1. Market Surveillance Europe Jan Deconinck, M.Sc. Prosafe Chairman 4th International Workshop on Conformity Assessment - Rio De Janeiro - 8 / 9 December 2008

2. Overview 1.Legal framework - "New Approach" 2.Overview of national organisation 1.Belgium 2.France 3.Spain 4.Portugal 3.Market surveillance (case study Belgium) 1.Tasks 2.Powers 3.Organisation 4.Conclusions 4th International Workshop on Conformity Assessment - Rio De Janeiro - 8 / 9 December 2008

3. Product Safety Enforcement Forum of Europe Established in 1990 by market surveillance officers Over 20 EU and EFTA member states regularly represented at meetings 4th International Workshop on Conformity Assessment - Rio De Janeiro - 8 / 9 December 2008

4. Goal to improve market surveillance by promoting closer co-operation and collaboration amongst national authorities Partner with European Commission on EMARS Project and Lighters Project,... www.prosafe.org 4th International Workshop on Conformity Assessment - Rio De Janeiro - 8 / 9 December 2008

6. GPSD Producers shall be obliged to place only safe products on the market. 1. Legal Framework "New Approach"

7. GPSD Producers shall be obliged to place only safe products on the market. A product shall be presumed safe as far as the risks and risk categories covered by relevant national standards are concerned when it conforms to voluntary national standards transposing European standards, … 1. Legal Framework

8. New approach The directives establish only the essential requirements which the products must satisfy. Products which do satisfy these requirements must be authorised by the various Member States on their respective markets. Manufacturers may of course place on the market products which satisfy higher quality and safety levels. But Member States cannot require this (except in certain specific cases). Products which do not meet these requirements may not be placed on the market. The essential requirements imposed in the directives specifically relate to the risks linked to use of the products. The requirements are imposed on the designers, producers and importers and bear on the design, manufacture and sale. 1. Legal Framework

9. These Directives have a dual purpose: - ensuring the free movement of goods through technical harmonisation of entire product sectors, and of - guaranteeing a high level of protection of public interest 1. Legal Framework

10. Key principles : - the definition of mandatory essential requirements, - the setting up of appropriate conformity assessment procedures - the introduction of CE marking. - Business and industry are given a wide choice of how to meet their obligations. - The European standards bodies have the task of drawing up technical specifications. 1. Legal Framework

11. Products manufactured in conformity with harmonised standards are presumed to be conformant to the essential requirements Standards are not mandatory, they remain voluntary (Alternate paths are possible but the producer has an obligation to prove his products are conformant to the essential requirements) Standards must offer a guarantee of quality with regard to the essential requirements of the directives 1. Legal Framework

12. 1. Legal framework Europe General Product Safety Directive 2001/95/EC of 3 DEC 2001 effective: 15 JAN 2004 Consumer Products for those aspects and risks which are not covered by specific Community law with the same objective Belgium Law on Safety of Products and Services of 9 FEB 1994 (modified 18 December 2002) effective: 16 FEB 2003 + professional products + services

13. 1. Legal framework Belgium Professional products Integration of the regulations concerning the safety of machinery personal protective equipment pressure equipment lifts... into the law on safety of products and services

14. 1. Legal framework Belgium Services The fact to make a product (or installation) available to a consumer Each use that might endanger the consumer playgrounds fair grounds active leisure (karting, bungee, in-door climbing,...) renting of products (DIY, ice skating,...)...

15. 1. Legal framework Belgium The law is the horizontal legal base for : - the transposition of several new approach directives - Belgian ‘ New Approach Type ’ royal decrees Law on the safety of products and services MachineryToysPPEPED...Lifts PlaygroundsFair groundsRentingActive leisure...

16. 2. Overview of national organisation PopulationSurface Belgium10 million 30,500 km² France61 million552,000 km² Spain45 million506,000 km² Portugal10 million92,000 km²

17. Geographic-Administrative structure Belgium is a federal country which comprises 3 Regions : FlandersWallonia Brussels-Capital 3 Languages (Dutch, French and German) 2.1 Overview of national organisation BELGIUM

18. Market Surveillance Organisation Federal Public Service (FPS) Economy, S.M.E.'s, Self- employed and Energy 3 regional services Other authorities include: FPS Labour FPS Mobility and transport FPS Health FPS Finance 2.2 Overview of national organisation BELGIUM

19. Market Surveillance Organisation General coordination: Central Contact Point for Consumer Products Consumer Safety Commission (CSC) The CSC is an independent assembly To issue recommendations and suggest any measure to better the prevention of risks as regards the safety of products and services To make evaluations of risks concerning consumer products To co-ordinate all federal goverment campaigns concerning product safety 2.1 Overview of national organisation BELGIUM

20. 2.2 Overview of national organisation FRANCE Geographic-Administrative structure France is a republic divided into 26 Regions 100 Departments

21. Market Surveillance Organisation The general Directorat for Competition, Consumption and Fraud Repression is the General authority for market surveillance. (DGCCRF): All consumer products, food, feed and industrial products on all levels (production, import, distribution) Safety of services 23 regional directorates (regions) Use of own laboratories (DGCCRF + DGDDI (Customs), total of 9 labs 470 workers) 2.2 Overview of national organisation FRANCE

23. Market Surveillance Organisation Other authorities include: The general directorate on customs (DGDDI) General directorate on regional action, quality and industrial safety General directorate on housing and construction Directorate on working relations General coordination: The Interministerial Committee on Consumer Affairs 2.2 Overview of national organisation FRANCE

24. Consumer Safety Commission (CSC) The CSC is an independant public authority Missions: To issue recommendations (> 350) and suggest any measure to better the prevention of risks as regards the safety of products and services To bring to the public’s knowledge all the information the Commission thinks necessary To search and make a list of all data on the dangers presented by products or services 2.2 Overview of national organisation FRANCE

25. 2.3 Overview of national organisation SPAIN Geographic-Administrative structure Spain is, what is called a State of Autonomies, formally unitary but, in fact, functioning as a highly decentralized Federation of Autonomous Communities 50 provinces 17 autonomous communities It is regarded as the most decentralized nation in Europe

26. Market Surveillance Organisation The Autonomous Communities are each completely responsible for all consumer issues. The practice of market surveillance is the responsibility of the autonomous communities. General coordination: The Spanish National Consumer Institute Link with European Commission RAPEX 2.3 Overview of national organisation SPAIN

27. 2.4 Overview of national organisation PORTUGAL Geographic-Administrative structure Portugal consists of 308 municipalities, witch are organised in a very complex manner. The main structures are: 18 districts 5 NUTS II Regions (Comissões de Coordenação e Desenvolvimento Regional - Nomenclature of Territorial Units for Statistics)

28. Market Surveillance Organisation Instituto do Consumidor (Institute of the Consumer) The Institute is in charge of the control of compliance: advertising code, direct marketing consumer safety 2.4 Overview of national organisation PORTUGAL

29. Consumer (Services and Products) Safety Commission (CSC) The CSC is an independant public authority Missions: To issue recommendations and suggest any measure to better the prevention of risks as regards the safety of products and services To bring to the public’s knowledge all the information the Commission thinks necessary To search and make a list of all data on the dangers presented by products or services 2.4 Overview of national organisation PORTUGAL

30. 3. Market Surveillance Tasks - Powers - Organisation Europe Competent Authorities Nominate the authorities competent to monitor the compliance of products and define their: tasks powers organisation

31. 3.1 Market Surveillance – Tasks Market Surveillance Ensure that producers and distributors comply with their obligations

32. 3.1 Market Surveillance – Tasks Market Surveillance Ensure that producers and distributors comply with their obligations Producers shall only place safe products on the market Introduction of ‘harmonised’ standards which give presumption of conformity Producers shall provide relevant information to enable consumers to assess the risks inherent in a product Producers shall adopt measures to enable them to be informed of risks an take appropriate actions Traceability --- RAPEX

33. 3.1 Market Surveillance – Tasks Market Surveillance Ensure that producers and distributors comply with their obligations Distributors shall not supply products of which they (should) know that they don’t comply with the applicable safety requirements Distributors shall participate in monitoring the safety of products

34. 3.1 Market Surveillance – Tasks Market Surveillance Ensure that producers and distributors comply with their obligations Give the opportunity to consumers and other interested parties to submit complaints and follow op these complaints Establish sectoral surveillance programmes Follow-up of scientific and technical knowledge concerning product safety Periodical review and assessment of the surveillance activities and approach

35. 3.2 Market Surveillance - Powers Europe Powers Give the authorities the necessary powers to take appropriate action and measures

36. Belgium Powers (1) By royal decree rules can be established for the manufacturing, the import, the export, the modification, the marketing, the renting, the distribution for free, the labelling, the use... of products or types of products Advice is needed from the Consumer Safety Commission 3.2 Market Surveillance - Powers

37. By royal decree rules can be established for the manufacturing, the import, the export, the modification, the marketing, the renting, the distribution for free, the labelling, the use... of products or types of products 3.2 Market Surveillance - Powers

38. Belgium Powers (2) The Minister can order: to stop the selling of the product to withdraw the products of the market to inform the public to recall very dangerous products to destroy products if needed to publish the results of tests and decisions a warning to the manufacturer the manufacturer to have the product tested by an independent laboratory 3.2 Market Surveillance - Powers

39. The Minister can order: to withdraw the products of the market foto eclipsbril 3.2 Market Surveillance - Powers

40. The Minister can order: to publish the results of tests and decisions 3.2 Market Surveillance - Powers

41. The Minister can order: to recall very dangerous products 3.2 Market Surveillance - Powers

42. The Minister can order: to inform the public 3.2 Market Surveillance - Powers

43. The Minister can order: to inform the public 3.2 Market Surveillance - Powers

44. The Minister can order: to inform the public 3.2 Market Surveillance - Powers

45. The Minister can order: to destroy products if needed 3.2 Market Surveillance - Powers

46. The Minister can order: to stop the selling of the product 3.2 Market Surveillance - Powers

47. The Minister can order: the manufacturer to have the product tested by an independent laboratory 3.2 Market Surveillance - Powers

48. Belgium Powers (3) The competent authorities can: enter every storage shed, shop, plant take samples free of charge and examine them take every document they need hear producers and employees use the finding of other competent authorities block stocks 3.2 Market Surveillance - Powers

49. The competent authorities can: take samples free of charge and examine them 3.2 Market Surveillance - Powers

50. The competent authorities can: take samples free of charge and examine them 3.2 Market Surveillance - Powers

51. The competent authorities can: take samples free of charge and examine them 3.2 Market Surveillance - Powers

52. The competent authorities can: take every document they need 3.2 Market Surveillance - Powers

53. Europe Penalties Provide for effective, proportionate and dissuasive penalties

54. Belgium Penalties In case of non-respect of the law, penalties can go up to € 20.000 for each infringement Penalties are doubled when the infringement is repeated within 5 years Excessive/unauthorised profits can be confiscated Publication of the judgement by any means can be ordered 3.2 Market Surveillance - Powers

55. 3.3 Market Surveillance - Organisation Belgian Competent Authorities FPS Economy, SMEs, Self-employed and Energy

56. Belgian Competent Authorities FPS Economy, SMEs, Self-employed and Energy FPS Employment, Labour and Social dialogue 3.3 Market Surveillance - Organisation

57. Belgian Competent Authorities FPS Economy, SMEs, Self-employed and Energy FPS Employment, Labour and Social dialogue FPS Health, Food Chain Safety and Environment 3.3 Market Surveillance - Organisation

58. Belgian Competent Authorities FPS Economy, SMEs, Self-employed and Energy FPS Employment, Labour and Social dialogue FPS Mobility and Transport FPS Health, Food Chain Safety and Environment 3.3 Market Surveillance - Organisation

59. Belgian Competent Authorities FPS Economy, SMEs, Self-employed and Energy FPS Employment, Labour and Social dialogue FPS Mobility and Transport FPS Health, Food Chain Safety and Environment FPS Finance 3.3 Market Surveillance - Organisation

60. Belgian Competent Authorities FPS Economy, SMEs, Self-employed and Energy FPS Employment, Labour and Social dialogue FPS Mobility and Transport FPS Health, Food Chain Safety and Environment FPS Finance Central Contact Point 3.3 Market Surveillance - Organisation

61. Belgian Competent Authorities FPS Economy, SMEs, Self-employed and Energy FPS Employment, Labour and Social dialogue FPS Mobility and Transport FPS Health, Food Chain Safety and Environment FPS Finance Central Contact Point Consumer Safety Commission 3.3 Market Surveillance - Organisation

62. Belgian Competent Authorities FPS ECONOMY 3.3 Market Surveillance - Organisation

63. Belgian Competent Authorities CENTRAL CONTACT POINT 3.3 Market Surveillance - Organisation Consumers, producers and distributors report products and services that don’t fulfill the safety requirements Belgian contact point for the European Exchange systems (RAPEX, CIRCA,...) Statiscal evaluations of risks concerning consumer products Co-ordinate all federal goverment campaigns concerning product safety

64. Central Contact Point 3.3 Market Surveillance - Organisation Belgian Competent Authorities CENTRAL CONTACT POINT

65. ConsumersIndustryAuthorities Central Contact Point 3.3 Market Surveillance - Organisation

66. ConsumersIndustryAuthorities Central Contact Point RAPEX 3.3 Market Surveillance - Organisation

67. ConsumersIndustryAuthorities Central Contact Point Advisory commissions Ext. experts and mediation RAPEX 3.3 Market Surveillance - Organisation

68. Market surveillance Market surveillance by the authorities Administration Consumers, industry, notified bodies... Product control Follow up ConsumersIndustryAuthorities Central Contact Point Advisory commissions Ext. experts and mediation RAPEX 3.3 Market Surveillance - Organisation

69. 4. Conclusions 4.1 Organisation The organisation of the Market Surveillance Authorities is closely linked to the geographic administrative structure of the country. In highly decentralised countries a coordination authority is needed: Belgium: Central Contact Point for Consumer Products France: Interministerial Committee on Consumer Affairs Spain: the National Consumer Institute

70. 4. Conclusions 4.2 Enforcement <> Information In most countries a distinction is made between: the Market Surveillance Authority surveillance enforcement an (independent) Commission (outside authority) to give independent advice to inform the public to gather statistical information

71. 4. Conclusions 5.3 Effectiveness In order to be effective, a MSA needs: the necessary powers to take appropriate action and measures to participate in networking (information exchange) - nationally - European-wide - internationally

72. 5. Questions ? 4th International Workshop on Conformity Assessment - Rio De Janeiro - 8 / 9 December 2008