Transcript Food Fortification: Benefits and Possible Risks

Regulation on Nutrition & Health Claims:
Scientific substantiation of claims and
nutrient profiles
Albert Flynn
University College Cork
Outline
• Regulation on Nutrition and Health Claims
• EFSA’s scientific advice on nutrition and health
claims
– Scientific substantiation of claims
– Nutrient profiles
• Conclusions
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)
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
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?
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
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)
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
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
EFSA Conference on Nutrition & Health Claims
Bologna, 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 EFSA’s 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
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
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
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)
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)
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
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
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)
Foods that may not carry health claims
• Beverages containing >1.2% 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?
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
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
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
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
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)
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