eCFR Reference Browser

---

title: "21 CFR §170.106"

source: "https://www.ecfr.gov/current/title-21/section-170.106"

title_number: "21"

volume_number: "3"

chapter_number: "Unknown"

subchapter_code: "B"

subchapter_subject: "FOOD FOR HUMAN CONSUMPTION (CONTINUED)"

part_code: "170"

part_subject: "FOOD ADDITIVES"

subpart_code: "D"

subpart_subject: "Premarket Notifications"

section_number: "170.106"

section_subject: "Notification for a food contact substance formulation (NFCSF)."

cfr_reference: "21 CFR 170.106"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 170 to 199"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

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