Health Canada Update

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• 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
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• Allergens, Gluten Sources and Sulphites

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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.

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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

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Food Allergy Incidents rationale for action

• Food allergy incidents are preventable
• Avoidance is the most effective risk management
  approach for food allergic consumers

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Stakeholders
Regulations Enforcement Education
Safe Products Education Information Offer of
Choice
Responsibility Choice Action
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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

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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.

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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

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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).

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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.

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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

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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

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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

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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

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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.

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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.

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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.

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Examples of Comments Received

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

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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.

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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

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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

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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.
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Precautionary labelling Truthful /Helpful ?
Ingredient list much shorter than allergen
precautionary statement
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Precautionary Labelling
What does it mean ? Risk? /No risk ?
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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

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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.

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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

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

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Outline

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

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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

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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
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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
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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

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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.
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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

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• 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.

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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

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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

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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

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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

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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

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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.

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• 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

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• Update on Health Claims in Canada

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Outline

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

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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)

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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

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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

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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

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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
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Requirements
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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

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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

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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

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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

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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

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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

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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.

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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

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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

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Thank You

• E-mail candice_biggar_at_hc-sc.gc.ca