AseBio welcomes progress in the european reform of genetically modified microorganism legislation and calls for maintaining regulatory ambition

The European Union's current regulatory framework for genetically modified microorganisms (GMMs) is based on a set of directives and regulations governing both their contained use—for example, in industrial or research facilities—and their placing on the market when incorporated into products, particularly in the food sector. This legislative framework, developed more than two decades ago and transposed into Spanish law through Law 9/2003 and Royal Decree 178/2004, has supported the development of European biotechnology. However, scientific progress and the emergence of new applications have highlighted the need to modernise the existing legislation.

To address this need, the European Commission presented a legislative package in December 2025 to modernise the regulation of genetically modified microorganisms. The package includes a dedicated proposal for a Directive on GMMs, the Omnibus Food & Feed Safety proposal, and the Biotech Act, which introduces new tools to foster innovation, including regulatory sandboxes. The legislative process has now reached a new milestone with the Council of the European Union adopting its negotiating position on the proposed Directive, introducing several amendments to the Commission's original proposal.

In light of these developments, the Spanish Bioindustry Association (AseBio) welcomes the overall direction of the reform, considering it an opportunity to provide Europe with a regulatory framework that is better aligned with scientific progress, evidence-based decision-making and a risk-proportionate approach. However, we believe that the proposal can still be strengthened during negotiations with the European Parliament to ensure that it genuinely promotes innovation and enhances the competitiveness of the biotechnology sector.

A Regulatory Framework Better Adapted to Innovation

AseBio particularly welcomes the progress made by the European institutions towards establishing a dedicated regulatory framework for genetically modified microorganisms, recognising their specific characteristics within European legislation. We consider this to be the most significant achievement of the reform and are pleased that both the European Commission and the Council support this science-based and proportionate approach.

We believe the reform has the potential to improve legal certainty for companies, simplify administrative procedures and create a more competitive regulatory environment while maintaining Europe's high safety standards.

We also support the broader simplification agenda promoted through the European Commission's legislative package, provided that implementation remains consistent across all Member States and avoids divergent interpretations that could fragment the Single Market.

The Main Changes Introduced by the Council

The Council of the European Union has adopted its position on the amendment of Directive 2001/18/EC, introducing several important changes. These include a more comprehensive development of the Qualified Presumption of Safety (QPS) concept, reinforcing the role of scientific evidence and assessments carried out by the European Food Safety Authority (EFSA).

The Council's position also modifies the authorisation system by replacing the Commission's original proposal for indefinite authorisations from the outset with a system providing for an initial time-limited authorisation, which may become indefinite following its first renewal unless there are justified reasons to decide otherwise.

In addition, the Council replaces the category of "low-risk genetically modified microorganisms" with "genetically modified microorganisms eligible for an accelerated procedure." Eligibility remains based on appropriate taxonomic and molecular characterisation, inclusion within a taxonomic unit holding QPS status, and the absence of genes of concern.

The proposal also introduces a more detailed definition of genes of concern and allows competent authorities to request expert support from National Reference Laboratories regarding analytical methods, a measure that we believe could help streamline procedures. Furthermore, it maintains a risk-based approach to post-market monitoring and promotes the development of new technical guidance by EFSA and the European laboratory network to support the harmonised implementation of the future regulatory framework. AseBio particularly welcomes this risk-based approach, as it avoids imposing environmental monitoring requirements that are not justified by the product's actual risk profile, regardless of whether it involves genetic modification.

Maintaining Ambition Throughout the Negotiations

While we welcome the progress achieved so far, we believe that there is still room for improvement during negotiations with the European Parliament.

In particular, we advocate ensuring that the future category of microorganisms eligible for the accelerated procedure is genuinely operational and is not constrained by overly restrictive eligibility criteria.

We also believe that the QPS system should not become the sole pathway to the accelerated procedure, as this could exclude microorganisms with appropriate safety profiles, particularly those intended for industrial applications outside the food sector.

We therefore support the consolidation of a regulatory framework based on the characteristics and risk profile of the product, greater consistency between the future GMM Directive and the wider body of European legislation, harmonised implementation across Member States, and monitoring requirements proportionate to the identified level of risk.

Regulatory Sandboxes to Accelerate Innovation

AseBio also welcomes the inclusion of regulatory sandboxes under the Biotech Act I, as we believe they will facilitate early dialogue between companies and competent authorities, promote the generation of scientific evidence and contribute to regulatory learning.

An Opportunity to Strengthen Europe's Leadership in Biotechnology

Ultimately, AseBio believes that the reform currently under negotiation represents an important opportunity for Europe to establish a modern, coherent and competitive regulatory framework capable of keeping pace with the rapid development of biotechnology. Such a framework would help ensure that innovations developed in Europe reach the market more efficiently while preserving the high standards of safety that define the European regulatory model.