[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: 21CFR170.100]

[Page 21-22]
 
                        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.  170.100  Submission of a premarket notification for a food 

    Source: 67 FR 35729, May 21, 2002, unless otherwise noted.


contact substance (FCN) to the Food and Drug Administration (FDA).

    (a) An FCN is effective for the food contact substance manufactured 
or prepared by the manufacturer or supplier identified in the FCN 
submission. If another manufacturer or supplier wishes to market the 
same food contact substance for the same use, that manufacturer or 
supplier must also submit an FCN to FDA.
    (1) An FCN must contain all of the information described in Sec.  
170.101.
    (2) An FCN may incorporate by reference any information in FDA's 
files provided that the manufacturer or supplier is authorized to 
reference the information. The FCN must include information establishing 
that the manufacturer or supplier is authorized to reference information 
in FDA's files.
    (3) Any material submitted in or referenced by an FCN that is in a 
foreign language must be accompanied by an English translation verified 
to be complete and accurate.
    (b) FDA may choose not to accept an FCN for either of the following:

[[Page 22]]

    (1) A use of a food contact substance that is the subject of a 
regulation in parts 173 through 189 of this chapter; or
    (2) A use of a food contact substance that is the subject of an 
exemption under the threshold of regulation process described in Sec.  
170.39.
    (c) A petition must be submitted under Sec.  171.1 of this chapter 
to authorize the safe use of a food contact substance in either of the 
following circumstances, unless FDA agrees to accept an FCN for the 
proposed use.
    (1) The use of the food contact substance increases the cumulative 
dietary concentration to a certain level. For a substance that is a 
biocide (e.g., it is intended to exert microbial toxicity), this level 
is equal to or greater than 200 parts per billion in the daily diet (0.6 
milligram (mg)/person/day). For a substance that is not a biocide, this 
level is equal to or greater than 1 part per million in the daily diet 
(3 mg/person/day); or
    (2) There exists a bioassay on the food contact substance, FDA has 
not reviewed the bioassay, and the bioassay is not clearly negative for 
carcinogenic effects.
    (d) A manufacturer or supplier for which a notification is effective 
must keep a current address on file with FDA.
    (1) The current address may be either the manufacturer's (or 
supplier's) address or the address of the manufacturer's (or supplier's) 
agent.
    (2) FDA will deliver correspondence to the manufacturer's or 
supplier's current address.