Meeting the EU’s Nutrition and Health Goals: A Business Perspective

1. Meeting the EU’s Nutrition and Health Goals: A Business Perspective Bas van Buijtenen DSM Nutritional Products ELC Symposium 21 November 2012, Brussels

2. Topics The contributionofFortificationand Supplementation The regulatoryframework An outlook

3. normal osteoporotic Example Vitamin D: In many ways an essential nutrient • Classical role of vitamin D: bone health • Improves bone mineral density through calcium • absorption and deposition • Necessary to prevent rickets & osteomalacia • Emerging health benefits of vitamin D • Muscle: - Reduces risk of falling by • improving muscle strengths • Immunity: - Strengthens the immune system • - Reduces risk of multiple • sclerosis and diabetes type II • Cardiovascular: - Lowers blood pressure • Cancer: - Inhibits cell proliferation

4. Adequacy of Vitamin D intake depends on sunshineand the diet • ...influenced by various • determinants • Sunshine exposure • Latitude > 37 / Season • Ethnicity (skin pigmentation) • Aging • Weather & air pollution • Sunlight expossure • Sunscreen use (>SPF 8) • Obesity • ...further factors • Degree of clothing (veiling) • Increase in urbanization • Lifestyle (limited outdoor activity) • Main source: • Sunlight (UVB 290–315 nm) induces vitamin D production in skin (80 – 90%) • Minor source: • Food intake of vitamin D is scarce (10 -20%) (mainly fatty fish) • Alternative source: • Fortification and supplements

5. Worldmap Latitudes

6. Most of us do not get enough of it… Vitamin D status in adults (> 18 years) around the world

7. The cost of Vitamin D deficiency to society is sizeable (example Germany) Net socio-economic benefit ranges from* : 585 mio € Including medical and therapeutic costs for prevention, treatment and supplementation costs vitamin D up to778 mio € Including societal perspective, e.g. family care, reha costs • Hip and vertebral fractures have the most „cost-intense“ medical • implications • Number osteoporosis patients: 8-10 mio (2010)* • Number of hip and vertebral fractures p.a.: 150.000* • Optimized vitamin-D status reduces number of fractures by 20 % • Reduction of 5.478 hip fractures and 18.420 less vertebral fractures • (in osteoporosis-diagnosed population) 6 Source: * Sproll 2011

8. This cost / benefit increases steeply if you consider additional health indicators Risk reduction by optimal vitamin status: Bone fractures 20 % Cardio Vascular Diseases 20 % Multiple Sclerosis 50% Diabetes 25% Cancer and others 25 % Source: Grant et al 2009

9. Large health care cost savings could be achieved with adequate vitamin D status Adequate levels can be achieved with voluntary food fortification and/or supplementation for risk groups with costs of only 20-30 EUR/person per year Source: vitamin D and socioeconomic costs, T. Sproll

10. Another example: Folic Acidessential for growth and development • Rich food sources are • Liver, dark green leafy vegetables, beans, wheat germ and yeast • Other sources are egg yolk, fortified foods e.g. fortified cereals, beets, orange juice, milk and dairy products (Souci, Fachmann, Kraut; whittaker 2001)

11. Folic acid status is directly related to the incidence of birth defect Neural Tube Defects (NTDs) Congenital malformations that result from failure of the neural tube to close during embryogenesis Occur between twenty-two and twenty-eight days after conception, before most women know they are even pregnant Estimated incidence of > 300 000 new cases each year Neural-tube defects, the main adverse health outcome of folate deficiency, are characterized by malformations of the spine (such as spina bifida), skull or brain (eg. anencephaly; encephalocele), and are considered to be the most common congenital malformations in the world www.genetics.edu.au/ images/factsheets Obicˇan, et al; FASEB J. 24, 4167–4174 (2010) Badovinas RL, Birth Defects Res Clin Mol Teratol, Vol 79, No 1, pp 8-15 (2007).

12. Because dietary intake is generally insufficient, many countries have introduced fortification programs Source: Flour Fortification Initiative. Map of global progess. Available at http://www.sph.emory.edu/wheatflour/globalmap.php The figure above shows countries with regulations for fortification of wheat flour with folic acid, by program status, worldwide as of June 2010. A total of 53 countries had regulations for mandatory fortification of wheat flour with folic acid, although many of these programs had not been fully implemented, and the existence of regulations did not imply compliance.

13. In Europe, no progress towards the prevention of NTD’s in the last decadeThe consequences are financial and ethical • Since the 1980s periconceptional folic acid supplementation is a well known instrument for primary prevention of NTDs • No progress in Europe towards the prevention of NTDs over the last decade The total prevalence of NTDs in Europe, between 2004 and 2008, was 0.96 per 1,000 births The LB prevalence in Europe, between 2004 and 2008, was 0.24 per 1,000 births 72% of these pregnancies were terminated following PND Rhonda Curran et al., Presented in Brussels 2011 www.eurocat-network.eu

14. Deficiencies are everywhere. Also in the EU.Without fortification / supplementation they would be even bigger Germany United States United Kingdom The Netherlands Troesch et al BJN 2012

15. …and there remains a huge untapped potential that innovation will uncover Understanding the influence of genetics

16. Topics The contributionofFortificationand Supplementation The regulatoryframework An outlook

17. Prerequisites for a strong and innovative food ingredients sector • Predictability through clarity • Speed in decision making • Ability to differentiate • A level playing field • Reasonable effort & cost of compliance • An opportunity to make a reasonable return on investment

18. + Δ The EU regulatory framework:Opportunities and Challenges • Burdens on innovation: time and money • Complexity • Does enforcement create a level playing field? • „information“ or warning? • Health claims and novel food • Harmonisation: one large common market • Safety for consumers well safeguarded • Less misleading advertising • Improved information and labelling

19. The regulatory framework influences ‘time-to-safety’ and ‘time-to-claim’ = time to marketFood ingredients do not offer ‘pharma’ returns. Extra efforts strongly influence the business case for innovation investment € mln Saturation, “Winners” • Product Pull • Awareness development • Fulfillment and market development “Take-off” Launch Turnover (ingredient sales) • Meets value proposition criteria • Solid business case • Available for sales in pilot markets • Product Push • Awareness creation • Market creation • Justified existence • Ready for adoption by large CPG • Proof of sustainability • Solid business case • Global roll out Opportunity Development Early adoption Market capturing Time Feasibility Up-Scaling 4-6 year – € 5-8 mln 4 year – € 4-8 mln 6 year – € 3-6 mln

20. SME’s can least afford big upfront investmentBut they are the biggest engine for market innovation Established Natural flow of business “Take-off” Market capturing Regional B companies, and dietary suppl. marketers Global A companies, dietary suppl. first, then global food & beverage high Consumer awareness Science proof Early adoption No sustainable examples low Launch Small local B&C companies, dietary suppl. marketers New Small companies Large CPG companies high low Willingness to take risk

21. “The highest standard of scientific evaluation”The EFSA interpretation of the regulation pushes out time to market and increases requirements for innovation investment.

22. Labeling requirements can negate investment in safety assessment 21

23. 5 versions of this product labeling were tested to measure risk perception of consumers Siegrist & Keller, 2011 22 Prof. Dr. Michael Siegrist – Institute for Environmental Decisions (IED)

24. Even a „neutral“ nano label increased risk perception, by as much as a formal warning Siegrist & Keller, 2011 23 Prof. Dr. Michael Siegrist – Institute for Environmental Decisions (IED)

25. Topics The contributionofFortificationand Supplementation The regulatoryframework An outlook

26. Quo Vadis Europa? How will we make Europeans healthier if we do not incentivise private sector scientific advances?

27. Ingredient supplier Raw mats Consumer Scenario 1: marketeersfocuse on products with a healthy image. Backed on science? Supplement Marketer Toller Food Marketer Base producer “Healthy” foodstuffs: Green tea, (Super)fruits, Fish oil, Vegetables, Gingko, Ginseng

28. Ingredient supplier Raw mats Consumer Public money Scenario 2: public spending takes the place of private sector investment. At the same cost benefit to society? Supplement Marketer Toller Food Marketer Base producer

29. Scenario 3: companies – and talented individuals – move innovation to other parts of the world Health benefits become available to European consumers long after consumers in other parts of the world?

30. Our vision for Europe • Europe embraces fortification and supplementation as essential components in a healthy lifestyle • Europe has clear regulations, where stakeholders, large or small, understand the requirements, and can take their innovation decisions accordingly • European procedures have well defined timelines, that do not include administrative delays, but focus on content • Europe enforces legislation uniformly, creating a level playing field throughout the union • European health claims legislation integrates the concept of proportionality, and allows a path to market for ‘probable’ innovations • European labellingprovides information as well as warnings, but never confuses the two • Europe has a world class, innovative and strong food (ingredients) sector