Plant Approval or Registration for Export of Intermediate Products Intended for Technical Use to the European Union
July 6, 2012
Amendment: This directive has been extensively revised according to the European Parliament and the Council of the European Union’s new Animal By-Product (ABP) Regulations (EC) No. 1069/2009 and (EU) No. 142/2011 replacing Regulation (EC) No. 1774/2002. It completely replaces any previous versions.
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.)
Regulation No. 1069/2009 - PDF (1.49 mb) of the European Parliament and of the Council lays down health rules as regards animal by-products and derived products not intended for human consumption and repeals Regulation (EC) No. 1774/2002 (Animal By-Products Regulation).
Regulation No. 142/2011 - PDF (7.74 mb) implements Regulation (EC) No. 1069/2009 of the European Parliament and of the Council that lays down health rules as regards animal by-products and derived products not intended for human consumption and implements Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that directive.
The Regulations require that the CFIA register or approve facilities exporting intermediate products according to Annex XII of Regulation (EU) No. 142/2011. To grant this registration or approval, the CFIA must consider such factors as the adequacy of the facility to ensure the design, processing and manufacturing stages; its self-inspection programs; and its hygiene and storage conditions.
Approved facility: This term applies to facilities approved by the CFIA to process for export to the EU intermediate products intended for technical use.
Intermediate products: As per definition 35 of Annex I of Regulation (EU) No. 142/2011, this term means a derived product:
- 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;
- 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;
- 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.
Export of Intermediate Products from Canada to the EU
The import and transit of intermediate products shall be authorised, provided that:
- they are derived from the following materials:
- Category 3 material, other than materials referred to in parts (c), (n), (o) and (p) of paragraph C of Directive TAHD-DSAT-IE-2009-9 - Definition of Categories 1, 2, and 3 Animal Products and By-Products According to the European Legislation (EC) 1069/2009.
- products generated by the animals referred to in parts (i), (l) and (m) of paragraph C of Directive TAHD-DSAT-IE-2009-9, or
- mixtures of the materials referred to in points (i) and (ii);
- in the case of intermediate products destined for the production of medical devices, in vitro diagnostic medical devices and laboratory reagents, they are derived from:
- materials which fulfil the criteria referred to in point (a), except that they may have originated from animals which have been submitted to illegal treatment as defined in Article 1(2)(d) of Directive 96/22/EC or Article 2(b) of Directive 96/23/EC,
- Category 2 material referred to in parts (f) and (h) of paragraph B of Directive TAHD-DSAT-IE-2009-9, or
- mixtures of the materials referred to in points (i) and (ii);
- in the case of intermediate products destined for the production of active implantable medical devices, medicinal products and veterinary medicinal products, they are derived from the materials referred to in point (b), where the competent authority considers the use of such materials justified for the protection of public or animal health;
- they come from a third country listed as a member of the World Organisation for Animal Health (OIE) in the OIE bulletin;
- they come from an establishment or plant registered or approved by the competent authority of a third country referred to in point (d), in accordance with the conditiond set out in this directive;
- each consignment is accompanied by a declaration of the importer in accordance with the model declaration set out in Chapter 20 of Annex XV of Regulation (EU) No. 142/2011 (page 245), which must be at least in one of the official languages of the Member State in which the inspection at the border inspection post must be carried out and of the Member State of destination; these Member States may allow the use of other languages and request official translations for declarations in such other languages; and
- the outer packaging is labelled “For medicinal products / veterinary medicinal products / medical devices / active implantable medical devices / in vitro diagnostics medical devices / laboratory reagents only.”
Plant Registration or Approval
An establishment or plant may be registered or approved by the competent authority of a third country (the CFIA for Canada), with the following provisos:
Responsibilities of the Operator or Owner of the Plant, or a Representative
a) The operator or owner of the plant or his or her representative:
- demonstrates that the plant has adequate facilities for the transformation of the materials referred to in previous section at points (a), (b) or (c), as applicable, to ensure the completion of the necessary design, transformation and manufacturing stages;
- establishes and implements methods of monitoring and checking the critical control points on the basis of the process used;
- keeps a record of the information obtained pursuant to point (ii) for a period of at least two years for submission to the competent authority; and
- informs the competent authority if any available information reveals the existence of a serious animal health or public health risk.
Responsibilities of the CFIA
b) The CFIA carries out, at regular intervals, inspections of the establishment or plant and supervises the plant in accordance with the following conditions:
- the frequency of inspections and supervision shall depend on the size of the plant, the type of products manufactured, risk assessment and guarantees offered, based on a system of checks which has been set up in accordance with the Hazard Analysis and Critical Control Points (HACCP) principles (see Notes below);
- if the inspection carried out by the CFIA reveals that the provisions of Regulation (EU) No. 142/2011 are not being complied with, the CFIA shall take appropriate action; and
- the CFIA shall draw up a list of establishments or plants approved or registered in accordance with this directive and shall assign an official number to each plant, which identifies the establishment or plant with respect to the nature of its activities. That list and subsequent amendments to it shall be submitted to the Member State where the inspection at the border inspection post must be carried out and to the Member State of destination.
Notes: The EU does not specifically require a plant to run under the HACCP system, but indicates minimum requirements that must be present in a self inspection plan.
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) hazards. 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, 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 point (b) above mentioned, are met.
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).
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.
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 Janet Goodall 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 Janet Goodall 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.)
Appendix A – Notarized Animal By-Products Form for Processors of Intermediate Products
This serves to inform the Canadian Food Inspection Agency (CFIA) officials that the establishment (Plant's name and full address)
produces, only for export to the European Union (EU), intermediate products about which the following statements are true:
the products are derived from raw material listed in Appendix B of this document; and/or
the products used in the manufacturing of intermediate products are imported from EU approved plants or establishments; and
the design, processing and manufacturing stages have been sufficiently completed in order for the products to be regarded as processed 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; and
the products are intended for technical uses, For medicinal products / Veterinary medicinal products / Medical devices / Active implantable medical devices / In vitro diagnostics medical devices / Laboratory reagents only.
Sources of Raw Material or Animal By-Product:
Canadian origin: From federally inspected abattoirs; provincial abattoirs with full-time veterinary supervision; holdings approved by the CFIA (a traceability certificate is required).
Imported material: Official certification from the competent authority of the third country demonstrating that the raw material meets one of the definitions of Appendix B must be provided to the veterinarian before the inspection of the facility.
|Raw Material or Product Name||Name and Address||CFIA Approved Number or EU - Third Country Establiments List|
I certify that the statements provided above are accurate to the best of my knowledge and belief.
Notary seal and signature:
Appendix B – List of Animal By-Products From Which Intermediate Products Can Be Derived
Regulation (EC) No. 142/2011 (Chapter 20, Model Declaration, pages 245-248)
Carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons.
Carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
- carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
- heads of poultry;
- hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of animals other than ruminants;
- pig bristles;
Blood of animals which did not show any signs of disease communicable through blood to humans or animals, obtained from animals other than ruminants that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation.
Animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing.
Products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise.
Petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises.
Blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals.
Aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals.
Animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption.
The following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
- shells from shellfish with soft tissue or flesh;
- the following originating from terrestrial animals:
- hatchery by-products,
- egg by-products, including egg shells;
- day-old chicks killed for commercial reasons.
Animal by-products from aquatic or terrestrial invertebrates other than species pathogenic to humans or animals.
Animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) and Category 2 material as referred to in Article 9(a) to (g) of Regulation (EC) No. 1069/2009.
Products derived from or generated by:
- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of disease communicable to humans or animals;
- aquatic or terrestrial invertebrates other than species pathogenic to humans or animals;
- animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) and Category 2 material as referred to in Article 9(a) to (g) of Regulation (EC) No. 1069/2009.
Animals and parts of animals, other than those referred to in Article 8 or Article 10 of Regulation (EC) No. 1069/2009:
- that die other than by being slaughtered or killed for human consumption, including animals killed for disease control purposes;
- oocytes, embryos and semen which are not destined for breeding purposes; and
- dead-in-shell poultry.
Animal by-products other than Category 1 material or Category 3 material.
Appendix C – CFIA Plant Inspection Checklist for Approval of Facilities Processing Intermediate Products
1. Canadian Food Inspection Agency (CFIA) Approval Number:
(For newly inspected facilities, leave blank.)
2. Plant/company name:
3. Address of location being inspected:
4. Address of headquarters if different from the location beionf inspected:
5. Contact name at plant:
6. Yes No
Does the plant have adequate facilities for the transformation of the materials referred to in the section on Export of Intermediate Products from Canada to the EU, 1 (a), (b) or (c) of the present directive, as applicable, to ensure the completion of the necessary design, transformation and manufacturing stages?
7. Yes No
Does the facility process intermediate products only from raw material referred to in the section on Export of Intermediate Products from Canada to the EU, 1 (a), (b) or (c) of this document?
The company must provide supporting documentation (traceability certificates, supporting documentation from the competent authority of third country[ies]) if raw material were imported.
Did you observe any unhygienic conditions during your inspection? (Attach explanation if the answer is “yes.”)
9. Yes No
Did the plant show you a written self-inspection program?
10. Yes No
Has the plant established and implemented methods of monitoring and verification of the critical control points (CCPs) for the appropriate processing method?
11. Yes No
Does the plant have in place a written 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 must be contacted if product is produced without meeting the critical limit?
12. Yes No
Does the plant maintain CCP records as well as traceability certificates and supporting documentation from the competent authority of third country(ies) for two years (or since the beginning of the CCP implementation, if less than two years)?
13. Yes No
If the facility receives animal products from a slaughter facility, have they verified that the products were adequately transported from the slaughter facility?
14. Yes No
Please list the intermediate products that this plant produces for export to the EU:
16. Recommendation for approval to export to the EU:
Signature of Inspector
Name of inspector (printed)
Signature of area network export specialist concurring with above recommendation for approval.
17. Approval valid until (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 shall be based on the principles of the HACCP system, with at least one inspection once every 12 months.
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