[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.5]

[Page 28]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 172.5  General provisions for direct food additives.


    (a) Regulations prescribing conditions under which food additive 
substances may be safely used predicate usage under conditions of good 
manufacturing practice. For the purposes of this part, good 
manufacturing practice shall be defined to include the following 
restrictions.
    (1) The quantity of the substance added to food does not exceed the 
amount reasonably required to accomplish its intended physical, 
nutritive, or other technical effect in food.
    (2) Any substance intended for use in or on food is of appropriate 
food grade and is prepared and handled as a food ingredient.
    (b) The existence of a regulation prescribing safe conditions of use 
for a food additive shall not be construed to relieve the use of the 
substance from compliance with any other provision of the Act.
    (c) The existence of any regulation prescribing safe conditions of 
use for a nutrient substance does not constitute a finding that the 
substance is useful or required as a supplement to the diet of humans.