[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.10]
[Page 290-291]
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
[[Page 291]]
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 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]
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