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IADSA
The global Alliance
An introductory presentation
for industry groups
2010
IADSA Origins?
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Established 1998
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Focussed on three areas:
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Coordinated action on the development of global standards in
Codex Alimentarius
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Information exchange: good news, bad news and managing
responses to this
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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.
The Challenge
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Legislation is a critical factor in determining market
opportunities and market entry.
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Most authorities do not like supplements! Restrictive legislation
is the natural default!
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Many decision-makers have little to no understanding of the
beneficial effects and safety of supplements.
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IADSA’s role is to create the optimal regulatory and policy
environment to be able to market supplements worldwide.
Creating a clear, viable category
Functional
Food
Food
Supplements
Traditional
Medicines
Medicin
e
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
Codex
Codex
Alimentarius
Commission
Executive
Committee
182 Member
Countries + EU
Codex
Secretariat
Commodity
Committees
Horizontal
Committees
Regional
Committees
Milk Products
Contaminants
Asia
Chocolate
Additives
Africa
Oils & Fats
Labelling
Europe
Nutrition & FSDU
N. Am & SWP
Latin America
Opportunities
-Submissions
-Role
-Language
-Coordination
Codex
Codex
Alimentarius
Commission
Executive
Committee
182 Member
Countries + EU
Codex
Secretariat
Impact:
- Regional
- National
- Legal force
Commodity
Committees
Horizontal
Committees
Regional
Committees
Milk Products
Contaminants
Asia
Chocolate
Additives
Africa
Oils & Fats
Labelling
Europe
Nutrition & FSDU
N. Am & SWP
Latin America
Scientific Programme
Role/Benefits
Safety of ingredients
Other Key Areas
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
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
Codex to WHO
2005
2006
2009
Codex Guidelines
for Vitamin and
Mineral Food
Supplements
FAO/WHO Model for
Establishing Upper
Levels of Intake for
Nutrients and Related
Substances
Nutritional Risk
Analysis Principles for
Application by
Codex Nutrition
Committee
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
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
Codex: Claims & Additives
CLAIMS
ADDITIVES
Recommendations
on the Scientific
Substantiation of
Health Claims
Ongoing revision of
the General
Standard for Food
Additives
Takes into account the
totality of the available
relevant scientific data
and weighing of the
evidence to
substantiate a health
claim
The use in food
supplements of 8 food
colours were adopted
last year and two
additional additives this
year
,
Codex Programme 2010
CCFA
Additives
CCCF
Contaminants
CCFL
Labelling
Prevent deletions and achieve the adoption at adequate
levels of use of key additives (GSFA).
Monitor development of General Standard on Contaminants
& potential impact on supplements &, if so, defend realistic
levels.
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.
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.
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
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
ASEAN & EU HARMONISATION
Overview of legislative activity
CODEX
GUIDELINES ON
VITAMINS AND MINS
WHO/FAO
RISK ASSESSMENT
VITS & MINS
NUTRITION STRATEGY
CLAIMS / CLAIM
SUBSTANTIATION
PRIORITY NATIONAL/
REGIONAL ISSUES
ASEAN
EU
RISK ANALYSIS
LATIN AMERICA
ADDITIVES
CHINA
CONTAMINANTS
USE OF OTHER
INGREDIENTS
LABELLING
DIETARY
SUPPLEMENTS
SE EUROPE
JAPAN
INDIA
RUSSIA
NRVs
DIETARY FIBRE
Focus of Regulation
50
45
40
35
30
25
20
15
10
5
0
Max V&M Levels
Claims
Botanicals
Other Bioactives
GMPs
Russian Food Safety Law
Canada: Registration
EU: Max Levels,
botanicals & claims
USA:
GMP Application
Japan: New Regulations
China: Registration,
& claims
SE Europe: New
regulation
India: new regulations
Latin America:
Vit & Min Levels
Botanicals
ASEAN Harmonisation
IADSA’s Structure
Members
Annual
Meeting
Executive Council
Board
IADSA Office
Company Council
IADSA Approach
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World-leading expertise in science, technical and regulatory.
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Very low administrative base: 95% of energy and time goes
into global, regional and national programmes.
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Non-confrontational where possible
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Authorities need to see us as a “Partners”
PRIORITY REGIONAL &
NATIONAL PROGRAMMES
ASEAN
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
ASEAN Progress so far….
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Creation of the ASEAN Alliance of Health Supplement
Associations (AAHSA) in Spring 2006
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Seat at government table 2007
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Operation of Scientific Committee
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Lead on Maximum levels of vitamins and minerals
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Co-lead on claims, negative listing, stability and shelf-life…
Where do governments look?
1
Codex/WHO
2
EU
3
OTHER
MODELS
US
Where do governments look?
1
EU
2
3
US
OTHER
MODELS
Why Europe?
•
Multinational
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Non-compromising on consumer protection
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Very visible and vocal in Codex
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European Food Safety Authority
•
EU policy to export regulation worldwide.
EU: The three key issues
1.
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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 2011-12.
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.
Latin America
• Most problematic region
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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 American Progress
• Creation of a Latin American industry working group
• Four key events were organised last two years:
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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
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:
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Analysis of existing regulatory systems
Provision of ideal models
Expert workshop
Ongoing advice also through website