AseBio is involved in three key European initiatives aimed at boosting biotechnology competitiveness and scaling

Biotechnology has established itself as a strategic sector for Europe’s competitiveness, industrial autonomy, and resilience. With this objective in mind, the European Commission has launched the Biotech Act I, its first major regulatory initiative aimed at strengthening the European biotechnology and biomanufacturing ecosystem.

At the Spanish Bioindustry Association (AseBio), we have actively contributed to its development and, after reviewing the proposal together with our members, we have prepared a position paper containing recommendations to enhance its impact in key areas. In this context, we have also participated in several related processes aimed at shaping the next generation of European biotechnology policies.

Specifically, we have contributed to the Fraunhofer Institute’s technical questionnaire on the Biotech Act II, the European Commission’s public consultation on this forthcoming legislative initiative, and the feedback process for the Food & Feed Safety Simplification Omnibus. These three processes will have a direct impact on the competitiveness, industrial scale-up, and market uptake of biotechnological solutions in Europe.

Europe does not need more diagnoses—it needs tools to turn science into industry

In our contributions to the future Biotech Act II, we argue that Europe must move beyond the political recognition of biotechnology as a strategic sector and focus on creating the conditions needed for innovation to reach the market, scale industrially, and generate competitive value chains within the European Union.

We believe that Europe does not face a shortage of knowledge, scientific excellence, or talent. Rather, the challenge lies in transforming that potential into industrial investment, manufacturing capacity, and market opportunities. For this reason, we have called on European institutions to ensure that the next generation of biotechnology policies includes concrete measures to facilitate industrial scale-up and remove the barriers that currently constrain the growth of innovative companies.

Among the priorities identified is the need to strengthen financing instruments tailored to the demonstration, first-of-a-kind plant, and industrial replication stages, particularly for SMEs and scale-ups. We also advocate for the development of mechanisms that support market creation for biotechnology and bio-based products, combining tools such as public procurement, tax incentives, and contracts for difference with regulatory frameworks that are realistic and aligned with the timelines and needs of industry.

At AseBio, we emphasize the importance of ensuring that any European targets related to the use of renewable feedstocks or non-fossil carbon take into account the realities of industrial processes. In this regard, we call for the recognition of mechanisms such as mass balance and bio-attributed products, which are essential to enabling a gradual, verifiable, and competitive transition towards more sustainable production models.

Alongside measures to strengthen industrial growth and investment, we stress the need to move towards a clearer, more harmonized, and risk-based regulatory framework. Regulatory fragmentation, divergent interpretations across Member States, and administrative complexity continue to represent significant barriers to innovation and to the market access of biotechnology solutions.

We therefore call for greater coordination among regulatory authorities, more predictable procedures, and a regulatory framework that better reflects the scientific and industrial realities of areas such as industrial fermentation, microorganisms, and products derived from these processes. We also believe that the development of regulatory sandboxes is essential to foster closer dialogue between innovators and regulators and to accelerate the uptake of new technologies without compromising safety or regulatory standards.

Regulatory simplification that fosters innovation without creating new barriers

With regard to the Food & Feed Safety Simplification Omnibus, we believe that the European Commission’s regulatory simplification efforts should translate into greater legal certainty, more consistent implementation across Member States, and a regulatory environment that supports innovation and enhances the competitiveness of biotechnology companies.

In this context, we welcome the European Commission’s decision to open the discussion on the regulatory treatment of certain products obtained through production processes involving genetically modified microorganisms, an issue of particular relevance for activities such as industrial fermentation and other biomanufacturing processes. We believe that greater regulatory clarity in this area would help reduce uncertainty, prevent divergent interpretations across the Single Market, and facilitate the market entry of new biotechnology solutions.

Through our contributions, we stress that any simplification must be applied in a proportionate manner and based on scientific and operational criteria, avoiding the emergence of new regulatory barriers or overly restrictive interpretations that could hinder the development and commercialization of safe products already present on the market.

We also underline the importance of ensuring that future regulation takes into account the realities of industrial processes and avoids technically unfeasible requirements that could limit biotechnology’s potential to contribute to Europe’s sustainability and competitiveness objectives.

Finally, we support measures aimed at reducing unnecessary administrative burdens in areas such as the authorization of certain feed additives, as we consider that a more efficient and predictable regulatory framework can help accelerate innovation without compromising food and health safety standards.

With these contributions, AseBio reinforces its role as a key interlocutor for the Spanish biotechnology ecosystem vis-à-vis European institutions, putting forward results-oriented technical proposals to ensure that future regulatory reforms respond to the real needs of companies.

As an association, we will continue working to ensure that Europe moves towards a regulatory framework that not only recognises the strategic nature of biotechnology, but also facilitates its development, industrialisation, and commercialisation, turning Europe’s scientific and innovation potential into investment, competitiveness, and sustainable growth.