Approval of Facilities to Export Animal By-Products Not Intended for Human Consumption to the European Union (EU)

AHPD-DSAE-2009-8-1

I. Purpose

The purpose of this document is to:

• explain the European Union’s (EU) import requirements for animal products and by-products destined for animal consumption or intended for technical use; and
• standardize Canadian Food Inspection Agency (CFIA) inspections of facilities in which these products are collected, processed, and stored.

This document does not cover the following:

• facilities approved by Veterinary Biologics
• facilities approved by the Pet Food Program
• finished products exported in final package form and ready for distribution to the end user that are exempt from the Regulation (EC) No. 1774/2002 in Portable Document Format - PDF (5018 kb).

II. Background

The Regulation (EC) No. 1774/2002 establishes the requirements for the importation of animal by-products not intended for human consumption into the EU. These animal by-products may only be imported from an eligible country and from a facility approved for export to the EU.

Under the Regulation, the competent authority of the exporting country—for Canada, this is the CFIA—is mandated to approve facilities to export animal by-products not intended for human consumption to the EU. To determine whether facilities can be approved, the CFIA must consider various factors, such as the nature and origin of the raw materials, processing methods, existence of own-check programs, the nature of the processed materials, hygiene conditions, and product storage.

Prior to the CFIA’s inspection of facilities , owners are required to submit to the CFIA, for examination, specific forms, attesting that the facility meets the minimum requirements. The district office will conduct an inspection of the facilities after examining these forms.

III. Definitions

The EU Regulation (EC) No. 1774/2002 classifies animal by-products into three categories: 1, 2, and 3, based on the risk that they pose to animal health. Apart from a few exceptions (which will be covered in specific directives), only Category 3 animal by-products are eligible for export. Generally, products classified as Category 3 must meet a minimum criterion; that is, they must come from animals that were not condemned during ante-mortem inspection. To prevent the cross-contamination between by-products of different categories, this categorization extends to the facilities that collect, process, or store animal by-products, as well as to the means of transport and the personnel handling these products.

European definition of Categories 1, 2, and 3 animal by-products: See AHPD-DSAE-IE-2009-9-1

Approved facility: In this document, this term applies to facilities that have received authorization from the CFIA to collect and/or process and/or store one or more animal by-products destined for export to the EU (e.g. hides and skins, blood, dairy products).

Approval of facilities to export to the European Union

Category 3 intermediate plant: A plant in which unprocessed Category 3 material is sorted and/or cut and/or chilled or deep-frozen into blocks and/or temporarily stored for further transporting to its final destination.

Category 3 processing plant: A plant in which Category 3 material is processed.

Storage plant: A plant (other than an intermediary) in which processed products are temporarily stored before their final use or disposal.

Note: A single facility may include an intermediate section, a processing section, as well as a storage section. In this case, the entire facility or only part of the facility may be approved (as an intermediate or processing or storage plant).

IV. Approval of Facilities to Export to the European Union

IV.a Hygiene requirements for Category 3 intermediate plants

1. Premises and facilities must meet at least the following requirements:

1. The premises must be adequately separated from other premises, such as slaughterhouses. The layout of plants must ensure the total separation of Category 1 and Category 2 material from Category 3 material from reception until dispatch.

   The plant must have the following:

2. a covered space to receive animal by-products;
3. be constructed in such a way to ease cleaning and disinfecting. Floors must be laid down in a way that facilitates the draining of liquids;
4. adequate lavatories, changing rooms, and washbasins for staff;
5. appropriate arrangements for protection against pests, such as insects, rodents, and birds;
6. a waste water disposal system that meets hygiene requirements;
7. where it is necessary for achieving the objectives of this Regulation, plants must have suitable temperature-controlled facilities of sufficient capacity for maintaining animal by-products (chilled or frozen) at appropriate temperatures, and must be designed to allow the monitoring and recording of those temperatures.

2. The plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which animal by-products are received, and the vehicles, other than ships, in which they are transported. Adequate facilities must be provided for disinfecting vehicle wheels.

3. The sorting of Category 3 material must be carried out in a way that avoids any risk of propagation of animal diseases.

4. At all times during sorting or storage, Category 3 material must be handled and stored separately from goods, other than Category 3 material, in a way that prevents any propagation of pathogens and that ensures compliance with Article 22.

5. Category 3 material must be stored properly, and, where appropriate, chilled or frozen, until re‑dispatched.

IV.b Hygiene requirements for Category 3 storage plants

Premises and facilities must meet at least the following requirements:

1. Premises storing processed products derived from Category 3 material must not be at the same site as premises storing processed products derived from Category 1 or 2 material, unless in a completely separate building.

2. The plant must have the following:

1. a covered space to receive the products;
2. be constructed in such a way that eases cleaning and disinfecting. Floors must be laid down in such a way that facilitates the draining of liquids;
3. adequate lavatories, changing rooms, and wash basins for staff;
4. appropriate arrangements for protection against pests, such as insects, rodents, and birds.

3. The plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which the products are received, and the vehicles in which they are transported. Adequate facilities must be provided for disinfecting vehicle wheels.

4. Products must be stored properly until re-dispatched.

IV.c Hygiene requirements for Category 3 processing plants

1. Premises and facilities must meet at least the following requirements:

1. Premises for the processing of animal by-products must not be at the same site as slaughterhouses, unless in a completely separate building. However, a conveyor system may link a slaughterhouse to an individual processing plant on the same site, on condition that:
   1. there are separate entrances, reception bays, equipment, exits, and personnel for the processing plant and the slaughterhouse; and
   2. the animal by-products to be processed originate from the same premises. Unauthorized persons and animals must not have access to the plant.
2. The processing plant must have a clean and unclean sector, adequately separated. The unclean sector must have a covered space to receive animal by-products and must be constructed in such a way that eases cleaning and disinfecting. Floors must be laid in a way that facilitates the draining of liquids. The plant must have adequate lavatories, changing rooms, and wash basins for staff.
3. To prevent contamination of the finished product by incoming animal by-products, there must be a clear separation between the area of the plant where incoming material for processing is unloaded and the areas set aside for the processing of that product and the storage of the processed product.

2. The processing plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which animal by-products are received, and for the vehicles in which they are transported.

3. Adequate facilities must be provided for the disinfecting of vehicle wheels when leaving the unclean sector of the processing plant.

4. All processing plants must have a waste-water disposal system that meets the competent authority’s requirements.

5. Category 3 material must be processed as soon as possible after arrival. It must be stored properly until processed.

6. Containers, receptacles, and vehicles used for transporting unprocessed materials must be cleaned in a designated area. That area must be situated or designed to prevent the risk of contamination of processed products.

7. Persons who work in the unclean sector must not enter the clean sector without changing their work clothes and footwear or without disinfecting the latter. Equipment and utensils must not be taken from the unclean sector into the clean sector, unless first cleaned and disinfected. Personnel movement procedures must be established to control the movement of personnel between areas and to prescribe the proper use of foot baths and wheel baths.

8. Preventive measures against birds, rodents, insects, or other vermin must be systematically taken. A documented pest control program must be used for that purpose.

9. Cleaning procedures must be established and documented for all parts of the premises. Suitable equipment and cleaning agents must be provided for cleaning.

10. Hygiene control must include regular inspections of the environment and equipment. Inspection schedules and results must be documented and maintained for at least two years.

11. Installations and equipment must be kept in a good state of repair, and measuring equipment must be calibrated at regular intervals.

12. Processed products must be handled and stored at the processing plant in a way that precludes contamination.

IV.d Supervision of production

1. The competent authority must supervise processing plants to ensure compliance with the Regulation requirements. It must, in particular:

1. check the:
   1. general conditions of hygiene of the premises, equipment, and staff;
   2. efficacy of the own-checks carried out by the plant, in accordance with Article 25 of the Regulation (EC) No. 1774/2002, mainly by examining the results;
   3. standards of the products after processing; and
   4. storage conditions.
2. Conduct any other checks considered necessary to ensure compliance with this Regulation.

2. To allow the competent authority to carry out its responsibilities under paragraph 1, it must have free access at all times to all parts of the processing plant and to records, commercial documents, and health certificates.

IV.e Validation procedures

1. The competent authority must validate the processing plant in accordance with the following procedures and indicators:

1. describe the process (by a process flow diagram);
2. identify critical control points (CCPs), including the material process rate for continuous systems;
3. comply with the specific process requirements laid down by this Regulation.

2. The competent authority must repeat the validation procedures periodically, when it considers it necessary, and in any case, each time any significant alterations are made to the process (for example, modification of the machinery or a change of raw materials).

IV.f Plant’s own-checks–Hazard Analysis Critical Control Points type

The EU requires that processing plants carry out an own-check program similar to the system of Hazard Analysis Critical Control Points (HACCP).

Article 25 of the Regulation (EC) No. 1774/2002 states that:

1. Operators and owners of intermediate and processing plants, or their representatives, shall adopt all measures necessary to comply with the requirements of this Regulation. They shall put in place, implement, and maintain a permanent procedure, developed in accordance with the principles of HACCP. They shall in particular:

1. identify and control the critical control points in the plants;
2. establish and implement methods for monitoring and checking such critical control points;
3. record the results of the checks and tests referred to in point (b) and keep them for a period of at least two years for presentation to the competent authorities;
4. introduce a system ensuring the traceability of each batch dispatched.

2. When the results of checks made pursuant to paragraph 1(c) do not comply with the provisions of this Regulation, the operator of the processing plant must:

1. notify the competent authority immediately of the full details of the nature of the sample and the batch from which it was derived;
2. establish the causes of failures of compliance;
3. reprocess or dispose of the contaminated batch under the supervision of the competent authority;
4. ensure that no material suspected or known to be contaminated is moved from the plant before being reprocessed under the supervision of the competent authority and re-sampled officially to comply with the standards laid down in this Regulation, unless destined for disposal;
5. increase the frequency of sampling and testing of production;
6. investigate animal by-product records appropriate to the finished sample;
7. instigate appropriate decontamination and cleaning procedures within the plant.

V. Official Control and List of Approved Plants

Article 26 of the Regulation (EC) No. 1774/2002 states that:

1. The competent authority shall at regular intervals carry out inspections and supervision at plants approved in accordance with this Regulation. Inspections and supervision of processing plants shall take place in accordance with Annex V, Chapter IV.

2. The frequency of inspections and supervision shall depend on the size of the plant, the type of products manufactured, risk assessment, and guarantees offered in accordance with the principles of HACCP.

3. If the inspection carried out by the competent authority reveals that one or more requirements of this Regulation are not being met, the competent authority shall take appropriate action.

VI. Hygiene Requirements for the Collection and Transport of Animal By-Products and Processed Products

The Regulation requires that the CFIA approve the hygiene and storage conditions in the plant, as well as the conditions for the transport of products.

Identification

1. All necessary measures must be taken to ensure that:

1. Category 3 material is identifiable and kept separate and identifiable from Category 1 and Category 2 products during collection and transportation;
2. processed products are identifiable and kept separate and identifiable during transportation;
3. a marking substance for the identification of animal by-products or processed products of a specific category is only used for the category for which its use is required;
4. animal by-products and processed products are dispatched from a third country to the EU in packaging, containers, or vehicles that are prominently, and at least for the period of transport, indelibly identified.

2. During transport, a label attached to the packaging, container, or vehicle must:

1. clearly indicate the category of the animal by-products or, in the case of processed products, the category of animal by-products from which the processed products were derived.

Vehicles and containers

1. Animal by-products and processed products must be collected and transported in sealed new packaging, or covered leak-proof containers or vehicles.

2. Vehicles and reusable containers, and all reusable items of equipment or appliances that come into contact with animal by-products or processed products, must be:

1. cleaned, washed, and disinfected after each use; and
2. maintained in a clean condition.

3. Reusable containers must be dedicated to the transport of Category 3 material in accordance with the prescribed procedures to avoid cross-contamination.

Records

Article 26 and Chapter IV of Annex II of the Regulation (EC) No. 1774/2002 state that:

1. Any person consigning, transporting, or receiving animal by-products must keep a record of the delivery slip.

2.The delivery slip must contain the information indicated in the traceability certificate and must be kept for a period of at least two years for presentation to the competent authority.

Temperature conditions

1. The transport of animal by-products must take place at an appropriate temperature to avoid any risk to animal or public health.

2. The design of vehicles used for refrigerated transport must ensure the maintenance of an appropriate temperature throughout transport.

VII. Pre-Inspection Procedures

Before scheduling the inspection, the district office must send all the necessary documents to the facility’s management, including th e following:

1. A form to be certified by a commissioner for oaths concerning the nature and origin of the processors’ raw materials.
2. A form to be certified by a commissioner for oaths regarding the processing method used. This form also requires that the facility attest to the application of an own-check program ensuring compliance with the required critical limits.

Prior to inspection by the CFIA, management of the facility must complete and submit the following documents to the district office.

Prior to inspection of the facility, the district office must confirm that the requisite forms have been submitted and that they meet all the requirements. All the forms must be certified by a commissioner for oaths. The certified forms must also indicate the signatory’s position within the company, and said position should be such that the signatory may be expected to be aware of the information contained in the form certified by a commissioner for oaths. These documents must be updated (signed and submitted to the district office) annually.

VIII. Inspection Procedures

Prior to arrival at the facility, the inspector must review the forms submitted to the district office, as well as the inspection checklist.

The inspection must begin in the facility management’s office. The inspector must then review the requisite forms and the facility’s own-check program with management.

The inspector may then review, with the facility’s guide, the appropriate checklist for each type of animal product or by-product, entitled Appendix C: CFIA Plant Inspection Checklist for Approval of Facilities to Export to the European Union. This checklist provides the questions that require answering during the tour. The guide must then take the inspector on a tour of the facility, taking care to cover each point on the checklist. At the end of the tour, the inspector must ask the guide to return to any areas that he needs to check again or to provide supporting evidence for any unanswered questions.

During the inspection, the inspector must keep in mind the information that he reviewed in the forms provided, which are certified by a commissioner for oaths, as well as the own-check plan, and be vigilant in identifying any inaccuracies.

IX. Billing for Inspections

Facility approval inspections for export of hides and skins to the EU will be billed according to the CFIA Fees Notice, Part II, Item 27: $30 for each inspection (code 1483).

X. Inspection Reports

A copy of the duly completed inspection form and of all the requisite forms, certified by a commissioner for oaths, must be sent to the CFIA area network export specialist for approval.

The documents for submission are indicated in the checklist. The form must be completed legibly. If notes taken during the inspection are illegible, the inspection form must be typed or completed again in legible block letters. A copy of the inspection documents must be kept at the district office.

The facility will not be approved to export to the EU until the area network export specialist has reviewed the inspection results and provided approval. Before signing any export certificate, the district office must consult the list of approved facilities.

XI. Approval Numbers

Facility approval numbers are issued by headquarters. The area network export specialist will send the appropriate information (name, address of facility, and approval date) by e-mail to Claire Bellefeuille. A central list of approved facilities will be maintained and made available by headquarters.

The district office must not sign certificates for export to the EU, unless the facility approval number is identical to the number on the list of approved facilities.

XII. 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 e-mail to Claire Bellefeuille for an amendment to the list. If a facility’s physical address changes, the new facility will require an inspection.