henk aalten - specialty food ingredients · 3 what are specialty food ingredients? specialty food...
TRANSCRIPT
Bringing a novel food ingredient to market: Today’s challenges, tomorrow’s perspectives
Henk Aalten DSM Nutritional Products
Informa Life Sciences' Inaugural Conference on Food Ingredients Regulations, Barcelona, September 2014
The opportunity for speciality food ingredients
Today’s challenges
Tomorrow’s perspectives
Bringing a novel food ingredient to market: Today’s challenges, tomorrow’s perspectives
3
What are specialty food ingredients?
Specialty food ingredients typically preserve, texture, emulsify, colour and improve the nutritional profile and the physiolgical properties of processed food.
Specialty Food
Ingredients
Specific fats,
omega 3
Fibres
Specific proteins
Vitamins
Additives
Cultures
Minerals
Enzymes
4
Staple Ingredients
flour, starch, rice, sugar, oils, coffee, cocoa, meat, milk, eggs etc.
…tasty, pleasant to eat, safe, healthy,
affordable
Informed choice
Safe and healthy diet
The importance of specialty food ingredients in the food chain.
Farmers, Traders
Primary Food Processors
Food Industry Retailers Consumers
enable
Specialty food ingredients have technological and/or functional benefits. They are essential in providing today’s consumer with a wide range of tasty,
safe, healthy, affordable, qualitative and sustainably produced foods.
Specialty Food Ingredients Industries
5
R&D investments
3-8%
90,000 employees
An industry contributing over
€ 40 billion
the annual turnover of EU food and drinks industry
… 200 international and national specialty food ingredients
companies
The ELC at a glance
40 members,
representing more than…
€ 1 trillion Annual turnover EU food
and drinks industry Specialty Food Ingredients
are present in almost all processed foodstuffs, thus contributing to the competitiveness of the European
food and drink industry, the largest manufacturing sector in the EU in
terms of annual turnover
* < 250 employees and TO < € 50 m.
These are guesstimates 2013, based on internal data gathering amongst our diverse membership (CEFIC is a member of ELC but is excluded from calculations due to unclear representation of industrial chemicals vs specialty food ingredients).
About
22% SMEs*
Quo Vadis Europa?
Opportunity: To make Europeans healthier by promoting private sector scientific advances?
Prerequisites for an innovative food industry
To support an innovative food industry, the regulatory environment should provide:
Speed in decision making
Reasonable effort & cost of compliance
An opportunity to make a reasonable return on investment
Ability to differentiate
A level playing field
PREDICTABILITY THROUGH CLARITY
4 year – € 4-8 mln
Nurturing the opportunity Food ingredients do not offer ‘pharma’ returns. The right incentives have to be in place for ingredient innovation.
Feasibility
Opportunity Development
Up-Scaling
Lau
nc
h
“Take
-off”
Tu
rno
ve
r (in
gre
die
nt 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
,
“Winners”
Market capturing
The opportunity
Today’s challenges
Tomorrow’s perspectives
Which type of novel ingredients have made it?
Innovation: The limited number of NF approvals
0
2
4
6
8
10
12
14
2000-03 2004-05 2006-07 2008-09 2010-11 2012-13
Traditional food
Proteins
Phytosterols
Other substances with nut/physiologicalfuntions
Glucids/sugar substitutes
Lipids
Others
Dietary fibre
The long road to the EU market…
How long does the process last? Are things improving?
Novel ingredient
Commission Decision
MS
EFSA
Comitology
Commission 2008:
Ave. timings
205 days
310 days
434 days
Total 1191 days
Circulation/MS comment 104 days
2010 Ave timings: 1441 days total
2011 Ave timings: 1242 days total
2012 Ave timings: 1292 days total
Lead company (that seeks authorisation)
Followers (using notifications)
IRR with no data protection/exclusive use
16%-17% 18%-21%
IRR with exclusive use for 3 years
18%-18.5% 12%-14%
The limited returns…
Assumptions: basis as earlier examples, exclusive use - sales assumed for 2ndary entrant in first 3 yrs awarded to lead company. 2ndary entrant then builds to 40% mkt share after 4 yrs entry (9 yrs after original authorisation);
Source: Brookes, 2007
Substantial equivalence notifications reduce incentives to innovate.
The opportunity
Today’s challenges
Tomorrow’s perspectives
1. Legal certainty: what is a NF?
Concerns for ingredient manufacturers about the scope of the new NF regulation.
Not hitherto (May 1997) consumed to a significant degree
New primary molecular structure
Ingredients from microorganisms, fungi
or algae
Ingredients isolated from plants, and food
ingredients
Ingredients with new production process
AND
Nanomaterials
Ingredients with new production process
Food subject to non-traditional breeding techniques
Traditional food
Ingredients used in food supplements destined for other
foods
NFX
Today
All non-novel ingredients legally entering market since 1997 could be challenged as novel foods
X = New (post 97) Ingredient produced through new production process not significantly changing food structure and affecting nutrition, metabolism/safety
X
Not hitherto (May 1997) consumed to a significant degree
New NFR Proposal
INCLUDING
2. Efficient procedures with predictability for business decisions?
Novel ingredient
Commission decision
Commission
EFSA
Comitology
New NFR proposal
150 days
270 days
270 days
Total 690 days
?
… but how can this relate to health claims?
Health claim on NF ingredient
EFSA
Commission
Comitology
Commission decision
150 days
60 days
180 days
Total 390 days
Today 1191 days
3. Adequate incentives for pursuing innovation?
Under new NFR framework, authorisations will be generic raising questions for manufacturers:
1. Can ingredients receive legal protection (e.g. patents) preventing immediate
entry to market by competitors?
2. Can data protection provisions work in way which will provide some incentive to be first to market?
3. Under Health Claims Regulation, no protection available to research that is the property of companies if in the public domain. Can NFR foresee a new approach?
Conclusion: A brighter future?
1. Need for greater speed & efficiency.
2. Centralised authorisation could help.
3. Opportunity to bring legal clarity to what is and what is not Novel Food…
4. Ensure a common interpretation across EU 28.
1. New categories of NF and new definitions will bring new legal problems.
2. Data protection provisions will not compensate for generic authorisations and fail to boost innovation.
3. Few guarantees that new procedures will bring real gains in efficiency.