On April 2, 2025, Ivona and Filip Miketa, founders of Bio-Mi, participated in an online workshop organized by the European Commission in collaboration with consulting firms Deloitte and Empirica, as part of a broader Study on the Regulatory Framework for Biotechnology and Biomanufacturing in the EU.
The aim of the workshop was to gather insights from key stakeholders in the field of biochemicals and bioplastics, particularly regarding how existing regulatory frameworks impact innovation, production, and market access for bio-based products and technologies.
As an SME from southeastern Europe, Bio-Mi is uniquely positioned at the intersection of biodegradable material development and production, while also actively participating in EU research and innovation projects under the Horizon programme. This role places the company under various legal frameworks, many of which do not fully accommodate the specificities of novel bio-based materials.
During the years, Bio-Mi gained experience and has encountered several key challenges, including the lack of differentiation between fossil-based and bio-based materials in current regulations, and the fragmented implementation of rules across EU member states. We believe that while the EU has heavily invested in the research and development of bio-based innovations, this investment must be safeguarded by appropriate and supportive legal frameworks.
Bio-Mi is among the few companies in Europe certified with TÜV “OK BIODEGRADABLE SOIL” for both raw materials (granulates) and finished products (such as mulch films). Drawing from our experience, we want to highlight the importance of promoting the use of certified biodegradable mulch films in agriculture, as they protect the soil, reduce microplastic pollution, and offer clear environmental and economic benefits. We also want to stress the need to protect certified producers through strict monitoring and enforcement of labeling standards, in order to prevent unfair competition, especially from non-EU markets.
We are grateful for the opportunity to contribute to this important dialogue and share our perspectives. We hope our input will support the development of a more coherent and forward-looking regulatory environment that fosters innovation and sustainability in the biotechnology and biomanufacturing sectors.
