European Community

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

AHPD-DSAE-2007-2-1

PDF (58 kb)

1. Purpose

The purpose of this document is to:

• Explain the European Community's import requirements for Canadian intermediate products derived from category 3 material intended for technical use in medical devices, in vitro diagnostics and laboratory reagents AND
• Standardize Canadian Food Inspection Agency (CFIA) inspections of facilities processing these products.

This document does not cover:

• Blood and blood products
• Equine serum
• Animal by-products for the manufacture of technical products and feed including pet food
• Facilities approved by Veterinary Biologics
• 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 (EC) No.1774/2002 in PDF - PDF (5018 kb) establishes the requirements for the importation of animal by-products not intended for human consumption into the EC. 

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

This regulation requires that CFIA registers or approves facilities exporting intermediate products according to the Annex II of the 2007/2006 EC Regulation. To grant this approval, the CFIA must consider items such as facility adequacy to ensure the design, processing and manufacturing stages, self-inspection programs (section 7 of this directive), conditions of hygiene and storage.

3. Definitions

Approved facility: This term applies to facilities approved by the CFIA to process intermediate products derived from category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents to be exported to the EC.

Intermediate products: This term applies to products derived from category 3 material and which design, processing and manufacturing stages have been sufficiently completed in order to be regarded as processed products and to qualify the material for that purpose, except for the fact that it requires 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 Community legislation applicable to the final products concerned.

• Category 3 material as defined in article 6 of Regulation (EC) 1774/2002 are listed in appendix A of this document.

4. Specific requirement

The material must:

• Be derived from category 3 material
• Not be diverted at any stage within the EC for any use in food, feed material, organic fertilizers or soil improvers AND
• Be conveyed directly to the establishment of the import country
• Its outer packaging must be labelled "FOR MEDICAL DEVICES/INVITRO DIAGNOSTICS/LABORATORY REAGENTS ONLY".

5. Export of intermediate products from Canada to the European Community

Prior to exporting intermediate products:

• District veterinarians must ensure that the facilities have been granted approval by the CFIA and are included in the list of facilities approved for export to the EC.
• Each consignment must be accompanied by a commercial document indicating the country of origin, the name of the establishment and the outer packaging labelling.
• The consignment is accompanied by a declaration of the importer in accordance with the model declaration set out in Annex II of the 2007/2006 EC regulation (see Appendix B).

6. Hygiene and Storage

The EC regulation requires that CFIA approves conditions of hygiene and storage at the facility as indicated below in Section 7.

7. Inspection Procedures

The EC does not specifically require a HACCP (Hazard Analysis Control Critical Points) system. Regulation EC No.2007/2006 does, however, mention minimal requirements that must be present in a "self inspection".

HACCP system requires the company to examine each type of hazard to which the product might be exposed to. Examples of categories of hazards include: physical (e.g., metal contamination), biological (e.g., bacteria and viruses) and chemical (e.g., residues). The company identifies whether each hazard could be present at the facility, then determines at what 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 facility then determines at what point, and under what conditions, the hazard can be eliminated. The condition required to eliminate the hazard is the Critical Limit. An example of a critical limit would be a requirement to heat items to a certain temperature to inactivate bacteria.

An on-site inspection has to be performed to ensure that the requirements mentioned in Annex II of the 2007/2006 EC regulation are met as follows:

The operator or owner of the plant or his representative must:

1. Ensure 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 Article 2;
2. Establish and implement methods of monitoring and checking the critical control points on the basis of the process used;
3. Keep a record of the information obtained pursuant to item 7.2 of this directive, available for a period of at least two years to the CFIA;
4. Inform the CFIA if any available information reveals the existence of a serious animal health or public health hazard.

8. Billing for Inspections

Facility approval inspections for intermediate products for export to the EC will be billed according to the CFIA Fee Notice, Part 11, and item 27: $30.00 for each inspection (code 1483).

9. 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 EC until the area network export specialist has reviewed the inspection report and provided final approval.

10. Approval Numbers

Facility approval numbers are issued by headquarters after approval of the inspection report by the area network export specialist. The area network export specialist will send appropriate information (name, address of facility and approval date) by electronic mail to Ms. Carole-Lynn Pilon at carole-lynn.pilon@inspection.gc.ca in the Animal Health, Import/Export section. A central list of approved facilities will be maintained and made available by headquarters.

11. 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 by electronic mail to Ms. Carole-Lynn Pilon at carole-lynn.pilon@inspection.gc.ca in the Animal Health, Import/Export section, for amendment to the list. "Mailing address" refers to a change in the street address for the same physical building. If a facility's physical address changes, the new facility will need to be inspected.

In effect: January 2007

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Appendices

Appendix A - List of category 3 materials (referred to in Regulation (EC) No. 1774/2002 - OJ L 273, 10.10.2002, page 1) reagents

Appendix B - Model declaration for the importation from third countries and for the transit through the European Community of intermediate products to be used for medical devices, in vitro diagnostics and laboratory reagents

Appendix C - CFIA Plant Inspection Checklist for Approval of Facilities to Export Intermediate Products to be used for medical devices, in vitro diagnostics and laboratory reagents

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Appendix A

List of Category 3 materials (referred to in Regulation (EC) No. 1774/2002 - OJ L 273, 10.10.2002, page 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 were 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. milk originating from animals which do not show any 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. 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

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Appendix B

Model Declaration For The Importation From Third Countries And For The Transit Through The European Community Of Intermediate Products To Be Used For Medical Devices, In Vitro Diagnostics And Laboratory Reagents

Click on Image for Larger View

MODEL DECLARATION FOR INTERMEDIATE PRODUCTS TO BE USED FOR MEDICAL DEVICES, IN VITRO DIAGNOSTICS AND LABORATORY REAGENTS, FOR DISPATCH TO OR FOR TRANSIT THROUGH THE EUROPEAN COMMUNITY

I, the undersigned, declare that the intermediate products referred to above are intended to be imported by me into the Community and that:

1. they are derived from Category 3 material referred to in Article 6 of Regulation (EC) No. 1774/2002¹ and are intended for the manufacture of medical devices, in vitro diagnostics or laboratory reagents;
2. their design, transformation and manufacturing stages have been sufficiently completed in order to be regarded as processed products and to qualify them for that purpose, except for the fact that they require some further handling or transformation such as mixing, coating, assembling, packaging or labelling to make them suitable for placing on the market or putting into service in accordance with the Community legislation applicable to the final products concerned;
3. their outer packaging is labelled 'FOR MEDICAL DEVICES / IN VITRO DIAGNOSTICS / LABORATORY REAGENTS ONLY'; and
4. they will not be diverted at any stage within the Community for any use in food, feed material, organic fertilisers or soil improvers and will be conveyed directly to the following establishment:

1 List of Category 3 materials (referred to in Regulation (EC) No. 1774/2002 - OJ L 273, 10.10.2002, page 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 were 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. milk originating from animals which do not show any 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. 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.

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Appendix C

CFIA Plant Inspection Checklist for Approval of Facilities to Export Intermediate Products derived from Category 3 Material Intended for Dispatch to the European Community for Technical Uses in Medical Devices, In Vitro Diagnostics and Laboratory Reagents to the European Community

1. Canadian Food Inspection Agency (CFIA) Approval Number:
(This blank 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

• Yes
• No
• N/A

7. Has the facility established and implemented methods of monitoring and checking of the Critical Control Points (CCPs) for the appropriate processing method?

• Yes
• No
• N/A

8. Did the plant show you a written "Self Inspection" program?

• Yes
• No
• N/A

9. Is the plant maintaining CCP records for 2 years (or since the beginning of the CCP implementation if less than 2 years)?

• Yes
• No
• N/A

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

• Yes
• No
• N/A

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 CFIA will be contacted if product is produced without meeting the critical limit?

• Yes
• No
• N/A

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

• Yes
• No
• N/A

13. Does the facility process intermediate products only from category 3 material according to section 4 of this document?

• Yes
• No
• N/A

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

• Yes
• No
• N/A

16. Please list the intermediate products produced at this plant for export to the EC :

17. Comments:

18. Recommendation for approval to export to the EC (check all that apply):
Approve
Disapprove

Name of inspector (printed)
Signature of Inspector Inspection
Date

Signature of area network export specialist concurring with recommendation in number 18.
Date

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 system of HACCP with at least one inspection once every 12 months.