1. IADSA The global Alliance An introductory presentation for industry groups 2009

2. IADSA Origins? -Established 1998 -Focussed on three areas: -Coordinated action on the development of global standards in Codex Alimentarius -Information exchange: good news, bad news and managing responses to this -Building global network & structures to achieve above. -21 member associations growing to 54 today, with companies representing more than 70% of the global USD 65bn market.

3. The Challenge -Legislation is a critical factor in determining market opportunities and market entry. -Most authorities do not like supplements! Restrictive legislation is the natural default! -Many decision-makers have little to no understanding of the beneficial effects and safety of supplements. -IADSA’s role is to create the optimal regulatory and policy environment to be able to market supplements worldwide.

4. Creating a clear, viable category Medicin e FunctionalFood FoodSupplementsTraditionalMedicines

5. Food Supplement Ingredients 1.Vitamins and minerals (natural & synthetic sources) 2.Amino acids and derivatives 3.Enzymes 4.Probiotics 5.Animal ingredients 6.Botanicals and phytonutrients 7.Miscellaneous

6. Codex Codex Alimentarius Commission Executive Committee Codex Secretariat Commodity Committees Horizontal Committees Regional Committees Additives Labelling Nutrition & FSDU Asia Africa Europe N. Am & SWP Latin America Contaminants 180 Member Countries + EU Chocolate Milk Products Oils & Fats Opportunities -Submissions -Role -Language -Coordination

7. Codex Codex Alimentarius Commission Executive Committee Codex Secretariat Commodity Committees Horizontal Committees Regional Committees Additives Labelling Nutrition & FSDU Asia Africa Europe N. Am & SWP Latin America Contaminants 180 Member Countries + EU Chocolate Milk Products Oils & Fats Impact: - Regional - National - Legal force

8. Scientific Programme Role/BenefitsSafetyOther Key Areas

11. Codex Vitamin and Mineral Supplement Guideline 2005 Preamble The need for a balanced diet / If insufficient, supplement the daily diet Scope Composition Packaging Labelling Applies only to vitamin and mineral food supplements regulated as foods Maximum levels: based on scientific risk assessment not RDAs Containers to safeguard the hygienic and other qualities of the food Advice not to exceed the maximum one-day amount / not to replace meals

12. Codex to WHO Codex Guidelines for Vitamin and Mineral Food Supplements FAO/WHO Model for Establishing Upper Levels of Intake for Nutrients and Related Substances 20052006 provides the structure for establishing the maximum levels of permissible vitamins and minerals and other ingredients in a supplement provides guidance to governments across the world on how to do this

13. Codex Programme 2009 Monitor and provide input to Nutrient Reference Values and Addition of Essential Nutrients to Foods. Monitor development of General Standard on Contaminants & potential impact on supplements &, if so, defend realistic levels. Monitor discussions on GMO labelling and on the list of nutrients, potential mandatory labelling and legibility/readability of labels. CCFA Additives CCCF Contaminants CCFL Labelling CCNFSDU Nutrition CAC Commission Prevent deletions and achieve the adoption at adequate levels of use of key additives (GSFA). Adoption of Nutrient Risk Analysis Principles & Recommendations on the Scientific Substantiation of Health Claims.

14. Codex Additives LEVEL (mg/kg) Allura Red AC300 Annatto extracts, bixin-based60 Annatto norbixin-based100 Caramel Colour class III20000 Caramel Colour class IV20000 Carotenoids300 Chlorophylls500 Erythrosine300 Fast Green FCF600 Grape Skin Extracts500 Indigotine300 Iron Oxides7500 Lycopene50000 LEVEL (mg/kg) Aspartame-Acesulfame Salt200 Aluminium silicateGMP Calcium aluminium silicateGMP Sodium aluminosilicateGMP

15. Codex Commission Shared by 2004 IADSA Safety Report Basis for Setting Maximum Levels of Vitamins & Minerals FAO/WHO Nutrient Risk Assessment Report Nutrient Risk Analysis Principles

16. Codex Commission Authoritative statements: history of use Word “clinical” deleted: human intervention studies Observational/ epidemiological studies: totality of the evidence Health Claims Substantiat ion

17. New legislation in development Austria Belgium Brazil Brunei Bulgaria Cambodia China Colombia Croatia Czech Republic Cyprus Denmark Estonia Finland France Germany Greece Hungary India Indonesia Ireland Israel Italy Japan Laos Latvia Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Philippines Poland Romania Russia Singapore Slovakia South Africa Spain Sweden Thailand Turkey United Kingdom Uruguay Venezuela Vietnam

18. New legislation in development Austria Belgium Brazil Brunei Bulgaria Cambodia China Colombia Croatia Czech Republic Cyprus Denmark Estonia Finland France Germany Greece Hungary India Indonesia Ireland Israel Italy Japan Laos Latvia Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Philippines Poland Romania Russia Singapore Slovakia South Africa Spain Sweden Thailand Turkey United Kingdom Uruguay Venezuela Vietnam ASEAN & EU HARMONISATION

19. Overview of legislative activity ASEAN NUTRITION STRATEGY RISK ASSESSMENT VITS & MINS TRADITIONAL MEDICINES STRATEGY MONOGRAPHS & QUALITY CODEX GUIDELINES ON VITAMINS AND MINS CLAIMS / CLAIM SUBSTANTIATION ADDITIVES CONTAMINANTS EU LATIN AMERICA JAPAN CHINA MEXICO DIETARY SUPPLEMENTS PRIORITY NATIONAL/ REGIONAL ISSUES WHO/FAO RISK ANALYSIS USE OF OTHER INGREDIENTS GINSENG NRV INDIA RUSSIA DIETARY FIBRE

20. Focus of Regulation Number Of Countries

21. ASEAN Harmonisation: max levels, botanicals, claims, GMPs… EU: Max Levels, botanicals & claims India: new regulations Latin America: RDAs & Safety BotanicalsDistribution China: New regulations: registration, claims Japan: New Regulations Russian registration SE Europe: New regulation

22. IADSA’s Structure Annual Meeting Board Executive CouncilCompany Council Secretariat MEMBERS

23. IADSA Approach -World-leading expertise in science, technical and regulatory. -Very low administrative base: 95% of energy and time goes into global, regional and national programmes. -Non-confrontational where possible -Authorities need to see us as a “Partners”

24. PRIORITY REGIONAL & NATIONAL PROGRAMMES

25. ASEAN

26. ASEAN Health Supplement Law 1.Classification 2.Definition 3.Ingredient Safety / Negative Lists 4.Additives 5.Labelling / Packaging 6.Claims 7.GMP 8.Registration/notification 9.Post marketing surveillance 10.Borderline/Interface zone

27. ASEAN Progress so far…. -Creation of the ASEAN Alliance of Health Supplement Associations (AAHSA) in Spring 2006 -Seat at government table 2007 -Operation of Scientific Committee -Lead on Maximum levels of vitamins and minerals -Co-lead on claims, negative listing, stability and shelf-life … -Request to IADSA to advice on framing the legislation.

29. Where do governments look? Codex/WHO EUUS OTHERMODELS 1 2 3

30. EU OTHERMODELS 1 2 3 US

31. Why Europe? Multinational Non-compromising on consumer protection Very visible and vocal in Codex European Food Safety Authority EU policy to export regulation worldwide.

32. EU: The three key issues 1.Maximum Levels of vitamins and minerals – Proposal expected in June/July -EHPM/ERNA model still favoured. -Major battle between more liberal and more restrictive member states. -Final result: expected 2010-11. 2.Claims: -EFSA taking highest standard for evaluation -Many established claims under threat. -Extensive action program underway. 3.Botanicals: -Support for continued use of botanicals in Strategy Document. -Challenges from some Member Countries -New model and support developed in European Botanical Forum.

33. Latin America Most problematic region. –RDA based vitamin and mineral levels common –Limited claims permitted –Registration procedures lengthy and complex. –Limited range of ingredients permitted. –Restrictions on distribution in some countries. Currently no harmonisation: Mercosur, Andean Community.

34. Latin American Progress Creation of a Latin American industry working group. Operating the regional information gathering, communication, education programme around four key events at present: –South Cone Workshop: Buenos Aires, June 2008 –Andean Workshop: Lima, January 2009 –Central America Regulatory Forum: Cancun, May 2009 –Brazil Workshop: Brasilia, October/November 2009 –LA Regulatory Conference: 2010 Demand for help and support from national authorities and regional groups growing every day.

35. Russia Four key barriers to market: –Registration time –Claims limitations –Testing requirements –Restrictions on distribution. Built a plan for change: –Build international links with authorities. –Creation of effective national association. –Work with association on proposing changes. –Support association and authorities in process of making change.

36. Progress 2007: –Meeting in Moscow between IADSA and authorities –Organisation of workshop with authorities in Washington to expose to international regulation and meet with associations. 2008: –Authorities stimulate creation of a new association 2009: –Association joins IADSA –Association publishes proposals to change regulations. –IADSA International Scientific Forum with Academy of Sciences and new association: Moscow. –Joint “ political ” event with association in June 2009.

37. China Food Safety Law to be finally adopted 5 March: Opportunity for change: Notification not registration Joint programme with SFDA to educate and work for change, potentially including: –Analysis of existing regulatory systems –Provision of ideal models –Expert workshop –Ongoing advice - also through website.