Five Phases to a Food Contact Notification: Turning Food Contact Innovation into Market Reality

23 Jun 2026

Innovation in food packaging is moving faster than ever. Each year, new materials, coatings, additives, and manufacturing technologies are developed to improve food quality, extend shelf life, reduce waste, and support sustainability goals.

However, before many of these innovations can enter the United States (U.S.) market, they must clear an important regulatory milestone: demonstrating safety for their intended use.

For many food contact substances, the pathway to market is through a Food Contact Notification (FCN) to the U.S. Food and Drug Administration (FDA).

Although the FCN process can appear complex, it ultimately answers a simple question: Is a food contact substance used in food packaging safe for consumers when used as intended?

Answering that question requires robust science, reliable data, and a clear understanding of FDA requirements. The FCN journey follows a structured process designed to evaluate those factors and move innovative food contact technologies from concept to commercialization.

At Intertek Assuris, we help companies navigate every stage of the FCN process, from early product development and regulatory strategy to submission preparation and FDA review. Whether you're introducing a novel packaging material, evaluating a new additive, or exploring an innovative processing aid, our multidisciplinary team of regulatory specialists, toxicologists, analytical chemists, and food contact experts can identify an efficient regulatory pathway, build the supporting scientific rationale, and prepare a submission that aligns with FDA expectations. The result: a more structured route to market and greater confidence that your innovation is backed by the data regulators expect to see.

The sections that follow explore the 5 key phases of a successful FCN.

Phase 1: Start With the End Use in Mind

One of the most common misconceptions about FCNs is that they begin with chemistry. In reality, they begin with understanding how a substance will be used.  Imagine 2 companies are using the same additive. One intends to use it in refrigerated beverage packaging, while the other wants to incorporate it into a material that comes into contact with hot foods during processing. Even though the substance may be identical, the potential for consumer exposure could be very different.

That's why the FDA wants a clear picture of the intended use from the outset. They want to know: what type of food will come into contact with the material? At what temperatures? For how long? What function does the substance serve?

These details shape every other aspect of the FCN, from testing requirements to safety evaluations.

Phase 2: Tell the Complete Chemistry Story

Once the intended use is established, the focus shifts to understanding the substance itself.

FDA reviewers need to know exactly what they are evaluating. That means companies should document the substance's identity, how it is manufactured, its composition, and any impurities or byproducts that could be present.

Think of this phase as building a complete profile of the material. The more clearly the    chemistry is understood, the easier it becomes to assess potential risks and determine what additional information may be needed.

This phase is particularly important for polymers,, and complex formulations where the final product may contain multiple components that require evaluation.

Phase 3: Understand What Could Reach the Food

One of the central concerns in an FCN is not simply what the substance is, but how much of it could potentially migrate into food.

A food contact substance may perform an important function within packaging or processing equipment, but if it remains bound within the material, consumer exposure could be extremely low. In other situations, small amounts may transfer into food over time.

Migration studies and exposure assessments help answer this question. Scientists evaluate how the material behaves under realistic conditions and estimate the amount consumers might realistically ingest.

This phase is often where science meets real-world use. The goal is to understand exposure as accurately as possible because exposure ultimately drives the level of safety data the FDA will require for their review.

Phase 4: Demonstrate Safety

Once the exposure is established, the next step is to determine whether that exposure presents any health concerns. This is where toxicology comes into the picture.

Depending on the estimated dietary exposure, the FDA may require varying levels of scientific evidence. In some cases, existing data may be sufficient. In others, additional assessments or studies may be needed to address specific safety questions. Always, the objective is to demonstrate that the anticipated exposure level is well within a range considered safe for consumers.

While this phase is highly scientific, its purpose is simple: ensuring that the materials used to package, process, or transport food do not create unintended health risks.

Phase 5: Build a Submission the FDA Can Review Efficiently

By the time the chemistry, migration, exposure, and safety evaluations are complete, a significant amount of information has been generated. The final phase is compiling all those pieces into a clear and well-organized FCN submission.

A strong FCN does more than present data. It tells a coherent scientific story that allows FDA reviewers to understand the substance, its intended use, the expected exposure, and why the proposed use is safe.

Well-prepared submissions often lead to a smoother review process because the FDA reviewers can more easily follow the rationale behind the conclusions.

Conversely, incomplete or poorly organized submissions can result in questions and requests for clarification and, thus, potentially longer review timelines.

Why Expertise Matters

Although the FCN process follows a logical sequence, each phase requires specialized expertise. Chemistry, migration science, exposure assessment, toxicology, and regulatory strategy all play important roles in developing a successful notification.

A challenge in one area can quickly impact the others. For example, a change in the intended use may alter migration assumptions, which can affect exposure estimates and potentially increase toxicological data requirements.

This interconnected nature of FCNs is why many companies seek experienced regulatory partners, such as Intertek Assuris, to guide the process.

From Innovation to Approval

The food contact landscape continues to evolve as companies pursue more sustainable materials, new technologies, and innovative packaging solutions. While the regulatory requirements may seem complex, the FCN process provides a well-established framework for demonstrating safety and supporting market access.

With the right strategy and scientific expertise, companies can move through the process more efficiently and focus on what they do best: bringing innovative products to market.

Intertek Assuris submitted approximately 30% of all FCNs for new materials last year. Our experts are here to support every phase of the journey because, when it comes to food contact compliance, success starts long before a notification is submitted. It begins with understanding the science behind the story.

Would you like to find out more on this topic? Contact Intertek Assuris’s Food Contact support staff at: foodcontact.assuris@intertek.com.