(2)
(a) 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.
(b) Except as
provided in subsections (2)(h), (2)(l), and (2)(n) of this rule 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 603-029-1036(a) using the procedures described in this section (2).
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
603-029-1036(a) shall be used for purposes of evaluating whether weight-control
products that are available only through a weight-control program qualify for
nutrition claims.
(c) 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 that are not ground or chopped meat products described in OAR
603-029-1028may be declared on the basis of the product "as consumed." For
single-ingredient, raw products that are not ground or chopped meat products
described in OAR
603-029-1028, if data are based on the product -as consumed,'
the data must be presented in accordance with 603-029-1042(4). In addition to
the required declaration on the basis of "as packaged" for products other than
single-ingredient, raw products that are not ground or chopped meat products
described in OAR
603-029-1028, the declaration may also be made on the basis of
"as consumed," provided that preparation and cooking instructions are clearly
stated.
(d) 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:
(A) 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.
(B) 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.
(C) If a unit weighs 67 percent or more but
less than 200 percent of the Reference Amount, the serving size shall be one
unit.
(D) 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.
(E) 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.
(F) 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 OAR
603-029-1036(3).
(G) For packages
containing several individual single-serving containers, each of which is
labeled with all required information including nutrition labeling as specified
in this rule (i.e., are labeled appropriately for individual sale as
single-serving containers), the serving size shall be 1 unit.
(e) 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 OAR
603-029-1036(4) 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 OAR
603-029-1036(3. 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.
(f) For non-discrete 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 OAR
603-029-1036(3).
(g) 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 (2)(g)(D), (E), and (F) of this rule, the following
rules shall be used:
(A) 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, 11/3, 11/2, 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.
(B) If cups, tablespoons or
teaspoons are not applicable, units such as piece, slice, tray, jar, and
fraction shall be used.
(C) 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).
(D) A description of the
individual container or package shall be used for single-serving containers 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).
(E) 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.
(F) 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 subsections (2)(d), (2)(e), and (2)(f) of
this rule.
(G) 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).
(H) When a serving size, determined from the
Reference Amount in OAR
603-029-1036(2) and the procedures described in OAR
603-029-1000 to
603-029-1058, 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.
(h) 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.
(i) A label statement
regarding a serving shall be the serving size expressed in common household
measures as set forth in subsections (2)(b) through (2)(h) of this rule 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.
(A) 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 subsection (2)(k) of this rule. However, if a manufacturer
voluntarily provides the metric quantity on products that can be sold as
single-servings, then the numerical value provided as part of the serving size
declaration must be identical to the metric quantity declaration provided as
part of the net quantity of contents statement.
(B) The gram or milliliter quantity
equivalent to the household measure should be rounded to the nearest whole
number except for quantities that are less than 5 g (mL). The gram (mL)
quantity between 2 and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and
the g (mL) quantity less than 2 g (mL) should be expressed in 0.1-g (mL)
increments.
(C) In addition,
serving size may be declared in ounce, in parenthesis, following the metric
measure separated by a slash where other common household measures are used as
the primary unit for serving size, e.g., 1 slice (28 g/1 oz) for sliced
bologna. The ounce quantity equivalent to the metric quantity should be
expressed in 0.1-oz increments.
(D)
If a manufacturer elects to use abbreviations for units, the following
abbreviations shall be used: tbsp for tablespoon, tsp for teaspoon, g for gram,
mL for milliliter, and oz for ounce.
(j) Determination of the number of servings
per container shall be based on the serving size of the product determined by
following the procedures described in this rule.
(A) The number of servings shall be rounded
to the nearest whole number except for the number of servings between 2 and 5
servings and random weight products. The number of servings between 2 and 5
servings shall be rounded to the nearest 0.5 serving. Rounding should be
indicated by the use of the term "about" (e.g., about 2 servings; about 3.5
servings).
(B) When the serving
size is required to be expressed on a drained solids basis and the number of
servings varies because of a natural variation in unit size (e.g., pickled pigs
feet), the manufacturer may state the typical number of servings per container
(e.g., usually 5 servings).
(C) For
random weight products, a manufacturer may declare "varied" for the number of
servings per container provided the nutrition information is based on the
Reference Amount expressed in ounces. The manufacturer may provide the typical
number of servings in parenthesis following the "varied" statement (e.g.,
varied (approximately 8 servings per pound)).
(D) For packages containing several
individual single-serving containers, each of which is labeled with all
required information including nutrition labeling as specified in this OAR
603-029-1000 to
603-029-1058 (i.e., are labeled appropriately for individual
sale as single-serving containers), the number of servings shall be the number
of individual packages within the total package.
(E) For packages containing several
individually packaged multi-serving units, the number of servings shall be
determined by multiplying the number of individual multi-serving units in the
total package by the number of servings in each individual unit. The
declaration of the number of servings per container need not be included in
nutrition labeling of single-ingredient, raw meat products that are not ground
or chopped meat products described in OAR
603-029-1028, including those that
have been previously frozen.
(j) The declaration of nutrient and food
component content shall be on the basis of product as packaged or purchased
with the exception of single-ingredient, raw products that are not ground or
chopped meat products described in OAR
603-029-1028 and products that are
packed or canned in water, brine, or oil but whose liquid packing medium is not
customarily consumed. Declaration of the nutrient and food component content of
products that are packed in liquid which is not customarily consumed shall be
based on the drained solids.
(k)
The serving size for meal-type products and main-dish products as defined in
OAR
603-029-1038 (12) and (13) in single-serving containers will be the entire
edible content of the package. Serving size for meal-type products and
main-dish products in multi-serve containers will be based on the reference
amount applicable to the product in OAR
603-029-1038(2) if the product is
listed in OAR
603-029-1038(2). Serving size for meal-type products and
main-dish products in multi-serve containers that are not listed in OAR
603-029-1038(2) will be based on the reference amount according to OAR
603-029-1038 (3), (4), and (5).
(l)
Another column of figures may be used to declare the nutrient and food
component information in the same format as required by OAR
603-029-1034(5),
(A) Per 100 grams, 100 milliliters, or 1
ounce of the product as packaged or purchased.
(B) Per one unit if the serving size of a
product in discrete units in a multi-serving container is more than one
unit.
(m) If a product
consists of assortments of meat or meat products (e.g., variety packs) in the
same package, nutrient content shall be expressed on the entire package
contents or on each individual product.
(n) If a product is commonly combined with
other ingredients or is cooked or otherwise prepared before eating, and
directions for such combination or preparations are provided, another column of
figures may be used to declare the nutrient contents on the basis of the
product as consumed for the product alone (e.g., a cream soup mix may be
labeled with one set of Daily Values for the dry mix (per serving), and another
set for the serving of the final soup when prepared (e.g., per serving of cream
soup mix and 1 cup of vitamin D fortified whole milk)): Provided, That the type
and quantity of the other ingredients to be added to the product by the user
and the specific method of cooking and other preparation shall be specified
prominently on the label.
(3) The declaration of nutrition information
on the label or in labeling of a meat or meat product shall contain information
about the level of the following nutrients, except for those nutrients whose
inclusion, and the declaration of amounts, is voluntary as set forth in this
section. No nutrients or food components other than those listed in this
section as either mandatory or voluntary may be included within the nutrition
label. Except as provided for in section (6) or (7) of this rule, nutrient
information shall be presented using the nutrient names specified and in the
following order in the formats specified in section (4) or (5) of this rule.
(a) "Calories, total," "Total calories," or
"Calories": A statement of the caloric content per serving, expressed to the
nearest 5-calorie increment up to and including 50 calories, and 10-calorie
increment above 50 calories, except that amounts less than 5 calories may be
expressed as zero. Energy content per serving may also be expressed in
kilojoule units, added in parenthesis immediately following the statement of
the caloric content.
(A) Caloric content may
be calculated by the following methods. Where either specific or general food
factors are used, the factors shall be applied to the actual amount (i.e.,
before rounding) of food components (e.g., fat, carbohydrate, protein, or
ingredients with specific food factors) present per serving.
(i) Using specific Atwater factors (i.e., the
Atwater method) given in Table 13, page 25, "Energy Value of Foods-Basis and
Derivation," by A. L. Merrill and B. K. Watt, United States Department of
Agriculture (USDA), Agriculture Handbook No. 74 (Slightly revised February
1973), which is incorporated by reference;
(ii) Using the general factors of 4, 4, and 9
calories per gram for protein, total carbohydrate, and total fat, respectively,
as describe' in USDA's Agriculture Handbook No. 74 (Slightly revised February
1973), pages 9-11, which is incorporated by reference;
(iii) Using the general factors of 4, 4, and
9 calories per gram for protein, total carbohydrate less the amount of
insoluble dietary fiber, and total fat, respectively, as describe' in USDA's
Agriculture Handbook No. 74 (Slightly revised February 1973), pages 9-11, which
is incorporated by reference; or
(iv) Using data for specific food factors for
particular foods or ingredients approved by the Food and Drug Administration
(FDA) and provided in parts 172 or 184 of
21 CFR, or by other means, as
appropriate.
(B)
"Calories from fat": A statement of the caloric content derived from total fat
as defined in subsection (3)(b) of this rule per serving, expressed to the
nearest 5-calorie increment, up to and including 50 calories, and the nearest
10-calorie increment above 50 calories, except that label declaration of
"calories from fat" is not required on products that contain less than 0.5 gram
of fat per serving and amounts less than 5 calories may be expressed as zero.
This statement shall be declared as provided in subsection (4)(e) of this
rule.
(C) "Calories from saturated
fat" or "Calories from saturated" (VOLUNTARY): A statement of the caloric
content derived from saturated fat as defined in paragraph (3)(b)(A) of this
rule per serving may be declared voluntarily, expressed to the nearest
5-calorie increment, up to and including 50 calories, and the nearest
10-calorie increment above 50 calories, except that amounts less than 5
calories may be expressed as zero. This statement shall be indented under the
statement of calories from fat as provided in subsection (4)(e) of this
rule.
(b) "Fat, total" or
"Total fat": A statement of the number of grams of total fat per serving
defined as total lipid fatty acids and expressed as triglycerides. Amounts
shall be expressed to the nearest 0.5 ( 1/2)-gram increment below 5 grams and
to the nearest gram increment above 5 grams. If the serving contains less than
0.5 gram, the content shall be expressed as zero.
(A) "Saturated fat" or "Saturated": A
statement of the number of grams of saturated fat per serving defined as the
sum of all fatty acids containing no double bonds, except that label
declaration of saturated fat content information is not required for products
that contain less than 0.5 gram of total fat per serving if no claims are made
about fat or cholesterol content, and if "calories from saturated fat" is not
declared. Saturated fat content shall be indented and expressed as grams per
serving to the nearest 0.5 ( 1/2)-gram increment below 5 grams and to the
nearest gram increment above 5 grams. If the serving contains less than 0.5
gram, the content shall be expressed as zero.
(i) "Stearic Acid" (VOLUNTARY): A statement
of the number of grams of stearic acid per serving may be declared voluntarily,
except that when a claim is made about stearic acid, label declaration shall be
required. Stearic acid content shall be indented under saturated fat and
expressed to the nearest 0.5 ( 1/2)-gram increment below 5 grams and the
nearest gram increment above 5 grams. If the serving contains less than 0.5
gram, the content shall be expressed as zero.
(ii) [Reserved]
(B) "Polyunsaturated fat" or
"Polyunsaturated" (VOLUNTARY): A statement of the number of grams of
polyunsaturated fat per serving defined as cis, cis-methylene-interrupted
polyunsaturated fatty acids may be declared voluntarily, except that when
monounsaturated fat is declared, or when a claim about fatty acids or
cholesterol is made on the label or in labeling of a product other than one
that meets the criteria in OAR
603-029-1052(2)(a) for a claim for "fat free,"
label declaration of polyunsaturated fat is required. Polyunsaturated fat
content shall be indented and expressed as grams per serving to the nearest 0.5
( 1/2)-gram increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 gram, the content shall be
expressed as zero.
(C)
"Monounsaturated fat" or "Monounsaturated" (VOLUNTARY): A statement of the
number of grams of monounsaturated fat per serving defined as
cis-monounsaturated fatty acids may be declared voluntarily, except that when
polyunsaturated fat is declared, or when a claim about fatty acids or
cholesterol is made on the label or in labeling of a product other than one
that meets the criteria in OAR
603-029-1052(2)(a) for a claim for "fat free,"
label declaration of monounsaturated fat is required. Monounsaturated fat
content shall be indented and expressed as grams per serving to the nearest 0.5
( 1/2)-gram increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 gram, the content shall be
expressed as zero.
(c)
"Cholesterol": A statement of the cholesterol content per serving expressed in
milligrams to the nearest 5-milligram increment, except that label declaration
of cholesterol information is not required for products that contain less than
2 milligrams of cholesterol per serving and make no claim about fat, fatty
acids, or cholesterol content, or such products may state the cholesterol
content as zero. If the product contains 2 to 5 milligrams of cholesterol per
serving, the content may be stated as "less than 5 milligrams."
(d) "Sodium": A statement of the number of
milligrams of sodium per serving expressed as zero when the serving contains
less than 5 milligrams of sodium, to the nearest 5-milligram increment when the
serving contains 5 to 140 milligrams of sodium, and to the nearest 10-milligram
increment when the serving contains greater than 140 milligrams.
(e) "Potassium" (VOLUNTARY): A statement of
the number of milligrams of potassium per serving may be declared voluntarily,
except that when a claim is made about potassium content, label declaration
shall be required. Potassium content shall be expressed as zero when the
serving contains less than 5 milligrams of potassium, to the nearest
5-milligram increment when the serving contains 5 to 140 milligrams of
potassium, and to the nearest 10-milligram increment when the serving contains
greater than 140 milligrams.
(f)
"Carbohydrate, total" or "Total carbohydrate": A statement of the number of
grams of total carbohydrate per serving expressed to the nearest gram, except
that if a serving contains less than 1 gram, the statement "Contains less than
1 gram" or "less than 1 gram" may be used as an alternative, or, if the serving
contains less than 0.5 gram, the content may be expressed as zero. Total
carbohydrate content shall be calculated by subtraction of the sum of the crude
protein, total fat, moisture, and ash from the total weight of the product.
This calculation method is described in USDA's Agriculture Handbook No. 74
(Slightly revised February 1973), pages 2 and 3, which is incorporated by
reference.
(A) "Dietary fiber": A statement
of the number of grams of total dietary fiber per serving, indented and
expressed to the nearest gram, except that if a serving contains less than 1
gram, declaration of dietary fiber is not required, or, alternatively, the
statement "Contains less than 1 gram" or "less than 1 gram" may be used, and if
the serving contains less than 0.5 gram, the content may be expressed as zero.
(i) "Soluble fiber" (VOLUNTARY): A statement
of the number of grams of soluble dietary fiber per serving may be declared
voluntarily except when a claim is made on the label or in labeling about
soluble fiber, label declaration shall be required. Soluble fiber content shall
be indented under dietary fiber and expressed to the nearest gram, except that
if a serving contains less than 1 gram, the statement "Contains less than 1
gram" or "less than 1 gram" may be used as an alternative, and if the serving
contains less than 0.5 gram, the content may be expressed as zero.
(ii) "Insoluble fiber" (VOLUNTARY): A
statement of the number of grams of insoluble dietary fiber per serving may be
declared voluntarily except when a claim is made on the label or in labeling
about insoluble fiber, label declaration shall be required. Insoluble fiber
content shall be indented under dietary fiber and expressed to the nearest
gram, except that if a serving contains less than 1 gram, the statement
"Contains less than 1 gram" or "less than 1 gram" may be used as an
alternative, and if the serving contains less than 0.5 gram, the content may be
expressed as zero.
(B)
"Sugars": A statement of the number of grams of sugars per serving, except that
label declaration of sugars content is not required for products that contain
less than 1 gram of sugars per serving if no claims are made about sweeteners,
sugars, or sugar alcohol content. Sugars shall be defined as the sum of all
free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose).
Sugars content shall be indented and expressed to the nearest gram, except that
if a serving contains less than 1 gram, the statement "Contains less than 1
gram" or "less than 1 gram" may be used as an alternative, and if the serving
contains less than 0.5 gram, the content may be expressed as zero.
(C) "Sugar alcohol" (VOLUNTARY): A statement
of the number of grams of sugar alcohols per serving may be declared
voluntarily on the label, except that when a claim is made on the label or in
labeling about sugar alcohol or sugars when sugar alcohols are present in the
product, sugar alcohol content shall be declared. For nutrition labeling
purposes, sugar alcohols are defined as the sum of saccharide derivatives in
which a hydroxyl group replaces a ketone or aldehyde group and whose use in the
food is listed by FDA (e.g., mannitol or xylitol) or is generally recognized as
safe (e.g., sorbitol). In lieu of the term "sugar alcohol," the name of the
specific sugar alcohol (e.g., "xylitol") present in the product may be used in
the nutrition label, provided that only one sugar alcohol is present in the
product. Sugar alcohol content shall be indented and expressed to the nearest
gram, except that if a serving contains less than 1 gram, the statement
"Contains less then 1 gram" or "less than 1 gram" may be used as an
alternative, and if the serving contains less than 0.5 gram, the content may be
expressed as zero.
(D) "Other
carbohydrate" (VOLUNTARY): A statement of the number of grams of other
carbohydrate per serving may be declared voluntarily. Other carbohydrate shall
be defined as the difference between total carbohydrate and the sum of dietary
fiber, sugars, and sugar alcohol, except that if sugar alcohol is not declared
(even if present), it shall be defined as the difference between total
carbohydrate and the sum of dietary fiber and sugars. Other carbohydrate
content shall be indented and expressed to the nearest gram, except that if a
serving contains less than 1 gram, the statement "Contains less than 1 gram" or
"less than 1 gram" may be used as an alternative, and if the serving contains
less than 0.5 gram, the content may be expressed as zero.
(g) "Protein": A statement of the number of
grams of protein per serving expressed to the nearest gram, except that if a
serving contains less than 1 gram, the statement "Contains less than 1 gram" or
"less than 1 gram" may be used as an alternative, and if the serving contains
less than 0.5 gram, the content may be expressed as zero. When the protein in
products represented or purported to be for adults and children 4 or more years
of age has a protein quality value that is a protein digestibility-corrected
amino acid score of less than 20 expressed as a percent, or when the protein in
a product represented or purported to be for children greater than 1 but less
than 4 years of age has a protein quality value that is a protein
digestibility-corrected amino acid score of less than 40 expressed as a
percent, either of the following shall be placed adjacent to the declaration of
protein content by weight: The statement "not a significant source of protein,"
or a listing aligned under the column headed "Percent Daily Value" of the
corrected amount of protein per serving, as determined in paragraph (3)(g)(B)
of this rule, calculated as a percentage of the Daily Reference Value (DRV) or
Reference Daily Intake (RDI), as appropriate, for protein and expressed as
percent of Daily Value. When the protein quality in a product as measured by
the Protein Efficiency Ratio (PER) is less than 40 percent of the reference
standard (casein) for a product represented or purported to be for infants, the
statement "not a significant source of protein" shall be placed adjacent to the
declaration of protein content. Protein content may be calculated on the basis
of the factor of 6.25 times the nitrogen content of the food as determined by
appropriate methods of analysis in accordance with OAR
603-029-1034(8), except
when the procedure for a specific food requires another factor.
(A) A statement of the corrected amount of
protein per serving, as determined in paragraph (3)(g)(B) of this rule,
calculated as a percentage of the RDI or DRV for protein, as appropriate, and
expressed as percent of Daily Value, may be placed on the label, except that
such a statement shall be given if a protein claim is made for the product, or
if the product is represented or purported to be for infants or children under
4 years of age. When such a declaration is provided, it shall be placed on the
label adjacent to the statement of grams of protein and aligned under the
column headed "Percent Daily Value," and expressed to the nearest whole
percent. However, the percentage of the RDI for protein shall not be declared
if the product is represented or purported to be for infants and the protein
quality value is less than 40 percent of the reference standard.
(B) The corrected amount of protein (grams)
per serving for products represented or purported to be for adults and children
1 or more years of age is equal to the actual amount of protein (grams) per
serving multiplied by the amino acid score corrected for protein digestibility.
If the corrected score is above 1.00, then it shall be set at 1.00. The protein
digestibility-corrected amino acid score shall be determined by methods given
in sections 5.4.1, 7.2.1, and 8 in "Protein Quality Evaluation, Report of the
Joint FAO/WHO Expert Consultation on Protein Quality Evaluation," Rome, 1990,
which is incorporated by reference. For products represented or purported to be
for infants, the corrected amount of protein (grams) per serving is equal to
the actual amount of protein (grams) per serving multiplied by the relative
protein quality value. The relative protein quality value shall be determined
by dividing the subject product's protein PER value by the PER value for
casein. If the relative protein value is above 1.00, it shall be set at
1.00.
(C) For the purpose of
labeling with a percent of the DRV or RDI, a value of 50 grams of protein shall
be the DRV for adults and children 4 or more years of age, and the RDI for
protein for children less than 4 years of age, infants, pregnant women, and
lactating women shall be 16 grams, 14 grams, 60 grams, and 65 grams,
respectively.
(h)
Vitamins and minerals: A statement of the amount per serving of the vitamins
and minerals as described in this section, calculated as a percent of the RDI
and expressed as percent of Daily Value.
(A)
For purposes of declaration of percent of Daily Value as provided for in
sections (4) through (7) of this rule, products represented or purported to be
for use by infants, children less than 4 years of age, pregnant women, or
lactating women shall use the RDI's that are specified for the intended group.
For products represented or purported to be for use by both infants and
children under 4 years of age, the percent of Daily Value shall be presented by
separate declarations according to section (5) of this rule based on the RDI
values for infants from birth to 12 months of age and for children under 4
years of age. Similarly, the percent of Daily Value based on both the RDI
values for pregnant women and for lactating women shall be declared separately
on products represented or purported to be for use by both pregnant and
lactating women. When such dual declaration is used on any label, it shall be
included in all labeling, and equal prominence shall be given to both values in
all such labeling. All other products shall use the RDI for adults and children
4 or more years of age.
(B) The
declaration of vitamins and minerals as a percent of the RDI shall include
vitamin A, vitamin C, calcium, and iron, in that order, and shall include any
of the other vitamins and minerals listed in paragraph (3)(h)(D) of this rule
when they are added, or when a claim is made about them. Other vitamins and
minerals need not be declared if neither the nutrient nor the component is
otherwise referred to on the label or in labeling or advertising and the
vitamins and minerals are:
(i) Required or
permitted in a standardized food (e.g., thiamin, riboflavin, and niacin in
enriched flour) and that standardized food is included as an ingredient (i.e.,
component) in another product; or
(ii) Included in a product solely for
technological purposes and declared only in the ingredients statement. The
declaration may also include any of the other vitamins and minerals listed in
paragraph (3)(h)(D) of this rule when they are naturally occurring in the food.
The additional vitamins and minerals shall be listed in the order established
in paragraph (3)(h)(D) of this rule.
(C) The percentages for vitamins and minerals
shall be expressed to the nearest 2-percent increment up to and including the
10-percent level, the nearest 5-percent increment above 10 percent and up to
and including the 50-percent level, and the nearest 10-percent increment above
the 50-percent level. Amounts of vitamins and minerals present at less than 2
percent of the RDI are not required to be declared in nutrition labeling but
may be declared by a zero or by the use of an asterisk (or other symbol) that
refers to another asterisk (or symbol) that is placed at the bottom of the
table and that is followed by the statement "Contains less than 2 percent of
the Daily Value of this (these) nutrient (nutrients)." Alternatively, if
vitamin A, vitamin C, calcium, or iron is present in amounts less than 2
percent of the RDI, label declaration of the nutrient(s) is not required if the
statement "Not a significant source of ___ (listing the vitamins or minerals
omitted)" is placed at the bottom of the table of nutrient values.'
(D) The following RDI's and nomenclature are
established for the following vitamins and minerals which are essential in
human nutrition:
Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1.0 gram
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 0.4 milligram
Vitamin B12, 6 micrograms
Biotin, 0.3 milligram
Pantothenic acid, 10 milligrams
Phosphorus, 1.0 gram
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Copper, 2.0 milligrams
(i) The following synonyms may be added in
parenthesis immediately following the name of the nutrient or dietary
component:
Vitamin C-Ascorbic acid
Thiamin-Vitamin B1
Riboflavin-Vitamin B2
Folate-Folacin
Calories-Energy
(E) A statement of the percent of vitamin A
that is present as beta-carotene may be declared voluntarily. When the vitamins
and minerals are listed in a single column, the statement shall be indented
under the information on vitamin A. When vitamins and minerals are arrayed
horizontally, the statement of percent shall be presented in parenthesis
following the declaration of vitamin A and the percent of Daily Value of
vitamin A in the product (e.g., "Percent Daily Value: Vitamin A 50 (90 percent
as beta-carotene)"). When declared, the percentages shall be expressed in the
same increments as are provided for vitamins and minerals in paragraph
(3)(h)(C) of this rule.
(4)
(a)
Nutrient information specified in section (3) of this rule shall be presented
on products in the following format, except on products on which dual columns
of nutrition information are declared as provided for in section (5) of this
rule, on those products on which the simplified format is permitted to be used
as provided for in section (6) of this rule, on products for infants and
children less than 4 years of age as provided for in OAR
603-029-1060(3), and
on products in packages that have a total surface area available to bear
labeling of 40 or less square inches as provided for in section (7) of this
rule.
(A) The nutrition information shall be
set off in a box by use of hairlines and shall be all black or one color type,
printed on a white or other neutral contrasting background whenever
practical.
(B) All information
within the nutrition label shall utilize:
(i)
A single easy-to-read type style,
(ii) Upper and lower case letters,
(iii) At least one point leading (i.e., space
between two lines of text) except that at least four points leading shall be
utilized for the information required by subsections (4)(g) and (4)(h) of this
rule, and
(iv) Letters should never
touch.
(C) Information
required in subsections (4)(c), (4)(e), (4)(g), and (4)(h) of this rule shall
be in type size no smaller than 8 point. Except for the heading "Nutrition
Facts," the information required in subsections (4)(d), (4)(f), and (4)(h) of
this rule and all other information contained within the nutrition label shall
be in type size no smaller than 6 point. When provided, the information
described in subsection (4)(j) of this rule shall also be in type no smaller
than 6 point.
(D) The headings
required by subsections (4)(b), (4)(d), and (4)(f) of this rule (i.e.,
"Nutrition Facts," "Amount per Serving," and "% Daily Value*"), the names of
all nutrients that are not indented according to requirements of section (3) of
this rule (i.e., Calories, Total fat, Cholesterol, Sodium, Potassium, Total
carbohydrate, and Protein), and the percentage amounts required by paragraph
(4)(g)(B) of this rule shall be highlighted by bold or extra bold type or other
highlighting (reverse printing is not permitted as a form of highlighting) that
prominently distinguishes it from other information. No other information shall
be highlighted.
(E) A hairline rule
that is centered between the lines of text shall separate "Amount Per Serving"
from the calorie statements required in subsection (4)(e) of this rule and
shall separate each nutrient and its corresponding percent of Daily Value
required in paragraphs (4)(g)(A) and (4)(g)(B) of this rule from the nutrient
and percent of Daily Value above and below it.
(b) The information shall be presented under
the identifying heading of "Nutrition Facts" which shall be set in a type size
larger than all other print size in the nutrition label and, except for labels
presented according to the format provided for in subsection (4)(k) of this
rule, unless impractical, shall be set the full width of the information
provided under subsection (4)(g) of this rule.
(c) Information on serving size shall
immediately follow the heading. Such information shall include:
(A) "Serving Size": A statement of the
serving size as specified in subsection (2)(i) of this rule.
(B) "Servings Per Container": The number of
servings per container, except that this statement is not required on
single-serving containers as defined in subsection (2)(h) of this rule or on
single-ingredient, raw meat products that are not ground or chopped meat
products described in OAR
603-029-1028.
(d) A subheading "Amount Per Serving" shall
be separated from serving size information by a bar.
(e) Information on calories shall immediately
follow the heading "Amount Per Serving" and shall be declared in one line,
leaving sufficient space between the declaration of "Calories" and "Calories
from fat" to allow clear differentiation, or, if "Calories from saturated fat"
is declared, in a column with total "Calories" at the top, followed by
"Calories from fat" (indented), and "Calories from saturated fat"
(indented).
(f) The column heading
"% Daily Value," followed by an asterisk (e.g., "% Daily Value*"), shall be
separated from information on calories by a bar. The position of this column
heading shall allow for a list of nutrient names and amounts as described in
subsection (4)(g) of this rule to be to the left of, and below, this column
heading. The column headings "Percent Daily Value," "Percent DV," or "% DV" may
be substituted for "% Daily Value."
(g) Except as provided for in section (7) of
this rule, and except as permitted by OAR
603-029-1060(4)(b), nutrient
information for both mandatory and any voluntary nutrients listed in section
(3) of this rule that are to be declared in the nutrition label, except
vitamins and minerals, shall be declared as follows:
(A) The name of each nutrient, as specified
in section (3) of this rule, shall be given in a column and followed
immediately by the quantitative amount by weight for that nutrient appended
with a "g" for grams or "mg" for milligrams.
(B) A listing of the percent of the DRV as
established in paragraphs (3)(g)(C) and (3)(i) of this rule shall be given in a
column aligned under the heading "% Daily Value" established in subsection
(4)(f) of this rule with the percent expressed to the nearest whole percent for
each nutrient declared in the column described in paragraph (4)(g)(A) of this
rule for which a DRV has been established, except that the percent for protein
may be omitted as provided in subsection (3)(g) of this rule. The percent shall
be calculated by dividing either the amount declared on the label for each
nutrient or the actual amount of each nutrient (i.e., before rounding) by the
DRV for the nutrient, except that the percent for protein shall be calculated
as specified in paragraph (3)(g)(B) of this rule. The numerical value shall be
followed by the symbol for percent (i.e., %).
(h) Nutrient information for vitamins and
minerals shall be separated from information on other nutrients by a bar and
shall be arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%,
Iron 4%) or may be listed in two columns, except that when more than four
vitamins and minerals are declared, they may be declared vertically with
percentages listed under the column headed "% Daily Value."
(i) A footnote, preceded by an asterisk,
shall be placed beneath the list of vitamins and minerals and shall be
separated from that list by a hairline.
(A)
The footnote shall state: Percent Daily Values are based on a 2,000 calorie
diet. Your daily values may be higher or lower depending on your calorie
needs.
(B) If the percent of Daily
Value is given for protein in the Percent of Daily Value column as provided in
paragraph (4)(g)(B) of this rule, protein shall be listed under dietary fiber,
and a value of 50 g shall be inserted on the same line in the column headed
"2,000" and value of 65 g in the column headed "2,500."
(C) If potassium is declared in the column
described in paragraph (4)(g)(A) of this rule, potassium shall be listed under
sodium and the DRV established in subsection (3)(i) of this rule shall be
inserted on the same line in the numeric columns.
(D) The abbreviations established in
subsection (7)(b) of this rule may be used within the footnote.
(j) Caloric conversion information
on a per-gram basis for fat, carbohydrate, and protein may be presented beneath
the information required in subsection (4)(i), separated from that information
by a hairline. This information may be presented horizontally (i.e., "Calories
per gram: Fat 9, Carbohydrate 4, Protein 4") or vertically in
columns.
(k)
(A) If the space beneath the information on
vitamins and minerals is not adequate to accommodate the information required
in subsection (4)(i) of this rule, the information required in subsection
(4)(i) may be moved to the right of the column required in paragraph (4)(g)(B)
of this rule and set off by a line that distinguishes it and sets it apart from
the percent of Daily Value information. The caloric conversion information
provided for in subsection (4)(j) of this rule may be presented beneath either
side or along the full length of the nutrition label.
(B) If the space beneath the mandatory
declaration of iron is not adequate to accommodate any remaining vitamins and
minerals to be declared or the information required in subsection (4)(i) of
this rule, the remaining information may be moved to the right and set off by a
line that distinguishes it and sets it apart from the percent of Daily Value
information given to the left. The caloric conversion information provided for
in subsection (4)(j) of this rule may be presented beneath either side or along
the full length of the nutrition label.
(C) If there is not sufficient continuous
vertical space (i.e., approximately 3 inches) to accommodate the required
components of the nutrition label up to and including the mandatory declaration
of iron, the nutrition label may be presented in a tabular display in which the
footnote required by subsection (4)(i) of the rule is given to the far right of
the label, and additional vitamins and minerals beyond the four that are
required (i.e., vitamin A, vitamin C, calcium, and iron) are arrayed
horizontally following declarations of the required vitamins and
minerals.
(l) The
following sample label illustrates the provisions of section (4) of this
rule:
(m)
(A) Nutrition labeling on the outer label of
packages of meat or meat products that contain two or more products in the same
packages (e.g., variety packs) or of packages that are used interchangeably for
the same type of food (e.g., meat salad containers) may use an aggregate
display.
(B) Aggregate displays
shall comply with format requirements of section (4) of this rule to the
maximum extent possible, except that the identity of each food shall be
specified to the right of the "Nutrition Facts" title, and both the
quantitative amount by weight (i.e., g/mg amounts) and the percent Daily Value
for each nutrient shall be listed in separate columns under the name of each
food.
(n) When nutrition
labeling appears in a second language, the nutrition information may be
presented in a separate nutrition label for each language or in one nutrition
label with the information in the second language following that in English.
Numeric characters that are identical in both languages need not be repeated
(e.g., "Protein/Proteinas 2 g"). All required information must be included in
both languages.
(5)
Nutrition information may be presented for two or more forms of the same
product (e.g., both "raw" and "cooked") or for common combinations of foods as
provided for in section (2) of this rule, or for different units (e.g., per 100
grams) as provided for in section (2) of this rule, 'r for two or more groups
for which RDI's are established (e.g., both infants and children less than 4
years of age) as provided for in paragraph (3)(h)(A) of this rule. When such
dual labeling is provided, equal prominence shall be given to both sets of
values. Information shall be presented in a format consistent with section (4)
of this rule, except that:
(a) Following the
subheading of "Amount Per Serving," there shall be two or more column headings
accurately describing the forms of the same product (e.g., "raw" and
"roasted"), the combinations of foods, the units, or the RDI groups that are
being declared. The column representing the product as packaged and according
to the label serving size based on the Reference Amount in OAR
603-029-1036(2)
shall be to the left of the numeric columns.
(b) When the dual labeling is presented for
two or more forms of the same product, for combinations of foods, or for
different units, total calories and calories from fat (and calories from
saturated fat, when declared) shall be listed in a column and indented as
specified in subsection (4)(e) of this rule with quantitative amounts declared
in columns aligned under the column headings set forth in subsection (5)(a) of
this rule.
(c) Quantitative
information by weight required in paragraph (4)(g)(A) of this rule shall be
specified for the form of the product as packaged, but may be on the basis of
'as consumed' for single-ingredient, raw meat products that are not ground or
chopped meat products described in OAR
603-029-1028, and according to the label
serving size based on the Reference Amount in OAR
603-029-1036(2).
(A) Quantitative information by weight may be
included for other forms of the product represented by the additional column(s)
either immediately adjacent to the required quantitative information by weight
for the product as packaged, but may be on the basis of 'as consumed' for
single-ingredient, raw meat products that are not ground or chopped meat
products described in OAR
603-029-1028, and according to the label serving size
based on the Reference Amount in OAR
603-029-1036(2) or as a footnote.
(i) If such additional quantitative
information is given immediately adjacent to the required quantitative
information, it shall be declared for all nutrients listed and placed
immediately following and differentiated from the required quantitative
information (e.g., separated by a comma). Such information shall not be put in
a separate column.
(ii) If such
additional quantitative information is given in a footnote, it shall be
declared in the same order as the nutrients are listed in the nutrition label.
The additional quantitative information may state the total nutrient content of
the product identified in the second column or the nutrient amounts added to
the product as package, but may be on the basis of 'as consumed for
single-ingredient, raw meat products that are not ground or chopped meat
products described in OAR
603-029-1028, for only those nutrients that are
present in different amounts than the amounts declared in the required
quantitative information. The footnote shall clearly identify which amounts are
declared. Any subcomponents declared shall be listed parenthetically after
principal components (e.g., 1/2 cup skim milk contributes an additional 40
calories, 65 mg sodium, 6 g total carbohydrate (6 g sugars), and 4 g
protein).
(B) Total fat
and its quantitative amount by weight shall be followed by an asterisk (or
other symbol) (e.g., "Total fat (2 g)*") referring to another asterisk (or
symbol) at the bottom of the nutrition label identifying the form(s) of the
product for which quantitative information is presented.
(d) Information required in paragraphs
(4)(g)(B) and (4)(h) of this rule shall be presented under the subheading "%
DAILY VALUE" and in columns directly under the column headings set forth in
subsection (5)(a) of this rule.
(e)
The following sample label illustrates the provisions of section (5) of this
rule:
(6)
(a) Nutrition information may be presented in
a simplified format as set forth herein when any required nutrients, other than
the core nutrients (i.e., calories, total fat, sodium, total carbohydrate, and
protein), are present in insignificant amounts. An insignificant amount shall
be defined as that amount that may be rounded to zero in nutrition labeling,
except that for total carbohydrate, dietary fiber, sugars and protein, it shall
be an amount less than 1 gram.
(b)
The simplified format shall include information on the following nutrients:
(A) Total calories, total fat, total
carbohydrate, sodium, and protein;
(B) Any of the following that are present in
more than insignificant amounts: Calories from fat, saturated fat, cholesterol,
dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and
(C)
(iii)
Any vitamins and minerals listed in paragraph (3)(h)(D) of this rule when they
are added in fortified or fabricated foods.
(c) Other nutrients that are naturally
present in the product in more than insignificant amounts may be voluntarily
declared as part of the simplified format.
(d) Any required nutrient, other than a core
nutrient, that is present in an insignificant amount may be omitted from the
tabular listing, provided that the following statement is included at the
bottom of the nutrition label, "Not a significant source of ____." The blank
shall be filled in with the appropriate nutrient or food component.
Alternatively, amounts of vitamins and minerals present in insignificant
amounts may be declared by the use of an asterisk (or symbol) that is placed at
the bottom of the table of nutrient values and that is followed by the
statement "Contains less than 2 percent of the Daily Value of this (these)
nutrient (nutrients)."
(e) Except
as provided for in section (7) of this rule and in OAR
603-029-1060(3) and (4),
nutrient information declared in the simplified format shall be presented in
theme manner as specified in sections (4) or (5) of this rule, except that the
footnote required in subsection (4)(i) of this rule is not required. When the
footnote is omitted, an asterisk shall be placed at the bottom of the label
followed by the statement "Percent Daily Values are based on a 2,000 calorie
diet" and, if the term "Daily Value" is not spelled out in the heading, a
statement that "DV" represents "Daily Value."
(7) Foods in packages that have a total
surface area available to bear labeling of 40 or less square inches may modify
the requirements of sections (3) through (6) of this rule and OAR
603-029-1030(1) by one or more of the following means:
(a)
(A)
Presenting the required nutrition information in a tabular or linear (i.e.,
string) fashion, rather than in vertical columns if the product has a total
surface area available to bear labeling of less than 12 square inches, or if
the product has a total surface area available to bear labeling of 40 or less
square inches and the package shape or size cannot accommodate a standard
vertical column or tabular display on any label panel. Nutrition information
may be given in a linear fashion only if the package shape or size will not
accommodate a tabular display.
(B)
When nutrition information is given in a linear display, the nutrition
information shall be set off in a box by the use of a hairline. The percent
Daily Value is separated from the quantitative amount declaration by the use of
parenthesis, and all nutrients, both principal components and subcomponents,
are treated similarly. Bolding is required only on the title "Nutrition Facts"
and is allowed for nutrient names for "Calories," "Total fat," "Cholesterol,"
"Sodium," "Total carbohydrate," and "Protein."
(b) Using any of the following abbreviations:
Serving size-Serv size
Servings per container-Servings
Calories from fat-Fat cal
Calories from saturated fat-Sat fat cal
Saturated fat-Sat fat
Monounsaturated fat-Monounsat fat
Polyunsaturated fat-Polyunsat fat
Cholesterol-Cholest
Total carbohydrate-Total carb
Dietary fiber-Fiber
Soluble fiber-Sol fiber
Insoluble fiber-Insol fiber
Sugar alcohol-Sugar alc
Other carbohydrate-Other carb
(c) Omitting the footnote required in
subsection (4)(i) of this rule and placing another asterisk at the bottom of
the label followed by the statement "Percent Daily Values are based on a 2,000
calorie diet" and, if the term "Daily Value" is not spelled out in the heading,
a statement that "DV" represents "Daily Value."
(d) Presenting the required nutrition
information on any other label panel.
(8) Compliance with this rule shall be
determined as follows:
(a) A production lot is
a set of food production consumer units that are from one production shift.
Alternatively, a collection of consumer units of the same size, type, and style
produced under conditions as nearly uniform as possible, designated by a common
container code or marking, constitutes a production lot.
(b) The sample for nutrient analysis shall
consist of a composite of a minimum of six consumer units, each from a
production lot. Alternatively, the sample for nutrient analysis shall consist
of a composite of a minimum of six consumer units, each randomly chosen to be
representative of a production lot. In each case, the units may be individually
analyzed and the results of the analyses averaged, or the units would be
composited and the composite analyzed. In both cases, the results, whether an
average or a single result from a composite, will be considered by the Agency
to be the nutrient content of a composite. All analyses shall be performed in
accordance with the methods and procedures used by FSIS under
9 CFR §
317.309(h)(2).
(c) Two classes of nutrients are defined for
purposes of compliance:
(A) Class I. Added
nutrients in fortified or fabricated foods; and
(B) Class II. Naturally occurring
(indigenous) nutrients. If any ingredient which contains a naturally occurring
(indigenous) nutrient is added to a food, the total amount of such nutrient in
the final food product is subject to Class II requirements unless the same
nutrient is also added, which would make the total amount of such nutrient
subject to Class I requirements.
(d) A product with a label declaration of a
vitamin, mineral, protein, total carbohydrate, dietary fiber, other
carbohydrate, polyunsaturated or monounsaturated fat, or potassium shall be
deemed to be misbranded under section 1(n) of the Federal Meat Inspection Act
(21
U.S.C.
601(n)(1)) unless it
meets the following requirements:
(A) Class I
vitamin, mineral, protein, dietary fiber, or potassium. The nutrient content of
the composite is at least equal to the value for that nutrient declared on the
label.
(B) Class II vitamin,
mineral, protein, total carbohydrate, dietary fiber, other carbohydrate,
polyunsaturated or monounsaturated fat, or potassium. The nutrient content of
the composite is at least equal to 80 percent of the value for that nutrient
declared on the label; Provided, That no regulatory action will be based on a
determination of a nutrient value which falls below this level by an amount
less than the variability generally recognized for the analytical method used
in that product at the level involved, and inherent nutrient variation in a
product.
(e) A product
with a label declaration of calories, sugars, total fat, saturated fat,
cholesterol, or sodium shall be deemed to be misbranded under section 1(n) of
the Federal Meat Inspection Act (21 U.S.C.
601(n)(1)) if the nutrient
content of the composite is greater than 20 percent in excess of the value for
that nutrient declared on the label; Provided, That no regulatory action will
be based on a determination of a nutrient value which falls above this level by
an amount less than the variability generally recognized for the analytical
method used in that product at the level involved, and inherent nutrient
variation in a product.
(f) The
amount of a vitamin, mineral, protein, total carbohydrate, dietary fiber, other
carbohydrate, polyunsaturated or monounsaturated fat, or potassium may vary
over labeled amounts within good manufacturing practice. The amount of
calories, sugars, total fat, saturated fat, cholesterol, or sodium may vary
under labeled amounts within good manufacturing practice.
(g) Compliance will be based on the metric
measure specified in the label statement of serving size.
(h) The management of the establishment must
maintain records to support the validity of nutrient declarations contained on
product labels. Such records shall be made available to the inspector or any
duly authorized representative of the Agency upon request.
(i) The compliance provisions set forth in
subsection (8) (a) through (h) of this rule shall not apply to
single-ingredient, raw meat products that are not ground or chopped meat
products described in OAR
603-029-1028, including those that have been
previously frozen, when nutrition labeling is based on the most current
representative data base values contained in USDA's National Nutrient Data Bank
or its released form, the USDA National Nutrient Database for Standard
Reference as provided in OAR
603-029-1042(5) and (6).