Regulatory considerations and challenges for bioproduct innovations

Abstract

As the demand for sustainable alternatives grows, biomaterials are becoming increasingly relevant across industries. However, their adoption is often slowed by regulatory frameworks not yet adapted to their unique characteristics. This thesis explores how EU regulations particularly REACH and the Ecodesign for Sustainable Products Regulation (ESPR) affect the development and market entry of biomaterials. Through a literature review and a case study of regenerated cellulose, this research highlights key regulatory challenges, including inconsistent classification, limited support for circular use, and high compliance burdens for smaller companies. The findings suggest that while current regulations are effective at managing chemical safety, they often overlook the specific needs and advantages of biomaterials, particularly in terms of end of life performance and sustainability. The thesis concludes by proposing improvements to regulatory processes, aiming to better align safety requirements with environmental goals and support innovation in the growing bioeconomy.