product.
Enzyme product. A processed, standardized enzyme-containing material which
has been produced with the intention of being sold for use on animal feed and feed
ingredients. Examples of enzyme products would include feed grain treatments,
commercial premixes and ready-to-use or apply materials.
Enzyme substrate. The material or substance which is acted upon catalytically by
the enzyme.
Enzymatic activity (unit of). The catalytic activity required to convert a given
amount of assay substrate to a given amount of product per unit time under the standard
conditions set forth in the assay procedure.

Regulatory Approach
The US Food and Drug Administration (FDA) considers all feed enzymes to be
either food additives or GRAS substances as defined by the Federal Food, Drug, and
Cosmetic Act. However, the FDA plans at the present time to utilize regulatory discretion
in the regulation of feed enzymes that present no safety concerns. A food additive petition
will not be required for many products. However, if the Agency has concerns about an
enzyme/source organism, a formal food additive petition may be required.
This document, written jointly by the AAFCO, FDA, Agriculture and Agri-Food
Canada and industry, describes the information which may be necessary for confirmation
of the suitability of an enzyme/source organism for inclusion in the Official Publication.
Issuance of a favorable informal opinion by the FDA may provide the safety and
functionality substantiation necessary for AAFCO to adopt an official definition for
a feed enzyme/source organism. All marketed enzymes must meet at least one of the
following criteria: 1) be published in the Official Publication; 2) be the subject of a Food
Additive regulation under 21 CFR 573; 3) be affirmed as GRAS; 4) be GRAS; or 5) be
the subject of an informal no objection letter from the FDA (will be published in the next
Official Publication). If an enzyme is published in the Code of Federal Regulations as an
approved food additive it will also be included in the Official Publication. It should be
noted that publication of an enzyme/source organism in the Official Publication does not
remove a firm’s responsibility of complying with applicable Canadian regulations.
The sponsor of an unpublished enzyme/source organism is to provide information
which addresses issues of safety, functionality, labeling, and manufacturing. The request
for review should be sent to the designated AAFCO contact. The supporting information
should be sent to the Division of Animal Feeds, Center for Veterinary Medicine, FDA.
The FDA will be asked to evaluate the information and determine its adequacy. If the
FDA determines that the enzyme/source organism does not require an approved food
additive petition to ensure its safe use, AAFCO will be asked to propose a new or modify
an existing definition under which the enzyme/source organism would be published in the
Official Publication. Any restrictions on claims and use conditions will be addressed by
the FDA in its statements to AAFCO and the sponsor. The official definition will include:
trivial name and/or International Union of Biochemistry (IUB) name, if available;
enzyme classification; source organism; and substrate(s).
In the information package the sponsor may include material from the literature or
current research. International data are acceptable provided conditions of testing simulate
practices in this country. Supporting empirical information should be summarized and
appropriate statistical analysis applied. Information that must be submitted by the sponsor
CHAPTER SIX
includes: the sponsor’s name and address, the enzyme, its proposed use and source
organism. If any material written in a foreign language is included, a complete translation
must be provided.
An appropriate section of the Official Publication is to be reserved for listing an
enzyme and its source organism(s). After FDA evaluation of the information submitted
for a new enzyme/source organism, a letter will be sent to the designated AAFCO
contact. A copy of the letter will also be sent to the sponsor. Both the States and FDA will
monitor the industry for compliance.

The following specific areas must be addressed by the sponsor:
Enzyme Identity
The enzyme present in the enzyme preparation or product is to be identified and
activity determined. The enzyme preparation or product is to be shown to contain no
viable source organisms above an appropriate background. A suggested maximum is 1 ×
104 colony forming units (CFU/gram) of the source organism. If the source organism is
published in the Official Publication under definition 36.14, there shall be no restriction
on source organism numbers.
Identity information should include the following:

a. Active enzyme substance-- should be identified, preferably using the
nomenclature system developed by the IUB. Specific terminology, such as
phytase, pectinase, amylase or glucanase, is preferred.
b. Enzyme substrate-- the specific substance on which the enzyme acts should be
identified. General terminology such as carbohydrate, fiber, lipids, and protein
are acceptable; however, specific terminology such as starch, cellulose, phytin,
and lactose are preferred.
c. Reaction products-- the primary resultant product(s) from the enzyme-substrate
reaction should be identified to the extent that it is practical.
d. Site of enzyme activity-- the site of activity is recognized to be on the feed/
ingesta. Any other statement regarding site of activity is subject to FDA review.
Bioengineered Sources of Enzymes

A source organism may be bioengineered using recombinant deoxyribonucleic
acid (rDNA) technology. This type of technology is defined as “any method by which
DNA is manipulated in vitro and introduced into the source organism.” Initially, use of
bioengineered source organisms will be handled on a case-by-case basis. If the structure/
amino acid sequence of an enzyme has not been significantly affected by changes in the
genome of the source organism, it is not anticipated that additional requirements will be
imposed for inclusion in the Official Publication. However, if a source organism has been
modified by rDNA techniques to contain an antibiotic resistance gene, then the enzyme
product should contain no detectable, viable source organisms and no transformable
antibiotic resistance DNA.
Safety
Animal/Human/Environment
Safety is the overriding issue with food and food ingredients and thus, for enzyme/
source materials for animal use. Initial questions will reside around whether the enzyme
preparation has adverse effects on either the animal, the environment, or humans via
edible products from animals fed the enzyme.
Animal Safety
Enzymes, as defined in this document, are amino acid-based catalysts used at
low levels to alter animal feedstuffs. Because of this basic structure, it is reasonable to
assume that these molecules will be digested in the gastro-intestinal tract, as would any
other protein. Since an enzyme will be broken down into its constituent amino acids
and cofactors and thus, be indistinguishable from other food molecules, the potential
for residues in edible animal tissues appears minimal. Thus, the only other major factor

which may raise a safety concern is the possible presence of compounds produced by
or derived from the source organism. Pariza and Foster (1983)1 have developed a set
of guidelines to assess the safety of enzymes used in food processing. These guidelines
address the safety of the source organism and the enzyme itself. Enzyme preparations
that meet or surpass the criteria proposed by Pariza and Foster for human food should be
safe for use in animal feed when utilized at the low levels normally employed for these
catalysts.
Alternatively, the sponsor can provide data demonstrating no adverse effects when
the most sensitive target animal is fed at least 5 times the maximum supplementation
level for a period of 90 days or 50% of the species normal growing period, whichever is
less. The species will be determined by product labeling and/or manufacturer suggestions.
Enzyme sponsors should also address the presence of enzymatic cofactors in the
enzyme preparation. The presence of cofactors, such as the vitamins or nicotinamide
adenine dinucleotide (NAD) is not of concern, but should be reported. If the enzyme
requires potentially toxic cofactors, such as selenium or molybdenum, the submission
should indicate the identity and amount of the cofactor.
Enzymes produced using current good manufacturing practices from food animals,
edible and nontoxic plants or nontoxigenic and nonpathogenic microorganisms which
do not produce antibiotics, should be safe for consumption at the low levels one would
normally expect to encounter in animal feeds. In addition, the enzyme preparation should
comply with the chemical and microbiological purity standards established by the Joint
FAO/WHO Expert Committee on Food Additives2 and the Food Chemical Codex3.
Carriers, diluents, and processing aids used in the production of enzyme preparations
and products must be substances that are acceptable for feed usage. If an enzyme
preparation or product is standardized or diluted with feed grade material, then applicable
chemical and microbiological standards for the feed material will apply.
Human Safety
Enzymes, as defined in this document, are amino acid-based catalysts used at
low levels to alter animal feedstuffs. Because of this basic structure, it is reasonable to
assume that these molecules will be digested in the gastro-intestinal tract, as would any
other protein. However, it is the responsibility of the sponsor to provide appropriate data
to assure human safety. Enzymes used in animal feed that pass the safety assessment
proposed by Pariza and Foster should raise no human safety concerns.
If the Pariza and Foster decision tree is not used to evaluate the enzyme preparation,
the sponsor must provide information regarding the fate of the enzyme in the target
CHAPTER SIX
animal. If it cannot be assured that the enzyme is broken down to non-toxic metabolites, it
may be necessary to quantify the amount of residue and identify safety concerns for these
molecules. If an enzyme preparation is currently approved for addition to or conditioning
of human foods, human safety data may not be required. However, human food use must
be substantiated and a statement of similar/identical usage will be required. If human food
safety is an issue, a food additive petition under 21 CFR 570 will be required.
Environmental Safety
Information is required on each enzyme/source organism to assure that it does not
adversely affect the environment. Information showing that the enzyme is composed
of or broken down to normal non-toxic degradation products in the digestive tract of
supplemented animals would be adequate to answer questions of environmental safety.
If degradation metabolites have an unusual chemical composition not normally present
in foods, it may be necessary to demonstrate metabolite safety for non-target species that
may be exposed to target animal wastes. Environmental safety concerns could also be

allayed if it could be demonstrated that the same or similar enzymes in approximately the
same concentrations are excreted by free living organisms in a similar environment.
Functionality
The functionality of the enzyme itself must be documented. Either in vivo or in vitro data
are acceptable to demonstrate enzyme functionality. The functionality statement associated
with an enzyme/source organism combination will be determined by the data submitted
under this proposal. The chosen research approach, either in vivo or in vitro, should answer
questions relating to the amount of enzyme material necessary to have the intended effect
and the use conditions (restrictions) for the enzyme. All experimental protocols should be
described as would be required for publication in a peer-review journal. The procedure used
to determine enzyme functionality should be described in detail. If functionality is determined
by end product measurements, assay sensitivity and cross-reactivity to other constituents/
contaminants should be discussed. Functionality data must substantiate the proposed label.
Animal experiments demonstrating enzyme functionality are highly recommended. Trial
design should ensure that statistical analysis of experimental data is possible. The number of
trials should be adequate to document enzyme functionality under field conditions. Indicators
of enzyme functionality could include increased nutrient digestibility and/or increased free
nutrient levels. Sponsors should note, however, that label/advertising claims for improved
animal performance or health will cause an enzyme to be classified as a new animal drug.
Functionality can also be addressed using in vitro studies with either complete feeds,
feed ingredients or feed substrates being utilized as the enzyme substrate. Experimental
design and the accompanying statistical analysis must be adequate to support enzyme
functionality under field conditions. Dependent on the reaction catalyzed, the sponsor
may wish to measure the disappearance of undegraded feed substrate or the appearance
of enzyme reaction products. This approach directly measures the enzymatic digestion
of feedstuffs when compared to a similarly treated control sample. Either experimental
approach is acceptable. However, the sponsor must explain how observed in vitro effects
translate to practical functionality of the enzyme on feed or feed ingredients.
Factors which should be explained in detail in the submission include the apparatus/
reagents/protocol used to conduct all functionality experiments. Buffer solutions should
be selected so as to provide appropriate pH environments similar to those in which the
enzyme product is expected to be used. All control (untreated) samples of feedstuffs
shall be treated identically to the enzyme samples, except for the addition of the
enzyme. Incubation temperatures for the digestion period should not exceed the range
of temperatures normally encountered under practical conditions for enzyme use. The
enzyme containing material may be either research or technical grade, but must be similar
to that which will be used commercially.
Complete feeds, feed ingredients or feed substrates obtained from a feed ingredient,
can be used to simulate the feed to which the enzyme will be applied. These experimental
substrates should be similar in analysis and in physical/chemical treatment to the feed which
the enzyme will be used for in commercial situations. No less than five samples of each grain/
treatment should be used in the trial. Use of feed, feed ingredients or substrates containing
grain from several different lots (origins) would be desirable. However, the experimental
design should ensure that lots (origins) are not confounded with enzyme treatment, i.e. all of
lot 1 treated with the enzyme, while all control samples came from a different lot.
Enzyme Functionality Tested by In Vitro Activity on Feed

• Collect samples of typical target feed or feed ingredient.
• Treat with candidate enzyme mixture for a given period of time at appropriate
pH and temperature

• Analyze samples for increased levels of breakdown products or decreased

concentrations of targeted substrate
• Compare results with untreated control samples.
• Enzyme treatments which result in significantly altered concentrations of
targeted substrate or breakdown products are judged to be utilitarian for
practical application
Quantification of Enzyme Product

Methodology is needed to measure the amount of activity of the enzyme product in
its marketed concentrated (premix) form. Activity should be expressed as micromoles
(moles) of released catalytic product per minute per gram of market product or in other
standardized units. It is the responsibility of the sponsor to provide this methodology
along with supporting information about its specificity, sensitivity, and accuracy.
a. Assay Methodology
1. Enzyme product; and/or
2. Finished feed
b. Specificity/Sensitivity
1. Two-external laboratory validation; or
2. AOAC International validation, which can include the short form; or
3. Other recognized methods
Labeling
The label should: describe the enzyme source (specific microbial or other source)
that is recognized by FDA/AAFCO as safe and useful for the intended purpose; have
a full listing of ingredients in order of preponderance; have a guaranteed analysis that
is stated in meaningful terms; show a net quantity of product; contain warning and
caution statements as needed; not have therapeutic or production claims; allow product
identification by means such as lot numbers, expiration dates or another appropriate
method of identification; and provide information on product storage, if necessary.
The product should be labeled in accordance with AAFCO and federal regulations.
The label will include a guarantee of enzyme activity(ies), expressed in appropriate units.
Clear directions for use which are reasonably certain to be followed in practice must be
included, as should any known product limitations, such as ineffectiveness on specific
forages. Adequate directions for use to enable the user to achieve the functionality of the
enzyme(s) should be included, such as the feed ingredient(s) that the enzyme(s) acts on,
CHAPTER SIX
the amount of product necessary to produce the intended effect, and the length of time
required to achieve this effect. If environmental factors, such as feed pH or moisture, or
mechanical processing methods, like pelleting or extrusion affect enzyme activity, these
restrictions should also be noted on the label. Draft labeling should be included in the
initial request of the sponsor.

The label must contain the following sections:
Name of Product
Functionality Statement
“Contains a source of (enzymatic activity) which can (function and/or
current supported use as stated in Section 30.1).” (statement based on information present
in submission)
Guaranteed Analyses
(see AAFCO regulations 3 and 4.)
Enzymatic guarantees shall be expressed in appropriate units using either metric or
avoirdupois measurements. The chosen units shall correspond with those present in the
Use section. The source organism for each type of enzymatic activity shall be specified,
such as: Protease (Bacillus subtilis) 5.5 mg amino acids liberated/min./milligram.
If two sources have the same type of activity, they shall be listed in order of
predominance based on the amount of enzymatic activity provided. However, the order of
the ingredients in the Ingredients section is still determined by the amount (weight) of the
different materials in the product.
Ingredients
(listed in order of predominance by weight)
Directions for Use

Use instructions shall clearly state amount of enzyme required to achieve intended
effect and other necessary information required for enzyme functionality.
Caution/Warning Statements. (when required)
Quantity Statement
Manufacturing
The sponsor is to provide information on the manufacture of the enzyme or quality
controls (specifications) on the enzyme. The quality controls on the raw materials, on
the manufacturing process/conditions, and on the enzyme product are to be presented.
Appropriate information on product stability, labeling restrictions and special marketing
controls are to be provided.
_____________________
1 Pariza, M. W., and E. M. Foster. 1983. Determining the safety of enzyme used in food processing.
Journal of Food Protection. 46(5): 453-468.
2 JointFAO/WHO Expert Committee on Food Additives. 1990. General specifications for enzyme
preparations used in food processing. Food and Nutrition Paper No. 49. Pages 80-03.
3 Anonymous. 1980. Food Chemical Codex. Page 107. National Academy Press: Washington.

33. Fats and Oils

Investigator and Section Editor—Brett Boswell, MN
NOTE: The use of the term “feed grade” requires that the specific type of product be
adequately tested to prove its safety for feeding purposes. In mixed feeds containing fats
or fat derivatives the term “feed grade” may be omitted in the ingredient declaration.
NOTE: Any mixture of two or more fats or fat derivatives defined below is to be
identified by listing each component: e.g., “animal fat and hydrolyzed vegetable oil.”
NOTE: Fats or fat derivatives must come from acceptable animal feed sources.
Waste water sludge that contains sanitary sewer water, is not an acceptable source of
animal feed. FDA should be contacted regarding the safe use in animal feed of all other
sludge material that does not contain sanitary waste water. (Sludge: The suspended or
dissolved solid matter resulting from the processing of animal or plant tissue for human
food. Waste Water Sludge: The sanitary sewer water and suspended or dissolved solid
matter resulting from the processing of animal or plant tissues for human food.
Official
33.1 Animal Fat is obtained from the tissues of mammals and/or poultry in
commercial processes of rendering or extracting. It consists predominately of glyceride
esters of fatty acids and contains no additions of free fatty acids or other materials
obtained from fats. It must contain, and be guaranteed for, not less than 90% total
fatty acids, not more than 2.5% unsaponifiable matter, and not more than 1% insoluble
impurities. Maximum free fatty acids and moisture must also be guaranteed. If the
product bears a name descriptive of its kind or origin, e.g., “beef,” “pork,” “poultry,”
it must correspond thereto. Rendered animal fat derived from only pork raw materials
can be labeled as white grease. Rendered animal fat derived from only cattle raw
materials can be labeled as beef tallow. Tallow containing greater than 0.15% insoluble
impurities must be labeled with the BSE caution statement “do not feed to cattle or other
ruminants.” If an antioxidant(s) is used, the common name or names must be indicated,
followed by the words “used as a preservative.” (Proposed 1989, Amended 2017)
IFN 4-00-409 Animal poultry fat
33.2 Vegetable Fat, or Oil is the product of vegetable origin obtained by extracting
the oil from seeds or fruits which are commonly processed for edible purposes. It consists
predominantly of glyceride esters of fatty acids and contains no additions of free fatty
acids or other materials obtained from fats. It must contain, and be guaranteed for, not
less than 90% total fatty acids, not more than 2% unsaponifiable matter and not more than
CHAPTER SIX
1% insoluble impurities. Maximum free fatty acids and moisture must also be guaranteed.
If the product bears a name descriptive of its kind or origin; e.g., “soybean oil,”
“cottonseed oil,” it must correspond thereto. If an antioxidant(s) is used, the common
name or names must be indicated, followed by the words “used as a preservative.”
(Proposed 1989)
IFN 4-05-077 Vegetable oil
33.3 Hydrolyzed ____________ Fat, or Oil, Feed Grade, is obtained in the fat
processing procedures commonly used in edible fat processing or soap making. It consists
predominately of fatty acids and must contain, and be guaranteed for, not less than 85%
total fatty acids, not more than 6% unsaponifiable matter, and not more than 1% insoluble
impurities. Maximum moisture must also be guaranteed. Its source must be stated in the
product name; e.g., “hydrolyzed animal fat,” “hydrolyzed vegetable fat,” or “hydrolyzed
animal and vegetable fat.” If an antioxidant(s) is used, the common name or names must
be indicated, followed by the words “used as a preservative.” (Proposed 1989)
IFN 4-00-376 Animal fat hydrolyzed, IFN 4-05-076 Vegetable oil hydrolyzed

33.4 ____________ Ester ____________, Feed Grade, is the product consisting

of methyl, ethyl, or other non-glyceride ester of fatty acids derived from animal and/or
vegetable fats. It consists predominantly of the ester and must contain not less than 85%
total fatty acids, not more than 10% free fatty acids, not more than 6% unsaponifiable
matter (2% for methyl esters) and not more than 1% insoluble matter. Its source must
be stated in the product name; e.g., “methyl ester of animal fatty acids,” “ethyl ester of
vegetable oil fatty acids.” Methyl esters must contain not more than 150 parts per million
(0.015%) free methyl alcohol. If an antioxidant(s) is used, the common name or names
must be indicated, followed by the word “preservative(s).” (Proposed 1958, Amended
1962, Adopted 1968.) Reg. 573.640
IFN 4-00-377 Animal fatty acids of ethyl ester
IFN 4-00-378 Animal fatty acids of methyl ester
IFN 4-00-379 Animal fatty acids of non-glyceride ester
IFN 4-12-240 Vegetable fatty acids of ethyl ester
IFN 4-05-075 Vegetable fatty acids of non-glyceride ester
IFN 4-05-074 Vegetable fatty acids of methyl ester
33.7 Vegetable Oil Refinery Lipid, Feed Grade, is obtained in the alkaline
refining of a vegetable oil for edible use. It consists predominantly of the salts of fatty
acids, glycerides, and phosphates. It may contain water and not more than 22% ash on a
water-free basis. It may or may not be acidulated before using in commercial feeds, but
if acidulated, it should be neutralized. (Proposed 1964, Adopted 1968, Amended 1980,
IFN 4-05-078 Vegetable oil refinery lipid
33.8 Corn Syrup Refinery Insolubles, Feed Grade, is obtained in the refining of
a corn syrup. It consists predominantly of the fatty fraction of corn starch together with
protein and residual carbohydrate. It may contain water and not more than 7% ash nor
less than 50% fat on a water-free basis. (Proposed 1964, Adopted 1968)
IFN 4-02-893 Maize syrup process residue
33.10 _____ Distillers Oil, Feed Grade, is obtained after the removal of ethyl
alcohol by distillation from the yeast fermentation of a grain or a grain mixture and
mechanical or solvent extraction of oil by methods employed in the ethanol production
industry. It consists predominantly of glyceride esters of fatty acids and contains no
additions of free fatty acids or other materials obtained from fats. It must contain, and
be guaranteed for, not less than 85% total fatty acids, not more than 2.5% unsaponifiable
matter, and not more than 1% insoluble impurities. Maximum free fatty acids and
moisture must be guaranteed. If an antioxidant(s) is used, the common or usual name
must be indicated, followed by the words “used as a preservative.” If the product bears
a name descriptive of its kind or origin, e.g., “corn, sorghum, barley, rye,” it must
correspond thereto with the predominating grain declared as the first word in the name.
(Proposed 2015, Adopted 2016 rev. 1)
33.14 Calcium Salts of Long-Chain Fatty Acids are the reaction products between
calcium and long-chain fatty acids of vegetable and/or animal origin. They shall contain
a maximum of 20% lipid not bound in the calcium salt form and the percent total fat shall
be indicated. The unsaponifiable matter (exclusive of calcium salts) shall not exceed 4%
and moisture shall not exceed 5%. If an antioxidant(s) is used, its common name(s) must
be indicated on the label. Prior to conducting an assay for total fats, hydrolysis of the
calcium salts should be performed to liberate the lipid fraction. (Adopted 1993)
33.15 Hydrolyzed ____________ Sucrose Polyesters, Feed Grade, is the product
resulting from the acid hydrolysis of sucrose polyesters, such as olestra, to make them
digestible. It shall consist predominantly of fatty acids and contain, and be guaranteed
for, not less than 85% total fatty acids, not more than 2% Sucrose Polyesters (hex ester
and above), not more than 2% unsaponifiable matter, and not more than 2% insoluble

impurities. Maximum moisture must also be guaranteed. Its source must be stated in the
product name; e.g., “Hydrolyzed animal sucrose polyesters,” “Hydrolyzed vegetable
sucrose polyesters,” or “Hydrolyzed animal and vegetable sucrose polyesters.” If an
antioxidant(s) is used, the common name or names must be indicated, followed by the
words “used as a preservative.” (Proposed 1993, Adopted 1994)
33.16 Methyl Esters of Conjugated Linoleic Acid (cis-9, trans-11 and trans-10,
cis-12-octadecadienoic acids) may be safely used in swine feed in accordance with the
prescribed conditions:
(a) The food additive is manufactured by the reaction of refined sunflower oil with
methanol to produce fatty acid methyl esters, which then undergo conjugation
to yield methyl esters of octadecadienoic acid. The additive consists of not less
than 28% methyl ester of cis-9, trans-11-octadecadienoic acid, and not less than
28% methyl ester of trans-10, cis-12-octadecadienoic acid with the sum of the
other methyl esters of octadecadienoic acid not to exceed 4%. The additive
shall contain not less than 35% of other fatty acid esters composed of oleic
acid, palmitic acid, stearic acid, linoleic acid, and other associated acid esters.
(b) The additive is used or intended for use in the feed of growing and finishing
swine as a source of fatty acids at levels not to exceed 0.6% in the finished
feed.
(c) The additive meets the following specifications:
(1) Free methyl alcohol not to exceed 0.015%.
(2) Insoluble impurities not to exceed 0.1%.
(3) Moisture not to exceed 0.5%
(4) Unsaponifiable matter not to exceed 1.0%
(d) To assure safe use of the additive, in addition to the other information required
by the act:
(1) The label and labeling of the additive and any feed premix shall bear the
following:
(i) The name of the additive.
(ii) A statement to indicate that methyl esters of conjugated linoleic acid
(cis-9, trans-11 and trans-10, cis-12- octadecadienoic acids must not
be added to vitamin or mineral premixes.
(2) The label and labeling of the additive, any feed premix, or complete feed
prepared therefrom shall bear adequate directions for use.
21 CFR 573.637 (Proposed 2009, Adopted 2013)
33.17 Gamma-Linolenic Acid Safflower Oil—The food additive gamma-linolenic
CHAPTER SIX
acid safflower oil may be safely used in animal food as a source of gamma-linolenic acid
and other omega-6 fatty acids in accordance with the following conditions:
(a) The additive is the oil obtained from whole seeds and/or partially dehulled
seeds of a Carthamus tinctorius L. safflower Centennial variety genetically
engineered to express the delta-6-desaturase gene from Saprolegnia diclina
Humphrey. The 453 amino acid, delta-6-desaturase enzyme converts the fatty
acid linoleic acid to gamma-linolenic acid (all-cis-6,9,12-octadecatrienoic acid)
during seed development.
(1) The additive obtained from the seeds of the genetically engineered
safflower Centennial variety may be blended with oil obtained from
seeds of non-engineered oleic acid safflower varieties in order to meet the
specifications required for the additive or the blend in paragraph (a)(2) of
this section.
(2) The additive or a safflower oil blend containing the additive for use in
animal food meets the following specifications:

(i) Crude fat content of the additive or the safflower oil blend is not less
than 99.5%.
(ii) Gamma-linolenic acid content is between 350 and 450 milligrams
(mg) gamma-linolenic acid per gram of the additive or the safflower
oil blend.
(iii) Total content of stearidonic acid and cis, cis-6,9-octadecadienoic acid
in the additive or the safflower oil blend must not exceed a total of
0.3%.
(b) Addition of the additive, or the safflower oil blend, to complete dry adult
maintenance dog food must meet the following:
(1) Addition of the additive or the safflower oil blend cannot provide more
than 36 mg gamma-linolenic acid per kilogram body weight of the dog
per day in more than 86 mg of the additive or the safflower oil blend.
This maximum addition rate of the additive, or the safflower oil blend,
is 0.3% of a complete dry adult maintenance dog food containing 3,600
kilocalories of metabolizable energy per kilogram of food as-fed.
(2) Adjustments must be made for differing concentrations of gamma-
linolenic acid and for dog food formulas of different caloric density and/or
that are fed to specific weights, breeds, or dogs of different activity levels
to meet the requirements of this paragraph.
(c) Addition of the additive, or the safflower oil blend, to complete dry adult
maintenance cat food must meet the following:
(1) Addition of the additive or the safflower oil blend cannot provide more
than 33 mg gamma-linolenic acid per kilogram body weight of the cat per
day in more than 79 mg of the additive or the safflower oil blend. This
maximum addition rate of the additive, or the safflower oil blend, is 0.5%
of a complete dry adult maintenance cat food containing 4,000 kilocalories
of metabolizable energy per kilogram of food as-fed.
(2) Adjustments must be made for differing concentrations of gamma-
linolenic acid and for cat food formulas of different caloric density and/or
that are fed to specific weights, breeds, or cats of different activity levels
to meet the requirements of this paragraph.
(d) To assure safe use of the additive, in addition to other information required
by the Federal Food, Drug, and Cosmetic Act, the label and labeling of the
additive shall bear the following:
(1) The name of the additive, gamma-linolenic acid safflower oil, or GLA
safflower oil;
(2) A guarantee for the minimum content of gamma-linolenic acid; and
(3) Adequate directions for use such that the finished animal food complies
with the provisions of paragraphs (b) and (c) of this section.
21 CFR 573.492 (Adopted 2018 rev. 1, Amended 2020)
33.21 Yellow Grease, Feed Grade, is the rendered product from the tissues of
mammals and/or poultry blended with used cooking or frying oil from human food
preparation, consisting of animal and/or vegetable fats or oils. It must contain, and be
guaranteed for, not less than 90% total fatty acids, not more than 2.5% unsaponifiable
matter, not more than 0.5% insoluble impurities, and not more than 1% moisture.
Maximum free fatty acids must also be guaranteed. This product may not include
recovered trap grease or material recovered from sanitary sewer sources. If an
words “used as a preservative.” If the product contains tallow (from cattle) containing

greater than 0.15% insoluble impurities, then it must be labeled with the BSE caution
statement “do not feed to cattle or other ruminants.” (Proposed 2017, Adopted 2018)
33.24 Used Cooking Oil, Feed Grade, is the product of used cooking or frying
oil from human food preparation, consisting of animal and/or vegetable fats or oils,
collected from commercial human food facilities and then heated to reduce moisture. It
must contain, and be guaranteed for, not less than 90% total fatty acids, not more than
1% unsaponifiable matter, not more than 0.5% insoluble impurities, and not more than
1% moisture. Maximum free fatty acids must also be guaranteed. This product may not
include recovered trap grease or material recovered from sanitary sewer sources. If an
words “used as a preservative.” (Proposed 2017, Adopted 2018)
33.27 Marine Microalgae—The food additive marine microalgae may be safely
used as a source of docosahexaenoic acid (DHA) and other omega-3 fatty acids in
accordance with the following prescribed conditions:
(a) The additive is dried whole cells of nonviable, nontoxigenic, nonpathogenic
Schizochytrium sp. algae grown as a pure culture.
(b) The additive is used in complete, dry adult maintenance food for dogs in
accordance with good manufacturing and feeding practices not to exceed
16.5 pounds per ton (7.5 kilograms (kg) per 1000 kg) of complete, dry, adult
maintenance dog food.
(c) The additive consists of not less than 17.0% (4Z,7Z,10Z,13Z,16Z,19Z)-docosa-
4,7,10,13,16,19-hexaenoic acid (docosahexaenoic acid or DHA).
(d) The additive meets the following specifications:
(1) Not less than 40% crude fat;
(2) Not more than 12% ash;
(3) Not more than 8% unsaponifiable matter;
(4) Not more than 5% insoluble impurities;
(5) Not more than 5% free fatty acids; and
(6) Not more than 6% water.
(e) To ensure the safe use of the additive, in addition to other information required
by the Federal Food, Drug, and Cosmetic Act:
(1) The label and labeling of the additive, any feed premix, and complete feed,
shall contain the name of the additive, marine microalgae.
(2) The label and labeling of the additive and any feed premix shall also
contain:
(i) A statement to indicate that the maximum use level of the additive
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shall not exceed 16.5 pounds per ton (7.5 kg per 1000 kg) of
complete, dry, adult maintenance dog food.
(ii) Adequate directions for use.
21 CFR 573.615 (Adopted 2019 rev. 1)
Tentative
T33.25 Stearic Acid is a waxy solid derived from the hydrolysis of vegetable
oils and/or animal fats, including hydrogenated oils. It is used as an energy source in
growing and adult ruminant diets up to a maximum inclusion of 3% (w/w) in the finished
feed. It cannot be used in pre-ruminant animal feed or in milk replacers. The final
ingredient is produced by fractional distillation of the hydrolyzed fats and oils. It contains
predominantly stearic acid, with lesser amounts of palmitic acid. It must contain, and be
guaranteed for, minimum 92% stearic acid, maximum 5% palmitic acid, minimum 99%
total free fatty acids, maximum 1% sulfated ash, and maximum 5 ppm lead. Maximum
moisture must also be guaranteed. Animal fats, vegetable oils, and hydrogenated
vegetable oils used in the hydrolysis reaction to produce stearic acid must meet the

specifications stated in the respective AAFCO definitions, 33.1 (for Animal Fat), 33.2 (for
Vegetable Fat or Oil), and/or 33.19 (for Hydrogenated Glycerides). If tallow is used, the
starting material must comply with the BSE feed regulation under 21 CFR 589.2000 and
589.2001. (Proposed 2017 rev. 1)
T33.26 Palmitic Acid is a waxy solid derived from the hydrolysis of vegetable
oils and/or animal fats, including hydrogenated oils. It is used as an energy source
in growing and adult ruminant diets up to a maximum inclusion of 2% (w/w) in the
finished feed. It cannot be used in pre-ruminant animal feed or in milk replacers. The
final ingredient is produced by fractional distillation of the hydrolyzed fats and oils.
It contains predominantly palmitic acid, with lesser amounts of myristic acid. It must
contain, and be guaranteed for, minimum 98% palmitic acid, maximum 0.8% myristic
acid, minimum 99% total free fatty acids, maximum 1% sulfated ash, and maximum 5
ppm lead. Maximum moisture must also be guaranteed. Animal fats, vegetable oils, and
hydrogenated vegetable oils used in the hydrolysis reaction to produce palmitic acid must
meet the specifications stated in the respective AAFCO definitions, 33.1 (for Animal Fat),
33.2 (for Vegetable Fat or Oil), and/or 33.19 (for Hydrogenated Glycerides). If tallow
is used, the starting material must comply with the BSE feed regulation under 21 CFR
589.2000 and 589.2001. (Proposed 2017 rev. 1)
36. Fermentation Products

Investigator and Section Editor—Maggie Faba, MN
Official
36.1 Condensed, Extracted Glutamic Acid Fermentation Product is a
concentrated mixture of the liquor remaining from the extraction of glutamic acid,
combined with the cells of Corynebacterium lilium or Corynebacterium glutamicum used
to produce the glutamic acid. It is used or intended for use as follows: in poultry feed as a
source of protein in an amount not to exceed 5% of the total ration; and in cattle feed as a
source of protein in an amount not to exceed 10% of the feed. In order to assure safe use,
the label and labeling of the additive shall bear the following:
(2) A statement of the concentration of the additive contained in any mixture.
(3) Adequate directions for use.
(4) Non-protein nitrogen content must be guaranteed when present. (Proposed 1964,
Adopted 1965, Amended 1995, Adopted 1997, Amended 2012, 2013, Adopted 2014 rev.
1) Reg. 573.500
36.2 Extracted ____________ Presscake is the filtered and dried mycelium
obtained from ________ fermentation. (For label identification the source must be
indicated as Penicillium, Streptomyces, citric acid, etc.) (Adopted 1951)
IFN 5-07-154 Penicillium fermentation presscake dehydrated
IFN 5-07-155 Streptomyces fermentation presscake dehydrated
IFN 5-07-156 Citric acid fermentation presscake dehydrated
36.3 Extracted ____________ Meal is the ground ________ presscake. (For label
identification the source must be indicated as Penicillium, Streptomyces, citric acid, etc.)
(Adopted 1951)
IFN 5-06-163 Penicillium fermentation presscake meal extracted
IFN 5-06-164 Streptomyces fermentation presscake meal extracted
IFN 5-06-162 Citric acid fermentation presscake meal extracted
36.4 Dried Extracted ____________ Fermentation Solubles is the dried extracted
broth obtained from __________fermentation. (For label identification the source must

be indicated such as Penicillium, Streptomyces, or citric acid, or as permitted by FDA.)

(Proposed 1988, Amended 1992, Amended 1997, Adopted 2000)
IFN 5-06-166 Penicillium fermentation solubles extracted dehydrated
IFN 5-06-176 Streptomyces fermentation solubles extracted dehydrated
IFN 5-06-165 Citric acid fermentation solubles extracted dehydrated
36.6 Dried ____________ Fermentation Extract is the dried product resulting
from extracting and precipitating by means of non-aqueous solvents or other suitable
means, the water soluble materials from a fermentation conducted for maximum
production of enzymes using a non-pathogenic strain of the microorganism ________
in accordance with good manufacturing practices. (For label identification the source
must be indicated such as Bacillus subtilis, Aspergillus oryzae, Aspergillus niger, or
as permitted by FDA.) (Proposed 1988, Amended 1992, Amended 1997, Adopted
2000)
IFN 5-06-147 Bacillus subtilis fermentation extract dehydrated
IFN 5-06-148 Aspergillus niger fermentation extract dehydrated
IFN 5-06-149 Aspergillus oryzae fermentation extract dehydrated
36.7 Dried ____________ Fermentation Solubles is the dried material resulting from
drying the water soluble materials after separation of suspended solids from a fermentation
conducted for maximum production of enzymes using a non-pathogenic strain of the
microorganism ____________in accordance with good manufacturing practices. (For
label identification the source must be indicated such as Bacillus subtilis, Aspergillus
oryzae, Aspergillus niger, or as permitted by FDA.) (Proposed 1988, Amended 1992,
IFN 5-29-779 Bacillus subtilis fermentation solubles dehydrated
IFN 5-29-781 Aspergillus niger fermentation solubles dehydrated
IFN 5-29-780 Aspergillus oryzae fermentation solubles dehydrated
36.9 Undried Extracted ____________ Solids and Fermentation Solubles
is undried mycelium and extracted broth or the extracted and undried mycelium and
broth obtained from __________ fermentation. (For label identification the source must
be indicated such as Penicillium, Streptomyces, citric acid, or as permitted by FDA.)
IFN 5-06-171 Citric acid fermentation solids with solubles liquid
IFN 5-06-172 Penicillium fermentation solids with solubles liquid
IFN 5-06-173 Streptomyces fermentation solids with solubles liquid
36.10 Condensed ____________ Fermentation Solubles is the product resulting
from the removal of a considerable portion of the liquid by-product resulting from the
CHAPTER SIX
action of the ferment on the basic medium of grain, molasses, whey, or other media. Non-
protein nitrogen content (when present) must be guaranteed. (For label identification,
the source must be indicated as “Condensed (Whey, Grain, or Molasses) Fermentation
Solubles.” (Adopted 1958, Amended 1951, 1980, 2012, 2013, Adopted 2014 rev. 1)
IFN 5-06-300 Cattle whey fermentation solubles condensed
IFN 4-07-153 Cereals grain fermentation solubles condensed
IFN 5-25-399 Sugarcane molasses fermentation solubles condensed
36.11 Dried ____________ Fermentation Product is the product derived by
culturing ________ on appropriate nutrient media for the production of one or more of
the following: enzymes, fermentation substances, or other microbial metabolites, and
dried in accordance with approved methods and good manufacturing practices. Protein,
amino acids, fat, fiber, cell count, enzyme activity or nutrient metabolite level shall be
guaranteed where applicable. Use of Lactobacillus buchneri is limited to silage and high
moisture corn grain in plant inoculant products. [For label identification the source must
be indicated such as Bacillus subtilis, Aspergillus oryzae, Aspergillus niger, Lactobacillus
acidophilus, Lactobacillus buchneri, Lactobacillus bulgaricus or Enterococcus faecium,

or as permitted by FDA.] (Proposed 1976, Adopted 1983, Amended 1997, Amended

1999, Amended 2001, Adopted 2003, Amended 2010, Adopted 2014 rev. 1)
IFN 5-06-150 Bacillus subtilis fermentation product dehydrated
IFN 5-06-151 Aspergillus niger fermentation product dehydrated
IFN 5-06-152 Aspergillus oryzae fermentation product dehydrated
IFN 5-06-153 Lactobacillus acidophilus fermentation product dehydrated
IFN 5-06-154 Lactobacillus bulgaricus fermentation product dehydrated
IFN 5-06-155 Enterococcus faecium fermentation product dehydrated
36.12 Liquid ____________ Fermentation Product is the liquid product derived by
culturing or fermenting ________ on appropriate liquid nutrient media for the production
of one or more of the following: enzymes, fermentation substances, or other microbial
metabolites, and stabilized by approved methods in accordance with good manufacturing
practices. Percent solids, cell count, enzyme activity or nutrient metabolite level shall be
guaranteed where applicable. [For label identification the source must be indicated such
as Bacillus subtilis, Aspergillus oryzae, Aspergillus niger, Lactobacillus acidophilus,
Lactobacillus bulgaricus or Enterococcus faecium, or as permitted by FDA.] (Proposed
1976, Amended 1979, Adopted 1983, Amended 1997)
IFN 5-06-156 Bacillus subtilis fermentation product liquid
IFN 5-06-157 Aspergillus niger fermentation product liquid
IFN 5-06-158 Aspergillus oryzae fermentation product liquid
IFN 5-06-159 Lactobacillus acidophilus fermentation product liquid
IFN 5-06-160 Lactobacillus bulgaricus fermentation product liquid
IFN 5-06-161 Enterococcus faecium fermentation product liquid
Note: Dried Cultured Skimmed Milk—refer to 54.5 Milk Products Section.
Condensed Cultured Skimmed Milk—refer to 54.6 Milk Products Section.
36.13 Extracted ______________ _____________ is the filtered and dried
mycelium obtained from _____________fermentation. (For label identification the
source must be indicated as Penicillium, Streptomyces, or citric acid and must be stated
as that in the second word of the name. The third word of the name is for the form of the
ingredient, i.e., presscake, meal, or pellets.) (Proposed 1988, Adopted 1997)
IFN 5-07-154 Penicillium fermentation presscake dehydrated
IFN 5-07-155 Streptomyces fermentation presscake dehydrated
IFN 5-07-156 Citric acid fermentation presscake dehydrated
IFN 5-06-163 Penicillium fermentation presscake meal extracted
IFN 5-06-164 Streptomyces fermentation presscake meal extracted
IFN 5-06-162 Citric acid fermentation presscake meal extracted
36.14 Direct-Fed Microorganisms—The following microorganisms were
reviewed by the Food and Drug Administration, Center for Veterinary Medicine, and
found to present no safety concerns when used in direct-fed microbial products. These
microorganisms must be nontoxigenic.
Aspergillus niger
Aspergillus oryzae
Bacillus amyloliquefaciens
Bacillus coagulans
Bacillus lentus
Bacillus pumilus
Bacillus subtilis
Bacteroides amylophilus
Bacteroides capillosus
Bacteroides ruminocola
Bacteroides suis
Bifidobacterium adolescentis

Bifidobacterium animalis
Bifidobacterium bifidum
Bifidobacterium infantis
Bifidobacterium longum
Bifidobacterium thermophilum
*Enterococcus cremoris
*Enterococcus diacetylactis
Enterococcus faecium
*Enterococcus intermedius, correct to Streptococcus intermedius**
*Enterococcus lactis
*Enterococcus thermophilus, correct to Streptococcus thermophilus**
Lactobacillus acidophilus
Lactobacillus animalis
Lactobacillus brevis
Lactobacillus buchneri (cattle only)
Lactobacillus bulgaricus, renamed to Lactobacillus delbrueckii**
Lactobacillus casei
Lactobacillus cellobiosus, renamed to Lactobacillus fermentum**
Lactobacillus curvatus
Lactobacillus delbrueckii
Lactobacillus farciminis (swine only)
Lactobacillus fermentum
Lactobacillus helveticus
Lactobacillus lactis, renamed to Lactobacillus delbrueckii**
Lactobacillus plantarum
Lactobacillus reuteri
Leuconostoc mesenteroides
Megasphaera elsdenii (cattle only)
Pediococcus acidilactici
Pediococcus cerevisiae (damnosus), renamed to Pediococcus damnosus***
Pediococcus pentosaceus
Propionibacterium acidipropionici (cattle only)
Propionibacterium freudenreichii
Propionibacterium shermanii, renamed to Propionibacterium freudenreichii**
Rhodopseudomonas palustris (broiler chickens only)
Saccharomyces cerevisiae
Yeast (as defined elsewhere)
*Formerly cataloged as Streptococcus.
**Date of compliance January 2022.
CHAPTER SIX
***Date of compliance January 2023.

(Proposed 1991, Adopted 1993, Amended 2001, 2004, 2006, 2011, 2017, 2018 rev. 1)
36.15 Dried Fermentation Biomass is a nonviable biomass product resulting from
the production of the amino acids by the fermentation of nonpathogenic, nontoxigenic,
risk group 1 Escherichia coli. The product must contain a minimum of 75% crude
protein on a dry matter basis. The product is intended as a source of protein. Non-protein
nitrogen content must be guaranteed when present. (Proposed 2007, Adopted 2010)
36.16 Dried L-Lysine Fermentation Product is the dry biomass product from
the fermentation of Corynebacterium glutamicum on an appropriate nutrient media and
stabilized in accordance with good manufacturing practices. The product is intended
as a source of lysine in livestock, poultry and aquaculture feeds. The L-lysine content
must not be less than 50% on a dry matter basis. The label shall include guarantees for
minimum L-lysine and maximum sulfur. (Proposed 2014 rev. 1, Adopted 2015 rev. 1)
36.17 Liquid L-Lysine Fermentation Product is the liquid biomass product from
the fermentation of Corynebacterium glutamicum on appropriate nutrient media and

stabilized in accordance with good manufacturing practices. The product is intended as a

source of lysine in livestock and poultry feeds. The L-lysine content must not be less than
50% on a dry matter basis. The label shall include guarantees for minimum L-lysine and
maximum sulfur. (Proposed 2010, Adopted 2014 rev. 1)
39. Flax Products

(See Other Oilseed Products Section 71)
40. Human Food By-Products

Investigator and Section Editor—Melanie Marquez, MN
NOTE: All ingredients must be feed grade. Firms should perform a safety
assessment of materials that may be included in the offered feed ingredient, at the
maximum use level (including cocoa products and non-nutritive sweeteners), to
determine safety for the intended animal species and the safety of milk, meat, or eggs
from animals consuming the ingredient. The safety assessment should be archived in the
firm’s files and provided to state or federal regulators upon request.
Official
40.1 (old 60.1) Dried Apple Pomace is the sound, dried residue obtained by the
removal of cider from apples. (Adopted 1929)
IFN 4-00-423 Apple pomace dehydrated
40.2 (old 60.2) Dried Apple Pectin Pulp is the sound, dried residue obtained by the
removal of pectin from apple products. (Adopted 1929)
IFN 4-00-425 Apple pomace without pectin dehydrated
40.8 (old 60.8) Dried Tomato Pomace is the dried mixture of tomato skins, pulp,
and crushed seeds. If the pomace contains spices used in the production of the tomato
product, this must be shown in the name as “Dried Spiced Tomato Pomace.” (Adopted
1953, Amended 1964)
IFN 5-05-041 Tomato pomace dehydrated
40.14 (old 60.14) Cereal Food Fines consists of particles of breakfast cereals
obtained as a by-product of their processing. (Adopted 1957)
IFN 5-01-199 Cereals food fines
40.15 (old 60.15) Dried Bakery Product is a mixture of bread, cookies, cake,
crackers, flours, and doughs which has been mechanically separated from non-edible
material, artificially dried and ground. If the product contains more than 3.5% salt, the
maximum percentage of salt must be a part of the name; i.e. Dried Bakery Product with
_____ % Salt. (Proposed 1962, Adopted 1967)
IFN 4-00-466 Bakery waste dehydrated
40.28 (old 60.28) Dried Potato Products is the dried residue of potato pieces,
peeling, culls, etc., obtained from the manufacture of processed potato products for
human consumption. The residue may contain up to 3% hydrate of lime which may be
added to aid in processing. (Proposed 1972, Adopted 1973)
IFN 4-03-775 Potato process residue dehydrated
40.29 (old 60.29) Gelatin By-Products is the dried residue from the various process
streams from the manufacture of edible gelatin. The total crude protein content will
contain a minimum of 85% digestible protein as determined by the AOAC pepsin method
22.025-22.031. A 25% maximum of diatomaceous earth will not be exceeded. This

product is for use in poultry feeds not to exceed 5% of the total rations. (Proposed 1972,
Adopted 1973)
IFN 5-14-503 Gelatin process residue
40.34 (old 60.34) Dried Beans are the residue of the normal packaging and
processing of _____ dried beans for human consumption. This residue shall consist of the
broken, small, shriveled, and cull _____beans. They shall be identified by variety such as
navy, Northern, pinto, kidney, et al. Where further processing, such as grinding, roasting,
etc., has occurred, ground, roasted, or other acceptable description may be part of the
name, i.e., ground roasted _____ dried beans. (Proposed 1976, Adopted 1977)
IFN 5-00-594 Bean seeds
IFN 5-00-600 Bean kidney seeds
IFN 5-00-623 Bean navy seeds
IFN 5-00-624 Bean pinto seeds
40.35 (old 60.35) Sugar Foods By-Product is the product resulting from the
grinding and mixing of the inedible portions derived from the preparation and packaging
of sugar based food products such as candy, dry packaged drinks, dried gelatin mixes,
and similar food products which are largely sugar. It shall contain not less than 80% total
sugar expressed as invert. It shall be free from foreign materials harmful to animals.
IFN 4-20-865 Sugar foods process residue
40.93 (old 60.93) Pasta Product is a mixture of dry, whole and broken particles of
noodles, macaroni, spaghetti, etc., or a mixture of these resulting from the manufacturing
and packaging of edible pasta products and which has been mechanically separated from
any non-edible materials. (Proposed 1995, Adopted 1996)
*40.96 (old 60.96) Food Processing Waste is composed of any and all animal
and vegetable products from basic food processing. This may include manufacturing
or processing waste, cannery residue, production over-run, and otherwise unsaleable
material. The guaranteed analysis shall include the maximum moisture, unless the
product is dried by artificial means to less than 12% moisture and designated as
“Dehydrated Food Processing Waste.” If part of the grease and fat is removed, it must be
designated as “Degreased.” (Proposed 1998, Adopted 2000)
*40.97 (old 60.97) Restaurant Food Waste is composed of edible food waste
collected from restaurants, cafeterias, and other institutes of food preparation. Processing
and/or handling must remove any and all undesirable constituents including crockery,
glass, metal, string, and similar materials. The guaranteed analysis shall include
maximum moisture, unless the product is dried by artificial means to less than 12%
CHAPTER SIX
moisture and designated as “Dehydrated Restaurant Food Waste.” If part of the grease
and fat is removed it must be designated as “Degreased.” (Proposed 1998, Adopted 2000)
40.100 Recovered Retail Food is composed of edible human food products safe
and suitable for livestock feed that are collected from retail food establishments, domestic
holding facilities, and domestic packing facilities. Permitted recovered retail foods are
products from overstocks, lacking consumer acceptance, or beyond their sell-by date
that include items such as bruised, cut, or overly ripe produce (fruit and vegetables),
bakery goods, eggs, and dairy products. It shall be safe and appropriately labeled for
its intended use and shall be free of material harmful to animals. Materials excluded
from this definition include pet foods and products containing beef, lamb, pork, poultry,
fish, or shellfish. It must not contain packaging materials (e.g., plastics, glass, metal,
string, Styrofoam, cardboard, and similar materials), flowers, potted plants, or potting
soil. The recovered foods shall be collected and intermixed in secure holding containers
to exclude unauthorized addition of trash, materials harmful to animals, or infestation
and adulteration by pests. Egg and dairy products (and other products ordinarily held at
refrigerator temperatures) must be kept in cold storage until the scheduled pick-up. To

minimize spoilage, the recovered retail food shall be collected at least weekly, or more
frequently if necessary. The establishment should have a sanitation plan in place, and the
containers should be cleaned and sanitized as necessary. The collected material may be
further processed or delivered as is to an animal feeding facility. The product must be
handled to preserve its safety and nutritional value. (Proposed 2017, Adopted 2019)
40.107 (old 60.107) Mixed Feed Nuts are the residue of the normal packaging and
processing for human consumption of shelled tree nut and peanut products. This residue
shall consist of broken, small, shriveled and cull edible tree nuts or peanuts of two or
more kinds and shall be suitable for animal consumption. If salt has been added during
processing, a guarantee must be made for maximum sodium. (Proposed 2004, Adopted
2006)
40.112 (old 60.112) (*blank - fruit) Pomace is the sound residue from the normal
processing of fruits for human consumption. This residue shall be suitable for animal
feed usage and may contain the skin, peel, seed, and pulp, exclusive of stems except in
accordance with good manufacturing practices. It must contain a maximum guarantee
for moisture percentage and acid detergent fiber. The source must be declared as the first
word in the ingredient name, i.e., apple pomace, etc. Moisture may be removed by an
acceptable method and the term “dried” included in the name, i.e., dried apple pomace,
etc. (Proposed 2015, Adopted 2015 rev. 1)
*Acceptable products: apple
42. Grain Sorghums (Milo, Hegari, Kaffir, or Feterita)

Official
42.1 Ground Grain Sorghum is the entire product made by grinding the grains of
grain sorghum. (Adopted 1947, Amended 1962, 1964)
IFN 4-04-379 Sorghum grain ground
IFN 4-04-378 Sorghum grain cracked
NOTE: The word “cracked” must be substituted for the word “ground” in the above
definition when the product is cracked instead of ground.
42.2 Grain Sorghum Gluten Feed is that part of the grain of grain sorghums that
remains after the extraction of the larger part of the starch and germ, by the processes
employed in the wet milling manufacture of starch or syrup. (Adopted 1948, Amended
1950)
IFN 5-04-389 Sorghum gluten with bran meal
42.3 Grain Sorghum Gluten Meal is that part of the grain of grain sorghums that
remains after the extraction of the larger part of the starch and germ, and the separation
of the bran by the processes employed in the wet milling manufacture of starch or syrup.
IFN 5-04-388 Sorghum gluten meal
42.4 Grain Sorghum Germ Cake or Grain Sorghum Germ Meal consists of
the germ of grain sorghum grains from which part of the oil has been pressed and is the
product obtained in the wet milling process of manufacture of starch, syrup, and other
grain sorghum products. (Adopted 1948, Amended 1950, 1960, 1963)
IFN 5-04-377 Sorghum germs meal mechanical extracted
IFN 5-12-178 Sorghum germs mechanical extracted caked
42.6 Rolled Grain Sorghum is obtained by running whole grain sorghum over
smooth flaking rolls, after properly tempering, removing most of the fine particles and
subsequently dried and cooled. (Adopted 1953)
IFN 4-04-380 Sorghum grain rolled

42.7 Grain Sorghum Grits consists of the hard flinty portions of sorghums
containing little or no bran or germ. (Adopted 1959)
IFN 4-04-384 Sorghum grits
42.8 Gelatinized Sorghum Grain Flour is obtained from the endosperm of
sorghum grain which has been gelatinized and reduced to a finely ground meal and must
contain not more than 1% crude fiber. (Proposed 1965, Adopted 1966)
IFN 4-08-035 Sorghum flour gelatinized
42.9 Partially Aspirated Sorghum Grain Flour is obtained from whole sorghum grain
which has been partially aspirated and has been gelatinized and reduced to a finely ground
meal and must contain not more than 2.5% crude fiber. (Proposed 1965, Adopted 1966)
IFN 4-08-036 Sorghum flour partially aspirated gelatinized
42.10 Grain Sorghum Mill Feed is a mixture of grain sorghum bran, grain sorghum
germ, part of the starchy portion of grain sorghum kernels, or mixture thereof as produced
in the manufacture of grain sorghum grits and refined meal and flour and must contain not
less than 5% crude fat and not more than 6% crude fiber. (Proposed 1964, Adopted 1968)
IFN 4-04-385 Sorghum grits by-product
NOTE: Any of the types shown parenthetically in the heading for this section may
be substituted for the words “grain sorghums” in the above definitions. If the name of the
type is given it must correspond thereto.
45. Lespedeza Products

Official
45.1 Lespedeza Meal is obtained by grinding lespedeza hay which is reasonably
free of other crop plants, weeds, and mold. It must not contain more than 28% crude fiber.
IFN 1-02-523 Lespedeza hay sun-cured ground
45.2 Lespedeza Stem Meal is the ground product remaining after the separation of
the leafy material from lespedeza hay or meal. It must be reasonably free from other crop
plants and weeds. (Adopted 1938, Amended 1963)
IFN 1-02-529 Lespedeza stems sun-cured ground
48. Maize Products

CHAPTER SIX
Official
48.1 Corn Cob Fractions is obtained by the mechanical separation of one or
more fractions of corn cobs. For identification purposes the name of the fraction must
be included parenthetically following the name of the product; i.e., Corn Cob Fractions
(Hard Woody Ring and Beeswings). (Proposed 1958, Adopted 1964)
IFN 1-02-779 Maize cob fractions screened
48.2 Corn Bran is the outer coating of the corn kernel, with little or none of the
starchy part of germ. (Adopted 1931)
IFN 4-02-841 Maize bran
48.3 Corn Feed Meal is the fine siftings obtained from screened cracked corn, with
or without its aspiration products added. (Adopted 1941)
IFN 4-02-880 Maize grain fines
48.4 Ground Corn is the entire corn kernel ground or chopped. It must contain not
more than 4% foreign material. May also appear in the ingredient list of a mixed feed as
Corn Meal or Corn Chop. (Adopted 1931)
IFN 4-02-861 Maize grain ground

48.5 Cracked Corn is the entire corn kernel ground or chopped. It must contain not
more than 4% foreign material. (Adopted 1931)
IFN 4-02-854 Maize grain cracked
48.6 Screened Cracked Corn is the coarse portion of cracked corn from which
most of the fine particles have been removed and may be fine, medium, or coarse. It must
contain not more than 4% foreign material. (Adopted 1941)
IFN 4-02-862 Maize grain cracked screened
48.7 Corn Grits is the medium sized hard flinty portions of ground corn containing
little or none of the bran or germ. May also appear in the ingredient list of a mixed feed
as Hominy Grits. (Adopted 1941)
IFN 4-02-886 Maize grits
48.8 Corn Flour is the fine sized hard flinty portions of ground corn containing little
or none of the bran or germ. (Adopted 1941, Amended 1960)
IFN 4-08-024 Maize flour
48.9 Ground Ear Corn is the entire ear of corn ground, without husks, with no
greater portion of cob than occurs in the ear corn in its natural state. May also appear in
the ingredient list of a mixed feed as Corn and Cob Meal or Ear Corn Chop. (Adopted
prior to 1928, Amended 1956)
IFN 4-02-849 Maize ears ground
48.10 Ground Ear Corn with Husks is the entire ear of corn with husks ground or
chopped, with not greater proportion of cob than occurs in the ear corn in its natural state.
May also appear in the ingredient list of a mixed feed as Corn and Cob Meal with Husks,
or Ear Corn Chop with Husks. (Adopted prior to 1928, Amended 1956)
IFN 4-02-850 Maize ears with husks ground
48.11 Flaked Corn is obtained by running cracked corn which has been aspirated
and properly tempered, over smooth flaking rolls and subsequently dried and cooled.
(Adopted 1946)
IFN 4-02-859 Maize grain flaked
48.12 Toasted Corn Flakes is obtained by running cracked corn which has been
aspirated and properly tempered, over smooth flaking rolls, and subsequently dried,
cooled, and toasted. (Adopted 1953)
IFN 4-02-860 Maize grain flaked toasted
48.13 Corn Gluten Feed is that part of the commercial shelled corn that remains
after the extraction of the larger portion of the starch, gluten, and germ by the processes
employed in the wet milling manufacture of corn starch or syrup. It may or may not
contain one or more of the following: fermented corn extractives, corn germ meal.
IFN 5-02-903 Maize gluten with bran
48.14 Corn Gluten Meal is the dried residue from corn after the removal of the
larger part of the starch and germ, and the separation of the bran by the process employed
in the wet milling manufacture of corn starch or syrup, or by enzymatic treatment of the
endosperm. It may contain fermented corn extractives and/or corn germ meal. (Adopted
1936, Amended 1960)
IFN 5-02-900 Maize gluten meal
48.16 Hominy Feed is a mixture of corn bran, corn germ, and part of the starchy
portion of either white or yellow corn kernels or mixture thereof, as produced in the
manufacture of pearl hominy, hominy grits, or table meal, and must contain not less
than 4% crude fat. If prefixed with the words “white” or “yellow,” the product must
correspond thereto. (Adopted 1935)
IFN 4-02-887 Maize grits by-product (Hominy Feed)
IFN 4-02-011 Maize dent yellow grits by-product (Hominy Feed)
IFN 4-02-990 Maize dent white grits by-product (Hominy Feed)

48.17 Dried Corn Syrup is a dried product from corn syrup, a purified concentrated
aqueous solution of nutritive saccharides obtained from starch having a dextrose
equivalent of 20 or more. (Proposed 1971, Adopted 1973)
IFN 4-02-892 Maize syrup dehydrated
48.18 Hydrolyzed Corn Protein is the product resulting from complete hydrolysis
of isolated corn gluten, and after partial removal of the glutamic acid. (Adopted 1956)
IFN 5-02-901 Maize gluten hydrolyzed
48.19 Kibbled Corn is obtained by cooking cracked corn under steam pressure and
extruding from an expeller or other mechanical pressure device. (Adopted 1958)
IFN 4-02-866 Maize grain kibbled
48.20 Dehydrated Corn Plant is the entire corn plant consisting of the ear, leaves,
and stalk, which has been artificially dried and ground. (Adopted 1958)
IFN 1-02-768 Maize aerial part dehydrated
48.21 Ground Corn Cob is the product resulting from grinding the entire cob. If it
is designated as “Fine Ground,” the entire grind must pass through a number 10 sieve and
33% of the total material must pass through a number 20 sieve. If it is designated “Coarse
Ground,” the entire grind must pass through a number four sieve and 50% must pass
through a number 10 sieve. If it is designated as “Dehydrated,” it must contain not more
than 10% moisture. (Adopted 1958)
IFN 1-02-780 Maize cobs dehydrated coarse ground
IFN 1-02-781 Maize cobs dehydrated fine ground
IFN 1-02-782 Maize cobs ground
48.22 Corn Germ Meal (Dry Milled) is ground corn germ which consists of corn
germ with other parts of the corn kernel from which part of the oil has been removed and
is the product obtained in the dry milling process of manufacture of corn meal, corn grits,
hominy feed, and other corn products. (Definitions combined 1960)
IFN 5-02-894 Maize germs meal dry milled mechanical extracted
48.23 Corn Germ Meal (Wet Milled) is ground corn germ from which most of the
solubles have been removed by steeping and most of the oil removed by hydraulic, expeller,
or solvent extraction processes, and is obtained in the wet milling process of manufacture
of corn starch, corn syrup, or other corn products. (Proposed 1960, Adopted 1961)
IFN 5-02-897 Maize germs without extractives meal wet milled mechanical
extracted
IFN 5-02-898 Maize germs without extractives meal wet milled solvent extracted
48.24 Condensed Fermented Corn Extractives is obtained by the partial removal
of water from the liquid resulting from steeping corn in a water and sulphur dioxide
CHAPTER SIX
solution which is allowed to ferment by the action of naturally occurring lactic acid
producing microorganisms as practiced in the wet milling of corn. (Proposed 1959,
IFN 4-02-890 Maize extractives fermented condensed
48.25 Maltodextrins is a purified concentrated aqueous solution of nutritive
saccharides, or a dried product derived from said solution, derived from starch having a
dextrose equivalent of less than 20. (Proposed 1971, Adopted 1973)
IFN 4-08-023 Maize starch heat hydrolyzed
48.26 Solvent Extracted Hominy Feed is hominy feed from which the fat has been
extracted by the solvent process. (Proposed 1965, Adopted 1966)
IFN 4-08-025 Maize grits by-product solvent extracted (Hominy feed)
IFN 4-29-354 Maize grain heat processed
IFN 4-02-863 Maize grain heat processed flaked
IFN 4-02-864 Maize grain heat processed ground
IFN 4-02-865 Maize grain heat processed pelleted

48.30 Liquified Corn Product is the product resulting from pressure hydrolysis of corn
(steam cooking) and enzymatic treatment of the corn without removing any of the component
parts. It shall contain not less than 30% solid. (Proposed 1978, Amended 2002, Adopted 2004)
IFN 4-28-211 Maize grain hydrolyzed liquid
48.31 Gelatinized Corn Flour is obtained from endosperm of corn which has been
gelatinized and reduced to a finely ground meal and must contain not more than 1% crude
fiber. (Proposed 1978, Adopted 2002)
IFN 4-07-022 Maize flour gelatinized
48.32 Corn Germ Dehydrated consists of whole corn germ with other parts of the
corn kernel from which the oil has not been removed, and is the product obtained in the
dry and wet milling process of manufacture of corn meal, corn grits, hominy feed, corn
starch, corn syrup or other corn products. (Proposed 2002, Adopted 2004)
48.88 Corn Refinery Concentrate is the concentration of sweetwaters, by filtration and
evaporation, which are by-products in the production of corn syrup. The total sugars expressed
as invert and the moisture level shall be guaranteed. (Proposed 1993, Adopted 2005)
48.89 Corn Protein Concentrate is the dried proteinaceous fraction of the corn
primarily originating from the endosperm after removal of the majority of the non-
protein components by enzymatic solubilization of the protein stream obtained from the
wet-mill process. This proteinaceous fraction of the corn must contain not less than 80%
protein on a moisture free basis and not more than 1% starch on a moisture free basis.
The product must be labeled on “as fed” basis. This fraction shall be free of fermented
corn extractives, corn germ meal, and other non-protein components except in such
amounts as might occur unavoidably in good manufacturing processes. Vegetable oils
or other appropriate ingredients as defined in Section 87 in the Association of American
Feed Control Officials Official Publication (AAFCO OP) may be added in concentrations
not to exceed 3% to reduce dust during handling. The name of the conditioning dust
control agent, if used, must be shown as an added ingredient. (Adopted 2008, Amended
2010)
51. Marine Products

Investigator and Section Editor—Michael Blume, SD
Official
51.14 Fish Meal is the clean, dried, ground tissue of undecomposed whole fish or
fish cuttings, either or both, with or without the extraction of part of the oil. If it contains
more than 3% salt (NaCl), the amount of salt must constitute a part of the product name,
provided that in no case must the salt content of this product exceed 7%. The label shall
include guarantees for minimum crude protein, minimum crude fat, maximum crude
fiber, minimum phosphorus (P) and minimum and maximum calcium (Ca). If it bears a
name descriptive of its kind, it must correspond thereto. (Adopted 1933, Amended 1984,
Amended 2003, 2004)
IFN 5-01-977 Fish meal mechanical extracted
51.24 Fish Residue Meal is the clean, dried, undecomposed residue from the
manufacture of glue from non-oily fish. If it contains more than 3% salt (NaCl), the
amount of salt must constitute a part of the product name, provided that in no case must
the salt content of this product exceed 7%. (Adopted 1933, Amended 2003)
IFN 5-01-966 Fish glue residue meal
51.34 Fish Liver and Glandular Meal is obtained by drying the complete viscera
of the fish. At least 50% of the dry weight of the product must be derived from fish
liver and must contain at least 18 milligrams of riboflavin per pound. (Adopted 1944,
Amended 1945)
IFN 5-01-973 Fish viscera meal

51.4 Crab Meal is the undecomposed ground dried waste of the crab and contains
the shell, viscera, and part or all of the flesh. It must contain not less than 25% crude
protein. If it contains more than 3% salt (NaCl), the amount of salt must constitute a part
of the product name, provided that in no case must the salt content of this product exceed
7%. (Adopted 1933, Amended 2003)
IFN 5-01-663 Crab process residue meal
51.5 Shrimp Meal is the undecomposed ground dried waste of shrimp and contains
parts and/or whole shrimp. If it contains more than 3% salt (NaCl), the amount of salt
must constitute a part of the product name, provided that in no case must the salt content
of this product exceed 7%. (Adopted 1933, Amended 1963, Amended 2003)
IFN 5-04-226 Shrimp process residue meal
51.6 Condensed Fish Solubles is obtained by evaporating excess moisture from
the stickwater, aqueous liquids, resulting from the wet rendering of fish into fish meal,
with or without removal of part of the oil. Minimum percentage of solids, minimum
percentage of crude protein, and minimum percentage of crude fat must be guaranteed.
51.7 Dried Fish Solubles is obtained by dehydrating the stickwater. It must contain
not less than 60% crude protein. (Proposed 1963, Adopted 1964)
IFN 5-01-971 Fish solubles dehydrated
51.8 Fish Oil is the oil from rendering whole fish or cannery waste. (Proposed 1963,
Adopted 1964)
IFN 7-01-965 Fish oil
51.9 Fish Protein Concentrate, Feed Grade, is prepared from clean,
undecomposed whole fish or fish cuttings using the solvent extraction process developed
for the production of edible whole fish protein concentrate. It must contain not less than
70% protein and not more than 10% moisture. If the degree of fineness is stated, it must
conform thereto. Solvent residues are not to exceed those established in Food Additive
Regulations. (Proposed 1969, Adopted 1970, Amended 1971) Reg. 573.440
IFN 5-09-334 Fish protein concentrate solvent extracted
51.10 Fish By-Products must consist of non-rendered, clean undecomposed
portions of fish (such as, but not limited to, heads, fins, tails, ends, skin, bone and viscera)
which result from the fish processing industry. If it bears a name descriptive of its kind,
it must correspond thereto. Any single constituent used as such may be labeled according
to the common or usual name of the particular portion used (such as fish heads, fish tails,
etc). (Proposed 1974, Adopted 1975)
IFN 5-14-509 Fish process residue fresh
CHAPTER SIX
51.11 Dried Fish Protein Digest is the dried enzymatic digest of clean
undecomposed whole fish or fish cuttings using the enzyme hydrolysis process. The
product must be free of bones, scales and undigested solids with or without the extraction
of part of the oil. It must contain not less than 80% protein and not more than 10%
moisture. If the degree of fineness is stated, it must conform thereto. If the product bears a
name descriptive of its kind, composition or origin, it must correspond thereto. (Proposed
1978, Adopted 1979, Amended 2009)
IFN 5-18-778 Fish Protein hydrolyzed dehydrated
51.12 Condensed Fish Protein Digest is the condensed enzymatic digest of
clean undecomposed whole fish or fish cuttings using the enzyme hydrolysis process.
The product must be free of bones, scales, and undigested solids with or without the
extraction of part of the oil. It must contain not less than 30% protein. (Proposed 1978,
Adopted 1979)
IFN 5-17-779 Fish Protein hydrolyzed condensed
51.13 Fish Digest Residue is the clean, dried, undecomposed residue (bones-scales-
undigested solids) of the enzymatic digest resulting from the enzyme hydrolysis process

of producing fish protein digest. It must be designated according to its protein, calcium
and phosphorus content. (Proposed 1978, Adopted 1979)
IFN 5-27-467 Fish Protein Residue hydrolyzed dehydrated
51.15 Fish Stock/Broth is obtained by cooking fish and/or other marine animal
products, including bones, shells, parts, and/or muscle, but not including fish solubles.
The crude protein content of the stock/broth base material must be no less than 80% on a
dry matter basis. In order for the stock/broth to be labeled as such, the moisture-to-crude
protein ration must not exceed 135:1 (135 parts water to 1 part crude protein). If the product
bears a name descriptive of its kind, composition or origin, it must correspond thereto;
and may be called either stock or broth. (Proposed 1999, Amended 2001, Adopted 2002,
Amended 2015)
51.16 Dried Shellfish Digest is the dried enzymatic digest of clean undecomposed
shellfish (crustaceans and/or mollusks), using the enzyme hydrolysis process. The product
may contain shells, viscera, and part or all of the flesh, and must be free of undigested
solids with or without the extraction of part of the oil. It must contain not less than 50%
crude protein with not more than 10% moisture. If the degree of fineness is stated, it
must conform thereto. If the product bears a name descriptive of its kind, composition or
origin, it must correspond thereto. (Proposed 2001, Adopted 2002)
54. Milk Products

Section Editor—Kent Kitade, Life Member
Official
54.1 Dried Buttermilk, Feed Grade, is the residue obtained by drying buttermilk.
It contains 8% maximum moisture, 13% maximum ash, and 5% minimum milk fat
(Roese-Gottlieb method).* (Adopted 1932, Amended 1964)
IFN 5-01-160 Cattle buttermilk dehydrated
54.2 Condensed Buttermilk is the residue obtained by evaporating buttermilk. It
contains 27% minimum total solids, 0.055% minimum milk fat for each % of total solids, and
0.14% maximum ash for each % of total solids. (Adopted prior to 1928, Amended 1944, 1964)
IFN 5-01-159 Cattle buttermilk condensed
54.3 Dried Skimmed Milk, Feed Grade, is the residue obtained by drying defatted
milk. It contains 8% maximum moisture.* (Adopted 1930, Amended 1964)
IFN 5-01-175 Cattle skim milk dehydrated
54.4 Condensed Skimmed Milk is the residue obtained by evaporating defatted
milk. It contains 27% minimum total solids. (Adopted 1930, Amended 1964)
IFN 5-01-172 Cattle skim milk condensed
54.5 Dried Cultured Skim Milk is the residue obtained by drying lactic acid
bacteria cultured in defatted milk. It contains 8% maximum moisture. (Adopted 1932,
Amended 1964)
IFN 5-01-174 Cattle skim milk cultured dehydrated
54.6 Condensed Cultured Skim Milk is the residue obtained by evaporating lactic
acid bacteria cultured defatted milk. It contains 27% minimum total solids. (Adopted
1932, Amended 1964)
IFN 5-01-173 Cattle skim milk cultured condensed
54.7 Dried (Dry) Whey is the product obtained by removing water from whey. It
contains not less than 11% protein nor less than 61% lactose. (Adopted 1934, Amended
1948, 1950, 1951, 1964, 1981)
IFN 4-01-182 Cattle whey dehydrated

54.8 Condensed Whey is the product obtained by partially removing water

from whey. Minimum percentage of solids must be prominently declared on the label.
(Adopted 1944, Amended 1951, 1963, 1964, 1982)
IFN 4-01-180 Cattle whey condensed
54.9 Dried (Dry) Whey Solubles is obtained by drying the whey residue after
removal of whey protein, with or without partial removal of lactose. Minimum percentage
of crude protein and lactose and maximum percentage ash must be prominently declared
on the label. (Adopted 1944, Amended 1964, 1982)
IFN 4-01-189 Cattle whey solubles dehydrated
54.10 Condensed Whey Solubles is the product obtained by concentrating the
whey residue after removal of whey protein, with or without partial removal of lactose.
Minimum percentage of solids, crude protein and lactose and maximum percentage of ash
must be prominently declared on the label. (Adopted 1944, Amended 1964, 1982)
IFN 4-01-188 Cattle whey solubles condensed
54.11 Dried Hydrolyzed Whey is the residue obtained by drying lactase enzyme
hydrolyzed whey. It contains 30% minimum total glucose and galactose. (Adopted 1955,
Amended 1964)
IFN 4-01-184 Cattle whey hydrolyzed dehydrated
54.12 Condensed Hydrolyzed Whey is the residue obtained by evaporating lactase
enzyme hydrolyzed whey. It contains 50% minimum total solids and 0.3% minimum total
glucose and galactose for each percent total solids. (Adopted 1955, Amended 1964)
IFN 4-01-183 Cattle whey hydrolyzed condensed
54.13 Condensed Whey Product is the product obtained by partially removing
water from whey from which a portion of the lactose, protein and/or minerals have been
removed. The minimum percent of solids, crude protein, and lactose and the maximum
percent ash must be prominently declared on the label. May also be labeled “condensed
reduced minerals whey” or “condensed reduced lactose whey,” if appropriate. (Adopted
1948, Amended 1964, 1982)
IFN 4-01-185 Cattle whey low lactose condensed
54.14 Dried (Dry) Whey Product is the product obtained by drying whey from
which a portion of the lactose, protein and/or minerals have been removed. The minimum
percent of crude protein and lactose and maximum percent ash must be prominently
declared on the label. May also be labeled as “dried reduced minerals whey” or “dried
reduced lactose whey” if appropriate. (Adopted 1951, Amended 1952, 1964, 1982)
IFN 4-01-186 Cattle whey low lactose dehydrated
54.15 Condensed Cultured Whey is the product obtained by partially removing
CHAPTER SIX
water from whey which has been cultured. The minimum percent of solids must be
prominently declared on the label. (Adopted 1949, Amended 1964)
IFN 4-01-181 Cattle whey cultured condensed
54.16 Casein is the solid residue obtained by acid or rennet coagulation of defatted
milk. It contains 80% minimum crude protein. (Adopted 1946, Amended 1964)
IFN 5-01-162 Casein acid precipitated dehydrated
54.17 Cheese Rind is obtained by cooking cheese trimming devoid of fat other than
milk fat. (Adopted 1935, Amended 1964)
IFN 5-01-163 Cattle cheese rind
54.18 Dried Lactalbumin is the dried coagulated protein residue from whey. It contains
80% minimum crude protein on a moisture free basis. (Adopted 1952, Amended 1964, 1989)
IFN 5-01-177 Cattle whey albumin
54.19 Dried Milk, Feed Grade, is the residue obtained by drying whole milk or
milk of intermediate fat levels other than defatted milk. If the product qualifies as dried
whole milk by containing a minimum of 26% milk fat, that term may be used as the

ingredient name. The label must contain a guarantee for minimum crude protein and for
minimum crude fat (Roese-Gottlieb method)* (Adopted 1952, Amended 1964, 1995)
54.20 Dried Milk Protein is obtained by drying the coagulated protein residue
resulting from the controlled co-precipitation of casein, lactalbumin, and minor milk
proteins from defatted milk. (Proposed 1965, Adopted 1966)
IFN 5-08-044 Cattle milk protein dehydrated
54.21 Dried Hydrolyzed Casein is the residue obtained by drying the water-soluble
product resulting from the enzymatic digestion of casein. It contains 74% minimum crude
protein. (Proposed 1966, Adopted 1967)
IFN 5-08-055 Casein hydrolyzed dehydrated
54.22 Dairy Food By-Products are the products resulting from the collection of
solids contained in the wash water from the normal processing and packaging of various
foods manufacturing plants. Dairy products are the primary source but non-dairy products
may occasionally constitute a minor amount of the total volume. No sanitary sewer
wastes may be included. This product is to be fed at levels less than 25% of the animal’s
total dry matter intake. Minimum percent of solids, crude protein and crude fat and
maximum percent ash must be prominently declared on the label. (Adopted 1982)
IFN 5-30-260 Cattle milk process residue
54.23 Condensed Modified Whey Solubles is the product obtained by
concentrating the whey residue after removal of whey protein and partial removal of
lactose, and modifying the sugar content so that there is a minimum of 0.3% nonlactose
carbohydrate for each percent solids. The minimum percent of solids and the maximum
percent ash must be prominently declared on the label. (Adopted 1982)
IFN 4-01-188 Cattle whey solubles condensed
54.24 Whey is the product obtained as a fluid by separating the coagulum from
milk, cream, or skimmed milk and from which a portion of the milk fat may have been
removed. (Adopted 1982)
IFN 4-08-134 Cattle whey fresh
54.25 Dried (Dry) Whey Protein Concentrate is the product obtained by removal
or separation of water, lactose and/or minerals from whey by ultrafiltration, dehydration
or other process. It shall contain 25% minimum crude protein. The minimum percent of
crude protein and lactose and the maximum percent ash must be prominently declared on
the label. (Adopted 1982)
IFN 5-06-836 Cattle whey protein dehydrated
54.26 Dried Cultured Whey Product is that product obtained by drying whey from
which a portion of the lactose, protein and/or minerals has been removed and which has
been cultured. (Proposed 1988, Adopted 1989)
IFN 5-30-43 Cattle whey low lactose cultured dehydrated
54.27 Dried Cultured Whey is the product obtained by drying whey which has been
cultured. The label shall include a guarantee for the minimum amount of lysine and methionine.
NOTE: This is the dried version of 54.15 condensed, cultured whey. AOAC HPLC
methods are recommended to be used to quantitate the amino acids. (Proposed 1992,
Adopted 1993)
54.28 Dried Chocolate Milk is the residue obtained by drying chocolate milk
originally intended for human consumption. (Proposed 1992, Adopted 1993)
54.31 Dried Cheese is the product obtained by dehydrating cheeses as defined in 21
CFR, Part 133. No more than 10% of the fat may be other than milk fat. (Proposed 1992,
Adopted 1999)
54.32 Dried Cheese Product is the product obtained by processing various cheese
products from the food industry, including dried cheese, cheese rind, processed cheese
foods, and cheese-flavored powders. The product shall have characteristic cheese color

and aroma. The crude protein, crude fat, and crude fiber shall be guaranteed. (Proposed
2001, Adopted 2003)
54.33 Bovine Colostrum is lacteal secretions obtained within 48 hours after
parturition. It contains 3% maximum lactose, 15% minimum total solids, and 60%
minimum of the solids must be protein. The minimum specific gravity is 1.04 g/mL.
(Proposed 2014 rev. 1, Adopted 2017 rev. 1)
54.34 Dried Bovine Colostrum is the product obtained by removing water from
bovine colostrum. It contains 8% maximum moisture, 20% maximum lactose, and 50%
minimum of the solids must be protein. (Proposed 2014 rev. 1, Adopted 2017 rev. 1)
*The words “feed grade” are not required when listed as an ingredient in a manufactured
feed.
57. Mineral Products

Investigator and Section Editor—Jennifer Kormos, Canada
The mineral products section includes ingredients that come from mined and
processed rock and ore deposits, chemically manufactured salts, recovered natural salts,
residue or remains of living organisms, and organic salts or organically bound elements
as well as other similar ingredients.
Minerals from animal and plant sources can be found in other sections of the Official
Publication.
(See Official Guidelines for Contaminant Levels Permitted in
Mineral Feed Ingredients located on page 300)
Official
57.265 Ammonium Chloride is the product resulting from the neutralization of
hydrochloric acid with ammonia generally expressed as NH4Cl. It must contain not less
than 25.6% nitrogen (equivalent to 160% crude protein). It must contain not more than
0.1% moisture, 0.4% salt (NaCl), 15 ppm iron (Fe), 3 ppm arsenic (As), and 10 ppm
heavy metals reported as lead. It may be treated with not more than 1.0% tricalcium
phosphate to prevent caking. It shall not be made from by-product ammonia recovered
CHAPTER SIX
from coke oven gas. It is to be used only in feeds for cattle, sheep, and goats as a source
of both non-protein nitrogen and chloride at a level not to exceed 1.0% ammonium
chloride in the total daily ration to provide not more than 1.6% equivalent crude protein.
Labels for feed containing ammonium chloride include premixes, concentrates, and
supplements shall contain adequate directions for use and the following prominent
statements: “CAUTION: Use only as directed. For ruminants (cattle, sheep, and goats)
only.” (Adopted 1984, Amended 2001, Adopted 2003, Amended 2011, Adopted 2014 rev.
1)
IFN 8-08-814 Ammonium Chloride
57.27 Ammonium Sulfate is the product resulting from the neutralization of
sulfuric acid with ammonia. It shall contain not less than 21% nitrogen (N) and not less
than 24% sulfur (S). It shall contain not more than 75 ppm arsenic (As) and 30 ppm
heavy metals reported as lead. This does not include ammonium sulfate made from
by-product ammonia recovered from coke-oven gas. It shall be used only in ruminant
feeds as a source of sulfur and nitrogen in an amount that supplies not more than 2% of
equivalent crude protein in the total daily ration. If a premix, concentrate, or supplement

contains more than 2% of equivalent crude protein from ammonium sulfate, the label
shall have adequate directions for use and a prominent statement, “Caution--This feed
shall be used only in accordance with directions furnished on the label.” (Proposed 1969,
Adopted 1972) Reg. 582.1143
IFN 6-09-339 Ammonium sulfate
57.154 Basic Copper Chloride is the copper salt of hydrochloric acid and hydrated
form of copper oxide generally expressed as Cu2(OH)3Cl and its hydrated forms.
Minimum copper (Cu) must be specified. (Proposed 1995, Adopted 1997)
57.1 Bone Ash is the ash obtained by burning bones with free access to air, and
containing a minimum of 15.3% phosphorus (P). The label must show a guarantee for
calcium (Ca) and phosphorus (P). (Adopted 1935, Amended 1952)
IFN 6-00-401 Animal bone ash
57.2 Bone Charcoal is obtained by charring bones in closed retorts. It must contain
a minimum of 14% phosphorus (P). It must be labeled with guarantees for calcium (Ca)
and phosphorus (P). (This product is sometimes referred to as “Bone Black,” however,
bone charcoal must be used in all labeling.) (Adopted 1938, Amended 1952, 1963)
IFN 6-00-402 Animal bone charcoal
57.17 Bone Charcoal, Spent, is the product resulting from the repeated charring
of bone charcoal after use in clarifying sugar solutions. It must contain a minimum of
11.5% phosphorus (P). It must be labeled with guarantees for phosphorus (P) and calcium
(Ca). (This product is sometimes referred to as “Spent Bone Black,” however, spent bone
charcoal must be used in all labeling.) (Adopted 1938, Amended 1952, 1963)
IFN 6-00-404 Animal bone charcoal spent
*57.141 Bone Meal, Cooked, is the dried and ground sterilized product resulting
from wet cooking without steam pressure of undecomposed bones. Fat, gelatin, and meat
fiber may or may not be removed. When labeled as a commercial feed ingredient, it shall
carry guarantees for protein, phosphorus (P), and calcium (Ca). Cooked bone meal shall
be used in all labeling. (Proposed 1984)
IFN 6-17-171 Animal bone meal boiled
*57.18 Bone Meal, Steamed, is the dried and ground product sterilized by cooking
undecomposed bones with steam under pressure. Grease, gelatin, and meat fiber may or
may not be removed. It must be labeled with guarantees for phosphorus (P) and calcium
(Ca). Steamed bone meal must be used in all labeling. (Proposed 1957, Adopted 1962,
Amended 1964)
IFN 6-00-400 Animal bone meal steamed
57.14 Bone Phosphate is the residue of bones that have been treated first in a
hydrochloric acid solution and thereafter precipitated with lime and dried. It must contain
a minimum of 17% phosphorus (P). It must be labeled with guarantees for calcium (Ca)
and phosphorus (P). (Proposed 1952, Amended 1963, Amended 1997)
IFN 6-00-406 Animal bone phosphate
57.3 Calcite is an acceptable source of calcium carbonate. It must be true to name
and contain not less than 33% calcium (Ca). (Adopted 1952)
IFN 6-01-067 Calcite ground
57.10 Calcium Carbonate is a product true to name which contains a minimum of
38% calcium (Ca). (Adopted 1946, Amended 1963) Reg. 582.5191.
IFN 6-01-069 Calcium carbonate
57.7 Calcium Carbonate, Precipitated, is an acceptable source of calcium
carbonate. It must be true to name and contain not less than 33% calcium (Ca).
Precipitated calcium carbonate must be used in all labeling. (Adopted 1952)
IFN 6-01-071 Calcium carbonate, precipitated CaCO3

57.51 Calcium Chloride is the calcium salt of hydrochloric acid generally

expressed as CaCl2 and its hydrated forms. Minimum calcium (Ca) and chlorine (Cl)
must be specified. (Adopted 1975)
IFN 6-20-774 Calcium chloride CaCl2
57.52 Calcium Gluconate is the calcium salt of gluconic acid generally expressed
as Ca(C6H11O7)2 and its hydrated forms. Minimum Calcium (Ca) must be specified.
(Adopted 1975)
IFN 6-01-073 Calcium gluconate monohydrate Ca(C6H11O7)2·H2O
57.53 Calcium Hydroxide is the hydrated form of calcium oxide generally
expressed as Ca(OH)2. Minimum calcium (Ca) must be specified. (Adopted 1975)
IFN 6-14-014 Calcium hydroxide Ca(OH)2
57.54 Calcium Iodate is the calcium salt of iodic acid generally expressed as
Ca(IO3)2 and the monohydrate form. Minimum calcium (Ca) and iodine (I) must be
specified. (Adopted 1975)
IFN 6-01-075 Calcium iodate Ca(IO3)2·6H2O
IFN 6-16-610 Calcium iodate monohydrate Ca(IO3)2·H2O
57.55 Calcium Iodobehenate is the calcium salt of iodobehenic acid generally
expressed as Ca(C21H42ICO2)2 and its hydrated forms. Minimum calcium (Ca) and
minimum iodine (I) must be specified. (Adopted 1975)
IFN 6-01-077, Calcium iodobehenate Ca(C21H42ICO2)2
57.56 Calcium Oxide is the oxide form of calcium generally expressed as CaO
(commonly called quicklime). The product of calcining limestone. A strong alkali
requiring caution in its use. Minimum calcium (Ca) must be specified. (Adopted 1975)
IFN 6-14-003 Calcium oxide CaO
57.25 Calcium Periodate is an acceptable source of iodine. It is produced by
reacting calcium iodate with calcium hydroxide or calcium oxide to form a substance
consisting of not less than 60% by weight of penta calcium orthoperiodate containing 28
to 31% by weight of iodine. It is used or intended for use in salt for livestock as a source
of iodine. Reg. 573.240 (Proposed 1969, Adopted 1971)
IFN 6-09-355 Calcium periodate Ca5(IO6)2
57.57 Calcium Sulfate is the calcium salt of sulfuric acid generally expressed as
CaSO4 and its hydrated forms. Minimum calcium (Ca) and minimum sulfur (S) must be
IFN 6-01-087 Calcium sulfate anhydrous CaSO4
IFN 6-01-090 Calcium sulfate dihydrate CaSO4·2H2O
57.73 Seaweed-Derived Calcium is the dried ground product resulting from the
CHAPTER SIX
harvest of skeletal remains of the marine algae species Lithothamnium corallioides and
Phymatolithon calcareum. It is composed of mixtures of calcium carbonate (CaCO3) and
magnesium carbonate (MgCO3) and is intended as a supplemental source of calcium and
magnesium for animals. It contains not less than 32% calcium as calcium carbonate and
2.3% magnesium as magnesium carbonate. It shall not contain more than 40 ppm fluorine,
40 ppm iodine, 5 ppm lead, and 5 ppm arsenic. (Proposed 2011, Adopted 2014 rev. 1)
57.8 Chalk, Precipitated, is an acceptable source of calcium carbonate. It must be
true to name and contain not less than 33% calcium (Ca). Precipitated chalk must be used
in all labeling. (Adopted 1952)
IFN 6-01-201, Chalk precipitated
57.155 Chromium Tripicolinate—Chromium tripicolinate is the product resulting
from reaction of chromium chloride with picolinic acid. It is to be used as a source of
supplemental chromium in swine diets, not to supply more than 200 ppb of chromium to
the complete diet. Chromium from all sources of supplemental chromium cannot exceed
this limit. Minimum chromium from chromium tripicolinate must be specified. (Proposed
1996, Adopted 2000, Amended 2010, Adopted 2012)

57.6 Chalk Rock is an acceptable source of calcium carbonate. It must be true to

name and contain not less than 33% of calcium (Ca). (Adopted 1952)
IFN 6-01-202 Chalk rock ground
57.131 Clam Shells, Ground, is an acceptable source of calcium carbonate. It must be
true to name and contain not less than 35% calcium (Ca). (Proposed 1979, Adopted 1981)
IFN 6-01-259 Clam shells ground
57.58 Cobalt Acetate is the cobalt salt of acetic acid generally expressed as
Co(C2H3O2)2, and its hydrated forms. Minimum cobalt (Co) must be specified. (Adopted
1975)
IFN 6-01-554 Cobalt acetate Co(C2H3O2)2
57.59 Cobalt Carbonate is the cobalt salt of carbonic acid generally expressed as
CoCO3 and its hydrated forms. Minimum cobalt (Co) must be specified. (Adopted 1975)
IFN 6-01-566 Cobalt carbonate CoCO3
57.60 Cobalt Chloride is the cobalt salt of hydrochloric acid generally expressed as
CoCl2, and its hydrated forms. Minimum cobalt (Co) must be specified. (Adopted 1975)
IFN 6-01-556 Cobaltous chloride anhydrous CoCl2
57. 123 Cobalt Choline Citrate Complex is the product resulting from the
complexing of the soluble cobalt salt with choline dihydrogen citrate. Minimum cobalt
(Co) must be specified. When used as a commercial feed ingredient, it must be declared
as “cobalt choline citrate.” (Proposed 1976)
IFN 6-20-869 Cobalt choline citrate complex
57.148 Cobalt Glucoheptonate is the cobalt salt of glucoheptonic acid generally
expressed as C14H26O16Co·H2O. Minimum cobalt (Co) must be specified. (Proposed
1988, Adopted 1989)
IFN 6-19-211 Cobalt glucoheptonate
57.147 Cobalt Gluconate is the cobalt salt of gluconic acid, generally expressed
as Co(C6H1107)2, and its hydrated forms. Minimum cobalt (Co) must be specified.
IFN 6-19-210 Cobalt gluconate
57.61 Cobalt Oxide is the oxide form of cobalt generally expressed as CoO.
Minimum cobalt (Co) must be specified. (Adopted 1975)
IFN 6-01-560 Cobalt Oxide
57.62 Cobalt Sulfate is the cobalt salt of sulfuric acid generally expressed as
CoSO4 and its hydrated forms. Minimum cobalt (Co) must be specified. (Adopted
1975)
IFN 6-01-562 Cobalt sulfate monohydrate CoSO4·H2O
IFN 6-01-564 Cobalt sulfate heptahydrate CoSO4·7H2O
57.153 Copper Acetate Monohydrate is the copper salt of acetic acid generally
expressed as Cu(C2H3O2)2·H2O and its hydrated forms. Minimum copper must be
specified. (Proposed 1993, Adopted 2000)
57.63 Copper Carbonate is the copper salt of carbonic acid generally expressed as
CuCO3. Minimum copper (Cu) must be specified. (Adopted 1975)
IFN 6-01-703 Cupric carbonate CuCO3
57.64 Copper Chloride is the copper salt of hydrochloric acid generally expressed
as CuCl or CuCl2 and their hydrated forms. Minimum copper (Cu) must be specified.
(Adopted 1975)
IFN 6-07-135 Cuprous chloride CuCl2
IFN 6-01-705 Cupric chloride dihydrate. CuCl2·2H2O
57.122 Copper Choline Citrate Complex is the product resulting from the
complexing of the soluble copper salt with choline dihydrogen citrate. Minimum copper

(Cu) must be specified. When used as a commercial feed ingredient, it must be declared
as “copper choline citrate.” (Proposed 1976, Adopted 1977)
IFN 6-20-868 Copper choline citrate complex
57.158 Copper Citrate is the copper salt of citric acid generally expressed as
C6H4Cu2O7. It is to be used as a source of copper in broiler feeds at levels not exceeding
185 ppm of total dietary copper. Minimum copper (Cu) must be specified. (Proposed
1997, Adopted 2000)
57.65 Copper Gluconate is the copper salt of gluconic acid generally expressed
as Cu(C6H11C7)2 and its hydrated forms. Minimum copper (Cu) must be specified.
(Adopted 1975)
IFN 6-01-707 Cupric gluconate Cu(C6H11C7)2
57.66 Copper Hydroxide is the hydrated form of copper oxide generally expressed
as Cu(OH)2. Minimum copper (Cu) must be specified. (Adopted 1975)
IFN 6-01-709 Cupric hydroxide Cu(OH)2
57.67 Copper Orthophosphate is the copper salt of phosphoric acid generally
expressed as Cu3(PO4)2 and its hydrated forms. Minimum copper (Cu) must be specified.
(Adopted 1975)
IFN 6-01-713 Cupric orthophosphate Cu3(PO4)2
57.68 Copper Oxide is the oxide form of copper generally expressed as CuO or
Cu2O. Minimum copper (Cu) must be specified. (Adopted 1975)
IFN 6-28-224 Cuprous oxide Cu2O
IFN 6-01-711 Cupric oxide CuO
57.69 Copper Sulfate is the copper salt of sulfuric acid generally expressed as
CuSO4 and its hydrated forms. Minimum copper (Cu) must be specified. (Adopted 1975)
IFN 6-01-717 Cupric sulfate anhydrous CuSO4
IFN 6-01-719 Cupric sulfate pentahydrate CuSO4·5H2O
57.70 Cuprous Iodide is the copper salt of hydriodic acid generally expressed as
CuI. Minimum copper (Cu) must be specified. (Adopted 1975)
IFN 6-01-721 Cuprous iodide CuI
57.72 Diiodosalicylic Acid is an iodine compound of salicylic acid generally
expressed as C7H4I2O3. Minimum iodine (l) must be specified. (Adopted 1975)
IFN 6-01-787 Diiodosalicylic acid C7H4I2O3
57.75 Ethylenediamine Dihydroiodide is an organic compound of iodine generally
expressed as C2H8N2·2HI. Minimum iodine (I) must be specified. (Adopted 1975)
IFN 6-01-842 Ethylenediamine dihydriodide C2H4NH2·2HI
57.76 Ferric Ammonium Citrate is an ammoniacally complexed iron salt of citric
CHAPTER SIX
acid of indefinite composition sometimes expressed as Fe(NH4)C6H5O7 and its hydrated

forms. Minimum iron (Fe) must be specified. (Adopted 1975)
IFN 6-01-857 Ferric ammonium citrate
57.78 Ferric Chloride is the iron salt of hydrochloric acid generally expressed as
FeCl3 and its hydrated forms. Minimum iron (Fe) must be specified. (Adopted 1975)
IFN 6-01-865 Ferric chloride FeCl3
57.121 Ferric Choline Citrate Complex is the product resulting from the
complexing of the soluble iron salt with choline dihydrogen citrate. Minimum iron (Fe)
must be specified. When used as a commercial feed ingredient it must be declared as
“ferric choline citrate.” (Adopted 1977)
IFN 6-20-867 Ferric choline citrate complex
57.127 Ferric Formate is an iron salt of formic acid generally expressed as
Fe(HCO2)3. (Adopted 1980)
IFN 6-630-089 Ferric formate monohydrate Fe(HCO2)3·H2O

57.81 Ferric Phosphate is the iron salt of phosphoric acid generally expressed as
FePO4 and its hydrated forms. Minimum iron (Fe) must be specified. (Adopted 1975)
IFN 6-01-859 Ferric phosphate FePO4
57.82 Ferric Pyrophosphate is the iron salt of pyrophosphoric acid generally
expressed as Fe4(P2O7)3 and its hydrated forms. Minimum iron (Fe) must be specified.
(Adopted 1975)
IFN 6-01-861 Ferric pyrophosphate Fe4(P2O7)3
57.129 Ferric Sulfate is the iron salt of sulfuric acid generally expressed as
Fe2(SO4)3 and its hydrated forms. Minimum iron (Fe) must be specified. (Adopted 1980)
IFN 6-30-086 Ferric sulfate Fe2(SO4)3
57.77 Ferrous Carbonate is the iron salt of carbonic acid generally expressed as
FeCO3. Minimum iron (Fe) must be specified. (Adopted 1975)
IFN 6-01-863 Ferrous carbonate FeCO3
57.128 Ferrous Chloride is the iron salt of hydrochloric acid generally expressed
as FeCl2 and its hydrated forms. Minimum iron (Fe) must be specified. (Proposed 1979,
Adopted 1981)
IFN 6-30-090 Ferrous chloride FeCl2
57.164 Ferrous Fumarate is an iron salt of fumaric acid generally expressed as
FeC4H2O4. Minimum iron (Fe) must be specified. (Adopted 1975)
IFN 6-08-097 Ferrous fumarate FeC4H2O4
57.79 Ferrous Gluconate is the iron salt of gluconic acid generally expressed as
Fe(C6H11O7)2 and its hydrated forms. Minimum iron (Fe) must be specified. (Adopted
1975)
IFN 6-01-867 Ferrous gluconate dihydrate Fe(C6H11O7)2·2H2O
57.139 Ferrous Glycine Complex is the reaction product of one molecular
equivalent of ferrous iron salt and two or more molecular equivalents of glycine,
generally expressed as FeC4N2H8O4. Minimum iron (Fe) must be specified. When used
as a commercial feed ingredient it must be declared as Ferrous Glycine. (Proposed 1984)
IFN 6-17-227 Ferrous glycine complex FeC4N2H8O4
57.83 Ferrous Sulfate is the iron salt of sulfuric acid generally expressed as FeSO4
and its hydrated forms. Minimum iron (Fe) must be specified. (Adopted 1975)
IFN 6-01-869 Ferrous sulfate monohydrate FeSO4·H2O
IFN 6-20-734 Ferrous sulfate heptahydrate FeSO4·7H2O
57.30 Gypsiferrous Shale is a natural occurring shale type rock containing native
calcium sulfate (CaSO4). It must carry guarantees of calcium (Ca) and sulfur (S).
IFN 6-14-505 Shale gypsiferrous
57.80 Iron Oxide is the oxide form of iron occurring both naturally and
synthetically in various chemical valence compositions and colors -- sometimes
expressed as Fe2O3. Minimum iron (Fe) must be specified. (Adopted 1975)
IFN 6-02-431 Ferric oxide Fe2O3
57.84 Iron, Reduced, is a metallic form of iron obtained by reducing ferric oxide
with hydrogen. Minimum iron (Fe) must be specified. (Adopted 1975)
IFN 6-02-429 Iron Reduced
57.9 Limestone, Ground, is an acceptable source of calcium carbonate. It must be
true to name and contain not less than 33% calcium (Ca). Ground limestone must be used
in all labeling. (Adopted 1952)
IFN 6-02-632 Limestone ground
57.11 Limestone, Magnesium or Dolomitic, is an acceptable source of magnesium
and calcium carbonate. The terms are synonymous and designate a native mineral
composed of mixtures of magnesium carbonate (MgCO3), and calcium carbonate
(CaCO3). It must contain not less than 10% magnesium (Mg) and must be declared as

an ingredient as magnesium limestone or dolomitic limestone. (Adopted 1946, Amended

1952, 1965)
IFN 6-02-633 Limestone dolomitic ground
IFN 6-06-934 Limestone magnesium ground
57.85 Magnesium Carbonate is a magnesium salt of carbonic acid generally
expressed as MgCO3·Mg(OH)2 and its hydrated forms. Minimum magnesium (Mg) must
be specified. (Adopted 1975)
IFN 6-02-754 Magnesium carbonate MgCO3·Mg(OH)2
IFN 6-08-797 Magnesium carbonate trihydrate MgCO3·Mg(OH)2·3H2O
IFN 6-29-798 Magnesium carbonate pentahydrate MgCO3·Mg(OH)2·5H2O
57.126 Magnesium Chloride is the magnesium salt of hydrochloric acid generally
expressed as MgCl2 and its hydrated forms. Minimum magnesium (Mg) must be
specified. (Proposed 1976, Adopted 1977)
IFN 6-20-872 Magnesium chloride MgCl2
57.161 Magnesium Gluconate is the magnesium salt of gluconic acid generally
expressed as Mg(C6H11O7)2 and its hydrated forms. Minimum magnesium (Mg) must be
specified. For use in animal feeds, excluding aquatic species. (Proposed 2000, Adopted 2002)
57.86 Magnesium Hydroxide is the hydrated form of magnesium generally
expressed as Mg(OH)2. Minimum magnesium (Mg) must be specified. (Adopted 1975)
IFN 6-26-012 Magnesium hydroxide Mg(OH)2
57.140 Magnesium Phosphate is the magnesium salt of phosphoric acid, generally
expressed as MgHPO4 and its hydrated forms. Minimum magnesium (Mg) and
phosphorus (P) and maximum fluorine (F) must be specified. It must contain not more
than one part fluorine (F) to 100 parts phosphorus. (Proposed 1984)
IFN 6-23-294 Magnesium phosphate MgHPO4
57.87 Magnesium Oxide is the oxide of magnesium generally expressed as MgO.
Minimum magnesium (Mg) must be specified. (Adopted 1975)
IFN 6-02-756 Magnesium oxide MgO
57.24 Magnesium-Mica is a natural occurring magnesium, iron, and potassium
layer silicate. It must be labeled with guarantees for magnesium (Mg), iron (Fe), and
potassium (K). (Proposed 1968, Adopted 1971, Amended 1987)
IFN 6-08-999 Magnesium-Mica
57.88 Magnesium Sulfate is the magnesium salt of sulfuric acid generally
expressed as MgSO4 and its hydrated forms. Minimum magnesium (Mg) must be
IFN 6-26-134 Magnesium sulfate MgSO4.
CHAPTER SIX
IFN 6-12-209 Magnesium sulfate monohydrate MgSO4·H2O.

IFN 6-02-758 Magnesium sulfate heptahydrate MgSO4·7H2O
57.89 Manganese Acetate is the manganese salt of acetic acid generally expressed
as Mn(C2H3O2)2 and its hydrated forms. Minimum manganese (Mn) must be specified.
(Adopted 1975)
IFN 6-03-034 Manganese acetate tetrahydrate Mn(C2H3O2)2·4H2O
57.90 Manganese Carbonate is the manganese salt of carbonic acid generally
expressed as MnCO3 and its hydrated forms. Minimum Manganese (Mn) must be
IFN 6-03-036 Manganous carbonate MnCO3
57.91 Manganese Chloride is the manganese salt of hydrochloric acid generally
expressed as MnCl2 and its hydrated forms. Minimum manganese (Mn) must be
IFN 6-03-038 Manganous chloride tetrahydrate MnCl2·4H2O

57.92 Manganese Citrate (Soluble) is the manganese salt of citric acid generally
expressed as Mn3(C6H5O7)2 and its hydrated forms. Minimum manganese (Mn) must be
IFN 6-03-040 Manganous citrate soluble Mn3(C6H5O7)2
57.93 Manganese Gluconate is the manganese salt of gluconic acid generally
expressed as Mn(C6H11O7)2. Minimum manganese (Mn) must be specified. (Adopted 1975)
IFN 6-03-044 Manganous gluconate Mn(C6H11O7)2
57.94 Manganese Orthophosphate is the manganese salt of phosphoric acid
generally expressed as Mn3(PO4)2 and its hydrated forms. Minimum manganese (Mn)
IFN 6-03-047 Manganese orthophosphate trihydrate Mn3(PO4)2·3H2O
57.95 Manganese Phosphate (dibasic) is the manganese salt of phosphoric acid
generally expressed as MnHPO4 and its hydrated forms. Minimum manganese (Mn) must
be specified. (Adopted 1975)
IFN 6-03-048 Manganese phosphate dibasic MnHPO4
57.96 Manganese Sulfate is the manganese salt of sulfuric acid generally expressed
as MnSO4 and its hydrated forms. Minimum manganese (Mn) must be specified.
(Adopted 1975)
IFN 6-03-050, Manganous sulfate tetrahydrate MnSO4·4H2O
57.97 Manganous Oxide is an oxide form of manganese generally expressed as
MnO. Minimum manganese (Mn) must be specified. (Adopted 1975)
IFN 6-03-054 Manganous oxide MnO
57.150 Metal Amino Acid Complex is the product resulting from complexing of
a soluble metal salt (such as potassium or manganese) with an amino acid(s). Minimum
metal content must be declared. When used as a commercial feed ingredient, it must be
declared as a specific metal amino acid complex, i.e., potassium amino acid complex,
copper amino acid complex, zinc amino acid complex, magnesium amino acid complex,
iron amino acid complex, cobalt amino acid complex, calcium amino acid complex, and
manganese amino acid complex.(Adopted 1990)
IFN 6-32-053 Copper amino acid complex
IFN 6-32-054 Zinc amino acid complex
IFN 6-32-055 Magnesium amino acid complex
IFN 6-32-056 Iron amino acid complex
IFN 6-32-057 Cobalt amino acid complex
IFN 6-32-058 Calcium amino acid complex
IFN 6-32-059 Potassium amino acid complex
IFN 6-32-060 Manganese amino acid complex
57.151 Metal (specific amino acid) Complex is the product resulting from
complexing a soluble metal salt with a specific amino acid. Minimum metal content must
be declared. When used as a commercial feed ingredient, it must be declared as a specific
metal, specific amino acid, i.e., copper lysine complex, zinc lysine complex, ferric
methionine complex, manganese methionine complex and zinc methionine complex
IFN Copper lysine complex
IFN Zinc lysine complex
IFN 6-16-294 Ferric methionine complex
IFN 6-19-212 Manganese methionine complex
IFN 6-16-293 Zinc methionine complex
57.142 Metal Amino Acid Chelate is the product resulting from the reaction of a
metal ion from a soluble metal salt with amino acids with a mole ratio of one mole of metal
to one to three (preferably two) moles of amino acid to form coordinate covalent bonds.
The chelating ligand(s) are a mixture of hydrolyzed amino acids with an average molecular

weight of approximately 150, or are specific amino acid(s). The resulting molecular weight
of the chelate must not exceed 800. The minimum metal content must be declared. When
used as a commercial feed ingredient it must be declared as a specific metal amino acid
chelate; i.e., Calcium Amino Acid Chelate, Cobalt Amino Acid Chelate, Copper Amino Acid
Chelate, Iron Amino Acid Chelate, Magnesium Amino Acid Chelate, Manganese Amino
Acid Chelate or Zinc Amino Acid Chelate. (Proposed 1986, Adopted 1988, Amended 2009)
IFN 6-20-981 Calcium amino acid chelate
IFN 6-20-982 Cobalt amino acid chelate
IFN 6-20-983 Copper amino acid chelate
IFN 6-20-984 Iron amino acid chelate
IFN 6-20-985 Magnesium amino acid chelate
IFN 6-20-986 Manganese amino acid chelate
IFN 6-20-987 Zinc amino acid chelate
57.28 Metal Methionine Hydroxy Analogue Chelate is the product resulting from
the reaction of a metal salt with 2-hydroxy-4-methylthiobutanoic acid (HMTBa), having
a chelated molar ratio of one mole of metal to two moles of HMTBa to form coordinate
covalent bonds. This ingredient is intended to be used as a source of trace minerals. The
specific metal chelate must be declared as a metal methionine hydroxyl analogue chelate;
i.e. copper methionine hydroxy analogue chelate, manganese methionine hydroxy
analogue chelate, or zinc methionine hydroxy analogue chelate. The minimum metal
content must be declared, and must be at least 15% for copper, 13% for manganese and
16% for zinc. (Proposed 2012, Adopted 2014 rev. 1)
57.29 Metal Polysaccharide Complex is the product resulting from complexing
of a soluble salt with a polysaccharide solution declared as an ingredient as the specific
metal complex i.e., copper polysaccharide complex, zinc polysaccharide complex, iron
polysaccharide complex, cobalt polysaccharide complex, magnesium polysaccharide
complex and manganese polysaccharide complex (Proposed 1971, Adopted 1973,
Amended 2007)
IFN 8-09-822 Copper polysaccharide complex
IFN 8-09-898 Iron polysaccharide complex
IFN 8-09-899 Zinc polysaccharide complex
IFN 8-19-206 Magnesium polysaccharide complex
57.160 Zinc Propionate is the product resulting from reaction of a zinc salt with
propionic acid. Zinc propionate is prepared with an excess of propionic acid, at an
appropriate stoichiometric ratio. Minimum zinc content must be declared. (Proposed
2017 rev. 1, Adopted 2017 rev. 1)
CHAPTER SIX
57.166 Chromium Propionate—The food additive chromium propionate may be

safely used in animal feed as a source of supplemental chromium in accordance with the
following prescribed conditions:
(a) The additive is manufactured by the reaction of a chromium salt with propionic
acid, at an appropriate stoichiometric ratio, to produce triaqua-(mu3-oxo)
hexakis (mu2-propionato-O,O′) trichromium propionate with the empirical
formula, [Cr3(O)(CH3CH2CO2)6(H2O)3]CH3CH2CO2.
(b) It is added to feed as follows:
(1) In the complete feed of broiler chickens and swine at a level not to exceed
0.2 mg of chromium from chromium propionate per kilogram of feed.
(2) In cattle diets at a level not to exceed 0.5 mg of chromium from chromium
propionate per kilogram of the complete feed. Chromium propionate
must be premixed with dry ingredients prior to adding to high moisture
ingredients or forages.
(1) Total chromium content, 8 to 10%.

(2) Hexavalent chromium content, less than 2 parts per million.

(3) Arsenic, less than 1 part per million.
(4) Cadmium, less than 1 part per million.
(5) Lead, less than 0.5 part per million.
(6) Mercury, less than 0.5 part per million.
(7) Viscosity, not more than 2,000 centipoise.
(d) The additive shall be incorporated into feed as follows:
(1) It shall be incorporated into each ton of complete feed by adding no less
than one pound of a premix containing no more than 181.4 mg of added
chromium from chromium propionate per pound.
(2) The premix manufacturer shall follow good manufacturing practices in
the production of chromium propionate premixes. Inventory, production,
and distribution records must provide a complete and accurate history of
product production.
(3) Chromium from all sources of supplemental chromium cannot exceed 0.2
part per million of the complete feed for broiler chickens and swine and
0.5 part per million of the complete feed for cattle.
(e) To assure safe use of the additive in addition to the other information required
(1) The label and labeling of the additive, any feed premix, and complete feed
shall contain the name of the additive.
contain:
(i) A guarantee for added chromium content.
(ii) Adequate directions for use and cautions for use including this
statement: Caution: Follow label directions. Chromium from all
sources of supplemental chromium cannot exceed 0.2 part per million
of the complete feed for broiler chickens and swine and 0.5 part per
million of the complete feed for cattle.
(21 CFR 573.304) (Adopted 2017 rev. 1)
57.23 Metal Proteinate is the product resulting from the chelation of a soluble salt
with amino acids and/or partially hydrolyzed protein. It must be declared as an ingredient
as the specific metal proteinate: i.e., Copper Proteinate, Zinc Proteinate, Magnesium
Proteinate, Iron Proteinate, Cobalt Proteinate, Manganese Proteinate or Calcium
Proteinate. (Proposed 1967, Adopted 1970, Amended 1977, Amended 1987)
IFN 6-09-896 Copper proteinate
IFN 6-09-897 Zinc proteinate
IFN 6-26-149 Magnesium proteinate
IFN 6-26-150 Iron proteinate
IFN 6-26-151 Cobalt proteinate
IFN 6-16-834 Manganese proteinate
IFN 6-16-833 Calcium proteinate
57.4 Oyster Shell Flour is an acceptable source of calcium carbonate. It must be
true to name and contain not less than 33% calcium (Ca). (Adopted 1952)
IFN 6-03-481 Oyster shells fine ground (Oyster shell flour)
57.22 Ammonium Polyphosphate Solution is the product resulting from the
neutralization of superphosphoric acid. It must contain not less than 9% nitrogen (N) and
13% phosphorus (P). It must contain not more than one (1) part fluorine (F) to 100 parts
phosphorus (P), 75 ppm of arsenic (As), and 30 ppm of heavy metals reported as lead.
It may be used in ruminant feeds as a source of both phosphorus and nitrogen in an
amount that supplies not more than 2% of equivalent crude protein in the total daily ration.

It may be used in non-ruminant feeds as a source of phosphorus only. The maximum

equivalent crude protein from this source shall not exceed 1.25% of the total daily ration.
When incorporated into a feed for non-ruminants the label will carry a statement that
the equivalent crude protein is nutrionally unavailable to the non-ruminant. It shall be
labeled as follows:
(example) BLUE BIRD HOG FINISHER

Crude Protein (Minimum)....16%
(This includes not more than ______%
equivalent crude protein which is not
nutritionally available to swine.)
If a premix, concentrate or supplement for ruminants contains more than 2%
equivalent crude protein from ammonium polyphosphate or if a premix concentrate or
supplement for non-ruminants contains more than 1.25% equivalent crude protein from
ammonium polyphosphate, then the label must contain adequate directions for use, and
a prominent statement: “Warning -- This feed must be used only in accordance with
directions furnished on the label.” (Proposed 1966, Adopted 1967, Amended 1981)
IFN 6-08-42 Ammonium polyphosphate solution
57.134 Calcium Phosphate is a calcium phosphate product either calcined, fused,
precipitated or reacted. It must contain not more than one part fluorine (F) to 100 parts of
phosphorus (P). The minimum percent of calcium (Ca) and phosphorus (P) and maximum
percent of fluorine (F) must be stated on the label. (Proposed 1980, Adopted 1981)
IFN 6-12-311 Calcium phosphate
57.16 Diammonium Phosphate is the product resulting from neutralization of
phosphoric acid, feed grade, or defluorinated wet-process phosphoric acid which contains
not less than 17% nitrogen (N) and 20% phosphorus (P). It must contain not more than
1 part fluorine (F) to 100 parts phosphorus (P), 75 ppm of arsenic (As), and 30 ppm of
heavy metals reported as lead. This does not include diammonium phosphate made from
by-product ammonia absorbed from coke-oven gas.
It may be used in ruminant feeds as a source of both phosphorus and nitrogen in
an amount that supplies not more than 2% of equivalent crude protein in the total daily
ration.
equivalent crude protein from diammonium phosphate must be guaranteed and the
When incorporated into a feed for non-ruminants, the label will carry a statement
CHAPTER SIX
that the equivalent crude protein is nutritionally unavailable to the non-ruminant. It shall
be labeled as follows:
Crude protein (minimum).....16%
equivalent crude protein from diammonium phosphate or if a premix concentrate or
diammonium phosphate, then the label must contain adequate directions for use, and a
prominent statement: “Warning -- This feed must be used only in accordance with
directions furnished on the label.” (Proposed 1961, Amended 1967, 1981)
IFN 6-00-370 Ammonium phosphate dibasic (NH4)2HPO4
57.71 Dicalcium Phosphate is a calcium salt of phosphoric acid generally
expressed as CaHPO4 and its hydrated forms. Minimum phosphorus (P), minimum

calcium (Ca) and maximum fluorine (F) must be specified. It must not contain more than
1 part of fluorine (F) to 100 parts phosphorus (P). (Adopted 1975)
IFN 6-01-080 Calcium phosphate dibasic from defluorinated phosphoric acid.
IFN 6-26-335 Calcium phosphate dibasic from furnaced phosphoric acid (Dicalcium
phosphate)
57.32 Disodium Phosphate is a sodium salt of phosphoric acid generally expressed
as Na2HPO4 and its hydrated forms. Minimum phosphorus (P), minimum sodium (Na)
and maximum fluorine (F) must be specified. It must not contain more than 1 part fluorine
(F) to 100 parts phosphorus (P). (Adopted 1975)
IFN 6-04-286 Sodium phosphate dibasic Na2HPO4
57.33 Monoammonium Phosphate is the product resulting from the neutralization
of phosphoric acid, feed grade, or defluorinated wet-process phosphoric acid which
contains not less than 9% nitrogen (N) and 23% phosphorus (P). It must contain not more
than 1 part fluorine (F) to 100 parts phosphorus (P), 75 ppm of arsenic (As) and 30 ppm
of heavy metals reported as lead (Pb).
It may be used in ruminant feeds as a source of both phosphorus and nitrogen in
an amount that supplies not more than 2% of equivalent crude protein in the total daily
ration.
equivalent crude protein from mono-ammonium phosphate must be guaranteed and the
When incorporated into a feed for non-ruminants the label will carry a statement that
the equivalent crude protein is nutritionally unavailable to the non-ruminant. It shall be
labeled as follows:
Crude Protein (Minimum)......16%
equivalent crude protein from mono-ammonium phosphate or if a premix concentrate or
mono-ammonium phosphate, then the label must contain adequate directions for use, and
a prominent statement: “Warning—This feed must be used only in accordance with
directions furnished on the label.” (Proposed 1973, Adopted 1976) Reg. 582.1141
IFN 6-09-338 Ammonium phosphate monobasic (NH4)H2PO4
57.98 Monocalcium Phosphate is a calcium salt of phosphoric acid generally
expressed as CaH4(PO4)2 and its hydrated forms. Minimum phosphorus (P), minimum
calcium (Ca) and maximum fluorine (F) must be specified. It must contain not more than
1 part fluorine (F) to 100 parts phosphorus (P). (Adopted 1975)
IFN 6-01-082 Calcium phosphate, monobasic, from defluorinated phosphoric acid
IFN 6-26-334 Calcium phosphate, monobasic, from furnaced phosphoric acid
(monocalcium phosphate)
57.99 Monosodium Phosphate is a sodium salt of phosphoric acid generally
expressed as NaH2PO4 and its hydrated forms. Minimum phosphorus (P), minimum
sodium (Na) and maximum fluorine (F) must be specified. It must contain not more than
1 part fluorine (F) to 100 parts phosphorus (P). (Adopted 1975)
IFN 6-04-288 Sodium phosphate monobasic monohydrate NaH2PO4·H2O
57.19 Phosphoric Acid, _____%, is a solution of phosphoric acid in water generally
expressed as H3PO4. Minimum phosphorus (P) must be specified. It must not contain
more than 100 parts per million fluorine (F) and 3.2 parts per million Arsenic (As) for
each percentage of phosphorus present. When this ingredient is used as a constituent in

mixed feeds, it must be indicated in the ingredient list as “phosphoric acid.” (Proposed
1957, Adopted 1962, Amended 1967, 1968, 1975, 1976)
IFN 6-03-707 Phosphoric acid H3PO4
57.12 Phosphate, Defluorinated, includes either calcined, fused, precipitated or
reacted calcium phosphate. It must contain not more than one part of fluorine (F) to
100 parts of phosphorus (P). The minimum percent of calcium (Ca) and phosphorus
(P) and the maximum percent of fluorine (F) must be stated on the label. The term
“defluorinated” must not be used as a part of the name of any product containing more
than one part of fluorine (F) to 100 parts of phosphorus (P). The term “defluorinated
phosphate” must be used, where appropriate, in labeling ingredient listings. (Adopted
1952, Amended 1965)
IFN 6-01-780 Phosphate defluorinated
IFN 6-12-330 Phosphate defluorinated 18.5% phosphorus
IFN 6-12-324 Phosphate defluorinated 18% phosphorus
IFN 6-12-331 Phosphate defluorinated 21% phosphorus
57.15 Rock Phosphate, Soft, is the very finely divided by-product (washings)
obtained from mining Florida rock phosphate by the hydraulic process. It must contain a
minimum of 9% phosphorus (P) and 15% calcium (Ca), and not more than 30% clay and
1.5% fluorine (F). The term soft rock phosphate must be used in all labeling. (Proposed
IFN 6-03-947 Rock phosphate soft
57.20 Rock Phosphate, Ground, is ground phosphate rock. It must be labeled with
guarantees for calcium (Ca) and phosphorus (P) and a maximum guarantee for fluorine
(F). Ground rock phosphate must be used in all labeling. (Proposed 1963, Adopted 1964)
IFN 6-03-945 Rock phosphate ground
57.21 Rock Phosphate, Ground, Low Fluorine is ground phosphate rock that
contains not more than 0.5% fluorine (F). Low fluorine ground rock phosphate must
be used in all labeling. It must be labeled with guarantees for minimum percentages
of calcium (Ca) and phosphorus (P) and for a maximum percentage of fluorine (F).
IFN 6-03-946 Rock phosphate ground low fluorine
57.132 Sodium Hexametaphosphate is the sodium salt of Phosphoric Acid
generally expressed as (NaPO3)x·H2O (x=6-20) Minimum sodium and maximum
fluorine must be specified. It must not contain more than one part fluorine (F) to 100 parts
phosphorus (P), 75 parts per million of arsenic (As) and 30 parts per million of heavy
metals reported as lead. (Proposed 1980, Adopted 1981)
CHAPTER SIX
IFN 6-12-315 Sodium hexametaphosphate (NaPO3)x·H2O (x=6-20)

57.110 Sodium Tripolyphosphate, is a sodium salt of phosphoric acid generally
expressed as Na5P3O10. Minimum sodium (Na) and maximum fluorine (F) must be
specified. It must contain not more than 1 part fluorine (F) to 100 parts phosphorus (P).
(Adopted 1975)
IFN 6-08-076, Sodium tripolyphosphate Na5P3O10
57.125 Tribasic Sodium Phosphate is the sodium salt of phosphoric acid generally
expressed as Na3PO4 and its hydrated forms. Minimum phosphorus (P), minimum
sodium (Na) and maximum fluorine (F) must be specified. It must contain not more than
1 part fluorine (F) to 100 parts of phosphorus (P). (Proposed 1976, Adopted 1977)
IFN 6-20-871 Sodium phosphate tribasic Na3PO4
57.113 Tricalcium Phosphate is a calcium salt of phosphoric acid generally
expressed as Ca3(PO4)2. Minimum phosphorus (P), minimum calcium (Ca) and
maximum fluorine (F) must be specified. It must contain not more than 1 part fluorine (F)
to 100 parts phosphorus (P). (Adopted 1975)
IFN 6-01-084 Calcium phosphate tribasic

57.100 Potassium Bicarbonate is a potassium salt of carbonic acid generally

expressed as KHCO3. Minimum potassium (K) must be specified. (Adopted 1975)
IFN 6-09-337 Potassium bicarbonate KHCO3
57.101 Potassium Carbonate is a potassium salt of carbonic acid generally
expressed as K2CO3. Minimum potassium (K) must be specified. (Adopted 1975)
IFN 6-09-336 Potassium carbonate K2CO3
57.130 Potassium Citrate is a potassium salt of citric acid generally expressed as
K3C6H5O7· H2O and its hydrated forms. Minimum potassium (K) must be specified.
(Adopted 1980)
IFN 6-30-087 Potassium citrate K3C6H5O7·H2O
57.102 Potassium Chloride, is the potassium salt of hydrochloric acid generally
expressed as KCl. Minimum potassium (K) must be specified. (Adopted 1975)
IFN 6-03-755 Potassium chloride KCl
57.162 Potassium Gluconate is the potassium salt of gluconic acid generally
expressed as KC6H11O7 and its hydrated forms. Minimum potassium must be specified.
For use in animal feeds, excluding aquatic species. (Proposed 2000, Adopted 2002)
57.124 Potassium Hydroxide is the hydroxyl form of potassium generally
expressed as KOH. Minimum potassium (K) must be specified. (Proposed 1976,
Adopted; 1977) Reg. 582-1631.
IFN 6-20-870 Potassium hydroxide KOH
57.103 Potassium Iodate is the potassium salt of iodic acid generally expressed
as KIO3. Minimum potassium (K) and minimum iodine (I) must be specified. (Adopted
1975)
IFN 6-08-072 Potassium iodate KIO3
57.104 Potassium Iodide is the potassium salt of hydriodic acid generally expressed
as KI. Minimum potassium (K) and iodine (I) must be specified. (Adopted 1975)
IFN 6-03-759 Potassium iodide KI
57.105 Potassium Sulfate is the potassium salt of sulfuric acid generally expressed
as K2SO4. Minimum potassium (K) and sulfur (S) must be specified. (Adopted 1975)
IFN 6-08-098 Potassium sulfate K2SO4
57.31 Salt is an acceptable source of sodium chloride. It must be true to name and
contain not less than 95% sodium chloride. (Proposed 1973, Adopted 1975)
IFN 6-04-152 Salt NaCl
57.13 Iodized Salt, is a common salt (NaCl) containing not less than 0.007% iodine,
uniformly distributed. (Adopted 1942)
IFN 6-04-151 Salt iodine added 0.007% iodine
57.5 Shell Flour is an acceptable source of calcium carbonate. It must be true to
name and contain not less than 33% calcium (Ca). (Adopted 1952)
IFN 6-05-688 Mollusks shells fine ground
57.137 Sodium Acid Pyrophosphate is the disodium salt of pyrophosphoric
acid, generally expressed as Na2HP2O7·6H2O and other hydrated forms. Minimum
phosphorus; (P), minimum sodium (Na), and maximum fluorine (F), must be specified.
It must contain not more than 1 part fluorine (F) to 100 parts phosphorus (P). (Adopted
1984)
IFN 6-16-830 Sodium, Pyrophosphate, Hexahydrate
57.106 Sodium Bicarbonate is the sodium salt of carbonic acid generally expressed
as NaHCO3. Minimum sodium (Na) must be specified. (Proposed 1988, Adopted 1989)
IFN 6-04-272 Sodium bicarbonate NaHCO3
57.133 Sodium Carbonate is the sodium salt of carbonic acid generally expressed
as Na2CO3 and its hydrated forms. Minimum sodium (Na) must be specified. (Proposed
1980, Adopted 1981)
IFN 6-12-316 Sodium carbonate Na2CO3

57.107 Sodium Iodate is the sodium salt of iodic acid generally expressed as
NaIO3. Minimum iodine (I) must be specified. (Adopted 1975)
IFN 6-04-277 Sodium iodate NaIO3
57.108 Sodium Iodide is the sodium salt of hydriodic acid generally expressed as
NaI. Minimum sodium (Na) and minimum iodine (I) must be specified. (Adopted 1975)
IFN 6-04-279 Sodium iodide NaI
57.145 Sodium Molybdate is the sodium salt of molybdenum, generally expressed
as Na2MoO4, and its hydrated forms. Minimum molybdenum must be specified
IFN 6-19-30 Sodium molybdate
57.120 Sodium Selenate is a sodium salt of selenic acid generally expressed
as Na2SeO4 and its hydrated forms. Minimum selenium (Se) must be specified. All
premixes shall bear adequate directions and cautions for use including this statement
“Caution. Follow label directions. The addition to feed of higher levels of this premix
containing selenium is not permitted.” (Adopted 1975) Reg. 573.920
IFN 6-26-014 Sodium selenate Na2SeO4
57.119 Sodium Selenite is a sodium salt of selenious acid generally expressed
as Na2SeO3 and its hydrated forms. Minimum selenium (Se) must be specified. All
premixes shall bear adequate directions and cautions for use including this statement
“Caution. Follow label directions. The addition to feed of higher levels of this premix
containing selenium is not permitted.” (Adopted 1975) Reg. 573.920
IFN 6-26-013 Sodium selenite Na2SeO3
57.138 Sodium Sesquicarbonate is the mixed sodium salt of carbonic acid,
generally expressed as Na2CO3·NaHCO3·2H2O, providing not less than 90% of the
hydrated double salt with 42% minimum sodium carbonate, 33% minimum sodium
bicarbonate, and providing not less than 27.5% sodium. (Proposed 1988, Adopted 1989.
IFN 6-17-895 Sodium sesquicarbonate
57.109 Sodium Sulfate is the sodium salt of sulfuric acid generally expressed as
Na2SO4 and its hydrated forms. The minimum sodium (Na) and minimum sulfur (S)
IFN 6-04-291, Sodium sulfate decahydrate Na2SO4·10H2O
57.111 Sulfur is elemental sulfur generally expressed as sulfur (S). Minimum sulfur
(S) must be specified. (Adopted 1975)
IFN 6-04-705 Sulfur
57.112 Thymol Iodide is a mixture of iodine derivatives of thymol generally
expressed as C20H24I2O2. Minimum iodine (I) must be specified. (Adopted 1975)
CHAPTER SIX
IFN 6-04-857 Thymol iodide C20H24I2O2

57.114 Zinc Acetate, is the zinc salt of acetic acid generally expressed as Zn(C2H3O2)2
and its hydrated forms. Minimum zinc (Zn) must be specified. (Adopted 1975)
IFN 6-05-547, Zinc acetate dihydrate Zn(C2H3O2)2·2H2O
57.115 Zinc Carbonate is the zinc salt of carbonic acid generally expressed as
ZnCO3 and its hydrated forms. Minimum zinc (Zn) must be specified. (Adopted 1975)
IFN 6-05-549 Zinc carbonate ZnCO3
57.116 Zinc Chloride is the zinc salt of hydrochloric acid generally expressed as
ZnCl2 and its hydrated forms. Minimum zinc (Zn) must be specified. (Adopted 1975)
IFN 6-05-551 Zinc chloride ZnCl2
57.143 Zinc Chloride Diammine Complex is the product resulting from the
complexing of zinc with ammonium chloride and is generally expressed as [Zn(NH3)2]
Cl2. Minimum zinc (Zn) must be specified. (Proposed 1986, Adopted 1987)
IFN 6-20-988 Zinc chloride diammine complex

57.117 Zinc Oxide is the oxide form of zinc generally expressed as ZnO. Minimum
zinc (Zn) must be specified. (Adopted 1975)
IFN 6-05-553 Zinc oxide ZnO
57.118 Zinc Sulfate is the zinc salt of sulfuric acid generally expressed as ZnSO4
and its hydrated forms. Minimum zinc (Zn) must be specified. (Adopted 1975)
IFN 6-05-555 Zinc sulfate monohydrate ZnSO4·H2O
IFN 6-20-729 Zinc sulfate heptahydrate ZnSO4·7H2O
57.163 Selenium Yeast is a dried non-viable yeast, Saccharomyces cerevisiae,
cultivated in a fed-batch fermentation that provides incremental amounts of cane
molasses and selenium salts in a manner that minimizes the detrimental effects of
selenium salts on the growth rate of the yeast and allows for optimal incorporation
of inorganic selenium into cellular organic material. Residual inorganic selenium is
eliminated in a rigorous washing process and must not exceed 2% of the total selenium
content in the final selenium yeast product. Guaranteed organic selenium content must be
declared on the product label. The additive selenium yeast may be added to:
1) complete feeds for chickens, turkeys, swine, beef cattle, dairy cattle, bison,
sheep, goats, llamas, alpacas, and horses at a level not to exceed 0.3 part per
million of selenium, and to complete dog foods at a level not to exceed 0.333
part per million of selenium on a dry matter basis;
2) feed supplements for limit feeding for beef cattle, bison, and horses at a level
not to exceed an intake of 3 milligrams per head per day;
3) feed supplements for limit feeding for goats, llamas, and alpacas at a level not
to exceed an intake of 0.7 milligrams per head per day;
4) salt-mineral mixtures for free-choice feeding of beef cattle, bison, and horses
up to 120 parts per million in a mixture for free-choice feeding at a rate not to
exceed an intake of 3 milligrams per head per day;
5) salt-mineral mixtures for free-choice feeding for goats, llamas, and alpacas
up to 90 parts per million in a mixture for free-choice feeding at a rate not to
exceed an intake of 0.7 milligrams per head per day.
Selenium yeast shall be incorporated into each ton of complete feed by adding
no less than 1 pound of a premix containing no more than 272.4 milligrams of added
selenium per pound. 21 CFR 573.920. The label or labeling of any selenium premix
shall bear adequate directions and cautions for use including this statement:
“Caution: Follow label directions. The addition to feed of higher levels of this
premix containing selenium is not permitted.” (Proposed 2002, Amended 2003, 2004,
2007*, 2008, 2009, Adopted 2011, Amended 2017)
57.165 Zinc Hydroxychloride is the hydrolysis product of zinc chloride having the
empirical formula Zn5(OH)8Cl2·(H2O). The particle size must not exceed 100 microns.
It must contain not less than 54% zinc and is intended to be a source of zinc for use
in livestock, poultry, and companion animal diets. It must not contain more than 20%
chloride, 90 ppm lead, 15 ppm chromium, 10 ppm arsenic, 10 ppm cadmium, and 0.2
ppm mercury. (Proposed 2015 rev. 1, Adopted 2017 rev. 1)
57.168 Selenomethionine Hydroxy Analogue [R,S-2-hydroxy-4-
methylselenobutanoic acid (CAS 873660-49-2)] is manufactured by the reaction of
elemental selenium with methyllithium to form a methylseleno salt, which is then reacted
with R,S-2-hydroxybutyrolactone to form a salt of 2-hydroxy-4-methylselenobutanoic
acid. After acidification and purification, the additive consists of not less than 39.5% total
selenium by weight with a selenomethionine hydroxy analogue content of not less than
98% of total selenium. The total organic selenium content of the additive is not less than
99% of total selenium.
(a) The selenomethionine hydroxy analogue meets the following specifications:
(1) Arsenic, not more than 2 parts per million (ppm);

(2) Cadmium, not more than 1 ppm;

(3) Lead, not more than 1 ppm; and
(4) Mercury, not more than 1 ppm.
(b) Selenium, as selenomethionine hydroxy analogue, is added to complete feed for
chickens, turkeys, and swine at a level not to exceed 0.3 ppm.
(c) To ensure safe use of the additive, in addition to the other information required
by the Federal Food, Drug, and Cosmetic Act, the label and labeling of
selenomethionine hydroxy analogue in its packaged form shall contain:
(1) The name, selenomethionine hydroxy analogue;
(2) Minimum and maximum guarantees for a total selenium content of not
less than 2.08% (weight/weight) and not more than 2.24%;
(3) Minimum guarantee for selenomethionine hydroxy analogue content of
not less than 5.2%;
(4) The following statement, “Storage Conditions: Selenomethionine hydroxy
analogue must be stored in a closed package at temperatures not higher
than 20°C (68°F).”; and
(5) An expiration date not to exceed 1 year from the date of manufacture.
(d) Selenomethionine hydroxy analogue shall be incorporated into each ton of
complete feed by adding no less than 1 pound of a premix containing no more
than 272.4 milligrams of added selenium per pound.
(e) The premix manufacturer shall follow good manufacturing practices in the
production of selenium premixes. Inventory, production, and distribution
records must provide a complete and accurate history of product production.
Production controls must assure products to be what they are purported and
labeled. Production controls shall include analysis sufficient to adequately
monitor quality.
(f) The label or labeling of any selenium premix shall bear adequate directions and
cautions for use including this statement: “Caution: Follow label directions.
The addition to feed of higher levels of this premix containing selenium is not
permitted.”
21 CFR 573.920 (Proposed 2020)
Descriptions of Salts, Complexes and Chelates

Metal (Mineral) Salt. an ionic substance containing a metal cation and either
an inorganic or an organic anion. The water soluble portion of a Metal (Mineral) Salt
dissociates in water to give the hydrated metal cation and the free anion (or its hydrolysis
CHAPTER SIX
product) in solution.
Metal (Mineral) Complex. a substance in which a metal cation (electron pair
acceptor) accepts an electron pair from one or more anionic or neutral bonding partners
(ligands, electron pair donors) to form chemical bonds. The water soluble portion of the
complex remains as the intact complex in aqueous solution.
Metal (Mineral) Chelate. a metal complex (see preceding term) in which at least
one ligand (electron pair donor) forms two or more bonds to the central metal ion through
different atoms of the ligand. A distinctive feature of a metal chelate is the presence of
a heterocyclic ring(s) in which the metal is a member of the ring. In the water soluble
portion of the chelate, the heterocyclic ring(s) remains intact.
Tentative
T57.167 Manganese Hydroxychloride is the reaction product of manganese
oxide and hydrochloric acid at the appropriate stoichiometric ratio, having the empirical
formula Mn2(OH)3Cl. Particle size must not exceed 100 microns. It must contain not less

than 44% manganese and is intended to be a source of manganese for use in livestock,
poultry, and companion animal diets. It must not contain more than 20% chloride, 50 ppm
lead, 50 ppm arsenic, 10 ppm cadmium, and 0.5 ppm mercury. (Proposed 2019 rev. 1)
60. Miscellaneous Products


Official
60.7 Almond Hulls are obtained by drying the pericarp which surrounds the nut.
Almond hulls shall contain not more than 13% moisture, 15% crude fiber and
9% ash. Total soluble sugars expressed as invert shall not be less than 18%. Almond hulls
shall be processed in accordance with good manufacturing practices and be reasonably
free of foreign material. (Proposed 1984, Adopted 1985)
IFN 4-00-358 Almond hulls ground
60.72 Almond Hulls with Almond Shells—Almond hulls with almond shells
must not contain more than 29% crude fiber, 9% ash and 13% moisture. They shall be
processed in accordance with good manufacturing practices and be reasonably free of
foreign material. (Proposed 1984, Adopted 1985)
IFN 1-27-475 Almond hulls with shells
60.42 Ground Almond Shells is obtained by drying and grinding that portion of the
almond fruit which surrounds the nut. It must be reasonably free of the nut shell and other
foreign material. (Adopted 1953)
IFN 4-00-358 Almond hulls ground
60.44 Ground Whole Aspen and/or Parts is generally recognized as a feed
ingredient in cattle diets when used in accordance with good nutritional practices. Ground
whole aspen (Populus tremuloides Michiz and Populus gradidentata) is composed of
the entire tree including leaves, branches, trunk, and bark. Ground aspen parts may
also include leaves, branches, trunk, and bark. Roots and stumps are excluded to avoid
contamination of dirt and rocks in the product. The particle size of the product shall not
exceed 3/8 inches. (Proposed 1979, Adopted 1980)
IFN 1-30-183 Aspen quaking/Aspen large toothed aerial part ground
IFN 1-12-241 Aspen aerial part ground
60.43 Aspirated Grain Fractions are obtained during the normal aspiration of
cereal grains and/or oil seeds for the purpose of environmental control and safety within
a grain handling facility. It shall consist primarily of seed parts and may not contain more
than 15% ash. It shall not contain aspirations from medicated feeds. (Proposed 1979,
IFN 4-12-208 Cereals-oil seeds grain and seed fractions aspirated
60.27 Coastal Bermudagrass Hay is the dried aerial portion of the perennial
hybrid grass, Coastal bermuda (Cynodon dactylon) (L.)a (Pers.), reasonably free of
other crop plants, weeds and mold, which has been cultivated as a crop and harvested
during an period of active growth. If it is fully ground, it must be designated as “Coastal
Bermudagrass Meal.” If it is dried by thermal means, it should be designated as
“Dehydrated Coastal Bermudagrass Hay” or “Dehydrated Coastal Bermudagrass Meal.”
IFN 1-10-609 Bermudagrass coastal dehydrated
IFN 1-00-716 Bermudagrass coastal hay

60.17 Buckwheat Hulls is the product consisting primarily of the outer covering of
the buckwheat obtained in the milling of buckwheat flour. (Proposed 1963, Adopted 1968)
IFN 1-12-238 Buckwheat hulls
60.6 Buckwheat Middlings is that portion of the buckwheat grain immediately
under the hull after separation of the flour. It must contain no more hulls than is obtained
in the usual process of buckwheat milling, and must contain not more than 10% crude
fiber. (Adopted 1944)
IFN 5-12-237 Buckwheat flour by-product without hulls
60.98 L-Carnitine is a nutritional supplement with a minimum content of 97.0%
L-Carnitine and a maximum of 0.5% D-isomer. L-Carnitine is for use in swine feeds at
levels not to exceed 0.1% (1000 ppm) of complete feed, for use in chicken and turkey
feeds at levels not to exceed 0.02% (200 ppm) of complete feed, for use in fish feed at
levels not to exceed 0.25% (2500 ppm) of complete feed, for use in milk replacers for
ruminant animals at levels not to exceed 0.075% (750 ppm) of milk replacer powder.
L-Carnitine is also for use for dog foods at levels not to exceed 0.075% (750 mg/kg)
on a dry matter basis, and for use in cat foods (intended for adult maintenance only) at
levels not to exceed 0.10% (1000 mg/kg) on a dry matter basis. L-Carnitine is a fatty
acid carrier that plays a role in fat oxidation in the body. (Proposed 1997, Amended 1999,
Amended 2002, Adopted 2004, Amended 2009, Amended 2011, Adopted 2012, 2013)
60.11 Ground Grass is obtained by drying and grinding grass which has been cut
before formation of the seed. If a specie name is used, the produce must correspond
thereto. (Adopted 1949, Amended 1964)
IFN 1-02-215 Grass hay sun-cured ground
60.18 Guar Meal is obtained from whole guar beans after removal of most of
the endosperm. If the product is heat treated, it may be designated as “heat treated” or
“toasted.” (Proposed 1966, Adopted 1968)
IFN 5-05-687 Guar seeds without endosperm ground
60.19 Dried Kelp is dried seaweed of the families Laminariacae and Fucaceae.
The maximum percentage of salt (NaCl) and the minimum percentage of potassium (K)
must be declared. If the kelp is sold as a source of iodine (I), the minimum percentage of
iodine must be declared. If the product is prepared by artificial drying, it may be called
“Dehydrated Kelp.” (Proposed 1966, Adopted 1968)
IFN 1-08-073 Seaweed kelp whole dehydrated
60.24 Paunch Product, Dehydrated is a product composed of the contents of the
rumen of slaughtered cattle, dehydrated at temperatures over 100°C to a moisture content
of 12% or less, such dehydration designed to destroy any pathogenic bacteria. It shall be
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dehydrated promptly after removal from the rumen to prevent decomposition. (Proposed
1969, Adopted 1970)
IFN 1-09-327 Animal rumen contents dehydrated
60.12 Quinoa Seed consists of cleaned, sound, whole seed of the quinoa plant
(Chenopodium quinoa) from which the saponin contained in the seed’s outer layer has
been removed. (Proposed 2002, Ingredient Definition Number Amended 2010, Adopted
2012)
60.20 Dehydrated Silage (ensilage) Pellets are pellets made from wholesome silage
(ensilage) which has been dried by thermal means and formed into pellets by compacting
and forcing through die openings by a mechanical process. The product should bear a
name descriptive of the type of silage (ensilage) pelleted, such as “Dehydrated Alfalfa
Silage (ensilage) Pellets,” etc. (Proposed 1967, Adopted 1968)
IFN 3-08-812 Alfalfa silage dehydrated pelleted
60.10 Ground Straw is the ground product remaining after separation of the seed
from mature forage plants. The source of the material shall constitute a part of the name

of the product; i.e., “Ground Blue Grass Straw,” “Ground Alfalfa Straw.” (Adopted 1948,
Amended 1964)
IFN 1-04-682 Cereals straw ground
IFN 1-12-232 Alfalfa straw ground
IFN 1-12-233 Bluegrass straw ground
60.9 Yeast Dried Grains is the properly dried residue from the mixture of cereals,
malt, and malt sprouts (sometimes cottonseed meal) obtained in the manufacture of yeast
or vinegar, and consists of corn or corn and rye from which most of the starch has been
extracted, together with malt added during the manufacturing process to change the starch
to sugar, and malt sprouts (sometimes cottonseed meal) added during the manufacturing
process to aid in filtering the residue from the wort and to serve as a source of food
supply for the yeast. If residue is from manufacture of vinegar, may also be listed as
“Vinegar Dried Grains.” (Adopted prior to 1928)
IFN 5-02-158 Cereals vinegar fermentation grains dehydrated
IFN 5-02-159 Cereals yeast fermentation grains dehydrated
60.73 Salts of Volatile Fatty Acids is a blend containing the ammonium or calcium
salt of isobutyric acid and the ammonium or calcium salts of a mixture of 5-carbon acids/
isovaleric, 2-methylbutyric, and n-valeric. The contained ammonium or calcium salts
of volatile fatty acids shall conform to the specifications in 21 CFR 573.914. It is used
as a source of energy in dairy cattle feed. The label of the product shall bear adequate
directions for use including statements expressing maximum use levels: for ammonium
salts of volatile fatty acids—not to exceed 160 grams per head per day thoroughly mixed
in dairy cattle feed as a source of energy; for calcium salts of volatile fatty acids—not to
exceed 135 grams per head per day thoroughly mixed in dairy cattle feed as a source of
energy. (Proposed 1985, Adopted 1986, Amended 2017) Reg 21 CFR 573.914
60.74 Tapioca/Manioca and Cassava Root is the whole root chipped mechanically
into small pieces and sun dried on concrete surfaces for 2 to 3 days and then the chips are
pelleted. (Adopted 1993)
IFN 4-18-896 Cassava Tubers, Sun-cured Pelleted
60.75 Ethyl Alcohol Containing Ethyl Acetate is a product containing not less than
92.5% ethyl alcohol, each 100 gallons having had added the equivalent of 4.25 gallons of
100% ethyl acetate. It is used in ruminant feed supplements as a source of added energy.
(Proposed 1986, Adopted 1990) Reg. 21CFR 584.200
IFN 4-18-895 Ethyl Alcohol-Ethyl Acetate
60.76 Dried Seaweed Meal is the product resulting from drying and grinding
non-toxic macroscopic marine algae (marine plants) of the following botanical divisions:
Division RHODOPHYTA (Red Algae); Division PHAEOPHYTA (Brown Algae); Division
CHLOROPHYTA (Green Algae). The maximum percentage of salt (NaCl) (determined by
sodium content), the minimum percentage of potassium (K), and the percentage of iodine
(I) shall be guaranteed. If the product is prepared by artificial drying it must be labeled as:
Dehydrated Seaweed Meal. The family(ies) shall be identified on the label.
Note: The following families are accepted for use under the definition, Dried
Seaweed Meal: RHODOPHYTA (Red Algae): Gelidiaceae, Endocladiaceae,
Gigartinaceae, Gracilariaceae, Phyllophoraceae, Solieriaceae, Hypneaceae, Palmariaceae,
Bangiaceae; PHAEOPHYTA (Brown Algae): Chordaceae, Laminariaceae, Lessoniaceae,
Alariaceae, Fucaceae, Sargassaceae, Durvillaeaceae; CHLOROPHYTA (Green Algae):
Monostromataceae, Ulvaceae. (Proposed 1986, Adopted 1991, Amended 1994)
IFN 5-18-897 Algae Whole Meal
60.78 Sweet Lupin Meal is the product resulting from the grinding of the entire
seed of the species of Lupinus albus (white), L. augustifolius (blue), or L. luteus (yellow)
which contain less than 0.03% alkaloids. (Proposed 1993, Adopted 1996)

60.79 Sweet Lupin Meal Dehulled is the product resulting from the grinding of
seeds after mechanical removal of the hulls from the species of Lupinus albus (white),
L. augustifolius (blue), or L. luteus (yellow) which contain less than 0.03% alkaloids.
60.80 Sweet Lupin Meal Solvent Extracted is the product obtained by grinding
of the flakes after the removal of most of the oil by a solvent extraction process from the
seeds of the species of Lupinus albus (white), L. augustifolius (blue), or L. luteus (yellow)
which contain less than 0.03% alkaloids. It must contain not more than 7% crude fiber.
Note: The sweet lupin species defined above are of Mediterranean origin and
are quite distinct from the Lupine’s of North America. The two differ evolutionarily
and genetically in their origin and thus the sweet lupin cannot be “contaminated” by
outcrossing with the North American lupine.
60.84 Psyllium Seed Husk is the cleaned, dried seed coat separated by winnowing
and thrashing of psyllium seeds. It is to be used as a source of dietary fiber and the crude
fiber level must be declared on the label. (Proposed 1991, Adopted 1993)
IFN 1-32-187 Plantago seed husk
60.86 1, 3-Butylene Glycol (1, 3-Butanediol) is a viscous, colorless liquid of
99% purity, with a specific gravity at 20 degrees centigrade:1.004 to 1.006, and has a
distillation range of 200-215 degrees centigrade. It is to be used as a source of energy
in swine feed at a level not to exceed 9% of the dry matter of the total ration. It should
be thoroughly mixed in feed, not less than 5 minutes after its addition, with equipment
adapted for the addition of liquids. (Reference 21 CFR 573.225 and 21 CFR 173.220.
60.94 Potato Protein is derived from de-starched potato juice from which the
proteinaceous fraction has been precipitated by thermal coagulation followed by
dehydration. (Proposed 1996, Adopted 2000)
60.95 Lablab (Lablab purpureus or Dolichos lablab) also known as hyacinth bean,
is an annual legume that produces forage as either hay or pasture for ruminants. Leaves
and/or stems can be used as a feed ingredient if it is free of mature seed. (Proposed 1997,
Adopted 2007)
60.99 Chia Seed consists of cleaned, sound, dry, whole seed of the chia plant
(Salvia hispanica). Typically it contains 18% crude protein, 32% crude fat and 32% crude
fiber. (Proposed 1998, Adopted 2006)
60.101 Hydrolyzed Roughage is the residue from the acid hydrolysis and steam
stripping of roughage products. The product will contain a minimum of 50% acid
CHAPTER SIX
detergent fiber and a maximum of 5% ash. The product is used as a carrier for oils, fats,
and molasses and as a source of acid detergent fiber for ruminants. (Proposed 2000,
Adopted 2010)
60.104 Dried Chicory Root is the dried, non-roasted root Cichorium intybus L.,
intended as a source of inulin, a soluble, fermentable fiber. It shall contain no less than
50% inulin and no more than 13% moisture. (Proposed 2002, Adopted 2006)
60.105 Fructooligosaccharide is a carbohydrate product composed of short chain
fructose units bound by B-(2-1) linkages attached to a terminal glucose unit. The final
product must contain a minimum of 80% fructooligosaccharide on a dry weight basis.
60.106 Inulin is a polysaccharide product obtained from plant sources such as
chicory (Cichorium intybus L.), agave (Agave azul tequilana), and Jerusalem artichoke
(Helianthus tuberosus) by hot water extraction. It is intended as a source of soluble,
fermentable fiber. It must contain not less than 90% inulin. It may contain products of
partially hydrolyzed inulin. (Proposed 2004, Adopted 2010)

*60.108 Salvage Pet Food is a product resulting from pet food manufacturing. This
product may consist of, but is not limited to, start-up and over-run product, unfinished
pet food, pet food fines and other product not suitable for packaging for retail sale. If
it contains, or may contain, any material identified by 21 CFR 589.2000 as prohibited
from use in the feed of ruminant animals, or if it is no longer accompanied by a detailed
label listing all of the ingredients in the salvage pet food, the label must contain the
precautionary statement “Do not feed to cattle or other ruminants.” It shall be free
of foreign materials harmful to animals, suitable for the purpose for which it is being
marketed, and properly labeled for its intended use. (*The asterisk indicates that this
ingredient may be subject to 21 CFR 589.2000). (Proposed 2004, Amended 2006,
Adopted 2011)
*60.109 Distressed Pet Food is a product resulting from pet food distribution,
but which is no longer available for retail sale. This product may be pet food in, but not
limited to, dented cans, torn bags, product past its sell-by date, or returned product that is
suitable for use in feed. It may consist of a single formula, still in the original packaging,
or a variety of formulas commingled into one bulk container and containing none of
the original packaging or labeling. It if contains, or may contain, any material identified
by 21 CFR 589.2000 as prohibited from use in the feed of ruminant animals, or if it is
no longer accompanied by a detailed label listing all of the ingredients in the distressed
product, the label must contain the precautionary statement “Do not feed to cattle or
other ruminants.” It shall be free of foreign materials harmful to animals, suitable
for the purpose for which it is being marketed, and properly labeled for its intended
use. (*The asterisk indicates that this ingredient may be subject to 21 CFR 589.2000.)
60.110 Ground Pecan Shells is obtained by grinding the hard outer shell. It must
be reasonably free of the nut meat and other foreign material. It is to be used as a source
of dietary fiber. A minimum crude fiber level must be guaranteed on the label. (Proposed
2009, Adopted 2011)
60.111 Biodiesel-Derived Glycerin is a liquid co-product of biodiesel production
by a base catalyzed transesterification process. It must be derived from processes utilizing
sources of fatty acids compliant with the term “feed grade” and if animal fat of ruminant
origin is utilized, sources must not contain more than 0.15% insoluble impurities. It
is intended as a source of energy in livestock diets. It must contain not less than 80%
glycerin, not more than 15% water, not more than 0.5% methanol, and not more than 5
ppm heavy metals. It may contain up to 8% salt. It must be labeled with guarantees for
minimum percentage glycerin, maximum percentage moisture, maximum percentage
sulfur, maximum percentage ash, and maximum percentage methanol as well as the
statement “For further mixing into livestock feed.” It is for use in an amount not to
exceed 15% of the complete feed for ruminants and 10% of the complete feed for all
other livestock species, including poultry. (Proposed 2015, Adopted 2016 rev. 1)
60.113 Pulse Fiber consists primarily of the outer coverings or hull of pulse
crops derived from pulse dry milling. Pulse crops include the edible seeds of legumes
(excluding oil seeds). Acceptable pulse crops are listed below. The product must contain
not less than 23% crude fiber on a dry matter basis. If a conditioning agent is used, the
name of the conditioning agent must be shown as an added ingredient. If the ingredient
bears a name descriptive of its kind or origin, it must correspond thereto (e.g., pea fiber).
Accepted pulse crops:
Lentil (Lens culinaris)
IFN 05-17-726 Pea (Pisum sativum L.)
60.114 Pulse Flour is the fraction remaining after removal of fiber from pulse
seeds. It is obtained from mechanically dehulled and dry milled pulse seeds. This flour

fraction must be free of fiber and seed hull/pod, except in such amounts as might occur
unavoidably in good manufacturing practices. Pulse crops include the edible seeds of
legumes (excluding oil seeds). Acceptable pulse crops are listed below. The ingredient
must contain not less than 20% crude protein and not more than 3% crude fiber on a dry
matter basis. If a conditioning agent is used, the name of the conditioning agent must
be shown on the product label as an added ingredient. If the ingredient bears a name
descriptive of its kind or origin, it must correspond thereto (e.g., pea flour). (Proposed
2015, Adopted 2016 rev. 1)
60.115 Pulse Protein is the protein fraction of pulse seeds. It is obtained from
mechanically dehulled, dry milled pulse seeds that are further separated through air
classification or the addition of water, acid, and alkali. The ingredient may be obtained
from pulse seed separated by dry separation, wet separation, or both. Pulse crops include
the edible seeds of legumes (excluding oil seeds). Acceptable pulse crops are listed
below. The ingredient must contain not less than 53% crude protein on a dry matter basis,
and a label shall include a guarantee for minimum crude protein. If a conditioning agent
is used, the name of the conditioning agent must be shown as an added ingredient. If
the ingredient bears a name descriptive of its kind or origin, it must correspond thereto.
(Proposed 2016 rev. 1, Adopted 2018)
60.116 Pulse Starch is the fraction remaining after removal of protein and fiber
from pulse seeds. It is obtained from mechanically dehulled, dry milled pulse seeds that
are further separated through air classification or through the addition of water. The
ingredient may be obtained from pulse seed separated by dry separation, wet separation,
or both. Pulse crops include the edible seeds of legumes (excluding oil seeds). Acceptable
pulse crops are listed below. The product must contain not less than 65% dietary starch
on a dry matter basis, and the label shall include a guarantee for minimum dietary starch.
If a conditioning agent is used, the name of the conditioning agent must be shown on the
product label as an added ingredient. If the ingredient bears a name descriptive of its kind
or origin, it must correspond thereto. (Proposed 2016 rev. 1, Adopted 2018)
CHAPTER SIX

60.117 Dried Black Soldier Fly Larvae is the dried larvae of the Black Soldier
Fly, Hermetia illucens, with or without mechanical extraction of part of the oil, that has
been raised on a feedstock composed exclusively of feed grade materials. The ingredient
must be labeled with guarantees for minimum crude protein and minimum crude fat on an
as-fed basis. If oil is mechanically extracted, maximum crude fat must also be guaranteed
on the ingredient label. The ingredient is dried by artificial means to no more than
10% moisture. It is for use in salmonid and poultry feed as a source of protein and fat
consistent with good feeding practices. (Proposed 2018 rev. 1, Adopted 2019 rev. 1)
Tentative
T60.118 Ground Juniper is a roughage consisting of the entire aerial portion of the
juniper plant (trunk, bark, branches, leaves, and berries), obtained only from Juniperus
pinchotii and/or Juniperus ashei. Any plant part below ground level is excluded to
avoid contamination with soil and/or rocks. It is ground to pass a screen no larger than
5/8 inches (15.875 mm). The ingredient must be guaranteed for crude protein and acid

detergent fiber. Ground juniper is to be fed as a dietary roughage for cattle, sheep, or
goats in accordance with good feeding practices. (Proposed 2020)
63. Molasses and Molasses Products

Investigator and Section Editor—Mark LeBlanc, LA
Official
63.1 Beet Molasses is a by-product of the manufacture of sucrose from sugar
beets. It must contain not less than 48% total sugars expressed as invert. (Adopted 1941,
Amended 1960, 2008)
IFN 4-30-289 Beet sugar molasses
63.3 Citrus Molasses is the partially dehydrated juices obtained from the
manufacture of dried citrus pulp. It must contain not less than 45% total sugars expressed
as invert. (Adopted 1952, Amended 1960, 2008)
IFN 5-01-241 Citrus syrup
63.5 Hemicellulose Extract is a by-product of the manufacture of pressed wood.
It is the concentrated soluble material obtained from the treatment of wood at elevated
temperature and pressure without use of acids, alkalis, or salts. It contains pentose and
hextose sugars, and has a total carbohydrate content of not less than 55%. (Proposed
1965, Adopted 1966) Reg. 573.520
IFN 4-08-030 Hemicellulose extract
63.6 Starch Molasses is a by-product of the manufacture of dextrose from starch
derived from corn or grain sorghums in which the starch is hydrolized by use of enzymes
and/or acid. It must contain not less than 43% reducing sugars expressed as dextrose and
not less than 50% total sugars expressed as dextrose. It shall contain not less than 73%
total solids. (Proposed 1967, Adopted 1968)
IFN 4-08-037 Maize-sorghum grain starch molasses
63.7 Cane Molasses is a by-product of the manufacture of sucrose from sugar cane.
It must contain not less than 43% total sugars expressed as invert and not less than 73%
total solids. (Proposed 1973, Adopted 1987, 2008)
IFN 4-13-251 Sugarcane molasses
63.26 Bagasse is that portion of the stalk of sugar cane, after removal of leaves and
tops, remaining after extraction of the juice. (Proposed 1971, Adopted 1972)
IFN 1-04-686 Sugarcane bagasse dehydrated
63.36 Beet pulp, dried, plain is the dried residue from sugar beets which has been
cleaned and freed from crowns, leaves, and sand, and which has been extracted in the
process of manufacturing sugar. (Proposed 1976, Adopted 1977)
IFN 4-00-669 Beet sugar pulp dehydrated
63.37 Beet Pulp, dried, molasses is the dried residue from sugar beets which has
been cleaned and freed from crowns, leaves, and sand, and which has been extracted in
the process of manufacturing sugar to which has been added (beet) molasses obtained in
the extraction of sugar. (Proposed 1976, Adopted 1977)
IFN 4-00-672 Beet sugar pulp with molasses dehydrated
63.38 Beet pulp, dried product CSF, RNS, is the dried residue from sugar beets
which has been cleaned and freed from crowns, leaves, and sand, and which has been
extracted in the process of manufacturing sugar to which has been added the concentrated
Steffen’s filtrate obtained in the extraction of the sugar from the beets. (Proposed 1976,
Adopted 1977)
IFN 4-00-675 Beet sugar pulp with steffens filtrate dehydrated

63.39 Beet molasses, dried product, is the properly dried mixture of molasses and
molasses dried beet pulp containing not less than 45% total sugar expressed as invert.
IFN 4-20-866 Beet sugar pulp with molasses dehydrated more than 45% invert sugar
63.41 Concentrated Steffen Filtrate (CSF) is obtained as a by-product of the
recovery of sucrose from beet molasses by utilization of the Steffen process (precipitation
with calcium oxide). (Proposed 1978, Adopted 1979)
IFN 5-00-679 Beet sugar steffens filtrate condensed
63.81 Concentrated Separator By-Product (CSB) is obtained as a by-product
of the recovery of sucrose from beet molasses by utilization of molecular exclusion
chromatography. (Proposed 1991, Adopted 1993)
IFN 5-32-051 Beet, Sugar, separator by-product, condensed
63.83 Beet Fiber, dried, plain is the refined plant material derived from sugar beet
pulp after sugar extraction which has been further refined by washing, drying and milling.
It shall contain a total dietary fiber (crude fiber) content of not less than 80% and an ash
content of not more than 3%. (Proposed 1991, Adopted 1993)
IFN 1-32-188 Beet, Sugar-Fiber, Dehydrated
66. Non-Protein Nitrogen

Investigator and Section Editor—George Ferguson, NC
Official
66.1 Urea is predominantly urea but may contain other non-toxic nitrogenous
compounds which are present as by-products from the commercial synthesis and
processing of Urea. It must contain not less than 45% nitrogen (equivalent to 281.25%
crude protein). If it contains less than 45% N but 41% or more N, it must be designated
as “Urea and Conditioner(s).” If the name of the conditioner(s) does not appear
in the product name, the ingredient listing must contain the specific name of the
conditioner(s).
If the Urea and Conditioner(s) contribute more than 0.5% conditioner(s) to the
mixed feed, the conditioner(s) must be named in the mixed ingredient list. (Proposed
1958, Amended 1962, 1963, 1964, Adopted 1968)
IFN 5-05-070 Urea 45% nitrogen 281% protein equivalent
66.2 Feed Grade Biuret is predominantly composed of biuret (55% minimum)
together with related non-toxic nitrogenous compounds resulting from the controlled
pyrolysis of urea and subsequent processing. It must contain not less than 35%
CHAPTER SIX
nitrogen (equivalent to 218.7% crude protein) with not more than 15% nitrogen
(equivalent to 93.75% crude protein) being from urea. It shall not contain more than
0.5% mineral oil.
concentrate, feed additive premix, or complete feed prepared therefrom, must contain the
following information in addition to any other required information:
(1) The name of the additives
nitrogen.
(3) Directions for use to provide:
(a) The diet be balanced to provide adequate nutrients when equivalent crude
protein from all forms of non-protein nitrogen exceed one-third of the total
crude protein in the total daily ration.

(b) Use only in mixed feeds for ruminants (cattle, sheep and goats.)
(4) This feed should be used only in accordance with directions furnished on the
label. (Proposed 1972, Adopted 1974, Amended 1975, 2004) Reg. 573.220
IFN 5-09-824 Biuret
66.3 Gelatinized Starch-Urea Product is obtained by processing a mixture of
finely ground grains or other carbohydrate containing materials with urea under regulated
conditions of temperature (250 to 250°F), moisture (15 to 30%) and pressure (400 to 500
p.s.i.). It is to be used in the feed of ruminants as a source of protein and/or as the sole
(1) The name of the additive
nitrogen.
ration and a prominent statement:
“Warning--This feed should be used in accordance with the directions furnished
on the label.” (Proposed 1972, Adopted 1975)
IFN 5-14-506 Starch-urea product gelatinized
66.4 Liquid Starch-Controlled Urea Product is obtained by processing a slurry
of finely ground grains or other carbohydrate-containing materials with urea in a
hydroheater under regulated conditions of temperature (250 to 350°F), moisture (50 to
70%) and pressure (15 to 150 p.s.i.). It is to be used in the feed of ruminants as a source
of protein and/or as the sole source of non-protein nitrogen in an amount not to exceed
25% of the total ration.
concentrate or feed additive premix prepared therefrom, must contain the following
nitrogen.
ration and a prominent statement: “WARNING—This feed should be used
only in accordance with the directions furnished on the label.” (Proposed
1978, Adopted 1980)
IFN 5-30-264 Starch-urea product liquid
66.5 Fermented Ammoniated Condensed Whey is the product produced by the
Lactobacillus bulgaricus fermentation of whey with the addition of ammonia. It must
contain 35% to 55% crude protein and not more than 42% equivalent crude protein
from non-protein nitrogen. It is to be used as a source of crude protein and non-protein
nitrogen for cattle.
concentrate or feed additive premix prepared therefrom must contain the following
(2) The maximum percentage of equivalent crude protein from non-protein nitrogen.
(3) Directions for storage and use:
(a) Store in closed vented tank equipped for agitation. Agitate five (5) minutes
before using. Do not store at temperatures above 110°F (43°C).

(b) Mix with grain, roughage, or grain and roughage prior to feeding or as
a component of free choice liquid feeds, used to supplement the diets of
cattle fed other sources of nutrients. Fermented ammoniated condensed
whey shall not exceed 80% of free choice liquid feed.
(c) The maximum equivalent crude protein from fermented ammoniated
condensed whey and equivalent crude protein from all other added forms
of non-protein nitrogen shall not exceed 30% of the dietary crude protein.
(4) A prominent statement: “CAUTION--This feed should be used only in
accordance with the directions furnished on the label.” (Proposed 1979,
Amended 1980, Adopted 1981, Amended 1983) Reg. 573.450
IFN 5-28-223 Cattle whey fermented ammoniated condensed
Notes
Ammoniated Cottonseed Meal. See Definition 87.9 in Special Purpose Products
Section; Ammoniated Cottonseed Meal as source of Non-Protein Nitrogen.
Ammoniated Rice Hulls. See Definition 87.7 in Special Purpose Products Section;
Ammoniated Rice Hulls as a source of Non-Protein Nitrogen.
Ammonium Chloride. See Definition 57.265 in Mineral Products Section;
Ammonium Chloride as a source of Non-Protein Nitrogen.
Ammonium Polyphosphate Solution. See Definition 57.22 in Mineral Products
Section; Ammonium Polyphosphate Solution as source of Non-Protein Nitrogen.
Ammonium Sulfate. See Definition 57.27 in Mineral Products Section; Ammonium
Sulfate as source of Non-Protein Nitrogen.
Anhydrous Ammonia. See Definition 87.11 in Special Purpose Products Section;
Anhydrous ammonia as source of Non-Protein Nitrogen.
Condensed, Extracted Glutamic Acid Fermentation Product. See Definition 36.1
in Fermentation Products Section; Condensed, Extracted Glutamic Acid Fermentation
Product as a source of Non-Protein Nitrogen.
Condensed____ Fermentation Solubles. See Definition 36.10 in Fermentation
Products Section; Condensed ____ Fermentation Solubles as a source of Non-Protein
Nitrogen.
Diammonium Phosphate. See Definition 57.16 in Mineral Products Section;
Diammonium Phosphate as source of Non-Protein Nitrogen.
Dried Fermentation Biomass. See Definition 36.15 in Fermentation Products
Section; Dried Fermentation Biomass as source of Non-Protein Nitrogen.
Monoammonium Phosphate. See Definition 57.33, in Mineral Products Section
CHAPTER SIX
Mono-Ammonium Phosphate as source of Non-Protein Nitrogen.
69. Oat Products

Official
69.1 Oat Groats are cleaned oats with the hulls removed. (Adopted 1931, Amended
1963)
IFN 4-03-331 Oats groats
69.2 Oat Hulls consists primarily of the outer covering of oats, obtained in the milling of
table cereals or in the groating of oats from clean oats. (Adopted prior to 1928, Amended 1963)
IFN 1-03-281 Oats hulls
69.3 Feeding Oat Meal is obtained in the manufacture of rolled oat groats or rolled
oats and consists of broken oat groats, oat groat chips, and floury portions of the oat groats,

with only such quantity of finely ground oat hulls as is unavoidable in the usual process of
commercial milling. It must not contain more than 4% crude fiber. (Adopted 1938)
IFN 4-03-303 Oats cereal by-product less than 4% fiber
69.4 Clipped Oat By-Product is obtained in the manufacture of clipped oats. It may
contain the light chaffy material broken from the end of the hulls, empty hulls, light immature
oats, and dust. It must not contain an excessive amount of oat hulls. (Adopted prior to 1928)
IFN 1-03-269 Oats grain clipped by-product
69.6 Mixed Feed Oats consists of a mixture of grain containing at least 30% of
cultivated oats provided that the mixture consists of either (a) not less than 65% of
cultivated and wild oats combined or (b) not less than 65% of wild oats. It must contain
more than 25% of other grains, not more than 6% heat damaged kernels of oats, wild
oats, and other grains, and not more than 10% foreign material which may include 4%
fine seeds. (Adopted 1958, Amended 1964)
IFN 4-08-026 Oats wild--oats grain
NOTE: Foreign material must be all matter except wild oats and grains for which
standards have been established under the United States Grain Standards Act.
69.7 Oat Mill By-Product is the by-product obtained in the manufacture of oat
groats, consisting of oat hulls, and particles of the groat, and containing not more than
25% crude fiber. (Proposed 1963, Adopted 1964)
IFN 1-03-332 Oats groats by-product less than 22% fiber
Tentative
T69.8 Oat Fiber is obtained from oat hulls that have been processed through a
continuous wet and dry process to modify soluble and insoluble fractions of the fiber, and
to reduce the content of lignin. The ingredient must be guaranteed for neutral detergent
fiber, acid detergent fiber, and acid insoluble lignin. Oat fiber is to be used a source of
insoluble fiber in animal feed and pet food. (Proposed 2019)
71. Other Oilseed Products

Investigator and Section Editors—David Beard, MT
Official
71.35 Brassica carinata Meal, Solvent Extracted,** is the meal obtained after the
removal of most of the oil by solvent extraction of Brassica carinata seeds. The meal shall
contain less than 2.0% erucic acid and less than 30 micromoles of total glucosinolates per
gram. It is a source of protein for beef cattle in an amount not to exceed 10% of the total
diet. The maximum sulfur content must be guaranteed. (Proposed 2017 rev. 1, Adopted
2019 rev. 1)
71.300 Camelina Meal, Extracted, is the product obtained from high-pressure
crushing of seed, or from a pre-press solvent extraction process, which removes the
oil from the whole seed of the species Camelina sativa. The meal may be heated. The
meal is the material which remains after most of the oil has been removed. It must not
contain less than 30% crude protein, and a maximum of 12% crude fiber. It may contain
up to 15% residual oil. The meal contains less than 30 micromoles of any mixture
of 9-Methylsulfinylnonyl glucosinolate, 10-Methylsulfinyldecyl glucosinolate, and
11-Methylsulfinylundecyl glucosinolate per gram of dry oil free solid. It is used in the
diets of broiler chickens, cattle fed in confinement for slaughter, and laying hen chickens
at an inclusion of no more than 10% of the diet. (Proposed 2010, Amended 2011,
Adopted 2013)
71.77 Canola Meal low erucic acid low glucosinolate consists of the meal obtained
after the removal of most of the oil by mechanical extraction, or by direct solvent or
prepress solvent extraction process, from the whole seeds of the species Brassica napus,

Brassica campestris or Brassica juncea. The oil component of which seed contains
less than 2% erucic acid and the solid component of which seed contains less than
5 micromoles of allyl glucosinolate and less than 30 micromoles of any mixture of
3-butenyl glucosinolate, 4-pentenyl glucosinolate, 2-hydroxy-3-butenyl glucosinolate and
2-hydroxy-4-pentenyl glucosinolate, and ally glucosinolate per gram of air dry, oil free
solid. It must contain a maximum of 12% crude fiber and a maximum of 30 micromoles
of glucosinolates per gram.
Note: A method of analysis for glucosinolates is contained in the publication by J.
K. Daun and D. I. McGregor, December 15, 1981, Glucosinolate Analysis of Rapeseed
(Canola). Method of the Canadian Grain Commission, Grain Research Laboratory. (The
method is on file with the Feed Methods Clearinghouse, Division of Animal Feeds,
Center for Veterinary Medicine, Food and Drug Administration. (Proposed 1987, Adopted
1991, Amended 1995, Adopted 1998, Amended 2011, Adopted 2013)
IFN 5-05-145 Canola Meal Prepress Solvent Extracted, Low Erucic Acid, Low
Glucosinolate
IFN 5-05-146 Canola Meal Solvent Extracted, Low Erucic Acid, Low Glucosinolate
71.60 Coconut Meal, Mechanical Extracted,** is the ground residue which remains
after removal of most of the oil from dried meat of coconuts by a mechanical extraction
process. May also be called “Copra Meal.” (Adopted 1955, Amended 1963, 1968)
IFN 5-01-572 Coconut kernels with coats meal mechanical extracted
71.61 Coconut Meal, Solvent Extracted,** is the ground residue which remains
after removal of most of the oil from dried meat of coconuts by a solvent extraction
process. May also be called “Copra Meal.” (Adopted 1955, Amended 1963, 1968)
IFN 5-01-573 Coconut kernels with coats meal solvent extracted
71.62 Crambe Meal, Heat Toasted, is the seed meal of Crambe abyssinica after
the removal of oil from the seed and hull by pre-press solvent extraction or by solvent
extraction alone. The resulting seed meal is heat toasted. It shall conform to the restriction
of glucosinolate, goitrin, and nitrogen soluble as set forth in 21 CFR 573, Section 310.
It shall have a crude protein, crude fat, and a crude fiber guarantee. Myrosinase enzyme
activity shall be absent. It is used or intended for use in the feed of feedlot cattle as a
source of protein in an amount not to exceed 4.2% of the total ration. (Proposed 1982,
Adopted 1983) Reg. 21CFR 573.310
IFN 5-16-280 Crambe abyssinian seeds meal solvent extracted toasted
71.1 Linseed Meal, Mechanical Extracted,** is the product obtained by grinding
the cake or chips which remain after removal of most of the oil from flaxseed by a
mechanical extraction process. It must contain no more than 10% fiber. (Adopted 1943,
CHAPTER SIX
Amended 1947, 1949, 1960, 1961, 1964, 1968)

IFN 5-30-287 Flax seeds meal mechanical extracted
71.11 Linseed Meal, Solvent Extracted,** is the product obtained by grinding the
flakes which remain after removal of most of the oil from flaxseed by a solvent extraction
process. It must contain no more than 10% fiber. (Adopted 1943, Amended 1947, 1949,
1960, 1961, 1964, 1968)
IFN 5-30-288 Flax seeds meal solvent extracted
71.40 Low Glucosinolate High Erucic Acid Rapeseed Meal, Solvent
Extracted,** is the meal obtained after the removal of most of the oil by the prepress
solvent extraction of whole seeds obtained from the genus Brassica [Brassica napus,
Brassica rapa (formerly B. campestris), or Brassica juncea] from which the oil shall
contain more than 2% erucic acid and the solid component shall contain less than
30 micromoles of any one or any mixture of 3-butenyl glucosinolate, 4-pentenyl
glucosinolate, 2-hydroxy-3-butenyl glucosinolate and 2-hydroxy-4-pentenyl
glucosinolate, and allyl glucosinolate per gram of air dry, oil free solid. It must contain
a maximum of 2% erucic acid, a maximum of 12% crude fiber, and a maximum of 30

micromoles of glucosinolates per gram. It is used in the diets of animals as a source of

protein, in accordance with good feeding practice. (Proposed 2019, Adopted 2020)
71.30 Mustard Meal, Solvent Extracted,** is the product obtained by grinding the
cake that remains after removal of some of the oil by mechanical extraction, and removing
most of the remaining oil by solvent extraction. It is obtained from the seed of the cultivated
mustard plants Brassica juncea, Brassica nigra, and Sinapis alba (formerly Brassica alba).
Use should be restricted to cattle and sheep and at no more than 10% of the ration. It should
not be fed to lactating dairy cows if milk production is for human consumption because of
objectionable taste and/or odor. (Proposed 2015 rev. 1, Adopted 2017 rev. 1)
IFN 5-12-149 Mustard seeds meal solvent extracted
71.2 Flaxseed Screenings Meal, Solvent Extracted,** is the ground product
obtained after solvent extraction of part of the oil from the smaller imperfect flaxseeds,
weed seeds, other oilseeds and other foreign material having feeding value, separated in
cleaning flaxseed. (Adopted 1943, Amended 1962, 1964, 1968)
IFN 5-12-228 Flax seed screenings meal solvent extracted
71.3 Flax Plant Product is that portion of the flax plant having feeding value
remaining after harvesting the seed and separation of the base fibers and flax shives. It
consists of the leaves, corticle tissues, flax seed bolls, broken and immature flax seeds.
It must contain a minimum of 9% crude protein and a maximum of 35% crude fiber.
(Adopted 1957)
IFN 1-12-230 Flax fiber process residue dehydrated
71.4 Flax Straw By-Product is the ground product remaining after the removal of
the longer fiber material from flax straw by mechanical processing. It must contain not
less than 2% crude protein and not more than 70% crude fiber. (Proposed 1964, Adopted
1968)
IFN 1-12-229 Flax straw fiber process residue ground
71.21 Peanut Skins is the outer covering of the peanut kernel, exclusive of hulls,
as obtained in ordinary commercial processing. The product may contain broken peanut
kernels. (Adopted 1946, Amended 1964)
IFN 1-03-631 Peanut seed coats
71.6 Peanut Hulls consists of the outer hull of the peanut shell. (Proposed 1965,
Adopted 1966)
IFN 1-08-028 Peanut pods (hulls)
71.7 Peanut Meal and Hulls, Mechanical Extracted and Solvent Extracted,**
is a product of shelled peanuts, composed principally of the kernels and hulls, with such
portion of the oil, as may be left in the ordinary course of manufacture. (Adopted 1978)
IFN 5-03-655 Peanut pods with seeds meal mechanical extracted
IFN 5-03-656 Peanut pods with seeds meal solvent extracted
71.8 Ground Peanut Hay is composed of ground peanut leaves and stems from
which the peanuts have been removed. (Proposed 1976)
IFN 1-03-627 Peanut hay sun-cured ground
71.9 Peanut Meal, Mechanical Extracted and Solvent Extracted,** is a ground
product of the shelled peanuts, composed principally of the kernels, with such portion
of the hull, or fiber, and oil as may be left in the ordinary course of manufacture. It must
contain no more than 7% crude fiber. (Adopted 1978)
IFN 5-03-649 Peanut seeds without coats meal mechanical extracted
IFN 5-03-650 Peanut seeds without coats meal solvent extracted
71.130 Safflower Meal, Mechanical Extracted,** is the ground residue obtained
after extracting the oil from whole safflower seed by a mechanical extraction process.
(Adopted 1954, Amended 1964, 1968)
IFN 5-04-109 Safflower seeds meal mechanical extracted

71.131 Safflower Meal, Solvent Extracted,** is the ground residue obtained after
extracting the oil from whole safflower seed by a solvent extraction process. (Adopted
1954, Amended 1964, 1968)
IFN 5-04-110 Safflower seeds meal solvent extracted
71.23 Sunflower Hulls consists of the outer covering of sunflower seed. (Proposed
1967, Adopted 1968)
IFN 1-04-720 Sunflower hulls
71.210 Sunflower Meal, Dehulled, Mechanical Extracted,** is obtained by grinding
the residue remaining after the extraction process. (Proposed 1967, Adopted 1969)
IFN 5-30-033 Sunflower seeds without hulls meal mechanical extracted
71.211 Sunflower Meal, Dehulled, Solvent Extracted,** is obtained by grinding
the residue remaining after extraction of most of the oil from dehulled sunflower seed by
a solvent extraction process. (Proposed 1967, Adopted 1969)
IFN 5-30-034 Sunflower seeds without hulls meal solvent extracted
71.220 Sunflower Meal, Mechanical Extracted,** is obtained by grinding the
residue remaining after extraction of the oil from whole sunflower seed by a mechanical
extraction process. (Proposed 1967, Adopted 1969)
IFN 5-27-477 Sunflower seeds meal mechanical extracted
71.221 Sunflower Meal, Solvent Extracted,** is obtained by grinding the residue
remaining after extraction of most of the oil from whole sunflower seed by a solvent
extraction process. (Proposed 1967, Adopted 1969)
IFN 5-30-032 Sunflower seeds meal solvent extracted
Section Note: ** after an ingredient name means the words “Mechanical Extracted”
or “Solvent Extracted” are not required when listed as an ingredient in a manufactured
feed.
73. Technical Additives

Section Editor—Richard Ten Eyck, OR
Substances added to feed during manufacturing that assist in the production

of feed. Examples include, but are not limited to: acidifying agent, additives for
biofuel processes that generate co-products used for feed, anticaking agents, anti-gel,
antioxidant, binding agent, bioengineered yeast (biofuel), carrier, clear grease, diluent,
dispersant, dust control, emulsifiers, flocculating agents, lubricant, pelleting aids, pH
modulation, precipitating agent, preservative, processing aid, recover proteinaceous
CHAPTER SIX
material, sequestrants, solubilizer, stabilizers, surfactant, suspension aid, and thickener.
Official
73.001 Technical Additives Table
Classification
Under Food
Name Regulationa Amendment Restrictions
Aluminum sulfate 21 CFR Anti-gelling agent In accordance with good
IFN 8-20-861 582.1125 for molasses, manufacturing practices
dewater of beetpulp
(continued)

Classification
Under Food
Attapulgite clay Anti-caking agent Not to exceed 2.0%c
IFN 8-14-008 and pelleting aid Not to exceed 2.5% in
Suspension aid supplementc
in liquid feed
supplement
Calcium silicate 21 CFR Anti-caking agent Not to exceed 2%
IFN 8-08-043 573.260
Calcium aluminates Pellet binder Maximum of 2% in
poultry, swine, and rodent
feeds, and a maximum of
1% in feed for all other
species
Calcium stearate 21 CFR Anti-caking agent In accordance with good
IFN 8-09-345 573.280 manufacturing practices
(feed grade)
Carrageenan 21 CFR Emulsifier, To be refined only
172.620 stabilizer, or from those red seaweed
thickener for pet sources listed in 21 CFR
foods 172.620
Chondrus extract 21 CFR Stabilizer In accordance with good
Diacetyl tartaric acid 21 CFR Emulsifying agent In accordance with good
esters of mono and 582.4101 manufacturing practices
diglycerides or edible
fats or oils, or edible
fat-forming fatty
acids
IFN 8-07-248
Diatomaceous earth 21 CFR Inert carrier and Not to exceed 2% of total
IFN 8-09-363 573.340 anti-caking agent ration
Disodium EDTA 21 CFR To solubilize trace Not to exceed 0.024%
IFN 8-05-689 573.360 minerals in aqueous (240 ppm) in finished
solutions feed
Ethyl cellulose 21 CFR Binder or filler
IFN 4/-08-045 573.420 in dry vitamin
preparations
Ethoxylated mono 21 CFR Emulsifier Not to exceed 0.5% in
and diglycerides 172.834 dry milk replacers
Fumaric acid pH adjuster, Not to exceed 0.5% of
preservative, or the diet
flavoring agent
(continued)

Classification
Under Food
Gellan gum 21 CFR Stabilizer and/or Not to exceed 0.4% in
172.665 thickener in canned canned dog or cat food
dog or cat food
Glucono-delta- 21 CFR pH control agent in In accordance with good
lactone 184.1318 pet or specialty pet manufacturing practices
food only
Guar gum (mucilage) 21 CFR Stabilizer In accordance with good
Hydrophobic silica Anti-caking free Not to exceed 5% in
flow agent vitamin preparations
Iron ammonium 21 CFR Anti-caking agent Not to exceed 0.0025%
citrate 573.560 in salt (25 ppm) in the finished
IFN 6-01-857 salt
Kaolin Anti-caking agent Not to exceed 2.5% in
IFN 8-08-040 (in non-medicated finished feedc
feeds)
Lecithin 21 CFR Stabilizer In accordance with good
Locust bean gum 21 CFR Stabilizer In accordance with good
(Carob bean gum) 582.7343 manufacturing practices
IFN 8-07-250
Magnesium stearate Die lubricating and In accordance with good
release agent in the manufacturing practices
tableting process
Methyl glucoside 21 CFR Surfactant in Not to exceed 0.032%
Coconut oil ester 573.660 molasses (320 ppm) in the
IFN 8-09-346 molasses
Mineral oil 21 CFR To reduce dustiness Not to exceed 3% in
CHAPTER SIX
IFN 8-03-123 573.680 of feed or mineral mineral supplements. Not

supplements, to to exceed 0.06% of the
serve as a lubricant total ration.
in the preparation To serve as a diluent
of pellets, cubes, carrier in the manufacture
and blocks, to of feed grade biuret.
improve resistance
to moisture of such
pellets, cubes,
and blocks, and to
prevent segregation
of trace minerals in
mineralized salt
(continued)

Classification
Under Food
Mono and 21 CFR Emulsifying agent In accordance with good
diglycerides of edible 582.4505 manufacturing practices
fats or oils, or edible
fat-forming acids
IFN 8-07-251
Monosodium 21 CFR Emulsifying agent In accordance with good
phosphate 582.4521 manufacturing practices
derivatives of mono
and diglycerides of
edible fats or oils, or
edible fat-forming
fatty acids
IFN 8-07-252
Montmorillonite Anti-caking aid, Not to exceed 2% of the
clays pelleting aid, and finished materialc
IFN 8-09-364 non-nutritive carrier
Paraffin Dust control agent Not to exceed 3% in
IFN 8-02-027 mineral supplements. Not
to exceed 0.06% of the
total ration.
Petrolatum or a 21 CFR To reduce dustiness Not to exceed 3% in
combination of 573.720 of feed or mineral mineral supplements. Not
mineral oil and supplements; to to exceed 0.06% of the
petrolatum serve as a lubricant total ration.
IFN 8-05-691 in the preparation
of pellets, cubes,
and blocks; to
improve resistance
to moisture of such
pellets, cubes, and
blocks
Petroleum jelly 21 CFR Dust control agent Not to exceed 3% in
IFN 8-08-029 573.720 in mineral mixes mineral supplements. Not
to exceed 0.06% of the
total ration.
Polyethylene glycol 21 CFR Processing aid when Not to exceed 0.025%
(400) mono and 573.800 present as a result (250 ppm) in the
dioleate of its additions to molasses
IFN 8-09-348 molasses
Polyoxyethylene 21 CFR Emulsifier Calf milk replacers
glycol (400) mono 573.820
and dioleates
IFN 8-08-053
(continued)

Classification
Under Food
Polysorbate 80 21 CFR Emulsifier Calf milk replacers
IFN 8-08-053 573.860 Vitamin and mineral
Polysorbate 80 Emulsifier premixes
FDA/CVM/
DAF letter of
5/21/08
Polysorbate 60 21 CFR Emulsifier Calf milk replacers and
(Polyoxy ethylene 573.840 mineral premixes
(20) sorbitan
monostearate)
IFN 8-08-032
Polyvinyl alcohol Processing aid for Not to exceed 200 mg/kg
dry granular feed in finished feed
enzymes
Propylene glycol 21 CFR Emulsifying agent GRASb except in cat
IFN 8-03-809 582.1666 food
Stearic acid 21 CFR Lubricant/binder in Not to exceed 3% (wt/wt)
172.860 tablets and pellets in finished feed
Sodium 21 CFR Stabilizer Not to exceed 2% in
carboxymethyl- 582.1745 finished feed
cellulose
IFN 8-08-100
Sodium 21 CFR Sequestrant In accordance with
hexametaphosphate 582.6760 good manufacturing
or feeding practices as
a tartar control agent
coated on dry food
products for reducing the
accumulation of dental
tartar in dogs and cats
CHAPTER SIX
Sodium silico 21 CFR Anti-caking agent Not to exceed 2% in

aluminate 582.2727 finished feed
IFN 8-08-101
Sodium stearoyl 21 CFR Emulsifier for dry, Not to exceed 0.35% in
lactylate 172.846 semi-moist, and finished dog food
canned dog food
Sorbitan mono- 21 CFR Emulsifier in In accordance with good
stearate with or 573.960 mineral premixes manufacturing practices
without polysorbate and dietary
60 supplement for
IFN 8-05-695 animal feed
(continued)

Classification
Under Food
Talc FDA/CVM/ Die lubricant, Not to exceed 2% in the
IFN 8-16-378 DAF letters finishing agent, and finished feed. Not to
of 8/5/83 and anti-caking agent exceed 10% as a carrier
4/6/86 in animal feed premixes.
Tara gum Thickener, stabilizer Up to 0.25% in dry
in dry powdered and powdered calf milk
reconstituted liquid replacer, or 0.04% in
calf milk replacers reconstituted liquid calf
milk replacer
Tetra sodium 21 CFR Dispersant In accordance with good
pyrophosphate 582.6789 manufacturing practices
IFN 8-20-862
Urea formaldehyde Coating for feed Not to exceed 1% of the
IFN 8-08-995 grade urea for finished product
ruminant animal
feed
Yellow prussiate of 21 CFR Anti-caking agent Not to exceed 0.0013%
soda 573.1020 in salt (13 ppm)
IFN 8-05-697
aIngredients listed in 21 CFR part 582 are subject to the GMPs located at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=582.1.
bGRAS = abbreviation for the phrase “generally recognized as safe.” A substance that is
generally recognized as safe by experts qualified to evaluate the safety of the substance
(for its intended use.)
cNOTE: Attapulgite Clay, Bentonite, Kaolin, and Montmorillonite Clays are “GRAS”
in non-medicated feeds as binders or pelleting aids when used in accordance with good
manufacturing practices and do not exceed the limitations listed above. These special
purpose products are not prohibited in medicated feeds for the same purpose and at the
same level when it can be demonstrated that they do not interfere with the analysis of
the drug by acceptable methods. It is the manufacturer’s responsibility to determine and
submit adequate data to support the conclusion that interference does not occur before
using these products in a feed containing a drug. Based on current information, these
products are acceptable for use in medicated feeds containing the following drugs:
Chlortetracycline 4 Nitrophenyl-Arsonic Acid
IFN 8-01-224 IFN 8-05-561
Lasalocid Sodium Ractopamine
IFN 6-26-333
Lincomycin Hydrochloride Sulfathiazole
IFN 8-12-192 IFN 8-04-704
Melengestrol Acetate Sulfaquinoxaline
IFN 8-08-197 IFN 8-04-703
Monensin Tylosin
IFN 8-09-373 IFN 8-05-069
Based on current information found in the new animal drug regulations (part 558) the
following drugs are not permitted in animal feeds containing bentonite because bentonite
has been shown to interfere with the analysis of the drugs by the acceptable methods:

Amprolium 558.55
IFN 8-00-373
Carbadox 558.115 NOTE:
IFN 8-20-775 International feed
Decoquinate 558.195 name and AAFCO
IFN 8-09-371 names are identical
Morantel tartrate 558.360 for these 25 drugs.
IFN 8-16-451
Nequinate 558.365
IFN 8-09-828
Pyrantel Tartrate 558.485
IFN 8-14-011
Robenidine hydrochloride 558.515
IFN 8-14-012
Thiabendazole 558.615
IFN 8-04-827
Tilmicosin 558.618
Acidifiers (73.020–029)
73.020 Ammonium Formate—The food additive ammonium formate may be
safely used in the manufacture of complete swine feeds in accordance with the following
(a) The additive is manufactured by the reaction of 99.5% ammonia gas and 99%
formic acid in a continuous loop reactor to produce a solution made up of 37%
ammonium salt of formic acid and 62% formic acid.
(b) The additive is used or intended for use as a feed acidifying agent, to lower the
pH, in complete swine feeds at levels not to exceed 1.2% of the complete feed.
(c) To ensure safe use of the additive, formic acid and formate salts from all added
sources cannot exceed 1.2% of complete feed when multiple sources of formic
acid and its salts are used in combination.
by the Federal Food, Drug, and Cosmetic Act (the act), the label and labeling
shall contain:
(2) Adequate directions for use including a statement that ammonium formate
must be uniformly applied and thoroughly mixed into complete swine
feeds and that the complete swine feeds so treated shall be labeled as
containing ammonium formate.
CHAPTER SIX
(3) Cautions for use including this statement: Caution: Follow label
directions. Formic acid and formate salts from all added sources cannot
exceed 1.2% of complete feed when multiple sources of formic acid and
its salts are used in combination.
(e) To assure safe use of the additive, in addition to the other information required
by the Federal Food, Drug, and Cosmetic Act and paragraph (d) of this section,
the label and labeling shall contain:
(1) Appropriate warnings and safety precautions concerning ammonium formate
(37% ammonium salt of formic acid and 62% formic acid).
(2) Statements identifying ammonium formate in formic acid (37%
ammonium salt of formic acid and 62% formic acid) as a corrosive and
possible severe irritant.
(3) Information about emergency aid in case of accidental exposure as follows:
(i) Statements reflecting requirements of applicable sections of the
Superfund Amendments and Reauthorization Act (SARA), and the

Occupational Safety and Health Administration’s (OSHA) human

safety guidance regulations.
(ii) Contact address and telephone number for reporting adverse reactions
or to request a copy of the Safety Data Sheet (SDS).
(Proposed 2011, Adopted 2013, Amended 2017, Amended 2019) 21 CFR 573.170
73.021 Benzoic Acid—The food additive benzoic acid may be safely used in
the manufacture of complete swine feeds in accordance with the following prescribed
conditions:
(a) The additive is used or intended for use as a feed acidifying agent, to lower the
pH, in complete swine feeds at levels not to exceed 0.5% of the complete feed.
(b) The additive consists of not less than 99.5% benzoic acid (CAS 65-85-0) by
weight with the sum of 2-methylbiphenyl, 3-methylbiphenyl, 4-methylbiphenyl,
benzyl benzoate, and isomers of dimethylbiphenyl not to exceed 0.01% by
weight.
(c) To assure safe use of the additive, in addition to the other information required
by the Federal Food, Drug, and Cosmetic Act and paragraph (b) of this section,
the label and labeling shall contain:
(1) The name of the additive;
(2) Adequate directions for use, including a statement that benzoic acid must
be uniformly applied and thoroughly mixed into complete swine feeds
and that the complete swine feeds so treated shall be labeled as containing
benzoic acid;
(3) Appropriate warnings and safety precautions concerning benzoic acid;
(4) A warning statement identifying benzoic acid as a possible irritant;
(5) Information about emergency aid in case of accidental exposure; and
(6) Contact address and telephone number for reporting adverse reactions or
to request a copy of the Material Safety Data Sheet (MSDS).
21 CFR 573.210
73.025 Formic Acid is manufactured by heating carbon dioxide and NaOH under
pressure and decomposing the resulting sodium formate with H2SO4; the resulting formic
acid, CH2O2, has a molecular weight of 46.02. The food additive formic acid may be
safely used in accordance with the following conditions:
(a) The additive is used as a preservative in hay crop silage in an amount not to
exceed 2.25% of the silage on a dry weight basis or 0.45% when direct cut, as
follows:
(1) The top foot of silage stored should not contain formic acid and
(2) Silage should not be fed to livestock within 4 weeks of treatment.
pH, in complete swine and poultry feeds at levels not to exceed 1.2% of the
complete feed.
(1) The additive consists of not less than 85% formic acid (CAS 64-18-6).
(2) The additive meets the following specifications:
(i) Free methyl alcohol not to exceed 1,000 parts per million (ppm);
(ii) Methyl formate not to exceed 1,000 ppm; and
(iii) Moisture not to exceed 15%.
(3) To assure safe use of the additive, formic acid and formate salts from
all added sources cannot exceed 1.2% of complete feed when multiple
sources of formic acid and its salts are used in combination.
(4) To assure safe use of the additive, in addition to the other information
required by the Federal Food, Drug and Cosmetic Act, the label and
labeling shall contain:


(ii) Adequate directions for use including a statement that formic acid
must be uniformly applied and thoroughly mixed into complete feeds
and that the complete feeds so treated shall be labeled as containing
formic acid.
(iii) Cautions for use including this statement: Caution: Follow label
directions. Formic acid and formate salts from all added sources
cannot exceed 1.2% of complete feed when multiple sources of
formic acid and its salts are used in combination.
(5) To ensure safe use of the additive, in addition to the other information
required by the Federal Food, Drug, and Cosmetic Act and paragraph (b)
(4) of this section, the label and labeling shall contain:
(i) Appropriate warnings and safety precautions concerning formic acid
(85% formic acid).
(ii) Statements identifying formic acid (85% formic acid) as a corrosive
and possible severe irritant.
(iii) Information about emergency aid in case of accidental exposure.
(A) Statements reflecting requirements of applicable sections of the
Superfund Amendments and Reauthorization Act (SARA), and
the Occupational Safety and Health Administration's (OSHA)
human safety guidance regulations.
(B) Contact address and telephone number for reporting adverse
reactions or to request a copy of the Safety Data Sheet (SDS). 21
CFR 573.480 (Proposed 2011, Adopted 2012, 2013, Amended
2015 rev. 1, 2017, Amended 2019)
73.026 Feed Grade Sodium Formate—The food additive feed grade sodium
formate may be safely used in the manufacture of complete swine and poultry feeds in
(a) The additive is manufactured by the reaction of 99% formic acid and 50%
sodium hydroxide in water to produce a solution made up of at least 20.5%
sodium salt of formic acid and not more than 61% formic acid.
pH, in complete swine and poultry feeds at levels not to exceed 1.2% of the
complete feed.
(c) To assure safe use of the additive, formic acid and formate salts from all added
sources cannot exceed 1.2% of complete feed when multiple sources of formic
CHAPTER SIX
acid and its salts are used in combination.

by the Federal Food, Drug, and Cosmetic Act, the label and labeling shall
contain:
(2) Adequate directions for use, including a statement that feed grade sodium
formate must be uniformly applied and thoroughly mixed into complete
feeds and that the complete feeds so treated shall be labeled as containing
feed grade sodium formate.
(3) Cautions for use including this statement: Caution: Follow label
directions. Formic acid and formate salts from all added sources cannot
exceed 1.2% of complete feed when multiple sources of formic acid and
its salts are used in combination.
(e) To assure safe use of the additive, in addition to the other information required
by the act and paragraph (d) of this section, the label and labeling shall contain:

(1) Appropriate warnings and safety precautions concerning feed grade

sodium formate.
(2) Statements identifying feed grade sodium formate as a corrosive and
possible severe irritant.
(3) Information about emergency aid in case of accidental exposure as
follows:
(i) Statements reflecting requirements of applicable sections of the
Occupational Safety and Health Administration (OSHA) human
safety guidance regulations. 8
(ii) Contact address and telephone number for reporting adverse reactions
or to request a copy of the Material Safety Data Sheet (MSDS).
21 CFR § 573.696 (Adopted 2017 rev. 1)
Antimicrobial Agents (73.030–039)
73.030 Formaldehyde—The food additive formaldehyde may be safely used in the
manufacture of animal feeds in accordance with the following conditions:
(a) The additive is used, or intended for use, to improve the handling
characteristics of animal fat in combination with certain oilseed meals by
producing them from a dry, free-flowing product as follows:
(1) For animal fat in combination with certain oilseed meals, as a component
of dry, nonpelleted feeds for beef and non-lactating dairy cattle.
(i) For aqueous blend of soybean and sunflower meals in a ratio of 3:1,
respectively, is mixed with animal fat such that the oilseed meals
and animal fat are in a ratio of 3:2. The feed ingredients are those
defined by the “Official Publication” of the Association of American
Feed Control Officials, Inc., 2003 small ed., small pp. 303, 308, and
309, which is incorporated by reference. The Director of the Office
of the Federal Register approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain copies from the Assistant Secretary-Treasurer, Association
of American Feed Control Officials Inc., PO Box 478, Oxford,
IN 47971, or you may examine a copy at the Division of Dockets
Management, Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, or at the National Archives and
Records Administration (NARA). For information on the availability
of this material at NARA, call (202) 741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(ii) Formaldehyde (37% solution) is added to the mixture at a level of
4% of the dry matter weight of the oilseed meals and animal fat. This
mixture, upon drying, contains not more than 1% formaldehyde and
not more than 12% moisture.
(iii) To assure the safe use of the additive, in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act
(the Act), the label and labeling of the dried mixture shall bear:
(A) The name of the additive.
(B) Adequate directions for use providing that the feed as consumed
does not contain more than 25% of the mixture.
(2) For soybean and canola seeds and/or meals to which there may be added
vegetable oil as a component of dry, nonpelleted feeds for beef and dairy
cattle, including lactating dairy cattle.

(i) An aqueous blend of oilseed and/or meals, with or without added

vegetable oil, in a ratio such that, on a dry matter basis, the final
protein level will be 25 to 35% and the fat content will be 20 to 45%.
The feed ingredients are those defined by the “Official Publication”
of the Association of American Feed Control Officials, Inc., 2003
ed., pp. 301, 307, 308, and 309, which is incorporated by reference.
The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies from the Assistant Secretary-
Treasurer, Association of American Feed Control Officials Inc.,
PO Box 478, Oxford, IN 47971, or you may examine a copy at the
Division of Dockets Management, Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, or at the
National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call (202)
741-6030, or go to: http://www.archives.gov/federal_register/code_
of_federal_regulations/ibr_locations.html.
(ii) Formaldehyde (37% solution) is added to the mixture at a level of
2.7% of the dry matter weight basis of the oilseeds and/or meals and
the vegetable oil. This mixture, upon drying, contains not more than
0.5% formaldehyde and not more than 12% moisture.
(iii) To assure the safe use of the additive, in addition to the other
information required by the Act, the label and labeling of the dried
mixture shall bear:
(A) The name of the additive.
(B) The statement, “This supplement is not to exceed 12.5% of the
total ration. Dietary calcium and magnesium levels should be
considered when supplementing the diet with fat.”
(C) The minimum and maximum levels of crude fat must be
guaranteed and must be between −5% and +5% of the analyzed
fat content for each batch.
(b)
(1) The food additive is formaldehyde (CAS No. 50-00-0; 37% aqueous
solution). It is used at a rate of 5.4 pounds (2.5 kilograms) per ton of
animal feed or feed ingredient. It is an antimicrobial agent used to
maintain complete animal feeds or feed ingredients Salmonella negative
CHAPTER SIX
for up to 21 days.
required by the Act, the label and labeling shall contain:
(ii) A statement that formaldehyde solution which has been stored below
40 deg. F or allowed to freeze should not be applied to complete
animal feeds or feed ingredients.
(iii) Adequate directions for use including a statement that formaldehyde
should be uniformly sprayed on and thoroughly mixed into the
complete animal feeds or feed ingredients and that the complete
animal feeds or feed ingredients so treated shall be labeled as
containing formaldehyde. The label must prominently display the
statement: “Treated with formaldehyde to maintain feed Salmonella
negative. Use within 21 days.”

(iv) The labeling for feed or feed ingredients to which formaldehyde has
been added under the provisions of paragraph (b)(1) of this section is
required to carry the following statement: “Treated with formaldehyde
to maintain feed Salmonella negative. Use within 21 days.”
required by the Act, the label and labeling shall contain:
(i) Appropriate warnings and safety precautions concerning
formaldehyde.
(ii) Statements identifying formaldehyde as a poison with potentials for
adverse respiratory effects.
(iii) Information about emergency aid in case of accidental inhalation.
(iv) Statements reflecting requirements of applicable sections of the
Occupational Safety and Health Administration’s (OSHA) human
safety guidance regulations.
(v) Contact address and phone number for reporting adverse reactions or
to request a copy of the Materials Safety Data Sheet (MSDS). [68 FR
65633, Nov. 21, 2003]
(Proposed 1977, Adopted 1978, Amended 1996, 2005, Adopted 2008, Amended 2011)
IFN 8-26-243 Formaldehyde solution
Anticaking Agents (73.040–060)
73.040 Bentonite is a naturally occurring mineral consisting primarily of the tri-
layered aluminum silicate, montmorillonite. It may contain calcium or sodium as the
predominant available or exchange ion. It is used or intended for use in non-medicated
animal feed as an anti-caking agent and pelleting aid in an amount not to exceed 2% in
total ration. It is not prohibited in medicated animal feed for the same purposes and at the
same levels when it can be demonstrated that it does not interfere with the bioavailability
of the medicament to animals and the analysis of the feed for the medicament by
acceptable methods. It is the manufacturer’s responsibility to determine and submit
adequate data to support the conclusion that interference does not occur before using it
in a feed containing medicaments. Medicaments with which it may currently be used are
listed in 73.001. (Proposed 1974, Adopted 1975) Reg. 582.1155
IFN 8-00-695 Bentonite
73.042 Castor oil is a triglyceride obtained by the extraction of oil from seeds of
the castor bean plant, Ricinus communis. It consists predominately of triglyceride ester
of fatty acids. It must meet the specifications in the Food Chemical Codex, 5th Edition,
2004, and be guaranteed for not less than 87% ricinoleic acid. Castor oil may be safely
used as an anticaking agent, a releasing agent, and as diluent in animal feeds at levels not
to exceed 250 ppm in complete feed. (Proposed 2011, Adopted 2012)
73.044 Perlite is the expanded, powdered form of a glassy volcanic rock, consisting
essentially of fused sodium potassium aluminum silicate. It meets the specifications of
current edition and supplements of the Food Chemicals Codex. It is used as a filter aid or
pressing aid in the processing of foods and feed ingredients and also may be used as an
anti-caking agent. It may not exceed 4% by weight of the product in which it is present as
a processing aid. (Proposed 1977, Amended 1978, Adopted 1979)
IFN 8-26-242 Perlite
73.045 Pyrophyllite (aluminum silicate monohydrate) may be safely used as
the sole anticaking aid, blending agent, pelleting aid, or carrier in animal feed when
incorporated therein in an amount not to exceed 2% in complete animal feed. (Adopted
2018 rev. 1)
21 CFR 573.900

73.046 Silicon Dioxide—The food additive silicon dioxide may be safely used in
animal feed in accordance with the following conditions:
(a) The food additive is manufactured by vapor phase hydrolysis or by other means
whereby the particle size is such as to accomplish the intended effect.
(b) It is used or intended for use in feed components as an anticaking agent, and/or
grinding aid, as follows:
Feed component Limitation (percent)
BHT (butylated hydroxytoluene) 2
Methionine hydroxy analog and its calcium salts 1
Piperazine, piperazine salts 0.8
Sodium propionate 1
Urea 1
Vitaminsa 3
aSilicon dioxide may be mixed with Vitamin E at levels up to 50%, to produce
Vitamin E Supplement for addition to animal feed. Where silicon dioxide is
used as a dispersant and/or flow agent to assist with uniform and consistent
distribution of the vitamin E supplements in animal feed, silicon dioxide should
be declared on the ingredient list of the vitamin E supplement.
(c) It is used in feed as an anticaking agent in an amount not to exceed that
reasonably required to accomplish its intended effect and in no case in an
amount to exceed 2% by weight of the finished feed.
(d) It is used or intended for use in feed components, as a carrier as follows:
Feed component Limitation (percent)
Flavors 50
Selenomethionine hydroxy analogue 95
(e) To assure safe use of the additive, silicon dioxide is to be used in an amount not
to exceed that reasonably required to accomplish its intended effect, and silicon
dioxide from all sources cannot exceed 2% by weight of the complete feed.
21 CFR 573.940 (Proposed 1964, Adopted 1965, Amended 2008, Adopted 2010,
Amended 2019 rev. 1, Amended 2020)
73.048 Sodium Bentonite is a naturally occurring mineral consisting primarily of
the tri-layered hydrous aluminum silicate, montmorillonite characterized by a sodium
CHAPTER SIX
exchange or available ion content of not less than 1% and not more than 2% of the air
dried material. It is used or intended for use in non-medicated animal feed as an anti-
caking agent and pelleting aid in an amount not to exceed 2% in total ration. To reduce
seepage in silage, the amount added would not exceed 1% sodium bentonite. It is not
prohibited in medicated animal feed for the same purposes and the same levels when it
can be demonstrated that it does not interfere with the bioavailability of the medicament
to animals and the analysis of the feed for the medicament by acceptable methods. It
is the manufacturer’s responsibility to determine and submit adequate data to support
the conclusion that interference does not occur before using it in a feed containing
medicaments. Medicaments with which it may currently be used are listed in 73.1.
(Proposed 1974, Adopted 1975, Amended 1983) Reg. 582.1155
IFN 8-14-512 Sodium bentonite

73.050 Verxite (exfoliated hydrobiotite), an additive, is a magnesium-aluminum-

iron silicate conforming to one of the following:
Verxite Granules contain a minimum of 98% Hydrobiotite, is thermally expanded
and has a bulk density of 5 to 9 pounds per cubic foot.
IFN 8-08-993 Verxite granules
It is used or intended for use in poultry feed at a level not to exceed 5% of the
weight of the finished feed as a non-nutritive bulking agent for restricting calorie intake
in pullet replacement feeds, or as anticaking or blending agent, pelleting aid, or non-
nutritive carrier for the incorporation of nutrients in poultry, swine, dog, or ruminant
feeds, in an amount not to exceed that necessary to accomplish its intended effect and in
no case to exceed 1.5% of the dog feed or 5% of the final feed for other animals.
Verxite Flakes contain a minimum of 98% Hydrobiotite and has a bulk density of
20 to 30 pounds per cubic foot.
IFN 8-08-994 Verxite flakes
It is used or intended for use as an anticaking or blending agent in ruminant feeds in
an amount not to exceed that necessary to accomplish its intended effect and in no case to
exceed 1% by weight of the final feed for ruminants.
Verxite Grits contains a minimum of 80% Hydrobiotite. It has a bulk density of
from 40 to 50 pounds per cubic foot.
IFN 8-09-350 Verxite grits
It is used or intended for use as a partial roughage replacement in ruminant feeds in
an amount not to exceed that necessary to accomplish its intended effect and is in no case
to exceed 1% by weight of the final feed.
To ensure safe use of the additive, the label of any feed additive supplement, feed
additive concentrate, feed additive premix, or complete feed prepared therefrom shall
bear, in addition to the other information required by the act, the name of the additive
(verxite granules or verxite flakes or verxite grits) and when the additive is present in
excess of 1%, a statement of the quantity of the additive contained therein and the term
“non-nutritive” in juxtaposition therewith. (Reg. 573.1000) (Proposed 1961, Adopted
1964, Amended 1968 and 1969)
73.051 Iron Tartrates is the reaction product of sodium tartrates [D-, L-, and meso-
tartrates] and iron(III) chloride for use as an anticaking agent in salt. The molar ratio of
iron(III) to meso-tartrate must be 1:1. It must contain no less than 8% iron(III) on a dry
weight basis. It must contain no more than 1.5% oxalic acid, 3 ppm arsenic, 2 ppm lead,
and 1 ppm mercury on a dry weight basis. The maximum iron tartrates inclusion rate
(calculated as iron) is not more than 12 ppm. (Proposed 2018 rev. 1, Adopted 2019 rev. 1)
Binders (73.106–130)
73.107 Lignin Sulfonate is either one, or a combination of, the ammonium,
calcium, magnesium, or sodium salts of the extract of spent sulfite liquor derived from
the sulfite digestion of wood or of abaca (Musa textilis) or of Sisal (Agave sisalana) in
either a liquid form (moisture not to exceed 50% by weight) or dry form (moisture not
to exceed 6% by weight). It may be used in animal feed in amounts calculated on a dry
weight basis, as: (1) A pelleting aid, in the liquid or dry form, in an amount not to exceed
4% of the finished pellets. (2) A binding aid, in the liquid form, in the flaking of feed
grains in an amount not to exceed 4% of the flaked grain. (3) A surfactant in molasses
used in feeds, as liquid lignin sulfonate, in an amount not to exceed 11% of the molasses.
(4) A source of metabolizable energy, in the liquid or dry form, in an amount not to
exceed 4% of the finished feed. Reg. 573.600. (Proposed 1963, Adopted 1964, Amended
1970, 1971, and 1973)
IFN 8-02-627 Lignin sulfonate dehydrated
IFN 8-29-786 Lignin sulfonate condensed

73.109 Sodium Salts of Fatty Acids are obtained by the neutralization of feed grade
vegetable origin free fatty acids, or saponification of vegetable oil, or a combination
thereof. The specifications of the starting materials must meet the requirements stated
in the AAFCO definition 33.3 (Hydrolyzed Vegetable Fats, or Oils, Feed Grade) and
the AAFCO definition 33.2 (Vegetable Fat, or Oil), respectively. Sodium hydroxide is
used in the neutralization or saponification reactions. The resulting sodium salts are
used as a binder and/or lubricant in the pelleted and flaked feed. The source of the fatty
acids or vegetable oil shall be indicated on the label. Sodium salts are in dry form with
the maximum moisture not to exceed 8% by weight. It may be used in animal feed in
amounts calculated on an “as-is” basis not to exceed 5.5 lb./ton. Sodium Salts of Fatty
Acids shall be labeled with guarantees on an “as-is” basis for no more than 0.5% free
fatty acids, no more than 12% glycerin, not less than 67% total sodium salts of fatty
acids, and no more than 1% unsaponifiable matter. (Proposed 2015 rev. 1, Adopted 2017
rev. 1)
73.111 Potassium Salts of Fatty Acids are obtained by the neutralization of feed
grade vegetable origin free fatty acids, or saponification of vegetable oil or a combination
thereof. The specifications of the starting materials must meet the requirements stated
in the AAFCO definition 33.3 (Hydrolyzed Vegetable Fats, or Oils, Feed Grade) and the
AAFCO definition 33.2 (Vegetable Fat, or Oil), respectively. Potassium hydroxide is used
in the neutralization or saponification reactions. The resulting potassium salts are used
as a binder and/or lubricant in the pelleted and flaked feed. The source of the fatty acids
or vegetable oil shall be indicated on the label. Potassium salts are in liquid form with
the maximum moisture not to exceed 68% by weight. It may be used in animal feed in
amounts calculated on an “as-is” basis not to exceed 15.5 lb./ton. Potassium Salts of Fatty
Acids shall be labeled with guarantees on an “as-is” basis for no more than 0.5% free
fatty acids, no more than 10% glycerin, not less than 24% total potassium salts of fatty
acids, and no more than 1% unsaponifiable matter. (Proposed 2015 rev. 1, Adopted 2017
rev. 1)
Biofuel Production (73.090–104)
73.100 Yeast for Production of Distillers Products. The ingredients list of the
yeast marketed to the ethanol manufacturer should declare the genus species of the yeast
and the enzyme(s) expressed.
Saccharomyces cerevisiae expressing glucoamylase from Saccharomycopsis
fibuligera for use in dry grind corn fuel ethanol production of distillers coproducts for
animal feed. Distillers products for use in animal feed contain no live bioengineered
yeast.
CHAPTER SIX
and/or
Saccharomyces cerevisiae expressing pyruvate formate lyase activating enzyme,
pyruvate formate lyase, and bifunctional acetaldehyde-CoA/alcohol dehydrogenase from
Bifidobacterium adolescentis and a glucoamylase from Saccharomycopsis fibuligera
for use in dry grind corn fuel ethanol production of distillers products for animal feed.
Distillers products for use in animal feed contain no live bioengineered yeast. (Proposed
2013, 2014, rev. 1, Adopted 2015 rev. 1)
Emulsifiers (73.200–220)
73.200 Xanthan Gum as per 21 CFR 573.1010 is classified as a food additive as a
stabilizer, emulsifier, thickener, suspending agent, or bodying agent in calf milk replacer
and liquid feed supplements. Also per informal review processes, it can be used in canned
dog and cat foods.
Maximum inclusion levels are 0.1% in calf milk replacers (as fed) and 0.25% in
liquid feed supplements and canned dog and cat foods. (Proposed 2013, Adopted 2015
rev. 1)

Floculants (73.221–240)
73.221 Chitosan is a cationic carbohydrate polymer intended for use as a
precipitating agent of proteinaceous material from food processing plants. It is chemically
derived by deacetylation of the naturally occurring chitin in crab and shrimp shells. It
may be used in an amount not to exceed that necessary to accomplish its intended effect.
Chitosan when fed as a component of feed to livestock shall be present at no more than
0.1% of the feed. Proteinaceous material coagulated with chitosan must have safety and
efficacy data approved before it can be registered or offered for sale. (Proposed 1984,
Adopted 1985)
IFN 8-17-730 Chitosan
73.223 Kraft Lignin and its salts (ammonium, calcium, magnesium or sodium) is
obtained from the acid precipitation of lignin from spent black liquor produced in the
sulfate digestion process of wood and is dehydrated to less than 8% moisture by weight.
It is used; (1) as an aid in recovering proteinaceous material during the rendering process,
limited to 0.1% of the crax, (2) in the clarification of spent grease, and (3) as a coating
agent for fat soluble vitamins limited to 50% of the vitamin premix matrix and 3% of the
finished feed. (Proposed 1993, Amended 1994, Adopted 2003)
Nutritional Diluents (73.241–249)
73.241 Reed-Sedge Peat is a natural, partially decomposed plant material, formed
from a mixture of reeds, sedges, grasses and some hypnum mosses occurring in wetlands
and containing one third to two thirds peat fibers. It should be dehydrated to a moisture
content of not more than 15% and be in a state free from all harmful micro-organisms.
It is intended for use in animal feed as a carrier for liquid products and premixes or as a
nutritional diluent for lowered energy diets at a level not to exceed 5% of the total daily
ration. (Proposed 1986, Adopted 2012)
IFN 1-18-898 Peat Whole Dehydrated
Pelleting Aids (73.300–340)
73.305 Hide Glue (Technical Gelatin) is a collagen-based product manufactured
only from cattle hide pieces. Maximum moisture is 13.5%, maximum ash is 4% and
minimum protein is 90%. The product is used as a processing aid, pelleting aid, or feed
binder, not to exceed 2% of the feed by weight. (Either term, “hide glue” or “technical
gelatin,” may be used in the ingredient statement.) (Proposed 2003, Adopted 2010)
73.307 Rice By-Products Fractions is obtained by screening and aspirating Ground
Rice Hulls. It is used primarily as a pelleting aid and is composed of such fine particles
of Ground Rice Hulls, Spongy Parenchyma, and minute amounts of Rice Flour, Rice
Germ, Pericarp, and Rice Starch as will pass an 80 mesh screen and contain not less than
5% crude protein, 1.5% crude fat, and not more than 25% crude fiber. (Proposed 1965,
IFN 1-08-033 Rice hull fines
73.309 Urea Formaldehyde Condensation Polymer is a pelleting aid for use
in animal feeds, excluding aquatic species. Restrictions: Not to exceed 0.1 ppm free
formaldehyde in the finished pelleted product. (Proposed 1989, Adopted 1990)
IFN 8-30-422 Urea Formaldehyde Condensation Polymer
73.310 Sodium Hydroxide Lignin Dehydrated is obtained from the acid
precipitation of lignin from spent black liquor produced in the sodium hydroxide and
steam digestion of wheat straw without a bleaching process. The final product is dried
to a powder with less than 4% moisture by weight. It must contain, and be guaranteed
for, not less than 83% total lignin (including acid insoluble and acid soluble lignins) and
not more than 3.5% of ash. It is used as a pelleting aid in livestock and poultry feeds
in an amount calculated on a dry weight basis not to exceed 4% of the finished pellets.

Surfactants (73.341–360)
73.341 Poloxalene consists of polyoxypropylene-polyoxyethylene glycol non-ionic
block polymer. It may be used as a surfactant for the flaking of feed grain, when added
to liquid grain conditioner in an amount not to exceed 1% of the conditioner, and the
conditioner is added to the feed grain at a rate of 1 quart per ton of feed grain. (Reg.
573.760) (Proposed 1970, Adopted 1971)
IFN 8-08-063 Poloxalene
Thickening Agents (73.370–390)
73.370 Cassia Gum is the purified flour from the endosperm of the seeds of
Cassia tora or Cassia obtusifolia, which belong to the family Leguminosae. It is a
galactomannan comprised of at least 75% polysaccharide consisting primarily of a linear
chain of 1,4-B-D-mannopyranose units. The ratio of galactose to mannose is 1:5. Cassia
gum is the product obtained by mechanical separation of the endosperm from the germ
and husk in a heated process, with subsequent purification by sieving, pulverization,
extraction, and drying. It contains not more than 10 ppm chrysophanic acid. Cassia gum
is suitable for use as a stabilizer (thickening and gelling agent) in canned dog and cat
food and shall be permitted at concentrations up to 4000 ppm. (Proposed 1999, Adopted
2002)
Tracers (73.400–425)
73.400 Iron Nickel Tracer the particles resulting from water atomization of high
purity iron and nickel. The nickel content of the particles is between 35% and 51%
with the remainder being iron. The particle size of the iron nickel alloy must range
between 150 and 300 microns. This ingredient may be used in animal foods as a tracer
for other ingredients or premixes present in a finished animal food. The inclusion level
of the ingredient must not exceed 10 ppm in the finished food. The label shall include a
maximum nickel guarantee and a caution statement indicating the maximum permitted
inclusion level. (Proposed 2017 rev. 1, Adopted 2019 rev. 1)
Tentative
T73.311(A) Hydrogenated Glycerides are obtained by hydrogenation of animal
fats or vegetable oils and are used as a coating agent for ingredients or a binder and
lubricant in pelleting of feed (pelleting aid) of all animal species. The maximum use
rate of hydrogenated glycerides is 4 lb per ton of complete feed. Specifications of
animal fats or vegetable oils used to produce the hydrogenated glycerides must meet the
requirements stated in AAFCO definition 33.1 (for Animal Fat) and AAFCO definition
33.2 (for Vegetable Fat, or Oil), respectively. The specification for tallow must specify
CHAPTER SIX
insoluble impurities not more than 0.15% to be consistent with BSE feed regulation
21 CFR 589.2000 and 589.2001, and a guaranteed titer above 40°C. The source of the
hydrogenated glycerides must be indicated on the label. The hydrogenated glycerides
must contain, and be guaranteed for, not less than 90% total ester content, not more than
0.8 % unsaponifiable matter, not more than 0.001% heavy metals, and not more than 5 of
iodine value. The maximum moisture, maximum insoluble matter, maximum free fatty
acids, saponification value and melting range must also be guaranteed on the label. If an
antioxidant is used, the common name or names must be indicated on the label, followed
by the words “used as a preservative.” (Proposed 2019 rev. 1)
T73.401 Colored Graphite Tracer are the particles resulting from the milling of
naturally occurring graphite coated with a color additive(s) approved for use in animal
food. The graphite must be of feed grade material and may be used in animal food as a
colored tracer for other ingredients or premixes present in a finished animal food. The
inclusion level of the tracer must not exceed 50 ppm in the finished food. The label shall
include a caution statement indicating the maximum permitted inclusion level. (Proposed
2019 rev. 1)

Antioxidants (73.450–500)
T73.450 Cashew Nut Shell Liquid is the heat extracted liquid from cashew nut
shells to be used as an antioxidant in fats and oils (excluding highly unsaturated oils
with iodine value higher than 150) that are suitable for use in animal food. Cashew nut
shell liquid can be used at levels up to 6000 mg/kg in fats and oils. The level of cashew
nut shell liquid in complete feed must not exceed 600 mg/kg. The liquid ingredient must
contain, and be guaranteed for, not less than 10% cardol, not less than 55% cardanol, and
not more than 1% moisture. (Proposed 2019)
74. Processed Animal Waste Products

Any person seeking or receiving registration of any processed animal waste product
shall test, by representative sampling and assaying of such samples, and keep accurate
records thereof, the processed animal waste product for which the registration is sought
or received. The sample shall be of sufficient size so as to provide meaningful data,
statistically reliable in carrying out the purpose of such sampling and analysis.
The registrant, manufacturer, or producer of any such processed animal waste
product ingredient shall conform to the following sample and assay requirements, in
addition to quality standards, testing on the same production run of lots:
(a) Drugs suspected or known to be used in the feed or as a therapeutic treatment
of source animals.
(b) Pesticides used on the source animal, facility, and wastes for pest control.
(c) Pathogenic organisms, at least to include Salmonella and E. coli.
(d) Heavy metals: arsenic, cadmium, copper, lead, mercury and selenium, at least.
(e) Parasitic larva or ova.
(f) Mycotoxins, such as aflatoxins.
Periodic analyses shall be conducted on production runs no less than one per
calendar quarter, except that less frequent testing may be allowed where analytical results
show continued uniformity and a consistent margin of compliance. Any processed animal
waste product that does not meet the quality standards for the product shall be further
processed until standards are met, or shall be diverted to non-feed uses or destroyed.
If a product contains drug residues, then the label shall contain the following
statement in bold face type: “WARNING: THIS PRODUCT CONTAINS DRUG
RESIDUES. DO NOT USE WITHIN 15 DAYS OF SLAUGHTER AND DO NOT
USE 15 DAYS PRIOR TO OR DURING THE FOOD PRODUCTION PERIOD OF
DAIRY ANIMALS AND LAYING HENS.”
If the product contains 25 ppm or greater of copper, a maximum guarantee of copper
and the following statement in bold face type is required: “WARNING: CONTAINS
HIGH LEVELS OF COPPER: DO NOT FEED TO SHEEP.”
Any person seeking or receiving registration of any processed animal waste product
shall keep for a period of two years, accurate records of:
(a) All sources of raw materials and date acquired, including information on drug
and pesticide usage.
(b) All production output, including a code or other method to identify the date of
production.
(c) All sales and distribution, including the name and address of the purchaser or to
whom distributed, date, quantity and product code.
(d) Sample and assay records of testing specified above.
Product definitions—Processed animal waste products as a class, offered for sale
or distributed for sale, shall not contain extraneous materials such as, but not limited
to, metal, glass, nails or other harmful matter. They shall be free of harmful pathogenic

organisms, pesticide residues, parasites, or drug residues, above levels permitted by State
or Federal statute or regulation, which could be harmful to animals or could result in
residues in human food products or by-products of animals at levels in excess or those
allowed by State or Federal statute or regulation.
74.1 Dried Poultry Waste (DPW) means a processed animal waste product
composed primarily of feces from commercial poultry, which has been thermally
dehydrated to a moisture content not in excess of 15.0%. It shall contain not less than
18.0% crude protein, and not more than 15.0% crude fiber, 30.0% ash, and 1.0% feathers.
(Adopted 1982)
IFN 4-07-255 Poultry manure non-protein nitrogen extracted dehydrated
74.2 Dried Poultry Waste—NPN Extracted means a processed animal waste
product composed primarily of feces from commercial poultry which has been processed
to remove part or all of the equivalent crude protein, NPN as urea and/or uric acid and
which has been thermally dehydrated to a moisture content not in excess of 15.0%. It
shall contain not less than 11.0% crude protein, and not more than 15.0% crude fiber,
30.0% ash, and 1.0% feathers. (Adopted 1982)
IFN 4-07-255 Poultry manure non-protein nitrogen extracted dehydrated
74.3 Dried Poultry Litter (DPL) means a processed animal waste product
composed of a processed combination of feces from commercial poultry together with
litter that was present in the floor production of poultry, which has been artificially
dehydrated to a moisture content not in excess of 15.0%. It shall contain not less than
18.0% crude protein, and not more than 25.0% crude fiber, 20.0% ash, and 4.0% feathers.
(Adopted 1982)
IFN 5-05-587 Poultry manure and litter dehydrated
74.4 Dried Ruminant Waste (DRW) means a processed animal waste product
composed primarily of processed ruminant excreta which has been artificially dehydrated
to a moisture content not in excess of 15.0%. It shall contain not less than 12.0% crude
protein, and not more than 40.0% crude fiber, including straw, woodshavings, etc., and
not more than 30.0% ash. (Adopted 1982)
IFN 1-07-526 Animal manure dehydrated
74.5 Dried Swine Waste (DSW) means a processed animal waste product composed
primarily of swine excreta which has been artificially dehydrated to a moisture content
not in excess of 15.0%. It shall contain not less than 20.0% crude protein, not more than
35.0% crude fiber, including other material such as straw, woodshavings, or acceptable
other bedding materials, and not more than 20.0% ash. (Adopted 1982)
IFN 5-02-790 Swine manure dehydrated
CHAPTER SIX
74.6 Undried Processed Animal Waste Products means a processed animal waste
product composed of excreta, with or without litter, from poultry, ruminants or any other
animal except humans, which may or may not include other feed ingredients, and which
contains in excess of 15.0% feed ingredients, and which contains in excess of 15.0%
moisture. It shall contain no more than 30% combined wood, woodshavings, litter, dirt,
sand, rocks, and similar extraneous materials. The specific name of each component
material in the product must be declared on the label. (Adopted 1982)
IFN 2-07-258 Animal-poultry manure and litter processed wet
74.7 Processed Animal Waste Derivative means a product resulting from the
chemical, physical or microbiological alteration of an animal waste. Examples of
processed animal waste derivatives are composts, yeasts, algae or other organisms
produced from non-human animal wastes, or wastes treated with ammonia,
formaldehyde, or other chemicals. The specific name of each such animal waste
derivative product must be descriptive, and efficacy and safety data must be submitted
and approved before the product is registered or offered for sale. (Adopted 1982)
IFN 1-07-307 Animal waste processed derivative

75. Rice Products

Official
75.1 Rice Polishings is a by-product of rice obtained in the milling operation of
brushing the grain to polish the kernel. (Adopted 1938)
IFN 4-03-943 Rice polishings
75.2 Ground Rough Rice or Ground Paddy is the entire product obtained in
grinding the whole rice grain including the hulls. (Adopted prior to 1928, Amended
1959)
IFN 4-03-938 Rice grain ground
75.3 Rice Bran, Solvent Extracted is obtained by removing part of the oil from
rice bran by the use of solvents and must contain not less than 14% crude protein and not
more than 14% crude fiber. (Adopted 1951, Amended 1959)
IFN 4-03-930 Rice bran with germ meal solvent extracted
75.4 Chipped Rice, Broken Rice, or Brewers Rice is the small fragments of rice
kernels that have been separated from the larger kernels of milled rice. (Proposed 1959,
Adopted 1960)
IFN 4-03-932 Rice groats polished broken
75.5 Ground Brown Rice is the entire product obtained in grinding the rice kernels
after the hulls have been removed. (Proposed 1959, Adopted 1960)
IFN 4-03-935 Rice groats ground
75.6 Rice Hulls consists primarily of the outer covering of the rice. (Proposed 1959,
Adopted 1960)
IFN 1-08-075 Rice hulls
75.7 Rice Bran is the pericarp or bran layer and germ of the rice, with only such
quantity of hull fragments, chipped, broken, or brewers’ rice, and calcium carbonate as
is unavoidable in the regular milling of edible rice. It must contain not more than 13%
crude fiber. When the calcium carbonate exceeds 3% (Ca.-1.2%), the percentage must
be declared in the brand name; i.e., Rice Bran with Calcium Carbonate not exceeding
_____%. (Proposed 1963, Adopted 1964)
IFN 4-03-928 Rice bran with germs
75.8 Rice Mill By-Product is the total offal obtained in the milling of rice. It
consists of rice hulls, rice bran, rice polishings and broken rice grains. Its crude fiber
content must not exceed 32%. (Proposed 1961, Adopted 1965)
IFN 1-03-941 Rice mill run NOTE: See also 87.6 and 87.7
75.9 Parboiled Rice Bran is about 5 to 7% by weight of Parboiled Rough Rice and
is a mixture made up of a combination of several botanical tissues: pericarp, seed coat,
nucleus, and the outermost portion of the endosperm (the aleurone layer). It may contain
hull fragments, broken grains and traces of added calcium carbonate as is unavoidable in
the milling of parboiled rice. (Proposed 1992, Adopted 1996)
75.10 ____________ Stabilized Rice Bran is rice bran that has been treated soon
after milling by heat or other means that will substantially reduce the lipase activity.
Free fatty acid content of the crude fat extracted shall not exceed 4%. (AOAC 940.28)
Stabilization process must be specified (i.e., Heat Stabilized Rice Bran). (Proposed 2013,

78. Rye Products

Official
78.1 Rye Mill Run is obtained in the usual process of the milling of rye flour from
cleaned and scoured rye, consisting principally of the mill-run of the outer covering of
the rye kernel and the rye germ with small quantities of rye flour and aleurone, and must
not contain more than 9.5% crude fiber. (Adopted 1946)
IFN 4-04-034 Rye mill run less than 9.5% fiber
78.2 Rye Middlings consist of rye feed and rye red dog combined in the proportions
obtained in the usual process of milling rye flour, and must not contain more than 8.5%
crude fiber. (Adopted 1946)
IFN 4-04-031 Rye flour by-product less than 8.5% fiber
81. Screenings
Official
Screenings are obtained in the cleaning of grains which are included in the United
States Grain Standard Act and other agricultural seeds. It may include light and broken
grains and agricultural seeds, weed seeds, hulls, chaff, joints, straw, elevator or mill dust,
sand, and dirt. It must be designated as Grain Screenings, Mixed Screenings and Chaff
and/or Dust.
No grade of screenings may contain any seeds or other material in amount that is
either injurious to animals or will impart an objectionable odor or flavor to their milk or
flesh. The screenings must contain not more than four whole prohibited noxious weed
seeds per pound and must contain not more than 100 whole restricted noxious weed seeds
per pound. The prohibited and restricted noxious weed seeds must be those named as
such by the seed control law of the state in which the screenings is sold or used.
EPA allows a “Non-Food/Non-Feed” status for some crops on a state-by-state basis.
This allows the producer a wider range of pesticides to use in the production of a seed
crop. This is especially important for minor seed crops. In some states alfalfa, clover,
carrot and cabbage seed may be designated non-food/non-feed in their state pesticide
laws. When so designated there are special labeling, record keeping, and by-product
disposal requirements. Most cereal grains and large seeds like bean, pea, and corn have
never been allowed a non-food/non-feed status due to their propensity to enter food
CHAPTER SIX
channels. If you are using seed screenings in the manufacture of a feed, you should check
with your state pesticide regulatory authority as to the non-food/non-feed status of that
commodity.
All grades of screenings must bear minimum guarantees of crude protein and crude
fat and maximum guarantees of crude fiber and ash. (Adopted 1953, Amended 1959,
1960)
81.1 Grain Screenings are those screenings containing 70% or more grains,
including light and broken grains. It may contain wild buckwheat and wild oats. The term
“Grain Screenings” may be used for unspecified kinds of grain, or the predominating kind
of grain (if in excess of 50%) may be declared as the first word or words in the name. It
may contain no more than 6.5% ash. (Proposed 1989, Adopted 1992)
IFN 4-00-542 Barley screenings
IFN 4-20-687 Maize screenings
IFN 4-03-329 Oats screenings
IFN 4-08-085 Rice screenings

IFN 4-27-721 Sorghum screenings

IFN 4-05-216 Wheat screenings
81.2 Mixed Screenings are screenings excluded from the preceding definition. It
must contain not more than 27% crude fiber and not more than 15% ash. (Adopted 1953,
Amended 1954, 1960)
IFN 4-02-157 Cereals mixed grain screenings
81.3 Chaff and/or Dust is material that is separated from grains or seeds in the
usual commercial cleaning processes. It may include hulls, joints, straw, mill or elevator
dust, sweepings, sand, dirt, grains, seeds. It must be labeled, “chaff and/or dust.” If
it contains more than 15% ash the words “sand” and “dirt” must appear on the label.
(Adopted 1953)
IFN 4-02-149 Cereals--legumes chaff and/or dust
84. Soybean Products

Investigator and Section Editor—David Beard, WA
Official
84.1 Ground Soybeans is obtained by grinding whole soybeans without cooking or
removing any of the oil. (Adopted 1933)
IFN 5-04-596 Soybean seeds ground
84.2 Ground Soybean Hay is the ground soybean plant including the leaves and
beans. It must be reasonably free of other crop plants and weeds and must contain not
more than 33% crude fiber. (Adopted 1944, Amended 1964)
IFN 1-04-559 Soybean hay sun-cured ground
84.3 Soybean Hulls consist primarily of the outer covering of the soybean.
(Adopted 1948)
IFN 1-04-560 Soybean seed coats (hulls)
*84.4 Soybean Feed, Solvent Extracted, is the product remaining after the partial
removal of protein and nitrogen free extract from dehulled solvent extracted soybean
flakes. The words “Solvent Extracted” are not required when listing as an ingredient in a
manufactured feed.(Adopted 1948, Amended 1960, 1964)
IFN 5-04-613 Soybean seeds low protein low carbohydrates meal solvent
extracted
84.5 Soy Grits is the granular material resulting from the screened and graded
product after removal of most of the oil from selected, sound, clean and dehulled
soybeans by a mechanical or solvent extraction process. It must contain not more than
4.0% crude fiber. (Proposed 1978, Adopted 1980)
IFN 5-12-176 Soybean grits mechanical extracted
IFN 5-04-592 Soybean grits solvent extracted
84.7 Soybean Meal, Dehulled, Solvent Extracted is obtained by grinding the
flakes remaining after removal of most of the oil from dehulled soybeans by a solvent
extraction process. It must contain not more than 3.5% crude fiber. It may contain
calcium carbonate or an anti-caking agent not to exceed 0.5% as defined in section 87
(Special Purpose Products) to reduce caking and improve flowability. The name of the
conditioning agent must be shown as an added ingredient. When listed as an ingredient
in a manufactured feed it may be identified as “Dehulled Soybean Meal.” The words
“Solvent Extracted” are not required when listing as an ingredient in a manufactured
feed.(Proposed 1989, Adopted 1992)
IFN 5-04-612 Soybean seeds without hulls meal solvent extracted
84.8 Soybean Mill Feed is composed of soybean hulls and the offal from the tail of
the mill which results from the manufacture of soy grits or flour. It must contain not less

than 13% crude protein and not more than 32% crude fiber. (Proposed 1960, Adopted
1961, Amended 1964)
IFN 4-04-594 Soybean flour by-product
84.9 Soybean Mill Run is composed of soybean hulls and such bean meats that
adhere to the hulls which result from normal milling operations in the production of
dehulled soybean meal. It must contain not less than 11% crude protein and not more than
35% crude fiber. (Proposed 1960, Adopted 1961, Amended 1964)
IFN 4-04-595 Soybean mill run
84.10 Soy Phosphate or Soy Lecithin is the mixed phosphatide product obtained
from soybean oil by a degumming process. It contains lecithin, cephalin, and inositol
phosphatides, together with glycerides of soybean oil and traces of tocopherols,
glucosides, and pigments. It must be designated and sold according to conventional
descriptive grades with respect to consistency and bleaching. (Proposed 1958, Adopted
1961)
IFN 4-04-562 Soybean lecithin
84.11 Heat Processed Soybeans is the product resulting from heating whole
soybeans without removing any of the component parts. It may be ground, pelleted,
flaked, or powdered. The maximum pH rise using standard urease testing procedure
should not exceed 0.10 pH units. It must be sold according to its crude protein, crude
fat and crude fiber content. (Proposed 1960, Adopted 1964, Amended 1991, Adopted
1992)
IFN 5-04-597 Soybean seeds heat processed
84.12 Soy Protein Concentrate is prepared from high quality sound, clean,
dehulled soybean seeds by removing most of the oil and water soluble non-protein
constituents and must contain not less than 65% protein on a moisture-free basis.
IFN 5-32-183 Soybean protein concentrate
84.13 Kibbled Soybean Meal is the product obtained by cooking ground solvent
extracted soybean meal, under pressure and extruding from an expeller or other
mechanical pressure device. It must be designated and sold according to its protein
content and shall contain not more than 7% crude fiber. (Proposed 1969, Adopted
1971)
IFN 5-09-343 Soybean seeds kibbled solvent extracted
84.14 Soybean Solubles, Condensed, is the product resulting from the washing
of soy flour or soybean flakes with water and acid; water, alkali and acid; or water and
alcohol. The wash water is then concentrated to a solids content of not less than 50%.
CHAPTER SIX

IFN 5-09-344 Soybean solubles condensed
84.15 Ground Extruded Whole Soybeans is the meal product resulting from
extrusion by friction heat and/or steam, whole soybeans without removing any of the
component parts. It must be sold according to its crude protein, fat, and fiber content.
IFN 5-14-005 Soybean seeds extruded ground
IFN 5-26-010 Soybean protein product chemically modified
84.16 ______ Protein Modified is a Soybean Product that has been processed to
primarily modify the natural protein structure by utilizing heat or elevated temperatures,
acids, alkalies or other chemicals and without removing significant amounts of any
nutrient constituent. The defined name under Section 84 of the applicable soybean
product so modified shall be declared in the product name. (Proposed 1982, Adopted

84.17 Soybean Solubles, Dried, is the product resulting from the washing of soy
flour or soybean flakes with water and acid; water, alkali and acid; or water and alcohol.
The wash water is then dried. (Proposed 1983, Adopted 1990)
IFN 5-16-733 Soybean Solubles dehydrated
84.51 Soy Flour is the finely powdered material resulting from the screened and
graded product after removal of most of the oil from selected, sound, cleaned and
dehulled soybeans by a mechanical or solvent extraction process. It must contain not
more than 4.0% crude fiber. (Proposed 1978, Adopted 1980)
IFN 5-12-177 Soybean flour mechanical extracted
IFN 5-04-593 Soybean flour solvent extracted
84.60 Soybean Meal, Mechanical Extracted is the product obtained by grinding
the cake or chips which remain after removal of most of the oil from soybeans by a
mechanical extraction process. It must contain not more than 7.0% crude fiber. It may
contain calcium carbonate or an anti-caking agent not to exceed 0.5% as defined in
section 87 (Special Purpose Products) to reduce caking and improve flowability. The
name of the conditioning agent must be shown as an added ingredient. The words
“Mechanical Extracted” are not required when listing as an ingredient in a manufactured
feed. (Proposed 1989, Adopted 1992)
IFN 5-04-600 Soybean seeds meal mechanical extracted
84.61 Soybean Meal, Solvent Extracted is the product obtained by grinding
the flakes which remain after removal of most of the oil from soybeans by a solvent
extraction process. It must contain not more than 7.0% crude fiber. It may contain
calcium carbonate or an anti-caking agent not to exceed 0.5% as defined in section 87
(Special Purpose Products) to reduce caking and improve flowability. The name of the
conditioning agent must be shown as an added ingredient. The words “Solvent Extracted”
are not required when listing as an ingredient in a manufactured feed. (Proposed 1989,
Adopted 1992)
IFN 5-04-604 Soybean seeds meal solvent extracted
84.62 Soy Protein Isolate is the major proteinaceous fraction of soybeans prepared
from dehulled soybeans by removing the majority of non-protein components and must
contain not less than 90% protein on a moisture-free basis. (Proposed 1988, Adopted
1990)
IFN 5-24-811 Soy Protein Isolate
84.63 Hydrolyzed Soy Protein is made from soybean flours, concentrates or
isolates, treated with an acid or a base or an enzyme and then dried. (Proposed 1993,
Adopted 1994)
84.64 Textured Soy Protein Product is made from defatted soy flour mixed with
water and/or steam, extruded and then dried. (Proposed 1993, Adopted 1994)
84.71 Soybean Meal, Dehulled, Mechanical Extracted is the product obtained
by grinding of cakes that remain after removal of most of the oil from dehulled soybean
seeds by mechanical extraction process. It must contain not more than 3.5% crude fiber
and not less than 46.5% crude protein. It may contain calcium carbonate or an anti-caking
agent not to exceed 0.5% as defined in section 87 (Special Purpose Products) to reduce
caking and improve flowability. The name of the conditioning agent must be shown as an
added ingredient. When listed as an ingredient in a manufactured feed it may be identified
as “Dehulled Soybean Meal.” The words “Mechanical Extracted” are not required when
listing as an ingredient in a manufactured feed. (Proposed 2004, Adopted 2009)

87. Special Purpose Products

Color, flavor, sweetener, tissue pigmentor (color additive), miscellaneous and/or

general purpose, manure odor control, crude fiber source, non-protein nitrogen source,
roughage replacement.
It is impracticable to list all common special purpose feed ingredients, together
with the status, classification, tolerance, and limitations or restrictions, in the Official
Publication.
The Association of American Feed Control Officials regard such common special
purpose feed ingredients as salt, sugar, and pepper as safe for their intended use, when
used in accordance with good manufacturing practice.
The less common special purpose feed ingredients, together with the status,
classification, tolerance, and limitations or restrictions, are listed in the Official
Publication.
The least common special purpose feed ingredients, together with the status,
classification, tolerance, and limitations or restrictions, are also listed in the Code
of Federal Regulations; Title 21, Food and Drugs; Chapter 1—Food and Drug
Administration, Department of Health and Human Services; Sub-Chapter A—General;
Part 73—Color Additives, or Part 74—Color Certification, or Sub-Chapter E—Animal
Drugs, Feeds, and Related Products; Part 573—Food Additives Permitted in Feed and
Drinking Water of Animals or Part 582—Substances Generally Recognized as Safe
or Part 584—Food Substances Affirmed as Generally Recognized as Safe in Feed and
Drinking Water of Animals.
A number of ingredients have been approved by the FDA Informal Review Process
(I.R.P.) (see AAFCO Official Publication: A guide to submitting New Ingredient
Definitions to AAFCO).
Official
87.1 Dried Algae Meal—The color additive, dried algae meal, may be safely
used in the manufacture of chicken feed in accordance with the following prescribed
conditions:
(a) Identity.
The color additive dried algae meal is a dried mixture of algae cells (genus
Spongiococcum, separated from its culture broth), molasses, cornsteep liquor,
and a maximum of 0.3% ethoxyquin. The algae cells are produced by suitable
CHAPTER SIX
fermentation, under controlled conditions, from a pure culture of the genus

Spongiococcum.
(b) Uses and restrictions.
The color additive dried algae meal may be safely used in chicken feed in
(1) The color additive is used to enhance the yellow color of chicken skin and
eggs.
(2) The quantity of the color additive incorporated in the feed is such that the
finished feed:
(i) is supplemented sufficiently with xanthophyll and associated
carotenoids so as to accomplish the intended effect described in
paragraph (b)(1) of this definition; and
(ii) meets the tolerance limitation for ethoxyquin in animal feed
prescribed in part 573.380 of Title 21 of the Code of Federal
Regulations (21 CFR 573.380).

(c) Labeling.
The label of the color additives and any premixes prepared therefrom shall bear
in addition to the information required by 21 CFR 70.25
(1) a statement of the concentrations of xanthophyll and ethoxyquin contained
therein; and
(2) adequate directions to provide a final product complying with the
limitations prescribed in paragraph (b) of this definition.
(d) 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.
21 CFR 73.275
(Adopted 2017)
87.5 Additional Special Purpose Products:

Classification
Under Food
Aloe vera gel Flavoring agent Not to exceed 125 ppm
concentrate (0.0125%) in finished
feed
Anise seed 21 CFR Spices, seasonings, In accordance with good
IFN 8-00-416 582.10 essential oils, oleo manufacturing practices
resins, and natural
extractives
Capsicum; red 21 CFR Spices, seasonings, In accordance with good
pepper 582.10 etc. manufacturing practices
IFN 8-03-685
Fennel 21 CFR Spices, seasonings, In accordance with good
IFN 8-01-855 582.10 essential oils, etc. manufacturing practices
Fenugreek seed 21 CFR Spices, seasonings, In accordance with good
Fumaric acid pH adjuster, Not to exceed 0.5% of
preservative, or the diet
flavoring agent
Ginger 21 CFR Spices, seasonings, In accordance with good
Glutamic acid n/a Flavoring agent Up to 400 ppm in finished
feed
Glycyrrhizin 21 CFR Spices, seasonings, In accordance with good
ammoniated 582.20 essential oils, etc. manufacturing practices
IFN 8-08-099
Monosodium 21 CFR 582.1 Spices, seasonings, In accordance with good
glutamate etc. manufacturing practices
IFN 8-09-347
(continued)

Classification
Under Food
Phosphoric acid 21 CFR Misc. and/or general In accordance with good
IFN 6-03-707 582.1073 purpose manufacturing practices
Saccharin sodium GRASb Non-nutritive In accordance with good
IFN 8-04-103 sweeteners manufacturing practices
Sodium bisulfate General purpose
feed additive
aIngredients listed in 21 CFR part 582 are subject to the GMPs located at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=582.1.
bGRAS = abbreviation for the phrase “generally recognized as safe.” A substance that is
generally recognized as safe by experts qualified to evaluate the safety of the substance
(for its intended use.)
87.6 Rice By-Products Fractions is obtained by screening and aspirating Ground
Rice Hulls. It is used primarily as a pelleting aid and is composed of such fine particles
of Ground Rice Hulls, Spongy Parenchyma, and minute amounts of Rice Flour, Rice
Germ, Pericarp, and Rice Starch as will pass an 80 mesh screen and contain not less than
5% crude protein, 1.5% crude fat, and not more than 25% crude fiber. (Proposed 1965,
IFN 1-08-033 Rice hull fines
87.7 Ammoniated Rice Hulls is obtained by the treatment of ground rice hulls
with monocalcium phosphate and anhydrous ammonia at a temperature of 350 F and
a pressure of 175 lb. per square inch. It is to be used in beef cattle feeds at a level not
to exceed 20% of the total rations as a source of crude fiber and as the sole source of
non-protein nitrogen. The label of the additive and of any feed additive supplement,
feed additive concentrate, or feed additive premix prepared therefrom, must contain the
following information in addition to any other required information.
ration and a prominent statement: “Warning--This feed should be used only
in accordance with the directions furnished on the label.” (Reg. 573.160)
CHAPTER SIX

IFN 1-05-698 Rice hulls ammoniated
87.8 Polyethylene Roughage Replacement consists of basic polymers manu-
factured by the catalytic polymerization of ethylene, is designed in a pellet form in a
configuration presenting maximum angular surface having the following dimensions in
centimeters. 0.9 + 0.1 × 0.8 + 0.1 × 1.2 + 0.1. It is used as a replacement for roughage in
feedlot rations for finishing slaughter cattle. The labels and labeling shall bear the name
of the additive “Polyethylene Roughage Replacement,” and adequate directions for use
which shall provide for the administration of one-half pound of polyethylene pellets per day
for 6 successive days. All natural roughage should be removed for a minimum of 12 hours
prior to administration of polyethylene roughage replacement. Roughage replacement must
be adequately mixed in the ration for uniform distribution. (Proposed 1969, Adopted 1970)
Reg. 573.780
IFN 8-09-351 Polyethylene

87.9 Ammoniated Cottonseed Meal is obtained by the treatment of cottonseed

meal with anhydrous ammonia until a pressure of 50 pounds per square inch gauge is
reached. It is to be used in the feed of ruminants as a source of protein and/or as the sole
ration and a prominent statement: “Warning—This feed should be used only
in accordance with the directions furnished on the label.”
(Reg. 573.140) (Proposed 1969, Adopted 1970)
IFN 5-09-352 Cotton seeds meal solvent extracted ammoniated
87.11 Anhydrous Ammonia is applied to corn plant material prior to ensiling as a
source of non-protein nitrogen in accordance with any one of the following methods:
(1) As a component of an aqueous premix containing 16 to 17% ammonia, with
molasses, minerals, and not less than 83% crude protein. The labeling must
bear the following statements:
(a) An expiration date of not less than 10 weeks after date of manufacture,
(b) additional protein should not be fed to lactating dairy cows producing less
than 32 pounds of milk per day or beef cattle consuming less than 1% of
their body weight daily in shelled corn, and
(c) do not use additional trace mineral supplementation with treated silage;
(2) After being diluted to a 15 to 30% aqueous ammonia solution (by weight) and:
(a) does not exceed anhydrous ammonia equivalent to 0.3% of the corn plant
material,
(b) the corn plant material contains 28 to 38% dry matter, and
(c) the treated silage is fed to dairy cattle only; and
(3) Directly, and
(a) does not exceed anhydrous ammonia equivalent to 0.35% of the corn plant
material,
(b) the corn plant material contains 30 to 35% dry matter,
(c) 75 to 85% of the anhydrous ammonia is liquid at ambient pressure during
the direct application, and
(d) the treated material is used in dairy or beef cattle rations.
The labeling of the article must contain the following information in addition to any
other required information:
(1) The name of the article.
(2) The concentration of ammonia.
(3) The maximum percentage of equivalent crude protein from non-protein nitrogen
(4) Directions for use consistent with 1) (b) and (c), 2) (c), and 3) (d) above, and
(5) A prominent: “Warning--This feed should be used only in accordance
with the directions furnished on the label.” (Proposed 1974, Adopted 1975,
Revised 1982, Adopted 1983) Reg. 573.180.
IFN 5-14-511 Ammonia anhydrous
87.14 Powdered Cellulose is purified, mechanically disintegrated cellulose prepared
by processing alpha cellulose obtained as a pulp from fibrous plant materials. (Proposed
1975, Adopted 1976)
IFN 1-15-514 Cellulose powdered

87.20 Guanidinoacetic acid: The food additive guanidinoacetic acid may be safely
used in broiler chicken and turkey feeds in accordance with the following prescribed
conditions:
(a) The additive is manufactured by reacting glycine with cyanamide in an aqueous
solution.
(b) The additive is used or intended for use to spare arginine and as a precursor of
creatine in broiler chicken and turkey feeds at levels not to exceed 0.12% of the
complete feed.
(c) The additive consists of not less than 97% guanidinoacetic acid
[N-(aminoiminomethyl)-glycine] (CAS 352-97-6) by weight.
(d) The additive meets the following specifications:
(1) Dicyandiamide not to exceed 0.5%;
(2) Cyanamide not to exceed 0.01%;
(3) Melamine not to exceed 15 parts per million (ppm);
(4) Sum of ammeline, ammelide, and cyanuric acid not to exceed 35 ppm; and
(5) Water not to exceed 1%.
(e) To assure safe use of the additive in addition to the other information required
(1) The label and labeling of the additive, any feed premix, and complete feed
shall contain the name of the additive.
contain:
(i) A statement to indicate that the maximum use level of
guanidinoacetic acid must not exceed 0.12% of the complete feed for
broiler chickens and turkeys; and
(ii) Adequate directions for use.
21 CFR 573.496 (Adopted 2018)
87.22 Microcrystalline Cellulose is purified, partially depolymerized cellulose
prepared by processing alpha cellulose obtained as a pulp from fibrous plant material by
treating with mineral acids. (Proposed 1995, Adopted 2003)
87.25 Neohesperidin Dihydrochalcone is the product resulting from hydrogenation of
neohesperidin, a flavonoid extracted from bitter orange (Citrus aurantium), under alkaline condi-
tions in the presence of a palladium-on-charcoal catalyst. It is to be used as a flavoring agent in
weanling pig diets at levels not to exceed 15 ppm of complete feed. (Proposed 2005, Adopted
2007)
87.29 Yucca schidigera Extract may be used as a flavoring agent in all animal
CHAPTER SIX
foods. It is also an aid in the control of manure odor (post-excretion) when added to
finished feeds of poultry, livestock, rats, mice, hamsters, gerbils, and hedgehogs. The
inclusion rate shall be the minimum quantity necessary to produce the intended effect,
but not exceeding 125 ppm in the finished feed. 21 CFR 172.510. (Proposed 2015 rev. 1,
IFN 8-19-700 Yucca, Mohave extract
87.30 Flavoring Agents. Flavoring substances and adjuvants may be safely used in
animal food in accordance with the following conditions.
(a) They are used in the minimum quantity required to produce their intended technical
effect and in accordance with all the principles of good manufacturing practice.
(b) In the appropriate forms (plant parts, fluid and solid extracts, concentrates,
absolutes, oils, gums, balsams, resins, oleoresins, waxes, and distillates)
consisting of one or more of the following:

Common Name Botanical Name of Plant Source Limitations

Aloe Aloe perryi Baker, Aloe
barbadensis Mill., Aloe ferox
Mill., and hybrids of this sp. with
Aloe Africana Mill. and Aloe
spicata Baker
Althea root and flowers Althea officinalis L.
Amyris (West Indian Amyris balsamifera L.
sandalwood)
Artemisia (wormwood) Artemisia spp. Finished food
thujone freea
Benzoin resin Styrax benzoin Dryander, Styrax
paralleloneurus Perkins, Styrax
tonkinensis (Pierre) Craib ex
Hartwich, or other spp. of the
Section Anthostyrax of the genus
Styrax
Blackberry bark Rubus, Section Eubatus
Boronia flowers Boronia megastigma Nees
Buchu leaves Barosma betulina Bartl. et Wendl.,
Barosma crenulata (L.) Hook. or
Barosma serratifolia Willd
Cajeput Melaleuca leucadendron L. and
other Melaleuca spp.
Camphor tree Cinnamomum camphora (L.) Nees Safrole free
et Eberm
Cascara sagrada Rhamnus purshiana DC
Cassie flowers Acacia farnesiana (L.) Willd
Castor oil Ricinus communis L.
Catechu, black Acacia catechu Willd
Cedar, white (aborvitae), Thuja occidentalis L. Finished food
leaves and twigs thujone freea
Cherry pits Prunus avium L. or Prunus Not to exceed 25
cerasus L. ppm prussic acid
Cherry-laurel leaves Prunus laurocerasus L. Not to exceed 25
ppm prussic acid
Chestnut leaves Castanea dentate (Marsh.) Borkh
Copaiba South American spp. of Copaifera
L.
Costus root Saussurea lappa Clarke
Cubeb Piper cubeba L.
Currant, black, buds and Ribes nigrum L.
leaves
(continued)


Damiana leaves Turnera diffusa Willd
Davana Artemisia pallens Wall
Dill, Indian Anethum sowa Roxb.
(Peucedanum graveolens Benth et
Hook., Anethum graveolens L.)
Dittany of Crete Origanum dictamnus L.
Dragon's blood (dracorubin) Daemonorops spp.
Elemi Canarium commune L. or
Canarium Luzonicum Miq
Erigeron Erigeron canadensis L.
Eucalyptus globulus leaves Eucalyptus globulus Labill
Fir ("pine") needles and Abies sibirica Ledeb., Abies alba
twigs Mill., Abies sachalinesis Masters,
or Abies mayriana Miyabe et
Kudo
Fir, balsam, needles and Abies balsamea (L.) Mill
twigs
Galbanum Ferula galbaniflua Boiss. et Buhse
and other Ferula spp.
Gambir (catechu, pale) Uncaria gambir Roxb
Genet flowers Spartium junceum L.
Gentian rhizome and roots Gentiana lutea L.
Guaiac Guaiacum officinale L., Guaiacum
santum L., Bulnesia sarmienti Lor
Guarana Paullinia cupana HBK
Haw, black, bark Viburnum prunifolium L.
Hemlock needles and twigs Tsuga canadensis (L.) Carr. or
Tsuga heterophylla (Raf.) Sarg
Hyacinth flowers Hyacinthus orientalis L.
CHAPTER SIX
Imperatoria Peucedanum ostruthium (L.) Koch

(Imperatoria ostruthium L.)
Labdanum Cistus spp.
Linaloe wood Bursera delpechiana Poiss. and
other Bursera spp.
Lovage Levisticum officinale Koch
Lungmoss (lungwort) Sticta pulmonacea Ach
Maple, mountain Acer spicatum Lam
Mimosa (black wattle) Acacia decurrens Willd. var.
flowers dealbata
(continued)


Myrrh Commiphora molmol Engl.,
Commiphora abyssinica (Berg)
Engl., or other Commiphora spp.
Oak, white, chips Quercus alba L.
Oak moss Evernia prunastri (L.) Ach., Finished food
Evernia furfuracea (L.) Mann, and thujone freea
other lichens
Olibanum Boswellia carteri Birdw. and other
Boswellia spp.
Opopanax (bisabolmyrrh) Opopanax chironium Koch
(true opopanax) of Commiphora
erythraea Engl. var. Llabrescens
Orris root Iris germanica L. (including its
variety florentina Dykes) and Iris
pallida Lam
Passion flower Passiflora incarnate L.
Patchouli Pogostemon cablin Benth. and
Pogostemon heyneanus Benth
Pennyroyal, American Hedeoma pulegioides (L.) Pers
Pennyroyal, European Mentha pulegium L.
Pine, dwarf, needles and Pinus mugo Turra var. pumilio
twigs (Haenke) Zenari
Pine, Scotch, needles and Pinus sylvestris L.
twigs
Pine, white oil Pinus palustris Mill. and other
Pinus spp.
Quassia Picrasma excelsa (Sw.) Planch, or
Quassia amara L.
Quebracho bark Aspidosperma quebracho-blanco Schinopsis lorentzii
Schlecht, or Quebrachia lorentzii (Griseb.) Engl.
(Griseb)
Quillaia (soapbark) Quillaja saponaria Mol
Rhatany root Krameria triandra Ruiz et Pav. or
Krameria argentea Mart
Rhubarb root Rheum officinale Baill., Rheum
palmatum L., or other spp.
(excepting Rheum rhaponticum
L. or hybrids of Rheum grown in
China)
Sandalwood, white (yellow, Santalum album L.
or East Indian)
(continued)


Sarsaparilla Smilax aristolochiaefolia Mill.,
(Mexican sarsaparilla), Smilax
regelii Killip et Morton (Honduras
sarsaparilla), Smilax febrifuga
Kunth (Ecuadorean sarsaparilla),
or undetermined Smilax spp.
(Ecuadorean or Central American
sarsaparilla)
Sassafras leaves Sassafras albidum (Nutt.) Nees Safrole free
Senna, Alexandria Cassia acutifolia Delile
Snakeroot, Canadian (wild Asarum canadense L.
ginger)
Spruce needles and twigs Picea glauca (Moench) Voss or
Picea mariana (Mill.) BSP
Storax (styrax) Liquidambar orientalis Mill. or.
Liquidambar styraciflua L.
Tagetes (marigold) Tagetes patula L., Tagetes erecta As oil only
L., or Tagetes minuta L. (Tagetes
glandulifera Schrank)
Thymus capitatus (Spanish Thymus capitatus Hoffmg. et Link
"origanum")
Tolu Myroxylon balsamum (L.) Harms
Turpentine Pinus palustris Mill. and other
Pinus spp. that yield terpene oils
exclusively
Valerian rhizome and roots Valeriana officinalis L.
Violet, Swiss Viola calcarata L.
Walnut husks (hulls), Juglans nigra L. or Juglans regia
leaves, and green nuts L.
Yerba santa Eriodictyon californicum (Hook et
CHAPTER SIX
Arn.) Torr.
Yucca, Joshua-tree Yucca brevifolia Engelm.
Yucca, Mohave Yucca schidigera Roezl ex Ortgies
(Yucca mohavensis Sarg.)
aAs determined by using the method (or, in other than alcoholic beverages, a suitable
adaptation thereof) in section 9.129 of the Official Methods of Analysis of the Association
of Official Analytical Chemists, 13th edition (1980), which is incorporated by reference.
Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave.,
suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and
Records Administration (NARA). For information on the availability of this material at
NARA, call (202) 741-6030, or go to http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
(Table Adopted 2015 rev. 1)
87.35 Glucose Syrup is the purified, concentrated, aqueous solution of nutritive
saccharides obtained from edible starch. It shall meet the following specifications: total

solids content not less than 70.0% mass/mass (m/m) and reducing sugar content (dextrose
equivalent), expressed as D-glucose, not less than 20.0% m/m calculated on a dry basis.
The sulfated ash content is not more than 1.0% m/m (calculated on a dry basis), and the
sulfur dioxide content is not more than 40 mg/kg. If the product bears a name descriptive
of its kind or origin, e.g., “corn syrup,” “grain sorghum syrup,” it must correspond
thereto. (21 CFR 168.120) (Proposed 2017, Adopted 2019 rev. 1)
87.36 Phaffia Yeast—The color additive, phaffia yeast, may be safely used in
the manufacture of salmonid fish feed in accordance with the following prescribed
conditions:
(a) Identity.
(1) The color additive phaffia yeast consists of the killed, dried cells of a
nonpathogenic and nontoxicogenic strain of the yeast Phaffia rhodozyma.
(2) Phaffia yeast may be added to the fish feed only as a component of a
stabilized color additive mixture. Color additive mixtures for fish feed use
made with phaffia yeast may contain only those diluents that are suitable
and are listed in part 73.1 of Title 21 of the Code of Federal Regulations
(21 CFR 73.1) as safe for use in color additive mixtures for coloring foods.
(b) Specifications.
Phaffia yeast shall conform to the following specifications and shall be free
from impurities other than those named to the extent that such impurities may
be avoided by good manufacturing practice:
Physical state, solid.
Lead (as Pb), not more than 5 parts per million.
Arsenic (as As), not more than 2 parts per million.
Mercury (as Hg), not more than 1 part per million.
Heavy metals, not more than 10 parts per million.
Astaxanthin, not less than 0.4%.
(c) Uses and restrictions.
Phaffia yeast may be safely used in the feed of salmonid fish 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 quantity of astaxanthin in finished feed, from phaffia yeast when used
alone or in combination with other astaxanthin color additive sources
listed in 21 CFR 73, shall not exceed 80 milligrams per kilogram (72
grams per ton) of finished feed.
(d) Labeling requirements.
(1) The labeling of the color additive and any premixes prepared therefrom
shall bear expiration dates for the sealed and open container (established
through generally accepted stability testing methods), other information
required by 21 CFR 70.25, and adequate directions to prepare a final
product complying with the limitations prescribed in paragraph (c) of this
definition.
(2) The presence of the color additive in finished fish feed prepared according
to paragraph (c) of this definition shall be declared in accordance with 21
CFR 501.4.
(3) The presence of the color additive in salmonid fish that have been fed
feeds containing phaffia yeast shall be declared in accordance with 21
CFR 101.22(b), (c), and (k)(2) and 21 CFR 101.100(a)(2).
(e) Exemption from certification.

21 CFR 73.355 (Proposed 2015, Adopted 2016 rev. 1, Amended 2017)
87.100 FD&C Blue No. 1—The color additive, FD&C Blue No. 1, may be safely
used in the manufacture of animal foods in accordance with the following prescribed
conditions:
(a) Identity.
(1) The color additive FD&C Blue No. 1 is principally the disodium salt of
ethyl [4-[p-[ethyl (m-sulfobenzyl) amino]-α-(o-sulfophenyl) benzylidene]-
2,5-cyclohexadien-1-ylidene] (m-sulfobenzyl) ammonium hydroxide
inner salt with smaller amounts of the isomeric disodium salts of ethyl
[4-[p-[ethyl(p-sulfobenzyl) amino]-α-(o-sulfophenyl) benzylidene]-2,5-
cyclohexadien-1-ylidene] (p-sulfobenzyl) ammonium hydroxide inner
salt and ethyl [4-[p-[ethyl (o-sulfobenzyl) amino]-α-(o-sulfophenyl)
benzylidene]-2,5-cyclohexadien-1-ylidene] (o-sulfobenzyl) ammonium
hydroxide inner salt.
(2) Color additive mixtures for food use made with FD&C Blue No. 1 may
contain only those diluents that are suitable and that are listed in part 73.1
of Title 21 of the Code of Federal Regulations (21 CFR 73.1) as safe for
use in color additive mixtures for coloring foods.
(b) Specifications.
FD&C Blue No. 1 shall conform to the following specifications and shall
be free from impurities other than those named to the extent that such other
impurities may be avoided by current good manufacturing practice:
Sum of volatile matter (at 135°C) and chlorides and sulfates (calculated as
sodium salts), not more than 15.0%.
Water-insoluble matter, not more than 0.2%.
Leuco base, not more than 5%.
Sum of o-, m-, and p-sulfobenzaldehydes, not more than 1.5%.
N-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not more than 0.3%.
Subsidiary colors, not more than 6.0%.
Chromium (as Cr), not more than 50 parts per million.
Manganese (as Mn), not more than 100 parts per million.
Total color, not less than 85.0%.
CHAPTER SIX

FD&C Blue No. 1 may be safely used for coloring foods generally in amounts
consistent with good manufacturing practice except that it may not be used
to color foods for which standards of identity have been promulgated under
section 401 of the Federal Food, Drug, and Cosmetic Act unless added color is
authorized by such standards.
(d) Labeling.
The label of the color additive and any mixtures prepared therefrom intended
solely or in part for coloring purposes shall conform to the requirements of 21
CFR 70.25.
(e) Certification.
All batches of FD&C Blue No. 1 shall be certified in accordance with
regulations in 21 CFR 80.
(Adopted 2017) 21 CFR 74.101

87.102 FD&C Blue No. 2—The color additive, FD&C Blue No. 2, may be safely
conditions:
(a) Identity.
(1) The color additive FD&C Blue No. 2 is principally the disodium salt of
2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-
indole-5-sulfonic acid (CAS Reg. No. 860-22-0) with smaller amounts of
the disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2H-indol-2-ylidene)-
2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 54947-75-0)
and the sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-2,3-
dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 605-18-5).
Additionally, FD&C Blue No. 2 is obtained by heating indigo (or indigo
paste) in the presence of sulfuric acid. The color additive is isolated and
subjected to purification procedures. The indigo (or indigo paste) used
above is manufactured by the fusion of N-phenylglycine (prepared from
aniline and formaldehyde) in a molten mixture of sodamide and sodium
and potassium hydroxides under ammonia pressure. The indigo is isolated
and subjected to purification procedures prior to sulfonation.
(2) Color additive mixtures for food use made with FD&C Blue No. 2 may
(b) Specifications.
The color additive FD&C Blue No. 2 shall conform to the following
specifications and shall be free from impurities other than those named
to the extent that such other impurities may be avoided by current good
manufacturing practice:
Sum of volatile matter at 135°C (275°F) and chlorides and sulfates
(calculated as sodium salts), not more than 15%.
Isatin-5-sulfonic acid, not more than 0.4%.
5-Sulfoanthranilic acid, not more than 0.2%.
Disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2H-indol-2-ylidene)-2,3-
dihydro-3-oxo-1H-indole-5-sulfonic acid, not more than 18%.
Sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-2,3-dihydro-3-
oxo-1H-indole-5-sulfonic acid, not more than 2%.
Total color, not less than 85%.
The color additive FD&C Blue No. 2 may be safely used for coloring foods
generally in amounts consistent with current good manufacturing practice
except that it may not be used to color foods for which standards of identity
have been promulgated under section 401 of the Federal Food, Drug, and
Cosmetic Act unless added color is authorized by such standards.
(d) Labeling.
CFR 70.25.

(e) Certification.
All batches of FD&C Blue No. 2 shall be certified in accordance with
(Adopted 2017) 21 CFR 74.102
87.103 FD&C Green No. 3—The color additive, FD&C Green No. 3, may be safely
conditions:
(a) Identity.
(1) The color additive FD&C Green No. 3 is principally the inner salt
disodium salt of N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]
phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-
ylidene]-3-sulfobenzenemethanaminium hydroxide (CAS Reg. No.
2353-45-9); with smaller amounts of the isomeric inner salt disodium
salt of N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl]
(4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-
4-sulfobenzenemethanaminium hydroxide; of N-ethyl-N-[4-[[4-
[ethyl[(4-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)
methylene]-2,5-cyclohexadien-1-ylidene]-4-sulfobenzenemethanaminium
hydroxide and of N-ethyl-N-[4-[[4-[ethyl[(2-sulfophenyl)methyl]amino]
phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-
ylidene]-3-sulfobenzenemethanaminium hydroxide. Additionally, FD&C
Green No. 3 is manufactured by the acid catalyzed condensation of one
molecule of 2-formyl-5-hydroxybenzenesulfonic acid with 2 molecules
from a mixture consisting principally of 3-[(ethylphenylamino)methyl]
benzensulfonic acid, and smaller amounts of 4-[(ethylphenylamino)
methyl] benzenesulfonic acid and 2-[(ethylphenylamino)methyl]
benzenesulfonic acid to form the leuco base. The leuco base is then
oxidized with lead dioxide and acid or with dichromate and acid to
form the dye. The intermediate 2-formyl-5-hydroxybenzenesulfonic
acid is prepared by the potassium permanganate oxidation of
2,2′-(1,2-ethenediyl)-bis(5-aminobenzenesulfonic acid) to sodium
5-amino-2-formylbenzenesulfonate. This amine is diazotized, and
the resulting diazonium salt is hydrolyzed to the desired 2-formyl-5-
hydroxybenzenesulfonic acid.
(2) Color additive mixtures for food use made with FD&C Green No. 3 may
CHAPTER SIX
use in color additive mixtures for coloring food.
(b) Specifications.
The color additive FD&C Green No. 3 shall conform to the following
Leuco base, not more than 5%.
Sum of 2-, 3-, 4-formylbenzenesulfonic acids, sodium salts, not more than
0.5%.
Sum of 3- and 4-[[ethyl(4-sulfophenyl)amino]methyl] benzenesulfonic
acid, disodium salts, not more than 0.3%.

2-Formyl-5-hydroxybenzenesulfonic acid, sodium salt, not more than

0.5%.
Subsidiary colors, not more than 6%.
Chromium (as Cr), not more than 50 parts per million.
The color additive FD&C Green No. 3 may be safely used for coloring foods
generally in amounts consistent with current good manufacturing practice
(d) Labeling.
CFR 70.25.
(e) Certification.
All batches of FD&C Green No. 3 shall be certified in accordance with
regulations in 21CFR 80.
(Adopted 2017) 21 CFR 74.203
87.104 FD&C Red No. 3—The color additive, FD&C Red No. 3, may be safely
conditions:
(a) Identity.
(1) The color additive FD&C Red No. 3 is principally the monohydrate of
9 (o- carboxyphenyl)-6-hydroxy-2,4,5,7-tetraiodo-3H-xanthen-3-one,
disodium salt, with smaller amounts of lower imdinated fluoresceins.
(2) Color additive mixtures for food use made with FD&C Red No. 3 may
(b) Specifications.
FD&C Red No. 3 shall conform to the following specifications and shall be free
from impurities other than those named to the extent that such other impurities
may be avoided by good manufacturing practice:
Volatile matter (at 135°C) and chlorides and sulfates (calculated as the
sodium salts), total not more than 13%.
Unhalogenated intermediates, total not more than 0.1%.
Sodium iodide, not more than 0.4%.
Triiodoresorcinol, not more than 0.2%.
2(2′,4′-Dihydroxy-3′, 5′-diiodobenzoyl) benzoic acid, not more than 0.2%.
Monoiodofluoresceins not more than 1.0%.
Other lower iodinated fluoresceins, not more than 9.0%.
FD&C Red No. 3 may be safely used for coloring foods generally in amounts

(d) Labeling.
CFR 70.25.
(e) Certification.
All batches of FD&C Red No. 3 shall be certified in accordance with
(Adopted 2017) 21 CFR 74.303
87.105 FD&C Red No. 40—The color additive, FD&C Red No. 40, may be safely
conditions:
(a) Identity.
(1) The color additive FD&C Red No. 40 is principally the disodium
salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-
naphthalenesulfonic acid.
(2) Color additive mixtures for food use (including dietary supplements)
made with FD&C Red No. 40 may contain only those diluents that are
suitable and that are listed in part 73.1 of Title 21 of the Code of Federal
Regulations (21 CFR 73.1) as safe for use in color additive mixtures for
coloring foods.
(3) The listing of this color additive includes lakes prepared as described in
21 CFR 82.51, except that the color additive used is FD&C Red No. 40
and the resultant lakes meet the specification and labeling requirements
prescribed by 21 CFR 82.51.
(b) Specifications.
FD&C Red No. 40 shall conform to the following specifications and shall
impurities may be avoided by good manufacturing practice:
sodium salts), not more than 14.0%.
Higher sulfonated subsidiary colors (as sodium salts), not more than 1.0%.
Lower sulfonated subsidiary colors (as sodium salts), not more than 1.0%.
CHAPTER SIX
Disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl) azo]-

8-(2-methoxy-5-methyl-4-sulfophenoxy)-2-naphthalenesulfonic acid, not
more than 1.0%.
Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid (Schaeffer’s salt),
not more than 0.3%.
4-Amino-5-methoxy-o-toluenesulfonic acid, not more than 0.2%.
Disodium salt of 6,6′-oxybis (2-naphthalene-sulfonic acid), not more than
1.0%.
FD&C Red No. 40 may be safely used for coloring foods generally in amounts

(d) Labeling.
The label of the color additive and any lakes or mixtures prepared therefrom
intended solely or in part for coloring purposes shall conform to the
requirements of 21 CFR 70.25.
(e) Certification.
All batches of FD&C Red No. 40 and lakes thereof shall be certified in
accordance with regulations in 21 CFR 80.
(Adopted 2017) 21 CFR 74.340
87.106 FD&C Yellow No. 6—The color additive, FD&C Yellow No. 6, may
be safely used in the manufacture of animal foods in accordance with the following
(a) Identity.
(1) The color additive FD&C Yellow No. 6 is principally the disodium salt
of 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid (CAS
Reg. No. 2783-94-0). The trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)
azo]-2,7-naphthalenedisulfonic acid (CAS Reg. No. 50880-65-4) may be
added in small amounts. The color additive is manufactured by diazotizing
4-aminobenzenesulfonic acid using hydrochloric acid and sodium nitrite
or sulfuric acid and sodium nitrite. The diazo compound is coupled with
6-hydroxy-2-naphthalene-sulfonic acid. The dye is isolated as the sodium
salt and dried. The trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-
naphthalenedisulfonic acid which may be blended with the principal color
is prepared in the same manner except the diazo benzenesulfonic acid is
coupled with 3-hydroxy-2,7-naphthalenedisulfonic acid.
(2) Color additive mixtures for food use made with FD&C Yellow No. 6 may
(b) Specifications.
The color additive FD&C Yellow No. 6 shall conform to the following
sodium salts), not more than 13%.
Sodium salt of 4-aminobenzenesulfonic acid, not more than 0.2%.
Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid, not more than 0.3%.
Disodium salt of 6,6′-oxybis[2-naphthalenesulfonic acid], not more than
1%.
Disodium salt of 4,4′-(1-triazene-1,3-diyl)bis[benzenesulfonic acid], not
more than 0.1%.
Sum of the sodium salt of 6-hydroxy-5-(phenylazo)-2-naphthalenesulfonic
acid and the sodium salt of 4-[(2-hydroxy-1-naphthalenyl)azo]
benzenesulfonic acid, not more than 1%.
Sum of the trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-
naphthalenedisulfonic acid and other higher sulfonated subsidiaries, not
more than 5%.
4-Aminoazobenzene, not more than 50 parts per billion.
4-Aminobiphenyl, not more than 15 parts per billion.

Aniline, not more than 250 parts per billion.

Azobenzene, not more than 200 parts per billion.
Benzidine, not more than 1 part per billion.
1,3-Diphenyltriazene, not more than 40 parts per billion.
1-(Phenylazo)-2-naphthalenol, not more than 10 parts per million.
The color additive FD&C Yellow No. 6 may be safely used for coloring foods
generally in amounts consistent with current good manufacturing practice,
(1) The label of the color additive and any mixtures intended solely or
in part for coloring purposes prepared therefrom shall conform to the
requirements of 21 CFR 70.25 of this chapter.
(e) Certification.
All batches of FD&C Yellow No. 6 shall be certified in accordance with regulations
in 21 CFR 80.
(Adopted 2017) 21 CFR 74.706
87.107 FD&C Yellow No. 5—The color additive, FD&C Yellow No. 5, may
be safely used in the manufacture of animal foods in accordance with the following
(a) Identity.
(1) The color additive FD&C Yellow No. 5 is principally the trisodium salt of
4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[4-sulfophenyl-azo]-1H-pyrazole-
3-carboxylic acid (CAS Reg. No. 1934-21-0). To manufacture the
additive, 4-amino-benzenesulfonic acid is diazotized using hydrochloric
acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-
5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid or with the methyl
ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is
purified and isolated as the sodium salt.
(2) Color additive mixtures for food use made with FD&C Yellow No. 5 may
CHAPTER SIX
(b) Specifications.
FD&C Yellow No. 5 shall conform to the following specifications and shall
4,4′-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1H-pyrazol-1,3-
diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1%.
4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-
sulfophenyl)-1H-pyrazole-3-carboxylic acid, tetrasodium salt, not more
than 1%.

Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)

hydrazono]-1H-pyrazole-3-carboxylate, disodium salt, not more than 1%.
Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1H-pyrazole-
3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-
(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, disodium salt, not more
than 0.5%.
4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2%.
4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid,
disodium salt, not more than 0.2%.
Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-
carboxylate, sodium salt, not more than 0.1%.
4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not
more than 0.05%.
4-Aminoazobenzene, not more than 75 parts per billion.
4-Aminobiphenyl, not more than 5 parts per billion.
Aniline, not more than 100 parts per billion.
Azobenzene, not more than 40 parts per billion.
Benzidine, not more than 1 part per billion.
1,3-Diphenyltriazene, not more than 40 parts per billion.
FD&C Yellow No. 5 may be safely used for coloring foods generally in
amounts consistent with good manufacturing practice, except that it may not
be used to color foods for which standards of identity have been promulgated
under section 401 of the Federal Food, Drug, and Cosmetic Act unless added
color is authorized by such standards.
The label of the color additive and any mixtures intended solely or in part for coloring
purposes prepared therefrom shall conform to the requirements of 21 CFR 70.25.
(e) Certification.
All batches of FD&C Yellow No. 5 shall be certified in accordance with
(Adopted 2017) 21 CFR 74.705
87.110 Annatto Extract—The color additive, annatto extract, may be safely used in
the manufacture of animal foods in accordance with the following prescribed conditions:
(a) Identity.
(1) The color additive annatto extract is an extract prepared from annatto seed,
Bixa orellana L., using any one or an appropriate combination of the food-
grade extractants listed in paragraph (a)(1)(i) and (ii) of this definition:
(i) Alkaline aqueous solution, alkaline propylene glycol, ethyl alcohol
or alkaline solutions thereof, edible vegetable oils or fats, mono- and
diglycerides from the glycerolysis of edible vegetable oils or fats. The
alkaline alcohol or aqueous extracts may be treated with food-grade
acids to precipitate annatto pigments, which are separated from the
liquid and dried, with or without intermediate recrystallization, using
the solvents listed under paragraph (a)(1)(ii) of this definition. Food-
grade alkalis or carbonates may be added to adjust alkalinity.
(ii) Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl
alcohol, methylene chloride, trichloroethylene.

(2) Color additive mixtures for food use made with annatto extract may
contain only diluents that are suitable and that are listed in part 73.1 of
Title 21 of the Code of Federal Regulations (21 CFR 73.1) as safe in color
additive mixtures for coloring foods.
(b) Specifications.
Annatto extract, including pigments precipitated therefrom, shall conform to
the following specifications:
(1) Arsenic (as As), not more than 3 parts per million; lead (as Pb), not more
than 10 parts per million.
(2) When solvents listed under paragraph (a)(1)(ii) of this definition are used,
annatto extract shall contain no more solvent residue than is permitted
of the corresponding solvents in spice oleoresins under applicable food
additive regulations in 21 CFR 170 through 189.
Annatto extract may be safely used for coloring foods generally, in amounts
consistent with good manufacturing practice, except that it may not be used
(d) Labeling.
The label of the color additive and any mixtures prepared therefrom
and intended solely or in part for coloring purposes shall conform to the
requirements of 21 CFR 70.25. Labels shall bear information showing that
the color is derived from annatto seed. The requirements of 21 CFR 70.25(a)
that all ingredients shall be listed by name shall not be construed as requiring
the declaration of residues of solvents listed in paragraph (a)(1)(ii) of this
definition.
21 CFR 73.30
87.112 Astaxanthin Dimethyldisuccinate—The color additive, astaxanthin
dimethyldisuccinate, may be safely used in the manufacture of salmonid fish feed in
(a) Identity.
CHAPTER SIX
(1) The color additive astaxanthin dimethyldisuccinate is 3,3′-bis(4-methoxy-

1,4-dioxobutoxy)-β,β-carotene-4,4′-dione.
(2) Astaxanthin dimethyldisuccinate may be added to the fish feed only as a
component of a stabilized mixture. Color additive mixtures for fish feed
use made with astaxanthin dimethyldisuccinate may contain only those
diluents that are suitable and are listed in part 73.1 of Title 21 of the Code
of Federal Regulations (21 CFR 73.1) as safe for use in color additive
mixtures for coloring foods.
(b) Specifications.
Astaxanthin dimethyldisuccinate shall conform to the following specifications
and shall be free from impurities other than those named to the extent that such
(1) Physical state, solid.
(2) 0.05% Solution in chloroform, complete and clear.
(3) Absorption maximum wavelength 484 to 493 nanometers (in chloroform).
(4) Residue on ignition, not more than 0.1%.

(5) Total carotenoids other than astaxanthin dimethyldisuccinate, not more

than 4%.
(6) Lead, not more than 5 milligrams per kilogram (mg/kg) (5 parts per
million).
(7) Arsenic, not more than 2 mg/kg (2 parts per million).
(8) Mercury, not more than 1 mg/kg (1 part per million).
(9) Heavy metals, not more than 10 mg/kg (10 parts per million).
(10) Assay including astaxanthin dimethyldisuccinate, astaxanthin
monomethylsuccinate, and astaxanthin, minimum 96%.
Astaxanthin dimethyldisuccinate may be safely used in the feed of salmonid
fish in accordance with the following prescribed conditions:
(2) The quantity of astaxanthin dimethyldisuccinate in the finished feed, when
used alone or in combination with other astaxanthin color additive sources
listed in 21 CFR 73, shall not exceed 110 mg/kg, which is equivalent to 80
mg/kg astaxanthin (72 grams per ton).
definition.
CFR 501.4.
87.114 Astaxanthin—The color additive, astaxanthin, may be safely used in
the manufacture of salmonid fish feed in accordance with the following prescribed
conditions:
(a) Identity.
(1) The color additive astaxanthin is 3, 3′-dihydroxy-β, β-carotene-4, 4′-dione.
(2) Astaxanthin may be added to the fish feed only as a component of a
stabilized color additive mixture. Color additive mixtures for fish feed use
made with astaxanthin may contain only those diluents that are suitable
and are listed in part 73.1 of Title 21 of the Code of Federal Regulations
(21 CFR 73.1) as safe for use in color additive mixtures for coloring foods.
(b) Specifications.
Astaxanthin shall conform to the following specifications and shall be free from
impurities other than those named to the extent that such impurities may be
avoided by good manufacturing practice:
0.05% Solution in chloroform, complete and clear.
Absorption maximum wavelength 484 to 493 nanometers (in chloroform).
Residue on ignition, not more than 0.1%.
Total carotenoids other than astaxanthin, not more than 4%.
Lead, not more than 5 parts per million.
Arsenic, not more than 2 parts per million.
Mercury, not more than 1 part per million.
Assay, minimum 96%.


Astaxanthin may be safely used in the feed of salmonid fish in accordance with
(2) The quantity of color additive in feed is such that the color additive shall
not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.
required 21 CFR 70.25, and adequate directions to prepare a final
definition.
CFR 501.4.
feeds containing astaxanthin shall be declared in accordance with 21 CFR
101.22(k)(2) and 21 CFR 101.100(a)(2).
21 CFR 73.35
87.115 Canthaxanthin—The color additive canthaxanthin may be safely used in the
manufacture of animal foods in accordance with the following prescribed conditions:
(a) Identity.
(1) The color additive canthaxanthin is β-carotene-4,4′-dione.
(2) Color additive mixtures for food use made with canthaxanthin may
(b) Specifications.
Canthaxanthin shall conform to the following specifications and shall be free from
impurities other than those named to the extent that such other impurities may be
CHAPTER SIX
avoided by good manufacturing practice:

1% solution in chloroform, complete and clear.
Melting range (decomposition), 207 to 212°C (corrected).
Loss on drying, not more than 0.2%.
Total carotenoids other than trans-canthaxanthin, not more than 5%.
Lead, not more than 10 parts per million.
Arsenic, not more than 3 parts per million.
Mercury, not more than 1 part per million.
Assay, 96 to 101%.
(c) Use and restrictions.
(1) The color additive canthaxanthin may be safely used for coloring foods
generally subject to the following restrictions:
(i) The quantity of canthaxanthin does not exceed 30 milligrams per
pound of solid or semisolid food or per pint of liquid food; and

(ii) It may not be used to color foods for which standards of identity have
been promulgated under section 401 of the Federal Food, Drug, and
(2) Canthaxanthin may be safely used in broiler chicken feed to enhance the
yellow color of broiler chicken skin in accordance with the following
conditions: The quantity of canthaxanthin incorporated in the feed shall
not exceed 4.41 milligrams per kilogram (4 grams per ton) of complete
feed to supplement other known sources of xanthophyll and associated
carotenoids to accomplish the intended effect.
(3) Canthaxanthin may be safely used in the feed of salmonid fish in
(i) Canthaxanthin may be added to the fish feed only in the form of a
stabilized color additive mixture;
(ii) The color additive is used to enhance the pink to orange-red color of
the flesh of salmonid fish; and
(iii) The quantity of color additive in feed shall not exceed 80 milligrams
per kilogram (72 grams per ton) of finished feed.
(1) The labeling of the color additive and any mixture prepared therefrom
intended solely or in part for coloring purposes shall conform to the
(2) For purposes of coloring fish, the labeling of the color additive and any
premixes prepared therefrom shall bear expiration dates (established
through generally accepted stability testing methods) for the sealed and
open container, other information required by 21 CFR 70.25, and adequate
directions to prepare a final product complying with the limitations
prescribed in paragraph (c)(3) of this definition.
(3) The presence of the color additive in feed prepared according to paragraph
(c) of this definition shall be declared in accordance with 21 CFR 501.4.
feeds containing canthaxanthin shall be declared in accordance with 21
CFR 101.22(b), (c), and (k)(2), and 101.100(a)(2).
21 CFR 73.75 (Adopted 2018)
87.116 Caramel—The color additive, caramel, may be safely used in the
(a) Identity.
(1) The color additive caramel is the dark-brown liquid or solid material
resulting from the carefully controlled heat treatment of the following
food-grade carbohydrates:
Dextrose.
Invert sugar.
Lactose.
Malt syrup.
Molasses.
Starch hydrolysates and fractions thereof.
Sucrose.

(2) The food-grade acids, alkalis, and salts listed in this subparagraph may
be employed to assist caramelization, in amounts consistent with good
manufacturing practice.
(i) Acids: acetic acid, citric acid, phosphoric acid, sulfuric acid, and
sulfurous acid.
(ii) Alkalis: ammonium hydroxide, calcium hydroxide U.S.P., potassium
hydroxide, and sodium hydroxide.
(iii) Salts: ammonium, sodium, or potassium carbonate, bicarbonate,
phosphate (including dibasic phosphate and monobasic phosphate),
sulfate, and sulfite.
(3) Polyglycerol esters of fatty acids, identified in part 172.854 of Title 21
of the Code of Federal Regulations (21 CFR 172.854), may be used as
antifoaming agents in amounts not greater than that required to produce
the intended effect.
(4) Color additive mixtures for food use made with caramel may contain only
diluents that are suitable and that are listed in 21 CFR 73.1 as safe in color
(b) Specifications.
Caramel shall conform to the following specifications:
Mercury (as Hg), not more than 0.1 part per million.
Caramel may be safely used for coloring foods generally, in amounts consistent
with good manufacturing practice, except that it may not be used to color foods
for which standards of identity have been promulgated under section 401 of the
Federal Food, Drug, and Cosmetic Act unless added color is authorized by such
standards.
(d) Labeling.
requirements of section 721(c) of Federal Food, Drug, and Cosmetic Act.
CHAPTER SIX
21 CFR 73.85
87.118 Carmine—The color additive, carmine, may be safely used in the
(a) Identity.
(1) The color additive carmine is the aluminum or calcium-aluminum
lake on an aluminum hydroxide substrate of the coloring principles,
chiefly carminic acid, obtained by an aqueous extraction of cochineal
[Dactylopius coccus costa (Coccus cacti L.)].
(2) Color additive mixtures for food use made with carmine may contain
only diluents that are suitable and that are listed in part 73.1 of Title 21 of
the Code of Federal Regulations (21 CFR 73.1) as safe in color additive
(b) Specifications.
Carmine shall conform to the following specifications:
Volatile matter (at 135°C for 3 hours), not more than 20.0%.
Ash, not more than 12.0%.


Arsenic (as As), not more than 1 part per million.
Carminic acid, not less than 50.0%.
Carmine shall be pasteurized or otherwise treated to destroy all viable
Salmonella microorganisms. Pasteurization or such other treatment is deemed
to permit the adding of safe and suitable substances (other than chemical
preservatives) that are essential to the method of pasteurization or other
treatment used. For the purposes of this definition, safe and suitable substances
are those substances that perform a useful function in the pasteurization or other
treatment to render the carmine free of viable Salmonella microorganisms,
which substances are not food additives as defined in section 201(s) of the
Federal Food, Drug, and Cosmetic Act or, if they are food additives as so
defined, are used in conformity with regulations established pursuant to section
409 of the Federal Food, Drug, and Cosmetic Act.
Carmine may be safely used for coloring foods generally in amounts consistent
with good manufacturing practice, except that they may not be used to color
foods for which standards of identity have been promulgated under section 401
of the Federal Food, Drug, and Cosmetic Act unless added color is authorized
by such standards.
The label of the color additives and any mixtures intended solely or in part for
coloring purposes prepared therefrom shall conform to the requirements of 21
CFR 70.25.
21 CFR 73.100
87.120 Carrot Oil—The color additive, carrot oil, may be safely used in the
(a) Identity.
(1) The color additive carrot oil is the liquid or the solid portion of the mixture
or the mixture itself obtained by the hexane extraction of edible carrots
(Daucus carota L.) with subsequent removal of the hexane by vacuum
distillation. The resultant mixture of solid and liquid extractives consists
chiefly of oils, fats, waxes, and carrotenoids naturally occurring in carrots.
The definition of “carrot oil” in this paragraph is for the purpose of
identity as a color additive only and shall not be construed as setting forth
an official standard for carrot oil or carrot oleoresin under section 401 of
the Federal Food, Drug, and Cosmetic Act.
(2) Color additive mixtures for food use made with carrot oil may contain
only those diluents listed in part 73.1 of Title 21 of the Code of Federal
Regulations (21 CFR 73.1) as safe and suitable in color additive mixtures
for coloring foods.
(b) Specifications.
Carrot oil shall contain no more than 25 parts per million of hexane.
Carrot oil may be safely used for coloring foods generally, in amounts

section 401 of the Federal Food, Drug, and Cosmetic Act unless the use of
added color is authorized by such standards.
CFR 70.25.
21 CFR 73.300
87.122 Cochineal Extract—The color additive, cochineal extract, may be safely
conditions:
(a) Identity.
(1) The color additive cochineal extract is the concentrated solution obtained
after removing the alcohol from an aqueous-alcoholic extract of cochineal
[Dactylopius coccus costa (Coccus cacti L.)]. The coloring principle is
chiefly carminic acid.
(2) Color additive mixtures for food use made with cochineal extract may
(b) Specifications.
Cochineal extract shall conform to the following specifications:
pH, not less than 5.0 and not more than 5.5 at 25°C.
Protein (N × 6.25), not more than 2.2%.
Total solids, not less than 5.7% and not more than 6.3%.
Methyl alcohol, not more than 150 parts per million.
Carminic acid, not less than 1.8%.
Cochineal extract shall be pasteurized or otherwise treated to destroy all viable
Salmonella microorganisms. Pasteurization or such other treatment is deemed
to permit the adding of safe and suitable substances (other than chemical
preservatives) that are essential to the method of pasteurization or other
CHAPTER SIX
treatment used. For the purposes of this definition, safe and suitable substances
are those substances that perform a useful function in the pasteurization or
other treatment to render the cochineal extract free of viable Salmonella
microorganisms, which substances are not food additives as defined in section
201(s) of the Federal Food, Drug, and Cosmetic Act or, if they are food
additives as so defined, are used in conformity with regulations established
pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act.
Cochineal extract may be safely used for coloring foods generally in amounts
consistent with good manufacturing practice, except that they may not be used
The label of the color additives and any mixtures intended solely or in part for


CFR 70.25.
21 CFR 73.100
87.124 Corn Endosperm Oil—The color additive, corn endosperm oil, may
be safely used in the manufacture of chicken feed in accordance with the following
(a) Identity.
(1) The color additive corn endosperm oil is a reddish-brown liquid composed
chiefly of glycerides, fatty acids, sitosterols, and carotenoid pigments
obtained by isopropyl alcohol and hexane extraction from the gluten
fraction of yellow corn grain. The definition of corn endosperm oil in
this paragraph is for the purpose of a color additive only and shall not be
construed as a food standard of identity under section 401 of the Federal
Food, Drug, and Cosmetic Act.
(2) Color additive mixtures for food use made with corn endosperm oil may
contain only those diluents listed in part 73.1 of Title 21 of the Code of
Federal Regulations (21 CFR 73.1) as safe and suitable in color additive
(b) Specifications.
Corn endosperm oil shall conform to the following specifications:
Total fatty acids, not less than 85%.
Iodine value, 118 to 134.
Saponification value, 165 to 185.
Unsaponifiable matter, not more than 14%.
Hexane, not more than 25 parts per million.
Isopropyl alcohol, not more than 100 parts per million.
The color additive corn endosperm oil may be safely used in chicken feed in
eggs.
finished feed is supplemented sufficiently with xanthophyll and associated
carotenoids so as to accomplish the intended effect described in paragraph
(c)(1) of this definition.
The label of the color additive and any premixes prepared therefrom shall bear,
in addition to the information required by 21 CFR 70.25, a statement of the
concentration of xanthophyll contained therein.
21 CFR 73.315
87.126 Dehydrated Beets—The color additive, dehydrated beets, may be safely
conditions:
(a) Identity.

(1) The color additive dehydrated beets is a dark red powder prepared by
dehydrating sound, mature, good quality, edible beets.
(2) Color additive mixtures made with dehydrated beets may contain as
diluents only those substances listed in this part 73.1 of Title 21 of the
Code of Federal Regulations (21 CFR 73.1) as safe and suitable for use in
color additive mixtures for coloring foods.
(b) Specifications.
The color additive shall conform to the following specifications:
Volatile matter, not more than 4%.
Acid insoluble ash, not more than 0.5%.
Dehydrated beets may be safely used for the coloring of foods generally in
under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use
of added color is authorized by such standards.
(d) Labeling.
solely or in part for coloring purposes shall conform to the requirements 21
CFR 70.25.
21 CFR 73.40
87.128 Fruit Juice—The color additive, fruit juice, may be safely used in the
(a) Identity.
(1) The color additive fruit juice is prepared either by expressing the juice
from mature varieties of fresh, edible fruits, or by the water infusion of the
dried fruit. The color additive may be concentrated or dried. The definition
of fruit juice in this paragraph is for the purpose of identity as a color
additive only and shall not be construed as a standard of identity under
CHAPTER SIX
section 401 of the Federal Food, Drug, and Cosmetic Act. However, where
a standard of identity for a particular fruit juice has been promulgated
under section 401 of the Federal Food, Drug, and Cosmetic Act, it shall
conform to such standard.
(2) Color additive mixtures made with fruit juice may contain as diluents
only those substances listed in part 73.1 of Title 21 of the Code of Federal
for coloring foods.
Fruit juice may be safely used for the coloring of foods generally, in amounts
section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of
(c) Labeling.
The color additive and any mixtures intended solely or in part for coloring

purposes prepared therefrom shall bear, in addition to the other information

required by the Federal Food, Drug, and Cosmetic Act, labeling in accordance
with the provisions of 21 CFR 70.25.
21 CFR 73.250
87.130 Haematococcus Algae Meal—The color additive, Haematococcus algae
meal, may be safely used in the manufacture of salmonid fish feed in accordance with the
following prescribed conditions:
(a) Identity.
(1) The color additive haematococcus algae meal consists of the comminuted
and dried cells of the alga Haematococcus pluvialis.
(2) Haematococcus algae meal may be added to the fish feed only as a
component of a stabilized color additive mixture. Color additive mixtures
for fish feed use made with haematococcus algae meal may contain only
those diluents that are suitable and are listed in part 73.1 of Title 21 of
the Code of Federal Regulations (21 CFR 73.1) as safe for use in color
(b) Specifications.
Haematococcus algae meal shall conform to the following specifications and
shall be free from impurities other than those named to the extent that such
Astaxanthin, not less than 1.5%.
Haematococcus algae meal may be safely used in the feed of salmonid fish in
(2) The quantity of astaxanthin in finished feed, from haematococcus algae
meal when used alone or in combination with other astaxanthin color
additive sources listed in 21 CFR 73, shall not exceed 80 milligrams per
kilogram (72 grams per ton) of finished feed.
definition.
CFR 501.4.
(3) The presence of the color additive in salmonid fish that have been
fed feeds containing haematococcus algae meal shall be declared in
accordance with 21 CFR 101.22(b), (c), and (k)(2), and 101.100(a)(2).


21 CFR 73.185
87.132 Paprika Oleoresin—The color additive, paprika oleoresin, may be safely
conditions:
(a) Identity.
(1) The color additive paprika oleoresin is the combination of flavor and color
principles obtained from paprika (Capsicum annuum L.) by extraction,
using any one or a combination of the following solvents: acetone,
isopropyl alcohol, ethyl alcohol, methyl alcohol, ethylene dichloride,
methylene chloride, hexane, and trichloroethylene.
The definition of paprika oleoresin in this paragraph is for the purpose of
identity as a color additive only, and shall not be construed as setting forth
an official standard for paprika oleoresin under section 401 of the Federal
(2) Color additive mixtures made with paprika oleoresin may contain as
diluents only those substances listed in part 73.1 of Title 21 of the Code of
(b) Specifications.
Paprika oleoresin shall contain no more residue of the solvents listed in
paragraph (a)(1) of this definition than is permitted of the corresponding
solvents in spice oleoresins under applicable food additive regulations in 21
CFR 170 through 189.
Paprika oleoresin may be safely used for the coloring of foods generally in
(d) Labeling.
CHAPTER SIX
with the provisions of 21 CFR 70.25 of this chapter.
21 CFR 345
87.134 Paprika—The color additive, paprika, may be safely used in the
(a) Identity.
(1) The color additive paprika is the ground dried pod of mild capsicum
(Capsicum annuum L.). The definition of paprika in this paragraph is for
the purpose of identity as a color additive only and shall not be construed
as setting forth an official standard for paprika under section 401 of the
Federal Food, Drug, and Cosmetic Act.

(2) Color additive mixtures made with paprika may contain as diluents only
those substances listed in part 73.1 of Title 21 of the Code of Federal
for coloring foods.
Paprika may be safely used for the coloring of foods generally, in amounts
(c) Labeling.
with the provisions of 21 CFR 70.25 of this chapter.
21 CFR 340
87.136 Paracoccus Pigment—The color additive, paracoccus pigment, may be
safely used in the manufacture of salmonid fish feed in accordance with the following
(a) Identity.
(1) The color additive paracoccus pigment consists of the heat-killed, dried
cells of a nonpathogenic and nontoxicogenic strain of the bacterium
Paracoccus carotinifaciens and may contain added calcium carbonate to
adjust the astaxanthin level.
(2) Color additive mixtures for fish feed use made with paracoccus pigment
may contain only those diluents that are suitable and are listed in part 73.1
(b) Specifications.
Paracoccus pigment shall conform to the following specifications and shall be
free from impurities, other than those named, to the extent that such impurities
may be avoided by good manufacturing practice:
(1) Physical state, solid.
(2) Lead (as Pb), not more than 5 milligrams per kilogram (mg/kg) [5 parts
per million (ppm)].
(3) Arsenic (as As), not more than 2 mg/kg (2 ppm).
(4) Mercury (as Hg), not more than 1 mg/kg (1 ppm).
(5) Heavy metals, not more than 10 mg/kg (10 ppm).
(6) Astaxanthin, not less than 1.75%.
Paracoccus pigment may be safely used in the feed of salmonid fish in
(2) The quantity of astaxanthin in finished feed, from paracoccus pigment
when used alone or in combination with other astaxanthin color additive
sources listed in 21 CFR 73, shall not exceed 80 mg/kg (72 grams per ton)
of finished feed.


definition.
CFR 501.4.
feeds containing paracoccus pigment shall be declared in accordance with
21 CFR 101.22(b), (c), and (k)(2), and 101.100(a)(2).
21 CFR 352
87.138 Riboflavin—The color additive, riboflavin, may be safely used in the
(a) Identity.
(1) The color additive riboflavin is the riboflavin defined in the Food
Chemicals Codex, third edition (1981), pp. 262 to 263, which is
incorporated by reference. Copies may be obtained from the National
Academy Press, 2101 Constitution Ave. NW, Washington, DC 20418,
or at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call (202) 741-
6030, or go to http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.
(2) Color additive mixtures made with riboflavin may contain as diluents
Regulations (21 CFR 73.1) as safe and suitable for use in color additive
(b) Specifications.
Riboflavin shall meet the specifications given in the Food Chemicals Codex,
third edition (1981), which is incorporated by reference. The availability of this
CHAPTER SIX
incorporation by reference is given in paragraph (a)(1) of this definition.

Riboflavin may be safely used for the coloring of foods generally, in amounts
(d) Labeling.
The label of the color additive shall conform to the requirements of 21 CFR
70.25.
21 CFR 73.450

87.140 Saffron—The color additive, saffron, may be safely used in the manufacture
of animal foods in accordance with the following prescribed conditions:
(a) Identity.
(1) The color additive saffron is the dried stigma of Crocus sativus L. The
definition of saffron in this paragraph is for the purpose of identity as a
color additive only, and shall not be construed as setting forth an official
standard for saffron under section 401 of the Federal Food, Drug, and
Cosmetic Act.
(2) Color additive mixtures made with saffron may contain as diluents only
for coloring foods.
Saffron may be safely used for the coloring of foods generally, in amounts
(c) Labeling.
required by the act, labeling in accordance with the provisions of 21 CFR
70.25.
21 CFR 73.500
87.142 Synthetic Iron Oxide—The color additive, synthetic iron oxide, may be
safely used in the manufacture of dog and cat foods in accordance with the following
(a) Identity.
(1) The color additive synthetic iron oxide consists of any one or any
combination of synthetically prepared iron oxides, including the hydrated
forms. It is free from admixture with other substances.
(2) Color additive mixtures for food use made with synthetic iron oxide may
contain only those diluents that are suitable and that are listed in this part
73.1 of Title 21 of the Code of Federal Regulations (21 CFR 73.1) as safe
for use in color additive mixtures for coloring foods.
(b) Specifications.
Synthetic iron oxide for dog and cat food use shall conform to the following
specifications:
Mercury (as Hg), not more than 3 parts per million.
Synthetic iron oxide may be safely used for the coloring of dog and cat foods in
an amount not exceeding 0.25% by weight of the finished food.
The label of the color additive and any mixture prepared therefrom intended
CFR 70.25.


21 CFR 73.200
87.144 Tagetes (Aztec Marigold) Extract—The color additive, tagetes (Aztec
marigold) extract, may be safely used in the manufacture of chicken feed in accordance
with the following prescribed conditions:
(a) Identity.
The color additive tagetes (Aztec marigold) extract is a hexane extract of the
flower petals of the Aztec marigold (Tagetes erecta L.). It is mixed with an
edible vegetable oil, or with an edible vegetable oil and a hydrogenated edible
vegetable oil, and not more than 0.3% ethoxyquin. It may also be mixed with
soy flour or corn meal as a carrier.
(b) Specifications.
Tagetes (Aztec marigold) extract shall be prepared from tagetes (Aztec
marigold) petals free from admixture with other plant material from Tagetes
erecta L. or from plant material or flowers of any other species of plants and
shall conform to the following additional specifications:
Melting point, 53.5–55.0°C.
Iodine value, 132–145.
Saponification value, 175–200.
Acid value, 0.60–1.20.
Titer, 35.5–37.0°C.
Unsaponifiable matter, 23–27%.
Hexane residue, not more than 25 parts per million.
All determinations, except the hexane residue, shall be made on the initial
extract of the flower petals (after drying in a vacuum oven at 60°C for 24 hours)
prior to the addition of the oils and ethoxyquin. The hexane determination
shall be made on the color additive after the addition of the vegetable oils,
hydrogenated vegetable oils, and ethoxyquin.
The color additive tagetes (Aztec marigold) extract may be safely used in
chicken feed in accordance with the following prescribed conditions:
eggs.
CHAPTER SIX
finished feed
paragraph (c)(1) of this definition; and
in addition to the information required 21 CFR 70.25:
(1) A statement of the concentrations of xanthophyll and ethoxyquin
contained therein.
(2) Adequate directions to provide a final product complying with the
limitations prescribed in paragraph (c) of this definition.


21 CFR 73.295
87.145 Tagetes (Aztec Marigold) Meal—The color additive, tagetes (Aztec
marigold) meal, may be safely used in the manufacture of chicken feed in accordance
with the following prescribed conditions:
(a) Identity.
The color additive tagetes (Aztec marigold) meal is the dried, ground flower
petals of the Aztec marigold (Tagetes erecta L.) mixed with not more than 0.3%
ethoxyquin.
(b) Specifications.
Tagetes (Aztec marigold) meal is free from admixture with other plant material
from Tagetes erecta L. or from plant material or flowers of any other species of
plants.
The color additive tagetes (Aztec marigold) meal may be safely used in chicken
feed in accordance with the following prescribed conditions:
eggs.
finished feed
paragraph (c)(1) of this definition; and
in addition to the information required 21 CFR 70.25:
(1) A statement of the concentrations of xanthophyll and ethoxyquin
contained therein.
(2) Adequate directions to provide a final product complying with the
limitations prescribed in paragraph (c) of this definition.
21 CFR 73.295
87.146 Titanium Dioxide—The color additive, titanium dioxide, may be safely
conditions:
(a) Identity.
(1) The color additive titanium dioxide is synthetically prepared TiO2, free
from admixture with other substances.
(2) Color additive mixtures for food use made with titanium dioxide may
contain only those diluents that are suitable and that are listed in part
73.1 of Title 21 of the Code of Federal Regulations (21 CFR 73.1) as safe
in color additive mixtures for coloring foods, and the following: silicon

dioxide, SiO2, and/or aluminum oxide, Al2O3, as dispersing aids—not

more than 2% total.
(b) Specifications.
Titanium dioxide shall conform to the following specifications:
Antimony (as Sb), not more than 2 parts per million.
Loss on ignition at 800°C (after drying for 3 hours at 105°C), not more
than 0.5%.
Water-soluble substances, not more than 0.3%.
Acid-soluble substances, not more than 0.5%.
TiO2, not less than 99.0% after drying for 3 hours at 105°C.
Lead, arsenic, and antimony shall be determined in the solution obtained
by boiling 10 grams of the titanium dioxide for 15 minutes in 50 milliliters
of 0.5N hydrochloric acid.
The color additive titanium dioxide may be safely used for coloring foods
generally, subject to the following restrictions:
(1) The quantity of titanium dioxide does not exceed 1% by weight of the
food.
(2) It may not be used to color foods for which standards of identity have been
promulgated under section 401 of the Federal Food, Drug, and Cosmetic
Act unless added color is authorized by such standards.
(d) Labeling.
The label of the color additive and any mixtures intended solely or in part for
CFR 70.25.
21 CFR 73.575
87.148 Toasted Partially Defatted Cooked Cottonseed Flour—The color additive,
toasted partially defatted cooked cottonseed flour, may be safely used in the manufacture
of animal foods in accordance with the following prescribed conditions:
CHAPTER SIX
(a) Identity.
(1) The color additive toasted partially defatted cooked cottonseed flour is
a product prepared as follows: Food quality cottonseed is delinted and
decorticated; the meats are screened, aspirated, and rolled; moisture is
adjusted, the meats heated, and the oil expressed; the cooked meats are
cooled, ground, and reheated to obtain a product varying in shade from
light to dark brown.
(2) Color additive mixtures for food use made with toasted partially defatted
cooked cottonseed flour may contain only diluents that are suitable
and that are listed in this part 73.1 of Title 21 of the Code of Federal
Regulations (21 CFR 73.1) as safe in color additive mixtures for coloring
foods.
(b) Specifications.
Toasted partially defatted cooked cottonseed flour shall conform to the
following specifications:

Arsenic (as As): It contains no added arsenic compound and therefore may
not exceed a maximum natural background level of 0.2 part per million
total arsenic, calculated as As.
Free gossypol content, not more than 450 parts per million.
The color additive toasted partially defatted cooked cottonseed flour may be
safely used for coloring foods generally, in amounts consistent with good
manufacturing practice, except that it may not be used to color foods for which
standards of identity have been promulgated under section 401 of the Federal
Food, Drug, and Cosmetic Act, unless added color is authorized by such
standards.
(d) Labeling.
21 CFR 73.140
87.150 Tomato Lycopene Concentrate—The color additive, tomato lycopene
concentrate, may be safely used in the manufacture of animal foods in accordance with
(a) Identity.
(1) The color additive tomato lycopene concentrate is a powder prepared from
tomato lycopene extract by removing most of the tomato lipids with ethyl
acetate and then evaporating off the solvent.
(2) Color additive mixtures made with tomato lycopene concentrate may
contain only those diluents listed in part 73.1 of Title 21 of the Code of
Federal Regulations (21 CFR 73.1) as safe and suitable for use in color
additive mixtures for coloring food.
(b) Specifications.
Tomato lycopene concentrate shall conform to the following specifications:
Lycopene, not less than 60% of oleoresin as determined by the method entitled
“Qualitative Analysis of Lycopene, Its Isomers and Other Carotenoids in
Different Concentrations of Lyc-O-Mato® (Tomato Oleoresin) and in Tomato
Pulp by High Performance Liquid Chromatography (HPLC),” S.O.P. number:
Lab/119/01, Revision 01, dated May 30, 2001, published by LycoRed Natural
Products Industries, which is incorporated by reference, or an equivalent
method. The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. You may obtain a copy of the method from the Center for Food Safety
and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740. You may inspect a copy at the Center
for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch Pkwy.,
College Park, MD, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA, call
(202) 741-6030, or go to http://www.archives.gov/federal_register/code_of_
Tomato lycopene concentrate may be safely used for coloring foods generally

in amounts consistent with good manufacturing practice, except that they may
not be used to color foods for which standards of identity have been issued
(d) Labeling.
70.25.
21 CFR 73.585
87.152 Tomato Lycopene Extract—The color additive, tomato lycopene extract,
may be safely used in the manufacture of animal foods in accordance with the following
(a) Identity.
(1) The color additive tomato lycopene extract is a red to dark brown viscous
oleoresin extracted with ethyl acetate from tomato pulp followed by
removal of the solvent by evaporation. The pulp is produced from fresh,
edible varieties of the tomato by removing the liquid. The main coloring
component is lycopene.
(2) Color additive mixtures made with tomato lycopene extract may contain
only those diluents listed in part 73.1 of Title 21 of the Code of Federal
Regulations (21 CFR 73.1) as safe and suitable for use in color additive
mixtures for coloring food.
(b) Specifications.
Tomato lycopene extract shall conform to the following specification:
Lycopene, not less than 5.5% of oleoresin as determined by the method entitled
“Qualitative Analysis of Lycopene, Its Isomers and Other Carotenoids in
Different Concentrations of Lyc-O-Mato® (Tomato Oleoresin) and in Tomato
Pulp by High Performance Liquid Chromatography (HPLC),” S.O.P. number:
Lab/119/01, Revision 01, dated May 30, 2001, published by LycoRed Natural
Products Industries, which is incorporated by reference, or an equivalent
method. The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. You may obtain a copy of the method from the Center for Food Safety
CHAPTER SIX
and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740. You may inspect a copy at the Center
for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch Pkwy.,
College Park, MD, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA, call
(202)741-6030, or go to http://www.archives.gov/federal_register/code_of_
Tomato lycopene extract may be safely used for coloring foods generally in
amounts consistent with good manufacturing practice, except that they may not
be used to color foods for which standards of identity have been issued under
(d) Labeling.
70.25.


21 CFR 73.585
87.154 Turmeric Oleoresin—The color additive, turmeric oleoresin, may be safely
conditions:
(a) Identity.
(1) The color additive turmeric oleoresin is the combination of flavor and
color principles obtained from turmeric (Curcuma longa L.) by extraction
using any one or a combination of the following solvents: acetone,
isopropyl alcohol, ethyl alcohol methyl alcohol, ethylene dichloride,
methylene chloride, hexane, and trichloroethylene.
The definition of turmeric oleoresin in this paragraph is for the purpose of
identity as a color additive only, and shall not be construed as setting forth
an official standard for turmeric oleoresin under section 401 of the Federal
(2) Color additive mixtures made with turmeric oleoresin may contain as
diluents only those substances listed in part 73.1 of Title 21 of the Code of
(b) Specifications.
Turmeric oleoresin shall contain no more residue of the solvents listed under
paragraph (a)(1) of this definition than is permitted for the corresponding
solvents in spice oleoresins under applicable food additive regulation in 21
CFR parts 170 through 189.
Turmeric oleoresin may be safely used for the coloring of foods generally, in
(d) Labeling.
70.25.
21 CFR 73.615
87.155 Turmeric—The color additive, turmeric, may be safely used in the
(a) Identity.
(1) The color additive turmeric is the ground rhizome of Curcuma longa L.
The definition of turmeric in this paragraph is for the purpose of identity as
a color additive only, and shall not be construed as setting forth an official
standard for turmeric under section 401 of the Federal Food, Drug, and
Cosmetic Act.

(2) Color additive mixtures made with turmeric may contain as diluents only
for coloring foods.
Turmeric may be safely used for the coloring of foods generally, in amounts
(c) Labeling.
70.25.
21 CFR 73.600
87.156 Ultramarine Blue—The color additive, ultramarine blue, may be safely
used to color salt intended for animal foods in accordance with the following prescribed
conditions:
(a) Identity.
The color additive ultramarine blue is a blue pigment obtained by calcining a
mixture of kaolin, sulfur, sodium carbonate, and carbon at temperatures above
700°C. Sodium sulfate and silica may also be incorporated in the mixture in
order to vary the shade. The pigment is a complex sodium aluminum sulfo-
silicate having the approximate formula Na7Ai6Si6O24S3.
(b) Specifications.
Ultramarine blue shall conform to the following specifications:
The color additive ultramarine blue may be safely used for coloring salt
CHAPTER SIX
intended for animal feed subject to the restriction that the quantity of
ultramarine blue does not exceed 0.5% by weight of the salt.
The color additive shall be labeled in accordance with the requirements of part
70.25 of Title 21 of the Code of Federal Regulations (21 CFR 70.25).
21 CFR 73.50
87.158 Vegetable Juice—The color additive, vegetable juice, may be safely used in
the manufacture of animal foods in accordance with the following prescribed conditions:
(a) Identity.
(1) The color additive vegetable juice is prepared either by expressing the
juice from mature varieties of fresh, edible vegetables, or by the water
infusion of the dried vegetable. The color additive may be concentrated or

dried. The definition of vegetable juice in this paragraph is for the purpose
of identity as a color additive only, and shall not be construed as a standard
of identity under section 401 of the Federal Food, Drug, and Cosmetic
Act. However, where a standard of identity for a particular vegetable juice
has been promulgated under section 401 of the Federal Food, Drug, and
Cosmetic Act, it shall conform to such standard.
(2) Color additive mixtures made with vegetable juice may contain as diluents
for coloring foods.
Vegetable juice may be safely used for the coloring of foods generally, in
(c) Labeling.
with the provisions of 21 CFR 70.25.
21 CFR 73.260
87.160 β-Apo-8′-Carotenal—The color additive, β-apo-8′-carotenal, may be safely
conditions:
(a) Identity.
(1) The color additive is β-apo-8′-carotenal.
(2) Color additive mixtures for food use made with β-apo-8′-carotenal may
(b) Specifications.
β-Apo-8′-carotenal shall conform to the following specifications:
1% solution in chloroform, clear.
Melting point (decomposition), 136–140°C (corrected).
Loss of weight on drying, not more than 0.2%.
Assay (spectrophotometric), 96–101%.
The color additive β-apo-8′-carotenal may be safely used for coloring foods
generally, subject to the following restrictions:
(1) The quantity of β-apo-8′-carotenal does not exceed 15 milligrams per
pound of solid or semisolid food or 15 milligrams per pint of liquid food.

(2) It may not be used to color foods for which standards of identity have been
promulgated under section 401 of the Federal Food, Drug, and Cosmetic
Act unless added color is authorized by such standards.
(d) Labeling.
21 CFR 73.90
87.164 β-Carotene—The color additive, β-carotene, may be safely used in the
(a) Identity.
(1) The color additive is β-carotene prepared synthetically or obtained from
natural sources.
(2) Color additive mixtures for food use made with β-carotene may contain
only diluents that are suitable and that are listed in part 73.1 of Title 21 of
the Code of Federal Regulations (21 CFR 73.1) as safe in color additive
(b) Specifications.
β-Carotene shall conform to the following specifications:
1% solution in chloroform, clear.
Loss of weight on drying, not more than 0.2%.
Assay (spectrophotometric), 96–101%.
The color additive β-carotene may be safely used for coloring foods generally,
in amounts consistent with good manufacturing practice, except that it may
not be used to color those foods for which standards of identity have been
promulgated under section 401 of the Federal Food, Drug, and Cosmetic Act
unless added color is authorized by such standards.
CHAPTER SIX
(d) Labeling.
21 CFR 73.95
Tentative
T87.50 Cashew Nut Shell Extract is the mechanical cold-pressed liquid from
cashew nut shells to be used as a flavor additive in cattle feeds in amounts not to
exceed 500 ppm in complete feed. The liquid ingredient must contain not less than 59%
anacardic acid, not less than 18% cardol, and not more than 3% moisture. Minimum
percent anacardic acid must be guaranteed. (Proposed 2019)

90. Vitamins
Investigator and Section Editor—Tom Phillips, MD
Official
90.1 Cod Liver Oil is the oil obtained from the livers of gadus morrhuae or other
species of the family gadidae, either or both. It must contain not less than 385,900
International Units of vitamin A per pound (850 units per gram) and not less than 29,510
International Chick Units of vitamin D per pound (65 units per gram). (Adopted 1937,
Amended 1945, 1950, 1973, 1995, 1996)
IFN 7-01-993 Fish cod liver oil
90.2 Cod Liver Oil with Added Vitamins A and D is the product consisting of cod
liver oil to which has been added vitamins A and D. The product must contain not less
than 136,000 International Chick Units of vitamin D per pound (300 per gram). (Adopted
1948, Amended 1950, 1964, 1967)
IFN 7-08-047 Fish cod liver oil vitamins A and D added
90.3 Vitamin A Oil is an oil of animal or vegetable origin with or without vitamin A
supplementation for which vitamin A potency is claimed. (Adopted 1944, Amended 1945,
1959, 1964, 1967)
IFN 7-05-141 Vitamin A oil
90.4 Vitamin D2 Supplement is a feeding material used for its vitamin D2 activity.
It must contain a minimum of 100,000 International Units of vitamin D2 per pound.
(Adopted 1956, Amended 1973, 1995, 1996)
IFN 7-05-149 Vitamin D2 supplement
90.5 Vitamin D Oil is an oil of animal or vegetable origin with or without vitamin
D supplementation for which vitamin D potency is claimed. (Adopted 1944, Amended
1945, 1959, 1964, 1967)
IFN 7-05-147 Vitamin D oil
90.6 Vitamin A and D Oil is an oil of animal or vegetable origin with or without
vitamins A and D supplementation for which vitamin potencies are claimed. (Adopted
1944, Amended 1945, 1950, 1959, 1964, 1967)
IFN 7-05-145 Vitamin A and D oil
90.7 Cholecalciferol (D-Activated Animal Sterol) is obtained by activation
of a sterol fraction of animal origin with ultra-violet light or other means. For label
identification it may be followed with the parenthetical phrase (Source of Vitamin D3).
(Adopted 1942, Amended 1993.)
IFN 7-00-408 Animal sterol irradiated
90.8 Ergocalciferol (D-Activated Plant Sterol) is obtained by activation of a sterol
fraction of plant origin with ultra-violet light or other means. For label identification it
may be followed with the parenthetical phrase (Source of Vitamin D2). (Adopted 1944,
Amended 1993)
IFN 7-03-728 Plant sterol irradiated
90.9 25-hydroxyvitamin D3—The food additive 25-hydroxyvitamin D3 may be
safely used in accordance with the following prescribed conditions:
(a) The additive is used or intended for use as a source of vitamin D3 activity in
animal feed or drinking water in accordance with good manufacturing and
feeding practices as follows:
(1) In feed or drinking water of chickens not to exceed 69 parts per billion
(ppb) in feed or 34.5 ppb in drinking water.
(2) In feed or drinking water of turkeys not to exceed:
(i) 92 ppb in feed; or

(ii) in drinking water, 25 ppb for turkeys up to 3 weeks of age, 36 ppb

for turkeys from 4 to 11 weeks of age, or 45 ppb for turkeys over 11
weeks of age.
(b) The additive consists of not less than 94% 25-hydroxyvitamin D3
(9,10-secocholesta-5,7,10(19)-triene-3β, 25-diol).
(1) Not more than 1% of any individual sterol.
(2) Not more than 5% water.
(3) Not more than 20 parts per million (ppm) lead.
(4) Not more than 20 ppm aluminum.
(5) Not more than 1.0% solvents and non-detectable levels of 2', 4', 5', 7'
tetraiodofluorescin.
(6) Not more than 1 ppb 1,25-dihydroxycholecalciferol.
by the Federal Food, Drug, and Cosmetic Act, the label and labeling shall
contain:
(2) A statement to indicate the maximum use level of 25-hydroxyvitamin D3
must not exceed 69 ppb in feed or 34.5 ppb in drinking water for chickens.
(3) A statement to indicate for turkeys the maximum use level of
25-hydroxyvitamin D3 must not exceed 92 ppb in feed; or in drinking
water, 25 ppb for turkeys up to 3 weeks of age, 36 ppb for turkeys from 4
to 11 weeks of age, or 45 ppb for turkeys over 11 weeks of age.
(4) Adequate use directions to ensure that 25-hydroxyvitamin D3 (and all
premixes) is uniformly blended throughout the feed or drinking water.
(5) An expiration date on all premix labeling.
(6) A statement on all premix labeling (feed and drinking water forms) that
25-hydroxyvitamin D3 cannot be used simultaneously in both feed and
water.
21 CFR 573.550, 584.725 (Adopted 2019 rev. 1)
90.11 Vitamin B12 Supplement is a feeding material used for its vitamin B12
activity. It must contain a minimum vitamin B12 activity of 1.5 milligrams per pound.
The term must not be applied to products for which there are accepted names and
definitions. (Adopted 1952)
IFN 7-05-146 Vitamin B12 supplement
90.12 Vitamin E Supplement is a feeding material used for its vitamin E activity. It
CHAPTER SIX
must contain a minimum vitamin E activity equal to 10,000 International Units of vitamin
E per pound. (Adopted 1953, Amended 1967)
IFN 7-05-150 Vitamin E supplement
90.13 Riboflavin Supplement is a feeding material used chiefly for its riboflavin
content, and must contain not less than 1,000 milligrams of riboflavin per pound.
The label must bear a parenthetical statement of origin immediately following this
declaration. (Adopted 1957)
IFN 7-03-921 Riboflavin supplement
90.14 Vitamin A Supplement is a feeding material used for its vitamin A content.
It must contain a minimum of two million International Units of vitamin A per pound.
The label must bear a statement of the source of vitamin A and a minimum guarantee of
International Units of vitamin A per pound with additional permissive International Units
of vitamin A per gram. (Proposed 1959, Adopted 1960, Amended 1973, 1995, 1996)
IFN 7-05-144 Vitamin A supplement

90.15 Vitamin D3 Supplement is a feeding material used for its vitamin D3 activity.
It must contain a minimum of 100,000 International Chick Units of vitamin D3 per
pound. (Proposed 1966)
IFN 7-05-699 Vitamin D3 supplement
90.16 Niacin Supplement is a term that may be used in the ingredient list on a feed
label of a mixed feed to indicate the addition of either Niacin or Niacinamide. Sources
containing only Niacin or Niacinamide must state the source of Niacin on their label.
IFN 7-26-003 Niacin supplement
90.17 Betaine (hydrochloride or anhydrous) is the crystalline chloride of betaine
or anhydrous betaine; a partial replacement for choline. (Proposed 1990, Adopted 1991)
IFN 7-00-722 Betaine hydrochloride
90.25 Additional Officially Recognized Vitamin Ingredients for Animal Feed Use at
Nutritional Levels and in Conformity with Current Good Manufacturing Practices
Status Under Food
Article or Substance Additive Amendments
Recognized English Name Indicated 21 CFR
25-Hydroxyvitamin D3 Source of vitamin D3 activity Reg. 584.725, only for
25-hydroxyvitamin D3 broiler chickens up
commercial feed grade to 69 parts per billion
(ppb) in feed or up to
34.5 ppb in drinking
water
Ascorbic acid Crystalline ascorbic acid Reg. 582.5013
IFN 7-00-433 commercial feed grade (GRASa)
L-Ascorbyl-2-polyphosphate Stabilized ascorbic acid feed
grade
L-Ascorbyl-2-sulfate Stabilized ascorbic acid feed Aquatic species
grade (salmon, trout, catfish,
shrimp, and tilapia)
Biotin Biotin—commercial feed Reg. 582.5159 (GRAS)
IFN 7-00-723 grade
Calcium ascorbate Commercial grade Vitamin C activity
in dry feeds (<13%
moisture) only
Calcium L-ascorbyl-2- Stabilized ascorbic acid
monophosphate feed grade, may be used in the
feed of any species provided
that it is not promoted for
species that do not have
a dietary requirement for
vitamin C
Calcium pantothenate Crystalline calcium Reg. 582.5212 (GRAS)
IFN 7-07-079 pantothenate—commercial
feed grade
(continued)

Status Under Food

Carotene The refined crystalline Reg. 582.5245 (GRAS)
IFN 7-01-134 carotene fraction of plants
Choline chloride Choline chloride— Reg. 582.5252 (GRAS)
IFN 7-01-228 commercial feed grade
Choline pantothenate Crystalline choline
IFN 7-01-229 pantothenate—commercial
feed grade
Choline xanthate Choline xanthate— Reg. 573.300
Erythorbic acid Either the acid or the sodium Reg. 582.3041
(Iso ascorbic acid) salt
IFN 7-09-823
Folic acid Crystalline folic acid—
Herring oil The oil extracted from whole
IFN 7-08-048 parts of herring
Inositol Vitamin B complex vitamin; Reg. 582.5370 (GRAS)
IFN 7-09-354 lipotropic, chemical name—
cyclohexandehexol. Also
referred to as i-inostol or
meso-inositol.
Magnesium L-ascorbyl-2- Stablized ascorbic acid Fish feeds only
phosphate
Menadione Crystalline menadione— Poultry 2 to 4 g/ton
commercial feed grade
Menadione Crystalline menadione— Reg. 573.620
dimethylpyrimidinol dimethylpyrimidinol Chicken and turkey
bisulfite bisulfite—commercial feed feeds at 2 g/ton
IFN 7-08-102 grade Growing and finishing
CHAPTER SIX
swine feeds at 10 g/ton

21 CFR 573.620
Menadione nicotinamide Source of vitamin K activity Chicken and turkey
bisulfite and supplemental niacin feeds at 2 g/ton
Growing and finishing
swine feeds at 10 g/ton
21 CFR 573.625
Menadione sodium bisulfite The addition product of Poultry
complex menadione and sodium 2 to 4 g/ton
IFN 7-03-078 bisulfite containing not less
than 30% of menadione
Menhaden oil The oil extracted from whole
IFN 7-08-049 menhaden
(continued)

Status Under Food

Niacin; nicotinic acid Crystalline nicotine acid— Reg. 582.5530 (GRAS)
Niacinamide; nicotinamide Crystalline amide of nicotinic Reg. 582.5535 (GRAS)
IFN 7-03-215 acid—commercial feed grade
p-Aminobenzoic acid p-Aminobenzoic acid—
Pyridoxine hydrochloride Crystalline chloride of Reg. 582.5676 (GRAS)
IFN 7-03-822 pyridoxine—commercial feed
grade
Riboflavin Crystalline riboflavin— Reg. 582.5695 (GRAS)
Salmon oil The oil extracted from
IFN 7-08-050 cannery refuse of salmon
Salmon liver oil The oil extracted from salmon
IFN 7-02-013 livers
Sardine oil The oil extracted from
IFN 7-02-016 cannery refuse of the packing
of sardine
Shark liver oil The oil extracted from shark
IFN 7-02-019 liver
Thiamine hydrochloride Crystalline chloride of Reg. 582.5875 (GRAS)
IFN 7-04-828 thiamine—commercial feed
grade
Thiamine mononitrate Crystalline mononitrate of Reg. 582.5878 (GRAS)
IFN 7-04-829 thiamine—commercial feed
grade
Tocopherol a-Tocopherol—commercial Reg. 582.5890 (GRAS)
IFN 7-00-001 feed grade
a-Tocopherol acetate Commercial feed grade dl-a- Reg. 582.5892 (GRAS)
IFN 7-18-777 tocopheryl acetate
d-a-tocopheryl acetate
Tuna oil The oil extracted from
IFN 7-02-024 cannery refuse of tuna
Vitamin A acetate Vitamin A acetate— Reg. 582.5933 (GRAS)
Vitamin A palmitate Vitamin A palmitate— Reg. 582.5936 (GRAS)
Vitamin A propionate Consists of retinol or esters
IFN 7-26-311 of retinol formed from edible
fatty acids
Wheat germ oil The oil extracted or expressed
IFN 7-05-207 from wheat germ

aGRAS = abbreviation for the phrase “generally recognized as safe” by experts qualified
to evaluate the safety of the substance for its intended use.
90.26 Source of Vitamins and Their Levels

Vitamin/Vitaminc
Vitamin Compounda Vitaminb Compound
L-Ascorbyl-2-polyphosphate Ascorbic acid 0.800
Menadione dimethylpyrimidinol bisulfite Menadione 0.454
Menadione sodium bisulfite complex Menadione 0.330
Riboflavin-5-phosphate Riboflavin 0.730
d-Calcium pantothenate d-Pantothenic acid 0.920
Thiamine hydrochloride Thiamine 0.892
Thiamine mononitrate Thiamine 0.919
Pyridoxine hydrochloride Vitamin B6 0.823
Choline chloride Choline 0.746
Choline bitartrate Choline 0.469
Ferric choline citrate Choline 0.330
Sodium ascorbate Ascorbic acid 0.889
aTerm to be used in ingredient statement when declaring fortification, Model Bill, Section
5.
bTerm to be used in guaranteed analysis statement when guaranteeing the level of the
vitamin, Model Regulation 4(c).
cThe ratio is based on molecular weights and may not be proportional to biological
activity. (Adopted 1991, Amended 2007)
93. Wheat Products

Investigator and Section Editor—vacant
Official
93.1 Wheat Bran is the coarse outer covering of the wheat kernel as separated from
cleaned and scoured wheat in the usual process of commercial milling. (Adopted prior to
1928)
IFN 4-05-190 Wheat bran
CHAPTER SIX
93.2 Wheat Flour consists principally of wheat flour together with fine particles of
wheat bran, wheat germ, and the offal from the “tail of the mill.” This product must be
obtained in the usual process of commercial milling and must contain not more than 1.5%
crude fiber. (Adopted 1949)
IFN 4-05-199 Wheat flour less than 1.5% fiber
93.3 Wheat Germ Meal consists chiefly of wheat germ together with some bran
and middlings or shorts. It must contain not less than 25% crude protein and 7% crude
fat. (Adopted 1949, Amended 1953)
IFN 5-05-218 Wheat germs ground
93.4 Wheat Mill Run consists of coarse wheat bran, fine particles of wheat bran,
wheat shorts, wheat germ, wheat flour, and the offal from the “tail of the mill.” This
product must be obtained in the usual process of commercial milling and must contain
not more than 9.5% crude fiber. (Proposed 1959, Adopted 1960)
IFN 4-05-206 Wheat mill run less than 9.5% fiber

93.5 Wheat Middlings consists of fine particles of wheat bran, wheat shorts, wheat
germ, wheat flour, and some of the offal from the “tail of the mill.” This product must be
obtained in the usual process of commercial milling and must contain not more than 11%
crude fiber. (Proposed 1959, Adopted 1960, Amended 2017 rev. 1)
IFN 4-05-205 Wheat flour by-product less than 9.5% fiber
93.6 Wheat Shorts consists of fine particles of wheat bran, wheat germ, wheat
flour, and the offal from the “tail of the mill.” This product must be obtained in the usual
process of commercial milling and must contain not more than 7% crude fiber. (Proposed
1959, Adopted 1960)
IFN 4-05-201 Wheat flour by-product less than 7% fiber
93.7 Wheat Red Dog consists of the offal from the “tail of the mill” together with
some fine particles of wheat bran, wheat germ, and wheat flour. This product must be
obtained in the usual process of commercial milling and must contain not more than 4%
crude fiber. (Proposed 1959, Adopted 1960)
IFN 4-05-203 Wheat flour by-product less than 4% fiber
93.8 Defatted Wheat Germ Meal is obtained after the removal of part of the oil or
fat from wheat germ meal and must contain not less than 30% crude protein. (Proposed
IFN 5-05-217 Wheat germs meal mechanical extracted
NOTE: When “Ground Wheat Screenings” are added to any wheat product such
screenings added must be limited to ground wheat screenings not exceeding the run of the
mill; and screenings from outside sources must not be added. The declaration of “ground
wheat screenings” must be made in the name and in the same size type as the product
name itself; i.e., “Wheat Bran with Ground Wheat Screenings,” “Wheat Shorts with
Ground Wheat Screenings.”
93.9 _______Wheat Gluten is the major water-insoluble proteinaceous fraction of
wheat, consisting primarily of gliadin and glutenin proteins. Wheat gluten is prepared
from wheat flour that is free from other seeds and foreign matter, by washing with water
to remove most of the water-soluble non-protein components. Vital Wheat Gluten is dried
gluten that has retained its viscoelasticity when hydrated, whereas Devitalized Wheat
Gluten has reduced viscoelasticity as a result of denaturation by heat. Moisture content
shall not exceed 10%. Wheat gluten, on a moisture-free basis, must contain not less than
80% crude protein (crude protein based on N × 6.25), and not more than 1.5% crude fiber
and 2.0% ash. (For identification of the viscoelastic properties on the ingredient label,
“vital” or “devitalized” must be specified.) The words “vital” or “devitalized” are not
2017 rev. 1)
96. Yeast
Investigator and Section Editor—Darrell Johnson, KY
Official
96.1 Primary Dried Yeast or Dried Yeast is the dried, non-fermentative yeast of
the botanical classification Saccharomyces which has been separated from the medium in
which propagated. It must consist of yeast cells with no fillers and contain not less than
40% crude protein. (Adopted 1955, Amended 1993, Adopted 1997)
IFN 7-05-533 Yeast primary dehydrated
96.2 Active Dry Yeast is yeast which has been dried in such a manner as to preserve
a large portion of its fermenting power. It must contain no added cereal or filler and must
contain not less than 15 billion live yeast cells per gram. (Adopted 1951)
IFN 7-05-524 Yeast active dehydrated

96.3 Irradiated Dried Yeast, Irradiated ________ Dried Yeast is the dried, non-
fermentative yeast which has been subjected to ultraviolet rays in order to produce anti-
rachitic potency. (Proposed 1958, Adopted 1959)
IFN 7-05-529 Yeast irradiated dehydrated
NOTE: When Irradiated Dried Yeast or Irradiated ________ Dried Yeast is used as
an ingredient of proprietary feeds for four-footed animals, the name may be followed by a
parenthetical phrase (Source of Vitamin D2). (Adopted 1945, Amended 1959)
96.4 Brewers Dried Yeast is the dried, non-fermentative, non-extracted yeast of the
botanical classification Saccharomyces resulting as a by-product from the brewing of beer
and ale. It must contain not less than 35% crude protein. It must be labeled according to
its crude protein content. (Adopted 1955, Amended 1975, Adopted 1978)
IFN 7-05-527 Yeast brewers dehydrated
96.5 Grain Distillers Dried Yeast is the dried, non-fermentative yeast of the
botanical classification Saccharomyces resulting from the fermentation of grains and
yeast, separated from the mash, either before or after distillation. It must contain not less
than 40% crude protein. (Adopted 1955, Withdrawn 1993, Proposed 2006, Adopted 2009)
96.7 Torula Dried Yeast or Candida Dried Yeast is the dried, non-fermentative
yeast of the botanical classification (torulopsis) Candida utilis (formerly Torulopsis utilis)
which has been separated from the medium in which propagated. It must contain not less
than 40% crude protein. (Adopted 1955, Amended 1993)
IFN 7-05-534 Yeast torula dehydrated
96.8 Yeast Culture* is the dried product composed of yeast (Saccharomyces
cerevisiae and/or Kluyveromyces marxianus) and the media on which it was grown, dried
in such a manner as to preserve the fermenting activity of the yeast. The media must be
stated on the label. (Adopted 1957, Amended 2008)
IFN 7-05-520 Yeast culture dehydrated
*NOTE: No reference to media in main ingredient listing is required when yeast
culture forms a component of a proprietary mixed feed.
96.9 Molasses Yeast Condensed Solubles is obtained by condensing to a syrup
consistency the broth remaining after the removal of baker’s yeast cells propagated on
molasses. (Proposed 1973, Amended 1974)
IFN 5-14-009 Sugarcane molasses yeast solubles condensed
96.10 Brewers Liquid Yeast is the non-fermentative, non-extracted yeast of the
botanical classification Saccharomyces resulting as a by-product from the brewing of
beer and ale. It must contain not less than 35% crude protein on a dry weight basis. The
guaranteed analysis shall include the maximum moisture. (Proposed 1976, Adopted 1978)
CHAPTER SIX
IFN 7-20-878 Yeast brewers liquid

96.11 Yeast Extract is the concentrated solubles of mechanically ruptured cells of a
selected strain of the yeast, Saccharomyces cerevisiae. It may be dried or concentrated. It
must contain not less than 9% crude protein. (Proposed 1998, Amended 2006, Adopted 2010)
96.12 Hydrolyzed Yeast is a concentrated, non-extracted, partially soluble, yeast digest.
Solubilization is accomplished by enzymatic hydrolysis of whole Saccharomyces cerevisiae
cells. Salts may be added as processing aids in accordance with good manufacturing practice.
It must not contain less than 35% crude protein. (Proposed 2007, Adopted 2010)
96.13 Molasses Hydrolyzed Yeast is a concentrated, non-extracted, partially
soluble yeast digest. Yeast cells are sourced from the fermentation of molasses for
ethanol production. Solubilization is accomplished by enzymatic hydrolysis of whole
Saccharomyces cerevisiae cells. Salts may be added as processing aids in accordance
with good manufacturing practices. It must not contain less than 30% crude protein.
96.14 Scheffersomyces stipitis Dried Yeast is the dried, non-viable yeast of the
botanical classification Scheffersomyces stipitis that has been grown on thin stillage from

the ethanol production process from the fermentation of a grain or grain mixture, and
is separated by centrifugation from the media on which it was propagated. The product
is produced in accordance with good manufacturing practices to control the potential
for mycotoxin and other contaminants. The product is intended as a source of protein in
cattle, sheep, goat, and swine feeds at levels up to 15%. It must contain not less than 40%
crude protein. The label shall include guarantees from minimum crude protein and crude
fat and maximum sulfur contents. Non-protein nitrogen content must be guaranteed when
added. (Proposed 2018, Adopted 2019 rev. 1)
99. Withdrawn Ingredients

33.5 Fat Product, Feed Grade, is any fat product that does not meet the definitions
for animal fat, vegetable fat or oil, hydrolyzed fat or fat ester. It must be sold on its
individual specifications, which will include the minimum percentage of total fatty acids,
the maximum percentage of unsaponifiable matter, the maximum percentage of insoluble
impurities, the maximum percentage of free fatty acids and moisture. The above listed
specifications must be guaranteed on the label. If an antioxidant(s) is used, the common
name or names must be indicated, followed by the words “used as a preservative.”
(Proposed 1989, Withdrawn 2016 rev. 1 and replaced with 33.20)
IFN 4-00-414 Animal vegetable fat product
33.19 Hydrogenated Glycerides are obtained by hydrogenation of animal fats
or vegetable oils. Specifications of animal fats or vegetable oils used to produce the
hydrogenated glycerides must meet the requirements stated in AAFCO definition 33.1
(for Animal Fat) and AAFCO definition 33.2 (for Vegetable Fat, or oil), respectively.
The specification for tallow must specify insoluble impurities not more than 0.15% to be
consistent with BSE feed regulation 21 CFR 589.2000 and 589.2001 and a guaranteed
titer above 40°C. The source of the hydrogenated glycerides must be indicated on the
label. The hydrogenated glycerides must contain, and be guaranteed for, not less than
90% total ester content, not more than 0.8% unsaponifiable matter, not more than 0.001%
heavy metals, and not more than 5 of iodine value. The maximum moisture, maximum
insoluble matter, maximum free fatty acids, saponification value, and melting range must
also be guaranteed on the label. If an antioxidant is used, the common name or names
must be indicated on the label, followed by the words “used as a preservative.” (Proposed
2012, Adopted 2015)
Table 87.5 Ball Clay (withdrawn) is not accepted for use as a feed ingredient.
(Removed 1999)
T57.152 Calcium Formate (withdrawn) is the calcium salt of formic acid
generally expressed as Ca(HOCO2)2 and its hydrated forms. It is to be used as a source
of supplemental calcium in swine diets, not to supply more than 0.6% calcium to the
diet. Calcium Formate is currently considered an unapproved food additive, and a food
additive petition must be approved prior to its use in feeds. (Adopted 1993, Amended
1999, Removed 1999)
T57.164 Chromium L-Methionine Complex (withdrawn) is the stable, water-soluble
monohydrochloride complex containing one molar equivalent of chromium (III) and three
molar equivalents of L-methionine generally expressed as (C5H10NO2S)3Cr(III)HCl. It is
not accepted for use as a feed ingredient. (Proposed 2004, Removed 2007, Amended 2010)
T71.25 Rapeseed Meal, Mechanical Extracted.** (withdrawn) Rapeseed meal,
mechanical extracted, obtained by grinding the cake which remains after removal of most
of the oil by mechanical extraction of the seed from the rapeseed plant (Brassica). It must

contain a minimum of 32% protein and a maximum of 12% crude fiber. (Proposed 1970,
Adopted 197, Removed 2011)
IFN 5-03-870 Rape seeds meal mechanical extracted
Charcoal (feed term) (withdrawn). Dark-colored porous forms of carbon made
from the organic parts of vegetable or animal substances, by their incomplete combustion.
(Removed 2010)
CHAPTER SIX
2019 AAFCO Annual First-Time Attendee Regulatory Members: (front row, left to right):
Roxanne Magnus, MO; Ashlee-Rose Ferguson, WA. (back row, left to right) Greg Olson,
LA; Jessica Gore, NC; Samuel Nobo, KS; Justin Lontz, DE; Denver Alsup, MO.

100. CFR Listed Feed Ingredients

Section Editor—David Edwards, FDA
The following list of Least Common Feed Ingredients are listed in the US Code
of Federal Regulations as food additives (21 CFR 573) or generally recognized as safe
(GRAS) ingredients (21 CFR 582).
Please note the ingredients marked with • are also defined elsewhere in the OP.
PART 573—Food Additives Permitted in Feed

and Drinking Water of Animals
Subpart B—Food Additive Listing

573.120 Acrylamide-acrylic acid resin. 573.870 Poly(2-vinylpryidine-co-
573.440 Ethylene dichloride. styrene).
573.530 Hydrogenated corn syrup. 573.880 Normal propyl alcohol.
573.740 Odorless light petroleum 573.1010 Xanthan gum. •
hydrocarbons.
PART 582–—Substances Generally Recognized

as Safe in Animal Feeds
582.80 Trace Minerals Added to Animal Feeds

These substances added to animal feeds as nutritional dietary supplements are
generally recognized as safe when added at levels consistent with good feeding practice.
All substances listed may be in anhydrous or hydrated form.
Element Source compounds Element Source compounds

Cobalt Cobalt acetate • Iron Iron ammonium citrate •
Cobalt carbonate • Iron carbonate •
Cobalt chloride • Iron chloride •
Cobalt oxide • Iron gluconate •
Cobalt sulfate • Iron oxide •
Copper Copper carbonate • Iron phosphate •
Copper chloride • Iron pyrophosphate •
Copper gluconate • Iron sulfate •
Copper hydroxide • Reduced iron •
Copper orthophosphate • Manganese Manganese acetate •
Copper oxide • Manganese carbonate •
Copper pyrophosphate Manganese citrate (soluble) •
Copper sulfate • Manganese chloride •
Iodine Calcium iodate • Manganese gluconate •
Calcium iodobehenate • Manganese orthophosphate •
Cuprous iodide • Manganese phosphate
3,5-Diiodosalicylic acid • (dibasic) •
Ethylenediamine Manganese sulfate •
dihydroiodide • Manganous oxide •
Potassium iodate • Zinc Zinc acetate •
Potassium iodide • Zinc carbonate •
Sodium iodate • Zinc chloride •
Sodium iodide • Zinc oxide •
Thymol iodide • Zinc sulfate •

Subpart B–—General Purpose Food Additives

Section Source compounds Section Source compounds
582.1005 Acetic acid 582.1366 Hydrogen peroxide
582.1009 Adipic acid 582.1400 Lecithin •
582.1033 Citric acid • 582.1425 Magnesium carbonate •
582.1057 Hydrochloric acid 582.1428 Magnesium hydroxide •
582.1061 Lactic acid 582.1431 Magnesium oxide •
582.1069 Malic acid 582.1480 Methylcellulose
582.1073 Phosphoric acid • 582.1500 Monoammonium glutamate
582.1077 Potassium acid tartrate 582.1516 Monopotassium glutamate
582.1087 Sodium acid pyrophosphate 582.1540 Nitrogen
582.1091 Succinic acid 582.1585 Papain •
582.1095 Sulfuric acid 582.1613 Potassium bicarbonate •
582.1099 Tartaric acid 582.1619 Potassium carbonate •
582.1125 Aluminum sulfate • 582.1625 Potassium citrate •
582.1127 Aluminum ammonium sulfate 582.1631 Potassium hydroxide •
582.1129 Aluminum potassium sulfate 582.1643 Potassium sulfate •
582.1131 Aluminum sodium sulfate 582.1655 Propane
582.1135 Ammonium bicarbonate 582.1666 Propylene glycol (not in or on
582.1137 Ammonium carbonate cat food, 21 CFR 589.1001) •
582.1139 Ammonium hydroxide 582.1685 Rennet
582.1141 Ammonium phosphate • 582.1711 Silica aerogel
582.1143 Ammonium sulfate • 582.1721 Sodium acetate
582.1155 Bentonite • 582.1736 Sodium bicarbonate •
582.1165 Butane 582.1742 Sodium carbonate •
582.1191 Calcium carbonate • 582.1745 Sodium carboxymethylcellulose •
582.1193 Calcium chloride • 582.1748 Sodium caseinate
582.1195 Calcium citrate 582.1751 Sodium citrate
582.1199 Calcium gluconate • 582.1763 Sodium hydroxide
582.1205 Calcium hydroxide • 582.1775 Sodium pectinate
582.1207 Calcium lactate 582.1778 Sodium phosphate •
582.1210 Calcium oxide • 582.1781 Sodium aluminum phosphate
582.1217 Calcium phosphate • 582.1792 Sodium sesquicarbonate •
582.1235 Caramel 582.1804 Sodium potassium tartrate
582.1240 Carbon dioxide 582.1810 Sodium tripolyphosphate •
582.1275 Dextrans 582.1901 Triacetin
CHAPTER SIX
582.1320 Glycerin • 582.1973 Beeswax

582.1324 Glyceryl monostearate 582.1975 Bleached beeswax
582.1355 Helium 582.1978 Carnauba wax
Subpart C–—Anticaking Agents

582.2122 Aluminum calcium silicate 582.2729 Hydrated sodium calcium
582.2227 Calcium silicate • aluminosilicate
582.2437 Magnesium silicate 582.2906 Tricalcium silicate
582.2727 Sodium aluminosilicate •

Subpart D–—Chemical Preservatives

582.3013 Ascorbic acid • 582.3616 Potassium bisulfite •
582.3021 Benzoic acid • 582.3637 Potassium metabisulfite •
582.3041 Erythorbic acid • 582.3640 Potassium sorbate •
582.3081 Propionic acid • 582.3660 Propyl gallate •
582.3089 Sorbic acid • 582.3670 Propylparaben •
582.3109 Thiodipropionic acid • 582.3731 Sodium ascorbate •
582.3149 Ascorbyl palmitate • 582.3733 Sodium benzoate •
582.3169 Butylated hydroxyanisole • 582.3739 Sodium bisulfite •
582.3173 Butylated hydroxytoluene • 582.3766 Sodium metabisulfite •
582.3189 Calcium ascorbate • 582.3784 Sodium propionate •
582.3221 Calcium propionate • 582.3795 Sodium sorbate •
582.3225 Calcium sorbate • 582.3798 Sodium sulfite •
582.3280 Dilauryl thiodipropionate • 582.3845 Stannous chloride •
582.3336 Gum guaiac • 582.3862 Sulfur dioxide •
582.3490 Methylparaben • 582.3890 Tocopherols •
Subpart E—Emulsifying Agents

582.4101 Diacetyl tartaric acid esters 582.4521 Monosodium phosphate
of mono- and diglycerides of derivatives of mono- and
edible fats or oils, or edible fat- diglycerides of edible fats or oils,
forming fatty acids • or edible fat-forming fatty acids •
582.4505 Mono- and diglycerides of 582.4666 Propylene glycol (not in or on
edible fats or oils, or edible fat- cat food, 21 CFR 589.1001) •
forming acids •
Subpart F––Nutrients and/or Nutritional Supplements1

1Amino acids listed in this subpart may be free hydrochloride salt, hydrated, or
anhydrous form, where applicable.

582.5013 Ascorbic acid • 582.5273 Cystine
582.5017 Aspartic acid 582.5301 Ferric phosphate •
582.5049 Aminoacetic acid (glycine) • 582.5304 Ferric pyrophosphate •
582.5065 Linoleic acid 582.5306 Ferric sodium pyrophosphate
582.5118 Alanine 582.5308 Ferrous gluconate •
582.5145 Arginine • 582.5311 Ferrous lactate
582.5159 Biotin • 582.5315 Ferrous sulfate •
582.5191 Calcium carbonate • 582.5361 Histidine
582.5195 Calcium citrate 582.5370 Inositol •
582.5201 Calcium glycerophosphate 582.5375 Iron reduced •
582.5210 Calcium oxide • 582.5381 Isoleucine
582.5212 Calcium pantothenate • 582.5406 Leucine
582.5217 Calcium phosphate • 582.5411 Lysine •
582.5223 Calcium pyrophosphate 582.5431 Magnesium oxide •
582.5230 Calcium sulfate • 582.5434 Magnesium phosphate •
582.5245 Carotene • 582.5443 Magnesium sulfate •
582.5250 Choline bitartrate • 582.5446 Manganese chloride •
582.5252 Choline chloride • 582.5449 Manganese citrate •
582.5260 Copper gluconate • 582.5452 Manganese gluconate •
582.5271 Cysteine 582.5455 Manganese glycerophosphate

582.5458 Manganese hypophosphite 582.5835 Sorbitol

582.5461 Manganese sulfate • 582.5875 Thiamine hydrochloride •
582.5464 Manganous oxide • 582.5878 Thiamine mononitrate •
582.5470 Mannitol 582.5881 Threonine •
582.5475 Methionine • 582.5890 Tocopherols •
582.5477 Methionine hydroxy analog and 582.5892 Alpha-tocopherol acetate •
its calcium salts • 582.5915 Tryptophane •
582.5530 Niacin • 582.5920 Tyrosine •
582.5535 Niacinamide • 582.5925 Valine
582.5580 D-Pantothenyl alcohol 582.5930 Vitamin A •
582.5590 Phenylalanine 582.5933 Vitamin A acetate •
582.5622 Potassium chloride • 582.5936 Vitamin A palmitate •
582.5628 Potassium glycerophosphate 582.5945 Vitamin B12 •
582.5634 Potassium iodide • 582.5950 Vitamin D2 •
582.5650 Proline 582.5953 Vitamin D3 •
582.5676 Pyridoxine hydrochloride • 582.5985 Zinc chloride •
582.5695 Riboflavin • 582.5988 Zinc gluconate
582.5697 Riboflavin-5-phosphate • 582.5991 Zinc oxide •
582.5701 Serine 582.5994 Zinc stearate
582.5772 Sodium pantothenate 582.5997 Zinc sulfate •
582.5778 Sodium phosphate •
Subpart G–—Sequestrants
582.6033 Citric acid • 582.6625 Potassium citrate •
582.6085 Sodium acid phosphate 582.6751 Sodium citrate
582.6099 Tartaric acid 582.6754 Sodium diacetate
582.6185 Calcium acetate 582.6757 Sodium gluconate
582.6193 Calcium chloride • 582.6760 Sodium hexametaphosphate •
582.6195 Calcium citrate 582.6769 Sodium metaphosphate
582.6197 Calcium diacetate 582.6778 Sodium phosphate •
582.6199 Calcium gluconate • 582.6787 Sodium pyrophosphate
582.6203 Calcium hexametaphosphate 582.6789 Tetra sodium pyrophosphate •
582.6215 Monobasic calcium phosphate • 582.6801 Sodium tartrate
582.6219 Calcium phytate 582.6804 Sodium potassium tartrate
582.6285 Dipotassium phosphate 582.6807 Sodium thiosulfate
CHAPTER SIX
582.6290 Disodium phosphate • 582.6810 Sodium tripolyphosphate •

582.6386 Isopropyl citrate 582.6851 Stearyl citrate
582.6511 Monoisopropyl citrate
Subpart H–—Stabilizers
582.7115 Agar-agar 582.7339 Guar gum •
582.7133 Ammonium alginate 582.7343 Locust bean gum •
582.7187 Calcium alginate 582.7349 Sterculia gum
582.7255 Chondrus extract • 582.7351 Gum tragacanth
582.7330 Gum arabic 582.7610 Potassium alginate
582.7333 Gum ghatti 582.7724 Sodium alginate

582.10 Spices and Other Natural Seasonings and Flavorings

Botanical name of plant source is in the CFR.
Alfalfa herb and seed • Ginger •

Allspice Glycyrrhiza
Ambrette seed Grains of paradise
Angelica Horehound (hoarhound)
Angelica root Horseradish
Angelica seed Hyssop
Angostura (cusparia bark) Lavender
Anise • Licorice
Anise, star Linden flowers
Balm (lemon balm) Mace
Basil, bush Marigold, pot
Basil, sweet Marjoram, pot
Bay Marjoram, sweet
Calendula Mustard, black or brown
Camomile (chamomile), English or Roman Mustard, brown
Camomile (chamomile), German or Mustard, white or yellow
Hungarian Nutmeg
Capers Oregano (oreganum, Mexican oregano,
Capsicum • Mexican sage, origan)
Caraway Paprika
Caraway, black (black cumin) Parsley
Cardamom (cardamon) Pepper, black
Cassia, Chinese Pepper, cayenne
Cassia, Padang or Batavia Pepper, red
Cassia, Saigon Pepper, white
Cayenne pepper Peppermint
Celery seed Poppy seed
Chervil Pot marigold
Chives Pot marjoram
Cinnamon, Ceylon Rosemary
Cinnamon, Chinese Rue
Cinnamon, Saigon Saffron
Clary (clary sage) Sage
Clover Sage, Greek
Cloves Savory, summer
Coriander Savory, winter
Cumin (cummin) Sesame
Cumin, black (black caraway) Spearmint
Dill Star anise
Elder flowers Tarragon
Fennel, common • Thyme
Fennel, sweet (finocchio, Florence fennel) • Thyme, wild or creeping
Fenugreek • Turmeric
Galanga (galangal) Vanilla
Garlic Zedoary
Geranium

582.20 Essential Oils, Oleoresins (Solvent-Free), and Natural

Extractives (Including Distillates) As a Source of Flavor
Alfalfa Clover
Allspice Coca (decocainized)
Almond, bitter (free from prussic acid) Coffee
Ambrette (seed) Cola nut
Angelica root Coriander
Angelica seed Corn silk
Angelica stem Cumin (cummin)
Angostura (cusparia bark) Curacao orange peel (orange, bitter peel)
Anise Cusparia bark
Asafetida Dandelion
Balm (lemon balm) Dandelion root
Balsam of Peru Dill
Basil Dog grass (quackgrass, triticum)
Bay leaves Elder flowers
Bay (myrcia oil) Estragole (esdragol, esdragon, tarragon)
Bergamot (bergamot orange) Estragon (tarragon)
Bitter almond (free from prussic acid) Fennel, sweet
Bois de rose Fenugreek
Cacao Galanga (galangal)
Camomile (chamomile) flowers, Hungarian Garlic
Camomile (chamomile) flowers, Roman or Geranium
English Geranium, East Indian
Cananga Geranium, rose
Capsicum Ginger
Caraway Glycyrrhiza
Cardamom seed (cardamon) Glycyrrhizin, ammoniated •
Carob bean Grapefruit
Carrot Guava
Cascarilla bark Hickory bark
Cassia bark, Chinese Horehound (hoarhound)
Cassia bark, Padang or Batavia Hops
Cassia bark, Saigon Horsemint
CHAPTER SIX
Celery seed Hyssop

Cherry, wild, bark Immortelle
Chervil Jasmine
Chicory Juniper (berries)
Cinnamon bark, Ceylon Kola nut
Cinnamon bark, Chinese Laurel berries
Cinnamon bark, Saigon Laurel leaves
Cinnamon leaf, Ceylon Lavender
Cinnamon leaf, Chinese Lavender, spike
Cinnamon leaf, Saigon Lavandin
Citronella Lemon
Citrus peels Lemon balm (see balm)
Clary (clary sage) Lemon grass
Clove bud Lemon peel
Clove leaf Licorice
Clove stem Lime

Linden flowers Rose absolute

Locust bean Rose (otto of roses, attar of roses)
Lupulin Rose buds
Mace Rose flowers
Malt (extract) Rose fruit (hips)
Mandarin Rose geranium
Marjoram, sweet Rose leaves
Mate 1 Rosemary
Melissa (see balm) Rue
Menthol Saffron
Menthyl acetate Sage
Molasses (extract) Sage, Greek
Mustard Sage, Spanish
Naringin St. John’s bread
Neroli, bigarade Savory, summer
Nutmeg Savory, winter
Onion Schinus molle
Orange, bitter, flowers Sloe berries (blackthorn berries)
Orange, bitter, peel Spearmint
Orange leaf Spike lavender
Orange, sweet Tamarind
Orange, sweet, flowers Tangerine
Orange, sweet, peel Tannic acid
Origanum Tarragon
Palmarosa Tea
Paprika Thyme
Parsley Thyme, white
Pepper, black Thyme, wild or creeping
Pepper, white Triticum (see dog grass)
Peppermint Tuberose
Peruvian balsam Turmeric
Petitgrain Vanilla
Petitgrain lemon Violet flowers
Petitgrain mandarin or tangerine Violet leaves
Pimenta Violet leaves absolute
Pimenta leaf Wild cherry bark
Pipsissewa leaves Ylang-ylang
Pomegranate Zedoary bark
Prickly ash bark
582.30 Natural Substances Used in Conjunction with

Spices and Other Natural Seasonings and Flavorings
Algae, brown (kelp) Dulse

Algae, red

582.40 Natural Extractives (Solvent-Free) Used in

Conjunction with Spices, Seasonings, and Flavorings
Algae, brown Peach kernal (persic oil)

Algae, red Peanut stearine
Apricot kernel (persic oil) Persic oil (see apricot kernel and peach
Dulse kernel)
Kelp (sea algae, brown) Quince seed
582.50 Certain Other Spices, Seasonings, Essential

Oils, Oleoresins, and Natural Extracts
Scientific name of source is in the CFR.
Ambergris Cognac oil, white and green

Castioreum Musk (Tonquin musk)
Civet (zibeth, zibet, zibetum)
582.60 Synthetic Flavoring Substances and Adjuvants

Acetaldehyde (ethanal) so-called strawberry aldehyde, C-16
Acetoin (acetyl methylcarbinol) aldehyde)
Aconitic acid (equisetic acid, citridic acid, Ethyl vanillin
achilleic acid) Eugenol
Anethole (parapropenyl anisole) Geranoil (3,7‑dimethyl‑2,6 and
Benzaldehyde (benzoic aldehyde) 3,6‑octadien‑l‑ol)
N-Butyric acid (butanoic acid) Geranyl acetate (geraniol acetate)
d-or l-Carvone (carvol) Glycerol (glyceryl) tributyrate (tributyrin,
Cinnamaldehyde (cinnamic aldehyde) butyrin)
Citral (2,6-dimethyloctadien-2,6,al-8, Limonene (d-, l-, and dl-)
geranial, neral) Linalool (linalol, 3,7-dimethyl-1,6-
Decanal (N-decylaldehyde, capraldehyde, octadien-(3-ol)
capric aldehyde, caprinaldehyde, Linalyl acetate (bergamol)
aldehydeC-10) 1-Malic acid
Diacetyl (2,3-butandeione). Methyl anthranilate (methyl-2-
Ethyl acetate. aminobenzoate)
Ethyl butyrate Piperonal (3,4-methylenedioxy-
3-Methyl-3-phenyl glycidic acid ethyl benzaldehyde-heliotropin)
CHAPTER SIX
ester (ethyl-methyl-phenyl-glycidate, Vanillin
101. GRAS Notified Substances Intended for Animal Food

Section Editor—Nathan Price, ID
The following is a list of GRAS Notices filed voluntarily by the notifiers pursuant to
21 CFR 570.205 that the FDA has evaluated (21 CFR 570.265) and determined that it had
no questions regarding the conclusion that the notified animal food substance is generally
recognized as safe (GRAS) under the intended conditions of use. The filed notice and the
FDA response letter provide information (identity, manufacture, specifications, intended
effect, and safety) on the substance under the intended use conditions, and the most up-
to-date version is posted at the following website:
https://www.fda.gov/animal-veterinary/generally-recognized-safe-gras-notification-
program/current-animal-food-gras-notices-inventory. This section is provided as a
convenience for the State Feed Control Officials.

While the information on the substance and the intended use is specific to that
provided by the notifier, other firms may use information within the notice along with
other data specific to their substance to support the GRAS conclusion (see 21 CFR
570.3-570.280). Such other firms who conclude that an animal food substance is GRAS
under the conditions of its intended use by relying on a posted GRAS notice submitted
by another person shall carefully evaluate whether their production process, product
specifications, and intended conditions of use fall within the parameters addressed by
the referenced GRAS notice. GRAS conclusions are not legally required to be submitted
to the FDA but may be voluntarily submitted in accordance with the GRAS Notice
regulation (21 CFR Part 570.205). Nevertheless, firms that elect to make use of the
GRAS provision must document their GRAS conclusions prior to marketing a substance
for a particular intended use. State Feed Control Officials may request the GRAS
Conclusion to support their registration or inspection duties.
Table 101.1 is adapted from the FDA Animal GRAS Notification website and
includes ingredient definition information [substance, common or usual name (from the
FDA response letter), and intended use (including use limitations, if any)]. For other
information, see the FDA response letter for the GRAS Notice (available at link provided
above).
At each AAFCO Ingredient Definitions Committee (IDC) meeting, the section editor
will provide an updated list of animal food GRAS Notices that have been evaluated by
the FDA and have received a no questions letter from the Agency. Firms making GRAS
conclusions should be prepared to answer questions from the IDC or Association if
needed. The listed notices below have been voted on by the IDC and accepted by the
Association for publication in the AAFCO Official Publication.

Table 101.1. GRAS Notified Substances with No Questions Letters from the FDA
AGRN
(select for FDA’s Letter
detailed Common or Date of (select to
record) Notifier Substance Usual Name Intended Use Intended Species Filing view letter)
5 Emerald Hydrophobic silica Hydrophobic As a defoaming component Beef cattle, dairy cattle, May 12, FDA has no
(PDF, 67 Carolina silica of a defoamer used in poultry (turkey, broiler 2011 questions.
pages) Chemicals the removal of oil from chickens, and egg laying (PDF, 3
LLC condensed distillers solubles, hens), sheep, goats, and pages)
at levels up to 20 ppm swine
6 Emerald Polyethylene glycol Polyethylene As an emulsifier component Beef cattle, dairy cattle, May 12, FDA has no
(PDF, 57 Carolina (400) dioleate glycol (400) of a defoamer used in poultry (turkey, broiler 2011 questions.
pages) Chemicals dioleate the removal of oil from chickens, and egg laying (PDF, 3
LLC condensed distillers, at levels hens), sheep, goats, and pages)
up to 64 ppm swine
7 Emerald Polyoxyethylene Polysorbate 60 As an emulsifier component Beef cattle, dairy cattle, May 12, FDA has no
(PDF, 101 Carolina (20) sorbitan of a defoamer used in poultry (turkey, broiler 2011 questions.
pages) Chemicals monostearate the removal of oil from chickens, and egg laying (PDF, 3

LLC (polysorbate 60) condensed distillers solubles, hens), sheep, goats, and pages)
at levels up to 20 ppm swine
(continued)
Official Names and Definitions of Feed Ingredients
517
CHAPTER SIX
AGRN
518

14 DSM Phytase enzyme Phytase To increase the digestibility Poultry (turkey, broiler Nov 14, FDA has no
(PDF, 576 Nutritional produced by an of phytin-bound phosphorous chickens, and egg laying 2012 questions.
pages) Products Aspergillus oryzae or to increase phosphorous hens) (PDF, 3
strain expressing availability from phytate in pages)
a synthetic gene poultry diets when fed at the
coding for a rate of 250–4000 FYT/kg feed
6-phytase from
Citrobacter braakii
15 DSM Phytase enzyme Phytase To increase the digestibility Swine Aug 8, FDA has no
(PDF, 505 Nutritional produced by an of phytin-bound phosphorous 2013 questions.
pages) Products Aspergillus oryzae or to increase phosphorous (PDF, 3
strain expressing availability from phytate in pages)
a synthetic gene swine diets when fed at the
coding for a rate of 500–4000 FYT/kg feed

6-phytase from
Citrobacter braakii
16 Metabolic L-methionine L-methionine Nutrient at levels up to 0.3% All animals Jan 3, FDA has no
(PDF, 87 Explorer 85% produced by 85% in animal feed 2014 questions.
pages) a bioengineered (PDF, 4
Escherichia coli pages)
K-12
(continued)
AGRN
17 DSM Canthaxanthin Canthaxanthin To be used in breeder hen Breeder hens used for Jul 22, FDA has no
(PDF, 170 Nutritional diets at the rate of 6 mg/kg of hatching egg production 2014 questions.
pages) Products feed as a nutritive antioxidant (PDF, 4
to support the development of pages)
chicks
19 Freedom L-Glutamine L-Glutamine Utility information not Post-weaning horses. Mar 22, FDA has no
(PDF, 123 Health evaluated for GRAS, see 2016 questions.
pages) L.L.C. FDA’s letter for more (PDF, 3
information. pages)
20 DSM Inactivated modified Saccharomyces As a component of animal Pets, poultry (broilers, Apr 29, FDA has no
(PDF, 899 Innovation Saccharomyces cerevisiae feed when used in the layers, and breeding 2016 questions.
pages) Inc., cerevisiae expressing fermentation of corn to chickens; turkeys), swine (PDF, 4
BioProducts xylose produce ethanol (piglets, growers, finishers, pages)
& Services isomerase from gestating and lactating

Division Piromyces sp. sows), bovine (beef and
E2 dairy), fish (salmonoids,
catfish, tilapia), and minor
species such as ducks,
Official Names and Definitions of Feed Ingredients
quail, sheep, and goats

(continued)
519
CHAPTER SIX
AGRN
520

21 Agrivida, Ground grain Phytase To increase the digestibility Poultry Jul 28, FDA has no
(PDF, 598 Inc. obtained from a of phytin-bound phosphorous 2016 questions.
pages) corn (Zea mays) or to increase phosphorous (PDF, 4
variety that availability from phytate in pages)
expresses an altered poultry feeds when used at
appA 6-phytase a rate of 75 g to 1.7 kg per
gene obtained from ton of complete feed and
Escherichia coli providing 250-6000 phytase
strain K12 units (FTU)/kg complete feed.
24 CJ L-methionine L-methionine To be used as a nutrient in All animals Aug 17, FDA has no
(PDF, 194 CheilJedang 90% produced by 90% animal food. 2017 questions.
pages) Corporation a bioengineered (PDF, 4
Escherichia coli pages)
K-12


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What information should be provided in a request for a new ingredient definition?

What information should be provided in a request for a new ingredient definition?

What is the role of the requester in submitting a new ingredient definition?

What is the role of the requester in submitting a new ingredient definition?

Copyright Disclaimer: The AAFCO Official Publication, including

Chapter Six, is an original work authored by AAFCO, which holds

New and Modified Ingredient Definitions

(8) Use limitations, if any.

2020 Official Publication

2020 Official Publication

The Expert Panel

2020 Official Publication

Canadian Food Inspection Agency

2020 Official Publication

Animal Food Additives Approved by FDA

2020 Official Publication

Feed Terms and Definitions

Official Feed Terms

Additive. An ingredient or combination of ingredients added to the basic feed mix or

Aerial parts. (Part) The above ground parts of plants.

2020 Official Publication

exclusive of hair, hoofs, horns, and contents of the digestive tract.

2020 Official Publication

2020 Official Publication

Dextrose Equivalent (D.E.). is the reducing power calculated as dextrose, expressed

Emulsifier. A material capable of causing fat or oils to remain in liquid suspension.

2020 Official Publication

Etiolated. (Process) A material grown in the absence of sunlight, blanched, bleached,

2020 Official Publication

Fresh. (Process) Ingredient(s) having not been subject to freezing, to treatment by

heat. Usually, water and fat are removed.

2020 Official Publication

2020 Official Publication

Precipitated, precipitating. (Process) Separated from suspension or a solution as a result

2020 Official Publication

2020 Official Publication

2020 Official Publication

2020 Official Publication

water-soluble extracts from malted mash.

Deleted Feed Terms

2020 Official Publication

Official Common or Usual Names

As Established By The Association Of American Feed Control Officials

2020 Official Publication

NOTE 2: A guarantee of the beta carotene content of alfalfa products expressed in

6. Amino Acids and Related Products

2020 Official Publication

2020 Official Publication

6.13 L-Arginine is a product which contains a minimum of 98% L-2-amino-

2020 Official Publication

2020 Official Publication

2020 Official Publication

2020 Official Publication

as might occur unavoidably in good manufacturing processes. A large portion of

2020 Official Publication

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2020 Official Publication

12. Barley Products

15. Brewers Products

33.4 Ester , Feed Grade, is the product consisting