Article 33 Essential requirements regarding interoperability of data, of data sharing mechanisms and services, as well as of common European data spaces

1.   Participants in data spaces that offer data or data services to other participants shall comply with the following essential requirements to facilitate the interoperability of data, of data sharing mechanisms and services, as well as of common European data spaces which are purpose- or sector-specific or cross-sectoral interoperable frameworks for common standards and practices to share or jointly process data for, inter alia, the development of new products and services, scientific research or civil society initiatives:

The requirements can have a generic nature or concern specific sectors, while taking fully into account the interrelation with requirements arising from other Union or national law.

2.   The Commission is empowered to adopt delegated acts, in accordance with Article 45 of this Regulation to supplement this Regulation by further specifying the essential requirements laid down in paragraph 1 of this Article, in relation to those requirements that, by their nature, cannot produce the intended effect unless they are further specified in binding Union legal acts and in order to properly reflect technological and market developments.

The Commission shall when adopting delegated acts take into account the advice of the EDIB in accordance with Article 42, point (c)(iii).

3.   The participants in data spaces that offer data or data services to other participants in data spaces which meet the harmonised standards or parts thereof, the references of which are published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such harmonised standards or parts thereof.

4.   The Commission shall, pursuant to Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards that satisfy the essential requirements laid down in paragraph 1 of this Article.

5.   The Commission may, by means of implementing acts, adopt common specifications covering any or all of the essential requirements laid down in paragraph 1 where the following conditions have been fulfilled:

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(2).

6.   Before preparing a draft implementing act referred to in paragraph 5 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 5 of this Article have been fulfilled.

7.   When preparing the draft implementing act referred to in paragraph 5, the Commission shall take into account the advice of the EDIB and views of other relevant bodies or expert groups and shall duly consult all relevant stakeholders.

8.   The participants in data spaces that offer data or data services to other participants in data spaces that meet the common specifications established by implementing acts referred to in paragraph 5 or parts thereof shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such common specifications or parts thereof.

9.   Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. Where the reference of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 5 of this Article, or parts thereof which cover the same essential requirements as those covered by that harmonised standard.

10.   When a Member State considers that a common specification does not entirely satisfy the essential requirements laid down in paragraph 1, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

11.   The Commission may adopt guidelines taking into account the proposal of the EDIB in accordance with Article 30, point (h), of Regulation (EU) 2022/868 laying down interoperable frameworks for common standards and practices for the functioning of common European data spaces.