United States · Food Contact

Food Contact Substance Compliance in the United States

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

Who needs it

Manufacturers and importers of food contact materials and articles; Brands selling packaging, tableware, or kitchenware in the United States

Authority

U.S. Food and Drug Administration

Legal basis

21 CFR Parts 174-178

Local representative

The importer is normally responsible for compliance

Timeline

Before sale; testing usually takes weeks

Cost

Migration testing is the main cost

If you do not comply

Withdrawal, recall, and fines

Who needs this

Manufacturers and importers of food contact materials and articles
Brands selling packaging, tableware, or kitchenware in the United States

Documents you need

Food contact declaration of compliance
Migration test reports
Material composition and supplier declarations
GMP evidence for the converting site

Compliance checklist

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

Food contact declaration of compliance
Migration test reports
Material composition and supplier declarations
GMP evidence for the converting site

How to comply

Confirm the material is in scope of food contact rules
Review composition against the positive list
Test migration where required
Issue the declaration of compliance

Brief for your lab or agent

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

Request: Food Contact Substance Compliance — United States
Product category: Food Contact
Authority: U.S. Food and Drug Administration
Legal basis: 21 CFR Parts 174-178

Documents we already have:
  1. Food contact declaration of compliance
  2. Migration test reports
  3. Material composition and supplier declarations
  4. GMP evidence for the converting site

Questions:
  1. Does our product fall under Food Contact Substance Compliance 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

Before sale; testing usually takes weeks.

Migration testing is the main cost.

Common rejection reasons

No declaration of compliance
Migration limits exceeded
Non-authorised substance in the formulation
Supplier declarations missing

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.

Official sources

FAQ

Who needs Food Contact Substance Compliance in the United States?

Manufacturers and importers of food contact materials and articles. Brands selling packaging, tableware, or kitchenware in the United States. The importer of record normally holds the evidence.

What documents do I need for Food Contact Substance Compliance?

Food contact declaration of compliance; Migration test reports; Material composition and supplier declarations; and gmp evidence for the converting site.

What is the first step for Food Contact Substance Compliance?

Confirm the material is in scope of food contact rules, then review composition against the positive list. Before sale; testing usually takes weeks.

How long does Food Contact Substance Compliance take?

Before sale; testing usually takes weeks.

How much does Food Contact Substance Compliance cost?

Migration testing is the main cost.

What happens if I sell without it?

Withdrawal, recall, and fines.

Who regulates Food Contact Substance Compliance in the United States?

U.S. Food and Drug Administration.