[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: 21CFR170.104]

[Page 23]
 
                        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. 170.104  Action on a premarket notification for a food contact substance (FCN).

    (a) If the Food and Drug Administration (FDA) does not object to an 
FCN within the 120-day period for FDA review, the FCN becomes effective.
    (b) If an FCN is complete when received, the 120-day review period 
begins on the date FDA receives the FCN.
    (1) If any element required under Sec. 170.101 is missing from an 
FCN, then FDA will not accept that FCN and FDA will send an FCN 
nonacceptance letter to the manufacturer or supplier. If the 
manufacturer or supplier submits the missing information before FDA 
sends an FCN nonacceptance letter, the 120-day review period begins on 
the date of receipt of the missing information.
    (2) If FDA accepts an FCN, then FDA will acknowledge in writing its 
receipt of that FCN.
    (c) Objection to an FCN:
    (1) If FDA objects to an FCN, then FDA will send an FCN objection 
letter. The date of the letter will be the date of FDA's objection for 
purposes of section 409(h)(2)(A) of the act.
    (2) If FDA objects to an FCN within the 120-day period for FDA 
review, the FCN will not become effective.
    (3) FDA may object to an FCN if any part of FDA's 120-day review 
occurs during a period when this program is not funded as required in 
section 409(h)(5) of the act.
    (d) If FDA and a manufacturer or supplier agree that the notifier 
may submit a food additive petition proposing the approval of the food 
contact substance for the use in the manufacturer's or supplier's FCN, 
FDA will consider that FCN to be withdrawn by the manufacturer or 
supplier on the date the petition is received by FDA.