United States · Food Contact

FDA Food Contact Notification in the United States

A practical guide to FDA Food Contact Notification for food contact sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Food contact substances not covered by an existing regulation; New packaging materials and additives

Authority

U.S. Food and Drug Administration (FDA)

Legal basis

FD&C Act Section 409; Food Contact Notification program

Local representative

The notifier must be a U.S. entity or have a U.S. agent

Timeline

The notification must be effective before marketing

Cost

FDA does not charge a notification fee; data and consultant costs vary

If you do not comply

Adulterated food and enforcement action

Who needs this

Food contact substances not covered by an existing regulation
New packaging materials and additives

Documents you need

Food Contact Notification submission
Safety and exposure data
Conditions of use

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

Food Contact Notification submission
Safety and exposure data
Conditions of use

How to comply

Determine whether the substance is a food additive
Check for an existing effective notification or regulation
Prepare and submit the notification
Wait for the notification to become effective

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: FDA Food Contact Notification — United States
Product category: Food Contact
Authority: U.S. Food and Drug Administration (FDA)
Legal basis: FD&C Act Section 409; Food Contact Notification program

Documents we already have:
  1. Food Contact Notification submission
  2. Safety and exposure data
  3. Conditions of use

Questions:
  1. Does our product fall under FDA Food Contact Notification in the United States?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

The notification must be effective before marketing.

FDA does not charge a notification fee; data and consultant costs vary.

Common rejection reasons

Insufficient safety data
Intended use not adequately described
Substance already covered by another notification

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.