HEALTH and NUTRITION CLAIMS Overview and Update

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HEALTH and NUTRITION CLAIMS Overview and Update

• Neville Craddock MA (Cantab.), CSci, FIFST
• Neville Craddock Associates
• Food Law Consultants
• United Kingdom

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OVERVIEW

• Current legal situation
• labelling and claims
• General background to current concerns
• Proposed European Regulation
• scope and purpose
• definitions
• general principles
• prohibitions, restrictions and authorisations
• comparative nutrition claims
• Outstanding issues

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EU LEGISLATION on HEALTH CLAIMS

• Legislation already in place
• Labelling Directive 2000 / 13
• Medicines Directives 2001 / 83 and 2004 / 27
• Misleading Advertising Directive 85 / 450 (as
  amended)
• Directive 89 / 398 (Foods for Particular
  Nutritional Uses)
• General Food Law Regulation 178 / 2002
• European Court Judgements
• Did we really need more?
• Probably not - but nevertheless its coming!

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DIRECTIVE 2000 / 13 - Article 2.1(b)

• The labelling, presentation and advertising of a
  food must not attribute the property of
  preventing, treating or curing a human disease,
  or refer to such properties.
• Labelling words, particulars, trade marks,
  brand name, pictorial matter or symbol placed on
  any packaging, document, notice, label, ring or
  collar accompanying or referring to the food.
• Presentation shape, appearance or packaging,
  packaging materials used, way in which they are
  arranged and setting in which they are
  displayed.
• Applies equally to explicit and implied claims
• UK forbids any tonic claims
• Arguably does not prevent health maintenance
  claims
• But disease risk reduction has been a very grey
  area!

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LEGAL BACKGROUND current problems

• Interpretations of ban on prevention,
  treatment, curing vary
• Wide spectrum of provisions between Member States
• National traditions / semantics / literal
  interpretations in some MSs
• approach based on the perceived spirit of the
  legislation in others
• ECJ Case C-221/00 ban applies to all health
  claims ( other ECJ cases)
• No EU-wide legal definitions of prevention and
  disease
• Overlap and conflict between Food and Medicines
  legislation
• Leads to legal uncertainty, inconsistent and
  arbitrary interpretation
• Codex Guidelines Claims, Nutrition claims,
  Health claims also exist

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CONSUMER BACKGROUND - summary

• Consumer interest in health generally
• Health and obesity concerns CHD, cancer,
  diabetes
• massive, and rapidly increasing cost to Health
  Service
• WHO / FAO Diet, Nutrition and Chronic Diseases
  Report
• Global Obesity Task Force Report
• Consumer concerns about plethora of dubious
  claims
• Concerns over inadequate enforcement of existing
  legislation
• Good / Bad foods debate
• also marketing practices - fortification -
  promotion to children etc

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THE PROPOSED HEALTH CLAIMS REGULATION
Proposal for a Regulation of the European
Parliament and of the Council on Nutrition and
Health Claims made on Foods

• Trialogue Spring 2006
• Awaiting Jurist-linguists confirmation
• Expected autumn 2006 (October?)

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EU CLAIMS PROPOSAL - Aim and Scope

• Effective functioning of Internal Market - fair
  competition
• High level of consumer protection
• Encompasses labelling, presentation and
  commercial communications
• not dietary guidelines / PH advice press /
  scientific publications
• special provisions for trade marks and brand /
  fancy names
• Applies to foods to be delivered as such to the
  final consumer - includes unpacked and bulk
  sales, and supplies to mass caterers
• Without prejudice to PARNUTS, Natural Mineral
  Waters, Drinking Water and Food Supplements
  legislation
• Complements the principles of Labelling Directive
  2000 / 13

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EU CLAIMS PROPOSALS Trialogue 2006

• Retain ban on prevention, treatment and cure
• Distinguishes reduction of disease risk factor
• Restriction on childrens development and
  health claims
• Restriction on non-specific and psychological /
  behavioural claims
• A priori approval for novel / specific claims
• Wording to be taken into account by EFSA
• All claims must be scientifically verifiable
• Generic list of recognised health claims
• Public Register of approved claims
• Quantitative criteria for wide range of nutrition
  claims
• Absolute ban on alcoholic drink health claims

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EU CLAIMS PROPOSAL - Key Definitions

• Claim any non-mandatory message or
  representation (including pictorial, graphic or
  symbolic) that states, suggests or implies a food
  has particular characteristics.
• Health Claim any claim that states, suggests
  or implies relationship between a food category,
  a food or one of its constituents and health.
• Reduction of disease risk claim any health
  claim that consumption of a food category, a
  food or one of its constituents significantly
  reduces a risk factor in the development of a
  human disease.

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EU CLAIMS PROPOSAL - Key Definitions

• Nutrition claim any claim that a food has
  particular beneficial nutrition properties due to
  
• energy it does / does not provide (including
  reduced / increased)
• nutrients or other substances it contains /
  contains in reduced or increased proportions /
  does not contain.
• Nutrient protein, carbohydrate, fat, fibre,
  sodium, vitamins and minerals in Annex to
  Directive 90/496 and their components.
• Other substance substance other than a
  nutrient that has a nutritional or
  physiological effect.

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EU CLAIMS PROPOSAL General Principles

• Only claims that comply with the Regulation will
  be permitted
• Claims must be supported by generally-accepted
  scientific evidence
• capable of justification by operator
• Product must contain significant quantity of
  beneficial substance, or reduction of harmful
  substance, and able to deliver claimed effect
• in quantity of food reasonably expected to be
  consumed
• substance must be biologically available
• Refers to food ready for consumption (c.f. to
  be delivered earlier?)
• N.B. Cannot include other foods in claims
  justification

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EU CLAIMS PROPOSAL General Principles

• Claims must not
• be false, ambiguous or misleading
• create doubts about safety and/or nutritional
  adequacy of other foods
• encourage or condone excess consumption of a food
• state / imply that balanced diet cannot provide
  adequate nutrients (possibility of national
  derogations?)
• refer to changes in bodily function - textually,
  pictorially, graphically or symbolically that
  could give rise to / exploit fear in consumer
• Claims must be understood by average consumer

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WHAT IS AN AVERAGE CONSUMER?

• ECJ rulings consistently describe average
  consumer as
• reasonably well-informed, reasonably observant
  and circumspect
• Claims proposal "It is appropriate to protect
  all consumers from misleading claims. However,
  the ECJ has found it necessary since the
  Misleading Advertising Directive to examine the
  effect on a notional, typical consumer. In line
  with proportionality, and to enable the
  effective application of the protective measures
  contained in it, this Regulation takes as a
  benchmark the average consumer as interpreted by
  the ECJ, taking into account social, cultural and
  linguistic factors but makes provision to prevent
  the exploitation of consumers whose
  characteristics make them particularly vulnerable
  to misleading claims".
• Labelling Directive could mislead the
  purchaser to a material degree
• Can Claims Regulation go beyond ECJ?

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HEALTH CLAIMS

• Prohibited unless comply with Regulation, are
  authorised and registered
• i.e. all are subject to prior authorisation
  (specific or generic)
• Absolute prohibitions
• claims that health could be affected if the food
  is not consumed
• reference to amount or rate of weight loss
• general, non-specific benefits for overall good
  health and well-being unless accompanied by
  specific, listed claim
• reference to individual doctors, health
  professionals or associations
• but MS rules for national associations or
  health-related charities
• Commission may publish Guidelines on non-specific
  health claims

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EU CLAIMS PROPOSAL Nutrient Profiles Article 4

• Claims must respect nutrient profiles ()
• To be established (12 months EFSA advice)
  taking account of
• nutrients and other substances such as fat,
  saturated fat, trans fats, sugars, salt / sodium
• role and importance of the food / category in
  diet
• in general, or
• as appropriate certain risk groups, including
  children
• overall nutritional composition and presence of
  nutrients with scientifically-recognised (good
  and / or bad?) effects on health
• exemptions may be defined (e.g. olive oil, cheese
  etc)
• Single nutrient may exceed profile High X
  content labelling
• () except reduction of fat, saturated fat,
  trans fats, sugars, salt / sodium

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EU CLAIMS PROPOSAL Alcoholic beverages

• Beverages gt1.2 alcohol (excluding supplements)
  may not bear
• health claims
• nutrition claims, except low / reduced energy /
  alcohol
• n.b. national rules for low alcohol levels
• Other foods / categories of foods may also be
  defined

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HEALTH CLAIMS

• All subject to prior authorisation (specific or
  generic)
• Label, presentation and advertising must include
  statements / advice
• importance of varied and balanced diet and
  healthy lifestyle ()
• quantity of food and pattern of consumption to
  achieve effect ()
• if appropriate, persons who should avoid the food
• appropriate warning, for products likely to
  present a health risk if consumed to excess
• () not required at point of loose food sales
• Guidelines may be adopted

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GENERALLY-ACCEPTED HEALTH CLAIMS other than
Disease Risk Reduction and Child Development

• Prior authorisation will not be required for
  claims describing
• role of nutrient etc in growth, development or
  normal body functions
• psychological and behavioural functions
• slimming, weight control
• reduction in sense of hunger or increase in
  satiety
• reduction in available energy from the diet
• Provided they are
• based on generally-accepted scientific evidence
• well-understood by average consumer
• included on Community list
• 12 months - Member States to provide Commission
  with list
• 36 months - Community list, after consulting
  EFSA, permitted claims

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DISEASE RISK REDUCTION and CHILD DEVELOPMENT /
HEALTH CLAIMS

• May be made following formal authorisation
• must meet all other conditions of the Regulation
• will be included in the public Register
• for DRR, label must also state ()
• the disease to which claim refers has multiple
  risk factors
• altering one of these may / may not have a
  beneficial effect
• () if no label, presentation or advertising must
  state

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COMMUNITY REGISTER of CLAIMS

• Public Community-wide Register will be
  developed
• generally-accepted health claims
• specific authorised health claims, including
  amendments
• disease risk reduction claims
• childrens development and health
• proprietary (commercially-protected) claims
  (separate annex)
• nutrition claims and conditions / restrictions
  applicable
• rejected health claims (and reasons for
  rejection)
• restrictions on foods other than alcoholic
  beverages

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NUTRITION CLAIMS

• NUTRITION CLAIMS
• Only permitted if listed in, and comply with,
  detailed conditions in Annex
• COMPARATIVE CLAIMS
• Comparison only between foods of same category,
  taking into account a range of foods in category
• Difference in quantity of nutrient and / or
  energy must be stated
• Comparison must relate to same quantity of food
• Comparison against range of foods whose
  composition does not allow a claim, including
  other brands

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EU CLAIMS PROPOSAL Nutrition Information

• Mandatory if health or nutrition claim made
• big eight in accordance with Directive 90 / 496
• (bulk supplies, in accompanying documents)
• If claimed substance(s) not in nutrition
  labelling, must be stated in same field of vision
  as nutrition information, expressed per 100g or
  100ml
• Special rules for Food Supplements (Directive
  2002/46 art. 8)
• Not required for foods sold loose
• Generic advertising excluded

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APPLICATION for AUTHORISATION

• Submission to EFSA, via MS National Competent
  Authority
• Specified procedure, data requirements and
  timescales (including)
• nutrient / food / food category and particular
  characteristics
• scientific studies - independent, peer-reviewed
  if available
• other relevant scientific studies
• proposed wording, and specific conditions of use
  (if appropriate)
• summary of dossier
• 14 days MS CA acknowledge receipt without
  delay to EFSA
• EFSA without delay to other Member States and
  Commission
• Summary to be made publicly available
• Commission to establish implementing rules
• EC and EFSA to publish Guidance on application
  preparation/presentation

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EFSA OPINION on Lists of Claims

• 5 months - extendable by 2 months for more
  information to verify
• claim is substantiated by scientific evidence
• wording is understandable and meaningful to
  average consumer
• Favourable Opinion to include
• food / category of food for which claim is
  authorised
• proposal for wording
• conditions or restrictions of use, if appropriate
• additional / warning statements, if appropriate
• Opinion to be sent to applicant, Commission and
  MS and made public
• 30 days for public comment

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COMMUNITY AUTHORISATION of Lists

• 2 months for Commission to draft Decision
• justify differences if not in accord with EFSA
• Adoption by Standing Committee procedure
• Publish in OJ
• Claims included in Register available for use
  by any operator unless designated proprietary
• Authorisation does not lessen civil / criminal
  liability

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AUTHORISATION OF NEW SCIENCE CLAIMS

• N.B. other than Childrens Development and Health
  claims
• Submission to MS National Competent Authority
• 14 days MS CA acknowledge receipt
• without delay to EFSA
• other Member States and Commission for
  information
• EFSA Opinion 5 months
• extendable by 1 month for more information
• 15 days for applicant to supply requested
  information
• Opinion to be sent to applicant, Commission and
  MS and made public
• 30 days for public comment
• If favourable EC 2 months to TAKE a decision
  after consulting MS
• If unfavourable decision by Standing Committee

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EU CLAIMS Transition Periods as defined

• On market / labelled prior to legislation in
  force expiry / 30 months
• Not compliant with nutrition profile 24 months
  from adoption
• Pre 1.1.2005 trade marks and brand names,
  non-compliant 15 years
• Pre 1.1.2006 nutrition claims, not in Annex 3
  years
• Pictorial nutrition claims compliant with Reg. /
  MS rules but not in Annex
• MS to notify Commission (12 months) formal
  Commission Decision
• if not authorised 12 months
• Nutrient role / behaviour / weight control /
  satiety / available energy
• under responsibility of business until list
  published transition unclear
• Other Health claims authorised under current
  National provisions
• MS to notify Commission (12 months) formal
  Commission Decision
• if not authorised 6 months
• Other Health claims not evaluated by MS
  application within 12 months
• if not authorised 6 months after Decision

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DATA PROTECTION

• Company-specific scientific and other data
  protected from use by other applicants for 5
  years from date of authorisation, providing
• confidentiality stated at time of application
• exclusive right to data
• impossible to approve claim without submission of
  data
• If not based on proprietary data, will be
  available for general use when placed on
  Community list

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MEMBER STATES - obligations

• May not restrict or forbid trade in / advertising
  of compliant foods
• Must comply with notification procedure if
  national legislation envisaged notify other MS
  and Commission and give reasons
• MS and EC may temporarily suspend use of claim if
  believe
• claim is non-compliant, or
• scientific substantiation is insufficient
• Decision, via SCFCAH, may involve Opinion from
  EFSA
• MS may require notification by submission of
  model label

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EU CLAIMS PROPOSAL - Timing

• Comes into force 20 days from OJ publication
• Applies from first day of 6th month following
  date of entry into force
• Commission to Report to EP and Council (6 years)
  on
• application of Regulation
• evolution of market
• consumer understanding
• impact on dietary choices
• potential impact on obesity and non-communicable
  diseases

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MISCELLANEOUS ISSUES

• Trade Marks, Brand Names or Fancy Names perceived
  as a claim
• may continue without new authorisation but must
  carry compliant claim
• Generic, traditional descriptors (digestive)
  derogations possible
• business application to MS to forward to EC
  (SCFCAH procedure)
• EC to publish rules to enable transparency and
  reasonable time
• Yellow fat spreads Regulation still applies but
  will be adapted
• National / EU alcohol abuse messages are excluded
• Liquid food supplements with gt1.2 alcohol are
  not beverages
• Non-beneficial claims are not covered (recital
  6)
• believed aimed at FSA traffic light and similar
  schemes

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EU HEALTH and NUTRITION CLAIMSOutstanding Issues
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EU HEALTH CLAIMS Outstanding Issues

• Nutrient profiles" (Article 4)
• what parameters will they comprise?
• in particular fat, saturated fat, trans fat,
  salt / sodium, sugar
• as well as poly-/mono-unsaturated fats,
  available carbohydrates (other than sugar),
  vitamins, minerals, protein and fibre
• definition of food categories?
• how will they take account of MS dietary habits
  and consumption?
• how will exemptions be determined?
• labelling contradictions likely to arise from
  specific drafting
• Proposed timetables look very optimistic!

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EU HEALTH CLAIMS Outstanding Issues

• No legal definition of children
• Mechanism for EFSA scientific substantiation of
  claims
• EU ILSI PassClaim / UK JHCI
• Transitional periods for child development and
  health claims
• Clarification of possible overlapping transition
  periods

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LADIES and GENTLEMEN Thank you for your
attention!Comments Questions Discussion
37
Neville Craddock AssociatesTun House 28 High
Street BletchingleySurrey UKnevillecraddock_at_tu
nhouse28.fsnet.co.ukTel 44 (0) 1883 740
553Mob 44 (0) 7802 641 081