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Canadian Food Health Claim Roadmap good for health healthy for business 11 January 2012 Outline • Roadmap Document • Roadmap Flow Chart • Roadmap Decision Model 2 Roadmap Document Canadian Food Health Claim Roadmap 4 Objectives • Use Roadmap tools to: – access information – understand Canada’s regulatory environment – understand required actions – create a logical decision process 5 Accessing Information • When accessing information: – get Health Canada’s definitions – get most current documents • Roadmap – Appendix 1 – Definitions and terminology • e-Roadmap – glossary 6 Appendix 1 – Definitions & Terminology Term Definition/Source Bioactive Substance A bioactive substance is one that is demonstrated or purported to have a favourable effect on health. Bioactive substances include nutrients or non-nutrients in foods or other substances with medicinal or pharmacological properties from non-food sources. Examples: vitamins, minerals, isoflavones from soybeans, probiotic cultures, botanical materials (i.e. Hypericum perforatum [St. John’s Wort]) Report on Stakeholder Feedback on Modernizing Canada’s Framework for Health Claims on Food, September 2009 www.hc-sc.gc.ca/fn-an/pubs/label-etiquet/_claims-reclam/2009feedback-commentaire/index-eng.php This term is no longer used. This category of function claim has Biological Role Claims been renamed “nutrient function claim.” See Nutrient Function Claim. 7 Appendix 1 – Definitions & Terminology Term Definition/Source General Health Claim General health claims are broad claims that promote health through healthy eating or that provide dietary guidance. These claims do not refer to a specific or general health effect, disease, or health condition. Examples: “Include low-fat product X as part of healthy eating.” “As part of healthy eating, this food may assist in achieving and maintaining a healthy body weight because it is portion controlled.” Guide to Food Labelling and Advertising, Chapter 8 www.inspection.gc.ca/english/fssa/labeti/guide/ch8e.shtml 8 Glossary 9 Appendix 2 – Resource Documents Title Description/Source Food and Drugs Act This is the legal document that covers the manufacture and sale of food, drug, cosmetic and therapeutic products in Canada. Department of Justice http://laws.justice.gc.ca/eng/F-27/index.html Food and Drug Regulations These are the Regulations that provide the details for enforcement of the Food and Drugs Act. The Regulations, where applicable, prescribe the standards of composition, strength, potency, purity, quality or other property of the food or drug to which they refer. Department of Justice http://laws.justice.gc.ca/eng/C.R.C.-c.870/index.html 10 Appendix 2 – Resource Documents Title Description/Source A Guide for the Preparation of Submissions on Food Additives The purpose of this guide is to assist food manufacturers and distributors in the preparation of food additive submissions. Information is also provided on irradiated food submissions and on requests for opinions on substances not regulated as food additives. This guide is not legally binding but merely represents an interpretation and elaboration of the provisions of section B.16.002 of the Food and Drug Regulations. Health Canada www.hc-sc.gc.ca/fn-an/pubs/guide-eng.php December 2007 The Food Additive Submission Checklist summarizes both administrative and scientific/technical information that is meant to assist both the petitioner in preparing a submission and the scientific evaluator in verifying that the required information has been submitted. Health Canada www.hc-sc.gc.ca/fn-an/pubs/additive-checklist_additifs-aidememoire-eng.php 11 Appendix 2 – Resource Documents Title Description/Source Health Canada’s Regulatory Modernization Strategy for Food and Nutrition This document summarizes Health Canada’s strategy to modernize its way of regulating the industry as based on feedback from industry and consumers. The Strategy’s five goals are: 1. improving Predictability, Effectiveness, Efficiency, and Transparency in Health Canada’s Food Regulatory System 2. promoting Regulatory Responsiveness to Food Innovation and Promoting Consumer Access to Foods with Assessed Health Benefits 3. modernizing the Regulatory Toolkit to Address “Food Contributors” to Chronic Disease 4. improving Health Canada’s Responsiveness to Acute Food Safety Health Risks—Responding to New Threats While Managing Ongoing Risks 5. promoting a Sustainable and Integrated System for Food Safety and Nutrition December 2008 Health Canada www.hc-sc.gc.ca/fn-an/pubs/rm_strat_mr-eng.php 12 Appendix 2 – Resource Documents Title Description/Source Implementation of Health Canada’s Revised Guidance Document for Preparing a Submission for Food Health Claims: Walnuts and Blood Cholesterol Nutri-Net Canada funded Cantox Health Sciences International to: apply Canada’s revised guidance document for food health claim submissions to a food–health relationship (specifically walnuts and coronary heart disease with blood cholesterol as a surrogate marker); and provide feedback and recommendations on the comprehensibility and ease of use of the guidance document. Note: This is an excellent resource to use as an example of how a submission should be prepared and organized. April 2009 Cantox Health Sciences International http://admin.nutrinetcanadannc.ca/useredits/File/FINAL%20NutriNet%20Walnuts%20 and%20Blood%20Cholesterol%20Apr%202009.pdf 13 Resources 14 Appendix 3 – International Health Claims • Roadmap focuses on Canada • International claims can provide information • Appendix 3 – by country / region – classification of health claims – list of disease risk reduction claims 15 Appendix 5 – Technology Resources Facility / Program Type Description and Contact Information Food Technology Centres Agriculture and Agri-Food Canada Pacific Agri-Food Research Centre 4200 Highway #97, South Summerland, BC V0H 1Z0 Phone: 250-494-7711 Fax: 250-494-0755 Website: www4.agr.gc.ca/AAFC-AAC/displayafficher.do?id=1180620561099&lang=eng The Pacific Agri-Food Research Centre in British Columbia is one of 19 research centres in Agriculture and Agri-Food Canada’s national network. It has two research sites (the location in Agassiz) and a separate facility in Summerland, including the Kamloops Range 16 Appendix 5 – Technology Resources Facility / Program Type Description and Contact Information University Food Science Programs University of British Columbia Faculty of Land and Food Systems 2357 Main Mall Vancouver, BC Phone: 604-796-2221 Website: www.landfood.ubc.ca The Food Science department has research laboratories with modern analytical instrumentation, including analytical ultracentrifuge, scintillation counter, electrophoretic analysis and imaging instrumentation, chromatography systems including FPLC, HPLC, and GC, UV-visible spectrophotometers, spectrofluorometers, Raman 17 Appendix 5 – Technology Resources Facility / Program Type Description and Contact Information University Food/Nutrition Programs University of Alberta Dept. of Agricultural, Food and Nutritional Science Faculty of Agriculture, Forestry and Home Economics 4-10 Agriculture Forestry Building Edmonton, AB T6G 2P5 Phone: 780-492-9287 Fax: 780-492-4265 Website: www.afns.ualberta.ca The Department of Agricultural, Food and Nutritional Science (AFNS) at the University of Alberta is unique, the first of its kind in North America, reflecting the integration of many disciplines to meet growing demands for safe and nutritious foods, bioproducts and healthy human environments. 18 Appendices 6, 7 and 8 • Roadmap – add health benefit promotion to plans • Appendix 6 – market plan description and resources • Appendix 7 – business plan description and resources • Appendix 8 – additional cost considerations 19 Appendix 9 – Index to Regulations Food and Drug Regulations January 10, 2011 version http://laws.justice.gc.ca/PDF/Readability/CRC870.pdf B.01.054 Temporary Marketing Authorization Letters….64 B.01.301 – B.01.312 Declaring values on labels……….74 B.01.400 – B.01.467 Nutrition labelling………………….80 B.01.500 – B.01.513 Nutrient content claims………….158 B.01.600 – B.01.603 Health claims...……………………205 Div 8 Dairy products....…………………………………….283 Div 9 Fats and oils.…………………………………………367 20 Regulatory Environment • Chapter 2 • Regulatory Organizations – Health Canada – Canadian Food Inspection Agency • Flow Chart – Explains all the terms in the boxes 21 Roadmap Flow Chart STEP 1 • The Preliminary Review - Does your product have the potential to make a nutrient and/or health claim? - List all potential relationships between food components and health 23 STEP 2 • Two separate regulatory systems – Food Regulations – Natural Health Products Regulations • Separate claims under each one 24 STEP 3 • check all ingredients • check the process 25 STEP 3 - NOVEL FIBRE • Check for novel fibre ingredients – Not traditional source of fibre – Processing has altered structure – Highly concentrated • Ask suppliers for status • Check allowable claims – CFIA Guidance (Chapter 6) 26 STEP 3 - NOVEL FIBRE 27 STEP 3 - NOVEL FOOD • One of the following: – No history of safe use in Canada – Undergone a major change – Genetically modified • Health Canada safety evaluation – Letter of no objection – Check website or ask supplier for copy 28 STEP 3 - VITAMINS & MINERALS • Adding as ingredient • FDA & Regs - section D – permitted foods – level of addition • Temporary Marketing Authority Letter 29 STEP 3 - ADDITIVE • Check food divisions for standards [S] – 4 : cocoa and chocolate products – 13 : bakery products • Check additive tables (Div 16) – sweeteners – yeast • Check ingredient divisions – 6: colours – 18 : sweetening agents 30 STEP 3 - CONCLUSION All ingredients okay + All processes okay OR Applications filed 31 STEP 4 - CLAIM OPTIONS 32 STEP 4 - Nutrition Facts Table • Calories plus 13 core nutrients • Per serving size • Mandatory on most pre-packaged foods – Nutrient with claim must appear • CFIA’s “Guide to Food Labelling and Advertising – Chapters 5 and 6” 33 STEP 4 - Nutrition Facts Table 34 STEP 4 - Nutrient Content Claims • reflects quantity – “good source” or “excellent source” of … – fibre, vitamin C, calcium, etc. • does not indicate benefit • CFIA Guide… Chapter 7 35 STEP 4 - Nutrient Content Claims 36 STEP 4 - Non-Nutrients Constituents not list in Nutrition Facts Table Declare outside Nutrition Facts Table “has X mg of constituent per 100 g serving” 37 STEP 4 - Nutrient Function Claims • Function claims – well-established roles for maintenance of good health or normal growth and development – nutrient function claims are a subset • CFIA Guide … Chapter 8 38 STEP 4 - Nutrient Function Claims 39 STEP 4 - Food Health Claim Options State, suggest or imply that a relationship exists between a food, or a component of that food, and health Must be truthful and not misleading 40 STEP 4 - General Health Claims • Promote overall health – in context of overall diet • Canada’s Food Guide – Number of recommended servings 41 STEP 4 - Function Claims • Function claims – well-established roles for maintenance of good health or normal growth and development – health effect has specific end point • CFIA Guide … Chapter 8 42 STEP 4 - Function Claims • Wheat bran example – 100 g serving of “X” bar contains 7 g of fibre from coarse wheat bran which promotes laxation (or regularity) – … contains 4 g of fibre …. Consuming 7 g of fibre from coarse wheat bran daily promotes laxation. 43 STEP 4 - Function Claims • Existing function claims – See Chapter 8 • New function claims – Recommend pre-market approval – Specific endpoint • Biological marker or performance 44 STEP 4 - Disease Risk Reduction Claims • Relates to the effects on a risk factor for disease • Require pre-market approval from Health Canada • Regulatory amendment required 45 STEP 4 - Disease Risk Reduction Claims • Chapter 8 - lists 5 : – Sodium / blood pressure / heart disease – Calcium / bones / osteoporosis – Saturated and trans fats / heart disease – Fruits and vegetables / cancer – Tooth decay 46 STEP 4 - Therapeutic Claims • Treatment or mitigation of a healthrelated disease or condition, or about restoring, correcting or modifying body functions. • Require pre-market approval • Require regulatory amendment 47 STEP 4 - Therapeutic Claims • Chapter 8 - not included – Health Canada assessment notices • Plant sterols, oats and psyllium – Helps reduce / lower cholesterol – Risk factor for heart disease 48 Roadmap Decision Model The Decision Model • Four-step flow chart • Activities for each step • Deciding on best option • Section 3 – general description • Section 4 – detailed description 50 Four Tracks Regulatory Track Scientific Track Market Track Business Planning Track Step 1 Step 2 Step 3 Step 4 51 Track Activities – Overview (Section 3) Step 2: Food or NHP Regulatory Stream Assessment Regulatory Track Scientific Track Market Track Business Planning Track Purpose is to identify if target material is an NHP or a food additive, food ingredient or food: Purpose is to gain an understanding of the breadth and depth of scientific information available to support an NHP submission or designation of the target material as a food. Purpose is to create a preliminary estimate of the size and attractiveness of each option (i.e. NHP and food). Purpose is to create a framework to compare each option to the resource requirements for the NHP/regulatory framework/ distribution channel option versus the food product/food regulations/ distribution channel option. If NHP, determine activities and information required to comply with NHP regulations and related guidance documents Activities concentrate on assessing the intended use, product form and potential claim of ingredient or bioactive under review, These market snapshots are matched with the output of the Scientific and Regulatory Tracks to demonstrate the relative attractiveness of Activities are focused on assessing the fit of: 52 Decision Making • Leaders for each track meet to share findings • End of step has a decision point – exit model – redo step as more information is required – go ahead to next step • Decision based on pre-arranged criteria 53 Decision Criteria • Financial risk • Uncertainties • Long-term versus short-term profitability 54 Veto Criteria • Information that would stop that path • Examples: – identified market of < X size – safety issues in other countries – < X quality clinical trials supporting claim 55 Comparative Criteria • More than one option : – Competitive advantage ? – Best chance of financial success ? – Short term / long term 56 Decision Point Step 2: Food or NHP Regulatory Stream Assessment Regulatory Track Scientific Track Market Track Business Planning Track Step 2 Go/No Go Decision Options: 1) NHP: Proceed as NHP: (1) Initiate NHP Process (2) Exit Model 2) Food: Proceed to Step 3 3) NHP / Food status uncertain: Redo Current or Previous Step 4) No non-nutrient declaration, nutrient and/or health claim: Exit Model 57 Decision Point 58 Track Activities – Details (Section 4) Step 1: Nutrient / Health Claim Potential — Preliminary Review Regulatory Track 1. Define the target market segments that have potential for each of the different nutrient and/or health claims that the Regulatory Track and Scientific Track show might be made. 2. Conduct literature review, executive interview and other types of preliminary secondary and Business Planning Track Busin ess Plann ing Track 1. Describe product and its intended use in detail by considering the following questions: Is it a whole food, a food product or a food constituent? Is it a vitamin, mineral or amino acid? Is it a substance that could be a natural health product? Is it a substance with a specific technical function in a food (e.g. Market Track Mark et Track Scien tific Track Regu latory Track 1. Review the following documents, which are described and referenced in Appendix 2. Food and Drugs Act, Part 1 Food and Drug Regulations (FDR), Part A and Part B (Foods) FDR, Part D (Vitamins, Minerals and Amino Acids) Scientific Track 1. Assess the fit of each option for the various nutrient and/or health claims into the existing business strategy. 2. Determine the financial and human resources required to complete the claim process compared with what the business has available. 59 Track Activities – Details 60 Sample Review Process • Track managers activities • Decision meeting agenda • Sample veto criteria • Sample comparative criteria • Sample decision point 61 SUMMARY • Understand Health Canada terms – access HC and CFIA documents • Create a list of healthy aspects – collect supporting data • Select regulatory stream – food or natural health product • Check ingredients and processes – ask suppliers for confirmation • Create list of nutrient / health claims – analyze product • Select best claim(s) for business – apply to HC if necessary 62 NEXT HEALTH CANADA SESSION • Daily Value requirements changes (i.e. Vitamin D) • Energy drink issues • Food Fortification (added vitamins / minerals) • Food sweeteners / sweetening agents (i.e. Stevia) • Gluten-free guidelines • How to choose health claims for your products • New allergen labelling requirements • New fiber definition and novel fibres 63 NEXT HEALTH CANADA SESSION • Novel foods • Probiotic and Prebiotic • Salt and sodium reduction guidelines • Terminology use (Natural, Organic, Made in Canada) • How to determine serving size • How to apply for a TMAL • US/ Canadian labelling harmonization 64 Roadmap Copies www . agr.gc.ca / food-regulatory-issues Claim assistance ARD shirzad.chunara @ gov.ab.ca ARD annette.anderwald @ gov.ab.ca ARD susan.lutz @ gov.ab.ca AAFC info.frid-dera @ agr.gc.ca QUESTIONS ?