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.

1 - Theoretical aspects of regulation
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
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
16 - Introduction
17 - The Community institutions involved and their mechanisms of governance
18 - Safety and risk
19 - Conclusions
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

Christopher Hodges is a Visiting Research Fellow at the Centre for Socio-Legal Studies, Oxford, and Partner at CMS Cameron McKenna.