Biotechnology is essential to the EU's competitiveness, strategic autonomy and economic security. It is one of the fastest growing innovative industries, growing at twice the speed of the EU economy in the last 10 years, whilst contributing close to €40 billion to the EU's gross domestic product, and creating more than 900,000 jobs.

Today's Biotech Act is focussed particularly on health biotech, although it also includes provisions on food and feed. Health biotech currently accounts for more than 80% of the value of the entire sector, and 75% of all jobs in this sector in Europe. The Biotech Act also proposes to amend specific parts of EU health and food regulations, to adapt the whole ecosystem to the needs of modern society and this fast-growing sector. Today's proposals include revising EU rules on clinical trials, advanced therapy medicinal products, substances of human origin, veterinary medicinal products, general food law, human organs and genetically modified organisms.

What this means for industry

Below, we highlight some of the main regulatory developments in the Proposal that are particularly relevant for life sciences companies.  We will provide further detail on specific aspects of the Biotech Act in future blogs.

• Boost access to funding to help EU biotech companies grow and scale-up, with economic incentives to facilitate the biotech sector's access to capital in the EU. Already in 2026 and 2027, in cooperation with the European Investment Bank Group, the Commission will run a health biotech pilot to complement the EIB's BiotechEU initiative that will mobilise up to €10 billion investment in the sector. This initiative will stream into the EU health biotechnology investment pilot, established for an initial period of 2 years with the option to renew.
• Reinforce EU industrial capabilities and support for innovation, to deliver high impact biotechnology developments including centres of excellence for advance therapy medicinal products, testing and training environments for biomanufacturing, data quality accelerators and biodefence capability projects.
• Reward key EU innovations in health and veterinary biotech with a targeted extension of patent rights, along with support for strategic areas such as biosimilar development and production.
• Harness the use of artificial intelligence, data and digital solutions in the biotech sector, by implementing the European Health Data Space, creating trusted AI testing environments, facilitating data-sharing, and supporting small and medium enterprises, start-ups and scale-ups in using high performance technologies.
• Simplify and accelerate regulatory procedures to reduce time-to-market for biotech products; for example, with harmonised requirements and the use of regulatory sandboxes, as controlled environments for companies to experiment and trial innovative solutions, regulatory procedures and technologies.
• Provide biosecurity safeguards to protect against the misuse of biotechnologies and boost the EU's biodefence capabilities.

In particular to the food industry, it ammends the General Food Law:

Amendments to Regulation (EC) No 178/2002 (General Food Law) This Regulation proposes amendments to Regulation (EC) No 178/200287 laying down the general principles and requirements of food law, in order to streamline risk assessment processes. Key changes include: 

(i) broadening pre-submission advice to include scientific matters, such as study design and testing strategies, while merging it with the renewal-related advice into a single, unified procedure to simplify application procedures; 

(ii) shortening the procedural delay for non-compliance with the study notification requirements at presubmission phase from six to three months to reduce time-to-market; 

(iii) requiring EFSA staff to chair panels and serve as vice-chairs of the Scientific Committee (without voting rights) to improve efficiency and coherence across Panels; 

(iv) introducing provisions for regulatory sandboxes, allowing Member States to test innovative technologies under harmonised conditions that foster innovation while safeguarding consumer health and safety. Such amendments should contribute, amongst others, to accelerating the risk assessment process carried out by EFSA for products that are subject to pre-market authorisation in accordance with Union food and feed law and foster innovation in the sector. As such, those are necessary amendments with a view to ensure the effectiveness of the substantive measures put forward in this proposal towards the strengthening of an innovative biotechnology sector in food and feed safety.