[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: 21CFR170.101]

[Page 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. 170.101  Information in a premarket notification for a food contact 
substance (FCN).

    An FCN must contain the following:
    (a) A comprehensive discussion of the basis for the manufacturer's 
or supplier's determination that the use of the food contact substance 
is safe. This discussion must:
    (1) Discuss all information and data submitted in the notification; 
and
    (2) Address any information and data that may appear to be 
inconsistent with the determination that the proposed use of the food 
contact substance is safe.
    (b) All data and other information that form the basis of the 
determination that the food contact substance is safe under the intended 
conditions of use. Data must include primary biological data and 
chemical data.
    (c) A good laboratory practice statement for each nonclinical 
laboratory study, as defined under Sec. 58.3(d) of this chapter, that 
is submitted as part of the FCN, in the form of either:
    (1) A signed statement that the study was conducted in compliance 
with the good laboratory practice regulations under part 58 of this 
chapter; or
    (2) A brief signed statement listing the reason(s) that the study 
was not conducted in compliance with part 58 of this chapter.
    (3) Data from any study conducted after 1978 but not conducted in 
compliance with part 58 of this chapter must be validated by an 
independent third party prior to submission to the Food and Drug 
Administration (FDA), and the report and signed certification of the 
validating party must be submitted as part of the notification.
    (d) Information to address FDA's responsibility under the National 
Environmental Policy Act, in the form of either:
    (1) A claim of categorical exclusion under Sec. 25.30 or Sec. 
25.32 of this chapter; or
    (2) An environmental assessment complying with Sec. 25.40 of this 
chapter.
    (e) A completed and signed FDA Form No. 3480.