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Understanding the Safe Food for Canadians Regulations: a handbook for food businesses

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Introduction

Purpose of the handbook

1. The handbook provides a general overview of the Safe Food for Canadians Regulations (SFCR) to help you:

Intended audience

2. The handbook is intended for food businesses, including exporters and importers, who need to comply with the SFCR. The SFCR came into force on January 15th, 2019.

3. The SFCR and the Safe Food for Canadians Act (SFCA) cover imported, exported, or inter-provincially traded food products. Some provisions of the SFCA and SFCR also apply intra-provincially.

Improving food safety in Canada

4. The safety of food is vital to all consumers and food businesses. Consumers want to be confident that the food they buy and eat is what they expect, and that it will cause them no harm. Consumer confidence is very important for food businesses.

5. Food safety affects all Canadians. It is the responsibility of all food businesses, no matter how large or small, to ensure anyone who is importing, exporting, manufacturing, processing, treating, preserving, grading, packaging, or labelling the food has not compromised food safety.

6. As a food business,you should familiarize yourself with the SFCA. The SFCA received royal assent (became law in Canada) in November 2012. It establishes a modern legislative framework for the safety of food commodities. The Act, which fully came into force on January 15th, 2019, when the SFCR was adopted, marked an important first step in the transformation of Canada's food safety system.

Why change

7. The Canadian Food Inspection Agency (CFIA) is a global leader in regulating food, animal and plant health and safety. The existing control system has served us well, but it was developed decades before the creation of the CFIA, when most Canadian food originated in Canada, food technology was less evolved, and supply chains were simple. As risks to food, animal health and plants have changed considerably and continue to change rapidly, the Agency must continue to adapt and be more efficient and responsive while supporting Canada's ability to compete in the global market. These changes position the Agency as a nimble, responsive regulator.

8. By consolidating 14 sets of existing food regulations into a single set of regulations, the SFCR

9. A list of the 14 regulations, which were repealed when the SFCR came into force, is found in Annex A.

How does your business benefit

10. The SFCR are aligned with internationally recognized standards, such as Codex Alimentarius, for food safety and consumer protection requirements.

11. As a result of these regulations, food businesses subject to the SFCR are better able to:

Roles and responsibilities

12. As a food business that is subject to the SFCR, you are responsible for the following

13. It is the role of the CFIA to

For more information refer to following CFIA web pages: Regulatory compliance, What to expect when inspected, and Compliance and enforcement.

14. Provincial and territorial authorities continue to enforce their applicable legislation for food. This will not change as a consequence of the SFCR. The CFIA continues to work closely with its provincial and territorial partners to help improve consistency and move towards a more national approach to food safety in Canada.

What other federal legislation applies to food

15. The following legislative regimes apply to food in Canada within the CFIA mandate:

16. CFIA could also issue Administrative Monetary Penalties (AMPs), which are issued under the authority of the Agriculture and Agri-Food Administrative Monetary Penalties Act and Regulations (AAAMPA and AAAMPR). AMPs are part of a range of compliance and enforcement tools that the CFIA will use to encourage compliance with federal legislation and regulations it enforces. For more information refer to the CFIA's Compliance and Enforcement Operational Policy.

Overview of the Safe Food for Canadians Regulations

Scope of the Safe Food for Canadians Regulations

17. The SFCR generally applies to food for human consumption (including ingredients) that is imported, exported, or inter-provincially traded for commercial purposes. It also applies to the slaughter of food animals from which meat products to be exported or inter-provincially traded may be derived.

18. Some of the traceability, labelling and advertising, and grading provisions also apply to intra-provincially traded foods. Refer to Part 5, Part 11, and Part 12 within this handbook for more details.

19. The Safe Food for Canadians Act (SFCA) and SFCR do not apply to the following

20. Such food must still be safe and meet applicable requirements of the Food and Drugs Act and the Food and Drug Regulations.

Fundamental new elements of the Safe Food for Canadians Regulations

21. While there are many provisions in the SFCR which will be covered later in this handbook, there are three fundamental new elements that are of particular interest to most food businesses. They include the following

  1. Licensing (Part 3): This Part enables the CFIA to: authorize persons to conduct certain activities through licensing; identify food businesses, collect information about the activities of food businesses; and take responsive action when non-compliant activities are found.
  2. Preventive Controls (Part 4): This Part describes key food safety control principles that must be met by all food businesses. It also outlines the requirements for developing, implementing, and maintaining a written preventive control plan that documents how food businesses meet food safety, humane treatment and consumer protection requirements (for example, for labelling, packaging, standards of identity, grades, and net quantity).
  3. Traceability (Part 5): This Part requires that food be traced forward to the immediate customer and backward to the immediate supplier (one step forward, one step back).

Incorporation by reference

22. There are 17 documents incorporated by reference into the SFCR. The content of these documents are considered law, but they are maintained outside of the regulations. There are 11 documents prepared by the CFIA and 6 documents prepared by third parties.

23. Documents that are incorporated by reference have the flexibility to be changed and updated to reflect advances in science, innovation, and global trade agreements. It is the CFIA's policy to consult food businesses and interested parties prior to making changes to the documents prepared by the CFIA which are incorporated by reference.

Summary of the parts of the Safe Food for Canadians Regulations

Part 1: Interpretation

Summary

24. This Part contains the definitions of key terms used in the regulations.

25. The definitions in Part 1 apply throughout the SFCR, including documents prepared by the CFIA that are incorporated by reference.

Learn more on key topics

Refer to the Safe Food for Canadians Regulations: Glossary of key terms for definitions of terms commonly used in the SFCR and associated guidance materials.

Application of definitions

26. There are additional definitions found at the beginning of other Parts of the Regulations or within the incorporated by reference documents. Those definitions are specific to that Part only and do not have the same meaning if the term is mentioned in other Parts of the SFCR or other incorporated by reference documents.

27. Some definitions in Part 1 apply only to one type of food. In these cases, the definition only applies to the specified food. For example:

Definitions not found in the SFCA or SFCR

28. When a definition is not found in the Safe Food for Canadians Act (SFCA) or SFCR, the term takes on its plain and ordinary meaning in the applicable context. Where unclear, the commonly understood meaning or the dictionary definition of the term is taken into consideration.

Additional information on key terms

Establishment

29. The SFCA defines "establishment" as meaning "any place, including a conveyance where a food is manufactured, prepared, stored, packaged, or labelled". The definition of establishment is quite broad, and extends beyond the physical structure. It includes conveyances on which certain activities are conducted or open areas that are not contained by a building (for example, fields). A conveyance is considered an "establishment" when the food is manufactured, prepared, stored, packaged, or labelled in the conveyance. For example: a fishing vessel that processes, freezes, and packages scallops.

Prepare

30. The SFCA defines "prepare", in respect of a food commodity, as meaning "include to process, treat, preserve, handle, test, grade, code or slaughter it or to do any other activity in respect of it that is prescribed." In the SFCR, growing and harvesting of fresh fruits or vegetables, is also a prescribed activity under the definition of "prepare." This means growing and harvesting is included anytime the term "prepare" is used in the SFCR.

"Manufacture, process, treat, preserve, grade, package, or label"

31. Refer to the Food business activities that require a licence under the Safe Food for Canadians Regulations guidance material to determine whether your business practices are considered to be manufacturing, processing, treating, preserving, grading, packaging, or labelling. These terms are also defined in the Safe Food for Canadians Regulations: Glossary of key terms.

Differences between key terms

Document and record

32. "Document" is a broad term that can include many different types of information, for example, a scheduled process. A record is a type of document that is kept as proof that something happened, for example, complaints received or monitoring a piece of equipment. What are commonly known as records are covered by the broader term "document."

Conveyance, conveyance or equipment, facility, and facility or conveyance

33. Refer to the Safe Food for Canadians Regulations: Glossary of key terms to help you to understand the difference between these terms. Briefly

Although the following terms/phrases are not specifically defined in the SFCA nor SFCR, in general terms, when used in Part 4 of the SFCR (Preventive Controls) they refer to the following

Person and "individual"

34. When the term "individual" is used, the scope of the definition is limited to one individual as opposed to an organization. The term "person" is defined more broadly and its meaning can range from one individual to one organization.

Consumer prepackaged, "prepackaged other than consumer prepackaged" and prepackaged

35. "Consumer prepackaged" foods are in their final packaging, and ready for sale to an individual to be used for non-commercial purposes.

The term "prepackaged other than consumer prepackaged" food includes food packaged in shipping or other bulk containers and usually sold to a person rather than an individual and for commercial purposes (see above clarification on the term "person" in item 34.

A "prepackaged" food can include both of those: consumer prepackaged foods or prepackaged other than consumer prepackaged foods.

The term "prepackaged product" is defined in the Food and Drug Regulations (FDR) and is closely aligned with the SFCR definition of "prepackaged" food. For a comparison between the SFCR terms described above and the FDR definition of a "prepackage product", refer to

Definition of "prepackaged" and "consumer prepackaged".

Resources

Part 2: Trade

Summary

36. Part 2 establishes who needs to be licensed by the Canadian Food Inspection Agency (CFIA). It also sets the rules around trading food internationally and inter-provincially. This Part includes information on

Learn more on key topics

Address requirements for importing food

37. If you are an importer, the SFCR permits you to import food without a Canadian address (fixed place of business) as long as you

Exported food

38. In general, food that is exported must meet SFCR requirements. However, a person is permitted to export a food that meets a foreign country's requirement that is different from the SFCR requirement, only if the food was prepared by a licence holder under sanitary conditions. The person is required to keep written documents that substantiate the foreign requirements have been met and the food must be clearly labelled for export as described in the SFCR.

39. If a foreign country does not have a requirement for non-food safety elements such as compositional standards, grades or container sizes, the food that is exported can meet the specifications of a foreign buyer instead of the specific requirement in the SFCR.

Return of exported food to Canada

40. If a food needs to be returned (in its exported condition), it must be returned to the licence holder or the person who prepared the food.

41. The return of meat products needs to be authorized by a CFIA inspector before it is returned. The licence holder will store and handle the product in its imported condition.

Mixing of contaminated and uncontaminated food

42. Mixing contaminated product with non-contaminated product is an unacceptable practice, unless you are authorized to do so by the CFIA.

Resources

Part 3: Licences

Summary

43. There are two divisions within Part 3:

Learn more on key topics

Why licences are needed

44. A licence authorizes a food business to conduct an activity identified in their licence and enables the CFIA to know who those persons are, and communicate directly with them.

How to apply for a licence

45. For the latest information on obtaining a licence, refer to the Licensing.

Resources

Part 4: Preventive Controls

Summary

46. Part 4 contains the majority of the food safety provisions in the SFCR.

Part 4 covers two key concepts:

47. There are six divisions within Part 4

Learn more on key topics

How to conduct a hazard analysis

48. Refer to the following guidance materials for examples and resources to help you identify potential hazards

More information on hazards may be provided by provincial authorities and companies that specialize in hazard analysis.

Preventive control plans and exporting

49. As an exporter, you need a written preventive control plan if you require an export certificate or other export permission, such as being on an export eligibility list, from the CFIA. If a certificate is not required and your activity is limited only to exporting the food, for example, if you are a broker, then you do not need a written preventive control plan. For more information refer to Exporting Food: A step-by-step guide.

Resources

Part 5: Traceability

Summary

50. The traceability requirements are based on Codex Alimentarius principles – tracing of food forward to the person to whom the food was provided and back to the immediate supplier.

51. This Part outlines the requirements on the following:

Learn more on key topics

Traceability and retailers

52. Some of the traceability requirements apply to persons who sell food to consumers at retail, excluding restaurants or other similar enterprises. Persons who sell food at retail are required to trace the food back to the immediate supplier, but not trace forward to the consumer.

The terms lot code and unique identifier

53. A lot code or other unique identifier is used to identify a defined quantity of food to be traced. The lot code or unique identifier can help you trace affected product in the event of a food safety incident. You are responsible to determine what a lot code or unique identifier represents and how it is represented. For more information, refer to the Fact Sheet: Traceability.

Resources

Part 6: Commodity-specific Requirements

Summary

54. Part 6 contains additional requirements for certain foods. If your business is not involved in the food commodities listed below, you do not need to consider Part 6.

55. There are seven commodity-specific divisions within Part 6

56. There are also commodity-specific packaging, labelling, and grade provisions in Parts 10, 11 and 12 of the SFCR, as well as the Beef, Bison and Veal Carcass Grade Requirements - PDF (260 kb), the Canadian Grade Compendium and the Canadian Standards of Identity.

Division 1: Application

57. The requirements in Part 6 apply to

Division 2: Dairy

58. This division sets out the additional requirements for any raw milk or raw cream used in preparing a dairy product sent or conveyed from one province to another or exported which must meet the applicable requirements of the legislation of the province where the dairy product is prepared.

Resources

Division 3: Eggs

59. This division sets out the conditions for pasteurizing eggs and trading graded and ungraded eggs.

Resources

Division 4: Processed Egg Products

60. This division sets out the conditions for processing, and treating eggs. It also sets out the conditions for processing, treating and trading processed egg products.

Resources

Division 5: Fish

61. This division sets out the

Resources

Division 6: Fresh Fruits or Vegetables

62. This division focuses mainly on

Resources

Division 7: Meat Products and Food Animals

63. This division sets out the requirements for

Resources

Part 7: Recognition of Foreign Systems

Summary

64. Part 7 sets out the requirements for the recognition (by the CFIA) of a foreign state's inspection system and recognition of an establishment within that foreign state. These requirements include the application, recognition, suspension, and cancellation of the recognition. Currently, this Part only applies to meat products and live or raw shellfish. Part 6, Division 5 also provides requirements for foreign recognition in relation to live and raw shellfish.

Learn more on key topics

65. To better understand the requirements for recognition of foreign food safety systems, refer to the Foreign Food Safety Systems Recognition Framework.

Part 8: Ministerial Exemptions

Summary

66. Part 8 outlines the conditions for obtaining an exemption to some requirements of the SFCA or SFCR. If granted, the exemption will

67. Ministerial exemptions may be granted only when the following conditions are met

68. Ministerial exemptions and test markets are valid until the date indicated in the exemption, or when no date is indicated, two years.

Learn more on key topics

Transition of current ministerial exemptions and test markets

69. Ministerial exemptions and test markets issued prior to January 15th, 2019 under previous legislation will remain valid until their expiry dates unless cancelled by the Minister. The Minister may cancel an exemption if the Minister is of the opinion that the food poses a risk to human health or to interprovincial or export trade; or the person who received the exemption does not comply with the condition thereof. Once the ministerial exemption or test market is expired, the food will have to comply with the SFCR.

Resources

Part 9: Inspection Legends

Summary

70. This Part sets out the conditions for applying and using inspection legends in connection with edible meat products, fish and processed egg products. The inspection legends shown in Schedule 2 of the SFCR are trademarks owned by the CFIA and can only be used as indicated in this Part.

71. Additional requirements for applying inspection legends include applying the legend to a carcass or carcass side before refrigeration (section 151) and applying the legend to a food before it is exported or traded inter-provincially (section 258, 282, 287).

Learn more on key topics

Transition of inspection legends

72. Beginning on January 15th, 2019, when the SFCA and SFCR came into force, you will be permitted to use the former inspection legend for up to 36-months.

Resources

Part 10: Packaging

Summary

73. Part 10 covers the requirements for food packages.

There are three divisions within Part 10

Resources

Part 11: Labelling

Summary

74. Part 11 combines the food labelling requirements from the Consumer Packaging and Labelling Act and its Regulations, Canada Agricultural Products Act and its Regulations, Meat Inspection Act and its Regulations and the Fish Inspection Act and its Regulations.

The labelling requirements under the Food and Drugs Act and Food and Drug Regulations will continue to apply.

75. There are four divisions within Part 11

Resources

Part 12: Grades and Grade Names

Summary

76. This Part sets out the requirements for using and applying grades and grade names for certain foods.

There are six divisions within Part 12

77. The grade names and grade requirements can be found in two documents that have been incorporated by reference.

  1. The Beef, Bison and Veal Carcass Grade Requirements - PDF (260 kb) (The Grades Document) – the Canadian Beef Grading Agency (CBGA) maintains and hosts the document, according to conditions outlined in a Memorandum of Understanding between the CBGA and the CFIA.
  2. The Canadian Grade Compendium – it consolidates all other Canadian grade requirements is organized by commodity.

Learn more on key topics

Grading eggs

78. A licence is necessary in order to meet provincial requirements for grading, even if the food is only traded intra-provincially (for example, grading eggs)

Resources

Part 13: Organic Products

Summary

79. The main intent of Part 13 is to include the requirements of the Organic Products Regulations, 2009 formed under the Canada Agricultural Products Act.

80. The organic requirements include

The organic requirements also include organic aquaculture products, which need to be certified in accordance with the organic aquaculture standard.

81. The standards for organic products can be found in documents that have been incorporated by reference. These are listed in Annex B.

Learn more on key topics

Certification body authorities

82. The certification body has the authority to verify compliance of methods and control mechanisms in place to ensure that they meet the requirements set out in the Canada Organics Standards, as part of the product certification to allow organic integrity to be maintained along the entire supply chain.

Resources

Part 14: Seizure and Detention

Summary

83. This Part consolidates the existing food regulations related to the seizure and detention of foods.

84. This Part also contains requirements for the use of detention tags, notices of detention, and notices of release.

Part 15: Transitional Provisions

Summary

85. Part 15 sets out the transitional provisions from the current regulations to the SFCR, for certain foods and for certain persons.

Learn more on key topics

Who is eligible for additional time to comply with the SFCR

86. Part 15 describes a phased implementation approach with respect to licensing, preventive controls, preventive control plan, and/or traceability requirements for certain foods and/or persons. The amount of additional time given to comply with the specified requirements (up to 30 months) depends on the following

87. In addition, Part 15 describes the 24 month transition period for certification of organic aquaculture products. Certification of these organic products will be available to the aquaculture industry, if requested, during the 24 month transition.

Compliance of pre-SFCR products

88. Part 15 also sets out that foods that are compliant under previous legislation will be considered to be compliant under the SFCR on January 15th, 2019, in relation to the activities that were conducted prior to that date. Activities that are conducted after January 15th, 2019, must be compliant with the SFCR.

Resources

Part 16: Consequential Amendments, Repeals and Coming into Force

Summary

89. Part 16 sets out that, among other things, the following Regulations were repealed when the SFCR came into force

Key changes between the pre-published and final versions of the Safe Food for Canadians Regulations

90. The Canadian Food Inspection Agency examined and analyzed over 1717 written submissions received by various stakeholders during the consultation on the pre-publication of the Safe Food for Canadians Regulations (SFCR). A summary of the key messages from these written submissions can be found in the What We Heard Report.

91. Some of the key changes that resulted from the comments received on the pre-publication of the SFCR are highlighted below. As this list is not exhaustive, it is important for food businesses to review the final regulatory text and associated guidance to understand the requirements that will apply to them.

Annex A: List of acts and regulations that were repealed on January 15, 2019 when the Safe Food for Canadians Regulations came into force

The following Acts and Regulations are being replaced by the Safe Food for Canadians Act and Safe Food for Canadians Regulations.

Canada Agricultural Products Act

Consumer Packaging and Labelling Act (as it relates to food)

Fish Inspection Act

Meat Inspection Act

Annex B: List of documents incorporated by reference into the Safe Food for Canadians Regulations

Maximum Quantity Limits for Personal Use Exemption

Canadian Standards of Identity

Fundamentals of the Post-mortem Defect Management Program

Preventive Control Plan Requirements for Biological Hazards in Meat Products

Common Names for Prepackaged Fish

Grade Standard Requirements for Fresh Fruits or Vegetables Imported from the United States

Ante-Mortem Examination and Presentation Procedures for Food Animals

Fundamentals of the Post-Mortem Examination Program

Minimum Drained Weights and Average Drained Weights for Processed Fruit or Vegetable Products in a Hermetically Sealed Package

Units of Measurement for the Net Quantity Declaration of Certain Foods

Beef, Bison and Veal Carcass Grade Requirements - PDF (260 kb)

Canadian Grade Compendium

CAN/CGSB 32.310 Standard of the Canadian General Standards Board – Organic Production Systems – General Principles and Management Standards

CAN/CGSB 32.311 Standard of the Canadian General Standards Board – Organic Production Systems – Permitted Substances Lists

CAN/CGSB 32.312 Standard of the Canadian General Standards Board – Organic Aquaculture Standards (Available through the suppliers Techstreet and IHS Global Standards)

ISO/IEC 17011 Standard of the International Organization for Standardization – Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies

ISO/IEC 17065 Standard of the International Organization for Standardization – Conformity assessment – Requirements for bodies certifying products, processes and services

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