MARKET SURVEILLANCE ON COSMETICS IN THE CZECH REPUBLIC

1
MARKET SURVEILLANCE ON COSMETICS IN THE CZECH
REPUBLIC

• National Institute of Public Health
• Prague, Czech Republic
• UNECE FORUM ON MARKET SURVEILLANCE
• Geneva, 29 October 2002

2
COSMETIC PRODUCTS LEGISLATIONIN THE CZECH
REPUBLIC

• Act No 258/2000 Coll., on Public Health
  Protection
• Decree No 26/2001 Coll., on Hygienic Requirements
  on Cosmetics
  (Cosmetic
  Directive 76/768/EEC)
• Official Journal of the Ministry of Health No 7/
  July 2001, on Methods of Analysis
  
  (Directive 80/1335/EEC)
• Act No 102/2001 Coll., on General Products Safety
• 
  (Directive 76/769/EC)
• Act No 634/1992 Coll., on Consumers Protection

3
COSMETIC PRODUCTS MARKETING IN THE CZECH REPUBLIC

• No pre-market control is performed.
• Products have free access to the market providing
  they comply
• with requirements on
• product composition (negative and positive lists
  of ingredients)
• mandatory product labelling (producer/importer
  address, INCI, minimum durability, batch,
  consumer texts in Czech...)
• mandatory product documentation - kept available
  in the CR(composition, safety assessment, proof
  of effects...)
• product manufacture (GMP, labor safety...)
• product notification (list of products,
  producer/importer address)

4
COSMETIC PRODUCTS NOTIFICATIONIN THE CZECH
REPUBLIC

• The start of manufacture or importation should be
  notified
• before product marketing.
• Notification
• is performed at Ministry of Health, Registry of
  Chemicals
• by a person or company responsible for the
  product that is permanent resident in the Czech
  Republic
• should indicate
• residence address
• address in the CR where the product documentation
  is available for control purposes
• list of products
• address of manufacturing

5
COSMETIC PRODUCTS PACKAGING IN THE CZECH REPUBLIC

• Act No 477/2001 Coll., on Packaging
• Requirements on quality and waste management
• RESPONSIBLE AUTHORITIES
• Ministry of Health
• control of requirements on size and
  toxicological parameters, labelling and
  declaration of conformity
• Czech Environmental Inspection
• control of requirements on packaging waste
  management

6
COSMETIC PRODUCTS MARKET SURVEILLANCE

• PUBLIC HEALTH SERVICE HYGIENIC SERVICE
• Central governmental market surveillance
  authority
• responsible for
• Inspections routine
• goal-directed
• At the site of registered office
• manufacture
• market

7
MARKET SURVEILLANCE

• Inspections include
• Product control
• product safety (primarily)
• product quality proof of effects
• mandatory product labelling
• Producer/importer control
• notification documents
• mandatory product documentation
• quality of product manufacture
• labor safety and qualification of personnel
• in the place of manufacture

8
ORGANIZATION OF MARKET SURVEILLANCE
State Budget
Ministry of Health Chief Public Health Officer
National Institute of Public Health NRC for
Cosmetics
Health Institutes
Regional Public Health Centers
Territorial Units
Advisory bodies - PROKOS- CSZV- Consumers
Associations- COLIPA
Economic management Methodical management Cooperat
ion
9
NUMBER OF EMPLOYEES OF REGIONAL PUBLIC HEALTH
CENTERS(altogether 387)
14 regions 76 districts
10
INSPECTIONS ON COSMETICS IN THE CZECH REPUBLIC

• No general problems, satisfactory sense of
  responsibility
• of manufacrurers, importers and distributors
  due to
• systematic pre-market control in the past.
• Total inspections in 2001
• 127 enterprises (17 repeated for non-compliance)
• 658 cosmetic products
• Goal-directed supervision in course
• absence of preservatives in products claiming to
  be preservative-free

11
CONCLUSIONS

• requirements on cosmetic products safety, quality
  and marketing are fully specified in effective
  regulations
• market surveillance is performed by state owned
  control authorities on national/regional level
• high quality of market surveillance is guaranteed
  by skilled and permanently trained medical and
  technical personnel in sufficient number