European Union: European Commission opened consultation on draft Implementing Regulation on Artificial Intelligence Regulatory Sandboxes

On 2 December 2025, the European Commission opened a consultation on the draft Implementing Regulation on Artificial Intelligence Regulatory Sandboxes, until 30 December 2025. The draft regulation establishes rules for the creation, operation, and supervision of AI regulatory sandboxes under the EU AI Act. It outlines general terms and conditions for participation, prioritising Small and Medium-sized Enterprises (SMEs), including start-ups, with free participation for them, while allowing for cost recovery for larger companies. The draft regulation details the application and selection process, requiring proposals to be eligible for an AI system not yet placed on the market or undergoing substantial modification. It mandates that competent authorities record sandbox activities, publish compliance tools, and agree on a sandbox plan with participants, specifying objectives, timelines, and risk management safeguards. Upon completion, a written proof and an exit report will be issued for documentation and regulatory learning purposes, although these do not carry the same legal effect as a declaration of conformity. The draft regulation also addresses the suspension of projects and requires annual reports on sandbox activities to be publicly available.