Source: http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr;rgn=div8;view=text;node=21%3A2.0.1.1.2.1.1.8;idno=21;cc=ecfr
Timestamp: 2015-10-06 05:33:46
Document Index: 571992228

Matched Legal Cases: ['art 101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', 'art 10', '§25', '§25', '§25']

Title 21 → Chapter I → Subchapter B → Part 101 → Subpart A → §101.12
§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 Foods1 2 3 4Product categoryReference amountLabel statement5Cereals, dry instant15 g_ cup (_ g)Cereals, prepared, ready-to-serve110 g_ cup(s) (_ g)Other cereal and grain products, dry ready-to-eat, e.g., ready-to-eat cereals, cookies, teething biscuits, and toasts7 g for infants and 20 g for toddlers for ready-to-eat cereals; 7 g for all others_ cup(s) (_ g) for ready-to-eat cereals; _ piece(s) (_ g) for othersDinners, desserts, fruits, vegetables or soups, dry mix15 g_ tbsp(s) (_ g); _ cup(s) (_ g)Dinners, desserts, fruits, vegetables or soups, ready-to-serve, junior type110 g_ cup(s) (_ g); _ cup(s) (_ mL)Dinners, desserts, fruits, vegetables or soups, ready-to-serve, strained type60 g_ cup(s) (_ g); _ cup(s) (_ mL)Dinners, stews or soups for toddlers, ready-to-serve170 g_ cup(s) (_ g); _ cup(s) (_ mL)Fruits for toddlers, ready-to-serve125 g_ cup(s) (_ g)Vegetables for toddlers, ready-to- serve70 g_ cup(s) (_ g)Eggs/egg yolks, ready-to-serve55 g_ cup(s) (_ g)Juices, all varieties120 mL4 fl oz (120 mL)1These 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.2Unless 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).3Manufacturers 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).4Copies 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 20740.5The 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 Supply1 2 3 4Product categoryReference amountLabel statement5Bakery products:Biscuits, croissants, bagels, tortillas, soft bread sticks, soft pretzels, corn bread, hush puppies55 g_ piece(s) (_ g)Breads (excluding sweet quick type), rolls50 g_ piece(s) (_ g) for sliced bread and distinct pieces (e.g., rolls); 2 oz (56 g/_ inch slice) for unsliced breadBread sticks—see crackersToaster pastries—see coffee cakesBrownies40 g_ piece(s) (_ g) for distinct pieces; fractional slice (_ g) for bulkCakes, heavy weight (cheese cake; pineapple upside-down cake; fruit, nut, and vegetable cakes with more than or equal to 35 percent of the finished weight as fruit, nuts, or vegetables or any of these combined)6125 g_ piece(s) (_ g) for distinct pieces (e.g., sliced or individually packaged products); _ fractional slice (_ g) for large discrete unitsCakes, medium weight (chemically leavened cake with or without icing or filling except those classified as light weight cake; fruit, nut, and 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)780 g_ piece(s) (_ g) for distinct pieces (e.g., cupcake); _ fractional slice (_ g) for large discrete units Cakes, light weight (angel food, chiffon, or sponge cake without icing or filling)855 g_ piece(s) (_ g) for distinct pieces (e.g., sliced or individually packaged products); _ fractional slice (_ g) for large discrete unitsCoffee cakes, crumb cakes, doughnuts, Danish, sweet rolls, sweet quick type breads, muffins, toaster pastries55 g_ piece(s) (_ g) for sliced bread and distinct pieces (e.g., doughnut); 2 oz (56 g/visual unit of measure) for bulk products (e.g., unsliced bread)Cookies30 g_ piece(s) (_ g)Crackers that are usually not used as snack, melba toast, hard bread sticks, ice cream cones915 g_ piece(s) (_ g)Crackers that are usually used as snacks30 g_ piece(s) (_ g)Croutons7 g_ tbsp(s) (_ g); _ cup(s) (_ g); _ piece(s) (_ g) for large piecesFrench toast, pancakes, variety mixes110 g prepared for french toast and pancakes; 40 g dry mix for variety mixes_ piece(s) (_ g); _ cup(s) (_ g) for dry mixGrain-based bars with or without filling or coating, e.g., breakfast bars, granola bars, rice cereal bars40 g_ piece(s) (_ g)Ice cream cones—see crackersPies, cobblers, fruit crisps, turnovers, other pastries125 g_ piece(s) (_g) for distinct pieces; _ fractional slice (_ g) for large discrete unitsPie crust1/6 of 8 inch crust; 1/8 of 9 inch crust1/6 of 8 inch crust (_ g); 1/8 of 9 inch crust (_ g)Pizza crust55 g_ fractional slice (_ g)Taco shells, hard30 g_ shell(s) (_ g)Waffles85 g_ piece(s) (_ g)Beverages:Carbonated and noncarbonated beverages, wine coolers, water240 mL8 fl oz (240 mL)Coffee or tea, flavored and sweetened240 mL prepared8 fl oz (240 mL)Cereal and Other Grain Products:Breakfast cereals (hot cereal type), hominy grits1 cup prepared; 40 g plain dry cereal; 55 g flavored, sweetened dry cereal_ cup(s) (_ g)Breakfast cereals, ready-to-eat, weighing less than 20 g per cup, e.g., plain puffed cereal grains15 g_ cup(s) (_ g)Breakfast cereals, ready-to-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 g30 g_ cup(s) (_ g)Breakfast cereals, ready-to-eat, weighing 43 g or more per cup; biscuit types55 g_ piece(s) (_ g) for large distinct pieces (e.g., biscuit type);_ cup(s) (_ g) for all othersBran or wheat germ15 g_ tbsp(s) (_ g); _ cup(s) (_ g)Flours or cornmeal30 g_ tbsp(s) (_ g); _ cup(s) (_ g)Grains, e.g., rice, barley, plain140 g prepared; 45 g dry_ cup(s) (_ g)Pastas, plain140 g prepared; 55 g dry_ cup(s) (_ g); _ 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, e.g., fried canned chow mein noodles25 g_ cup(s) (_ g)Starches, e.g., cornstarch, potato starch, tapioca, etc.10 g_ tbsp (_ g)Stuffing100 g_ cup(s) (_ g)Dairy Products and Substitutes:Cheese, cottage110 g_ cup (_ g)Cheese used primarily as ingredients, e.g., dry cottage cheese, ricotta cheese55 g_ cup (_ g)Cheese, grated hard, e.g., Parmesan, Romano5 g_ tbsp (_ g)Cheese, all others except those listed as separate categories—includes cream cheese and cheese spread30 g_ piece(s) (_ g) for distinct pieces;_ tbsp(s) (_ g) for cream cheese and cheese spread; 1 oz (28 g/visual unit of measure) for bulkCheese sauce—see sauce categoryCream or cream substitutes, fluid15 mL1 tbsp (15 mL)Cream or cream substitutes, powder2 g_ tsp (_ g)Cream, half & half30 mL2 tbsp (30 mL)Eggnog120 mL1/2 cup (120 mL); 4 fl oz (120 mL)Milk, condensed, undiluted30 mL2 tbsp (30 mL)Milk, evaporated, undiluted30 mL2 tbsp (30 mL)Milk, milk-based drinks, e.g., instant breakfast, meal replacement, cocoa240 mL1 cup (240 mL); 8 fl oz (240 mL)Shakes or shake substitutes, e.g., dairy shake mixes, fruit frost mixes240 mL1 cup (240 mL); 8 fl oz (240 mL)Sour cream30 g_ tbsp (_ g)Yogurt225 g_ cup (_ g)Desserts:Ice cream, ice milk, frozen yogurt, sherbet: all types, bulk and novelties (e.g., bars, sandwiches, cones)1/2 cup-includes the volume for coatings and wafers for the novelty type varieties_ piece(s) (_ g) for individually wrapped or packaged products; 1/2 cup (_ g) for othersFrozen flavored and sweetened ice and pops, frozen fruit juices: all types, bulk and novelties (e.g., bars, cups)85 g_ piece(s) (_ g) for individually wrapped or packaged products; _ cup(s) (_ g) for othersSundae1 cup1 cup (_ g)Custards, gelatin or pudding1/2 cup_ piece(s) (_ g) for distinct unit (e.g., individually packaged products); 1/2 cup (_ g) for bulkDessert Toppings and Fillings:Cake frostings or icings35 g_ tbsp(s) (_ g)Other dessert toppings, e.g., fruits, syrups, spreads, marshmallow cream, nuts, dairy and nondairy whipped toppings2 tbsp2 tbsp (_ g); 2 tbsp (30 mL)Pie fillings85 g_ cup(s) (_ g)Egg and Egg Sustitutes:Egg mixtures, e.g., egg foo young, scrambled eggs, omelets110 g_ piece(s) (_ g) for discrete pieces; _ cup(s) (_ g)Eggs (all sizes)950 g1 large, medium, etc. (_ g)Egg substitutesAn amount to make 1 large (50 g) egg_ cup(s) (_ g); _ cup(s) (_ mL)Fats and Oils:Butter, margarine, oil, shortening1 tbsp1 tbsp (_ g); 1 tbsp (15 mL)Butter replacement, powder2 g_ tsp(s) (_ g)Dressings for salads30 g_ tbsp (_ g); _ tbsp (_ mL)Mayonnaise, sandwich spreads, mayonnaise-type dressings15 g_ tbsp (_ g)Spray types0.25 gAbout _ seconds spray (_ g)Fish, Shellfish, Game Meats10, and Meat or Poultry Substitutes:Bacon substitutes, canned anchovies,11 anchovy pastes, caviar15 g_ piece(s) (_ g) for discrete pieces; _ tbsp(s) (_ g) for othersDried, e.g., jerky30 g_ piece(s) (_ g)Entrees with sauce, e.g., fish with cream sauce, shrimp with lobster sauce140 g cooked_ cup(s) (_ g); 5 oz (140 g/visual unit of measure) if not measurable by cupEntrees without sauce, e.g., plain or fried fish and shellfish, fish and shellfish cake85 g cooked; 110 g uncooked12_ piece(s) (_ g) for discrete pieces; _ cup(s) (_ g); _ oz (_ g/visual unit of measure) if not measurable by cup13Fish, shellfish or game meat10, canned1155 g_ piece(s) (_ g) 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 meat, meat spreads, Canadian bacon, sausages and frankfurters55 g_ piece(s) (_ g) for distinct pieces (e.g., slices, links); _ cup(s) (_ g); 2 oz (56 g/visual unit of measure) for nondiscrete bulk productSmoked or pickled11 fish, shellfish, or game meat10; fish or shellfish spread55 g_ piece(s) (_ g) for distinct pieces (e.g., slices, links) or _ cup(s) (_ g); 2 oz (56 g/visual unit of measure) for nondiscrete bulk productSubstitutes for bacon bits—see miscellaneous categoryFruits and Fruit Juices:Candied or pickled1130 g_ piece(s) (_ g)Dehydrated fruits—see snacks categoryDried40 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 flavor, e.g., maraschino cherries114 g1 cherry (_ g)Fruit relishes, e.g., cranberry sauce, cranberry relish70 g_ cup(s) (_ g)Fruits used primarily as ingredients, avocado30 gSee footnote 13Fruits used primarily as ingredients, others (cranberries, lemon, lime)55 g_ piece(s) (_ g) for large fruits; _ cup(s) (_ g) for small fruits measurable by cup13Watermelon280 gSee footnote 13All other fruits (except those listed as separate categories), fresh, canned, or frozen140 g_ piece(s) (_ g) for large pieces (e.g., strawberries, prunes, apricots, etc.); _ cup(s) (_ g) for small pieces (e.g., blueberries, raspberries, etc.)13Juices, nectars, fruit drinks240 mL8 fl oz (240 mL)Juices used as ingredients, e.g., lemon juice, lime juice5 mL1 tsp (5 mL)Legumes:Bean cake (tofu)11, tempeh85 g_ piece(s) (_ g) for discrete pieces; 3 oz (84 g/visual unit of measure) for bulk productsBeans, plain or in sauce130 g for beans in sauce or canned in liquid and refried beans prepared; 90 g for others prepared; 35 g dry_ cup (_ g)Miscellaneous Category:Baking powder, baking soda, pectin0.6 g_ tsp (_ g)Baking decorations, e.g., colored sugars and sprinkles for cookies, cake decorations1 tsp or 4 g if not measurable by teaspoon_ piece(s) (_ g) for discrete pieces; 1 tsp (_ g)Batter mixes, bread crumbs30 g_ tbsp(s) (_ g);_ cup(s) (_ g)Cooking wine30 mL2 tbsp (30 mL)Dietary supplementsThe maximum amount recommended, as appropriate, on the label for consumption per eating occasion, or, in the absence of recommendations, 1 unit, e.g., tablet, capsule, packet, teaspoonsful, etc._ tablet(s), _ capsule(s), _ packet(s), _ tsp(s) (_ g), etc.Drink mixers (without alcohol)Amount to make 240 mL drink (without ice)_ fl oz (_ mL)Chewing gum93 g_ piece(s) (_ g)Meat, poultry and fish coating mixes, dry; seasoning mixes, dry, e.g., chili seasoning mixes, pasta salad seasoning mixesAmount to make one reference amount of final dish_ tsp(s) (_ g); _ tbsp(s) (_ g)Salad and potato toppers, e.g., salad crunchies, salad crispins, substitutes for bacon bits7 g_ tbsp(s) (_ g)Salt, salt substitutes, seasoning salts (e.g., garlic salt)1/4 tsp1/4 tsp (_g); _piece(s) (_g) for discrete pieces (e.g., individually packaged products)Spices, herbs (other than dietary supplements)1/4 tsp or 0.5 g if not measurable by teaspoon1/4 tsp (_ g); _ piece(s) (_ g) if not measurable by teaspoons (e.g., bay leaf)Mixed Dishes:Measurable with cup, e.g., casseroles, hash, macaroni and cheese, pot pies, spaghetti with sauce, stews, etc.1 cup1 cup (_ g)Not measurable with cup, e.g., burritos, egg rolls, enchiladas, pizza, pizza rolls, quiche, all types of sandwiches140 g, add 55 g for products with gravy or sauce topping, e.g., enchilada with cheese sauce, crepe with white sauce14_ piece(s) (_ g) for discrete pieces; _ fractional slice (_ g) for large discrete unitsNuts and Seeds:Nuts, seeds, and mixtures, all types: sliced, chopped, slivered, and whole30 g_ piece(s) (_ g) for large pieces (e.g., unshelled nuts);_ tbsp(s) (_ g) ;_ cup(s) (_ g) for small pieces (e.g., peanuts, sunflower seeds)Nut and seed butters, pastes, or creams2 tbsp2 tbsp (_ g)Coconut, nut and seed flours15 g_ tbsp(s) (_ g); _ cup (_ g)Potatoes and Sweet Potatoes/Yams:French fries, hash browns, skins, or pancakes70 g prepared; 85 g for frozen unprepared french fries_ piece(s) (_ g) for large distinct pieces (e.g., patties, skins); 2.5 oz (70 g/_ pieces) for prepared fries; 3 oz (84 g/_ pieces) for unprepared friesMashed, candied, stuffed, or with sauce140 g_ piece(s) (_ g) for discrete pieces (e.g., stuffed potato); _ cup(s) (_ g)Plain, fresh, canned, or frozen110 g for fresh or frozen; 125 g for vacuum packed; 160 g for canned in liquid_ piece(s) (_ g) for discrete pieces;_ cup(s) (_ g) for sliced or chopped productsSalads:Gelatin salad120 g_ cup (_ g)Pasta or potato salad140 g_ cup(s) (_ g)All other salads, e.g., egg, fish, shellfish, bean, fruit, or vegetable salads100 g_ cup(s) (_ g)Sauces, Dips, Gravies and Condiments:Barbecue sauce, hollandaise sauce, tartar sauce, other sauces for dipping (e.g., mustard sauce, sweet and sour sauce), all dips (e.g., bean dips, dairy-based dips, salsa)2 tbsp2 tbsp (_ g); 2 tbsp (30 mL)Major main entree sauces, e.g., spaghetti sauce125 g_ cup (_ g); _ cup (_ mL)Minor main entree sauces (e.g., pizza sauce, pesto sauce), other sauces used as toppings (e.g., gravy, white sauce, cheese sauce), cocktail sauce1/4 cup1/4 cup (_ g); 1/4 cup (60 mL)Major condiments, e.g., catsup, steak sauce, soy sauce, vinegar, teriyaki sauce, marinades1 tbsp1 tbsp (_ g); 1 tbsp (15 mL)Minor condiments, e.g., horseradish, hot sauces, mustards, worcestershire sauce1 tsp1 tsp (_ g); 1 tsp (5 mL)Snacks:All varieties, chips, pretzels, popcorns, extruded snacks, fruit- based snacks (e.g., fruit chips,) grain-based snack mixes30 g_ cup(s) (_ g) for small pieces (e.g., popcorn) _ piece(s) (_ g) for large pieces (e.g., large pretzels; pressed dried fruit sheet); 1 oz (28 g/visual unit of measure) for bulk products (e.g., potato chips)Soups:All varieties245 g_ cup (_ g); _ cup (_ mL)Sugars and Sweets:Baking candies (e.g., chips)15 g_ piece(s) (_ g) for large pieces; _ tbsp(s) (_ g) for small pieces; 1/2 oz (14 g/visual unit of measure) for bulk productsHard candies, breath mints2 g_ piece(s) (_ g)Hard candies, roll-type, mini-size in dispenser packages5 g_ piece(s) (_ g)Hard candies, others15 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 productsAll other candies40 g_ piece(s) (_ g); 11/2 oz (42 g/visual unit of measure) for bulk productsConfectioner's sugar30 g_ cup (_ g)Honey, jams, jellies, fruit butter, molasses1 tbsp1 tbsp (_ g); 1 tbsp (15 mL)Marshmallows30 g_ cup(s) (_ g) for small pieces; _ piece(s) (_ g) for large piecesSugar4 g_ tsp (_ g) ; _ piece(s) (_ g) for discrete pieces (e.g., sugar cubes, individually packaged products)Sugar substitutesAn amount equivalent to one reference amount for sugar in sweetness_ tsp(s) (_ g) for solids; _ drop(s) (_ g) for liquid; _ piece(s) (_ g) (e.g., individually packaged products)Syrups30 mL for syrups used primarily as an ingredient (e.g., light or dark corn syrup); 60 mL for all others2 tbsp (30 mL) for syrups used primarily as an ingredient; 1/4 cup (60 mL) for all othersVegetables:Vegetables primarily used for garnish or flavor, e.g., pimento, parsley4 g_ piece(s) (_ g); _ tbsp(s) (_ g) for chopped productsChili pepper, green onion30 g_ piece(s) (_ g)13; _ tbsp(s) (_ g); _ cup(s) (_ g) for sliced or chopped productsAll other vegetables without sauce: fresh, canned, or frozen85 g for fresh or frozen; 95 g for vacuum packed; 130 g for canned in liquid, cream-style corn, canned or stewed tomatoes, pumpkin, or winter squash_ piece(s) (_ g) for large pieces (e.g., brussel sprouts); _ cup(s) (_ g) for small pieces (e.g., cut corn, green peas); 3 oz (84 g/visual unit of measure) if not measurable by cup13All other vegetables with sauce: fresh, canned, or frozen110 g_ piece(s) (_ g) for large pieces (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 cupVegetable juice240 mL8 fl oz (240 mL)Olives1115 g_ piece(s) (_ g); _ tbsp(s) (_ g) for sliced productsPickles, all types1130 g1 oz (28 g/visual unit of measure)Pickle relishes15 g_ tbsp (_ g)Vegetable pastes, e.g., tomato paste30 g_ tbsp (_ g) Vegetable sauces or purees, e.g, tomato sauce, tomato puree60 g_ cup (_ g); _ cup (_ mL)1These 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.2Unless 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).3Manufacturers 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).4Copies 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 20740.5The 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).6Includes cakes that weigh 10 g or more per cubic inch.7Includes cakes that weigh 4 g or more per cubic inch but less than 10 g per cubic inch.8Includes cakes that weigh less than 4 g per cubic inch.9Label 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.10Animal 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.11If 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).12The 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).13For 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).14Pizza 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]