Food > Fish and Seafood > Imports Guide to Canadian Regulatory Requirements and Examination Procedures for Imported FishSeptember 8, 2006 A. IntroductionThe purpose of this document is to outline certain basic information regarding the inspection procedures in place to determine compliance to requirements for safety, wholesomeness, composition and labelling as they relate to imported fish products. While this Guide is not a comprehensive summary, it does deal with some important aspects of Canadian inspection requirements and procedures for imported fish intended for human consumption. B. AuthoritiesThe authority for the control and inspection of fish is provided by:
In discharging its responsibility, the Canadian Food Inspection Agency also takes into consideration the requirements of other Canadian Acts and Regulations applicable to the inspection of food. C. Definitions/Concepts
D. Program Elements1. Import Licence
2. Notification Importers are required to notify the CFIA, prior to importation of a product or within 48 hours following importation, of the product type and quantity, the name of the producer, the country of origin and the storage location of each product contained in a shipment. Product is not to be moved pending inspection or notification by an inspector concerning the inspection requirements of the products. For canned products, the import notification must be accompanied by a code list which indicates the processing establishment and the number of containers for each production code. Failure to provide proper written notification for each imported shipment may result in enforcement action by CFIA. 2.1. Inspection Service Fee Fees will be charged for imported products based on the declared weight (i.e., the quantity of fish identified in the written notification provided to CFIA) at the time of importation in the following manner:
*Imported product destined for significant transformation in a federally registered establishment The above fees are subject to change. 3. Sampling Based on past knowledge of product compliance, and the QMPI importer status, the CFIA will decide on the need for withdrawing samples for examination. An inspector may take samples free of charge for the purpose of inspection. Products new to the Canadian market are sampled on entry until the CFIA is satisfied that safety, wholesomeness, and identity requirements are satisfactory. Shipments subjected to sampling and examination procedures are detained pending the results of inspection, and may only be released for sale in Canada if they are found to comply with the requirements of the Fish Inspection Regulations and other Canadian federal agency requirements. Importers who have chosen the Shared QMPI must describe in their submission the activities they will implement to assess their supplier's quality management program. They also must perform or have performed product testing in Canada at a minimum frequency as specified in the Fish Products Inspection Manual or as otherwise established in a bilateral agreement or a memorandum of understanding. These analyses must ensure that the product meets all requirements monitored by standard analyses. The Agency will perform specialised testing at the pre-established frequency. Importers who have chosen the Enhanced QMPI must describe in their submission the activities they will implement to assess their supplier's quality management program. They also must perform or have performed product testing in Canada at a minimum frequency as specified in the Fish Products Inspection Manual or as otherwise established in a bilateral agreement or a memorandum of understanding. These importers must also have chemical and microbiological evaluations performed in Canada at the prescribed frequencies. These analyses must ensure that the product meets all requirements monitored by standard and specialised analyses. 4. Results 4.1. Fish Import Licence Holders CFIA will inform Fish Import Licence Holders about the inspection results upon completion of all testing. Importers cannot move or sell their product without consent from the CFIA. When an imported product fails to comply with the Fish Inspection Regulations, Food and Drug Regulations or the Consumer Packaging and Labelling Regulations, it will be listed on the Agency's Import Alert List, and all subsequent importation of this product from the same producer will be subject to mandatory inspection until such time as four (4) consecutive shipments pass import inspection requirements. In the case of a label infraction, only one pass is necessary to remove the product from the Import Alert List. Shipments of fish that do not conform to the requirements are not permitted entry into Canada. In such case, the importer is notified on the refusal of entry and, subject to the appeal process provided by the Fish Inspection Regulations, the shipment must be destroyed or removed from Canada, within forty-five days of the date of notification. Where labelling infractions are the cause for rejection, permission for re-labelling may be granted. 4.2. Shared/Enhanced QMPI Importers who have chosen the Shared or Enhanced QMPI are required to record their inspection results, and keep them on file in accordance with the terms of their QMPI submission. The CFIA must be notified immediately when inspections identify products that are non-compliant for health and safety reasons. Except for importer specific label rejections, the CFIA must be notified within 5 working days for all other cases of product non-compliance. These importers must ensure that non-compliant products are not placed on the Canadian market. Products imported by Shared QMPI that are inspected by the CFIA for specialised analyses will be detained during the inspection. Shared QMPI may not move or sell these products without consent from the CFIA. 5. Reinspections Any person interested in the decision of an inspector may appeal that decision and request a reinspection. A reinspection of a lot will only be granted after: a) an initial inspection has been completed and official written notification of the
results has been given to the owner of the goods or his/her agent; and A reinspection shall not be ordered where: a) the identity of the fish or containers of fish in dispute has not been preserved; A reinspection fee will be charged for all analyses conducted during a reinspection. E. Requirements1. General The following requirements are mandatory for all importers, including those participating in the Shared or Enhanced QMPI. The records described below are subject to inspection by CFIA and must be maintained by the importer in Canada for a period of 3 years. A submission that details company systems and information to support compliance to requirements for recall, complaints and process control information is to be submitted with the license application. Instructions on preparing your company's submission can be found in this guide (please see Appendix A). 1.1. Recall System All importers are required to maintain records of distribution to the first point of sale. This includes as a minimum, a record of the name and address of the person to whom the fish is sold, and the date on which the fish is shipped from the importer. The importer can choose to track distribution by lot or code. The importer must also maintain records to document appropriate disposition of product which is found to be non-compliant with Canadian requirements. 1.2 Complaints The importer will be required to keep a record of all complaints received, evaluations conducted and any actions taken as a result of the complaint. Where the complaint is valid, any corrective actions taken and any measures implemented to prevent it's reoccurrence are also recorded. The importer must ensure that appropriate notification is provided to CFIA upon investigation of legitimate complaints. 1.3 Process Controls Documentation and evidence of adequate processing (including process controls as described below) must be made available for review to determine compliance to Canadian requirements for canned foods and ready-to-eat products. Canned Fish Documentation must precede or accompany the first shipment from each processor for each type of canned fish, and a copy maintained in Canada by the importer. For subsequent shipments of the same product, such documentation must be available to the importer and to CFIA on request. This documentation must show an adequate thermal process approved by a recognised thermal process authority and process controls to ensure adequate delivery of that thermal process to the product. It must also show adherence to seam specifications and container integrity requirements. The information should include the following details:
Ready-to-eat fish Appropriate process documentation must precede or accompany the first shipment from each processor for each type of ready-to-eat product, and a copy maintained in Canada by the importer. For subsequent shipments of the same product, such documentation must be available to the importer and to CFIA on request. These records must demonstrate the adequacy of the methods and processes employed and their correct application to eliminate, reduce and/or control pathogenic bacteria in order to ensure product safety. The information should include the following details:
Should concerns be identified by ongoing product inspection with respect to the safety of a canned or ready-to-eat product, additional information regarding the process would be requested from the importer on a priority basis. 1.4. Bivalve Molluscs Fresh and/or frozen oysters, clams, mussels and other bivalve molluscs excepting scallop meats are not permitted entry from any country except those which have sanitary control programs that have been approved by the CFIA. 1.5. Prohibited Fish Import of any species of:
is prohibited. 2. Requirements Monitored by Standard Analyses 2.1. Code Markings The identity of the establishment at which the fish is packed and the day, month and year of packing must be legibly marked on one end of the carton or case in which the containers of fish are shipped. If the information is supplied in code, the importer must supply a key which explains the meaning of the code. The country of origin must also be shown on the container. For high-risk fish products, the importer must provide a list indicating the establishment and the number of containers for each production code. Each can of fish must be embossed or otherwise permanently marked in a code that identifies the name of the establishment and day, month and year of processing, and where required in the Fish Inspection Regulations, the species. 2.2. Packaging All fish entering Canada that are intended for human consumption must be packed in clean, sound containers. 2.3. Labelling Fish must not be labelled in a manner that is false, misleading or deceptive and all declarations regarding net or drained weight must be accurate. The general labelling requirements for fish and fishery products are summarised as follows: a) the common name of the product must be shown on the main panel of the label in
letters of equal height and prominence;
Generally speaking, terms such as "Choice", "Fancy", "Prime", "Supreme", "Premium", "Superior", "Highest Grade", "Grade 1", "Top Grade", and "Excellent" are considered to be quality designations and, therefore, are not permissible. The CFIA recommends that labels be designed and/or reviewed by parties knowledgeable in Canadian labelling requirements. Fees for label evaluation will be charged when labels are submitted to the CFIA for evaluation. 2.4. Net Content Products will be evaluated by physical examination to determine conformity to all weight declarations including net and/or drained weight declarations and fluid measurements where applicable. 2.5. Sensory Evaluation Products will be evaluated by sensory and physical examination to determine compliance to standards for taint (rancid or abnormal odours), decomposition and wholesomeness. Products will also be evaluated for the presence of foreign matter, parasites and undesirable parts. This evaluation will also be used to evaluate conformity to label declarations for style, count, composition, etc. 3. Requirements Monitored by Specialised Analyses Specialised analyses will be performed to determine compliance with health and safety requirements. These evaluations will also be used to detect specific fraudulent practices. The required specialised analyses will be performed an all shipments of new products and those on the Import Alert List. In all other cases, specialised analyses will be conducted at prescribed frequencies as specified in the Fish Products Inspection Manual . 3.1. Bacteria Fish imported into Canada must not be unwholesome and must not have upon it bacteria of public health significance or substances toxic to humans. This will be determined by evaluations to ensure that indicator organisms do not exceed regulatory guidelines and that products are free from pathogenic organisms. This would include evaluations for E. coli, Listeria monocytogenes, Staphylococcus aureus and salmonella species. 3.2. Safety Parameters Low-acid foods that are packed in containers sealed to exclude air and that do not depend solely on heat sterilization, refrigeration or freezing for their safety, must meet requirements for pH and/or water activity and/or salt content to ensure product safety. For example, smoked or smoke-flavoured fish or fish products packed in a container that has been sealed to exclude air (excluding packages in oxygen permeable membranes with acceptable transmissions rates) may not be sold in Canada unless it: a) has been heat-processed after sealing at a temperature and for a time sufficient to
destroy all spores of the species Clostridium botulinum;
or 3.3. Additives And Ingredients Only additives and ingredients specified in Division 21, Marine and Fresh Water Animal Products and the additive tables in Division 16 of the Canadian Food and Drug Regulations may be used in the formulation of fish products. It is the importer's responsibility to determine that the additives and ingredients used by the foreign supplier are permitted in Canada and do not exceed permissible tolerances. 3.4. Chemical Contaminants Fish products will be tested to verify that chemical contaminants do not exceed Canadian guidelines. This includes environmental contaminants such as mercury (0.5 ppm), polychlorinated biphenyls (2 ppm) and DDT and derivatives (5 ppm). The levels of therapeutic agents in aquacultured fish products must not exceed Canadian guidelines. 3.5. Natural Toxins Naturally occurring biological toxins such as histamines, paralytic toxins, domoic acid, ciguatera toxin must not exceed Canadian tolerances. 3.6. Container Integrity Of Low-Acid Canned Fish Canned fish must be processed and properly sealed in accordance with all Canadian requirements. This will be determined by visual inspection and/or other types of tests to determine compliance to Canadian standards for container integrity. 3.7. Other Products not normally associated with a specific hazard may require specialised analyses when there is a concern that the fish may be exposed to chemical or microbiological contamination. 4. Records Inspections The CFIA will audit records of all importers to verify compliance to the mandatory requirements for Recall, Complaints and Process Control Systems. 5. Shared/Enhanced QMPI Audit The CFIA will audit an importer's Shared or Enhanced QMPI on a routine basis at a prescribed frequency. The audit will evaluate the QMPI to determine that it works effectively and that the design is appropriate to ensure that only products in compliance with regulatory requirements are marketed. QMPI audits will consist of a review of testing procedures, product control systems, record keeping and product sampling and testing. F. Enforcement ActionsWith respect to imported fish, the CFIA may take one or more of the following enforcement actions when violations of the applicable Acts or Regulations occur: a) issue a formal letter of warning; Licence sanctions may occur for the following reasons: a) provision of false information for the purpose of obtaining an import licence; G. Requested InspectionsWhen an inspection or evaluation of a product is requested, a fee will be charged. This includes all requested label evaluations. H. InvoicingImporters will be invoiced for all inspection and import fees on at least a monthly basis. I. Further InformationInformation concerning the procedures for importing fish products such as the Import Alert List, inspection frequencies and the Quality Management Program for Importers (QMPI) can be found on the CFIA web site. The Fish Inspection Regulations, and the schedule of fees can also be found on the Internet site. J. Importation of Sturgeon and CaviarIf 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 will apply. CITES, or the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) controls the movement of endangered species between countries. CITES has listed over 30,000 species of wild animals and plants whose movement from one country to another for commercial purposes requires government authorization in the form of a CITES permit. CITES permits apply to specimens of the species listed whether they are alive or dead, as well as all parts or products processed from these species. CITES operates through an import/export permit system. Animals and plants are classified into one of three appendices depending on how endangered they are: - Appendix I deals with species threatened with extinction. Trade for commercial purposes is prohibited. - Appendix II lists species that are not considered threatened with extinction but may become so if their trade is not regulated. A CITES export permit or CITES certificate from the country of export is required. - Appendix III lists species is not considered threatened with extinction, but are under special management in certain countries. A CITES export permit or a CITES certificate of origin is required. Both the Short-nosed sturgeon (Acipenser brevirostrum) and the Baltic sturgeon (Acipenser sturio) are listed as Appendix I, and any export of specimens of either species, including caviar, for commercial purposes, is prohibited. All other species of sturgeon are listed in Appendix II. Commercial trade is permitted provided the country of export has issued a CITES export permit. If you import these species without a valid CITES export permit, you risk losing your shipment and you could be prosecuted. For more information on CITES, visit the website for the Canadian Wildlife Services of Environment Canada at http://www.cites.ec.gc.ca/. For permit information, contact the Canadian CITES Office at 819-997-1840. ANNEX AInstructions to Complete the Application for Fish Import Licenses An application form is available which you may use to renew your import licence. Completed applications and a cheque or money order for the amount of $500 in Canadian funds must be forwarded to the nearest regional office. A list of these offices is identified below. The following sections must be completed in their entirety to process and issue an import license. Incomplete applications may be subject to delays or or result in the inability to issue a license. The CFIA reserves the right to suspend, revoke or prohibit license issuance to companies that have been subject to enforcement and legal actions that indicate past and potential future non-compliance to Canadian regulatory requirements. 1. Company Data Please complete the information regarding your company in the first section to indicate whether this is a new license or existing license, and the details of your company. Please include the complete, registered name of your company. This should be the same name you use to identify your company with the Canada Border Services Agency and any other government departments. 2. Language of Correspondence Please indicate if you wish to receive future correspondence in English or French. 3. Importer Record Keeping Requirements and Company Submissions All importers are required by the Fish Inspection Regulations to obtain and maintain: records of product distribution for recall purposes; documentation of investigations of any complaints received by the importer; and process information for ready-to-eat and canned fish products that demonstrates product safety. Documents must be kept on company files for a minimum of three years, and must be provided to the CFIA upon request. Please identify the Canadian location where records for Recall, Complaints, and Process Controls will be maintained. A company submission that provides information about your system developed to meet the requirements for recall, complaints and process control information must be included with this application. Failure to submit information to outline company systems and evidence of compliance to recall, complaints or process control information may delay or prohibit issuance of new licenses and/or license renewals. All importers on an ongoing basis must ensure imported products are safe, adequately processed, packaged in sound and appropriate containers and meet all applicable regulatory requirements. Please contact your local Fish Inspection office or refer to the CFIA website for more information on specific Fish Inspection regulatory references and compliance requirements. Company Submission The company submission must include: i) Recall System Details as to how the company will maintain records and institute recalls of imported product to the first point of sale. The document should provide key company contact names, addresses, phone numbers, faxes, etc., including contact numbers for regular and after hour emergencies. You may choose to track the distribution of your products by lot or by code. The recall information must include the name and address of the person to whom each shipment of fish was shipped from the importer and the date on which the fish was shipped. This information should include a description of the product (including any code markings) and the quantity shipped. Information on record keeping systems and examples of distribution records are also recommended. ii) Complaints The company must describe in detail how it will evaluate and respond to valid complaints that relate to regulatory requirements. The document should provide key company contacts and their role in the process; information as to how the company will assess validity, and record corrective actions taken for valid complaints. Companies must investigate all complaints related to regulatory compliance to determine their validity and if valid and related to health and safety, notify CFIA immediately. You may contact the CFIA for guidance in cases where you are uncertain of the nature of the complaints under investigation. iii) Process Controls This applies to canned and ready-to-eat products only. For the first time importation of each product from each processor, and/or subsequently when processes, products and suppliers are changed, fish importers must obtain and keep on file documentation and evidence of adequate processing. Companies may be requested at any time to provide process information records and related document for specific shipments to confirm compliance to Canadian health and safety and safety requirements. Details as to how the company will ensure products are safe, wholesome and adequately processed must be provided using one of two options that follow. Option 1 Companies may utilize information from the supplier's HACCP programs to meet the requirements of process control information, provided the HACCP program documentation includes sufficient information to demonstrate that the products will meet Canadian health and safety requirements. In the case of canned fish products, the HACCP program documentation must include at least thermal processing controls and container integrity standards. In the case of ready-to-eat fish, the HACCP program documentation must include at least a description of handling, packaging, and processing controls. HACCP documentation would be filed by the importer for each unique product/process/supplier. General statements that a processor has implemented a HACCP plan, in the absence of any further details, are not in themselves sufficient documentation to meet the process control regulatory requirements. The information listed in the CFIA Process Control Form for Canned Fish and Ready-to-Eat Fish Products (see below) would be covered in a HACCP program. Option 2 Companies may utilize process authorities or process specialists to evaluate processing data for each unique product/process/processor, to determine their compliance to Canadian requirements. A process authority is any person or organization that has been recognized as being competent in developing and evaluating thermal processes. A process specialist is a person or organization having expert knowledge of thermal processing requirements for foods. In the case of canned fish products, the information provided by the process authority or process specialist would include (not all inclusive examples) time/temperature critical limits and container integrity. In the case of ready to eat fish, this information would include processing control steps, safety parameters such as pH and/or water activity, pasteurization steps, and maintenance of sanitation zones via separation of processing rooms. Statements or documentation that has been completed by the process authority or specialist for the company, that acknowledge compliance would be filed with the importer for each unique product/process/supplier. Information in the documentation must include the name, address and telephone number of the person who developed the process, the container type and size, style of pack, the species packed, the type of process, the description of the process, and a statement in writing by the process authority or specialists that attests the process results in the production of safe fish products. In the case of canned products, the document must also include the sterilizing value (F0), unless the thermal process has been published in scientific literature recognized by the CFIA. The importer can capture all relevant process control information in any format that meets these requirements, or can utilize the CFIA Process Control Forms for Canned Fish and Ready-to-Eat Fish Products (see below). These forms provide a listing of the kind of information that should be obtained and evaluated by the process authority or process specialist. 4. Method of Payment Please specify your method of payment. FORMS
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