the values declared in nutrition labeling or the actual nutrient values, provided that the resulting labeling is internally consistent (i.e., that the values stated in the nutrition information, the nutrient values in the accompanying information, and the declaration of the percentage of nutrient by which the product has been modified are consistent and will not cause consumer confusion when compared), and that the actual modification is at least equal to the percentage specified in the definition of the claim.

(2) For products bearing relative claims:

(i) The label or labeling must state the identity of the reference product and the percent (or fraction) of the amount of the nutrient in the reference product by which the nutrient has been modified, (e.g., "50 percent less fat than 'reference product'" or " fewer calories than 'reference product'"); and

(ii) This information shall be immediately adjacent to the most prominent claim in easily legible boldface print or type, in distinct contrast to other printed or graphic matter, that is no less than that required by §317.2(h) for net quantity of contents, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the referral statement shall be no less than one-half the size of the claim, but no smaller than 16-inch minimum height, except as §317.400(d)(2).

permitted

by

labeled serving size with that in the reference product; and

(B) This statement shall appear adjacent to the most prominent claim or to the nutrition information.

(3) A relative claim for decreased levels of a nutrient may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the requirement for a "low" claim for that nutrient.

(k) The term "modified" may be used in the statement of identity of a product that bears a relative claim that complies with the requirements of this part, followed immediately by the name of the nutrient whose content has been altered (e.g., "modified fat 'product'"). This statement of identity must be immediately followed by the comparative statement such as "contains 35 percent less fat than 'reference product'." The label or labeling must also bear the information required by paragraph (j)(2) of this section in the manner prescribed.

(1) For purposes of making a claim, a "meal-type product" shall be defined as a product that:

(1) Makes a significant contribution to the diet by weighing at least 6 ounces, but no more than 12 ounces per serving (container), and

(2) Contains ingredients from two or more of the following four food groups: (i) Bread, cereal, rice and pasta group,

(ii) Fruits and vegetables group, (iii) Milk, yogurt, and cheese group, and

(iv) Meat, poultry, fish, dry beans, eggs, and nuts group, and

(3) Is represented as, or is in a form commonly understood to be a breakfast, lunch, dinner, meal, main dish, entree, or pizza. Such representations may be made either by statements, photographs, or vignettes.

(m) [Reserved]

(n) Nutrition labeling in accordance with $317.309, shall be provided for any food for which a nutrient content claim is made.

(0) Compliance with requirements for nutrient content claims shall be in accordance with § 317.309(h).

(p)(1) Unless otherwise specified, the reference amount customarily consumed set forth in §317.312(b) through

(e) shall be used in determining whether a product meets the criteria for a nutrient content claim. If the serving size declared on the product label differs from the reference amount customarily consumed, and the amount of the nutrient contained in the labeled serving does not meet the maximum or minimum amount criterion in the definition for the descriptor for that nutrient, the claim shall be followed by the criteria for the claim as required by $317.312(f) (e.g., "very low sodium, 35 mg or less per 55 grams").

(2) The criteria for the claim shall be immediately adjacent to the most prominent claim in easily legible print or type and in a size that is no less than that required by §317.2(h) for net quantity of contents, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the criteria statement shall be no less than one-half the size of the claim but no smaller than 16-inch minimum height, except as permitted by § 317.400(d)(2).

(q) The following exemptions apply: (1) Nutrient content claims that have not been defined by regulation and that appear as part of a brand name that was in use prior to November 27, 1991, may continue to be used as part of that brand name, provided they are not false or misleading under section 1(n) of the Act (21 U.S.C. 601(n)(1)).

(2) [Reserved]

(3) A statement that describes the percentage of a vitamin or mineral in the food, including foods intended specifically for use by infants and children less than 2 years of age, in relation to a Reference Daily Intake (RDI) as defined in §317.309 may be made on the label or in the labeling of a food without a regulation authorizing such a claim for a specific vitamin or mineral.

(4) The requirements of this section do not apply to infant formulas and medical foods, as described in 21 CFR 101.13(q)(4).

(5) [Reserved]

(6) Nutrient content claims that were part of the name of a product that was subject to a standard of identity as of November 27, 1991, are not subject to the requirements of paragraph (b) of this section whether or not they meet the definition of the descriptive term.

(7) Implied nutrient content claims may be used as part of a brand name, provided that the use of the claim has been authorized by FSIS. Labeling applications requesting approval of such a claim may be submitted pursuant to § 317.369.

[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 59 FR 40213, Aug. 8, 1994; 59 FR 45196, Sept. 1, 1994; 60 FR 187, Jan. 3, 1995]

§§ 317.314-317.342 [Reserved]

$317.343 Significant participation for voluntary nutrition labeling.

(a) In evaluating significant participation for voluntary nutrition labeling, FSIS will consider only the major cuts of single-ingredient, raw meat products, as identified in §317.344, including those that have been previously frozen.

(b) FSIS will judge a food retailer to be participating at a significant level if the retailer provides nutrition labeling information for at least 90 percent of the major cuts of single-ingredient, raw meat products, listed in §317.344, that it sells, and if the nutrition label is consistent in content and format with the mandatory program, or nutrition information is displayed at pointof-purchase in an approriate manner.

(c) To determine whether there is significant participation by retailers under the voluntary nutrition labeling guidelines, FSIS will select a representative sample of companies allocated by type and size.

(d) FSIS will find that significant participation by food retailers exists if at least 60 percent of all companies that are evaluated are participating in accordance with the guidelines.

(e) FSIS will evaluate significant participation of the voluntary program every 2 years beginning in May 1995.

(1) If significant participation is found, the voluntary nutrition labeling guidelines shall remain in effect.

(2) If significant participation is not found, FSIS shall initiate rulemaking to require nutrition labeling on those products under the voluntary program. § 317.344 Identification of major cuts of meat products.

The major cuts of single-ingredient, raw meat products are: Beef chuck

blade roast, beef loin top loin steak, beef rib roast large end, beef round eye round steak, beef round top round steak, beef round tip roast, beef chuck arm pot roast, beef loin sirloin steak, beef round bottom round steak, beef brisket (whole, flat half, or point half), beef rib steak small end, beef loin tenderloin steak, ground beef regular without added seasonings, ground beef about 17% fat, pork loin chop, pork loin country style ribs, pork loin top loin chop boneless, pork loin rib chop, pork spareribs, pork loin tenderloin, pork loin sirloin roast, pork shoulder blade steak, pork loin top roast boneless, ground pork, lamb shank, lamb shoulder arm chop, lamb shoulder blade chop, lamb rib roast, lamb loin chop, lamb leg (whole, sirloin half, or shank half), veal shoulder arm steak, veal shoulder blade steak, veal rib roast, veal loin chop, and veal cutlets. [58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994]

§ 317.345 Guidelines for voluntary nutrition labeling of single-ingredient, raw products.

(a) Nutrition information on the cuts of single-ingredient, raw meat products, including those that have been previously frozen, shall be provided in the following manner:

(1) If a retailer or manufacturer chooses to provide nutrition information on the label of these products, these products shall be subject to all requirements of the mandatory nutrition labeling program, except that nutrition labeling may be declared on the basis of either "as consumed" or "as packaged." In addition, the declaration of the number of servings per container need not be included in nutrition labeling of single-ingredient, raw meat products (including ground beef), including those that have been previously frozen.

(2) A retailer may choose to provide nutrition information at the point-ofpurchase, such as by posting a sign, or by making the information readily available in brochures, notebooks, or leaflet form in close proximity to the food. The nutrition labeling information may also be supplemented by a video, live demonstration, or other media. If a nutrition claim is made on

point-of-purchase materials all of the requirements of the mandatory nutrition labeling program apply. However, if only nutrition information-and not a nutrition claim-is supplied on pointof-purchase materials:

(i) The requirements of the mandatory nutrition labeling program apply, but the nutrition information may be supplied on an "as packaged" or "as consumed," basis;

(ii) The listing of percent of Daily Value for the nutrients (except vitamins and minerals specified in §317.309(c)(8)) and footnote required by §317.309(d)(9) may be omitted; and

(iii) The point-of-purchase materials are not subject to any of the format requirements.

(b) [Reserved]

(c) The declaration of nutrition information may be presented in a simplified format as specified in §317.309(f) for the mandatory nutrition labeling program.

(d) The nutrition label data should be based on either the raw or cooked edible portions of meat cuts with external cover fat at trim levels reflecting current marketing practices. If data are based on cooked portions, the methods used to cook the products must be specified and should be those which do not add nutrients from other ingredients such as flour, breading, and salt. Additional nutritional data may be presented on an optional basis for the raw or cooked edible portions of the separable lean of meat cuts.

(e) Nutrient data that are the most current representative data base values contained in USDA's National Nutrient Data Bank or its published form, the Agriculture Handbook No. 8 series, may be used for nutrition labeling of single-ingredient, raw meat products (including ground beef), including those that have been previously frozen. These data may be composite data that reflect different quality grades of beef or other variables affecting nutrient content. Alternatively, data that reflect specific grades or other variables may be used, except that if data are used on labels attached to a product which is labeled as to grade of meat or other variables, the data must represent the product in the package when

such data are contained in the representative data base. When data are used on labels attached to a product, the data must represent the edible meat tissues present in the package.

(f) If the nutrition information is in accordance with paragraph (e) of this section, a nutrition label or labeling will not be subject to the Agency compliance review under §317.309(h), unless a nutrition claim is made on the basis of the representative data base values.

(g) Retailers may use data bases that they believe reflect the nutrient content of single-ingredient, raw meat products (including ground beef), including those that have been previously frozen; however, such labeling shall be subject to the compliance procedures of paragraph (e) of this section and the requirements specified in this subpart for the mandatory nutrition labeling program.

[58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 60 FR 189, Jan. 3, 1995] §§ 317.346-317.353 [Reserved]

$317.354 Nutrient content claims for

"good source," "high," and "more." (a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a product in relation to the Reference Daily Intake (RDI) or Daily Reference Value (DRV) established for that nutrient (excluding total carbohydrate) in §317.309(c), may only be made on the label or in labeling of the product if:

(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in §317.313; and

(3) The product for which the claim is made is labeled in accordance with § 317.309.

(b) "High" claims. (1) The terms "high," "rich in,” or “excellent source of" may be used on the label or in labeling of products, except meal-type products as defined in §317.313(1), provided that the product contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed.

(2) The terms defined in paragraph (b)(1) of this section may be used on the label or in labeling of a meal-type product as defined in §317.313(1), provided that:

(i) The product contains a food that meets the definition of "high" in paragraph (b)(1) of this section; and

(ii) The label or labeling clearly identifies the food that is the subject of the claim (e.g., "the serving of broccoli in this meal is high in vitamin C”).

(c) "Good Source" claims. (1) The terms "good source," "contains," or "provides" may be used on the label or in labeling of products, except mealtype products as described in $317.313(1), provided that the product contains 10 to 19 percent of the RDI or the DRV per reference amount customarily consumed.

(2) The terms defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product as defined in §317.313(1), provided that:

(i) The product contains a food that meets the definition of "good source" in paragraph (c)(1) of this section; and

(ii) The label or labeling clearly identifies the food that is the subject of the claim (e.g., "the serving of sweet potatoes in this meal is a good source of fiber").

(d) Fiber claims. (1) If a nutrient content claim is made with respect to the level of dietary fiber, i.e., that the product is high in fiber, a good source of fiber, or that the product contains "more" fiber, and the product is not "low" in total fat as defined in §317.362(b)(2) or, in the case of a mealtype product, is not "low" in total fat as defined in §317.362(b)(3), then the labeling shall disclose the level of total fat per labeled serving size (e.g., "contains 12 grams (g) of fat per serving"); and

(2) The disclosure shall appear in immediate proximity to such claim and be in a type size no less than one-half the size of the claim.

(e) "More" claims. (1) A relative claim using the terms "more" and "added" may be used on the label or in labeling to describe the level of protein, vitamins, minerals, dietary fiber, or potassium in a product, except meal-type

products as defined in §317.313(1), provided that:

(i) The product contains at least 10 percent more of the RDI or the DRV for protein, vitamins, minerals, dietary fiber, or potassium (expressed as a percent of the Daily Value) per reference amount customarily consumed than an appropriate reference product as described in §317.313(j)(1); and

(ii) As required in §317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the nutrient is greater relative to the RDI or DRV are declared in immediate proximity to the most prominent such claim (e.g., "contains 10 percent more of the Daily Value for fiber than 'reference product'"); and

(B) Quantitative information comparing the level of the nutrient in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., "fiber content of ‘reference product' is 1 g per serving; 'this product' contains 4 g per serving").

(2) A relative claim using the terms "more" and "added" may be used on the label or in labeling to describe the level of protein, vitamins, minerals, dietary fiber, or potassium in meal-type products as defined in §317.313(1), provided that:

(i) The product contains at least 10 percent more of the RDI or the DRV for protein, vitamins, minerals, dietary fiber, or potassium (expressed as a percent of the Daily Value) per 100 g of product than an appropriate reference product as described in §317.313(j)(1); and

(ii) As required in §317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the nutrient is greater relative to the RDI or DRV are declared in immediate proximity to the most prominent such claim (e.g., "contains 10 percent more of the Daily Value for fiber per 3 ounces (oz) than does 'reference product'"), and

(B) Quantitative information comparing the level of the nutrient in the meal-type product per specified weight with that of the reference product that

it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., "fiber content of 'reference product' is 2 g per 3 oz; 'this product' contains 5 g per 3 oz❞).

[60 FR 189, Jan. 3, 1995]

$317.355 [Reserved]

§317.356 Nutrient content claims for "light" or "lite."

(a) General requirements. A claim using the terms "light" or "lite" to describe a product may only be made on the label or in labeling of the product if:

(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in §317.313; and

(3) The product for which the claim is made is labeled in accordance with $317.309.

(b) "Light" claims. The terms "light" or "lite" may be used on the label or in labeling of products, except meal-type products as defined in §317.313(1), without further qualification, provided that:

(1) If the product derives 50 percent or more of its calories from fat, its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to an appropriate reference product as described in § 317.313(j)(1); or

(2) If the product derives less than 50 percent of its calories from fat:

(i) The number of calories is reduced by at least one-third (33% percent) per reference amount customarily consumed compared to an appropriate reference product as described in §317.313(j)(1); or

(ii) Its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to the appropriate reference product as described in §317.313(j)(1); and

(3) As required in §317.313(j)(2) for relative claims:

(i) The identity of the reference product and the percent (or fraction) that the calories and the fat were reduced are declared in immediate proximity to the most prominent such claim (e.g.,