Food Law and Regulations in Canada Flashcards

(253 cards)

1
Q

When were food laws first enforced in Canada?

A
  • 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

The last territory to join the confederation was Nunavet in 1999.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What Act was passed as a result of the massive adulteration of liquor with copper sulphate, opium, or salt?

A

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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

When was the 1875 Act superseded?

A
  • 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)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

In Canada foods are regulated by:

A
  • Federal Government – inter-provincial (interterritorial) trade
  • Provincial/Territorial/Municipal Government – within specific Province/Territories
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Describe the Federal-Provincial/Territorial cooperative mechanism.

A
  • 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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What are the federal organizations responsible for food regulations in Canada? [4]

A
  • Health Canada
    • Health Products and Food Branch (HPFB)
      • Food Directorate (FD)
      • Natural and Non-prescription Health Products Directorate (NNHPD)
  • Canadian Food Inspection Agency
  • Agriculture and Agri-Food Canada
  • Industry Canada
    • Measurement Canada
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Describe the organization of Health Canada.

A

Note the Health Products & Food Branch

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Describe the Health Products and Food Branch (HPFB) Organizational Chart.

A
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What is the scope of roles of responsibilities of Health Canada with regard to foods and nutrition? [9]

A
  • 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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Describe the role of Health Canada in establishing policies, standards, and guidance regarding the safety and nutritional value of food. [3]

A
  • (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 well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

How does Health Canada help Canadians maintain and improve their health? [3]

A

(1) Health promotion, (2) disease prevention, and (3) safety messaging (FD, Office of Nutrition Policy and Promotion)

Example of HC messaging.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Describe HC’s role in establishing food labelling regulations. [3]

A
  • (1) Nutritional information and (2) health claims (FD, Bureau of Nutritional Sciences, together with CFIA)
  • (3) Canadian Nutrient File
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Who is the contact point for the Codex Alimentarius Commission?

A

Health Canada
Liaison with national and international health organizations regarding safety standards in food products (FD)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Describe the role of HC in auditing the CFIA. [4]

A
  • 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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Describe HC’s role in evaluation of submissions, chemical testing, and standards. [4]

A
  • (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.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Describe the role of Food Directorate - Office on Nutrition Policy and Promotion. [5]

A
  • 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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What defines powers, duties, and functions for Health Canada and its divisions? [2]

A
  • Food and Drugs Act and Regulations
  • Department of Health Act (DHA)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

What defines the organizational structure, responsibilities, and authority of the CFIA and Federal-Provincial corporations and audits?

A

Canadian Food Inspection Agency Act

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Who has the authority to assess the CFIA?

A

The Food Directorate (HC)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

What is the Natural and Non-Prescription Health Products Directorate?

A
  • Regulating authority for natural health products (NHP) and non-prescription and disinfectant drugs in Canada
  • Authorized under Natural Health Products Regulations (NHPR)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

What are the NNHPD responsibilities for natural health products? [5]

A
  • 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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

What is the primary role of the CFIA?

A
  • Conducting all federal food inspection activities
  • Animal health and plant protection
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

At the federal level, the responsibility for food safety is shared between:

A
  • The Minister of Agriculture and Agri-Food Canada (AAFC), through the CFIA
  • The Minister of Health, through HC
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

The CFIA is more autonomous than the traditional government departments, but they still report to:

A

The Minister of Agriculture and Agri-Food Canada

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
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
26
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
27
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**
28
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.
29
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.
30
Class I
A reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
31
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.
32
Class III recall
The use of, or exposure to, a violative product is not likely to cause any adverse health consequences.
33
A reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class I
34
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
35
The use of, or exposure to, a violative product is not likely to cause any adverse health consequences.
Class III recall
36
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
37
Discuss the recent CFIA analysis for Food Fraud.
38
What are the responsibilities of Agriculture and Agri-Food Canada? [5] ## Footnote 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 ## Footnote The Minister must prepare and submit to Parliament an annual report on the Department's operations
39
The appointment of a Minister and a Deputy Minister of Agriculture and Agri-Food is governed by:
The AAFC Act
40
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
41
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
42
Describe the legislation process in Canada.
1. Introduction: A bill is introduced in either the House of Commons or the Senate. 2. First Reading: The bill is presented and read without debate. 3. Second Reading: The bill is debated on its principle and then voted on. 4. Committee Stage: A committee reviews the bill in detail, holds hearings, and may make amendments. 5. Report Stage: The committee reports the bill back with any changes for consideration. 6. Third Reading: The final version is debated and voted on. 7. Senate Review: If the bill started in the House, it moves to the Senate for a similar process, or vice versa. 8. Royal Assent: If passed by both Houses, the bill receives royal assent from the Governor General and becomes law.
43
Use 'interim market authorizations' as an example to the legislation process in Canada.
44
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 ## Footnote 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.
45
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
46
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 ## Footnote 5 year long process!
47
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. ## Footnote The Act is divided into two parts: 1. Relates to foods, drugs, cosmetics, and medical devices 2. Relates to administration and enforcement
48
Where does the Food and Drugs Act and Regulations apply?
All provinces and territories | This is a Federal Law
49
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.
50
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.
51
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
52
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)
53
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]).
54
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)
55
Define package.
Includes anything in which any food is wholly or partly contained, placed, or packed
56
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.
57
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
58
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
59
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) ## Footnote Section 4 and 7 covers safety, integrity, and 'freedom from adulteration' of foods.
60
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.
61
How does the Food and Drugs Act prevent economic fraud?
* Prohibits the label or sale of any food that is false, misleading, or deceptive ## Footnote Section 5.2
62
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 ## Footnote Note: Standardized foods in Canada is the same concept as foods with a Standard of Identity in the US.
63
Who is responsible for enforcement of the Food and Drugs Act? ## Footnote 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.
64
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
65
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.
66
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)
67
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
68
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)
69
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
70
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
71
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
72
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)
73
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. ## Footnote 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.)
74
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)
75
Salt, sugar, and starch are defined as additives. True or False?
False. These are food ingredients or products sold as foods.
76
Salt, sugar, and starch are not defined as additives. True or False?
True. These are food ingredients or products sold as foods.
77
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 ## Footnote Also recall that salt, sugar, and starch are not defined as additives either.
78
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) ## Footnote If max limit is specified as GMP, then use in minimum amount to elicit desired effect.
79
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)
80
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
81
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 ## Footnote This Division is new!
82
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. ## Footnote Novel foods are anything that do not have history of safe consumption. A great example are insect foods. Functional foods also go through here.
83
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**
84
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 ## Footnote Vitamins, Minerals, and Amino Acids are in a separate part because they are not only used in foods, but also many other products.
85
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.
86
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 ## Footnote These regulations are administered by the CFIA and the Canada Border Services Agency (Import)
87
Who administers the Food and Drugs Act and Regulations?
CFIA Canada Border Services Agency (Imports only)
88
Discuss standardized cheese in Canada. [2]
* Max moisture % * Min milk fat %
89
Discuss Egg Sizes for Canada A Eggs. [6]
90
What are CFIA Registration Marks?
* **Mandatory** for companies selling products to other provinces/territories/countries
91
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**
92
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 ## Footnote The administration and enforcement of the CPLAR, as they relate to food products, are the responsibility of the CFIA.
93
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
94
All food in Canada within the mandate of the CFIA will be regulated by [...]
Two federal legislative acts - the SFCA and the FDA
95
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)
96
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
97
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. ## Footnote 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.
98
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
99
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 ## Footnote Modernization of food inspection
100
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) ## Footnote Modernization of food inspection
101
How were legislative authorities enhanced?
* CFIA authority is enhanced: * Higher penalties for offenses ($250k to $5 million) ## Footnote Modernization of food inspection
102
What information is collected to enable evaluation of potential risk? [6]
* Product type (e.g., fish; dairy) * Intended use (e.g., RTE; preserved) * Target consumers (e.g., children; elderly) * Processing (e.g., canning; freezing) * Annual production volume * Country of origin (imports) ## Footnote Modernization of food inspection
103
What online services does 'My CFIA' provide? [3]
* Permissions for licences, permits, registrations, and export certificates * Application forms * Webinars ## Footnote Modernization of food inspection
104
How many Canadians get sick each year from contaminated foods?
~4 million
105
What information is used to remove suspected foods from retail shelves?
* In 2019, *at the request of the CFIA*, Health Canada conducted food-related health risk assessments. * Health Canada's reviews *help inform the CFIA's risk management actions* * Based on this information, suspected foods are removed from retail shelves.
106
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
107
How were the current regulations for labelling and standards of identity of different commodities streamlined?
* Reduced duplication and inconsistency (MIR, FIR, CLPA, CAPA) * FDR amended (SFCA refers to FDR) * Standards of identity remain unchanged, duplications are removed ## Footnote Modernization of food labelling
108
How is industry innovation supported?
* Continuum: Food safety and preventive health ## Footnote Modernization of food labelling
109
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)
110
Why is food labelling important? [2]
* **Communication** * The food label is one of the most important and direct means of communicating product information between buyers and sellers * **Informed purchasing choice** * Based on label information, customers can make an educated choice between various food products
111
What are the primary functions of a label? [3]
* Basic product information * Nutrition, health, and safety information * Food marketing, promotion, and advertising
112
What is the basic product information included on a label? [7]
* Common name * List of ingredients * Net quantity * Durable life date * Grade/quality * Country of origin * Name and address of manufacturer/dealer/importer
113
What is the nutrition, health and safety information included on a label? [4]
* Nutrition facts table (serving size, calories, nutrients, etc.) * Health and nutrient content claims * Specific information on products for special dietary use * Instructions for safe storage and handling
114
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
115
What are the basic labelling rules (CPLAR, FDAR)? [3]
* Labels **must apply** to all prepackaged food products * The label must be **visible** * If a wrapper is used, the label must either be on the overwrap or easily read through the overwrap * **False or misleading** representations, whether in symbol or words, are **prohibited**
116
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*
117
What are the CFIA's responsibilities regarding Canadian Federal Food Labelling?
* **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
118
All prepackaged food requires a label. What are exceptions to this? [7]
* One-bite confections (e.g., candy, or a stick of chewing gum, sold individually) * Fresh fruits or vegetables (in a wrapper or confining band of less than half an inch/ 12.7cm) * Clerk-served foods (that are packed at the time of sale - i.e., not considered to be pre-packaged) * Meat and poultry that has been barbecued, roasted, or broiled on the retailed premises * Horse meat (wtf) * Food additives * Flour (treated with gamma radiation)
119
What are the requirements for a basic food label? [8]
* Common name * Net quantity * Name and address of business * Ingredient list * Durable life date * Nutrition facts * Other mandatory information | All information (but name and address) must be in both EN & FR.
120
What is the common name required by basic labelling regulations? [4]
* The name by which the food is generally known * The name that appears in any federal regulations (e.g., meat or fish inspection act) * It should not be misleading * Name must be shown on the PDP in both French and English
121
Describe specifics for how a common name should not be misleading. [3]
* It should not incorporate words not justified by the composition of the food (some exceptions, e.g., Canada Dry) * It should not improperly suggest a place of origin * It should not resemble, directly or phonetically, the name of another product for which it is an imitation or substitute (e.g., Rits crackers versus Ritz crackers)
122
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
123
Describe the basic labelling of imitation food.
* Food substitute - contains fewer nutrients (protein, vitamins, minerals) than the original product * 'Imitation' is part of the name, e.g., Pollock imitation crab sticks
124
A net quantity declaration is required for all prepackaged food products except foods that are: [3]
* Prepackaged single servings sold in vending machines or mobile canteens * Prepackaged single portions served by a restaurant, airline, etc., with a meal or snack * Strawberries or raspberries packaged in the field in containers with a capacity of 1.14 litres or less (SFCR)
125
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
126
Describe the contact information required on Canadian labels.
* Name & Address of the responsible party by or for whom a pre-packaged product is manufactured or produced must be declared on ANY panel, except the bottom, in EITHER of the official languages * Address must be complete enough for postal purposes * A telephone number, e-mail, website, or other means of communication is required (SFCR)
127
All information on a Canadian label must be declared in both official languages. True or False?
False. The Name and Address of the Responsible Party can be declared in either English or French Other mandatory components such as the common name, net quantity, list of ingredients, and durable life date must appear in both languages.
128
Not all information on a Canadian label must be declared in both official languages. True or False?
True. The Name and Address of the Responsible Party can be declared in either English or French Other mandatory components such as the common name, net quantity, list of ingredients, and durable life date must appear in both languages.
129
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
130
The Comprehensive Economic and Trade Agreement (CETA) came into force on September of 2018. What does it do?
* Protects EU “**geographical indications**” –meaning: * Camembert cheese can only be made in France * Prosciutto di Parma ham – only in Italy * EU tariffs on some Canadian foods reduced to zero – maple syrup, oats, frozen mackerel; No Canadian tariffs on – EU chocolate * Tariff-free quotas on EU cheese from 18,500 to 31,972 tonnes ## Footnote Geographical indications are part of EU regulations, not Canadian.
131
Foods require an ingredient list. What are the exceptions to this? [4]
* Bulk products at retail, except mixed nuts * Individual portions of food served with meals or snacks by a restaurant or airline in mobile canteens or machines * Meat, poultry, and poultry meat by-products barbecued, roasted, or broiled on retail premises * Standardized alcoholic beverages and vinegar
132
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' ## Footnote These ingredients may be shown at the end in any order.
133
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'
134
What are component declarations?
* Components are ingredients of ingredients * Must be declared either: ## Footnote Components (e.g., butter, lard, salt, baking powder) are exempted from declaration from ingredients. Must be declared, but not necessary to decare their ingredients.
135
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)
136
Describe ingredient common names used on labels. [3]
* Ingredients and their components must be declared by their common names * Same food may be listed by COLLECTIVE or CLASS NAMES for ingredients * Vitamins, mineral nutrients, food additives, or flavour enhancers must be listed by the common name of the ACTIVE INGREDIENT(s) present, e.g., vitamin A palmitate
137
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
138
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. ## Footnote It is required on prepacked foods with a durable life of **90 days or less** destined for retail.
139
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. ## Footnote Exemptions: * Food is intended to be consumed within 24 hours (e.g., pastry) * The deterioration is evident (e.g., fresh produce)
140
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) ## Footnote It is required on prepackaged foods with a shelf life of **90 days or less** destined for retail.
141
When food has an expiration date, the 'best before' date is not required. True or False?
True.
142
When food has an expiration date, the 'best before' date is still required. True or False?
False.
143
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) ## Footnote When food has an expiration date, the 'best before' date is not required.
144
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
145
What is a specific labelling requirement for dairy products?
Percent of milk fat
146
What is a specific labelling requirement for vinegar?
Percent acetic acid
147
What is a specific labelling requirement for alcoholic beveverages?
Percent alcohol by volume (>5%)
148
What is a specific labelling requirement for flavoured food?
The term flavour to be declared ## Footnote 'strawberry flavoured ice cream' but not 'strawberry ice cream'
149
Discuss allergen declaration requirements.
* Canada's food allergen labelling regulations entered into force on August 4, 2012 * Foods with undeclared allergens on a label are subject to recall * Canadian Food and Drug Regulations B.01.010.1 – B.01.010.3
150
Describe allergen declaration required for gluten.
When a food contains gluten protein or modified gluten protein from: * barley, oats, rye, triticale, or wheat * Spelt and Kamut must be declared as “wheat” * or present in the wax coating
150
What are priority food allergens?
Foods or any protein derived from one of the following: * specific nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts); * peanuts * sesame seeds * wheat; triticale * eggs; milk * soybeans * crustaceans; shellfish; and fish. * mustard seeds | Mustard seeds are not an allergen in the US. ## Footnote Also gluten (not priority)
151
Describe allergen declaration required for added sulphites.
* When the prepackaged food contains **10 parts per million or more** of added sulphites * Sulphites must be identified by their common names (sulfites, sulfiting agents, sulphites or sulphating agents) * The presence of naturally occurring sulphites is not a subject of a declaration ## Footnote 10 mL per 1 L | 10 mg per 1 kg | etc...
152
The presence of naturally occurring sulphites is not a subject of a declaration. True or False?
True.
153
The presence of naturally occurring sulphites is a subject of a declaration. True or False?
False. The presence of naturally occurring sulphites is not a subject of a declaration.
154
Describe allergen declarations required for starch, hydrolyzed proteins, and lecithin.
* The name of the sources of protein be identified in the common name of all hydrolyzed proteins, starch, or modified starch – e.g., hydrolyzed vegetable protein (soya) * The name of the sources of lecithin be identified in the common name of lecithin – e.g., soya lecithin
155
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
156
Spelt and Kamut must be declared as [...]
wheat
157
Seasonings are [...] which are exempted from [...]
Seasonings are **multi-component ingredients** which are exempted from **component declaration**.
158
Beers are required to declare: [3]
Beers are required to declare **(1)** food allergens, **(2)** gluten sources and **(3)** added sulphites
159
When are prepackaged foods exempted from the 'ingredients list'? [4]
* If made and sold at the same retail store (**except a prepackaged mixture of nuts**) * Meat, poultry, and their by-products that are barbecued, roasted, or broiled on the retail premises; * Sandwiches made at a commissary and sold through automatic vending machines or mobile canteens * Individual portions of foods served by a restaurant or other commercial enterprise with meals or snacks such as condiments or crackers
160
What are Health Canada's Nutrition Labelling objectives? [3]
* To provide comparative information about the nutrient content of food * Prevents consumers' confusion * Makes easier choices at the point of purchase * Makes choices about reducing the risk of developing chronic diseases * Permits dietary management of chronic diseases of public health significance * Encourages manufacturers to produce foods that contribute to a healthy diet * To be **compatible with the U.S. system** * To accept nutrition labellng requirements between these two countries. ## Footnote Mandatory since December 2005.
161
Nutrition labelling is required for all prepackaged foods, with the exception of: [7]
* Beverages with an alcohol content of more than 0.5% * Fresh fruits or vegetables * Single-ingredient meats, poultry and their by-products * Single-ingredient marine or freshwater animal products * One-bite confections, such as a candy or a stick of chewing gum, sold individually * Milk is sold in a refillable glass container * Clerk-served foods which are packed at the time of sale
162
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)
163
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
164
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.
165
Describe the bilingual horizontal format.
166
Describe the simplified standard format.
Used when product does not have significant sources of nutrients (e.g., herbal tea)
167
Describe the simplified horizontal format.
168
Describe the bilingual dual format.
Foods requiring preparation
169
Describe the aggregate format.
Different kinds of foods
170
Describe the linear format.
171
Describe the simplified linear format.
172
What is a serving size?
* The nutrition information is based on a specific amount of food – a serving size * The serving size is expressed in one of the following units: * Cups, tablespoons, slices, fractions (household measure) followed by the size expressed in grams or milliliters (metric measure) * In the case of food eaten as a whole container, the entire container is a serving size ## Footnote Depends on whether a product is a single-serving or a multiple serving prepackaged product.
173
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 ## Footnote Reference amount is described in Table of Reference Amounts for Food
174
Describe changes to reference amounts.
175
Describe the decision tree for the determination of serving size in a prepackaged product.
176
Give examples of calculations of serving sizes in Canada for cookies (RA = 30 g) and for milk (RA = 250 mL)
177
Define: fresh
* used to describe a food's nature, age, and sensory qualities. * may be used for an ingredient or **food that has not been processed or preserved** in any way.
178
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. ## Footnote Minimally processed: https://inspection.canada.ca/en/food-labels/labelling/industry/method-production-claims#c10
179
Define: new
Generally permitted to describe a product for one year from its launch ## Footnote Manufacturers love this.
180
Define: organic
* An agricultural product that has been certified as organic * “Organic” (*biologique*) is a labelling term that denotes products made under organic production standards and certified by the authority * Products **must** be certified by a regulatory body that has been accredited, based upon the recommendation of the CFIA | 100% organic claim is not permitted in Canada. ## Footnote Organic Foods is governed by Safe Food for Canadian Regulations (SOR/2018-108) - Part 13 - Organic Products
181
Organic product
≥ 95% organic | 100% organic claim is not permitted - in US it is!
182
Multi-ingredient organic product
Contains at least 95% organic content
183
Product contains organic ingredients (X%)
Contains less than 95% but at least 70% organic contents
184
When are the following claims allowed? * Organic * Organically grown * Organically produced
Only on ≥ 95% organic products
185
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 ## Footnote Purpose: to reduce risk of obesity, heart disease, and hypertension.
186
What are exemptions to the proposed front-of-package labelling? [6]
butter, honey, maple syrup, salt, vegetable oils, dairy products | Compliance date: January 2026 ## Footnote Purpose: to reduce risk of obesity, heart disease, and hypertension.
187
What is a nutrient content claim?
* Describe, directly or indirectly, the level of a nutrient in a food or group of foods * E.g. “low in sodium”, “cholesterol free”, “high in fibre” ## Footnote Must meet certain regulatory requirements (Part B, Division 1; B.01.500) and cannot be made if not present in regulations.
188
What are the general requirements for nutrient content claims? [2]
* Must meet regulatory requirements * Must be based on 'Reference Amount' for each food * For example, any claims related to bagels must be based on an 85 g (RA) serving of bagel * Where the reference amount of food is 30 g or less, a claim must refer not only to serving size but also must meet the criteria based on 50 g of that food ## Footnote **If food does not have a reference amount listed in the Table of RA for foods, a nutrient content claim cannot be made!**
189
What are the requirements for a fat free claim?
Less than 0.5g of fat per reference amount and stated serving size ## Footnote Same in US.
190
What are the requirements to make a low fat claim?
* 3 g or less per reference amount and serving of stated size of 30 g and larger; * 3 g or less per reference amount and serving of stated size and per 50 g of food if serving size is smaller than 30 g ## Footnote Same in US.
191
What are the requirements to make a saturated fat free claim?
* Less than 0.2 g/serving and less than 0.2 g/serving of trans fatty acids ## Footnote Different in US. In US: less than 0.5 g saturated fat per serving.
192
What are the requirements to make a low in saturated fat claim?
* 2 g of less of saturated and trans fatty acids combined per serving * No more than 15% of calories from saturated and trans fatty acids combined ## Footnote Different in the US. In US: 1 g or less per reference amount and serving of stated size. No more than 15% of calories from saturated fat.
193
What is the requirement to make a trans fat free claim?
* Less than 0.2 g of trans fatty acids per reference amount and serving of stated size. * Also meets conditions for low in saturated fat: * 2 g of less of saturates and trans fatty acids combined per serving * No more than 15% of calories from saturated and trans fatty acids combined ## Footnote Different in US. In US: Less than 0.5 g/serving and less than 0.5 g saturated fat/serving
194
What are the requirements to make a cholesterol free claim?
* Less than 2 mg of cholesterol per reference amount and serving of stated size. * Also meets conditions for low in saturated fat: * 2 g of less of saturated and trans fatty acids combined per serving * No more than 15% of calories from saturated and trans fatty acids combined ## Footnote Different in US. In US: Less than 2 mg/serving and 13 g or less of total fat/serving of 30 g (two tablespoons) or larger; 13 g or less/serving size and per 50 g of food if serving size is smaller than 30 g
195
What are the requirements to make a omega-3 or omega-6 claim?
* The food contains 0.3 g or more of omega-3 per reference amount and a serving of the stated size * 2g or more of omega-6 PUFA per reference amount and a serving of the stated size ## Footnote No such claims in the US.
196
What are the requirements to make a calorie/energy free claim?
Less than 5 calories per reference amount ## Footnote Same in US.
197
What are the requirements to make a low calorie/energy claim?
* 40 calories or less per reference amount and serving of stated size of 30 g and larger; 40 calories or less per reference amount and serving of stated size and per 50 g of food if serving size is smaller than 30 g ## Footnote Same in US.
198
What are the requirements to make a reduced calorie claim?
At least 25% less energy per reference amount of the food, than the reference amount of the similar reference food ## Footnote Same in US.
199
What is the requirement to make a sugar free claim?
* The food contains less than 0.5 g of sugars per reference amount and serving of stated size. * Also meets the conditions for “calories free”: * Less than 5 calories per reference amount and serving of stated size ## Footnote Same in US.
200
What are the requirements to make a reduced sugar claim?
At least 25% less sugar (totaling at least 5 g less) than the reference amount of the similar reference food. ## Footnote Different in US. In US: At least 25% less sugar than the reference food. (e.g., “Sugar content has been lowered from 8 g to 6 g per serving.”)
201
What are the requirements to make a source of fiber claim?
Food contains 2 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 ## Footnote No such claim in US.
202
What are the requirements to make a good source of fiber claim?
No such claim in Canada! ## Footnote Different in US. In US: Food contains 2.5 to 4.9 g of fiber per serving size
203
What are the requirements to make a high source of fibre claim?
Food contains 4 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 ## Footnote Different in US. In US: Food contains 5 g or more of fiber per serving size
204
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 ## Footnote No such claim in the US.
205
What is the requirement to make a sodium free claim?
Less than 5 mg per reference amount and serving of stated size ## Footnote Same in US.
206
What is the requirement to make a low sodium claim?
140 mg or less per serving size; 140 mg or less per serving size and per 50 g of food if serving size is smaller than 30 g ## Footnote Same in US.
207
What is the requirement to make a very low sodium claim?
No such claim in Canada! ## Footnote Different in US. In US: 35 mg or less sodium per reference amount customarily consumed
208
What is the requirement to make a reduced sodium claim?
The food contains at least 25% less sodium per reference amount of the food, than the reference amount of the similar reference food. ## Footnote Same in US.
209
What is the requirement for to claim a food is a 'source' of vitamin/minerals?
5% or more of the DV ## Footnote Claims can only be made for vitamins and minerals which regulations have established an RDI.
210
What is the requirement to claim 'good source' for vitamin/minerals?
15% or more of DV | or at least 30% of DV in the case of vitamin C ## Footnote Claims can only be made for vitamins and minerals which regulations have established an RDI.
211
What is the requirement to claim 'excellent source' for a vitamin/mineral?
25% or more of DV | or at least 50% of DV in the case of vitamin C ## Footnote Claims can only be made for vitamins and minerals which regulations have established an RDI.
212
What is a health claim?
* A statement that characterizes the relationship between a nutrient or food and a specific disease or condition. * Foods claiming to cure or mitigate diseases are prohibited.
213
Food claims relating to curing or mitigating diseases are prohibited. True or False?
True.
214
Food claims relating to curing or mitigating diseases are allowed. True or False?
False. Food claims relating to curing or mitigating diseases are prohibited.
215
When are disease risk reduction claims and therapeutic claims allowed?
Only where specifically permitted by the Food and Drug Regulations.
216
What are the health claim categories? [4]
* Function claims (3 claims - green tea; psyllium; wheat bran) * Nutrient function claims (21 claims) * Therapeutic claims (3 claims - flaxseed; soy; plant sterols and lowering blood cholesterol) * Disease risk reduction claims * Probiotic claims (16 bacterial species)
217
What are functional health claims?
* 3 claims (coarse wheat bran, green tea, psyllium)
218
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.
219
What is a probiotic claim?
* 16 bacterial species eligible for claims in food
220
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. ## Footnote Health claims concerning blood pressure, osteoporosis and heart disease must be associated with “a diet low in saturated and trans fats”
221
Health claims concerning blood pressure, osteoporosis and heart disease must be associated with [...]
“a diet low in saturated and trans fats”
222
What claims must be associated with “a diet low in saturated and trans fats”?
Health claims concerning blood pressure, osteoporosis and heart disease
223
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".”
224
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.”
225
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.
226
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
227
What are the general prerequisites regarding making claims about bioactives and heart disease? [5]
* contains at least 10% of the weighted recommended nutrient intake of a vitamin or mineral per reference amount and serving of the stated size * contains 100 mg or less of cholesterol per 100 g of food; * contains 0.5% or less alcohol; * contains 480 mg or less of sodium per reference amount and serving of stated size, and per 50 g if the reference amount is 30 g or 30 mL or less; * meets the criterion "low in saturated fatty acids."
228
No Yes Yes No Yes
229
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%.
230
Compare USA Dietary Supplements and Canada Health Products.
231
Describe the new labelling required for natural health products.
* On July 6, 2022, NHP Regulations amendments were published in Canada Gazette, Part II * Products Fact Table (PFT) – the outer or inner label * Medicinal ingredients, uses, warnings, directions, other information, non-medicinal ingredients, questions? * Allergens (e.g., nuts, gluten, added sulphites) * Formatting ## Footnote The new labelling requirements come immediately (Sections 1-16, e.g., allergens) but sections 17-22 will come into force in 2025.
232
What are natural health products?
* Naturally occurring substance to have a physiological benefit or protection against chronic disease, restore or maintain good health. * Products are produced from plants, animals, microorganisms, and marine sources. * Sold in pills, capsules, tinctures, powders, potions, creams, and other medicinal forms. * A substance or a combination of substances that may contain: * Medicinal ingredients * A homeopathic medicine or a traditional medicine * Manufactured/sold or represented for: * Their health benefits * Use in the diagnosis, treatment, mitigation, or prevention of a disease * Restoring, correcting, or modifying organic function in humans to maintain or promote health.
233
A natural health product is a substance or a combination of substances that may contain: [2]
* Medicinal ingredients * A homeopathic medicine or a traditional medicine
234
A natural health product is manufactured/sold or represented for: [3]
* Their health benefits * Use in the diagnosis, treatment, mitigation, or prevention of a disease * Restoring, correcting, or modifying organic function in humans to maintain or promote health.
235
What are the natural health products categories? [8]
* A plant or plant material, an algae, a bacterium, a fungus, or a non-human animal material * Extracts or isolates, synthetic duplicates of substances * Vitamins, minerals, or trace elements * Amino acids * Essential fatty acids * Probiotics * Homeopathic preparations * Traditional medicines
236
What are the acceptable delivery vehicles for natural health products?
* Acceptable delivery vehicle includes a range of dose forms, such as capsules, tablets, and liquids * Food formats such as snack bars or beverages are not allowed, and they are regulated by the Food Directorate
237
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. ## Footnote Ask classmates for clarification.
238
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
239
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)
240
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
241
Describe NHP claims by related to health conditions.
* Serious disease/condition * For the treatment of prostate cancer * Helps prevent rheumatoid arthritis * Major disease/condition * Helps to reduce blood triglycerides * Lowers plasma cholesterol levels * Minor disease/condition * Helps to relieve the symptoms of the common cold
242
Describe NHP claims related to health effect. [5]
* Diagnostic claims * E.g., assess glucose intolerance in the diagnosis of diabetes mellitus * Treatment/Cure/Prevention claims * E.g., elimination of disease either permanently or for a significant length of time * Risk reduction claims * General health maintenance claims * E.g., maintains healthy gums * Antioxidant claims * E.g., provide antioxidant(s) for the maintenance of good health or source of antioxidant(s)
243
Describe the heirarchy of traditional and modern claims and the type of evidence required.
244
Describe the heirarchy of clinical substantiation.
245
What type of claim does this support?
246
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.
247
Describe the NHP regulations requirements for manufacturers and importers. [3]
* All manufacturers and importers must demonstrate that safety and efficacy have been established regarding: * **Product licensing** * Labelling and packing of NHPs (review of claims) * **Site licensing** * Good Manufacturing Practices (GMPs) * **Adverse reaction reporting**
248
Regarding NHP regulations requirements, what does the applicant (manufacturer or importer) need to provide? [3]
* The recommended conditions of use of the product, including claims, dosages, cautions, and all quantitative information about the ingredients * Information supporting the safety and efficacy of the product when used under the recommended conditions * Contact information – address in Canada (manufacturer or Canadian representative)
249
Describe NHP approval.
* All products approved under the NHPD will carry a unique identification number, in much the same way as pharmaceuticals. * NPN or DIN-HM on the label (Natural Product Number or Drug Identification Number – Homeopathic Medicine)
250
What is the purpose of an NPN or DIN-HM?
* Indication that the product has undergone and passed a review of its formulation, labelling and instruction for use * To allow the easy recall of products for which safety concerns emerge
251
What is the difference between food and food commodity?
**Food:** 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. **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; generally refers to unprocessed or raw agricultural products, such as fruits, vegetables, grains, meat, and fish. | All foods are food commodities, but not all food commodities are foods.
252
What agency oversees regulations pertaining to imports?
Canada Border Services Agency