The European Commission’s Call for Evidence on the upcoming Biotech Act II is open until 10 June 2026, with one week remaining for companies to provide input. Companies should consider engaging now to help shape the outcome.
The initiative is expected to have a broad impact across sectors including chemicals, agriculture, agri-biotech, food and feed, consumer products, and industrial manufacturing, as part of a wider EU effort to scale biotechnology and biomanufacturing as an alternative to fossil-based production.
This blog outlines what the Biotech Act II is expected to cover, which parts of the value chain may be affected, the types of measures under consideration, and how companies can engage in the current consultation.
Link to 1. What is the EU Biotech Act II? 1. What is the EU Biotech Act II?
The EU Biotech Act II is the Commission’s planned initiative on industrial biotechnology and biomanufacturing, complementing the earlier Biotech Act I, which as we reported, focuses primarily on health biotechnology. The Biotech Act II is expected to have a much broader application and:
- Establish a cross-sector framework for biotechnology and biomanufacturing.
- Address industrial applications beyond health (e.g., chemicals, consumer products, food and feed, agri-food).
- Cover the entire value chain, from feedstock sourcing and processing to manufacturing, scale-up and market deployment.
Importantly, the initiative reflects a broader policy shift from product-based regulation toward value chain and market-shaping approaches. Rather than introducing a standalone regulatory regime, the Act is likely to combine simplification and alignment of existing rules, enabling frameworks for scale-up and innovation, and market-creation tools to drive uptake.
Link to 2. What will the Act regulate? 2. What will the Act regulate?
Although the Biotech Act II will affect a wide range of sectors, its defining feature is that it operates across both products and the conditions under which they are developed and brought to market.
- Bio-based chemicals and materials, e.g., polymers, textiles, plastics.
- Agriculture and Agri-biotech, e.g., fertilizers, plant protection products.
- Food and feed, e.g., GMOs, NGTs, labelling.
- Biofuels, e.g., SAF, biodiesel, algal fuel.
- Cross-sector “biosolutions” (e.g., enzymes, microbial products)
- Feedstock sourcing (e.g., biomass, recycled carbon).
- Biomanufacturing processes (e.g., fermentation, synthetic biology).
Link to 3. What Measures are being considered? 3. What Measures are being considered?
At this stage, the initiative remains at the Call for Evidence phase. However, the Commission has already identified several key intervention areas:
Link to Regulatory Simplification Regulatory Simplification
- Improving Competitiveness through streamlining permitting and authorization procedures for bio-based products.
- Enabling Cross-Sector Innovation by addressing fragmentation in existing regulations, e.g., through harmonised interpretation across Member States and EU Agencies.
- Regulatory Innovation and Support Measures by expanding the use of regulatory sandboxes and pilot frameworks to a broader range of bio-based products.
Link to Market Creation Market Creation
- Creating Lead Markets for EU-based Production through demand-side measures (e.g., minimum content requirements, public procurement measures), particularly in sectors such as chemicals, plastics, textiles, construction and fertilisers.
- Replacing fossil-based raw material use through measures such as minimum content requirements to incentivize the use of bio-based and recycled carbon inputs, particularly in sectors such as chemicals, plastics and fuels.
Link to Support for Scale-up Support for Scale-up
- Building a circular bioeconomy by introducing sustainability criteria for biomass and feedstocks use.
- Supporting investment and scale-up by improving investment predictability and access to funding for industrial biomanufacturing.
Link to 4. What Information should Companies submit? 4. What Information should Companies submit?
The current Call for Evidence invites practical, evidence-based input, including:
- Concrete regulatory barriers through examples of overlapping or inconsistent requirements (e.g., duplicative risk assessments, unclear classification, diverging Member State implementation).
- Investment and scale-up constraints through examples of financing challenges, including delayed or foregone investments, long return-on-investment timelines, and barriers to scaling first-of-a-kind industrial facilities in the EU.
- Data or examples demonstrating difficulties in competing with fossil-based incumbents (e.g., price differentials or limited market uptake despite regulatory approval).
- Feedback on proposed measures.
Companies should be mindful that responses will become publicly available on the Commission’s “Have Your Say” portal unless confidentiality is requested, which may influence how commercially sensitive information is presented.
***
Should you require assistance in assessing how the proposed Biotech Act II may affect your activities, or wish to engage in the ongoing consultation process, the Covington team is available to support you. Please do get in touch with Bart Van Vooren: bvanvooren@cov.com