Foodborne illness is a global public health burden. Over the past decade in Australia, despite advances in microbiological detection and control methods, there has been an increase in the incidence of foodborne illness. Therefore improvements in the regulation and implementation of food safety policy are crucial for protecting public health. In 2000, Australia established a national food safety regulatory system, which included the adoption of a mandatory set of food safety standards. These were in line with international standards and moved away from a “command and control” regulatory approach to an “outcomes-based” approach using risk assessment. The aim was to achieve national consistency and reduce foodborne illness without unnecessarily burdening businesses. Evidence demonstrates that a risk based approach provides better protection for consumers; however, sixteen years after the adoption of the new approach, the rates of food borne illness are still increasing. Currently, food businesses are responsible for producing safe food and regulatory bodies are responsible for ensuring legislative controls are met. Therefore there is co-regulatory responsibility and liability and implementation strategies need to reflect this. This analysis explores the challenges facing food regulation in Australia and explores the rationale and evidence in support of this new regulatory approach.