Q.01

What is an FDA food contact notification?

An FDA food contact notification (FCN) is a premarket submission under section 409(h) of the Federal Food, Drug, and Cosmetic Act. It is the main route FDA uses to regulate food additives that are food contact substances (FCSs), meaning substances used in materials that touch food, such as packaging. Once an FCN is effective, the substance can be lawfully marketed for the use it describes. That authorisation covers only the manufacturer or supplier named in the notification.

What counts as a food contact substance Section 409(h)(6) defines an FCS as "any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if the use is not intended to have any technical effect in such food."

What the notification must contain

  • The notifier must provide enough scientific information to show the substance is safe for its intended use.
  • FDA describes this data package as comparable to a food additive petition or a Threshold of Regulation submission.
  • The procedures are in 21 CFR Part 170, Subpart D (§§170.100–170.106).

Who it covers

  • FDA states that an FCN "is only effective for the manufacturer or supplier identified in the notification."
  • The authorisation belongs to that company. A buyer must get the substance from the listed manufacturer or supplier.
  • Anyone who buys the substance from that listed company "may rely on that notification to legally market or use the food contact substance."
  • Anyone marketing an FCS on the basis of an FCN "must be able to demonstrate that the notification is effective for their food contact substance."
  • This is the key difference from a food additive regulation in 21 CFR Parts 174–179, which anyone can use.

Other ways a component can be authorised FDA treats an effective FCN as one of five ways a food contact component can comply. The other four are:

  • a listing in 21 CFR Parts 174–179
  • GRAS (generally recognized as safe) status
  • a prior sanction
  • a Threshold of Regulation exemption under 21 CFR 170.39

The public inventory FDA publishes an Inventory of Effective FCS Notifications. For each FCN it lists:

  • the substance
  • the notifier and the manufacturer
  • the intended use
  • limits on conditions of use, and specifications
  • the effective date
  • the environmental decision

A notification takes effect after an FDA review period. The FDA pages I could open don't give the length of that period, so I haven't stated it here.

Approach: I read FDA's FCN guidance and its pages on the FCN inventory and on the regulatory status of food contact materials. I couldn't pull an example record from the FDA FCN inventory this time.

Sources:

Q.02

Can another supplier rely on the same notification?

No. Another supplier cannot rely on the notification for a substance it makes or sources elsewhere, even if the substance is chemically identical. FDA states that an FCN "is only effective for the manufacturer or supplier identified in the notification," citing section 409(h)(2)(C) of the FD&C Act. FDA also says: "If another manufacturer wants to use the same substance, they must submit their own application to the FDA."

Who can rely on an existing FCN

  • The company named in the notification. FDA says an effective FCN "applies only to the food contact substance that is the subject of the FCN and is applicable to the manufacturer/supplier listed within the notification."
  • Anyone who buys the substance from that named company. This covers converters, packaging makers, food companies and distributors. Per FDA, "All persons who purchase a food contact substance manufactured or supplied by a manufacturer or supplier identified in an effective notification may rely on that notification to legally market or use the food contact substance for the use that is the subject of the notification, consistent with any limitations in that notification."
  • The supply chain test. Anyone marketing a food contact substance on the basis of an FCN "must be able to demonstrate that the notification is effective for their food contact substance." In practice, that means being able to trace the material back to the company named in the FCN.

Who cannot

  • A second manufacturer of the same substance. FDA says FCNs are "specific to each manufacturer or supplier," so this company needs its own notification.
  • A reseller using a different source. A distributor that sells the named company's material is a purchaser and is covered. One that switches to material from an unnamed producer loses that coverage.

Practical points for a second supplier

  • Review period. A new FCN goes through FDA's review period, which FDA calls "a mandated 120-day time-period." If FDA raises no objection in that window, the notifier may market the substance. (This is the review period I couldn't confirm in my last answer.)
  • Other routes. The manufacturer-specific limit applies only to FCNs. A listing in 21 CFR Parts 174–179, GRAS status, a prior sanction or a Threshold of Regulation exemption is not tied to one company.

Approach: Our datasets have the eCFR text of 21 CFR Part 170 and the FDA FCN Inventory, but I couldn't search either this time. I answered from FDA's own pages instead. I also couldn't open the PDF of FDA's administrative guidance on preparing FCNs, so nothing above is taken from it.

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Q.03