21 CFR § 130.10 - Requirements for foods named by use of a nutrient content claim and a standardized term.
(a) Description. The foods prescribed by this general definition and standard of identity are those foods that substitute (see § 101.13(d) of this chapter) for a standardized food defined in parts 131 through 169 of this chapter and that use the name of that standardized food in their statement of identity but that do not comply with the standard of identity because of a deviation that is described by an expressed nutrient content claim that has been defined by FDA regulation. The nutrient content claim shall comply with the requirements of § 101.13 of this chapter and with the requirements of the regulations in part 101 of this chapter that define the particular nutrient content claim that is used. The food shall comply with the relevant standard in all other respects except as provided in paragraphs (b), (c), and (d) of this section.
(b) Nutrient addition.
(1) Nutrients shall be added to the food to restore nutrient levels so that the product is not nutritionally inferior, as defined in § 101.3(e)(4) of this chapter, to the standardized food as defined in parts 131 through 169 of this chapter. The addition of nutrients shall be reflected in the ingredient statement.
(2) Yogurt containing less than 3.25 percent milkfat is exempt from compliance with paragraph (b)(1) of this section with respect to vitamin A fortification provided the product complies with all other requirements.
(c) Performance characteristics. Deviations from noningredient provisions of the standard of identity (e.g., moisture content, food solids content requirements, or processing conditions) are permitted in order that the substitute food possesses performance characteristics similar to those of the standardized food. Deviations from ingredient and noningredient provisions of the standard must be the minimum necessary to qualify for the nutrient content claim while maintaining similar performance characteristics as the standardized food, or the food will be deemed to be adulterated under section 402(b) of the act. The performance characteristics (e.g., physical properties, flavor characteristics, functional properties, shelf life) of the food shall be similar to those of the standardized food as produced under parts 131 through 169 of this chapter, except that if there is a significant difference in performance characteristics that materially limits the uses of the food compared to the uses of the standardized food, the label shall include a statement informing the consumer of such difference (e.g., if appropriate, “not recommended for cooking”). Such statement shall comply with the requirements of § 101.13(d) of this chapter. The modified product shall perform at least one of the principal functions of the standardized product substantially as well as the standardized product.
(d) Other ingredients.
(1) Ingredients used in the product shall be those ingredients provided for by the standard as defined in parts 131 through 169 of this chapter and in paragraph (b) of this section, except that safe and suitable ingredients may be used to improve texture, add flavor, prevent syneresis, extend shelf life, improve appearance, or add sweetness so that the product is not inferior in performance characteristics to the standardized food defined in parts 131 through 169 of this chapter.
(2) An ingredient or component of an ingredient that is specifically required by the standard (i.e., a mandatory ingredient) as defined in parts 131 through 169 of this chapter, shall not be replaced or exchanged with a similar ingredient from another source unless the standard, as defined in parts 131 through 169 of this chapter, provides for the addition of such ingredient (e.g., vegetable oil shall not replace milkfat in light sour cream).
(3) An ingredient or component of an ingredient that is specifically prohibited by the standard as defined in parts 131 through 169 of this chapter, shall not be added to a substitute food under this section.
(4) An ingredient that is specifically required by the standard as defined in parts 131 through 169 of this chapter, shall be present in the product in a significant amount. A significant amount of an ingredient or component of an ingredient is at least that amount that is required to achieve the technical effect of that ingredient in the food.
(5) Water and fat analogs may be added to replace fat and calories in accordance with § 130.10(c), (d)(1), and (d)(2).
(f) Label declaration.
(2) Ingredients not provided for, and ingredients used in excess of those levels provided for, by the standard as defined in parts 131 through 169 of this chapter, shall be identified as such with an asterisk in the ingredient statement, except that ingredients added to restore nutrients to the product as required in paragraph (b) of this section shall not be identified with an asterisk. The statement “*Ingredient(s) not in regular ______” (fill in name of the traditional standardized food) or “*Ingredient(s) in excess of amount permitted in regular ______” (fill in name of the traditional standardized food) or both as appropriate shall immediately follow the ingredient statement in the same type size.
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