Highly Processed Products

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TAHD-DSAT-IE-2001-8-5
May 9, 2012

Amendments: The addition of information regarding medicinal and natural health products for animals and milk products, and the addition of Health Canada contact information as Appendix I.

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, as well as medicinal or natural health products for animals, 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. (Please see Appendix I for more information on Health Canada requirements.)

Specific CFIA 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.

Please contact your nearest CFIA Animal Health Office 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 uses risk assessment methodology 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.

Consult the lists of Reportable and Immediately Notifiable Diseases on the CFIA website.

Canada accepts the OIE classifications for country bovine spongiform encephalopathy risk categorization; therefore, the CFIA no longer carries out independent assessment regarding a country's BSE categorization. Please refer to the OIE website provided above or the list included within the Bovine Spongiform Encephalopathy Import Policy for Bovine Animals and Their Products and By-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 – Characteristics

These commodities are as follows:

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

Examples of Highly Processed Products

(Partial list)

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

Note: Highly processed products such as casein, lactose, lactulose, or other compounds, that are extracted and purified from milk, do not have any BSE requirements. They fall under Section I or III of this directive, depending on end use, even when of bovine origin.

Procedures for Importers of Highly Processed Products

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

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

Section III explains the procedures related to products for use in farm animal 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 umbrella import document, Bovine Spongiform Encephalopathy Import Policy for Bovine Animals and Their Products and By-Products. Import conditions for such products should be confirmed using these import procedural directives and AIRS.

Section I – General Requirements

1. A highly processed product 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," the Health of Animals Regulations and the Feeds Act.)

  1. The shipment must be accompanied by the following:
    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 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. In the case of highly processed products of bovine origin for human consumption, or intended 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 the following:
    1. that the product was not prepared using the following bovine tissues or any protein products from which they were derived: 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. that 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 as follows:

  1. 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 and specifies the country of origin.
  2. Of 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. In the case of 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, clearly describing the product (i.e. bovine parts – bones versus hides – used in the production of the product), and specifying the country of origin.

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

  1. An 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 handled as follows:
      • 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. That the product was produced using an alkalinization process (i.e. liming or a NaOH step or a combination of the two processes).

6. In the case of bovine-origin gelatin and collagen prepared from bones from countries of controlled risk for BSE or of undetermined risk for BSE, for all end uses, the shipment must be accompanied by the following:

  1. An official zoosanitary export certificate from the country of origin stating the following:
    1. that 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. that 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. that 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. 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 specifies what that process entails.

7. In the case of bovine-origin dicalcium phosphate, with no trace of protein or fat, from countries as follows:

  1. 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 and specifies the country of origin.
  2. Of 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 the following of the product:
      • that it was not prepared from or contaminated with distal ileum from bovine animals of all ages, and
      • that it 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. Of controlled and undetermined risk for BSE for inedible or industrial uses – the shipment must be accompanied by the folloiwng:
    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, and
      • that the end use of the product is not for human consumption.

8. In the case of 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 the following:

  1. A shipping invoice that states the following:
    1. the names of the consignor and consignee; and
    2. that 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 at 8.a) and 8.b), above, a shipment of bovine-origin dicalcium phosphate, with traces of protein or fat, from countries as follows:

  3. Of negligible risk for BSE – for any end use, must be accompanied by an official zoosanitary export certificate, clearly describing the product and specifying the country of origin.
  4. Of controlled risk for BSE – for any end use, must be accompanied by an official zoosanitary export certificate from the country of origin, stating the following of the product:
    1. that it 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. that it is not prepared from or contaminated with distal ileum from bovine animals of all ages;
    3. that it 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. that it is a by-product of bone gelatin produced according to all the steps listed in 6.a)iii., above. (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

(Used either as such or as ingredients.)

Note: 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 may be imported as follows:

  1. From the U.S. – according to TAHD, if the Canada Border Services Agency (CBSA) determines that the country of origin is the U.S., according to section 53 and subsection 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 subsection 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 (according to section 52.1 of the Health of Animals Regulations). Commodity-specific import requirements will be listed in AIRS.

Note: See "animal feed" definition in the Health of Animals Regulations.

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 as follows:
    • with pH equal to or less than 3 for at least two hours;
    • with pH 14 for at least 10 days;
    • with pH 12 for at least 12 days; or
    • with pH 9 for at least 16 days.

    and

  2. Extraction at at least 60°C for not less than two hours.

    and

  3. Sterilization or pasteurization as follows:
    • at a temperature of at least 110°C for at least five seconds, or
    • at a temperature of at least 90°C for at least 30 seconds.

    and

  4. Drying at at least 32°C for at least two hours.

Note: In the case of 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 adrenocorticotopic hormone (ACTH), and insulin may be imported as follows:

  1. From the U.S. – according to the TAHD, if the CBSA determines that the country of origin is the U.S., as per section 53 and subsection 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 section 53 and subsection 41(2) of the Health of Animals Regulations.
  3. From non-designated countries – if accompanied by an import permit in accordance with section 52.2 of the Health of Animals Regulations, after a successful case-by-case evaluation by the 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 TAHD.

Importation of tallow and its derivatives is addressed in the Terrestrial Animal Health Import Requirements for Rendered and Inedible Products directive.

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

Appendix I: Health Canada Contact Information – Requirements for Medicinal or Natural Health Products Used by Humans or Animals

For animal products or animal by-products used in, or as, medicinal or natural health products, importers must verify with Health Canada the requirements for sale or use of such products in Canada. Both medicinal and natural health products, used by animals or humans, may require a drug identification number (DIN) or a natural product number (NPN), depending on the commodity or its end use.

Some of the Health Canada requirements for active pharmaceutical ingredients (API) can be found on the Notice of Intent web page.

For products used in or by animals, contact the Veterinary Drugs Directorate's Submission and Knowledge Management Division for their requirements:

Submission and Knowledge Management Division
Veterinary Drugs Directorate
Holland Cross Complex
Ground Floor, Suite 14
11 Holland Avenue
Address Locator 3000A
Ottawa, Ontario K1A 0K9
vetdrugs-medsvet@hc-sc.gc.ca
Fax: 613-946-1125
Teletypewriter: 1-800-267-1245

Additional Information

  • For medicinal or natural health products for human use, see Health Canada's guidance documents.
  • The employee directory for the Therapeutics Products Directorate includes information on the organization and a telephone list.
  • The Submission and Information Policy Division (SIPD) of Health Canada deals with the following categories: Submission Processing (drugs); Performance Reports (drugs); Information Dissemination and Publications; and DIN Issuance and Notification. Contact via email at SIPDMail@hc-sc.gc.ca; or by telephone at 613-941-0827, or by fax at 613-941-0825.
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