Health certificate

  • The FDA issues health certificates for collagen and gelatin products destined for sale to the European Union (EU).
  • A “specified risk materials certificate” is required when exporting collagen and gelatin goods to non-EU countries.
  • As a precondition for market access, US exports of collagen and gelatin goods to the United Kingdom (UK) and the European Union (EU) are relevant to the establishment listing requirements.
  • The EU’s listing requirements will apply to organizations that produce collagen or gelatin, organizations that use collagen or gelatin as an ingredient in export products to the EU, and foundations that use collagen or gelatin as an ingredient in export products to the EU.
  • Only US establishments that manufacture collagen and gelatin in the US or use collagen or gelatin sourced from US establishments on the EU lists are eligible for inclusion on the EU lists for collagen and gelatin.
  • Organizations have to provide supporting documents identifying the origin of the collagen and gelatin in the products intended for export, as well as a laboratory report from an accredited, private laboratory, to be eligible for the UK and EU collagen and gelatin export lists.

FDA documents received by mail Regular Service

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  • Must be paid by a check or money order.
  • Must include UPS or USPS Return.
  • Must fill the US Department of State form.

FDA documents received by mail Expedited Service

Fee

Processing time

  • Billing is available.
  • Shorter processing time.
  • Credit card payment is OK.
  • No need for the US Department of State form.
  • Return FedEx or UPS is required, or add $12.
  • Track your history and your annual spending online
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FDA documents received online Regular Service

Fee

Processing time

  • Must be paid by a check or money order.
  • Must include UPS or USPS Return.
  • Must fill the US Department of State form.

FDA documents received online Expedited Service

Fee

Processing time

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  • No need to ship your document. You may upload it here.
  • Billing is available.
  • Shorter processing time.
  • Credit card payment is OK.
  • US Department of State fee is included.
  • No need for the US Dept. of State form.
  • Track your history and spending online.