Frequently Asked Questions - Food and Drug Regulations

This document is an unofficial summary of the Regulations. It is not intended to substitute for, supersede or limit the requirements under the applicable legislation. In case of any discrepancy between this summary and the legislation, the legislation will prevail.

What is the purpose of this regulation?

The  Food and Drug Regulations help to protect the health and safety of Canadians with respect to the sale of food and drug products.

What are the key elements of this regulation?

The Food and Drug Regulations set out requirements for the manufacture, packaging, labelling, storage, importation, distribution and sale of foods, and prescription and non-prescription drugs in Canada. Requirements for drug clinical trials are also set out in the regulations.

Part A: Administration

Part A of the Food and Drug Regulations consists of prohibitions (what is not permitted), powers (what Health Canada has the authority to do), definitions and obligations (what Health Canada, businesses, and other stakeholders need to do) that generally apply throughout the regulations.

Part B: Food

Division 1 - General

Division 1 sets out additional regulatory definitions specific to foods as well as requirements for general labelling, allergen labelling and nutrition labelling (including the Nutrition Facts Table); permissible nutrient content claims; and permissible health claims for foods.

Divisions 2 to 14 and 17 to 22 - Standards of Composition

Divisions 2 to 14 and 17 to 22 set out 334 standards of composition for a wide range of foods (i.e. what must and can be included in the food). These divisions are categorized on a commodity basis as follows:

  • Division 2 - Alcoholic Beverages
  • Division 3 - Baking Powder
  • Division 4 - Cocoa And Chocolate Products
  • Division 5 - Coffee
  • Division 6 - Food Colours
  • Division 7 - Spices, Dressings And Seasonings
  • Division 8 - Dairy Products
  • Division 9 - Fats And Oils
  • Division 10 - Flavouring Preparations
  • Division 11 - Fruits, Vegetables, Their Products And Substitutes
  • Division 12 - Prepackaged Water And Ice
  • Division 13 - Grain And Bakery Products
  • Division 14 - Meat, Its Preparations And Products
  • Division 17 - Salt
  • Division 18 - Sweetening Agents
  • Division 19 - Vinegar
  • Division 20 - Tea
  • Division 21 - Marine And Fresh Water Animal Products
  • Division 22 - Poultry, Poultry Meat, Their Preparations And Products

Each division includes a number of standards, each of which prescribe the common name(s) of a particular food and its compositional requirements (i.e. ingredients the food must and may contain and any associated quantities and conditions). Certain divisions also prescribe additional labelling and packaging requirements (for instance, specific labelling requirements for mechanically tenderized beef under Division 14) for the standardized foods captured within the division. It should be noted that not all foods have a corresponding standard.

Division 15 - Adulteration of Food

Division 15 references the maximum levels (MLs) and maximum residue limits (MRLs) for pest control products, veterinary drugs and other chemical substances (such as arsenic and lead) that may be present in specified foods. Foods containing these substances in excess of the established MLs or MRLs are considered adulterated and as such prohibited from sale in Canada.

Division 16 - Food Additives

The sale of a food additive or of a food that contains a food additive that has not been approved by Health Canada is not permitted. The food additives that have been assessed and approved for use in Canada are set out in the Lists of Permitted Food Additives. Division 16 also sets out the submission requirements for stakeholders seeking approval for the use of a new food additive, to extend the use of an existing food additive, or any other change pertaining to food additives.

Division 23 - Food Packaging Materials

Division 23 sets out a general prohibition against the sale of food in a package that may be harmful to health. The division also prescribes conditions for the use of specified substances in food packaging.

Division 24 - Foods for Special Dietary Use

Division 24 prescribes the compositional requirements (including the vitamins and mineral nutrients that must be added) and labelling requirements specific to foods represented and sold for special dietary use. Such foods include: formulated liquid diets, meal replacements, nutritional supplements, prepackaged meals, foods sold by weight reduction clinics, and foods represented for use in very low energy diets.

Division 25 - Infant Foods and Human Milk Substitutes (i.e. Infant Formulas)

Division 25 prescribes the compositional requirements (including the vitamins and mineral nutrients that must be added), acceptable food additives and labelling requirements specific to infant foods, human milk substitutes and foods containing human milk substitutes.

Division 26 - Food Irradiation

Division 26 prohibits the sale of foods that have been irradiated, except as permitted by the Division. Foods that may be irradiated, the permitted source and purpose of the irradiation as well as the acceptable dose absorbed by the food are set out in a table to this Division. Division 26 also sets out the submission requirements for stakeholders seeking approval to irradiate a new food, to use a new source of irradiation, to change a purpose of treatment and/or an absorption dose.

Division 27 - Low-Acid Foods Packaged In Hermetically Sealed Containers

Division 27 sets out the requirements for the sale of low-acid foods in hermetically sealed containers (i.e. containers designed to guard against the entry of microorganisms, including spores).

Division 28 - Novel Foods

Division 28 sets out the definition of a novel food as well as the pre-market notification requirements for the sale of such foods in Canada. Foods derived from Genetically Modified Organisms (GMOs) are considered novel foods.

Part C: Drugs

Division 1 - General

Division 1 applies to the sale or importation of drugs for human and veterinary use. In order to sell a drug in Canada, a Drug Identification Number (DIN) is required. This Division describes the requirements for obtaining, renewing, updating and cancelling a DIN. It also outlines requirements for drug labelling, packaging, testing, advertising and distributing samples. Post-authorization obligations, including adverse drug reaction reporting, are also described in this Division.

Division 1A - Establishment Licences

The purpose of this division is to provide oversight of activities that may impact a drug's quality and therefore compromise safety. A Drug Establishment Licence is required for any person fabricating, packaging, labelling, testing, importing or distributing drugs, or wholesaling certain drugs in Canada. This division sets out procedures related to establishment licence applications, renewals, suspensions and cancellations.

Division 2 - Good Manufacturing Practices (GMP)

Division 2 sets out the GMP standards that apply to all activities in the drug supply chain: fabricating, testing, importing, packaging, labelling, storing, and transporting of the drug. The purpose of this division is to prevent the sale of drugs that are adulterated or manufactured under unsanitary conditions and to ensure that drugs are consistently produced and controlled to meet quality standards.

Division 3 - Schedule C Drugs

This division sets out additional and/or alternate requirements for a specific type of drug, radiopharmaceutical drugs. Radiopharmaceuticals are radioactive drugs that emit nuclear particles; they are listed in Schedule C to the Food and Drugs Act. Due to the particular nature of these drugs, additional and/or alternate oversight is necessary for labelling and basic clinical research studies.

Division 4 - Schedule D Drugs

This division sets out additional and/or alternate requirements for a specific type of drug, biologic drugs. Biologics are isolated from or manufactured using living organisms and are susceptible to contamination such as with viruses; they are listed in Schedule D to the Food and Drugs Act. Due to the particular nature of these drugs, additional and/or alternate oversight is necessary for fabricating, packaging, labelling, testing, and storage.

Division 5 - Drugs for Clinical Trials Involving Human Subjects

This division provides a mechanism to regulate the sale or importation of drugs used for clinical trials in humans and helps protect patients participating in these trials.

Division 6 - Canadian Standard Drugs

This division sets standards for six specified drugs (conjugated estrogens, digitoxin, digoxin, esterified estrogens, gelatin and thyroid). The use of specific well-established standards for these drugs provides necessary controls to help prevent harm.

Division 7 - Sale of Drugs for the Purposes of Implementing the General Council Decision

This division provides the mechanism for a manufacturer to export, for humanitarian purposes, a drug that cannot be sold in Canada due to patent restrictions. This provision permits access to lower cost generic drugs in regions of the world, such as emerging nations, where the drug would otherwise be unavailable.

Division 8 - New Drugs

New drugs include drugs that have not been sold in sufficient quantity or for sufficient time to establish their safety and effectiveness. This division sets out the pre- and post-authorization requirements for new drugs for both human and veterinary use, and adds to the requirements found in Division 1. It also includes requirements for extraordinary use new drugs, clinical testing of a new drug for veterinary use, and experimental studies.

Division 9 - Non-prescription drugs

This division sets out additional requirements for a few commonly used non-prescription pain or fever medications for human use.

Part D: Vitamins, Minerals and Amino Acids

Divisions 1, 2 and 3

Divisions 1 to 3 of Part D of the Regulations identify the foods that must and may be fortified with vitamins, minerals and amino acids. They specify which vitamins, minerals, and amino acids are permitted in which foods and their respective amounts. These divisions also set out specific labelling, packaging and advertising (including claims) requirements for fortified foods.

Part E: Cyclamate and Saccharin Sweeteners

Part E prescribes labelling and advertising requirements specific to cyclamate and saccharin sweeteners.

Part G: Controlled Drugs

Part G of the FDR describes the circumstances and requirements in which persons (including businesses), pharmacists, practitioners (including doctors, veterinarians and dentists) and hospitals can engage in regulated activities including possession, production, sale, provision, sending, delivery, transportation, and importation and exportation of controlled drugs.

Part J: Restricted Drugs

Part J of the FDR describes the circumstances and requirements in which persons (including businesses) can conduct regulated activities including possession, production, sale, provision, sending, delivery, transportation, and importation and exportation of restricted drugs for clinical trial or research purposes.

How does this regulation affect Canadian businesses?

Sale of Foods in Canada

Parts A, B, D and E: Food

The requirements set out in Parts A, B, D and E of the Food and Drug Regulations and described in the previous section apply to those businesses involved in the manufacture, packaging, labelling, importation, advertisement and/or distribution for sale of foods in Canada.

Under the Food and Drug Regulations, there are no mandatory pre-market licensing or notification requirements for the sale of foods in Canada, with the exception of infant formulas and novel foods (further information below). Most foods can proceed directly to market provided they comply with the applicable compositional, labelling, packaging and advertising rules and requirements set out in the Regulations. It is the food industry's responsibility to ensure that their products meet all applicable requirements.

Infant Formulas and Novel Foods

Infant formulas and novel foods must notify and receive approval from Health Canada prior to sale in the form of a "letter of no objection". Notification requirements are provided in the Regulations under Division 25 (specifically section  B.25.046) for infant formulas and Division 28 (specifically sections  B.28.002 and B.28.003) for novel foods. Additional guidance on novel food submissions is also available in the Guidelines for the Safety Assessment of Novel Foods.

New Food Additives and Extensions of Use to Existing Food Additives

All permitted food additives and their conditions of use are housed in the Lists of Permitted Food Additives.

If the Lists do not allow for a particular use of a food additive, the manufacturer is required to file a food additive submission to Health Canada's Food Directorate for assessment. Once approved, the food additive will be enabled through the Lists at which point it can be legally used in foods sold in Canada. Guidance on food additive submissions is available in Health Canada's A Guide for the Preparation of Submissions on Food Additives.

Vitamin and Mineral levels, Health and Nutrient Content Claims and Other Rules and Requirements

The food industry and other stakeholders may at any time request that food rules and requirements be amended, for instance, to permit the use of a new nutrient content claim or to increase a permissible vitamin or mineral level for a particular food. There is no fee for submitting such requests to Health Canada. Guidance on submission requirements is provided on Health Canada's Website.

Submissions are thoroughly assessed by Health Canada's Food Directorate. If the assessment concludes that the proposal and supporting evidence are sufficient and appropriate, the requested change will be enabled through a formal amendment to the Regulations or, as the case may be, the relevant incorporated document.

Sale of Drugs in Canada

Part C: Drugs

Division 1 - General

A drug manufacturer, authorized representative or importer of a drug must apply for and receive a Drug Identification Number (DIN) in order to sell or import a drug in Canada. A DIN is required for both prescription and non-prescription drugs. This section outlines some of the requirements that must be met by DIN applicants. Post-authorization obligations of DIN holders are also outlined, and include: notification of when they start selling or when they discontinue the sale of the drug, annual notification to confirm information, adverse drug reaction reporting, annual summary reports, maintenance of records, and recalls.

Division 1A - Establishment Licences

Businesses that make, import, package, label, distribute, and/or test drugs must submit an application for an establishment licence. In order to obtain an establishment licence, the applicable requirements outlined in Divisions 2 to 4 must be met. Establishment licence holders must also follow certain post-authorization obligations.

Division 2 - Good Manufacturing Practices

Businesses that make, package, label, test and/or store drugs must follow the requirements of this division in order to ensure the manufacture of products of high quality.

Division 3 - Schedule C Drugs

Businesses that fabricate, import, package, label, test, store, or distribute radiopharmaceutical drugs must meet the requirements outlined in this section in order to further ensure patient safety.

Division 4 - Schedule D Drugs

Businesses that fabricate, import, package, label, test, store, or distribute biologic drugs must meet the requirements outlined in this division in order to further ensure patient safety.

Division 5 - Drugs for Clinical Trials Involving Human Subjects

A clinical trial sponsor (a person responsible for the conduct of a trial) must seek permission from Health Canada to conduct a clinical trial. Sponsors must meet the requirements outlined in this division, including: following good clinical practices, obtaining informed consent from participants, keeping records, ensuring that the drug is manufactured according to GMP, reporting serious unexpected adverse reactions and notifying Health Canada of the discontinuance of a trial.

Division 6 - Canadian Standard Drugs

Businesses must meet the standards outlined in this division for the following drugs: conjugated estrogen, digitoxin, digoxin, esterified estrogen, gelatin and thyroid.

Division 7 - Sale of Drugs for the Purposes of Implementing the General Council Decision

A manufacturer must receive authorization from the Commissioner of Patents in order to sell a drug under Canada's Access to Medicines Regime. The manufacturer must notify the Minister before making the first lot of an authorized drug and before exporting each subsequent lot. The manufacturer must also fulfill the same post-authorization record keeping and reporting obligations as for a new drug sold in Canada.

Division 8 - New Drugs

This section outlines requirements for the authorization of a new drug. Businesses must submit sufficient information for the assessment of the new drug's safety, efficacy and quality. Post-authorization obligations include: collecting safety information about the drug and its effects, record keeping and reporting information to Health Canada.

Division 9 - Non-prescription drugs

Businesses must follow the requirements outlined in this division with respect to certain non-prescription drugs that may be taken for pain or fever.

Part G: Controlled Drugs

Prior to possessing or engaging in an activity such as production, sale, provision, sending, delivery, transportation, importation or exportation of a controlled drug regulated under Part G, persons, including businesses, may require authorization from Health Canada. Such authorizations can include a dealer's licence. Licensed dealers must meet certain terms and conditions such as security and record-keeping requirements. In addition, licensed dealers must obtain a permit from Health Canada for each import or export of a controlled drug.

Compliance with the regulations is monitored by Health Canada. Authorized places such as licensed businesses and pharmacies are subject to on-site inspections to verify compliance.

Part J: Restricted Drugs

Prior to possessing or engaging in an activity such as production, sale, provision, sending, delivery, transportation, importation or exportation of a restricted drug regulated under Part J, persons, including businesses, may require authorization from Health Canada. Such authorizations can include a dealer's licence. Licensed dealers must meet certain terms and conditions such as security and record-keeping requirements. In addition, licensed dealers must obtain a permit from Health Canada for each import or export of a restricted drug.

To purchase a restricted drug from a licensed dealer for clinical trial or research purposes, research institutions must obtain an authorization from Health Canada. The licensed dealer must also receive authorization from Health Canada in order to make that sale.

Compliance with the regulations is monitored by Health Canada. Authorized places such as licensed businesses, and institutions are subject to on-site inspections to verify compliance.

What is the timeline for implementation?

The Food and Drugs Regulations are made under the authority of the Food and Drugs Act.

Following the establishment of a federal Department of Health Act in 1919, the Food and Drugs Act was introduced in 1920. By the late 1920s, Regulations developed under the Act established specific requirements for authorizing drugs and foods. These regulations have been amended periodically since then in response to emerging health and safety needs and technological innovations.

Part G is located within the FDR, but is under the authority of the Controlled Drugs and Substances Act (CDSA). Part G came into force on August 9, 1961.

Part J is located within the FDR, but is under the authority of the CDSA. Part J came into force on August 13, 1969.

Where can I get more information on the Food and Drug Regulations?

A copy of the current  Food and Drug Regulations is available on Justice Canada's website.

Further information on the regulation of food in Canada is available under the Food & Nutrition section of Health Canada's website.

The Prescription Drug List which is incorporated by reference into the Food and Drug Regulations is available in the Drugs and Health Products section of Health Canada's website.

Visit our "Contact Us" page.

Please visit the Health Canada website for additional information or contact the Office of Controlled Substances to request a licence or permit application form or to make an enquiry.

For More Information

To learn about upcoming or ongoing consultations on proposed federal regulations, visit the  Canada Gazette and  Consulting with Canadians websites.

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