Approved U.S. Establishments

The EU maintains lists of approved establishments based on submissions from U.S. Government agencies.  Only those products processed at approved establishments may enter the EU.  The up-to-date lists of eligible third country establishments are available from: 

Links

Product specific lists are maintained in the following categories: food, germinal products and animal by-products.

 

The U.S. agencies involved in listing are the Food Safety and Inspection Service (FSIS), the Food and Drug Administration (FDA) and the Animal and Plant Health Inspection Service (APHIS).  Approved establishments may be subject to EU inspection.

Regulations

The requirement to source materials only from approved establishments adds to other required EU approvals at the country level:

 

Commission Implementing Regulation (EU) 2021/404

Outlines the list of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with the EU’s Animal Health Law.  Restrictions currently apply to the export of poultry products from several areas in the United States.  These restrictions are frequently updated based on the development of the animal health status in the affected areas.

 

Commission Implementing Regulation (EU) 2021/405

Outlines the list of third countries or regions thereof authorized for the entry into the Union of certain animals and goods intended for human consumption: Shellfish is restricted from all U.S. states except Washington State and Massachusetts. In the absence of an approved U.S. residue plan for horsemeat, the United States has effectively been restricted from exporting horsemeat to the EU since 2011. The United States is authorized to export beef and pork but only from products produced under the Non-Hormone Treated Beef Program (NHTC) and the Pork for the European Union Program (PFEU).  These programs address the EU’s requirements for a split system to guarantee that animals have not been treated with growth promoters if their products are exported to the EU.

The listing of the United States on the relevant country lists as well as the listing of the exporting establishment on the relevant establishment lists are pre-conditions for U.S. export to the EU of animal origin products.  In addition, animal or public health certificates based on the model certificates published by the European Union and signed by U.S. officials must accompany all shipments.  The U.S. certifying agency will cross out or delete any statements in the model certificate that are not applicable.