Product Safety System in Japan

1. ICPHSO Asia-Pacific SymposiumMonday, October 31, 2011Panel "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 EvaluationAustralia: Ruth Mackay, General Manager, Product Safety, Branch, Australian Competition & Consumer CommissionU.S: Marc J. Schoem, Deputy Director, Office of Compliance and Field Operations, U.S. Consumer Product Safety Commission (CPSC), USACanada: Helen Ryan, acting Director General of Consumer Product Safety Directorate, Health CanadaEU: 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. Product Safety System in Japan October 31, 2011 The National Institute of Technology and Evaluation

3. Product Safety System in Japan: Pre-Marketing Product Safety-related laws Consumer Products Safety Law General law Electrical Appliances and Materials Safety Act Special laws Gas Business Act Law Concerning the Securing of Safety and the Optimization of Transaction of Liquefied Petroleum Gas • 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.

4. Product Safety System in Japan: Post-Marketing Measures for deterioration • 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. 【year of manufacture】 20XX 【Standard period of Use】△△ years Beyond standard period of use, it may cause fire or injury by deterioration. ! • 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.

5. Product Safety System in Japan: Post-Marketing 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. Serious accident: Accident causing death, serious injury or disease(requiring 30 days or more of treatment), leaving residual disability, carbon monoxide poisoning or fires. The number of serious accident reports in FY2010

6. Product Safety System in Japan: In the Near Future 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) Enforcement: July 1 (Sunday), 2012 • Power strip and code set for home use • (Under consideration) 5

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

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

10. 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

11. 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

12. Joint Compliance / Enforcement Publicise enforcement outcomes; Direct action with secondary and tertiary suppliers; Undertakings and orders Vigilance, visibility, publicise proactive actions, trade fairs, ag. fairs Compliance incentive Customs interventions

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

14. Safety Standards Activities Regulation Enforcement Education 29

15. 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

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

17. 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

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

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

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

21. 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.

22. 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

23. 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

24. Maija LaurilaEuropean Commission DG Health and Consumers EU Internal market of safe consumer products

25. 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

26. 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

27. 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”)

28. 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 businessC=Consumers: a more homogeneous internal market of safe goods - better protection of health and safety, increased consumer confidence