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United States

FDA Food Contact Materials

In the US, substances that may migrate into food from packaging, processing equipment or utensils are regulated by the FDA as food contact substances — treated as indirect food additives rather than as articles. Clearance normally comes through a Food Contact Notification, a prior sanction, a regulation, or a determination that the substance is generally recognised as safe. For manufacturers the practical consequence is that a component's compliance depends on its use conditions, including temperature and food type, not on the material alone.

What it obliges you to do

  • Establish the clearance basis for each food contact substance used
  • Match clearance to the actual conditions of use, not the material in isolation
  • Obtain supplier letters of guarantee referencing the specific clearance
  • Reassess when a supplier changes resin, additive or masterbatch

Latest activity

From Federal Register. Each item links to the original, and is credited to whoever published it.

Notice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles

The Food and Drug Administration (FDA or the Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Health and Human Services Department·via Federal Register

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Notice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Health and Human Services Department·via Federal Register

Read original
Notice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Health and Human Services Department·via Federal Register

Read original
Notice

Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Guidance for Industry; Availability

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk." This guidance is…

Health and Human Services Department·via Federal Register

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Does FDA Food Contact actually apply to your products?

Scope is the part a summary cannot answer. Send us your product families and target markets and a steward will tell you which obligations attach, what evidence you would need, and what is already covered by declarations you hold.

  • A written read on whether FDA Food Contact applies to your range
  • The evidence gaps that would surface in an audit
  • No obligation, and no sales sequence attached

Ask about FDA Food Contact

Not legal advice. This page describes a regulatory framework in general terms and is maintained by people, not generated from the legislature. Requirements change, and scope depends on your product, your role in the supply chain and your markets. Confirm the current consolidated text before acting — or ask us to check it against your portfolio.