U.S. FDA Food Contact Notification (FCN) Application – A Complete Guide

Introduction

Food contact substances (FCS) in the US are regulated by the FDA to ensure consumer safety. Understanding what qualifies as an FCS, when a Food Contact Notification (FCN) is required, and the detailed application process is essential for manufacturers seeking legal market entry and compliance.

What Is a Food Contact Substance (FCS)?

In the United States, food contact substances (FCS) are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 409(h)(6) of the FD&C Act defines a FCS as:

any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food, if such use is not intended to have any technical effect in such food.

In simple terms, FCS refers to any substance that comes into contact with food through materials or articles such as packaging, containers, or processing equipment, provided the substance is not intended to affect the food’s characteristics (e.g., flavor, color, or preservation).

In addition to this statutory definition, certain substances are also permitted for use as FCS under specific conditions:

• GRAS substances: Generally Recognized As Safe by qualified experts.
• Prior-sanctioned substances: Those approved by the FDA before the 1958 Food Additives Amendment.

When Is an FCN (Food Contact Notification) Application Required?

The Code of Federal Regulations (CFR) Title 21, Parts 174–186, outlines substances authorized for food contact use under specific conditions. Parts 174–178 form the positive list, covering common FCS types such as adhesives, coatings, polymers, paper materials, and additives. These listings specify allowable chemical identities, usage conditions, and limitations.

If your substance is:

• Not listed, or
• Used under different conditions than permitted,

then an FCN application must be submitted to the FDA.

What Makes FCNs Unique?

According to Section 409(h)(1)(C) of the FD&C Act, an FCN is effective only for the specific manufacturer or supplier identified in the submission. This means that:

Even if another company has received FCN approval for the same substance, you must file your own FCN to use it legally.

There is no “universal authorization” for materials via FCN—it is company- and product-specific.

FCN Application Process

Here’s a step-by-step outline of how an FCN is submitted and reviewed:

1. Technical Dossier Submission
   The applicant prepares a complete dossier and submits it to the FDA’s Office of Food Additive Safety (OFAS).
2. FCN Number Assignment & Preliminary Review
   The FDA assigns an FCN number and conducts an initial check for data completeness.
3. Formal Review (120-Day Period Begins)
   If the dossier is accepted, the FDA sends an acknowledgement letter. The 120-day official review period starts from the date on this letter.
4. Automatic Effectiveness or Data Supplement
   If the FDA finds no safety concerns within 120 days, the FCN becomes automatically effective. If issues arise, the FDA will request additional data or revisions.

What Information Is Required for an FCN?

Applicants must provide robust scientific data to demonstrate the safety of the FCS. The FDA’s Form 3480 outlines the standard structure of the technical submission, typically including:

• Section A – Identification of the FCS (name, chemical structure)
• Section B – Manufacturing process
• Section C – Impurities and by-products analysis
• Section D – Intended use (conditions, food types)
• Section E – Stability of the substance
• Section F – Migration testing results
• Section G – Estimated Daily Intake (EDI)
• Section H – Toxicological data based on EDI
• Section I – Environmental assessment

FAQs About FCN Applications

Q1: Can I rely on an existing FCN approved for another company?
No, an FCN is not a universal substitute for material authorization. It is a customized approval granted to a specific company for a specific use. Therefore, each FCN is only valid for the applicant. However, in certain cases, it is possible to request a data citation from the FDA to reduce the workload required for a new submission.

Q2: My material is already listed in 21 CFR. Why do I still need an FCN?
If your use case differs—such as a different food type, temperature, or purity—from what’s listed in the CFR, a new FCN is required.

Q3: What if there’s a change in my manufacturing process?
If the change affects the chemical identity, purity, or intended use, a “replaced” FCN (or amendment) is likely required.

Q4: Is full toxicology data always required?
Not necessarily. The requirement depends on the level of migration into food. Lower migration levels may allow reliance on publicly available toxicology data, avoiding the need for full testing.

Our FCN Compliance Services

Navigating the FDA’s FCN process requires precision and regulatory expertise. We offer comprehensive support services to streamline your application:

FCN Dossier Preparation

We compile a fully compliant FCN dossier, including identity, use, chemistry, toxicology, and environmental sections, formatted to FDA specifications.

Testing Strategy & Laboratory Coordination

We help design cost-effective, scientifically sound testing plans and liaise with qualified labs for material analysis and migration testing.

Technical Communication with FDA

Our team manages all FDA communications, including clarifications, data supplement responses, and regulatory explanations during the review period.

Risk Assessment & Regulatory Advisory

We assess the regulatory status of your materials and guide you through strategic decision-making to minimize review time and cost.