Regulatory, ethical, and standardization aspects of smart and intelligent food packaging

Smart and intelligent food packaging systems are transforming food safety, traceability, and sustainability by incorporating active agents, nanomaterials, biosensors, and digital monitoring platforms. Their rapid development, however, has outpaced regulatory and standardization frameworks, creating gaps in safety validation, interoperability, and ethical governance. This chapter provides a comparative analysis of key regulatory models across the EU, US, and selected international contexts, with emphasis on Codex Alimentarius, ISO, and ASTM standards. It examines unresolved challenges such as migration testing for multifunctional systems, assessment of nonintentionally added substances (NIAS), and liability in AI- and IoT-enabled compliance monitoring. Ethical dimensions, including informed consent, data protection, and consumer trust, are evaluated alongside sustainability imperatives under the EU Green Deal and UN SDGs. Policy pathways are identified through harmonization initiatives, public-private partnerships, and integration of Safe and Sustainable by Design (SSbD) principles. The chapter highlights convergence opportunities to enable safe, equitable, and globally scalable adoption of smart packaging.