1. TAIEX GPSD Free Movement and Safety Vitomir Fister Beograd, 28. 5. 2008

2. 2 Free Movement Safety Elimination of Technical Barriers to Trade/High Level of Safety ● Harmonization ● Mutual recognition ● Notification procedure

3. Technical Regulations ● Old Approach ● New Approach ● Non-harmonised area EU technical legislation is comprised of app. 1000 legal acts (30 groups of products)

4. Legal analysis: What legislation must it comply with? Are they connected? What standards cover it? What do I know about it? Is it safe, does it perform...? Horizontal and Sector Rules

5. Reference to Standards in TR ● Exclusive (Old Approach) ▪ Standards are mandatory ● Indicative (New Approach) ▪ Standards are voluntary

6. Horizontal Framework ● Standardization ● Accreditation ● Notification Directive (98/34/EC) ● Low Voltage Directive (73/23/EEC) ● EMC Directive (89/336/EEC) ● General Product Safety Directive (2001/95/EC) ● Product Liability Directive (85/374/EEC)

7. New Internal Market Package for Goods ● Regulation on the Requirements for Accreditation and Market Surveillance ● Decision on a Common Framework for the Marketing of Products ● Regulation on Mutual Recognition ● Communication on Car Registration

8. Conformity Assessment Procedures (NA) ●Testing (Laboratories), ● Certification (Certification Bodies), ● Inspection (Inspection Bodies). (CAB) ● Predominantly private organizations, ● Competitive environment, ● They have to be evaluated, designated and notified (Notified Bodies).

9. Types of Assessment Product Accreditation Consumers WTO/EU Authorities Manufacturer Laboratory Quality Department Self Assessment Certification Body Control Body Laboratory Competition No competition First Level Assessment Second Level Assessment Requirements Assessment Requirements

10. Trade Relations ILAC IAF Conformity assessment WTO ISO CGPM TRADE Tracebility Technical regulations Accreditation Standardization

11. General Product Safety General Product Safety Directive 92/59/EGS 2001/95/ES Came into force: 15. January 2004

12. Aim of GPSD ● To ensure a high level of consumer protection. ● To establish on a Community level a general safety requirement for any product placed on the market and available to the consumers. ● To ensure the proper functioning of the internal market.

13. Scope of GPSD ● GPSD applies to non-food consumer products, including: ▪ products migrated from professional use, ▪ products supplied within a service. ● Applies in its entirety to products not covered by “sector” legislation. ● Applies partially to products covered by “sector” legislation.

14. What does this mean? ● For products not covered by “sector” legislation: ▪ product safety requirements. ● For nearly all consumer products: ▪ safety management requirements for producers and distributors, ▪ market surveillance obligations, ▪ RAPEX, ▪ powers for Community emergency measures.

15. Legislation on Different products Approach Horizontal legislation Horizontal Directive

16. Guideline Relationship GPSD/ “Sector” Directives: ▪ Toys, Cosmetics, ▪ LVD, PPE, ▪ Medical devices, Med. products, ▪ Machinery, Motor vehicles, ▪ Construction products.

17. When it should be applied? To products intended for or likely to be used by consumers, irrespective of the selling techniques, including distance and electronic selling. NOTE: Some MS include professional equipment

18. Exceptions ▪ Second–hand products supplied as antiques. ▪ Products to be repaired or reconditioned prior to being used.

19. Services? NO, BUT…… Its provisions should apply to products that are supplied or made available to consumers in the context of service provision for use by them.

20. Safe Product Any product which does not present any risk or only the minimum risks compatible with the product’s use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons: ▪ characteristics of product, ▪ effect on other products, ▪ presentation of product, ▪ categories of consumers (children/elderly).

21. Important! The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be "dangerous“.

22. Dangerous Product Any product which does not meet the definition of “Safe product”: ▪ dangerous product – “moderate risk”, ▪ dangerous product – “serious risk” (RAPEX). Risk assessment: ▪ Publication on comparative review of methods, ▪ RAPEX guideline, ▪ Risk assessment guideline – draft.

23. Producer ● Manufacturer and any other person presenting himself as the manufacturer by affixing to the product his name, trade mark or other distinctive mark, ● Manufacturer’s representative, or if there isn’t any, the importer of the product, ● Other professionals in the supply chain if their activities may affect the safety of a product.

24. Distributor Any professional in the supply chain whose activity does not affect the safety properties of a product.

25. Conformity Assessment Criteria Conformity to: ● National technical legislation, ● Voluntary national standards, ● Commission recommendations, ● Codes of good practice, ● State of the art and technology, ● Reasonable consumer expectations.

26. Who Monitors Conformity? It is a continual process and dialogue: ● Producer – in design, production and on market, ● Distributor – on market, ● Market Surveillance – on market, ● Consumers – on market.

27. Obligations of Producers (1) Producers are obliged: ● to place only safe products on the market, ● to supply consumers with information enabling them to assess and prevent risks, ● to warn consumers of the risks posed by dangerous products already supplied to them.

28. Obligations of Producers (2) Producers have the obligation: to withdraw dangerous products from the market, and as a last resort to recall them when necessary.

29. Obligations of Distributors Distributors are required: ● to help to ensure compliance with technical requirements, ● not to supply non-compliant products, ● to participate in monitoring the safety of products, ● to keep and provide the documentation, ● to participate in actions to avoid the risks.

30. Obligations of Producers and Distributors Producers and distributors shall: ● immediately inform the authorities about non-compliant products, ● at the request co-operate with the authorities in removing the risks.

31. Powers of Member States (1) Authorities are responsible for monitoring product safety and have powers, to: ● impose effective, proportionate and dissuasive penalties, ● organise immediately and efficiently, the withdrawal or as a last resort recall of the of dangerous products already placed on the market.

32. Powers of Member States (2) Competent authorities should observe the principles of: ● proportionality, ● precaution.

33. Guidelines ● Guidelines for the notification of dangerous consumer products to the competent authorities of MS by producers and distributors. ● Guidelines for the management of RAPEX (for Authorities and Business). ● Product Safety in Europe – A Guide to corrective actions including recalls.

34. Exchange of Information Collaboration between the enforcement authorities of the Member States and the Commission, enabled by: ● European Network of the Enforcement Authorities (collaboration between the enforcement authorities of the Member States). ● Community Rapid Information System (RAPEX).

35. ● Ensures operation of RAPEX ● Analyses information transmitted ● Validates notifications and reactions ● Distributes information to MS ● Forwards information from Commission to the national authorities and vice versa ● Monitors operation of RAPEX ● Check if notified products are found on the national market ● Collect additional information about notifiedproducts ● Provide the results of MS activities to RAPEX Contact Point National RAPEX Contact Point European Commission Customs authorities Market surveillance authority Market surveillance authority Market surveillance authority

36. RAPEX 2007 Comparison with previous years

37. Notifications by notifying country

38. Notifications by product category

39. Notifications by type of risk

40. Number of notifications by type of measure

41. Notifications by country of origin of the notified product

42. Notifications by country of origin of the notified product (2004-2007)

43. Thank you! +386 41 689 186 vitomir.fister@siol.net