GLOBAL PRODUCT RECALL FOURTH EDITION Handbook Global Product Recall Handbook Fourth Edition Global Product Recall Handbook | Fourth Edition Foreword Baker McKenzie was founded in 1949. For almost seven decades, we have provided nuanced, sophisticated advice and leading-edge legal services to many of the world’s most dynamic and successful business organizations. With more than 7,000 internationally experienced lawyers in 47 countries, including 36 of the world’s largest economies, Baker McKenzie provides expertise in all of the substantive disciplines needed to formulate, develop and implement a global product recall. Our fluency in working across borders, issues and practices allows us to simplify legal complexity, foresee regulatory, legal, compliance, reputational, and commercial risks others may overlook and identify commercial opportunities that many miss. Taken together, this combination of deep practical experience and technical and substantive skills makes us advisers of choice to many of the world’s leading multinational corporations. Our clients want a new breed of lawyers with excellent technical skills and industry expertise who can look ahead to help them navigate a constantly changing product regulatory landscape. It means having lawyers who can anticipate what is coming next and provide practical legal resources that are helpful to the business at all levels. The Global Product Recall Handbook is one such resource, collecting, combining and synthesizing the advice of lawyers throughout Baker McKenzie focused on the consumer goods, pharmaceutical and medical devices, food and beverage, and motor vehicle industries. We are pleased also to make this edition of the Handbook available on a dedicated Dynamic Publisher site and accompanying mobile app. Both the site and the app make accessing the content easy and allow our readers to search and compare topics for jurisdictions of interest, at the click of a button. On behalf of the editors and contributors, we are very proud to publish the fourth edition of our extremely popular Global Product Recall Handbook. We hope you continue to find it a useful tool. Michael J. Wagner Executive Editor Baker McKenzie Global Executive Committee Member Chair, North America Global Product Recall Hotline Erin M. Maus Kate Corby David McCredie (North America) (EMEA) (Asia Pacific) Dispute Resolution Partner Dispute Resolution Partner Dispute Resolution Partner Chicago Office London Office Sydney Office Tel: +1 312 861 8202 Tel: +44 20 7919 1966 Tel: +61 2 8922 5358 Mobile: +1 312 656 3930 Mobile: +44 7779 099143 Mobile: +61 411 770 320 erin.maus kate.corby david.mccredie @bakermckenzie.com @bakermckenzie.com @bakermckenzie.com Global Product Recall Handbook | Fourth Edition Table of Contents Global Product Recall Hotline ............................................................. ii Editors’ Note .................................................................................... xiii Chapter 1 Introduction .......................................................................... 1 Chapter 2 Managing a Global Product Recall – Best Practice Guidelines ............................................................................................. 5 Argentina ............................................................................................ 17 1. Definition of a “consumer product” ...................................... 17 2. Agencies involved in regulating consumer products ............. 17 3. Reporting requirements and recall procedures ...................... 17 4. Product-specific regimes ....................................................... 18 5. Legal consequences of noncompliance ................................. 19 Australia ............................................................................................. 20 1. Definition of a “consumer product” ...................................... 20 2. Agencies involved in regulating consumer products ............. 20 3. Reporting requirements and recall procedures ...................... 20 4. Product-specific regimes ....................................................... 28 5. Legal consequences of noncompliance ................................. 31 Austria ................................................................................................ 35 1. Definition of a “consumer product” ...................................... 35 2. Agencies involved in regulating consumer products ............. 36 3. Recording requirements and recall procedures ..................... 36 4. Product-specific regimes ....................................................... 38 5. Legal consequences of noncompliance ................................. 40 Belgium .............................................................................................. 43 1. Definition of a “consumer product” ...................................... 43 Baker McKenzie | i 2. Agencies involved in regulating consumer products ............. 43 3. Reporting requirements and recall procedures ...................... 43 4. Product-specific regimes ....................................................... 45 5. Legal consequences of noncompliance ................................. 47 Brazil .................................................................................................. 49 1. Definition of a “consumer product” ...................................... 49 2. Agencies involved in regulating consumer products ............. 50 3. Reporting requirements and recall procedures ...................... 53 4. Product-specific regimes ....................................................... 59 5. Legal consequences of noncompliance ................................. 60 Canada ................................................................................................ 62 1. Definition of a “consumer product” ...................................... 62 2. Agencies involved in regulating consumer products ............. 63 3. Reporting requirements and recall procedures incident reporting ................................................................................ 64 4. Product-specific regimes ....................................................... 69 5. Legal consequences of noncompliance ................................. 74 Chile ................................................................................................... 77 1. Definition of a “consumer product” ...................................... 77 2. Agencies involved in regulating consumer products ............. 77 3. Reporting requirements and recall procedures ...................... 77 4. Product-specific regimes ....................................................... 80 5. Legal consequences of noncompliance ................................. 81 China .................................................................................................. 82 1. Definition of a “consumer product” ...................................... 82 2. Agencies involved in regulating consumer products ............. 83 3. Reporting requirements and recall procedures ...................... 84 ii | Baker McKenzie Global Product Recall Handbook | Fourth Edition 4. Product-specific regimes ....................................................... 86 5. Legal consequences of noncompliance ................................. 92 Colombia ............................................................................................ 96 1. Definition of a “consumer product” ...................................... 96 2. Agencies involved in regulating consumer products ............. 96 3. Reporting requirements and recall procedures ...................... 96 4. Product-specific regimes ....................................................... 97 5. Legal consequences of noncompliance ............................... 101 Czech Republic ................................................................................. 103 1. Definition of a “consumer product” .................................... 103 2. Agencies involved in regulating consumer products ........... 103 3. Reporting requirements and recall procedures .................... 104 4. Product-specific regimes ..................................................... 105 5. Legal consequences of noncompliance ............................... 107 Egypt ................................................................................................ 110 1. Definition of a “consumer product” .................................... 110 2. Agencies involved in regulating consumer products ........... 110 3. Reporting requirements and recall procedures .................... 110 4. Product-specific regimes ..................................................... 111 5. Legal consequences of noncompliance ............................... 114 European Union ................................................................................ 116 1. Definition of a “consumer product” .................................... 116 2. Agencies involved in regulating consumer products ........... 116 3. Reporting requirements and recall procedures .................... 118 4. Product-specific regimes ..................................................... 119 5. Legal consequences of noncompliance ............................... 122 Baker McKenzie | iii France ............................................................................................... 124 1. Definition of a “consumer product” .................................... 124 2. Agencies involved in regulating consumer products ........... 124 3. Reporting