EU member states have agreed a negotiating position on proposed changes to health laws covering genetically modified micro-organisms and the processing of organs.
The draft European Biotech Act I directive would amend two existing EU directives, with changes focused on the rules for placing certain genetically modified micro-organisms (GMMs) on the market and on updating requirements for organ processing to reflect scientific advances, the Council of the EU informed on Tuesday.
GMMs are micro-organisms whose genetic material has been altered using genetic engineering techniques, and they are used in areas such as biotechnology and research.
The Council said its mandate would add clarity and detail to the text, including aligning terminology with other EU laws and setting out the respective roles of the European Commission and member states.
It also stated that the wording “low-risk GMMs” would be replaced with “GMMs eligible for an expedited procedure”, to avoid implying that other GMMs are “high risk” by default.
Changes to organ processing and consent rules
On organ processing, the Council said it had clarified the distinction between “autologous” use — transplantation within the same person — and transplants to another person, adding that autologous procedures can happen in emergency situations.
Rules on consent for placing a GMM on the market would also change under the Council’s position: initial consent would be limited to a maximum of 10 years, it said. Renewals would be granted indefinitely unless certain exceptions apply.
The mandate also introduces provisions on personal data in the context of organ transplants, where information may be processed to support patient safety and healthcare standards, and to enable cross-border data sharing to analyse transplant outcomes. In those cases, processing can be deemed to be in the public interest.
Cyprus health minister Neophytos Charalambides said the agreement “modernis[es] rules on genetically modified micro-organisms and organ processing” while maintaining “high standards of safety, transparency and public trust”.
The European Parliament will set its own position next, before it enters negotiations with the Council to agree the final text.
The European Biotech Act I directive was published on 16 December 2025 as part of the European Commission’s “Health Package.”
