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101.12 Reference amounts customarily consumed per eating occasion.

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[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.12]

[Page 46-56]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 101_FOOD LABELING--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  101.12  Reference amounts customarily consumed per eating occasion.

    (a) The general principles and factors that the Food and Drug 
Administration (FDA) considered in arriving at the reference amounts 
customarily consumed per eating occasion (reference amounts) which are 
set forth in paragraph (b) of this section, are that:
    (1) FDA calculated the reference amounts for persons 4 years of age 
or

[[Page 47]]

older to reflect the amount of food customarily consumed per eating 
occasion by persons in this population group. These reference amounts 
are based on data set forth in appropriate national food consumption 
surveys.
    (2) FDA calculated the reference amounts for an infant or child 
under 4 years of age to reflect the 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. These reference amounts are based 
on data set forth in appropriate national food consumption surveys. Such 
reference amounts are to be used only when the food is specially 
formulated or processed for use by an infant or by a child under 4 years 
of age.
    (3) An appropriate national food consumption survey includes a large 
sample size representative of the demographic and socioeconomic 
characteristics of the relevant population group and must be based on 
consumption data under actual conditions of use.
    (4) To determine the amount of food customarily consumed per eating 
occasion, FDA considered the mean, median, and mode of the consumed 
amount per eating occasion.
    (5) When survey data were insufficient, FDA took various other 
sources of information on serving sizes of food into consideration. 
These other sources of information included:
    (i) Serving sizes used in dietary guidance recommendations or 
recommended by other authoritative systems or organizations;
    (ii) Serving sizes recommended in comments;
    (iii) Serving sizes used by manufacturers and grocers; and
    (iv) Serving sizes used by other countries.
    (6) Because they reflect the amount customarily consumed, the 
reference amount and, in turn, the serving size declared on the product 
label are based on only the edible portion of food, and not bone, seed, 
shell, or other inedible components.
    (7) The reference amount is based on the major intended use of the 
food (e.g., milk as a beverage and not as an addition to cereal).
    (8) The reference amounts for products that are consumed as an 
ingredient of other foods, but that may also be consumed in the form in 
which they are purchased (e.g., butter), are based on use in the form 
purchased.
    (9) FDA sought to ensure that foods that have similar dietary usage, 
product characteristics, and customarily consumed amounts have a uniform 
reference amount.
    (b) The following reference amounts shall be used as the basis for 
determining serving sizes for specific products:

  Table 1--Reference Amounts Customarily Consumed Per Eating Occasion:
                   Infant and Toddler Foods \1,2,3,4\
------------------------------------------------------------------------
        Product category         Reference amount   Label statement \5\
------------------------------------------------------------------------
Cereals, dry instant...........  15 g............  -- cup (-- g)
Cereals, prepared, ready-to-     110 g...........  -- cup(s) (-- g)
 serve.
Other cereal and grain           7 g for infants   -- cup(s) (-- g) for
 products, dry ready-to-eat,      and 20 g for      ready-to-eat
 e.g., ready-to-eat cereals,      toddlers for      cereals; -- piece(s)
 cookies, teething biscuits,      ready-to-eat      (-- g) for others
 and toasts.                      cereals; 7 g
                                  for all others.
Dinners, desserts, fruits,       15 g............  -- tbsp(s) (-- g); --
 vegetables or soups, dry mix.                      cup(s) (-- g)
Dinners, desserts, fruits,       110 g...........  -- cup(s) (-- g); --
 vegetables or soups, ready-to-                     cup(s) (-- mL)
 serve, junior type.
Dinners, desserts, fruits,       60 g............  -- cup(s) (-- g); --
 vegetables or soups, ready-to-                     cup(s) (-- mL)
 serve, strained type.
Dinners, stews or soups for      170 g...........  -- cup(s) (-- g); --
 toddlers, ready-to-serve.                          cup(s) (-- mL)
Fruits for toddlers, ready-to-   125 g...........  -- cup(s) (-- g)
 serve.
Vegetables for toddlers, ready-  70 g............  -- cup(s) (-- g)
 to- serve.
Eggs/egg yolks, ready-to-serve.  55 g............  -- cup(s) (-- g)
Juices, all varieties..........  120 mL..........  4 fl oz (120 mL)
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
  eating occasion and were primarily derived from the 1977-1978 and the
  1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture.
\2\ Unless otherwise noted in the Reference amount column, the reference
  amounts are for the ready-to-serve or almost ready-to-serve form of
  the product (i.e., heat and serve, brown and serve). If not listed
  separately, the reference amount for the unprepared form (e.g., dry
  cereal) is the amount required to make the reference amount of the
  prepared form. Prepared means prepared for consumption (e.g., cooked).

[[Page 48]]


\3\ Manufacturers are required to convert the reference amount to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures in 21 CFR 101.9(b).
\4\Copies of the list of products for each product category are
  available from the Office of Nutritional Products, Labeling and
  Dietary Supplements (HFS-800), Center for Food Safety and Applied
  Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
  College Park, MD 20740.
\5\ The label statements are meant to provide guidance to manufacturers
  on the presentation of serving size information on the label, but they
  are not required. The term ``piece'' is used as a generic description
  of a discrete unit. Manufacturers should use the description of a unit
  that is most appropriate for the specific product (e.g., sandwich for
  sandwiches, cookie for cookies, and bar for frozen novelties).


  Table 2--Reference Amounts Customarily Consumed Per Eating Occasion:
                      General Food Supply \1,2,3,4\
------------------------------------------------------------------------
        Product category         Reference amount    Label statement\5\
------------------------------------------------------------------------
Bakery products:
    Biscuits, croissants,        55 g............  -- piece(s) (-- g)
     bagels, tortillas, soft
     bread sticks, soft
     pretzels, corn bread, hush
     puppies.
    Breads (excluding sweet      50 g............  -- piece(s) (-- g)
     quick type), rolls.                            for sliced bread and
                                                    distinct pieces
                                                    (e.g., rolls); 2 oz
                                                    (56 g/-- inch slice)
                                                    for unsliced bread
    Bread sticks--see crackers.  ................  .....................
    Toaster pastries--see        ................  .....................
     coffee cakes.
    Brownies...................  40 g............  -- piece(s) (-- g)
                                                    for distinct pieces;
                                                    fractional slice (--
                                                    g) for bulk
    Cakes, heavy weight (cheese  125 g...........  -- piece(s) (-- g)
     cake; pineapple upside-                        for distinct pieces
     down cake; fruit, nut, and                     (e.g., sliced or
     vegetable cakes with more                      individually
     than or equal to 35                            packaged products);
     percent of the finished                        -- fractional slice
     weight as fruit, nuts, or                      (-- g) for large
     vegetables or any of these                     discrete units
     combined) \6\.
    Cakes, medium weight         80 g............  -- piece(s) (-- g)
     (chemically leavened cake                      for distinct pieces
     with or without icing or                       (e.g., cupcake); --
     filling except those                           fractional slice (--
     classified as light weight                     g) for large
     cake; fruit, nut, and                          discrete units
     vegetable cake with less
     than 35 percent of the
     finished weight as fruit,
     nuts, or vegetables or any
     of these combined; light
     weight cake with icing;
     Boston cream pie; cupcake;
     eclair; cream puff) \7\.
    Cakes, light weight (angel   55 g............  -- piece(s) (-- g)
     food, chiffon, or sponge                       for distinct pieces
     cake without icing or                          (e.g., sliced or
     filling) \8\.                                  individually
                                                    packaged products);
                                                    -- fractional slice
                                                    (-- g) for large
                                                    discrete units
    Coffee cakes, crumb cakes,   55 g............  -- piece(s) (-- g)
     doughnuts, Danish, sweet                       for sliced bread and
     rolls, sweet quick type                        distinct pieces
     breads, muffins, toaster                       (e.g., doughnut); 2
     pastries.                                      oz (56 g/visual unit
                                                    of measure) for bulk
                                                    products (e.g.,
                                                    unsliced bread)
    Cookies....................  30 g............  -- piece(s) (-- g)
    Crackers that are usually    15 g............  -- piece(s) (-- g)
     not used as snack, melba
     toast, hard bread sticks,
     ice cream cones \9\.
    Crackers that are usually    30 g............  -- piece(s) (-- g)
     used as snacks.
    Croutons...................  7 g.............  -- tbsp(s) (-- g); --
                                                    cup(s) (-- g); --
                                                    piece(s) (-- g) for
                                                    large pieces
    French toast, pancakes,      110 g prepared    -- piece(s) (-- g); --
     variety mixes.               for french         cup(s) (-- g) for
                                  toast and         dry mix
                                  pancakes; 40 g
                                  dry mix for
                                  variety mixes.
    Grain-based bars with or     40 g............  -- piece(s) (-- g)
     without filling or
     coating, e.g., breakfast
     bars, granola bars, rice
     cereal bars.
    Ice cream cones--see         ................  .....................
     crackers.
    Pies, cobblers, fruit        125 g...........  -- piece(s) (--g) for
     crisps, turnovers, other                       distinct pieces; --
     pastries.                                      fractional slice (--
                                                    g) for large
                                                    discrete units
    Pie crust..................  1/6 of 8 inch     1/6 of 8 inch crust
                                  crust; 1/8 of 9   (-- g); 1/8 of 9
                                  inch crust.       inch crust (-- g)
    Pizza crust................  55 g............  -- fractional slice
                                                    (-- g)
    Taco shells, hard..........  30 g............  -- shell(s) (-- g)
    Waffles....................  85 g............  -- piece(s) (-- g)
Beverages:
    Carbonated and               240 mL..........  8 fl oz (240 mL)
     noncarbonated beverages,
     wine coolers, water.
    Coffee or tea, flavored and  240 mL prepared.  8 fl oz (240 mL)
     sweetened.
Cereal and Other Grain
 Products:
    Breakfast cereals (hot       1 cup prepared;   -- cup(s) (-- g)
     cereal type), hominy grits.  40 g plain dry
                                  cereal; 55 g
                                  flavored,
                                  sweetened dry
                                  cereal.

[[Page 49]]


    Breakfast cereals, ready-to- 15 g............  -- cup(s) (-- g)
     eat, weighing less than 20
     g per cup, e.g., plain
     puffed cereal grains.
    Breakfast cereals, ready-to- 30 g............  -- cup(s) (-- g)
     eat weighing 20 g or more
     but less than 43 g per
     cup; high fiber cereals
     containing 28 g or more of
     fiber per 100 g.
    Breakfast cereals, ready-to- 55 g............  -- piece(s) (-- g)
     eat, weighing 43 g or more                     for large distinct
     per cup; biscuit types.                        pieces (e.g.,
                                                    biscuit type);--
                                                    cup(s) (-- g) for
                                                    all others
    Bran or wheat germ.........  15 g............  -- tbsp(s) (-- g); --
                                                    cup(s) (-- g)
    Flours or cornmeal.........  30 g............  -- tbsp(s) (-- g); --
                                                    cup(s) (-- g)
    Grains, e.g., rice, barley,  140 g prepared;   -- cup(s) (-- g)
     plain.                       45 g dry.
    Pastas, plain..............  140 g prepared;   -- cup(s) (-- g); --
                                  55 g dry.         piece(s) (-- g) for
                                                    large pieces (e.g.,
                                                    large shells or
                                                    lasagna noodles) or
                                                    2 oz (56 g/visual
                                                    unit of measure) for
                                                    dry bulk products
                                                    (e.g., spaghetti)
    Pastas, dry, ready-to-eat,   25 g............  -- cup(s) (-- g)
     e.g., fried canned chow
     mein noodles.
    Starches, e.g., cornstarch,  10 g............  -- tbsp (-- g)
     potato starch, tapioca,
     etc..
    Stuffing...................  100 g...........  -- cup(s) (-- g)
Dairy Products and Substitutes:
    Cheese, cottage............  110 g...........  -- cup (-- g)
    Cheese used primarily as     55 g............  -- cup (-- g)
     ingredients, e.g., dry
     cottage cheese, ricotta
     cheese.
    Cheese, grated hard, e.g.,   5 g.............  -- tbsp (-- g)
     Parmesan, Romano.
    Cheese, all others except    30 g............  -- piece(s) (-- g)
     those listed as separate                       for distinct
     categories--includes cream                     pieces;-- tbsp(s) (--
     cheese and cheese spread.                       g) for cream cheese
                                                    and cheese spread; 1
                                                    oz (28 g/visual unit
                                                    of measure) for bulk
    Cheese sauce--see sauce
     category.
    Cream or cream substitutes,  15 mL...........  1 tbsp (15 mL)
     fluid.
    Cream or cream substitutes,  2 g.............  -- tsp (-- g)
     powder.
    Cream, half & half.........  30 mL...........  2 tbsp (30 mL)
    Eggnog.....................  120 mL..........  1/2 cup (120 mL); 4
                                                    fl oz (120 mL)
    Milk, condensed, undiluted.  30 mL...........  2 tbsp (30 mL)
    Milk, evaporated, undiluted  30 mL...........  2 tbsp (30 mL)
    Milk, milk-based drinks,     240 mL..........  1 cup (240 mL); 8 fl
     e.g., instant breakfast,                       oz (240 mL)
     meal replacement, cocoa.
    Shakes or shake              240 mL..........  1 cup (240 mL); 8 fl
     substitutes, e.g., dairy                       oz (240 mL)
     shake mixes, fruit frost
     mixes.
    Sour cream.................  30 g............  -- tbsp (-- g)
    Yogurt.....................  225 g...........  -- cup (-- g)
Desserts:
    Ice cream, ice milk, frozen  1/2 cup-includes  -- piece(s) (-- g)
     yogurt, sherbet: all         the volume for    for individually
     types, bulk and novelties    coatings and      wrapped or packaged
     (e.g., bars, sandwiches,     wafers for the    products; 1/2 cup (--
     cones).                      novelty type       g) for others
                                  varieties.
    Frozen flavored and          85 g............  -- piece(s) (-- g)
     sweetened ice and pops,                        for individually
     frozen fruit juices: all                       wrapped or packaged
     types, bulk and novelties                      products; -- cup(s)
     (e.g., bars, cups).                            (-- g) for others
    Sundae.....................  1 cup...........  1 cup (-- g)
    Custards, gelatin or         1/2 cup.........  -- piece(s) (-- g)
     pudding.                                       for distinct unit
                                                    (e.g., individually
                                                    packaged products);
                                                    1/2 cup (-- g) for
                                                    bulk
Dessert Toppings and Fillings:
    Cake frostings or icings...  35 g............  -- tbsp(s) (-- g)
    Other dessert toppings,      2 tbsp..........  2 tbsp (-- g); 2 tbsp
     e.g., fruits, syrups,                          (30 mL)
     spreads, marshmallow
     cream, nuts, dairy and
     nondairy whipped toppings.
    Pie fillings...............  85 g............  -- cup(s) (-- g)
Egg and Egg Sustitutes:
    Egg mixtures, e.g., egg foo  110 g...........  -- piece(s) (-- g)
     young, scrambled eggs,                         for discrete pieces;
     omelets.                                       -- cup(s) (-- g)
    Eggs (all sizes) \9\.......  50 g............  1 large, medium, etc.
                                                    (-- g)
    Egg substitutes............  An amount to      -- cup(s) (-- g); --
                                  make 1 large      cup(s) (-- mL)
                                  (50 g) egg.
Fats and Oils:
    Butter, margarine, oil,      1 tbsp..........  1 tbsp (-- g); 1 tbsp
     shortening.                                    (15 mL)
    Butter replacement, powder.  2 g.............  -- tsp(s) (-- g)

[[Page 50]]


    Dressings for salads.......  30 g............  -- tbsp (-- g); --
                                                    tbsp (-- mL)
    Mayonnaise, sandwich         15 g............  -- tbsp (-- g)
     spreads, mayonnaise-type
     dressings.
    Spray types................  0.25 g..........  About -- seconds
                                                    spray (-- g)
Fish, Shellfish, Game Meats
 \10\, and Meat or Poultry
 Substitutes:
    Bacon substitutes, canned    15 g............  -- piece(s) (-- g)
     anchovies, \11\ anchovy                        for discrete pieces;
     pastes, caviar.                                -- tbsp(s) (-- g)
                                                    for others
    Dried, e.g., jerky.........  30 g............  -- piece(s) (-- g)
    Entrees with sauce, e.g.,    140 g cooked....  -- cup(s) (-- g); 5
     fish with cream sauce,                         oz (140 g/visual
     shrimp with lobster sauce.                     unit of measure) if
                                                    not measurable by
                                                    cup
    Entrees without sauce,       85 g cooked; 110  -- piece(s) (-- g)
     e.g., plain or fried fish    g uncooked \12\.  for discrete pieces;
     and shellfish, fish and                        -- cup(s) (-- g); --
     shellfish cake.                                oz (-- g/visual unit
                                                    of measure) if not
                                                    measurable by cup
                                                    \13\
    Fish, shellfish or game      55 g............  -- piece(s) (-- g)
     meat \10\, canned \11\.                        for discrete pieces;
                                                    -- cup(s) (-- g); 2
                                                    oz (56 g/-- cup) for
                                                    products that are
                                                    difficult to measure
                                                    the g weight of cup
                                                    measure (e.g.,
                                                    tuna); 2 oz (56 g/--
                                                    pieces) for products
                                                    that naturally vary
                                                    in size (e.g.,
                                                    sardines)
    Substitute for luncheon      55 g............  -- piece(s) (-- g)
     meat, meat spreads,                            for distinct pieces
     Canadian bacon, sausages                       (e.g., slices,
     and frankfurters.                              links); -- cup(s) (--
                                                     g); 2 oz (56 g/
                                                    visual unit of
                                                    measure) for
                                                    nondiscrete bulk
                                                    product
    Smoked or pickled \11\       55 g............  -- piece(s) (-- g)
     fish, shellfish, or game                       for distinct pieces
     meat \10\; fish or                             (e.g., slices,
     shellfish spread.                              links) or -- cup(s)
                                                    (-- g); 2 oz (56 g/
                                                    visual unit of
                                                    measure) for
                                                    nondiscrete bulk
                                                    product
    Substitutes for bacon bits--
     see miscellaneous category.
Fruits and Fruit Juices:
    Candied or pickled \11\....  30 g............  -- piece(s) (-- g)
    Dehydrated fruits--see       ................  .....................
     snacks category.
    Dried......................  40 g............  -- piece(s) (-- g)
                                                    for large pieces
                                                    (e.g., dates, figs,
                                                    prunes); -- cup(s)
                                                    (-- g) for small
                                                    pieces (e.g.,
                                                    raisins)
    Fruits for garnish or        4 g.............  1 cherry (-- g)
     flavor, e.g., maraschino
     cherries \11\.
    Fruit relishes, e.g.,        70 g............  -- cup(s) (-- g)
     cranberry sauce, cranberry
     relish.
    Fruits used primarily as     30 g............  See footnote 13
     ingredients, avocado.
    Fruits used primarily as     55 g............  -- piece(s) (-- g)
     ingredients, others                            for large fruits; --
     (cranberries, lemon, lime).                    cup(s) (-- g) for
                                                    small fruits
                                                    measurable by cup
                                                    \13\
    Watermelon.................  280 g...........  See footnote 13
    All other fruits (except     140 g...........  -- piece(s) (-- g)
     those listed as separate                       for large pieces
     categories), fresh,                            (e.g., strawberries,
     canned, or frozen.                             prunes, apricots,
                                                    etc.); -- cup(s) (--
                                                    g) for small pieces
                                                    (e.g., blueberries,
                                                    raspberries, etc.)
                                                    \13\
    Juices, nectars, fruit       240 mL..........  8 fl oz (240 mL)
     drinks.
    Juices used as ingredients,  5 mL............  1 tsp (5 mL)
     e.g., lemon juice, lime
     juice.
Legumes:
    Bean cake (tofu) \11\,       85 g............  -- piece(s) (-- g)
     tempeh.                                        for discrete pieces;
                                                    3 oz (84 g/visual
                                                    unit of measure) for
                                                    bulk products
    Beans, plain or in sauce...  130 g for beans   -- cup (-- g)
                                  in sauce or
                                  canned in
                                  liquid and
                                  refried beans
                                  prepared; 90 g
                                  for others
                                  prepared; 35 g
                                  dry.
Miscellaneous Category:
    Baking powder, baking soda,  0.6 g...........  -- tsp ( -- g)
     pectin.
    Baking decorations, e.g.,    1 tsp or 4 g if   -- piece(s) (-- g)
     colored sugars and           not measurable    for discrete
     sprinkles for cookies,       by teaspoon.      pieces;1 tsp (-- g)
     cake decorations.
    Batter mixes, bread crumbs.  30 g............  -- tbsp(s) (-- g);--
                                                    cup(s) (-- g)
    Cooking wine...............  30 mL...........  2 tbsp (30 mL)

[[Page 51]]


    Dietary supplements........  The maximum       -- tablet(s), --
                                  amount            capsule(s), --
                                  recommended, as   packet(s), -- tsp(s)
                                  appropriate, on   (-- g), etc.
                                  the label for
                                  consumption per
                                  eating
                                  occasion, or,
                                  in the absence
                                  of
                                  recommendations
                                  , 1 unit, e.g.,
                                  tablet,
                                  capsule,
                                  packet,
                                  teaspoonsful,
                                  etc..
    Drink mixers (without        Amount to make    -- fl oz (-- mL)
     alcohol).                    240 mL drink
                                  (without ice).
    Chewing gum \9\............  3 g.............  -- piece(s) (-- g)
    Meat, poultry and fish       Amount to make    -- tsp(s) (-- g); --
     coating mixes, dry;          one reference     tbsp(s) (-- g)
     seasoning mixes, dry,        amount of final
     e.g., chili seasoning        dish.
     mixes, pasta salad
     seasoning mixes.
    Salad and potato toppers,    7 g.............  -- tbsp(s) (-- g)
     e.g., salad crunchies,
     salad crispins,
     substitutes for bacon bits.
  Salt, salt substitutes,        1/4 tsp.........  1/4 tsp ( --g); --
   seasoning salts (e.g.,                           piece(s) ( --g) for
   garlic salt).                                    discrete pieces
                                                    (e.g., individually
                                                    packaged products)
    Spices, herbs (other than    1/4 tsp or 0.5 g  1/4 tsp (-- g); --
     dietary supplements).        if not            piece(s) (-- g) if
                                  measurable by     not measurable by
                                  teaspoon.         teaspoons (e.g., bay
                                                    leaf)
Mixed Dishes:
    Measurable with cup, e.g.,   1 cup...........  1 cup (-- g)
     casseroles, hash, macaroni
     and cheese, pot pies,
     spaghetti with sauce,
     stews, etc..
    Not measurable with cup,     140 g, add 55 g   -- piece(s) (-- g)
     e.g., burritos, egg rolls,   for products      for discrete pieces;
     enchiladas, pizza, pizza     with gravy or     -- fractional slice
     rolls, quiche, all types     sauce topping,    (-- g) for large
     of sandwiches.               e.g., enchilada   discrete units
                                  with cheese
                                  sauce, crepe
                                  with white
                                  sauce \14\.
Nuts and Seeds:
    Nuts, seeds, and mixtures,   30 g............  -- piece(s) (-- g)
     all types: sliced,                             for large pieces
     chopped, slivered, and                         (e.g., unshelled
     whole.                                         nuts);-- tbsp(s) (--
                                                    g) ;-- cup(s) (-- g)
                                                    for small pieces
                                                    (e.g., peanuts,
                                                    sunflower seeds)
    Nut and seed butters,        2 tbsp..........  2 tbsp (-- g)
     pastes, or creams.
    Coconut, nut and seed        15 g............  -- tbsp(s) (-- g); --
     flours.                                        cup (-- g)
Potatoes and Sweet Potatoes/
 Yams:
    French fries, hash browns,   70 g prepared;    -- piece(s) (-- g)
     skins, or pancakes.          85 g for frozen   for large distinct
                                  unprepared        pieces (e.g.,
                                  french fries.     patties, skins); 2.5
                                                    oz (70 g/-- pieces)
                                                    for prepared fries;
                                                    3 oz (84 g/--
                                                    pieces) for
                                                    unprepared fries
    Mashed, candied, stuffed,    140 g...........  -- piece(s) (-- g)
     or with sauce.                                 for discrete pieces
                                                    (e.g., stuffed
                                                    potato); -- cup(s)
                                                    (-- g)
    Plain, fresh, canned, or     110 g for fresh   -- piece(s) (-- g)
     frozen.                      or frozen; 125    for discrete
                                  g for vacuum      pieces;-- cup(s) (--
                                  packed; 160 g     g) for sliced or
                                  for canned in     chopped products
                                  liquid.
Salads:
    Gelatin salad..............  120 g...........  -- cup (-- g)
    Pasta or potato salad......  140 g...........  -- cup(s) (-- g)
    All other salads, e.g.,      100 g...........  -- cup(s) (-- g)
     egg, fish, shellfish,
     bean, fruit, or vegetable
     salads.
Sauces, Dips, Gravies and
 Condiments:
    Barbecue sauce, hollandaise  2 tbsp..........  2 tbsp (-- g); 2 tbsp
     sauce, tartar sauce, other                     (30 mL)
     sauces for dipping (e.g.,
     mustard sauce, sweet and
     sour sauce), all dips
     (e.g., bean dips, dairy-
     based dips, salsa).
    Major main entree sauces,    125 g...........  -- cup (-- g); -- cup
     e.g., spaghetti sauce.                         (-- mL)

[[Page 52]]


    Minor main entree sauces     1/4 cup.........  1/4 cup (-- g); 1/4
     (e.g., pizza sauce, pesto                      cup (60 mL)
     sauce), other sauces used
     as toppings (e.g., gravy,
     white sauce, cheese
     sauce), cocktail sauce.
    Major condiments, e.g.,      1 tbsp..........  1 tbsp (-- g); 1 tbsp
     catsup, steak sauce, soy                       (15 mL)
     sauce, vinegar, teriyaki
     sauce, marinades.
    Minor condiments, e.g.,      1 tsp...........  1 tsp (-- g); 1 tsp
     horseradish, hot sauces,                       (5 mL)
     mustards, worcestershire
     sauce.
Snacks:
    All varieties, chips,        30 g............  -- cup(s) (-- g) for
     pretzels, popcorns,                            small pieces (e.g.,
     extruded snacks, fruit-                        popcorn) -- piece(s)
     based snacks (e.g., fruit                      (-- g) for large
     chips,) grain-based snack                      pieces (e.g., large
     mixes.                                         pretzels; pressed
                                                    dried fruit sheet);
                                                    1 oz (28 g/visual
                                                    unit of measure) for
                                                    bulk products (e.g.,
                                                    potato chips)
Soups:
    All varieties..............  245 g...........  -- cup (-- g); -- cup
                                                    (-- mL)
Sugars and Sweets:
    Baking candies (e.g.,        15 g............  -- piece(s) (-- g)
     chips).                                        for large pieces; --
                                                    tbsp(s) (-- g) for
                                                    small pieces; 1/2 oz
                                                    (14 g/visual unit of
                                                    measure) for bulk
                                                    products
    Hard candies, breath mints.  2 g.............  -- piece(s) (-- g)
    Hard candies, roll-type,     5 g.............  -- piece(s) (-- g)
     mini-size in dispenser
     packages.
    Hard candies, others.......  15 g............  -- piece(s) (-- g)
                                                    for large pieces;--
                                                    tbsp(s) (-- g) for
                                                    ``mini-size''
                                                    candies measurable
                                                    by tablespoon; 1/2
                                                    oz (14 g/visual unit
                                                    of measure) for bulk
                                                    products
    All other candies..........  40 g............  -- piece(s) (-- g); 1
                                                    1/2 oz (42 g/visual
                                                    unit of measure) for
                                                    bulk products
    Confectioner's sugar.......  30 g............  -- cup (-- g)
    Honey, jams, jellies, fruit  1 tbsp..........  1 tbsp (-- g); 1 tbsp
     butter, molasses.                              (15 mL)
    Marshmallows...............  30 g............  -- cup(s) (-- g) for
                                                    small pieces; --
                                                    piece(s) (-- g) for
                                                    large pieces
    Sugar......................  4 g.............  -- tsp (-- g) ; --
                                                    piece(s) (-- g) for
                                                    discrete pieces
                                                    (e.g., sugar cubes,
                                                    individually
                                                    packaged products)
    Sugar substitutes..........  An amount         -- tsp(s) (-- g) for
                                  equivalent to     solids; -- drop(s)
                                  one reference     (-- g) for liquid; --
                                  amount for         piece(s) (-- g)
                                  sugar in          (e.g., individually
                                  sweetness.        packaged products)
    Syrups.....................  30 mL for syrups  2 tbsp (30 mL) for
                                  used primarily    syrups used
                                  as an             primarily as an
                                  ingredient        ingredient; 1/4 cup
                                  (e.g., light or   (60 mL) for all
                                  dark corn         others
                                  syrup); 60 mL
                                  for all others.
Vegetables:
    Vegetables primarily used    4 g.............  -- piece(s) (-- g); --
     for garnish or flavor,                          tbsp(s) (-- g) for
     e.g., pimento, parsley.                        chopped products
    Chili pepper, green onion..  30 g............  -- piece(s) (-- g)
                                                    \13\; -- tbsp(s) (--
                                                    g); -- cup(s) (-- g)
                                                    for sliced or
                                                    chopped products
    All other vegetables         85 g for fresh    -- piece(s) (-- g)
     without sauce: fresh,        or frozen; 95 g   for large pieces
     canned, or frozen.           for vacuum        (e.g., brussel
                                  packed; 130 g     sprouts); -- cup(s)
                                  for canned in     (-- g) for small
                                  liquid, cream-    pieces (e.g., cut
                                  style corn,       corn, green peas); 3
                                  canned or         oz (84 g/visual unit
                                  stewed            of measure) if not
                                  tomatoes,         measurable by cup
                                  pumpkin, or       \13\
                                  winter squash.
    All other vegetables with    110 g...........  -- piece(s) (-- g)
     sauce: fresh, canned, or                       for large pieces
     frozen.                                        (e.g., brussel
                                                    sprouts); -- cup(s)
                                                    (-- g) for small
                                                    pieces (e.g., cut
                                                    corn, green peas); 4
                                                    oz (112 g/visual
                                                    unit of measure) if
                                                    not measurable by
                                                    cup
    Vegetable juice............  240 mL..........  8 fl oz (240 mL)

[[Page 53]]


    Olives \11\................  15 g............  -- piece(s) (-- g); --
                                                     tbsp(s) (-- g) for
                                                    sliced products
    Pickles, all types \11\....  30 g............  1 oz (28 g/visual
                                                    unit of measure)
    Pickle relishes............  15 g............  -- tbsp (-- g)
    Vegetable pastes, e.g.,      30 g............  -- tbsp (-- g)
     tomato paste.
    Vegetable sauces or purees,  60 g............  -- cup (-- g); -- cup
     e.g, tomato sauce, tomato                      (-- mL)
     puree.
------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food
  customarily consumed per eating occasion and were primarily derived
  from the 1977-1978 and the 1987-1988 Nationwide Food Consumption
  Surveys conducted by the U.S. Department of Argiculture.
\2\ Unless otherwise noted in the Reference Amount column, the reference
  amounts are for the ready-to-serve or almost ready-to-serve form of
  the product (i.e., heat and serve, brown and serve). If not listed
  separately, the reference amount for the unprepared form (e.g., dry
  mixes; concentrates; dough; batter; fresh and frozen pasta) is the
  amount required to make the reference amount of the prepared form.
  Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures in 21 CFR 101.9(b).
\4\ Copies of the list of products for each product category are
  available from the Office of Nutritional Products, Labeling and
  Dietary Supplements (HFS-800), Center for Food Safety and Applied
  Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
  College Park, MD 20740.
\5\ The label statements are meant to provide guidance to manufacturers
  on the presentation of serving size information on the label, but they
  are not required. The term ``piece'' is used as a generic description
  of a discrete unit. Manufacturers should use the description of a unit
  that is most appropriate for the specific product (e.g., sandwich for
  sandwiches, cookie for cookies, and bar for ice cream bars). The
  guidance provided is for the label statement of products in ready-to-
  serve or almost ready-to-serve form. The guidance does not apply to
  the products which require further preparation for consumption (e.g.,
  dry mixes, concentrates) unless specifically stated in the product
  category, reference amount, or label statement column that it is for
  these forms of the product. For products that require further
  preparation, manufacturers must determine the label statement
  following the rules in Sec.   101.9(b) using the reference amount
  determined according to Sec.   101.12(c).
\6\ Includes cakes that weigh 10 g or more per cubic inch.
\7\ Includes cakes that weigh 4 g or more per cubic inch but less than
  10 g per cubic inch.
\8\ Includes cakes that weigh less than 4 g per cubic inch.
\9\ Label serving size for ice cream cones and eggs of all sizes will be
  1 unit. Label serving size of all chewing gums that weigh more than
  the reference amount that can reasonably be consumed at a single-
  eating occasion will be 1 unit.
\10\ Animal products not covered under the Federal Meat Inspection Act
  or the Poultry Products Inspection Act, such as flesh products from
  deer, bison, rabbit, quail, wild turkey, geese, ostrich, etc.
\11\ If packed or canned in liquid, the reference amount is for the
  drained solids, except for products in which both the solids and
  liquids are customarily consumed (e.g., canned chopped clam in juice).
\12\ The reference amount for the uncooked form does not apply to raw
  fish in Sec.   101.45 or to single-ingredient products that consist of
  fish or game meat as provided for in Sec.   101.9(b)(j)(11).
\13\ For raw fruit, vegetables, and fish, manufacturers should follow
  the label statement for the serving size specified in Appendices A and
  B to the regulation entitled ``Food Labeling; Guidelines for Voluntary
  Nutrition Labeling; and Identification of the 20 Most Frequently
  Consumed Raw Fruits, Vegetables, and Fish; Definition of Substantial
  Compliance; Correction'' (56 FR 60880 as amended 57 FR 8174, March 6,
  1992).
\14\ Pizza sauce is part of the pizza and is not considered to be sauce
  topping.

    (c) If a product requires further preparation, e.g., cooking or the 
addition of water or other ingredients, and if paragraph (b) of this 
section provides a reference amount for the product in the prepared but 
not the unprepared form, then the reference amount for the unprepared 
product shall be determined using the following rules:
    (1) Except as provided for in paragraph (c)(2) of this section, the 
reference amount for the unprepared product shall be the amount of the 
unprepared product required to make the reference amount for the 
prepared product as established in paragraph (b) of this section.
    (2) For products where the entire contents of the package is used to 
prepare one large discrete unit usually divided for consumption, the 
reference amount for the unprepared product shall be the amount of the 
unprepared product required to make the fraction of the large discrete 
unit closest to the reference amount for the prepared product as 
established in paragraph (b) of this section.
    (d) The reference amount for an imitation or substitute food or 
altered food, such as a ``low calorie'' version, shall be the same as 
for the food for which it is offered as a substitute.
    (e) If a food is modified by incorporating air (aerated), and 
thereby the density of the food is lowered by 25 percent or more in 
weight than that of an appropriate reference regular food as described 
in Sec.  101.13(j)(1)(ii)(A), and the reference amount of the regular 
food is in grams, the manufacturer may determine the reference amount of 
the aerated food by adjusting for the difference in density of the 
aerated food relative to the density of the appropriate reference food 
provided that the

[[Page 54]]

manufacturer will show FDA detailed protocol and records of all data 
that were used to determine the density-adjusted reference amount for 
the aerated food. The reference amount for the aerated food shall be 
rounded to the nearest 5-g increment. Such products shall bear a 
descriptive term indicating that extra air has been incorporated (e.g., 
whipped, aerated). The density-adjusted reference amounts described in 
paragraph (b) of this section may not be used for cakes except for 
cheese cake. The differences in the densities of different types of 
cakes having different degrees of air incorporation have already been 
taken into consideration in determining the reference amounts for cakes 
in Sec.  101.12(b). In determining the difference in density of the 
aerated and the regular food, the manufacturer shall adhere to the 
following:
    (1) The regular and the aerated product must be the same in size, 
shape, and volume. To compare the densities of products having nonsmooth 
surfaces (e.g., waffles), manufacturers shall use a device or method 
that ensures that the volumes of the regular and the aerated products 
are the same.
    (2) Sample selections for the density measurements shall be done in 
accordance with the provisions in Sec.  101.9(g).
    (3) Density measurements of the regular and the aerated products 
shall be conducted by the same trained operator using the same 
methodology (e.g., the same equipment, procedures, and techniques) under 
the same conditions.
    (4) Density measurements shall be replicated a sufficient number of 
times to ensure that the average of the measurements is representative 
of the true differences in the densities of the regular and the 
``aerated'' products.
    (f) For products that have no reference amount listed in paragraph 
(b) of this section for the unprepared or the prepared form of the 
product and that consist of two or more foods packaged and presented to 
be consumed together (e.g., peanut putter and jelly, cracker and cheese 
pack, pancakes and syrup, cake and frosting), the reference amount for 
the combined product shall be determined using the following rules:
    (1) For bulk products (e.g., peanut butter and jelly), the reference 
amount for the combined product shall be the reference amount, as 
established in paragraph (b) of this section, for the ingredient that is 
represented as the main ingredient plus proportioned amounts of all 
minor ingredients.
    (2) For products where the ingredient represented as the main 
ingredient is one or more discrete units (e.g., cracker and cheese pack, 
pancakes and syrup, cake and frosting), the reference amount for the 
combined product shall be either the number of small discrete units or 
the fraction of the large discrete unit that is represented as the main 
ingredient that is closest to the reference amount for that ingredient 
as established in paragraph (b) of this section plus proportioned 
amounts of all minor ingredients.
    (3) If the reference amounts are in compatible units, they shall be 
summed (e.g., the reference amount for equal volumes of peanut butter 
and jelly for which peanut butter is represented as the main ingredient 
would be 4 tablespoons (tbsp) (2 tbsp peanut butter plus 2 tbsp jelly). 
If the reference amounts are in incompatible units, the weights of the 
appropriate volumes should be used (e.g., 110 grams (g) pancakes plus 
the gram weight of the proportioned amount of syrup).
    (g) The reference amounts set forth in paragraphs (b) through (f) of 
this section shall be used in determining whether a product meets the 
criteria for nutrient content claims, such as ``low calorie,'' and for 
health claims. If the serving size declared on the product label differs 
from the reference amount, and the product meets the criteria for the 
claim only on the basis of the reference amount, the claim shall be 
followed by a statement that sets forth the basis on which the claim is 
made. That statement shall include the reference amount as it appears in 
paragraph (b) of this section followed, in parenthesis, by the amount in 
common household measure if the reference amount is expressed in 
measures other than common household measures (e.g., for a beverage, 
``Very low sodium, 35 mg or less per 240 mL (8 fl oz)'').

[[Page 55]]

    (h) The Commissioner of Food and Drugs, either on his or her own 
initiative or in response to a petition submitted pursuant to part 10 of 
this chapter, may issue a proposal to establish or amend a reference 
amount in paragraph (b) of this section. A petition to establish or 
amend a reference amount shall include:
    (1) Objective of the petition;
    (2) A description of the product;
    (3) A complete sample product label including nutrition label, using 
the format established by regulation;
    (4) A description of the form (e.g., dry mix, frozen dough) in which 
the product will be marketed;
    (5) The intended dietary uses of the product with the major use 
identified (e.g., milk as a beverage and chips as a snack);
    (6) If the intended use is primarily as an ingredient in other 
foods, list of foods or food categories in which the product will be 
used as an ingredient with information on the prioritization of the use;
    (7) The population group for which the product will be offered for 
use (e.g., infants, children under 4 years of age);
    (8) The names of the most closely related products (or in the case 
of foods for special dietary use and imitation or substitute foods, the 
names of the products for which they are offered as substitutes);
    (9) The suggested reference amount (the amount of edible portion of 
food as consumed, excluding bone, seed, shell, or other inedible 
components) for the population group for which the product is intended 
with full description of the methodology and procedures that were used 
to determine the suggested reference amount. In determining the 
reference amount, general principles and factors in paragraph (a) of 
this section should be followed.
    (10) The suggested reference amount shall be expressed in metric 
units. Reference amounts for fluids shall be expressed in milliliters. 
Reference amounts for other foods shall be expressed in grams except 
when common household units such as cups, tablespoons, and teaspoons, 
are more appropriate or are more likely to promote uniformity in serving 
sizes declared on product labels. For example, common household measures 
would be more appropriate if products within the same category differ 
substantially in density, such as frozen desserts.
    (i) In expressing the reference amounts in milliliters, the 
following rules shall be followed:
    (A) For volumes greater than 30 milliliters (mL), the volume shall 
be expressed in multiples of 30 mL.
    (B) For volumes less than 30 mL, the volume shall be expressed in 
milliliters equivalent to a whole number of teaspoons or 1 tbsp, i.e., 
5, 10, or 15 mL.
    (ii) In expressing the reference amounts in grams, the following 
general rules shall be followed:
    (A) For quantities greater than 10 g, the quantity shall be 
expressed in the nearest 5-g increment.
    (B) For quantities less than 10 g, exact gram weights shall be used.
    (11) A petition to create a new subcategory of food with its own 
reference amount shall include the following additional information:
    (i) Data that demonstrate that the new subcategory of food will be 
consumed in amounts that differ enough from the reference amount for the 
parent category to warrant a separate reference amount. Data must 
include sample size; and the mean, standard deviation, median, and modal 
consumed amount per eating occasion for the petitioned product and for 
other products in the category, excluding the petitioned product. All 
data must be derived from the same survey data.
    (ii) Documentation supporting the difference in dietary usage and 
product characteristics that affect the consumption size that 
distinguishes the petitioned product from the rest of the products in 
the category.
    (12) A claim for categorical exclusion under Sec.  25.30 or 25.32 of 
this chapter or an environmental assessment under Sec.  25.40 of this 
chapter, and
    (13) In conducting research to collect or process food consumption 
data in support of the petition, the following general guidelines should 
be followed.
    (i) Sampled population selected should be representative of the 
demographic and socioeconomic characteristics of the target population 
group for which the food is intended.

[[Page 56]]

    (ii) Sample size (i.e., number of eaters) should be large enough to 
give reliable estimates for customarily consumed amounts.
    (iii) The study protocol should identify potential biases and 
describe how potential biases are controlled for or, if not possible to 
control, how they affect interpretation of results.
    (iv) The methodology used to collect or process data should be fully 
documented and should include: study design, sampling procedures, 
materials used (e.g., questionnaire, and interviewer's manual), 
procedures used to collect or process data, methods or procedures used 
to control for unbiased estimates, and procedures used to correct for 
nonresponse.
    (14) A statement concerning the feasibility of convening 
associations, corporations, consumers, and other interested parties to 
engage in negotiated rulemaking to develop a proposed rule consistent 
with the Negotiated Rulemaking Act (5 U.S.C. 561).

[58 FR 44051, Aug. 18, 1993; 58 FR 60109, Nov. 15, 1993, as amended at 
59 FR 371, Jan. 4, 1994; 59 FR 24039, May 10, 1994; 62 FR 40598, July 
29, 1997; 62 FR 49848, Sept. 23, 1997; 63 FR 14818, Mar. 27, 1998; 64 FR 
12890, Mar. 16, 1999; 66 FR 56035, Nov. 6, 2001]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 101, Section 12


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