Program Shipments Affected by European Commission Import Regulations

Last updated: May 9, 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 required to obtain appropriate import permits for all programs containing animal by-product(s) (ABP).

Impacted laboratories must submit a copy of their import permit(s) to the College of American Pathologists (CAP) no later than Thursday, May 31, 2025.*  The CAP is holding all impacted proficiency testing (PT)/external quality assessment (EQA) shipments until the laboratory provides this permit. If your laboratory does not obtain a permit, your PT/EQA shipment will be canceled.  

To obtain import permits and receive your shipments, your laboratory must:
1.    Contact your local authorities.

• 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 permits cover all these materials.

2. Email the following to the CAP via EuropeLogistics@cap.org once you receive 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. If your laboratory is actively in the process of obtaining a permit but is at risk of missing the deadline of May 31, 2025, 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.

*Note to CAP-accredited laboratories: You are required to successfully participate in CAP PT/EQA. Failure to do so may result in noncompliance.

If your laboratory is unable to participate in CAP PT/EQA and is CAP accredited, you 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 +1-847-832-7000, Option 1 (for customers outside the US) or 800-323-4040, Option 1 or email EuropeLogistics@cap.org.