Certificate of Free Sale (CFS)
For dietary supplements and medical foods.
FDA Health Certificate Apostille
Exporting collagen or gelatin? The FDA issues a health certificate for shipments to the European Union and a specified risk materials (SRM) certificate for other markets. When your buyer, customs broker or the importing authority needs it legalized, we have it apostilled or authenticated by the U.S. Department of State and ship it to you by FedEx.
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
9 business days
- We accept credit card payments.
- Track your order history and expenses online.
- The U.S. Department of State fee is already included.
- Submit the files you received from the FDA electronically.
- We use the State Department minimum processing time.
- You may update your own FedEx air waybill or purchase a new one.
- U.S. Department of State Form DS-4194 is not required; we handle it.
Exp. Service fee
US Dept. of State fee
Total:
Click here toupload your first FDA digital filePDF only · or drag and drop it here
What the FDA Health Certificate Covers
“Health certificate” is a broad term in international trade. The FDA uses it for a specific product group: collagen and gelatin produced in the United States. Importing countries want assurance about how these materials were sourced and processed, so they ask for an official U.S. attestation before the product clears customs.
The FDA issues two related documents for this product group:
- Health certificate: for collagen and gelatin exported to the European Union.
- Specified risk materials (SRM) certificate: for collagen and gelatin exported to countries outside the EU.
The FDA does not charge for these certificates. Requests go to the FDA by email rather than through its online export certificate portals.
Who typically needs one
- Gelatin manufacturers supplying food, pharmaceutical capsule and confectionery makers abroad
- Collagen peptide and supplement ingredient exporters
- Traders and distributors shipping bulk collagen or gelatin
- Customs brokers assembling an EU or overseas import file
Is Your Health Certificate from the FDA?
Many food exports need a health or sanitary certificate, but the FDA doesn’t issue all of them. Before you order, check which agency signed yours:
| Product | Issuing U.S. agency |
|---|---|
| Collagen and gelatin | FDA (health certificate or SRM certificate) |
| Dairy products | USDA Agricultural Marketing Service, Dairy Grading Branch |
| Seafood | NOAA Seafood Inspection Program |
| Egg products | USDA Agricultural Marketing Service |
| Honey | USDA Specialty Crops Inspection Division |
| Alcoholic beverages | Alcohol and Tobacco Tax and Trade Bureau (TTB) |
Exporting supplements, conventional foods or infant formula? You probably need a Certificate of Free Sale or a Certificate to a Foreign Government instead. If your certificate came from another federal agency, contact us before ordering.
Apostille or Authentication: Which Does Your Market Need?
The FDA is a federal agency, so the signature on its health certificate can only be verified by the U.S. Department of State. Which document the State Department issues depends on where the shipment is going:
EU & other Hague countries
Apostille
All EU member states belong to the Hague Apostille Convention. An apostilled health certificate is accepted there without an embassy step, as it is in other member countries.
Non-Hague countries
Authentication
For SRM certificates going to non-member countries, the State Department issues an authentication. The destination country’s embassy then legalizes it.
Check your destination on our countries page.
How It Works and What It Costs
Get the FDA certificate
Request the health or SRM certificate from the FDA for your collagen or gelatin shipment.
Upload it
Upload the certificate as the FDA issued it and tell us the destination country. If you have a paper original, contact us first.
State Department
We submit it to the Office of Authentications and track it until the apostille or authentication is issued.
FedEx delivery
The legalized certificate ships to you, your broker or your buyer, ideally before your goods arrive.
| Item | Amount | Notes |
|---|---|---|
| FDA health or SRM certificate | $0 | The FDA does not charge for these certificates |
| Our service fee | $68 / doc. | Review, submission, tracking and dispatch |
| U.S. Department of State fee | $20 / doc. | Paid by us on your behalf |
| Total | $88 / doc. | Standard processing: 9 business days |
Keep Your Shipment Moving
Order before the ship sails
Shipments often wait at the border for paperwork. Start the apostille as soon as the FDA issues the certificate, and use our expedited service if the arrival date is close.
Match the consignment
Product description, quantities, lot details and the consignee should match your commercial invoice and bill of lading.
EU or SRM certificate?
Use the health certificate for EU destinations and the SRM certificate elsewhere. The wrong one can’t be fixed by an apostille.
One certificate per shipment
Certificates are generally tied to a specific consignment. Plan an apostille for each shipment that needs one.
Health Certificate Apostille FAQs
What products does the FDA issue health certificates for?
Collagen and gelatin. The FDA issues a health certificate for exports to the European Union and a specified risk materials certificate for exports to other countries.
Does the FDA charge for a health certificate?
No. The FDA does not charge for collagen and gelatin health or SRM certificates. Our $88 fee covers only the apostille or authentication, including the $20 State Department fee.
Who apostilles an FDA health certificate?
The U.S. Department of State, Office of Authentications. Because the FDA is a federal agency, a state Secretary of State cannot apostille its certificates.
Do EU countries accept an apostille?
Yes. All EU member states are parties to the Hague Apostille Convention, so an apostille is the standard way to legalize a U.S. federal document for use there.
My dairy or seafood certificate is called a “health certificate.” Is this the right service?
Those are issued by USDA or NOAA, not the FDA. Contact us with a copy and we’ll tell you how it can be legalized for your destination.
Is this for a personal medical or travel health certificate?
No. This page covers FDA export certificates for products. A personal certificate signed by a doctor follows a different route, usually notarization and a state-level apostille.
Other FDA Certificates We Apostille
Certificate to a Foreign Government (CFG)
For devices, conventional foods and infant formula marketed in the U.S.
Certificate of Exportability
For products made in the U.S. for export only.
Certificate of a Pharmaceutical Product (CPP)
The WHO-format certificate for human drugs.
Certificate for Cosmetics
For skincare, makeup and fragrance.
All FDA Certificates
Compare every certificate type side by side.
Apostille Your FDA Health Certificate
Upload your collagen or gelatin health certificate today. You’ll have it apostilled and on its way by FedEx in 9 business days, for $88 with the State Department fee included.
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