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Canadian Regulatory Requirements for Quality Management Program Import Licence Holders (QMPI Importers)
Table of Contents
1. Purpose
2. Scope
3. Relevant Legislation
3.1 Regulatory Framework
3.2 Authorities
4. QMPI
Importer Regulatory Requirements
4.1 Licencing
4.1.1 Duration and Validity of a Licence
4.1.1 Documented QMPI Plan
4.1.2 Licence Renewal
4.1.3 Licence Suspension, Revocation or Refusal
4.1.4 Licence Reinstatement
4.2 QMPI
Plan
4.2.1 QMPI Plan
Development
4.2.2 QMPI Plan
Implementation
4.3 Import Product Restrictions
4.3.1 Prohibited Fish
4.3.2 Live and Raw Molluscan Shellfish
4.3.3 Fish Product Containing Meat Product
4.3.4 Novel Fish
4.3.5 Endangered Species
4.3.6 Fish By-Products and Natural Health Products
4.4 Import Product Notification
4.5 Service Fees
4.6 Fish Program Updates
Appendix A - Forms
A.1 QMPI
Licence application
A.2 Application for Credit CFIA/ACIA 0015
A.3 Import Notification Form including instructions
A.4 Import Products Destined for Further Processing in a Federally Registered
Establishment
A.5 Mandatory Inspection List Update
1. Purpose
This regulatory directive outlines the Canadian regulatory requirements for importing fish and seafood products into Canada for commercial purposes as food for direct human consumption or further processing. This directive describes the responsibilities of the importer as they apply to importing fish and seafood products into Canada under a quality management program import licence.
2. Scope
This directive applies to all quality management program import (QMPI) licence holders and applicants who are interested in the requirements for importing fish into Canada under a QMPI licence. These importers are called "QMPI Importers".
3. Relevant Legislation
3.1 Regulatory Framework
The Canadian Food Inspection Agency (CFIA) is the federal agency that enforces the policies and standards set by Health Canada, governing the safety and nutritional quality of all food sold in Canada. CFIA's mandate is to safeguard Canada's food, animals, and plants and to protect public health.
The Fish Inspection Act requires persons who import fish into Canada to be licenced by the CFIA. The responsibilities of the importer and licencing requirements are outlined in the Fish Inspection Regulations.
3.2 Authorities
The authority for the control and inspection of fish is provided by:
- Fish Inspection Act (R.S.C., 1985. c.F-12)
- Fish Inspection Regulations (C.R.C. 1978 c.802, as amended)
- Canadian Food Inspection Agency Fees Notice, Part 16
- Food and Drugs Act and Food and Drug Regulations (as it relates to food)
- Consumer Packaging and Labelling Act and Consumer Packaging and Labelling Regulations (as it relates to food)
The CFIA also takes into consideration the requirements of other Canadian Acts and Regulations applicable to the inspection of food, such as applicable legislation relating to the National Aquatic Animal Health Program and Provincial/Territorial requirements.
4. QMPI Importer Regulatory Requirements
4.1 Licencing [FIR, 6.(2)(d), 6.1(1.1); CFIA Fees Notice, Part 16]
To apply for a quality management program import licence, you need to submit a complete application package to a local CFIA office. By applying for a licence you agree to be responsible for the fish you import and you will ensure that it meets all the applicable Canadian regulatory requirements. As well, you must meet all the applicable import licence and Fish Inspection Regulation requirements.
An Application for a Fish Import Licence CFIA/ACIA 5587 QMPI can be found at www.inspection.gc.ca or Appendix B.1. A complete application package for a QMPI licence must include the following:
- completed application form for QMPI licence
- for new importers, Application for Credit CFIA/ACIA 0015
- $5000 fee as fixed by the Canadian Food Inspection Agency Fees Notice
- Canada Revenue Agency Business Number documentation
- a documented quality management program import (QMPI) plan
4.1.1 Duration and Validity of a Licence [FIR, 6.1(2)]
A licence cannot be transferred or assigned to another business or person. The licence would become void if this were to occur.
If there is a change in shareholder status, or the transfer of ownership of a parent company, a licence will remain valid if the immediate ownership of the licence remains the same.
4.1.2 Documented QMPI Plan [FIR, 6.1(3)(e)]
The QMPI licence holder must develop and submit a written QMPI plan that meets both the QMPI Reference Standard and relevant regulatory requirements. The CFIA will review the application package to ensure it meets all the requirements prior to issuing the licence. Incomplete application packages will be returned to the applicant.
4.1.3 Licence Renewal
To request a licence renewal you must re-submit a completed application form and the import license fees. In order to maintain a valid import licence, your request for renewal should be initiated prior to the expiration of your current licence.
The licence renewal process takes into consideration your compliance to the Fish Inspection Regulations and maintaining your QMPI program in good standing.
4.1.4 Licence suspension, revocation or refusal [FIR, 6.2 (1)]
To maintain your import license in good standing, you must meet all the applicable FIR requirements. Providing false information or failure to meet the applicable FIR requirements may lead to a suspension or revocation of the import licence. The CFIA may refuse to issue a license if you are unable to demonstrate that you are willing or able to comply with the FIR, including the payment of fees. A license will also not be issued to legitimize the importation of product that has been imported without a license.
4.1.5 License reinstatement [FIR, 6.2(2), (3) and (4), CFIA Fees Notice]
The result of the determination is final. CFIA will charge the applicable fees for the services rendered as fixed by the CFIA Fees Notice, Part 16, Table 3.
4.2 QMPI Plan
4.2.1 QMPI Plan Development [FIR, 6.1(1.1)(c)]
The QMPI plan must address all the applicable regulatory requirements within the 7 control elements of the QMPI reference standard:
- License holder responsibilities
- Product sourcing plan
- Pre-requisite plan
- Product safety assessment and management plan
- Product compliance plan
- Verification and maintenance of the QMPI plan
- Record and document control.
4.2.2 QMPI Plan Implementation [FIR, 6.1(1.1), 6.1(4)(a)]
Once CFIA has accepted your QMPI plan, you must implement your QMPI plan as written. At least once a year, the CFIA will conduct a compliance verification (CV) of the delivery of your QMPI plan. To maintain your licence in good standing, you must correct the non-conformities within the time frame agreed to by CFIA. The assessment of a critical non-conformity may result in enforcement action including suspension or revocation of your licence.
4.3 Import Product Restrictions
4.3.1 Prohibited Fish [FIR, 6.(4)(a), and (b)]
Importation of the following fish is strictly prohibited:
- live freshwater mitten crab of the genus Eriocheir; and
- puffer fish of the family Tetraodontidae
4.3.2 Live and Raw Molluscan Shellfish [FIR, 6.(1)(b)]
These requirements and the procedures you must follow are described on the CFIA website in the document "Importing Live and Raw Molluscan Shellfish").
1Imports of geoduck meat free of viscera, and scallop meat/adductor muscle free of viscera and roe are exempt from these requirements.
4.3.3 Fish Product Containing Meat Product [FIR 6.1(a), 3.(2)(b)]
The product can only be imported if the meat establishment where the animal was slaughtered and where the meat was processed is authorized to export meat product to Canada. On the Fish Import Notification, the importer must include the country and the establishment number where the animal was slaughtered and the country and the establishment number where the meat was processed.
Meat products containing fish ingredients and which are considered meat products are exempted from the Fish Inspection Act and Regulations and are regulated under the Meat Inspection Act and Regulations.
A listing of the products that falls into this category, can be found at on the CFIA website in the document "Classification of Products Containing Fish and Meat - Table of Accepted Processes and Ingredients".
If you are importing a product containing both meat and fish which is not listed, you must submit an application to the CFIA requesting an exemption from either the Meat Inspection Regulations or the Fish Inspection Regulations as outlined in Chapter 2, Subject 8 of the Fish Products Inspection Manual.
4.3.4 Novel Fish [FIR 6.1(a), FDR Division 28]
Prior to importing a new fish species, a fish product processed in a new way, or a fish product in new packaging that is new to Canada, you must contact Health Canada to assess the product for safety. For more on novel foods and the safety assessment guidelines, visit the website for Health Canada at www.hc-sc.gc.ca.
4.3.5 Endangered Species
The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) is an international agreement between governments which controls the movement of endangered species between countries. A CITES permit is required for species on the list whether they are alive or dead, as well as products processed from these species. If you import any "CITES-listed" species without a valid CITES export permit, you risk losing your shipment and you could be prosecuted.
If you import, or intend to import, sturgeon or caviar (sturgeon eggs), you should be aware that sturgeon species are "CITES-listed", and specific import restrictions apply. Other fish species may be on the CITES list and you should verify this prior to importation to ensure that commercial trade is permitted and a CITES permit accompanies the shipment where applicable.
For more information on CITES, visit the website for the Canadian Wildlife Services of Environment Canada at www.cites.ec.gc.ca. For permit information, contact the Canadian CITES office at 1-800-668-6767 or 819-997-1840.
4.3.6 Fish By-Products and Natural Health Products
Fish by-products imported for human consumption as a food or food ingredient or imported for further processing at an establishment registered under the Fish Inspection Regulations (FIR) are considered fish products and must meet the requirements of the FIR.
Fish by-products imported for further processing at an establishment licenced with Health Canada (HC) for the manufacture of Natural Health Products and/or drugs is not considered a fish product. However, you must be able to demonstrate that the fish by-product is going to an establishment licenced with HC for the manufacture of Natural Health Products and/or drugs in order for these products to be exempted from the FIR.
Fish by-products imported as a ready to use Natural Health Product (NHP) are regulated under the Natural Health Product Regulations. Before you can import an NHP for sale in Canada, the product must have received market authorisation from HC by way of a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). You must also obtain a site license from HC in order to import for sale a NHP. Additional information on NHPs and the requirements for importing NHPs can be found on Health Canada's website.
4.4 Import Product Notification [FIR, 6.(2)(b), and (e), 6.(2.1)]
AND
The importer must notify CFIA of each shipment of fish imported into Canada either prior to entry or within 48 hours after importation into Canada.
You are required to report to the Canada Border Services Agency (CBSA) each shipment imported. For information on CBSA importer requirements refer to the CBSA website. http://www.cbsa-asfc.gc.ca/import/menu-eng.html
You are also required to notify the CFIA of all fish imported. Each shipment of imported fish must be notified either prior to entry into Canada or within 48 hours after importation into Canada. The import notification form (INF) and instructions to complete an INF can be found at www.inspection.gc.ca or Appendix B.3. You must include the following additional information with your notification where applicable:
- for each lot of canned and ready-to-eat products, a can code list that identifies the foreign producer's establishment, the number of containers for each production code, and instructions on how to read the code.
- for fish imported for further processing in a Canadian facility registered with the CFIA, a completed "Import Products Destined for Further Processing in a Federally Registered Establishment" which can be found at www.inspection.gc.ca or Appendix A.4. You must make sure the products meet all Canadian regulatory requirements prior to it being processed by the federally registered establishment.
The notification of a shipment can only be made to a single CFIA inspection office or Import Service Centre closest to the final storage location, as per instruction below.
- For shipments where the final storage destination is in:
Yukon, Northwest Territories, Nunavut, British Columbia, Alberta, Saskatchewan, Manitoba, and Ontario,
notify: One (1) CFIA Inspection Office closest to the location of the imported shipment of fish - For shipments where the final storage destination is in:
Quebec, New Brunswick, Nova Scotia, Prince Edward Island, Newfoundland and Labrador
notify: CFIA Eastern Importation Centre
7101 Jean Talon Street East, Rm 600
Montreal, QC
H1M 3N7
Telephone: 514-493-0468 or 1-866-493-0468
Facsimile: 514-493-4103
4.5 Service Fee [FIR, 6.2(1)(e), 6.4, CFIA Fees Notice]
A service fee is charged by the CFIA for each lot of fish imported as set by the CFIA Fees Notice, Part 16, Table 2. This service fee is based on the total lot weight imported, the type of import licence you hold and the type of product imported. You will receive an invoice for these fees at set intervals from the CFIA. Failure to pay the service fees or any other fish inspection fee set out in the CFIA Fees Notice will lead to licence sanctions.
Imported products intended for further processing are charged the service fee which applies to products for further processing only when the processing is done at a facility registered with the CFIA.
4.6 Fish Program Updates
All updates for the fish program will be delivered electronically through CFIA's Email Notification Services. It is recommended that you sign up for this service. To sign up, go to www.inspection.gc.ca, under Email Notification Services - Food - Fish Inspection Manuals.
Appendix A - Forms
A.1 Application for a Fish Import
Licence (CFIA/ACIA 5587) QMPI
A.2 Application for Credit
(CFIA/ACIA 0015 )
A.3 Import Notification Form
(CFIA/ACIA 5588) / Instructions
A.4 Import Products Destined for
Further Processing in Federally Registered Establishments (CFIA/ACIA
5608)
A.5 Mandatory Inspection List
Update (CFIA/ACIA 5467)
Date: April 1, 2009 / Review Date: March 31, 2010
