21 C.F.R. § 101.12   Reference amounts customarily consumed per eating occasion.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 101—FOOD LABELING
Subpart A—General Provisions

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§ 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 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).\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) for     quick type), rolls.                            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) for     cake; pineapple upside-                        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) for     (chemically leavened cake                      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) for     food, chiffon, or sponge                       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) for     doughnuts, Danish, sweet                       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 dry                                  toast and         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                                  inch crust.       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.    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) for     eat, weighing 43 g or more                     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) for     those listed as separate                       distinct pieces;_     categories_includes cream                      tbsp(s) (_ g) for     cheese and cheese spread.                      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) for     yogurt, sherbet: all         the volume for    individually wrapped     types, bulk and novelties    coatings and      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) for     sweetened ice and pops,                        individually wrapped     frozen fruit juices: all                       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) for     pudding.                                       distinct unit (e.g.,                                                    individually                                                    packaged products);                                                    1/2 cup (_ g) for                                                    bulkDessert 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) for     young, scrambled eggs,                         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)    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) for     anchovies, \11\ anchovy                        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 oz     fish with cream sauce,                         (140 g/visual unit     shrimp with lobster sauce.                     of measure) if not                                                    measurable by cup    Entrees without sauce,       85 g cooked; 110  _ piece(s) (_ g) for     e.g., plain or fried fish    g uncooked \12\.  discrete pieces; _     and shellfish, fish and                        cup(s) (_ g); _ oz     shellfish cake.                                (_ g/visual unit of                                                    measure) if not                                                    measurable by cup                                                    \13\    Fish, shellfish or game      55 g............  _ piece(s) (_ g) for     meat \10\, canned \11\.                        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) for     meat, meat spreads,                            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) for     fish, shellfish, or game                       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) for     ingredients, others                            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) for     those listed as separate                       large pieces (e.g.,     categories), fresh,                            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) for     tempeh.                                        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) for     colored sugars and           not measurable    discrete pieces; 1     sprinkles for cookies,       by teaspoon.      tsp (_ g)     cake decorations.    Batter mixes, bread crumbs.  30 g............  _ tbsp(s) (_ g);_                                                    cup(s) (_ g)    Cooking wine...............  30 mL...........  2 tbsp (30 mL)    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) for     e.g., burritos, egg rolls,   for products      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) for     all types: sliced,                             large pieces (e.g.,     chopped, slivered, and                         unshelled nuts);_     whole.                                         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) for     skins, or pancakes.          85 g for frozen   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) for     or with sauce.                                 discrete pieces                                                    (e.g., stuffed                                                    potato); _ cup(s) (_                                                    g)    Plain, fresh, canned, or     110 g for fresh   _ piece(s) (_ g) for     frozen.                      or frozen; 125    discrete pieces;_                                  g for vacuum      cup(s) (_ g) for                                  packed; 160 g     sliced or chopped                                  for canned in     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)    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 (5     horseradish, hot sauces,                       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) for     chips).                                        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) for     without sauce: fresh,        or frozen; 95 g   large pieces (e.g.,     canned, or frozen.           for vacuum        brussel sprouts); _                                  packed; 130 g     cup(s) (_ g) for                                  for canned in     small pieces (e.g.,                                  liquid, cream-    cut corn, green                                  style corn,       peas); 3 oz (84 g/                                  canned or         visual unit of                                  stewed            measure) if not                                  tomatoes,         measurable by cup                                  pumpkin, or       \13\                                  winter squash.    All other vegetables with    110 g...........  _ piece(s) (_ g) for     sauce: fresh, canned, or                       large pieces (e.g.,     frozen.                                        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)    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 § 101.9(b) using the reference amount  determined according to § 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 § 101.45 or to single-ingredient products that consist of  fish or game meat as provided for in § 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 §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 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 §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 §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)”).

(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 §25.30 or 25.32 of this chapter or an environmental assessment under §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.

(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]

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