Foreign packaging manufacturers do not universally need a Food Contact Notification (FCN). Establish the regulatory basis for each relevant component and its actual intended use. This guide was substantively corrected against primary sources on 5 October 2026; its original publication date remains 28 July 2026.
Start with the component and use, not an FCN assumption
FDA describes several possible bases: an applicable food-additive regulation in the CFR, a qualifying generally recognized as safe (GRAS) or prior-sanction status, an issued threshold of regulation (TOR) exemption, or an effective FCN. A basis for one substance or use does not authorize every formulation, impurity, food type or contact condition. Assess components reasonably expected to migrate, their identity, purity and specifications, and all limitations on the intended use.
Part 174 contains general provisions for indirect food additives, including suitable purity and good manufacturing practice. Parts 175–178 address adhesives/coatings, paper/paperboard, polymers and adjuvants or production aids respectively. Finding a material name in a regulation is only the start: match the relevant specifications, limitations and conditions of use.
FDA component-status guidance: https://www.fda.gov/food/packaging-food-contact-substances-fcs/determining-regulatory-status-components-food-contact-material
Can a purchaser use a supplier's effective FCN?
Yes, if the substance is from the manufacturer or supplier identified in that effective notification and the proposed use is covered. Retain traceability to that identified source and evidence matching the substance, specifications and use limitations. A supplier statement or letter of guaranty may support the record, but it does not broaden the notification. Chemically similar or even identical material from an unrelated manufacturer is not automatically covered by someone else's FCN; assess another valid authorization basis or a new notification as appropriate.
Check FDA's current inventory and the notification's conditions rather than assuming that a notification number remains effective or covers every downstream use. There is no useful fixed inventory count for determining your product's status.
Effective FCN inventory: https://www.fda.gov/food/packaging-food-contact-substances-fcs/inventory-effective-food-contact-substance-fcs-notifications
The 120-day review clock and current effectiveness rules
Under 21 CFR 170.104, the 120-day review period runs from receipt of a complete notification. If the initial submission is incomplete, the clock starts when FDA receives a complete submission. The notification becomes effective if FDA does not object within the applicable review period; this is not a promise of approval or a guaranteed end-to-end project timetable.
Current 170.105 permits FDA to determine that an FCN is no longer effective on specified grounds: available data show the intended use is no longer safe; the identified manufacturer or supplier has ceased or intends to cease producing, supplying or using the substance for that use; the use is authorized by a food-additive regulation; or the use is covered by an issued TOR exemption. The rule provides applicable notification/response procedures and a Federal Register notice explaining the determination. Check the actual notice, basis, scope and any specified compliance date; do not infer a universal expiry or automatic score-like status.
21 CFR 170.104: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-170/subpart-D/section-170.104
21 CFR 170.105: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-170/subpart-D/section-170.105
TOR is an issued exemption, not a low-migration shortcut
The criteria in 170.39 include no evidence that the substance is carcinogenic in humans or animals and no structural reason to suspect carcinogenicity. If it contains a carcinogenic impurity, the impurity's TD50 must not be less than 6.25 mg/kg body weight/day. The rule also requires either a dietary concentration at or below 0.5 parts per billion, or a currently regulated direct food additive whose dietary exposure from the proposed food-contact use is at or below 1% of its acceptable daily intake. There must be no technical effect in or on the food and no significant adverse environmental impact. The substance must present no other health or safety concerns. FDA may decline an exemption when available information establishes that the proposed use may pose a public-health risk.
Supply the required identity/composition, conditions of use, exposure and safety information and environmental documentation for FDA's review. An exposure estimate alone does not create an exemption: confirm that FDA has issued an applicable TOR exemption. No 60-day processing promise is made here.
21 CFR 170.39: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-170/subpart-B/section-170.39
FDA TOR submission guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-submitting-requests-under-21-cfr-17039-threshold-regulation-substances-used-food
Migration evidence and recycled plastic
FDA's chemistry guidance uses the material, proposed food types, contact time and temperature, single/repeated use and relevant exposure assumptions to determine suitable evidence. Appropriate migration studies, calculations or modeling may support an assessment; there is no single testing recipe for every material, and a test result does not independently authorize an otherwise unauthorized use. Explain assumptions, analytical sensitivity and relevant impurities or degradation products.
FDA's recycling-process review is voluntary. A recycler without an FDA no-objection letter is not automatically prohibited from supplying food packaging. The supplier still needs appropriate evidence that the material and intended use meet applicable authorization, purity and safety requirements, including control of feedstock contamination and the effectiveness of the recycling process. A no-objection letter concerns the evaluated process and conditions; it is not blanket approval of every recycled formulation or use.
FDA chemistry guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-preparation-premarket-submissions-food-contact-substances-chemistry
FDA recycled-plastics guidance: https://www.fda.gov/food/packaging-food-contact-substances-fcs/recycled-plastics-food-packaging
Packaging manufacture versus food registration
Manufacturing food-contact materials alone does not trigger FDA food-facility registration or biennial renewal. Actual manufacturing/processing, packing or holding of food requires a separate applicability and exemption assessment; placing food into packaging is different from making the empty packaging. FDA's FSMA FAQ explains that packaging-material manufacturers are not subject to Part 117 Subparts C and G on those packaging-only facts, but applicable Subpart B current good manufacturing practice duties still apply, including contamination precautions and appropriate quality controls.
FDA FSMA FAQ, food packaging materials: https://www.fda.gov/food/food-safety-modernization-act-fsma/frequently-asked-questions-fsma
Recommended component-and-use evidence worksheet
This is an original recommended workflow, not an FDA form. Create one row per component, supplier and intended use. Suggested columns: component identity and grade; actual manufacturer and supplier with lot/source traceability; authorization basis and exact regulation/FCN/TOR reference; specifications and purity limits; food type; contact duration and temperature; single or repeated use; supporting supplier documents, studies and exposure assumptions; current status and unresolved gaps; responsible owner; evidence review date; formulation, process, supplier or use changes and required reassessment.
Keep the authorization decision separate from purchasing paperwork. Have the technical owner match substance/specifications/use, procurement verify the identified source and traceability, and the responsible compliance owner record the decision and next review trigger. These are suggested owners, not additional statutory job titles.
Hypothetical example 1: purchasing covered material
Assume a converter buys a polymer from the supplier identified in an effective FCN. Its grade, specifications, food type and contact temperature/duration fall within the notification. The converter retains the notification, supplier/source evidence and lot traceability. On those assumed facts, a separate FCN from the converter is not automatically required for that covered substance and use. Other components and the finished article still need their own applicable assessment.
Hypothetical example 2: supplier or use changes
Assume the converter changes to an unrelated producer offering a chemically similar polymer, or changes a cold-food container to a high-temperature use outside the notification. The earlier FCN does not automatically cover the change. Reassess the actual manufacturer, specifications, conditions and other possible authorizations before relying on it. A marketing claim that a grade is “FDA compliant” is not a substitute for that evidence.
Conditional next steps and professional services
If your site also handles food and must register, use the existing food registration service and 2026 renewal guide. Required food facilities renew during 1 October–31 December 2026; an earlier registration or update does not substitute for that renewal. FDA charges no food registration or renewal filing fee. Professional charges and annual US Agent coverage are separate from statutory biennial renewal. Packaging-only manufacturers should not buy food registration merely because they make packaging.
FDABridge is an independent service provider. Contact us to confirm the scope actually available for your situation; this article does not promise FCN/TOR preparation, laboratory services, FDA approval or border release. Do not send passwords or PINs.
Food registration service, only where applicable: https://fdabridge.com/food-facility-registration
2026 renewal guide: https://fdabridge.com/blog/fda-food-facility-registration-renewal-2026
Enquiries: https://fdabridge.com/contact
FDA voluntary recycling review: https://www.fda.gov/food/food-ingredients-packaging/food-packaging-other-substances-come-contact-food-information-consumers