Covington & Burling llp Brussels London New York San Francisco Washington Food & Drug E-Alert July 19, 2007 Cadbury and the Chocolate Factory E-Alert - Cadbury Case In a landmark case for the UK food industry, on 16 July 2007, Cadbury Ltd was fined £1m and ordered to pay £152,000 legal costs for knowingly selling chocolate contaminated with salmonella. This fine is unprecedented and demonstrates that the UK authorities are adopting a “zero tolerance” approach to breaches of food safety legislation. The Facts - The company first discovered salmonella contamination at its Bournville site in April 2002. Further positive samples were found between 2003 and 2006 in raw materials and end products, as well as manufacturing and distribution equipment. Cadbury Ltd began an internal investigation but, despite numerous routine visits from environmental health officers, did not inform the authorities until June 2006. The salmonella outbreak led to three people being treated in hospital and 39 - including babies and children under 10 - suffering from food poisoning after eating Cadbury’s products. The company recalled one million chocolate bars after the incident came to light. The Prosecution - Brought by Birmingham City Council against Cadbury Ltd. The company pleaded guilty to three offences under the General Food Regulations 2004 and the Food Hygiene Regulations 2006 for: ♦ Placing chocolate on the market that was injurious to health and unfit for human consumption; ♦ Failing to immediately inform the competent authorities; and ♦ Failing to identify hazards and critical control points, and take corrective action in line with Hazard Analysis and Critical Control Points (HACCP) principles. The Judgment - The Judge said this was “a serious case of negligence”, but added that he was “not satisfied that at the time of the introduction of the new system Cadbury consciously thought that it was taking a risk with people’s health.” A Precedent - This case sets a precedent for how food safety legislation will operate and be enforced in future. Many companies have tried to balance the requirements of notifying the Food Standards Agency (FSA) against the risk of being prosecuted for failing to report issues immediately. If a company notifies the FSA, there is always the possibility that the Agency could demand a product recall, even for relatively minor issues, which would be costly and could impact on brand reputation. This case sends a clear message that food companies can no longer attempt to deal with safety matters internally. They must involve the FSA and inform the Agency at the earliest opportunity. The Future - Despite the fine imposed by the court, some commentators believe this amount is too low for a multinational company to have any incentive to improve its behaviour in future. As a result of this case, the UK government or the European Commission could decide to carry out a review of the food safety penalties to ensure that these types of companies are fined a significant percentage of their profits for breaches of food safety legislation. Already, there is a European www.cov.com Covington & Burling LLP Community Penalties Regulation for pharmaceutical companies in force across Europe. These rules allow the European Commission to impose significant financial penalties on companies that infringe pharmaceutical rules. The food industry could be next in line. * * * This information is not intended as legal advice, which may often turn on specific facts. Readers should seek specific legal advice before acting with regard to the subjects mentioned herein. If you have any questions concerning the material discussed in this client alert, please contact the following members of our life sciences group: Anne Ware Peter Bogaert Joanna Wheeler +44.(0)20.7067.2124 +32.(0)2.549.5243 +44.(0)20.7067.2056 aware@cov.com pbogaert@cov.com jwheeler@cov.com Covington & Burling LLP is a leading law firm known for handling sensitive and important client matters. This alert is intended to bring breaking developments to our clients and other interested colleagues in areas of interest to them. Please send an email to unsubscribe@cov.com if you do not wish to receive future alerts. © 2007 Covington & Burling LLP. All rights reserved. www.cov.com Page 2