European Regulation of Consumer Product Safety

This book examines the European Community legislation that regulates the safety of consumer products. Hodges surveys the extent to which this legislation aims to and succeeds in achieving safety for a wide range of products. There are different legal requirements for medicines, machines, electronics, toys and so on, which employ different regulatory mechanisms, including pre-marketing assessment, provision of information, control of the manufacturing environment, post-marketing obligations on producers and authorities, and obligations on distributors and users. Hodges compares the various mechanisms relating to medicinal products, products covered by 'New Approach' Directives, cosmetics, biocides, tobacco products, and consumer products covered by the General Product Safety Directive, and asks why particular mechanisms are used, or not used for different products. The book then moves on to consider what is meant by product 'safety', demonstrating the relativity of this concept. Hodges highlights an important problem: that consumers, the media, and experts can all have differing ideas on the level of safety that is relevant and acceptable. Hodges contends that the systems are in need of review, to ensure they work effectively and give value for money. In some cases, there is an need for more or less control. He argues for more systematic collection of safety data, and for consistecy in surveillance and enforcement mechanisms across Europe, pointing towards the need for a European Product Safety Agency.

Table of Legislation ; Table of Cases ; List of Figures ; List of Tables ; List of Abbreviations ; Introduction ; 1. Theoretical aspects of regulation ; PART ONE: DESCRIPTION OF THE MAIN REGULATORY SYSTEMS AT COMMUNITY LEVEL ; 2. Introduction ; 3. The limits on the Community's jurisdictional competence in product safety legislation ; 4. Medicinal products ; 5. New Approach products ; 6. Biocides, cosmetics, tobacco, and general consumer products ; PART TWO: PROCEDURAL MECHANISMS FOR SAFETY ; 7. Introduction ; 8. Pre-market assessment: authorization to market ; 9. Control of the manufacturing environment and process ; 10. Providing information ; 11. Producers' Post-marketing obligations ; 12. The role of the authorities in post-marketing safety ; 13. Control of distribution ; 14. Obligations on users ; 15. Conclusions on safety mechanisms ; PART THREE: THEORETICAL ISSUES AND CONCLUSIONS ; 16. Introduction ; 17. The Community institutions involved and their mechanisms of governance ; 18. Safety and risk ; 19. Conclusions ; APPENDICES ; Appendix 1 The Pharmacovigilance System ; Appendix 2 Statistics on the safety of general consumer products ; Appendix 3 Statistics on the safety of medicinal products ; Appendix 4 Statistics on the safety of electrical products ; Appendix 5 Modules for conformity assessment procedures under the New Approach ; BIBLIOGRAPHY ; INDEX