Standard & market guideFDA / FCMTTS / Product testing

Where it applies

Applies to packaging, containers, kitchenware and processing contact parts in the US. Food type, temperature, time, repeated use and manufacturer-specific authorisations can affect the conclusion.

What the evidence needs to show

  • Review formulation and regulatory status of each component first
  • An effective FCN can be specific to a manufacturer, substance and conditions of use
  • Migration or extraction tests must match intended conditions and the compliance basis

Build the evidence in this order

  1. Collect full material/formulation and supplier compliance letters
  2. Define food types and time/temperature
  3. Check 21 CFR, FCN or other authorisation scope
  4. Add necessary tests and issue a documented assessment

Common misunderstandings

  • “FDA test passed” does not replace review of the lawful basis for formulation components
  • The same substance can have different status under different food types or temperatures

Official reference

US FDA: food-contact substances ↗

Confirm product-specific scope and the applicable edition with TTS before making a compliance decision.

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