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The impact of the health claims regulation
on the food industry and future
innovation potentialApril 7, 2016
Katia Merten-Lentz, PartnerKeller and Heckman LLP
Brussels Office
+32 (0) 2.645.5073
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OVERVIEW
Nutrition and Health Claims Regulation• Experiences
• Fundamentals
• Pitfalls
• REFIT evaluation
Opportunities• Innovation Potential
• Key to success
• Legal viability
• Claims as a marketing tool
Conclusion
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Nutrition and Health Claims Regulation
Regulation (EC) No 1924/2006 of the European
Parliament and the Council of 20 December 2006 on
nutrition and health claims made on foods
Experience of 10 years• Protection of substantiated claims
• Unauthorized claims
• Absence of nutrient profiles
• Re-evaluation on its way (REFIT)
• Opportunities
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NHCR - definitions
‘claim’ means any message or representation, which is notmandatory under Community or national legislation, includingpictorial, graphic or symbolic representation, in any form,which states, suggests or implies that a food has particularcharacteristics;
‘nutrition claim’ means any claim which states, suggests orimplies that a food has particular beneficial nutritionalproperties due to the energy (calorific value) the nutrients orother substances
‘health claim’ means any claim that states, suggests orimplies that a relationship exists between a food category, afood or one of its constituents and health;
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NHCR – types of claims
Nutrition claims listed in Annex
Health claims
Art. 13 (1) health claims:
• ‘generally accepted evidence’
• Regulation 432/2012
Art. 13 (5) health claims:
• ‘recently generated scientific evidence’
Calcium is needed for the
maintenance of normal teeth
Sugar beet fibre contributes to
an increase in faecal bulk
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NHCR - types of claims
Art. 14 claims
• “reduction of disease health claims”
• Focus on risk factor
• “children’s development and health”
Data should relate to children
Plant sterols and plant sterol esters have been shown to lower
blood cholesterol. High cholesterol is a risk factor in the
development of coronary heart disease.
Iron contributes to normal cognitive development of children
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NHCR – authorization procedure
Relevant institutions
• Member State authority
• Commission
• EFSA – NDA Panel
Risk Managers
Risk Assessor
Authorisation; wording and conditions of use
Based on EFSA assessment, consumer
understanding or other legitimate factors
Scientific assessment to the ‘highest possible
standard’
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NHCR – general principles
Article 3: the use of claims shall not:– be false, ambiguous or misleading
– give rise to doubt on safety/ nutritional adequacy with other foods
– Encourage/condone excess consumption of a food
– Suggest a balanced and varied diet cannot provide adequate quantities of nutrients
– Refer to changes in bodily functions which could give rise to or exploit fear in the consumers
Article 5: general conditions– Proven beneficial effect
– Present in significant quantity – reduced quantity that will produce claimed effect
– In readily available form
– Product quantity provides significant quantity of the compound
– The average consumer can be expected to understand the beneficial effect as expressed
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NHCR – nutrient Profiles
Article 4: “…nutrient profiles and the conditions,
including exemptions, which shall be respected for
the use of nutrition and health claims on foods
and/or categories of foods.”
• Fundamental restriction on the use of claims
• But currently no NPs in place
• Uncertainty about introduction, application, consequences
for new-existing claims
Creating legal uncertainty for innovative food producers
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NHCR – general principles
Article 6: scientific substantiation
1. Nutrition and health claims shall be based on and
substantiated by generally accepted scientific data
2. A food business operator making a nutrition or
health claim shall justify the use of the claim
3. The competent authorities of the Member States
may request a food business operator or a person
placing a product on the market to produce all relevant
elements and data establishing compliance with this
Regulation
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NHCR – scientific substantiation
Elements of scientific assessment
A. Characterization of the food/constituent
B. Claimed beneficial effect can be measured (or
is based on nutrient essentiality)
C. Establishing cause-effect relationship between
A and B
Required evidenceTotality of the available scientific evidence in order to
establish the cause-effect relationship for the chosen target
population under the proposed conditions of use
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NHCR – scientific substantiation
Element B: ‘beneficial physiological effect’
• Essentiality of nutrient
– Exempted from randomized controlled trails
– E.g.: Effect of Vitamin C on the immune system
• Other claims:
– Claimed effect refers to a specific body function, has a
beneficial physiological effect for the target population for
which the claim is intended, and can be assessed in vivo
– Pertinent Human studies absolute requirement
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NHCR – scientific substantiation
Complications in scientific substantiation
• highest possible standard (Recital 23);
including pertinent human studies
• Previous lack of guidance
• Pending or insufficient applications and non-
authorizations
• Disparity between claims on botanical foods and
(herbal) medicinal products
Legal burden for innovative food producers
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NHCR - Wording
Application of general principles– Not false, ambiguous or misleading
– Average consumer expected to understand
Proposed wording applicant– Consider legal and scientific correctness and consumer
understanding
– R&D, marketing and legal
Consideration by NDA Panel (EFSA)– Reflecting the scientific evidence
Authorized wording EC– Taking account of other legitimate factors
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NHCR – data protection
Protection of scientific data and other information in the application (art. 20)
• Conditions: - Requested by applicant
- Data owned by the applicant
- Essential for substantiation of claim
• Cannot be used by for the benefit of subsequent applications
Proprietary health claim• Restricted use of 5 years for applicant
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NHCR - evaluation
Pitfalls of the NHCR
• Absence of Nutrient Profiles
• High standard of proof for health claims
• Scope:
• Complexity, costs and length of procedure
• No remedies against negative EFSA opinion
Necessity of human studies
No acceptance of traditional use as proof
Wide definition of claim
Only beneficial claims
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NHCR - evaluation
REFITRegulatory Fitness and Performance Programme
Questioning the fitness of the NHCR considering the objectives of the Regulation:
» Consumer protection and facilitate healthy choices
» Protection of fair competition; promote and protect innovation
» Improve free movement of foods with claims by increasing legal certainty
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NHCR - evaluation
Extent of REFIT- evaluation
• Nutrient profiles
• Plants and their preparations used in foods
– 1500 applications on hold
– Assessment of safety and health effect
Need for pertinent human studies v. proof of traditional use
Other pitfalls?
‘…an evaluation of the Regulation in its entirety would be
premature at this stage given that the list of authorised health
claims only came into application in December 2012.’
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NHCR - evaluation
Expected outcome of REFIT- evaluation
End date REFIT evaluation: June 2017
Consideration on Nutrient profiles
• Need, effectiveness, alternatives, costs and
benefits, ..
Consideration on plants used in foods
• Legal deficits, alternatives, costs and benefits, ..
Solutions to pitfalls not yet in sight
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NHCR - opportunities
Innovation potential under NHCR?
Scientific substantiation
Limitations on wording
• Protection of well-founded claims
messages – fair competition
• EFSA guidances (2011, 2015) available
• Examples available
• Data protection
• Protection of meaningful claims
understood by consumers
• Increases consumer trust
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NHCR - opportunities
Key to success
• Application procedure takes between 5-10 years
• Speed up application by integrating R&D and legal and marketing strategy early in the process
– Consider scientific substantiation;
– with marketing strategy, and
– legal viability
Facilitates authorization procedure
Time and cost reducing
Increases effectiveness of claim
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Legal viability
Consider innovations in the light of legal
constraints
– NHCR, food supplement and/or novel food?
– Consider complex aspects of authorization
procedure
– Cope with the legal uncertainties (nutrient profiles,
high standard of proof, …)
– Examine the experiences and examples of earlier
claims
– Correspond scientific and effective wording to legal
requirements
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NHCR – marketing strategy
Why do producers use claims?
• Product differentiation
– Competitive advantage
Proprietary health claim!
– Marketing of food products
– From sensory aspects to health functionality
– Focus on target group
– …
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Claims as a marketing tool
Consider innovation in the light of
marketing potential
Identify consumer understanding process
A. Assess needs of consumers
B. Acceptance of the functional food product
C. Branding effects
D. Trust regarding branded product
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Claims as a marketing tool
• Identify what consumers are looking for:
- something different from other products
- something that cannot, or not easily, be
attained by balance and healthy diet
Need
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Claims as a marketing tool
Acceptance
• How to introduce new products with consumers?
- Analyze dietary habits
- Avoid changes in taste or convenience
- Only minor changes for the sake of healthiness
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Claims as a marketing tool
• Well known and trusted brands generally
generate higher confidence towards
functionality
• Front of pack indication – facilitate the
reading of claims
Branding
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Claims as a marketing tool
Understanding
• Short, easy to read messages
• Clear wording and explanation
• Balance between substantive explanation
and understandable message
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Claims as a marketing tool
• Importance of legislation; high protection of
consumers will lead to higher confidence in
messages
• Importance of only well-substantiated claims
TRUST
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Conclusion
10 years of NHCR: pitfalls creating legal
uncertainty
Opportunities for innovative food producers
• Protection of product innovation
• Product differentiation
• Ways to facilitate authorization
Combine R&D, legal and marketing strategy
to generate bigger impact
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Washington, DC • Brussels • San Francisco • Shanghai • Paris
Keller and Heckman LLP
THANK YOUKatia Merten-Lentz, Partner
Keller and Heckman LLPBrussels Office
+32 (0) 2.645.5073