1. IADSA The global Alliance An introductory presentation
A short introduction to IADSA, its role, its priorities and programmes. Please note that this presentation contains sensitive messages shared within the industry and not with government regulators.
An introductory presentation
for industry groups
2010

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.
More than 50 member associations today which represent companies which make up more than 70% of the global US$ 80bn market.
Founded in 1998 to focus on very limited areas: the harmonisation of global food supplement legislation by the international food standards setting body, Codex Alimentarius, and to share information across the sector.
Evolved quickly from the original 21 members to more than 50 today, representing more than 70% of the global 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.
The issues facing IADSA in those days, and still often today, were significant. Legislation is the most significant barrier to market entry for companies, determining what can be sold with what information and sometimes even where it can be sold. Most authorities do not like our products! Very often it is due to them facing on a regular basis the worst excesses - sports products with drug ingredients in them, products mislabelled, outrageous cancer-curing claims for example. These products and this abusive behaviour of a relatively small number of companies seriously damages our industry’s reputation and means that a good regulatory framework is that much more difficult to achieve.
In addition, decision-makers often have little to no understanding of both the benefits of our products and how safe they area. This is not due to any fault on their part, but due to a lack of information and education.
IADSA’s role is therefore to address these issues and thereby create the optimal regulatory and policy environment to be able able to market products worldwide .

4. Creating a clear, viable category
Functional
Food
Food
Supplements
Traditional
Medicines
Medicine
A central problem in many countries around the world has been that supplements are not defined or have no category. This is slowly changing, although in a huge market such as Japan this is still the case. While this specific category can be created alongside functional foods and traditional medicines, it is acknowledged that grey areas in regulation and categorisation will continue to exist. These may be due to overlaps between categories: botanicals for example that can be sold as a functional food, a food supplement, a traditional medicine and a conventional medicine. These grey zones cannot be eradicated easily and maybe never will be. The focus of regulatory attention has to go to making sure the food supplements category is well constructed and suitably broad to include the wide range of products. Problems arise most commonly where the food supplements category is determined too narrowly.

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
Having determined that a separate category for supplements is required, it is then necessary to ensure that a wide range of ingredients are incorporated within any definition of a supplement. The broad range of ingredients are included within these seven categories listed and operates as a checklist for any definition or any new regulation. It goes without saying that botanicals is today the most threatened of the ingredient groupings, under pressure from classification under drug law.

6. Codex Alimentarius Commission Horizontal Committees
Executive Committee
Codex
Secretariat
Commodity Committees
Horizontal Committees
Regional Committees
182 Member
Countries + EU
Opportunities
Submissions
Role
Language
Coordination
The Codex Alimentarius Commission was created in the 1960s to develop international standards and guidelines. While the Commission is the highest decision-making body in Codex, the detailed discussion on these standards and guidelines take place in the specific expert Committees. The Committee on Nutrition and Foods for Special Dietary Uses is the commodity committee that deals with food supplements. IADSA actively participates in Codex meetings to defend the interests of the food supplement industry, through its member associations and companies, by providing scientific and technical input to Codex on the key issues for the industry on vitamin and mineral food supplements, additives, labelling, claims, contaminants, etc. IADSA action includes the submission of its positions directly to Codex before and during meetings and also via IADSA members through a coordinated global action to ensure that the IADSA positions are adopted by Codex.
Milk Products
Contaminants
Asia
Chocolate
Additives
Africa
Oils & Fats
Labelling
Europe
Nutrition & FSDU
N. Am & SWP
Latin America

7. Codex Alimentarius Commission Horizontal Committees
Executive Committee
Codex
Secretariat
Commodity Committees
Horizontal Committees
Regional Committees
182 Member
Countries + EU
Impact:
- Regional
- National
- Legal force
Despite that Codex standards and guidelines are not mandatory for Codex member countries and organisations (EU), they are the primary reference point for them when developing national and regional regulations. In addition, Codex standards and guidelines are taking as the basis to resolve trade disputes in the context of the World Trade Organisation.
Milk Products
Contaminants
Asia
Chocolate
Additives
Africa
Oils & Fats
Labelling
Europe
Nutrition & FSDU
N. Am & SWP
Latin America

8. Scientific Programme Role/Benefits Safety of ingredients
Other Key Areas
A key element of work was to demonstrate the benefit and safety of supplements, something that was seriously questioned by many government delegations in Codex. Through a range of publications, the case for supplementation was made in Codex and, over the years, nearly 2,000 copies of these have been eagerly snapped up in Codex committees and the Codex Commission meeting.

9. Having the science was one thing
Having the science was one thing. What was also required was a way to meet governments outside of Codex and convince them of the IADSA position. It was decided to intiatiate this action through regional workshops. A first one being in Bangkok in 2002 bringing in government officials from more than 10 countries and….

10. A second one in Rio de Janeiro in 2003, followed by further events in Prague and Beijing.

11. Codex Vitamin and Mineral Supplement Guideline 2005
Preamble
The need for a balanced diet /
If insufficient, supplement the daily diet
Scope
Applies only to vitamin and mineral food supplements regulated as foods
Composition
Maximum levels: based on scientific risk assessment not RDAs
The result of this coordinated work were Guidelines adopted in 2005 which would have been considered impossible back in 1998 when IADSA was established. Of most importance was the section on composition which set out the basic conditions for establishing maximum levels for vitamins and minerals. This established a global rule that it could not be on the basis of multiples of the RDA but had to be based on safety and effectively condemned to illegality rules that maintained the RDA limits for products regulated under food law.
Packaging
Containers to safeguard the hygienic and other qualities of the food
Labelling
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
2005
FAO/WHO Model for Establishing Upper Levels of Intake for Nutrients and Related Substances
Provides guidance to governments across the world on how to do this
2006
2009
Implements the “2006 FAO/WHO Model” providing guidance to governments on how to establishing the maximum levels of permissible vitamins and minerals and other ingredients in a supplement
Nutritional Risk Analysis Principles for Application by
Codex Nutrition Committee
Codex Guidelines
for Vitamin and Mineral Food Supplements
Provides the structure for establishing the maximum levels of permissible vitamins and minerals and other ingredients in a supplement
But while the Guidelines were immensely strong, they were missing the methodology to actually establish maximum levels. In 2006, WHO provided the answer which with a report on establishing upper limits for nutrients and related substances that was firmly in line with IADSA’s own model. On this basis, work could now be accelerated to change the RDA-based regulations that existed around the world. In 2009, the Committee on Nutrition implemented the “2006 FAO/WHO Model”, providing guidance to governments on how to establishing the maximum levels of permissible vitamins and minerals and other ingredients in a supplement.

13. Codex: Claims & Additives
Recommendations on the Scientific Substantiation of Health Claims
Takes into account the totality of the available relevant scientific data and weighing of the evidence to substantiate a health claim
Ongoing revision of the General
Standard for Food Additives
The use in food supplements of 8 food colours were adopted last year and two additional additives this year,
In 2008, Codex adopted its recommendations on the scientific substantiation of health claims that take into account the totality of the available relevant scientific data and weighing of the evidence as supported by IADSA. In addition, IADSA is also engaged in the ongoing revision of the General Standard for Food Additives, a Codex positive list of food additives, to ensure that the additives used by the food supplement industry are included in the Standard.

14. Codex Programme 2010
CCFA
Additives
Prevent deletions and achieve the adoption at adequate levels of use of key additives (GSFA).
CCCF
Contaminants
Monitor development of General Standard on Contaminants & potential impact on supplements &, if so, defend realistic levels.
CCFL
Labelling
Provide input on discussions on GMO labelling and amendment of the Nutrition Labelling Guidelines regarding the list of nutrients & potential mandatory labelling and on the legibility of labels.
This is the IADSA action programme in Codex for Position papers are developed in consultation with IADSA members for the key issues for the industry that will be discussed by these Committees and the Commission. In addition, a delegation of IADSA will be present at each of these Committees and the Commission to actively represent the interests of the sector.
CAC
Commission
Adoption of key texts recommended by the Committees on Nutrition, Additives, Contaminants and Labelling.
CCNFSDU
Nutrition
Monitor and provide input to Nutrient Reference Values and Addition of Essential Nutrients to Foods.

15. New legislation in development
Argentina
Austria
Belgium
Brazil
Brunei
Bulgaria
Cambodia
China
Colombia
Croatia
Czech Republic
Cyprus
Denmark
Ecuador
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
Partly due to the Codex guidelines, partly due to the growing market, the number of governments increasingly looking to change their regulation has been increasing over the years. Today this list is a long one. But what is most interesting about this is that….

16. ASEAN & EU HARMONISATION
New legislation in development
Argentina
Austria
Belgium
Brazil
Brunei
Bulgaria
Cambodia
China
Colombia
Croatia
Czech Republic
Cyprus
Denmark
Ecuador
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
Two regions - ASEAN and EU - are currently responsible for covering the vast majority of these countries, with harmonising legislation being developed in both.
ASEAN & EU HARMONISATION

17. Overview of legislative activity
CODEX
WHO/FAO
GUIDELINES ON
VITAMINS AND MINS
CLAIMS / CLAIM
SUBSTANTIATION
RISK ASSESSMENT
VITS & MINS
PRIORITY NATIONAL/
REGIONAL ISSUES
NUTRITION STRATEGY
ASEAN
RISK ANALYSIS EU
ADDITIVES
CONTAMINANTS
LATIN AMERICA
DIETARY
SUPPLEMENTS
CHINA
USE OF OTHER
INGREDIENTS
LABELLING
SE EUROPE
And this balance between Codex and regional actions to help shape legislation across the world now forms IADSA's approach to legislative activity
JAPAN
INDIA
RUSSIA
NRVs
DIETARY FIBRE

18. Focus of Regulation Number Of Countries
A quick analysis of all these countries shows that the issues being tackled are broadly similar, with maximum levels of vitamins and minerals topping the list, followed by botanicals, other bioactive ingredients, claims and GMPs. Broadly, the challenges and questions being faced by regulators worldwide are very similar.

19. Russian Food Safety Law Canada: Registration Japan: New Regulations
EU: Max Levels, botanicals & claims
SE Europe: New regulation
China: Registration, & claims
USA:
GMP Application
India: new regulations
The areas that IADSA is involved with or watching closely across the world are the following, with the key issues highlighted.
ASEAN Harmonisation
Latin America:
Vit & Min Levels
Botanicals

20. IADSA’s Structure Members Annual Meeting Board IADSA Office
The Structure of IADSA reflects it diverse membership. Membership is open to all who conform to the basic principles of IADSA and meet once a year in the Annual Meeting. The Board is elected for two year terms to direct the day to day operation of IADSA. They rely on the guidance of the Executive Council, comprised of representatives of associations and the Company Council comprising representatives of companies. IADSA is managed by an office based in Brussels.
Board
Executive Council
Company Council
IADSA Office

21. 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”
IADSA has been exceedingly effective over the years. Part of that is due to the quality of the scientists, technical and regulatory experts involved. Part of this is down to the commitment shown by members and individuals to implementing the IADSA programme and achieving a better environment for the benefit of consumers. In addition, the resource allocation to action to achieve results is very high, with not more than 5% of all funding ever being spent on administration or management of the association.
However, what is very important is also that IADSA aims not be confrontation and to work with government authorities as partners. This is not always easy or possible, but this approach has build remarkable relationships which help both government and industry long term.

22. PRIORITY REGIONAL & NATIONAL PROGRAMMES

23. ASEAN
ASEAN is a grouping of 10 countries of SE Asia who are creating the largest single trade bloc in the world of 570 million people.

24. 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
Post marketing surveillance
10. Borderline/Interface zone
They have decided that supplements is a priority sector for harmonisation and their work is focussing on areas including the 10 listed.

25. 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…
Significant progress has already been achieved considering the differences in legislation across the region. This progress started with the creation of the industry group AAHSA in 2006 with the support of IADSA, and the granting of the governments of a seat at the government table for the organisation in Significant work continues supporting the Scientific Committee and work by AAHSA with IADSA and expert support on issues such as claims and maximum levels of vitamins and minerals. IADSA's role is to provide expert international advice as requested by the governments.

26. The ten countries of ASEAN in the supplement product working group plus the ASEAN Secretariat and the AAHSA Chairman.

27. Where do governments look?1
Codex/WHO 2 EU US
In many parts of the world, including ASEAN, governments take Codex and the WHO as the primary reference point in developing legislation. The EU and US are often second in line for reference.
OTHER
MODELS 3

28. Where do governments look?1 EU 2 US
However, Codex and the WHO often do not determine regulatory options in clear terms and governments then look almost always to the EU or guidance. This makes it of vital importance for the world's industry that EU legislation is broadly acceptable both in principle and in detail.
OTHER
MODELS 3

29. Why Europe? Multinational Non-compromising on consumer protection
Very visible and vocal in Codex
European Food Safety Authority
EU policy to export regulation worldwide.
The reason why so many countries look to Europe is since it is multinational and therefore already reflects many cultures and traditions; it is known to have a tough approach to consumer protection and product safety; the EU is very visible and vocal in Codex; the European Food Safety Authority is establishing itself as the primary scientific body across the world; and the EU has a deliberate policy of trying to export its legislation worldwide.

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

31. 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.
Latin America is today one of the most challenging regions for regulation and where the basic problems to marketing food supplement products continue to exist. One of the reasons of this challenging environment is that regulations vary greatly across the region as there is no harmonised legislation on food supplements in the two major regional associations of countries, Mercosur (Argentina, Brazil, Paraguay and Uruguay) and Andean Community (Bolivia, Colombia, Ecuador and Peru).

32. Latin American Progress
Creation of a Latin American industry working group
Four key events were organised last two years:
Mexican Workshop: Mexico City, May 2008
Mercosur Workshop: Buenos Aires, June 2008
Andean Workshop: Lima, January 2009
Brazilian Workshop: Brasilia, November 2009
Major event in 2010:
LA Regulatory Forum: Santiago de Chile, 2010
Demand for help and support from national authorities and regional groups growing every day
Due to the demand for help and support from national authorities and groups within the region, IADSA created in 2008 a Latin American Working Group to help in the implementation of a strategy focused on organising educational sessions on food supplement regulatory models and best practices for government officials across the region and to support the creation of food supplement focused associations. Plans are underway to organise a Latin American Forum towards the end of the year to which international government officials and scientists, and particularly from across Latin America, will be invited to participate.

33. China Food Safety Law finally adopted 1 June 2009
Opportunity for change: Notification not registration
Scientific Conference and Regulatory Workshop being organised in Beijing 2010
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
China is another key country for IADSA; both for the potential size of its market and its potential regional and global importance in regulatory terms in the future. The drive for change in China has been driven most recently by food safety scares and scandals. But there is now an opportunity for change and IADSA is working with the regulatory agencies to organise events in 2010 to help provide expertise on both scientific and regulatory issues.