This electronic document was downloaded from the GPO web site, October 2005,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.106]
[Page 24]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170_FOOD ADDITIVES--Table of Contents
Subpart D_Premarket Notifications
Sec. 170.106 Notification for a food contact substance formulation
(NFCSF).
(a) In order for the Food and Drug Administration (FDA) to accept an
NFCSF, any food additive that is a component of the formulation must be
authorized for its intended use in that NFCSF.
(b) FDA may publish a notice in the Federal Register stating that
the agency has insufficient resources to review NFCSFs. From the date
that this notice publishes in the Federal Register, FDA will no longer
accept NFCSFs.
(c) An NFCSF must contain the following:
(1) A completed and signed FDA Form No. 3479; and
(2) Any additional documentation required to establish that each
component of the formulation already may be marketed legally for its
intended use.