[Code of Federal Regulations]

[Title 21, Volume 3, Parts 170 to 199]

[Revised as of April 1, 1999]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR170.30]

(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.

(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corroborated by unpublished studies and other data and information.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 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 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]