CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (parts 100 to 191) > PART 170—FOOD ADDITIVES > SUBPART D—Premarket Notifications (§170.100 to §170.106) > 170.106—Notification for a food contact substance formulation (NFCSF).

170.106—Notification for a food contact substance formulation (NFCSF).

(a) In order for the Food and Drug Administration (FDA) to accept an NFCSF, any food additive that is a component of the formulation must be authorized for its intended use in that NFCSF.
(b) FDA may publish a notice in the Federal Register stating that the agency has insufficient resources to review NFCSFs. From the date that this notice publishes in the Federal Register, FDA will no longer accept NFCSFs.
(c) An NFCSF must contain the following:
(1) A completed and signed FDA Form No. 3479; and
(2) Any additional documentation required to establish that each component of the formulation already may be marketed legally for its intended use.