Kemianteollisuus ry feedback on the Biotech Act II

Kemianteollisuus ry welcomes the European Biotech Act II initiative and its objective to strengthen the competitiveness, scale-up capacity and industrial deployment of biotechnology and biomanufacturing in the EU. The initiative should be designed as a key competitiveness and industrial policy instrument, supporting the transition from research and pilot-scale innovation to commercial-scale production and market uptake.
Kemianteollisuus strongly supports the Commission’s aims to untap the potential of the EU’s industrial
biotechnology and biomanufacturing for strategic autonomy, competitiveness, industrial innovation and
technology excellence, circularity and sustainability. However, the scope of the initiative should not be
limited too narrowly to biotechnology and biomanufacturing. In order to fully realise the potential of the
bioeconomy, Biotech Act II should cover the wider bioeconomy, including bio-based chemicals and
materials, sustainable biomass conversion, renewable carbon, biogenic carbon, captured carbon and
relevant industrial value chains.
The Biotech Act II should be closely aligned with other ongoing EU policy initiatives that share the
objective of boosting EU industrial competitiveness, resilience and EU-based sustainable production,
including the Industrial Accelerator Act, the Critical Chemicals Alliance, the EU Bioeconomy Strategy, the
Circular Economy Act and the wider sustainable carbon policy framework. Care must be taken to harness
synergies between these initiatives and to avoid creating separate, overlapping or potentially conflicting
regulatory requirements.
In this respect, Kemianteollisuus supports the use of common terminology and coherent definitions across
EU industrial policy. For example, the “sustainable carbon sources” definition proposed in the
Commission’s Industrial Accelerator Act should be used consistently across relevant EU policy files. This
definition refers to RED III sustainability criteria, waste and carbon from captured carbon dioxide
emissions. Kemianteollisuus considers this an important step towards developing a more horizontal EU
framework for sustainable carbon and biomass use, including bio-based materials and chemicals beyond
the energy sector.
Key deliverables of the Biotech Act II should in our view be:
- Create lead markets for bio-based and sustainable carbon-based products
Biotech Act II should send a clear and credible signal that the EU intends to foster and scale up industrial
biomanufacturing and bio-based production in Europe. The initiative should remove existing bottlenecks
and incentivise industry to increase the use of feedstock from sustainable carbon sources, going beyond
energy uses and supporting higher-value industrial applications.
Lead market measures should be developed in a technology-neutral and product-relevant manner. They
should support the market uptake of bio-based chemicals, materials and other sustainable carbon-based
products where they can contribute to circularity, fossil carbon substitution, industrial resilience and value
creation in Europe. - Improve investment predictability and support industrial scale-up
The main challenge is not only research and innovation, but the transition from pilot and demonstration phases to first-of-a-kind industrial deployment and commercial production. Biotech Act II should therefore improve investment predictability, reduce administrative burden and compliance costs, and create a more coherent regulatory environment for industrial biomanufacturing. This requires streamlined terminology, harmonised regulatory approaches, proportionate permitting and better coordination between EU policy instruments. The objective should be to make Europe an attractive location for investments in industrial biotechnology, biomanufacturing and sustainable carbon-based production. - Ensure coherence with existing and upcoming EU product legislation
Biotech Act II should be designed to work coherently with existing and upcoming EU product and circular
economy legislation, including the Packaging and Packaging Waste Regulation, the Single-Use Plastics
Directive, the Ecodesign for Sustainable Products Regulation and other relevant sectoral frameworks. It
should not create additional layers of complexity, but rather provide a horizontal enabling framework for
bio-based and sustainable carbon-based products.
Where content targets or market-pull instruments are considered, they should be developed carefully,
based on robust impact assessment, product relevance, sustainability performance and availability of
sustainable feedstock. The aim should be to create demand without creating disproportionate compliance
costs or unintended barriers for industrial value chains. - Provide clarity on sustainable biomass use and cascading principles
Biotech Act II should establish clear, proportionate and workable principles for sustainable biomass use.
Cascading principles can support efficient use of biomass, but they must be designed in a way that
recognises the diversity of industrial applications and allows biomass to be used in high-value products,
including chemicals and materials.
The framework should avoid rigid or overly prescriptive allocation rules that could unintentionally restrict
access to biomass for industrial biomanufacturing. Instead, it should support balanced access to
sustainable biomass, taking into account food security, biodiversity, climate objectives, industrial value
creation and the role of bio-based materials in replacing fossil carbon.
An EU-wide crop and biomass monitoring mechanism could support food security, improve transparency
and help prevent unintended supply-chain constraints. Such a mechanism should be used to support
evidence-based policymaking and should not become an additional administrative burden for companies. - Establish a unified certification and labelling framework
Kemianteollisuus supports the development of a unified EU certification and labelling framework for biobased, mass-balanced and sustainable carbon-based materials and chemicals outside energy applications.
Existing recognised certification systems, such as ISCC+, could provide useful building blocks.
A coherent EU framework would improve trust, comparability and market acceptance, while reducing
fragmentation between Member States and sectors. Certification should be practical, internationally compatible and suitable for complex chemical value chains, including mass balance approaches where physically segregated supply chains are not feasible. - Ensure feedstock-neutral and science-based life-cycle assessment
Biotech Act II should promote feedstock-neutral, science-based and transparent life-cycle assessment
methodologies. Comparisons between fossil-based, bio-based, recycled and captured-carbon-based
products should be based on up-to-date datasets, consistent system boundaries and fair treatment of
mature and emerging technologies.
This is particularly important for polymers, chemicals and materials, where the sustainability profile
depends on feedstock, process, energy input, product performance, durability, recycling options and endof-life treatment. Life-cycle assessment should support informed decision-making and avoid
methodological choices that structurally disadvantage emerging bio-based or sustainable carbon-based
alternatives. - Consider renewable and sustainable carbon content targets where appropriate
Biotech Act II should assess how sustainable carbon and bio-based content targets could be used in
relevant product legislation to incentivise market uptake. Such targets could be considered, for example,
in relation to the Packaging and Packaging Waste Regulation, the Single-Use Plastics Directive and the
Ecodesign for Sustainable Products Regulation.
Any targets should be realistic, product-specific, based on sustainable feedstock availability and aligned
with existing circular economy and climate objectives. They should support market creation while avoiding
regulatory fragmentation, double regulation or conflicting requirements across EU legislation.
Europe must ensure that industrial biomanufacturing investments are made in Europe rather than in
competing regions that already have more targeted and predictable support frameworks.
In conclusion, Biotech Act II should become a practical industrial scale-up and market-creation instrument
for the European bioeconomy. Its success will depend on whether it can create predictable investment
conditions, coherent regulation, lead markets and sustainable access to feedstock for industrial
biomanufacturing and bio-based value chains. For the chemical industry, the initiative should enable the
transition from fossil carbon to sustainable carbon sources while strengthening EU competitiveness,
resilience and high-value industrial production. - Strengthen skills, competence and talent for industrial biomanufacturing
Biotech Act II should also address the skills and competence base needed to scale industrial
biotechnology, biomanufacturing and the wider bioeconomy in Europe. Industrial deployment will not be
achieved through regulation, investment incentives and lead markets alone. It also requires a sufficient
availability of skilled professionals across the full value chain, from research and process development to
industrial production, permitting, sustainability assessment, product development, commercialisation and
international scale-up.
For the chemical industry, skills are a key enabling condition for competitiveness and industrial renewal. Bio-based chemicals, sustainable carbon-based materials, fermentation technologies, biomass conversion, circular raw materials and new production processes require multidisciplinary expertise combining chemistry, biotechnology, process engineering, materials science, data analytics, automation, sustainability assessment, regulatory competence and business development.
Biotech Act II should therefore be linked with the EU Union of Skills agenda and relevant EU education, research and innovation instruments. The initiative should support the identification of future skills needs in industrial biotechnology and bio-based value chains, promote upskilling and reskilling of the existing workforce, and strengthen cooperation between industry, vocational education, higher education institutions and research organisations.
Particular attention should be paid to applied industrial skills. Europe needs experts who can operate, scale and optimise bioprocesses and industrial biotechnology solutions in real production environments. This includes competence in industrial fermentation, bioprocess engineering, process safety, quality systems, environmental permitting, product regulation, life-cycle assessment, certification, digital process control, data analytics and the integration of new feedstocks into existing industrial processes.
The skills dimension should also cover SMEs and scale-ups. Many emerging bioeconomy companies need access not only to research expertise, but also to experienced professionals in industrial scale-up, regulatory pathways, production planning, market access, financing, export readiness and international partnerships. Strengthening these capabilities would improve the ability of European companies to move from laboratory and pilot scale to commercial production in Europe.
Biotech Act II should support a European skills ecosystem for the bioeconomy. This could include common competence profiles for industrial biotechnology and biomanufacturing, support for industry-led training programmes, stronger work-based learning models, European professional master’s programmes, and improved recognition and mobility of qualifications across Member States. The objective should be to ensure that Europe has both the scientific excellence and the industrial skills base needed to make biomanufacturing a competitive European strength.
In addition, the attractiveness of the chemical industry and the wider bioeconomy should be strengthened. Young people, students and professionals should be better informed about the role of chemistry, biotechnology and bio-based production in solving major societal challenges, including fossil carbon substitution, circularity, resource efficiency, climate neutrality and strategic autonomy. Skills policy should therefore also support awareness-raising and education pathways that make industrial biotechnology and bio-based chemistry visible and attractive career options. In conclusion, skills should be treated as a horizontal enabling condition under Biotech Act II. A strong European skills base is necessary to ensure that investments, lead markets and regulatory simplification translate into actual industrial capacity, high-quality jobs and long-term competitiveness in Europe.


