§101.12. Reference amounts customarily consumed per eating occasion.
21 C.F.R. § 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.
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.
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:
Serving sizes used in dietary guidance recommendations or recommended by other authoritative systems or organizations;
Serving sizes recommended in comments;
Serving sizes used by manufacturers and grocers; and
Serving sizes used by other countries.
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.
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:
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 form, but not the unprepared form, then the reference amount for the unprepared product must 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 butter 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:
The reference amount for the combined product must be the reference amount, as established in paragraph (b) of this section, for the ingredient that is represented as the main ingredient (e.g., peanut butter, pancakes, cake) plus proportioned amounts of all minor ingredients.
If the reference amounts are in compatible units, the weights or volumes must 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, all amounts must be converted to weights and summed, e.g., the reference amount for pancakes and syrup would be 110 g (the reference amount for pancakes) plus the 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 product;
A complete sample product label including nutrition label, using the format established by regulation;
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);
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;
The population group for which the product will be offered for use (e.g., infants, children under 4 years of age);
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.
Sampled population selected should be representative of the demographic and socioeconomic characteristics of the target population group for which the food is intended.
Sample size (i.e., number of eaters) should be large enough to give reliable estimates for customarily consumed amounts.
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.
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).
Notes, amendments, and revision history
Amendments
[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; 81 FR 34041, May 27, 2016]
Authority
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.
Source
Source: 42 FR 14308, Mar. 15, 1977, unless otherwise noted.
Amendments
[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; 81 FR 34041, May 27, 2016]