Together with the Food and Feed Safety Simplification Omnibus (COM(2025) 1030 final/2), published in mid-December 2025, the European Biotech Act (COM(2025) 1022 final/2) marks a significant step towards simplifying and modernising EU food and feed legislation. These two initiatives reflect a broader EU ambition to strengthen competitiveness, support innovation and reduce regulatory complexity, while maintaining high standards of safety and public health.
In this blog, I outline the key elements of the European Biotech Act that are particularly relevant to the food and feed regulatory landscape and explain what these changes may mean in practice for food and feed business operators. This is a legislative development that many stakeholders across the food and feed sector have been waiting for.
What is the European Biotech Act?
The European Biotech Act is a landmark legislative proposal aimed at strengthening the EU’s biotechnology and biomanufacturing ecosystem. While its primary focus is on health-related applications, the Act has important implications for food and feed regulation, particularly where advanced biotechnological processes are involved.
The Act responds to long-standing structural challenges within the EU, including fragmented governance, regulatory complexity, limited access to finance and skills shortages. These factors have hindered the EU’s ability to translate scientific excellence into commercial and manufacturing success, especially when compared with other global regions such as the United States and China.
The Biotech Act is aligned with the EU’s One Health approach, covering human, animal and plant health. It applies across the entire lifecycle of biotechnology products, including those used in food and feed, and amends related legislation to improve regulatory coherence across sectors.
Why the Biotech Act matters for food and feed
Although not exclusively a food and feed initiative, the Biotech Act has several direct and indirect consequences for food and feed regulation:
- it promotes regulatory simplification and faster access to scientific advice
- it supports innovation, particularly for SMEs and start-ups
- it encourages the use of digital tools and data-driven approaches in biotechnology
- it introduces safeguards to address biosecurity risks relevant to food and feed supply chains
Importantly, the proposal also introduces the European Competitiveness Fund, which, according to the Commission’s proposal, would receive a total allocation of EUR 20.4 billion for the period 2028–2034. As part of this initiative, both the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA) are expected to be reinforced, both in terms of staffing and financial resources, to support tasks related to Biotech Act projects.
Key regulatory changes affecting food and feed
Expanded EFSA mandate: nutrition
One of the most significant changes for the food sector is the extension of EFSA’s scientific remit. Under the Biotech Act, EFSA’s role would expand beyond food and feed safety risk assessment to explicitly include nutrition.
The General Food Law (Regulation (EC) No 178/2002) would be revised to clarify that EFSA provides scientific advice and technical support on human nutrition. This change reflects the increasing prevalence of diet-related health issues and the growing relevance of nutritional properties in food products, including those derived from advanced biotechnological processes.
See also: EFSA’s role in human nutrition: why nutrition science matters
Streamlined risk assessment and scientific advice
The Act proposes to broaden and unify EFSA’s pre-submission advice, including guidance on scientific study design and testing strategies. This aims to simplify and accelerate the application process for food and feed products, especially those involving biotechnology.
This scientific advice is particularly targeted at SMEs and start-ups. It is important to note that the advice is non-binding and is provided by EFSA staff and external experts based on existing guidance and current scientific knowledge.
Shortened procedural delays in study notifications
To further accelerate time-to-market, the procedural delay (penalty) applied in cases of non-compliance with study notification requirements at the pre-submission stage would be reduced from six months to three months.
Improved EFSA panel efficiency
The Act introduces changes to EFSA’s internal governance, allowing EFSA staff to chair panels and act as vice-chairs of the Scientific Committee (without voting rights). This measure aims to improve efficiency, consistency and harmonisation across EFSA’s risk assessment panels.
Regulatory sandboxes for food and feed
The Biotech Act introduces the possibility for regulatory sandboxes in the food and feed sector. These controlled environments would allow Member States to test innovative products, processes and technologies under defined regulatory conditions and monitoring.
Novel foods and certain GMOs remain subject to existing regulatory frameworks, but regulatory sandboxes may provide valuable opportunities for piloting new approaches while maintaining safety standards.
Fees for EFSA evaluations
The Act also opens the possibility for EFSA to introduce fees for certain evaluations, following a model already applied by the European Chemicals Agency (ECHA) under the REACH Regulation.
What to expect next for food and feed regulation
Later in 2026, the European Commission is expected to address the broader biotechnology ecosystem beyond health, with the aim of ensuring a competitive and well-functioning internal market for all areas of biotechnology. Further regulatory developments affecting food and feed can therefore be expected. We at Medfiles keep a close watch on these developments, and will inform our clients and blog followers.
Taken together, the European Biotech Act modernises and accelerates the regulatory environment for food and feed biotechnology in the EU. It promotes a more innovation-friendly framework while reinforcing safety, sustainability and public health objectives.
For food and feed business operators, these changes will increasingly influence how regulatory strategies are developed and how dossiers are prepared and assessed, particularly in areas such as nutrition, biotechnology-based processes and early regulatory engagement.
Medfiles supports clients across the full lifecycle of food and feed regulatory activities, including strategic planning, dossier preparation, submissions and post-authorisation support. Our teams closely monitor legislative developments, including biotech-related initiatives, and our experienced nutrition specialists are well positioned to support clients on questions related to nutrition and EFSA’s expanding role.
Whether you are developing innovative foods or feeds, adapting to new regulatory expectations or addressing biotechnology and nutrition considerations in your applications, Medfiles provides tailored support to help you achieve compliant and timely market access in a rapidly evolving regulatory environment.
Mari Eskola, Ph.D. | Team leader, Regulatory Science and Reports // Senior Regulatory Affairs Expert, Food and Feed
Mari Eskola joined Medfiles in 2021 and leads the Regulatory Science and Reports Team. Since starting at Medfiles, she has been involved in a wide range of projects relating to food, feed, and cosmetics safety.
Mari has nearly 30 years of broad international expertise in the chemical and regulatory safety of food and feed, acquired across the European Union, national authorities, and industry. At Medfiles, she brings over 15 years’ experience as a regulatory food and feed risk assessor. Mari developed her risk assessment expertise working for 10 years at the European Food Safety Authority (EFSA), where she conducted regulatory risk assessments of contaminants in food and feed. She also served as Acting and Deputy Head of the EFSA Contaminants Unit. She is a food chemist specialising in analytical chemistry and obtained her PhD in food science in 2002.
In addition, Mari has extensive food and feed research and regulatory experience from several European institutes, including the European Commission Joint Research Centre (EC JRC), the European Chemicals Agency (ECHA), Teagasc in Ireland, the University of Natural Resources and Life Sciences in Austria, and the former Finnish Food Safety Authority. She has international experience in project and people management and has authored numerous scientific publications, including many EFSA scientific opinions and risk assessments.
See also:
- EFSA’s role in human nutrition: why nutrition science matters
- Food and feed innovation funding: key programmes and requirements
- What’s on the horizon for feed additives regulatory affairs in the EU and UK
- For novel food ingredients, the faster EU market access is to sell them first as feeds and cosmetics
