# Presentation: 145833

##  FOOD SUPLEMENTS IN CZECH REPUBLICLEGAL FRAMEWORK

- Martina Šímová, 12th May 2008

- ČASP

## LEGAL FRAMEWORK

**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

- ČASP

## LEGISLATION RELATED TO FS 

**Label****l****ing Issues **
**GMO****s****, Allergens, **
**Nutrition**

**C****ontamin****ants**** **

**Food additives**
**&**** ****flavourings**

**Health Claims**
** ****& Fortification**
**Regulations**

**Traditional Herbal **
**Medicinal products**

**Novel Foods**

**FS Directive**

** **
**General Food Law**
**Regulation**

## EU REGULATORY FRAMEWORK Food Supplement Directive (FSD)2002/46/EC  

**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

- ČASP

## 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.  

- Purpose of use:
- 	to supplement the normal diet with vitamins and minerals or other substances with a nutritional or physiological effect.

- FS DirectiveDefinition of Food Suplements

## FS are concentrated sources  of substances with

- Fatty Acids

- Amino Acids

- Other substances

***FS are concentrated sources  of substances with***
***nutritional & physiological effect***

- Probiotics/Prebiotics

- Herbs/Herbal
- extracts

- Enzymes

## FS DirectiveOngoing 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 ?)

## 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)

## 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).

## 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

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

- 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...

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

- Positive list of herbs (Annex IV.) of proposed new Czech FS Decree (not adopted yet)

## 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)

## 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](http://www.sukl.cz/)_

## Mandatory labelling of FSMust 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.“

## Presentation of FSDeclarations 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

## Presentation of FSNutrition and Health Claims

**Nutrition  **
**Claims**

**Funclional**
**Health Claims **
**„****Generic“**

**Medicinal **
**Claims**

**Medicinal **
**products**

- EU list of
- approved
- nutrition
- claims

- EU list of
- HC based on
- generally
- accepted
- scientific data

- Vitamin A is essential for normal vision
- Calcium is essential for the structure of healthy bones.

- Prevent,
- treat  or
- cure
- human
- diseases

**Reduction of **
**Disease Risk **
**Claims**

- Reduction
- of one or more
- risk factors in
- development of
- human disease

- ...low energy,
- light, etc.
- ...source of
- Calcium

- Prevention of cardiovascular diseasesPrevention of osteoporosis

- FOODS – FOOD SUPPLEMENTS
- Regulation EC/1924/2006 on Nutrition and Health Claims made on food

## PLACES OF SALE

- 		Food Supplements	      Medicinal Products

-  Supermarkets
-  Drugstores
-  Gas stations
-  Health food
-    stores

- Pharmacies

## HOW TO PUT FOOD SUPPLEMENTS ON THE CZECH MARKET

- Notification on the Czech Ministry of Health

- 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

- Contains new active substances
- or in higher doses than
- is commonly used

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

## Czech national authorities in charge of Food Supplements

- Czech Ministry of Health _[www.mzcr.cz](http://www.mzcr.cz/)_
- 	Notification of FS
- The National Institute of Public Health _[www.szu.cz](http://www.szu.cz/)_
- 	Gives the expert opinion on safety of FS
- State institute of Drug Control _[www.sukl.cz](http://www.sukl.cz/)_
- 	Classification of borderline products
- Czech Agriculture and Food Inspection Authority
- 	_[www.szpi.cz](http://www.szpi.cz/)_
- 	Inspections

## THANK YOU 

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