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Any substance that contacts food during manufacturing, packaging, or storage and is not already authorized under FDA regulations requires a Food Contact Notification (FCN) before it can be legally marketed. QSS works with your team to prepare a notification that meets FDA's scientific and administrative requirements under 21 CFR 170.100.
A food contact substance (FCS) is any substance used as a component of materials that contact food, including packaging, coatings, adhesives, polymers, and processing equipment. Under Section 409(h) of the Federal Food, Drug, and Cosmetic Act, the Food Contact Notification (FCN) process is the primary route by which FDA authorizes new food contact substances.
An FCN must demonstrate that the substance is safe for its intended use under the same standard applied to food additive petitions: a reasonable certainty of no harm. Once effective, an FCN authorizes use only for the specific manufacturer or supplier named in the notification.
FDA has 120 days from receipt of a complete submission to raise an objection. If none is raised, the FCN becomes effective and is listed in FDA's Inventory of Effective Food Contact Substance Notifications. QSS assesses your substance's regulatory status, confirms the appropriate pathway, and prepares your notification to meet CFSAN's current standards.
Before preparing an FCN, your company needs to know whether your substance is already authorized under existing regulations in 21 CFR Parts 174 to 186, whether a Threshold of Regulation exemption applies, or whether a full FCN is required. QSS assesses your substance’s regulatory status and confirms the right pathway before work begins.
FDA’s Office of Food Additive Safety offers pre-notification consultation to help notifiers understand data requirements before formal submission. QSS prepares your consultation materials, supports your engagement with OFAS, and incorporates agency feedback into your notification strategy.
QSS prepares your complete Food Contact Notification under 21 CFR 170.100 and 170.101, covering all required sections: substance identity and manufacturing information, intended use and conditions of use, dietary exposure assessment, safety assessment, and environmental documentation.
A dietary exposure assessment is a core component of every FCN. QSS develops intake estimates using FDA-recognized methodologies and databases, accounting for migration of the substance from the contact material into food under the intended conditions of use.
QSS develops the safety narrative demonstrating a reasonable certainty of no harm under your substance’s intended conditions of use, drawing on migration data, toxicological studies, and structural and metabolic considerations as required by OFAS guidance.
Your FCN must include either an Environmental Assessment or a claim of categorical exclusion under 21 CFR Part 25. QSS prepares the appropriate documentation based on your substance’s profile and intended use.
FDA has 120 days to review a complete FCN. QSS monitors the review period, manages follow-up communication with OFAS, and prepares responses to any agency requests for additional information.
Explore articles, blogs, and videos on food contact notifications, FDA CFSAN requirements, and food packaging compliance.
A food contact substance is any substance intended for use as a component of a material that contacts food, including packaging films, coatings, adhesives, paper and paperboard, polymers, and processing equipment surfaces. An FCN is required when a substance is not already authorized under existing food additive regulations in 21 CFR Parts 174 to 186 and does not qualify for a Threshold of Regulation exemption. QSS assesses your substance and confirms which pathway applies.
Both routes require demonstrating a reasonable certainty of no harm and involve comparable scientific data. The key differences are in process and outcome. An FCN becomes effective automatically if FDA does not object within 120 days of receiving a complete notification, making it faster than a food additive petition. However, an FCN is company-specific: it only authorizes use by the manufacturer or supplier named in the notification. A food additive petition, by contrast, results in a publicly available regulation that any company may rely on.
No. An FCN is effective only for the specific manufacturer or supplier identified in the notification. Even if another company has received FCN authorization for the same substance and intended use, your company must file its own FCN to legally market or use that substance. QSS prepares company-specific FCN submissions and advises on how to leverage existing public data where available.
Under 21 CFR 170.101, an FCN must address the substance’s identity and method of manufacture, its intended use and conditions of use, a dietary exposure assessment based on migration into food, a safety assessment demonstrating a reasonable certainty of no harm, and an Environmental Assessment or categorical exclusion claim. QSS prepares all sections to meet OFAS’s current data quality expectations.
The Threshold of Regulation process under 21 CFR 170.39 provides an exemption from food additive regulation for substances that migrate into food at very low levels and do not present a safety concern. If your substance’s dietary exposure falls below the applicable threshold and it has no known safety concerns, it may qualify for this exemption rather than requiring a full FCN. QSS assesses whether the exemption applies and advises on the appropriate pathway.
FDA has 120 days from receipt of a complete notification to raise an objection. If no objection is raised within that period, the FCN becomes effective and is added to FDA’s Inventory of Effective Food Contact Substance Notifications. A complete, well-prepared notification that meets OFAS’s data requirements from the outset is the most reliable way to move through the 120-day window without extension or objection.
Yes. FDA amended its regulations in 2024 to allow FCNs to be determined no longer effective for reasons beyond safety concerns, including situations where the use is no longer in commerce or where new information raises questions about the accuracy of the original submission. QSS advises on post-authorization compliance and monitors developments that could affect the status of your FCN.