FOOD SUPLEMENTS IN CZECH REPUBLIC LEGAL FRAMEWORK

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FOOD SUPLEMENTS IN CZECH REPUBLICLEGAL
FRAMEWORK
CASP

• Martina ímová, 12th May 2008

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LEGAL FRAMEWORK
CASP

• EU Legislation
• Regulations immediately applicable in all MS
  (do not have to be implemented into the national
  legislations)
• Directives more like guidelines, mandatory
  parts must be implemented into the national
  legislations
• Czech legislation
• Applicable only where there is no harmonization
  on the EU level

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LEGISLATION RELATED TO FS
General Food Law Regulation
Labelling Issues GMOs, Allergens, Nutrition
FS Directive
Contaminants
Novel Foods
Traditional Herbal Medicinal products
Food additives flavourings
Health Claims Fortification Regulations
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EU REGULATORY FRAMEWORK Food Supplement
Directive (FSD)2002/46/EC
CASP

• Mandatory in all EU countries
• Transposition of the EU Directive into national
  law by August 2003
• Definition of Food Supplements
• Specific labelling requirements for food
  supplements
• EU positive list of permitted vitamin mineral
  forms

• National option
• Notification
• Regulation of other substances (plants and herbal
  extracts, amino acids, probiotics...)
• Derogation to the use of other vitamin mineral
  forms until December 2009

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FS DirectiveDefinition of Food Suplements

• Foodstuffs marketed in form of tablets, capsules,
  sachets of powder, ampoules of liquids etc.
  (designed to be taken in measured small unit
  quantities)
• Purpose of use
• to supplement the normal diet with vitamins and
  minerals or other substances with a nutritional
  or physiological effect.

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FS are concentrated sources of substances
with nutritional physiological effect
Vitamins Minerals
Herbs/Herbal extracts
Other substances
Probiotics/Prebiotics
Fatty Acids
Amino Acids
Enzymes
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FS DirectiveOngoing harmonization

• Setting of Maximum Levels for Vitamins and
  Minerals
• Discussions within the EU already started,
  should be finished till the end of 2009
• Extending current positive lists of vitamins
  and minerals to other sources
• EFSA for evaluation - possible temporary
  national derogation till 31.12.2009
• Potential Extension of FSD to regulate other
  substances Recommendation from EC due July
  2007 (positive list or negative lists approach
  ?)

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CZECH NATIONAL LEGISLATION Food Supplement
Decree No. 446/2004

• Harmonized part
• (from the EU FS Directive)
• Positive list of Vitamins and Minerals (Annex I)
• Positive list of Vitamin and Mineral substances
• (Annex 2)

• Non harmonized part
• (national rules)
• Maximal limits form Vitamins and minerals (Annex
  3)
• Positive list of other substances (Annex 4)
• Negative list of herbs (Annex 5)

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CZECH FOOD SUPPLEMETS DECREE Max. levels for
Vitamins and Minerals (Annex III)

• Vitamin A 2000 mcg
• Vitamin D 10 mcg
• Vitamin K 60 mcg (not stated)
• Vitamin B1 10 mg
• Vitamin B2 10 mg
• Niacine 500 mg (NA 35 mg)
• Pantothenic acid 40 mg
• Vitamin B6 10 mg
• Folic acid 1000 mcg
• Vitamin B12 50 mcg
• Biotin 500 mcg
• Vitamin C 2000 mg (1200 mg)
• Vitamin E 100 mg

• Potassium 1000 mg
• Calcium 2500 mg (2000 mg)
• Magnesium 400 mg
• Iron 20 mg
• Zinc 25 mg
• Copper 3 mg
• Iodine 200 mcg
• Selenium 200 mcg
• Manganese 5 mg
• Chromium 200 mcg
• Molybdenum 100 mcg
• Fluorine 1 mg
• Chlorine (not
  stated)
• Phosphorus (not stated)
• Sodium (not stated)

Max. levels according to the new proposal of
the Czech FSD (under discussion).
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CZECH FOOD SUPPLEMETS DECREE Some other
substances allowed for use in FS (Annex IV)

• Koenzym Q10 60 mg
• Carnitine 1000 mg
• Carotens 20 mg
• Creatine 2500 mcg
• Royal Jelly 200 mg
• Propolis 50 mg
• Bees pollen not limited
• Lecitine not limited
• Inositole not limited
• Colostrum not limited
• Probiotics not limited
• Green algae not limited
• Red and brown
• eatable algae not limited

• Proposal in the new Czech FS Decree
• Acetylcarnitine 500 mg
• DMAE 20 mg
• Orotic Acid 50 mg
• Pycnogenol 100 mg
• Taurine 2000 mg

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CZECH FOOD SUPPLEMETS DECREE Some herbs commonly
used on the Czech market

• Max. limits
• 500 mg
• 40 mg (60 mg)
• 2500 mg
• 1000 mg
• 500 mg
• 300 mg
• 20 mg (40 mg)

• Echinacea (dried herb and root)
• Gingo biloba (standardized extract 24/6 from
  leafs)
• Gingo biloba (dried leaf)
• Panax ginseng (dried root)
• Valeriana oficinalis (dried root)
• Hypericum perforatum (dried herb)
• Black cohosh (dried root)
• Citrus aurantium, Hawthorn Dioscorea (Yam)
• Garcinia camborgia, Ptychopetalum olacoides,
• Rhodiola rosea, Schizandra chinensis, Tabebuia
• Impetiginosa, Tribulus terrestris, Turnera
  diffusa,
• Uncaria tomentosa, etc

Positive list of herbs (Annex IV.) of proposed
new Czech FS Decree (not adopted yet)
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CZECH FOOD SUPPLEMETS DECREE Some substances not
allowed for use in FS

• Acetyltryptophan
• DHEA (Dehydroepiandrosteron)
• GABA (Gama Aminobutyric Acid)
• 5-HTP (5-hydroxytryptophan)
• Colloidal Silver
• Lactulose
• Melatonine
• H-acetylcysteine

Negative list of some other substances (Annex
IV.) of proposed new Czech FS Decree (not adopted
yet)
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Borderline products Food Supplement or Medicinal
Product ?

• Decision body State Institute of Drug Control
  (SUKL)
• In case of doubts company has to submit
  application for expert opinion on SUKL
• Decision must be issued within 60 days
• more information on www.sukl.cz

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Mandatory labelling of FSMust be in Czech
language

• Food Supplement under the name of product
• Content of Vitamins, Minerals and other
  substances,
• RDA (if stated).
• List of all ingredients (denomination of
  allergens)
• Information about number of units (tablets,
  capsules,...) in the package
• Special warnings (if required)
• Recommended daily dose and warning not to exceed
  the daily dose.
• Sentence that Product should not substitute
  variety diet.
• Warning Keep out of reach of children.

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Presentation of FSDeclarations that are not
allowed on FS

• Property to prevent human diseases
• Property to treat or cure human diseases
• Could not even refere to these properties

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Presentation of FSNutrition and Health Claims
FOODS FOOD SUPPLEMENTS Regulation EC/1924/2006
on Nutrition and Health Claims made on food
Medicinal products
Nutrition Claims
Funclional Health Claims Generic
Reduction of Disease Risk Claims
Medicinal Claims
EU list of approved nutrition claims
EU list of HC based on generally accepted
scientific data
Reduction of one or more risk factors in
development of human disease
Prevent, treat or cure human diseases
Vitamin A is essential for normal vision Calcium
is essential for the structure of healthy bones.
low energy, light, etc. source of Calcium

Prevention of cardiovascular diseasesPreventio
n of osteoporosis
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PLACES OF SALE

• Food Supplements Medicinal Products

• Supermarkets
• Drugstores
• Gas stations
• Health food
• stores

Pharmacies
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HOW TO PUT FOOD SUPPLEMENTS ON THE CZECH MARKET
Contains new active substances or in higher
doses than is commonly used
Comply to the Czech FSD and to the common
practice
Submition of sample of the product label in the
day of placing on the market

• Submition of
• expert opinion on safety
• (SZU, SUKL)
• sample of the product label

Notification on the Czech Ministry of Health
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Czech national authorities in charge of Food
Supplements

• Czech Ministry of Health www.mzcr.cz
• Notification of FS
• The National Institute of Public Health
  www.szu.cz
• Gives the expert opinion on safety of FS
• State institute of Drug Control www.sukl.cz
• Classification of borderline products
• Czech Agriculture and Food Inspection Authority
• www.szpi.cz
• Inspections

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THANK YOU

• Czech Association of Special Foods (CASP)
• http//www.casponline.cz/
• European Federation of Associations of Health
  Product Manufacturers
• (EHPM)
• http//www.ehpm.org/
• International Alliance of Dietary/Food Supplement
  Associations (IADSA)
• http//www.iadsa.org/