Functional Foods

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Functional Foods

• Pat OMahony
• Chief Specialist Biotechnology
• FSAI
• Novel Food, GM Food, Irradiated Food Organic
  Food

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What are Functional Foods?

• All foods are functional (Definition in law?)
• The first truly deliberate functional food
  product was probably iodized salt, which Morton
  introduced in 1924 to help prevent goitre.
• Folate enriched cereals Calcium enriched
  milk vitamin enriched juice phytosterol
  enriched spreads
• Medicines/Novel food/Additives/Supplements/Fortifi
  ed foods
• Foods for particular nutritional uses infant
  formula, follow on formula and food, food for
  special medical uses and energy restricted diets

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Are Functional Foods Real?

• Marketing ploy?
• Probiotics/Prebiotics new or not?
• Bioactive substances (OECD, Codex)
• Folic acid in flour?, fluoride in water?
• Fortified foods vitamins minerals certain
  other substances - for a start
• GM foods in the future
• Functional food RD in Ireland?

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Authorising Legislation

• Novel foods May 15 1997
• Medicines
• Additives a technological function such as
  emulsifier, stabiliser, acid, anti foaming agent
  etc.
• Colourings Sweeteners have their own
  legislation
• Flavourings
• Food supplements

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Labelling

• General Labelling Directive (2000/13/EC)
• Nutrition and Health Claims
• Fortified foods
• Food Enzymes Chymosin/Rennet

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Nutrition Health Claims

• Medicinal claims e.g. cures/prevents a disease
• Nutrition Health claims
• Scientifically justified- High, Low, Good for
  you, Reduced, Increased
• Nutrition profiling, no claims on alcohol
  products
• Food supplements concentrated doses of
  nutrients or other substances - vitamins and
  minerals - Limits set, Claims limited, Purity
  criteria specified
• Fortified Foods

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Fortified Foods

• Vitamins and minerals Certain other substances
• e.g. Stimulant drinks - taurine, glucuronalactone
  etc.
• Negative/positive list, Not for fresh produce
• Nutritional profiles - Adding benefit to
  unhealthy food?
• Food fortification through enriched feed?
• e.g. Super eggs Omega 3 fatty acids, Vitamin E,
  Selenium

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Novel Foods Regulation of the Parliament and the
Council No. EC
258/97

• - foods and food ingredients which have not
  hitherto been used for human consumption to a
  significant degree within the Community and which
  fall under the following categories -
• May 15, 1997

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Categories of Novel Foods

• Containing or consisting of GMOs
• Produced from but not containing GMOs
• New or modified primary structure
• Consisting or isolated from microorganisms, fungi
  or algae
• Consisting of or isolated from plants, isolated
  from animals - not those developed by traditional
  breeding and propagation
• New production process that may alter some
  properties of a food

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Novel Foods in Europe

• 51 Novel Food applications - 13 GM
• 14 Approved (Bt11 sweet maize)
• 4 Rejected
• 11 Withdrawn
• 1 Additive
• 21 Pending
• 22 Notifications

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Novel Food Decisions

• Stevia rebaudiana Rejected 2000
• Phospholipids from Egg Yolk - Authorised 2000
• Phytosterol ester in spreads (Flora ProActive) -
  Authorised 2000
• High Pressure Pasteurisation - Authorised 2001
• Ngali (Nangai) nuts - Rejected 2001
• Bacterial Dextrans - Authorised 2001
• Trehalose - Authorised 2001
• Coagulated potato proteins - Authorised 2002
• Iodine enriched wild-type eggs Rejected 2003
• Noni juice - Authorised 2003
• DHA-rich oil - Authorised 2003
• Phytosterol containing products - Authorised 2004
• Deer horn powder Rejected 2004

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EU Novel Food Catalogue

• List of all the foods and ingredients about which
  there have been enquiries with respect to novel
  food status
• 140 items listed

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Change in Legislation
Novel Food EC 258/97
Novel Food (in revision)
GM Food and Feed Regulation EC 1829/2003
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Authorisation
Draft Decision
Member States
DG SANCO
EFSA
Opinion
SCFCAH/Council/Commission
Competent Authority
FINAL DECISION QMV
Dossier
Applicant
Decision?
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Scientific Data Required

• Composition
• Nutritional value
• Toxicology
• Allergenicity potential
• Anticipated intake/use
• Purity
• Source/history of use/production process

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Labelling

• General Labelling Directive 2000/13
• Any specific labels on a case by case basis

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Simplified Procedure

• Substantially equivalent to product already on
  the market (composition, nutritional value,
  metabolism, intended use and undesirable
  substances)
• Based on an application to Commission including
  with scientific evidence
• Based on application to a Competent Authority for
  opinion on substantial equivalence

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Problems with the Regulation!

• New Member States
• Monopoly v Cost effectiveness
• Legislative demarcation
• Medicine v Food
• Additive v Novel Food
• Cost
• Time between application and decision
• Politics v Science
• Policing the market

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Over/Under Regulation

• Consumer safety / Consumer choice
• Stifling innovation
• Creating monopolies

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