Plant approval or registration for export of intermediate products intended for technical use to the European Union

TAHD-DSAT-IE-2007-2-5
October 2021

Amendment: following the implementation of the new animal product and by-products inspection checklist and its annexes, for the Registration or approval of facilities to export animal by-products not intended for human consumption to the European Union (EU), previous appendices of this directive have been withdrawn.

On this page

• 1. Purpose
• 2. Background
• 3. Definitions
• 4. Registration or approval of plants for export to the European Union
• 5. Specific requirements for intermediate products exported to EU
• 6. Export certification to EU, of intermediate products

Purpose

The purpose of this directive is as follows:

• to explain the import requirements of the European Union (EU) for Canadian intermediate products intended for technical use in medical devices, in vitro diagnostics medical devices, laboratory reagents, active implantable medical devices, medicinal products, veterinary medicinal products; and
• to standardize Canadian Food Inspection Agency (CFIA) inspections of facilities processing these products

This document does not cover the following:

• blood and blood products
• equine serum
• facilities approved by Veterinary Biologics; or
• materials exported in final packaged form. (Materials ready for distribution to the end user are exempt from Regulation [EC] No. 1774/2002)

2. Background

Regulation (EU) No. 142/2011 establishes the requirements for the importation of animal by-products not intended for human consumption into the EU.

These requirements for intermediate products are set in the following:

• Annex XII of Regulation (EU) No. 142/2011.

See directive TAHD-DSAT-IE-2009-8 for additional information on the EU regulations

3. Definitions

Intermediate product: As per definition 35 of Annex I of Regulation (EC) No. 142/2011, this term means a derived product:

1. which is intended for the manufacture of medicinal products, veterinary medicinal products, medical devices, active implantable medical devices, in vitro diagnostic medical devices or laboratory reagents
2. whose design, transformation and manufacturing stages have been sufficiently completed in order for it to be regarded as a derived product and to qualify the material directly or as a component of a product for that purpose
3. which, however, requires some further handling or transformation, such as mixing, coating, assembling, packaging or labelling, to make it suitable for placing the product on the market or putting it into service, as applicable, as a medicinal product, veterinary medicinal product, medical device, active implantable medical device, in vitro diagnostic medical device or laboratory reagent

See directive TAHD-DSAT-IE-2009-8 for other definitions.

4. Registration or approval of plants for export to the European Union

Additional information on registration or approval of facilities to export animal by-products not intended for human consumption to the European Union (EU) is available in TAHD-DSAT-IE-2009-8:

• Registration or approval of facilities to export to the European Union
• Hygiene requirements for the collection and transport of animal by-products and derived products
• Official control and final provisions
• Inspection procedures, billing and reports
• Approval numbers
• Facility name or address changes

5. Specific requirements for intermediate products exported to EU

In general, intermediate products intended for import into the EU must, among other things, be derived:

1. from material listed in Annex XV, chapter 20
2. transported and stored chilled or frozen, unless they are processed within 24 hours after being harvested from animals

6. Export certification to EU, of intermediate products.

• No CFIA certification is required for the export of intermediate products to EU
• Establishment must be approved by the CFIA and appear on the list of facilities approved for export to the EU
• Each shipment must be accompanied with an importer declaration drawn up in accordance with the model declaration in Annex XV, chapter 20