A study on extended HACCP and preventive control systems for novel foods through comparison of global regulations

In this mini-review, the authors propose an extended HACCP-based preventive control framework for novel foods, including plant-based and cultured meat, to address emerging safety requirements that surpass traditional process-centered controls. Regulatory approaches among different jurisdictions were found to be characterized by substantial heterogeneity, which complicates industry compliance. Furthermore, managing non-process hazards, such as allergen cross-contact in complex supply chains or atypical risks in bioreactors (e.g., unforeseen toxicity), poses challenges regarding the capacity of conventional manual monitoring. On the basis of a synthesis of global industrial practices adopting Smart HACCP, this review emphasizes that integrating AI-driven predictive modeling (e.g., digital twins and multi-omics), IoT sensors, and blockchain can contribute to ensuring data integrity and real-time verification. These digital capabilities will be essential for satisfying the rigorous pre-market approval requirements. Ultimately, combining traditional critical control point management, non-process hazard controls, and robust digital infrastructure will provide a practical basis for improving safety assurance and harmonizing compliance strategies in the production of novel foods.