THE IHTA 2011THE IHTA 2011ANNUAL MEETINGANNUAL MEETING

Santry, DublinSantry, Dublin1818thth May 2011 May 2011

THE 800-POUND THE 800-POUND GORILLA IN THE GORILLA IN THE

ROOM…ROOM…

IHTA 2011 AGMIHTA 2011 AGM

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

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

WOT GORILLA?WOT GORILLA?::

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’

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:

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:

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:

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:

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:

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:

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:

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:

PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:

PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:

‘Effect of Dietary Supplements

on US Health Care Cost Reduction’

HEALTHCARE COST SAVINGS:HEALTHCARE COST SAVINGS:

PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:

PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:

September 2010:

ECONOMIC IMPACT:ECONOMIC IMPACT:

PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:

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:

PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:

Legal opinions

Complaint to EU Ombudsman?

LEGAL ARGUMENTS:LEGAL ARGUMENTS:

PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:

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::

THE DIFFERENCE-MAKER:THE DIFFERENCE-MAKER:

THE DIFFERENCE-MAKER:THE DIFFERENCE-MAKER:

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:

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::

POLITICAL LOBBYINGPOLITICAL LOBBYING::

PAN-EU NHCR CAMPAIGN:PAN-EU NHCR CAMPAIGN:

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:

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:

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:

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:

QUESTIONS?QUESTIONS?

IHTA 2011 AGMIHTA 2011 AGM