Highly Processed Products

AHPD-DSAE-IE-2001-8-4
October 23, 2009

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Amendments: The number of changes and additions to this directive are too many to summarize. This directive comes into effect October 11, 2009.

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General

This directive 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 other government departments. Products for human consumption are also regulated by Health Canada through product-specific regulatory programs, which are administered under the authority of the Food and Drugs Act and Food and Drug Regulations. Specific import conditions by commodity can be found in the Automated Import Reference System (AIRS).

Note: All ingredients and mixed feeds for livestock use must be approved and/or registered by the Animal Feed Division of the CFIA prior to importation.

CFIA Local Animal Health Offices (by province) should be contacted for further guidance on this directive.

Definitions

Animal food: food containing an animal product or animal by-product for chickens, turkeys, ducks, geese, ratites, game birds, ruminants, swine, or horses.

Designated country or zone: a country or zone determined by the CFIA to be free of reportable and immediately notifiable diseases that either affect or are transmitted by the species of origin of the animal, animal product, or by-product to be imported into Canada. Please note that the recognition of disease freedom by the CFIA is not solely dependent on World Organisation for Animal Health (OIE) status or country self-determination. The CFIA utilizes risk assessment methodology in order to determine whether a hazard is present in a country and to evaluate the risk of transmission of that hazard resulting from the importation of animals, animal products, or by-products.

To consult the Reportable and Immediately Notifiable Diseases list, view our Web site.

Please note that Canada accepts the OIE classification for country bovine spongiform encephalopathy (BSE) risk categorization; therefore, the CFIA no longer routinely carries out independent assessment regarding a country's BSE categorization. Please refer to the OIE Web site or the list included within the BSE Import Policy for Bovine Animals and their Products for BSE categorization of countries.

Livestock: horses, cattle, sheep, goats, swine, foxes, fish, mink, rabbits, and poultry, as well as other creatures that may be designated by Regulation as livestock.

Highly Processed Products - Commodity Characteristics

These commodities are:

• manufactured from ingredients of animal origin derived mammals or birds;
• in final packaging or in bulk;
• submitted to various and usually multiple treatments, either chemical or physical;
• commercially processed;
• generally used in/for:
  • food industry;
  • cosmetics;
  • industry use;
  • pharmaceuticals;
  • laboratory use.

Examples of highly processed products

(List to be reviewed regularly)

• albumin (including bovine serum Albumin or bovine serum albumin [BSA])
• amino acids
• animal glue
• bone charcoal
• bone oil
• chondroitin sulphate
• collagen
• collagen casings
• dicalcium phosphate
• enzymes of animal origin (e.g. rennet, phosphatase, peroxidase)
• fatty acid
• fibrin
• gelatin
• gelatin capsules
• glycerides
• glycerol
• glycolipids
• hormones of animal origin (e.g. insulin, adrenocorticotropic hormone)
• lactic acid
• lactose
• lactulose
• oleostearin
• ossein
• peptides
• peptone
• phospholipids
• purified DNA that does not confer disease
• serum substitutes (for laboratory uses)
• sorbitan esters
• tricalcium phosphate (bone ash)
• triglycerides
• vitamins containing ingredients of animal origin

Overview - Procedures for Importers of Highly Processed Products

Section I explains general procedures for importers of highly processed products.

Section II describes the specific bovine-derived commodity requirements when these highly processed products are for uses other than poultry and livestock feed.

Section III explains the procedures related to products for use in poultry and livestock feeds, either as stand-alone highly processed products or as ingredients within poultry and livestock feeds.

Note: Highly processed products of bovine origin may require further documentation for import into Canada. Import conditions are specifically identified for such bovine products in Section I, or in the BSE Import Policy for Bovine Animals and their Products. Import conditions for such products should be confirmed using this directive, the BSE Import Policy for Bovine Animals and their Products, and the AIRS.

Section I - General requirements

1. Highly processed products of any animal origin, including bovine origin for industrial use (e.g. mining) or laboratory use (e.g. in vitro), from any country must be clearly identified as a highly processed product or as an ingredient in finished product and clearly identified for use in industrial or laboratory processes:

1. The shipment must be accompanied by a written declaration from the importer (dated, signed, and linked to the shipment being imported), indicating the species of origin and the end use of the product.

2. Highly processed products, other than those of bovine origin, for any end use except livestock feeds, from any country must be clearly identified as such or declared as an ingredient in the finished product. (See Definitions, and the Health of Animals Regulations and the Feeds Act):

1. The shipment must be accompanied by:
   1. a written declaration from the importer (dated, signed, and linked to the shipment being imported), indicating the species of origin and end use of the product; and
   2. other import documentation as may be required. (See details by commodity in the AIRS.)

3. For non-bovine origin products, such as bone ash and other products derived from subjecting animal bones to rigorous processes of extraction and purification (e.g. glue, oleosterin, glycerol, sorbitan esters, ossein, bone charcoal, bone oil), from any country, the shipment must be accompanied by a written declaration from the importer (dated, signed, and linked to the shipment being imported), stating that the product is not derived from bones of bovine origin.

Section II - Specific Bovine-Derived Commodity Requirements for Uses other than Livestock Feed

1. Highly processed products of bovine origin for human consumption, or as raw material for the preparation of pet food, cosmetics, pharmaceuticals, natural health products, medical devices, or veterinary biologics, from a country considered to be of negligible BSE-risk:

1. The shipment must be accompanied by an official zoosanitary export certificate of origin, clearly describing the product (i.e. species and part or substance taken from said animal or animals) and specifying the country of origin.

2. Highly processed products of bovine origin for human consumption, or as raw material for the preparation of pet food, cosmetics, pharmaceuticals, natural health products, medical devices, or veterinary biologics, from a country considered to be of controlled or undetermined BSE-risk:

1. The shipment must be accompanied by an official zoosanitary export certificate from the country of origin, stating that the product was not prepared using the following bovine tissues or any protein products from which they were derived:
   1. 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; and
   2. the product was not prepared using the distal ileum from bovine animals of all ages.

3. For bovine-origin products derived from subjecting bones to rigorous processes of extraction and purification (e.g. glue, oleosterin, glycerol, sorbitan esters, ossein, bone charcoal, bone oil) from countries of:

1. negligible risk for BSE: for any end use, the shipment must be accompanied by an official zoosanitary export certificate that clearly describes the product and specifies the country of origin.
2. controlled risk for BSE: for any end use, the shipment must be accompanied by an official zoosanitary export certificate from the country of origin, stating that the product was not prepared using the following bovine tissues or any protein products from which they were derived:
   1. distal ileum from bovine animals of all ages; and
   2. 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.
3. The importation of products of bovine origin that were derived from subjecting bones to rigorous processes of extraction and purification (e.g. glue, oleosterin, glycerol, sorbitan esters) from countries of undetermined BSE-risk is restricted at this time.

4. For bovine-origin gelatin and collagen prepared from hides and skins, or bones from countries of negligible risk for BSE for any end use, the shipment must be accompanied by an official zoosanitary export certificate that clearly describes the product (i.e. bovine parts - bones versus hides - used in the production of the product), and specifies the country of origin.

5. For bovine-origin gelatin and collagen prepared from hides and skins from countries of controlled risk and undetermined risk for BSE, for any end use, the shipment must be accompanied by an:

1. Official zoosanitary export certificate, stating the following:
   1. That the product is derived solely from bovine hides and skins (not from bovine bones) and that the hides and skins from the head (face plates only) of bovine animals aged 30 months or older, which were stunned with a penetrating device, were:
      • removed; or
      • trimmed of hide a minimum of 2.5 cm around the stun hole and a minimum of 2.5 cm around all parts of the face plate which were visibly contaminated with brain tissue; or
      • washed, scraped, vacuumed, or otherwise processed to remove visible brain materials;
      and
   2. The product was produced using an alkalinization process (i.e. liming or a NaOH step or a combination of the two processes).

6. For bovine-origin gelatin and collagen prepared from bones from countries of controlled risk for BSE and of undetermined risk for BSE, for all end uses:

1. The shipment must be accompanied by an official zoosanitary export certificate from the country of origin stating that:
   1. the bones used to prepare the product were derived from bovine animals that 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, and were subjected to and passed ante-mortem and post-mortem inspection;
   2. the bones used to prepare the product do not include skulls and vertebrae (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) from bovine animals 30 months of age or older; and
   3. the bones used to prepare the product have been subjected to a process that includes all of the following steps:
      • pressure washing (degreasing);
      • acid demineralization;
      • acid or alkaline treatment;
      • filtration; and
      • sterilization at a temperature of at least 138°C for a minimum of four seconds.
   or
2. The shipment must be accompanied by an import permit and an official zoosanitary export certificate with an equivalent or better process for reducing BSE infectivity as determined by CFIA Headquarters - Terrestrial Animal Health Division (TAHD) Import Section. The determination of equivalent or better process must be made prior to issuing the permit for importation, and the import permit will specify what that process entails.

7. For bovine-origin dicalcium phosphate, with no trace of protein or fat, from countries of:

1. negligible risk for BSE, for any end use, the shipment must be accompanied by an official zoosanitary export certificate that clearly describes the product and specifies the country of origin.
2. controlled risk for BSE and undetermined risk for BSE for human consumption, the shipment must be accompanied by the following:
   1. an official zoosanitary export certificate from the country of origin, stating that the product:
      • was not prepared from or contaminated with distal ileum from bovine animals of all ages;
      • was not prepared from or contaminated with 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
   2. a written declaration from the importer (dated, signed, and linked to the shipment being imported), stating that the product does not contain any trace of protein or fat.
3. Controlled and undetermined risk for BSE for inedible or industrial uses, the shipment must be accompanied by:
   1. an official zoosanitary export certificate that clearly describes the product and specifies the country of origin; and
   2. a written declaration from the importer (dated, signed, and linked to the shipment being imported), indicating the following:
      • the species of origin
      • that the product does not contain any trace of protein or fat
      • the end use of the product is not for human consumption

8. For bovine-origin dicalcium phosphate, with traces of protein or fat, the shipment from both negligible and controlled risk for BSE countries must be accompanied by:

1. a shipping invoice that states the following:
   1. the names of the consignor and consignee
   2. the product contains prohibited material

2. a label on the product that bears the cautionary statement: Do Not Feed To Cattle, Sheep, Deer, Or Other Ruminants.

   In addition to meeting the label and shipping invoice requirements in 8.a) and 8.b) for bovine-origin dicalcium phosphate, with traces of protein or fat, from countries of:

3. negligible risk for BSE, for any end use, the shipment must be accompanied by an official zoosanitary export certificate that clearly describes the product and specifies the country of origin.
4. controlled risk for BSE, for any end use, the shipment must be accompanied by an official zoosanitary export certificate from the country of origin, stating that the product:
   1. is derived from bovine animals that 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, and that were subjected to and passed ante-mortem and post-mortem inspection;
   2. is not prepared from or contaminated with distal ileum from bovine animals of all ages;
   3. is not prepared from, or contaminated with, 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 bovine animals aged 30 months or older; and
   4. is a by-product of bone gelatin produced according to all the steps listed in 6.a)iii) These processing steps must be specifically listed within the official zoosanitary export certificate.
5. The importation of dicalcium phosphate of bovine origin, containing traces of protein or fat from countries of undetermined BSE risk, is restricted at this time.

Section III - Products for use in livestock feeds

(Either as stand-alone highly processed products or as ingredients)

All ingredients and mixed feeds for livestock use must be registered with the Animal Feed Division of the CFIA prior to importation.

1. Highly processed products, other than those of bovine, caprine, or ovine origin, and livestock feed (see animal feed definition in the Health of Animals Regulations) may be imported:

1. from the U.S. according to the TAHD, if the Canada Border Services Agency (CBSA) determines that the country of origin is the U.S., as per Sections 53 and 41.(1) of the Health of Animals Regulations.
2. from designated countries, if the shipment is accompanied by an official zoosanitary export certificate from the country of origin, in accordance with Section 53 and 41.(2) of the Health of Animals Regulations, which clearly describes the product and specifies that the country of origin and the country is free of the diseases of concern.
3. from non-designated countries if accompanied by an import permit as per Section 52.2 of the Health of Animals Regulations and certification attesting to acceptable processing may be required. The conditions will be determined, prior to importation, by CFIA Headquarters, TAHD, Import Section, (as per Section 52.1 of the Health of Animals Regulations). Commodity-specific import requirements will be listed in the Automated Import Reference System.

2. Bovine- and non-bovine-origin gelatine from any country must be accompanied by official zoosanitary export certification, attesting to all four of the following treatments:

1. Acid treatment or alkaline treatment with:
   • pH equal to, or less than, 3 for at least 2 hours; or
   • pH 14 for at least 10 days; or
   • pH 12 for at least 12 days; or
   • pH 9 for at least 16 days; and
2. Extraction at:
   • at least 60°C for not less than 2 hours; and
3. Sterilization or Pasteurization at:
   • at least 110°C for at least 5 seconds; or
   • at least 90°C for at least 30 seconds; and
4. Drying at:
   • at least 32°C for at least 2 hours.

Note: For bovine-origin gelatin, extra certification requirements apply. See Section II of this directive for the specific import conditions for such products.

3. Highly processed products of bovine, ovine, or caprine origin, as well as enzymes, such as adrenocorticotropic hormone (ACTH), and insulin may be imported:

1. from the U.S., according to the TAHD, if the CBSA determines that the country of origin is the U.S., as per Sections 53 and 41.(1) of the Health of Animals Regulations.
2. from designated countries, if the shipment is accompanied by an official zoosanitary export certificate from the country of origin that clearly describes the product and specifies the country of origin and that the country is free of the diseases of concern, in accordance with Sections 53 and 41.(2) of the Health of Animals Regulations.
3. from non-designated countries if accompanied by an import permit as per Section 52.2 of the Health of Animals Regulations, after a successful case-by-case evaluation by CFIA, Headquarters - TAHD, Import Section, according to Section 52.1 of the Health of Animals Regulations.

Note: Importation of lanolin and licensed veterinary drugs is not regulated by the TAHD.

Importation of tallow and its derivatives is addressed in the Rendered Products and Inedible Products general import directive.

Highly processed products of animal origin intended for livestock feed listed in Schedule IV, PART II, of Feeds Regulations, must be registered with the Feed Section prior to importation to Canada.