European Regulation Of Consumer Product Safety

This book examines European legislation that regulates the safety of consumer products. There are different legal requirements for medicines, machines, electronics, toys and so on, which employ different regulatory mechanisms. Hodges compares the various mechanisms 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.

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

Table of Cases

xi

Table of Legislation

xiii

List of Figures

xx

List of Tables

xxi

List of Abbreviations

xxii

Introduction

1

(6)

Theoretical Aspects of Regulation

7

(14)

I. DESCRIPTION OF THE MAIN REGULATORY SYSTEMS AT COMMUNITY LEVEL

Introduction

21

(6)

The Limits on the Community's Jurisdictional Competence in Product Safety Legislation

27

(11)

Medicinal Products

38

(15)

New Approach Products

53

(21)

Biocides, Cosmetics, Tobacco, and General Consumer Products

74

(11)

II. PROCEDURAL MECHANISMS FOR SAFETY

Introduction

85

(2)

Pre-market Assessment: Authorization to Market

87

(26)

Control of the Manufacturing Environment and Process

113

(4)

Providing Information

117

(12)

Producers' Post-marketing Obligations

129

(26)

The Role of Authorities in Post-marketing Safety

155

(36)

Control of Distribution

191

(4)

Obligations on Users

195

(3)

Conclusions on Safety Mechanisms

198

(5)

III. THEORETICAL ISSUES AND CONCLUSIONS

Introduction

203

(2)

The Community Institutions Involved and their Mechanisms of Governance

205

(19)

Safety and Risk

224

(27)

Conclusions

251

(46)

IV. APPENDICES

1. The Pharmacovigilance System

265

(4)

2. Statistics on the Safety of General Consumer Products

269

(12)

3. Statistics on the Safety of Medicinal Products

281

(6)

4. Statistics on the Safety of Electrical Products

287

(5)

5. Modules for Conformity Assessment Procedures Under the New Approach

292

(5)

Bibliography

297

(10)

List of UK Government Publications

307

(2)

Index

309

What is included with this book?

The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.

FREE SHIPPING

Amazon no longer offers textbook rentals. We do!

European Regulation Of Consumer Product Safety

Summary

Author Biography

Table of Contents

Supplemental Materials