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

Bas van BuijtenenDSM Nutritional Products

ELC Symposium21 November 2012, Brussels

Topics

The contribution of Fortification and Supplementation

The regulatory framework

An outlook

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 &

osteomalaciaEmerging 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

osteoporotic

normal

Adequacy of Vitamin D intake depends on sunshineand the diet

• 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)

...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)

• Alternative source: Fortification and

supplements

Worldmap Latitudes

Most of us do not get enough of it…

Vitamin D status in adults (> 18 years) around the world

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 to 778 mio €Including societal perspective, e.g. family care, reha costs

7 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)

Source: * Sproll 2011

This cost / benefit increases steeply if you consider additional health indicators

Bone fractures20 %

Cardio Vascular Diseases20 %

Multiple Sclerosis50%

Diabetes

25%

Cancer and others25 %

Source: Grant et al 2009

Risk reduction by optimal vitamin status:

Large health care cost savings could be achieved with adequate vitamin D status

Source: vitamin D and socioeconomic costs, T. Sproll

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

Zittermann 2010

Germany: € 37,5 bn/y overall perspective,including direct and indirect costs and implications

Grant et al 2009

17 countries in Europe: € 187 bn/y direct and indirect cost savings (= 16,7 % of total health care costs)

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

Food Folate (μg/100 g)

Beef liver 592

Peanuts 169

Spinach 145

Broccoli 114

Asparagus 108

Egg 67

Strawberries 43

Orange juice (freshly squeezed)

41

Wheat cereal (fortified) 200 - 400

Milk (whole) 6.7(Souci, Fachmann, Kraut; whittaker 2001)

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).

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.phpThe 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.

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 2011www.eurocat-network.eu

Germany

The Netherlands

United States

United Kingdom

Troesch et al BJN 2012

Deficiencies are everywhere. Also in the EU.Without fortification / supplementation they would be even

bigger

…and there remains a huge untapped potential that innovation will uncover

Understanding the influence of genetics

Topics

The contribution of Fortification and Supplementation

The regulatory framework

An outlook

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

The EU regulatory framework:Opportunities and Challenges

+ Harmonisation: one large common market

+ Safety for consumers well safeguarded

+ Less misleading advertising+ Improved information and

labelling

+∆ Burdens on innovation: time

and money∆ Complexity∆ Does enforcement create a

level playing field?∆ „information“ or warning?∆ Health claims and novel food

Δ

4 year – € 4-8 mln

The regulatory framework influences ‘time-to-safety’ and ‘time-to-claim’ = time to market

Food ingredients do not offer ‘pharma’ returns. Extra efforts strongly influence the business case for innovation investment

Feasibility

Opportunity Development

Up-Scaling

La

un

ch

“Ta

ke

-off

”

Turn

over

(in

gre

dien

t sa

les)

Time

4-6 year – € 5-8 mln 6 year – € 3-6 mln

Early adoption

• Product Push• Awareness

creation• Market creation

• Product Pull• Awareness

development• Fulfillment and

market development

• Meets value proposition criteria

• Solid business case

• Available for sales in pilot markets

• Justified existence• Ready for adoption

by large CPG• Proof of sustainability• Solid business case• Global roll out

€ mln

Sa

tura

tio

n,

“Win

ne

rs”

Market capturing

high

low

lowhigh

SME’s can least afford big upfront investmentBut they are the biggest engine for market innovation

Willingness to take risk

Consumer awareness

Science proof

New

Established

Small companies Large CPG companies

No sustainabl

e examples

Regional B companies, and dietary suppl. marketers

Global A companies, dietary suppl. first, then global food & beverage

Small local B&C companies, dietary suppl. marketers

Ea

rly

ad

op

tio

n

Market capturing

Launch

“Ta

ke

-off

”

Natural flow of business

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

5 versions of this product labeling were tested to measure risk perception of consumers

23Prof. Dr. Michael Siegrist – Institute for Environmental Decisions (IED)

Condition Label Additional text in the questionnaire

1 No No text

2 Yes No text

3 Yes This product contains synthetic nanoparticles and is therefore labeled

4 YesOverall risk information of free nanoparticles (e.g., sprays) and nanoparticles in a matrix (e.g., nano sunscreen)

5 Yes Risk information about nanoparticles in a matrix (e.g., nano sunscreen)

6 Yes Information about the benefits of sunscreen

Siegrist & Keller, 2011

Even a „neutral“ nano label increased risk perception, by as much as a formal warning

24Prof. Dr. Michael Siegrist – Institute for Environmental Decisions (IED)

Condition Risk perception

No label2.76 (SD = 1.30)

n = 237

Label3.27 (SD = 1.42)

n = 224

Label and reference3.32 (SD = 1.45)

n = 222

Label and general risk information

3.19 (SD = 1.36)n = 229

Label and risk information related to a matrix

3.32 (SD = 1.44)n = 210

Label and benefit information

3.10 (SD = 1.38)n = 236

Siegrist & Keller, 2011

Topics

The contribution of Fortification and Supplementation

The regulatory framework

An outlook

Quo Vadis Europa?

How will we make Europeans healthier if we do not incentivise private sector scientific advances?

Scenario 1: marketeers focuse on products with a healthy image. Backed on science?

Supplement Marketer

“Healthy” foodstuffs:Green tea, (Super)fruits, Fish oil,

Vegetables, Gingko, Ginseng

Toller

Raw mats Ingredient supplier

Food Marketer

Consumer

Base producer

Scenario 2: public spending takes the place of private sector investment. At the same cost benefit to society?

Supplement MarketerToller

Raw mats Ingredient supplier

Food Marketer

Consumer

Base producer

Public money

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?

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 labelling provides information as well as warnings, but never confuses the two

• Europe has a world class, innovative and strong food (ingredients) sector