Source: http://www.law.cornell.edu/cfr/text/21/101.12
Timestamp: 2014-07-24 03:50:28
Document Index: 19852045

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

21 CFR 101.12 - Reference amounts customarily consumed per eating occasion. | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter B › Part 101 › Subpart A › Section 101.12 21 CFR 101.12 - Reference amounts customarily consumed per eating occasion.
There are 2 Updates appearing in the Federal Register for 21 CFR 101. View below or at eCFR (GPOAccess)
§ 101.12
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:
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.
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.
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.
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:
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).
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.
FDA sought to ensure that foods that have similar dietary usage, product characteristics, and customarily consumed amounts have a uniform reference amount.
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
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).
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.
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).
Cereals, prepared, ready-to-serve
_ cup(s) (_ g) for ready-to-eat cereals; _ piece(s) (_ g) for others
Dinners, desserts, fruits, vegetables or soups, dry mix
Dinners, desserts, fruits, vegetables or soups, ready-to-serve, junior type
Dinners, desserts, fruits, vegetables or soups, ready-to-serve, strained type
Vegetables for toddlers, ready-to- serve
Table 2—Reference Amounts Customarily Consumed Per Eating Occasion: General Food Supply 1,2,3,4
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).
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.
Bread sticks—see crackers
Toaster pastries—see coffee cakes
Cakes, 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) 6
Cakes, 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) 7
Cakes, light weight (angel food, chiffon, or sponge cake without icing or filling) 8
Crackers that are usually not used as snack, melba toast, hard bread sticks, ice cream cones 9
Ice cream cones—see crackers
Cheese, all others except those listed as separate categories—includes cream cheese and cheese spread
Cheese sauce—see sauce category
Eggs (all sizes) 9
Fish, Shellfish, Game Meats 10, and Meat or Poultry Substitutes:
Bacon substitutes, canned anchovies, 11 anchovy pastes, caviar
85 g cooked; 110 g uncooked 12
_ piece(s) (_ g) for discrete pieces; _ cup(s) (_ g); _ oz (_ g/visual unit of measure) if not measurable by cup 13
Fish, shellfish or game meat 10, canned 11
Smoked or pickled 11 fish, shellfish, or game meat 10; fish or shellfish spread
Substitutes for bacon bits—see miscellaneous category
Candied or pickled 11
Dehydrated fruits—see snacks category
Fruits for garnish or flavor, e.g., maraschino cherries 11
_ piece(s) (_ g) for large fruits; _ cup(s) (_ g) for small fruits measurable by cup 13
_ piece(s) (_ g) for large pieces (e.g., strawberries, prunes, apricots, etc.); _ cup(s) (_ g) for small pieces (e.g., blueberries, raspberries, etc.) 13
Bean cake (tofu) 11, tempeh
140 g, add 55 g for products with gravy or sauce topping, e.g., enchilada with cheese sauce, crepe with white sauce 14
_ 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
_ piece(s) (_ g); 11/2 oz (42 g/visual unit of measure) for bulk products
_ piece(s) (_ g) 13; _ tbsp(s) (_ g); _ cup(s) (_ g) for sliced or chopped products
_ 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 cup 13
Pickles, all types 11
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:
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.
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.
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:
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.
Sample selections for the density measurements shall be done in accordance with the provisions in § 101.9(g).
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.
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.
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:
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.
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.
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).
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)”).
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:
Objective of the petition;
A description of the form (e.g., dry mix, frozen dough) in which the product will be marketed;
The intended dietary uses of the product with the major use identified (e.g., milk as a beverage and chips as a snack);
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);
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.
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.
In expressing the reference amounts in milliliters, the following rules shall be followed:
For volumes greater than 30 milliliters (mL), the volume shall be expressed in multiples of 30 mL.
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.
In expressing the reference amounts in grams, the following general rules shall be followed:
For quantities greater than 10 g, the quantity shall be expressed in the nearest 5-g increment.
For quantities less than 10 g, exact gram weights shall be used.
A petition to create a new subcategory of food with its own reference amount shall include the following additional information:
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.
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.
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
In conducting research to collect or process food consumption data in support of the petition, the following general guidelines should be followed.
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.
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).
Title 21 published on 2013-04-01The following are only the Rules published in the Federal Register after the published date of Title 21.For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.2014-04-28; vol. 79 # 81 - Monday, April 28, 201479 FR 23262 - Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids
Title 21 published on 2013-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 101 after this date.2014-04-28; vol. 79 # 81 - Monday, April 28, 201479 FR 23262 - Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids