Chapter II, Article 3 · Commission Implementing Regulation (EU) 2025/1420

Contents

Article 3Criteria for the establishment of interoperability regulatory sandboxes#

1.Any public sector body or Union entity may take part in establishing an interoperability regulatory sandbox, subject to the conditions laid down in this Regulation.

2.The goal of an interoperability regulatory sandbox should contribute to the objectives set out in Article 11(2) of Regulation (EU) 2024/903.

3.Public sector bodies or Union entities shall assess the possibility to join an existing interoperability regulatory sandbox with the same scope or to link to existing regulatory sandboxes with an overlapping scope before establishing a new interoperability regulatory sandbox.

4.The regulatory sandbox coordinators shall conclude a specific agreement on the establishment of an Interoperability regulatory sandbox that shall, at least, contain the following elements:

(a)a description of the interoperability regulatory sandbox objective, scope and deliverables, in particular how the interoperability regulatory sandbox, effectively contributes to the objectives set out in Article 11(2) of Regulation (EU) 2024/903, the innovative interoperability solutions that may be developed, trained, tested or validated in the interoperability regulatory sandbox and the open regulatory issues covered in the interoperability regulatory sandbox, as well as its planned duration;

(b)a governance plan outlining how the interoperability regulatory sandbox will operate, including the management of projects in the interoperability regulatory sandbox, setting out clear and transparent arrangements for collaboration between the participants, regulatory authorities, and any other actor involved in the interoperability regulatory sandbox, and outlining roles and responsibilities of the participants entering or exiting the interoperability regulatory sandbox; the regulatory sandbox coordinators may agree on the division of the tasks set out in Article 9 of this Regulation among them;

(c)description of a risk management mechanism to supervise, monitor, and mitigate risks, ensuring the protection of fundamental rights, health, safety and personal data protection supported by clear policies and procedures to address potential violations of these fundamental rights, health and safety standards and personal data protection;

(d)description of a framework for evaluation and reporting across the interoperability regulatory sandbox and on the projects running within the interoperability regulatory sandbox, including mechanisms for monitoring progress, addressing challenges, documenting lessons learned and potential follow-up, and ensuring alignment with regulatory objectives;

(e)where the processing of personal data in the projects running in the interoperability regulatory sandbox is envisioned, specifying the information referred to in in Article 11(4) of Regulation (EU) 2024/903.

5.The regulatory sandbox coordinators shall agree on initiating at least one project subject to the conditions set out in the specific agreement, and Chapter III of this Regulation by establishing a draft specific plan.