Registration or approval of facilities to export animal by-products not intended for human consumption to the European Union (EU)
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TAHD-DSAT-2009-8-4
June 2021
Amendment: following the implementation of the new animal product and by-products inspection checklist, previous appendices of this directive have been withdrawn and replaced with new annexes.
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On this page
- Purpose
- Background
- Definitions
- Approval of facilities to export to the European Union
- Hygiene requirements for the collection and transport of animal by-products and derived products
- Registration of facilities to export to the European Union
- Official control and final provisions
- Operational guidance
- Approval numbers
- Facility name or address changes
1. 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 to be used outside the feed chain; and
- to standardize Canadian Food Inspection Agency (CFIA) inspections of facilities in which these products are collected, processed, and stored
This document does not cover:
- facilities approved by Veterinary Biologics
- facilities approved by the Pet Food Program; and
- finished products exported in final package form and ready for distribution to the end user that are exempt from Regulation (EC) 1069/2009
2. Background
Regulation (EC) 1069/2009 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) 1774/2002 (Animal By-Products Regulation).
Regulation (EU) 142/2011 implements Regulation (EC) 1069/2009 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 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 (Article 23 of Regulation [EC] 1069/2009) or approve (Article 24 of Regulation [EC] 1069/2009) facilities exporting animal by-products not intended for human consumption. To grant this registration or approval, the CFIA must consider various factors, such as the nature and origin of the raw materials, processing methods, the existence of own check programs, the nature of the processed materials, hygiene conditions, and product storage.
These animal by-products may only be imported into the EU from an eligible country and from a facility approved for export to the EU.
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.
Regulation (EC) 853/2004 of the European Parliament and of the Council of 29 April 2004 lays down specific hygiene rules for food of animal origin.
3. Definitions
- European definition of Categories 1, 2, and 3 animal by-products
The EU Regulation (EC) 1069/2009 classifies animal by-products into 3 categories, based on the risk that they pose to animal health. Apart from a few exceptions, in general, only Category 3 animal by-products are eligible for export; however for some uses outside the feed chain, the EU accepts derived products from Category 1 or 2 material (for example, rendered fats for biodiesel). 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.
See the directive, Definition of Categories 1, 2, and 3 animal products and by-products according to the European Legislation (EC) 1069/2009.
- 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 (for example, hides and skins, blood, dairy products).
- Intermediate plant
According to Article 19(b) of Regulation (EU) 142/2011, this terms applies to a plant in which intermediate operations (which generally do not change the health status of the material) are carried out on animal by-products after their collection, such as the following:
- sorting, cutting, chilling, freezing, sieving, salting or other preservative processes
- removal of hides and skins or specified risk material; and
- operations involving the handling of animal by-products which are carried out in compliance with obligations under Union veterinary legislation
- Processing plant
- This term applies to a plant in which raw material of animal origin is processed. In general, the health status of the material is changed after the processing (for example, plant processing animal proteins, rendered fats, hides salted in brine solution, treated blood).
- Storage plant
This term applies to a plant (other than an intermediary) in which raw material or processed products are temporarily stored before their processing, 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).
Nature of operations to be registered or approved
- Approval
- According to Article 24 of Regulation (EC) 1069/2009, operators shall ensure that establishments or plants under their control are approved by the competent authority, where such establishments or plants carry out one or more of the activities listed. See Title II, Chapter I, Section 2, Article 24 of Regulation (EC) 1069/2009 for Approval of establishments or plants for the list of activities.
- Registration
See Title II, Chapter I, section 2, Article 23 of Regulation (EC) 1069/2009, for registration of operators, establishments or plants.
For the requirements applicable to registered operators see Annex IX, Chapter IV of Regulation (EU) 142/2011.
4. Approval of facilities to export to the European Union
The general hygiene requirements can be found in Article 25 of Regulation [EC] 1069/2009.
- 4.1 Requirements for intermediate plants
- 4.2 Requirements for storage plants
- 4.3 Requirements for processing plants
- 4.4 Hygiene and processing requirements
- 4.5 Supervision of production
- 4.6 Validation procedures
- 4.7 Own checks and hazard analysis and critical control points
4.1 Requirements for intermediate plants
See Annex IX, Chapter II, Sections 1, 2 of Regulation [EU] 142/2011 for requirements applicable to certain approved and registered establishments and plants.
4.2 Requirements for storage plants
See Annex IX, Chapter III, Sections 1, 2 of Regulation [EU] 142/2011 for the requirements for storage of derived products.
4.3 Requirements for processing plants
See Annex IV, Chapter I, of Regulation [EU]142/2011 for the requirements for processing plants:
- Section 1 General conditions
- Section 3 Specific requirements for the processing of Category 1 and Category 2 materials, and
- Section 4 Specific requirements for the processing of Category 3 materials
4.4 Hygiene and processing requirements
See Annex IV, Chapter II, Sections 1, 2, 3 and 4 of Regulation (EU) 142/2011 for hygiene and processing requirements (for example, processed animal proteins and rendered fats).
4.5 Supervision of production
See Annex XVI, Chapter I, Section 1 of Regulation [EU] 142/2011 for supervision of the production in processing plants (for example, processed animal proteins and rendered fats, salted hides and treated blood).
4.6 Validation procedures
See Annex XVI, Chapter I, Section 2 of Regulation [EU] 142/2011 for validation procedures in processing plants (for example, processed animal protein and rendered fats).
4.7 Own checks and hazard analysis and critical control points
See Title II, Chapter I, Section 3, Article 28 and Article 29 of Regulation [EC] 1069/2009 for the requirements for operators to implement and maintain:
- own checks in their establishments or plants
- a permanent written procedure or procedures based on the hazard analysis and critical control points (HACCP)
5. Hygiene requirements for the collection and transport of animal by-products and derived products
See Title II, Chapter I, Section 1, Article 21 of Regulation (EC) 1069/2009 for collection and identification as regards to category and transport. Annex VIII, Chapter I of Regulation (EU) 42/2011 provides the requirements for the collection and transport of animal by-products and derived products (vehicles and containers, temperature conditions).
5.1 Identification
Annex VIII of Regulation (EU) 142/2011, Chapter 2 states that all necessary measures must be taken to ensure that:
- consignments of animal by-products and derived products are identifiable and kept separate and identifiable during collection where the animal by-products originate and during transportation.
5.2 Traceability and records
See Title II, Chapter I, Section 1, Article 22 of Regulation (EC) 1069/2009 for traceability.
Chapter III of Annex VIII of Regulation (EU) 142/2011 provides information on commercial documents and health certificates.
A summary of the requirements are as follows:
During transportation, a commercial document, a traceability or sanitary certificate, must accompany animal by-products and derived products:
- the commercial document (issued by the operator), the traceability or sanitary certificate (issued by the CFIA) must be produced at least in triplicate (1 original and 2 copies)
- the original must accompany the consignment to its final destination
- the receiver must retain it
- the producer must retain 1 of the copies and the carrier the other
However the CFIA may authorize that animal by-products and derived products which are transported on its territory are accompanied by the following:
- a different commercial document, in paper or in electronic form; and
- a commercial document in which the quantity of the material is expressed in weight or volume of the material or in the number of packages
The commercial document, traceability or sanitary certificate must specify:
- the date on which the material was taken from the premises
- the description of the material, including:
- the identification of the material according to one of the 3 categories
- the animal species and the nature of the material; and
- the quantity of the material, in volume, weight or number of packages
- the place of origin of the material, from where the material is dispatched
- the name and the address of the carrier of the material
- the name and the address of the receiver and, if applicable, its approval or registration number; and
- if appropriate, the approval or registration number of the establishment or plant of origin, and the nature and the methods of the treatment
The original of the accompanying document must be completed and signed by the responsible person (operator for the commercial document or the veterinarian for the traceability or sanitary certificate)
- the colour of the signature of the responsible person shall be different to that of the printing
- the document reference number shall only be issued once for the same consignment
Note: Records and related commercial documents, or the traceability or sanitary certificate, shall be kept for a period of at least 2 years for presentation to the competent authority.
6. Registration of operators to export to the European Union
See Annex IX, Chapter IV of Regulation (EU) 142/2011 for requirements applicable to registered operators.
7. Official control and final provisions
7.1 Procedure for approval
See Title III, Chapter I, Article 44 of Regulation (EC) 1069/2009 for procedure for approval.
7.2 Official control
See Article 32 of Regulation (EU) 142/2011 for official controls.
7.3 Suspensions, withdrawals and prohibitions on operations
See Title III, Chapter I, Article 46 of Regulation (EC) 1069/2009 for suspensions, withdrawals and prohibitions on operations.
8. Operational guidance
Refer to OP-31410 Use of the inspection checklist to export animal products and by-products not intended for human consumption, including pet food, to all countries except the United States (internal access only – RDIMS 14156149) for information on:
- Pre-inspection procedures
- Inspection procedures
- Billing for inspections
- Inspection reports
Note: A facility will not be approved to export to the EU until the area approving veterinarian has reviewed the inspection results and provided approval. Once the approval is given, the eligibility of the production for export begins the date of recommendation for approval.
An export certificate must not be issued before the facility is registered in the TRAde Control and Expert System (TRACES).
Checklist and annexes
- Generic inspection checklist – Export of APABP not for HC (internal access only – RDIMS 11187075)
- Annex A: Source of animal origin raw material and ingredients (internal access only – RDIMS 11028292)
- Annex B: Approved supplier form (internal access only – RDIMS 11016879)
- Annex C: List of products processed or manufactured by plant (internal access only – RDIMS 11027251)
- Annex D: Processing method form (internal access only – RDIMS 11016726)
- Annex E: Sampling and testing procedures performed on raw material, ingredients and finished products (internal access only – RDIMS 12776409)
- Annex F: Verification checklist (internal access only – RDIMS 11031688)
- Annex G: Non-compliance form (internal access only – RDIMS 11116515)
9. Approval numbers
Facility approval numbers are issued by headquarters. The area approving veterinarian will send the appropriate information (name, address of facility, and approval date) by email to Janet Goodall. 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.
10. 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 approving veterinarian, who will send the information by email to Janet Goodall for an amendment to the list. If a facility's physical address changes, the new facility will require an inspection.
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