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• These delays• Leave some food safety standards out of date, out of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 classesincorporating 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 referenceWhat 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?

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 Registration15

Example: Updating approved Food Additives – After the Scientific Assessment is Completed

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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

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C-38Clause

FDA Provision

Status 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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Bill C-38, Jobs, Growth and Long Term Prosperity Act - Division 19 Clauses 412, 414(2), 415, 416, 417, 419

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Clause FDA Provision

Status Description

416 30.2 Replace IMA in 30.2

MA authority to allow claims prohibited 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

Appendix 1: Summary of Amendments

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Bill C-38, Jobs, Growth and Long Term Prosperity Act - Division 19 Clauses 412, 414(2), 415, 416, 417, 419

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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

Appendix 1: Summary of Amendments

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Bill C-38, Jobs, Growth and Long Term Prosperity Act - Division 19 Clauses 412, 414(2), 415, 416, 417, 419

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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

Appendix 1: Summary of Amendments