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Health Canada Update

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Title: Health Canada Update


1
  • Health Canada Update
  • Allergens, Gluten Sources and Sulphites
  • Dietary Sodium Reduction
  • Health Claims
  •  Supporting the Growth of Local Living Economies
    in Saskatchewan 
  • Saskatoon, SK
  • March 24, 2009

Candice Biggar Regional Food Liaison
Officer Manitoba/Saskatchewan Region Health Canada
2
  • Allergens, Gluten Sources and Sulphites

3
Food Allergies and Celiac Disease
Prevalence
  • Food allergies affect an estimated 6 of Canadian
    children and 3-4 of adults.
  • Celiac disease affects approximately 1 of the
    Canadian population.
  • Celiac disease is widely under-diagnosed.

4
Food Allergies and Celiac Disease
Impacts
  • 150-200 deaths/year due to food anaphylaxis in
    North America
  • Celiac disease is linked to osteoporosis and
    cancer

5
Food Allergy Incidents rationale for action
  • Food allergy incidents are preventable
  • Avoidance is the most effective risk management
    approach for food allergic consumers

6
Stakeholders
Regulations Enforcement Education
Safe Products Education Information Offer of
Choice
Responsibility Choice Action
7
Policy Objectives
  • Enhanced protection to avoid inadvertant
    consumption of foods containing the  culprit
    ingredient 
  • Minimize risks associated with inadvertent
    consumption of undeclared allergens in food
  • Avoid undue restrictions on choice for a safe and
    nutritious food supply
  • Maximize Choices for food allergic consumers

8
Pre-packaged foods Importance of food labels
AVOIDANCE The Key to Preventing Potentially
Serious Health Consequences
  • Consumers depend on the information provided on
    the label to avoid the food allergen, gluten
    sources and added sulphites in a pre-packaged
    food.

9
Pre-packaged foods Importance of food labels
Labelling Key to identify common allergens
  • Consumer Surveys indicating importance of
    labelling
  • Canadian Survey 2008 41.5 respondents
    experienced accidental exposure to allergens in
    their lifetime
  • From those, 33.6 attributed this accident to
    complex, incomplete labelling or mislabelling
  • 31.9 attributed this accident to failure to
    read the label
  • 6.3 to ignoring a precautionary statement

10
Current Labelling Regulations
Current Requirements
Gaps
  • Certain ingredients are exempt from component
    declaration.
  • Some prepackaged foods do not require a list of
    ingredients
  • Ingredient names do not always reflect the
    source of the ingredient
  • The Food and Drug Regulations require that a
    complete and accurate list of ingredients appear
    on the label of most prepackaged foods
  • In most cases, the list of ingredients must
    include the components of ingredients (i.e.
    ingredients of ingredients).

11
Proposed Regulatory Amendments
Primary Objectives
  • To require the mandatory source declaration of
    the common food allergens and gluten using
    simple, plain language in English and French
  • Including allergens and gluten present in
    components of ingredients that are currently
    exempt from component declaration.
  • To enhance the declaration of sulphites when
    present in the pre-packaged food in a total
    amount of 10 ppm or more.
  • Scope Applicable for all ingredients
    intentionally added to pre-packaged foods.

12
Proposed Regulatory Amendments (cont)
  • Food Allergen Defined
  • Any protein from any of the following foods or
    any modified protein, including any protein
    fraction, that is derived from the following
    foods
  • Almonds, Brazil nuts, cashews, hazelnuts,
    macadamia nuts, pecans, pine nuts, pistachios,
    walnuts
  • Peanuts
  • Sesame seeds
  • Wheat, kamut, spelt, triticale
  • Eggs
  • Milk
  • Soybeans
  • Crustacea
  • Fish
  • Shellfish

13
Proposed Regulatory Amendments (cont)
  • Gluten Defined
  • Any gluten protein from the grain of any of the
    following cereals or the grain of a hybridized
    strain created from at least one of the following
    cereals
  • Wheat, spelt, kamut
  • Oats
  • Barley
  • Rye
  • Triticale

14
Proposed Regulatory Amendments (cont)
Label Declaration
  • Sources of common food allergens and gluten must
    be declared either
  • in the list of ingredients,
  • OR
  • in the statement Allergy and Intolerance
    Information Contains
  • Sulphites must be declared
  • in a statement Allergy and Intolerance
    Information Contains when present at levels
    of 10 ppm or higher
  • All current requirements for ingredient
    declaration will remain in place

15
Proposed Regulatory Amendments (cont)
  • For products which do not require a list of
    ingredients but which choose to add an ingredient
    list, the list would have to be complete and
    accurate for food allergens, gluten sources and
    sulphites

16
Proposed Regulatory Amendments (cont)
  • Common names of starches, modified starches,
    hydrolyzed protein and lecithin would now be
    modified as follows
  • The name of the source of protein be identified
    in the common name of all hydrolyzed proteins
  • The name of the plant source be identified in the
    common name of all forms of starch or modified
    starch
  • The name of the source of lecithin be identified
    in the common name of lecithin.

17
Current Status Next Steps
  • Publication in CGI in July 2008
  • Health Canadas consideration of public comments
    First half of 2009
  • Preparation of final version of amendments
  • Publication in Canada Gazette Part II
  • By January, 2010
  • New regulatory amendments enacted with a
    transition period.

18
Summary of Comments
  • Comment period ended November 28, 2008
  • Over 140 comments were received from various
    stakeholders including, the general public,
    allergy consumer groups, food manufacturers and
    food manufacturing groups, allergists and
    nutritionists etc.
  • Health Canada also met with a number of
    stakeholders to discuss and clarify the
    regulatory proposal.

19
Examples of Comments Received
  • Definitions of food allergen and gluten
  • Allergy and Intolerance Information Contains
    statement
  • Transition period
  • Legibility criteria

20
Precautionary Labelling
  • Precautionary labelling, which is used to deal
    with the issue of cross contamination, is not
    part of this regulatory proposal, but updated
    guidance on the appropriate use of precautionary
    labelling is being developed by Health Canada
    under a separate initiative.

21
Precautionary Labelling
  • In Canada,  may contain  labelling was
    identified as a judicious risk management measure
  • To address instances of  unavoidable 
    cross-contamination or cross-contact during food
    processing
  • To alert allergic consumers of the
     unsuitability of the product  for their
    condition and of a possible risk
  • Statement differs from a  contains  statement,
    however risk may be identical

22
Precautionary Labelling (cont)
  • Current studies show instances of over-use /
    mis-use of precautionary statements, which impact
    on food allergic consumers
  • Precautionary statements
  • No longer provide meaningful information to
    allergic consumers or their family/social circles
  • Can lead to allergic incidents (warning
    statements do not clearly reflect the risk level
    and/or are misinterpreted or ignored)
  • Can unnecessarily limit food choices

23
Precautionary Labelling (cont)
Illustration of the efficacy of precautionary
labelling against frequency of use
From Crevel RWR. Allergy management in the food
industry. In Mills C, Wichers H,
Hoffman-Sommergruber K. Managing allergens in
food. CRC Press, Woodhead Publishing Limited,
Cambridge, England, 2007, pp 262-279.
24
Precautionary labelling Truthful /Helpful ?
Ingredient list much shorter than allergen
precautionary statement
25
Precautionary Labelling
What does it mean ? Risk? /No risk ?
26
Precautionary Labelling (cont)
Precautionary labelling whats in the products?
  • In 2007, Health Canada surveyed chocolate and
    granola bars
  • The most common statement found was  May contain
    traces of 
  • Levels of food allergens found varied widely,
    from non-detected to 6 500ppm (or 0.65) in a
    chocolate product which consistently used  may
    contain traces 
  • The word  traces  can be misleading
  • Corroborate the fact that allergic consumers must
    avoid products with precautionary statements

27
Policy Review Objective
Precautionary labelling may contain
  • Reinstating the use of precautionary statements
    as a meaningful and effective risk management
    tool in order to
  • minimize risks associated with inadvertent
    consumption of undeclared priority allergens in
    food and
  • maximize available choice of safe and nutritious
    foods for consumers with food allergies and
    celiac disease.

28
Food Allergies Precautionary Labelling
Proposed option for policy change
  • The renewed policy on precautionary labelling
    would
  • Restrict statements from a short list of
    precautionary statements (PS)
  • Any other PS than those on the short list would
    be considered misleading and enforcement would
    take place if they are used
  • Mandate the justification of the use of
    precautionary labelling
  • i.e. documentation of the reasons invoked by the
    manufacturer/processor to use PS as a risk
    mitigating tool
  • Be complemented by the development and
    implementation of
  • Education initiatives (consumers/industry)
  • A code of practice on allergens handling

29
For more information www.healthcanada.gc.ca/food
allergies www.inspection.gc.ca/english/fssa/fssae
.shtml
Merci !
30
  • Update on Dietary Sodium

31
Outline
  • Sodium intake in Canada compared to DRI
  • Food sources of sodium in Canada
  • What has been done in Canada re sodium

32
Dietary Requirements for Sodium
  • Adequate Intakes (AIs) for good health for people
    aged one year and over, range from 1000 mg/day to
    1500 mg/day.
  • Tolerable Upper Intake Level (UL) for sodium for
    people aged 14 and over is 2300 mg of sodium per
    day, (IOM, 2004).
  • UL is the highest intake level likely to
    pose no risk of adverse health effects

33
Sodium Intake in Canada
  • Canadians, aged 1, consume on average about 3100
    mg/day of sodium (7.9 g Salt), (CCHS 2.2, 2004)
  • Does not include salt added in cooking and at the
    table, (an additional 10-15 on daily sodium
    intake)
  • Over 90 of men and 66 of women, (aged 19 to
    70), have sodium intakes exceeding the UL (CCHS
    2.2)

Canadian Community Health Survey-Cycle 2.2 on
Nutrition, Statistics Canada
34
Percentage of Canadians Exceeding the Tolerable
Upper Intake Level for Sodium
Data based on Canadian Community Health Survey-
Cycle 2.2 on Nutrition, Statistics Canada
35
Sources of Sodium in the North American Diet
  • Sources of sodium found in the typical North
    American diet (Mattes and Donnelly,1991)
  • 77 is derived from sodium in processed food
    products
  • 12 occurs naturally in food and
  • 11 is added during cooking or at the table

36
Percentage of total sodium consumed from major
grouped-food sources by all respondents
Data are based on the Canadian Community Health
Survey - Cycle 2.2 on Nutrition, Statistics
Canada, 2004.
37
Nutrition Labelling
  • Regulations Dec 2002, effective December 12,
    2005
  • Mandatory on most pre-packaged foods, with some
    exemptions
  • Calories and 13 core nutrients must always appear
  • Additional nutrients must appear if subject of a
    claim
  • Sodium one of the core nutrients

38
  • Compare the Nutrition Facts table on food labels
    to choose products that contain less fat,
    saturated fat, trans fat, sugar and sodium
  • Choose vegetables and fruit prepared with little
    or no added fat, sugar or salt
  • Choose grain products that are lower in fat,
    sugar or salt
  • Select lean meat and alternatives prepared with
    little or no added fat or salt.
  • If you eat luncheon meats, sausages or
    prepackaged meats, choose those lower in salt
    (sodium) and fat.

39
Motivators for action on sodium
  • High blood pressure is an important risk factor
    for cardiovascular diseases, the number one cause
    of death for Canadians
  • More than half of Canadians have intakes of
    sodium, mostly from commercially prepared foods,
    that put them at risk for high blood pressure
  • During the development of the 2007 Canadas Food
    Guide to Healthy Eating it was almost impossible
    to design a diet with sodium intakes less than
    the UL using foods normally consumed by Canadians

40
Motivators for action on sodium
  • Since the main contributors to dietary sodium
    intake are commercially prepared foods, a major
    focus of interventions to reduce sodium intakes
    needs to be the reduction of salt and
    sodium-containing additives in these foods
  • The proposal to develop a strategy for reducing
    dietary sodium was initiated at the request of
    the health sector and the food industry
  • In October, 2007, Health Canada announced the
    establishment of a Working Group that will
    develop and oversee the implementation of a
    strategy to reduce sodium intake by Canadians

41
Multi-Stakeholder WG on Dietary Sodium Reduction
  • The Sodium Working group includes 24
    representatives from
  • Scientific and Health-professional Community
  • Health-focused Consumer NGO
  • Food Manufacturing Food Service Industry
  • Government

42
Mandate of the Sodium Working Group
  • The WG is responsible for developing,
    implementing and overseeing a strategy to reduce
    the overall consumption of sodium by Canadians.
    The strategy would include
  • education/consumer awareness
  • voluntary reduction of sodium levels in processed
    food products and foods sold in food service
    establishments
  • research

43
SWG Update
  • Sodium Working Group has
  • Focussed on obtaining agreement and understanding
    of TOR
  • Established a common knowledge base for members
    with respect to the issue
  • Identified data gaps
  • Obtained input via a public consultation session
    and an on-line questionnaire

44
SWG Update
  • A report on the Working Groups recent
    consultation meeting (Feb. 19, 2009), and on the
    responses to an on-line questionnaire will be
    made available on the HC web site.

45
  • Health Canada Website links
  • The Issue of Sodium gt http//www.hc-sc.gc.ca/fn-a
    n/nutrition/sodium/index-eng.php
  • Sodium - It's Your Health gt http//www.hc-sc.gc.c
    a/hl-vs/iyh-vsv/food-aliment/sodium-eng.php
  • Consultation session of the Multi-stakeholder
    Working Group on Dietary Sodium Reduction gt
    http//www.hc-sc.gc.ca/fn-an/consultation/init/sod
    ium/index-eng.php

46
  • Update on Health Claims in Canada

47
Outline
  • Food, Drug, Functional Food
  • Current Situation
  • Towards a Modernized Framework
  • Food/NHP Interface

48
Food
  • In the Food and Drugs Act
  • any article manufactured, sold or represented
    for use as a food or drink for human beings,
    chewing gum, and any ingredient that may be mixed
    with a food for any purpose whatever
  • A food for the purpose of a health claim
    submission refers to a food category (fruits) a
    food (type of breakfast cereal) or a constituent
    of a food, added or inherent (e.g. a nutrient or
    other non-nutrient bioactive substance)

49
Drug Claims?
  • Claims that bring a food within the definition of
    a drug would normally make the food subject to
    the drug-related sections of the Food and Drug
    Regulations
  • Drug includes
  • any substance or mixture of substances
    manufactured, sold or represented for use in
  • the diagnosis, treatment, mitigation or
    prevention of a disease, disorder or abnormal
    physical state, or its symptoms, in human beings
    or animals,
  • restoring, correcting or modifying organic
    functions in human beings or animals.
  • To address this, an exemption from the drug
    regulations has been provided in the regulations
    for foods with such claims

50
Functional Food
  • Working definition
  • A functional food is similar in appearance to,
    or may be, a conventional food, is consumed as
    part of a usual diet, and is demonstrated to have
    physiological benefits and/or reduce the risk of
    chronic disease beyond basic nutritional
    functions
  • A food product with claimed health benefits

51
Health Claim
  • Any representation in labelling and advertising
    that states, suggests or implies that a relation
    exists between a food or a component of that food
    and health (Codex Alimenarius Commission, 2004)
  • General or specific, stated or implied

52
4 Categories of Health Claims1
  • Disease risk reduction and drug-like function
    claims
  • E.g. Reduces risk of heart disease or lowers
    blood cholesterol
  • Non drug-like function claims
  • Function associated with health or performance
  • E.g. Promotes regularity
  • Biological role claims
  • Nutrient function claims
  • Function of nutrients or energy necessary for
    normal growth and development
  • E.g. Aids normal bone and tooth development
  • General health claims
  • E.g. Include low fat product x as part of healthy
    eating

1 Based on International Guidelines of Codex
Alimentarius
53
Requirements
54
First Disease Risk Reduction Claims
  • 2003 Food and Drug Regulations publication
    permitting five disease risk reduction (DRR)
    claims
  • Saturated and trans fats and heart disease
  • Sodium, potassium and hypertension
  • Calcium, vitamin D and osteoporosis
  • Vegetables, fruit and some cancers
  • Non-fermentable carbohydrates and dental caries

55
Claims in the Works
  • 2006 Position Paper on Five US Health Claims
    Considered for Use in Canada, reporting on
    results of review of the remaining US claims that
    were authorized as of 1999
  • Proposing acceptance of two additional claims
  • Folate and neural tube defects
  • Vegetables, fruit, whole grains and heart disease
  • Confirming two other claims not supported by
    updated science and will not be approved in
    Canada
  • Fat and cancer
  • Fibre-containing grain products and cancer
  • One claim subject of current review through
    industry submission
  • Anticipate publication in Canada Gazette Part I
    in mid-2009

56
Health Claims Modernization
  • Initiated in November 2007, with release of
    discussion paper Managing Health Claims for
    Foods in Canada Towards a Modernized Framework
  • Deadline for comments was April 2008 72 comments
    received
  • Objective is to increase government efficiency
    and flexibility in the approval of health claims,
    while retaining high standards of oversight to
    ensure their credibility
  • Regional workshops in 6 locations across Canada
    were held in Jan/Feb 2008
  • There was broad representation of
    comments/participation from government/ public
    health, industry, academia, health/disease
    organizations, health professionals and consumers

57
What We Heard?
Stakeholders agree that
  • The issues are profoundly complex and challenging
  • There should be greater predictability for the
    review of claims
  • The efficiency of claim reviews needs improvement
  • Openness and transparency is necessary to ensure
    accountability of the approvals system
  • There should be clearer submission requirements
    and processes
  • Disease risk reduction claims and drug function
    claims should be based on a high level of
    scientific certainty
  • Disclaimers on labels are not desirable
    (qualified health claims)
  • Consumer education is necessary

58
What We Heard?
Stakeholders disagree on some issues
  • Scientific substantiation of claims
  • Disagreement on level of certainty required for
    non drug-like function claims
  • Disagreement on the need for transparency
    regarding the level of scientific certainty for
    non-drug like claims
  • The addition of bioactive substances to foods
  • Industry focussed on disseminating benefits of
    new substances
  • Consumers/public health interested in preventing
    misrepresentation and encouraging good basic
    nutrition
  • Nutrition criteria to make foods eligible to
    carry health claims
  • No consensus on the need for nutrition criteria
  • As this is an emerging area, many declined to
    comment, suggesting the need for a focussed
    consultation on this issue

59
Next steps
  • Summary reports to be published shortly
  • Recommendations for moving forward to be
    developed
  • Continue ongoing Modernization of the Submission
    Review Process
  • Continue to work to assist industry in the
    preparation of good quality submissions
  • Publish update of Guidance Document for Preparing
    a Submission for the authorization of Food Health
    Claims
  • Publish process for review of Decisions from
    other jurisdictions
  • Clarify relationship with Natural Health Products

60
Food/NHP Interface
  • Since the Natural Health Products Regulations
    (NHPR) came into force in January 2004, the
    Natural Health Products Directorate (NHPD) has
    received a number of product licence applications
    (PLAs) for products that are in food formats
    (e.g., juices, yogurts, teas).
  • Over 600 PLAs in this group.

61
Food/NHP Interface
  • In Canada, products that have characteristics of
    both foods and NHPs could fall under both FDR and
    NHPR
  • FD is working with NHPD to
  • clarify the basis for classification of products
    at the food-NHP interface
  • set out guidelines for the risk management of
    these products
  • review monographs of common interest
  • FD is preparing communications information for
    industry regarding the current situation with
    NHPs in food format

62
Health Canada Website
  • New Document
  • Classification of Products at the Food-Natural
    Health Products Interace Products in Food
    Formats
  • http//www.hc-sc.gc.ca/dhp-mps/prodnatur/bulletins
    /food_nhp_aliments_psn-2009-eng.php

63
Thank You
  • E-mail candice_biggar_at_hc-sc.gc.ca
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