[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: 21CFR174.5]
[Page 153]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 174 INDIRECT FOOD ADDITIVES: GENERAL--Table of Contents
Sec. 174.5 General provisions applicable to indirect 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 purpose of this part and parts 175, 176,
and 177 of this chapter, good manufacturing practice shall be defined to
include the following restrictions:
(1) The quantity of any food additive substance that may be added to
food as a result of use in articles that contact food shall not exceed,
where no limits are specified, that which results from use of the
substance in an amount not more than reasonably required to accomplish
the intended physical or technical effect in the food-contact article;
shall not exceed any prescribed limitations; and shall not be intended
to accomplish any physical or technical effect in the food itself,
except as such may be permitted by regulations in parts 170 through 189
of this chapter.
(2) Any substance used as a component of articles that contact food
shall be of a purity suitable for its intended use.
(b) The existence in the subchapter B of a regulation prescribing
safe conditions for the use of a substance as an article or component of
articles that contact food shall not be construed to relieve such use of
the substance or article from compliance with any other provision of the
Federal Food, Drug, and Cosmetic Act. For example, if a regulated food-
packaging material were found on appropriate test to impart odor or
taste to a specific food product such as to render it unfit within the
meaning of section 402(a)(3) of the Act, the regulation would not be
construed to relieve such use from compliance with section 402(a)(3).
(c) The existence in this subchapter B of a regulation prescribing
safe conditions for the use of a substance as an article or component of
articles that contact food shall not be construed as implying that such
substance may be safely used as a direct additive in food.
(d) Substances that under conditions of good manufacturing practice
may be safely used as components of articles that contact food include
the following, subject to any prescribed limitations:
(1) Substances generally recognized as safe in or on food.
(2) Substances generally recognized as safe for their intended use
in food packaging.
(3) Substances used in accordance with a prior sanction or approval.
(4) Substances permitted for use by regulations in this part and
parts 175, 176, 177, 178 and Sec. 179.45 of this chapter.
(5) Food contact substances used in accordance with an effective
premarket notification for a food contact substance (FCN) submitted
under section 409(h) of the act.
[42 FR 14534, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002]
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