This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 9, is updated January 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317]
[Page 153-154]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec.
317.1 Labels required; supervision by Program employee.
317.2 Labels: definition; required features.
317.3 Approval of abbreviations of marks of inspection; preparation of
marking devices bearing inspection legend without advance
approval prohibited; exception.
317.4 Labeling approval.
317.5 Generically approved labeling.
317.6 Approved labels to be used only on products to which they are
applicable.
317.7 Products for foreign commerce; printing labels in foreign
language permissible; other deviations.
317.8 False or misleading labeling or practices generally; specific
prohibitions and requirements for labels and containers.
317.9 Labeling of equine products.
[[Page 154]]
317.10 Reuse of official inspection marks; reuse of containers bearing
official marks, labels, etc.
317.11 Labeling, filling of containers, handling of labeled products to
be only in compliance with regulations.
317.12 Relabeling products; requirements.
317.13 Storage and distribution of labels and containers bearing
official marks.
317.14-317.15 [Reserved]
317.16 Labeling and containers of custom prepared products.
317.17 Interpretation and statement of labeling policy for cured
products; special labeling requirements concerning nitrate and
nitrite.
317.18 Quantity of contents labeling.
317.19 Definitions and procedures for determining net weight
compliance.
317.20 Scale requirements for accurate weights, repairs, adjustments,
and replacement after inspection.
317.21 Scales: testing of.
317.22 Handling of failed product.
317.23 [Reserved]
317.24 Packaging materials.
Subpart B--Nutrition Labeling
317.300 Nutrition labeling of meat or meat food products.
317.301 [Reserved]
317.302 Location of nutrition information.
317.303-317.307 [Reserved]
317.308 Labeling of meat or meat food products with number of servings.
317.309 Nutrition label content.
317.310-317.311 [Reserved]
317.312 Reference amounts customarily consumed per eating occasion.
317.313 Nutrient content claims; general principles.
317.314-317.342 [Reserved]
317.343 Significant participation for voluntary nutrition labeling.
317.344 Identification of major cuts of meat products.
317.345 Guidelines for voluntary nutrition labeling of single-
ingredient, raw products.
317.346-317.353 [Reserved]
317.354 Nutrient content claims for "good source," "high," and
"more".
317.355 [Reserved]
317.356 Nutrient content claims for "light" or "lite".
317.357-317.359 [Reserved]
317.360 Nutrient content claims for calorie content.
317.361 Nutrient content claims for the sodium content.
317.362 Nutrient content claims for fat, fatty acids, and cholesterol
content.
317.363 Nutrient content claims for "healthy".
317.364-317.368 [Reserved]
317.369 Labeling applications for nutrient content claims.
317.370-317.379 [Reserved]
317.380 Label statements relating to usefulness in reducing or
maintaining body weight.
317.381-317.399 [Reserved]
317.400 Exemption from nutrition labeling.
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
Source: 35 FR 15580, Oct. 3, 1970, unless otherwise noted.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.1]
[Page 154-155]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.1 Labels required; supervision by Program employee.
(a) When, in an official establishment, any inspected and passed
product is placed in any receptacle or covering constituting an
immediate container, there shall be affixed to such container a label as
described in Sec. 317.2 except that the following do not have to bear
such a label.
(1) Wrappings of dressed carcasses and primal parts in an
unprocessed state, bearing the official inspection legend, if such
wrappings are intended solely to protect the product against soiling or
excessive drying during transportation or storage, and the wrappings
bear no information except company brand names, trade marks, or code
numbers which do not include any information required by Sec. 317.2;
(2) Uncolored transparent coverings, such as cellophane, which bear
no written, printed, or graphic matter and which enclose any unpackaged
or packaged product bearing all markings required by part 316 of this
subchapter which are clearly legible through such coverings;
(3) Animal and transparent artificial casings bearing only the
markings required by part 316 of this subchapter;
(4) Stockinettes used as "operative devices", such as those
applied to cured meats in preparation for smoking, whether or not such
stockinettes are removed following completion of the operations for
which they were applied;
(5) Containers such as boil-in bags, trays of frozen dinners, and
pie pans which bear no information except company brand names,
trademarks, code numbers, directions for preparation and serving
suggestions, and which are
[[Page 155]]
enclosed in a consumer size container that bears a label as described in
Sec. 317.2;
(6) Containers of products passed for cooking or refrigeration and
moved from an official establishment under Sec. 311.1 of this
subchapter.
(b) Folders and similar coverings made of paper or similar
materials, whether or not they completely enclose the product and which
bear any written, printed, or graphic matter, shall bear all features
required on a label for an immediate container.
(c) No covering or other container which bears or is to bear a label
shall be filled, in whole or in part, except with product which has been
inspected and passed in compliance with the regulations in this
subchapter, which is not adulterated and which is strictly in accordance
with the statements on the label. No such container shall be filled, in
whole or in part, and no label shall be affixed thereto, except under
supervision of a Program employee.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.2]
[Page 155-163]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.2 Labels: definition; required features.
(a) A label within the meaning of this part shall mean a display of
any printing, lithographing, embossing, stickers, seals, or other
written, printed, or graphic matter upon the immediate container (not
including package liners) of any product.
(b) Any word, statement, or other information required by this part
to appear on the label must be prominently placed thereon with such
conspicuousness (as compared with other words, statements, designs, or
devices, in the labeling) and in such terms as to render it likely to be
read and understood by the ordinary individual under customary
conditions of purchase and use. In order to meet this requirement, such
information must appear on the principal display panel except as
otherwise permitted in this part. Except as provided in Sec. 317.7, all
words, statements, and other information required by or under authority
of the Act to appear on the label or labeling shall appear thereon in
the English language: Provided, however, That in the case of products
distributed solely in Puerto Rico, Spanish may be substituted for
English for all printed matter except the USDA inspection legend.
(c) Labels of all products shall show the following information on
the principal display panel (except as otherwise permitted in this
part), in accordance with the requirements of this part or, if
applicable, part 319 of this subchapter:
(1) The name of the product, which in the case of a product which
purports to be or is represented as a product for which a definition and
standard of identity or composition is prescribed in part 319 of this
subchapter, shall be the name of the food specified in the standard, and
in the case of any other product shall be the common or usual name of
the food, if any there be, and if there is none, a truthful descriptive
designation, as prescribed in paragraph (e) of this section;
(2) If the product is fabricated from two or more ingredients, the
word "ingredients" followed by a list of the ingredients as prescribed
in paragraph (f) of this section;
(3) The name and place of business of the manufacturer, packer, or
distributor for whom the product is prepared, as prescribed in paragraph
(g) of this section;
(4) An accurate statement of the net quantity of contents, as
prescribed in paragraph (h) of this section;
(5) An official inspection legend and, except as otherwise provided
in paragraph (i) of this section, the number of the official
establishment, in the form required by part 312 of this subchapter;
(6) Any other information required by the regulations in this part
or part 319 of this subchapter.
(d) The principal display panel shall be the part of a label that is
most likely to be displayed, presented, shown, or examined under
customary conditions of display for sale. Where packages bear alternate
principal display panels, information required to be placed on the
principal display panel shall be duplicated on each principal display
panel. The principal display panel shall be large enough to accommodate
all the mandatory label information required to be placed thereon by
this part and part 319 of this subchapter with clarity and
conspicuousness and without obscuring of such information by
[[Page 156]]
designs or vignettes or crowding. In determining the area of the
principal display panel, exclude tops, bottoms, flanges at tops and
bottoms of cans, and shoulders and necks of bottles or jars. The
principal display panel shall be:
(1) In the case of a rectangular package, one entire side, the area
of which is at least the product of the height times the width of that
side.
(2) In the case of a cylindrical or nearly cylindrical container:
(i) An area that is 40 percent of the product of the height of the
container times the circumference of the container, or
(ii) A panel, the width of which is one-third of the circumference
and the height of which is as high as the container: Provided, however,
That if there is immediately to the right or left of such principal
display panel, a panel which has a width not greater than 20 percent of
the circumference and a height as high as the container, and which is
reserved for information prescribed in paragraphs (c) (2), (3), and (5),
such panel shall be known as the "20 percent panel" and such
information may be shown on that panel in lieu of showing it on the
principal display panel.
(3) In the case of a container of any other shape, 40 percent of the
total surface of the container.
(e) Any descriptive designation used as a product name for a product
which has no common or usual name shall clearly and completely identify
the product. Product which has been prepared by salting, smoking,
drying, cooking, chopping, or otherwise shall be so described on the
label unless the name of the product implies, or the manner of packaging
shows that the product was subjected to such preparation. The
unqualified terms "meat," "meat byproduct," "meat food product,"
and terms common to the meat industry but not common to consumers such
as "picnic," "butt," "cala," "square," "loaf," "spread,"
"delight," "roll," "plate," "luncheon," and "daisy" shall not
be used as names of a product unless accompanied with terms descriptive
of the product or with a list of ingredients, as deemed necessary in any
specific case by the Administrator in order to assure that the label
will not be false or misleading.
(f)(1) The list of ingredients shall show the common or usual names
of the ingredients arranged in the descending order of predominance,
except as otherwise provided in this paragraph.
(i) The terms spice, natural flavor, natural flavoring, flavor and
flavoring may be used in the following manner:
(A) The term "spice" means any aromatic vegetable substance in the
whole, broken, or ground form, with the exceptions of onions, garlic and
celery, whose primary function in food is seasoning rather than
nutritional and from which no portion of any volatile oil or other
flavoring principle has been removed. Spices include the spices listed
in 21 CFR 182.10, and 184.
(B) The term "natural flavor," "natural flavoring," "flavor"
or "flavoring" means the essential oil, oleoresin, essence or
extractive, protein hydrolysate, distillate, or any product or roasting,
heating or enzymolysis, which contains the flavoring constituents
derived from a spice, fruit or fruit juice, vegetable or vegetable
juice, edible yeast, herb, bark, bud, root, leaf or any other edible
portion of a plant, meat, seafood, poultry, eggs, dairy products, or
fermentation products thereof, whose primary function in food is
flavoring rather than nutritional. Natural flavors include the natural
essence or extractives obtained from plants listed in 21 CFR 182.10,
182.20, 182.40, 182.50 and 184, and the substances listed in 21 CFR
172.510. The term natural flavor, natural flavoring, flavor or flavoring
may also be used to designate spices, powered onion, powdered garlic,
and powdered celery.
(ii) The term "corn syrup" may be used to designate either corn
syrup or corn syrup solids.
(iii) The term "animal and vegetable fats" or "vegetable and
animal fats" may be used to designate the ingredients of mixtures of
such edible fats in product designated "compound" or "shortening."
"Animal fats" as used herein means fat derived from inspected and
passed cattle, sheep, swine, or goats.
(iv) When a product is coated with pork fat, gelatin, or other
approved
[[Page 157]]
substance and a specific declaration of such coating appears contiguous
to the name of the product, the ingredient statement need not make
reference to the ingredients of such coating.
(v) When two meat ingredients comprise at least 70 percent of the
meat and meat byproduct ingredients of a formula and when neither of the
two meat ingredients is less than 30 percent by weight of the total meat
and meat byproducts used, such meat ingredients may be interchanged in
the formula without a change being made in the ingredients statement on
labeling materials: Provided, That the word "and" in lieu of a comma
shall be shown between the declaration of such meat ingredients in the
statement of ingredients.
(vi)(A) Product ingredients which are present in individual amounts
of 2 percent or less by weight may be listed in the ingredients
statement in other than descending order of predominance: Provided, That
such ingredients are listed by their common or usual names at the end of
the ingredients statement and preceded by a quantifying statement, such
as "Contains ---------- percent of ---------- ," "Less than --------
--percent of ---------- ." The percentage of the ingredient(s) shall be
filled in with a threshold level of 2 percent, 1.5 percent, 1.0 percent,
or 0.5 percent, as appropriate. No ingredient to which the quantifying
statement applies may be present in an amount greater than the stated
threshold. Such a quantifying statement may also be utilized when an
ingredients statement contains a listing of ingredients by individual
components. Each component listing may utilize the required quantifying
statement at the end of each component ingredients listing.
(B) Such ingredients may be adjusted in the product formulation
without a change being made in the ingredients statement on the
labeling, provided that the adjusted amount complies with
Sec. 318.7(c)(4) and part 319 of this subchapter, and does not exceed
the amount shown in the quantifying statement. Any such adjustments to
the formulation shall be provided to the inspector-in-charge.
(2) On containers of frozen dinners, entrees, pizzas, and similar
consumer packaged products in cartons the ingredient statement may be
placed on the front riser panel: Provided, That the words "see
ingredients" followed immediately by an arrow is placed on the
principal display panel immediately above the location of such statement
without intervening print or designs.
(3) The ingredient statement may be placed on the 20 percent panel
adjacent to the principal display panel and reserved for required
information, in the case of a cylindrical or nearly cylindrical
container.
(4) The ingredients statement may be placed on the information
panel, except as otherwise permitted in this subchapter.
(g)(1) The name or trade name of the person that prepared the
product may appear as the name of the manufacturer or packer without
qualification on the label. Otherwise the name of the distributor of the
product shall be shown with a phrase such as "Prepared for * * *". The
place of business of the manufacturer, packer, or distributor shall be
shown on the label by city, State, and postal ZIP code when such
business is listed in a telephone or city directory, and if not listed
in such directory, then the place of business shall be shown by street
address, city, State, and postal ZIP code.
(2) The name and place of business of the manufacturer, packer, or
distributor may be shown:
(i) On the principal display panel, or
(ii) On the 20 percent panel adjacent to the principal display panel
and reserved for required information, in the case of a cylindrical or
nearly cylindrical container, or
(iii) On the front riser panel of frozen food cartons, or
(iv) On the information panel.
(h)(1) The statement of net quantity of contents shall appear on the
principal display panel of all containers to be sold at retail intact,
in conspicuous and easily legible boldface print or type in distinct
contrast to other matter on the container, and shall be declared in
accordance with the provisions of this paragraph.
[[Page 158]]
(2) The statement as it is shown on a label shall not be false or
misleading and shall express an accurate statement of the quantity of
contents of the container. Reasonable variations caused by loss or gain
of moisture during the course of good distribution practices or by
unavoidable deviations in good manufacturing practices will be
recognized. Variations from stated quantity of contents shall be as
provided in Sec. 317.19. The statement shall not include any term
qualifying a unit of weight, measure, or count such as "jumbo quart,"
"full gallon," "giant quart," "when packed," "minimum," or words
of similar importance.
(3) The statement shall be placed on the principal display panel
within the bottom 30 percent of the area of the panel in lines generally
parallel to the base: Provided, That on packages having a principal
display panel of 5 square inches or less, the requirement for placement
within the bottom 30 percent of the area of the label panel shall not
apply when the statement meets the other requirements of this paragraph
(h). In any case, the statement may appear in more than one line. The
terms "net weight" or "net wt." shall be used when stating the net
quantity of contents in terms of weight, and the term "net contents"
or "content" when stating the net quantity of contents in terms of
fluid measure.
(4) Except as provided in Sec. 317.7, the statement shall be
expressed in terms of avoirdupois weight or liquid measure. Where no
general consumer usage to the contrary exists, the statement shall be in
terms of liquid measure, if the product is liquid, or in terms of weight
if the product is solid, semisolid viscous or a mixture of solid and
liquid. For example, a declaration of \3/4\-pound avoirdupois weight
shall be expressed as "Net Wt. 12 oz." except as provided for in
paragraph (h)(5) of this section for random weight packages; a
declaration of 1\1/2\ pounds avoirdupois weight shall be expressed as
"Net Wt. 24 oz. (1 lb. 8 oz.)," "Net Wt. 24 oz. (1\1/2\ lb.)," or
"Net Wt. 24 oz. (1.5 lbs.)."
(5) On packages containing 1 pound or 1 pint and less than 4 pounds
or 1 gallon, the statement shall be expressed as a dual declaration both
in ounces and (immediately thereafter in parentheses) in pounds, with
any remainder in terms of ounces or common or decimal fraction of the
pound, or in the case of liquid measure, in the largest whole units with
any remainder in terms of fluid ounces or common or decimal fractions of
the pint or quart, except that on random weight packages the statement
shall be expressed in terms of pounds and decimal fractions of the
pound, for packages over 1 pound, and for packages which do not exceed 1
pound the statement may be in decimal fractions of the pound in lieu of
ounces. Paragraph (h)(9) of this section permits certain exceptions from
the provisions of this paragraph for margarine packages, random weight
consumer size packages, and packages of less than \1/2\ ounce net
weight. Pargraph (h)(12) of this section permits certain exceptions from
the provision of this paragraph for multi-unit packages.
(6) The statement shall be in letters and numerals in type size
established in relationship to the area of the principal display panel
of the package and shall be uniform of all packages of substantially the
same size by complying with the following type specifications:
(i) Not less than one-sixteenth inch in height on packages, the
principal display panel of which has an area of 5 square inches or less;
(ii) Not less than one-eighth inch in height on packages, the
principal display panel of which has an area of more than 5 but not more
than 25 square inches;
(iii) Not less than three-sixteenths inch in height on packages, the
principal display panel of which has an area of more than 25 but not
more than 100 square inches;
(iv) Not less than one-quarter inch in height on packages, the
principal display panel of which has an area of more than 100 but not
more than 400 square inches.
(v) Not less than one-half inch in height on packages, the principal
display panel of which has an area of more than 400 square inches.
(7) The ratio of height to width of letters and numerals shall not
exceed a differential of 3 units to 1 unit (no more than 3 times as high
as it is wide). Heights pertain to upper case or
[[Page 159]]
capital letters. When upper and lower case or all lower case letters are
used, it is the lower case letter "o" or its equivalent that shall
meet the minimum standards. When fractions are used, each component
numeral shall meet one-half the height standards.
(8) The statement shall appear as a distinct item on the principal
display panel and shall be separated by a space at least equal to the
height of the lettering used in the statement from other printed label
information appearing above or below the statement and by a space at
least equal to twice the width of the letter "N" of the style of type
used in the quantity of contents statement from other printed label
information appearing to the left or right of the statement. It shall
not include any term qualifying a unit of weight, measure, or count such
as, "jumbo quart," "full gallon," "giant quart," "when packed,"
"Minimum" or words of similar import.
(9) The following exemptions from the requirements contained in this
paragraph (h) are hereby established:
(i) Individually wrapped, random weight consumer size packages
shipped in bulk containers (as specified in paragraph (h)(11) of this
section) and meat products that are subject to shrinkage through
moisture loss during good distribution practices and are designated as
gray area type of products as defined under Sec. 317.19 need not bear a
net weight statement when shipped from an official establishment,
provided that a net weight shipping statement which meets the
requirements of paragraph (h)(2) of this section is applied to their
shipping container prior to shipping it from the official establishment.
Net weight statements so applied to the shipping container are exempt
from the type size, dual declaration, and placement requirements of this
paragraph, if an accurate statement of net weight is shown conspicuously
on the principal display panel of the shipping container. The net weight
also shall be applied directly to random weight consumer size packages
prior to retail display and sale. The net weight statement on random
weight consumer size packages for retail sale shall be exempt from the
type size, dual declaration, and placement requirements of this
paragraph, if an accurate statement of net weight is shown conspicuously
on the principal display panel of the package.
(ii) Individually wrapped and labeled packages of less than \1/2\
ounce net weight and random weight consumer size packages shall be
exempt from the requirements of this paragraph if they are in a shipping
container and the statement of net quantity of contents on the shipping
container meets the requirements of paragraph (h)(2) of this section;
(iii) Individually wrapped and labeled packages of less than \1/2\
ounce net weight bearing labels declaring net weight, price per pound,
and total price, shall be exempt from the type size, dual declaration,
and placement requirements of this paragraph, if an accurate statement
of net weight is shown conspicuously on the principal display panel of
the package.
(iv) Margarine in 1 pound rectangular packages (except packages
containing whipped or soft margarine or packages that contain more than
four sticks) is exempt from the requirements of paragraphs (h) (3) and
(5) of this section regarding the placement of the statement of the net
quantity of contents within the bottom 30 percent of the principal
display panel and that the statement be expressed both in ounces and in
pounds, if the statement appears as "1 pound" or "one pound" in a
conspicuous manner on the principal display panel.
(v) Sliced shingle packed bacon in rectangular packages is exempt
from the requirements of paragraphs (h)(3) and (h)(5) of this section
regarding the placement of the statement of the net quantity of contents
within the bottom 30 percent of the principal display panel, and that
the statement be expressed both in ounces and in pounds, if the
statement appears in a conspicuous manner on the principal display
panel.
(10) Labels for containers which bear any representation as to the
number of servings contained therein shall bear, contiguous to such
representation, and in the same size type as is used for such
representation, a statement of the net quantity of each such serving.
(11) As used in this section, a "ran- dom weight consumer size
package" is
[[Page 160]]
one which is one of a lot, shipment or delivery of packages of the same
product with varying weights and with no fixed weight pattern.
(12) On a multiunit retail package, a statement of the net quantity
of contents shall appear on the outside of the package and shall include
the number of individual units, the quantity of each individual unit,
and in parentheses, the total net quantity of contents of the multiunit
package in terms of avoirdupois or fluid ounces, except that such
declaration of total quantity need not be followed by an additional
parenthetical declaration in terms of the largest whole units and
subdivisions thereof, as required by paragraph (h)(5) of this section.
For the purposes of this section, "multiunit retail package" means a
package containing two or more individually packaged units of the
identical commodity and in the same quantity, with the individual
packages intended to be sold as part of the multiunit retail package but
capable of being individually sold in full compliance with all
requirements of the regulations in this part. Open multiunit retail
packages that do not obscure the number of units and the labeling
thereon are not subject to this paragraph if the labeling of each
individual unit complies with the requirements of paragraphs (h) (2),
(3), (6), and (8) of this section.
(i) The official establishment number of the official establishment
in which the product was processed under inspection shall be placed as
follows:
(1) Within the official inspection legend in the form required by
part 312 of this subchapter; or
(2) Outside the official inspection legend elsewhere on the exterior
of the container or its labeling, e.g., the lid of a can, if shown in a
prominent and legible manner in a size sufficient to insure easy
visibility and recognition and accompanied by the prefix "EST"; or
(3) Off the exterior of the container, e.g., on a metal clip used to
close casings or bags, or on the back of a paper label of a canned
product, or on other packaging or labeling material in the container,
e.g., on aluminum pans and trays placed within containers, when a
statement of its location is printed contiguous to the official
inspection legend, such as "EST. No. on Metal Clip" or "Est. No. on
Pan", if shown in a prominent and legible manner in a size sufficient
to insure easy visibility and recognition; or
(4) On an insert label placed under a transparent covering if
clearly visible and legible and accompanied by the prefix "EST".
(j) Labels of any product within any of the following paragraphs
shall show the information required by such paragraph for such product:
(1) A label for product which is an imitation of another food shall
bear the word "imitation" immediately preceding the name of the food
imitated and in the same size and style of lettering as in that name and
immediately thereafter the word "ingredients:" and the names of the
ingredients arranged in the order of their predominance.
(2) If a product purports to be or is represented for any special
dietary use by man, its label shall bear a statement concerning its
vitamin, mineral, and other dietary properties upon which the claim for
such use is based in whole or in part and shall be in conformity with
regulations (21 CFR part 125) established pursuant to sections 403, and
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343, 371).
(3) When an artificial smoke flavoring or an smoke flavoring is
added as an ingredient in the formula of a meat food product, as
permitted in part 318 of this subchapter, there shall appear on the
label, in prominent letters and contiguous to the name of the product, a
statement such as "Artificial Smoke Flavoring Added" or "Smoke
Flavoring Added," as may be applicable, and the ingredient statement
shall identify any artificial smoke flavoring or smoke flavoring so
added as an ingredient in the formula of the meat food product.
(4) When any other artificial flavoring is permitted under part 318
of this subchapter to be added to a product, the ingredient statement
shall identify it as "Artificial Flavoring."
(5) When artificial coloring is added to edible fats as permitted
under part 318 of this subchapter such substance shall be declared on
the label in a prominent manner and contiguous to
[[Page 161]]
the name of the product by the words "Artificially colored" or
"Artificial coloring added" or "With added artificial coloring."
When natural coloring such as annatto is added to edible fats as
permitted under part 318 of this subchapter, such substance shall be
declared on the label in the same manner by a phrase such as "Colored
with annatto."
(6) When product is placed in a casing to which artificial coloring
is applied as permitted under part 318 of this subchapter, there shall
appear on the label, in a prominent manner and contiguous to the name of
the product, the words, "Artificially colored."
(7) If a casing is removed from product at an official establishment
and there is evidence of artificial coloring on the surface of the
product, there shall appear on the label, in a prominent manner and
contiguous to the name of product, the words "Artificially colored."
(8) When a casing is colored prior to its use as a covering for
product and the color is not transferred to the product enclosed in the
casing, no reference to color need appear on the label but no such
casing may be used if it is misleading or deceptive with respect to
color, quality, or kind of product, or otherwise.
(9) Product which bears or contains any other artificial coloring,
as permitted under part 318 of this subchapter, shall bear a label
stating that fact on the immediate container or if there is none, on the
product.
(10) When an antioxidant is added to product as permitted under part
318 of this subchapter, there shall appear on the label in prominent
letters and contiguous to the name of the product, a statement
identifying the officially approved specific antioxidant by its common
name or abbreviation thereof and the purpose for which it is added, such
as, "BHA, BHT, and Propylgallate added to help protect flavor."
(11) Containers of meat packed in borax or other preservative for
export to a foreign country which permits the use of such preservative
shall, at the time of packing, be marked "for export," followed on the
next line by the words "packed in preservative," or such equivalent
statement as may be approved for this purpose by the Administrator and
directly beneath this there shall appear the word "establishment" or
abbreviation thereof, followed by the number of the establishment at
which the product is packed. The complete statement shall be applied in
a conspicuous location and in letters not less than 1 inch in height.
(12) Containers of other product packed in, bearing, or containing
any chemical preservative shall bear a label stating that fact.
(13)(i) On the label of any "Mechanically Separated (Species)"
described in Sec. 319.5(a) of this subchapter, the name of such product
shall be followed immediately by the phrase "for processing" unless
such product has a protein content of not less than 14 percent and a fat
content of not more than 30 percent.
(ii) When any "Mechanically Separated (Species)" described in
Sec. 319.5 of this subchapter is used as an ingredient in the
preparation of a meat food product and such "Mechanically Separated
(Species)" contributes 20 mg or more of calcium to a serving of such
meat food product, the label of such meat food product shall state the
calcium content of such meat food product, determined and expressed as
the percentage of the U.S. Recommended Daily Allowance (U.S. RDA) in a
serving in accordance with 21 CFR 101.9(b)(1), (c)(7) (i) and (iv), and
(e), as part of any nutrition information included on such label, or if
such meat food product does not bear nutrition labeling information, as
part of a prominent statement in immediate conjunction with the list of
ingredients, as follows: "A ------ serving contains ----% of the U.S.
RDA of calcium", with the blanks to be filled in, respectively, with
the quantity of such product that constitutes a serving and the amount
of calcium provided by such serving: Provided, That, calcium content
need not be stated where (a) the percent of the U.S. RDA of calcium to
be declared would not differ from the percent of the U.S. RDA that would
be declared if the meat food product contained only hand deboned
ingredients or (b) the calcium content of a serving of the meat food
product would be 20 percent of the U.S. RDA or more
[[Page 162]]
if the meat food product contained only hand deboned ingredients.
(k) Packaged products which require special handling to maintain
their wholesome condition shall have prominently displayed on the
principal display panel of the label the statement: "Keep
Refrigerated," "Keep Frozen," "Perishable Keep Under
Refrigeration," or such similar statement as the Administrator may
approve in specific cases. Products that are distributed frozen during
distribution and thawed prior to or during display for sale at retail
shall bear the statement on the shipping container: "Keep Frozen." The
consumer-size containers for such products shall bear the statement
"Previously Handled Frozen for Your Protection, Refreeze or Keep
Refrigerated." For all perishable canned products the statement shall
be shown in upper case letters one-fourth inch in height for containers
having a net weight of 3 pounds or less, and for containers having a net
weight over 3 pounds, the statement shall be in upper case letters at
least one-half inch in height.
(l) Safe handling instructions shall be provided for: All meat and
meat products of cattle, swine, sheep, goat, horse, other equine that do
not meet the requirements contained in Sec. 318.17, or that have not
undergone other processing that would render them ready-to-eat; and all
comminuted meat patties not heat processed in a manner that conforms to
the time and temperature combinations in the Table for Permitted Heat-
Processing Temperature/Time Combinations For Fully-Cooked Patties in
Sec. 318.23, except as exempted under paragraph (l)(4) of this section.
(1)(i) Safe handling instructions shall accompany every meat or meat
product, specified in this paragraph (l) destined for household
consumers, hotels, restaurants, or similar institutions and shall appear
on the label. The information shall be in lettering no smaller than one-
sixteenth of an inch in size and shall be prominently placed with such
conspicuousness (as compared with other words, statements, designs or
devices in the labeling) as to render it likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use.
(ii) The safe handling information shall be presented on the label
under the heading "Safe Handling Instructions" which shall be set in
type size larger than the print size of the rationale statement and
handling statements as discussed in paragraphs (l)(2) and (l)(3) of this
section. The safe handling information shall be set off by a border and
shall be one color type printed on a single color contrasting background
whenever practical.
(2) The labels of the meat and meat products specified in this
paragraph (l) shall include the following rationale statement as part of
the safe handling instructions, "This product was prepared from
inspected and passed meat and/or poultry. Some food products may contain
bacteria that could cause illness if the product is mishandled or cooked
improperly. For your protection, follow these safe handling
instructions." This statement shall be placed immediately after the
heading and before the safe handling statements.
(3) Meat and meat products, specified in this paragraph (l), shall
bear the labeling statements:
(i) Keep refrigerated or frozen. Thaw in refrigerator or microwave.
(Any portion of this statement that is in conflict with the product's
specific handling instructions, may be omitted, e.g., instructions to
cook without thawing.) (A graphic illustration of a refrigerator shall
be displayed next to the statement.);
(ii) Keep raw meat and poultry separate from other foods. Wash
working surfaces (including cutting boards), utensils, and hands after
touching raw meat or poultry. (A graphic illustration of soapy hands
under a faucet shall be displayed next to the statement.);
(iii) Cook thoroughly. (A graphic illustration of a skillet shall be
displayed next to the statement.); and
(iv) Keep hot foods hot. Refrigerate leftovers immediately or
discard. (A graphic illustration of a thermometer shall be displayed
next to the statement.)
[[Page 163]]
(4) Meat or meat products intended for further processing at another
official establishment are exempt from the requirements prescribed in
paragraphs (l)(1) through (l)(3) of this section.
(m)(1) The information panel is that part of a label that is the
first surface to the right of the principal display panel as observed by
an individual facing the principal display panel, with the following
exceptions:
(i) If the first surface to the right of the principal display panel
is too small to accommodate the required information or is otherwise
unusable label space, e.g., folded flaps, tear strips, opening flaps,
heat-sealed flaps, the next panel to the right of this part of the label
may be used.
(ii) If the package has one or more alternate principal display
panels, the information panel is to the right of any principal display
panel.
(iii) If the top of the container is the principal display panel and
the package has no alternate principal display panel, the information
panel is any panel adjacent to the principal display panel.
(2) (i) Except as otherwise permitted in this part, all information
required to appear on the principal display panel or permitted to appear
on the information panel shall appear on the same panel unless there is
insufficient space. In determining the sufficiency of the available
space, except as otherwise prescribed in this part, any vignettes,
designs, and any other nonmandatory information shall not be considered.
If there is insufficient space for all required information to appear on
a single panel, it may be divided between the principal display panel
and the information panel, provided that the information required by any
given provision of this part, such as the ingredients statement, is not
divided and appears on the same panel.
(ii) All information appearing on the information panel pursuant to
this section shall appear in one place without intervening material,
such as designs or vignettes.
[35 FR 15580, Oct. 3, 1970]
Editorial Note: For Federal Register citations affecting Sec. 317.2,
see the List of CFR Sections Affected, which appears in the Finding Aids
section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.3]
[Page 163-164]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.3 Approval of abbreviations of marks of inspection; preparation of marking devices bearing inspection legend without advance approval prohibited;
exception.
(a) The Administrator may approve and authorize the use of
abbreviations of marks of inspection under the regulations in this
subchapter. Such abbreviations shall have the same force and effect as
the respective marks for which they are authorized abbreviations.
(b) Except for the purposes of preparing and submitting a sample or
samples of the same to the Administrator for approval, no brand
manufacturer, printer, or other person shall cast, print, lithograph, or
otherwise make any marking device containing any official mark or
simulation thereof, or any label bearing any such mark or simulation,
without the written authority therefor of the Administrator. However,
when any such sample label, or other marking device, is approved by the
Administrator, additional supplies of the approved label, or marking
device, may be made for use in accordance with the regulations in this
subchapter, without further approval by the Administrator. The
provisions of this paragraph apply only to labels, or other marking
devices, bearing or containing an official inspection legend shown in
Sec. 312.2(b), Sec. 312.3(a) (only the legend appropriate for horse meat
food products) or Sec. 312.3(b) (only the legend appropriate for other
(nonhorse) equine meat food products), or any abbreviations, copy or
representation thereof.
(c) No brand manufacturer or other person shall cast or otherwise
make, without an official certificate issued in quadruplicate by a
Program employee, a brand or other marking device containing an official
inspection legend, or simulation thereof, shown in Sec. 312.2(a),
Sec. 312.3(a) (only the legend appropriate for horse carcasses and parts
of horse carcasses), Sec. 312.3(b) (only the legend appropriate for
other equine (nonhorse) carcasses and parts of other (nonhorse) equine
carcasses) or Sec. 312.7(a).
(1) The certificate is a Food Safety and Inspection Service form for
signature by a Program employee and the
[[Page 164]]
official establishment ordering the brand or other marking device,
bearing a certificate serial number and a letterhead and the seal of the
United States Department of Agriculture. The certificate authorizes the
making of only the brands or other marking devices of the type and
quantity listed on the certificate.
(2) After signing the certificate, the Program employee and the
establishment shall each keep a copy, and the remaining two copies shall
be given to the brand or other marking device manufacturer.
(3) The manufacturer of the brands or other marking devices shall
engrave or otherwise mark each brand or other marking device with a
permanent identifying serial number unique to it. The manufacturer shall
list on each of the two copies of the certificate given to the
manufacturer the number of each brand or other marking device authorized
by the certificate. The manufacturer shall retain one copy of the
certificate for the manufacturer's records and return the remaining copy
with the brands or other marking devices to the Program employee whose
name and address are given on the certificate as the recipient.
(4) In order that all such brands or other marking devices bear
identifying numbers, within one year after June 24, 1985, an
establishment shall either replace each such brand or other marking
device which does not bear an identifying number, or, under the
direction of the inspector-in-charge, mark such brand or other marking
device with a permanent identifying number.
(Recordkeeping requirements approved by the Office of Management and
Budget under control number 0583-0015)
[35 FR 15580, Oct. 3, 1970, as amended at 50 FR 21422, May 24, 1985]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.4]
[Page 164-165]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.4 Labeling approval.
(a) No final labeling shall be used on any product unless the sketch
labeling of such final labeling has been submitted for approval to the
Food Labeling Division, Regulatory Programs, Food Safety and Inspection
Service, and approved by such division, accompanied by FSIS form,
Application for Approval of Labels, Marking, and Devices, except for
generically approved labeling authorized for use in Sec. 317.5(b). The
management of the official establishment or establishment certified
under a foreign inspection system, in accordance with part 327 of this
subchapter, must maintain a copy of all labeling used, along with the
product formulation and processing procedure, in accordance with part
320 of this subchapter. Such records shall be made available to any duly
authorized representative of the Secretary upon request.
(b) The Food Labeling Division shall permit submission for approval
of only sketch labeling, as defined in Sec. 317.4(d), for all products,
except as provided in Sec. 317.5(b) (2)-(9) and except for temporary use
of final labeling as prescribed in paragraph (f) of this section.
(c) All labeling required to be submitted for approval as set forth
in Sec. 317.4(a) shall be submitted in duplicate to the Food Labeling
Division, Regulatory Programs, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250. A parent company for a
corporation may submit only one labeling application (in duplicate form)
for a product produced in other establishments that are owned by the
corporation.
(d) "Sketch" labeling is a printer's proof or equivalent which
clearly shows all labeling features, size, location, and indication of
final color, as specified in Sec. 317.2. FSIS will accept sketches that
are hand drawn, computer generated or other reasonable facsimiles that
clearly reflect and project the final version of the labeling.
Indication of final color may be met by: submission of a color sketch,
submission of a sketch which indicates by descriptive language the final
colors, or submission with the sketch of previously approved final
labeling that indicates the final colors.
(e) Inserts, tags, liners, pasters, and like devices containing
printed or graphic matter and for use on, or to be placed within,
containers and coverings of product shall be submitted for approval in
the same manner as provided for labeling in Sec. 317.4(a), except that
such devices which contain no reference to product and bear no
misleading feature shall be used without
[[Page 165]]
submission for approval as prescribed in Sec. 317.5(b)(7).
(f)(1) Consistent with the requirements of this section, temporary
approval for the use of a final label or other final labeling that may
otherwise be deemed deficient in some particular may be granted by the
Food Labeling Division. Temporary approvals may be granted for a period
not to exceed 180 calendar days, under the following conditions:
(i) The proposed labeling would not misrepresent the product;
(ii) The use of the labeling would not present any potential health,
safety, or dietary problems to the consumer;
(iii) Denial of the request would create undue economic hardship;
and
(iv) An unfair competitive advantage would not result from the
granting of the temporary approval.
(2) Extensions of temporary approvals may also be granted by the
Food Labeling Division provided that the applicant demonstrates that new
circumstances, meeting the above criteria, have developed since the
original temporary approval was granted.
(g) The inspector-in-charge shall approve meat carcass ink brands
and meat food product ink and burning brands, which comply with parts
312 and 316 of this subchapter.
[60 FR 67454, Dec. 29, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.5]
[Page 165-166]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.5 Generically approved labeling.
(a)(1) An official establishment or an establishment certified under
a foreign inspection system, in accordance with part 327 of this
subchapter, is authorized to use generically approved labeling, as
defined in paragraph (b) of this section, without such labeling being
submitted for approval to the Food Safety and Inspection Service in
Washington or the field, provided the labeling is in accordance with
this section and shows all mandatory features in a prominent manner as
required in Sec. 317.2, and is not otherwise false or misleading in any
particular.
(2) The Food Safety and Inspection Service shall select samples of
generically approved labeling from the records maintained by official
establishments and establishments certified under foreign inspection
systems, in accordance with part 327 of this subchapter, as required in
Sec. 317.4, to determine compliance with labeling requirements. Any
finding of false or misleading labeling shall institute the proceedings
prescribed in Sec. 335.12.
(b) Generically approved labeling is labeling which complies with
the following:
(1) Labeling for a product which has a product standard as specified
in part 319 of this subchapter or the Standards and Labeling Policy Book
and which does not contain any special claims, such as quality claims,
nutrient content claims, health claims, negative claims, geographical
origin claims, or guarantees, or which is not a domestic product labeled
in a foreign language;
(2) Labeling for single-ingredient products (such as beef steak or
lamb chops) which does not contain any special claims, such as quality
claims, nutrient content claims, health claims, negative claims,
geographical origin claims, or guarantees, or which is not a domestic
product labeled with a foreign language;
(3) Labeling for containers of products sold under contract
specifications to Federal Government agencies, when such product is not
offered for sale to the general public, provided that the contract
specifications include specific requirements with respect to labeling,
and are made available to the inspector-in-charge;
(4) Labeling for shipping containers which contain fully labeled
immediate containers, provided such labeling complies with Sec. 316.13;
(5) Labeling for products not intended for human food, provided they
comply with part 325 of this subchapter;
(6) Meat inspection legends, which comply with parts 312 and 316 of
this subchapter;
(7) Inserts, tags, liners, pasters, and like devices containing
printed or graphic matter and for use on, or to be placed within
containers, and coverings of products, provided such devices contain no
reference to product and bear no misleading feature;
(8) Labeling for consumer test products not intended for sale; and
(9) Labeling which was previously approved by the Food Labeling
Division
[[Page 166]]
as sketch labeling, and the final labeling was prepared without
modification or with the following modifications:
(i) All features of the labeling are proportionately enlarged or
reduced, provided that all minimum size requirements specified in
applicable regulations are met and the labeling is legible;
(ii) The substitution of any unit of measurement with its
abbreviation or the substitution of any abbreviation with its unit of
measurement, e.g., "lb." for "pound," or "oz." for "ounce," or
of the word "pound" for "lb." or "ounce" for "oz.";
(iii) A master or stock label has been approved from which the name
and address of the distributor are omitted and such name and address are
applied before being used (in such case, the words "prepared for" or
similar statement must be shown together with the blank space reserved
for the insertion of the name and address when such labels are offered
for approval);
(iv) Wrappers or other covers bearing pictorial designs, emblematic
designs or illustrations, e.g., floral arrangements, illustrations of
animals, fireworks, etc. are used with approved labeling (the use of
such designs will not make necessary the application of labeling not
otherwise required);
(v) A change in the language or the arrangement of directions
pertaining to the opening of containers or the serving of the product;
(vi) The addition, deletion, or amendment of a dated or undated
coupon, a cents-off statement, cooking instructions, packer product code
information, or UPC product code information;
(vii) Any change in the name or address of the packer, manufacturer
or distributor that appears in the signature line;
(viii) Any change in the net weight, provided the size of the net
weight statement complies with Sec. 317.2;
(ix) The addition, deletion, or amendment of recipe suggestions for
the product;
(x) Any change in punctuation;
(xi) Newly assigned or revised establishment numbers for a
particular establishment for which use of the labeling has been approved
by the Food Labeling Division, Regulatory Programs;
(xii) The addition or deletion of open dating information;
(xiii) A change in the type of packaging material on which the label
is printed;
(xiv) Brand name changes, provided that there are no design changes,
the brand name does not use a term that connotes quality or other
product characteristics, the brand name has no geographic significance,
and the brand name does not affect the name of the product;
(xv) The deletion of the word "new" on new product labeling;
(xvi) The addition, deletion, or amendment of special handling
statements, provided that the change is consistent with Sec. 317.2(k);
(xvii) The addition of safe handling instructions as required by
Sec. 317.2(l);
(xviii) Changes reflecting a change in the quantity of an ingredient
shown in the formula without a change in the order of predominance shown
on the label, provided that the change in quantity of ingredients
complies with any minimum or maximum limits for the use of such
ingredients prescribed in parts 318 and 319 of this subchapter;
(xix) Changes in the color of the labeling, provided that sufficient
contrast and legibility remain;
(xx) A change in the product vignette, provided that the change does
not affect mandatory labeling information or misrepresent the content of
the package;
(xxi) A change in the establishment number by a corporation or
parent company for an establishment under its ownership;
(xxii) Changes in nutrition labeling that only involve quantitative
adjustments to the nutrition labeling information, except for serving
sizes, provided the nutrition labeling information maintains its
accuracy and consistency;
(xxiii) Deletion of any claim, and the deletion of non-mandatory
features or non-mandatory information; and
(xxiv) The addition or deletion of a direct translation of the
English language into a foreign language for products marked "for
export only."
[60 FR 67455, Dec. 29, 1995]
[[Page 167]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.6]
[Page 167]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.6 Approved labels to be used only on products to which they are applicable.
Labels shall be used only on products for which they are approved,
and only if they have been approved for such products in accordance with
Sec. 317.3: Provided, That existing stocks of labels approved prior to
the effective date of this section and the quantity of which has been
identified to the circuit supervisor as being in storage on said date at
the official establishment or other identified warehouse for the account
of the operator of the official establishment may be used until such
stocks are exhausted, but not later than 1 year after the effective date
of this section unless such labels conform to all the requirements of
this part and part 319 of this subchapter. The Administrator may upon
the show of good cause grant individual extension of time as he deems
necessary.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.7]
[Page 167]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations.
Labels to be affixed to packages of products for foreign commerce
may be printed in a foreign language and may show the statement of the
quantity of contents in accordance with the usage of the country to
which exported and other deviations from the form of labeling required
under this part may be approved for such product by the Administrator in
specific cases: Provided,
(a) That the proposed labeling accords to the specifications of the
foreign purchaser,
(b) That it is not in conflict with the laws of the country to which
the product is intended for export, and
(c) That the outside container is labeled to show that it is
intended for export; but if such product is sold or offered for sale in
domestic commerce, all the requirements of this subchapter apply. The
inspection legend and the establishment number shall in all cases appear
in English but in addition, may appear literally translated in a foreign
language.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.8]
[Page 167-172]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.8 False or misleading labeling or practices generally; specific prohibitions and requirements for labels and containers.
(a) No product or any of its wrappers, packaging, or other
containers shall bear any false or misleading marking, label, or other
labeling and no statement, word, picture, design, or device which
conveys any false impression or gives any false indication of origin or
quality or is otherwise false or misleading shall appear in any marking
or other labeling. No product shall be wholly or partly enclosed in any
wrapper, packaging, or other container that is so made, formed, or
filled as to be misleading.
(b) The labels and containers of product shall comply with the
following provisions, as applicable:
(1) Terms having geographical significance with reference to a
locality other than that in which the product is prepared may appear on
the label only when qualified by the word "style," "type," or
"brand," as the case may be, in the same size and style of lettering
as in the geographical term, and accompanied with a prominent qualifying
statement identifying the country, State, Territory, or locality in
which the product is prepared, using terms appropriate to effect the
qualification. When the word "style" or "type" is used, there must
be a recognized style or type of product identified with and peculiar to
the area represented by the geographical term and the product must
possess the characteristics of such style or type, and the word
"brand" shall not be used in such a way as to be false or misleading:
Provided, That a geographical term which has come into general usage as
a trade name and which has been approved by the Administrator as being a
generic term may be used without the qualifications provided for in this
paragraph. The terms "frankfurter," "vi- enna," "bologna,"
"lebanon bologna," "braunschweiger," "thuringer," "genoa,"
"leona," "berliner," "hol- stein," "goteborg," "milan,"
"polish," "italian," and their modifications, as applied to
sausages, the terms "bruns- wick" and "irish" as applied to stews
[[Page 168]]
and the term "boston" as applied to pork shoulder butts need not be
accompanied with the word "style," "type," or "brand," or a
statement identifying the locality in which the product is prepared.
(2) Such terms as "farm" or "country" shall not be used on
labels in connection with products unless such products are actually
prepared on the farm or in the country: Provided, That if the product is
prepared in the same way as on the farm or in the country these terms,
if qualified by the word "style" in the same size and style of
lettering, may be used: Provided further, That the term "farm" may be
used as part of a brand designation when qualified by the word "brand"
in the same size and style of lettering, and followed with a statement
identifying the locality in which the product is prepared: And Provided
further, That the provisions of this paragraph shall not apply to
products prepared in accordance with Sec. 319.106 of this subchapter.
Sausage containing cereal shall not be labeled "farm style" or
"country style," and lard not rendered in an open kettle shall not be
designated as "farm style" or "country style."
(3) The requirement that the label shall contain the name and place
of business of the manufacturer, packer, or distributor shall not
relieve any establishment from the requirement that its label shall not
be misleading in any particular.
(4) The term "spring lamb" or "genuine spring lamb" is
applicable only to carcasses of new-crop lambs slaughtered during the
period beginning in March and terminating not beyond the close of the
week containing the first Monday in October.
(5)(i) Coverings shall not be of such color, design, or kind as to
be misleading with respect to color, quality, or kind of product to
which they are applied. For example, transparent or semitransparent
coverings for such articles as sliced bacon or fresh (uncooked) meat and
meat food products shall not bear lines or other designs of red or other
color which give a false impression of leanness of the product.
Transparent or semitransparent wrappers, casings, or coverings for use
in packaging cured, cured and smoked, or cured and cooked sausage
products, and sliced ready-to-eat meat food products may be color tinted
or bear red designs on 50 percent of such wrapper or covering: Provided,
That the transparent or semitransparent portion of the principal display
panel is free of color tinting and red designs: And provided further,
That the principal display panel provides at least 20 percent
unobstructed clear space, consolidated in one area so that the true
nature and color of the product is visible to the consumer.
(ii) Packages for sliced bacon that have a transparent opening shall
be designed to expose, for viewing, the cut surface of a representative
slice. Packages for sliced bacon which meet the following specifications
will be accepted as meeting the requirements of this subparagraph
provided the enclosed bacon is positioned so that the cut surface of the
representative slice can be visually examined:
(a) For shingle-packed sliced bacon, the transparent window shall be
designed to reveal at least 70 percent of the length (longest dimension)
of the representative slice, and this window shall be at least 1\1/2\
inches wide. The transparent window shall be located not more than five-
eighths inch from the top or bottom edge of a 1-pound or smaller package
and not more than three-fourths inch from either the top or bottom edge
of a package larger than 1 pound.
(b) For stack-packed sliced bacon, the transparent window shall be
designed to reveal at least 70 percent of the length (longest dimension)
of the representative slice and be at least 1\1/2\ inches wide.
(6) The word "fresh" shall not be used on labels to designate
product which contains any sodium nitrate, sodium nitrite, potassium
nitrate, or potassium nitrite, or which has been salted for
preservation.
(7)(i) No ingredient shall be designated on the label as a spice,
flavoring, or coloring unless it is a spice, flavoring, or coloring, as
the case may be. An ingredient that is both a spice and a coloring, or
both a flavoring and a coloring, shall be designated as
[[Page 169]]
"spice and coloring", or "flavoring and coloring", as the case may
be, unless such ingredient is designated by its common or usual name.
(ii) Any ingredient not designated in Sec. 317.2(f)(1)(i) of this
part whose function is flavoring, either in whole or in part, must be
designated by its common or usual name. Those ingredients which are of
livestock and poultry origin must be designated by names that include
the species and livestock and poultry tissues from which the ingredients
are derived.
(8) As used on labels of product, the term "gelatin" shall mean
(i) the jelly prepared in official establishments by cooking pork skins,
tendons, or connective tissue from inspected and passed product, and
(ii) dry commercial gelatin or the jelly resulting from its use.
(9) Product (other than canned product) labeled with the term
"loaf" as part of its name:
(i) If distributed from the official establishment in consumer size
containers may be in any shape;
(ii) If distributed in a container of a size larger than that sold
intact at retail the product shall be prepared in rectangular form, or
as in paragraph (b)(9)(iii) of this section;
(iii) If labeled as an "Old Fashioned Loaf" shall be prepared in a
traditional form, such as rectangular with rounded top or circular with
flat bottom and rounded top.
(10) The term "baked" shall apply only to product which has been
cooked by the direct action of dry heat and for a sufficient time to
permit the product to assume the characteristics of a baked article,
such as the formation of a brown crust on the surface, rendering out of
surface fat, and the caramelization of the sugar if applied. Baked
loaves shall be heated to a temperature of at least 160 deg.F. and
baked pork cuts shall be heated to an internal temperature of at least
170 deg.F.
(11) When products such as loaves are browned by dipping in hot
edible oil or by a flame, the label shall state such fact, e.g., by the
words "Browned in Hot Cottonseed Oil" or "Browned by a Flame," as
the case may be, appearing as part of the product name.
(12) The term "meat" and the names of particular kinds of meat,
such as beef, veal, mutton, lamb, and pork, shall not be used in such
manner as to be false or misleading.
(13) The word "ham," without any prefix indicating the species of
animal from which derived, shall be used in labeling only in connection
with the hind legs of swine. Ham shanks as such or ham shank meat as
such or the trimmings accruing in the trimming and shaping of hams shall
not be labeled "ham" or "ham meat" without qualification. When used
in connection with a chopped product the term "ham" or "ham meat"
shall not include the skin.
(14) The terms "shankless" and "hockless" shall apply only to
hams and pork shoulders from which the shank or hock has been completely
removed, thus eliminating the entire tibia and fibula, or radius and
ulna, respectively, together with the overlying muscle, skin, and other
tissue.
(15) Such terms as "meat extract" or "extract of beef" without
qualification shall not be used on labels in connection with products
prepared from organs or other parts of the carcass, other than fresh
meat. Extracts prepared from any parts of the carcass other than fresh
meat may be properly labeled as extracts with the true name of the parts
from which prepared. In the case of extract in fluid form, the word
"fluid" shall also appear on the label, as, for example, "fluid
extract of beef."
(16) [Reserved]
(17) When any product is enclosed in a container along with a
packing substance such as brine, vinegar, or agar jelly, a declaration
of the packing substance shall be printed prominently on the label as
part of the name of the product, as for example, "frankfurts packed in
brine," "lamb tongue packed in vinegar," or "beef tongue packed in
agar jelly," as the case may be. The packing substance shall not be
used in such a manner as will result in the container being so filled as
to be misleading.
(18) "Leaf lard" is lard prepared from fresh leaf fat.
(19) When lard or hardened lard is mixed with rendered pork fat or
hardened rendered pork fat, the mixture
[[Page 170]]
shall be designated as "rendered pork fat" or "hardened rendered pork
fat," as the case may be.
(20) Oil, stearin, or stock obtained from beef or mutton fats
rendered at a temperature above 170 deg.F. shall not be designated as
"oleo oil," "oleo stearin," or "oleo stock," respectively.
(21) When not more than 20 percent of beef fat, mutton fat, oleo
stearin, vegetable stearin, or hardened vegetable fat is mixed with lard
or with rendered pork fat, there shall appear on the label, contiguous
to and in the same size and style of lettering as the name of the
product, the words "beef fat added," "mutton fat added," "oleo
stearin added," "vegetable stearin added," or "hardened vegetable
fat added," as the case may be. If more than 20 percent is added, the
product name shall refer to the particular animal fat or fats used, such
as, "Lard and Beef Fat." The designation "vegetable fat" is
applicable to vegetable oil, vegetable stearin, or a combination of such
oil and stearin, whereas the designations "vegetable oil" and
"vegetable stearin" shall be applicable only to the oil and the
stearin respectively, when used in meat food products.
(22) Cooked, cured, or pickled pigs feet, pigs knuckles, and similar
products, shall be labeled to show that the bones remain in the product,
if such is the case. The designation "semi-boneless" shall not be used
if less than 50 percent of the total weight of bones has been removed.
(23) When monoglycerides, diglycerides, and/or polyglycerol esters
of fatty acids are added to rendered animal fat or a combination of such
fat and vegetable fat, there shall appear on the label in a prominent
manner and contiguous to the name of the product a statement such as
"With Monoglycerides and Diglycerides Added," or "With Diglycerides
and Monoglycerides," or "With Polyglycerol Esters of Fatty Acids" as
the case may be.
(24) Section 407 of the Federal Food, Drug, and Cosmetic Act
contains provisions with respect to colored margarine or colored
oleomargarine (21 U.S.C. 347) which are set forth herein as footnote.
\1\
---------------------------------------------------------------------------
\1\ "Sec. 407(a) Colored oleomargarine or colored margarine which
is sold in the same State or Territory in which it is produced shall be
subject in the same manner and to the same extent to the provisions of
this Act as if it had been introduced in interstate commerce.
(b) No person shall sell, or offer for sale, colored oleomargarine
or colored margarine unless--
(1) Such oleomargarine or margarine is packaged,
(2) The net weight of the contents of any package sold in a retail
establishment is one pound or less,
(3) There appears on the label of the package (A) The word
`oleomargarine' or `margarine' in type or lettering at least as large as
any other type or lettering on such label, and (B) A full and accurate
statement of all the ingredients contained in such oleomargarine, or
margarine, and
(4) Each part of the contents of the package is contained in a
wrapper which bears the word `oleomargarine' or `margarine' in type or
lettering not smaller than 20-point type.
The requirements of this subsection shall be in addition to and not
in lieu of any of the other requirements of this Act.
(c) No person shall possess in a form ready for serving colored
oleomargarine or colored margarine at a public eating place unless a
notice that oleomargarine or margarine is served is displayed
prominently and conspicuously in such place and in such manner as to
render it likely to be read and understood by the ordinary individual
being served in such eating place or is printed or is otherwise set
forth on the menu in type or lettering not smaller than that normally
used to designate the serving of other food items. No person shall serve
colored oleomargarine or colored margarine at a public eating place,
whether or not any charge is made therefor, unless (1) each separate
serving bears or is accompanied by labeling identifying it as
oleomargarine or margarine, or (2) each separate serving thereof is
triangular in shape.
(d) Colored oleomargarine or colored margarine when served with
meals at a public eating place shall at the time of such service be
exempt from the labeling requirements of section 343 of this Act (except
subsection (a) and (f) of section 343 of this title) if it complies with
the requirements of subsection (b) of this section.
(e) For the purpose of this section colored oleomargarine or colored
margarine is oleomargarine or margarine having a tint or shade
containing more than one and six tenths degrees of yellow or of yellow
and red collectively, but with an excess of yellow over red, measured in
terms of Lovibond tintometer scale or its equivalent" (21 U.S.C. 347).
---------------------------------------------------------------------------
[[Page 171]]
(25) When approved proteolytic enzymes as permitted in part 318 of
this subchapter are used on steaks or other raw meat cuts, there shall
appear on the label, in a prominent manner, contiguous to the product
name, the statement, "Tenderized with [approved enzyme]," to indicate
the use of such enzymes. Any other approved substance which may be used
in the solution shall also be included in the statement.
When approved inorganic chlorides as permitted in part 318 of this
subchapter are used on steaks or other raw meat cuts there shall appear
on the label in a prominent manner, contiguous to the product name, the
statement, "Tenderized with (names of approved inorganic chloride(s))"
to indicate the use of such inorganic chlorides. Any other approved
substance which may be in the solution shall also be included in the
statement.
(26) When dimethylpolysiloxan is added as an antifoaming agent to
rendered fats, its presence shall be declared on the label contiguous to
the name of the product. Such declaration shall read
"Dimethylpolysiloxan Added."
(27) When pizzas are formulated with crust containing calcium
propionate or sodium propionate, there shall appear on the label
contiguous to the name of the product the statement "-------- added to
retard spoilage of crust" preceded by the name of the preservative.
(28) Sausage of the dry varieties treated with potassium sorbate or
propylparaben (propyl p-hydroxybenzoate) as permitted by part 318 of
this subchapter, shall be marked or labeled with a statement disclosing
such treatment and the purpose thereof, such as "dipped in a potassium
sorbate solution to retard mold growth."
(29) Meat of goats shall be identified as goat meat or chevon.
(30) The term "Chitterlings" shall apply to the large intestines
of swine, or young bovine animals when preceded with the word "Calf"
or "Veal." Meat food products that contain chitterlings or calf or
veal chitterlings, in accordance with Sec. 318.6(b)(8) of this
subchapter shall be identified with product names that refer to such
ingredients, as for instance, "Chitterling Loaf," "Chitterling Pie,"
or "Calf Chitterlings and Gravy," and shall be packed in containers
having a capacity of 3 pounds or less and of a kind usually sold at
retail intact and bearing such other information as is required by this
part.
(31) Products that contain blood from livestock as permitted by part
318 of this subchapter shall be labeled with a name that includes the
term "blood," and the specific kind of blood shall be declared in the
ingredient statement, e.g., "Swine blood," in the manner required by
this part.
(32) A calendar date may be shown on labeling when declared in
accordance with the provisions of this subparagraph:
(i) The calendar date shall express the month of the year and the
day of the month for all products and also the year in the case of
products hermetically sealed in metal or glass containers, dried or
frozen products, or any other products that the Administrator finds
should be labeled with the year because the distribution and marketing
practices with respect to such products may cause a label without a year
identification to be misleading.
(ii) Immediately adjacent to the calendar date shall be a phrase
explaining the meaning of such date, in terms of "packing" date,
"sell by" date, or "use before" date, with or without a further
qualifying phrase, e.g., "For Maximum Freshness" or "For Best
Quality", and such phrases shall be approved by the Administrator as
prescribed in Sec. 317.4.
(33) [Reserved]
(34) The terms "All," "Pure," "100%," and terms of similar
connotation shall not be used on labels for products to identify
ingredient content, unless the product is prepared solely from a single
ingredient.
(35) When agar-agar is used in canned jellied meat food products, as
permitted in part 318 of this subchapter, there shall appear on the
label in a prominent manner, contiguous to the product name, a statement
to indicate the use of agar-agar.
[[Page 172]]
(36) When sodium alginate, calcium carbonate, and lactic acid and
calcium carbonate (or glucono delta-lactone) are used together in a dry
binding matrix in restructured, formed meat food products, as permitted
in part 318 of this subchapter, there shall appear on the label
contiguous to the product name, a statement to indicate the use of
sodium alginate, calcium carbonate and lactic acid and calcium carbonate
(or glucono delta-lactone).
(37) The labels of sausages encased in natural casings made from
meat or poultry viscera shall identify the type of meat or poultry from
which the casings were derived, if the casings are from a different type
of meat or poultry than the encased meat or poultry. The identity of the
casing, if required, may be placed on the principal display panel or in
the ingredient statement. Establishments producing, manufacturing, or
using natural sausage casings are to maintain records documenting the
meat or poultry source in accordance with part 320 of this chapter.
(38) The labels of sausages encased in regenerated collagen casings
shall disclose this fact on the product label. The fact that the sausage
is encased in collagen may be placed on the principal display panel or
in the ingredient statement.
(39) When transglutaminase enzyme is used to bind pieces of meat to
form a cut of meat, or to reform a piece of meat from a multiple cuts,
there shall appear on the label, as part of the product name, a
statement that indicates that the product has been "formed" or
"reformed," in addition to other preparation steps, e.g., "Formed
Beef Tenderloin" or "Reformed and Shaped Beef Tenderloin."
[35 FR 15580, Oct. 3, 1970]
Editorial Note: For Federal Register citations affecting Sec. 317.8,
see the List of CFR Sections Affected, which appears in the Finding Aids
section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.9]
[Page 172]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.9 Labeling of equine products.
The immediate containers of any equine products shall be labeled to
show the kinds of animals from which derived when the products are sold,
transported, offered for sale or transportation or received for
transportation in commerce.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.10]
[Page 172]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.10 Reuse of official inspection marks; reuse of containers bearing official marks, labels, etc.
(a) No official inspection legend or other official mark which has
been previously used shall be used again for the identification of any
product, except as provided for in paragraph (b) of this section.
(b) All stencils, marks, labels, or other labeling on previously
used containers, whether relating to any product or otherwise, shall be
removed or obliterated before such containers are used for any product,
unless such labeling correctly indicates the product to be packed
therein and such containers are refilled under the supervision of a
Program employee.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.11]
[Page 172]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.11 Labeling, filling of containers, handling of labeled products to be only in compliance with regulations.
(a) No person shall in any official establishment apply or affix, or
cause to be applied or affixed, any label to any product prepared or
received in such establishment, or to any container thereof, or fill any
container at such an establishment, except in compliance with the
regulations in this subchapter.
(b) No covering or other container shall be filled, in whole or in
part, at any official establishment with any product unless it has been
inspected and passed in compliance with the regulations in this
subchapter, is not adulterated, and is strictly in accordance with the
statements on the label, and such filling is done under the supervision
of a Program employee.
(c) No person shall remove, or cause to be removed from an official
establishment any product bearing a label unless such label is in
compliance with the regulations in this subchapter, or any product not
bearing a label required by such regulations.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.12]
[Page 172-173]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.12 Relabeling products; requirements.
When it is claimed by an official establishment that any of its
products which bore labels bearing official
[[Page 173]]
marks has been transported to a location other than an official
establishment, and it is desired to relabel the product because the
labels have become mutilated or otherwise damaged, a request for
relabeling the product shall be sent to the Administrator, accompanied
with a statement of the reasons therefor. Labeling material intended for
relabeling inspected and passed product shall not be transported from an
official establishment until permission has been received from the
Administrator. The relabeling of inspected and passed product with
labels bearing any official marks shall be done under the supervision of
a Program inspector. The official establishment shall reimburse the
Program, in accordance with the regulations of the Department, for any
cost involved in supervising the relabeling of such product.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.13]
[Page 173]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.13 Storage and distribution of labels and containers bearing official marks.
Labels, wrappers, and containers bearing any official marks, with or
without the establishment number, may be transported from one official
establishment to any other official establishment provided such
shipments are made with the prior authorization of the inspector in
charge at point of origin, who will notify the inspector in charge at
destination concerning the date of shipment, quantity, and type of
labeling material involved. No such material shall be used at the
establishment to which it is shipped unless such use conforms with the
requirements of this subchapter.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.16]
[Page 173]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.16 Labeling and containers of custom prepared products.
Products that are custom prepared under Sec. 303.1(a)(2) of this
subchapter must be packaged immediately after preparation and must be
labeled (in lieu of information otherwise required by this part 317)
with the words "Not For Sale" in lettering not less than three-eighth
inch in height. Such exempted custom prepared products or their
containers may bear additional labeling provided such labeling is not
false or misleading.
[37 FR 4071, Feb. 26, 1972]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.17]
[Page 173-174]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.17 Interpretation and statement of labeling policy for cured products; special labeling requirements concerning nitrate and nitrite.
(a) With respect to sections 1(n) (7), (9), and (12) of the Act and
Sec. 317.2, any substance mixed with another substance to cure a product
must be identified in the ingredients statement on the label of such
product. For example, curing mixtures composed of such ingredients as
water, salt, sugar, sodium phosphate, sodium nitrate, and sodium nitrite
or other permitted substances which are added to any product, must be
identified on the label of the product by listing each such ingredient
in accordance with the provisions of Sec. 317.2.
(b) Any product, such as bacon and pepperoni, which is required to
be labeled by a common or usual name or descriptive name in accordance
with Sec. 317.2(c)(1) and to which nitrate or nitrite is permitted or
required to be added may be prepared without nitrate or nitrite and
labeled with such common or usual name or descriptive name when
immediately preceded with the term "Uncured" as part of the product
name in the same size and style of lettering as the product name,
provided that the product is found by the Administrator to be similar in
size, flavor, consistency, and general appearance to such product as
commonly prepared with nitrate or nitrite, or both.
(c)(1) Products described in paragraph (b) of this section or
Sec. 319.2 of this subchapter, which contain no nitrate or nitrite shall
bear the statement "No Nitrate or Nitrite Added." This statement shall
be adjacent to the product name in lettering of easily readable style
and at least one-half the size of the product name.
(2) Products described in paragraph (b) of this section and
Sec. 319.2 of this subchapter shall bear, adjacent to the product name
in lettering of easily readable style and at least one-half the
[[Page 174]]
size of the product name, the statement "Not Preserved--Keep
Refrigerated Below 40 deg.F. At All Times" unless they have been
thermally processed to Fo 3 or more; they have been fermented
or pickled to pH of 4.6 or less; or they have been dried to a water
activity of 0.92 or less.
(3) Products described in paragraph (b) of this section and
Sec. 319.2 of this subchapter shall not be subject to the labeling
requirements of paragraphs (b) and (c) of this section if they contain
an amount of salt sufficient to achieve a brine concentration of 10
percent or more.
[37 FR 16863, Aug. 22, 1972, as amended at 44 FR 48961, Aug. 21, 1979]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.18]
[Page 174]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.18 Quantity of contents labeling.
Sections 317.18 through 317.22 of this part prescribe the procedures
to be followed for determining net weight compliance and prescribe the
reasonable variations from the declared net weight on the labels of
immediate containers of products in accordance with Sec. 317.2(h) of
this part.
[55 FR 49834, Nov. 30, 1990]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.19]
[Page 174-175]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.19 Definitions and procedures for determining net weight compliance.
(a) For the purpose of Secs. 317.18 through 317.22 of this part, the
reasonable variations allowed, definitions, and procedures to be used in
determining net weight and net weight compliance are described in the
National Institute of Standards and Technology (NIST) Handbook 133,
"Checking the Net Contents of Packaged Goods," Third Edition,
September 1988, and Supplements 1, 2, 3, and 4 dated September 1990,
October 1991, October 1992, and October 1994, respectively, which are
incorporated by reference, with the exception of the NIST Handbook 133
and Supplements 1, 3, and 4 requirements listed in paragraphs (b) and
(c) of this section. Those provisions incorporated by reference herein,
are considered mandatory requirements. This incorporation was approved
by the Director of the Federal Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. (These materials are incorporated as they
exist on the date of approval.) A notice of any change in the Handbook
cited herein will be published in the Federal Register. Copies may be
purchased from the Superintendent of Documents, U.S. Government Printing
Office, Washington, DC 20402. It is also available for inspection at the
Office of the Federal Register Information Center, 800 North Capitol
Street NW., suite 700, Washington, DC 20408.
(b) The following NBS Handbook 133 requirements are not incorporated
by reference.
Chapter 2--General Considerations
2.13.1 Polyethylene Sheeting and Film
2.13.2 Textiles
2.13.3 Mulch
Chapter 3--Methods of Test for Packages Labeled by Weight
3.11. Aerosol Packages
3.14. Glazed Raw Seafood and Fish
3.15. Canned Coffee
3.16. Borax
3.17. Flour
Chapter 4--Methods of Test for Packages Labeled by Volume
4.7. Milk
4.8. Mayonnaise and Salad Dressing
4.9. Paint, Varnish, and Lacquers--Nonaerosol
4.11. Peat Moss
4.12. Bark Mulch
4.15. Ice Cream Novelties
Chapter 5--Methods of Test for Packages Labeled by Count, Length, Area,
Thickness, or Combinations of Quantities
5.4. Polyethylene Sheeting
5.5. Paper Plates
5.6. Sanitary Paper Products
5.7. Pressed and Blown Glass Tumblers and Stemware
Appendix D: Package Net Contents Regulations
D.1.1. U.S. Department of Health and Human Services, Food and Drug
Administration
D.1.2. Department of Agriculture, Food Safety and Inspection Service
D.1.3. Federal Trade Commission
D.1.4. Environmental Protection Agency
D.1.5. U.S. Department of the Treasury, Bureau of Alcohol, Tobacco, and
Firearms
(c) The following requirements of Supplement 1, dated September
1990, Supplement 3, dated October 1992, and Supplement 4, dated 1994, of
NIST Handbook 133 are not incorporated by reference.
[[Page 175]]
Supplement 1
Chapter 2 General Considerations
2.13.1. Polyethylene Sheeting and Film
2.13.2. Textiles
2.13.3. Mulch
Chapter 3 Methods of Test for Packages Labeled by Weight
3.11.4. Exhausting the Aerosol Container
Chapter 4 Methods of Test for Packages Labeled by Volume
4.6.4. Method D: Determining the Net Contents of Compressed Gas in
Cylinders
4.7. Milk
4.16. Fresh Oysters Labeled by Volume
Chapter 5 Methods of Test for Packages Labeled by Count, Length, Area,
Thickness, or Combinations of Quantities
5.4. Polyethylene Sheeting
Supplement 3
Chapter 3 Methods of Test for Packages Labeled by Weight
3.17. Flour and Dry Pet Food
Chapter 5 Methods of Test for Packages Labeled by Count, Length, Area,
Thickness, or Combination of Quantities
5.4. Polyethylene Sheeting
5.5. Paper Plates
5.8. Baler Twine
Appendix A. Forms and Worksheets
Supplement 4
3.11 Aerosol Packages
3.11.1 Equipment
3.11.2 Preparation for Test
3.11.3 The Determination of Net Contents: Part 1
3.11.4 Exhausting the Aerosol Container
3.11.5 The Determination of Net Contents: Part 2
Appendix A. Report Forms
[55 FR 49834, Nov. 30, 1990, as amended at 60 FR 12884, March 9, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.20]
[Page 175]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.20 Scale requirements for accurate weights, repairs, adjustments, and replacement after inspection.
(a) All scales used to weigh meat products sold or otherwise
distributed in commerce in federally inspected meat establishments shall
be installed, maintained and operated to insure accurate weights. Such
scales shall meet the applicable requirements contained in National
Institute of Standards and Technology Handbook 44, "Specifications,
Tolerances, and Other Technical Requirements for Weighing and Measuring
Devices", 1999 Edition, November 1998, which is incorporated by
reference. This incorporation was approved by the Director of the
Federal Register in accordance with 5 U.S.C.. 552(a) and 1 CFR part 51.
(These materials are incorporated as they exist on the date of
approval.) Copies may be purchased from the Superintendent of Documents,
U.S. Government Printing Office, Washington, DC 20402. It is also
available for inspection at the Office of the Federal Register
Information Center, 800 North Capitol Street NW., suite 700, Washington,
DC 20408.
(b) All scales used to weigh meat products sold or otherwise
distributed in commerce or in States designated under section 301(c) of
the Federal Meat Inspection Act, shall be of sufficient capacity to
weigh the entire unit and/or package.
(c) No scale shall be used at a federally inspected establishment to
weigh meat products unless it has been found upon test and inspection,
as specified in NIST Handbook 44, to provide accurate weight. If a scale
is reinspected or retested and found to be inaccurate, or if any
repairs, adjustments or replacements are made to a scale, it shall not
be used until it has been inspected and tested by a USDA official, or a
State or local government weights and measures official, or State
registered or licensed scale repair firm or person, and it must meet all
accuracy requirements as specified in NIST Handbook 44. If a USDA
inspector has put a retain tag on a scale it can only be removed by a
USDA inspector. As long as the tag is on the scale, it shall not be
used.
[55 FR 49834, Nov. 30, 1990, as amended at 60 FR 12884, Mar. 9, 1995; 64
FR 53187, Oct. 1, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.21]
[Page 175-176]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.21 Scales: testing of.
(a) The operator of each official establishment that weighs meat
food products shall cause such scales to be tested for accuracy, in
accordance with the technical requirements of NIST Handbook 44, at least
once during the calendar year. In cases where the scales are found not
to maintain accuracy between tests, more frequent tests may be required
and monitored by an authorized USDA program official.
[[Page 176]]
(b) The operator of each official establishment shall display on or
near each scale a valid certification of the scale's accuracy from a
State or local government's weights and measures authority or from a
State registered or licensed scale repair firm or person, or shall have
alternative documented procedures showing that the scale has been tested
for accuracy in accordance with the requirements of NIST Handbook 44.
[55 FR 49834, Nov. 30, 1990, as amended at 62 FR 45024, Aug. 25, 1997;
65 FR 34389, May 30, 2000; 66 FR 52486, Oct. 16, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.22]
[Page 176]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.22 Handling of failed product.
Any lot of product which is found to be out of compliance with net
weight requirements upon testing in accordance with Sec. 317.19 shall be
handled as follows:
(a) A lot tested in an official establishment and found not to
comply with net weight requirements may be reprocessed and must be
reweighed and remarked to satisfy the net weight requirements of this
section and be reinspected, in accordance with the requirements of this
part.
(b) A lot tested outside of an official establishment and found not
to comply with net weight requirements must be reweighed and remarked
with a proper net weight statement, provided that such reweighing and
remarking shall not deface, cover, or destroy any other marking or
labeling required under this subchapter and the net quantity of contents
is shown with the same prominence as the most conspicuous feature of a
label.
[55 FR 49834, Nov. 30, 1990]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.24]
[Page 176-177]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.24 Packaging materials.
(a) Edible products may not be packaged in a container which is
composed in whole or in part of any poisonous or deleterious substances
which may render the contents adulterated or injurious to health. All
packaging materials must be safe for their intended use within the
meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as
amended (FFDCA).
(b) Packaging materials entering the official establishment must be
accompanied or covered by a guaranty, or statement of assurance, from
the packaging supplier under whose brand name and firm name the material
is marketed to the official establishment. The guaranty shall state that
the material's intended use complies with the FFDCA and all applicable
food additive regulations. The guaranty must identify the material,
e.g., by the distinguishing brand name or code designation appearing on
the packaging material shipping container; must specify the applicable
conditions of use, including temperature limits and any other pertinent
limits specified under the FFDCA and food additive regulations; and must
be signed by an authorized official of the supplying firm. The guaranty
may be limited to a specific shipment of an article, in which case it
may be part of or attached to the invoice covering such shipment, or it
may be general and continuing, in which case, in its application to any
article or other shipment of an article, it shall be considered to have
been given at the date such article was shipped by the person who gives
the guaranty. Guaranties consistent with the Food and Drug
Administration's regulations regarding such guaranties (21 CFR 7.12 and
7.13) will be acceptable. The management of the establishment must
maintain a file containing guaranties for all food contact packaging
materials in the establishment. The file shall be made available to
Program inspectors or other Department officials upon request. While in
the official establishment, the identity of all packaging materials must
be traceable to the applicable guaranty.
(c) The guaranty by the packaging supplier will be accepted by
Program inspectors to establish that the use of material complies with
the FFDCA and all applicable food additive regulations.
(d) The Department will mmnitor the use of packaging material in
official establishments to assure that the requirements of paragraph (a)
of this section are met, and may question the basis for any guaranty
described under paragraph (b) of this section. Official establishments
and packaging suppliers providing written guaranties to those official
establishments will be
[[Page 177]]
permitted an opportunity to provide information tm designated Department
officials as needed to verify the basis for any such guaranty. The
required information will include, but is not limited to, manufacturing
firm's name, trade name or code designation for the material, complete
chemical composition, and use. Selection of a material for review does
not in itself affect a material's acceptability. Materials may continue
to be used during the review period. However, if information requested
from the supplier is not provided within the time indicated in the
request--a minimum of 30 days--any applicable guaranty shall cease to be
effective, and approval to continue using the specified packaging
material in official establishments may be denied. The Administrator may
extend this time where reasonable grounds for extension are shown, as,
for example, where data must be obtained from suppliers.
(e) The Administrator may disapprove for use in official
establishmelts packaging materials whose use cannot be confirmed as
complying with FFDCA and applicable food additive regulations. Before
approval to use a packaging material is finally denied by the
Administrator, the affected official establishment and the supplier of
the material shall be given notice and the opportunity to present their
views to the Administrator. If the official establishment and the
supplier do not accept the Administrator's determination, a hearing in
accordance with applicable rules of practice will be held to resolve
such dispute. Approval to use the materials pending the outcome of the
presentation of views or hearing shall be denied if the Administrator
determines that such use may present an imminent hazard to public
health.
(f) Periodically, the Administrator will issue to inspectors a
listing, by distinguishing brand name or code designation, of packaging
materials that have been reviewed and that fail to meet the requirements
of paragraph (a) of this section. Listed materials will not be permitted
for use in official establishments. If a subsequent review of any
material indicates that it meets the requirements of paragraph (a), the
material will be deleted from the listing.
(g) Nothing in this section shall affect the authority of Program
inspectors to refuse a specific material if he/she determines the
material may render products adulterated or injurious to health.
[49 FR 2235, Jan. 19, 1984. Redesignated at 55 FR 49833, Nov. 30, 1990]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.300]
[Page 177]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.300 Nutrition labeling of meat or meat food products.
Source: 58 FR 664, Jan. 6, 1993, unless otherwise noted.
(a) Nutrition labeling shall be provided for all meat or meat food
products intended for human consumption and offered for sale, except
single-ingredient, raw products, in accordance with the requirements of
Sec. 317.309; except as exempted under Sec. 317.400 of this subpart.
(b) Nutrition labeling may be provided for single-ingredient, raw
meat or meat food products in accordance with the requirements of
Secs. 317.309 and 317.345. Significant participation in voluntary
nutrition labeling shall be measured by the Agency in accordance with
Secs. 317.343 and 317.344 of this subpart.
[58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.302]
[Page 177-178]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.302 Location of nutrition information.
(a) Nutrition information on a label of a packaged meat or meat food
product shall appear on the label's principal display panel or on the
information panel, except as provided in paragraphs (b) and (c) of this
section.
(b) Nutrition information for gift packs may be shown at a location
other than on the product label, provided that the labels for these
products bear no nutrition claim. In lieu of on the product label,
nutrition information may be provided by alternate means such as product
label inserts.
(c) Meat or meat food products in packages that have a total surface
area
[[Page 178]]
available to bear labeling greater than 40 square inches but whose
principal display panel and information panel do not provide sufficient
space to accommodate all required information may use any alternate
panel that can be readily seen by consumers for the nutrition
information. In determining the sufficiency of available space for the
nutrition information, the space needed for vignettes, designs, and
other nonmandatory label information on the principal display panel may
be considered.
[58 FR 664, Jan. 6, 1993, as amended at 59 FR 40213, Aug. 8, 1994; 60 FR
176, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.308]
[Page 178]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.308 Labeling of meat or meat food products with number of servings.
The label of any package of a meat or meat food product that bears a
representation as to the number of servings contained in such package
shall meet the requirements of Sec. 317.2(h)(10).
[58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.309]
[Page 178-197]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.309 Nutrition label content.
(a) All nutrient and food component quantities shall be declared in
relation to a serving as defined in this section.
(b)(1) The term "serving" or "serving size" means an amount of
food customarily consumed per eating occasion by persons 4 years of age
or older, which is expressed in a common household measure that is
appropriate to the product. When the product is specially formulated or
processed for use by infants or by toddlers, a serving or serving size
means an amount of food customarily consumed per eating occasion by
infants up to 12 months of age or by children 1 through 3 years of age,
respectively.
(2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) of
this section and for products that are intended for weight control and
are available only through a weight-control or weight-maintenance
program, serving size declared on a product label shall be determined
from the "Reference Amounts Customarily Consumed Per Eating Occasion--
General Food Supply" (Reference Amount(s)) that appear in
Sec. 317.312(b) using the procedures described in this paragraph (b).
For products that are both intended for weight control and available
only through a weight-control program, a manufacturer may determine the
serving size that is consistent with the meal plan of the program. Such
products must bear a statement, "for sale only through the ------
program" (fill in the blank with the name of the appropriate weight-
control program, e.g., Smith's Weight Control), on the principal display
panel. However, the Reference Amounts in Sec. 317.312(b) shall be used
for purposes of evaluating whether weight-control products that are
available only through a weight-control program qualify for nutrition
claims.
(3) The declaration of nutrient and food component content shall be
on the basis of the product "as packaged" for all products, except
that single-ingredient, raw products may be declared on the basis of the
product "as consumed" as set forth in Sec. 317.345(a)(1). In addition
to the required declaration on the basis of "as packaged" for products
other than single-ingredient, raw products, the declaration may also be
made on the basis of "as consumed," provided that preparation and
cooking instructions are clearly stated.
(4) For products in discrete units (e.g., hot dogs, and individually
packaged products within a multi-serving package), and for products
which consist of two or more foods packaged and presented to be consumed
together where the ingredient represented as the main ingredient is in
discrete units (e.g., beef fritters and barbecue sauce), the serving
size shall be declared as follows:
(i) If a unit weighs 50 percent or less of the Reference Amount, the
serving size shall be the number of whole units that most closely
approximates the Reference Amount for the product category.
(ii) If a unit weighs more than 50 percent but less than 67 percent
of the Reference Amount, the manufacturer may declare one unit or two
units as the serving size.
(iii) If a unit weighs 67 percent or more but less than 200 percent
of the
[[Page 179]]
Reference Amount, the serving size shall be one unit.
(iv) If a unit weighs 200 percent or more of the Reference Amount,
the manufacturer may declare one unit as the serving size if the whole
unit can reasonably be consumed at a single eating occasion.
(v) For products that have Reference Amounts of 100 grams (or
milliliter) or larger and are individual units within a multi-serving
package, if a unit contains more than 150 percent but less than 200
percent of the Reference Amount, the manufacturer may decide whether to
declare the individual unit as 1 or 2 servings.
(vi) For products which consist of two or more foods packaged and
presented to be consumed together where the ingredient represented as
the main ingredient is in discrete units (e.g., beef fritters and
barbecue sauce), the serving size may be the number of discrete units
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount for the combined product as determined
in Sec. 317.312(c).
(vii) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., are
labeled appropriately for individual sale as single-serving containers),
the serving size shall be 1 unit.
(5) For products in large discrete units that are usually divided
for consumption (e.g., pizza), for unprepared products where the entire
contents of the package is used to prepare large discrete units that are
usually divided for consumption (e.g. pizza kit), and for products which
consist of two or more foods packaged and presented to be consumed
together where the ingredient represented as the main ingredient is a
large discrete unit usually divided for consumption, the serving size
shall be the fractional slice of the ready-to-eat product (e.g., \1/8\
quiche, \1/4\ pizza) that most closely approximates the Reference Amount
for the product category. The serving size may be the fraction of the
package used to make the Reference Amount for the unprepared product
determined in Sec. 317.312(d) or the fraction of the large discrete unit
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount of the combined product determined in
Sec. 317.312(c). In expressing the fractional slice, manufacturers shall
use \1/2\, \1/3\, \1/4\, \1/5\, \1/6\, or smaller fractions that can be
generated by further division by 2 or 3.
(6) For nondiscrete bulk products (e.g., whole roast beef, marinated
beef tenderloin, large can of chili), and for products which consist of
two or more foods packaged and presented to be consumed together where
the ingredient represented as the main ingredient is a bulk product
(e.g., roast beef and gravy), the serving size shall be the amount in
household measure that most closely approximates the Reference Amount
for the product category and may be the amount of the bulk product
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount for the combined product determined in
Sec. 317.312(c).
(7) For labeling purposes, the term "common household measure" or
"common household unit" means cup, tablespoon, teaspoon, piece, slice,
fraction (e.g., \1/4\ pizza), ounce (oz), or other common household
equipment used to package food products (e.g., jar or tray). In
expressing serving size in household measures, except as specified in
paragraphs (b)(7)(iv), (v), and (vi) of this section, the following
rules shall be used:
(i) Cups, tablespoons, or teaspoons shall be used wherever possible
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup
increments, tablespoons in whole number of tablespoons for quantities
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp),
1, 1\1/3\, 1\1/2\, or 1 \2/3\ tbsp for quantities less than 2 tbsp but
greater than or equal to 1 tbsp, and teaspoons in whole number of
teaspoons for quantities less than 1 tbsp but greater than or equal to 1
teaspoon (tsp), and in \1/4\-tsp increments for quantities less than 1
tsp.
(ii) If cups, tablespoons or teaspoons are not applicable, units
such as piece, slice, tray, jar, and fraction shall be used.
[[Page 180]]
(iii) If cups, tablespoons and teaspoons, or units such as piece,
slice, tray, jar, or fraction are not applicable, ounces may be used.
Ounce measurements shall be expressed in 0.5-ounce increments most
closely approximating the Reference Amount with rounding indicated by
the use of the term "about" (e.g., about 2.5 ounces).
(iv) A description of the individual container or package shall be
used for single-serving containers and meal-type products and for
individually packaged products within multi-serving containers (e.g.,
can, box, package, meal, or dinner). A description of the individual
unit shall be used for other products in discrete units (e.g., chop,
slice, link, or patty).
(v) For unprepared products where the entire contents of the package
is used to prepare large discrete units that are usually divided for
consumption (e.g., pizza kit), the fraction or portion of the package
may be used.
(vi) For products that consist of two or more distinct ingredients
or components packaged and presented to be consumed together (e.g., ham
with a glaze packet), the nutrition information may be declared for each
component or as a composite. The serving size may be provided in
accordance with the provisions of paragraphs (b)(4), (b)(5), and (b)(6)
of this section.
(vii) For nutrition labeling purposes, a teaspoon means 5
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 oz
in weight means 28 grams (g).
(viii) When a serving size, determined from the Reference Amount in
Sec. 317.312(b) and the procedures described in this section, falls
exactly half way between two serving sizes (e.g., 2.5 tbsp),
manufacturers shall round the serving size up to the next incremental
size.
(8) A product that is packaged and sold individually and that
contains less than 200 percent of the applicable Reference Amount shall
be considered to be a single-serving container, and the entire content
of the product shall be labeled as one serving, except for products that
have Reference Amounts of 100 g (or mL) or larger, manufacturers may
decide whether a package that contains more than 150 percent but less
than 200 percent of the Reference Amount is 1 or 2 servings. Packages
sold individually that contain 200 percent or more of the applicable
Reference Amount may be labeled as a single-serving if the entire
content of the package can reasonably be consumed at a single-eating
occasion.
(9) A label statement regarding a serving shall be the serving size
expressed in common household measures as set forth in paragraphs (b)(2)
through (b)(8) of this section and shall be followed by the equivalent
metric quantity in parenthesis (fluids in milliliters and all other
foods in grams), except for single-serving containers.
(i) For a single-serving container, the parenthetical metric
quantity, which will be presented as part of the net weight statement on
the principal display panel, is not required except where nutrition
information is required on a drained weight basis according to paragraph
(b)(11) of this section. However, if