General provisions
1. An interoperability regulatory sandbox shall be established through a specific agreement between at least three Union entities or public sector bodies. Legal entities forming a consortium may establish an interoperability regulatory sandbox, provided that the consortium involves at least three Union entities or public sector bodies and complies with the conditions set out in this Regulation.
2. Before formalising the specific agreement, the Union entities or public sector bodies establishing the interoperability regulatory sandbox shall ensure that:
(a)
the interoperability regulatory sandbox meets the criteria set out in Article 3 and specified in the checklist set out in the Annex to this Regulation;
(b)
the interoperability regulatory sandbox was notified to the Commission and, where applicable, authorised by the Commission pursuant to Article 11(4) of Regulation (EU) 2024/903 and Article 5 of this Regulation.
3. An interoperability regulatory sandbox shall be established for an initial period that should not exceed three years. An interoperability regulatory sandbox may be renewed, following the procedure set out in Article 7. Participation in the interoperability regulatory sandbox has to be started and terminated within the lifespan of the interoperability regulatory sandbox, not exceeding the maximum duration of participation in an interoperability regulatory sandbox set out in Article 12(2) of Regulation (EU) 2024/903.
Criteria 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.
Single point of contact
The regulatory sandbox coordinators shall designate among themselves, a single point of contact for the purposes of communication with the Commission throughout the entire lifespan of the interoperability regulatory sandbox.
Notification and authorisation of an interoperability regulatory sandbox
1. In the case that public sector bodies or Union entities want to establish an interoperability regulatory sandbox, they shall send a joint request through the Interoperable Europe Portal.
2. The joint request shall include all information necessary for the Commission to assess the compliance of requests by only public sector bodies with the criteria set out in Article 3 of this Regulation.
3. The Commission shall notify the single point of contact of its decision on the request referred to in paragraph 1. In case of a negative decision, the regulatory sandbox coordinators may submit a reasoned review request within 30 days of receiving the Commission’s decision. The Commission shall examine the review request within 30 days and shall notify the single contact point of its decision on that review request.
4. The start date of an interoperability regulatory sandbox set out in the specific agreement shall not be before receiving the notification referred to in paragraph 3.
Transparency
1. The Commission shall create a single, dedicated interface for information and exchange on interoperability regulatory sandboxes within the Interoperable Europe Portal, including:
(a)
general information and guidelines for Union entities and public sector bodies interested in establishing an interoperability regulatory sandbox, including features that help interested stakeholders to exchange information, requests and best practices;
(b)
dedicated information on each of the established interoperability regulatory sandboxes, including eligibility and selection criteria for participation in the interoperability regulatory sandboxes and information on running and closed projects in the interoperability regulatory sandbox.
2. The single contact point shall collect any missing information, specified in paragraph (1)(b), at least 10 days before the starting of the operations of the interoperability regulatory sandbox and share it with the Commission. The single point of contact shall regularly update the information on projects within the interoperability regulatory sandbox.
Renewal of the interoperability regulatory sandbox
1. Regulatory sandbox coordinators may decide to renew the interoperability regulatory sandbox under the following conditions:
(a)
the objectives of the interoperability regulatory sandbox have not yet been achieved;
(b)
the interoperability regulatory sandbox is not closed pursuant to Article 8.
2. In the case that the regulatory sandbox coordinators decide to renew the interoperability regulatory sandbox, they shall follow the procedure set out in Article 5.
3. In the case that the regulatory sandbox coordinators want to make substantial changes to the specific agreement, referred to in Article 2(1), including, among others, modifications regarding the number and the identity of the regulatory sandbox coordinators, or the extension of the initially agreed timeframe necessary to achieve the sandbox objectives, then the regulatory sandbox coordinators shall start the renewal procedure as set out in paragraph 2.
Closing of an interoperability regulatory sandbox
1. Regulatory sandbox coordinators shall close the interoperability regulatory sandbox in one of the following cases:
(a)
the interoperability regulatory sandbox has fulfilled its objectives;
(b)
the interoperability regulatory sandbox has reached its determined end date pursuant to Article 2(3) and the regulatory sandbox coordinators have not reached an agreement on its renewal;
(c)
the Commission has not authorised the renewal pursuant to Article 7;
(d)
the necessary funding to continue the activities of the interoperability regulatory sandbox is not available.
2. Upon closing of the interoperability regulatory sandbox, the regulatory sandbox coordinators shall ensure that all projects in the interoperability regulatory sandbox are properly terminated, as set out in Article 15.
3. Regulatory sandbox coordinators shall submit the final report referred to in Article 12(8) of Regulation (EU) 2024/903 within three months following the closing of the interoperability regulatory sandbox.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
