1. ICPHSO Asia-Pacific Symposium Monday, October 31, 2011 Panel "Regulatory Frameworks: Then and Now – A Comparative" Overview of Regulatory Systems, Legal Foundations Moderator: Stefano Soro, Head of Unit Product and Service Safety Directorate General Health and Consumers, European Commission Speakers: Korea: Nam-jung Kim, Director, Korean Agency for Technology and Standards (KATS) Japan: Katsumi Arai, Deputy Director-General, Product Safety Technology Center, National Institute of Technology and Evaluation Australia: Ruth Mackay, General Manager, Product Safety, Branch, Australian Competition & Consumer Commission U.S: Marc J. Schoem, Deputy Director, Office of Compliance and Field Operations, U.S. Consumer Product Safety Commission (CPSC), USA Canada: Helen Ryan, acting Director General of Consumer Product Safety Directorate, Health Canada EU: Maija Laurila, Deputy Head of Unit Product and Service Safety, Directorate General Health and Consumers, European Commission China: Liu Shiyuan, Deputy Director General, Department on Inspection Supervision, AQSIQ

2. Safety First

3. I II III

4. I

5. Product Safety Management System 5

6. 리콜 등 필요조치 High hazardous items(14 items) Manage products from production stage through product test and factory inspection High hazardous items(14 items) Manage products from production stage through product test and factory inspection Mandatory indication of hazard information(30 items) Mandatory indication of hazard information(30 items) Safety and quality labeling after manufacturers or importers do self- confirmation if their products meet safety and quality labeling standard Mandatory indication of hazard information(30 items) Mandatory indication of hazard information(30 items) Safety and quality labeling after manufacturers or importers do self- confirmation if their products meet safety and quality labeling standard Hazardous items which have concerns to induce safety incidents (47 items) Report to a certification body after manufacturers or importers confirm if their products meet safety standard through authorized testing laboratories Hazardous items which have concerns to induce safety incidents (47 items) Report to a certification body after manufacturers or importers confirm if their products meet safety standard through authorized testing laboratories

7. 리콜 등 필요조치 Hazardous items which have concerns to cause safety incidents (93 items) Report to a certification body after manufacturers or importers confirm if their products meet safety standard through authorized testing laboratories Hazardous items which have concerns to cause safety incidents (93 items) Report to a certification body after manufacturers or importers confirm if their products meet safety standard through authorized testing laboratories Sell products after manufacturers assure their product safety themselves (33 items) Sell products after manufacturers assure their product safety themselves (33 items) Indicate safety of products after manufacturers or importers do self- confirmation if their products meet the safety standard. Sell products after manufacturers assure their product safety themselves (33 items) Sell products after manufacturers assure their product safety themselves (33 items) Indicate safety of products after manufacturers or importers do self- confirmation if their products meet the safety standard. High hazardous items(53 items) Manage products from production stage through product test and factory inspection High hazardous items(53 items) Manage products from production stage through product test and factory inspection

8. 8 Certification Body Safety Certification Self-regulatory Safety confirmation Certification Body Manufacturers (domestic and international ) Importers High hazardous products are regulated as items subject to safety certification Low hazardous products are regulated as items subject to self-regulatory safety certification. Relevant act: Electrical Appliances Safety Control Act, Quality Control and Safety Management of Industrial Products Act 리콜 등 필요조치 Procedure for safety certification and self-regulatory safety confirmation Procedure for safety certification and self-regulatory safety confirmation Certification Body

9. 리콜 등 필요조치 Brief of the Framework Act on Product Safety Brief of the Framework Act on Product Safety ① The government may conduct safety investigations of the products distributed on the Korean markets to verify their safety. ② The government may analyze product incidents and conduct inspection to prevent recurrence of the incident. ③ The government may recommend the enterpriser to carry out a recall of the products which have minor defect. ④ The government may order the enterpriser to carry out a recall of the products and announce the case to the press for products having major defects. ⑤ If enterprisers are aware that their products are unsafe, they should report it to KATS and carry out a voluntary recall. ⑥ Where enterprisers do not conduct a product recall, the government may conduct a mandatory recall and then claim expenses to the enterpriser. ① The government may conduct safety investigations of the products distributed on the Korean markets to verify their safety. ② The government may analyze product incidents and conduct inspection to prevent recurrence of the incident. ③ The government may recommend the enterpriser to carry out a recall of the products which have minor defect. ④ The government may order the enterpriser to carry out a recall of the products and announce the case to the press for products having major defects. ⑤ If enterprisers are aware that their products are unsafe, they should report it to KATS and carry out a voluntary recall. ⑥ Where enterprisers do not conduct a product recall, the government may conduct a mandatory recall and then claim expenses to the enterpriser.

10. II

11. Conduct safety investigation cooperation with certification bodies, consumer groups and local government Enhance control of imported products by expanding scope of the products which should get safety confirmation from a custom director. Support R&D on the advance in safety to solve the original problems of product safety accidents - Fund 5 billion won(Korean currency) for 34 projects in 2009 - Fund 3.8 billion won for 30 projects in 2010. 153 items including 22 children products, 129 electric appliances Strengthen safety investigation of products distributed on the market Expand consumer participation for product safety monitoring *Safety investigation of products (‘07) 842 cases (‘08) 1,003 cases (‘09) 3,049 cases (‘10) 3,035 cases Place safety monitoring observers and safety keepers on the market * Safety keepers : (‘10) 150 people Strengthen safety management of imported products in cooperation with the Korea Customs Service Give support to develop difficult common technologies for weak common technologies for weak area of product safety

12. 12

13. III

14. Early industrialization Economic Growth (1980~1990) Entry of developed countries (since 2000) Expand self-regulatory safety management system Strengthen social responsibility(recalls) (since 2010) Assure minimum quality Export inspection Enhance product quality Model recognition Enhance consumer safety and autonomy of enterprisers Supplier's Declaration of Conformity Ensure consumer safety Safety Certification 1980 ~1990 1960 ~1970 Since 2000Since 2010

15. After product is released, Market surveillance system (Framework Act on Product Safety) Before a product is released, Before a product is released, Pre-regulation system (Individual acts) Safety Certification System Self-regulatory Safety Confirmation System Supplier’s Declaration of Conformity System Before a product is released, Before a product is released, Pre-regulation system ㅇ Before a product is released : Expand self-regulation of enterprisers from Safety Certification System to Self-regulatory Safety Confirmation System and Supplier’s Declaration of Conformity System ㅇ After a product is released: Encourage enterprisers to take corporate social responsibility by strengthening market surveillance according to the Framework Act on Product Safety Strengthen control and supervision after a product is released. After a product is released, Post-regulation system

16. Thank you for attention Thank you for attention !

17. Product Safety System in Japan October 31, 2011 The National Institute of Technology and Evaluation

18. 4 Items 6 Items Gas Business Act Law Concerning the Securing of Safety and the Optimization of Transaction of Liquefied Petroleum Gas Electrical Appliances and Materials Safety Act Consumer Products Safety Law General law Special laws  Notify : All person engaged in business of manufacturing or importing specified consumer products shall notify the competent minister.  Compliance: A Notifying Supplier manufacturing or importing specified consumer products shall comply with the technical requirements  Labeling: When a Notifying Supplier has performed the Supplier’s obligations in accordance with the applicable regulations, the supplier may affix the marks in accordance with the methods stipulated in the METI Ordinance. Product Safety System in Japan: Pre-Marketing 115 Items 339 Items 4 Items Product Safety-related laws 7 Items 9 Items

19.  The long-term Use Consumer Product Safety Inspection System Products with a high likelihood of causing a serious accident due to degradation are deemed specified maintenance products, and a standard period of use is established as a guideline for safe use. Measures for deterioration Measures for deterioration 【 year of manufacture 】 20XX 【 Standard period of Use 】△△ years Beyond standard period of use, it may cause fire or injury by deterioration. ! Product Safety System in Japan: Post-Marketing  The long-term Use Consumer Product Safety Indication System Products with a large number of accident reports due to deterioration are required to bear warning labels regarding deterioration and a standard period of use.

20. Report of Accidents  Reporting Obligation for serious accidents As stipulated under Article 35 of the consumer product safety law, manufacturer or importer shall submit report to the Consumer Affairs Agency (CAA) about the accident, giving model type/number, details of the accident and damage, etc. within 10 days. (requiring 30 days or more of treatment), leaving residual disability, carbon monoxide poisoning or fires. Serious accident: Accident causing death, serious injury or disease(requiring 30 days or more of treatment), leaving residual disability, carbon monoxide poisoning or fires. Death Serious Injury Fire Carbon Monoxide Poisoning Residual Disability Total Death due to fire Serious injury due to fire GasAppliances 7(6)13(6)17540199 Kerosene Appliances 11(10)3(3)12420140 Electrical Appliances 12(9)21053100564 Others 200190(1)2800238 Total 50(25)227(10)858601,141 4% 20% 75%1%0%100% The number of serious accident reports in FY2010 Product Safety System in Japan: Post-Marketing

21. 5 Electrical Appliances and Materials Safety Act Partial Revision of the Cabinet Order by the amendment to the government ordinance for the Electrical Appliances and Materials Safety Act (July 1, 2011)  LED lamps, etc. (Newly added as electrical appliances regulated under the Act)  Vacuum cleaners whose rated power consumption exceeds 1 kilowatt (The scope of regulation is expanded for vacuum cleaners)  Lithium-ion rechargeable batteries with specific structure (The scope of regulation is expanded for lithium-ion rechargeable batteries)  Power strip and code set for home use (Under consideration) Enforcement: July 1 (Sunday), 2012 Product Safety System in Japan: In the Near Future

22. Katsumi Arai Deputy Director-General Product Safety Technology Center, National Institute Technology and Evaluation, Japan Thank you for your attention.

24. Key Pillars of the Australian Regulatory System Ruth Mackay General Manager, Product Safety Branch Australian and Competition and Consumer Commission

25. Notification Recall notification Suppliers to notify ACCC within 2 days of taking recall action Notice before action is encouraged Recalls are then subject to scrutiny and effectiveness monitored Compulsory recall action can be taken Death, serious Injury or illness notification Suppliers of consumer products or of the services related to them to notify ACCC within 2 days of becoming aware of incident Intention is to enable regulator scrutiny of incident responses, early identification of trends and regulator involvement if necessary

26. Regulations (Standards and Bans) Mandatory standards − Created by the Australian Government (on ACCC recommendation) − Often mandate elements of Australian voluntary standards (quite often with some variation) − May pick up requirements of voluntary standards of other countries − May be a creation of government (ie rather than replicating a voluntary standard) Interim (up to 120 day) and permanent (ongoing) bans − Interim bans may be made by the Australian commonwealth Government or by state and territory governments − Permanent bans only made by the Commonwealth Government Currently 61 consumer product safety regulations in Australia

27. Joint Compliance / Enforcement Proactive compliance Guidance, FAQs, seminars, webinars, association liaison, partnering, fostering compliance culture Surveillance Find non-compliance Matter management Address non- compliance: - hazard remedies, - enforcement remedies against primary supplier Customs interventions Vigilance, visibility, publicise proactive actions, trade fairs, ag. fairs Publicise enforcement outcomes; Direct action with secondary and tertiary suppliers; Undertakings and orders Compliance incentive

28. 28 Views expressed in this presentation are those of the staff and do not necessarily represent the views of the Commission

29. Safety Standards Activities Regulation Enforcement Education 29

30. Use of Mandatory Standards (Technical Regulations) Advanced Notice Comment and Discussion Finalization Review and Use of Voluntary Standards Participation and Monitoring Development Section 15j Rules 30

31. Use of Regulation Toys and Children’s Products Other Consumer Products 31

32.  Reporting Obligations Product Defect and Incident Reporting Voluntary/Mandatory Product Recalls  Marketplace Surveillance Preventive and Responsive  Port Surveillance Preventive and Targeted  Internet Surveillance Preventive and Responsive 32

33. New Office of Education, Global Outreach, and Small Businessman Ombudsman Public/Private Partnerships 33

34. Marc Schoem Deputy Director Office of Compliance and Field Operations U.S. Consumer Product Safety Commission  Phone: 301-504-7520  mschoem@cpsc.gov mschoem@cpsc.gov

35. Canada’s Consumer Product Safety Regulatory Framework Helen Ryan – Director General Health Canada Consumer Product Safety Directorate

36. Canada’s Food and Consumer Safety Action Plan High profile consumer product recalls in 2007 highlighted the need for modernized product safety regulatory framework The government’s response was The Food and Consumer Safety Action Plan: Active Prevention – clearly articulating that industry is responsible for the safety of the products they sell and ensuring good information is available to consumers to help them use products safely. Targeted Oversight – provide tools for the early detection of safety problems. Rapid Response – strengthening the basis for response by industry and government to safety issues, including strengthening government authorities to compel or take action.

37. CCPSA: New Authorities and Requirements The Canada Consumer Product Safety Act came into force on June 20, 2011, replacing the Hazardous Product Act (HPA). New “ General Prohibition” Provision Mandatory reporting by industry on serious incidents with their products (including near misses) Ability to require tests and studies to verify compliance or prevent noncompliance Ability to order recall and other corrective actions Record-keeping to allow traceability in the event of a recall Sharing/disclosure of information Increased fines and penalties including an administrative monetary penalties scheme (AMPs) Product-specific regulations transferred from HPA

38. Key Elements Of Our Strategy Moving Forward Information and outreach with domestic and international stakeholders to ensure that importers, manufacturers, and retailers are aware of obligations Working in close partnership with domestic and international partners to collaborate on approaches to issues of common concern, including: standards development; risk assessment; training; outreach and recalls Development of an integrated system to improve our intelligence on imports in collaboration with Canada Border Services Agency Development and implementation of new regulations and administrative measures to enhance the product safety regime

39. Maija Laurila European Commission DG Health and Consumers EU Internal market of safe consumer products

40. General safety requirement legislation  General Product Safety Directive (GPSD) of 2004, New Legislative Framework Regulation for harmonised products of 2010, and sectoral Directives (e.g. for toys, electrical equipment) provide the legal framework  General safety requirement: all products must be safe to be placed on the EU market (27 + 3 countries), and if they fail this requirement, the law provides for corrective measures and sanctions

41. RAPEX rapid alert system European Rapid Alert System covering non-food products posing serious risks to consumers Ensures that information about dangerous consumer products identified in one country is quickly circulated to the other (29) countries and the Commission for appropriate follow-up, with the aim of preventing their further supply to consumers Also website informing consumers

42. Efficient cooperation network Market surveillance and enforcement are the responsibility of the EU States, the European Commission supervises Cooperation network between the enforcers of 30 countries, regular meetings, easy access to peer advice from other countries, pooling expertise, organising joint actions, learning from each other's progress etc. Also pilot of joint surveillance action involving China (“seemless surveillance”)

43. Legislative review pending Legislative proposal planned during 2012, entry into force later A= Authorities: better coordination of surveillance and enforcement actions, sharing of plans etc. B=Businesses: clearer obligations for economic operators in terms of identification on the product or packaging, making available a technical file etc., lower compliance costs, genuine level-playing field for legitimate business C=Consumers: a more homogeneous internal market of safe goods - better protection of health and safety, increased consumer confidence