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Article 53a

[Deleted]

Removed on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

[Previous version]

Removed on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

Modalities and Functioning of AI Regulatory Sandboxes

1. In order to avoid fragmentation across the Union, the Commission shall adopt an implementing act detailing the modalities for the establishment, development, implementation, operation and supervision of the AI regulatory sandboxes. The implementing act shall include common principles on the following issues:

  1. eligibility and selection for participation in the AI regulatory sandbox;
  2. procedure for the application, participation, monitoring, exiting from and termination of the AI regulatory sandbox, including the sandbox plan and the exit report;
  3. the terms and conditions applicable to the participants.

The implementing acts shall ensure that:

  1. regulatory sandboxes are open to any applying prospective provider of an AI system who fulfils eligibility and selection criteria. The criteria for accessing to the regulatory sandbox are transparent and fair and establishing authorities inform applicants of their decision within 3 months of the application;
  2. regulatory sandboxes allow broad and equal access and keep up with demand for participation; prospective providers may also submit applications in partnerships with users and other relevant third parties;
  3. the modalities and conditions concerning regulatory sandboxes shall to the best extent possible support flexibility for national competent authorities to establish and operate their AI regulatory sandboxes;
  4. access to the AI regulatory sandboxes is free of charge for SMEs and start-ups without prejudice to exceptional costs that national competent authorities may recover in a fair and proportionate manner;
  5. they facilitate prospective providers, by means of the learning outcomes of the sandboxes, to conduct the conformity assessment obligations of this Regulation or the voluntary application of the codes of conduct referred to in Article 69;
  6. regulatory sandboxes facilitate the involvement of other relevant actors within the AI ecosystem, such as notified bodies and standardisation organisations (SMEs, start- ups, enterprises, innovators, testing and experimentation facilities, research and experimentation labs and digital innovation hubs, centres of excellence, individual researchers), in order to allow and facilitate cooperation with the public and private sector;
  7. procedures, processes and administrative requirements for application, selection, participation and exiting the sandbox are simple, easily intelligible, clearly communicated in order to facilitate the participation of SMEs and start-ups with limited legal and administrative capacities and are streamlined across the Union, in order to avoid fragmentation and that participation in a regulatory sandbox established by a Member State, or by the EDPS is mutually and uniformly recognised and carries the same legal effects across the Union;
  8. participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of the project. This period may be extended by the national competent authority;
  9. the sandboxes shall facilitate the development of tools and infrastructure for testing, benchmarking, assessing and explaining dimensions of AI systems relevant for regulatory learning, such as accuracy, robustness and cybersecurity as well as measures to mitigate risks to fundamental rights and the society at large.

3. Prospective providers in the sandboxes, in particular SMEs and start-ups, shall be directed, where relevant, to pre-deployment services such as guidance on the implementation of this Regulation, to other value-adding services such as help with standardisation documents and certification, Testing & Experimentation Facilities, Digital Hubs and Centres of Excellence.

4. When national competent authorities consider authorising testing in real world conditions supervised within the framework of an AI regulatory sandbox established under this Article, they shall specifically agree with the participants on the terms and conditions of such testing and in particular on the appropriate safeguards with the view to protect fundamental rights, health and safety. Where appropriate, they shall cooperate with other national competent authorities with a view to ensure consistent practices across the Union.

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