Program Shipments Affected by European Commission Import Regulations

Last updated: February 21, 2025

Due to the enforcement of import regulations set forth by the European Commission (EC), laboratories that fall under the directive of the EC are now required to obtain an import permit(s) for all programs containing animal by-product(s) (ABP).

To receive your shipments, your laboratory must:

1. Obtain an import permit(s) for proficiency testing (PT)/external quality assessment (EQA) programs that contain ABP. The College of American Pathologists (CAP) is holding all 2025 impacted shipments.
   • Reach out to your local authorities to determine specific import permit requirements in your country as they relate to ABP. Note: Your program(s) may contain materials originating from bovine, porcine, horse, rabbit, etc. Please ensure your permit(s) cover all these materials.
2. Email the following to the CAP via EuropeLogistics@cap.org, upon receipt of your permit(s) from your local authority:
   • CAP Number
   • Copy of permit
   • List of your laboratory's PT/EQA programs

For more details on permitting and programs with ABP, contact EuropeLogistics@cap.org.

Programs impacted by the EC regulations that require you to obtain an import permit(s) are listed in the following table:

• 2025 Impacted Programs and Countries

All programs that contain ABP may experience delays in clearance due to veterinary inspection processes.

For current PT/EQA kits on the 2025 Impacted Programs and Countries list, if your laboratory is unable to obtain an import permit(s) prior to due date on your result form, report exception code 33 for analytes tested in your laboratory.

CAP-accredited laboratories are required to perform and document alternative performance assessment to meet accreditation requirements. More information about alternative performance assessment can be found here.

For laboratories enrolled in impacted Calibration Verification/Linearity (CVL) and Quality Cross Check (QCC) programs, analytical measurement range verification and instrument comparisons are still required via alternate methods. For CAP-accredited laboratories, checklist requirement CHM.13550 (and similar requirements in other checklists) provides guidance on other materials that can be used in place of CVL.

If you have any questions, call a Customer Contact Center representative at 800-323-4040, Option 1 or +1-847-832-7000, Option 1 (for customers outside the US), or email EuropeLogistics@cap.org.