Transcript IADSA Core Presentation

IADSA
The global Alliance
An introductory presentation
for industry groups
2009
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.
21 member associations growing to 54 today, with companies
representing more than 70% of the global USD 65bn 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 Structure
Codex
Alimentarius
Commission
Executive
Committee
Commodity
Committees
Secretariat
Horizontal
Committees
Regional
Committees
Contaminants
Asia
Additives
Africa
Labelling
Europe
Milk Products
Nutrition &
Foods for
Special Dietary
Uses
180 Member
Countries + EU
N. Am & SWP
Latin America
Codex Impact
Member
Countries
European
Union
NAFTA
Codex
Impact
ASEAN
MERCOSUR
Scientific Programme
Role/Benefits
Safety
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
Codex Guidelines
for Vitamin and
Mineral Food
Supplements
FAO/WHO Model for
Establishing Upper
Levels of Intake for
Nutrients and Related
Substances
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
Codex Programme 2009
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.
Monitor discussions on GMO labelling and on the list of
nutrients, potential mandatory labelling and
legibility/readability of labels.
CAC
Commission
Adoption of Nutrient Risk Analysis Principles &
Recommendations on the Scientific Substantiation of
Health Claims.
CCNFSDU
Nutrition
Monitor and provide input to Nutrient Reference Values and
Addition of Essential Nutrients to Foods.
Codex Additives
Allura Red AC
Annatto extracts, bixin-based
Annatto norbixin-based
Caramel Colour class III
Caramel Colour class IV
Carotenoids
Chlorophylls
Erythrosine
Fast Green FCF
Grape Skin Extracts
Indigotine
Iron Oxides
Lycopene
LEVEL (mg/kg)
300
60
100
20000
20000
300
500
300
600
500
300
7500
50000
LEVEL (mg/kg)
Aspartame-Acesulfame Salt
200
Aluminium silicate
Calcium aluminium silicate
Sodium aluminosilicate
GMP
GMP
GMP
Codex Commission
Basis for Setting
Maximum Levels of
Vitamins & Minerals
Nutrient
Risk
Analysis
Principles
FAO/WHO Nutrient
Risk Assessment
Report
Shared by 2004 IADSA
Safety Report
Codex Commission
Word “clinical”
deleted: human
intervention studies
Health
Claims
Substantiat
ion
Observational/
epidemiological
studies: totality of the
evidence
Authoritative
statements:
history of use
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
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
Overview of legislative activity
CODEX
GUIDELINES ON
VITAMINS AND MINS
CLAIMS / CLAIM
SUBSTANTIATION
WHO/FAO
RISK ASSESSMENT
VITS & MINS
TRADITIONAL
MEDICINES STRATEGY
NUTRITION STRATEGY
MONOGRAPHS &
QUALITY
PRIORITY NATIONAL/
REGIONAL ISSUES
ASEAN
EU
RISK ANALYSIS
LATIN AMERICA
ADDITIVES
CHINA
CONTAMINANTS
USE OF OTHER
INGREDIENTS
GINSENG
DIETARY
SUPPLEMENTS
MEXICO
JAPAN
INDIA
RUSSIA
NRV
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 registration
EU: Max Levels, botanicals
& claims
Japan: New Regulations
China: New
regulations:
registration, claims
SE Europe: New
regulation
India: new regulations
Latin America:
RDAs & Safety
Botanicals
Distribution
ASEAN Harmonisation: max
levels, botanicals, claims,
GMPs…
IADSA’s Structure
MEMBERS
Annual
Meeting
Executive Council
Board
Secretariat
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…
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Request to IADSA to advice on framing the legislation.
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
Non-compromising on consumer protection
Very visible and vocal in Codex
European Food Safety Authority
EU policy to export regulation worldwide.
EU: The three key issues
1.
Maximum Levels of vitamins and minerals
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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.
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.
• Operating the regional information gathering, communication,
education programme around four key events at present:
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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.
Russia
• Four key barriers to market:
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Registration time
Claims limitations
Testing requirements
Restrictions on distribution.
• Built a plan for change:
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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.
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.
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:
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Analysis of existing regulatory systems
Provision of ideal models
Expert workshop
Ongoing advice - also through website.