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Article 57 is amended as follows: in paragraph 1, the first subparagraph is replaced by the following: ‘1. Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national level, which shall be operational by 2 August 2027. That sandbox may also be established jointly with the competent authorities of other Member States. The Commission may provide technical support, advice and tools for the establishment and operation of AI regulatory sandboxes.’ ; paragraph 3 is replaced by the following: ‘3. The European Data Protection Supervisor may establish an AI regulatory sandbox for Union institutions, bodies, offices and agencies. For this purpose, references to national competent authorities in this Chapter shall be construed as references to the European Data Protection Supervisor.’ ; the following paragraph is inserted: ‘3a. The AI Office may establish an AI regulatory sandbox at Union level for AI systems covered by Article 75(1). For this purpose, references to national competent authorities in this Chapter shall be construed, where relevant, as references to the AI Office. That AI regulatory sandbox shall be implemented in close cooperation with relevant competent authorities, in particular where compliance with Union legislation other than this Regulation is supervised in the AI regulatory sandbox, and shall provide priority access to SMEs, including start-ups, and SMCs. The establishment of a Union level AI regulatory sandbox by the AI Office shall be without prejudice to the competences of Member States to establish and supervise AI regulatory sandboxes for AI systems under their supervision.’ ; paragraph 5 is replaced by the following: ‘5. AI regulatory sandboxes established under this Article shall provide for a controlled environment that fosters innovation and facilitates the development, training, testing and validation of innovative AI systems for a limited time before their being placed on the market or put into service pursuant to a specific sandbox plan agreed between the providers or prospective providers and the competent authorities, ensuring that appropriate safeguards are in place. Such sandboxes may include testing in real world conditions supervised therein. Where applicable, the sandbox plan shall incorporate the real-world testing plan referred to in Articles 60 and 60a.’ ; in paragraph 9, point (e) is replaced by the following: ; facilitating and accelerating access to the Union market for AI systems, in particular when provided by SMEs, including start-ups, and SMCs.’ paragraph 10 is replaced by the following: ‘10. National competent authorities shall ensure that, to the extent the innovative AI systems involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the competent data protection authorities and those other national or competent authorities are associated with the operation of the AI regulatory sandbox and involved in the supervision of those aspects to the extent of their respective tasks and powers.’ ; paragraph 14 is replaced by the following: ‘14. National competent authorities, the European Data Protection Supervisor and the AI Office, shall, as appropriate and within their respective competences, coordinate their activities and cooperate within the framework of the Board. They may support the joint establishment and operation of AI regulatory sandboxes, including in different sectors, and exchange best practices on related matters.’ ;

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Source: EUR-Lex (Cellar) · retrieved 2026-10-14 · Text as adopted (Official Journal); later amendments are not incorporated in this text.