The European Commission has opened a Call for Evidence for an impact assessment on Biotech Act II, a planned initiative focused on industrial biotechnology and biomanufacturing in the European Union.
The initiative follows the proposal for the European Biotech Act I, which primarily covers health biotechnology, and is intended to broaden the EU policy focus towards industrial applications, bio-based products and biomanufacturing. According to the Commission’s Call for Evidence, the likely form of the initiative is a Regulation of the European Parliament and of the Council, with an indicative timetable of Q4 2026 for the proposal.
The Commission identifies industrial biotechnology and biomanufacturing as areas with significant potential for EU strategic autonomy, competitiveness, industrial innovation, circularity and sustainability. At the same time, it points to several barriers that continue to limit deployment in Europe, including fragmented value chains, sub-optimal use of feedstock, low price competitiveness, strong global competition, investment uncertainty, and fragmentation in the EU single market and regulatory environment. The initiative is being developed by DG GROW and builds on existing EU policy work, including the 2024 communication on boosting biotechnology and biomanufacturing in the EU, the 2025 European chemicals industry action plan and the 2025 bioeconomy strategy.
Why EU action is being considered
The Commission argues that the issues identified are likely to require both legislative and non-legislative measures at EU level. This is because industrial biotechnology and biomanufacturing value chains are cross-border by nature, from biomass sourcing and biotechnology processing to manufacturing, distribution and operations. The Call for Evidence states that EU action could help address inconsistent market conditions for bio-based products and technologies, improve regulatory certainty and create conditions for companies to build a business case for European bio-based products.
The impact assessment will examine several intervention areas before the Commission decides on the final scope of the initiative. These include creating lead markets for bio-based and recycled carbon-based products, exploring market pull measures such as minimum content requirements, considering supply-side measures and regulatory sandboxes, and assessing options to improve investment predictability.
The Commission will also examine sustainability criteria for biomass used by industry, simplification measures to address permitting, authorisation and regulatory bottlenecks, and non-legislative support such as networks, access to funding and measures that foster the use of sustainable bio-based or recycled carbon feedstocks.
Why this matters for rare disease research
Biotech Act II is focused on industrial biotechnology and biomanufacturing rather than health policy, and it should not be presented as a rare disease-specific initiative. However, in areas where biotechnology, manufacturing capacity, regulatory predictability or supply-chain resilience affect the movement of research outputs towards practical use, patient organisations, researchers, SMEs and clinical research stakeholders may have relevant evidence to contribute.
For people living with rare diseases and their families, the key issue is not whether this initiative will directly change access to therapies, but whether future EU measures can help create a more predictable and resilient biotechnology ecosystem while maintaining appropriate safeguards. This is especially relevant for rare disease research, where small populations, specialised expertise and complex development pathways often make the translation of research into practical outputs particularly demanding.
How stakeholders can contribute
Until 10 June 2026, the Commission invites input from a broad range of stakeholders, including the public, innovators, entrepreneurs, researchers and academia, biotech companies of different sizes and sectors, industry federations, NGOs and civil society, users of biotechnologies, trade unions, policymakers, public authorities, investors and venture capitalists active in biotechnology and biomanufacturing.
Industry players are particularly encouraged to submit evidence on the challenges, obstacles and bottlenecks they face. Contributions can be made through the Commission’s Have Your Say page for Biotech Act II, and the feedback received will feed into the impact assessment and preparation of the proposal. A synopsis report covering consultation activities will be included in an annex to the impact assessment report.
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