[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.10]

[Page 285-286]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--CONTINUED
 
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 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 Sec. 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 Sec. 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. Nutrients shall be added to the food to 
restore nutrient levels so that the product is not nutritionally 
inferior, as defined in Sec. 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.
    (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 Sec. 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

[[Page 286]]

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 Sec. 130.10(c), (d)(1), and (d)(2).
    (e) Nomenclature. The name of a substitute food that complies with 
all parts of this regulation is the appropriate expressed nutrient 
content claim and the applicable standardized term.
    (f) Label declaration. (1) Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
part 101 of this chapter and part 130.
    (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.

[58 FR 2446, Jan. 6, 1993]