[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2004]
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.