(fra Kommisjonens initiativ 2.12.2025)

Implementing Regulation on AI Regulatory Sandboxes

Fra forordningens fortale: 

"(1) In accordance with Regulation (EU) 2024/1689, AI regulatory sandboxes are intended to provide a controlled framework established by competent authorities to enable the development, training, validation and testing, including in real-world conditions, of innovative AI systems under regulatory supervision for a limited time before their placement on the market.

(2) To avoid fragmentation across the Union, maximise the benefits of AI regulatory sandboxes for all, and guarantee the consistent implementation of Regulation (EU) 2024/1689, it is important to adopt common rules setting out the detailed arrangements regarding the establishment, development, implementation, operation and supervision of the AI regulatory sandboxes. Such rules should be in line with the objectives of the AI regulatory sandboxes and the other relevant provisions set out in Regulation (EU) 2024/1689. These rules should also ensure coherence and complementarity with Union initiatives supporting data-driven innovation and with relevant Union sectoral frameworks governing the development and placing on the market of regulated products and systems. 

(3) AI regulatory sandboxes aim to enhance legal certainty for innovators and support them in achieving regulatory compliance with Regulation 2024/1689 and, as appropriate, other Union law, such as Regulation (EU) 2016/679 (‘General Data Protection Regulation’), and Union product safety legislation. They should also promote responsible innovation and competitiveness and accelerate access of innovative AI systems to the Union market by removing barriers for SMEs, including start-ups. AI regulatory sandboxes play a key role in connecting innovators with competent authorities through a collaborative approach and in enhancing the competent authorities’ oversight and understanding of the opportunities, emerging risks and the impacts of AI use. Participation in AI regulatory sandboxes should focus on issues that may raise legal uncertainty for providers and prospective providers to innovate and experiment with AI in the Union. 

(4) This Regulation lays down detailed rules as regards the establishment, development, implementation, operation and supervision of AI regulatory sandboxes by competent authorities pursuant to Article 57(1), (2) and (3) of Regulation (EU) 2024/1689. For reasons of uniform application and common interpretation concerning regulatory questions examined in the AI regulatory sandbox, as well as mutual recognition of the results, this Regulation should apply to all AI regulatory sandboxes under Regulation (EU) 2024/1689."

Draft act

Feedback period: 02 December 2025 - 30 December 2025

Draft implementing regulation - Ares(2025)10569703