Regulation on Nutrition

1
Regulation on Nutrition Health Claims
Scientific substantiation of claims and
nutrient profiles

• Albert Flynn
• University College Cork

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Outline

• Regulation on Nutrition and Health Claims
• EFSAs scientific advice on nutrition and health
  claims
• Scientific substantiation of claims
• Nutrient profiles
• Conclusions

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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)

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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

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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?

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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

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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)

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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

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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

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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 EFSAs 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

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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

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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

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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)

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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)

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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

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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

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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)

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Foods that may not carry health claims

• Beverages containing gt1.2 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?

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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

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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

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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

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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

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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)

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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