Article 57 - AI regulatory sandboxes¶

Cross-References¶

Internal (AI Act)

Article 1 - Subject Matter
[To be identified based on content analysis]

Related Regulations

[To be identified based on content analysis]

Supporting Recitals

[To be identified based on content analysis]

Related Recitals

Recital (138), Recital (139)

Official Text¶

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 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.

2.

Additional AI regulatory sandboxes at regional or local level, or established jointly with the competent authorities of

other Member States may also be established.

3.

The European Data Protection Supervisor may also establish an AI regulatory sandbox for Union institutions, bodies,

offices and agencies, and may exercise the roles and the tasks of national competent authorities in accordance with this

Chapter.

4.

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

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.

5.

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 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 authority. Such sandboxes may include testing in real world

conditions supervised therein.

6.

Competent authorities shall provide, as appropriate, guidance, supervision and support within the AI regulatory

sandbox with a view to identifying risks, 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.

7.

Competent authorities shall provide providers and prospective providers participating in the AI regulatory sandbox

with guidance on regulatory expectations and how to fulfil the requirements and obligations set out in this Regulation.

Upon request of the provider or prospective provider of the AI system, 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 may use such

documentation to demonstrate their compliance with this Regulation through the conformity assessment process or

relevant market surveillance activities. In this regard, the exit reports and the written proof provided by the national

competent authority shall be taken positively into account by market surveillance authorities and notified bodies, with

a view to accelerating conformity assessment procedures to a reasonable extent.

8.

Subject to the confidentiality provisions in Article 78, and with the agreement of the provider or prospective provider,

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 or prospective provider and the national

competent authority explicitly agree, the exit report may be made publicly available through the single information

platform referred to in this Article.

9.

The establishment of AI regulatory sandboxes shall aim to contribute to the following objectives:

(a) improving legal certainty to achieve regulatory compliance with this Regulation or, where relevant, other applicable

Union and national law;

(b) supporting the sharing of best practices through cooperation with the authorities involved in the AI regulatory

sandbox;

(d) contributing to evidence-based regulatory learning;

(e) facilitating and accelerating access to the Union market for AI systems, in particular when provided by SMEs, including

start-ups.

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 national 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.

11.

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 to health and safety and fundamental

rights identified during the development and testing of such AI systems shall result in an adequate mitigation. National

competent authorities 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 of such decision. National competent

authorities 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 project, with the objective of supporting

innovation in AI in the Union.

12.

Providers and prospective providers participating in the AI regulatory sandbox 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 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, 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 in the sandbox and provided

guidance for compliance, no administrative fines shall be imposed regarding that law.

13.

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.

14.

National competent authorities shall coordinate their activities and cooperate within the framework of the Board.

15.

National competent authorities shall inform the AI Office and the Board of the establishment of a sandbox, and may

ask them for support and guidance. The AI Office 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.

16.

National competent authorities shall submit annual reports to the AI Office and to the Board, from one year after

the establishment of the AI regulatory sandbox 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 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.

17.

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

national competent authorities, where relevant.

ELI: http://data.europa.eu/eli/reg/2024/1689/oj

EN

OJ L, 12.7.2024

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