Imported Food Sector Regulatory Proposal
Questions & Answers

Question Categories:

1. The regulatory proposal for the Imported Food Sector (IFS)
2. Definition of Imported Food Sector Products
3. Responsibilities
4. Imported Food Sector Licences
5. Licensing Scenario Questions
6. Preventive Food Safety Control Systems
7. Canadian Food Inspection Agency Oversight
8. Coming into Force

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1. The proposed initiative for the Imported Food Sector

Q1. What is the Food Safety Action Plan?

The Food Safety Action Plan (FSAP) is part of the Government of Canada's broader Food and Consumer Safety Action Plan announced in December 2007.

The FSAP recognizes that the majority of today's manufacturers, processors, distributors, and importers provide Canadians with safe food. At the same time, it reflects the need to modernize and sharpen the focus of government action to protect Canadians.

The Action Plan is a five-year initiative that aims to:

• Modernize and strengthen Canada's food safety system and
• Increase collaboration and information sharing among government partners, industry, and consumers.

Q2. What is the "regulatory proposal" for the Imported Food Sector (IFS)?

As part of the Food and Consumer Safety Action Plan, this regulatory proposal is being introduced to:

• Minimize the risk of unsafe products entering the Canadian marketplace,
• Better identify and engage importers bringing food products and ingredients in the IFS into Canada,
• Enhance verification of compliance with minimum food safety requirements.

All importers of products in the IFS would be required to have a licence to import IFS products into Canada.

In order to be licensed, importers would have to develop, implement and maintain a written Preventive Food Safety Control System outlining the actions and measures taken to achieve the goal of safe and compliant food.

In addition, the importer would have to maintain records at an address in Canada, have a written recall plan, and notify the CFIA within 24 hours if they became aware that the product constitutes a risk to the public.

Q3. How will this regulatory proposal for the Imported Food Sector (IFS) better protect Canadian consumers?

The regulatory proposal would introduce new requirements for IFS Products, including:

• Mandatory implementation of Preventive Food Safety Control Systems by industry, which would provide a modern and proactive approach to minimize the likelihood that unsafe food is sold in Canada,
• Record keeping, recall, and traceability components, which will mean that information would be available to properly control/remove unsafe products from the Canadian marketplace.

The regulatory proposal would provide the Canadian Food Inspection Agency (CFIA) with an enhanced ability to communicate important information to importers that will assist in mitigating food safety risks. Importers who are unable or unwilling to meet the requirements intended to help minimize the likelihood of the marketing of unsafe food would not be able to import IFS products into Canada.

With the proposed IFS Regulations, by 2013 the CFIA will have tools in place to:

• Facilitate a proactive approach to prevent the marketing of unsafe imported food,
• Target inspection resources to areas of greatest risk and concern within industry, and
• Further strengthen its rapid response capacity to better mitigate food safety issues when they do occur.

Q4. Why is a new regulation for the Imported Food Sector (IFS) necessary?

As a first step toward strengthening and modernizing the legislative framework for IFS products, Canadian Food Inspection Agency (CFIA) is proposing to enhance controls of the imported products in the IFS for the following reasons:

• Over 70% of food products sold in Canada are imported and most of the domestic products contain imported ingredients. These products and ingredients are imported from more than 190 countries which have varying levels of food safety controls,
• An increase in the complexity of global marketing and mass distribution networks mean that the scope and impact of failures in food safety systems can be widespread,
• Food safety incidences involving products imported into Canada have increased over the last 5 years (e.g. E. coli in spinach, melamine in milk products, Salmonella in peanut butter and hydrolyzed vegetable protein) ¹
• Canadians have expressed concerns with respect to the safety of imported food products. ²

By introducing new regulatory requirements for products in the IFS, the CFIA intends to increase the safeguards in a sector that has not previously had preventive food safety controls or licensing requirements.

Q5. How does this proposed initiative fit with the commitment from the Speech from the Throne to reintroduce legislation to protect Canadian families from unsafe food, drugs and consumer products?

This proposal is consistent with this legislation, as it offers Canadian families additional assurance regarding the safety of the food they eat. It will do this by modernizing regulations for Imported Food Sector Products imported into Canada and increasing the safeguards in an area that has not previously had preventive food safety controls or licensing requirements.

Q6. Are requirements for imported products currently similar to those for domestic products?

Yes. Regardless of the source (domestic or imported), food offered for sale in Canada must comply with all provisions of the following:

• The Food and Drugs Act and Regulations
• The Consumer Packaging and Labelling Act and Regulations

Q7. Will this regulatory proposal impede access to the Canadian market?

Products in the Imported Food Sector that meet Canadian regulations would continue to have access to the Canadian marketplace.

The Canadian Food Inspection Agency (CFIA) recognizes that a properly implemented Preventive Food Safety Control System takes time to develop. Among other things, importers would have to retrieve additional information about the food from their foreign suppliers in order to be able to fulfill their responsibilities for the safety of the foods they import.

To provide Canadian importers with some time to develop their systems, the CFIA is proposing a phased-in approach. Under the current proposal, importers would have two years after the regulations come into force to develop and implement their Preventive Food Safety Control Systems.

Q8. What are the benefits of the Imported Food Sector (IFS) regulatory proposal to my business?

The proposal would help improve the Canadian Food Inspection Agency's ability to communicate important food safety information to potentially affected parties (so that a food safety incident can be avoided or managed more effectively). This will help to reduce costly and potentially reputation damaging events for the importer.

Importers will also have a Preventive Food Safety Control System in place. If products they import are implicated in a food safety incident, this system would:

• Position the importer to be better able to trace product and remove it from the marketplace rapidly,
• Equip them with the records and documentation to demonstrate that they have taken all necessary and reasonable steps to fulfill their responsibility for the safety of the products they import,
• Provide a way to demonstrate due diligence that promotes increased customer and consumer confidence in imported foods,
• Put in place formalized plans and standards that would provide a strong basis for communicating food safety and buyer requirements to foreign suppliers.

Finally, this proposal is expected to provide a more level playing field within the import sector itself, because all importers of products in this sector would have the same requirements and be held to the same standards.

Q9. Will stakeholders have an opportunity to comment on the Imported Food Sector Regulatory Proposal?

Yes. Additional background information is available, and you can submit your comments through the online consultation.

2. Definition of Imported Food Sector Products

Q1. Under the regulatory proposal, what is an Imported Food Sector (IFS) product?

IFS products represent approximately 70 percent of food products sold in Canada. The sector includes foods such as:

• Alcoholic beverages
• Bakery products and confectionaries
• Coffee and tea
• Fats and oils
• Infant formula
• Spices and seasonings
• Food ingredients

Under the regulatory proposal, products in the IFS are foods that:

1. Meet the definition of an "agricultural product" in the Canada Agricultural Products Act and
2. Are not already covered by other commodity-specific trade legislation.

In other words, it is a food or food ingredient for human consumption

1. That is, or is derived from, a plant or animal, and
2. That is not:
   • A meat product as defined in the Meat inspection Act;
   • A dairy product as defined in the Dairy Products Regulation;
   • Eggs as defined in the Egg Regulations;
   • Fresh fruit, fresh vegetable, nuts or edible fungi to which the Fresh Fruit and Vegetables Regulations apply;
   • Honey and honey products to which the Honey Regulations apply;
   • Maple products as defined in the Maple Products Regulations;
   • Processed egg as defined in the Processed Egg Regulations;
   • A processed product to which the Processed Products Regulations apply; or
   • Fish as defined in the Fish Inspection Act.

Q2. What are examples of food products not considered to be in the Imported Food Sector (IFS)?

These are products that are not covered by other commodity specific trade legislation and do not meet the definition of an "agricultural product" in the Canada Agricultural Products Act.

These are products that are regulated solely under the Food and Drugs Act and the Consumer Packaging and Labelling Act. Examples are products that are not derived from a plant or animal source, including:

• Bottled water
• Synthetic colours
• Minerals and salts

Because these products do not fall under the regulatory proposal, importers would not require a licence to import them.

3. Responsibilities

Q1. What are the responsibilities of the Canadian Food Inspection Agency (CFIA) with regard to the Imported Food Sector (IFS)?

The CFIA is responsible for providing all federal inspection and enforcement activities related to

• Food safety
• Economic fraud/misrepresentation
• Trade-related requirements
• Animal and plant disease

The CFIA contributes to food safety and consumer protection by administering a national risk-based program to verify that IFS products imported into Canada meet all legislative and regulatory requirements.

Q2. What are the responsibilities of importers who are importing Imported Food Sector (IFS) products?

Food sold in Canada (including imported food) must comply with all relevant regulations. There are also provisions dealing with nutritional and compositional labelling information, product composition, marketplace deception, net quantity requirements, and others. Importers of products in the IFS are responsible for ensuring that the products they import meet the requirements of all applicable legislation including (but not limited to):

• The Food and Drugs Act and Regulations,
• The Consumer Packaging and Labelling Act and Regulations,
• The Canada Agricultural Products Act, and the proposed regulations
• The Weights and Measures Act.

If approved, the regulatory proposal would require that all importers of products in the Imported Food Sector (IFS):

• Have a licence
• Develop, implement and maintain a written Preventive Food Safety Control System
• Maintain records at an address in Canada
• Notify the Canadian Food Inspection Agency within 24 hours if they become aware that the product may constitute a risk to the public, and
• Have a written recall plan

4. Imported Food Sector Import Licences

Q1. Who will need an Imported Food Sector (IFS) licence?

Anyone importing IFS products into Canada will require a licence to do so.

"Anyone" means an individual, a corporation, an association or an organization. The licence would authorize the importer to import any number of products in the IFS. Importers would have to maintain a Canadian address in order to apply for an import licence.

Q2. What is the process for applying for an imported food sector (IFS) licence?

The Canadian Food Inspection Agency will be developing an on-line application process. Should an importer be unable to submit an application on-line, hard copy procedures will be made available. However, these submissions may take longer to process.

Q3. Are there any import licensing exemptions?

Yes, there are some exemptions.

The Imported Food Sector (IFS) regulatory proposal would not apply in the case of an imported IFS product that is not intended for sale in Canada and:

• Weighs 5 kilograms or less and is for personal use or,
• Is used as food for the crew or passengers on any vessel, train, motor vehicle, aircraft or other means of transportation or,
• Is imported from the United States into the Akwesasne Reserve for use by an Akwesasne resident (because the reserve spans the Canada-U.S. border).

Products such as bottled water, salt, synthetic colours and minerals do not fall under the Canada Agricultural Products Act. A licence would not be required to import these products.

Q4. What are the service standards for issuing Imported Food Sector (IFS) licences?

The import licence will be issued automatically based on completion of the application and confirmation of payment of the licensing fee. It is anticipated that the on-line licence will be issued the same day the application is processed. The Canadian Food Inspection Agency will verify that the conditions of the licence are being met after it is issued on a risk basis.

Q5. How much will it cost to obtain an import licence for Imported Food Sector (IFS) products?

The Canadian Food Inspection Agency will be considering service standards and user fees for all new programming initiated by the Agency, including the IFS Regulatory Proposal. Consistent with the process described in the User Fees Act, thorough analysis and consultation with stakeholders will take place before new fees are put in place.

Q6. What are the conditions for obtaining, maintaining and renewing an import licence for the Imported Food Sector (IFS)?

To obtain an import licence for the IFS, applicants would have to:

• Complete an application,
• Attest that they have implemented and are maintaining a written Preventive Food Safety Control System,
• Pay the application fee.

Applicants that do not attest that they have implemented a Preventive Food Safety Control System will not be granted a licence. The licence will be valid for a period of two (2) years.

In order to maintain the licence, importers would have to demonstrate to the Canadian Food Inspection Agency (CFIA), upon request, that:

• The information that they provided in the application is accurate,
• That they are following their written Preventive Food Safety Control System.

Failure to do so would lead to enforcement action and possible suspension or cancellation of the licence. Licences could be reinstated upon written request from the importer, after the CFIA has made sure that the condition of licence is being met.

To renew a licence, applicants would have to reapply, re-confirm that a written Preventive Food Safety Control System is being maintained and pay the application fee.

Q7. Would internationally-accepted food safety systems (GFSI, ISO, etc.) be accepted by the Canadian Food Inspection Agency (CFIA) as a condition of licence?

Yes, provided they meet CFIA's definition for a Preventive Food Safety Control System.

Q8. Is the licensing provision under the Imported Food Sector (IFS) Regulatory Proposal intended to replace any existing licensing programs regulated by the Government of Canada?

No, the licensing provision under the IFS Regulatory Proposal would not replace any existing licensing program regulated by the Government of Canada.

Importers who hold a licence or registration issued under another regulation enforced by the Canadian Food Inspection Agency (such as the Fish Inspection Regulations, Dairy Products Regulations, Meat Inspection Regulations and Fresh Fruit and Vegetable Regulations, but who import IFS products would require an IFS licence.

Q9. How will exemptions under other Canadian Food Inspection Agency (CFIA) licensing programs affect this initiative?

If a product is exempted under another CFIA licensing program (e.g. a product with less than 2% meat content) and it meets the definition of an Imported Food Sector (IFS) product, an IFS licence will be required.

The only exemptions under the regulatory proposal are for products:

• in quantities of 5 kilograms or less for personal use,
• for consumption by passengers and crew during transportation (for example, a cruise ship), and
• for products imported from the United States into the Akwesasne Reserve for use by an Akwesasne resident.

Q10. Would an importer require a licence if they import products exempted from the Canada Agricultural Products Act, such as bottled water, salt, synthetic colours and minerals?

No. Products such as bottled water, salt, synthetic colours and minerals are not defined as "agricultural products" under the Canada Agricultural Products Act. Therefore, importers would not require a licence to import these products.

Only importers of products in the Imported Food Sector (IFS) that fall under the Canada Agricultural Products Act would be required to have an IFS licence.

5. Licensing Scenario Questions

Q1. Will a retail establishment that sells imported products in the Imported Food Sector (IFS) need an IFS licence?

If the retail establishment imports IFS products, then it would require a licence. If the retail establishment purchases products from the IFS from an importer, it would be the importer that needs the licence.

Q2. Will a domestic establishment that manufactures food in Canada and that imports the ingredients in the Imported Food Sector (IFS) used to produce the food require a licence?

Yes. A licence would be required to import ingredients that are IFS products and intended for further processing in Canada.

Q3. Would an importer already licensed or registered with the Canadian Food Inspection Agency under another food regulation also have to apply for an Imported Food Sector (IFS) Import licence?

If the importer is importing IFS products into Canada, they would require an IFS licence.

The IFS licence is not intended to replace any existing licensing program regulated by the Government of Canada.

Q4. Do I need a licence for each product of the imported food sector (IFS)? For example, if I import both tea and biscuits, do I need one or two import licences?

Only one licence would be required, regardless of the number of IFS products imported. As a condition of the licence however, the importer would be responsible for ensuring that their Preventive Food Safety Control System covers all the commodities that they import into Canada.

If products other than products from the IFS are also being imported, a separate licence may be required.

Q5. If someone at my head office holds an Imported Food Sector (IFS) import licence, as a branch office can I use their licence as well since I belong to the same company?

Yes. An IFS import licence could be issued to an individual, a corporation, an association or an organization. A licence issued to a business covers all employees operating for that business as well as any branch offices.

Q6. If I stop importing before my import licence expires, can I get a partial refund on the licence fee?

No. The fee is for granting the licence.

Q7. As a Canadian manufacturer that exports Imported Food Sector (IFS) products to other countries, what would happen if my product is rejected and sent back to Canada? Would I need a licence for re-entry into Canada?

Yes. Any product from the IFS that enters or re-enters Canada would be subject to import controls. The rejected product could only be brought back into Canada by someone with a valid IFS licence.

Importers can refer to the Automated Import Reference System (AIRS) and to the Food Imports section of this website for more information on import requirements for specific commodities.

Q8. Could I get an import licence after I import products in the Imported Food Sector (IFS) into Canada?

No. Products in the IFS could not be imported into Canada unless the importer had a valid IFS licence at the time of importation.

However, there would be a two-year grace period after the regulations come into force before this requirement is fully enforced.

6. Preventive Food Safety Control Systems

Q1. What is a Preventive Food Safety Control System?

A Preventive Food Safety Control System is a written plan outlining the actions and measures taken to ensure that food:

• Is safe,
• Is fit for human consumption,
• Conforms to safety and label requirements as outlined in
  • The Food and Drugs Act and Regulations,
  • The Consumer Packaging and Labelling Act and Regulations,
  • The Canada Agricultural Products Act and the proposed regulations.

It would include procedures that specify what needs to be done, when, how and by whom in order to achieve the goal of safe and compliant food.

The Canadian Food Inspection Agency would not prescribe how to implement a Preventive food safety control system. At a minimum, the preventive food safety control system should include the following:

• Food safety and labelling requirements for products imported and actions/measures taken to comply with requirements
• Criteria against which the performance of the importer's actions/measures are assessed
• Measures to ensure that products are stored in Canada in a safe, clean environment.

Q2. What records would have to be kept to demonstrate that the Preventive Food Safety Control System has been implemented, and for how long?

Any records of actions and measures taken in support of the Preventive Food Safety Control System would have to be kept at an address in Canada for a period of three (3) years, or for the shelf life of the product plus one year, whichever is greater.

Examples of records that could be kept as part of the Preventive Food Safety Control System include (but are not limited to):

• Shipment information
• Quality control results
• Product information
• Product distribution
• Buyer requirements
• Sanitation
• Pest control
• Consumer complaints
• Recalls
• Corrective actions

Q3. Can records be in electronic format?

Yes, records could be in electronic format provided they are kept for the required amount of time and are retrievable at the Canadian Food Inspection Agency's request.

If electronic records are kept, the Preventive Food Safety Control System could include procedures to protect the records with a password and to perform frequent, scheduled back ups of the electronic data.

Q4. Are there tools available to help importers develop and implement Preventive Food Safety Control Systems?

Yes. The Canadian Food Inspection Agency (CFIA) has several publications available, including Good Importing Practices for Food, Food Recalls: Importers' Guide, and a series of commodity-specific guidelines. The CFIA will also be working with industry and other stakeholders to develop additional tools/templates to achieve compliance with the new regulations.

7. Canadian Food Inspection Agency Oversight

Q1. How will the Canadian Food Inspection Agency (CFIA) verify and enforce the new regulation once it enters into force?

All importers of food products are subject to CFIA oversight.

The CFIA will use a risk-based approach in order to verify that:

• Preventive Food Safety Control Systems are in place,
• That these systems are functioning as intended,
• That importers are meeting all regulatory and legislative requirements.

Enforcement actions would include the suspension and cancellation of Imported Food Sector licences. All enforcement activities taken would be consistent with the CFIA's enforcement and compliance policy.

Q2. Will my storage facilities be inspected?

Yes, storage facilities would be subject to inspection. The Canadian Food Inspection Agency (CFIA) would select importers and facilities using a risk-based approach. This is not a new regulatory activity as the CFIA already inspects importer storage facilities in this manner.

Q3. How will food safety requirements be assessed/verified by the Canadian Food Inspection Agency (CFIA)?

Importers would be evaluated for compliance to regulatory requirements through a combination of verification and inspection activities.

CFIA inspectors would verify that importers have a valid licence as well as a written, implemented and maintained Preventive Food Safety Control System. This control system would have to meet the requirements set out in the Imported Food Sector regulatory proposal as well as the requirements of all applicable legislation such as the Food and Drugs Act and Regulations, Consumer Packaging and Labelling Act and Regulations and the Canada Agricultural Products Act.

The CFIA would develop acceptance criteria for the verification process in consultation with industry stakeholders.

Q4. How will the Canada Border Services Agency (CBSA) verify that I have a valid import licence?

In order for the CBSA to process and clear an Imported Food Sector product at the border, importers would have to enter a valid IFS import licence number into its product tracking system.

Those without a valid licence would not be able to import products in this sector into Canada and would be referred to the Canadian Food Inspection Agency to apply for licence.

8. Coming into Force

Q1. When will the regulatory proposal come into force?

The regulatory proposal will come into effect upon publication in Canada Gazette Part II, except for the licensing provisions. The licensing provisions will likely come into effect two years later. During this time, the CFIA will be working with industry to provide educational materials and to develop tools/templates to achieve compliance with the new regulation. This will also allow time for the CFIA to adequately train its staff on enforcement of the regulation.

When the regulations come into effect, importers would have to have in place:

• A recall plan,
• A process to record any complaints and how the complaints were handled,
• A process to keep records of all products imported, including the identity, code, date and shipment number and distribution records.

Two years after the regulations come into effect, importers would be required to have an Imported Food Sector licence to import these products into Canada. As a condition of receiving the license, importers would have to confirm that they have implemented a Preventive Food Safety Control System. In this way, the CFIA is providing importers with two years to develop their systems. The goal is to introduce the systems in a way that can be effectively managed both by industry and the CFIA.

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^1. Canadian Food Inspection Agency data.

^2. According to a Decima poll conducted in 2010.