[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.5]
[Page 31-32]
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
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
[[Page 32]]
a finding that the substance is useful or required as a supplement to
the diet of humans.
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