THE IHTA 2011 ANNUAL MEETING Santry, Dublin 18 th May 2011

THE 800-POUND GORILLA IN THE ROOM… IHTA 2011 AGM IHTA 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 26 th 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 30 th 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? :

‘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 13.1 Generic Article 13.5 Emerging Science Article 14 Childrens’ claims & Disease Risk Reduction 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 13.1 Generic Article 13.5 Emerging Science Article 14 Childrens’ claims & Disease Risk Reduction c. 5,000 claims submitted 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 13.1 Generic Article 13.5 Emerging Science Article 14 Childrens’ claims & Disease Risk Reduction c. 500 claims 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 13.1 Generic Article 13.5 Emerging Science Article 14 Childrens’ claims & Disease Risk Reduction c. 4,500 claims 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 13.1 Generic Article 13.5 Emerging Science Article 14 Childrens’ claims & Disease Risk Reduction 97% lost (‘other substances’) 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:

 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:

 A pan-European multi-faceted campaign focusing on science, and taking the scientific, economic and political arguments to the highest level ACTION: THE NHCR:

PAN-EU NHCR CAMPAIGN:

‘Effect of Dietary Supplements on US Health Care Cost Reduction’ HEALTHCARE COST SAVINGS:

PAN-EU NHCR CAMPAIGN:

September 2010:

ECONOMIC IMPACT:

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:

PAN-EU NHCR CAMPAIGN:

 Legal opinions  Complaint to EU Ombudsman? LEGAL ARGUMENTS:

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 LOBBYING :

THE DIFFERENCE-MAKER: THE DIFFERENCE-MAKER:

POLITICAL 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:  National technical experts  Other interested national government departments  PermReps of national governments  Members of national parliaments Member States:  Members of the European Parliament 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 targeted: EUROPEAN PARLIAMENT: 73 MEPS support; 6 unsupportive; 58 we don’t know yet POLITICAL LOBBYING :

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:

 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:  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… SUMMARY PAN-EU NHCR CAMPAIGN:

QUESTIONS? IHTA 2011 AGM IHTA 2011 AGM