Changes from report parliamentary committee draft to plenary report

Added17. Recommends developing a strategy to support biotechnology and biomanufacturing companies transitioning from the regulatory sandbox regime to full market access; requests that the strategy include, but not be limited to, support mechanisms, regulatory assistance and guidance on compliance with EU legislation;

The need to promote the advantages and specificities of the biotechnology and biomanufacturing industry

Change 4

Removed7. Underlines the need to account for the specificities of bio-based products and processes in the context of chemical and environmental legislation for petrochemical products;

Added18. Underlines that effectively scaling up biotechnology and biomanufacturing in the EU hinges on a robust, competitive and circular bioeconomy; calls on the Commission to present an updated bioeconomy strategy, which takes account of current challenges and reinforces the bioeconomy’s industrial dimension and its links to biotechnology and biomanufacturing, incentivising the development and production of sustainable, innovative, high-value added bio-based materials, products and solutions, to contribute to EU competitiveness and strategic autonomy;

Removed8. Is concerned that the European Investment Bank’s interpretation of the sustainability criteria under the Paris alignment framework may result in access to funding for bio-based materials and projects being denied; asks the Commission to examine definitions accordingly and enforce biotechnology- and biomanufacturing-friendly interpretations;

Added19. Acknowledges the important role biomass plays in biomanufacturing; recalls, in this regard, the importance of adopting an approach open to different sustainable biomass technologies grounded in robust analysis, and with the aim of enhancing feedstock access and use, as well as harnessing international supply chains, while aiming to avoid unintended environmental externalities;

Change 5

Changed9.20. Underlines the benefitneed andto contributionaccount for the specificities of biogenic carbon, bio-based products and processes to theprocesses, EU’sand CO2to reductiondifferentiate objectives,them whichfrom needpetrochemical toand befossil-based reflectedproducts, in respectivethe lifecontext cycleof assessments,EU informationand fornational consumerschemical, materials and publicenvironmental procurement;legislation;

Change 6

Removed10. Points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite;

Added21. Points out that essential components, such as enzymes, lactic acid bacteria and other microorganisms, run the risk of being prohibited or unduly disincentivised by EU regulations primarily designed for petrochemical and synthetic substances, such as the REACH Regulation;

Removed11. Underlines that biosecurity risks must be addressed in conjunction with biotechnology and biomanufacturing innovation, ensuring responsible access to and use of synthetic biology tools, genetic editing technologies and biological materials;

Added22. Is concerned that the European Investment Bank (EIB)’s interpretation of sustainability criteria under the EIB Group Paris alignment framework may result in access to funding for bio-based materials and projects being denied; asks the Commission to examine relevant definitions accordingly and encourage biotechnology- and biomanufacturing-friendly interpretations; calls on the EIB to propose de-risking instruments for biotechnology and biomanufacturing, in order to raise capital; calls, moreover, on the EIB to improve outreach, advisory support and information on financing instruments and opportunities for eligible biotechnology and biomanufacturing projects, in particular SMEs, start-ups and scale-ups;

Added23. Underlines the benefit and contribution of bio-based products and processes to the EU’s CO2 reduction objectives, which, given the potential of these products to increase sustainability and lower the EU’s environmental footprint, need to be reflected in respective life cycle assessments, information for consumers and public procurement;

Added24. Considers that, in order to accelerate the substitution of fossil-based feedstocks, the market demand and market uptake of sustainable bio-based products could be further incentivised in the EU; considers that bio-based feedstocks, such as sustainably sourced biomass, recycled waste and CO2 captured from biogenic sources, could be used as alternative feedstocks for the manufacturing of various products, contributing to the EU’s emissions reduction, resource efficiency and strategic autonomy; in this context, recalls the commitment in the EU’s Competitiveness Compass to develop policies to reward early movers; considers that coherent and adequate sustainability criteria should be ensured for biomass;

Added25. Underlines the importance of upholding the EU’s high standards of food and consumer safety and the potential of biotechnology applications when assessing biotechnology applications in food and feed to protect consumer health, assess impact on circularity and sustainability, and to consider social, ethical, economic, environmental and cultural aspects of food innovation; calls on the Commission to identify smooth routes to market for safe applications of biotechnology in food products, while reiterating that such biotechnology applications need to be properly examined, prior to any future authorisation and subsequent placing on the EU market, including gathering toxicological information and clinical and pre-clinical studies where relevant, and ensuring traceability;

Added26. Underlines that biosecurity risks, including bioethical considerations, must be addressed in conjunction with biotechnology and biomanufacturing innovation, ensuring responsible access to and use of synthetic biology tools, genetic editing technologies and biological materials; 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; stresses the importance of EU strategic autonomy in biotechnology supply chains, ensuring that critical biomanufacturing inputs and expertise remain within Europe; calls for stronger international cooperation on biosecurity standards, including mandatory international screening standards, ensuring that EU-based biotechnology and biomanufacturing companies benefit from global best practice while maintaining competitiveness;

Added27. Urges the Commission to conduct a study on biological materials and to present an updated communication and an action plan on chemical, biological, radiological and nuclear risks, in particular regarding bioterrorism and bio-risks;

Horizontal issues

Change 7

Changed12.28. Underlines the importance for supply chain security of havingensuring a sufficientsufficient, feedstockstable and competitive supply of feedstock, raw materials and essential components, such as sustainable biomass and enzymes for biotechnology and biomanufacturing companies; calls for potential risksrisks, gaps and dependencies to be closely monitored while safeguarding company-sensitive data and the functioning of the internal market;

Change 8

Removed13. Stresses the need to improve the transfer of knowledge and technology between academia and industry to ensure that EU-funded biotechnology and biomanufacturing research leads to commercial applications and industrial deployment;

Added29. Stresses the importance of developing EU raw material value chains and manufacturing, and enhancing self-sufficiency where possible, while also fostering strategic partnerships and cooperation with like-minded non-EU countries to secure resilient and diversified access to critical inputs of biotechnology and biomanufacturing industries in the EU;

Removed14. Stresses the need to decrease energy prices and facilitate the process of validating large-scale industrial plants with large bioreactors;

Added30. Stresses that, in an increasingly tense geopolitical context, biotechnology and biomanufacturing should be fully leveraged to strengthen the EU’s strategic autonomy, enhance food security and reduce dependence on non-EU countries; highlights the need to stimulate market demand and uptake of bio-based products to boost the growth, competitiveness and sustainability of the EU biotechnology and biomanufacturing sector;

Removed15. Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills;

Added31. Notes that the scale-up and commercialisation of research results remains a major challenge in the EU, and stresses the need to improve knowledge and technology transfer between academia and industry to ensure that EU-funded biotechnology and biomanufacturing research leads to commercial applications and industrial deployment; highlights the importance of strengthening public-private collaboration and supporting universities and research institutions with high levels of technology transfer, spin-offs, and start-up creation, for example by applying the CERN model of building start-up studios within research institutions; calls for strategic investments in shared EU infrastructure – such as pilot facilities, biobanks or innovation accelerators – to support the scale-up of prototypes and the market uptake of innovative biotechnology and biomanufacturing solutions; underlines that innovation cannot solely take place for short-term economic benefit, and that biotechnology and biomanufacturing innovation should be driven through a bottom-up approach under a standalone and long-term framework programme; calls on the Commission to facilitate the creation of world-leading research hubs for biotechnology and biomanufacturing to drive innovation and collaboration between academia, industry and venture capital; emphasises the need for robust physical testing facilities in the biotechnology and biomanufacturing sector to drive innovation and facilitate the production and market access for SMEs and start-ups;

Removed16. Calls for the urgent completion of the capital markets union to attract institutional investors to the biotechnology and biomanufacturing industry, including venture capital, pension funds and private equity; highlights that cross-border investment barriers need to be reduced to facilitate investment in biotechnology and biomanufacturing scale-ups;

Added32. Stresses the need to ensure access to affordable energy for biotechnology and biomanufacturing operators, given the high energy intensity of large-scale biological production processes; underlines the importance of facilitating the authorisation and validation of large industrial plants, such as bioreactors, which are essential for scale-up but also face significant construction and operating risks; welcomes the latest revision of the Renewable Energy Directive and its provisions to simplify permitting procedures, and calls on the Member States to swiftly implement relevant measures to support the deployment of biotechnology and biomanufacturing infrastructure;

Removed17. Notes that public-private partnerships and mission-driven EU investment strategies, such as the Circular Bio-based Europe Joint Undertaking, are essential for de-risking biotechnology and biomanufacturing innovation; urges that EU investment instruments such as the InvestEU programme be strengthened to support high-risk biotechnology and biomanufacturing projects; calls for a dedicated SME funding initiative to support biotechnology and biomanufacturing start-ups and scale-ups;

Added33. Underlines the need for a skilled and diverse European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills, in close collaboration with industry and research institutions; calls for increased investment in biotechnology and biomanufacturing education and targeted professional training, including in but not limited to areas such as regulatory compliance, quality assurance and process engineering; supports the development of competence centres and public-private training initiatives across all Member States to enable upskilling, reskilling and lifelong learning to safeguard the attractiveness of the biotechnology and biomanufacturing industry; highlights the importance of adapting educational curricula to the evolving needs of the sector, and of promoting science, technology, engineering and mathematics (STEM) subjects, with a particular focus on attracting more girls and women into biotechnology and biomanufacturing careers; encourages more public awareness about career opportunities in the field to attract talent from non-EU countries and suggests exploring the potential for transatlantic cooperation; welcomes the recently launched Choose Europe for Science pilot scheme to attract top non-EU researchers, scientists and academics to Europe;

Added34. Calls for the urgent completion of the capital markets union to attract institutional investors to the biotechnology and biomanufacturing industry, including venture capital, pension funds and private equity; underlines that the sector is characterised by high levels of risk and that reducing the cost of investment failure in the EU is necessary for attracting large-scale capital investment; calls for dedicated support to ensure that biotechnology and biomanufacturing SMEs, start-ups and scale-ups can access sufficient funding and compete globally; stresses that cross-border investment barriers must be reduced to facilitate investment in biotechnology and biomanufacturing scale-ups;

Added35. Notes that public-private partnerships and mission-driven EU investment strategies, such as the Circular Bio-based Europe Joint Undertaking, are essential for de-risking biotechnology and biomanufacturing innovation and for increasing the likelihood that IP and industrial capacity remain in Europe; urges EU investment instruments, such as the InvestEU programme, to be strengthened to support biotechnology and biomanufacturing projects considered as high-risk from an investment perspective; underlines that the sector is characterised by a high concentration of SMEs, which face disproportionate barriers in accessing capital despite being critical drivers of innovation; supports the exploration of a biotechnology Important Project of Common European Interest to facilitate industrial deployment and first-mover investments in bio-based chemicals, materials, and products and solutions;

Added36. Notes that public awareness of biotechnology and biomanufactured products in the EU should be further strengthened to boost public acceptance; recommends engaging with citizens and civil society organisations to communicate the characteristics, benefits and implications of the growing presence of biotechnology-based products and services in the European market;

Future-proof research and innovation

Change 9

Changed18.37. HighlightsRegrets that European private investment in research, development and innovation is lagging behind other major economies and that the scale-up and commercialisation of research results remain a major challenge in Europe; highlights the fact that European and national public systems for R&DR & D funding remain complex and insufficiently coordinated, resulting in duplications and inefficiencies; calls for an EU-wide approach to coordinatecoordinating public investment in R&DR & D for biotechnology and biomanufacturingbiomanufacturing, inwith orderthe todual closeobjective theof closing excellence gap;and innovation gaps and accelerating commercialisation; underlines the importance of strengthening European collaboration, pooling knowledge and resources, and leveraging public funding with private investment; recalls the key role of framework programmes such as Horizon Europe in fostering scientific excellence, innovation and technical development and calls for targeted investment in strategic biotechnology and biomanufacturing subfields, such as industrial, environmental, marine, health and agri-food biotechnology;

Change 10

Changed19.38. Reiterates the call to double the EU’s research budget and to reach the target of 3 % of EuropeanEU gross domestic product being devoted to R&D by 2030; calls for the mainstreaming of the ‘innovation principle’ as a cross-sectorial principleR for& allD EUby funding;2030;

Change 11

Changed20.39. Notes the growing role of synthetic biology, bioinformaticsbioinformatics, data and game-changing AI-driven biotechnology and biomanufacturing research; calls on the Commission to integrate biotechnology and biomanufacturing innovation into the EU digital and AI strategies;strategies, ensuring interoperability between biotechnology and biomanufacturing data infrastructure and AI-driven discovery platforms; notes that AI capabilities are dependent on the efficient use of data; considers that the creation of industrial data spaces for biotechnology and biomanufacturing is important for efficient data sharing;

Change 12

Removed°

Added40. Acknowledges that, while AI systems and quantum computing can significantly speed up research and lead to new innovations, enabling better computational designs of biological systems, they can also increase the risk of biological threats; underlines, therefore, the need to apply a risk-based approach to the use of AI in scientific research and manufacturing;

Removed° °

Added41. Considers that the ethical use of AI, bioinformatics and synthetic biology is crucial for building trust and for society at large to benefit from these technologies; underlines the need to safeguard data privacy, data security, transparency and human oversight of the use of AI systems in the health biotechnology sector;

42. Instructs its President to forward this resolution to the Council and the Commission.