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Quality & regulation

FDA compliance

Also known as: FDA compliance, FDA compliant packaging, FDA food contact, 21 CFR, FDA approved packaging, food contact substance

FDA compliance means packaging materials meet US Food and Drug Administration rules for food contact substances, required for sales in the US.

FDA compliance means that packaging materials meet the US Food and Drug Administration's rules for substances that contact food. Brands exporting food to the US must be able to show their packaging complies.

"FDA approved" is usually wrong

The FDA generally does not approve individual packages or certify packaging manufacturers. It regulates the substances used and the conditions under which they may contact food. The correct claim is "FDA compliant", supported by documentation from the supply chain.

Routes to compliance

  • 21 CFR food additive regulations, especially Parts 174–178, covering polymers, adhesives, coatings and additives
  • Food Contact Notifications (FCN), effective only for the notifier and the specified use
  • GRAS and prior-sanctioned substances
  • Threshold of regulation exemptions for very low migration

Conditions of use

Compliance often depends on food type and temperature, from frozen storage to hot fill. US and EU rules share a similar logic but differ in lists, tests and limits, so compliance with EU 10/2011 does not automatically mean FDA compliance. Ask your converter for a written statement covering films, inks, adhesives and lacquers, the food types and conditions it applies to, and any supporting test reports.

Frequently asked

Does the FDA certify packaging suppliers?

No. The FDA sets the rules; compliance is demonstrated through supplier declarations and, where needed, test data.

What is 21 CFR?

Title 21 of the US Code of Federal Regulations, which includes the rules on indirect food additives used in food contact materials.

Related terms

EU Regulation 10/2011 (plastic food contact)EU Regulation 10/2011 governs plastic materials in contact with food, setting authorised substances, migration limits and testing rules. Food contact complianceFood contact compliance means showing, under the relevant rules, that packaging does not transfer substances to food in harmful or unacceptable amounts. MigrationMigration is the transfer of substances from packaging into the food it touches; for food packaging it is limited by law and verified by testing. Turkish food contact materials regulationTürkiye's food contact materials regulation sets safety, labelling and traceability rules for all materials, including packaging, that touch food.

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