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e-CFR data is current as of February 23, 2021

Title 21Chapter ISubchapter BPart 170Subpart D → §170.101

Title 21: Food and Drugs
Subpart D—Premarket Notifications

§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 §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 §25.30 or §25.32 of this chapter; or

(2) An environmental assessment complying with §25.40 of this chapter.

(e) A completed and signed FDA Form No. 3480.

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