Food Law and Regulations in Canada Flashcards
When were food laws first enforced in Canada?
- Before the confederation was created on July 1st, 1867 (Canada day!)
- Influence by English initiatives
- In 1860, the English Parliament enacted a landmark broad food law, not designed to control specific items but to prevent adulteration of all food and drink.
- This law was amended in 1872 and again in 1875
- In 1860, the English Parliament enacted a landmark broad food law, not designed to control specific items but to prevent adulteration of all food and drink.
The last territory to join the confederation was Nunavet in 1999.
What Act was passed as a result of the massive adulteration of liquor with copper sulphate, opium, or salt?
Jan 1, 1875 – Act to Prevent the Adulteration of Food, Drink, and Drugs
- Introduced penalty of $100 and a month in jail
- Has been revised several times
Appeared before the Pure Food & Drugs Act of 1906 in the US.
When was the 1875 Act superseded?
- In 1920 when the Food & Drugs Act was enacted
- Amended and revised several times, most recently in 1954
- The act received constitutional authority in 1982
This was a large success of PM Trudeau (the original)
In Canada foods are regulated by:
- Federal Government – inter-provincial (interterritorial) trade
- Provincial/Territorial/Municipal Government – within specific Province/Territories
Describe the Federal-Provincial/Territorial cooperative mechanism.
- Committees
- Memorandum of Understanding
- MoU between the Health Protection Branch and the BC Ministry of Health (1982)
- Agreements
- Various agreements between CFIA and Provincial/Territorial Governments
- Use similar regulations and avoid duplication of inspections.
These mechanisms promote collaboration and consistency in health and safety standards between federal bodies like the CFIA (Canadian Food Inspection Agency) and provincial/territorial governments, improving efficiency and public health protection.
What are the federal organizations responsible for food regulations in Canada? [4]
- Health Canada
- Health Products and Food Branch (HPFB)
- Food Directorate (FD)
- Natural and Non-prescription Health Products Directorate (NNHPD)
- Health Products and Food Branch (HPFB)
- Canadian Food Inspection Agency
- Agriculture and Agri-Food Canada
- Industry Canada
- Measurement Canada
Describe the organization of Health Canada.
Note the Health Products & Food Branch
Describe the Health Products and Food Branch (HPFB) Organizational Chart.
What is the scope of roles of responsibilities of Health Canada with regard to foods and nutrition? [9]
- Administering the Food and Drugs Act that relates to public health, safety, and nutrition (HPFB)
- Regulatory amendments
- Establishing policies, standards, and guidance regarding the safety and nutritional value of food (HPFB, FD)
- Helping Canadians maintain and improve their health
- Establishes food labelling regulations
-
Liaison with national and international health organizations regarding safety standards in food products (FD)
- Partnering with other federal departments, agencies, provincial/territorial governments, and health organizations.
- Auditing the CFIA
- Evaluation of submissions, chemical testing, and standards (FD, Bureau of Chemical Safety)
- Development and evaluation of analytical methods
Describe the role of Health Canada in establishing policies, standards, and guidance regarding the safety and nutritional value of food. [3]
- (1) Risk assessments, (2) food safety research, and (3) disease surveillance by HC
- Together with the CFIA Bureau, developed “the Canadian Code of Practice for Food Irradiation.”
How does Health Canada help Canadians maintain and improve their health? [3]
(1) Health promotion, (2) disease prevention, and (3) safety messaging (FD, Office of Nutrition Policy and Promotion)
Describe HC’s role in establishing food labelling regulations. [3]
- (1) Nutritional information and (2) health claims (FD, Bureau of Nutritional Sciences, together with CFIA)
- (3) Canadian Nutrient File
Who is the contact point for the Codex Alimentarius Commission?
Health Canada
Liaison with national and international health organizations regarding safety standards in food products (FD)
Describe the role of HC in auditing the CFIA. [4]
- Review the design and operation of CFIA
- Assess compliance with health and safety standards
- Evaluation of results
- Preparation of reports to the Minister of Health
Describe HC’s role in evaluation of submissions, chemical testing, and standards. [4]
- (1) Food additives, allergens, chemical, and microbiological contaminants
- (2) Novel foods (including GMO)
- (3) Food irradiation (policies, standards, new processes, guidelines)
- (4) Development and evaluation of analytical methods.
Describe the role of Food Directorate - Office on Nutrition Policy and Promotion. [5]
- Conducting nutritional research
- Assessing the nutritional value of foods
- Surveillance of national nutrition system and nutritional status of Canadians
- Developing and revising dietary guidance policy for Canadians
- Establishing required standards of nutritional importance
- Canada’s Food Guide
- Dietary Reference Intakes
What defines powers, duties, and functions for Health Canada and its divisions? [2]
- Food and Drugs Act and Regulations
- Department of Health Act (DHA)
What defines the organizational structure, responsibilities, and authority of the CFIA and Federal-Provincial corporations and audits?
Canadian Food Inspection Agency Act
Who has the authority to assess the CFIA?
The Food Directorate (HC)
What is the Natural and Non-Prescription Health Products Directorate?
- Regulating authority for natural health products (NHP) and non-prescription and disinfectant drugs in Canada
- Authorized under Natural Health Products Regulations (NHPR)
What are the NNHPD responsibilities for natural health products? [5]
- Ensuring that the natural health products (NHP) are safe, effective, and of high standards
- Developing policies and guidelines for NHP
- Managing and processing submissions for approval of NHP
- Licensing products and manufacturing sites
- Authorization of clinical trials
What is the primary role of the CFIA?
- Conducting all federal food inspection activities
- Animal health and plant protection
At the federal level, the responsibility for food safety is shared between:
- The Minister of Agriculture and Agri-Food Canada (AAFC), through the CFIA
- The Minister of Health, through HC
The CFIA is more autonomous than the traditional government departments, but they still report to:
The Minister of Agriculture and Agri-Food Canada
What does the Minister of Health do?
- Establishes and provides policies and standards for the safety and nutritional quality of food sold in Canada to the Agency
- Based in part on the risk assessments, food safety research, and disease surveillance conducted by HC
- Assesses the effectiveness of the CFIA’s inspection activities
What are the responsibilities of the CFIA as defined by the CFIA Act 1997, C-16.5 sec 11?
- Enforcement of:
- The Consumer Packaging and Labelling Act as it relates to food, as that term that is defined in section 2 of the Food and Drugs Act
- Food and Drugs Act as it relates to food, as defined in part 1 of the act
- Administration of the provisions of the Food and Drugs Act as they relate to food, as defined in part II of that Act
- Administration and enforcement of the:
- Fish Inspection Act
- Health of Animals Act
- Meat Inspection Act
- Canada Agricultural Products Act
- Plant Breeders’ Rights Act
- Agriculture and Agri-Food Administrative Monetary Penalties Act
- Feeds Act
- Fertilizers Act
- Plant Protection Act
- Seeds Act
What two types of authority does the CFIA regulate the food industry through?
- Powers of criminal law - The Food and Drugs Act prohibits the manufacture or sale of all dangerous and adulterated food products anywhere in Canada
-
Powers of federal trade and commerce - Other acts (commodities like dairy, eggs, fresh and processed produce, honey, maple syrup, beef, pork, poultry, and fish; organic foods, retail foods, labelling) - Safe Food for Canadians Act (SFCA)
- All establishments that process and distribute these commodities inter-provincially, territorially or internationally must register with the CFIA and they are subject to auditing
Describe actions that may be taken by the CFIA.
- Require the recall of unsafe food, diseased animal, or plants
- Procure services from service providers outside the federal government (e.g., third party audits)
- Apply to a court for an interim injunction
- Establish and collect fees
- Withdraw or withhold services should a client fail to pay a prescribed fee.
The CFIA may enforce a mandatory recall. What are the classes of recalls?
- Class I- a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
-
Class II - the use of, or exposure to, a violative product may cause temporary adverse health consequences or where the probability of serious adverse health
consequences is remote - Class III - the use of, or exposure to, a violative product is not likely to cause any adverse health consequences
CFIA maintains a list of recalls and allergy alerts.
Class I
A reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II recall
The use of, or exposure to, a violative product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III recall
The use of, or exposure to, a violative product is not likely to cause any adverse health consequences.
A reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class I
The use of, or exposure to, a violative product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
Class II recall
The use of, or exposure to, a violative product is not likely to cause any adverse health consequences.
Class III recall
Describe safety programs encouraged by the CFIA.
- The CFIA encourages and supports the development, implementation, and maintenance of the Food Safety Enhancement Program
- HACCP Plan
- Preventive Control Plan
- Quality Management Program - federally registered fish processing plants
- On-Farm Food Safety Program
Discuss the recent CFIA analysis for Food Fraud.
What are the responsibilities of Agriculture and Agri-Food Canada? [5]
Department of the Government of Canada
- Agriculture
- Products derived from agriculture
- Technology and research related to agriculture (mostly GMO research)
- Policies and programs for the security of the food system
- Information:
- National and international markets
- Agriculture industries, suppliers, processors
- Regulations and assistance programs to advance exporting, importing, and investment activities
Info bolsters economy - e.g. international market demand informs farmers
The Minister must prepare and submit to Parliament an annual report on the Department’s operations
The appointment of a Minister and a Deputy Minister of Agriculture and Agri-Food is governed by:
The AAFC Act
Describe the research focus of Agriculture and Agri-Food Canada. [3]
-
Quality and safety of the food system
- Tracking, tracing, and identity preservation systems; contamination; adulturation
-
Security and protection of the food supply
- Detection and mitigation tools, techniques, and strategies for various threats to the security and protection of the food supply
- Human health and wellness
- Nutrition, functional foods, and innovative products; substantiation of health claims; disease prevention
What is measurement Canada responsible for?
- Responsible for integrity and accuracy of weights and measures
- Develop and administer laws and regulations as they pertain to measurements
Describe the legislation process in Canada.
- Introduction: A bill is introduced in either the House of Commons or the Senate.
- First Reading: The bill is presented and read without debate.
- Second Reading: The bill is debated on its principle and then voted on.
- Committee Stage: A committee reviews the bill in detail, holds hearings, and may make amendments.
- Report Stage: The committee reports the bill back with any changes for consideration.
- Third Reading: The final version is debated and voted on.
- Senate Review: If the bill started in the House, it moves to the Senate for a similar process, or vice versa.
- Royal Assent: If passed by both Houses, the bill receives royal assent from the Governor General and becomes law.
Use ‘interim market authorizations’ as an example to the legislation process in Canada.
What is the Canada Gazette?
- “Official newspaper” of the Government of Canada since 1841
- Part I - for consulting the general public on proposed regulations
- The vehicles to communicate and provide access to the acts (Part III) and regulations (Part II) for Canadians
The Canada Gazette is the official newspaper of the Government of Canada. It publishes new laws, proposed regulations, official notices, and government decisions. It serves as a key source of information on federal legislative and regulatory actions.
What are the important Acts and Regulations in Canada? [5]
- Food and Drugs Act and Regulations
- Canada Agriculture Products Act and Regulations (CAPA)
- Repealed and consolidated into FDR
- Meat and Fish Inspection Act and Regulations
- Repealed and consolidated into FDR
- Consumer Packaging and Labelling Act and Regulations
- Repealed and consolidated into FDR
- Safe Food For Canadian Act and Regulations
Describe how new regulations came about for this example.
- 1998 - Nutrition Labelling Advisory Committee
- Consultations and workshops with health professionals, consumers, NGOs, industry, federal and provincial/territorial government departments
- 1999 - Recommendations for mandatory nutrition labelling were presented to HC
- 2000 - Officially accepted by the Minister of HC
- 2001 - Proposed regulations published in the Canada Gazette, Part 1, for comments
- Extensive informal consultations on specific proposals were undertaken with interested parties, including industry
- Parties were invited to respond to the proposed regulations within 90 days from the date of publication
- 2001 - Public debate
- Approximately 4400 comments received
- Most expressed support
- Adjustments to proposed amendments made
- 2002 - Passage by the Senate, Royal Assent and Incorporation
- 2003 - Regulations were published in the Canada Gazette, Part II
5 year long process!
What is the Food and Drugs Act? [6]
The major law regarding:
- The (1) production, (2) import, (3) transport across provincial/territories and (4) sale of food, drugs, contraceptive devices, and cosmetics
- (4) Ensuring the safety of food supplies and (5) preventing deception
- (6) Overlooking sales and advertisement
Federal Law - applies across the whole country.
The Act is divided into two parts:
1. Relates to foods, drugs, cosmetics, and medical devices
2. Relates to administration and enforcement
Where does the Food and Drugs Act and Regulations apply?
All provinces and territories
This is a Federal Law
What are the two parts of the Food and Drugs Act and Regulations?
Part I relates to foods, drugs, cosmetics, and medical devices.
Part II relates to administration and enforcement.
Define food (aliment).
Includes any article manufactured, sold, or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever.
Pet food and animal feed are regulated separately under the Feeds Act.
Define food commodity.
- Any food as defined by the Food and Drugs Act
- Any animal or plant, or any of its parts, from which food may be derived
- Anything prescribed to be a food commodity
Define label.
Includes any legend, word, or mark attached to, included in, belonging to, or that accompanying any food ( a food commodity or a package)
Define advertisement.
- Includes any representation by any means for the purpose of promoting directly or indirectly the sale [or disposal - food only] of any food (or food commodity [SCFR]).
Define unsanitary conditions.
- Means such conditions or circumstances as might contaminate with dirt or filth, or render injurious to health, a food (such a food is injurious to health of a person, and consuming it may render a potential cumulative effect)
Define package.
Includes anything in which any food is wholly or partly contained, placed, or packed
Define prepackaged product.
Includes any product that is packaged in a container in such a manner that it is ordinarily sold or used or purchased by a consumer without being repacked.
What does section 3 of Part I of the Food and Drugs Act regulate?
Prohibited Advertising
Prohibits the advertising (including information on a label) and selling of any food, to the general public for the treatment, prevention, or cure of any of the diseases listed in Schedule A.1
* Includes arteriosclerosis, cancer, congestive heart failure, diabetes, hypertension, and obesity
Which health claims were exempted from Schedule A.1? [3]
- Potassium and hypertension
- Saturated/trans fat and heart disease
- Fruits and vegetables and some types of cancer
Describe the Prohibited Sales of Food (section 4) of Part I of the Food and Drugs Act. [3]
Prohibited sales of food
- That is poisonous or contains a harmful substance, adulterated, unfit for human consumption
- consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed, or diseased animal or vegetable substance
- manufactured, prepared, preserved, packaged or stored under unsanitary conditions (sec. 4 and 7)
Section 4 and 7 covers safety, integrity, and ‘freedom from adulteration’ of foods.
What are exemptions to adulteration prohibitions per the Food and Drugs Act? [4]
- If a food contains: (1) agricultural chemicals, (2) veterinary drugs, (3) pesticides, or (4) their derivatives up to the allowable maximum level it is not adulterated.
How does the Food and Drugs Act prevent economic fraud?
- Prohibits the label or sale of any food that is false, misleading, or deceptive
Section 5.2
How does the Food and Drugs Act prevent injury to the health of consumers?
- Compliance with Food Standards (section 6)
- Prohibits selling, importing, transporting, and possessing any food products that are not in compliance with prescribed standards
Note: Standardized foods in Canada is the same concept as foods with a Standard of Identity in the US.
Who is responsible for enforcement of the Food and Drugs Act?
Section 22
- The Minister of Health does this by designating inspectors for this purpose
- Inspector power (section 23)
- The inspector may, at a reasonable time, enter any place where an article is manufactured, prepared, preserved, packaged, or stored.
Describe seizure and forfeiture regulated by the Food and Drugs Act (section 24-27).
- Describe certain powers concerning articles seized and the right to obtain an order for forfeiture
- The inspector can examine, take samples of, open, make copies of, take photographs of, extract from, seize or detain any product that may be contravening the Act (or Regulations)
- Every person in a place entered by an inspector must provide the inspector with all reasonable assistance and information requested
- It is against the Act to obstruct an inspector to perform his/her duties and functions
Describe the analysis (sec 28-29) and punishment (sec 31-36) regulated by the Food and Drugs Act.
-
Analysis of seized articles
- Provides that an inspector may have an analysis prepared on the article seized
-
Offences and punishment to food
- Every person who contravenes any provision of the Act (or Regulations), as it relates to food, is guilty of an offence and liable to fines.
Use Labatt’s case (1980) to describe Federal Legislative Power.
- Labatt Brewing Co. produced a line of beer with a 4 percent alcohol content labelled “Labatt’s Special Lite” and sold in Ontario and British Columbia.
- Under Food and Drug Regulations beer could only be called “light” if it contained between 1.2 and 2.5 percent alcohol.
- The Court decided that the part of the Food and Drugs Act that prohibited the selling of “light” beer without proper labelling is not related to health and safety; therefore, a penalty of imprisonment cannot be applied.
- The criminal law power could be used to enact laws for the protection of health (which was not the case in this particular situation)
Describe the regulation of exports (section 37) per the Food and Drugs Act.
- The Act applies to packaged foods that have been manufactured for consumption in Canada
- If food is manufactured and sold for consumption outside Canada, it will not be required to meet the standard of the Act. However:
- It has been distinctly marked (on a package) “Export” or Exportation” and,
- A certificate must be issued that food does not contravene any known requirement of the law of the country to which it is consigned
What are the 7 distinct parts of the Food and Drugs Regulations?
- Administration/General (Part A)
- Foods (Part B)
- Drugs (Part C)
- Vitamins, Minerals, and Amino Acids (Part D)
- Cyclamates Sweeteners (Part E) - modified in 2016 by removing saccharin
- Controlled Drugs (Part G)
- Restricted Drugs (Part J)
Describe the new regulations for saccharin.
- Banned as a food additive in 1977
- Effective 2014 - saccharin and its salts (calcium, potassium, sodium) are approved for use in various unstandardized foods:
- Breath freshener
- Canned fruits
- Chewing gum
- Others
What does Part B: Foods set standards for? [6]
- The sale, advertisement, packaging, labelling, and importation of foods
- Specific requirements for foods: standards of composition, amount, strength, potency, purity, quality, and other properties
- Consists of 29 Divisions
What does Division 1 of Part B: Food regulate? [4]
Labelling
-
Labelling
- The basic and nutrition labelling
- Nutrient content and health claims
- Reference standards, serving sizes, etc.
- Provides for a Temporary Marketing Authorization Letter where the food or the packaging, labelling, or advertising of the food does not comply with the requirements of the regulations
What is contained within Divisions 2 to 22 of Part B: Foods?
- Standardized foods
- Dairy products (Division 8)
- Fats and oils (Division 9)
- Grain and bakery products (Division 13)
What does Division 16 of Part B: Foods regulate?
Additives
- Additives
- Lists 380 permitted food additives classified into 15 groups based on function
- Describes the process in which a food additive is added (or modified) to the list of additives
Less additives in Canada than the US.
Submission is required to the Minister with all specific information listed in this division (e.g., name of the additive, safety data, food to be used, maximum level, etc.)
Define food additive.
Any substance, including any source of radiation, the use of which affects the characteristics of food (i.e., its use causes a technical effect on the finished food)
Salt, sugar, and starch are defined as additives.
True or False?
False.
These are food ingredients or products sold as foods.
Salt, sugar, and starch are not defined as additives.
True or False?
True.
These are food ingredients or products sold as foods.
What ingredients are covered separately under the Food and Drug Regulations and excluded from the additive definition? [9]
- Vitamins
- Minerals
- Amino acids
- Spices
- Seasonings
- Flavouring preparations
- Agricultural chemicals
- Food-packaging materials
- Veterinary drugs
Also recall that salt, sugar, and starch are not defined as additives either.
What are the categories of additives in Division 16? [15]
- Anticaking agents (e.g., calcium silicate)
- Bleaching, maturing, and dough conditioning agents (dough conditioning agents like chloride are not permitted in EU)
- Colouring agents (e.g., paprika, saffron)
- Emulsifying, gelling, stabilizing, and thickening agents (e.g., pectin, carrageenan, stearoyl lactylate)
- Food enzymes (e.g., amylase, papain)
- Firming Agents
- Glazing and polishing agents (e.g., beeswax)
- Miscellaneous agents
- Sweeteners (e.g., aspartame)
- pH adjusting agents, acid-reacting materials, and water-correcting agents (e.g., citric acid)
- Preservative (e.g., K nitrate, Na sorbate, propionic acid)
– Class I, II, III, IV - Sequestering agents (e.g., EDTA)
- Starch modifying agents (starch is not additive!)
- Additives that may be used as yeast foods (e.g., Ca carbonate)
- Carrier or extraction solvents (e.g., CO2)
If max limit is specified as GMP, then use in minimum amount to elicit desired effect.
What does Division 15 of Part B: Foods regulate?
Adulterated Foods
- Foods are adulterated if the specific substance is present or added in an amount exceeding the prescribed amount
- Agricultural chemicals (e.g., pesticides; fertilizers)
- Veterinary drugs
- Other chemicals (e.g., additives used in amounts above the allowable limit)
What does Division 24 of Part B: Foods regulate?
Foods for Special Dietary Use
- Specially processed or formulated for people with:
- a) physical or physiological condition as a result of a disease, disorder, or injury
- b) specific needs, for example, weight loss, which can be obtained by a controlled intake of foods
What does Division 29 of Part B: Foods regulate?
Supplemented Foods
Supplemented Foods
- A prepackaged food with added permitted supplemental ingredients (vitamins, minerals, nutrients, and other substances)
- Foods for special dietary use
- Foods for infants, children (1-5 years old), pregnant and breastfeeding women
- Some other foods
This Division is new!
What does Division 28 of Part B: Foods regulate?
Novel Foods
Novel foods
- Foods derived from modern biotechnology
- Foods that are new or that do not have a history of safe use as a food
- Requires a pre-market notification from the manufacturer or importer before it can sell or advertise for sale
This Division was adopted from EU.
Novel foods are anything that do not have history of safe consumption. A great example are insect foods. Functional foods also go through here.
What are the three categories of novel foods?
- Substance, including microorganism, that does not have a history of safe use as food
- A food that has been manufactured, prepared, preserved, or packaged by a process that has not been previously applied to that food, and causes the food to undergo a major change
- A food that is derived from a plant, animal, or microorganism that has been genetically modified
Describe Part D of the Food and Drugs Regulations.
Vitamins, Minerals, and Amino Acids
- This part describes the status of vitamins and minerals (amounts, RDI):
- In foods
- As prescription drugs
- In combination with other drugs
- In specified foods
- Currently, some of the substances listed in part D can be used as natural health products
Vitamins, Minerals, and Amino Acids are in a separate part because they are not only used in foods, but also many other products.
What happened to Canada Agricultural Products Act (CAPA) in January of 2019?
It was repealed under the Safe Food for Canadians Act and consolidated into the Food and Drugs Act and Regulations.
When CAPA was repealed in January of 2019 and consolidated into the Food and Drugs Act and Regulations, what did this include? [3]
- Dairy, Egg, Fruit and Vegetable, Honey, Maple Products, Organic Products, Processed Products Regulations
- Regulation of the marketing of agriculture products in inter-provincial trade, import, and export
- Regulations of the national standards, grading and inspection of agricultural products
These regulations are administered by the CFIA and the Canada Border Services Agency (Import)
Who administers the Food and Drugs Act and Regulations?
CFIA
Canada Border Services Agency (Imports only)
Discuss standardized cheese in Canada. [2]
- Max moisture %
- Min milk fat %
Discuss Egg Sizes for Canada A Eggs. [6]
What are CFIA Registration Marks?
- Mandatory for companies selling products to other provinces/territories/countries
Per the Meat and Fish Inspection Acts and Regulations (repealed under SFCA and consolidated into Food and Drugs Act and Regulations) - what is the CFIA responsible for? [5]
- The inspection of animals and meat products in registered establishments (e.g., slaughterhouses and processing facilities)
- The standards for establishments (animals slaughtered and meat preparation)
-
Inspection of fish and marine plants (including Irish moss, kelp, and other saltwater plants)
- Inspection of processed fish and processing establishments
- The registration of establishments
- The import, export, and inter-provincial trade
What do the Consumer Packaging and Labelling Act and Regulations (amended under SFCA) regulate?
Who enforces these regulations?
The requirements for the packaging, labelling, sale, importation and advertising of prepackaged and certain other products
The administration and enforcement of the CPLAR, as they relate to food products, are the responsibility of the CFIA.
The administration and enforcement of the Consumer Packaging and Labelling Act and Regulations (amended under SFCA), as they relate to food products, is the responsibility of the […]
CFIA
All food in Canada within the mandate of the CFIA will be regulated by […]
Two federal legislative acts - the SFCA and the FDA
What were the goals of the Safe Food for Canadians Act? [3]
- Consolidate and simplify current regulations under the CAPA, Meat Inspection Act, Food Inspection Act, and food-related part of the Consumer Packaging and Labelling Act (replaces 13 regulations which were outdated and overlapping)
- Improve the food system and make it safer
-
Modernization
- Food inspection
- Food Labelling Modernization Initiative (CFIA)
Describe how the Safe Food for Canadians Act was modernized. [2]
Modernized the federal regulatory framework for food safety (improve food safety) – “based on international food safety best practices”
-
Mandatory registration/licenses of all food plants (interprovincial, import, and export trade)
- Licence renewal every two years (same renewal period as in the US)
- Certification for food for export
- Clearly state when foods are for export otherwise inspectors may assume they are in non-compliance with Canadian regulations.
- Modernize food safety management systems and GMP to reflect internationally recognized standards (Codex, the US)
- HACCP-based preventive control measures
- Enhance international market opportunities for the Canadian industry
What is a control measure?
A measure that can be applied to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of a food or to reduce the hazard to an acceptable level.
The operator must prevent, eliminate, or reduce to an acceptable level the hazards (biological, chemical, and physical) by using effective control measures shown by evidence.
How was food inspection modernized? [7]
-
More consistent food inspections for all foods based on food safety risk and compliance data
- Including information from third parties, other government agencies, trading partners
-
Increasing control of imported foods and food traceability
- Preventive control plans for imported foods
- CFIA inspection of foreign country producers (according to WTO agreements)
-
Enhanced legislative authorities
- Empowers CFIA; higher penalties for offences ($250k up to $5 million)
- Combination of traditional methods (end-product and process) and auditing (records, interviews, observation)
- New manuals for inspectors and regulatory guidance documents for the industry
- My CFIA - online services
- Permissions for licences, permits, registrations, and export certifications
- Application forms
- Webinars
- Collecting information to enable evaluation of the potential risk
What does more consistent food inspections for all foods based on food safety risk and compliance data include?
Information from third parties, other government agencies, and trading partners
Modernization of food inspection
How was control of imported foods and food traceability increased? [2]
- Preventive control plans for imported foods
- CFIA inspection of foreign country producers (according to WTO agreements)
Modernization of food inspection
How were legislative authorities enhanced?
- CFIA authority is enhanced:
- Higher penalties for offenses ($250k to $5 million)
Modernization of food inspection
How was food labelling modernized? [3]
-
Streamline the current regulations for labelling and standards of identity of different quantities
- Reduce duplication and inconsistency (MIR, FIR, CLPA, CAPA)
- FDR is amended (SFCA refers to FDR)
- Standards of identity remain unchanged, duplications are removed
- Improve transparency and communication with consumers and consumer protection
-
Support industry innovation
- Continuum: Food safety and preventive health
Describe the Cannabis Act and Regulations.
- These regulations were published in the Canada Gazette (Part II) in July of 2019 (effective on my birthday in 2019 lol)
- Regulations for edible cannabis (≤ 10 mg of THC), extracts (e.g., oil ≤ 30 mg of THC), and topicals (Part 6, cannabis products)
What are the food marketing, promotion, and advertising that may be included on a label?
- Promotional information (via label vignettes)
- Label claims
- ‘product of Canada’; ‘natural’; ‘organic’; and ‘no preservatives added’
- ‘low fat’; ‘cholesterol-free’; ‘high source of fibre’
- Health claims
What are Health Canada’s responsibilities regarding Canadian Federal Food Labelling?
Health Canada is responsible for the establishment of policies and standards relating to the health, safety, and nutritional quality of food sold in Canada under the Food and Drugs Act
What are the CFIA’s responsibilities regarding Canadian Federal Food Labelling?
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Enforcement and administration of the policies and regulations under the FDAR, SFCA, and other applicable laws concerning:
- Food labelling information and wording, net quantity, packaging, and advertising
- Commodity grade, quality, and composition
Describe the basic labelling of juice.
- Name ‘juice’ indicates 100% juice
- Less than 100% juice may be named drink, beverage, or cocktail as part of the name
- % juice must be declared
Describe net quantity declarations on Canadian labels.
- Net quantity must be declared in metric units on the PDP in both official languages
- Must be declared:
- By volume, for liquid: e.g., mL or L for amounts over 1000. mL
- By weight, for solids: e.g., g or kg (for amounts over 1000 g)
- By count, for certain foods such as candies, applies
- Must be rounded
- 453.59 becomes 454
- 85.6 becomes 86
- 6.53 becomes 6.5
Describe the name & address on a Canadian label for products wholly manufactured outside of Canada.
- The label carries the name and address of a Canadian dealer, the terms: Imported by/Importe par or Imported for/Importe pour must precede the address unless the geographic origin of the product is placed immediately adjacent to the Canadian name and address
Ingredients must be listed in descending order. What are the exceptions to this? [4]
- Spices, seasoning, herbs (except salt)
- Natural and artificial flavours, flavour enhancers
- Food additives, vitamins, mineral nutrients, and derivatives of salts
- Sugar-based ingredients must be grouped after the term ‘Sugars’
These ingredients may be shown at the end in any order.
Describe the basic labelling requirements for the list of ingredients.
- May appear on any label panel except the bottom
- It must be shown in both French and English
- Must be listed in descending order (exceptions exist)
- Sugar-based ingredients must be grouped after the term ‘sugars’
What are component declarations?
- Components are ingredients of ingredients
- Must be declared either:
Components (e.g., butter, lard, salt, baking powder) are exempted from declaration from ingredients. Must be declared, but not necessary to decare their ingredients.
Describe the list of ingredients before and after label modernization.
- Changes made for readability
- Bullets to separate ingredients
- Grouping of sugar-based ingredients
* This helps consumers identify sugars that are not obvious to everyone (e.g., fancy molasses)
What components must be declared? [6]
- Salt
- Glutamic acid or its salt
- Hydrolyzed plant protein
- Aspartame
- Potassium chloride
- Any ingredients or component that performs a function or has any effect, on that food
What is durable life data?
Means the period, starting on the day the food is packaged for retail sale, that the food will retain normal wholesomeness, palatability, and nutritional value, when its unopen and stored under appropriate conditions.
It is required on prepacked foods with a durable life of 90 days or less destined for retail.
When is durable life data required on a label?
It is required on prepacked foods with a durable life of 90 days or less destined for retail.
Exemptions:
- Food is intended to be consumed within 24 hours (e.g., pastry)
- The deterioration is evident (e.g., fresh produce)
What are exemptions to the durable life data requirements?
- Food is intended to be consumed within 24 hours (e.g., pastry)
- The deterioration is evident (e.g., fresh produce)
It is required on prepackaged foods with a shelf life of 90 days or less destined for retail.
When is an expiration date required?
To ensure that a food is safe, expiration date is required on foods that are formulated with specific nutritional composition
– Liquid diets
– Low-energy diet
– Meal replacement
– Nutritional supplements
– Human milk substitutes (infant formula)
When food has an expiration date, the ‘best before’ date is not required.
What is packaging date?
The date on which a food is placed for the first time in a package in which it will be offer for sale to a consumer
Declaration of allergens, gluten, and sulphites should be:
- “Contains”… - the statement appears immediately after the list of ingredients; or
- In bold type
- In the list of ingredients
- The source of the allergen, gluten, must be declared
- If the allergen is present in wine and spirits as a result of fining, the allergen source must be declared
- The sulphite common name must be declared
Seasonings are […] which are exempted from […]
Seasonings are multi-component ingredients which are exempted from component declaration.
Beers are required to declare: [3]
Beers are required to declare (1) food allergens, (2) gluten sources and (3) added sulphites
Describe the new Canadian standard nutrition panel. [9]
- Increased size of calories with thick underline
- Nutrients that provide calories are listed below calories
- Sodium is moved down close to potassium
- Vitamin A and Vitamin C are removed
- Potassium is added
- Serving size information increased
- % Daily Value for Sugars is added
- Amounts of Potassium, Iron, and Calcium are shown.
- Quick rule added (5% or less is a little; 15% or more is a lot)
Compare a normal nutrition facts panel with supplemented food facts panel. [5]
- Different title heading
- Same core nutrients
- Same % daily value footnote
- New section on the supplemental ingredients
- New footnote related to the supplemented ingredients
Describe the presentation of additional information on nutrition labels.
- The declaration of additional information is generally optional.
- However, in certain cases, manufacturers may be required to declare certain nutrients in the additional information list in the Nutrition Facts table.
Describe the bilingual horizontal format.
Describe the simplified standard format.
Used when product does not have significant sources of nutrients (e.g., herbal tea)
Describe the simplified horizontal format.
Describe the bilingual dual format.
Foods requiring preparation
Describe the aggregate format.
Different kinds of foods
Describe the linear format.
Describe the simplified linear format.
A prepackaged product is a single-serving container
based on the following criteria: [2]
- If the package contains less than 200% of the reference amount (RA) for that food or
- If one person can reasonably consume the quantity of food in the package on a single eating occasion
Reference amount is described in Table of Reference Amounts for Food
Describe changes to reference amounts.
Describe the decision tree for the determination of serving size in a prepackaged product.
Give examples of calculations of serving sizes in Canada for cookies (RA = 30 g) and for milk (RA = 250 mL)
Define: natural
- may be used for foods that do not contain any food additives, vitamins, minerals, or artificial flavours, and have not been processed (including removal of food constituents) or have only been minimally processed.
Organic products may not necessarily be natural.
Minimally processed: https://inspection.canada.ca/en/food-labels/labelling/industry/method-production-claims#c10
Product contains organic ingredients (X%)
Contains less than 95% but at least 70% organic contents
When are the following claims allowed?
- Organic
- Organically grown
- Organically produced
Only on ≥ 95% organic products
Describe the proposed front-of-package labelling.
For mandatory front-of-package nutrition symbols for foods high in:
- saturated fat and/or
- sugars and/or
- sodium
Purpose: to reduce risk of obesity, heart disease, and hypertension.
What are exemptions to the proposed front-of-package labelling? [6]
butter, honey, maple syrup, salt,
vegetable oils, dairy products
Compliance date: January 2026
Purpose: to reduce risk of obesity, heart disease, and hypertension.
What are the requirements to make a very high source of fiber claim?
Food contains 6 g or more of fibre per reference amount and serving of stated size
For identified source of fibre, name may be given, e.g., beta-glucan
No such claim in the US.
What are functional health claims?
- 3 claims (coarse wheat bran, green tea, psyllium)
What is a nutrient function claim?
- 21 acceptable claims (protein, fat, CHO, vitamins, minerals)
- Claim that shows the relationship between energy or nutrient and maintaining the function of the body necessary for the maintenance of good health and normal growth
- Energy is a factor in the maintenance of good health.
- Vitamin D is a factor in the formation and maintenance of bones and teeth
- Vitamin D enhances calcium and phosphorus absorption and utilization
- Pantothenic acid is a factor in energy metabolism and tissue formation.
What is a probiotic claim?
- 16 bacterial species eligible for claims in food
What is a disease risk reduction claim?
- The link between food and/or a food ingredient and the reduced risk of a particular chronic disease
- “This food may reduce the risk of coronary heart disease.
Health claims concerning blood
pressure, osteoporosis and heart
disease must be associated with “a
diet low in saturated and trans fats”
What are therapeutic health claims?
“Therapeutic claims are claims that would bring food into the definition of a drug or a natural health product (drug claims). These are claims about the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans, restoring or correcting organic functions in humans, or modifying organic functions in humans. Products that carry such claims are represented for “therapeutic use”.”
What are the therapeutic claims associated with plant sterols?
“(Serving size) of (Name of Product) provides X% of the daily amount (2g) of plant sterols (min 0.65g/RA) shown to help reduce/lower cholesterol in adults.”
What are the therapeutic claims associated with oat products and blood cholesterol lowering?
“(Serving size) of (Name of Product) provides X % of the daily amount (3 g) of the fibre (min 0.75g/RA of β-glucan from eligible source) shown to help reduce/lower cholesterol.”
Eligible fiber sources: Oat bran; rolled oats; whole oat flour.
What are the therapeutic claims associated with ground flaxseed and soy protein?
- Ground flaxseed and cholesterol-lowering (approved 2014)
- 8g (one tablespoon) of ground flaxseed supplies 20% of the daily amount (40 g) shown to lower cholesterol
- Soy protein and cholesterol-lowering (approved 2015)
- 150 g of tofu supplies 70% of the daily amount (25 g) of soy protein shown to help lower cholesterol
No
Yes
Yes
No
Yes
Describe the food - drug interface.
- Profit is associated with making health claims
- The Canada functional foods and natural health products market size was estimated at USD 18.29 billion in 2018
- It is also estimated that the market will reach 229 billion by 2025 at a compound annual growth rate of 8%.
Compare USA Dietary Supplements and Canada Health Products.
What are the challenges of Tropicana OJ in Canada?
Tropicana OJ in Canada faces challenges related to health claims, labeling, and regulatory classification. If making health benefit claims (e.g., vitamin C for immune support), Tropicana must comply with Health Canada’s regulations, including scientific evidence for claims and proper labeling. If marketed as a natural health product (NHP), it would require a separate license and adherence to stricter manufacturing and quality standards. Navigating these distinctions while competing with functional foods and NHPs adds complexity.
Tropicana orange juice is regulated as a food product in Canada under the Food and Drug Regulations. Since functional foods cannot be approved under the Natural Health Product (NHP) regulations (as of December 2013), Tropicana cannot be classified as an NHP, even if health claims are made. Any health or nutrient content claims (e.g., vitamin C for immune support) must comply with Health Canada’s food labeling and health claim requirements, rather than the NHP framework. This means Tropicana must ensure that all claims are supported by scientific evidence and meet the regulatory standards for foods, not NHPs.
Ask classmates for clarification.
Describe the natural health products regulations.
- In 2000, the Natural Health Products Directorate was established
- In 2003, NHP regulations received Royal assent and were enacted
- NHP regulations came into effect in 2004
- In 2012, underwent some changes:
- ‘New Approaches to NHP’
- New guidance documents were published:
- Licensing NHP with modern health claims
- Licensing NHPs with traditional health claims
- Requirements for ensuring high-quality NHPs
- Since December 2013, functional foods are not allowed to be approved under NHP regulations.
Natural and Non-prescription Health Products Directorate
Describe the NHP regulations for foods that look like and are consumed as foods.
Temporary marketing authorization - TM
- They must be regulated as foods (HC)
- Pre-packaged, RTE drings (e.g., juices and waters)
- Caffeinated energy drinks (max 180 mg/single serving)
- Conventional foods (e.g., yogurt and bars)
- Granulated and powdered products added to food or drinks (e.g., drink mixes and protein powders)
Unlike the regulations in many other countries, NHP regulations in Canada allow:
- A full range of health claims including:
- Modern health claims
- Supported by clinical studies, animal and in vitro studies
- Traditional health claims
- Based on knowledge, skills, practices, theories, beliefs
- Modern health claims
Describe the heirarchy of traditional and modern claims and the type of evidence required.
Describe the heirarchy of clinical substantiation.
What type of claim does this support?
Describe the typical randomized control trails designs.
- Parallel design is typically better for interventions with long-lasting or irreversible effects.
- Cross-over design is better for short-term interventions where the effects are reversible, and the carry-over effect can be managed with a washout period.
