Outline of the system
Under the Health of Animals Act and the Health of Animals Regulations, along with the associated Import Reference Documents for terrestrial animal health, the importation of live terrestrial and aquatic animals, animal and aquatic animal products, animal by-products, aquatic animal carcases, animal pathogens, and other things (such as used equipment) may be imported under certain conditions. Imports are permitted from countries that have negotiated export market access with Canada and comply with the negotiated animal health conditions.
Animal products and by-products used in the preparation of food, cosmetics, drugs (including pharmaceuticals for use in animals, pharmaceuticals and biologics for human use, and natural health products for use in animals or humans), and medical devices are also regulated by Health Canada through product-specific regulatory programs. For these products, the regulatory requirements for animal products and by-products are administered by the CFIA under the authority of the Food and Drugs Act and the Food and Drug Regulations. Veterinary biologics and their components are regulated by the CFIA under the Health of Animals Act and the Health of Animals Regulations. Importers must comply with the import requirements of all Canadian government departments or agencies for a particular commodity.
Authority for animal pathogens is shared between the CFIA and the Public Health Agency of Canada (PHAC). In 2013 an Order in Council (OIC SI/2013-41) transferred authority from the Minister of Agriculture to the Minister of Health for the responsibility of pure cultures of indigenous, terrestrial animal pathogens (HAR 51a). The CFIA maintains regulatory authority over non-indigenous terrestrial animal pathogens, aquatic animal pathogens and animal pathogens imported in an animal product or by-product (HAR 51a and 51b). For the pathogens under its authority, PHAC administers pathogen and toxins licences to certified containment laboratories for periods of one to five years depending of the risk groups of the pathogens. For pathogens under CFIA authority, answers are provided below.
In response to changes in health status, import requirements can change at any time.
For importation of aquatic animals (finfish, molluscs and crustaceans) and their products listed in the Health of Animals Regulations as susceptible to the diseases of concern, a permit and a zoosanitary certificate is required. For importation of aquatic animals (finfish, molluscs and crustaceans) and their products from shared waters within the U.S. which have been established as having the same health status for specific diseases of concern and are intended for specific end uses such as those for human consumption (Food Service, Retail Use and Further Processing), only an import permit may be required. Import permits are not required for aquatic animals not considered susceptible to diseases of concern and for products that are considered safe in accordance with international standards of the OIE or as a result of a risk assessment.
For the most up to date information and additional details on CFIA import requirements, please refer to the Automated Import Reference System (AIRS) at: http://www.inspection.gc.ca/english/imp/airse.shtml
The following products are covered: Terrestrial live animals and germplasm, Susceptible species of live aquatic animals (finfish, molluscs and crustaceans) and their germplasm and products, Terrestrial animal products and by-products, Animal pathogens and Veterinary biologics.
For countries other than the U.S., a permit is required for:
• all terrestrial animals (except pet dogs and domesticated cats, certain rodents, reptiles excluding turtles and their eggs, amphibians and marine mammals),
• susceptible species of live aquatic animals, germplasm and their products
• semen (except canine),
• veterinary biologics,
• animal pathogens (CFIA permit or PHAC pathogen and toxin license), and
• certain animal products and by-products depending on the species and country of origin.
For importation from the U.S., a permit is required for the following:
• semen (except for equine and canine),
• veterinary biologics,
• psittacine birds (other than pet birds),
• turtles, tortoises,
• skunks, foxes and raccoons,
• some ruminants and swine,
• dogs under eight months of age (commercial shipments and for research)
• certain rodents,
• certain animal products and by-products dependent on species,
• susceptible species of live aquatic animals, germplasm and their products, and
• animal pathogens (CFIA permit or PHAC pathogen and toxin license).
Nature of licensing
If Automatic, administrative purpose
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The permit system is intended to ensure that all items identified in No.1 are imported in conformity with Canada's sanitary health regulations to protect against the introduction of diseases into or spread within Canada. Decisions are made following a risk analysis and risk assessment process.
The value of imports is not restricted by import permits. For single entry permits a finite quantity may be stipulated in the permit and this quantity may not be exceeded. For multi entry permits this is no restriction on the quantity that may be imported.
Questions for products under restriction as to the quantity or value of imports
There are no quotas under the Health of Animals Act. If all aspects of an application package are compliant and it is for a commodity that may be imported into Canada, the import permit is issued.
The system applies to products originating from which country?
For terrestrial animals (both live animals and products/by-products): Imports are permitted only from countries which are recognized by the Canadian Food Inspection Agency as free of serious animal diseases which may affect the species of animal imported. However, certain animal products may be imported from countries that are not free of these diseases under an import permit if they have been treated or processed to eliminate the disease. Imports may also be restricted on behalf of other government agencies when there is concern about a disease which may be transmitted to people.
For aquatic animals: Imports are permitted only from countries with which a zoosanitary certificate has been negotiated based on an evaluation of their aquatic animal health regulatory system. Imports of aquatic animals and their products may be permitted without a zoosanitary certificate only from shared waters with the US that have been established as having the same health status for diseases of concern and are intended for certain end uses.
For animal pathogens: Imports may be permitted into containment laboratories certified and approved by the Government of Canada to appropriately handle the risks associated with the pathogen and/or the animal product or by-product associated with the animal pathogen. Animal pathogens in an animal product or by-product are subject to the same restrictions as indicated above - imports may be restricted from countries not recognized by the Canadian Food Inspection Agency as free of serious animal diseases. Under certain circumstances imports may be permitted if treated or processed to eliminate the disease.
If there is interest in importing a new commodity for which established import conditions do not exist, or from a country which has not been previously assessed by Canada, an Animal Health Risk Assessment (AHRA) may be conducted which is a science-based risk evaluation. If supported by the outcome of the AHRA, the commodity may be imported.
Expected duration of licensing procedure
Is the licensing statutorily required?
The Health of Animals Act and Regulations thereunder. Importers of aquatic and terrestrial animals or their products or by-products are also required to comply with the requirements of all other applicable CFIA legislation, regulations, policies and directives, such as the Safe Food for Canadians Act and Regulations, the Feeds Regulations, and the Fertilizers Act and Regulations.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Goods, products and animals requiring permits are specified see No.1
Is it possible for the government to abolish the system without legislative approval?
There is no authority to waive regulations.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
Any resident of Canada or company registered in Canada who has the necessary qualifications and facilities to satisfy the import permit conditions may apply for an import permit.
Is there a registration fee?
There are applicable fees for import permits.
Is there a published list of authorized importers?
There is no published list of authorized importers.
Contact point for information on eligibility
Submission of an application
Administrative body(ies) for submission of an application
What information is required in applications?
Application must be made electronically or in writing using the appropriate application form, and must specify the species, quantities, date of arrival, country of origin and purposes of import. For aquatic animals, Part XVI of the Health of Animals Regulations requires specific species listed in Schedule III to have an import permit. All aquatic animals must meet the requirements of Section 194 which includes name and address of the importer and exporter, taxonomic name, quantity/number and the location where the animal was born.
What documents is the importer required to supply with the application?
For rendered products and pet food, inspection questionnaires for the exporting premises must be completed by the competent authority of the exporting country and included with the application.
Import permits may be applied for through the National Centre for Permissions (NCP) https://inspection.canada.ca/about-cfia/complaints-and-appeals/eng/15471... (formerly the Centre of Administration). Formalities for completing applications can be found at this site https://www.inspection.gc.ca/about-the-cfia/permits-licences-and-approva....
Window of submission of an application
How far in advance of importation must application for a licence be made?
In the case of live animals, animal semen, animal by-products, animal pathogens, aquatic animals and their products an import permit must be issued prior to the commodity arriving in Canadian territory.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Issuing the license
Can a licence be granted immediately on request?
There is no lag time between the import permit being issued and when the shipment may enter Canada. However, an import permit may not be issued to a shipment that has already arrived in Canadian territory.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The permit describes the conditions of importation pertaining to health certification, post-import conditions, treatments, etc. that must be satisfied. On arrival at the port of entry in Canada:
(i) animals and their products may be subject to veterinary inspection, as applicable, and the accompanying permit and health certification (if required) are inspected to assure that import requirements are met;
(ii) product inspection may occur at designated receiving centres inland;
(iii) some aquatic and terrestrial animals require post-import quarantine;
(iv) some aquatic and terrestrial animals require post-import testing (in quarantine); and
(v) ornamental aquatic animals may be required to be imported to designated premises.
In the case of veterinary biologics, production outlines and data to support purity, safety, potency and efficacy for each product must be submitted and approved prior to the issuance of the permit. They are examined and reviewed to assure the product is safe, free from contaminants and that the label meets all requirements.
In the case of animal pathogens, the importing laboratory must demonstrate compliance to the applicable Canadian biosafety standard prior to the issuance of the permit.
Which administrative body is responsible for approving application of licences?
The National Centre for Permissions (NCP) (formerly the Centre of Administration of the Canadian Food Inspection Agency) delivers and coordinates the full range of operational administrative services required for import related permissions under this section (http://inspection.gc.ca/about-the-cfia/permits-licences-and-approvals/en...). All permit applications are sent to the NCP, Regulatory Permissions and Registration Division, National Service Centres Directorate of the Canadian Food Inspection Agency.
Must the applications be passed on to other organs for visa, note or approval?
Other regulatory bodies may also have applicable import requirements for the commodity. Examples include:
• The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)-listed species which require an additional permit from Environment Canada
• Other federal domestic requirements for introduction of aquatic animals into natural waters under Fisheries and Oceans Canada
• requirements for products with medicinal claims under the Veterinary Drugs Directorate of Health Canada
Are there any other conditions attached to the issue of a licence?
Some commodities may fall under the import requirements of the Health of Animals Act as well as the requirements of other legislation under the administration of the CFIA. They may also fall under the requirements of other government bodies. It is the importer's responsibility to comply with all applicable legislation.
The conditions within an import permit are tailored to the specific commodity and are intended to prevent the introduction of animal diseases into Canada. Examples may include, the disease status of the country or origin, testing, quarantine, treatments etc.
If an importer is not able to meet one of Canada's established import conditions they may apply to the Canadian Food Inspection Agency for a derogation. This requires that the importer provide a written request outlining the reason the import condition cannot be met and an equal alternative risk mitigation measure to be reviewed and considered by the CFIA.
There is provision for the importation of certain food products to a maximum amount for sample purposes only under approved conditions.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
What is the amount of the fee or charge?
See CFIA Fees notice at: https://inspection.canada.ca/about-cfia/acts-and-regulations/list-of-act....
Is there any deposit or advance payment required associated with the issue of licences?
Yes, payments are requested at the time of submitting the application.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
The CFIA can refuse to issue import permits on some occasions. Examples of these are:
(a) When the disease status of a country does not meet minimum criteria, a permit will not be issued.
(b)When a country does not have a satisfactory disease diagnosis capability or disease control organization, a permit may not be issued.
(c) Dependent on the departmental mandate for a particular commodity or risk factor/hazard, CFIA consults with either Health Canada, or Public Health Agency of Canada, with regard to zoonoses or communicable diseases common to humans and animals or in the case of aquatic animals, Fisheries and Oceans Canada with respect to introduction into natural waters.
(d) Commercial importers of veterinary biologics must be approved by the foreign company manufacturing the products and also must have acceptable facilities and procedures to meet the CFIA's import conditions, such as maintaining the cold chain and reporting adverse events.
Are the reasons for any refusal given to applicants?
Have applicants a right of appeal in the event of refusal to issue a licence?
If an applicant wishes to have a decision to decline an import permit reviewed or appealed, they may do so according to the protocol on the CFIA website.
If so, to what bodies and under what procedures?
Are there any limitations as to the period of year during which importation may be made?
What documents are required upon actual importation?
In addition to the permit to import animals, animal by-products, animal pathogens, aquatic animals and their products and the normal customs documentation, a zoosanitary certificate of health issued by the Competent Authority or Veterinary Services of the country of origin must accompany the shipment if required. Some exceptions exist for aquatic animals and their products. A customs document is also needed. For terrestrial animals, some form of animal identification is generally required. Please consult the Automated Import Reference System for additional information on import requirements.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Pre-import quarantine and testing may be required. For animal products and by-products the conditions for import vary by the risk posed by the commodity, the processing, end use and origin. The importer may be required to obtain an import permit, and zoosanitary certification endorsed by the exporting country. To verify import conditions for terrestrial animal products and by products, please check the Automated Import Reference System (AIRS) as well as published import policies at http://www.inspection.gc.ca/animals/terrestrial-animals/imports/policies....
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Will often vary depending on the commodity and the purpose of the importation. It varies from single entry shipment to multiple shipments over a one -year period. A single-entry permit is generally valid for three months.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Is a licence required as a condition to obtaining foreign exchange?
Is foreign exchange always available to cover licences issued?
What formalities must be fulfilled for obtaining the foreign exchange?