Foodstuffs for special dietary use administrative procedure

1
Foodstuffs for special dietary use
administrative procedure

• Eva Pribylová
• Ministry of Health
• Department of Public Health Protection
• 12th May 2008

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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

3
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

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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

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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

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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 quantitieset
  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

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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

8
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

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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

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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.

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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_at_mzcr.cz
• eva.pribylova_at_mzcr.cz
• THANK YOU FOR YOUR ATTENTION