Article 58 — Detailed Arrangements for AI Regulatory Sandboxes

Article 58
Detailed arrangements for, and functioning of, AI regulatory sandboxes

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

(a) eligibility and selection criteria for participation in the AI regulatory sandbox;

(b) procedures for the application, participation, monitoring, exiting from and termination of the AI regulatory sandbox,
including the sandbox plan and the exit report;

(c) the terms and conditions applicable to the participants.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).

2. The implementing acts referred to in paragraph 1 shall ensure:

(a) that AI regulatory sandboxes are open to any applying provider or prospective provider of an AI system who fulfils
eligibility and selection criteria, which shall be transparent and fair, and that national competent authorities inform

applicants of their decision within three months of the application;

(b) that AI regulatory sandboxes allow broad and equal access and keep up with demand for participation; providers and
prospective providers may also submit applications in partnerships with deployers and other relevant third parties;

(c) that the detailed arrangements for, and conditions concerning AI regulatory sandboxes support, to the best extent
possible, flexibility for national competent authorities to establish and operate their AI regulatory sandboxes;

(d) that access to the AI regulatory sandboxes is free of charge for SMEs, including start-ups, without prejudice to
exceptional costs that national competent authorities may recover in a fair and proportionate manner;

(e) that they facilitate providers and prospective providers, by means of the learning outcomes of the AI regulatory
sandboxes, in complying with conformity assessment obligations under this Regulation and the voluntary application
of the codes of conduct referred to in Article 95;

(f) that AI regulatory sandboxes facilitate the involvement of other relevant actors within the AI ecosystem, such as notified
bodies and standardisation organisations, SMEs, including start-ups, enterprises, innovators, testing and experimenta -
tion facilities, research and experimentation labs and European Digital Innovation Hubs, centres of excellence,
individual researchers, in order to allow and facilitate cooperation with the public and private sectors;

(g) that procedures, processes and administrative requirements for application, selection, participation and exiting the AI
regulatory sandbox are simple, easily intelligible, and clearly communicated in order to facilitate the participation of
SMEs, including start-ups, with limited legal and administrative capacities and are streamlined across the Union, in order
to avoid fragmentation and that participation in an AI regulatory sandbox established by a Member State, or by the
European Data Protection Supervisor is mutually and uniformly recognised and carries the same legal effects across the
Union;

(h) that participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of
the project and that may be extended by the national competent authority;

(i) that AI regulatory sandboxes 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 society at large.

3. Prospective providers in the AI regulatory 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 and experimentation facilities, European
Digital Innovation Hubs and centres of excellence.

90/144 ELI: http://data.europa.eu/eli/reg/2024/1689/oj
OJ L, 12.7.2024 EN

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