# Presentation: 913520

## Foodstuffs for special dietary  use           administrative procedure

- Eva Přibylová
- Ministry of Health
- Department of Public Health Protection
- 12th May 2008

## National authorities

- _Ministry of Agriculture_
- Food production, tobacco products production, Alcohol production
- Food legislation
- Coordination of Rapid Alert System for Food and Feed
- Coordination of supervion on food and feed market

## National authorities

- _Ministry of Health_
- Section of Chief Public Health Officer
- 3 departments – for Strategy and Promotion of Public Health, for Public Health Protection and Czech Inspectorate of Spas and Natural Mineral Water Resources
- Department of PHO – Unit of Epidemiology, Unit for Work Hygiene, Unit for Municipal Hygiene, Unit for Children and Adults and Unit for Food Safety and Common use Articles
- 14 regional Public Health Offices – supervisory functions

## National authorities

- _Unit for Food Safety and Common use Articles_
- Food legislation
- Safety and health aspects
- Catering services
- Common use articles – cosmetic products, food contact materials, toys and products for children under three years
- Supervision on the market – regional public health authorities

## National authorities

- _Food legislation_
- Food for special nutrition use
- Baby foods
- Food supplements
- Food additives
- Food contaminants
- Pesticide residues
- Food fortification
- Health claims
- Nutrition labelling
- Natural mineral waters

## Food supplements

- Special category of foodstuffs
- Definition – ‘food supplements’ means foodstuffs the purpose of which is to supplement the normal dibe taken in measured small unit quantities;et and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in small  unit quantities
- DIRECTIVE 2002/46/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements

## Food supplements

- The Act No 110/1997 Coll., on foodstuffs and tobacco products and on amendments and supplements of certain related acts, as amended
- The Decree No 446/2004 Coll., on requirements on food supplements and food fortification
- A new decree has been prepared
- List of plants and other substances banned for food production

## Food supplements

**REGULATION (EC) No 1924/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 December 2006 on nutrition and health claims made on foods**
**REGULATION (EC) No 1925/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 December 2006 on addition of vitamins and minerals and certain other substances in foodstuffs**
**REGULATION (EC) No 258/97 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 January 1997 concerning novel foods and novel food ingredients**
**The Decree No 113/2005 Coll., on labelling of foodstuffs and tobacco products, as amended**

## Food supplements

_**Obligation of food business operators**_** – to notify the competent authority placing of food supplements on the market by forwarding a model of labelling in the Czech language used for the product**
**The Register of Decisions of Chief Public Health Officer – list of notified foods for special dietary use (publicly accessible)**
**Two different administrative procedures – products complied with the Decree and products not complied with the Decree**
**Procedures based on risk analysis**

## Food supplements

_**Obligation of food business operators**_** – to be registered at the supervisory authority**
**Czech Agricultural and Foodstuffs Inspection Authority – supervision over food supplements on the market**
**Ministry of Trade and Industry – supervision on advertising and food presentation**
**The labelling, presentation and advertising of food supplements shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general and ust not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties.**
**The name under which products covered by this Directive are sold shall be ****‘****food supplement****’****.**

## Competent authority

- Ministry of Health
- Department of Public Health Protection
- Unit for Food Safety and Common Use Articles
- Palackého nám. 4
- 128 01 Praha 2
- _[hem@mzcr.cz](mailto:hem@mzcr.cz)_
- _[eva.pribylova@mzcr.cz](mailto:eva.pribylova@mzcr.cz)_
- THANK YOU FOR YOUR ATTENTION