[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.30]
 
[Page 12-15]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                          SERVICES (CONTINUED)
 
PART 170--FOOD ADDITIVES--Table of Contents
 
                     Subpart B--Food Additive Safety
 
Sec. 170.30  Eligibility for classification as generally recognized as safe (GRAS).
 
    (a) General recognition of safety may be based only on the views of
experts qualified by scientific training and experience to evaluate the
safety of substances directly or indirectly added to food. The basis of
such views may be either (1) scientific procedures or (2) in the case of
a substance used in food prior to January 1, 1958, through experience
based on common use in food. General recognition of safety requires
common knowledge about the substance throughout the scientific community
knowledgeable about the safety of substances directly or indirectly
added to food.
 
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    (b) General recognition of safety based upon scientific procedures
shall require the same quantity and quality of scientific evidence as is
required to obtain approval of a food additive regulation for the
ingredient. General recognition of safety through scientific procedures
shall ordinarily be based upon published studies which may be
corroborated by unpublished studies and other data and information.
    (c)(1) General recognition of safety through experience based on
common use in food prior to January 1, 1958, may be determined without
the quantity or quality of scientific procedures required for approval
of a food additive regulation. General recognition of safety through
experience based on common use in food prior to January 1, 1958, shall
be based solely on food use of the substance prior to January 1, 1958,
and shall ordinarily be based upon generally available data and
information. An ingredient not in common use in food prior to January 1,
1958, may achieve general recognition of safety only through scientific
procedures.
    (2) A substance used in food prior to January 1, 1958, may be
generally recognized as safe through experience based on its common use
in food when that use occurred exclusively or primarily outside of the
United States if the information about the experience establishes that
the use of the substance is safe within the meaning of the act (see
Sec. 170.3(i)). Common use in food prior to January 1, 1958, that
occurred outside of the United States shall be documented by published
or other information and shall be corroborated by information from a
second, independent source that confirms the history and circumstances
of use of the substance. The information used to document and to
corroborate the history and circumstances of use of the substance must
be generally available; that is, it must be widely available in the
country in which the history of use has occurred and readily available
to interested qualified experts in this country. Persons claiming GRAS
status for a substance based on its common use in food outside of the
United States should obtain FDA concurrence that the use of the
substance is GRAS.
    (d) The food ingredients listed as GRAS in part 182 of this chapter
or affirmed as GRAS in part 184 or Sec. 186.1 of this chapter do not
include all substances that are generally recognized as safe for their
intended use in food. Because of the large number of substances the
intended use of which results or may reasonably be expected to result,
directly or indirectly, in their becoming a component or otherwise
affecting the characteristics of food, it is impracticable to list all
such substances that are GRAS. A food ingredient of natural biological
origin that has been widely consumed for its nutrient properties in the
United States prior to January 1, 1958, without known detrimental
effects, which is subject only to conventional processing as practiced
prior to January 1, 1958, and for which no known safety hazard exists,
will ordinarily be regarded as GRAS without specific inclusion in part
182, part 184 or Sec. 186.1 of this chapter.
    (e) Food ingredients were listed as GRAS in part 182 of this chapter
during 1958-1962 without a detailed scientific review of all available
data and information relating to their safety. Beginning in 1969, the
Food and Drug Administration has undertaken a systematic review of the
status of all ingredients used in food on the determination that they
are GRAS or subject to a prior sanction. All determinations of GRAS
status or food additive status or prior sanction status pursuant to this
review shall be handled pursuant to Secs. 170.35, 170.38, and 180.1 of
this chapter. Affirmation of GRAS status shall be announced in part 184
or Sec. 186.1 of this chapter.
    (f) The status of the following food ingredients will be reviewed
and affirmed as GRAS or determined to be a food additive or subject to a
prior sanction pursuant to Sec. 170.35, Sec. 170.38, or Sec. 180.1 of
this chapter:
    (1) Any substance of natural biological origin that has been widely
consumed for its nutrient properties in the United States prior to
January 1, 1958, without known detrimental effect, for which no health
hazard is known, and which has been modified by processes first
introduced into commercial use
 
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after January 1, 1958, which may reasonably be expected significantly to
alter the composition of the substance.
    (2) Any substance of natural biological origin that has been widely
consumed for its nutrient properties in the United States prior to
January 1, 1958, without known detrimental effect, for which no health
hazard is known, that has had significant alteration of composition by
breeding or selection after January 1, 1958, where the change may be
reasonably expected to alter the nutritive value or the concentration of
toxic constituents.
    (3) Distillates, isolates, extracts, and concentration of extracts
of GRAS substances.
    (4) Reaction products of GRAS substances.
    (5) Substances not of a natural biological origin, including those
for which evidence is offered that they are identical to a GRAS
counterpart of natural biological origin.
    (6) Substances of natural biological origin intended for consumption
for other than their nutrient properties.
    (g) A food ingredient that is not GRAS or subject to a prior
sanction requires a food additive regulation promulgated under section
409 of the act before it may be directly or indirectly added to food.
    (h) A food ingredient that is listed as GRAS in part 182 of this
chapter or affirmed as GRAS in part 184 or Sec. 186.1 of this chapter
shall be regarded as GRAS only if, in addition to all the requirements
in the applicable regulation, it also meets all of the following
requirements:
    (1) It complies with any applicable food grade specifications of the
Food Chemicals Codex, 2d Ed. (1972), or, if specifically indicated in
the GRAS affirmation regulation, the Food Chemicals Codex, 3d Ed.
(1981), which are incorporated by reference, except that any substance
used as a component of articles that contact food and affirmed as GRAS
in Sec. 186.1 of this chapter shall comply with the specifications
therein, or in the absence of such specifications, shall be of a purity
suitable for its intended use. Copies may be obtained from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may
be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
    (2) It performs an appropriate function in the food or food-contact
article in which it is used.
    (3) It is used at a level no higher than necessary to achieve its
intended purpose in that food or, if used as a component of a food-
contact article, at a level no higher than necessary to achieve its
intended purpose in that article.
    (i) If a substance is affirmed as GRAS in part 184 or Sec. 186.1 of
this chapter with no limitation other than good manufacturing practice,
it shall be regarded as GRAS if its conditions of use are not
significantly different from those reported in the regulation as the
basis on which the GRAS status of the substance was affirmed. If the
conditions of use are significantly different, such use of the substance
may not be GRAS. In such a case a manufacturer may not rely on the
regulation as authorizing the use but must independently establish that
the use is GRAS or must use the substance in accordance with a food
additive regulation.
    (j) If an ingredient is affirmed as GRAS in part 184 or Sec. 186.1
of this chapter with specific limitation(s), it may be used in food only
within such limitation(s) (including the category of food(s), the
functional use(s) of the ingredient, and the level(s) of use). Any use
of such an ingredient not in full compliance with each such established
limitation shall require a food additive regulation.
    (k) Pursuant to Sec. 170.35, a food ingredient may be affirmed as
GRAS in part 184 or Sec. 186.1 of this chapter for a specific use(s)
without a general evaluation of use of the ingredient. In addition to
the use(s) specified in the regulation, other uses of such an ingredient
may also be GRAS. Any affirmation of GRAS status for a specific use(s),
without a general evaluation of use of the ingredient, is subject to
reconsideration upon such evaluation.
    (l) New information may at any time require reconsideration of the
GRAS status of a food ingredient. Any change in part 182, part 184, or
Sec. 186.1 of this
 
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chapter shall be accomplished pursuant to Sec. 170.38.
 
[42 FR 14483, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 53
FR 16546, May 10, 1988]