Animal Health Import Requirements for Raw Inedible Products and Rendered products

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TAHD-DSAT-IE-2002-10-10

Amendments:
Added table of contents
Negligible and controlled risk for BSE country lists updated
Added in links to Health Canada contact points for raw products for pharmaceutical uses
Expanded and clarified the following:
Raw inedible requirements – by end use
Inserted Health Canada guidance document URL's on raw inedible for pharmaceutical use
Facility questionnaire now in a separate document, and is generic for multiple commodities.

Note: This import policy relates to Animal Health import requirements and does not remove any obligation to the Canadian importer to comply with the import requirements of other Canadian Food Inspection Agency (CFIA) programs and/or departments, such as the Animal Feed Division, the Fertilizer section of the Plant Production Division, the Meat Programs Division, or the Aquatic Animal Health Division or other Government of Canada requirements.

Table of Contents

Requirements by Commodity type:

Authority

This policy falls under the legislative authority of the Health of Animals Act and Health of Animals Regulations. The importer is obligated to ensure compliance with the specific requirements of this and other CFIA policies and directives that fall under the legislative authority of the Meat Inspection Act and the Meat Inspection Regulations, the Feeds Act and the Feeds Regulations and the Fertilizers Act and Fertilizers Regulations.

Products for human consumption are also regulated by Health Canada through product-specific regulatory programs, which are administered under the authority of the Safe Food for Canadians Act, the Food and Drugs Act, the Food and Drugs Act and the Food and Drug Regulations. Veterinary-use products are also regulated by Health Canada. Contact information for Health Canada departments can be found within the Highly Processed Products import procedure, Appendix I. Specific import conditions by commodity can also be foundat the Terrestrial Animals Import Policies webpage and the Automated Import Reference System (AIRS).

Definitions

Definitions for Animal health Import Requirements for raw inedible products and rendered products

Overview of Import Requirements for Rendered Products and Raw Inedible Products

Importation of rendered animal protein products from any species (which includes blood meal from all species, feather meal, and fish meal, as defined by this policy) from any country that the CFIA does not recognize to be of negligible risk of BSE is prohibited, unless specific import conditions are described within this import policy.

Negligible risk countries, designated by CFIA as free of other diseases of concern may export to Canada, non-ruminant, and ruminant (prohibited material) rendered products, provided they comply with the import permit requirements. Negligible risk countries that are not designated by CFIA as free of other diseases of concern are prohibited from exporting any terrestrial animal origin rendered product, unless specific import conditions are described within this import policy. Such countries may apply to CFIA to have an evaluation of their disease status and their rendering inspections system's to be recognized as equivalent to Canada's 1997 Feed Ban and the 2007 Enhanced Feed Ban.

This prohibition on import of rendered animal protein applies to all end uses, including aquaculture and pet product manufacturing (food, treats, chews, etc.). Import conditions for finished pet food products can be found within the CFIA import procedures, under Import Policies – Animals Products and By-Products.

A facility questionnaire is required for assessment of an application for imports of rendered products. Please read and follow the instructions found within the CFIA Facility Questionnaire for Animal Products and Animal By-Products (APABP) document and submit the completed questionnaire to the appropriate CFIA office, along with the import permit application required.

Raw Inedible products must comply with published CFIA import conditions, within this policy, any other applicable import policies, and as summarized within AIRS.

An exemption or derogation from published import conditions for either rendered products or for raw inedible products may be considered on a case-by-case basis for certain animal origin commodities that are not of ruminant origin. This derogation will only be granted after the successful completion of a risk assessment. Factors for consideration in the risk assessment include, but are not limited to, the zoosanitary status of the country of origin, prior assessment of the veterinary infrastructure, the nature of the product, the process and treatment applied to the product, the end use, and the potential for cross-contamination with ruminant material.

To apply for such a derogation and evaluation of potential new import protocols, please follow the process as outlined within TAHD-DSAT-IE-2003-3-8 Development of New Import Protocols - Procedures for Clients Note this is a cost recovered evaluation, with no guarantee of a positive outcome for applicants, only that all hazards and known mitigation measures applicable will be evaluated.

Liquid or non-dry products for retail sale (not for further processing in Canada that would mitigate against disease; i.e. re-packaging), such as a digest or palatability enhancers, must be accompanied by a certificate of analysis – an original report issued by an independent (third party) laboratory, recognized by the Standards Council of Canada (SCA)/Conseil Canadien des Normes (CCN), using both qualitative and quantitative microbiological analysis for the micro-organisms of concern – along with all other documentation required (as listed in Section I, below). The certificate of analysis must accompany and be linked to the shipment(s). The specific conditions are to be determined prior to importation by Animal Import/Export Division (AIED) Headquarters. This requirement does not apply to fats and oils, such as fish oil or tallow. (See specific provisions for these products in Section II, below.)

When rendered products are included in prepared final products, such as pet food and fertilizers, importation of these finished commodities must be conducted in accordance with requirements of the import policy for the finished product. Please refer to the appropriate import policy on the Import Policies Web page.

Raw inedible products for the end uses specified in this policy

Must come from countries recognized by Canada as free of the following diseases of concern:

  1. For poultry: Notifiable Avian Influenza and Newcastle disease
  2. For ruminants: Contagious bovine pleuropneumonia; Foot-and-mouth disease (FMD); Lumpy skin disease; Peste des petits ruminants; Rift valley fever and Sheep pox and goat pox
  3. For swine: African swine fever; Classical swine fever (Hog cholera); Foot and Mouth Disease; Swine vesicular disease; Vesicular Stomatitis+
  4. For Horses &other equids: African horse sickness and Vesicular Stomatitis
  5. For Lagomorphs (domestic rabbits): rabbit viral haemorrhagic disease and myxamotisis

Note: For vesicular stomatitis - zoning is recognized by Canada for this disease; Animals must be from a free zone as declared by the CCVA and recognized by Canada and the animals are not from an area with an active outbreak of the disease, nor have been in direct contact with animals from either a declared outbreak, control or monitoring zone for vesicular stomatitis.

Rabbit viral haemorrhagic disease and myxamotosis: No CFIA country freedom list has been established, so establishment (farm) freedom is acceptable provided that it meets the requirements listed below for lagomorphs.

Documentation Requirements (General)

Import Permit

Under subsection 166 (1) of the Health of Animals Regulations, all products of a rendering plant require an Import Permit for entry into Canada. Other documentation requirements are detailed by commodity within this or other import policies, such as the BSE Import Policy. Importers are expected to verify the import conditions for their specific commodity, using the appropriate import policy on the Import Policies Web page, and AIRS.

The permit application process allows the CFIA to accurately classify imported material. The application provides the CFIA with the required information, including the presence of prohibited mammalian (i.e. ruminant) protein and the end use of the product. The finalized import conditions, listed in detail on the Import Permit, inform importers of their obligations associated with the classification of their imported product. The aim of the detailed listing of import conditions is to improve compliance with keeping prohibited material out of ruminant feeds. Importers must read and are legally required to comply with all of the conditions listed on their Import Permit.

Each shipment must be accompanied by a copy of the permit at the time of importation.

Facility Questionnaire

The Facility Questionnaire must accompany the application for Import Permit. It must be endorsed for accuracy by a full time, salaried veterinarian of the central competent veterinary authority. This endorsement does not specify if the facility may or may not meet Canadian import requirements, it simply assures that the statements on material and processing within the facility are complete and true.

Certification

An official zoosanitary export certificate, issued by the official veterinary services of the country of origin, and/or a certificate of analysis, which is an original report issued by an independent (third party) laboratory, must (dependent on commodity type) accompany each shipment of rendered product (except for fish oil) and must comply with the requirements in the Import Permit.

The zoosanitary export certificate for Prohibited material (PM) as defined within this policy (including the attached definitions), products that contain PM or that may contain PM must always bear this statement:

"The imported product contains or may contain prohibited material, as defined by section 162 of the Health of Animals Regulations. Feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animals Act."

The zoosanitary export certificate for Non-prohibited material (cannot even contain via cross contamination, PM) must have this statement:

"The imported product does not contain any prohibited material, as defined by section 162 of the Health of Animals Regulations. This product may be used in the manufacture of feed for ruminants."

Shipping Invoice

The shipping invoice must state the name of the consignor and consignee, the product and its end use, and the country of origin.

Note: If the product is made of, or contains, or may contain "prohibited material," the shipping invoice must state the names of the consignor and the consignee and indicate that the product contains prohibited material. It must also include on the product label and shipping invoice the following cautionary statement:

"Feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animals Act."

Record-Keeping Requirements for Rendered Products (Meals, Greaves, Fats, and Oils)

Records of the name and address of any place to which the imported product is sold ordistributed must be maintained for ten years following importation. These records must be made available for inspection by the CFIA upon request, as required by subsections 166(1) and (2) of the Health of Animals Regulations:

Every person who imports or has the possession, care or control of any product of a rendering plant shall keep a record of a) the name and address of the rendering plant and the date of production of the product; b) the name and address of the exporter; c) the name and quantity of, and any other information that is sufficient to identify, the product; d) the name and address of any person to whom any product is distributed or sold and the information referred to in paragraph c) with respect to that product; and e) whether or not the product is, or contains any, prohibited material.

List of Countries by BSE Designation

The OIE classifies countries for BSE risk into three categories: 1) negligible risk; 2) controlled risk; and 3) undetermined risk. Canada follows this classification.

see the TAHD-DSAT-IE-2005-9-6 Bovine Spongiform Encephalopathy Import Policy for Bovine Animals and Their Products and By-Products for the list of countries recognized by CFIA as having a negligible BSE risk in accordance with Chapter 11.4.3 of the Terrestrial Animal Health Code of the OIE:

Exemptions to the conditions for the importation of animals, products and by-products or any other commodities not listed, may be considered on a case-by-case basis, taking into account such factors as the intended use, the nature of the product, the bovine tissues from which it was derived and the manufacturing and processing methods to which it was subjected. Applicable import conditions would be developed on the basis of the outcome of a prior risk assessment.

Canada's determination, by country, of effective date of implementation of the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants was effectively enforcedFootnote 1 are also found in the TAHD-DSAT-IE-2005-9-6 Bovine Spongiform Encephalopathy Import Policy for Bovine Animals and Their Products and By-Products.

General Requirements

In this import policy, the requirements for the importation of rendered products are divided into three sections:

Section I – specific requirements for the import of meals and greaves

Section II – specific requirements for the import of fats and oils

Section III – specific requirements for the import of raw inedible products (prior to being rendered)

Section I – Meals or Greaves

Examples of meals or greavesare feather meal, meat meal, and liquid poultry digest.

Note: There are specific requirements forfish meals, dried bovine blood, and blood products.

1. Product of Terrestrial Animal Origin, Not Detailed Elsewhere

1.1 From a Country in Which the Rendering Inspection System Is Recognized as Equivalent to Canada's, which is Negligible Risk for BSE and Designated as Free of Diseases of Concern

a. Import Permit

Each shipment must be accompanied by a copy of the permit, which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate of Origin

Each shipment must be accompanied by an original, official zoosanitary export certificate, endorsed by a full-time salaried veterinarian of the central competent veterinary authority, (CCVA), clearly describing the product and specifying the country of origin.

The import permit will clearly lay out the exact certification language required from the country of origin & country of export (if different than first country) for country which is Negligible Risk for BSE and Designated as Free of Diseases of Concern Countries

1.2 From a Country in Which the Rendering Inspection System Is Recognized as Equivalent to Canada's, Which Is Designated as Free of Diseases of Concern, and Which Is of Controlled Risk for BSE.

Only non-prohibited materials are permitted at this time

a. Import Permit

Each shipment must be accompanied by a copy of the permit, which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate

Each shipment must be accompanied by an original export certificate, endorsed by a full-time, salaried veterinarian of the central competent veterinary authority (CCVA). The certificate must attest to the following:

  1. the (indicate name of products) covered by this export certificate and Import Permit #A (indicate Import Permit number) were only produced at (indicate name and address of the producer as identified in the Import Permit) and were only exported to Canada from (indicate name and address of the producer/exporter as identified in the Import Permit);
  2. the producing/exporting facility(ies) does not receive, store, or process any ruminants and things derived from ruminants, and the product has been prepared, processed, stored, and otherwise handled in a manner to avoid contamination with any ruminant tissues or things derived from ruminants; and
  3. The raw materials used to produce the meal have been reduced to a maximum particle size of 50 mm before heating. Subsequently, the raw material has been heated under saturated steam conditions to a temperature of not less than 133°C for a minimum of 20 minutes at an absolute pressure of 3-bar, or the rendered products have a moisture content of less than 10%. (It is a dry product.)

Note: The term "ruminant" designates an animal of the subfamily Bovinae and Caprinae, which includes cattle, buffalo, bison, sheep, goats, and their exotic relatives. Ruminants, along with the things derived from ruminants, of Canadian origin or from a negligible risk for BSE country are exempted and are permitted within the establishment. (For further instructions, please refer to the nearest CFIA Animal Health Office.)

1.3 From Non-Designated Countries Recognized to Be of Negligible BSE Risk by the CFIA

Please note that a permit to import may be issued only after successful completion of a risk assessment. Factors to be considered in the risk assessment include, but are not limited to, the zoosanitary status of the country of origin, prior assessment of the veterinary infrastructure, the nature of the product, the process and treatment applied to the product, the end use, and the potential for cross-contamination with products of a lesser zoosanitary status.

a. Import Permit

Each shipment must be accompanied by a copy of the permit, which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate

The certificate must be signed by an official full-time veterinarian of the competent authority and state the following:

  1. For meals or greaves that include prohibited (ruminant) material – The raw materials used to produce the meal have been reduced to a maximum particle size of 50 mm before heating. Subsequently, the raw material has been heated under saturated steam conditions to a temperature of not less than 133°C for a minimum of 20 minutes at an absolute pressure of 3-bar.
  2. For meals or greaves that include only non-prohibited (non-ruminant) material – The raw materials used to produce the meal have been reduced to a maximum particle size of 50 mm before heating. Subsequently, the raw material has been heated under saturated steam conditions to a temperature of not less than 133°C for a minimum of 20 minutes at an absolute pressure of 3-bar.
  3. Every precaution was taken during the handling, processing, packaging, and storage to prevent direct or indirect contact of the product with any animal product or by-product of a lesser zoosanitary status.

1.4 From Non-Designated Countries That Are Not at Negligible Risk of BSE

Terrestrial animal-derived protein is prohibited.

1.5 Liquid Products

Liquid products include such products as poultry digest and fish protein hydrolysate. However, the term does not apply to fats or oils. (Section III, below, includes the specific import conditions for fats and oils.)

Note: The 10% moisture content attestation does not apply to liquid products. These products must be accompanied by an Import Permit and the official zoosanitary export certificate, along with the following documentation:

a. Importer's Declaration (signed, dated, and linked to the shipment being imported), stating that the product is as follows:

  1. For further processing – The product is going for further processing in Canada (e.g. to a pet food or feed manufacturer), and the liquid rendered products imported will not be sold at the retail level without further processing to negate micro-organisms of concern; or
  2. For retail sale – The product is going for retail sale in Canada, and the liquid rendered products imported have been processed in a manner to negate micro-organisms of concern and are accompanied by a certificate of analysis (an original report issued by an independent [third party] laboratory and linked to the shipment that states freedom from the micro-organisms of concern). The specific conditions are to be determined prior to importation by AIED Headquarters. (Details will be listed on the Import Permit accompanying the shipment.)

2. Fish Meal

The following countries are currently approved to import fish meal into Canada.

Negligible risk for BSE countries as identified within the Bovine Spongiform Encephalopathy Import Policy for Bovine Animals and Their Products and By-Products:

Non-negligible risk for BSE countries approved for fish meal to Canada:

  1. Mauritania
  2. Mexico
  3. List of CFIA approved fish meal production establishments from the country of Morocco:
    1. SOVAPEC, registration number (numéro d'agrément) 1980, port of Tan Tan, in the region of Guelmin-Es-Smara; and
    2. CIBEL II, registration number (numéro d'agrément) 1029, port of Agadir, in the region of Souss Massa Drâa

Note: at this time no other fish meal facilities in Morocco are approved for export to Canada, so import permits may only be issued for fish meal manufactured in these two facilities.

a. Import Permit

Each shipment must be accompanied by a copy of the permit, which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate

Fish meal has been approved for import from all negligible risk for BSE countries, as well as for a small number of countries that are not negligible risk for BSE following a successful risk assessment. Please consult AIRS to verify the detailed certification requirements established by country for the countries listed above.

3. Dried Bovine Blood and Blood Meal Products From a Country in Which the Rendering Inspection System Is Recognized as Equivalent to Canada's

3.1 From Negligible Risk for BSE and Designated Countries

a. Import Permit

Each shipment must be accompanied by a copy of the permit, which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate of Origin

Each shipment must have an official zoosanitary export certificate clearly describing the product and specifying the country of origin.

3.2 From Countries Assessed by the CFIA as Free of All Important Ruminant Diseases and of Controlled or Undetermined Risk for BSE

Note that contamination (from cattle aged 30 months or older) of the blood via neural tissue leaking from the penetrative captive bolt stun hole would result in the blood being contaminated with specified risk material (SRM), and the subsequent material would be treated as SRM under Canadian regulations. This is the case whether the SRM contamination of bovine blood was incidental or otherwise.

a. Import Permit

Each shipment must be accompanied by a copy of the permit, which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate

The Official Zoosanitary Export Certificate must be signed by an official full-time veterinarian of the competent authority, and state that the blood has been collected from bovine animals which were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process. In addition, the certificate should state that the bovine animals were subjected to both ante-mortem and post-mortem inspection, and after collection via the method indicated below, no contamination of the blood or blood product occurred with the following tissues:

  • the skull including the brain, trigeminal ganglia and eyes; the spinal cord and the vertebral column, excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum; and the palatine tonsils from all bovine animals aged 30 months or older; plus the distal ileum from bovine animals of all ages;
  • and the blood was collected from/using one of the following methods:
    1. bovine animals that were killed using a non-penetrative method, in accordance with humane slaughter practices;Footnote 2 Footnote 3 or
    2. bovine animals that are under 30 months of age, as determined by an age determination plan (HACCP-type plan), approved by the veterinary competent authority, with appropriate controls, monitoring, verification, and corrective measures in place, ensuring no incidental inclusion of animals of 30 months or older; or
    3. using a closed collection system in a manner that avoids contamination with the neural tissue leaking from the stun hole of animals aged 30 months or older, whether incidental or otherwise; or
    4. trimming, washing, scraping and/or vacuuming the head hide to remove any grossly visible brain material, with subsequent leakage of brain material from the stun hole is prevented via the application of edible grease to the stun hole area immediately after stunning; and
    5. every precaution was taken to prevent direct or indirect contact during the slaughter, processing, and packaging of the blood/blood product with any animal product or by-product of a lesser zoosanitary status.

Alternative methods of prevention of cross-contamination of Bovinae blood/blood products with SRM will be assessed by the CFIA's review of scientific risk assessments, submitted by the applicant/exporting country before a permit may be issued.

3.3 From Countries Not Designated by the CFIA as Free of All Important Ruminant Diseases and Which Are of Controlled or Undetermined Risk for BSE

Note that contamination (from cattle aged 30 months or older) of the blood via neural tissue leaking from the penetrative captive bolt stun hole would result in the blood being contaminated with SRM, and the subsequent material would be treated as SRM under Canadian regulations. This is the case whether the SRM contamination of bovine blood was incidental or otherwise.

a. Import Permit

Each shipment must be accompanied by a copy of the permit, which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate

The Official Zoosanitary Export Certificate must be signed by an official salaried full-time veterinarian of the competent authority, and state that the blood has been collected from bovine animals which were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process. In addition, the certificate should state that the bovine animals were subject to both ante-mortem and post-mortem inspection and that, after collection via the method indicated below, no contamination of the blood or blood product occurred with the following tissues:

  • the skull including the brain, trigeminal ganglia and eyes; the spinal cord and the vertebral column, excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum; and the palatine tonsils from all bovine animals aged 30 months or older; plus the distal ileum from bovine animals of all ages;
  • and the blood was collected from/using one of the following methods:
    1. bovine animals that were killed using a non-penetrative method, in accordance with humane slaughter practices;3 ,4 or
    2. bovine animals that are under 30 months of age, as determined by an age determination plan (HACCP-type plan), approved by the veterinary competent authority, with appropriate controls, monitoring, verification, and corrective measures in place, ensuring no incidental inclusion of animals of 30 months or older; or
    3. using a closed collection system in a manner that avoids contamination with the neural tissue leaking from the stun hole of animals aged 30 months or older, whether incidental or otherwise; or
    4. trimming, washing, scraping and/or vacuuming the head hide to remove any grossly visible brain material, with subsequent leakage of brain material from the stun hole prevented via the application of edible grease to the stun hole area immediately after stunning; and
    5. the manufacturing method for the blood and blood products included heating to a minimum core temperature of 70°C for at least 30 minutes; and
    6. every precaution was taken to prevent direct or indirect contact during the slaughter, processing, and packaging of the blood/blood product with any animal product or by-product of a lesser zoosanitary status.

Alternative methods of prevention of cross-contamination of Bovinae blood/blood products with SRM will be assessed by the CFIA's review of scientific risk assessments, submitted by the applicant/exporting country before a permit may be issued.

Section II – Rendered Fats and Oils

(Requirements for fish oils, tallow, or suet showing a maximum level of insoluble impurities of 0.15% in weight, and their derivatives, mixed oils, yellow grease, and used cooking oils [restaurant waste].)

1. Fish Oil from All Countries and for All End Uses, Other than for Human Consumption

If fish oil is being imported for human consumption, see the Import Inspection Program of the CFIA's Fish and Seafood Division for import requirements.

Note: Each shipment of less than one litre of fish oil, as defined within this import policy, for scientific use (research or diagnostic uses) must be accompanied by the importer's declaration (a signed and dated letter), stating that the fish oil is for in vitro laboratory use and will not be fed, in any form, to any animal; in addition, the declaration must state that the fish oil will not be used as or incorporated into a fertilizer.

Import Permit

Subsection 166(1) of the Health of Animals Regulations specifies that records must be kept for a minimum of 10 years. (See Documentation section, under Overview of Import Requirements for Rendered Products, in the introduction to this policy.)

2. Avian and Mammalian Fats and Oils From a Country in Which the Rendering Inspection System Is Recognized as Equivalent to Canada's

Note: Fat and oil products for human consumption, not being "rendered" products, do not all require an import permit from all countries of origin. These products fall under the authority of both the Meat Inspection Act and its Regulations, as well as pertinent sections of the Health of Animals Act and its Regulations, and the Food and Drugs Act and its Regulations. Import conditions may vary based on assessments of these products and the equivalency of the country of origin. Importers are urged to verify import conditions by specific country of origin via the CFIA's Meat Hygiene Manual of Procedures, Chapter 10, Annex A; or in AIRS.

A non-bovine origin fat or oil that is produced on a fully dedicated line will be classified according to the category of species of origin, and must be accompanied by an official veterinary certificate to that effect (i.e. line dedication), along with the other requirements listed in the pertinent section below (points 3, 4, and 5).

The fat or oil that is produced on a non-dedicated line will be considered a mixed Bovinae fat or oil, due to the risk of cross-contamination with bovine fats and oils, and will have to meet either the certificate of analysis (an original report issued by an independent, or third party, laboratory) requirements for tallow with less than or equal to 0.15% insoluble impurities (points 3.1, 3.2, 3.3) or the zoosanitary export certificate requirements for tallow with greater than 0.15% insoluble impurities (point 3.3b).

Line dedication, or its absence, and the subsequent specific import conditions will be indicated on the Import Permit conditions which must accompany and be linked to the shipment.

3. Tallow with Less Than or Equal to 0.15% Insoluble Impurities of Bovine Origin

3.1 Tallow With Less Than or Equal to 0.15% Insoluble Impurities of Bovine Origin and Mixed Fats or Oils of Any Origin (Avian or Mammalian) for All End Uses, and Yellow Grease and Post-Consumer Cooking Oil for Animal Feed or Further Processing From Any Country

(Note: For bovine origin fats and oils to be used for human consumption, extra certification requirements are listed at 3.2, 3.3, and 3.4.)

a. Import Permit

Note that products for human consumption do not all require an import permit from all countries of origin. Verify import conditions by specific country of origin via the Meat Hygiene Manual of Procedures, Chapter 10, Annex A; or in AIRS.

Each shipment must be accompanied by a copy of the permit (if required), and the import permit, when required, must be presented at the first point of entry.

b. Certificate of Analysis

The certificate of analysis, which is an original report issued by an independent (third party) laboratory, showing a maximum level of insoluble impurities of 0.15% in weight, as established using the American Oil Chemists' Society (AOCS) method Ca 3a-46, must be tied directly to the shipment being imported. The testing methodology may be obtained by contacting AOCS at the following address:

AOCS
P.O. Box 17190
Urbana, IL 61802-6996 USA
general@aocs.org

c. Importer's Declaration (signed and dated), stating whether the product is intended for human consumption or inedible/industrial uses, must be tied to the shipment for export.

3.2 Tallow With Less Than or Equal to 0.15% Insoluble Impurities of Bovine Origin for Human Consumption From Negligible Risk of BSE Country

a. Official Meat Inspection Certificate (OMIC), also known as an Official Zoosanitary Export Certificate; and
b. Certificate of Analysis

The certificate of analysis, which is an original report issued by an independent (third party) laboratory, showing a maximum level of insoluble impurities of 0.15% in weight, as established using the AOCS method Ca 3a-46, must be tied directly to the shipment being imported. The testing methodology may be obtained by contacting AOCS at the coordinates above.

Importers are urged to verify import conditions by specific country of origin via the CFIA's Meat Hygiene Manual of Procedures, Chapter 10, Annex A; or AIRS.

3.3 Tallow With Less Than or Equal to 0.15% Insoluble Impurities of Bovine Origin for Human Consumption From Controlled Risk of BSE Country

a. OMIC/Official Zoosanitary Export Certificate

The official veterinary certification must state the following:

  1. that the tallow was derived from animals that were stunned using a BSE slaughter process and not subjected, prior to slaughter, to a stunning process with a device that injected compressed air or gas into the cranial cavity;
  2. that the product was not prepared from and was not contaminated with the following:
    • distal ileum of bovine animals of all ages; and
    • palatine tonsils; the skull, including the brain, trigeminal ganglia and eyes; the spinal cord and the vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) from all bovine animals aged 30 months or older.

and

b. Certificate of Analysis

The certificate of analysis, which is an original report issued by an independent (third party) laboratory, showing a maximum level of insoluble impurities of 0.15% in weight, as established using the AOCS method Ca 3a-46, must be tied directly to the shipment being imported. The testing methodology may be obtained by contacting AOCS at the coordinates above.

Importers are urged to verify import conditions by specific country of origin via the CFIA's Meat Hygiene Manual of Procedures, Chapter 10, Annex A; or in AIRS.

3.4 Tallow With Less Than or Equal to 0.15% Insoluble Impurities of Bovine Origin for Human Consumption From Undetermined Risk of BSE Country

a. OMIC/Official Zoosanitary Export Certificate

The official veterinary certification must state the following:

  1. that the tallow was derived from animals that were stunned using a BSE slaughter process and not subjected to air injection stunning and pithing; and
  2. that the product was not prepared from and was not contaminated with the following:
    • distal ileum of bovine animals of all ages; and
    • palatine tonsils; the skull, including the brain, trigeminal ganglia and eyes; the spinal cord and the vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) from all bovine animals aged 12 months or older.

and

b. Certificate of Analysis

The certificate of analysis, which is an original report issued by an independent (third party) laboratory, showing a maximum level of insoluble impurities of 0.15% in weight, as established using the American Oil Chemists' Society (AOCS) method Ca 3a-46, must be tied directly to the shipment being imported. The testing methodology may be obtained by contacting AOCS at the coordinates above.

Importers are urged to verify import conditions by specific country of origin via the CFIA's Meat Hygiene Manual of Procedures, Chapter 10, Annex A; or AIRS.

4. Suet (Tallow With Greater Than 0.15% Insoluble Impurities) and Its Derivatives From a Country in Which the Rendering Inspection System Is Recognized as Equivalent to Canada's

(Tallow with greater than 0.15% insoluble impurities derived from the carcasses of animals of the sub-family Bovinaefor any end use.)

4.1 From Negligible Risk of BSE Countries

a. Import Permit

Each shipment must be accompanied by a copy of the permit, which must be presented at the first point of entry.

b. OMIC/Official Zoosanitary Export Certificate

The official zoosanitary export certificate should clearly describe the product and specify the country of origin.

4.2 From Controlled Risk of BSE Countries

a. Import Permit

Each shipment must be accompanied by a copy of the permit, which must be presented at the first point of entry.

b. OMIC/Official Zoosanitary Export Certificate

The official veterinary certification must state the following:

  1. that the product was derived from bovine animals which were not subjected, prior to slaughter, to a stunning process with a device that injected compressed air or gas into the cranial cavity, or to a pithing process, and which were subject to and passed ante-mortem and post-mortem inspection; and
  2. that the product was not prepared from or was not contaminated with the following:
    • the distal ileum of all ages of bovine animals; and
    • palatine tonsils; the skull, including the brain, trigeminal ganglia and eyes; the spinal cord and the vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) from all bovine animals aged 30 months or older.

4.3 Tallow With Greater Than 0.15% Insoluble Impurities From Undetermined Risk of BSE Countries Is Restricted.

4.4 Derivatives of Tallow With Greater Than 0.15% Insoluble Impurities From Undetermined Risk of BSE Countries

a. Import Permit

Each shipment must be accompanied by a copy of the permit, which must be presented at the first point of entry.

b. OMIC/Official Zoosanitary Export Certificate

The official veterinary certification must state that the product(s) was/were as follows:

  1. derived from bovine animals from a negligible BSE risk country;
  2. derived from bovine animals from a controlled risk country, which meet all of the conditions listed in 4.2b; or
  3. produced by hydrolysis, saponification, or transesterification, using high temperature and pressure, as defined in this import policy. (See detailed attestation requirements under "General Overview.")

5. Other Fats and Oils

5.1 From Designated Countries

To be considered as "designated," the country of origin must be assessed by the CFIA as free of the following diseases of the species concerned:

Non-Bovinae ruminant origin – from countries designated by the CFIA as free from foot-and-mouth disease (FMD) and recognized to be of negligible risk for BSE.

Swine origin – from countries designated by the CFIA as free from swine vesicular disease, African swine fever, classical swine fever, and FMD.

Poultry origin – from countries designated by the CFIA as free from Newcastle disease and highly pathogenic avian influenza (fowl plague).

a. Import Permit

Each shipment must be accompanied by a copy of the permit, which must be presented at the first point of entry.

b. OMIC/Official Zoosanitary Export Certificate

The official zoosanitary export certificate should clearly describe the product and specify the country of origin.

5.2 From Non-Designated Countries

A permit to import may be issued only after successful completion of a risk assessment, considering the animal health status of the country, the nature of the product to be imported, the process and treatment applied to the product, the potential cross-contamination after processing, and the end uses of the product.

Section III – Raw Inedible Animal Products and By-Products

These products are also covered by the Meat Inspection Act and the Meat Inspection Regulations, as well as the Health of Animals Act and the Health of Animals Regulations. For any additional requirements beyond those listed in this import policy regarding importation of aquaculture commodities, please refer to the Aquatic Animal Imports section of the CFIA website. The importer should also verify import conditions in AIRS.

The Canadian Food Inspection Agency's (CFIA) Import/Export Aquatic Section implements controls to prevent aquatic animal diseases from being introduced into Canada and safeguards Canada's natural aquatic animal resources. Aquatic animal carcasses, parts of carcasses and offal are covered by the Safe Food for Canadians Act, its associated Regulations, as well as the Health of Animals Act and Health of Animals Regulations.

If imported aquatic animal carcasses, parts of carcasses and offal are used for any process in Canada that creates offal and/or effluent, the commodity must meet import requirements for entry into Canada.

Imports of aquatic animal carcasses, parts of carcasses and offal of susceptible species of finfish, molluscs and crustaceans must be accompanied by an Aquatic Animal Health Import Permit and when required, Zoosanitary Export Certification from foreign trade partners.

For any additional information beyond what is listed in this import policy regarding importation of aquatic animals into Canada, please refer to the Aquatic Animal Imports section of the CFIA website. The importer must also verify import requirements of aquatic animals and their products in AIRS.

The CFIA negotiates zoosanitary export certificates that must accompany such imports from countries recognized free of diseases of concern, by susceptible species for three end uses:

  • For manufacture of food for non-food producing animals (dog, cat, ferrets, pocket pets food, other non-livestock species)
  • For direct delivery to a CFIA permitted rendering plant
  • For manufacture in Canada of pharmaceutical products

For manufacture in Canada of pharmaceutical products, as well as complying with the above Acts & Regulations administered by CFIA, all fabricators, packagers/labellers, distributors, importers, testers, and wholesalers must have an Establishment Licence (EL) issued by Health Canada as per Division 1A of Food and Drugs Act and Food and Drug Regulations, and meet the applicable sections of Division 2 relating to Good Manufacturing Practices (GMP) and comply with other relevant sections of the Food and Drug Regulations. For additional guidance see the following Health Canada Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051)

Additional Guidance on Health Canada's regulatory requirements for imports of such commodities can be found at the following web sites:

Notice to Stakeholders link in relation to the amended regulations

Health Canada form (FRM-0033) in relation to establishments that will be manufacturers, packagers, testers, distributors, AND importers of Active Pharmaceutical Ingredients (API).

Notice of the amendment of the regulations for API

For other end uses, such as laboratory, please see the specific policy for that end use at the Import Policies Animal Import Export Division (Terrestrial)

1. From a Designated Country with an equivalent veterinary infrastructure:

CFIA has negotiated zoo sanitary export certificates for raw inedible products destined for Canada with the USA, EU, Australia, and New Zealand for the above three end uses.

The zoosanitary export certificate issued must be for the end use described. Note that all of the information listed (as applicable by contents of the shipment and species of origin) by the official certificate must be included on the final issued veterinary certificate. Various countries may use different formats for their export certificates; this is acceptable provide they meet or exceed the statements listed within the negotiated certificate.

The Terrestrial Animal Health Program requires that the zoosanitary export certificate that is issued and endorsed by the central competent veterinary authorities state that the animals from which the products are derived were raised and slaughtered in that country, and that the country is recognized by Canada as free of the above-mentioned diseases (for which the species of origin is susceptible).

The zoosanitary certificate must be issued and signed by a full time, salaried veterinarian of the central competent veterinary authority of [insert name of central competent veterinary authority and country]. It must include this following initial statement, as well as all the applicable species specific clauses (as determined by the composition of the shipment).

I, the undersigned, full time, salaried veterinarian of the central competent veterinary authority of [insert name of central competent veterinary authority] after due inquiry and to the best of my knowledge, do hereby certify that the products/by-products described above:

Other exporting countries designated by Canada as being free of diseases of concern, wishing to export to Canada, for the first three end uses should contact CFIA via email at:

APABP@inspection.gc.ca to initiate certificate negotiations,

with the subject line "raw inedible products for the end use of: (indicate which end use is intended 1.For manufacture of food for non-food producing animals (dog, cat, ferrets, pocket pets food, other non-livestock species); 2.For direct delivery to a CFIA permitted rendering plant; 3. For manufacture in Canada of pharmaceutical products)"

2. From Non-Designated Countries

Case-by-case evaluation by AIED Import Animal Products & By-products subject matter expert at Headquarters is required.

To apply for evaluation of potential new import protocols, please follow the process as outlined within TAHD-DSAT-IE-2003-3-8 Development of New Import Protocols - Procedures for Clients

If the evaluation has a positive outcome and permission is granted, the importation will require an Import Permit. The specific conditions on that permit must be read and adhered to by the importer.

Facility Questionnaire:

CFIA Facility Questionnaire for Export to Canada

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