[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: 21CFR170.105]

[Page 23-24]
 
                        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.  170.105  The Food and Drug Administration's (FDA's) determination

that a premarket notification for a food contact substance (FCN) is no 
longer effective.

    (a) If data or other information available to FDA, including data 
not submitted by the manufacturer or supplier, demonstrate that the 
intended use of the food contact substance is no

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longer safe, FDA may determine that the authorizing FCN is no longer 
effective.
    (b) If FDA determines that an FCN is no longer effective, FDA will 
inform the manufacturer or supplier in writing of the basis for that 
determination. FDA will give the manufacturer or supplier an opportunity 
to show why the FCN should continue to be effective and will specify the 
time that the manufacturer or supplier will have to respond.
    (c) If the manufacturer or supplier fails to respond adequately to 
the safety concerns regarding the notified use, FDA will publish a 
notice of its determination that the FCN is no longer effective. FDA 
will publish this notice in the Federal Register, stating that a 
detailed summary of the basis for FDA's determination that the FCN is no 
longer effective has been placed on public display and that copies are 
available upon request. The date that the notice publishes in the 
Federal Register is the date on which the notification is no longer 
effective.
    (d) FDA's determination that an FCN is no longer effective is final 
agency action subject to judicial review.