[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR582.1]

[Page 517-518]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 582--SUBSTANCES GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
                      Subpart A--General Provisions
 
Sec.  582.1  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, sugar, vinegar, baking powder, and monosodium glutamate as 
safe for their intended use. The lists in subparts B through H of this 
part include additional substances that, when used for the purposes 
indicated, in accordance with good manufacturing or feeding practice, 
are regarded by the Commissioner as generally recognized as safe for 
such uses.
    (b) For the purposes of this section, good manufacturing or feeding 
practice shall be defined to include the following restrictions:
    (1) The quantity of a substance added to animal food does not exceed 
the amount reasonably required to accomplish its intended physical, 
nutritional, or other technical effect in food; and
    (2) The quantity of a substance that becomes a component of animal 
food as a result of its use in the manufacturing, processing, or 
packaging of

[[Page 518]]

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 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 animals.
    (d) Substances that are generally recognized as safe for their 
intended use within the meaning of section 409 of the Act are listed in 
subparts B through H of this part. When the status of a substance has 
been reevaluated and affirmed as GRAS or deleted from subparts B through 
H of this part, an appropriate explanation will be noted, e.g., 
``affirmed as GRAS,'' ``food additive regulation,'' ``interim food 
additive regulation,'' or ``prohibited from use in food,'' with a 
reference to the appropriate new regulation. Such notation will apply 
only to the specific use covered by the review, e.g., direct animal food 
use and/or indirect animal food use and/or animal feed use and will not 
affect its status for other uses not specified in the referenced 
regulation, pending a specific review of such other uses.