The Council of the European Union has agreed its negotiating mandate on a draft directive under the European Biotech Act I package, which aims to strengthen biotechnology innovation by updating EU rules on genetically modified micro-organisms (GMMs) and organ processing. The proposal seeks to accelerate the market entry of certain GMMs that meet predefined safety standards and to reflect scientific advances in organ transplantation. The Council’s position clarifies terminology, aligns provisions with existing EU legislation, defines the respective responsibilities of the European Commission and Member States, and replaces the term ‘low-risk GMMs’ with ‘GMMs eligible for an expedited procedure’. It also distinguishes between autologous organ transplants and transplants between different individuals to ensure emergency procedures are not unnecessarily restricted. In addition, the Council introduced a safeguard limiting initial consent for placing GMMs on the market to a maximum of 10 years before renewal, and added provisions allowing the processing of personal data for organ transplantation where necessary for patient safety, healthcare quality and cross-border analysis of transplant outcomes. The European Parliament will now establish its position before negotiations begin on the final text.