Export of Intermediate Products Derived From Category 3 Material Intended for Dispatch to the European Union for Technical Use in Medical Devices, In Vitro Diagnostics and Laboratory Reagents

TAHD-DSAT-2007-2-2
October 21, 2010

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Amendments: This directive has been extensively revised and completely replaces any previous versions.

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Purpose

The purpose of this directive is as follows:

• To explain the import requirements of the European Union (EU) for Canadian intermediate products derived from Category 3 material and intended for technical use in medical devices, in vitro diagnostics and laboratory reagents; 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;
• animal by-products intended for the manufacture of technical products and feed including pet food;
• facilities approved by Veterinary Biologics; or
• materials exported in final packaged form. (Materials ready for distribution to the end user are exempt from Regulation No. 1774/2002.)

Background

Regulation No. 1774/2002 - PDF (4.90 mb) of the European Parliament and Council establishes the requirements for the importation into the EU of animal by-products not intended for human consumption.

Regulation No. 2007/2006 - PDF (83 kb) establishes the requirements for the importation into the EU of intermediate products derived from Category 3 materials intended for technical use in medical devices, in vitro diagnostics and laboratory reagents.

The Regulations require that the CFIA register or approve facilities exporting intermediate products according to Annex II of Regulation No. 2007/2006. To grant this approval, the CFIA must consider such factors as the adequacy of the facility to ensure the design, processing and manufacturing stages; self-inspection programs; and hygiene and storage conditions.

Definitions

Approved facility: This term applies to facilities approved by the CFIA to process for export to the EU intermediate products derived from Category 3 material and intended for technical use in medical devices, in vitro diagnostics and laboratory reagents.

Intermediate products: This term applies to products derived from Category 3 material (see Requirements for Non-Human Primates Imported into Canada [AHPD-DSAE-IE-2009-1]) for which the design, processing and manufacturing stages have been sufficiently completed in order for them to be regarded as processed products and to qualify the material for that purpose, except for the fact that it may require some further handling or transformation such as mixing, coating, assembling, packaging or labelling to make it suitable for placing on the market or use in accordance with the EU legislation applicable to the final products concerned. Note: Appendix B lists Category 3 materials as defined in Regulation No. 1774/2002.

Specific requirement

The following must be true of the product:

• it must be derived from Category 3 material;
• it must not be diverted at any stage within the EU for any use in food, feed material, organic fertilizers or soil improvers;
• it must be conveyed directly to the establishment of the import country; and
• its outer packaging must be labelled "For medical devices / in vitro diagnostics / laboratory reagents only."

Export of intermediate products from Canada to the EU

Prior to exporting intermediate products, district veterinarians must ensure that the facilities have been granted approval by the CFIA and that they are included in the list of facilities approved for export to the EU. Also, each consignment must be accompanied by a commercial document indicating the country of origin and the name of the establishment and indicating that the package is labelled.

It is the responsibility of the importer to provide, at the border inspection port of the EU member state, the declaration in accordance with the model declaration set out in Annex II of Regulation No. 2007/2006.

Hygiene and Storage

The Regulations require that the CFIA approve conditions of hygiene and storage at the facility as indicated below.

Plant inspection

The EU does not specifically require a HACCP (Hazard Analysis Control Critical Points) system. Annex I of Regulation No. 2007/2006 does, however, indicate minimum requirements that must be present in a self inspection.

The HACCP system requires the company to examine each category of hazard to which the product might be exposed. These categories include physical (e.g., metal contamination), biological (e.g., bacteria and viruses) and chemical (e.g., residues). The company must identify whether any of these hazards could be present at the facility, then determine at which point (receiving, processing, packaging, etc.) the hazard could be introduced or eliminated (or decreased to an acceptable level).

This point is defined as the critical control point (CCP). An example of a CCP is the point during processing when the material reaches the maximum temperature. The company must then determine at which point, and under what conditions, the hazard can be eliminated. The condition required to eliminate the hazard is defined as the critical limit. An example of a critical limit would be the requirement to heat items to a certain temperature to destroy bacteria.

An on-site inspection must be performed to ensure that the minimum requirements in Annex I of Regulation No. 2007/2006 are met, as follows:

Responsibilities of the operator or owner of the plant, or a representative

1. Verify that the plant has adequate facilities for the transformation of Category 3 material, to ensure the completion of the design, processing and manufacturing stages referred to in the "Background" section of this directive.

2. Demonstrate with adequate supporting documentation that the material received is Category 3 material and form federally inspected abattoirs or full-time inspected provincial abattoirs.

In the case of imported material, official certification relative to the following elements must be provided:

1. category of the material imported into Canada; and
2. establishment of origin approved for export to the EU by the competent authority of the foreign country.

3. Establish and implement methods of monitoring and checking the critical control points on the basis of the process used.

4. Make available to the CFIA a record of the information obtained pursuant to number 2 above for a period of at least two years.

5. Inform the CFIA if any available information reveals the existence of a serious animal health or public health hazard.

Responsibilities of the CFIA

1. When approving a facility for export to the EU, verify that adequate supporting documentation (Appendix A, C, the documentation referred to at number 2 above, etc.) has been provided and that it demonstrates that the requirements of Regulation No. 2007/2006 have been met.

2. As "the competent authority of the third country," inspect and supervise the registered and approved plants, at regular intervals.

3. Manage the frequency of inspections and supervision according to the size of the plant, the type of products manufactured, risk assessment and guarantees offered, based on the principles of the HACCP system.

4. Take appropriate action, if an inspection shows that the provisions of the Regulations are not being complied with.

5. Draw up a list of plants approved in accordance with the Regulations, assigning an official number to each which identifies the plant with respect to the nature of its activities. The list and subsequent amendments will be submitted to the EU member state in which the inspection at the border inspection post will be carried out and to the member state of destination.

Billing for inspections

Facility approval inspections for intermediate products for export to the EU will be billed according to the CFIA Fee Notice, Part 11, item 27, at a rate of $30.00 for each inspection (code 1483).

Inspection reports

A copy of the inspection report must be sent to the CFIA area network export specialist.

The facility will not be approved to export to the EU until the area network export specialist has reviewed the inspection report and provided final approval.

Approval numbers

Facility approval numbers are issued by headquarters after approval of the inspection report by the area network export specialist. The specialist will send the required information (name, address of facility and approval date) to Claire Bellefeuille in the Animal Health, Import/Export section. A central list of approved facilities will be maintained and made available by headquarters.

Facility name or address changes

Facilities must notify the district office of changes to names or mailing addresses. This notification should be sent to the area network export specialist who will send the information to Claire Bellefeuille in the Animal Health, Import/Export section, for amendment to the list. (Note: "Mailing address" refers to the street address of the building. If a facility's physical location changes, the new facility will require inspection.)

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Appendix A – Notarized Raw Material Form for Processors of Intermediate Products

This serves to inform officials of the Canadian Food Inspection Agency (CFIA) that
(Plant's name) located at

(street address, including city, province and postal code)

produces, only for export to the European Union (EU), intermediate products about which the following is/are true:

Either

Or

And

And

Sources of raw material: federally inspected abattoirs; provincial abattoirs with full time veterinary supervision; holdings approved by CFIA. In the case of imported material, the exporter must provide the CFIA with official certification from the foreign country demonstrating that the material is of Category 3 and that it originates from an establishment approved to export to the EU.

Raw Material	Name and Address	CFIA Approved Number

I certify that the statements listed above are accurate to the best of my knowledge and belief.

Signed by:

Date:

Position:

Company name:

Notary signature:

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Appendix B – List of Category 3 Materials

From Regulation No. 1774/2002 - OJ L 273, 10.10.2002, p. 1:

1. parts of slaughtered animals, which are fit for human consumption in accordance with Community legislation, but are not intended for human consumption for commercial reasons;
2. parts of slaughtered animals, which are rejected as unfit for human consumption but are not affected by any signs of diseases communicable to humans or animals and derive from carcasses that are fit for human consumption in accordance with Community legislation;
3. hides and skins, hooves and horns, pig bristles and feathers originating from animals that are slaughtered in a slaughterhouse, after undergoing ante mortem inspection, and were fit, as a result of such inspection, for slaughter for human consumption in accordance with Community legislation;
4. blood obtained from animals other than ruminants that are slaughtered in a slaughterhouse, after undergoing ante mortem inspection, and were fit, as a result of such inspection, for slaughter for human consumption in accordance with Community legislation;
5. animal by-products derived from the production of products intended for human consumption, including degreased bones and greaves;
6. former foodstuffs of animal origin, or former foodstuffs containing products of animal origin, other than catering waste, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects which do not present any risk to humans or animals;
7. raw milk originating from animals that do not show clinical signs of any disease communicable through that product to humans or animals;
8. fish or other sea animals, except sea mammals, caught in the open sea for the purposes of fishmeal production;
9. fresh by-products from fish from plants manufacturing fish products for human consumption;
10. shells, hatchery by-products and cracked egg by-products originating from animals which did not show clinical signs of any disease communicable through that product to humans or animals;
11. blood, hides and skins, hooves, feathers, wool, horns, hair and fur originating from animals that did not show clinical signs of any disease communicable through that product to humans or animals; and
12. catering waste other than as referred to in Article 4(1)(e).

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Appendix C – CFIA Plant Inspection Checklist for Approval of Facilities Processing Intermediate Products

1. Canadian Food Inspection Agency (CFIA) Approval Number:
(This space should be left blank for newly inspected facilities)

 

2. Plant/company name:

3. Address of location being inspected:

4. Address of headquarters if different from 3:

5. Contact person at plant:

Name:

Telephone: Facsimile:

6. Does the plant have adequate facilities for the transformation of Category 3 material to ensure the completion of the design, processing and manufacturing stages?

7. Has the facility established and implemented methods of monitoring and verification of the critical control points (CCPs) for the appropriate processing method?

8. Did the plant show you a written self inspection program?

9. Is the plant maintaining CCP records for two years (or since the beginning of the CCP implementation, if less than two years)?

10. Did you observe any unhygienic conditions during your inspection? (Attach explanation if the answer is "yes.")

11. Does the plant have in place a written action plan of action if one of the critical limits is not reached during the processing of product, and does this plan specify that the CFIA will be contacted if product is produced without meeting the critical limit?

12. Does the plant appear to have adequate storage space and equipment to meet its needs?

13. Does the facility process intermediate products only from Category 3 material according to the "Specific requirement" section of this document?

The company must provide supporting documentation demonstrating that the material received is of Category 3 and originates from establishments approved for export to EU as described in the "Plant Inspection" section of this document.

14. If the facility received animal products from a slaughter facility, have they verified that the products were adequately transported from the slaughter facility?

15. Please list the intermediate products that this plant produces for export to the EU:

16. Comments:

17. Recommendation for approval to export to the EU (check all that apply):

Please forward a copy of the completed form and all required notarized forms to the CFIA area network export specialist.

Note: To maintain approval, inspection and supervision of facility shall depend on the size of the plant, the type of products manufactured, risk assessment and guarantees offered, and are based on the principles of the HACCP system with at least one inspection once every 12 months.