the ihta 2011 annual meeting santry, dublin 18 th may 2011
TRANSCRIPT
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THE IHTA 2011THE IHTA 2011ANNUAL MEETINGANNUAL MEETING
Santry, DublinSantry, Dublin1818thth May 2011 May 2011
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THE 800-POUND THE 800-POUND GORILLA IN THE GORILLA IN THE
ROOM…ROOM…
IHTA 2011 AGMIHTA 2011 AGM
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An alliance of companies from within the food and nutrition
industry, including food supplement manufacturers, food
manufacturing companies and ingredient suppliers, concerned
about EFSA’s and the European Commission’s current application
of the Nutrition and Health Claims Regulation
The EHCA’s first priorities were:
• To stop the adoption of EFSA’s first tranche of Article 13.1 opinions at the SC meeting on April 26th 2010
• To stop the piecemeal adoption of the Community lists of ‘permitted’ and ‘prohibited’ health claims, pursuant to Article 13.3 of the Nutrition and Health Claims Regulation
Immediate actions:
• Prior to April SC meeting, a letter sent to the Commission President, signed by CEO’s/senior managers of over 400 EU-wide companies
• A major EU-wide Regulatory Impact Assessment to be commissioned, available Summer 2010
• A major international conference ‘In search of Solutions: A Stakeholder Dialogue on Article 13 Health Claims’, in Brussels, September 30th 2010
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An alliance of companies from within the food and nutrition
industry, including food supplement manufacturers, food
manufacturing companies and ingredient suppliers, concerned
about EFSA’s and the European Commission’s current application
of the Nutrition and Health Claims Regulation
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WOT GORILLA?WOT GORILLA?::
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WOT GORILLA?WOT GORILLA?::
‘An expression for a strong or powerful person or organisation. It is based on the idea that a gorilla is so mighty and powerful that it can do anything it wishes with complete disregard to everything and everyone around it’
‘One that is dominating or uncontrollable because of great size or power’
Or:
‘Something dangerous, menacing, or spooky that is obvious but not addressed’
‘To ignore a problem when everyone knows it's there, but pretends everything is OK’
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THE NUTRITION & HEALTH CLAIMS REGULATION (NHCR): In December 2006, after protracted negotiation, the EU adopted a Regulation
on the use of nutrition and health claims for foods. It lays down harmonised EU-wide rules for the use of such claims
The NHCR distinguishes between different categories of claim each with different processes of substantiation & evaluation:
For SMEs, the most important health claim category is for Article 13.1 generic health claims
Article 13.1Generic
Article 13.5Emerging Science
Article 14Childrens’ claims &Disease Risk Reduction
THE NHCR:THE NHCR:
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THE NUTRITION & HEALTH CLAIMS REGULATION (NHCR): In December 2006, after protracted negotiation, the EU adopted a Regulation
on the use of nutrition and health claims for foods. It lays down harmonised EU-wide rules for the use of such claims
The NHCR distinguishes between different categories of claim each with different processes of substantiation & evaluation:
For SMEs, the most important health claim category is for Article 13.1 generic health claims
Article 13.1Generic
Article 13.5Emerging Science
Article 14Childrens’ claims &Disease Risk Reduction
c. 5,000 claims submitted
THE NHCR:THE NHCR:
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THE NUTRITION & HEALTH CLAIMS REGULATION (NHCR): In December 2006, after protracted negotiation, the EU adopted a Regulation
on the use of nutrition and health claims for foods. It lays down harmonised EU-wide rules for the use of such claims
The NHCR distinguishes between different categories of claim each with different processes of substantiation & evaluation:
For SMEs, the most important health claim category is for Article 13.1 generic health claims
Article 13.1Generic
Article 13.5Emerging Science
Article 14Childrens’ claims &Disease Risk Reduction
c. 500 claims
THE NHCR:THE NHCR:
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THE NUTRITION & HEALTH CLAIMS REGULATION (NHCR): In December 2006, after protracted negotiation, the EU adopted a Regulation
on the use of nutrition and health claims for foods. It lays down harmonised EU-wide rules for the use of such claims
The NHCR distinguishes between different categories of claim each with different processes of substantiation & evaluation:
For SMEs, the most important health claim category is for Article 13.1 generic health claims
Article 13.1Generic
Article 13.5Emerging Science
Article 14Childrens’ claims &Disease Risk Reduction
c. 4,500claims
THE NHCR:THE NHCR:
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THE NUTRITION & HEALTH CLAIMS REGULATION (NHCR): In December 2006, after protracted negotiation, the EU adopted a Regulation
on the use of nutrition and health claims for foods. It lays down harmonised EU-wide rules for the use of such claims
The NHCR distinguishes between different categories of claim each with different processes of substantiation & evaluation:
For SMEs, the most important health claim category is for Article 13.1 generic health claims
Article 13.1Generic
Article 13.5Emerging Science
Article 14Childrens’ claims &Disease Risk Reduction
97% lost(‘other
substances’)
THE NHCR:THE NHCR:
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The market for Food Supplements is driven by claims
We already have robust regulation regarding use of unfounded & unsubstantiated claims
Science is being applied using an inappropriate pharmaceutical model
Worst-case scenario:
– Specific categories of Claims may be lost permanently (eg Joint Health, Probiotics, Botanicals, Antioxidants & Weight Management)
– Prohibition applies to all commercial communications
– Consumers vulnerable to claims from unregulated/less-regulated non-EU operators
GENERIC (i.e. ARTICLE 13.1) HEALTH CLAIMS:
THE NHCR:THE NHCR:
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An inappropriate and unforeseen pharmaceutical assessment model is being applied to generic health maintenance claims on food
Flexibilities suggested in the Terms of Reference are being ignored by EFSA
No timely guidance was provided on Article 13.1 claims thereby disadvantaging Small and Medium Enterprises
A strong level of unanimity within the scientific community that agrees that the EFSA model is inappropriate
PROBLEMS:
THE NHCR:THE NHCR:
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A pan-European multi-faceted campaign focusing on science, and taking the scientific, economic and political arguments to the highest level
ACTION:
THE NHCR:THE NHCR:
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PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:
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PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:
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‘Effect of Dietary Supplements
on US Health Care Cost Reduction’
HEALTHCARE COST SAVINGS:HEALTHCARE COST SAVINGS:
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PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:
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PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:
September 2010:
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ECONOMIC IMPACT:ECONOMIC IMPACT:
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PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:
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There is a surprising lack of systematic
research aimed at
evaluating to what
extent the ‘average consumer’
is able
to understand ‘qualified’ health
claims
In order to fill this gap a research project,
financed
jointly by the HFMA and CRN, is
being conducted by the University of
Reading, and which will attempt to gain valuable insights on
consumer understanding of nutrition and health claims
CONSUMER UNDERSTANDING:CONSUMER UNDERSTANDING:
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PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:
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Legal opinions
Complaint to EU Ombudsman?
LEGAL ARGUMENTS:LEGAL ARGUMENTS:
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PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:
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To bring increased political pressure on the Commission
To elevate the level of political discussion
To coordinate lobbying efforts across the Member States
POLITICAL LOBBYINGPOLITICAL LOBBYING::
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THE DIFFERENCE-MAKER:THE DIFFERENCE-MAKER:
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THE DIFFERENCE-MAKER:THE DIFFERENCE-MAKER:
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POLITICAL LOBBYINGPOLITICAL LOBBYING::
KEY POLITICAL PLAYERS AND TARGETS:
Commissioner for DG SANCO and his cabinet DG SANCO officials DG Enterprise and Industry (possibly Agriculture and Trade)
Commission:Commission:
National technical experts Other interested national government departments PermReps of national governments Members of national parliaments
Member States:Member States:
Members of the European Parliament
Commission:Commission:
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Chairs and Vice Chairs: influential amongst their peers
Political group coordinators: Coordinate members positions and advise on how to vote
MEPs with an interest in food related issues: willing to relay our concerns and be active in subject
Political advisors: permanent staff of political groups and advise MEPs in group
137 Key MEPs 137 Key MEPs targeted:targeted:
EUROPEAN PARLIAMENT:
73 MEPS support; 6 unsupportive; 58 we don’t know yet
POLITICAL LOBBYINGPOLITICAL LOBBYING::
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POLITICAL LOBBYINGPOLITICAL LOBBYING::
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PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:
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That there is additional appropriate science that EFSA is not taking into account when assessing Article 13.1 ‘generic’ health claim submissions
That there is a growing level of concern amongst eminent scientists in the field of human nutrition that their life’s work is not being considered or taken into account
That EFSA is being too rigid in its interpretation of the terms of reference laid down in the NHCR
To demonstrate to the Commission:
SCIENTIFIC CONSENSUS:SCIENTIFIC CONSENSUS:
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SCIENTIFIC CONSENSUS:SCIENTIFIC CONSENSUS:
Aim: To get consensus of academic experts on a more appropriate approach towards nutritional science as opposed to the approach by EFSA
Organisation: University of Hohenheim, 11 September 2009, 14 academic experts, moderated by Professor Hans Biesalski
Outcome: Consensus paper, ‘Scientific Substantiation of health claims: Evidence-based Nutrition’, to be published in the July 2011 edition of ‘Nutrition’
The 26th Hohenheim Consensus Conference:
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SCIENTIFIC CONSENSUS:SCIENTIFIC CONSENSUS:
Findings: to be presented to EFSA, the Commission, press and interested parties
3 further Consensus Workshops: all in 2011, each covering individual substances/conditions, and each exposing specific weaknesses in EFSA’s approach
Concluding scientific event: in Berlin, December 2011
Moving forward:
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An unprecedented level of activity
There is no complacency
EHCA needs more support, members and funding!
This particular gorilla is not being ignored…
SUMMARYSUMMARY
PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:
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QUESTIONS?QUESTIONS?
IHTA 2011 AGMIHTA 2011 AGM