Biotech Act

464 submissions in the snapshot (392 from organisations), portal total 464. Feedback list on the portal.

122 of 392 organisation submissions analysed; the model reads them as: opposes 2 supports 20 wants changes 94 6 held back for review (low confidence). 270 without readable text, so not analysed.

• Farmless Company, NLD; register: Companies & groups model reads as: wants changes source
  • Create a startup-friendly regulatory sandbox for natural fermentation companies with product-specific scientific advice and facilitation of confidential discussions.

    Creation of a startup friendly regulatory sandbox for natural fermentation companies.

  • Increase EFSA capacity with more personnel and technology-specific knowledge to improve efficiency in risk assessment processes.

    Increased capacity at EFSA (more personnel and increased technology-specific knowledge) to improve efficiency in risk assessment processes, for example by seconding national experts to EFSA

  • Simplify the Novel Foods regulatory procedure which is currently too expensive, unpredictable, complex and slow for startups.

    The current EFSA novel food process is not workable for startups. It is expensive, unpredictable, complex and slow.

• EWPA & EWPM (European Wood Protection Association & Wood Preservative Manufacturers Group) Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Expand carbon storage certification to cover all long-lasting wood construction applications beyond buildings.

    It is urgent for the Commission to start developing carbon storage certification schemes that cover all non-building applications of long-lasting products, in order to better incentivise substitution of carbon or energy intensive materials in all sectors.

  • Integrate climate impact assessment into EU chemical regulatory frameworks including BPR and REACH.

    To enable decarbonisation, the EU chemical regulatory framework (notably BPR & REACH) should systematically consider the climate impacts of chemicals, together with their health and environmental impacts.

  • Create harmonized EU-wide definitions and rules for wood waste classification to avoid unjustified hazardous classification.

    The EU waste legislation should include a single definition of hazardous wood waste, with clear rules framing the sorting of wood waste streams by the Member States, avoiding unjustified hazardous classification, and promoting reusing and recycling.

• Cepi Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Broaden the Biotech Act's scope to include all high-potential bioeconomy sectors, particularly the pulp and paper industry and forest-based bioeconomy.

    A broader scope for the Biotech Act that includes all high-potential bioeconomy sectors, including pulp and paper.

  • Fully integrate biorefineries and industrial biotechnology applications into the EU's regulatory and research and innovation framework.

    Full integration of biorefineries and industrial biotechnology applications into the EU's regulatory and R&I framework.

  • Recognize the forest-based sector as a key actor in major EU innovation programmes including FP10, CBE JU, and IPCEI.

    Recognition of the forest-based sector as a key actor in FP10, CBE JU, IPCEI and other innovation programmes.

• EU Specialty Food Ingredients Business association, BEL; register: Trade and business associations model reads as: supports source
  • Expand the scope of the EU Biotech Act to include biomanufacturing and a broader range of bio-based industries such as food, feed, chemicals, and materials rather than only healthcare and pharma.

    This should include a political mandate to accelerate the path from lab to factory by empowering biomanufacturing, including broader range of bio-based solutions, such as food and feed production technologies, chemicals, materials and consumer products, and not just healthcare and pharma.

  • Develop tailored financial instruments including loan guarantees, public procurement, de-risking mechanisms, and public-private capital to support bio-based companies scaling from lab to market.

    The EU should develop tailored financial instruments to support bio-based scale-up, including loan guarantees, public procurement, de-risking mechanisms, and public-private capital.

• Danish Standards Other, DNK model reads as: supports source
  • Establish a structured process for developing, identifying, and referencing harmonized standards in collaboration with CEN, ISO, and national standardization bodies.

    Danish Standards recommends that the European Biotech Act establish a structured process for developing, identifying, and referencing harmonized standards in collaboration with CEN, ISO, and national standardization bodies.

  • Incentivise standard-based certification and blended finance schemes linking public support to compliance with recognised standards to help SMEs secure investment.

    EU programmes could incentivise standard-based certification and blended finance schemes, linking public support to compliance with recognised standards.

  • Develop European standards for process safety, biosafety, life-cycle assessment, digital process control, and sustainability reporting to streamline permitting and reduce administrative duplication.

    European standards for process safety, biosafety, life-cycle assessment, digital process control, and sustainability reporting would streamline permitting, support mutual recognition of audits, and reduce administrative duplication.

• Evonik Industries AG Company, DEU; register: Companies & groups model reads as: wants changes source
  • Shift from process-based to product-based approach for evaluating genetically modified microorganisms.

    we propose a shift from the existing process-based approach for the evaluation of GMOs to a product-based approach, with a specific focus on microorganisms.

  • Implement a gradual categorization system for microorganisms to make approval requirements proportionate to the type of genetic modification.

    we believe a gradual categorization system (regardless of whether they are GMOs or non-GMOs) should be considered. This would allow the scope and effort of registration and the approval requirements to be proportionate to the type of genetic modification.

  • Regulate identical products the same way regardless of the method used to modify them when the modification method cannot be detected.

    Identical products should be regulated in the same way if there is no possibility of detecting the modification method of the microorganism in the product.

• ACRO (Association of Clinical Research Organizations) Business association, USA; register: Trade and business associations model reads as: wants changes source
  • Establish a maximum 60-day regulatory review timeline for EU clinical trial authorization.

    ACRO recommends a 60-day maximum regulatory review timeline for EU trial authorization.

  • Include measures in the Biotech Act to decrease divergent and duplicative submission requirements between member states.

    Measures should be included in the EU Biotech Act to decrease divergent/duplicative items in submission requirements between member states.

  • Replace multiple country-specific submissions with a single coordinated and consolidated submission process through a unified IT system.

    This multiple-submission process needs to be reduced to one single, coordinated and consolidated submission process and a single IT system (e.g., the Clinical Trial Information System (CTIS).

• Standing Committee of European Doctors (CPME) NGO, BEL; register: Trade unions and professional associations model reads as: wants changes source
  • Design AI in healthcare based on actual healthcare demands and in a dynamic feedback loop.

    Design AI on actual healthcare demands and in a dynamic loop;

  • Require AI systems to comply with medical ethics, data protection, and privacy standards.

    Compliance of AI systems with medical ethics, data protection and privacy required;

  • Establish adequate monitoring, oversight, and a clear liability regime for AI in healthcare.

    Adequate monitoring and oversight with a clear liability regime for AI in healthcare;

• Finnish Forest Industries Federation Business association, FIN; register: Trade and business associations model reads as: wants changes source
  • Integrate the forest-based bioeconomy into the Clean Industrial Deal and recognize the role of renewable bio-based European raw materials for strategic autonomy and competitiveness.

    Integrating the forest-based bioeconomy into the Clean Industrial Deal by recognising the role of renewable bio-based European raw materials for European strategic autonomy, competitiveness, and clean industrialisation.

  • Define renewable content as circular input under the Ecodesign for Sustainable Products Regulation, ensuring that product sustainability metrics treat renewable and recycled content equally.

    Defining the renewable content as circular input under the Ecodesign for Sustainable Products Regulation (ESPR) and related product regulations, ensuring that product sustainability metrics treat renewable and recycled content equally in accordance with ISO 59020.

  • Thematically recognize the forest-based sector in the next framework programme for research and innovation and the European Biotech Act.

    Thematically recognising the forest-based sector in the next framework programme for research and innovation (FP10) and other relevant European RDI-related initiatives, e.g. the European Biotech Act.

• Confederation of Danish Industry Business association, DNK; register: Trade and business associations model reads as: supports source
  • Split the Biotech Act into two separate acts.

    We support splitting the Biotech Act into two separate acts.

  • Accelerate approval of sustainable food and feed solutions using faster assessments based on risk-benefit analysis.

    To accelerate the green transition of the food sector, faster approval of sustainable food and feed solutions is needed, based on risk-benefit assessments.

  • Implement a GRAS-inspired approach where companies demonstrate safety and expert consensus to streamline market access for low-risk, high-benefit solutions.

    A GRAS-inspired approach, where companies demonstrate safety and expert consensus, could streamline market access for low-risk, high-benefit solutions.

• Pharmabiotic Research Institute NGO, FRA; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Develop tailored, proportionate, and harmonised regulatory frameworks that account for the complexity and novelty of microbiome-based innovations.

    The Biotech Act should prioritise the development of tailored, proportionate, and harmonised frameworks that account for the complexity and novelty of microbiome-based innovations.

  • Promote and facilitate early engagement between innovators and regulators through systematic early interactions and structured dialogues.

    The Biotech Act should promote and facilitate early engagement between innovators and regulators.

• BIO Deutschland e.V. Business association, DEU; register: Trade and business associations model reads as: wants changes source
• BASF Company, DEU; register: Companies & groups model reads as: wants changes source
  • Streamline and accelerate authorization procedures for biotech products, including GMOs, as the current process is lengthy and costly.

    Streamlining authorization for GM food and feed imports and GMO cultivation in the EU is essential and should be addressed in the EU Biotech Act.

  • Recognize a diverse range of biobased feedstocks through a feedstock-agnostic approach that includes first-generation sugars.

    The Biotech Act should adopt a feedstock-agnostic approach that does not promote any specific sustainable biobased raw material over the other.

• European Biosolutions Coalition Business association, DNK; register: Trade and business associations model reads as: wants changes source
  • The Biotech Act should encompass all relevant sectors including food, feed, chemicals, materials, agriculture, and industrial biotechnology, not just life science and healthcare.

    calls for a broad and ambitious Biotech Act encompassing all relevant sectors, such as food and feed, bio-based chemicals, plastics and materials (incl. materials for construction), agriculture, life science as well as industrial, environmental, and marine biotechnology.

• Johnson & Johnson Company, USA; register: Companies & groups model reads as: wants changes source
  • Introduce a centralized pan-European clinical trial approval process coordinated by the EMA with full reliance across Member States.

    Introduce centralised pan-European clinical trial approval process with the EMA coordinating central regulatory assessment of CTs, ensuring full reliance of all Member States on this central assessment. In parallel, introduce a central ethics assessment that explicitly prohibits MS's national divergent clinical trial requirements (see point 2 below). This will result in a single approval for all EU MS.

  • Reduce assessment timelines for multi-national trials to 30 days.

    Shorten the assessment timelines for multi-national trials to 30 days.

  • Establish aligned eligibility criteria for expedited regulatory pathways to eliminate separate applications for each pathway.

    Aligned eligibility criteria for expedited regulatory pathways (ERPs), i.e. PRIME, Accelerated Assessment Conditional Marketing Authorisation (CMA), Exceptional Circumstances Authorisation, Phased Review. If applicant notifies EMA of request for CMA, Exceptional Circumstances Authorisation and/or Phased Review, separate application for each ERP is not required.

• International Biosecurity and Biosafety Initiative for Science (IBBIS) NGO, CHE model reads as: supports source
  • Embed harmonised nucleic acid synthesis screening standards into the European Biotech Act to move from fragmented voluntary practices to a coherent, enforceable, and internationally-aligned system.

    The EU Biotech Act must address this challenge head-on by moving from a fragmented patchwork of voluntary practices to level the playing field across the EU's single market by developing a coherent, enforceable, and internationally-aligned system.

  • Link compliance with screening requirements to eligibility for Horizon Europe and FP10 funding.

    This should explicitly link compliance to eligibility for Horizon Europe and FP10 funding, thereby ensuring that only providers meeting high biosecurity standards benefit from EU support.

  • Strengthen international coordination by aligning EU screening frameworks with US, UK, ISO, WHO, and ASEAN standards to prevent regulatory divergence.

    Third, the EU must strengthen international coordination. Aligning with US, UK, ISO, WHO, and ASEAN frameworks will prevent regulatory divergence, enable interoperability, and facilitate trusted trade and research partnerships.

• Novo Nordisk A/S Company, DNK; register: Companies & groups model reads as: wants changes source
  • Establish a 'one-door entry' system for integral drug-device combination products to eliminate the fragmented regulatory maze.

    There is a need for a "one-door entry" for iDDCs eliminating the regulatory maze created in the EU.

  • Assign overall responsibility for iDDCs to the European Medicines Agency.

    Since Article 117 in the Medical Device Regulation is derived from pharmaceutical legislation, and iDDC is approved as a medicinal product, the overall responsibility should be assigned to the European Medicines Agency (EMA)

  • Streamline the approval process to create a predictable and simple regulatory framework.

    This will move the EU towards a more competitive regulatory framework with a predictable, smooth, and simple approval process.

• EFCG (European Fine Chemicals Group, a sector group of Cefic Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Establish uniform definitions for biotechnology and biomanufacturing to create common semantic understanding across EU policy

    Cefic proposes the following series of definitions aimed at clarifying each relevant term, which is necessary to establish a common semantic understanding of terms such as biotechnology and biomanufacturing:

  • Avoid overregulation and tackle fragmented policies by cross-checking existing regulations for overlaps and conflicting requirements

    Avoid overregulation and tackle fragmented policies, cross-check existing regulations, and thoroughly analyse potential overlaps or conflicting requirements within a clearly set timeline.

  • Provide clear regulatory environment and competitive market conditions to secure Europe's leadership and prevent offshoring of biomanufacturing

    To secure Europe's leadership in this field, it is essential to provide a clear and supportive regulatory environment and improve the conditions that allow industries to thrive

• SNIA DNA Data Storage Alliance Business association, USA model reads as: wants changes source
  • The European Biotech Act should specifically account for and reflect the distinctive characteristics and requirements of DNA data storage applications.

    It is therefore timely to ensure that the specificities of DNA data storage are taken into account in shaping EU policy frameworks.

  • Biosecurity policy should acknowledge that screening for sequences of concern is neither practically nor economically feasible for DNA data storage applications due to the massive number of unique sequences involved.

    Biosecurity screening of synthetic nucleic acids to detect sequences of concern (SOCs) is neither practically nor economically feasible for DNA Data Storage applications considering the large number of unique DNA sequences required to store data, which is many orders of magnitude more than current biological applications.

• National Institute for Public Health and the Environment, Netherlands Public authority, NLD model reads as: wants changes source
• POLLINIS NGO, FRA model reads as: opposes source
  • Strengthen and update risk evaluation procedures to be adapted to new risks linked to biotechnology use.

    Nous appelons au contraire à renforcer au maximum les procédures d'évaluation des risques et à les mettre à jour afin qu'elles soient adaptées aux nouveaux risques liés à l'utilisation des biotechnologies.

  • Conduct public democratic debate on the terms, impacts, and societal implications of biotechnologies before any deregulation or public financing.

    ainsi, avant de déréglementer et avant de financer ces nouvelles technologies avec de l'argent public, nous demandons à ce que les termes du débat soient posés publiquement et autrement.

  • Maintain mandatory risk evaluation, traceability, labeling, and publication of detection methods for genetically modified plants from NTG.

    Cette proposition, si elle est adoptée, permettrait à la quasi-totalité des plantes génétiquement modifiées issues des NTG d'être complètement dérégulées : entre autres, pas d'évaluation des risques, pas de traçabilité ni d'étiquetage, pas d'obligation de publier les méthodes de détection et d'identification.

• Aarhus University Academic or research institution, DNK model reads as: supports source
  • Universities must be recognized as central to the Biotech Act, serving as hubs for education, research, innovation, and providing access to research infrastructure for scaling new biotech companies.

    The role of universities must be central in the Biotech Act. As hubs for education, research, and innovation, universities are essential for training the next generation of biotech professionals, supporting start-ups and SMEs, and providing access to research infrastructures that enable scale-up and de-risking of new technologies.

  • The Act must support a seamless continuum from basic research to market deployment through streamlined regulatory pathways, alignment with national R&I programmes, and regulatory sandboxes.

    To ensure Europe's leadership in biotechnology, the Act must support a seamless continuum from basic research to market deployment. This includes better alignment with national R&I programmes, streamlined regulatory pathways, and the use of regulatory sandboxes to accelerate safe innovation.

• Tetra Pak Company, SWE; register: Companies & groups model reads as: supports source
  • Include food in the scope of the Biotech Act to establish a framework for safe and future-looking food production in Europe.

    Tetra Pak supports the inclusion of food in the scope of the Biotech Act to enable a framework for safe and future-looking food production in Europe.

  • Remove regulatory barriers and delays to facilitate market entry and secure investments and infrastructure development in Europe.

    To support European leadership and competitiveness it is essential to facilitate market entry and secure investments and infrastructure development in Europe by removing barriers and delays due to policy approaches.

  • Provide support for industrial-scale solutions for fermentation-based food production, including infrastructure, innovation, and workforce development.

    Provide support for industrial-scale solutions for fermentation-based food production, including infrastructure, innovation, and workforce development.

• Sekab Biofuels and Chemicals Company, SWE model reads as: wants changes source
  • The Biotech Act should adopt a dual focus on both fostering innovation and scaling the deployment of existing industrial biotechnologies.

    The Biotech Act should adopt a dual focus: fostering innovation and scaling existing industrial deployment.

  • The Biotech Act should set targets or quotas for sustainable and bio-based carbon content in chemicals, materials, and key industrial sectors.

    Set targets or quotas for sustainable and bio-based carbon content in chemicals, materials, and key industrial sectors.

  • The Biotech Act should establish clear and harmonised definitions of biotechnology-related terms to prevent loopholes and ensure regulatory coherence.

    Clear and harmonised definitions of "biotechnology", "biomanufacturing", "bio-based", and "sustainable carbon" are critical to prevent loopholes.

• traceless materials GmbH Company, DEU; register: Companies & groups model reads as: wants changes source
  • Recognise biological regeneration and material substitution as legitimate forms of circularity in the waste hierarchy and recyclability definitions.

    Recognise biological circularity in the waste hierarchy and recyclability definitions.

  • Formally acknowledge natural polymers as a separate category of packaging material to provide clear regulatory framework for producers.

    Formally acknowledging natural polymers as a separate category of packaging material.

  • Harmonise EPR schemes at EU level and apply eco-modulation based on real environmental performance to ensure fair competition.

    EU-level harmonisation of EPR to avoid fragmented national schemes.

• Association Française contre les Myopathies (AFM-Téléthon) NGO, FRA; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Place strong emphasis on rare diseases and implement dedicated instruments to support treatment development.

    AFM-Telethon calls for the Biotech Act to place a strong emphasis on rare diseases and promote concrete, long-term progress for the rare disease community through the adoption of targeted policies and the implementation of dedicated instruments to support the development of treatments for these conditions.

• Interministerial Council of GMOs - Ministry of Agriculture, Fisheries and Food Public authority, ESP model reads as: wants changes source
  • Implement procedures to adapt current legislation to new scientific and technological developments more quickly and efficiently.

    procedures should be implemented to adapt current legislation to new and future developments more quickly and efficiently.

  • Replace multiple periodic renewals of GM event authorizations with a single renewal after 10 years followed by indefinite validity while maintaining monitoring obligations.

    Explore the possibility of replacing multiple periodic renewals with a single renewal after the initial 10-year authorization period plus indefinite validity while maintaining the obligation to report any new information and, where relevant, post-market monitoring.

  • Clarify and simplify the regulatory status of products obtained with genetically modified microorganisms such as enzymes and additives.

    The regulatory status of products obtained with GM microorganisms (enzymes, additives, etc) should be clarified and simplified.

• Pandemic Action Network NGO, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: supports source
  • Implement mandatory NA synthesis screening requirements to establish the EU as a global standard-setter and fulfill dual-use control commitments.

    By implementing mandatory screening requirements, the EU can establish itself as a global standard-setter, secure critical supply chains, and fulfill its commitments under Regulation 2021/821 for dual-use items control.

  • Establish an EU biosecurity registry for synthetic DNA and genetic engineering equipment with improved transparency and risk-assessment mechanisms.

    calls for the establishment of an EU biosecurity registry for synthetic DNA, benchtop synthesis equipment and genetic engineering tools, improving transparency and risk-assessment mechanisms, in consultation with relevant stakeholders, such as industry and civil society, and while ensuring sensitive data is adequately protected;

  • Control access to nucleic acid sequences and screen all sequences being synthesized and delivered to prevent misuse.

    Effective governance requires controlling both who has access to nucleic acid sequences and which sequences are being synthesized and delivered.

• argenx Company, BEL; register: Companies & groups model reads as: supports source
  • Establish a 30-day review period for phase I clinical trials to accelerate clinical development across the EU.

    Expedite clinical trial approvals, targeting a 30-day review period for phase I trials (down from 100+ days), by adopting a risk-based evaluation that preserves regulatory rigour while enhancing global competitiveness.

  • Create a European Real-World Evidence sandbox to pilot and validate innovative methodologies in partnership with EMA and HTA bodies.

    Establish a European RWE sandbox to complement the existing EMA qualification procedure, providing a collaborative environment for piloting and validating innovative methodologies and data sources in partnership with EMA, Health Technology Assessment (HTA) bodies, and national authorities.

  • Modernise HTA and pricing frameworks to capture full therapeutic value and enable flexible access models for multi-indication products.

    Modernise HTA and P&R frameworks to capture the full spectrum of unmet need and value, including patient, caregiver, and societal impact, and develop access models suited to multi-indication products, such as Multi-Year Multi-Indication (MYMI) contracts.

• Union française des semenciers Business association, FRA; register: Trade unions and professional associations model reads as: supports source
  • The EU must advance on NGT regulation without delay to keep pace with other countries that have already modified their regulations.

    il est important d'avancer sans trop de temps par rapport au reste du monde (une trentaine de Pays ont déjà modifié leur règlementation sur le sujet)

  • Beyond proposing functional regulations, Europe should identify concrete actions to support biotech progress and investment in innovation.

    il est important qu'en plus de proposer une règlementation fonctionnelle, l'Europe se pose la question des actions qu'elle pourrait entreprendre pour accompagnement le progrès

  • EU regulations must be perfectly aligned with international standards to maintain competitiveness in third countries and market access.

    l'Europe se doit d'avoir une règlementation parfaitement articulée avec le reste du monde afin de garder son attractivité pour les Pays tiers mais aussi pour pouvoir accéder plus facilement aux marchés extérieurs

• Nuclear Medicine, Europe Business association, BEL model reads as: wants changes source
  • Explicitly include radioligand therapies (RLTs) and complex radiopharmaceuticals in the Biotech Act to create pragmatic legislation for European patients.

    RLT should be explicitly included in the Biotech Act, creating a major opportunity to develop a pragmatic legislation unlocking this innovative treatment modality for European patients in an equitable and scalable manner.

  • Establish clear definitions for radiopharmaceuticals and their components to enable centralized oversight and incentivize innovation.

    Clear definitions for radiopharmaceuticals and their components to enable centralized oversight and incentivize innovation

  • Create harmonized rules on radioprotection to prevent fragmentation and ensure consistent safety standards across the EU.

    Harmonized rules on radioprotection to prevent fragmentation and ensure consistent safety standards

• BioChem Europe (a sector group of Cefic) Business association, BEL; register: Trade and business associations model reads as: supports source
  • Establish the Biotech Act as cross-sectoral, integrating biotechnology and biomanufacturing across all relevant sectors and EU bioeconomy policies.

    A cross-sectoral Biotech Act

  • Create a coherent regulatory framework with harmonized processes across Member States to reduce administrative burdens and delays.

    A coherent regulatory framework

  • Introduce uniform terminology and clear definitions across EU institutions for biotechnology, biomanufacturing, and biomass-derived chemicals.

    Clear and consistent definitions

• EIT Food NGO, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Include agrifood biotechnology applications in the Biotech Act to create a coherent regulatory framework across both pharmaceutical and food sectors.

    Use the Biotech Act as an opportunity to cover not only pharmaceutical but also agrifood applications of biotechnology, creating a coherent regulatory framework that will allow Europe to retain its competitiveness.

  • Establish a fast-track procedure for well-characterised food proteins produced via precision fermentation using organisms with proven safe history.

    Establish a fast-track procedure for well-characterised food proteins, to include those proteins that are identical to proteins naturally found in food and produced via precision fermentation using production strains with a proven long history of safe use. This should apply to host organisms such as yeasts, bacteria, or fungi that have a long history of safe use and/or already undergone an EFSA safety assessment.

• From the Dutch government on behalf of the Dutch Ministry of Economic Affairs Public authority, NLD model reads as: supports source
  • Create an EU Biotech Act with broad scope covering medical, pharmaceutical, agri-food, industrial and environmental biotechnology sectors

    The Netherlands calls for an EU Biotech Act with a broad scope that includes the medical and pharmaceutical, agri-food, industrial and environmental biotechnology sectors.

  • Simplify and harmonize biotechnology regulations and procedures across the EU

    The Netherlands calls for clear, harmonized and simplified biotech regulations and procedures

  • Enable regulatory flexibility and experimentation through pilots, tastings, and sandboxes

    The Netherlands calls for future-oriented, flexible regulation based on the latest scientific findings with more room for experimentation for biotechnological innovations within existing laws and regulations, for example by means of pilots or tastings or sandboxes.

• European Bioeconomy Youth Champions by the The International Advisory Council on Global Bioeconomy (IACGB) Other, DEU model reads as: wants changes source
  • Establish an integrated EU Life Sciences Office to coordinate bioeconomic initiatives and streamline regulatory processes to reduce red tape

    Establish an integrated EU Life Sciences Office to drive bioeconomic initiatives, streamline cooperation, and cut red tape.

  • Redefine the bioeconomy strategy to prioritize biotechnology innovation across diverse sectors beyond traditional agriculture and forestry

    Redefine the bioeconomy strategy to prioritize biotechnology innovation across diverse sectors.

  • Develop clearer circularity standards and incentives tailored to bio-based products to maximize value chains and emphasize biomass benefits

    Develop clearer circularity standards and incentives tailored to bio-based products, emphasizing the unique benefits of biomass.

• Partnership for Policy Integrity NGO, USA; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Adopt stronger safety measures through a precautionary approach aligned with EU treaties.

    STRONGER safety measures are needed than for other sectors.

  • Establish top-down limits on biogenic material extraction and implement the cascading principle.

    The EC must establish top-down limits on extraction from ecosystems (e.g. forests, oceans), and the Biotech sector must not take more than its fair share.

  • Require biotech activities to be screened against key risk management principles before market entry.

    the Biotech Act should require evidence that biotech activities will not breach key risk management principles which, when contravened, are likely to cause problems that undermine a stable society and lead to the breaching of planetary boundaries.

• Medicines for Europe (Biosimilar medicines group) Trade union, BEL; register: Trade and business associations model reads as: wants changes source
  • Empower biosimilar developers and manufacturers with a predictable and supportive framework along with a multifaceted toolbox for innovation, investment, and scale-up operations.

    To remain globally competitive, Europe must empower biosimilar developers and manufacturers with a predictable and supportive framework along with a multifaceted toolbox conducive to innovation, investment, and scale-up of operations.

  • Adopt the four-pillar recommendations covering investment in R&D and manufacturing, regulatory simplification, IP framework optimization, and talent and skills development to close the biosimilar void.

    This white paper lays out actionable recommendations across four pillars - investment, regulatory simplification & market policy shaping, trade/IP policy, and sector attractiveness & talent skills-to close the biosimilar void and secure Europe's leadership in biomanufacturing.

• EU-SAGE (European Sustainable Agriculture through Genome Editing) - network representing plant scientists at 150 European plant science institutes and societies. Academic or research institution, BEL; register: Academic institutions model reads as: wants changes source
  • Create harmonized market access pathways across member states by developing schemes to recognize innovative product pricing across geographies.

    A great step forward would be to work with a coalition of willing member states to recognize e.g. pricing for innovative products across many geographies.

  • Reform field trial regulations to prevent public disclosure of trial locations and protect trials under sole developer responsibility subject to competent authority auditing.

    Field trials for biotechnology derived products should be under the sole responsibility of the developer, subject to auditing by competent authorities.

  • Align regulatory study requirements for genetically modified plants with actual risk levels, eliminating disproportionate requirements compared to conventional varieties.

    study requirements and resulting costs are disproportionate in comparison to what is required to register a conventional variety, considering that today risks associated with genetically modified plants are considered similar to those associated with conventional varieties.

• BIC Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Expand the EU Biotech Act's scope to include biomanufacturing and bio-based solutions across food, feed, chemicals, and materials sectors, not limited to healthcare and pharma.

    This should include a political mandate to accelerate the path from lab to factory by empowering biomanufacturing, including broader range of bio-based solutions, such as food and feed production technologies, chemicals, materials and consumer products, and not just healthcare and pharma.

  • Develop tailored financial instruments including loan guarantees, public procurement mechanisms, and de-risking support to enable bio-based companies to scale from lab to market.

    The EU should develop tailored financial instruments to support bio-based scale-up, including loan guarantees, public procurement, de-risking mechanisms, and public-private capital.

• Johns Hopkins Center for Health Security Academic or research institution, USA model reads as: wants changes source
  • Mandate adherence to nucleic acid synthesis screening as a legally binding requirement in the Biotech Act.

    With the Biotech Act, the EU has the opportunity to level the playing field and even surpass current US and UK approaches by mandating adherence to nucleic acid synthesis screening.

  • Establish a Biosecurity Data Level taxonomy and tiered access controls for dual-use pathogen data in Trusted Research Environments.

    We urge for the inclusion of the following data governance related measures in the Biotech Act: 1. Establish an expert elicitation process that develops a Biosecurity Data Level (BDL) taxonomy to classify biological and pathogen-related datasets by their potential to enable concerning AI capabilities and that is harmonized across Member States.

  • Clarify that biological AI models fall within the AI Act's general-purpose AI model definition and ensure adequate oversight.

    Clarify that BAIMs can fall in scope of the "general-purpose AI model" definition of the AI Act and require the AI Office to apply its policies to this class of models (with adequate resources).

• Retina International NGO, IRL model reads as: supports source
  • Accelerate the development and delivery of innovative therapies for rare diseases and rare eye diseases as a critical area of unmet medical need.

    The EU Biotech Act offers a strategic opportunity to strengthen Europe's position in biotechnology by accelerating the development and delivery of innovative therapies for rare diseases in general and rare eye diseases (REDs) in particular as an area of critical unmet medical need.

  • Provide targeted investment and tailored policies for rare diseases covering early diagnosis, innovative therapies and drug repurposing.

    Targeted investment and tailored policies for rare diseases, from early diagnosis to innovative therapies and drug repurposing, can reverse this trend.

• Corbion Company, NLD; register: Companies & groups model reads as: wants changes source
  • Involve EFSA from early stages in the Novel Food evaluation process to ensure consistent, harmonized and science-based assessment across all Member States.

    Involving EFSA from early stages of the process - specifically assessing novel food status - would ensure a more consistent, harmonized and science-based standards.

  • Allow companies to seek confidential, one-on-one pre-submission advice from EFSA on product-specific dossiers and analytical methods.

    Confidential, one-on-one meetings focused on the specifics of a dossier would enable applicants to share sensitive information vital for creating strong submissions and clarify doubts before deciding on testing methods or filling in an application.

  • Reform the six-month penalty for late or missing study notifications so it begins when EFSA notifies the applicant rather than from dossier withdrawal.

    A penalty for late or missing notifications may be justified, but it should start from the moment EFSA notifies the applicant, rather than from a dossier withdrawal.

• European Organisation for Research and Treatment of Cancer (EORTC) Academic or research institution, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Implement risk-proportionate regulatory approaches that differentiate between trials developing new drugs and pragmatic trials using established treatments.

    the notion of risk-proportionality seems to have gained less attention on the EU regulatory radar, requiring all clinical trials to go through the narrow eye of the CTR needle

  • Establish differentiated regulatory pathways for clinical research, recognizing that pragmatic and treatment optimization trials require different approaches than new drug development.

    Policy makers seem to have lost from sight the concept that, when it comes to clinical research and innovation, one size does not fit all

• Cellular Agriculture Europe Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Ensure the scope of the Biotech Act encompasses food biomanufacturing applications.

    The scope of the Biotech Act should be broad enough to recognise the diversity of biotech applications, including in the agri-food sector.

  • Refine the stop-the-clock procedure in Novel Foods Regulation assessment to allow resumption when applicants submit data before formal deadlines.

    The procedure could be refined so that the type of question raised does not unnecessarily delay the entire process. Moreover, if an applicant provides the necessary feedback before the deadline, the assessment could resume without waiting until the formal deadline.

  • Allow confidential, product-specific pre-submission meetings between applicants and EFSA to share sensitive dossier information.

    Confidential, one-on-one meetings about the content of the specific dossier, would allow applicants to share sensitive information essential to building robust dossiers - something not possible in a potential group setting.

• EuropaBio, the European Association for Bioindustries Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Increase the budget of the Circular Bioeconomy Joint Undertaking to effectively fill the innovation-commercialization gap in biotech.

    The EU bioeconomy needs an ambitious CBE JU to deliver on EU's Bioeconomy, competitiveness and resilience ambitions, with a bigger budget to back the efforts required to fill the 'innovation commercialization' gap effectively.

  • Establish a simplified and streamlined regulatory framework based on risk assessment rather than hazard-based approaches.

    A simplified & streamlined regulatory framework based on risk, not hazard, can lead to sustainable growth & further investment.

  • Enable public intervention through financial guarantees and dedicated funding mechanisms to de-risk advanced technology maturity level innovations in biotech and biomanufacturing.

    Besides a predictable regulatory framework to accelerate scale-up of biotechnology and biomanufacturing, public intervention is needed to de-risk advanced TRL innovations and capacity investments, for example, through financial guarantees.

• Micro company, FRA Business association, FRA model reads as: wants changes source
  • Protect local industrial producers to ensure production of strategic health and pharmaceutical products.

    nous appelons nos parlementaires à protéger les industriels qui font vivre nos territoires et assure la production de produits stratégiques

  • Simplify regulations and reduce bureaucratic complexity to improve industry competitiveness.

    à nous permettre de regagner en compétitivité en simplifiant la vie de nos entreprises

  • Provide stable and clear policy communication without adding uncertainty to industry investment and relocation ambitions.

    nous demandons à nos décideurs d'assurer une communication posée et de ne pas rajouter d'incertitude dans nos ambitions

• IBMA - International Biocontrol Manufacturers Association Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Ensure the scope of the Biotech Act is broad enough to encompass biocontrol and diverse agri-food applications.

    This is why the scope of the Biotech Act should be broad enough to recognise the diversity of agri-food applications, including biocontrol.

  • Establish a comprehensive EU-wide legal definition of biocontrol that reflects the range of biocontrol substances and products available.

    First and foremost, to ensure the market uptake of biocontrol products, there is an urgent need for a comprehensive EU-wide legal biocontrol definition that reflects the range of biocontrol substances and products available.

  • Grant indefinite authorisations for biocontrol products and remove costly re-registration procedures.

    It is key that the authorisations of biocontrol PPPs are granted for an indefinite period and do not need to go through the costly and burdensome process of re-registration

• Pour Demain Europe NGO, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Operationalise mandatory nucleic acid synthesis screening as a biosecurity imperative and cornerstone of responsible innovation.

    One of the most urgent and actionable steps the EU can take is the operationalisation of mandatory nucleic acid synthesis screening. This is not only a biosecurity imperative, but a cornerstone of responsible innovation.

  • Include a clear legal mandate embedding customer and sequence screening obligations within the Act, reinforced through delegated acts and linked to dual-use export control frameworks.

    A clear legal mandate embedding customer and sequence screening obligations within the EU Biotech Act, reinforced through delegated acts and linked to existing frameworks such as Regulation (EU) 2021/821 on the control of exports, brokering, technical assistance, transit and transfer of dual-use items, and the forthcoming EU CBRN Action Plan (2026).

  • Establish an EU-level governance infrastructure to manage a harmonised list of Sequences of Concern and coordinate conformity assessments.

    An EU-level governance infrastructure to manage a harmonised and regularly updated list of Sequences of Concern accessible via secure API; coordinate conformity assessments; and provide audit and reporting mechanisms.

• Danish Industry Business association, DNK; register: Trade and business associations model reads as: wants changes source
  • Implement a fast-track approval framework for biosolutions using risk-benefit approach and regulatory sandboxes.

    To accelerate the green transition, there is a need to allow for faster approval of sustainable biosolutions within several areas. It should build on a risk-benefit approach and ensure regulatory sandboxes, allowing for the development, testing and validation of innovative technologies in a controlled real-world environment, the full implementation of the Innovation Principle.

  • Ensure the Biotech Act II is bold and broad in scope, covering the entire biotechnology field.

    Danish Industry therefore urges that the European Biotech Act II be bold and broad in scope. It should cover the entire biotechnology field and deliver on the commitments outlined in the Commission's Communication 'Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU' from March 2024.

  • Incorporate food and feed into the Net-Zero Industry Act.

    Additionally, to this framework, food and feed should be incorporated into the Net-Zero Industry Act.

• European Federation of Allergy and Airways Diseases Patients' Associations (EFA) NGO, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Involve patients and patient organizations appropriately in biotechnology development and policy-making.

    As a patient organisation, EFA calls on the European Commission to consider patient experiences and the role of patients, and the organisations representing them and involve them appropriately in addressing biotechnologies.

  • Ensure biotechnologies are supported under the EU Health Technology Assessment Regulation to harmonize access and reimbursement decisions across member states.

    Biotechnologies should be supported under the EU Health Technology Assessment Regulation (HTAR).

• Centre for Future Generations NGO, BEL; register: Think tanks and research institutions model reads as: wants changes source
  • Establish a European biomanufacturing infrastructure network with federated pilot and demonstration facilities accessible to SMEs to bridge the scale-up valley of death.

    Establish a European biomanufacturing infrastructure network: federated pilot and demonstration facilities accessible to SMEs, bridging the scale-up 'valley of death'

  • Treat biomanufacturing capacity as strategic infrastructure with sustained public-private investment in dual-use facilities for both commercial innovation and crisis response.

    Treat biomanufacturing capacity as strategic infrastructure: sustained public-private investment in facilities that serve commercial innovation during normal times and can surge to crisis response when needed

  • Ensure the EU Biotech Act articulates clear policy intent, enables transnational coordination, and defines priority areas for phased implementation.

    What is essential is that the EU Biotech Act articulates a clear policy intent, enables transnational coordination, market appetite, regulatory commitment and defines priority areas for phased implementation.

• European Microbiome Innovation for Health (EMIH) Business association, FRA; register: Trade unions and professional associations model reads as: wants changes source
  • The European Biotech Act should explicitly address the needs of microbiome-based health products.

    it is essential that its Biotech Act explicitly addresses the needs of microbiome-based health products.

  • Establish science-based, fit-for-purpose regulatory pathways for biotechnology innovations.

    Science-based, fit-for-purpose regulatory pathways;

  • Clarify regulatory classification for emerging biotechnologies.

    Clarify regulatory classification for emerging biotechnologies

• European Synthetic Biology Society (EUSynbioS) NGO, FRA model reads as: supports source
  • Establish a biotechnology mobility framework enabling seamless professional movement and qualification recognition across all EU member states.

    Create a biotechnology mobility framework enabling seamless professional movement across the EU, with portable benefits and mutual recognition of qualifications across all 27 member states.

  • Create continuous funding streams for small community-building organizations (under €500K) operating across education, outreach, communication, and policy domains.

    Establish continuous funding streams for community-building organizations with budgets under €500K annually. Organizations operating through distributed volunteer teams across Education, Outreach, Communication, and Policy domains need accessible funding recognizing their unique value in talent retention and European identity building.

  • Launch trust-building communication initiatives addressing public health, climate solutions, and decentralized supply chains through diverse formats including festivals and seminars.

    Launch trust-building communication initiative highlighting three tangible domains: public health crisis preparedness (COVID-19 demonstrated this), climate solutions through sustainable manufacturing, and decentralised supply chains distributing high-value jobs beyond traditional industrial centers. Support diverse communication formats from themed festivals to training seminars, media content to interdisciplinary collaborations.

• Catalonia.health Business association, ESP model reads as: supports source
  • The EU Biotech Act must recognize and empower associations and clusters that create ecosystems of trust and cooperation through funding and cross-regional collaboration.

    The EU Biotech Act must recognize and empower associations and clusters that create ecosystems of trust and cooperation through funding connector organizations, enabling cross-regional collaboration, and investing in infrastructure supporting clinical translation.

  • Launch a Chips Act-style initiative of 5-10 billion euros through the EIB/EIF to finance biotech and life sciences innovation.

    Launch a Chips Act-style initiative of €5-10B scale via EIB/EIF

  • Mandate a single EU portal for clinical trials with parallel ethics and authority review to accelerate patient access to therapies.

    Mandate single EU portal for clinical trials with parallel ethics/authority review

• Kemira Oyj Company, FIN; register: Companies & groups model reads as: wants changes source
  • Update SUPD guidance to grant plastics-free status to innovative biopolymers identical to natural polymers, aligning with 2023 Microplastics Restriction exemptions.

    Update SUPD guidance to define plastics-free status for innovative biopolymers that are identical to natural polymers - and align with 2023 Microplastics Restriction exemptions.

  • Include primary feedstocks as a foundational element for scaling industrial bioeconomy manufacturing across sectors in the EU Taxonomy.

    Include primary feedstocks as a cornerstone for scaling industrial manufacturing across sectors in the bioeconomy.

  • Mandate feedstock-neutral scientific comparison of all polymers (fossil, biobased, emerging) in regulatory assessments along the full life-cycle.

    Mandate feedstock-neutral scientific comparison of all polymers (fossil, biobased, emerging) in regulatory assessments along the life-cycle.

• Ministerium für Umwelt, Klima und Energiewirtschaft Baden-Württemberg Public authority, DEU model reads as: wants changes source
  • Include circular bioeconomy and secondary raw material flows from waste, wastewater, and exhaust air as a central focus in the biotechnology initiative.

    We consider it important for the biotechnology initiative to focus on the circular bioeconomy, building on the EU bioeconomy strategy.

  • Ensure regions and municipalities are directly involved in the biotechnology initiative, with dedicated funding including from the ERDF.

    To this end, it is essential that the regional dimension is also taken into account in the planned biotechnology initiative and that regions and municipalities are addressed directly - also with regard to funding, including from the ERDF.

  • Facilitate a triple helix approach encouraging close cooperation between industry, government at all levels, and academia.

    It is important that the initiative facilitate a triple helix approach to encourage close cooperation between industry and all levels of government as well as academia.

• Finnish Food and Drink Industries' Federation Business association, FIN; register: Trade and business associations model reads as: wants changes source
  • Accelerate EU novel food approval processes through streamlined regulatory guidance, simplified requirements, and enhanced EFSA capacity to prevent stifling of product development and innovation.

    Promoting an innovative friendly regulatory environment for EU food companies should cover actions which ensure entry of new biotech innovations into the market. For example, the approval processes for novel foods and new plant breeding techniques must not stifle companies' product development and innovation.

• The International Sweeteners Association (ISA) Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Include food within the scope of the European Biotech Act.

    Our Association therefore wishes to join its parent organisation EU Specialty Food Ingredients' call for the inclusion of food within the scope of the European Biotech Act.

  • Simplify regulatory frameworks and establish cross-sectoral permitting pathways with improved pre-submission dialogue and education for policymakers.

    We thus advocate for the simplification of regulatory frameworks, the establishment of cross-sectoral permitting pathways, an improved pre-submission dialogue, as well as an enhanced education for policymakers and risk assessment experts.

  • Support biotech ecosystem development by simplifying access to investments, accelerating regulatory approvals, and offering financial incentives.

    Simplifying access to investments, accelerating regulatory approvals, and offering financial incentives can support innovative companies.

• Bayer AG Company, DEU; register: Companies & groups model reads as: wants changes source
  • Shift agricultural biotech regulation from regulating technologies to regulating final products in order to eliminate double regulation and align with global practice.

    To fully exploit the possibilities of all agricultural biotech innovation, the EU must aim to step away from regulating technologies towards regulating products, which would avoid the double regulation many technologies currently face, and would align the EU more with global practice.

  • Establish a connected EU regulatory system that operates seamlessly across all research and development stages and keeps pace with innovation.

    A connected EU regulatory system is needed that keeps pace with innovation and works seamlessly from start to finish.

  • Make the EMA an independent agency with autonomy for regulatory submissions and approvals and an orchestrating role across the medicines' lifecycle.

    EMA to be an independent agency with autonomy for regulatory submissions and approvals, an orchestrating role across the medicines' lifecycle, ensuring coordination, reliance, and risk-based oversight, driving uptake of advanced manufacturing technologies.

• European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Implement a holistic policy approach ensuring coherence and alignment in healthcare and industrial policy across EU and Member States levels.

    This must be accompanied by coherence and alignment in healthcare and industrial policy, as well as other horizontal areas at EU and Member States level.

  • Reduce clinical trial approval timelines to 30 days from the current over 100 days using a risk-based assessment approach.

    Reduce timelines for approvals of clinical trials to 30 days from currently over 100 days, with a risk-based assessment.

  • Establish a unified process for the submission and assessment of clinical trials involving combination products.

    Introduce a unified process for the submission and assessment of clinical trials involving combination products (therapeutics requiring IVDs or MDs).

56 more analysed submissions on the consultation page.