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

COSMETIC PRODUCTS LEGISLATION IN 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

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)

COSMETIC PRODUCTS NOTIFICATION IN 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

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

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

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

ORGANIZATION OF MARKET SURVEILLANCE State Budget Ministry of Health Chief Public Health Officer National Institute of Public Health NRC for Cosmetics Regional Public Health Centers Health Institutes Territorial Units Advisory bodies - PROKOS - ČSZV - Consumers Associations - COLIPA Economic management Methodical management Cooperation

NUMBER OF EMPLOYEES OF REGIONAL PUBLIC HEALTH CENTERS (altogether 387) 14 regions 76 districts

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

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