Biotech Act II

The Protein Project - Input to the Biotech Act II Call for Evidence The Protein Project is a Brussels-based NGO with a mission to move the protein debate from polarisation to progress. We convene pragmatic, value-chain-wide coalitions and translate shared roadmaps into concrete, politically realistic EU policy recommendations.

Central Denmark has numerous bioeconomy sectors, including energy production, food production, green transition, and construction material production. This feedback, written by Central Denmark EU Office, is a generalisation primarily based on input from Fjordland (regional agricultural advisory firm), Aarhus University Department of Agroecology, Business Skive, and Energy City Skive.

The National Bioconomy Coordination Board of the Italian Presidency of Council of Ministers welcome the Biotech Act II as a policy initiative able to play a pivotal role in advancing biotechnology and biomanufacturing across Europe. It can serve as a strategic driver for the sustainable use of biomass, fostering the development of a competitive, resilient and circular bioeconomy.

Introduction EFFA, the European Flavour Association, welcomes the opportunity to contribute to the Call for Evidence on the Biotech Act II. EFFA strongly supports biotechnology as a strategic enabler for Europe's competitiveness, resilience and open strategic autonomy.

Food Biomanufacturing as Strategic Infrastructure: Regulatory Simplification, Lead Markets, Regulatory Dialogue and Investment Architecture for European Food Biomanufacturing The Biotech Act II Call for Evidence identifies four intervention areas: creating lead markets, investment predictability, sustainability criteria, and simplification.

The PRECISEU consortium welcomes the continuation of the European Biotech Act framework through the development of Biotech Act II, building on the initial initiative which PRECISEU also supported. We see this as a critical step forward and look with strong interest towards its effective implementation. The challenges identified in the Call for Evidence are fully aligned with the experience emerging from PRECISEU.

LabFarm, Poland's only cultivated meat producer and a company with ambitions for European expansion, welcomes the announcement of Biotech Act II, covering the industrial biotechnology and biomanufacturing sector. Below we present specific recommendations drawn from our operational experience in Poland, a country with growing biotechnological potential. 1.

This submission is made on behalf of Green Alchemy, a regulatory affairs consultancy working with startups and scale-up companies developing biosoutions for agriculture, food, feed, industrial enzymes, chemicals, materials, fermentation-derived ingredients, biocontrol, fertilising products and circular bio-based value chains.

As an academic scientist dedicated to advancing synthetic biology from fundamental research to real-world applications, I fully endorse the objectives of the Biotech Act II initiative. Over the past years, remarkable progress has been made across numerous areas of biotechnology, including cutting-edge research in xenobiology, the development and incorporation of non-canonical amino acids, and the advancement of…

Coldiretti, the largest farmers’ representative organisation in Italy and Europe, with its 1.6 million members, welcomes the European Commission’s initiative to gather views on the Biotech Act II. See detailed position paper attached.

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ANOVE appreciated the Commission’s initiative as biotechnology is a key element for agriculture, industry and the environment, as it strengthens food security, fosters adaptation to climate change and contributes to more sustainable and resource-efficient production. Agricultural biotechnology should be recognised as a strategic component of the European bioeconomy under the Biotech Act II.

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Summary of the feedback in the attached document: Standardization plays a critical role in fostering a sustainable and competitive bioeconomy. This is especially true for horizontal standards which can create a level playing field between sectors while horizontal terminology fosters a better understanding both within the industry and towards consumers and other stakeholders.

APPLiA Home Appliance Europe, the industry association representing the home appliance manufacturing sector in Europe, welcomes the opportunity to provide feedback on the European Commission's Call for Evidence for the upcoming Biotech Act II.

Sofinnova welcomes the European Commissions call for evidence on the Biotech Act II and fully supports its ambition to strengthen Europes leadership in biotechnology. As an active investor across the biotech value chain, we are committed to mobilizing capital, expertise, and partnerships to accelerate innovation and industrial deployment.

According to its own statement, the initiative concerns the promotion of industrial biotechnology and biomanufacturing. In practice, however, the focus is on biomanufacturing, which may be beneficial rather than on industrial biotechnology. The latter should be given much more prominence as a potentially environmentally friendly method.

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This contribution by the European Tissue Symposium (ETS) welcomes the development of the Biotech Act II as a strategic opportunity to strengthen Europe's bioeconomy, competitiveness, resilience and strategic autonomy.

Who we are The ONEI is an independent French organisation that examines the insect farming sector on the basis of peer-reviewed science. Several of our members co-authored recent reviews on the economics and life-cycle impacts of insect rearing. We hold no commercial interest in the sector. We offer evidence on how industrial insect farming should be treated under the Acts feedstock and sustainability provisions. 1.

The Biotech Act placed biotechnology high on the EUs competitiveness agenda. The next phase, to be released later in 2026 as per the Commissions work programme, should build on this momentum by completing the pathway from healthcare innovation to a broader, more resilient biotechnology and biomanufacturing industry in Europe.

Please find attached our feedback submitted on behalf of Ocean Rainforest, a company dedicated to regenerative ocean cultivation of seaweed and the development of bio-based biostimulants across Europe and the United States. We greatly appreciate the opportunity to contribute to the European Commissions call for evidence for the Biotech Act II.

BASF supports the EU Bioeconomy Strategy and its upcoming Biotech Act II as a key instrument to accelerate the uptake of bio-based feedstock in European production and strengthen Europes sustainability, resilience, and industrial competitiveness. With its chemistry offerings, BASF is at the forefront of driving the green transformation across many industries.

Please see the attached feedback, submitted on behalf of the Insect Institute, a non-profit, non-governmental organization (NGO) dedicated to conducting research and providing policymakers, the public, investors, NGOs, and other stakeholders with evidence-based recommendations concerning the farming of insects as food and feed globally.

GO!PHA welcomes the Biotech Act II initiative and the focus on strengthening Europe's competitiveness in industrial biotechnology and biomanufacturing, where novel biobased and biodegradable materials play a key role.

The European Biotech Act II should turn industrial biomanufacturing into a growth engine in support of the EU Bioeconomy and the Clean Industrial Deal. It is an opportunity to extend the EUs competitive leadership in biotech and biomanufacturing and enable the clean transformation of Europe's industry.

COPA and COGECA are the two main umbrella organizations representing farmers and agricultural cooperatives at the European Union level. A key concern is that farmers could become subject to direct or indirect mandatory obligations to use bio-based fertilisers, while having limited ability to recover the resulting additional costs. Agricultural markets are highly competitive, and farmers are generally price takers.

COPA and COGECA are the two main umbrella organizations representing farmers and agricultural cooperatives at the European Union level. A key concern is that farmers could become subject to direct or indirect mandatory obligations to use bio-based fertilisers, while having limited ability to recover the resulting additional costs. Agricultural markets are highly competitive, and farmers are generally price takers.

Södra Input to the Call for Evidence on Biotech Act II About Södra Founded in 1938, Södra is Swedens largest forest-owner association with over 50,000 members. Together, they own a world-leading industrial operation producing renewable products such as pulp, timber, building systems and bioproducts. Södra employs around 3,200 people and reported sales of SEK 28 billion in 2025.

COLIPI welcomes the European Commissions initiative to strengthen industrial biotechnology and biomanufacturing in Europe. We support faster regulation, stronger scale-up support, improved access to finance, and market-pull mechanisms for bio-based products.

We welcome the opportunity to provide input to the Biotech Act Pt II. Farmless is a European company harnessing natural fermentation technology to create sustainable and versatile high-protein ingredients. We would like to make the following recommendations to advance European industrial biotechnology and biomanufacturing. 1.

The European Union is a global leader in safe, responsible, and innovation friendly biotechnology. But, as demonstrated in the Draghi report, there is an urgent need for closing the innovation gap, simplification, addressing regulatory barriers and speeding up approval procedures. Frustrated companies are moving elsewhere, and the EU is left behind, while other parts of the world sprint off at high speed.

Arkema supports the Biotech Act II as a mean to support a clear and strong commitment from the EU to support its bio-based materials and chemicals industrial base, both for mature and developing productions. This is essential to support decarbonisation, strategic autonomy and defossilisation. Please find attached our complete submission.

Alliance for Biosolutions welcomes the opportunity to provide input with the Commissions call for evidence on the forthcoming European Biotech Act II. We strongly support the ambition to strengthen Europes industrial biotechnology and biomanufacturing (biosolutions) ecosystem and to establish a horizontal, enabling and independent regulatory framework that improves competitiveness, strategic autonomy and…

Comments on the Impact Assessment for the Biotech Act II (Ref. Ares(2026)4842702) SCHWENK Zement GmbH & Co. KG is a family-owned company in the cement industry with locations in several European countries. Opportunities in biotechnological CO2 utilization In cement production, the calcination of raw materials inevitably releases CO2. We are actively researching ways to utilize this CO2 biotechnologically (CCUbio).

Assobioplastiche welcomes the Biotech Act II, a policy with the potential to have a pivotal role in advancing biotechnology and biomanufacturing across Europe and as a strategic driver for the sustainable use of biomass, enabling the development of a robust and circular bioeconomy.

New Harvest Netherlands welcomes the European Commissions request for evidence to inform drafting of the EU Biotechnology Act II. This act offers an opportunity to build on advances made in EU Biotech Act I. In particular, New Harvest would like it to include biotechnologies related to food production, such as those derived from cell culture or precision fermentation.

This comment recommends that the EU adopt a unified definition of biobased products and materials following the well-recognised and scientifically Carbon-14 standards (ASTM D6866 and European equivalents). This is particularly crucial to incentivise the development of the biobased products and biotechnologies in the EU and provide a strong market incentive for biomanufacturing investment in the EU, especially in the…

The FCIO warmly welcomes the Commission’s initiative on a Biotech Act II. The Biotech Act II should be designed as an ambitious, growth- and market-oriented EU framework for relevant knowledge giants, industrial bioeconomy and biotechnological production processes. The aim must be to translate scientific excellence into industrial value creation, employment and sustainable solutions.

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The EU's food system faces critical structural import dependencies in three key feed inputs soymeal, vitamins, and amino acids with a combined annual import-dependent value exceeding 11 billion. Around 96% of EU soymeal consumption depends on imports from Brazil and Argentina, increasingly exposed to climate risk.

The Centre for Future Generations (CFG) is a Brussels-based, independent think tank working at the intersection of emerging technology, science and policy. We help governments anticipate and govern the impacts of rapid technological change. CFG is a nonprofit supported by philanthropic foundations, public institutions, and individual donors, and does not accept funding that compromises its independence.

Green Biotech Europe Deutschland (GBE-D) begrüßt die Initiative der Europäischen Kommission zur Entwicklung eines europäischen Biotech Act II. Der Biotech Act II sollte Pflanzenbiotechnologie und Innovationen in der Pflanzenzüchtung ausdrücklich in seinen Anwendungsbereich einbeziehen.

Biorepack welcomes the European Commission's decision to introduce instruments in support of the production and use of innovative bio-based biomaterials and bioproducts. In addition to representing an opportunity to support the competitiveness and innovation of the European industrial sector, promoting the production and use of such materials and products is consistent with the bioeconomy model and with the…

The SeaMark (Seaweed Based Market Applications, ID: 101060379, HORIZON-CL6-2021-CIRCBIO-01) Consortium welcomes the European Commission´s initiative to establish a Biotech Act II and fully endorses its four core objectives to create lead markets, providing investment predictability, defining sustainability criteria, and simplifying the regulatory environment for industrial biotechnology and biomanufacturing.

We believe that moulded fibre products can play a major role in the European circular bioeconomy, especially when manufactured from renewable and sustainably sourced fibres like recycled paper and cardboard as well as agricultural by-products, as they help reduce waste, plastic pollution and greenhouse gas emissions.

The forthcoming European Biotech Act II represents a timely and strategic initiative to strengthen the Unions competitiveness, technological sovereignty and industrial leadership in biotechnology. While the strong focus on industrial biotechnology and biomanufacturing is encouraging, the current approach risk to insufficiently reflects the strategic importance of plant and agricultural biotechnology, including…

As a user of innovative bio-based materials, Ecolab supports the European Commissions ambition to strengthen Europes leadership in industrial technology and biomanufacturing through the Biotech Act II. To achieve this objective, the future framework should: (i) be based on robust sector-specific impact assessments that take into account feedstock availability, performance requirements, and technological maturity…

Lallemand welcomes and supports European Commissions initiative which should strengthen Europes leadership positioning and competitiveness in biotechnology and biomanufacturing. Biotech Act II must therefore be bold, ambitious and future proof; demonstrate its support of EU productivity (capacity) and innovation.

The Bio-based Industries Consortium (BIC) is a non-profit organisation representing the private sector in the Circular Bio-Based Europe Joint Undertaking (CBE JU). BIC's 350+ Industry Members cover the whole value chain, from primary production to market, across sectors including agriculture and agri-food, bio-based chemicals, bio-based materials, forestry, pulp and paper, and waste management.

The European Regions for Innovation in Agriculture, Food and Forestry - ERIAFF (https://www.eriaff.com/) welcomes the European Commissions initiative to develop a Biotech Act II, recognising its strategic potential to strengthen the competitiveness, sustainability and innovation capacity of the European Union in the fields of industrial biotechnology and biomanufacturing.

Shellworks is a biotechnology company that creates home compostable packaging for the personal care industry with Vivomer, a family of biobased and naturally biodegradable material formulations made using microbially derived PHA polymers.

The European Biostimulants Industry Council (EBIC) welcomes the European Commissions initiative to develop Biotech Act II, which provides an opportunity to ensure that agricultural biotechnology fully contributes to European competitiveness, strategic autonomy, food security, climate resilience, and sustainable growth.

The Alliance pour la Chimie du Végétal (ACDV), Bioeconomy for Change (B4C) community, welcomes the European Commission’s initiative to develop a Biotech Act II dedicated to industrial biotechnology, biomanufacturing and biosolutions.

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Helmholtz welcomes the European Commission's initiative to take EU action in the areas of industrial biotechnology and biomanufacturing by introducing it in the Work Programme 2026 and complementing the previous legislative act on health biotechnology.

Please find ECOFI's full feedback attached below. To summarise our input: To unlock the potential of organic-based and circular fertilisers, the Biotech Act II should have a two-pronged approach. It should look to remove the regulatory barriers that currently limit innovation, investment, and market access, as well as to promote the use of organic-based and circular fertilisers by European farmers.

Solar Foods welcomes the Biotech Act II initiative and recognises that some challenges are addressed in the forthcoming Food and Feed Safety Simplification Omnibus. However, based on practical experience progressing from R&D to industrial scale at Solar Foods Factory 01, significant regulatory and funding barriers remain.

The Biotech Act II should strengthen the business case for the industrial bioeconomy and biomanufacturing. It should boost resilience and competitiveness while accelerating the scale-up of sustainable biomass-derived solutions across European value chains. Biotech Act II should go beyond biomanufacturing to provide a coherent framework for the wider industrial bioeconomy.

SWM International strongly supports the Commission's ambition to create an enabling regulatory framework for industrial biotechnology and biomanufacturing. We urge the Commission to ensure that the Biotech Act II: Explicitly includes paper- and cellulosic fiber-based products within its scope as bio-based alternatives eligible for lead-market measures.

Lund University, Division of Biotechnology and Applied Microbiology (LU-Biotech) welcome the opportunity to provide input to the forthcoming Biotech Act II and strongly supports the ambition to strengthen Europe's industrial biotechnology.

CO2 Value Europe is the European association representing the Carbon Capture and Utilisation (CCU) community in Europe and working for the recognition of CCU as an essential pathway to reach EU climate goals in 2030, 2040 and 2050.

Nutrient recovery from wastewater is an under-recognized leverage point, yet it will rapidly become an absolute necessity. Beyond the obvious economic opportunity of transforming a waste product with high treatment costs into a marketable resource, this approach is essential for building a more sovereign, resilient, and decarbonized agriculture and society.

Unilever welcomes the European Commissions initiative to develop a Biotech Act II, recognising biotechnology as a strategic enabler for Europes clean transition, industrial competitiveness, and long-term resilience.

Scope: Strategic positioning of the Portuguese Textile and Clothing Industry (ITV) (focus on SMEs, vertical integration and nearshoring) in the face of the transition to industrial biotechnology and bio-biobased.

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Through its sugar and starch activities, the cooperative group Tereos makes a significant contribution to European agricultural and industrial sovereignty, as well as to the economic and social vitality of rural areas. As a processor of agricultural raw materials, our biorefineries represent a critical link between upstream farming and downstream industries.

CropLife Danmark (CLDK) welcomes the COMs initiative to enhance the innovation of agricultural biotechnology in the EU, which will increase competitiveness, secure food production and future-proof sustainable growth of the agricultural system.

Europe's future will be shaped by what it does in biotechnology. From food security and advanced materials to climate resilience and circular chemistry, Europes scientific leadership, industrial strength, and strategic autonomy face mounting pressure.

The Danish Agriculture & Food Council (DAFC) welcomes the opportunity to provide input to the Biotech Act II. From an agrifood perspective, the Biotech Act II is an important opportunity to address the parts of the biotechnology agenda that were not adequately reflected in Biotech Act I and to connect the broader biotech agenda more coherently with the ongoing simplification efforts in food and feed legislation.

The European treated wood sector represents a significant and underutilised resource base that can contribute to competitiveness, circularity, sustainability and industrial innovation. As the EU seeks to strengthen its bioeconomy and biomanufacturing capacity, treated wood should be recognised as a strategic bio-based resource capable of supporting multiple value chains across construction, manufacturing and…

Tetra Pak welcomes the opportunity to contribute to the Biotech Act II, which should be designed to unleash all potential for a competitive and resilient EU bioeconomy and become a driver towards strategic autonomy, industrial innovation and technology excellence for circularity and sustainability.

EFFCA, the European Food and Fermentation Cultures Association, welcomes the opportunity to provide input to the Call for Evidence on the Biotech Act II. EFFCA represents the European food and fermentation cultures sector. Food cultures are safe live bacteria, yeasts or filamentous fungi intentionally used in food production. They are also an important part of Europes biotechnology and fermentation capacity.

Dear Sir/Madam, Enclosed you will find the contribution of the Biosimilar medicines group, a Medicines for Europe sector group on the EC Call for Evidence for the Biotech Act II (industrial biotech). We remain at disposal should you need any clarification. Kind regards,

The Polish Union of the Cosmetics Industry supports the European Unions objectives related to industrial decarbonisation, circular economy and the development of sustainable, bio-based value chains. Our sector has already invested significantly in sustainable packaging, circularity initiatives, reformulation efforts, responsible sourcing and innovation involving renewable and bio-based ingredients.

ESPP welcomes that the Biotech II Call for Evidence identifies fertilisers as an area for action, citing creation of lead markets and simplification of legislation for (bio-derived) fertilisers. Biotech II should recognise the Importance of recycled nutrients for fertiliser supply resilience, food security and EU competitiveness, and engage actions for a single market for secondary nutrients across Europe, support…

The European lubricants industry, represented by ATIEL and UEIL, welcomes the Commissions initiative to develop a Biotech Act II, targeting industrial biotechnology and biomanufacturing. Lubricants are key to the success of Europes industry and transportation systems and already contribute to the bio-and circular economies through bio-based base oils and additives, as well as circular and re-refined products.

Bioenergy Association of Finland welcomes the overall aim of the Biotech Act II to strengthen Europes bioeconomy and industrial competitiveness. The initiative should build on clear framework conditions for sustainable bio-based value chains, support investment certainty, and accelerate the deployment of bio-based solutions that contribute to economic growth, decarbonisation, circularity, and European resilience.

The Belgian Coordinated Collections of Microorganisms (BCCM) are delighted to participate in the public consultation on the future EU Biotech Act II, which they welcome. BCCM is the Belgian consortium of microbial biological resource centres.

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Cargill provides food, ingredients, agricultural solutions and industrial products that are vital for everyday living. We connect farmers with markets, customers with ingredients and families with daily essentials from edible oils to eggs, from salt to skincare, from feed to flooring.

Focussing on enhancing the EU's competitiveness in the area of industrial biotechnology and biomanufacturing is important. It can drive innovation, not only in the health sector, but also in chemicals, food or plant protection. To reach the EUs full potential it is important to focus strongly on the newest scientific tools.

FEICA welcomes the Commissions initiative on Biotech Act II to enhance EUs industrial competitiveness and unlock innovation. We highlight that adhesives are primarily intermediate products, serving as functional components in the manufacturing of a wide range of downstream products.

Stora Enso is a global leader in renewable materials. We transform wood into low-emission, high-performance solutions for packaging, construction, and biomaterials, helping replace fossil-intensive materials, improve circularity, and strengthen Europes industrial resilience. With 15 000 employees across the EU, we also support European jobs, regional development, and sustainable growth in urban and rural areas.

LOréal welcomes the opportunity to contribute to the Biotech Act II call for evidence. As the worlds largest beauty company, we recognize our unique position and responsibility to drive real, meaningful change. For over 25 years, LOréal has proactively worked towards a sustainable and inclusive future, seeking to protect the planets beauty and empowering communities worldwide.

The World Bioeconomy Association (WBA) welcomes the preparation of the EU Biotech Act II as a critical opportunity to strengthen Europes competitiveness, industrial resilience and leadership in biotechnology and biomanufacturing. Europes primary challenge is no longer scientific excellence, but the ability to translate innovation into industrial deployment, market creation and global competitiveness.

The European Commission has a unique opportunity to position biotechnology as a strategic enabling technology for Europes future competitiveness, sustainability, and technological sovereignty. While the recently presented Biotech Act I addresses important sector-specific challenges, it does not sufficiently tackle the underlying governance barriers that affect biotechnology across all application domains.

REFOOD Polska highlights that the development of industrial biotechnology in the EU is largely dependent on access to high-quality, clean, and traceable bio-based feedstocks. At present, the main barrier is not technological limitations, but regulatory fragmentation and the lack of a coherent approach to managing biological waste streams across Member States.

As the Toulouse Biotechnology Institute, a public French laboratory working in biological and chemical process engineering, we welcome the EUs initiative and focus on these important issues. Our experience on these questions has brought two key facts to light: a) while high-tech processes that produce very pure products are very attractive, there are many contexts that can benefit from coarser, more low-tech…

AMFEP, the Association of Manufacturers and Formulators of Enzyme Products, representing 90% of the EU enzyme market, welcomes the opportunity to respond to the Biotech Act II call for evidence. Contributing over EUR 2 billion to the EU economy, enzymes are key cross-sectoral enablers of the bioeconomy, supporting numerous industries, including food and feed, detergents, textiles, and pulp and paper.

Corteva Agriscience welcomes the European Commissions initiative to develop a Biotech Act II as a strategic framework to strengthen Europes competitiveness, resilience and sustainability. The Act should explicitly recognise agricultural biotechnology, plant breeding and the seed sector as essential upstream contributors to sustainable biomass production, food security, climate adaptation and resource-efficient…

The Oss Biopharma Cluster welcomes the European Commissions Biotech Act II initiative. As a leading European biopharma ecosystem, we believe the Act should focus on strengthening Europes ability to scale, manufacture and commercialize biotechnology innovations. Europe excels in scientific research but often struggles to translate discoveries into industrial and commercial success.

Holiferm welcomes the EU Commission's proposed Biotech Act II, endorsing its aim to accelerate industrial biotechnology and biomanufacturing across the EU. The EU bioeconomy generates around 2.7 trillion in value and supports over 17 million jobs roughly 8% of total EU employment yet EU risks falling behind without decisive action.

For the Biotech Act II to unlock the potential of biomass-derived chemicals, BioChem Europe calls to: Make the Biotech Act II the framework to enable the biomass-derived chemicals sector Ensure access to all types of sustainable raw materials Implement strong and effective market-pull measures, such as biomass-derived content targets Harmonise and add clear definitions Attached you will find our complete input to…

IPA Europe, the European association representing leading producers of probiotic cultures, probiotic foods and food supplements, welcomes the European Commissions initiative on Biotech Act II and strongly supports its objective of strengthening Europes leadership in industrial biotechnology and biomanufacturing.

Yara International welcomes the European Commissions initiative on the Biotech Act II and its ambition to strengthen industrial biotechnology, create lead markets, and accelerate the transition towards a circular and climate-neutral economy. At Yara, we are committed to responsibly feeding the world while protecting the planet, with the ambition of becoming climate neutral by 2050.

Level playing field and market creation The fossil-based industry has a significant head start compared to the relatively new biobased industry. Over decades it has optimized processes, built infrastructure and established strong value chains, while subsidies and regulations have largely supported the fossil system. This creates an uneven playing field.

Biotechnology plays a crucial role in strengthening EUs economic resilience and competitiveness. BASF Agricultural Solutions welcomes initiatives to address regulatory bottlenecks and to safeguard EU position in all biotechnology-related fields, especially plant biotechnology.

Westenergy Ltd is a circular economy company owned by seven municipal waste management companies operating in Western Finland. Westenergys waste-to-energy plant located in the Vaasa region takes care of the residual waste management of more than 700 000 people by refining non-recyclable municipal waste into district heating, electricity and recovered materials.

EURAMET, the European Association of National Metrology Institutes, welcomes the opportunity to contribute to this initiative of the European Commission. Biotechnology relies fundamentally on the precise measurement of biological, chemical, and physical parameters.

As a global innovation leader in biotechnology, IFF is pleased to contribute to the European Commissions Call for Evidence on a future EU Biotech Act II. Building on the 2024 Communication on Biotech and Biomanufacturing, the Act should provide the missing deployment framework for industrial biotech and biomanufacturing in Europe.

As part of the Finnish Forest Industries, Metsä Group supports the EUs climate neutrality and competitiveness goals and highlights the importance of scaling biomanufacturing to strengthen resilience and reduce strategic dependencies.

Novonesis strongly supports the Commissions intention to develop an EU Biotech Act II that aims to strengthen Europes biotechnology and biomanufacturing base and enable the EU to become a global leader in safe, sustainable and competitive biotech innovation.

Contained applications of organ transplants and GMMs must be treated differently than release of GMMs into the environment. As the German Ecological Societys working group on New Genomic Techniques, we address the latter. Effects of novel organisms in their environment are largely unpredictable, especially in microorganisms: less than 1% of their genetic diversity has been identified.

Lesaffre is a key global player in fermentation for more than a century. Lesaffre, with a 3,2 billion turnover, and established on all continents, counts 11,700 employees and 62 applied science centers. As an industrial stakeholder, Lesaffre believes that the biotech act should concentrate on these 5 pillars: 1/Recognize biotechnologies as key drivers of EU competitiveness and resilience, enabling solutions to…

Support from VaLoo for the new regulatory framework on biotechnology A catalyst for the circular economy 10.6.2026 As the representatives of VaLoo, the Swiss network for the circular sanitation, and on behalf of our members and partners (120), we warmly welcome the European Commission's initiative regarding the Biotechnology Act II.

COTANCE welcomes the opportunity to contribute to the European Commissions Call for Evidence on the forthcoming Biotech Act II and strongly supports the objective of strengthening Europes bioeconomy and industrial biotechnology capacity.

Input from EIC Engineered Living Materials (ELMs) Portfolio Projects: REMEDY, Biorobot-Miniheart, BIOACTION, FUNGATERIA, NEXTSKINS, Bio-HhOST, ISOS, LoopOfFun The EIC Engineered Living Materials (ELMs) portfolio welcomes the European Commissions initiative to develop the Biotech Act II. It strongly supports its ambition to strengthen industrial biotechnology and biomanufacturing across the European Union.

Bayer welcomes the EU's commitment to strengthening competitiveness, resilience and leadership in key strategic technologies, including biotechnology. Biotech Act I marks an important step forward in supporting health biotech, and we must build on this to deliver a complete and comprehensive EU biotech framework.

The EU livestock breeding sector welcomes the Commissions initiative to further work on Biotechnology as a way to update the EU regulatory landscape and bring this up to date with scientific knowledge and third country legislation.

The refining industry has a crucial role to play in the development of a circular economy in Europe. By transforming waste streams (such as waste biomass from agriculture and forestry, recycled CO2, or plastic waste) into renewable or low-carbon fuels and other products (e.g.

Primary food processors welcome the Commissions ambition to strengthen Europes biotechnology and biomanufacturing ecosystem. The EU already possesses substantial industrial biomanufacturing capacity through its network of food and feed processing facilities, which transform agricultural raw materials into food, feed, ingredients, fermentation substrates and a wide range of bio-based products.

Biotech Heights response to the European Biotech Act II Biotech Heights welcome the opportunity to provide input to the forthcoming Biotech Act II and strongly supports the ambition to strengthen Europe's industrial biotechnology.

NEN: Contribution to the European Commission Call for Evidence on the Biotech Act II NEN welcomes the opportunity to contribute to the European Commissions Call for Evidence on the Biotech Act II and, based on its role within the European and international standardisation system, would like to share several observations regarding the evolving biotechnology standardisation landscape.

European Bioplastics (EUBP), representing the European bioplastics industry across the value chain, welcomes the opportunity to provide feedback to the European Commissions Call for Evidence on the Biotech Act II.

LyondellBasell (LYB) welcomes the opportunity to provide feedback on the European Commissions Call for Evidence on the Biotech Act II. As a global leader in the chemical and plastics industry, LYB develops and delivers innovative solutions that support everyday sustainable living and enable the transition to a circular and low carbon economy.

foodwatch welcomes the opportunity to provide comments to the call for evidence on the Biotech Act II. We understand from the Commission that the food and feed sector could be included in a future legal proposal, although this is not fully certain yet and the document up for consultation does not give enough details to provide in-depth feedback.

We welcome the Biotech Act II, a policy with the potential to have a pivotal role in advancing biotechnology and biomanufacturing across Europe and as a strategic driver for the sustainable use of biomass, enabling the development of a robust and circular bioeconomy.

Fertilizers Europe welcomes the opportunity to contribute to the impact assessment for the proposed Biotech Act II. As a sector explicitly identified as a potential lead market under this initiative, we have a direct stake in ensuring that the final framework is science-based, technologically neutral, and supportive of Europes food security and agricultural competitiveness. Please find attached our complete feedback.

The Biotech Act II presents an important opportunity to strengthen Europe's competitiveness in biotechnology while supporting broader sustainability objectives. To succeed, the Act must recognise that biotechnology's contribution extends beyond industrial applications and into the food system, where innovations such as advanced and precision fermentation can help reduce emissions, improve resource efficiency…

The European Compost Network (ECN), the European umbrella organisation representing the bio-waste recycling sector, welcomes the initiative of the Commission to extend the scope of the Biotech Act through a new Biotech Act II to include bio-based materials such as fertilisers.

We welcome the opportunity to contribute to the call for evidence on the Biotech Act II. The initiative has the potential to support the scale up of bio-based products, biomanufacturing and renewable carbon solutions, including those based on captured and recycled carbon.

As environmental biotechnology and microbiome researchers, we support efforts to foster innovation in industrial and applied biotechnology under Biotech Act II. At the same time, we wish to express concern about potential regulatory implications for genetically modified microorganisms (GMMs) in emerging agricultural and environmental applications.

Synadiet welcomes the European Commissions presentation of the Biotech Act I and the ongoing work towards the Biotech Act II. Strengthening Europes biotechnology sector is essential to maintaining global competitiveness and securing Europes strategic autonomy in innovation. Achieving this objective requires a regulatory framework that actively supports innovation.

AFYREN is a French green chemistry start-up in the industrial scale-up phase to produce low-carbon and bio-based carboxylic acids through the fermentation of local biomass of sugar industry co-products. This industrial biotechnology, via a single bioprocess, makes it possible to produce a carboxylic acid pool.

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The Finnish Water Utilities Association (FIWA) welcomes the European Commissions initiative to develop a Biotech Act II that promotes industrial biotechnology and bio-based materials while ensuring a sustainable supply of biomass. Wastewater and water services can contribute significantly to Europes bioeconomy by enabling the recovery of nutrients, materials, energy and water from wastewater streams.

Biotechnology and biomanufacturing are critical for Europes future competitiveness, sustainability and strategic autonomy. While the EU has a strong scientific base and broad political support for biotechnology, its potential remains underutilised due to persistent structural barriers that limit scale-up, market entry and uptake.

Concrete Europe welcomes the opportunity to provide feedback for the call for evidence on Biotech Act II. The call for evidence mentions the creation of lead markets for biobased construction products mentioning as possible measures the setting of mandatory minimum content requirements.

Cruelty Free Europe (CFE) thanks the European Commission for the opportunity to provide feedback on the Biotech Act II. We understand that plant protection products (PPPs) are being considered to fall under scope of this potential new Act.

VTT Technical Research Centre of Finland is a public research and technology organization (RTO) contributing to the development and scale-up of biotechnology and biomanufacturing solutions across industrial value chains. Biotech Act II represents an important opportunity to strengthen Europes competitiveness in industrial biotechnology and biomanufacturing, including in sectors such as food, chemicals and materials.

The German Federal Agency for Nature Conservation would like to reiterate, as already stated in the initial call for evidence for the impact assessment of a European Biotech Act, the essential role of a robust environmental risk assessment (ERA) for identifying and addressing potential environmental effects, together with the implementation of appropriate safeguards within the biotechnology sector, including genetic…

The Finnish Forest Industries Federation supports the EUs climate neutrality and competitiveness goals and highlights the importance of scaling biomanufacturing to strengthen resilience and reduce strategic dependencies.

Europe already possesses commercial-scale biomanufacturing infrastructure. Starch biorefineries are among the most mature examples, converting EU-grown raw materials primarily wheat, maize and starch potatoes into food and feed ingredients, fermentation feedstocks, bio-based materials, chemicals and other industrial products.

I am writing on behalf of the Portuguese Trade Association of Cosmetics, Fragrance and Toiletries (AIC).AIC is an Active Association Member of Cosmetics Europe and represents around 75 small and medium-sized enterprises (SMEs) including both national and multinational companies that conduct their economic activities within the cosmetics sector in Portugal.

The cosmetics industry supports the European Commission’s objectives to strengthen innovation, sustainability and competitiveness in the field of industrial biotechnology and biomanufacturing. Biotechnological processes already make an important contribution to the development of sustainable ingredients and the gradual de-fossilisation of value chains.

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Finnish Bioindustries welcomes the European Commissions initiative to prepare a Biotech Act II focusing on industrial biotechnology and biomanufacturing. The initiative is urgently needed to ensure that Europe can turn its strong scientific base into industrial scale-up, market deployment, resilient value chains and globally competitive companies that tackle the challenges the World critically needs solutions for.

Kemianteollisuus ry welcomes the European Biotech Act II initiative and the objective to strengthen the competitiveness, scale-up capacity and industrial deployment of biotechnology and biomanufacturing in the EU.

The Swedish Forest Industries Federation represents sawmills and pulp and paper mills supply a substantial share of the biomass and bio-based products in the EU, including side streams for energy use. The sector relies on the possibility to practice active sustainable management adapted to the local context to produce raw material.

From the CIRCALGAE perspective, one of the key regulatory challenges is that algae value chains (both seaweed and microalgae) sit at the intersection of multiple policy areas and regulatory frameworks, making navigation and market uptake difficult.

ARTE acknowledges the important role that bioeconomy-related solutions can play in supporting industrial decarbonisation and reducing dependence on fossil-based feedstocks, as acknowledged in the Strategy for a Competitive and Sustainable EU Bioeconomy.

EurEau welcomes the Commissions intention to present a Biotech Act II creating lead markets for industrial biotechnology and bio-based materials, while also ensuring sustainable biomass supply across the value chain. Water services have the potential to roll out large-scale resource recovery of biobased nutrients and materials, energy and water.

Food Fermentation Europe (FFE) welcomes the European Commissions Call for Evidence for Biotech Act II and urges the Commission to bring advanced fermentation for food and feed ingredients explicitly within its scope. The EUs dependence on third-country suppliers for proteins and fermentation-derived feed inputs is a structural vulnerability in the European food system.

Contribution to the Call for Evidence on the Biotech Act II 10 June 2026 About Vioneo Vioneo is a Swiss-based company, a pioneer in producing fossil-free plastics - using green methanol to make polypropylene and polyethylene at a commercial scale.

Planet B.io welcomes the European Commissions initiative to develop a Biotech Act II. As an innovation and scale-up ecosystem dedicated to industrial biotechnology, we see this as a critical opportunity to strengthen Europes competitiveness, strategic autonomy, and transition towards a sustainable and circular economy. The Biotech Act II should explicitly go beyond healthcare and pharmaceuticals.

APAG Oleochemicals Europe, a sector group of Cefic, is a longstanding pillar of the European bioeconomy. As other regions already have policies in place with ambitious targets, Europe must shift from enabling conditions to deployment. The Biotech Act II is a strategic opportunity to strengthen competitiveness, reduce external dependencies and support resilient bio-based value chains.

Dear madam, sir, Please see the input of the Dutch cabinet for the call for evidence/have your say regarding the European Biotech Act II in the attachment. Dutch Ministry of Economic Affairs and Climate Policy, Dutch Ministry of Agriculture, Fishery, Food security and Nature, and Dutch Ministry of Infrastructure and Waterstate.

Borregaards case is that EU policy should create stronger market pull for bio-based products by biobased content targets, improving cost competitiveness, reducing regulatory friction, and enabling broader recognition of the value of wood-based intermediates such as lignin-based products.

Ifremer (French Research Institute for Exploitation of the Sea) strongly supports the ambition of the future Biotech Act II to strengthen Europe's competitiveness in industrial biotechnology and biomanufacturing. Achieving this objective, however, requires the explicit recognition of the strategic contribution of blue biotechnology.

EIT Food welcomes this call for evidence supporting a thorough impact assessment, recognising that a strong innovation ecosystem is a cornerstone of a sustainable and competitive bioeconomy, driving innovation, economic growth, and environmental benefits.

The European Synthetic Biology Society (EUSynBioS) is a non-profit organisation advancing biotechnology and synthetic biology across Europe. We bring together stakeholders from academia, industry, governments and civil society to raise awareness, build partnerships and address shared challenges.

KWS welcomes the European Commissions intention to develop a European Biotech Act II. This initiative represents a key opportunity to strengthen Europes competitiveness, technological sovereignty, and resilience, while accelerating the transition to a sustainable bioeconomy.

Versalis, Enis chemical company, welcomes the Biotech Act II. This has a pivotal role in advancing biotechnology and biomanufacturing across Europe and as a strategic driver for the sustainable use of biomass, enabling the development of a robust and circular bioeconomy.

The European Branded Clothing Association (EBCA) recognises the important role that biotechnology and bio-based solutions can play in supporting industrial decarbonisation. However, EBCA is alarmed that the European Commission is considering including the textile apparel sector as a potential lead market to create demand for bio-based feedstock or captured emissions (CCU) for end products in the Biotech Act II.

INRAE welcomes the ambition of the EC to deliver a Biotech Act II unlocking the full transformative potential of biotechnology. INRAE insists that the Biotech Act II should strengthen the researchinnovation continuum, thus contributing to overcome the three main barriers hindering the EU biotech & biomanufacturing industry: limited market uptake, unpredictable investment, fragmented single market and regulation for…

APROVALS welcomes the preparation of the Biotech Act II as an opportunity to turn Europes food biotechnology potential into responsible market deployment. APROVALS is an EU-funded project supporting food biotech and cell-culture-based innovators through a structured sandbox methodology, expert engagement and policy dialogue.

Europe has already demonstrated that it can generate world-class biotechnology innovation. The next challenge is ensuring that these innovations can be deployed, financed and manufactured at industrial scale within Europe.

EU Specialty Food Ingredients (EU SFI) welcomes Biotech Act II as a key follow-up to Biotech Act I and an opportunity to strengthen industrial biotechnology and biomanufacturing in the EU. It should better reflect the needs of the agri-food supply chain through targeted measures for the food industry and biomanufacturing, including faster authorisation and permitting, support for scale-up, and market uptake…

FEFANA, the EU Association of Specialty Feed Ingredients and their Mixtures, is the united voice of the specialty feed ingredients industry in Europe. Our membership includes manufacturers and traders of feed additives, functional feed ingredients, premixes, and other specialty ingredient mixtures entering the food chain via feed.

We welcome the forthcoming Biotech Act II as a strategic initiative to strengthen Europes biotechnology and biomanufacturing capacity, enhance industrial competitiveness, and accelerate the transition towards a circular and sustainable bioeconomy.

The European Biosolutions Coalition (EBC) welcomes the opportunity to contribute to the European Commissions Call for Evidence for the impact assessment on Biotech Act II. The EBC brings together European biosolutions stakeholders working to strengthen the conditions for industrial biotechnology, biomanufacturing and the deployment of biosolutions across EU value chains.

The German Bioethanol Industry Association (BDBe) strongly welcomes the European Commissions initiative for a Biotech Act II to strengthen Europe as a leading hub for industrial biotechnology and bio-based value chains.

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Bio-manufacturing should be treated as an integrated industrial system, not merely a technology sector. Successful bio-based production depends on coordinated access to sustainable biomass, energy, chemicals, skilled labour, market demand, and waste-management infrastructure. Weaknesses in any part of the system undermine competitiveness. Main Recommendations 1.

The Triangle collaboration between Aarhus University (AU), INRAE and Wageningen University & Research (WUR) strongly welcomes the European Commissions ambition to deliver a regulatory framework for biotechnology that can fully embrace the entire scope of biotechnology and enable the very significant opportunities embedded within this domain.

The competitiveness level of the biopharma sector has only deteriorated recently. The General Pharmaceutical Legislation (GPL) represents a clear step backwards in terms of regulatory environment for the development of innovative medicines (notably regarding IP-protection).

BioBased Circular (BBC) welcomes the European Commission's initiative to develop Biotech Act II and its ambition to strengthen industrial biotechnology and biomanufacturing in Europe. As a Dutch National Growth Fund programme, BBC works to accelerate the development and deployment of biobased and circular materials.

Qorium B.V. is a Dutch industrial biotechnology company cultivating real leather from cells. Established in 2021 at the Brightlands Maastricht Health Campus, we have raised 30M to date (22M Series A closed November 2025) from Sofinnova Partners, Brightlands Venture Partners, Invest-NL and LIOF.

Avantiumis a Dutch SME in renewable chemistry whose origins in advanced catalysis laid the foundation for its development into a company focused oncommercialisingsustainable fossil-free chemical technologies.Avantiumsmost advanced technology,YXY® Technology, catalytically converts plant based sugars intoFDCA (furandicarboxylicacid),the key building block forPEF(Polyethylenefuranoate), a plant based and recyclable…

Please find attached the full text of comments. These can be summarised as follows. Comments from the Animal Right to Biotech Act II The Animal Right is Sweden’s leading animal rights and welfare organisation and would like to give the following indications on the proposed Biotech Act II. We thank you for your opportunity to comment.

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Synpa-les Ingredients Alimentaires de Specialité represents producers and distributors of specialty food ingredients in France. Many ingredients are at the heart of biotechnology: ferments, algae and microalgae, organic acids, ingredients produced by micro-organisms through fermentation (food enzymes, amino acids, certain vitamins, proteins).

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Sanofi welcomes the Commission's Biotech Act II initiative and submits one core message: biopharmaceuticals must be included within the scope of Biotech Act II as a strategic industrial capability. Biomanufacturing is a horizontal industrial capability shared across all end uses. Excluding biopharmaceuticals would leave out the segment where Europe retains its strongest industrial footprint.

Federchimica, the Italian Federation of the chemical industry, believes it is essential for the Biotech Act II to become a coherent, cross-sectoral regulatory framework for the bioeconomy. The Act must go beyond biotechnology and biofabrication to address the entire bioeconomy, so that the EU can continue to be global market leader.

CropEnergies welcomes the opportunity to contribute to the development of the EU Biotech Act II. To achieve the EUs climate and industrial objectives, the Biotech Act II should establish a tech-nology-neutral and harmonised framework that creates demand for renewable carbon from all sustainable sources, including biomass, recycled carbon and Carbon Capture and Utilisation (CCU).

Kyoto Club - https://www.kyotoclub.org/en/ - welcomes the Biotech Act II, a policy with the potential to have a pivotal role in advancing biotechnology and biomanufacturing across Europe and as a strategic driver for the sustainable use of biomass, enabling the development of a robust and circular bioeconomy.

Dansk Industri (DI) welcomes the opportunity to contribute to the European Commissions Call for Evidence for the impact assessment on Biotech Act II. DI's proposed structure for Biotech Act II is based on four regulatory design principles: (1) common information should be organised for reuse across procedures; (2) regulatory orientation should be provided before major data-generation investments are made; (3)…

Corbion welcomes the European Commissions initiative to develop a Biotech Act II, complementing the Biotech Act I by establishing a coherent, predictable, and innovation-friendly framework for industrial biotechnology and biomanufacturing in the EU. Europes competitiveness depends not only on innovation but also on the capacity to scale production within the Union.

The European Biogas Association (EBA) welcomes the opportunity to contribute to the public consultation on the Biotech Act II. Biogas production generates two valuable bio-based co-products: digestate, which serves as a bio-based fertiliser, and biogenic CO, which can be utilised across a range of industrial applications.

The Danish Association of Plant Breeders (DAPB) welcomes the European Commissions initiative to develop a European Biotech Act II and supports its ambition to strengthen European competitiveness, industrial biotechnology and the transition towards a sustainable bio-based economy.

Bioenergy Europe welcomes the ambition of the Biotech Act II to strengthen Europes bioeconomy and industrial competitiveness. The Act should adopt an inclusive, technology-neutral approach to biomanufacturing, recognising various sustainable biomass conversion pathways, and aim to reduce regulatory fragmentation across Member States by promoting harmonisation, predictability, and efficient market access for…

Statement on the Biotech Act As a European research infrastructure, IBISBA welcomes the Biotech Act, which signals a strong EU commitment to biotechnology, biomanufacturing, and the bioeconomy transition. Biotech Act I is a positive step for biotechnology innovation in health.

METAS (Swiss Federal Institute of Metrology) supports the European Commissions Biotech Act II and highlights the essential role of metrology in advancing industrial biotechnology and biomanufacturing in Europe. A strong, forward-looking framework is needed to harness biotechnologys potential in addressing climate change, resource efficiency, and sustainable industrial transformation.

Novamont - since 2023 part of Versalis, Enis chemical company is pioneer in the circular bioeconomy and among the international players in the production of bio-based biodegradable/compostable plastics, biochemicals and bioproducts, welcomes the Biotech Act II.

To me, Biotech Act II is a highly strategic and timely initiative that has strong potential to enhance Europes industrial competitiveness, accelerate de-fossilization, strengthen circular bioeconomy systems, and reduce dependence on imported fossil-based feedstocks through industrial biotechnology and biomanufacturing.

We welcome Biotech Act II as a decisive instrument to strengthen Europes competitiveness, resilience, strategic autonomy and industrial leadership through biotechnology. We call for agrifood biotechnology to be recognized as a strategic priority and an enabling pillar of Europes future bioeconomy.

FEDIAF, the voice of the European pet food industry, welcomes the EC's initiative to develop a European Biotech Act II and supports its objective to strengthen the EUs industrial biotechnology and biomanufacturing ecosystem. Biotechnology plays a key role in the pet food sector, which relies on a wide range of biotechderived ingredients to ensure safe, nutritious and sustainable products.

Position Paper Submitted in Response to the European Commission Call for Evidence on the Biotech Act II Accelerating Industrial Biotechnology and Advanced Biomanufacturing to Support Europe's Environmental, Public Health, and Competitiveness Objectives Prepared by the Movement for a Microplastic Free Future (www.mmpff.org) June 2026 Executive Summary The Movement for a Microplastic Free Future (MMPFF) welcomes the…

The proposed initiative reaffirms the strategic importance in multiple areas of biotechnology, which is essential for Europe’s competitiveness, resilience and clean and digital transitions. It aims to ensure a level playing field in the single market, eliminating fragmentation and ensuring that innovative biotechnology products and processes can quickly enter and circulate freely within the EU.Biotechnology needs to…

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The Biotech Act II shall complete the stated ambition from the European Commission and Member States for a far-reaching and multi-sector legislation. It should recognise EU advance through Biotech Act I in key aspects of biotechnology and extend these to the full delivery of biomanufacturing as central to Europes economic, supply chain and sustainable future.

Vinnova welcomes the Commissions Call for Evidence on Biotech Act II and supports its objective of creating an enabling framework for industrial biotechnology and biomanufacturing in Europe. Industrial biotechnology is a key enabler of a competitive, sustainable circular European economy but it will not happen without concerted efforts from EU and its member states.

This summary highlights key themes from the EEBio Programme response to the EU Biotech Act II Call for Evidence; further detail is included in the attached document. The response is submitted on behalf of the EEBio Programme, a UKRI EPSRC-funded interdisciplinary programme developing engineering biology platforms to enable reliable, robust and scalable biosolutions across sectors including health, agriculture…

We welcome the European Commission's effort to develop Biotech Act II as a framework for strengthening Europe's industrial biotechnology and biomanufacturing ecosystem. Our focus is preventing persistent microplastic generation through science-based policy, innovation, and deployment of environmentally safer material systems.

EABA Contribution to the Call for Evidence on the Biotech Act II The European Algae Biomass Association (EABA) welcomes the opportunity to contribute to the Biotech Act II initiative. Algae biotechnology is a strategic enabler of the EUs objectives on competitiveness, strategic autonomy, climate neutrality, circular economy, and sustainable food and feed systems.

The Biotech act II represents an important evolution in the policy conversation around biotechnology. Unlike earlier bioeconomy strategies, which focused primarily on research, innovation and sustainability, the new framework acknowledges that Europes challenge is increasingly one of industrialisation.

Federchimica Assobiotec welcomes the Commission’s recommendation on the Biotech Act II as a strategic tool to strengthen the EU’s industrial competitiveness, support the transition to sustainable production models and promote the circular bioeconomy.

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The European Aquaculture Technology & Innovation Platform (EATiP) is pleased to comment on a Call for Evidence concerning the Biotech Act II (The Act). EATiP welcomes the opportunites afforded by The Act & the broadening of EU biotechnology policy beyond health and into industrial biotechnology and biomanufacturing, noting that this will bring direct benefits for aquaculture.

World Animal Protection Netherlands welcomes the European Commissions Call for Evidence on the Biotech Act II. We recognise the potential of biotechnology to reduce dependence on fossil feedstocks and enable more sustainable protein systems. Industrial biotechnology can play an important role in the transition away from industrial agriculture.

Mr Gaia called on the European Commission to explicitly recognise cultivated meat as a strategic food biotechnology under the future Biotech Act part II. Cultivated meat, produced from animal cells grown in a controlled environment, can simultaneously contribute to several European objectives: improving animal welfare, reducing certain environmental and health pressures linked to intensive livestock farming…

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Water Europe welcomes the European Commissions objective to accelerate the transition towards a circular and bio-based economy through industrial biotechnology and biomanufacturing. This transition will contribute significantly to Europes resilience and competitiveness. However, these objectives should not be pursued at the expense of the EU water acquis or the objectives of the European Water Resilience Strategy.

VIB welcomes the European Commission's initiative to develop a European Biotech Act II as a key pillar of Europe's competitiveness agenda. Europe possesses world-leading capabilities in biotechnology research and innovation. However, despite its scientific excellence, Europe continues to underperform in translating discoveries into scalable companies, industrial deployment and market impact.

The Greek Bioeconomy Council (GBC), the national association representing the bio-based industry and the circular bioeconomy sector in Greece, welcomes the Commissions initiative to prepare the Biotech Act II and broaden EU biotech policy towards industrial biotechnology, biomanufacturing, bio-based materials and circular value chains.

Holis Earth is a collaborative LCA and eco-design platform. This feedback is consistent with EuropaBio positions (May 2026) and the joint industry statement on Biotech Act II (Plant ETP, April 2026). Full submission with 35 references available.

Croda is a specialty chemicals company that creates high performance ingredients and solutions principally for Consumer Care and Life Sciences markets. Established in 1925 and headquartered in the UK, Croda is a FTSE 100 company with over 5,900 employees across 91 locations in 36 countries.

MicroHarvest is a German-Portuguese SME specialising in biomass fermentation, a natural process converting plant-based by-products into nutrient-rich single-cell protein. Our ingredient contains over 60% protein, a complete amino acid profile, and emits up to 98% fewer greenhouse gases than animal protein, requiring no additional farmland.

The Life Science Manufacturers Association (LSMA) welcomes the opportunity to contribute to the development of the EU Biotech Act II. Life science manufacturers are the companies that develop and supply the materials, consumables, equipment, and specialised services that make pharmaceutical, biotechnology, and diagnostic production possible.

FEP - the European Parquet Federation - welcomes the launch of the Call for Evidence underpinning the forthcoming Biotech II initiative as a timely and important step to strengthen Europes bioeconomy. At the same time, FEP encourages an expanded scope that more explicitly encompasses biomanufacturing and the use of wood in construction products, including wood flooring.

Aurelia Stiftung is a non-profit, science-based foundation protecting pollinating insects. For pollinator and environmental protection, the Biotech Act II is highly relevant because it concerns living genetically modified micro-organisms (GMMs) in open environments. It is not merely about simplification, but whether the EU weakens its safety architecture for replicating, evolving and potentially spreading organisms.

The Biocontrol Coalition welcomes the opportunity to contribute to the European Commissions Call for Evidence on the Biotech Act II. The submission argues that the EU is not delivering sufficiently rapid and scalable access to biocontrol solutions despite repeated commitments on competitiveness, innovation and simplification.

Ragn-Sells welcomes the Commissions Call for Evidence on Biotech Act II. The issue of circular nutrient recovery from aquaculture side streams, however, highlights a broader systemic barrier affecting industrial biotechnology in Europe. Despite proven technologies, regulatory fragmentation across waste, animal by-product, fertiliser, and feed legislation continues to limit the scaling of biomanufacturing solutions.

The European Biotech Act Part I contains several welcome healthcare policy measures. To fully realise its objectives, EUCOPE has identified a set of additional recommendations for the Biotech Act Part II: Reframe biopharmaceutical spending as strategic investments; Promote uptake of biotechnology; Enhance biomanufacturing cooperation with international partners; Scale-up genome sequencing capability and newborn…

The Competitiveness Directorate of the Regional System of the Piedmont Region welcomes the establishment of a Biotech Act II, dedicated to European industrial biotechnology and biomanitisation and complementary to the Biotech Act I.

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Summary Perstorp welcomes the Commissions initiative for a Biotech Act II. The bioeconomy is a strategic pillar of the European economy and enhanced efforts are required in this sector to reach EUs climate targets and strengthen Europes self-sufficiency. The regulation should support an active bioeconomy that makes the best use of sustainably sourced carbon.

The Plantbased Network in West-Brabant welcomes the European Commissions ongoing efforts to further position biotechnology as a strategic enabling technology for Europe's competitiveness, economic resilience and green transition.

The Renewable Carbon Initiative (RCI) welcomes the opportunity to contribute to the development of the EU Biotech Act II. To achieve the EUs climate and industrial objectives, the Act must establish a technology-neutral and harmonised framework that actively creates demand for renewable carbon from all sustainable sources, including bio-based, bio-attributed, recycled and carbon capture and utilization (CCU)…

FoodDrinkEurope welcomes the European Commissions Call for Evidence on the upcoming European Biotech Act II and supports the objective of establishing an enabling EU framework for industrial biotechnology and biomanufacturing. The European food and drink industry is Europes largest manufacturing sector and a key actor in the biotechnology and biomanufacturing landscape.

FMTE, representing Europes food manufacturing technologies and equipment sector, welcomes the upcoming EU Biotech Act II and calls for food biotechnology to be explicitly included within its scope as a strategic pillar of Europes bioeconomy.

OCAPI is a public research-action program that studies how to make sanitation and agri-food systems more sustainable through the recycling of human excreta (urine and faeces) into bio-based fertilizers. We wish to draw the European Commissions attention on these emerging and fast-developing solutions for more sustainable, locally-produced fertilizers.

Since 2009, the Association Réseau de l’Assainissement Ecologique (RAE) has aimed to defend the general interest in sanitation and brings together more than 150 stakeholders: users, environmental associations, institutions, researchers, companies (consultancy firms, rental firms and dry toilet manufacturers, etc.).

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Euroseeds welcomes the Commissions initiative. Biotech is a key enabler across agriculture, industry and the environment, supporting EU value chains, food security, and climate adaptation.Agricultural biotechnology should be explicitly recognised as a strategic component of the European bioeconomy within Biotech Act II.The Call for Evidence refers to sustainable biomass, bio-based materials, and food and feed…

Direct solar fuels (DSF) offer a promising Carbon Capture and Utilisation (CCU) pathway supporting climate neutrality, energy security and European competitiveness. By converting sunlight and abundant feedstocks (water, carbon dioxide and nitrogen) into fuels and chemicals, DSF technologies can store renewable energy in energy-dense molecules while reducing dependence on fossil resources.

1. Concrete measures for lead markets in Europe As a company developing plant biostimulants, we see that Europe possesses the technological solutions for a resilient agriculture. The challenge is the speed of market adoption.

EFfCI strongly supports the Biotech Act II as a strategic instrument to strengthen industrial biotechnology, enhance the resilience of the European economy, & accelerate transition to sustainable, circular & low-carbon production systems. Industrial biotechnology is a critical enabling technology for defossilisation & innovation across multiple value chains, including chemicals & consumer products.

Evonik welcomes the opportunity to provide input on the challenges and policy intervention areas for industrial biotechnology & biomanufacturing in the EU. Challenges Regulatory complexity and outdated frameworks The current EU regulatory system remains fragmented, process-based, and insufficiently aligned with scientific progress.

Biotechnology is a strategic asset for European competitiveness and food security. The Biotech Act I was a missed opportunity, as its limited scope did not address regulatory barriers to biotechnology in agriculture. The Biotech Act II should include the topic of plant biotechnologies, including simplification of GMO authorisation procedures, without compromising health and environmental safety.

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Biotechnology is a strategic asset for EU competitiveness and economic security. The limited scope of Biotech Act I was a missed opportunity, and the limited initiatives across different packages (feed additives in Food and Feed Safety Omnibus, General Food Law in Biotech Act I, separate proposal on GMMs), risk only minor tweaks which fail to address the systemic regulatory barriers that constrain agricultural…

Modern biotechnology is a key pillar for the competitiveness and strategic autonomy of the European economy. Unfortunately, the first phase of the Biotech Act I did not sufficiently address the regulatory barriers that have long paralysed agricultural biotechnology in the EU.

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Citribel is a Belgian biotechnology company and one of Europe's leading producers of citric acid and biobased ingredients. Through industrial fermentation, Citribel converts renewable agricultural feedstocks into high-value bio-based products serving the food, pharmaceutical, feed, personal care and industrial sectors.

Ghent University is a leading institution in securing Horizon Europe Cluster 6 funding, and therefore excellent in biotech and bioeconomy research. We furthermore have a strong portfolio of exploitation and (commercial) valorisation of results.

Plastics Europe supports the European Commissions ambition to scale up the share of bio-based feedstocks in plastics production - a key pathway to reduce greenhouse gas emissions while supporting circularity and industrial competitiveness. The Biotech Act II can set an enabling, predictable and coherent framework to seize the opportunities offered by Europe's bioeconomy.

Europe has a high level of research in white and grey biotechnology by international standards. This shows that Europe has the potential to play a leading role in this cross-sectoral key technology. Biotechnology has the potential to affect many sectors of the economy, from the chemical and pharmaceutical industries to the recovery of raw materials in the recycling industry, and thus to become a powerful driver of…

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IBMA, the association representing biological control manufacturers in Europe and globally since 1995, with over 200 members, welcomes the European Commission's initiative to develop a Biotech Act II and its ambition to establish an enabling regulatory framework for industrial biotechnology and biomanufacturing in Europe. Please read our answer here attached.

Plantum, the Dutch trade association for breeding and young plant breeders, welcomes this initiative of the European Commission. As a sector that continuously translates scientific breakthroughs into practical solutions, we support a legislative framework that enables biotech innovation across Europe. In the attached document, we elaborate on our vision for the Biotech Act II.

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Input for Biotech Act II hearing Finnish Food and Drink Industries Federation values highly the current EU policy targets on promoting innova-tions, boosting productivity and creating right conditions for European business to thrive. Biotechnology offers essential tools in building the resilience, circularity and competitiveness of the sector that is critical part of comprehensive security.

The Biotech Act II should provide a framework that accelerates the market uptake of bio-based products and feedstocks, while supporting investment, innovation and industrial scale-up across Europe. Strengthening sustainable feedstock availability Increasing the availability of sustainable primary biomass plays an important role in biomanufacturing, and bio-based materials offer a major opportunity for the EUs…

Biotech Austria, an industry association gathering 60+ Austrian life science biotech startups, SMEs, and mid- sized companies, welcomes the EU Commissions proposed EU Biotech Act I (the Act) as a timely initiative that acknowledges biotechnology as a strategic pillar of Europes competitiveness, resilience, and health sovereignty.

Good afternoon I am sending contributions to the future European Biotechnology Law, drawn up by the Working Group on Biosafety, Biomedical Technologies and Biotechnology of the Official College of Biologists of the Community of Madrid. Greetings Nuria Asensio G.T. DE BIOSEGURIDAD, TECNOLOGÍAS biomedicas and BIOTECNOLOGIA-COBCM

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I welcome the European Commissions Call for Evidence on the Biotech Act II. Biotechnology is a strategic enabler of Europes competitiveness, resilience, sustainability and technological sovereignty. Europe has strong scientific capabilities in universities, public research institutions and application-oriented research environments.

The European Biosafety Association (EBSA) takes note of the European Commissions initiative to prepare a Biotech Act II focusing on industrial biotechnology and biomanufacturing. The Biotech Act II is expected to complement the European Biotech Act I, which focuses primarily on health biotechnology and is currently progressing through the legislative process.

The Netherlands National Institute for Public Health and the Environment (RIVM) houses the GMO office and in that role permits GMO activities and advises the Competent Authority on the GMO dossier. This contribution is submitted by RIVM-GMO Office and thus does not represent the position of the institute as a whole. We welcome the initiative to strengthen the European biotechnology sector.

Ecoxtract welcomes the European Commissions initiative to establish a Biotech Act II and strongly supports its objective of accelerating industrial biotechnology and biomanufacturing in Europe. As a company developing and commercialising a bio-based solvent for industrial extraction applications, Ecoxtract directly experiences several of the barriers identified in the Call for Evidence.

As a Belgian industrial player active in bio based chemicals and materials, Futerro welcomes the ambition of the forthcoming Biotech Act II and the opportunity to provide feedback through this call for evidence. The European Union has set ambitious objectives for climate neutrality, circular economy and industrial resilience.

Bio Base Europe Pilot Plant (BBEPP) is an independent open-access pilot facility supporting the scale-up and commercialisation of bio-based processes and products. Through our work with start-ups, SMEs, multinationals, investors, research organisations and public authorities, we have insights into the challenges faced by biotechnology companies across Europe.

EFPIA & VE welcome the ECs initiative to develop the Biotech Act II and supports the objective of strengthening Europes industrial biotechnology and biomanufacturing ecosystem. The Biotech Act II should primarily focus on improving framework conditions that enable advanced biomanufacturing and manufacturing innovation in Europe, helping to translate scientific excellence into commercial success.

Cellular Agriculture Europe welcomes the European Commissions initiative to develop a second Biotech Act focused on industrial biotechnology and biomanufacturing. The proposal is a timely opportunity to strengthen Europes competitiveness, resilience and clean industrial transition through biotechnology-enabled innovation.

Please see attached Response to the European Commission Call for Evidence on the Biotech Act II The Biotech Act II is an important opportunity to strengthen Europes industrial biotechnology and bio-based economy. To succeed, the initiative must focus not only on political objectives and market incentives, but also on the technical rules that determine how regulation works in practice.

Biotechnology is a strategic enabler of Europes competitiveness, sustainability, and resilience. Despite strong scientific capabilities, Europe continues to lag in translating research into industrial scale and market deployment, held back by regulatory complexity, limited biomanufacturing capacity, weak market demand, and investment gaps.

Animal Protection Denmark welcomes the opportunity to respond to the consultation on the EU Biotech Act II. Our response can be found in the attached document. Parts of our response simply repeat the additional information we submitted to the public consultation on the Biotech Act in November 2025, and we therefore also refer to that submission.

Fossil-based industries benefit from decades of optimisation, including mature technologies, global logistics, and highly efficient large-scale production systems. Bio-based sectors are still in a scale-up phase, facing: o Fragmented biomass supply o Higher logistics costs o Competing uses of biomass (energy, food, materials) Infrastructure lock-in (refineries, chemical plants, distribution systems) is a major…

World Animal Protection Sweden welcomes the opportunity to contribute to the European Commissions Call for Evidence on the Biotech Act II. We advocate for a transition away from industrial animal agriculture systems characterised by high-intensity and high-density production towards equitable, humane, sustainable and resilient protein systems, where animal welfare, environmental sustainability and food security are…

BMS Response to the European Commission Call for Evidence: Biotech Act II Bristol Myers Squibb (BMS) welcomes the European Commission's Call for Evidence for the Biotech Act II and commends the initiative's ambition to build a more competitive, innovation-friendly regulatory environment for industrial biotechnology and biomanufacturing in the EU.

Eurogroup for Animals welcomes the possibility to contribute to the call for evidence on the European Biotech Act II. This initiative provides a valuable occasion to support biotechnologies that can unlock just, circular, sustainable, and competitive food systems and to expand upon the Biotech Act I, the EU Life Sciences Strategy, the EU Roadmap towards phasing out animal testing, as well as other pertinent EU…

Flanders FOOD strongly welcomes the ambition of the EU Biotech Act II to strengthen Europes biotechnology ecosystem and industrial competitiveness. To fully unlock its potential, the Act should explicitly recognise the strategic role of food and feed biotechnology, while addressing key regulatory bottlenecks that currently limit innovation, scale-up and market uptake.

Industrial biotechnology and biomanufacturing are strategic enabling technologies for advancing European competitiveness, resilience, circularity, and climate neutrality. Drawing on the experience in research of the ENEAs Department for Sustainability in Italy, innovation, technology transfer, and the management of advanced research infrastructures across industrial, environmental, agri-food, and bio-based sectors…

Fertinagro Biotech welcomes the European Commissions initiative to develop a Biotech Act II. The initiative comes at a decisive moment for the EU: biotechnology can strengthen competitiveness, reduce external dependencies, accelerate the circular bioeconomy, support the resilience of European agriculture and ultimately, guarantee food security for European citizens.

Kemira supports the European Commissions initiative on the European Biotech Act II and its overall objective to improve the size and competitiveness of the European bioeconomy sector. Kemira particularly welcomes the efforts to clarify the definition of sustainable biomass, prioritize its uses, and improve traceability while creating stronger market demand for bio-based solutions, accelerating investments and…

Hellenic Cancer Federation (ELLOK) The Hellenic Cancer Federation (ELLOK) welcomes the European Commissions initiative to strengthen Europes biotechnology ecosystem and accelerate the translation of scientific discovery into health and societal benefit.

Łukasiewicz Research Network PORT Polish Center for Technology Development welcomes the European Commissions Biotech Act II initiative and the launch of the Call for Evidence, which represents an important step toward shaping the future regulatory framework for industrial biotechnology, medical biotechnology, and biomanufacturing in the European Union.

SUEZ views the EU Biotech Act II as a major opportunity to strengthen Europes industrial biotechnology sector, accelerate the deployment of bio-based solutions, and improve the EUs competitiveness and strategic autonomy.

AnimalhealthEurope, the association representing the manufacturers of veterinary medicines, vaccines and other animal health products, welcomes the Commissions intention to propose a European Biotech Act II. AnimalhealthEuropes membership covers 90% of the European market for animal health products.

As a global petrochemical and leading bio-based plastics producer, the attachment outlines our policy recommendations to accelerate the development of a scalable and competitive bioeconomy in the EU. Stronger policy support is needed to align with EU climate and bioeconomy objectives.

AseBio welcomes the Biotech Act II as an opportunity to provide the EU with a more coherent, competitive and operational framework for industrial biotechnology and biomanufacturing. From our perspective, the initiative will only fully achieve its purpose if it is designed as a genuine instrument for industrial deployment. 1. Industrial deployment as the central priority.

EPSO welcomes the European Commission call for evidence Biotech Act II and provides input with the following key recommendations: o Lead Markets: Explicitly include plant-based biomanufacturing; recognise plant-factory-derived inputs in bio-based content requirements.

The Biotech Act II is intended as an extension of the Biotech Act I to the field of application of industrial biotechnology and production. Both Acts focus on increasing the EU’s industrial competitiveness in biotechnology and biomanufacturing. This focus on late stages of the innovation chain is legitimate, but in the view of the German Life Sciences Association (VBIO) is not sufficient.

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Feccs feedback on the Biotech Act II urges the EU to bridge the scale-up gap for industrial biotechnologies and harmonise fragmented regulations to support SMEs. It calls for prioritising biomass for high-value industrial use, ensuring a global level playing field against lower-cost regions like Asia, and formally recognising distributors as essential market enablers.

*Submitted by Dr. Willian da Silveira and Dr. Ivelina Kadiri, on behalf of SEREN (Space Life Sciences European Research Network, serenspace.org), an informal European research network spanning more than twenty jurisdictions. SEREN welcomes the Call for Evidence on Biotech Act II.

ePURE the European Renewable Ethanol Association represents bioethanol producers from crops, wastes and residues committed to sustainable bio-based solutions. Our members operate 21 state-of-the-art biorefineries across the EU, transforming primary agricultural biomass into renewable ethanol, high-protein animal feed, food, and other valuable co-products.

The Federation of the German Waste, Water and Circular Economy Management Industry (BDE) welcomes the Commission's initiative to establish a Biotech Act II and underlines the crucial role of waste-derived biomass for the European bioeconomy. Decoupling the European economy from fossil raw materials must not be built on the expanded cultivation of primary agricultural feedstocks for biotechnological processes.

FibriTech is a Polish deep-tech company specializing in biomanufacturing. We have patented a technology for forming three-dimensional (3D) biomaterials from organic plant fibers without the use of artificial binders. Our flagship product, FibriAgri, is an innovative substrate for greenhouse crops featuring a solid, porous 3D structure, 100% biomass-based, biodegradable, and peat-free.

COFALEC, representing the European yeast industry, welcomes the Biotech Act II and the Commission's ambition to strengthen Europe's biotechnology and biomanufacturing capacity. This response sets out how the Act can support not only emerging biotech, but also the established fermentation industries that already underpin Europe's food, feed and bioeconomy value chains.

IKEM welcomes the European Commissions initiative to introduce a Biotech Act II. For IKEM, it is essential that Biotech Act II is designed broadly and cross-sectorally, encompassing biotechnology-based and bio-based solutions across the entire economy including food and feed, bio-based chemicals, plastics and materials, agriculture, industrial and environmental biotechnology, as well as marine biotechnology.

Bio Germany, as the industry association of the German biotech industry and the Industrial Biotechnology Cluster (CLIB), welcomes the EU Biotech Act I as an important step for health biotechnology. For the planned EU Biotech Act II, we call for a focus on industrial biotechnology and biomanufacturing to ensure Europe’s innovative capacity and competitiveness in the bioeconomy.

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Innovation Fund supports new manufacturing processes which reduce CO2. However, their GHG methodology for calculating CO2 savings are not aligned with biomanufacturing. It is a general problem that peat extraction as material (e.g. for growing plants) carries huge environmental problems with wet-lands destruction.

The Biotech Act II represents a timely opportunity to translate the objectives of the EU Bioeconomy Strategy into a concrete legislative framework capable of scaling up biomanufacturing across Europe. As global competition intensifies and strategic dependencies on fossil-based materials and imported raw materials continue to challenge European industry, the EU must establish the conditions necessary for innovative…

The German Environment Agency (UBA) welcomes the opportunity to contribute to the Call for evidence on the Biotech Act II, a proposal for regulation prepared by the EU Commission (DG GROW). From an environmental policy perspective, the identified challenge of insufficient market uptake of bio-based innovations is closely linked to persistent market distortions, regulatory gaps, and widespread uncertainty about…

We welcome the Call for Evidence for the Biotech Act II. As a European biomanufacturing company producing bio-based chemicals, our feedback is simple: Europe does not lack science, it lacks long-term demand certainty and a level playing field on capital.

The Province of North Brabant welcomes the European Commission’s initiative to further strengthen the regulatory framework for industrial biotechnology with the Biotech Act II. We recognise the importance of simplification, scaling up and strengthening the strategic autonomy and competitiveness of the European Union.

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WePlanet welcomes the opportunity to contribute to the Commission's call for evidence on the Biotech Act II and supports its goal of fostering an environment that encourages the growth of industrial biotechnology and biomanufacturing in Europe.

The Bezos Centre for Sustainable Protein at Imperial College London welcomes the European Commission's Call for Evidence for the Biotech Act II. As a leading research centre in engineering biology and synthetic biotechnology, with expertise in the development of novel fermentation platforms, metabolic engineering, and sustainable food technologies, we are committed to supporting evidence-based policy that enables…

The European Carbon and Graphite Advanced Materials Association (ECGA) welcomes the European Commission's initiative to develop a Circular, Regenerative, and Competitive Bioeconomy. We strongly support efforts to integrate bio-based feedstocks into industrial processes, which align with our commitment to reducing costs and the environmental footprint of our products.

Deutsche Hochschulmedizin e.V. (DHM) is the association of the University Hospitals of Germany (VUD) and the Medical Faculty Day (MFT). Together, they represent the 37 university hospitals and 40 medical faculties and thus publicly funded university medicine in Germany. These facilities bring together research, teaching and healthcare of the highest standards.

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The Swedish Food Federation welcomes the Commissions initiative to develop a second Biotech Act focusing on industrial biotechnology and biomanufacturing. Biotech Act II has the potential to strengthen Europes competitiveness, innovation capacity and resilience, while contributing to a more sustainable and robust food system.

The European Synthetic Cell initiative urges the European Commission to ensure that the Biotech Act II includes sustained investment in early-stage research, particularly in synthetic cell research, which - although currently still at low Technology Readiness Levels (TRLs) - is essential for enabling the next generation of biotechnologies.

Detailed explanation in pdf Strengthen scaling of biomanufacturing in Europe: Applying industrial biotechnology IWBio is a network of knowledge-based biotechnology that combines the industrial application and scale-up of biotechnological processes with active, pre-competitive exchanges between businesses, research and funding institutions.

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This feedback is given on behalf of the HE P2GreeN project, GA 101081883, as the Coordinators of the project: The EU prioritises developing a circular economy, achieving net-zero emissions, and eliminating pollution to address interconnected crises of pollution, biodiversity loss, and climate change.

At present, the commercial cultivation of genetically modified (GM) crops within the EU is virtually absent. This is largely due to the perception that the authorisation system is overly complex, lengthy, and unpredictable. As a result, practical activity is largely restricted to early-stage research and development, alongside the authorisation of imports of GM food and feed.

The use of fossil based feedstock results in GHG emissions, pollution, health hazards and loss of production capacity in Europe (as Europe has rightfully put in place though regulation against pollution and health hazard). The development of new supply chains based on bio-economy can help resolve these issues and become the basis for a new sustainable European supply chain.

I strongly believe as an investor in bioeconomy solutions across Europe, EU has an edge over many other markets when it comes to talent, infrastructure, security and institutions, but it needs to be having a long-term plan and acting accordingly to advance the transition towards a cleaner future, but also not just for european resilience, but also with the agenda of made with europe, across the world, especially the…

FEFAC representing the EU premixtures and compound feed industry welcomes the prospect of a biotech 2 proposal. FEFAC wants to stress that, at present, the EU biotech industry as a whole is not exploiting its full market potential, not only regarding innovative substances, but primarily for already existing substances like vitamins or amino-acids for which the demand exists already but exceeds dramatically the EU…

The future EU Biotech Act II should support not only biotechnology development, but also systemic bioeconomy frameworks enabling efficient, circular and regionally integrated biomass utilisation. Biotechnology should be embedded within broader territorial bioeconomy systems based on regional biomass flows, biohubs, integrated modular biorefineries and cascading biomass allocation pathways.

Amgen welcomes the European Commissions ambition to strengthen Europes leadership in biotechnology and biomanufacturing through the Biotech Act II. As one of the worlds leading independent biotechnology companies operating across global manufacturing and supply networks, with a strong presence in Europe, we appreciate the important steps taken under Biotech Act I to address regulatory and industrial policy…

Wagralim welcomes the ambition of the Biotech Act II to strengthen Europes position in biotechnology. However, the current draft remains primarily focused on health, while food and agricultural biotechnologies are essential for Europes food security, sustainability, and industrial competitiveness.

PhageEU (www.phageurope.eu) welcomes the call for evidence for Biotech Act II, which confirms biotechnology as a strategic technology across multiple sectors and not only human health. Bacteriophages, are viruses that target bacteria and can be applied in human medicine, veterinary medicine but also in agriculture and food and feed safety.

GFI Europe welcomes the European Commission's Call for Evidence on Biotech Act II and the recognition that food ingredients may fall within its scope. Advanced fermentation and biomanufacturing are inherently cross-sectoral, and the Act should reflect this logic by treating food biotechnology and food biomanufacturing as part of a wider industrial ecosystem rather than a niche sector.

As a professor of Analytical Chemistry with a focus on environmental analytics and wastewater treatment at a German University of Applied Sciences (Hochschule), I contribute applied research at the intersection of industrial biotechnology, circular bioeconomy, and environmental protection. My current projects directly address the challenges identified in this Call for Evidence.

This response addresses the five priority pillars for action: 1. Creating Lead Markets and Predictable Demand A central requirement is the creation of stable lead markets to drive industrial uptake of bio-based and biomanufactured products. Without predictable demand signals, private investment will not scale.

Find our feedback attached. Best wishes and thanks for this oportunity. Best [name removed] ______________________ peter gerhardt denkhausbremen e.V. am deich 45 28199 bremengermany www.denkhausbremen.de [email removed] [phone removed] [phone removed] [identifier removed] Independent work requires independent funding - donate now: https://denkhausbremen.de/spenden/

As key players in the EU biomanufacturing industries, the European woodworking industries welcome the European Commissions initiative to develop a Biotech Act II aimed at strengthening Europes industrial competitiveness, innovation capacity and strategic resilience.

The Subdirectorate-General for Food Safety and Public Health Laboratories of the Regional Ministry of Health has commented on the proposal for a European directive on biotechnology, with the aim of ensuring that it is compatible with the protection of public health.

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Make Europe the best place to approve, finance and buy sustainable biomanufactured ingredients NoPalm Ingredients welcomes the European Commissions Call for Evidence for Biotech Act II. We strongly support an ambitious Act that recognises industrial biotechnology and biomanufacturing as strategic tools for European competitiveness, resilience, circularity and climate action.

NOOSA® is a Belgian SME developing bio-based PLA fibres and textiles, with integrated closed-loop recycling solutions. We welcome the Biotech Act II initiative and strongly supports EU action to unlock industrial biotechnology and biomanufacturing as key enablers of EU competitiveness, strategic autonomy and de-fossilisation.

Klimafonden Skive considers that Biotech Act II should focus more explicitly on the framework conditions required to bring biosolutions from innovation to deployment at scale. This assessment is based on direct implementation experience as local anchor point for the first regulatory sandbox for green biorefining under the Danish Ministry for the Green Tripartite, and as operator of a real-scale living lab developing…

Please find attached the contribution of the SPHERE Group. Mr Sphere supported the Commission’s ambition to make the Biotech Regulation II an instrument for competitiveness, simplification and industrial sovereignty.

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1. Plant-based platforms for biotechnological production One of the central objectives of the Biotech Act II is to promote the biotechnological production of bio-based molecules as substitutes for fossil-derived or imported inputs.

As SMEs specialising in trading and research & development around bio-based and/or biodegradable polymeric materials, we welcome with great interest the Commission’s initiative and the public consultation on the Biotech Act II. The main obstacles to the wider deployment of the bioeconomy in Europe are listed in the document that can be consulted, namely not only the economic aspects but also the regulatory ones.

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Biotech Booster is a Dutch national accelerator program focused on translating biotechnology innovations into commercially viable companies. Our network spans research institutions, corporate partners, investors, and public stakeholders mainly in NL.

A.I.S.E. welcomes the opportunity to contribute to the Biotech Act II call for evidence. The paper outlines our sectors key considerations and recommendations, in particular regarding the need to address feedstock availability, bridge the green premium, avoid overlapping regulatory requirements, and ensure that policy measures remain proportionate and innovation-enabling for downstream users.

Biotech Act II should avoid creating parallel sustainability systems or additional reporting frameworks that would duplicate current obligations. To meet climate targets on time, the pace of implementation must be accelerated, but this is being slowed down by lengthy administrative processes (regulatory procedures).

Europe has a unique opportunity to strengthen its global leadership in biotechnology by creating a regulatory environment that enables innovation while maintaining high standards of safety and consumer trust. As a company developing novel proteins through methane-based microbial fermentation, we see significant potential for biotechnology to contribute to Europes food security, industrial resilience, and climate…

Our scale up company has encountered different challenges in scaling up and commercializing our technology to convert residuals into biochemicals and ingredients for biomaterials. Of the proposed measures, we support that Lead markets will be created Novel biobased products benefit from market creation to stabilize offtake and also increase defossilization of European supply chains.

The paper proposes three budget-conscious policy prescriptions to strengthen EU biotech competitiveness. First, the EU should fund a small number of world-class biotechnology R&D centers of excellence through open EU-wide tenders. The rationale is that biotech innovation is highly clustered around top universities, hospitals, startups, VC, and regulatory expertise.

Melt&Marble welcomes the Commissions Call for Evidence on Biotech Act II and supports its objective of creating an enabling framework for industrial biotechnology and biomanufacturing in Europe. Melt&Marble develops precision-fermentation-derived fats and lipid ingredients for food applications.

The feedback I am providing are my personal observations from the investments I have made for Circulate capital and Sagana. Please see my feedback in the the three critical points mentioned on the landing page - Insufficient market uptake - Finer problem - Market uptake will only work if there is a price parity.

Notpla is a UK-based sustainable packaging company at the forefront of commercialising seaweed and plant-based packaging materials. Our products are made from unmodified natural polymers and are fully biodegradable, compostable, and explicitly excluded from the definition of plastic under both REACH and the EU Single-Use Plastics Directive (SUPD).

The Biotech Act II should prioritise clear, harmonised frameworks that support the transition towards high-value, circular bio-based production, including the use of waste-derived and CO-based feedstocks. Targeted regulatory alignment, faster approval processes, and strong market incentives are essential to enable scale-up and competitiveness of innovative biotech companies.

The Protein Brewery welcomes the broadening of the scope to industrial biotechnology and biomanufacturing. Please make sure that microbial advanced fermentation technologies such as fungal biomass fermentation are part of the scope as well and will be a strategic priority in Biotech Act II, as these technologies will help strengthen food security and autonomy in Europe.

Europes challenge in industrial biotechnology and biofabrication is often presented as a technological one. In reality, Europe already possesses strong scientific capability, engineering expertise and innovative startups. The more fundamental challenge lies in scaling technologies into economically viable industrial systems capable of attracting long-term capital.

Bene Meat Technologies is active in the development of cultivated biomass. Our activities are primarily linked to the food and feed biotechnology area. Bene Meat wants to highlight the need for Biotech Act II to address non-microbial biotechnology applications in a coherent and future-proof manner.

As Founder of BIOAMA, I have spent the last five years navigating the valley of death that many environmental biotechnology startups face, especially in challenging ecosystems such as Mexico, where access to financing, pilot validation and industrial-scale implementation remains limited.

Our organisation welcomes the growing political momentum behind the upcoming Biotech Act II and sees it as a critical opportunity to strengthen Europes competitiveness and resilience. From our perspective, the priority is to ensure a framework that enables biosolutions to scale.

Europe's security environment has degraded drastically due to the ongoing illegal invasion of Ukraine by Russia since 2014, and the erosion of transatlantic trust catalyzed by erratic and unpredictable behavior of the current US administration.