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Albert Flynn University College Cork

Regulation on Nutrition & Health Claims: Scientific substantiation of claims and nutrient profiles. Albert Flynn University College Cork. Outline. Regulation on Nutrition and Health Claims EFSA’s scientific advice on nutrition and health claims Scientific substantiation of claims

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Albert Flynn University College Cork

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  1. Regulation on Nutrition & Health Claims: Scientific substantiation of claims and nutrient profiles Albert Flynn University College Cork

  2. Outline • Regulation on Nutrition and Health Claims • EFSA’s scientific advice on nutrition and health claims • Scientific substantiation of claims • Nutrient profiles • Conclusions

  3. Regulation on Nutrition & Health Claims • Regulation adopted by co-decision in October 2006 • Entry into force Jan 2007 • Implementation • Interpretation by EC [Regulatory Committee, EP, EFSA] • Application by industry • Enforcement by Member States • Evaluation (2013)

  4. Regulation - purpose • To help consumer in choosing a healthy diet • Communicate health benefits of foods to consumer • Accurate - independent scientific substantiation • Not misleading - overall nutritional quality of a food • Understandable • Incentive to industry to innovate • Improved choice of healthy foods for consumers • Other objectives - internal market, fair competition, legal security for economic operators

  5. Classification of claims • Nutrition claims • Nutrient content, ‘high fibre’, ‘low fat’, ‘reduced salt’, ‘light’ • Health claims • Function claims • ‘calcium helps maintain strong bones’ • based on generally accepted scientific evidence • based on newly developed scientific data/proprietary data • Reduction of disease risk claims • ‘substance A reduces blood cholesterol which may reduce the risk of heart disease’ • Claims for development and health of children • scope to be defined • Borderline claims? • contains antioxidants, probiotics? • Reduces cholesterol, blood pressure?

  6. Health Claims - key principles • Promote nutrition policy goals and help consumer in choosing a healthy diet • Scientifically substantiated - independently [EFSA] • Understood by the average consumer • Not mislead the consumer • Accompanied by nutrition labelling • Made for a food as part of a total dietary pattern • Apply to the amount of food normally consumed and the food as ready for consumption

  7. EFSA scientific advice on claims - scope • Scientific substantiation of claims • Evaluation of claims subject to authorization procedure (2007) • Reduction of disease risk claims • Claims for development and health of children • Function claims based on newly developed scientific data/ proprietary data • Guidance on preparation and presentation of applications subject to authorization procedure (2007) • Evaluation of function claims based on generally accepted scientific evidence (2008-9) • Community list of permitted claims • Other • Amendments to Annex (nutrition claims), if appropriate • Nutrient profiles • Scientific advice to EC on establishing and testing (2007)

  8. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Mandate • Scientific advice on dietetic products, human nutrition, food allergy, novel foods, nutrition and health claims Composition • 17 members; Chair (Prof. A. Flynn); Vice-chairs (Prof. H. Przyrembel; Prof. A. Palou) • Expertise: human nutrition, child nutrition, allergy, toxicology, intake assessment, biochemistry, epidemiology, microbiology, food chemistry www.efsa.europa.eu

  9. NDA Panel procedures for claims • NDA Panel • Adopts scientific opinions • All opinions published - EFSA Journal • NDA WG Claims: • Prepares draft scientific opinions • 11 Panel members currently • Additional independent experts will be added as needed • Evaluation of claims in specific areas • EFSA staff • Support work of Panel and WG

  10. EFSA Conference on Nutrition & Health ClaimsBologna, Italy, 8-10 November 2006 • 200 participants from 21 European countries, Australia, NZ, USA, Canada • Government agencies, consumer organisations, industry, Academia, EC, EP, EFSA • To explain EFSA’s scientific role in the new Regulation • To exchange views, experience, to discuss issues: • Scientific substantiation • Nutrient profiles • Outcome • To be used by NDA Panel for preparing scientific advice

  11. Approval of reduction of disease risk claims • Application submitted through MS to EFSA • EC/EFSA guidance on preparation and presentation • EFSA evaluation - opinion (5 months) • additional time if supplementary information needed • Community authorisation (2 months) • EC adopts decision through Regulatory Committee • Decision is notified to applicant and published in OJ • similar procedure for child health and development claims & function claims based on newly developed scientific evidence/ proprietary data protection

  12. EFSA opinion • verify • that the proposed wording of the health claim is substantiated by scientific data • complies with the criteria laid down in this Regulation; • include a proposal for the wording of the health claim, including, as the case may be, the specific conditions of use

  13. Scientific substantiation of health claims • Food business responsible for justifying claim • EFSA evaluation • EC + EFSA to provide detailed guidance on preparation and presentation of applications subject to authorization procedure • EFSA has given this highest priority - draft in preparation • Consultation with stakeholders on draft guidance (2007)

  14. What level/type of scientific evidence is required to substantiate a claim? • Regulation - substantiation based on • ‘Generally accepted scientific evidence’ • ‘Take into account the totality of available scientific data’ and ‘by weighing the evidence’ • EFSA guidance • Previous activities • Swedish Nutrition Foundation (1990, 1997, 2001) • Netherlands Ministry of Health (1998, 2004) • US FDA, CFSAN (1999, 2003) • UK JHCI (2002) • ILSI Europe PASSCLAIM (2001-2005)

  15. Evaluating scientific evidence(EFSA Conference, Bologna, 2006) • Transparent process for evaluating evidence • Hierarchy of evidence • Importance of human studies • Totality of evidence - multiple types/sources of evidence • Weighing of evidence • Allow for a case by case approach • Conference outcome • To NDA Panel for establishing a process for evaluating claims and preparing guidance to industry

  16. Data protection • Scientific data and other information submitted for substantiation of a health claim designated as proprietary by the original applicant are protected for a period of 5 years

  17. Health claims not allowed • Claims which suggest that health could be affected by not consuming the food • Claims which make a reference to the rate or amount of weight loss • Claims which make a reference to recommendations of individual doctors • Vague claims for health benefits of food (component)

  18. Foods that may not carry health claims • Beverages containing >1.2% by volume of alcohol • Foods (categories) with inappropriate nutrient profiles • to ensure consumer is not misled by unbalanced information on overall nutritional quality of a food • How to develop & apply nutrient profiles?

  19. Nutrient profiles - Regulation • Based on generally accepted scientific knowledge on the relationship between diet and health • Should take into account: • Nutrient content of a food (e.g. fat, saturated fat, trans fatty acids, sugar, salt + others with an effect on health) • Variability of dietary habits and traditions • Role, importance and dietary contribution of a food in the context of the overall diet • Product innovation

  20. Setting nutrient profiles • Will be set by the EC + Regulatory Committee • EFSA scientific advice • Consultation with industry, consumer groups • Co-ordination by EC + MS (+ EFSA) ongoing • Process for establishing profiles • Frame request to EFSA for scientific advice

  21. Nutrient profiles - EFSA role In setting the nutrient profiles, the Commission shall request EFSA to provide, within 12 months, relevant scientific advice, focusing on: • Profiles for food in general and/or food categories • Choice and balance of nutrients • Reference quantity/basis • Approach to calculation of profiles • Feasibility and testing of a proposed system

  22. Nutrient profiles - scientific aspects(EFSA Conference, Bologna, 2006) • General concept of nutrient profiles • Review of existing scientific approaches • Europe - UK, Sweden, NL • USA • Australia/NZ • Science-based validation of nutrient profiles • Consumers perspective • Industry perspective • Outcome • To NDA Panel for preparing scientific advice to EC

  23. Conclusions (1) • Regulation on Nutrition and Health Claims • Key aim - to help consumer in choosing a healthy diet • EFSA role - independent scientific advice • Claims - accurate, understandable, not misleading • Guidance to industry on preparation of claims applications (with EC) • Highest priority • Draft guidance for consultation with stakeholders in 2007 • Evaluation of claims applications subject to authorization (2007- ) • Evaluation of Community list of function claims (2008-9)

  24. Conclusions (2) Nutrient profiles • To be established by EC + MS (Jan 2009) • EFSA - scientific advice • EFSA committed to a transparent, consultative process • Ensure that consumers and industry have confidence in nutrition and health claims on foods

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