Proprietary Mixture Suppliers and Manufacturers
Questions and Answers
March 17, 1995
To: Proprietary Mixture Suppliers and Manufacturers
This letter is intended to supplement the previous letter to the Proprietary
Mixture Suppliers and Manufacturers (dated November 1, 1990), and FSIS Directive
7237.1 (Rev. 1), by conveying a compilation of updated questions and answers
(Enclosure) pertaining to ingredient review, use, and labeling. The questions
and answers are those frequently posed regarding current Agency issuance's on
ingredient policies, e.g., proprietary mixes and reaction flavors, and are
updated to reflect rule changes promulgated on January 6, 1993, by the Food and
Drug Administration on ingredient labeling.
Questions regarding ingredient mix formulation review, use, and labeling may
continue to be sent to the Labeling and Additives Policy Division (LAPD) at the
Robert C. Post, Ph. D., Director
USDA, FSIS, OPPD
Labeling and Consumer Protection Staff
1400 Independence Avenue, SW, Room 602 - Annex Building
Washington, DC 20250-3700
As always, proprietary ingredient mix formulations that are submitted by
companies to the Agency for review in order to respond to questions are exempt
from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552 (b)
(4), and will only be used to determine proper listing of the ingredients on
meat and/or poultry product labels.
Robert C. Post, Ph. D., Director
Labeling and Additives Policy Division
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AND ANSWERS RELATING TO USE AND LABELING OF INGREDIENTS, INCLUDING FLAVORINGS,
PROPRIETARY INGREDIENT MIXES, INGREDIENTS IN STANDARDIZED AND NON-STANDARDIZED
FOODS, AND PROTEIN HYDROLYSATES
Table of Contents
Labeling of Flavorings
Proprietary Ingredient Mixtures and
Ingredients in Standardized and Non-Standardized Foods
Labeling of Reaction Flavors
Labeling of Protein
- Question: What commonly used ingredient may be designated as
"flavors," "flavorings," "flavoring," or "flavor?"
Answer: Spices, spice extractives, essential oils, oleoresins, onion
powder, garlic powder, celery powder, onion juice, and garlic juice. Spices,
oleoresin, essential oils, and spice extractives are listed in 21 CFR 172.510,
182.10, 182.20, 182.40, 182.50, and 184.
- Question: What commonly used ingredients, which have been
designated as "flavors" prior to March 1990, must be designated by their
common or usual name?
Answer: Hydrolyzed (source) proteins (e.g., hydrolyzed corn gluten,
hydrolyzed casein, hydrolyzed wheat protein, and hydrolyzed milk protein),
gelatin, hydrolyzed meat and meat by-products (i.e., "hydrolyzed [species and
tissue of origin]"), autolyzed yeast, and autolyzed yeast extract are some
- Question: Can dry meat or poultry stocks, dried broth, extracts,
and dried beef plasma be designated as "flavors?"
Answer: No, because dried stocks, dried broths and extracts, and
blood fractions are of animal origin, they must be designated as dried
(species) stock, dried (species) broth, (species) extract, or dried (species)
- Question: Can commonly used organic acids be designated as flavors?
Answer: No, because they have restricted uses and use levels,
commonly used acids must be designated by their specific name (e.g., ascorbic,
citric, lactic, phosphoric, etc.).
- Question: Can fruit (or vegetable) juices, purees, powders, and
similar ingredients be designated as "flavors?"
Answer: No, with very few exceptions, these ingredients are foods
that have nutritional value and may not be designated as "flavor" and must be
listed by their common or usual name, e.g., tomato powder and lemon juice.
However, powdered onion, powdered garlic and powdered celery, as specifically
cited in the regulations (9 CFR 317.2 (f) (1) (i) and 381.118 (c) (2)), may be
labeled as "flavor," "natural flavors," or similar terms. Onion juice and
garlic juice, according to FDA, may also be termed "flavor," etc.
- Question: Must specific ingredients that meet the definition of
"flavor," e.g., rosemary, and are not proteinaceous, be identified on the
label application form?
Answer: No. Spices, oleoresins, essential oils, and spice
extractives may be grouped together and listed as "spices" or "flavor" or
similar terms without specific names. If color is imparted, they must be
designated as, for example, "spice and coloring" or by their specific name(s),
- Question: Can the use of mustard as part of the ingredient mix be
designated in the label application as "spice?"
Answer: Yes, mustard may be listed in the ingredient statement on
the label of a meat or poultry product as "mustard," "spice," or "flavoring"
(see 9 CFR 317.2 (f) (1) (i)).
- Question: Can "deflavored" or "decharacterized" mustard (or other
spices) be used as an ingredient in meat or poultry products? If so, how
should it be designated in the ingredient statement?
Answer: Deflavored (or decharacterized) mustard is an acceptable
ingredient in the preparation of meat or poultry products, under the
conditions of use that are acceptable for spices or flavorings, including
level of use. When used in a meat or poultry product, deflavored mustard may
be designated as "deflavored mustard," "deheated mustard," or "deactivated
mustard." According to FDA, deflavored mustard, however, may not be designated
as "mustard," "spice," or "flavoring." The same would hold true for other
- Question: If the processor declares spice(s) or spice extractive(s)
on the meat or poultry product label, is it necessary to identify the specific
spice(s) and spice extractive(s) on the label application form?
Answer: Generally, the processor need not identify each spice or
spice extractive and the quantity of each on the label application form. As
always, the total quantity of all spices versus all spice extractives will
need to be indicated on the label application form to determine order of
predominance for the different terms, i.e., spice(s) and spice extractive(s).
In addition, if the label is submitted by an establishment in a foreign
country, each spice and spice extractive must be identified on the label
application form by name because of differences between countries in
regulations for these ingredients.
- Question: Can paprika, saffron, and turmeric be designated as
"spice" or "flavoring" on meat and poultry product labels?
Answer: No. Paprika, saffron, turmeric, and extractives of these,
according to FDA, are both spices and coloring, or flavoring and coloring and
should be declared as "spice and coloring" or "flavoring and coloring" unless
the specific spice or spice extractive is named in the ingredients statement.
- Question: Can annatto be designated as
"spice" or "flavoring" on meat and poultry product labels?
Answer: No. Annatto may be called either "annatto" or "artificial
color" or "artificial coloring" but may not be labeled as spice or flavoring.
- Question: Does each constituent of ingredients designated, as
"artificial flavor(s)" have to be identified on the label application form?
Answer: No. It is not necessary to identify the specific components
of artificial flavors when the substances meet the definition in 21 CFR
172.515 and 182.60.
- Question: Do ingredients that
are designated as "spice(s)," "flavor," etc., in FDA-regulated foods that are
used as components in meat and poultry products need to be identified on the
label application form as to the specific spices or flavors used?
Answer: No, foods produced under FDA jurisdiction (e.g., sauces,
vegetable mixes, baked beans) that are purchased and used as components of
meat or poultry products need not identify the flavors on the label
application. The ingredients listed on the label of the FDA regulated product
may be listed as such on the label of the meat or poultry product because it
is expected they will be in conformance with FDA ingredient labeling rules.
- Question: When does a processor need to provide specific "flavor"
component information on purchased products?
Answer: Specific information need only be provided if the product is
a seasoning ingredient or if there is reason to suspect that the purchased
product contains ingredients that are inappropriately designated as "flavor,"
- Question: Does the Agency recognize a de minimis (minimal) level
below, which a flavoring ingredient need not be declared?
Answer: No, there is no de minimis level at which a flavoring
ingredient need no be declared by its common or usual name.
- Question: How much information must suppliers of natural flavors,
such as "tomato flavor" or "egg flavor," provide?
Answer: Suppliers of these types of ingredients must supply FSIS, at
the time of label approval, with the identification of all constituents
(ingredients) of that flavor.
- Question: Can natural smoke flavoring be listed as natural flavor?
Answer: No, the labeling of natural smoke flavorings is covered by 9
CFR 317.2 (j) (3) and 381.119 (a) and by Policy Memo 117, "Smoke Flavoring."
Natural smoke flavoring may not be listed as "natural flavor" or "flavor" in
the ingredients statement. It may be declared as "natural smoke flavoring" or
"smoke flavoring." Artificial smoke flavoring must be labeled as such.
- Question: Would a distillate of acid, alcohol, or food be
Answer: Yes, distillates from acid, alcohol, or food that are the
result of a distillation process, can be designated as "flavor," if they
contain solely the flavoring constituents that are not of nutritional
consequence. That is to say, no components of the substrate are present – only
the chemical constituents that provide flavor, e.g., aldehydes, ketones, etc.
- Question: Can cultured, fermented, or enzyme-modified products be
designated as "flavorings?"
Answer: No. According to FDA, these ingredients must be designated
by their common or usual name, e.g., "cultured whey" and "enzyme modified
cheddar cheese (sublisted ingredients)."
- Question: Can flavoring compounds which are separated from
fermented products be designated as "flavors" (e.g., aldehydes, ketones,
Answer: Yes, provided the mixture contains only the flavoring
compounds and does not contain the substrate from which the flavoring
compounds were removed.
- Question: How would the "natural" versus "artificial" status of a
flavoring compound be verified and by whom?
Answer: FSIS regulations do not provide criteria for differentiating
between "natural" and "artificial" flavoring compounds (e.g., "natural"
diacetyl). Determination for proper nomenclature can be obtained from the FDA.
- Question: Can sandalwood extract or yellow sandalwood may be
designated as "flavor" on labels of meat and poultry products?
Answer: White sandalwood extract or yellow sandalwood may be
designated as "flavor" in the ingredients statement. FDA does not permit the
use of red sandalwood extract in food, with the exception of alcoholic
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PROPRIETARY INGREDIENT MIXTURES AND
INGREDIENTS IN STANDARDIZED AND NON-STANDARDIZED FOODS
- Question: Does a proprietary ingredient mix formula have to be
reviewed approved by FSIS, LAPD, before it can be used in meat or poultry
Answer: No. Prior review and approval of proprietary
ingredient mixes intended for use in meat or poultry products have never been
required by the Agency. A letter of guaranty and a complete bulk label that
lists all ingredients of the mix in descending order by common or usual name
have always been a means of confirming the identity of ingredient mixes and
assuring compliance with FDA ingredient rules and the rules of this Agency.
Percentages of individual constituents of a mix may appear on bulk labels
depending on whether the ingredient is restricted in meat or poultry products
and/or the meat or poultry manufacturer intends to use a composite approach to
listing ingredients on the meat and poultry product label.
- Question: Can processors submit their proprietary ingredient mix
formulas to FSIS, LAPD, to be kept in confidential files for reference before
or during the label approval process?
Answer: Yes. Processors may submit the proprietary ingredient mix
formulas to FSIS. The formulas will remain I confidential files, as in the
past, and will be used for the purpose of verifying the ingredients statements
on labels for meat and poultry products.
- Question: What proprietary mix formulas can be submitted to FSIS?
Answer: The formulas for mixtures of non-meat and/or
non-poultry ingredients, e.g., breading mixes, seasonings, spices, marinades,
flavorings, cures, and antioxidants, may be voluntarily submitted.
- Question: Is there a prescribed format required for submission of
proprietary mix formulas?
Answer: The suggested format for submission is a list of the
following: (1) date of submission, (2) company name and mailing address, (3)
technical contact person, (4) telephone number, (5) name of proprietary
mixture (brand name, code, or other designation under which ingredient mix is
marketed), (6) intended use and level of use, (7) statement of composition
(list of the quantitative formula with percentages of each ingredient in
descending order of predominance – provide a sublisting of any ingredients
used to formulate another ingredient), (8) a description of the manufacturing
process used to formulate the ingredient mix, including temperatures and time,
(9) the proposed labeling of the mix in the meat/poultry ingredients
statement, and (10) certification by a company representative (including name,
signature, title, and date) that the description of the mix is accurate and
complete, and that it is in accordance with FSIS guidelines and rules.
- Question: Does FSIS provide advisory letters to manufacturers who
voluntarily submit their ingredient mix formulas?
Answer: FSIS will issue letters conveying labeling advice when
- Question: When spices, such as rosemary and thyme, are listed on a
proprietary mix label, must they be listed separately on the meat or poultry
product label or can they be termed as spices or flavorings?
Answer: Ingredients that are spices can be listed by their names,
e.g., rosemary and thyme, or as "spices," "flavorings," or similar terms,
regardless of the wording on the ingredient mix bulk label.
- Question: If an ingredient mix is to be used in a product such as
"Italian sausage," which must contain the spices, pepper and anise or fennel,
as required by 9 CFR 319.145, should the label application list the total
amount of spices and sublist each with its percentage?
Answer: While it is not necessary to list separately or provide the
percentage of each spice on the label submittal form nor to sublist each spice
by common or usual name on the proprietary mix label, it would be useful to
identify the required spices by name on the label application or on the
ingredient mix label because labels for an "Italian sausage" in which the mix
is used will not be approved unless the label application shows the mix
contains the required spices.
- Question: Is it necessary to disclose the individual
percentage of each proteinaceous ingredient in a mix on the label?
Answer: No, while each percentage disclosure for ingredient mixes
that are allowed in moisture controlled products has been a practice in the
past, we have reconsidered this requirement since publication of the
"flavoring" and "added water" regulations (9 CFR 317.2 (f) (1) (i), 318.22,
and 381.118) (c) (2)) in March 1990.
- Question: When are ingredients considered incidental additives?
Answer: Ingredients that are present in a meat or poultry product in
an insignificant amount and have no functional or technical effects in the
finished meat or poultry product may be considered incidental additives. The
definition of incidental additives provided by FDA (21 CFR 101.100 (a) (3)) is
applied to meat or poultry products. Compliance with these conditions is
determined by the Agency (LAPD/FSIS) on a case-by-case basis by considering
the use of the proposed incidental additive and the specific meat or poultry
product formulation to which it is added.
- Question: Are incidental additives declared in the ingredient
Answer: No, incidental additives are not required to be listed in
the ingredients statement of meat and poultry product labels. Anticaking
substances, as defined by FDA, such as silicon dioxide (used at less than 2
percent of a spice and seasoning blend), are examples of incidental additives
frequently used in spices and seasoning blends. When meat and poultry
processors use such spices in their products, they are not required to list
the anticaking agent in the ingredients statement because it is present in
insignificant amounts and because it no longer serves an anticaking function.
- Question: What are "carriers?"
Answer: Carriers are substances that are, in and of themselves,
non-functional (i.e., inert) but which are used to carry and distribute
functional additives added to meat and poultry product. Functional additives
which are frequently added to formulations through the use of carries are
flavorings, antioxidants, and other substances which are used in very small
quantities. The use of carriers assists in accurate quantitative measurement
and in uniform distribution of the functional additive.
- Question: Are carriers considered incidental additives? If not, how
should carriers be labeled on meat and poultry labels?
Answer: A carrier may be required to be designated in the
ingredients statement of the product to which it is added unless it is
determined to be an incidental additive. If the carrier is determined to be an
incidental additive, it need not be designated on the finished product label.
There is no precise level at which the carrier becomes an incidental additive
and the issue is handled on a case-by-case basis.
- Question: Under what circumstances is the listing of carriers on
the meat or poultry product ingredients statement required?
Answer: In cases where the carrier performs a functional role in the
product, the carrier is not an incidental additive and must be declared on the
label of the finished meat or poultry product in accordance with labeling
rules. However, when lactose, salt, and proteinaceous substances are used as
carriers, they are not considered to be incidental additives and must be
designated by their specific common or usual names on the meat or poultry
- Question: When is dextrose or sugar considered a carrier of spices?
Answer: Dextrose and/or sugar are commonly used as carriers for
spice extracts and resins of spices. The carrier must be declared in the
ingredients statement of the meat or poultry product, except in those cases
where a sweetening agent is used separately in formulating the meat or poultry
product and the use of the spice mixture will not result in the quantity of
the carrier being more than 0.75 percent of the product. When a determination
cannot be made from the information on a label application, declaration is
- Question: Are there any situations when the label declaration of
monosodium glutamate (MSG) as an added ingredient is not required?
Answer: No, there is no established limit, below which, monosodium
glutamate does not need to be declared on the label of a product to which it
is added. Therefore, when monosodium glutamate is used as an ingredient it
must be identified on the finished product label regardless of the amount
- Question: Do FDA certified color additives and their lakes have to
be individually declared in the ingredients statement?
Answer: Yes. According to FDA rules (21 CFR 101.22 (K) (1),
certified color additives and their lakes are distinct ingredients and, thus,
must be declared individually, e.g., "FD&C Red #40" or "Red 40," in the
ingredients statement and not by a grouped term such as "coloring."
- Question: Do FDA certified color additives and their lakes have to
be individually declared when added to the casings for sausage products and
the casings are removed but the surface color effect remains?
Answer: Yes. Certified colors must be declared whenever
used. In situations where colored casings on sausage products impart a color
to the product, the manufacturer must continue to apply the product name
qualifier "Casing Colored," and may either include the name of the certified
color in the qualifier (e.g., "Artificially Colored with FD&C Red #40," or may
include it in the ingredients statement of the sausage product.
- Question: Does an FD&C color, e.g., Red #3 or Red #40, have to be
declared in the ingredients statements of meat and poultry products when it is
added to cure mixes as a tint to distinguish nitrite from salt?
Answer: No. The policy has always been that since the color does not
function as a color additive in the meat or poultry product, it is considered
to be incidental and does not require declaration.
- Question: How are non-certified color additives identified?
Answer: Color additives not subject to certification may continue to
be declared as "artificial color," "artificial color added, " or "color
added." Alternatively, such color additives may be declared as "colored with ,
" or " color," with the blank space filled in with the name of the
color additive listed in 21 CFR 73, e.g., "colored with annatto," or "caramel
- Question: When used as ingredients in meat or poultry products, do
the common or usual names of ingredients of standardized FDA-foods and
ingredients have to be listed?
Answer: Yes. According to FDA rules (21 CFR 130.11), the
ingredients of standardized foods must be (1) declared parenthetically
following the name of the standardized ingredient (i.e., "component"
labeling), e.g., "cheddar cheese (milk, enzymes, salt)" or (2) declared by
dispersing each ingredient in its order of predominance in the ingredients
statement of the product in which it is used without naming the standardized
food specifically (i.e., "composite" labeling).
- Question: When used as ingredients in meat or poultry products, do
the ingredients of non-standardized FDA-foods and ingredients have to be
Answer: Yes. FDA has always required the ingredients in
non-standardized FDA-foods, e.g., egg products and Ricotta cheese, to be
listed when used as ingredients in other foods. In the past, FSIS has allowed
limited exceptions to the rule, however, after August 8, 1995, all meat and
poultry products containing FDA components as ingredients must list all
ingredients in those components.
- Question: What non-standardized foods will require full declaration
of ingredients after August 8, 1995?
Answer: Soy sauce and Worcestershire sauce are examples of the
non-standardized items used as ingredients in meat and poultry products that
will need full disclosure of ingredients.
- Question: What is the policy for declaring ingredients in
cured meat products that are used as ingredients in other meat and poultry
Answer: Consistent with the recent FDA rule changes requiring the
declaration of ingredients in all foods, FSIS is changing its policy on the
use of cured meat products as ingredients to require the declaration of
ingredients regardless of the use level.
- Question: How would vegetable oils be listed in an ingredients
statement in regard to source material?
Answer: FDA regulations require that the source of specific fats or
oils be identified. This provision is different with regard to Federal meat
inspection regulations which permit the use of a general term such as
"vegetable oil" (9 CFR 317.2 (f) (1) (iii), 317.8 (b) (21), 319. 701).
Therefore, "vegetable oil" is acceptable as an ingredient declaration and will
continue to be acceptable until the meat and poultry products inspection
regulations are amended accordingly.
- Question: What is the acceptable designation of vegetable starches
and starchy vegetable flours?
Answer: In some cases, USDA regulations (e.g., the Tables of
Approved Substances) require a specific source disclosure, e.g., "pea flour."
In many cases, however, the regulations use general terms, e.g., "vegetable
starches" and "starchy vegetable flour." Unless specified in FDA regulations,
source labeling of starches is not required by FDA and, therefore, is not
required by FSIS. Thus, terms like "modified food starch" are acceptable.
- Question: Is it acceptable to use an "and/or" (or "may contain")
approach to declare the ingredients of a FDA-foods or ingredient, e.g.,
ketchup, that is purchased from different manufacturers?
Answer: The use of "and/or" labeling will be permitted for the
declaration of ingredients in purchased FDA-foods and ingredients in
accordance with FDA’s regulations, only if they are listed as components in
the ingredients statements of meat and poultry products in which they are
- Question: Can the use of "and/or" (or "may contain") labeling be
applied to minor ingredients, i.e., those present at 2 percent or less, of
products such as cured meat or poultry products or such products that are
further processed (i.e., sliced, diced, etc.) and packaged?
Answer: The use of "and/or" labeling will be permitted for minor
ingredients of a component of meat or poultry products in accordance with
Policy Memo 072, "Composite Ingredient Labeling." Thus, the use of "and/or"
labeling will be permitted for cured meat components, such as bacon ends and
pieces, and ham, as well as for non-meat components, such as soy sauce.
Additionally, cured meat poultry items, e.g., ham, with variations in minor
ingredients in their formulations, can be sliced, diced, etc., and bear a
label containing an "and/or" or "may contain" statement in the ingredients
- Question: Is the term "seasoning" an acceptable ingredient
designation on meat and poultry product labels?
Answer: No. "Seasoning" is not established by FDA as a common or
usual name. Because it is a very general term, whenever "seasoning" is used in
the ingredients statement, its components must be identified as a sublisting.
- Question: Can approved phosphates be collectively designated as
"sodium phosphates" or "potassium phosphates," as the case may be?
Answer: Yes. As a convenience to meat and poultry processors, we are
continuing to allow these substances to be declared on labels of meat and
poultry products simply as "sodium phosphates" or "potassium phosphates."
However, if the processor chooses to use a more specific name, the phosphates
can be declared by their accepted chemical names.
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- Question: What are "reaction flavors?"
Answer: During the heating process, chemical reactions occur between
reducing sugars and amino acids or proteins. This process conforms to what is
commonly understood in chemistry to be the "Maillard reaction." End products
of Maillard reactions are referred to as Maillard reaction flavors, "processed
flavors," or as "reaction flavors."
- Question: What processing procedures must be used for reaction
Answer: Presently, reaction flavor products must be processed by
heating the reactant mixes at not less than 100° C for not less than 15
- Question: Are reaction flavors "flavoring?"
Answer: Yes. According to FDA’s advisory opinion, the reaction
mixture of free amino acid(s) (e.g., cysteine) and reducing sugar(s) (e.g.,
xylose) in a Maillard reaction system may be termed "flavor," etc.
- Question: If other substances are added to make a reaction flavor,
when should the reactants in a reaction system be listed in the ingredients
Answer: The following label guidelines apply to ingredients that are
part of a reaction system:
- All ingredients that are of animal origin must be identified by
species and tissue, if appropriate, e.g., beef fat, chicken broth,
gelatin, and must be listed in descending order of predominance.
- Complex carbohydrates, e.g., modified food starch and maltodextrin,
must always be declared because they are not totally consumed (i.e., used
up) under most reaction conditions.
- All non-animal proteinaceous substances, e.g., autolyzed yeast
extract, hydolyzed (source) protein, monosodium glutamate, soy sauce,
whether totally consumed or not, must be declared.
- All ingredients that are of seafood origin, e.g., Bonito fish extract
and shrimp must be listed.
- All ingredients that are foods, meat food products or poultry
products, e.g., fruit or vegetable juice, cheddar cheese, beef extract or
broth, pepperoni, and bacon must be declared by their standardized names.
- Thiamine hydrochloride, phosphates, salt, and vegetable oil must
always be listed because they are not consumed in reaction process.
- Reducing sugar(s) and amino acid(s) that produce a flavor when treated
with heat for at least 15 minutes at 100° C may be grouped together and
labeled as "flavors."
- Question: Is there a standard of composition or identity for
Answer: No, there is no standard of composition or identity for
reaction flavor products; they are merely required to bear non-misleading
descriptive names that comply with the established labeling guidelines.
- Question: How would a reaction flavor be labeled?
Answer: The Agency has established specific guidelines for labeling
of reaction flavors.
- If 40 percent water, 40 percent chicken meat, 10 percent hydrolyzed
soy protein, 5 percent chicken broth, and 5 percent sugar were reacted
with sufficient time and heat for a reaction to take place (100° C and 15
minutes), the product name would be Chicken Flavor (contains hydrolyzed
soy protein and chicken broth).
- If 30 percent water, 30 percent beef extract, 20 percent xylose, 10
percent cysteine, 5 percent thiamine, and 5 percent salt were reacted with
sufficient time and heat, the product would be labeled Beef Flavor
(contains beef extract, thiamine, and salt).
- If a chicken "type" flavor was produced from a reaction without
chicken as a substrate, using 40 percent water, 20 percent beef extract,
20 percent bacon fat, 10 percent dextrose, 5 pepperoni and 5 percent
cysteine, the resulting product would be called Chicken Type Flavor
(contains beef extract, bacon fat, and pepperoni).
- If the substrate is 90 percent chicken meat and 10 percent sugar,
under the prescribed reaction conditions, the label would state "Chicken
Meat and Chicken Flavor," unless it can be shown that the chicken meat is
broken down in the reaction to yield only amino acids. In this case, the
label would state "chicken flavor" or "flavor (contains chicken)."
- If the substrate is 50 percent pork trimmings, 30 percent xylose, 10
percent cysteine hydrochloride, 5 percent onion powder, 3 percent clove
oil, and 2 percent rosemary extract, the label would state "pork flavor"
or "flavor (contains pork)."
- Question: Are the labeling guidelines for reaction flavors intended
to encompass ingredients with a separate identity as a meat food product or
poultry product, e.g., dried beef plasma or pork stock?
- Question: Can reaction flavors be labeled as "natural flavor?"
Answer: No. The reaction mixture does not come from a natural
source, as such, but is carefully formulated in specific proportions to ensure
a product mixture of desired flavor characteristics.
- Question: Do processors have to declare water as an ingredient in a
Answer: No. Water that is needed in order for the Maillard reaction
to take place does not have to be declared.
- Question: Can ingredients that are precluded by regulations from
use in any meat or poultry product, e.g., sorbates, be used in the preparation
of a reaction flavor?
- Question: What is the appropriate labeling for a reaction mix that
is not heat processed?
Answer: The labeling guidelines for reaction flavors are not
applicable to a mix of reactants (e.g., amino acids and reducing sugars) where
heat has not been applied. Each ingredient, including amino acid(s) and
reducing sugar(s), in the mix must be individually identified just as
ingredients are listed in a seasoning or spice blend.
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- Question: Can protein hydrolysates be grouped in the ingredients
statement, e.g., "hydrolyzed vegetable protein (corn, soy, wheat)"?
Answer: No, "hydrolyzed vegetable protein" is not established by FDA
as a common or usual name, nor is it established as an appropriate collective
name for a variety of different protein hydrolysates. The common or usual name
of a protein hydrolysate should be specific to the ingredient and shall
include the identity of the source from which the protein was derived.
Hydrolyzed soy protein, hydrolyzed corn gluten, and hydrolyzed casein is
examples of acceptable names. The acceptable FDA designation is hydrolyzed
corn protein, hydrolyzed soy protein, and hydrolyzed wheat protein.
- Question: What is the rule of thumb when the
identity and function of a hydrolyzed substance is in question?
Answer: According to FDA, appropriate standards exist to allow a
distinction between commercially available "highly" hydrolyzed protein
hydrolysates and those variously termed "partially," "mildly," or "lightly"
hydrolyzed that are not used for flavor-related purpose.
According to the FDA, ‘highly" hydrolyzed proteins are declared as
"hydrolyzed (source protein)" and can be defined as those whose ratio of
alpha-amino nitrogen (AN) to total nitrogen (TN) is greater than 0.62 (AN:TN >
0.62). Proteins that are not highly hydrolyzed would have AN:TN of less than
0.62 (AN:TN < 0.62) and may be declared by using such terms as
"partially," "mildly," or "lightly," e.g., "partially hydrolyzed (source
When a problem arises regarding whether a hydrolyzed substance used in the
formulation of a meat or poultry product is accurately identified and serving
the primary function of flavoring, we consider these definitions and the level
of use of the substance in question. In our experience, substances that have
AN:TN > 0.62 would be used at less than 2 percent of the meat or poultry
product formulation when used for the primary purpose of flavoring.
- Question: What is the proper nomenclature of hydrolyzed protein
derived from an animal source when utilized as an ingredient in meat or
Answer: The hydrolyzed protein of slaughtered animal species and
tissue of origin, other than gelatin, must be indicated, e.g., "hydrolyzed
beef plasma," "hydrolyzed pork stock," and "hydrolyzed pork skin."
- Question: What are the acceptable declarations for protein
hydrolysates that are made of blends of proteins, i.e., the proteins from
different sources are hydrolyzed together or individually?
Answer: According to FDA rules, for proteins that are blended prior
to being hydrolyzed, an appropriate name for the hydrolyzed protein must be
sufficiently descriptive of the product and must include all of the various
proteins that were used to make the hydrolyzed protein. For example, a
hydrolyzed protein made from a blend of corn protein, soy, protein, and wheat
gluten would be "hydrolyzed corn, soy, and wheat gluten protein."
If proteins are hydrolyzed individually prior to blending, then the common
or usual name of each protein hydrolysate must be indicated, e.g., "hydrolyzed
corn protein, hydrolyzed soy protein, and hydrolyzed wheat gluten."
- Question: Is "hydrolyzed gelatin" an acceptable common or usual
Answer: No. According to a FDA decision, "hydrolyzed gelatin" falls
within the standard for Type B gelatin and, therefore, would be declared as
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