Modernization of Health
Canada Food Frameworks
Foundations for Change
Presentation to the Canadian Health Food Association
June 20 2012
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Today’s presentation
Responding to the need for change
Proposed Direction
How will these be implemented?
Building for the future
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Responding to need for change
• Food and Drugs Act and Regulations have served
Canadian consumers and industry well for over 50 years
• Modernization needed so that Canadian frameworks can
continue to address the food safety demands of 21st
century effectively and efficiently
• Consider the complete suite of elements:
• Tools
• Policies
• Processes
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Responding to need for change
• Key area for action: Tools available to act on food safety
decisions
• Currently, once Heath Canada scientists have made a
safety decision it can take months or years to implement
the decision through regulatory amendments – ex
– Allowing use of a new food additive or addition of
vitamin or minerals to a food
– Setting a limit of chemical contaminants
– Approving new health claims
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Responding to need for change
• These delays
• Leave some food safety standards out of date, out of
step internationally
• Limit access to safe innovative products for Canadians
• Limit governments responsiveness to new science
• Make an unpredictable business environment for
industry
• Identified as a priority area for food regulatory
modernization by government, stakeholders, in Red
Tape discussions
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Responding to need for change
• Budget 2012 (March 29 2012) pg 168 “plans to streamline and
accelerate the process by which foods are regulated”
• Objective: new tools that will
 Reduce delays,
 Cut red tape and enable risk based approaches
 Make the food regulatory system more efficient and flexible,
responsive to emerging issues and opportunities,
commensurate with risk
But at the same time
 Do not compromise health and safety
 Provide transparent and consultative decision making
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Targeted FDA amendments
• April 26 2012, the government tabled proposed revisions
to the Food and Drugs Act to meet these objectives
• Bill C-38, Jobs, Growth and Long Term Prosperity Act
(Division 19, clauses 412, 414(2) 415 – 417, 419)
• Proposed targeted amendments
 Marketing Authorizations: Ministerial approval for
some decisions to align better with risk, international
approaches
 Incorporation by reference: Manage enforceable
lists outside of regulations that can be amended
administratively
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Marketing Authorization (MA)
Allows the Minister of Health to act on certain food safety
decisions through Ministerial regulations  providing exemptions that permit
• substances in or on foods
 such as food additives, residue limits agricultural
chemicals or veterinary drugs, vitamins and minerals
• some health claims
 setting specific conditions on the exemption
• giving flexibility to address any particular risks
 establishing classes
 incorporating by reference
Note: Exempting authority, cannot establish new prohibitions
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Marketing Authorization (MA)
• Ministerial regulatory process has the same checks and balances as other
regulations:
• Subject to the Statutory Instruments Act: Review by justice,
registered (SOR) and publication by the Clerk, referred to the SJCSR
• Subject to government policies on responsible regulation (CDSR,
regulatory reform initiatives such as one to one)
• Maintains same scientific scrutiny and review
• Same international notifications and consultation
But
• Pace of the Ministerial regulatory process and challenge function can be
prioritized within HC
• less drafting required,
• can incorporate lists to make amendments administratively
for faster approval
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Incorporation by reference
What is it?
 Mechanism which allows a document or list that is not in the text of
the regulations to be made a part of the regulations
Amendments
 Explicitly allow documents to be incorporated into both the Food
and Drug Regulations and the MA
 Includes
• documents developed by the government that can be amended
after consultation/notification and the safety assessment
 ex lists of substances with levels and foods, methods,
• international documents such as Food Chemicals Codex,
JECFA Compendium of Food Additive Specifications
 Must be accessible
Updates to the list do not require regulatory amendments
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How would these be implemented ?
What would change?
 Faster implementation of certain changes to Canada’s food
safety rules, such as those for food additives and food health
claims, after the safety assessment completed
 Increased responsiveness to emerging issues and scientific
developments, safety standards keep pace
What would not change?
 Scientific scrutiny and rigour of analysis: will not compromise
health and safety
 Retain checks and balances, principles of regulatory reform
 Maintain consultative and transparent processes
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Example: CITREM
• HC received a submission to approve the use of a new
food additive ‘CITREM”
• citric acid esters of mono- and di-glycerides as an
emulsifying agent in infant formula based on
crystalline amino acids or protein hydrolysates, or
both, at a maximum level of use of 0.155% as
consumed
• Use to keep ingredients including nutritional
components evenly dispersed in infant formula
• Consistent and full delivery of nutrients to newborns
• Helps prevent clogging when infant formula is delivered
through a feeding tube
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Example: CITREM
• HC determined the safety and efficacy of CITREM in
June 2008 - not eligible for Interim Marketing Approval
• Time between safety assessment and final approval
required 41 months
• With the new tools
• An MA could be established for emulsifiers
• Defining a class for emulsifiers
• Identifying the incorporated list of approved emulsifiers kept
by Health Canada on the web
• Exempting foods compliant with the incorporated list from the
prohibitions in the Act and the food additive prohibitions in
the Regulations
• Setting conditions
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Example: CITREM
• A “List of Permitted Emulsifying , Gelling, Stabilizing and
Thickening Agents” would be published on the Health
Canada Website
• List would include the additive, the food, the maximum level of
use (i.e. look like Table IV Division 16 in the Food and Drug
Regulations)
• After the scientific review, complete consultation/
International notification
• Then amend the table administratively to allow use of
CITREM, possibly in as little as 6 months after the scientific
decision
• Do not need to amend the MA or the Food and Drug
Regulations
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How will this be implemented?
Example: Updating approved Food Additives – After the Scientific Assessment is
Completed
Current Steps
Steps After FDA Amendments – MA
with incorporated lists
Web and WTO consultation /notification
Web and WTO consultation/ notification
Drafting of regulatory amendments and
consequential amendments in the FDR,
approved by DoJ,
Health Canada to finalize list entry
Development of RIAS, and approval by
TBS - RAS of RIAS
Approval by Health Canada
Recommendation by the Minister
Update web listing of approved food
additives that is incorporated by
reference into an existing MA
Seek TB recommendation to the
Governor General
Publication and Registration
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Just a beginning – Building for the future
• New tools are only a starting point
• Sets the stage for updating other elements of the
frameworks, providing more flexible and nimble tools to
enable modernization
• Renewed Policies
• Streamlined Processes
Ex: Food Additives
• Exploring risk based policy approach
• Developing new submission management system,
performance standards
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Links
Health Canada
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-58-eng.php
http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/c-38-eng.php
Bill C-38
http://www.parl.gc.ca/LEGISInfo/BillDetails.aspx?Language=E&Mode=1&billId=5514128
Beth.Junkins@hc-sc.gc.ca
613-941-4001
Senior Advisor, Director General
Food Directorate
Health Canada
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Appendix 1: Summary of Amendments
Bill C-38, Jobs, Growth and Long Term Prosperity
Act - Division 19
 Clauses 412, 414(2), 415, 416, 417, 419
C-38
Clause
FDA
Status
Provision
Description
412
4(2)
revised
-remove IMA related exemptions
-retain and clarify exemption for pesticide
residues from 4(1)(a) and 4(1)(d)
414(2)
30(1)( r)
revised
-revise regulation making authority around the
IMA to apply now to the MA
415
30(1.1)
new
- Permit regulations to establish classes and
distinguish among them
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Appendix 1: Summary of Amendments
Bill C-38, Jobs, Growth and Long Term Prosperity
Act - Division 19
 Clauses 412, 414(2), 415, 416, 417, 419
Clause
FDA
Provision
Status
Description
416
30.2
Replace
MA authority to allow claims prohibited
IMA in 30.2 in the Act and Regulations, and set
conditions
30.3
MA authority to allow substances in or on
foods that are prohibited in the Act and
Regulations, and set conditions
30.4
MA authority to establish classes
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Appendix 1: Summary of Amendments
Bill C-38, Jobs, Growth and Long Term Prosperity
Act - Division 19
 Clauses 412, 414(2), 415, 416, 417, 419
Clause
FDA
Provision
Status
Description
416
30.5
New
-Authority for a Regulation or an MA to incorporate
any document by reference from any source.
-Must be accessible, does not need to be
transmitted to the Clerk or published in Gazette
30.6
new
IbRef for food not impinge on any other existing
ability to IbRef for other products in the Act
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Appendix 1: Summary of Amendments
Bill C-38, Jobs, Growth and Long Term
Prosperity Act - Division 19
 Clauses 412, 414(2), 415, 416, 417, 419
Clause
FDA
Provision
Status
Description
417
---
Transitional - Existing IMAs stay in effect until notice
cancelling it, or 2 years after it was
published
419
---
Coming
into force
- On day or days to be fixed by the
Governor in Council
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