Article 2 – Definitions

‘consent’ means consent as defined in Article 4, point (11), of Regulation (EU) 2016/679;

‘permission’ means giving data users the right to the processing of non-personal data;

‘access’ means data use, in accordance with specific technical, legal or organisational requirements, without necessarily implying the transmission or downloading of data;

‘data holder’ means a natural or legal person that has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation adopted in accordance with Union law, to use or make available data, including, where contractually agreed, product data or related service data, which it has retrieved or generated during the provision of a related service;

‘bodies governed by public law’ means bodies that have all of the following characteristics: (a) they are established for the specific purpose of meeting needs in the general interest, not having an industrial or commercial character; (b) they have legal personality; (c) they are financed, for the most part by the State, regional or local authorities, or by other bodies governed by public law; or are subject to management supervision by those authorities or bodies; or have an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities, or by other bodies governed by public law;

‘public undertaking’ means any undertaking over which a public sector body may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it. A dominant influence on the part of the public sector bodies shall be presumed in any of the following cases in which those bodies, directly or indirectly: (a) hold the majority of the undertaking's subscribed capital; (b) control the majority of the votes attaching to shares issued by the undertaking; (c) can appoint more than half of the undertaking's administrative, management or supervisory body;

‘data intermediation service’ means a service which aims to establish relationships of an economic character for the purposes of data sharing between an undetermined number of data subjects or data holders and data users, through technical, legal or other means, including for the purpose of exercising the rights of data subjects in relation to personal data, and which : (1) do not have as their main purpose the intermediation of copyright-protected content; (2) are not jointly procured by several legal persons for exclusive use among them;

‘data altruism’ means the voluntary sharing of data on the basis of the consent of data subjects to process personal data pertaining to them, or of permissions of data holders to allow the use of their non-personal data without seeking or receiving a reward that goes beyond compensation related to the costs that they incur where they make their data available for objectives of general interest as provided for in national law, where applicable, such as healthcare, combating climate change, improving mobility, facilitating the development, production and dissemination of official statistics, improving the provision of public services, public policy making or scientific research purposes in the general interest;

‘medium-sized enterprise’ means a medium-sized enterprise as defined in Article 2 of Annex I to Recommendation 2003/361/EC;

‘small mid-cap’ or ‘SMC’ means a small mid-cap enterprise as defined in Article 2 of the Annex to Commission Recommendation (EU) 2025/1099;

‘university’ means a public sector body that provides post-secondary-school higher education leading to academic degrees;

‘standard licence’ means a set of predefined re-use conditions in a digital format, preferably compatible with standardised public licences available online;

‘document’ means: (a) any content that is non-digital whatever its medium (paper or as a sound, visual or audiovisual recording); or (b) any part of such content;

‘dynamic data’ means data and documents in a digital form, subject to frequent or real-time updates, in particular because of their volatility or rapid obsolescence; data generated by sensors are typically considered to be dynamic data;

‘research data’ means data , other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

‘re-use’ means the use by natural persons or legal entities of documents held by: (a) public sector bodies, for commercial or non-commercial purposes other than the initial purpose within the public task for which the documents were produced, except for the exchange of documents between public sector bodies purely in pursuit of their public tasks; or (b) public undertakings, under Chapter VIIc Section 2 for commercial or non-commercial purposes other than for the initial purpose of providing services in the general interest for which the documents were produced, except for the exchange of documents between public undertakings and public sector bodies purely in pursuit of the public tasks of public sector bodies;

‘high-value datasets’ means data and documents the re-use of which is associated with important benefits for society, the environment and the economy, in particular because of their suitability for the creation of value-added services, applications and new, high-quality and decent jobs, and because of the number of potential beneficiaries of the value-added services and applications based on those data and documents;

‘certain categories of protected data’ means data and documents held by public sector bodies which are protected on the grounds of (a) commercial confidentiality, including business, professional and company secrets; (b) statistical confidentiality; (c) the protection of intellectual property rights of third parties; or (d) the protection of personal data, insofar as such data fall outside the scope of Section 2 of Chapter VIIc;

‘secure processing environment’ means the physical or virtual environment and organisational means to ensure compliance with Union law in particular with regard to data subjects’ rights, intellectual property rights, and commercial and statistical confidentiality, integrity and accessibility, as well as with applicable national law, and to allow the entity providing the secure processing environment to determine and supervise all data processing actions, including the display, storage, download and export of data and the calculation of derivative data through computational algorithms;

‘re-user’ means a natural or legal person who was granted the right to re-use data or documents held by a public sector body or a public undertaking under Chapter VIIc or to research data or certain categories of protected data;

‘machine-readable format’ means a file format structured so that software applications can easily identify, recognise and extract specific data, including individual statements of fact, and their internal structure;

‘open format’ means a file format that is platform-independent and made available to the public without any restriction that impedes the re-use of documents;

‘formal open standard’ means a standard which has been laid down in written form, detailing specifications for the requirements on how to ensure software interoperability;

‘reasonable return on investment’ means a percentage of the overall charge, in addition to the amount needed to recover the eligible costs, not exceeding 5 percentage points above the fixed interest rate of the ECB;

‘data localisation requirement’ means any obligation, prohibition, condition, limit or other requirement provided for in the laws, regulations or administrative provisions of a Member State or resulting from general and consistent administrative practices in a Member State and in bodies governed by public law, including in the field of public procurement, without prejudice to Directive 2014/24/EU, which imposes the processing of data in the territory of a specific Member State or hinders the processing of data in any other Member State;

‘pseudonymisation’ means pseudonymisation as referred to under Article 4(5) of Regulation (EU) 2016/679.