Food Contact Notifications (FCNs)

When a clearance, exemption or exception won’t do, an FCN is for you.

A Food Contact Notification (FCN) is a filing that companies submit to the US Food and Drug Administration (FDA) to request premarket review and authorization for a new or expanded use of a food contact substance (FCS) in one or more food-contact applications. 

Author's Note:

Given the potential complexity of an FCN submission, as well as an accompanying Environmental Assessment (EA), if required, the use of an agent such as Steptoe & Johnson to assist with the preparation of an FCN and supporting data and information is strongly encouraged. Effective FCNs appear on FDA's Inventory of Effective Food Contact Substance Notifications; this Inventory is updated by FDA approximately once per month.

History of the Food Contact Notification Program

Prior to the late 1990s, companies interested in requesting premarket review and authorization (i.e., permission from FDA) to market a new food contact substance (FCS), or a new use for a food contact substance, were required to submit a Food Additive Petition (FAP) to the Agency for consideration. The general provisions of an FAP, including the process and content of the petition, are described in FDA’s Food Additive Regulations at 21 C.F.R. Part 171 (Food Additive Petitions). The FAP was originally intended to address new uses of food additives, including ingredients added to food at significantly higher levels than that which may migrate from food packaging. The amount of information necessary to support an FAP is therefore significant, and in many instances, well beyond that which would be necessary to establish the safety of substantially lower exposures to components of food packaging. FAPs can be both cumbersome and extremely time consuming, both from a preparation and review standpoint. 

In the absence of an alternative mechanism, however, companies wishing to market new uses of food contact substances were required to follow the same FAP process as companies intending to market new food ingredients. The result was a significant bottleneck at FDA as the agency attempted to keep pace with an ever-increasing number of FCS submissions with the same or fewer number of resources. By the mid-1990's, it became apparent that a new approach was needed.

Enter the Food Contact Notification (FCN) – a submission to FDA like the FAP, but with a number of significant and important differences. At the urging of industry, language proposing the FCN program was included by Congress as part of the Food and Drug Administration Modernization Act of 1997 (FDAMA), and now appears in 21 C.F.R. Part 170 (Food Additives), Subpart D (Premarket Notifications), beginning at 21 C.F.R. Section 170.100.

Why an FCN is Different

The FCN program differs from FAPs in a number of important respects:

• A Food Contact Notification is not a petition. Officially, companies put FDA “on notice” of their intent to market a new FCS or an FCS for a new use.
• Consequently, FDA does not "approve" FCNs. Instead, it allows FCNs to become effective on the basis of the fact that the agency does not object to the proposed use at the present time.¹
• Unlike FAPs, FDA is required to consider and – if necessary – object to an FCN within 120 days of submission (this statutorily-defined timeframe can be extended if the Agency responds with questions in a "Deficiency Letter"). If FDA does not object to an FCN in that timeframe, an FCN automatically becomes effective.²
• FCNs are proprietary:
• Unlike FAPs (and a resulting food additive regulation upon authorization that any company can rely upon), FCNs may be relied upon only by the notifier, manufacturer/supplier and their customers.
• If another company wishes to market the same use of an FCS, it must first file its own FCN.
• Certain information contained in an FCN that is unique to the notifier/manufacturer can be claimed as confidential, including the manufacturing process description, certain product specifications, and the impurity profile.

In summary, the FCN program provides a number of unique advantages over an FAP for notifiers and manufacturers of food-contact materials and articles, including: (1) expedited review by FDA; (2) the ability to market (for a time, at least) to the exclusion of competitors that don’t hold a similar FCN; and (3) the ability to claim certain information as confidential.

FDA does not currently charge a user fee to evaluate an FCN; instead, Congress appropriates funding for the FCN program as part of its federal appropriations (budgetary) process. Note, however, that there is a provision that allows FDA to levy fees in the event that funding is not provided for by Congress in any future budget. 

Finally, FCNs are not accepted by FDA for substances that are already authorized for the same use in an existing food additive regulation; however, mixtures of otherwise cleared substances may be submitted to FDA (usually if deemed necessary by a notifier for marketing purposes) – though such submissions are very uncommon.

Components of a Food Contact Notification

FDA makes available a series of guidance documents on its’ website to support the development, preparation, and submission of an FCN. (These guidance documents also are particularly helpful in supporting other types of evaluations, including those that form the basis for relevant exemptions and exceptions). These guidance documents include, but are not necessarily limited to:

• Administrative Guidance: Preparation of Food Contact Substance Notifications (Administrative): Guidance for Industry (October 2021), available at: https://www.fda.gov/media/153218/download

• Chemistry Guidance: Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations) (December 2007), available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-preparation-premarket-submissions-food-contact-substances-chemistry
• Toxicology Guidance: Guidance for Industry: Preparation of Food Contact Substance Notifications (Toxicology Recommendations) (October 2021), available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-preparation-food-contact-substance-notifications-toxicology-recommendations
• Infant Foods Guidance: Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk (May 2019), available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-preparation-food-contact-notifications-food-contact-substances-contact-infant
• Environmental Guidance: Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to [the Center for Food Safety and Applied Nutrition] (CFSAN) (May 2006), available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-preparing-claim-categorical-exclusion-or-environmental-assessment-submission-cfsan

While each FCN is unique, the following describes those sections that commonly appear in most notifications:

• FDA Form 3480: This standardized form is available on FDA's website and provides the general framework for the components of an FCN. The Form 3480 includes administrative information regarding the notifier and agent preparing the FCN (such as Steptoe, if applicable), identifying information regarding the FCS, and pages used to summarize the sections that follow. The Form 3480 contains a table of attachments, an environmental assessment (EA) (if applicable), and a certification regarding the truth and accuracy of the information contained in the FCN. While a completed Form 3480 and accompanying EA (if applicable) effectively represents the minimum content of an FCN submission, in practice, most companies include attachments to expand upon each of the relevant sections contained in the Form 3480 document.
• Characterization data includes information such as the Chemical Abstract Services Registry Number (CASRN), the chemical structure of the substance; the chemical name (and other common names), the molecular weight of the FCS, and spectra used to identify the FCS – such as infrared (IR), ultraviolet (UV), nuclear magnetic resonance (NMR), mass spectra, or other appropriate identifying means. For polymeric substances, characterization data also generally includes the monomer ratio and identification of the fraction of Low Molecular Weight Oligomers (LMWO) below 1000 daltons.³
• Product specifications are necessarily unique to manufacturer, and depend on the type of food contact substance. Common examples of product specifications include: physical appearance (g., color, liquid/solid), freezing, boiling and melting temperatures, viscosity, and density. Importantly, product specifications are typically expressed as a range of values (or maximum values) reflective of quality control and Good Manufacturing Practice (GMP).⁴
• Manufacturing Process Description includes a list of all raw materials, corresponding use levels, and functions, as well as a discussion of reaction processes (times and temperatures), chemical equations and stoichiometry. Any expected or potential side reactions also should be noted. Where available, flow charts and other pictorial representations of the manufacturing process may be included for clarity.
• Impurity profile should include a complete list of impurities, byproducts, residual starting materials, catalysts, initiators, and other substances or materials that may remain available in the finished FCS (including both those potentially able to migrate to food, and those that are expected to be removed or otherwise unable to migrate), as well as their residual levels in the finished FCS. These impurities and byproducts, along with the FCS itself, should be evaluated for migration, dietary concentration, safety, and toxicology in the corresponding sections below.
• Intended Use Description, including the function of the FCS, Food Types and Conditions of Use, and the expected duration of contact (g., short-term or long-term, as well as single or repeated-use). The FCN, once effective, will necessarily be limited to those uses described in the notification. A description of the technical effect of the FCS, and information supporting this use also should be submitted to FDA. Note that, more recently, FDA evaluates exposure to components of packaging used to hold infant foods using different assumptions as described in the Infant Foods Guidance Document; therefore, FCNs that appear on FDA’s Inventory now explicitly sanction infant food contact applications (if applicable), or include a restriction to the effect that infant uses have not been evaluated as part of the FCN submission and are not authorized.
• Stability information should include details regarding the potential formation of degradation products that may intentionally or unintentionally form when the FCS is used as intended (for example, the intended reaction products and byproducts of scavenging materials embedded in polymers), as well as a demonstration of the stability of the FCS in the ambient environment in contact with the FCS. Similar to the impurity profile section above, intended and unintended reaction products and byproducts should be evaluated for migration, dietary concentration, safety, and toxicology in the corresponding sections below.
• Migration and Dietary Concentration of the FCS, as well as its impurities, byproducts, and degradation products should be evaluated using one of the procedures discussed in our previous StepLadder article, The 'No Migration' Position, including: (1) upper-bound (100%) calculations; (2) analytical modeling; or (3) actual migration studies using appropriate food-simulating solvents under specified time and temperature conditions, where resulting dietary concentration is evaluated using appropriate consumption factors and food type distribution factors. These values should be reported both in the tables in Form 3480 and in the safety narrative section discussed below.
• Safety Narrative contains an abbreviated summary of the migration and/or dietary concentration values described in the section above, evaluated based on the toxicology information contained in the section below. The safety narrative should effectively demonstrate that the calculated, modeled, or measured migration and/or dietary exposure values resulting from the intended use of the FCS are safe to a reasonable degree of certainty.
• Comprehensive Toxicology Profile (CTP) should contain a complete and detailed description of all relevant toxicology studies of which the notifier is aware, including both published and unpublished studies relevant to the safety of the FCS, its impurities, degradation byproducts, and residual substances. The threshold amount of toxicology information necessary to support the safety of calculated, modeled, or measured exposure should be based on FDA's Toxicology Guidance document; however, the notifier has an obligation to bring all relevant studies of which it is aware – both favorable and unfavorable – to FDA’s attention in the CTP.
• Environmental Information: In accordance with The National Environmental Policy Act of 1969 (NEPA) (Pub. L. 91–190 (1970)), federal agencies – including FDA – are required to evaluate and assess the environmental impacts of their activities. In response, FDA requires under 21 C.F.R. Section 25.40 that notifiers of an FCN either submit an environmental assessment of the potential effects of the use and disposal (but not the production) of the FCS, or submit a justification for a claim of categorical exclusion under one or more appropriately-defined criteria. While a future StepLadder article will review the contents of an EA in further detail, briefly, an EA (if required) should include a description of the proposed action (e., to permit the use of the FCS as intended), evaluate the potential introduction of substances into the environment as a result of use and disposal – including into wastewater, air, and landfill, describe the use of resources and energy associated with use and disposal, and describe both mitigation measures and alternatives to the proposed action (if such alternatives exist). Environmental assessments are publicly-available documents that are accessible online. Certain supporting information (such as production volume estimates for the first and fifth year of manufacturing upon which an EA often relies) can be maintained as confidential as a separate, confidential attachment to the EA. When an EA is required, FDA will make a "Finding of No Significant Impact" (FONSI) as part of the FCN review process.
  
  Importantly, a number of categorical exclusions from the need for an EA are defined under 21 C.F.R. Part 25, including for FCS that are intended to remain with the packaging material; substances used as components of coatings (or non-coating components), components of repeated-use articles, and substances already authorized for food-contact uses under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The development of an EA, if required, can often be a complex process. Therefore, identifying appropriate counsel with specific experience preparing EAs is strongly suggested.

Obtaining an FCN for a Competitor’s Existing Use

Finally, it should be noted that while companies are required to obtain their own FCNs for the proposed expanded or new use of an FCS, subsequent filers do sometimes benefit from the ability to rely on previously-submitted toxicology and safety data. That is, a company is permitted to rely on FDA’s existing file and previous assessment of such information in support of a second-comer’s FCN. For this reason, certain strategies, such as obtaining publicly-available information on a previous FCN from FDA through the Freedom of Information Act (FOIA) before preparing one’s own submission may prove beneficial in streamlining the FCN preparation process. Of course, the second-comer’s responsibility to review relevant toxicology and safety databases to ensure that information remains complete and current is still required, and confidential business information (CBI) from previous FCN submissions – such as the manufacturing process description, specifications, and impurity profile – remain protected from disclosure under FOIA.

Concluding Thoughts

The FCN process represents a significant step forward by FDA to more effectively and efficiently provide a mechanism for premarket evaluation of those food-contact substances that do not otherwise fall under an applicable exception or exemption (or where a notifier instead determines that explicit FDA "review" of an FCN is preferable for marketing or customer assurance purposes). The success of the program since its inception in the late 1990’s – and the over 2,000 FCNs that have become effective since that time – are a testament to the ability of industry and FDA to work together to propose and implement a reasonable and responsible way to safely and effectively bring new chemistries and new uses of existing chemistries to market.

¹ Companies listed on an FCN are responsible for notifying FDA in the event that they become aware of any new or adverse safety information that could call into question FDA's absence of an objection; similarly, FDA can request additional information from a notifier in the event that new information comes to light. FDA currently is currently in the process of proposing a rule that would provide an affirmative mechanism for a notifier or manufacturer to request that FDA "de-list" an FCN for reasons other than safety (e.g., abandonment).

² In practice, FDA provides notifiers with an "Acknowledgment Letter" and a "Final Letter" as part of the FCN review process.

³ It is this fraction of the polymer that FDA recognizes as available for absorption by the human body through the oral route of exposure and therefore significant from a toxicological and safety standpoint.

⁴ Therefore, product specifications defined in an FCN should be sufficiently broad to ensure that the FCS complies in the course of typical manufacture (including reasonable tolerances for product variation), but not so broad that GMP is no longer satisfied. 

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About the Steptoe StepLadder Series

Steptoe & Johnson LLP is pleased to publish the Stepladder series of articles for our clients, prospective clients, and interested companies as a way of educating attorneys and non-attorneys alike about legal and regulatory principles related to food packaging in meaningful ways. While there are many sources of information available online, the StepLadder series is intended to be accessible to, and understandable by all, to help support business decisions related to food packaging compliance.

This information is provided for educational purposes only, is not legal advice, and does not establish an attorney-client relationship with Steptoe. Our lawyers made us write that. If you have legal questions, please consult an attorney. Preferably from a team well-versed in food packaging regulation – and definitely from a group of attorneys that have a good sense of humor. Because you are what you eat… unless your food packaging isn’t a ‘food additive,' in which case you’re not food packaging.