Article 57 AI regulatory sandboxes

Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox means a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision; at national level, which shall be operational by 2 August 2026. 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.

The obligation under the first subparagraph may also be fulfilled by participating in an existing sandbox in so far as that participation provides an equivalent level of national coverage for the participating Member States.

Additional AI regulatory sandboxes at regional or local level, or established jointly with the competent authorities of other Member States may also be established.

The European Data Protection Supervisor may also establish an AI regulatory sandbox means a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision; for Union institutions, bodies, offices and agencies, and may exercise the roles and the tasks of national competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor; in accordance with this Chapter.

Member States shall ensure that the competent authorities referred to in paragraphs 1 and 2 allocate sufficient resources to comply with this Article effectively and in a timely manner. Where appropriate, national competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor; shall cooperate with other relevant authorities, and may allow for the involvement of other actors within the AI ecosystem. This Article shall not affect other regulatory sandboxes established under Union or national law. Member States shall ensure an appropriate level of cooperation between the authorities supervising those other sandboxes and the national competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor;.

AI regulatory sandboxes established under paragraph 1 shall provide for a controlled environment that fosters innovation and facilitates the development, training, testing and validation of innovative AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; for a limited time before their being placed on the market or put into service pursuant to a specific sandbox plan means a document agreed between the participating provider and the competent authority describing the objectives, conditions, timeframe, methodology and requirements for the activities carried out within the sandbox; agreed between the providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; and the competent authority. Such sandboxes may include testing in real world conditions supervised therein.

Competent authorities shall provide, as appropriate, guidance, supervision and support within the AI regulatory sandbox means a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision; with a view to identifying risks means the combination of the probability of an occurrence of harm and the severity of that harm;, in particular to fundamental rights, health and safety, testing, mitigation measures, and their effectiveness in relation to the obligations and requirements of this Regulation and, where relevant, other Union and national law supervised within the sandbox.

Competent authorities shall provide providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; and prospective providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; participating in the AI regulatory sandbox means a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision; with guidance on regulatory expectations and how to fulfil the requirements and obligations set out in this Regulation.

Upon request of the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; of the AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;, the competent authority shall provide a written proof of the activities successfully carried out in the sandbox. The competent authority shall also provide an exit report detailing the activities carried out in the sandbox and the related results and learning outcomes. Providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; may use such documentation to demonstrate their compliance with this Regulation through the conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; process or relevant market surveillance activities. In this regard, the exit reports and the written proof provided by the national competent authority means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor; shall be taken positively into account by market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; and notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;, with a view to accelerating conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedures to a reasonable extent.

Subject, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to the confidentiality provisions in Article 78, and with the agreement of the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge;, the Commission and the Board shall be authorised to access the exit reports and shall take them into account, as appropriate, when exercising their tasks under this Regulation. If both the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; and the national competent authority means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor; explicitly agree, the exit report may be made publicly available through the single information platform referred to in this Article.

1. improving legal certainty to achieve regulatory compliance with this Regulation or, where relevant, other applicable Union and national law;

2. supporting the sharing of best practices through cooperation with the authorities involved in the AI regulatory sandbox means a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision;;

3. fostering innovation and competitiveness and facilitating the development of an AI ecosystem;

4. contributing to evidence-based regulatory learning;

5. facilitating and accelerating access to the Union market for AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;, in particular when provided by SMEs, including start-ups.

National competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor; shall ensure that, to the extent the innovative AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; involve the processing of personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the national data protection authorities and those other national or competent authorities are associated with the operation of the AI regulatory sandbox means a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision; and involved in the supervision of those aspects to the extent of their respective tasks and powers.

The AI regulatory sandboxes shall not affect the supervisory or corrective powers of the competent authorities supervising the sandboxes, including at regional or local level. Any significant risks means the combination of the probability of an occurrence of harm and the severity of that harm; to health and safety and fundamental rights identified during the development and testing of such AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; shall result in an adequate mitigation. National competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor; shall have the power to temporarily or permanently suspend the testing process, or the participation in the sandbox if no effective mitigation is possible, and shall inform the AI Office means the Commission’s function of contributing to the implementation, monitoring and supervision of AI systems and general-purpose AI models, and AI governance, provided for in Commission Decision of 24 January 2024; references in this Regulation to the AI Office shall be construed as references to the Commission; of such decision. National competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor; shall exercise their supervisory powers within the limits of the relevant law, using their discretionary powers when implementing legal provisions in respect of a specific AI regulatory sandbox means a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision; project, with the objective of supporting innovation in AI in the Union.

Providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; and prospective providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; participating in the AI regulatory sandbox means a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision; shall remain liable under applicable Union and national liability law for any damage inflicted on third parties as a result of the experimentation taking place in the sandbox. However, provided that the prospective providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; observe the specific plan and the terms and conditions for their participation and follow in good faith the guidance given by the national competent authority means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor;, no administrative fines shall be imposed by the authorities for infringements of this Regulation. Where other competent authorities responsible for other Union and national law were actively involved in the supervision of the AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; in the sandbox and provided guidance for compliance, no administrative fines shall be imposed regarding that law.

The AI regulatory sandboxes shall be designed and implemented in such a way that, where relevant, they facilitate cross-border cooperation between national competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor;.

National competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor; shall coordinate their activities and cooperate within the framework of the Board.

National competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor; shall inform the AI Office means the Commission’s function of contributing to the implementation, monitoring and supervision of AI systems and general-purpose AI models, and AI governance, provided for in Commission Decision of 24 January 2024; references in this Regulation to the AI Office shall be construed as references to the Commission; and the Board of the establishment of a sandbox, and may ask them for support and guidance. The AI Office means the Commission’s function of contributing to the implementation, monitoring and supervision of AI systems and general-purpose AI models, and AI governance, provided for in Commission Decision of 24 January 2024; references in this Regulation to the AI Office shall be construed as references to the Commission; shall make publicly available a list of planned and existing sandboxes and keep it up to date in order to encourage more interaction in the AI regulatory sandboxes and cross-border cooperation.

National competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor; shall submit annual reports to the AI Office means the Commission’s function of contributing to the implementation, monitoring and supervision of AI systems and general-purpose AI models, and AI governance, provided for in Commission Decision of 24 January 2024; references in this Regulation to the AI Office shall be construed as references to the Commission; and to the Board, from one year after the establishment of the AI regulatory sandbox means a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision; and every year thereafter until its termination, and a final report. Those reports shall provide information on the progress and results of the implementation of those sandboxes, including best practices, incidents, lessons learnt and recommendations on their setup and, where relevant, on the application and possible revision of this Regulation, including its delegated and implementing acts, and on the application of other Union law supervised by the competent authorities within the sandbox. The national competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor; shall make those annual reports or abstracts thereof available to the public, online. The Commission shall, where appropriate, take the annual reports into account when exercising its tasks under this Regulation.

The Commission shall develop a single and dedicated interface containing all relevant information related to AI regulatory sandboxes to allow stakeholders to interact with AI regulatory sandboxes and to raise enquiries with competent authorities, and to seek non-binding guidance on the conformity of innovative products, services, business models embedding AI technologies, in accordance with Article 62(1), point (c). The Commission shall proactively coordinate with national competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor;, where relevant.