[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: 21CFR182.1]

[Page 448-449]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 182--SUBSTANCES GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 182.1  Substances that are generally recognized as safe.


    (a) It is impracticable to list all substances that are generally 
recognized as safe for their intended use. However, by way of 
illustration, the Commissioner regards such common food ingredients as 
salt, pepper, vinegar, baking powder, and monosodium glutamate as safe 
for their intended use. This part includes additional substances that, 
when used for the purposes indicated, in accordance with good 
manufacturing practice, are regarded by the Commissioner as generaly 
recognized as safe for such uses.
    (b) For the purposes of this section, good manufacturing practice 
shall be defined to include the following restrictions:
    (1) The quantity of a substance added to food does not exceed the 
amount reasonably required to accomplish its

[[Page 449]]

intended physical, nutritional, or other technical effect in food; and
    (2) The quantity of a substance that becomes a component of food as 
a result of its use in the manufacturing, processing, or packaging of 
food, and which is not intended to accomplish any physical or other 
technical effect in the food itself, shall be reduced to the extent 
reasonably possible.
    (3) The substance is of appropriate food grade and is prepared and 
handled as a food ingredient. Upon request the Commissioner will offer 
an opinion, based on specifications and intended use, as to whether or 
not a particular grade or lot of the substance is of suitable purity for 
use in food and would generally be regarded as safe for the purpose 
intended, by experts qualified to evaluate its safety.
    (c) The inclusion of substances in the list of nutrients does not 
constitute a finding on the part of the Department that the substance is 
useful as a supplement to the diet for humans.
    (d) Substances that are generally recognized as safe for their 
intended use within the meaning of section 409 of the act are listed in 
this part. When the status of a substance has been reevaluated, it will 
be deleted from this part, and will be issued as a new regulation under 
the appropriate part, e.g., ``affirmed as GRAS'' under part 184 or 186 
of this chapter; ``food additive regulation'' under parts 170 through 
180 of this chapter; ``interim food additive regulation'' under part 180 
of this chapter; or ``prohibited from use in food'' under part 189 of 
this chapter.

[42 FR 14640, Mar. 15, 1977, as amended at 53 FR 44875, Nov. 7, 1988]