Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on European data governance (Data Governance Act)
Date: 2020-11-25
Institutions: Directorate-General for Communications Networks, Content and Technology, European Commission
Subjects: access to information, administrative cooperation, data protection, data transmission, exchange of information, information storage and retrieval, personal data, public sector, right to reuse information, single market

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   EUROPEAN COMMISSION  Brussels, 25.11.2020  COM(2020) 767 final 2020/0340 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on European data governance (Data Governance Act) (Text with EEA relevance) {SEC(2020) 405 final} - {SWD(2020) 295 final} - {SWD(2020) 296 final}  
 
EXPLANATORY MEMORANDUM 

1. 

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CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

This  explanatory  memorandum  accompanies  the  proposal  for  a  Regulation  of  the  European 
Parliament  and  of  the  Council1  on  data  governance.  It  is  the  first  of  a  set  of  measures 
announced  in  the  2020  European  strategy  for  data2.  The  instrument  aims  to  foster  the 
availability  of  data  for  use  by  increasing  trust  in  data  intermediaries  and  by  strengthening 
data-sharing  mechanisms  across  the  EU.  The  instrument  would  address  the  following 
situations: 

- Making  public  sector  data  available  for  re-use,  in  situations  where  such  data  is 
subject to rights of others3. 

- Sharing of data among businesses, against remuneration in any form. 

- Allowing  personal  data  to  be  used  with  the  help  of  a  ‘personal  data-sharing 
intermediary’,  designed  to  help  individuals  exercise  their  rights  under  the  General 
Data Protection Regulation (GDPR). 

- Allowing data use on altruistic grounds. 

• 

Consistency with existing policy provisions in the policy area 

The current initiative covers different types of data intermediaries, handling both personal and 
non-personal data. Therefore, the interplay with the legislation on personal data is particularly 
important. With the General Data Protection Regulation (GDPR)4 and ePrivacy Directive5, the 
EU has put in place a solid and trusted legal framework for the protection of personal data and 
a standard for the world.  

The current proposal complements the Directive (EU) 2019/1024 of the European Parliament 
and of the Council of 20 June 2019 on open data and the re-use of public sector information 
(Open  Data  Directive)6.  This  proposal  addresses  data  held  by  public  sector  bodies  that  is 
subject to rights of others and therefore falls outside the scope of this Directive. The proposal 
has logical  and coherent links with  the other initiatives announced in  the European strategy 
for  data.  It  aims  at  facilitating  data  sharing  including  by  reinforcing  trust  in  data  sharing 
intermediaries  that  are  expected  to  be  used  in  the  different  data  spaces.  It  does  not  aim  to 
grant, amend or remove the substantial rights on access and use of data. This type of measures 
is envisaged for a potential Data Act (2021)7. 

The  instrument  draws  inspiration  from  the  principles  for  data  management  and  re-use 
developed  for  research  data.  The  FAIR  data  principles8  stipulate  that  such  data  should,  in 
principle, be findable, accessible, interoperable and re-usable.  

The final form of the legal act will be determined by the content of the instrument. 
COM/2020/66 final. 

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3  “Data the use of which is dependent on the rights of others” or “data subject to the rights of others” covers data 
that  might  be  subject  to  data  protection  legislation,  intellectual  property,  or  contain  trade  secrets  or  other 
commercially sensitive information. 
OJ L 119, 4.5.2016, p. 1-88.  
OJ L 201, 31.7.2002, p. 37-47.  
OJ L 172, 26.6.2019, p. 56–83. 
See COM/2020/66 final. 
https://www.force11.org/group/fairgroup/fairprinciples 

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Consistency with other Union policies 

Sector-specific  legislation  on  data  access  is  in  place  and/or  under  preparation  to  address 
identified  market  failures  in  fields  such  as  the  automotive  industry9,  payment  service 
providers10,  smart  metering  information11,  electricity  network  data12,  intelligent  transport 
systems13,  environmental  information14,  spatial  information15,  and  the  health  sector16.  The 
current proposal supports the use of data made available under existing rules without altering 
these rules or creating new sectoral obligations. 

Similarly,  the  proposal  is  without  prejudice  to  competition  law,  and  it  is  designed  in 
compliance with Articles 101 and 102 TFEU, and it is also without prejudice to the provisions 
of  Directive  2000/31/EC  of  the  European  Parliament  and  of  the  Council  of  8  June  2000  on 
certain legal aspects of information society services, in particular electronic commerce, in the 
internal market17. 

2. 

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LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

Article 114 of the Treaty on the Functioning of the European Union (TFEU) is identified as 
the  relevant  legal  basis  for  this  Regulation.  Pursuant  to  this  Article,  the  EU  has  to  adopt 
measures  for  the  approximation  of  the  provisions  laid  down  by  law,  regulation  or 
administrative  action  in  Member  States  which  have  as  their  object  the  establishment  and 
functioning  of  the  internal  market  in  the  EU.  This  initiative  is  part  of  the  2020  European 
strategy  for  data  that  aims  to  strengthen  the  single  market  for  data.  With  a  growing 
digitalisation of the economy and society, there is a risk that Member States will increasingly 
legislate data-related issues in an uncoordinated way, which would intensify fragmentation in 
the  single  market.  Setting  up  the  governance  structures  and  mechanisms  that  will  create  a 
coordinated approach to using data across sectors and Member States would help stakeholders 
in the data economy to capitalise on the scale of the single market. It will contribute towards 
the establishment of the single market for data, by ensuring the emergence and cross-border 
functioning of novel services through a set of harmonised provisions. 

Digital policies are a shared competence between the EU and its Member States. Article 4(2) 
and  (3)  of  the  TFEU  specifies  that,  in  the  area  of  the  single  market  and  technological 
development, the EU can carry out specific activities, without prejudice to the Member States’ 
freedom to act in the same areas. 

• 

Subsidiarity (for non-exclusive competence)  

Businesses  often  need  data  from  several  Member  States  so  they  can  develop  EU-wide 
products  and  services,  as  data  samples  available  in  individual  Member  States  often  do  not 

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OJ L 188 18.7.2009, p. 1 as amended by OJ L 151, 14.6.2018, p. 1. 
OJ L 337, 23.12.2015, p. 35-127. 
OJ L 158, 14.6.2019, p. 125-199; OJ L 211, 14.8.2009, p. 94-136. 
OJ L 220, 25.8.2017, p. 1-120; OJ L 113, 1.5.2015, p. 13-26. 
OJ L 207, 6.8.2010, p. 1-13. 
OJ L 41, 14.2.2003, p. 26-32. 
OJ L 108, 25.4.2007, p. 1-14. 
A legislative proposal for the European health data  space is envisaged for the  fourth quarter of 2021. 
https://eur-lex.europa.eu/resource.html?uri=cellar%3A91ce5c0f-12b6-11eb-9a54-
01aa75ed71a1.0001.02/DOC_2&format=PDF 
OJ L 178, 17.7.2000, p. 1-16. 

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have the richness and diversity allowing ‘Big Data’ pattern detection or machine learning. In 
addition,  data-based  products  and  services  developed  in  one  Member  State  may  need  to  be 
customised  to  suit  the  preferences  of  customers  in  another  Member  State,  and  this  requires 
local data on the Member States’ level. As such, data needs to be able to flow easily through 
EU-wide  and  cross-sector  value  chains,  for  which  a  highly  harmonised  legislative 
environment is essential. Furthermore, only action at Union level can ensure that a European 
model of data sharing, with trusted data intermediaries for B2B data sharing and for personal 
data  spaces,  takes  off,  given  the  cross-border  nature  of  data  sharing  and  the  importance  of 
such data sharing. 

A  single  market  for  data  should  ensure  that  data  from  the  public  sector,  businesses  and 
citizens  can  be  accessed  and  used  in  the  most  effective  and  responsible  manner  possible, 
while businesses and citizens keep control of the data they generate and the investments made 
into  their  collection  are  safeguarded.  Increased  access  to  data  would  have  as  a  result  that 
companies  and research  organisations would  advance  representative scientific developments 
and  market  innovation  in  the  EU  as  a  whole,  which  is  particularly  important  in  situations 
where EU coordinated action is necessary, such as the COVID-19 crisis. 

• 

Proportionality 

The  initiative  is  proportionate  to  the  objectives  sought.  The  proposed  legislation  creates  an 
enabling framework that does not  go beyond  what  is  necessary  to  achieve the objectives.  It 
harmonises  a  series  of  data-sharing  practices,  while  respecting  the  Member  States’ 
prerogative  to  organise  their  administration  and  legislate  on  access  to  public  sector 
information.  The  notification  framework  for  data  intermediaries,  as  well  as  the  mechanisms 
for data altruism serve to attain a higher level of trust in these services, without unnecessarily 
restricting these activities, and help develop an internal market for the exchange of such data. 
The  initiative  will  also  leave  a  significant  amount  of  flexibility  for  application  at  sector-
specific level, including for the future development of European data spaces. 

The proposed Regulation will give rise to financial and administrative costs, which are to be 
borne mainly by national authorities, while some costs will also burden data users, and data 
sharing  providers  in  order  to  ensure  compliance  with  the  obligations  set  in  this  Regulation. 
However,  the  exploration  of  different  options  and  their  expected  costs  and  benefits  led  to  a 
balanced  design  of  the  instrument.  It  will  leave  national  authorities  enough  flexibility  to 
decide on the level of financial investment and to consider possibilities to recover such costs 
through  administrative  charges  or  fees,  while  offering  overall  coordination  at  EU  level. 
Similarly, the costs to data users and sharing providers will be counterbalanced by the value 
emanating  from  broader  access  and  use  of  data,  as  well  as  the  market  uptake  of  novel 
services. 

• 

Choice of the instrument 

The choice of a regulation as the legal instrument is justified by the predominance of elements 
that  require  a  uniform  application  that  does  not  leave  margins  of  implementation  to  the 
Member  States  and  that  creates  a  fully  horizontal  framework.  These  elements  include  the 
notification  for  data  sharing  service  providers,  the  mechanisms  for  data  altruism,  the  basic 
principles that apply to the re-use of public sector data that cannot be available as open data or 
are not subject to sector-specific EU  legislation, and  the set-up of coordination  structures  at 
European  level.  The  direct  applicability  of  the  Regulation  would  avoid  an  implementation 

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period and process for the Member States, enabling at the same time the establishment of the 
common European data spaces in the near future, in line with the EU recovery plan.18 

At the same time, the provisions of the Regulation are not overly prescriptive and leave room 
for different levels of Member State action for elements that do not undermine the objectives 
of  the  initiative,  in  particular  the  organisation  of  the  competent  bodies  supporting  public 
sector bodies with their tasks relating to the re-use of certain categories of public sector data.  

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Stakeholder consultations 

An  online  public  consultation  was  launched  on  19  February  2020  on  the  day  the  European 
strategy for data19 was adopted, and was closed on 31 May 2020. The consultation explicitly 
indicated it was launched in order to prepare the current initiative, and it addressed the items 
covered  in  the  initiative  with  relevant  sections  and  questions.  It  targeted  all  types  of 
stakeholders.  

In total, the Commission received 806 contributions, of which 219 were from a company, 119 
from a business association, 201 from EU citizens, 98 from academic / research institutions, 
and 57 from public authorities. Consumers’ voices were represented by 7 respondents, and 54 
respondents were non-governmental organisations (including 2 environmental organisations). 
Among the 219 companies / business organisations, 43.4% were SMEs. Overall, 92.2% of the 
replies came from the EU-27. Very few respondents indicated whether their organisation had 
a local, regional, national or international scope. 

230  position  papers  were  submitted,  either  attached  to  questionnaire  answers  (210)  or  as 
stand-alone contributions (20). The papers provided different views on the topics covered by 
the online questionnaire,  in  particular  in relation  to the governance of common data spaces. 
They provided opinions on the key principles for those spaces, and expressed a high level of 
support  for  the  prioritisation  of  standards  as  well  as  the  data  altruism  concept.  They  also 
indicated the need for safeguards in developing measures related to data intermediaries.  

• 

Collection and use of expertise 

In order to explore with the relevant experts the framework conditions for creating common 
European data spaces in the identified sectors, a series of 10 workshops on common European 
data  spaces  took  place  in  2019  and  an  additional  workshop  was  organised  in  May  2020. 
Gathering a total of more than 300 stakeholders, mainly from the private and public sectors, 
the  workshops  covered  different  sectors  (agriculture,  health,  finance/banking,  energy, 
transport,  sustainability/environment,  public  services,  smart  manufacturing)  and  more  cross-
cutting aspects (data  ethics, data market  places). The Commission  departments  dealing with 
these  areas  participated  in  the  workshops.  The  sectoral  workshops  helped  to  identify  the 
common  elements  across  the  sectors,  which  need  to  be  addressed  by  way  of  laying  down  a 
horizontal governance framework. 

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COM(2020) 456 final. 
COM/2020/66 final. 

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Impact assessment 

An impact assessment was carried out for this proposal. On 9 September 2020, the Regulatory 
Scrutiny Board issued a negative opinion. On 5 October 2020 the Board delivered a positive 
opinion subject to reservations. 

The impact assessment examines the baseline scenarios, policy options and their impacts for 
four intervention areas, namely (a) mechanisms for the enhanced use of public sector data that 
cannot  be  available  as  open  data,  (b)  a  certification  or  labelling  framework  for  data 
intermediaries, (c) measures facilitating data altruism, and (d) mechanisms to coordinate and 
steer horizontal aspects of governance in the form of an EU-level structure.  

For  all  intervention  areas,  policy  option  1  of  having  coordination  at  EU  level  with  soft 
regulatory measures was found to be insufficient, since it would not significantly change the 
situation  compared  to  the  baseline  scenario.  Thus,  the  main  analysis  concentrated on policy 
options 2 and 3, which involved a low and high intensity regulatory intervention respectively. 
The preferred option turned out to be a combination of regulatory interventions of lower and 
higher intensity, in the following manner: 

Regarding mechanisms to enhance the  use of certain public  sector  data, the use of  which  is 
subject to the rights of others, both the low and high intensity options would introduce EU-
wide  rules  for  re-using  such  information  (in  particular  non-exclusivity).  The  low  intensity 
regulatory intervention  would require that  individual  public sector bodies allowing this  type 
of re-use to be technically equipped to ensure that data protection, privacy and confidentiality 
are fully preserved.  It would  also contain an obligation  for  Member States to provide for  at 
least a one-stop shop mechanism for the requests to access such data, without determining its 
exact institutional and administrative form. The high intensity option would have prescribed 
the establishment of one single data authorisation body per Member State. Given the costs and 
issues of feasibility related to the latter, the preferred option is the lower intensity regulatory 
intervention. 

For  the  certification  or  labelling  of  trusted  data  intermediaries,  a  lower  intensity  regulatory 
intervention  was  envisaged  to  consist  in  a  softer,  voluntary  labelling  mechanism,  where  a 
fitness  check  of  the  compliance  with  the  requirements  for  acquiring  the  label  as  well  as 
awarding  the  label  would  be  carried  out  by  competent  authorities  designated  by  Member 
States (which can also be the one-stop shop mechanisms also established for the enhanced re-
use  of  public  sector  data).  The  high  intensity  regulatory  intervention  consisted  of  a 
compulsory  certification  scheme  managed  by  private  conformity  assessment  bodies.  As  a 
compulsory  scheme  would  generate  higher  costs,  this  could  potentially  have  a  prohibitive 
impact  on  SMEs  and  startups,  and  the  market  is  not  mature  enough  for  a  compulsory 
certification scheme; therefore the lower intensity regulatory intervention was identified as the 
preferred policy option. However, the higher intensity regulatory intervention in the form of a 
compulsory  scheme  was  also  identified  as  a  feasible  alternative,  as  it  would  bring 
significantly higher trust to the functioning of data intermediaries, and would establish clear 
rules  for  how  these  intermediaries  are  supposed  to  act  in  the  European  data  market.  After 
further discussions in the Commission, an intermediate solution was retained. It consists of a 
notification  obligation  with  ex  post  monitoring  of  compliance  with  the  requirements  to 
exercise the activities by the competent authorities of the Member States. The solution has the 
advantages  of  a  compulsory  regime,  while  limiting  the  regulatory  burden  on  the  market 
players. 

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In the case of data altruism, the low intensity regulatory intervention consisted in a voluntary 
certification  framework  for  organisations  seeking  to  offer  such  services,  while  the  high 
intensity  regulatory  intervention  envisaged  a  compulsory  authorisation  framework.  As  the 
latter would ensure a higher level of trust in making data available, which could contribute to 
more data being made available by data subjects and companies and result in a higher level of 
development and research, while generating a similar amount of costs, it was flagged in the 
Impact  Assessment  as  the  preferred  option  for  this  intervention  area.  However,  the  further 
discussions  within  the  Commission  revealed  additional  concerns  around  the  potential 
administrative  burden  on  organisations  engaging  in  data  altruism,  and  the  relation  of  the 
obligations  with  future  sectoral  initiatives  on  data  altruism.  For  this  reason  an  alternative 
solution was retained, giving organisations engaging in data altruism the possibility to register 
as  a  ‘Data  Altruism  Organisation  recognised  in  the  EU’.  This  voluntary  mechanism  will 
contribute  to  increase  trust,  while  presenting  a  lower  administrative  burden  than  both  a 
compulsory authorisation framework and a voluntary certification framework. 

Finally,  for  the  European  horizontal  governance  mechanism,  the  low  intensity  regulatory 
intervention  referred  to  the  creation  of  an  expert  group,  while  the  high  intensity  regulatory 
intervention  consisted  in  the  creation  of  an  independent  structure  with  legal  personality 
(similar  to  the  European  Data  Protection  Board).  Given  the  high  costs  and  the  low  level  of 
political feasibility surrounding the inception of the higher intensity option, the low intensity 
policy option was chosen. 

The  impact  assessment  support  study20  indicated  that,  while  under  the  baseline  scenario  the 
data economy and the economic value of data sharing are expected to grow to an estimated 
EUR 533 to 510 billion (3.87% of the GDP), this would increase to between EUR 540.7 and 
EUR 544.4 billion (3.92% to 3.95% of the GDP) under the preferred, packaged option. These 
amounts take into account only in a limited way the downstream benefits, in terms of better 
products,  higher  productivity  and  new  ways  for  tackling  societal  challenges  (e.g.  climate 
change). Indeed, these benefits are likely to be considerably higher than the direct benefits. 

At the same time, this packaged policy option would make it  possible to create  a  European 
model for data sharing that would offer an approach that is alternative to the current business 
model  for  integrated  tech  platforms  through  the  emergence  of  neutral  data  intermediaries. 
This initiative can make the difference for the data economy by creating trust in data sharing 
and incentivising the development of common European data spaces, where natural and legal 
persons are in control of the data they generate.  

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Fundamental rights 

Since personal data falls within the scope of some elements of the Regulation, the measures 
are  designed  in  a  way  that  fully  complies  with  the  data  protection  legislation,  and  actually 
increases in practice the control that natural persons have over the data they generate. 

Regarding  the  enhanced  re-use  of  public  sector  data,  both  the  fundamental  rights  of  data 
protection, privacy  and  property (concerning proprietary rights  in  certain data, which is  e.g. 
commercially  confidential  or  protected  by  intellectual  property  rights)  will  be  respected. 
Similarly, data sharing service providers offering services to data subjects will have to comply 
with the applicable data protection rules. 

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European  Commission  (2020,  forthcoming).  Support  Study  to  this  Impact  Assessment,  SMART 
2019/0024, prepared by Deloitte.  

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The notification framework for data intermediaries would touch on the freedom to conduct a 
business, as it would place certain restrictions in the form of different requirements as a pre-
requisite for the functioning of such entities. 

4. 

BUDGETARY IMPLICATIONS 

This proposal will not have any budgetary implications. 

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

Due  to  the  dynamic  nature  of  the  data  economy,  monitoring  of  the  evolution  of  impacts 
constitutes  a  key  part  of  the  intervention  in  this  domain.  To  ensure  that  the  selected  policy 
measures  actually  deliver  the  intended  results  and  to  inform  possible  future  revisions,  it  is 
necessary to monitor and evaluate the implementation of this Regulation. 

Monitoring  the  specific  objectives  and  the  regulatory  obligations  will  be  achieved  through 
representative  surveys  of  stakeholders,  through  the  work  of  the  Support  Centre  for  Data 
Sharing,  via  records  of  the  European  Data  Innovation  Board  on  the  different  intervention 
areas reported by the dedicated national authorities and through an evaluation study to support 
the instrument’s review. 

• 

Detailed explanation of the specific provisions of the proposal 

Chapter  I  defines  the  subject  matter  of  the  regulation  and  sets  out  the  definitions  used 
throughout the instrument. 

Chapter II creates a mechanism for re-using certain categories of protected public sector data 
which is conditional on the respect of the rights of others (notably on grounds of protection of 
personal  data,  but  also  protection  of 
intellectual  property  rights  and  commercial 
confidentiality).This  mechanism  is  without  prejudice  to  sector-specific  EU  legislation  on 
access  to  and  the  re-use  of  this  data.  The  re-use  of  such  data  falls  outside  the  scope  of 
Directive (EU) 2019/1024 (Open Data Directive). Provisions under this Chapter do not create 
the right to re-use such data, but provide for a set of harmonized basic conditions under which 
the re-use of such data may be allowed (e.g. the requirement of non-exclusivity). Public sector 
bodies allowing this type of re-use would need to be technically equipped to ensure that data 
protection, privacy and confidentiality are fully preserved. Member States will have to set up 
a  single  contact  point  supporting  researchers  and  innovative  business  in  identifying  suitable 
data, and are required to put structures in place to support public sector bodies with technical 
means and legal assistance. 

Chapter  III  aims  to  increase  trust  in  sharing  personal  and  non-personal  data  and  lower 
transaction  costs  linked  to  B2B  and  C2B  data  sharing  by  creating  a  notification  regime  for 
data sharing providers. These providers will have to comply with a number of requirements, 
in particular the requirement to remain neutral as regards the data exchanged. They cannot use 
such data for other purposes. In the case of providers of data sharing services offering services 
for  natural  persons,  the  additional  criterion  of  assuming  fiduciary  duties  towards  the 
individuals using them will also have to be met. 

The  approach  is  designed  to  ensure  that  data  sharing  services  function  in  an  open  and 
collaborative  manner,  while  empowering  natural  and  legal  persons  by  giving  them  a  better 

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overview  of  and  control  over  their  data.  A  competent  authority  designated  by  the  Member 
States  will  be  responsible  for  monitoring  compliance  with  the  requirements  attached  to  the 
provision of such services. 

Chapter  IV  facilitates  data  altruism  (data  voluntarily  made  available  by  individuals  or 
companies for the common good). It establishes the possibility for organisations engaging in 
data altruism  to  register  as  a ‘Data Altruism Organisation recognised in  the EU’ in  order to 
increase trust in their operations. In addition, a common European data altruism consent form 
will be developed to lower the costs of collecting consent  and to facilitate portability of the 
data (where the data to be made available is not held by the individual). 

Chapter  V  sets  out  the  requirements  for  the  functioning  of  the  competent  authorities 
designated  to  monitor  and  implement  the  notification  framework  for  data-sharing  service 
providers  and  entities  engaged  in  data  altruism.  It  also  contains  provisions  on  the  right  to 
lodge complaints against the decisions of such bodies and on the means of judicial redress. 

Chapter VI creates a formal expert group (the ‘European Data Innovation Board’) which will 
facilitate  the  emergence  of  best  practices  by  Member  States’  authorities  in  particular  on 
processing  requests  for  the  re-use  of  data  which  is  subject  to  the  rights  of  others  (under 
Chapter  II),  on  ensuring  a  consistent  practice  regarding  the  notification  framework  for  data 
sharing service providers (under Chapter III), and for data altruism (Chapter IV). In addition, 
the formal expert group will support and advise the Commission on the governance of cross-
sectoral standardisation and the preparation of strategic cross-sector standardisation requests. 
This chapter establishes also the composition of the Board and organises its functioning. 

Chapter  VII  allows  the  Commission  to  adopt  implementing  acts  concerning  the  European 
data altruism consent form. 

Chapter  VIII  contains  transitional  provisions  for  the  functioning  of  general  authorisation 
scheme for data sharing providers and provides for final provisions. 

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2020/0340 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on European data governance 
(Data Governance Act) 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee21,  
Having regard to the opinion of the Committee of the Regions22, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

The  Treaty  on  the  functioning  of  the  European  Union  (‘TFEU’)  provides  for  the 
establishment  of  an  internal  market  and  the  institution  of  a  system  ensuring  that 
competition in the internal market is not distorted. The establishment of common rules 
and  practices  in  the  Member  States  relating  to  the  development  of  a  framework  for 
data governance should contribute to the achievement of those objectives. 

Over  the  last  few  years,  digital  technologies  have  transformed  the  economy  and 
society,  affecting  all  sectors  of  activity  and  daily  life.  Data  is  at  the  centre  of  this 
transformation:  data-driven  innovation  will  bring  enormous  benefits  for  citizens,  for 
example through improved personalised medicine, new mobility, and its contribution 
to  the  European  Green  Deal23.  In  its  Data  Strategy24,  the  Commission  described  the 
vision of a common European data space, a Single Market for data in which data could 
be used irrespective of its physical location of storage in the Union in compliance with 
applicable  law.  It  also  called  for  the  free  and  safe  flow  of  data  with  third  countries, 
subject  to  exceptions  and  restrictions  for  public  security,  public  order  and  other 
legitimate  public  policy  objectives  of  the  European  Union,  in  line  with  international 
obligations.  In  order  to  turn  that  vision  into  reality,  it  proposes  to  establish  domain-
specific  common  European  data  spaces,  as  the  concrete  arrangements  in  which  data 
sharing  and  data  pooling  can  happen.  As  foreseen  in  that  strategy,  such  common 

21 
22 
23 

24 

OJ C , , p. . 
OJ C , , p. . 
Communication from the Commission to the European Parliament, the European Council, the Council, 
the  European  Economic  and  Social  Committee  and  the  Committee  of  the  Regions  on  the  European 
Green Deal. Brussels, 11.12.2019. (COM(2019) 640 final) 
COM (2020) 66 final. 

EN 

9 

  EN 

                                                 
European  data  spaces  can  cover  areas  such  as  health,  mobility,  manufacturing, 
financial services, energy, or agriculture or thematic areas, such as the European green 
deal or European data spaces for public administration or skills.  

It  is  necessary  to  improve  the  conditions  for  data  sharing  in  the  internal  market,  by 
creating  a  harmonised  framework  for  data  exchanges.  Sector-specific  legislation  can 
develop,  adapt  and  propose  new  and  complementary  elements,  depending  on  the 
specificities  of  the  sector,  such  as  the  envisaged  legislation  on  the  European  health 
data space25 and on access to vehicle data. Moreover, certain sectors of the economy 
are already regulated by sector-specific Union law that include rules relating to cross-
border or Union wide sharing or access to data26. This Regulation is therefore without 
prejudice to Regulation (EU) 2016/679 of the European Parliament and of the Council 
(27),  and  in  particular  the  implementation  of  this  Regulation  shall  not  prevent  cross 
border  transfers  of  data  in  accordance  with  Chapter  V  of  Regulation  (EU)  2016/679 
from  taking  place,  Directive  (EU)  2016/680  of  the  European  Parliament  and  of  the 
Council (28), Directive (EU) 2016/943 of the European Parliament and of the Council 
(29), Regulation  (EU) 2018/1807 of the European Parliament and of the Council (30), 
Regulation  (EC)  No  223/2009  of  the  European  Parliament  and  of  the  Council  (31), 
Directive  2000/31/EC  of  the  European  Parliament  and  of  the  Council  (32),  Directive 
2001/29/EC  of  the  European  Parliament  and  of  the  Council  (33),  Directive  (EU) 
2019/790 of the European Parliament and of the Council (34), Directive 2004/48/EC of 

See: Annexes to the Communication from the Commission to the European Parliament, the Council, the 
European  Economic  and  Social  Committee  and  the  Committee  of  the  Regions  on  Commission  Work 
Programme 2021 (COM(2020) 690 final). 

26 For example, Directive 2011/24/EU in the context of the European Health Data Space, and relevant transport 
legislation  such  as  Directive  2010/40/EU,  Regulation  2019/1239  and  Regulation  (EU)  2020/1056,  in  the 
context of the European Mobility Data Space. 

Regulation  (EU)  2016/679  of  the  European  Parliament  and  of  the  Council  of  27  April  2016  on  the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data, and repealing Directive 95/46/EC (General Data Protection Regulation), (OJ L 119, 4.5.2016, 
p.1) 
Directive  (EU)  2016/680  of  the  European  Parliament  and  of  the  Council  of  27  April  2016  on  the 
protection of natural persons with regard to the processing of personal data by competent authorities for 
the  purposes  of  the  prevention,  investigation,  detection  or  prosecution  of  criminal  offences  or  the 
execution  of  criminal  penalties,  and  on  the  free  movement  of  such  data,  and  repealing  Council 
Framework Decision 2008/977/JHA. (OJ L 119, 4.5.2016, p.89) 
Directive  (EU)  2016/943  of  the  European  Parliament  and  of  the  Council  of  8  June  2016  on  the 
protection  of  undisclosed  know-how  and  business  information  (trade  secrets)  against  their  unlawful 
acquisition, use and disclosure. (OJ L 157, 15.6.2016, p.1) 
Regulation (EU) 2018/1807 of the European Parliament and of the Council of 14 November 2018 on a 
framework for the free flow of non-personal data in the European Union. (OJ L 303, 28.11.2018, p. 59) 
Regulation  (EC)  No  223/2009  of  the  European  Parliament  and  of  the  Council  of  11  March  2009  on 
European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament 
and  of  the  Council  on  the  transmission  of  data  subject  to  statistical  confidentiality  to  the  Statistical 
Office  of  the  European  Communities,  Council  Regulation  (EC)  No 322/97  on  Community  Statistics, 
and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of 
the European Communities. (OJ L 87, 31.03.2009, p. 164) 
Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000, on certain legal 
aspects  of  information  society  services,  in  particular  electronic  commerce,  in  the  Internal  Market 
(Directive on electronic commerce). (OJ L 178, 17.07.2000, p. 1) 
Directive  2001/29/EC  of  the  European  Parliament  and  of  the  Council  of  22  May  2001  on  the 
harmonisation of certain aspects of copyright and related rights in the information society. (OJ L 167, 
22.6.2001, p. 10) 
Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on copyright 
and related rights in the Digital Single Market and amending Directives 96/9/EC and 2001/29/EC. (OJ 
L 130, 17.5.2019, p. 92) 

(3) 

25 

27 

28 

29 

30 

31 

32 

33 

34 

EN 

10 

  EN 

                                                 
the  European  Parliament  and  of  the  Council  (35),  Directive  (EU)  2019/1024  of  the 
European  Parliament  and  of  the  Council  (36),  as  well  as  Regulation  2018/858/EU  of 
the  European  Parliament  and  of  the  Council  (37),  Directive  2010/40/EU  of  the 
European Parliament and of the Council (38) and Delegated Regulations adopted on its 
basis, and any other sector-specific Union legislation that organises the access to and 
re-use of data.  This  Regulation  should be without  prejudice to the access  and use of 
data  for  the  purpose  of  international  cooperation  in  the  context  of  prevention, 
investigation,  detection  or  prosecution  of  criminal  offences  or  the  execution  of 
criminal penalties. A horizontal regime for the re-use of certain categories of protected 
data held by public sector bodies, the provision of data sharing services and of services 
based on data altruism in the Union should be established. Specific characteristics of 
different sectors may require the design of sectoral data-based systems, while building 
on  the  requirements  of  this  Regulation.  Where  a  sector-specific  Union  legal  act 
requires public sector bodies, providers of data sharing services or registered entities 
providing  data  altruism  services  to  comply  with  specific  additional  technical, 
administrative  or  organisational  requirements,  including  through  an  authorisation  or 
certification  regime,  those  provisions  of  that  sector-specific  Union  legal  act  should 
also apply. 

Action at Union level is necessary in order to address the barriers to a well-functioning 
data-driven  economy  and  to  create  a  Union-wide  governance  framework  for  data 
access and use, in particular regarding the re-use of certain types of data held by the 
public sector, the provision of services by data sharing providers to business users and 
to  data  subjects,  as  well  as  the  collection  and  processing  of  data  made  available  for 
altruistic purposes by natural and legal persons. 

The  idea  that  data  that  has  been  generated  at  the  expense  of  public  budgets  should 
benefit  society  has  been  part  of  Union  policy  for  a  long  time.  Directive  (EU) 
2019/1024  as  well  as  sector-specific  legislation  ensure  that  the  public  sector  makes 
more  of  the  data  it  produces  easily  available  for  use  and  re-use.  However,  certain 
categories  of  data  (commercially  confidential  data,  data  subject  to  statistical 
confidentiality, data protected by intellectual property rights of third parties, including 
trade secrets and personal data not accessible on the basis of specific national or Union 
legislation, such as Regulation (EU) 2016/679 and Directive (EU) 2016/680) in public 
databases  is  often  not  made  available,  not  even  for  research  or  innovative  activities. 
Due to the sensitivity of this data, certain technical and legal procedural requirements 
must  be  met  before  they  are  made  available,  in  order  to  ensure  the  respect  of  rights 
others  have  over  such  data.  Such  requirements  are  usually  time-  and  knowledge-
intensive  to  fulfil.  This  has  led  to  the  underutilisation  of  such  data.  While  some 
Member States are setting up structures, processes and sometimes legislate to facilitate 
this type of re-use, this is not the case across the Union. 

(4) 

(5) 

35 

36 

37 

38 

Directive  2004/48/EC  of  the  European  Parliament  and  of  the  Council  of  29  April  2004  on  the 
enforcement of intellectual property rights. (OJ L 157, 30.4.2004). 
Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data 
and the re-use of public sector information. (OJ L 172, 26.6.2019, p. 56). 
Regulation  (EU)  2018/858  of  the  European  Parliament  and  of  the  Council  of  30  May  2018  on  the 
approval and market surveillance of motor vehicles and their trailers, and of systems, components and 
separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) 
No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018). 
Directive 2010/40/EU of the European Parliament and of the Council of 7 July 2010 on the framework 
for the deployment of Intelligent Transport Systems in the field of road transport and for interfaces with 
other modes of transport. (OJ L 207, 6.8.2010, p. 1) 

EN 

11 

  EN 

                                                 
(6) 

(7) 

(8) 

(9) 

39 

40 

There  are  techniques  enabling  privacy-friendly  analyses  on  databases  that  contain 
personal  data,  such  as  anonymisation,  pseudonymisation,  differential  privacy, 
generalisation,  or  suppression  and  randomisation.  Application  of  these  privacy-
enhancing  technologies,  together  with  comprehensive  data  protection  approaches 
should ensure the safe re-use of personal data and commercially confidential business 
data for research, innovation and statistical  purposes. In many cases this implies that 
the  data  use  and  re-use  in  this  context  can  only  be  done  in  a  secure  processing 
environment  set  in  place  and  supervised  by  the  public  sector.  There  is  experience  at 
Union  level  with  such  secure  processing  environments  that  are  used  for  research  on 
statistical  microdata  on  the  basis  of  Commission  Regulation  (EU)  557/2013  (39).  In 
general, insofar as personal data are concerned, the processing of personal data should 
rely  upon  one  or  more  of  the  grounds  for  processing  provided  in  Article  6  of 
Regulation (EU) 2016/679. 

The categories of data held by public sector bodies which should be subject to re-use 
under this Regulation fall outside the scope of Directive (EU) 2019/1024 that excludes 
data which is not accessible due to commercial and statistical confidentiality and data 
for which third parties have intellectual property rights. Personal data fall outside the 
scope of Directive (EU) 2019/1024 insofar as the access regime excludes or restricts 
access  to  such  data  for  reasons  of  data  protection,  privacy  and  the  integrity  of  the 
individual, in  particular  in  accordance with  data  protection rules. The re-use of data, 
which may contain trade secrets, should take place without prejudice to Directive (EU) 
2016/94340, which sets the framework for the lawful acquisition, use or disclosure of 
trade  secrets.  This  Regulation  is  without  prejudice  and  complementary  to  more 
specific obligations on public sector bodies to allow re-use of data laid down in sector-
specific Union or national law.  

The re-use regime provided for in this Regulation should apply to data the supply of 
which forms part of the public tasks of the public sector bodies concerned, as defined 
by law or by other binding rules in the Member States. In the absence of such rules the 
public tasks should be defined in accordance with common administrative practice in 
the  Member  States,  provided  that  the  scope  of  the  public  tasks  is  transparent  and 
subject  to  review.  The  public  tasks  could  be  defined  generally  or  on  a  case-by-case 
basis  for  individual  public  sector  bodies.  As  public  undertakings  are  not  covered  by 
the  definition  of  public  sector  body,  the  data  they  hold  should  not  be  subject  to  this 
Regulation.  Data  held  by  cultural  and  educational  establishments,  for  which 
intellectual property rights are not incidental, but which are predominantly contained 
in  works  and  other  documents  protected  by  such  intellectual  property  rights,  are  not 
covered by this Regulation. 

Public  sector  bodies  should  comply  with  competition  law  when  establishing  the 
principles  for  re-use  of  data  they  hold,  avoiding  as  far  as  possible  the  conclusion  of 
agreements,  which  might  have  as  their  objective  or  effect  the  creation  of  exclusive 
rights  for  the  re-use  of  certain  data.  Such  agreement  should  be  only  possible  when 
justified and necessary for the provision of a service of general interest. This may be 
the  case  when  exclusive  use  of  the  data  is  the  only  way  to  maximise  the  societal 
benefits of the data in question, for example where there is only one entity (which has 

Commission Regulation (EU) 557/2013 of 17 June 2013 implementing Regulation (EC) No 223/2009 
of the European Parliament and of the Council on European Statistics as regards access to confidential 
data  for  scientific  purposes  and  repealing  Commission  Regulation  (EC)  No  831/2002  (OJ  L  164, 
18.6.2013, p. 16). 
OJ L 157, 15.6.2016, p. 1–18 

EN 

12 

  EN 

                                                 
specialised in the processing of a specific dataset) capable of delivering the service or 
the product which allows the public sector body to provide an advanced digital service 
in  the  general  interest.  Such  arrangements  should,  however,  be  concluded  in 
compliance with public procurement rules and be subject to regular review based on a 
market  analysis  in  order  to  ascertain  whether  such  exclusivity  continues  to  be 
necessary.  In  addition,  such  arrangements  should  comply  with  the  relevant  State  aid 
rules, as appropriate, and should be concluded for a limited period, which should not 
exceed three years. In order to ensure transparency, such exclusive agreements should 
be  published  online,  regardless  of  a  possible  publication  of  an  award  of  a  public 
procurement contract.  

(10)  Prohibited  exclusive  agreements  and  other  practices  or  arrangements  between  data 
holders and data re-users which do not expressly grant exclusive rights but which can 
reasonably  be  expected  to  restrict  the  availability  of  data  for  re-use  that  have  been 
concluded or have been already in place before the entry into force of this Regulation 
should  not  be  renewed  after  the  expiration  of  their  term.  In  the  case  of  indefinite  or 
longer-term agreements, they should be terminated within three years from the date of 
entry into force of this Regulation. 

(11)  Conditions  for  re-use  of  protected  data  that  apply  to  public  sector  bodies  competent 
under national law to allow re-use, and which should be without prejudice to rights or 
obligations  concerning  access  to  such  data,  should  be  laid  down.  Those  conditions 
should  be  non-discriminatory,  proportionate  and  objectively  justified,  while  not 
restricting competition. In particular, public sector bodies allowing re-use should have 
in place the technical means necessary to ensure the protection of rights and interests 
of third parties. Conditions attached to the re-use of data should be limited to what is 
necessary to preserve the rights and interests of others in the data and the integrity of 
the  information  technology  and  communication  systems  of  the  public  sector  bodies. 
Public sector bodies should apply conditions which best serve the interests of the re-
user  without  leading  to  a  disproportionate  effort  for  the  public  sector.  Depending  on 
the case at hand, before its transmission, personal data should be fully anonymised, so 
as  to  definitively  not  allow  the  identification  of  the  data  subjects,  or  data  containing 
commercially  confidential  information  modified  in  such  a  way  that  no  confidential 
information is disclosed. Where provision of anonymised or modified data would not 
respond to the needs of the re-user, on-premise or remote re-use of the data within a 
secure  processing  environment  could  be  permitted.  Data  analyses  in  such  secure 
processing  environments  should  be  supervised  by  the  public  sector  body,  so  as  to 
protect  the  rights  and  interests  of  others.  In  particular,  personal  data  should  only  be 
transmitted  for  re-use  to  a  third  party  where  a  legal  basis  allows  such  transmission. 
The  public  sector  body  could  make  the  use  of  such  secure  processing  environment 
conditional on the signature by the re-user of a confidentiality agreement that prohibits 
the  disclosure  of  any  information  that  jeopardises  the  rights  and  interests  of  third 
parties  that  the  re-user  may  have  acquired  despite  the  safeguards  put  in  place.  The 
public sector bodies, where relevant, should facilitate the re-use of data on the basis of 
consent  of  data  subjects  or  permissions  of  legal  persons  on  the  re-use  of  data 
pertaining to them through adequate technical means. In this respect, the public sector 
body  should  support  potential  re-users  in  seeking  such  consent  by  establishing 
technical  mechanisms  that  permit  transmitting  requests  for  consent  from  re-users, 
where practically feasible. No contact information should be given that allows re-users 
to contact data subjects or companies directly.  

EN 

13 

  EN 

(12)  The  intellectual  property  rights  of  third  parties  should  not  be  affected  by  this 
Regulation.  This  Regulation  should  neither  affect  the  existence  or  ownership  of 
intellectual property rights of public sector bodies, nor should it limit the exercise of 
these rights in any way beyond the boundaries set by this Regulation. The obligations 
imposed  in  accordance  with  this  Regulation  should  apply  only  insofar  as  they  are 
compatible  with  international  agreements  on  the  protection  of  intellectual  property 
rights,  in  particular  the  Berne  Convention  for  the  Protection  of  Literary  and  Artistic 
Works  (Berne  Convention),  the  Agreement  on  Trade-Related  Aspects  of  Intellectual 
Property Rights (TRIPS Agreement) and the WIPO Copyright Treaty (WCT). Public 
sector bodies should, however, exercise their copyright in a way that facilitates re-use. 

(13)  Data  subject  to  intellectual  property  rights  as  well  as  trade  secrets  should  only  be 
transmitted  to  a  third  party  where  such  transmission  is  lawful  by  virtue  of  Union  or 
national law or with the agreement of the rightholder. Where public sector bodies are 
holders of the right provided for in Article 7(1) of Directive 96/9/EC of the European 
Parliament  and  of  the  Council  (41)  they  should  not  exercise  that  right  in  order  to 
prevent the re-use of data or to restrict re-use beyond the limits set by this Regulation. 

(14)  Companies  and  data  subjects  should  be  able  to  trust  that  the  re-use  of  certain 
categories of protected data, which are held by the public sector, will take place in a 
manner  that  respects  their  rights  and  interests.  Additional  safeguards  should  thus  be 
put in place for situations in which the re-use of such public sector data is taking place 
on the basis of a processing of the data outside the public sector. Such an additional 
safeguard could be found in the requirement that public sector bodies should take fully 
into  account  the  rights  and  interests  of  natural  and  legal  persons  (in  particular  the 
protection  of  personal  data,  commercially  sensitive  data  and  the  protection  of 
intellectual property rights) in case such data is transferred to third countries.  

(15)  Furthermore,  it  is  important  to  protect  commercially  sensitive  data  of  non-personal 
nature, notably trade secrets, but also non-personal data representing content protected 
by  intellectual  property  rights  from  unlawful  access  that  may  lead  to  IP  theft  or 
industrial  espionage.  In  order  to  ensure  the  protection  of  fundamental  rights  or 
interests of data holders, non-personal data which is to be protected from unlawful or 
unauthorised access under Union or national law, and which is held by public sector 
bodies, should be transferred only to third-countries where appropriate safeguards for 
the use of data are provided. Such appropriate safeguards should be considered to exist 
when  in  that  third-country  there  are  equivalent  measures  in  place  which  ensure  that 
non-personal  data  benefits  from  a  level  of  protection  similar  to  that  applicable  by 
means of Union or national law in particular as regards the protection of trade secrets 
and  the  protection  of  intellectual  property  rights.  To  that  end,  the  Commission  may 
adopt implementing acts that declare that a third country provides a level of protection 
that  is  essentially  equivalent  to  those  provided  by  Union  or  national  law.  The 
assessment  of  the  level  of  protection  afforded  in  such  third-country  should,  in 
particular,  take  into  consideration  the  relevant  legislation,  both  general  and  sectoral, 
including  concerning  public  security,  defence,  national  security  and  criminal  law 
concerning the access to and protection of non-personal data, any access by the public 
authorities  of  that  third  country  to  the  data  transferred,  the  existence  and  effective 
functioning  of  one  or  more  independent  supervisory  authorities  in  the  third  country 
with  responsibility  for  ensuring  and  enforcing  compliance  with  the  legal  regime 
ensuring  access  to  such  data,  or  the  third  countries’  international  commitments 

41 

Directive  96/9/EC  of  the  European  Parliament  and  of  the  Council  of  11  March  1996  on  the  legal 
protection of databases (OJ L 77, 27.3.1996, p. 20). 

EN 

14 

  EN 

                                                 
(16) 

regarding the protection of data the third country concerned has entered into, or other 
obligations arising from legally binding conventions or instruments as well as from its 
participation  in  multilateral  or  regional  systems.  The  existence  of  effective  legal 
remedies  for data holders, public sector bodies or data sharing providers  in  the third 
country  concerned  is  of  particular  importance  in  the  context  of  the  transfer  of  non-
personal  data  to  that  third  country.  Such  safeguards  should  therefore  include  the 
availability of enforceable rights and of effective legal remedies. 

In cases where there is no implementing act adopted by the Commission in relation to 
a third country declaring that it provides a level of protection, in particular as regards 
the  protection  of  commercially  sensitive  data  and  the  protection  of  intellectual 
property rights, which is essentially equivalent to that provided by Union or national 
law, the public sector body should only transmit protected data to a re-user, if the re-
user undertakes obligations in the interest of the protection of the data. The re-user that 
intends  to  transfer  the  data  to  such  third  country  should  commit  to  comply  with  the 
obligations laid out  in  this  Regulation  even after  the data has been transferred to  the 
third country. To ensure the proper enforcement of such obligations, the re-user should 
also accept the jurisdiction of the Member State of the public sector body that allowed 
the re-use for the judicial settlement of disputes. 

(17)  Some third countries adopt laws, regulations and other legal acts which aim at directly 
transferring or providing access to non-personal data in the Union under the control of 
natural  and  legal  persons  under  the  jurisdiction  of  the  Member  States.  Judgments  of 
courts  or  tribunals  or  decisions  of  administrative  authorities  in  third  countries 
requiring  such  transfer  or  access  to  non-personal  data  should  be  enforceable  when 
based on an international agreement, such as a mutual legal assistance treaty, in force 
between the requesting third country and the Union or a Member State. In some cases, 
situations may arise where the obligation to transfer or provide access to non-personal 
data arising from a third country law conflicts with a competing obligation to protect 
such  data  under  Union  or  national  law,  in  particular  as  regards  the  protection  of 
commercially  sensitive  data  and  the  protection  of  intellectual  property  rights,  and 
including  its  contractual  undertakings  regarding  confidentiality  in  accordance  with 
such law. In the absence of international agreements regulating such matters, transfer 
or access should only be allowed under certain conditions, in particular that the third-
country system requires  the reasons and proportionality of the decision to be set out, 
that the court order or the decision is specific in character, and the reasoned objection 
of the addressee is subject to a review by a competent court in the third country, which 
is empowered to take duly into account the relevant legal  interests of the provider of 
such data. 

(18) 

(19) 

In order to prevent unlawful access to non-personal data, public sector bodies, natural 
or legal persons to which the right to re-use data was granted, data sharing providers 
and  entities  entered  in  the  register  of  recognised  data  altruism  organisations  should 
take all reasonable measures to prevent access to the systems where non-personal data 
is stored, including encryption of data or corporate policies. 

In  order  to  build  trust  in  re-use  mechanisms,  it  may  be  necessary  to  attach  stricter 
conditions  for  certain  types  of  non-personal  data  that  have  been  identified  as  highly 
sensitive,  as  regards  the  transfer  to  third  countries,  if  such  transfer  could  jeopardise 
public policy objectives, in line with international commitments. For example, in the 
health  domain,  certain  datasets  held  by  actors  in  the  public  health  system,  such  as 
public hospitals, could be identified as highly sensitive health data. In order to ensure 
harmonised  practices  across  the  Union,  such  types  of  highly  sensitive  non-personal 

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public  data  should  be  defined  by  Union  law,  for  example  in  the  context  of  the 
European Health Data Space or other sectoral  legislation. The conditions  attached to 
the  transfer  of  such  data  to  third  countries  should  be  laid  down  in  delegated  acts. 
Conditions  should  be  proportionate,  non-discriminatory  and  necessary  to  protect 
legitimate public policy objectives identified, such as the protection of public health, 
public order, safety, the environment, public morals, consumer protection, privacy and 
personal  data  protection.  The  conditions  should  correspond  to  the  risks  identified  in 
relation  to  the  sensitivity  of  such  data,  including  in  terms  of  the  risk  of  the  re-
identification  of  individuals.  These  conditions  could  include  terms  applicable  for  the 
transfer  or  technical  arrangements,  such  as  the  requirement  of  using  a  secure 
processing environment, limitations as regards the re-use of data in third-countries or 
categories of persons which are entitled to transfer such data to third countries or who 
can access the data in the third country. In exceptional cases they could also include 
restrictions on transfer of the data to third countries to protect the public interest. 

(20)  Public sector bodies should be able to charge fees for the re-use of data but should also 
be able to decide to make the data available at lower or no cost, for example for certain 
categories of re-uses such as non-commercial re-use, or re-use by small and medium-
sized  enterprises,  so  as  to  incentivise  such  re-use  in  order  to  stimulate  research  and 
innovation  and  support  companies  that  are  an  important  source  of  innovation  and 
typically find it more difficult to collect relevant data themselves, in line with State aid 
rules.  Such  fees  should  be  reasonable,  transparent,  published  online  and  non-
discriminatory.  

(21) 

In  order  to  incentivise  the  re-use  of  these  categories  of  data,  Member  States  should 
establish  a  single  information  point  to  act  as  the  primary  interface  for  re-users  that 
seek to re-use such data held by the public sector bodies. It should have a cross-sector 
remit,  and  should  complement,  if  necessary,  arrangements  at  the  sectoral  level.  In 
addition,  Member States should designate, establish  or facilitate the establishment of 
competent  bodies  to  support  the  activities  of  public  sector  bodies  allowing  re-use  of 
certain  categories of protected data. Their tasks  may include  granting access  to  data, 
where  mandated  in  sectoral  Union  or  Member  States  legislation.  Those  competent 
bodies should provide support to public sector bodies with state-of-the-art techniques, 
including secure data processing environments, which allow data analysis in a manner 
that preserves the privacy of the information. Such support structure could support the 
data  holders  with  management  of  the  consent,  including  consent  to  certain  areas  of 
scientific  research  when  in  keeping  with  recognised  ethical  standards  for  scientific 
research. Data processing should be performed under the responsibility of the public 
sector  body  responsible  for  the  register  containing  the  data,  who  remains  a  data 
controller  in  the  sense  of  Regulation  (EU)  2016/679  insofar  as  personal  data  are 
concerned. Member States may have in place one or several competent bodies, which 
could act in different sectors. 

(22)  Providers of data sharing services (data intermediaries) are expected to play a key role 
in the data economy, as a tool to facilitate the aggregation and exchange of substantial 
amounts  of  relevant  data.  Data  intermediaries  offering  services  that  connect  the 
different actors have the potential to contribute to the efficient pooling of data as well 
as to the facilitation of bilateral data sharing. Specialised data intermediaries that are 
independent  from  both  data holders and data users can have a facilitating role in  the 
emergence  of  new  data-driven  ecosystems  independent  from  any  player  with  a 
significant  degree  of  market  power.  This  Regulation  should  only  cover  providers  of 
data sharing services that have as a main objective the establishment of a business, a 

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legal  and  potentially  also  technical  relation  between  data  holders,  including  data 
subjects, on the one hand, and potential users on the other hand, and assist both parties 
in a transaction of data assets between the two. It should only cover services aiming at 
intermediating between an indefinite number of data holders and data users, excluding 
data sharing services that are meant to be used by a closed group of data holders and 
users. Providers of cloud services should be excluded, as well as service providers that 
obtain data from data holders, aggregate, enrich or transform the data and licence the 
use  of  the  resulting  data  to  data  users,  without  establishing  a  direct  relationship 
between data holders and data users, for example advertisement or data brokers, data 
consultancies, providers of data products resulting from value added to the data by the 
service provider. At the same time, data sharing service providers should be allowed to 
make adaptations to the data exchanged, to the extent that this improves the usability 
of the data by the data user, where the data user desires this, such as to convert it into 
specific  formats.  In  addition,  services  that  focus  on  the  intermediation  of  content,  in 
particular  on  copyright-protected  content,  should  not  be  covered  by  this  Regulation. 
Data  exchange  platforms  that  are  exclusively  used  by  one  data  holder  in  order  to 
enable  the  use  of  data  they  hold  as  well  as  platforms  developed  in  the  context  of 
objects  and  devices  connected  to  the  Internet-of-Things  that  have  as  their  main 
objective to  ensure functionalities of the  connected object or device and  allow value 
added  services,  should  not  be  covered  by  this  Regulation.  ‘Consolidated  tape 
providers’  in  the  sense  of  Article  4  (1)  point  53  of  Directive  2014/65/EU  of  the 
European  Parliament  and  of  the  Council  42  as  well  as  ‘account  information  service 
providers’  in  the  sense  of  Article  4  point  19  of  Directive  (EU)  2015/2366  of  the 
European  Parliament  and  of  the  Council43  should  not  be  considered  as  data  sharing 
service  providers  for  the  purposes  of  this  Regulation.  Entities  which  restrict  their 
activities  to  facilitating  use  of  data  made  available  on  the  basis  of  data  altruism  and 
that  operate  on  a  not-for-profit  basis  should  not  be  covered  by  Chapter  III  of  this 
Regulation,  as  this  activity  serves  objectives  of  general  interest  by  increasing  the 
volume of data available for such purposes. 

(23)  A specific category of data intermediaries includes providers of data sharing services 
that  offer  their  services  to  data  subjects  in  the  sense  of  Regulation  (EU)  2016/679. 
Such  providers  focus  exclusively  on  personal  data  and  seek  to  enhance  individual 
agency and the individuals’ control over the data pertaining to them. They would assist 
individuals  in  exercising  their  rights  under  Regulation  (EU)  2016/679,  in  particular 
managing  their  consent  to  data  processing,  the  right  of  access  to  their  own  data,  the 
right to the rectification of inaccurate personal data, the right of erasure or right ‘to be 
forgotten’, the right to restrict processing and the data portability right, which allows 
data  subjects  to  move  their  personal  data  from  one  controller  to  the  other.  In  this 
context, it is important that their business model ensures that there are no misaligned 
incentives that encourage individuals to make more data available for processing than 
what  is  in  the  individuals’  own  interest.  This  could  include  advising  individuals  on 
uses  of  their  data  they  could  allow  and  making  due  diligence  checks  on  data  users 
before allowing them to contact data subjects, in order to avoid fraudulent practices. In 
certain  situations,  it  could  be  desirable  to  collate  actual  data  within  a  personal  data 
storage space, or ‘personal data space’ so that processing can happen within that space 

42 

43 

Directive  2014/65/EU  of  the  European  Parliament  and of the  Council of 15 May 2014  on  markets in 
financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU, OJ L 173/349.  
Directive  (EU)  2015/2366  of  the  European  Parliament  and  of  the  Council  of  25  November  2015  on 
payment  services  in  the  internal  market,  amending  Directives  2002/65/EC,  2009/110/EC  and 
2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC.  

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without  personal  data  being  transmitted  to  third  parties  in  order  to  maximise  the 
protection of personal data and privacy. 

(24)  Data  cooperatives  seek  to  strengthen  the  position  of  individuals  in  making  informed 
choices  before  consenting  to  data  use,  influencing  the  terms  and  conditions  of  data 
user  organisations  attached  to  data  use  or  potentially  solving  disputes  between 
members of a group on how data can be used when such data pertain to several data 
subjects within that group. In this context it is important to acknowledge that the rights 
under Regulation (EU) 2016/679 can only be exercised by each individual and cannot 
be conferred or delegated to a data cooperative. Data cooperatives could also provide a 
useful  means  for  one-person  companies,  micro,  small  and  medium-sized  enterprises 
that in terms of knowledge of data sharing, are often comparable to individuals.  

(25) 

In order to increase trust in such data sharing services, in particular related to the use 
of data and the compliance with the conditions imposed by data holders, it is necessary 
to create a Union-level regulatory framework, which would set out highly harmonised 
requirements  related  to  the  trustworthy  provision  of  such  data  sharing  services.  This 
will contribute to ensuring that data holders and data users have better control over the 
access to and use of their data, in accordance with Union law. Both in situations where 
data  sharing  occurs  in  a  business-to-business  context  and  where  it  occurs  in  a 
business-to-consumer context, data sharing providers should offer a novel, ‘European’ 
way of data governance, by providing a separation in the data economy between data 
provision,  intermediation  and  use.  Providers  of  data  sharing  services  may  also  make 
available  specific  technical  infrastructure  for  the  interconnection  of  data  holders  and 
data users.  

(26)  A key element  to  bring trust and more control  for data holder and data users in  data 
sharing services is the neutrality of data sharing service providers as regards the data 
exchanged  between  data  holders  and  data  users.  It  is  therefore  necessary  that  data 
sharing service providers act only as intermediaries in the transactions, and do not use 
the data exchanged for any other purpose. This will also require structural separation 
between the data sharing service and any other services provided, so as to avoid issues 
of  conflict  of  interest.  This  means  that  the  data  sharing  service  should  be  provided 
through  a  legal  entity  that  is  separate  from  the  other  activities  of  that  data  sharing 
provider.  Data  sharing  providers  that  intermediate  the  exchange  of  data  between 
individuals as data holders and legal  persons should,  in  addition,  bear fiduciary duty 
towards the individuals, to ensure that they act in the best interest of the data holders.  

(27) 

In  order  to  ensure  the  compliance  of  the  providers  of  data  sharing  services  with  the 
conditions  set  out  in  this  Regulation,  such  providers  should  have  a  place  of 
establishment  in  the  Union.  Alternatively,  where  a  provider  of  data  sharing  services 
not  established  in  the  Union  offers  services  within  the  Union,  it  should  designate  a 
representative. Designation of a representative is necessary, given that such providers 
of  data  sharing  services  handle  personal  data  as  well  as  commercially  confidential 
data,  which  necessitates  the  close  monitoring  of  the  compliance  of  such  service 
providers with the conditions laid out in this Regulation. In order to determine whether 
such a provider of data sharing services is offering services within the Union, it should 
be  ascertained  whether  it  is  apparent  that  the  provider  of  data  sharing  services  is 
planning  to  offer  services  to  persons  in  one  or  more  Member  States.  The  mere 
accessibility in  the  Union of the website or of an email  address  and of  other contact 
details of the provider of data sharing services, or the use of a language generally used 
in the third country where the provider of data sharing services is established, should 
be considered insufficient to ascertain such an intention. However, factors such as the 

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use of a language or a currency generally used in one or more Member States with the 
possibility of ordering services in that other language, or the mentioning of users who 
are  in  the  Union,  may  make  it  apparent  that  the  provider  of  data  sharing  services  is 
planning to offer services within the Union. The representative should act on behalf of 
the  provider  of  data  sharing  services  and  it  should  be  possible  for  competent 
authorities to contact the representative. The representative should be designated by a 
written  mandate  of  the  provider  of  data  sharing  services  to  act  on  the  latter's  behalf 
with regard to the latter's obligations under this Regulation. 

(28)  This  Regulation  should  be  without  prejudice  to  the  obligation  of  providers  of  data 
sharing  services  to  comply  with  Regulation  (EU)  2016/679  and  the  responsibility  of 
supervisory  authorities  to  ensure  compliance  with  that  Regulation.  Where  the  data 
sharing service providers are data controllers or processors in the sense of Regulation 
(EU) 2016/679 they are bound by the rules of that Regulation. This Regulation should 
be also without prejudice to the application of competition law. 

(29)  Providers  of  data  sharing  services  should  also  take  measures  to  ensure  compliance 
with competition law. Data sharing may generate various types of efficiencies but may 
also  lead to  restrictions  of competition,  in  particular where it includes the sharing of 
competitively sensitive information. This applies in particular in situations where data 
sharing  enables  businesses  to  become  aware  of  market  strategies  of  their  actual  or 
potential  competitors.  Competitively  sensitive 
includes 
information  on  future  prices,  production  costs,  quantities,  turnovers,  sales  or 
capacities. 

information 

typically 

(30)  A  notification  procedure  for  data  sharing  services  should  be  established  in  order  to 
ensure a data governance within the Union based on trustworthy exchange of data. The 
benefits of a trustworthy environment would be best achieved by imposing a number 
of  requirements  for  the  provision  of  data  sharing  services,  but  without  requiring  any 
explicit decision or administrative act by the competent authority for the provision of 
such services. 

(31) 

In  order  to  support  effective  cross-border  provision  of  services,  the  data  sharing 
provider should be requested to send a  notification only to the designated competent 
authority from the Member State where its main establishment is located or where its 
legal representative is located. Such a notification should not entail more than a mere 
declaration of the intention to provide such services and should be completed only by 
the information set out in this Regulation. 

(32)  The main establishment of a provider of data sharing services in the Union should be 
the Member State with the place of its central administration in the Union. The main 
establishment of a provider of data sharing services in the Union should be determined 
according  to  objective  criteria  and  should  imply  the  effective  and  real  exercise  of 
management activities. 

(33)  The competent  authorities designated to monitor compliance of data sharing services 
with  the  requirements  in  this  Regulation  should  be  chosen  on  the  basis  of  their 
capacity and expertise regarding horizontal or sectoral data sharing, and they should be 
independent as well as transparent and impartial in the exercise of their tasks. Member 
States  should  notify  the  Commission  of  the  identity  of  the  designated  competent 
authorities.  

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(34)  The notification framework laid down in this Regulation should be without prejudice 
to  specific  additional  rules  for  the  provision  of  data  sharing  services  applicable  by 
means of sector-specific legislation. 

(35)  There  is  a  strong  potential  in  the  use  of  data  made  available  voluntarily  by  data 
subjects  based  on  their  consent  or,  where  it  concerns  non-personal  data,  made 
available  by  legal  persons,  for  purposes  of  general  interest.  Such  purposes  would 
include  healthcare,  combating  climate  change,  improving  mobility,  facilitating  the 
establishment  of  official  statistics  or  improving  the  provision  of  public  services. 
Support  to  scientific  research,  including  for  example  technological  development  and 
demonstration, fundamental research, applied research and privately funded research, 
should  be  considered  as  well  purposes  of  general  interest.  This  Regulation  aims  at 
contributing  to  the  emergence  of  pools  of  data  made  available  on  the  basis  of  data 
altruism  that  have  a  sufficient  size  in  order  to  enable  data  analytics  and  machine 
learning, including across borders in the Union. 

(36)  Legal  entities  that  seek  to  support  purposes  of  general  interest  by  making  available 
relevant data based on data altruism at scale and meet certain requirements, should be 
able to register as ‘Data Altruism Organisations recognised in the Union’. This could 
lead to the establishment of data repositories. As registration in a Member State would 
be valid  across the  Union, and this should  facilitate cross-border data use within the 
Union and the emergence of data pools covering several Member States. Data subjects 
in  this  respect  would  consent  to  specific  purposes  of  data  processing,  but  could  also 
consent to data processing in certain areas of research or parts of research projects as it 
is  often  not  possible  to  fully  identify  the  purpose  of  personal  data  processing  for 
scientific  research  purposes  at  the  time  of  data  collection.  Legal  persons  could  give 
permission  to  the  processing  of  their  non-personal  data  for  a  range  of  purposes  not 
defined  at  the  moment  of  giving  the  permission.  The  voluntary  compliance  of  such 
registered  entities  with  a  set  of  requirements  should  bring  trust  that  the  data  made 
available on altruistic purposes is serving a general interest purpose. Such trust should 
result in particular from a place of establishment within the Union, as well as from the 
requirement that registered entities have a not-for-profit character, from transparency 
requirements  and  from  specific  safeguards  in  place  to  protect  rights  and  interests  of 
data subjects and companies. Further safeguards should include making it possible to 
process  relevant  data  within  a  secure  processing  environment  operated  by  the 
registered  entity,  oversight  mechanisms  such  as  ethics  councils  or  boards  to  ensure 
that the data controller maintains high standards of scientific ethics, effective technical 
means  to  withdraw  or  modify  consent  at  any  moment,  based  on  the  information 
obligations of data processors under Regulation (EU) 2016/679  as well as means for 
data subjects to stay informed about the use of data they made available.  

(37)  This  Regulation  is  without  prejudice  to  the  establishment,  organisation  and 
functioning of entities that seek to engage in data altruism pursuant to national law. It 
builds  on  national  law  requirements  to  operate  lawfully  in  a  Member  State  as  a  not-
for-profit organisation. Entities which meet the requirements in this Regulation should 
be able to use the title of ‘Data Altruism Organisations recognised in the Union’.  

(38)  Data Altruism Organisations recognised in the Union should be able to collect relevant 
data  directly  from  natural  and  legal  persons  or  to  process  data  collected  by  others. 
Typically, data altruism would rely on consent of data subjects in the sense of Article 
6(1)(a)  and  9(2)(a)  and  in  compliance  with  requirements  for  lawful  consent  in 
accordance  with  Article  7  of  Regulation  (EU)  2016/679.  In  accordance  with 
Regulation (EU) 2016/679, scientific research purposes can be supported by consent to 

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certain areas of scientific research when in keeping with recognised ethical standards 
for scientific research or only to certain areas of research or parts of research projects. 
Article  5(1)(b)  of  Regulation  (EU)  2016/679  specifies  that  further  processing  for 
scientific or historical research purposes or statistical purposes should, in accordance 
with Article 89(1) of Regulation (EU) 2016/679, not be considered to be incompatible 
with the initial purposes.  

(39)  To  bring  additional  legal  certainty  to  granting  and  withdrawing  of  consent,  in 
particular in the context of scientific research and statistical use of data made available 
on an altruistic basis, a European data altruism consent form should be developed and 
used  in  the  context  of  altruistic  data  sharing.  Such  a  form  should  contribute  to 
additional  transparency  for  data  subjects  that  their  data  will  be  accessed  and  used  in 
accordance  with  their  consent  and  also  in  full  compliance  with  the  data  protection 
rules.  It  could  also  be  used  to  streamline  data  altruism  performed  by  companies  and 
provide a mechanism allowing such companies to withdraw their permission to use the 
data.  In  order  to  take  into  account  the  specificities  of  individual  sectors,  including 
from  a  data  protection  perspective,  there  should  be  a  possibility  for  sectoral 
adjustments of the European data altruism consent form. 

(40) 

In order to successfully implement the data governance framework, a European Data 
Innovation  Board  should  be  established,  in  the  form  of  an  expert  group.  The  Board 
should  consist  of  representatives  of  the  Member  States,  the  Commission  and 
representatives of relevant data spaces and specific sectors (such as health, agriculture, 
transport  and  statistics).  The  European  Data  Protection  Board  should  be  invited  to 
appoint a representative to the European Data Innovation Board. 

(41)  The  Board  should  support  the  Commission  in  coordinating  national  practices  and 
policies on the topics covered by this Regulation, and in supporting cross-sector data 
use  by  adhering  to  the  European  Interoperability  Framework  (EIF)  principles  and 
through the utilisation of standards and specifications (such as the Core Vocabularies44 
and  the  CEF  Building  Blocks45),  without  prejudice  to  standardisation  work  taking 
place  in  specific  sectors  or  domains.  Work  on  technical  standardisation  may  include 
the  identification  of  priorities  for  the  development  of  standards  and  establishing  and 
maintaining  a  set  of  technical  and  legal  standards  for  transmitting  data  between  two 
processing  environments  that  allows  data  spaces  to  be  organised  without  making 
recourse  to  an  intermediary.  The  Board  should  cooperate  with  sectoral  bodies, 
networks or expert groups, or other cross-sectoral organisations dealing with re-use of 
data.  Regarding  data  altruism,  the  Board  should  assist  the  Commission  in  the 
development of the data altruism consent form, in consultation with the European Data 
Protection Board.  

(42) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation, 
implementing  powers  should  be  conferred  on  the  Commission  to  develop  the 
European data altruism consent form. Those powers should be exercised in accordance 
with Regulation (EU) No 182/2011 of the European Parliament and of the Council46. 

(43) 

In order to take account of the specific nature of certain categories of data, the power 
to  adopt  acts  in  accordance  with  Article  290  TFEU  should  be  delegated  to  the 

44 
45 
46 

https://joinup.ec.europa.eu/collection/semantic-interoperability-community-semic/core-vocabularies 
https://joinup.ec.europa.eu/collection/connecting-europe-facility-cef 
Regulation  (EU)  No  182/2011  of  the  European  Parliament  and  of  the  Council    of  16  February  2011 
laying down the rules and general principles concerning mechanisms for control by the Member States 
of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p.13). 

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Commission to lay down special conditions applicable for transfers to third-countries 
of certain non-personal data categories deemed to be highly sensitive in specific Union 
acts  adopted  though  a  legislative  procedure.  It  is  of  particular  importance  that  the 
Commission carry out appropriate consultations during its preparatory work, including 
at  expert  level,  and  that  those  consultations  be  conducted  in  accordance  with  the 
principles  laid  down  in  the  Interinstitutional  Agreement  of  13  April  2016  on  Better 
Law-Making  .  In  particular,  to  ensure  equal  participation  in  the  preparation  of 
delegated acts, the European Parliament and the Council receive all documents at the 
same time as Member States’ experts, and their experts systematically have access to 
meetings of Commission expert groups dealing with the preparation of delegated acts. 

(44)  This  Regulation  should not  affect  the application of the rules  on competition, and in 
particular  Articles  101  and  102  of  the  Treaty  on  the  Functioning  of  the  European 
Union.  The  measures  provided  for  in  this  Regulation  should  not  be  used  to  restrict 
competition  in  a  manner  contrary  to  the  Treaty  on  the  Functioning  of  the  European 
Union. This concerns in particular the rules on the exchange of competitively sensitive 
information between actual or potential competitors through data sharing services.  

(45)  The  European  Data  Protection  Supervisor  and  the  European  Data  Protection  Board 
were  consulted  in  accordance  with  Article  42  of  Regulation  (EU)  2018/1725  of  the 
European Parliament and of the Council (47)and delivered an opinion on […]. 

(46)  This Regulation respects the fundamental rights and observes the principles recognised 
in particular by the Charter, including the right to privacy, the protection of personal 
data,  the  freedom  to  conduct  a  business,  the  right  to  property  and  the  integration  of 
persons with disabilities,  

HAVE ADOPTED THIS REGULATION: 

CHAPTER I 
GENERAL PROVISIONS 

Article 1 
Subject matter and scope 

(1) 

This Regulation lays down: 

(a) 

(b) 

(c) 

 conditions for the re-use, within the Union, of certain categories of data held 
by public sector bodies; 

 a  notification  and  supervisory  framework  for  the  provision  of  data  sharing 
services; 

 a  framework  for  voluntary  registration  of  entities  which  collect  and  process 
data made available for altruistic purposes. 

This Regulation is without prejudice to specific provisions in other Union legal acts 
regarding access to or re-use of certain categories of data, or requirements related to 
processing of personal or non-personal data. Where a sector-specific Union legal act 
requires public sector bodies, providers of data sharing services or registered entities 
providing  data  altruism  services  to  comply  with  specific  additional  technical, 

Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the 
protection of natural persons with  regard to the processing of personal data by the  Union institutions, 
bodies,  offices  and  agencies  and  on  the  free  movement  of  such  data,  and  repealing  Regulation  (EC) 
No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). 

(2) 

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administrative or organisational requirements, including through an authorisation or 
certification regime, those provisions of that sector-specific Union legal act shall also 
apply. 

Article 2 
Definitions 

For the purpose of this Regulation, the following definitions apply: 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

(12) 

‘data’  means  any  digital  representation  of  acts,  facts  or  information  and  any 
compilation of such acts, facts or information, including in the form of sound, visual 
or audiovisual recording; 

‘re-use’  means  the  use  by  natural  or  legal  persons  of  data  held  by  public  sector 
bodies,  for  commercial  or  non-commercial  purposes  other  than  the  initial  purpose 
within the public task for which the data were produced, except for the exchange of 
data between public sector bodies purely in pursuit of their public tasks;  

‘non-personal  data’  means  data  other  than  personal  data  as  defined  in  point  (1)  of 
Article 4 of Regulation (EU) 2016/679; 

‘metadata’ means data collected on any  activity  of a natural  or legal  person for the 
purposes  of  the  provision  of  a  data  sharing  service,  including  the  date  ,  time  and  
geolocation  data,  duration  of  activity,  connections  to  other  natural  or  legal  persons 
established by the person who uses the service;  

‘data holder’ means a legal person or data subject who, in accordance with applicable 
Union or national law, has the right to grant access to or to share certain personal or 
non-personal data under its control;  

‘data user’ means a natural or legal person who has lawful access to certain personal 
or  non-personal  data  and  is  authorised  to  use  that  data  for  commercial  or  non-
commercial purposes; 

‘data  sharing’  means  the  provision  by  a  data  holder  of  data  to  a  data  user  for  the 
purpose of joint or individual use of the shared data, based on voluntary agreements, 
directly or through an intermediary; 

‘access’  means  processing  by  a  data  user  of  data  that  has  been  provided  by  a  data 
holder,  in  accordance  with  specific  technical,  legal,  or  organisational  requirements, 
without necessarily implying the transmission or downloading of such data; 

‘main establishment’ of a legal entity means the place of its central administration in 
the Union; 

‘data altruism’ means the consent by data subjects to process personal data pertaining 
to them, or permissions of other data holders to allow the use of their non-personal 
data  without  seeking  a  reward,  for  purposes  of  general  interest,  such  as  scientific 
research purposes or improving public services; 

‘public sector body’ means the State, regional or local  authorities, bodies governed 
by public law or associations formed by one or more such authorities or one or more 
such bodies governed by public law; 

‘bodies  governed  by  public 
characteristics: 

law’  means  bodies 

that  have 

the  following 

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(a) 

they  are  established  for  the  specific  purpose  of  meeting  needs  in  the  general 
interest, and do not have 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; 

(13) 

‘public undertaking’ means any undertaking over which the public sector bodies 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; for the purpose of 
this definition, 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: 

(14) 

(15) 

(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; 

‘secure  processing  environment’  means  the  physical  or  virtual  environment  and 
organisational  means  to  provide  the  opportunity  to  re-use  data  in  a  manner  that 
allows  for  the  operator  of  the  secure  processing  environment  to  determine  and 
supervise all data processing actions, including to display, storage, download, export 
of the data and calculation of derivative data through computational algorithms. 

‘representative’ means any natural or legal person established in the Union explicitly 
designated to  act  on  behalf  of  a  provider  of data  sharing  services or  an  entity  that 
collects  data  for  objectives  of  general  interest  made  available  by  natural  or  legal 
persons  on  the  basis  of  data  altruism  not  established  in  the  Union,  which  may  be 
addressed  by  a  national  competent  authority  instead  of  the provider  of  data  sharing 
services or  entity  with  regard  to  the  obligations  of  that provider  of  data  sharing 
services or entity set up by this Regulation. 

CHAPTER II 
RE-USE OF CERTAIN CATEGORIES OF PROTECTED DATA HELD BY 
PUBLIC SECTOR BODIES 

Article 3 
Categories of data 

(1) 

This  Chapter  applies  to  data  held  by  public  sector  bodies  which  are  protected  on 
grounds of: 

(a) 

commercial confidentiality ; 

(b) 

statistical confidentiality; 

(c) 

protection of intellectual property rights of third parties; 

(d)  protection of personal data.  

(2) 

This Chapter does not apply to:  

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(a) 

data held by public undertakings; 

(b)  data  held  by  public  service  broadcasters  and  their  subsidiaries,  and  by  other 
bodies or their subsidiaries for the fulfilment of a public service broadcasting 
remit; 

(c) 

data held by cultural establishments and educational establishments; 

(d)  data protected for reasons of national security , defence or public security; 

(e) 

data the supply of which is  an activity  falling outside the scope of the public 
task  of  the  public  sector  bodies  concerned  as  defined  by  law  or  by  other 
binding rules in the Member State concerned, or, in the absence of such rules, 
as defined in accordance with common administrative practice in that Member 
State, provided that the scope of the public tasks is transparent and subject to 
review. 

The provisions of this Chapter do not create any obligation on public sector bodies to 
allow  re-use  of  data  nor  do  they  release  public  sector  bodies  from  their 
confidentiality obligations. This Chapter is without prejudice to Union and national 
law or international agreements to which the Union or Member States are parties on 
the protection of categories of data provided in paragraph 1. This Chapter is without 
prejudice  to  Union  and  national  law  on  access  to  documents  and  to  obligations  of 
public sector bodies under Union and national law to allow the re-use of data. 

Article 4 
Prohibition of exclusive arrangements 

Agreements or other practices pertaining to the re-use of data held by public sector 
bodies containing categories of data referred to in Article 3 (1) which grant exclusive 
rights  or  which  have  as  their  object  or  effect  to  grant  such  exclusive  rights  or  to 
restrict  the  availability  of  data  for  re-use  by  entities  other  than  the  parties  to  such 
agreements or other practices shall be prohibited. 

By way of derogation from paragraph 1, an exclusive right to re-use data referred to 
in  that  paragraph  may  be  granted  to  the  extent  necessary  for  the  provision  of  a 
service or a product in the general interest. 

Such  exclusive  right  shall  be  granted  in  the  context  of  a  relevant  service  or 
concession  contract  in  compliance  with  applicable  Union  and  national  public 
procurement and concession award rules, or, in the case of a contract of a value for 
which neither Union nor national public procurement and concession award rules are 
applicable,  in  compliance  with  the  principles  of  transparency,  equal  treatment  and 
non-discrimination on grounds of nationality. 

In all cases not covered by paragraph 3 and where the general interest purpose cannot 
be fulfilled without granting an exclusive right, the principles of transparency, equal 
treatment and non-discrimination on grounds of nationality shall apply. 

The  period  of  exclusivity  of  the  right  to  re-use  data  shall  not  exceed  three  years. 
Where  a  contract  is  concluded,  the  duration  of  the  contract  awarded  shall  be  as 
aligned with the period of exclusivity. 

The  award  of  an  exclusive  right  pursuant  to  paragraphs  (2)  to  (5),  including  the 
reasons  why  it  is  necessary  to  grant  such  a  right,  shall  be  transparent  and  be  made 

(3) 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

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(7) 

(1) 

(2) 

(3) 

publicly available online, regardless of a possible publication of an award of a public 
procurement and concessions contract.  

Agreements or other practices falling within the scope of the prohibition in paragraph 
1,  which  do  not  meet  the  conditions  set  out  in  paragraph  2,  and  which  were 
concluded before the date of entry into force of this Regulation shall be terminated at 
the end of the contract and in any event at the latest within three years after the date 
of entry into force of this Regulation. 

Article 5 
Conditions for re-use 

Public sector bodies which are competent under national law to grant or refuse access 
for the re-use of one or more of the categories of data referred to in Article 3 (1) shall 
make  publicly  available  the  conditions  for  allowing  such  re-use.  In  that  task,  they 
may be assisted by the competent bodies referred to in Article 7 (1). 

Conditions  for  re-use  shall  be  non-discriminatory,  proportionate  and  objectively 
justified with regard to categories of data and purposes of re-use and the nature of the 
data  for  which  re-use  is  allowed.  These  conditions  shall  not  be  used  to  restrict 
competition. 

Public  sector  bodies  may  impose  an  obligation  to  re-use  only  pre-processed  data 
where  such  pre-processing  aims  to  anonymize  or  pseudonymise  personal  data  or 
delete commercially confidential information, including trade secrets. 

(4) 

Public sector bodies may impose obligations  

(a) 

(b) 

to access and re-use the data within a secure processing environment provided 
and controlled by the public sector ;  

to access and re-use the data within the physical premises in which the secure 
processing environment is located, if remote access cannot be allowed without 
jeopardising the rights and interests of third parties.  

The  public  sector  bodies  shall  impose  conditions  that  preserve  the  integrity  of  the 
functioning of the technical systems of the secure processing environment used. The 
public sector body shall be able to verify any results of processing of data undertaken 
by  the  re-user  and  reserve  the  right  to  prohibit  the  use  of  results  that  contain 
information jeopardising the rights and interests of third parties.  

Where the re-use of data cannot  be  granted in  accordance with  the obligations  laid 
down in paragraphs 3 to 5 and there is no other legal basis for transmitting the data 
under  Regulation  (EU)  2016/679,  the  public  sector  body  shall  support  re-users  in 
seeking consent of the data subjects and/or permission from the legal entities  whose 
rights  and  interests  may  be  affected  by  such  re-use,  where  it  is  feasible  without 
disproportionate cost  for the public sector.  In that  task they may  be assisted by the 
competent bodies referred to in Article 7 (1). 

Re-use of data shall only be allowed in compliance with intellectual property rights. 
The  right  of  the  maker  of  a  database  as  provided  for  in  Article  7(1)  of  Directive 
96/9/EC shall not be exercised by public sector bodies in order to prevent the re-use 
of data or to restrict re-use beyond the limits set by this Regulation. 

(5) 

(6) 

(7) 

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(8) 

(9) 

When  data  requested  is  considered  confidential,  in  accordance  with  Union  or 
national law on commercial confidentiality, the public sector bodies shall ensure that 
the confidential information is not disclosed as a result of the re-use. 

The Commission may adopt implementing acts declaring that the legal, supervisory 
and enforcement arrangements of a third country: 

(a) 

ensure  protection  of  intellectual  property  and  trade  secrets  in  a  way  that  is 
essentially equivalent to the protection ensured under Union law; 

(b) 

are being effectively applied and enforced; and 

(c) 

provide effective judicial redress. 

Those implementing acts shall be adopted in accordance with the advisory procedure referred 
to in Article 29 (2). 

(10) 

Public  sector  bodies  shall  only  transmit  confidential  data  or  data  protected  by 
intellectual  property  rights  to  a  re-user  which  intends  to  transfer  the  data  to  a  third 
country other than a country designated in accordance with paragraph 9 if the re-user 
undertakes: 

(a) 

(b) 

to comply with the obligations imposed in accordance with paragraphs 7 to 8 
even after the data is transferred to the third country; and 

to accept the jurisdiction of the courts of the Member State of the public sector 
body  as  regards  any  dispute  related  to  the  compliance  with  the  obligation  in 
point a). 

(11)  Where  specific  Union  acts  adopted  in  accordance  with  a  legislative  procedure 
establish that certain non-personal data categories held by public sector bodies shall 
be  deemed  to  be  highly  sensitive  for  the  purposes  of  this  Article,  the  Commission 
shall  be  empowered  to  adopt  delegated  acts  in  accordance  with  Article  28 
supplementing  this  Regulation  by  laying  down  special  conditions  applicable  for 
transfers to third-countries. The conditions for the transfer to third-countries shall be 
based on the nature of data categories identified in the Union act and on the grounds 
for  deeming  them  highly  sensitive,  non-discriminatory  and  limited  to  what  is 
necessary  to  achieve  the  public  policy  objectives  identified  in  the  Union  law  act, 
such as safety and public health, as well as risks of re-identification of anonymized 
data for data subjects, in accordance with the Union’s international obligations. They 
may  include  terms  applicable  for  the  transfer  or  technical  arrangements  in  this 
regard,  limitations  as  regards  the  re-use  of  data  in  third-countries  or  categories  of 
persons which are entitled to transfer such data to third countries or, in exceptional 
cases, restrictions as regards transfers to third-countries. 

(12) 

The  natural  or  legal  person  to  which  the  right  to  re-use  non-personal  data  was 
granted  may  transfer  the  data  only  to  those  third-countries  for  which  the 
requirements in paragraphs 9 to 11 are met. 

(13)  Where the re-user intends to transfer non-personal data to a third country, the public 
sector  body  shall  inform  the  data  holder  about  the  transfer  of  data  to  that  third 
country. 

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Article 6 
Fees 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(1) 

Public  sector  bodies  which  allow  re-use  of  the  categories  of  data  referred  to  in 
Article 3 (1) may charge fees for allowing the re-use of such data.  

Any  fees  shall  be  non-discriminatory,  proportionate  and  objectively  justified  and 
shall not restrict competition.  

Public  sector  bodies  shall  ensure  that  any  fees  can  be  paid  online  through  widely 
available  cross-border  payment  services,  without  discrimination  based  on  the  place 
of establishment of the payment service provider, the place of issue of the  payment 
instrument or the location of the payment account within the Union. 

Where they apply fees, public sector bodies shall take measures to incentivise the re-
use of the categories of data referred to in Article 3 (1) for non-commercial purposes 
and by small and medium-sized enterprises in line with State aid rules. 

Fees shall be derived from the costs related to the processing of requests for re-use of 
the  categories  of  data  referred  to  in  Article  3  (1).  The  methodology  for  calculating 
fees shall be published in advance. 

The public sector body shall publish a description of the main categories of costs and 
the rules used for the allocation of costs. 

Article 7 
Competent bodies 

Member  States  shall  designate  one  or  more  competent  bodies,  which  may  be 
sectoral,  to  support the public sector bodies which grant  access  to  the re-use of the 
categories of data referred to in Article 3 (1) in the exercise of that task.  

(2) 

The support provided for in paragraph 1 shall include, where necessary: 

(a) 

providing 
environment for providing access for the re-use of data;  

technical  support  by  making  available  a  secure  processing 

(b)  providing  technical  support  in  the  application  of  tested  techniques  ensuring 
data processing in a manner that preserves privacy of the information contained 
techniques  for 
in 
pseudonymisation, 
and 
randomisation of personal data; 

the  data  for  which  re-use 

anonymisation, 

generalisation, 

is  allowed, 

suppression 

including 

(c) 

assisting  the  public  sector  bodies,  where  relevant,  in  obtaining  consent  or 
permission by re-users for re-use for altruistic and other purposes in line with 
specific decisions of data holders, including on the jurisdiction or jurisdictions 
in which the data processing is intended to take place; 

(d)  providing public sector bodies with assistance on the adequacy of undertakings 

made by a re-user, pursuant to Article 5 (10).  

(3) 

The competent bodies may also be entrusted, pursuant Union or national law which 
provides for such access to be given, to grant access for the re-use of the categories 
of data referred to in Article 3 (1). While performing their function to grant or refuse 
access for re-use, Articles 4, 5, 6 and 8 (3) shall apply in regard to such competent 
bodies. 

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(4) 

(5) 

(1) 

(2) 

(3) 

(4) 

The competent body or bodies shall have adequate legal and technical capacities and 
expertise  to  be  able  to  comply  with  relevant  Union  or  national  law  concerning  the 
access regimes for the categories of data referred to in Article 3 (1).  

The  Member  States  shall  communicate  to  the  Commission  the  identity  of  the 
competent bodies designated pursuant to paragraph 1 by [date of application of this 
Regulation].  They  shall  also  communicate  to  the  Commission  any  subsequent 
modification of the identity of those bodies. 

Article 8 
Single information point 

Member States shall ensure that all relevant information concerning the application 
of Articles 5 and 6 is available through a single information point. 

The single information point shall receive requests for the re-use of the categories of 
data referred to in Article 3 (1) and shall transmit them to the competent public sector 
bodies,  or  the  competent  bodies  referred  to  in  Article  7  (1),  where  relevant.  The 
single  information  point  shall  make  available  by  electronic  means  a  register  of 
available  data  resources  containing  relevant  information  describing  the  nature  of 
available data. 

Requests for the re-use of the categories of data referred to in Article 3 (1) shall be 
granted  or  refused  by  the  competent  public  sector  bodies  or  the  competent  bodies 
referred  to  in  Article  7  (1)  within  a  reasonable  time,  and  in  any  case  within  two 
months from the date of the request. 

Any  natural  or  legal  person  affected  by  a  decision  of  a  public  sector  body  or  of  a 
competent  body,  as  the  case  may  be,  shall  have  the  right  to  an  effective  judicial 
remedy  against  such  decision  before  the  courts  of  the  Member  State  where  the 
relevant body is located. 

CHAPTER III 
REQUIREMENTS APPLICABLE TO DATA SHARING SERVICES 

Article 9 
Providers of data sharing services 

(1) 

The provision of the following data sharing services shall be subject to a notification 
procedure: 

(a) 

intermediation  services  between  data  holders  which  are  legal  persons  and 
potential data users, including making available the technical or other means to 
enable  such  services;  those  services  may  include  bilateral  or  multilateral 
exchanges  of  data  or  the  creation  of  platforms  or  databases  enabling  the 
exchange or joint exploitation of data, as well as the establishment of a specific 
infrastructure for the interconnection of data holders and data users;  

(b) 

intermediation services between data subjects that seek to make their personal 
data  available  and  potential  data  users,  including  making  available  the 
technical  or other means to  enable such services, in  the  exercise of the rights 
provided in Regulation (EU) 2016/679; 

(c) 

services of data cooperatives, that is to say services supporting data subjects or 
one-person companies or micro, small and medium-sized enterprises, who are 

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members  of  the  cooperative  or  who  confer  the  power  to  the  cooperative  to 
negotiate  terms  and  conditions  for  data  processing  before  they  consent,  in 
making  informed  choices  before  consenting  to  data  processing,  and  allowing 
for mechanisms to exchange views on data processing purposes and conditions 
that would best represent the interests of data subjects or legal persons.  

This  Chapter  shall  be  without  prejudice  to  the  application  of  other  Union  and 
national  law  to  providers  of  data  sharing  services,  including  powers  of  supervisory 
authorities  to  ensure  compliance  with  applicable  law,  in  particular  as  regard  the 
protection of personal data and competition law. 

Article 10 
Notification of data sharing service providers 

Any provider of data sharing services who intends to provide the services referred to 
in  Article 9 (1) shall submit a notification to  the competent  authority referred to  in 
Article 12.  

For  the  purposes  of  this  Regulation,  a  provider  of  data  sharing  services  with 
establishments  in  more  than  one  Member  State,  shall  be  deemed  to  be  under  the 
jurisdiction of the Member State in which it has its main establishment.  

A provider of data sharing services that is not established in the Union, but offers the 
services  referred  to  in  Article  9  (1)  within  the  Union,  shall  appoint  a  legal 
representative in one of the Member States in which those services are offered. The 
provider shall be deemed to be under the jurisdiction of the Member State in which 
the legal representative is established.  

Upon notification, the provider of data sharing services may start the activity subject 
to the conditions laid down in this Chapter. 

The  notification  shall  entitle  the  provider  to  provide  data  sharing  services  in  all 
Member States. 

(2) 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

The notification shall include the following information: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

the name of the provider of data sharing services; 

the provider’s legal status, form and registration number, where the provider is 
registered in trade or in another similar public register; 

the  address  of  the  provider’s  main  establishment  in  the  Union,  if  any,  and, 
where applicable, any secondary branch in another Member State or that of the 
legal representative designated pursuant to paragraph 3; 

a  website  where  information  on  the  provider  and  the  activities  can  be  found, 
where applicable; 

the provider’s contact persons and contact details; 

a description of the service the provider intends to provide; 

the estimated date for starting the activity; 

the Member States where the provider intends to provide services. 

(7) 

At the request of the provider, the competent authority shall, within one week, issue a 
standardised declaration, confirming that the provider has submitted the notification 
referred to in paragraph 4. 

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(8) 

(9) 

(10) 

The  competent  authority  shall  forward  each  notification  to  the  national  competent 
authorities of the Member States by electronic means, without delay. 

The competent authority shall notify the Commission of each new notification. The 
Commission shall keep a register of providers of data sharing services. 

The  competent  authority  may  charge  fees.  Such  fees  shall  be  proportionate  and 
objective  and  be  based  on  the  administrative  costs  related  to  the  monitoring  of 
compliance  and  other  market  control  activities  of  the  competent  authorities  in 
relation to notifications of data sharing services. 

(11)  Where  a  provider  of  data  sharing  services  ceases  its  activities,  it  shall  notify  the 
relevant competent authority determined pursuant to paragraphs 1, 2 and 3 within 15 
days. The competent authority shall forward without delay each such notification to 
the national  competent  authorities in  the Member States and to the Commission by 
electronic means.  

Article 11 
Conditions for providing data sharing services 

The  provision  of  data  sharing  services  referred  in  Article  9  (1)  shall  be  subject  to  the 
following conditions:  

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

the  provider  may  not  use  the  data  for  which  it  provides  services  for  other 
purposes than to put them at the disposal of data users and data sharing services 
shall be placed in a separate legal entity;  

the  metadata  collected  from  the  provision  of  the  data  sharing  service  may  be 
used only for the development of that service;  

the  provider  shall  ensure  that  the  procedure  for  access  to  its  service  is  fair, 
transparent  and  non-discriminatory  for  both  data  holders  and  data  users, 
including as regards prices; 

the provider shall facilitate the exchange of the data in the format in which it 
receives it from the data holder and shall convert the data into specific formats 
only to enhance interoperability within and across sectors or if requested by the 
data  user  or  where  mandated  by  Union  law  or  to  ensure  harmonisation  with 
international or European data standards; 

the  provider  shall  have  procedures  in  place  to  prevent  fraudulent  or  abusive 
practices in relation to access to data from parties seeking access through their 
services; 

the  provider  shall  ensure  a  reasonable  continuity  of  provision  of  its  services 
and, in the case of services which ensure storage of data, shall have sufficient 
guarantees  in  place  that  allow  data  holders  and  data  users  to  obtain  access  to 
their data in case of insolvency;  

the  provider  shall  put  in  place  adequate  technical,  legal  and  organisational 
measures  in  order  to  prevent  transfer  or  access  to  non-personal  data that  is 
unlawful under Union law;  

the  provider  shall  take  measures  to  ensure  a  high  level  of  security  for  the 
storage and transmission of non-personal data; 

the  provider  shall  have  procedures  in  place  to  ensure  compliance  with  the 
Union and national rules on competition; 

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(10)  the provider offering services to data subjects shall act in the data subjects’ best 
interest when facilitating the exercise of their rights, in particular by advising 
data subjects on potential data uses and standard terms and conditions attached 
to such uses; 

(11)  where  a  provider  provides  tools  for  obtaining  consent  from  data  subjects  or 
permissions to process data made available by legal persons, it shall specify the 
jurisdiction or jurisdictions in which the data use is intended to take place. 

Article 12 
Competent authorities 

Each Member State shall designate in its territory one or more authorities competent 
to carry out the tasks related to the notification framework and shall communicate to 
the Commission the identity of those designated authorities by [date of application of 
this  Regulation].  It  shall  also  communicate  to  the  Commission  any  subsequent 
modification.  

The designated competent authorities shall comply with Article 23. 

The  designated  competent  authorities,  the  data  protection  authorities,  the  national 
competition authorities, the authorities in charge of cybersecurity, and other relevant 
sectorial  authorities  shall  exchange  the  information  which  is  necessary  for  the 
exercise of their tasks in relation to data sharing providers. 

Article 13 
Monitoring of compliance 

The competent authority shall monitor and supervise compliance with this Chapter. 

The  competent  authority  shall  have  the  power  to  request  from  providers  of  data 
sharing  services  all  the  information  that  is  necessary  to  verify  compliance  with  the 
requirements laid down in Articles 10 and 11. Any request for information shall be 
proportionate to the performance of the task and shall be reasoned. 

Where the competent authority finds that a provider of data sharing services does not 
comply with one or more of the requirements laid down in Article 10 or 11, it shall 
notify  that  provider  of  those  findings  and  give  it  the  opportunity  to  state  its  views, 
within a reasonable time limit. 

The competent authority shall have the power to require the cessation of the breach 
referred to  in  paragraph  3 either immediately or  within a reasonable time limit  and 
shall take appropriate and proportionate measures aimed at ensuring compliance. In 
this regard, the competent authorities shall be able, where appropriate: 

(a) 

(b) 

to  impose dissuasive financial penalties which may include periodic penalties 
with retroactive effect;  

to  require  cessation  or  postponement  of  the    provision  of  the  data  sharing 
service. 

The  competent  authorities  shall  communicate  the  measures  imposed  pursuant  to 
paragraph 4 and the reasons on which they are based to the entity concerned without 
delay  and  shall  stipulate  a  reasonable  period  for  the  entity  to  comply  with  the 
measures. 

(1) 

(2) 

(3) 

(1) 

(2) 

(3) 

(4) 

(5) 

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(6) 

If  a  provider  of  data  sharing  services  has  its  main  establishment  or  legal 
representative in a Member State, but provides services in other Member States, the 
competent  authority  of  the  Member  State  of  the  main  establishment  or  where  the 
legal representative is located and the competent authorities of those other Member 
States  shall  cooperate  and  assist  each  other.  Such  assistance  and  cooperation  may 
cover  information  exchanges  between  the  competent  authorities  concerned  and 
requests to take the measures referred to in this Article. 

Article 14 
Exceptions 

This Chapter shall not apply to not-for-profit entities whose activities consist only in seeking 
to collect data for objectives of general interest, made available by natural or legal persons on 
the basis of data altruism. 

CHAPTER IV 
DATA ALTRUISM 

Article 15 
Register of recognised data altruism organisations 

(1) 

(2) 

(3) 

Each competent  authority  designated pursuant  to  Article 20 shall keep a register of 
recognised data altruism organisations. 

The  Commission  shall  maintain  a  Union  register  of  recognised  data  altruism 
organisations. 

An entity registered in the register in accordance with Article 16 may refer to itself as 
a  ‘data  altruism  organisation  recognised  in  the  Union’  in  its  written  and  spoken 
communication.  

Article 16 
 General requirements for registration 

In order to qualify for registration, the data altruism organisation shall:  

(a) 

(b) 

(c) 

(1) 

(2) 

be a legal entity constituted to meet objectives of general interest; 

operate on a not-for-profit basis and be independent from any entity that operates on 
a for-profit basis; 

perform  the  activities  related  to  data  altruism  take  place  through  a  legally 
independent structure, separate from other activities it has undertaken. 

Article 17 
Registration 

Any entity which meets the requirements of Article 16 may request to be entered in 
the register of recognised data altruism organisations referred to in Article 15 (1). 

For  the  purposes  of  this  Regulation,  an  entity  engaged  in  activities  based  on  data 
altruism  with  establishments  in  more  than  one  Member  State,  shall  register  in  the 
Member State in which it has its main establishment. 

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(3) 

An entity that is not established in the Union, but meets the requirements in Article 
16, shall appoint a legal representative in one of the Member States where it intends 
to  collect  data  based  on  data  altruism.  For  the  purpose  of  compliance  with  this 
Regulation,  that  entity  shall  be  deemed  to  be  under  the  jurisdiction  of  the  Member 
State where the legal representative is located. 

(4) 

Applications for registration shall contain the following information: 

(a) 

(b) 

name of the entity; 

the  entity’s  legal  status,  form  and  registration  number,  where  the  entity  is 
registered in a public register; 

(c) 

the statutes of the entity, where appropriate; 

(d) 

the entity’s main sources of income; 

(e) 

(f) 

(g) 

(h) 

(i) 

the address of the entity’s main establishment in the Union, if any, and, where 
applicable, any secondary branch in another Member State or that of the legal 
representative designated pursuant to paragraph (3); 

a website where information on the entity and the activities can be found; 

the entity’s contact persons and contact details; 

the purposes of general interest it intends to promote when collecting data; 

any other documents which demonstrate that the requirements of Article 16 are 
met. 

Where the entity has submitted all necessary information pursuant to paragraph 4 and 
the competent  authority  considers that the entity  complies with  the requirements of 
Article  16,  it  shall  register  the  entity  in  the  register  of  recognised  data  altruism 
organisations within twelve weeks from the date of application. The registration shall 
be  valid  in  all  Member  States.  Any  registration  shall  be  communicated  to  the 
Commission,  for  inclusion  in  the  Union  register  of  recognised  data  altruism 
organisations. 

The information  referred to  in paragraph 4, points (a), (b), (f), (g), and (h) shall be 
published in the national register of recognised data altruism organisations.  

Any  entity  entered  in  the  register  of  recognised  data  altruism  organisations  shall 
submit  any  changes  of  the  information  provided  pursuant  to  paragraph  4  to  the 
competent authority within 14 calendar days from the day on which the change takes 
place. 

(5) 

(6) 

(7) 

Article 18 
Transparency requirements 

(1) 

Any entity entered in the national register of recognised data altruism organisations 
shall keep full and accurate records concerning:  

(a) 

all natural or legal persons that were given the possibility to process data held 
by that entity; 

(b) 

the date or duration of such processing; 

(c) 

the purpose of such processing as  declared by the natural or legal person that 
was given the possibility of processing; 

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(d) 

the fees paid by natural or legal persons processing the data, if any. 

(2) 

Any  entity  entered  in  the  register  of  recognised  data  altruism  organisations  shall 
draw  up  and  transmit  to  the  competent  national  authority  an  annual  activity  report 
which shall contain at least the following: 

(a) 

(b) 

(c) 

(d) 

(e) 

information on the activities of the entity;  

a description of the way in which the general interest purposes for which data 
was collected have been promoted during the given financial year;  

a  list  of  all  natural  and  legal  persons  that  were  allowed  to  use  data  it  holds, 
including  a  summary  description  of  the  general  interest  purposes  pursued  by 
such data use and the description of the technical means used for it, including a 
description of the techniques used to preserve privacy and data protection; 

a  summary  of  the  results  of  the  data  uses  allowed  by  the  entity,  where 
applicable; 

information  on  sources  of  revenue  of  the  entity,  in  particular  all  revenue 
resulted from allowing access to the data, and on expenditure.  

Article 19 
Specific requirements to safeguard rights and interests of data subjects and legal entities as 
regards their data 

(1) 

Any  entity  entered  in  the  register  of  recognised  data  altruism  organisations  shall 
inform data holders: 

(a) 

about  the  purposes  of  general  interest  for  which  it  permits  the  processing  of 
their data by a data user in an easy-to-understand manner;  

(2) 

(3) 

(1) 

(2) 

(3) 

(b) 

about any processing outside the Union.  

The entity shall also ensure that the data is not be used for other purposes than those 
of general interest for which it permits the processing. 

Where  an  entity  entered  in  the  register  of  recognised  data  altruism  organisations 
provides  tools  for  obtaining  consent  from  data  subjects  or  permissions  to  process 
data made available by legal persons, it shall specify the jurisdiction or jurisdictions 
in which the data use is intended to take place. 

Article 20 
Competent authorities for registration 

Each Member State shall designate one or more competent authorities responsible for 
the  register  of  recognised  data  altruism  organisations  and  for  the  monitoring  of 
compliance  with  the  requirements  of  this  Chapter.  The  designated  competent 
authorities shall meet the requirements of Article 23. 

Each  Member  State  shall  inform  the  Commission  of  the  identity  of  the  designated 
authorities. 

The  competent  authority  shall  undertake  its  tasks  in  cooperation  with  the  data 
protection authority, where such tasks are related to processing of personal data, and 
with relevant sectoral bodies of the same Member State. For any question requiring 
an  assessment  of  compliance  with  Regulation  (EU)  2016/679,  the  competent 
authority  shall  first  seek  an  opinion  or  decision  by  the  competent  supervisory 

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authority  established  pursuant  to  that  Regulation  and  comply  with  that  opinion  or 
decision. 

Article 21 
Monitoring of compliance  

The competent authority shall monitor and supervise compliance of entities entered 
in  the  register  of  recognised  data  altruism  organisations  with  the  conditions  laid 
down in this Chapter. 

The  competent  authority  shall  have  the  power  to  request  information  from  entities 
included in the register of recognised data altruism organisations that is necessary to 
verify  compliance  with  the  provisions  of  this  Chapter.  Any  request  for  information 
shall be proportionate to the performance of the task and shall be reasoned. 

Where the competent authority finds that an entity does not comply with one or more 
of the requirements of this Chapter it shall notify the entity of those findings and give 
it the opportunity to state its views, within a reasonable time limit. 

The competent authority shall have the power to require the cessation of the breach 
referred to  in  paragraph  3 either immediately or  within a reasonable time limit  and 
shall take appropriate and proportionate measures aimed at ensuring compliance. 

If  an  entity  does  not  comply  with  one  or  more  of  the  requirements  of  this  Chapter 
even  after  having  been  notified  in  accordance  with  paragraph  3  by  the  competent 
authority, the entity shall:  

(a) 

lose its right to refer to itself as a ‘data altruism organisation recognised in the 
Union’ in any written and spoken communication;  

(b)  be removed from the register of recognised data altruism organisations. 

If an entity included in the register of recognised data altruism organisations has its 
main establishment or legal representative in  a  Member State but  is  active in  other 
Member  States,  the  competent  authority  of  the  Member  State  of  the  main 
establishment  or  where  the  legal  representative  is  located  and  the  competent 
authorities  of  those  other  Member  States  shall  cooperate  and  assist  each  other  as 
necessary.  Such  assistance  and  cooperation  may  cover  information  exchanges 
between  the  competent  authorities  concerned  and  requests  to  take  the  supervisory 
measures referred to in this Article. 

Article 22 
European data altruism consent form 

In  order  to  facilitate  the  collection  of  data  based  on  data  altruism,  the  Commission 
may  adopt  implementing  acts  developing  a  European  data  altruism  consent  form. 
The  form  shall  allow  the  collection  of  consent  across  Member  States  in  a  uniform 
format.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the  advisory 
procedure referred to in Article 29 (2). 

The  European  data  altruism  consent  form  shall  use  a  modular  approach  allowing 
customisation for specific sectors and for different purposes. 

Where  personal  data  are  provided,  the  European  data  altruism  consent  form  shall 
ensure  that  data  subjects  are  able  to  give  consent  to  and  withdraw  consent  from  a 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(1) 

(2) 

(3) 

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specific data processing operation in compliance with the requirements of Regulation 
(EU) 2016/679.  

(4) 

The  form  shall  be  available  in  a  manner  that  can  be  printed  on  paper  and  read  by 
humans as well as in an electronic, machine-readable form. 

CHAPTER V 
COMPETENT AUTHORITIES AND PROCEDURAL PROVISIONS 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(1) 

(2) 

Article 23 
Requirements relating to competent authorities 

The competent authorities designated pursuant to Article 12 and Article 20 shall be 
legally  distinct  from,  and  functionally  independent  of  any  provider  of  data  sharing 
services or entity included in the register of recognised data altruism organisations. 

Competent  authorities  shall  exercise  their  tasks  in  an  impartial,  transparent, 
consistent, reliable and timely manner. 

The  top-management  and  the  personnel  responsible  for  carrying  out  the  relevant 
tasks  of  the  competent  authority  provided  for  in  this  Regulation  cannot  be  the 
designer,  manufacturer,  supplier,  installer,  purchaser,  owner,  user  or  maintainer  of 
the  services  which  they  evaluate,  nor  the  authorised  representative  of  any  of  those 
parties or represent  them. This  shall not  preclude the use of evaluated services that 
are  necessary  for  the  operations  of  the  competent  authority  or  the  use  of  such 
services for personal purposes. 

Top-management  and  personnel  shall  not  engage  in  any  activity  that  may  conflict 
with  their  independence  of  judgment  or  integrity  in  relation  to  evaluation  activities 
entrusted to them. 

The  competent  authorities  shall  have  at  their  disposal  the  adequate  financial  and 
human  resources  to  carry  out  the  tasks  assigned  to  them,  including  the  necessary 
technical knowledge and resources. 

The  competent  authorities  of  a  Member  State  shall  provide  the  Commission  and 
competent  authorities  from  other  Member  States,  on  reasoned  request,  with  the 
information necessary to carry out their tasks under this Regulation. Where a national 
competent  authority  considers  the  information  requested  to  be  confidential  in 
accordance  with  Union  and  national  rules  on  commercial  and  professional 
confidentiality, the Commission and any other competent authorities concerned shall 
ensure such confidentiality. 

Article 24 
Right to lodge a complaint 

Natural and legal persons shall have the right to lodge a complaint with the relevant 
national competent authority against a provider of data sharing services or an entity 
entered in the register of recognised data altruism organisations. 

The  authority  with  which  the  complaint  has  been  lodged  shall  inform  the 
complainant of the progress of the proceedings and of the decision taken, and shall 
inform  the  complainant  of  the  right  to  an  effective  judicial  remedy  provided  for  in 
Article 25. 

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Article 25 
Right to an effective judicial remedy 

(1) 

Notwithstanding  any  administrative  or  other  non-judicial  remedies,  any  affected 
natural  and  legal  persons  shall  have  the  right  to  an  effective  judicial  remedy  with 
regard to: 

(a) 

a failure to act on a complaint lodged with the competent authority referred to 
in Articles 12 and 20; 

(b)  decisions  of  the  competent  authorities  referred  to  in  Articles  13,  17  and  21 
taken  in  the  management,  control  and  enforcement  of  the  notification  regime 
for  providers  of  data  sharing  services  and  the  monitoring  of  entities  entered 
into the register of recognised data altruism organisations. 

(2) 

Proceedings pursuant to this Article shall be brought before the courts of the Member 
State in which the authority against which the judicial remedy is sought is located. 

CHAPTER VI 
EUROPEAN DATA INNOVATION BOARD 

Article 26 
European Data Innovation Board 

(1) 

(2) 

(3) 

(4) 

The Commission shall establish a European Data Innovation Board (“the Board”) in 
the  form  of  an  Expert  Group,  consisting  of  the  representatives  of  competent 
authorities  of  all  the  Member  States,  the  European  Data  Protection  Board,  the 
Commission, relevant data spaces and other representatives of competent authorities 
in specific sectors.  

Stakeholders  and  relevant  third  parties  may  be  invited  to  attend  meetings  of  the 
Board and to participate in its work. 

The Commission shall chair the meetings of the Board.  

The Board shall be assisted by a secretariat provided by the Commission. 

Article 27 
Tasks of the Board 

The Board shall have the following tasks: 

(a) 

(b) 

(c) 

to  advise  and  assist  the  Commission  in  developing  a  consistent  practice  of  public 
sector  bodies  and  competent  bodies  referred  to  in  Article  7  (1)  processing  requests 
for the re-use of the categories of data referred to in Article 3 (1);  

to  advise  and  assist  the  Commission  in  developing  a  consistent  practice  of  the 
competent  authorities  in  the  application  of  requirements  applicable  to  data  sharing 
providers; 

to  advise  the  Commission  on  the  prioritisation  of  cross-sector  standards  to  be  used 
and developed for data use and cross-sector data sharing, cross-sectoral comparison 
and  exchange  of  best  practices  with  regards  to  sectoral  requirements  for  security, 
access  procedures,  while  taking  into  account  sector-specific  standardisations 
activities; 

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(d) 

(e) 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(1) 

(2) 

(3) 

to  assist  the  Commission  in  enhancing  the  interoperability  of  data  as  well  as  data 
sharing  services  between  different  sectors  and  domains,  building  on  existing 
European, international or national standards; 

to  facilitate  the  cooperation  between  national  competent  authorities  under  this 
Regulation through capacity-building and the exchange of information, in particular 
by  establishing  methods  for  the  efficient  exchange  of  information  relating  to  the 
notification  procedure  for  data  sharing  service  providers  and  the  registration  and 
monitoring of recognised data altruism organisations. 

CHAPTER VII 
COMMITTEE AND DELEGATION 

Article 28 
Exercise of the Delegation 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article. 

The power to adopt delegated acts referred to in Article 5 (11) shall be conferred on 
the Commission for an indeterminate period of time from […]. 

The delegation of power referred to in Article 5 (11) may be revoked at any time by 
the European Parliament or by the Council. A decision to revoke shall put an end to 
the  delegation  of  the  power  specified  in  that  decision.  It  shall  take  effect  the  day 
following  the  publication  of  the  decision  in  the  Official  Journal  of  the  European 
Union  or  at  a  later  date  specified  therein.  It  shall  not  affect  the  validity  of  any 
delegated acts already in force. 

Before adopting a delegated act, the Commission shall consult experts designated by 
each  Member  State 
the 
in  accordance  with 
Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 

the  principles 

laid  down 

in 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 

A  delegated  act  adopted  pursuant  to  Article  5  (11)  shall  enter  into  force  only  if  no 
objection  has  been  expressed  either  by  the  European  Parliament  or  by  the  Council 
within a period of three months of notification of that act to the European Parliament 
and  to  the  Council  or  if,  before  the  expiry  of  that  period,  the  European  Parliament 
and the Council have both informed the Commission that they will not object. That 
period shall be extended by three months at the initiative of the European Parliament 
or of the Council. 

Article 29 
Committee procedure 

The Commission shall be assisted by a committee within the meaning of Regulation 
(EU) No 182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  4  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  the  opinion  of  the  committee  is  to  be  obtained  by  written  procedure,  that 
procedure shall be terminated without result when, within the time-limit for delivery 

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of  the  opinion,  the  chair  of  the  committee  so  decides  or  a  committee  member  so 
requests.  In  such  a  case,  the  chair  shall  convene  a  committee  meeting  within  a 
reasonable time. 

CHAPTER VIII 
FINAL PROVISIONS  

Article 30 
International access 

(1) 

(2) 

(3) 

The public sector body, the natural or legal person to which the right to re-use data 
was  granted  under  Chapter  2,  the  data  sharing  provider  or  the  entity  entered  in  the 
register of recognised data altruism organisations, as the case may be, shall take all 
reasonable technical, legal and organisational measures in order to prevent transfer or 
access  to  non-personal data held in  the  Union where such transfer or access  would 
create a conflict with Union law or the law of the relevant Member State, unless the 
transfer or access are in line with paragraph 2 or 3. 

Any judgment of a court or tribunal and any decision of an administrative authority 
of a third country requiring a public sector body, a natural or legal person to which 
the right to re-use data was granted under Chapter 2, a data sharing provider or entity 
entered  in  the  register  of  recognised  data  altruism  organisations  to  transfer  from  or 
give access to non-personal data subject to this Regulation in the Union may only be 
recognised or enforceable in any manner if based on an international agreement, such 
as a mutual legal assistance treaty, in force between the requesting third country and 
the Union or any such agreement between the requesting third country and a Member 
State concluded before [the entry into force of this Regulation]. 

Where a public sector body, a natural or legal person to which the right to re-use data 
was granted under Chapter 2, a data sharing provider or entity entered in the register 
of recognised data altruism organisations is the addressee of a decision of a court or 
of  an  administrative  authority  of  a  third  country  to  transfer  from  or  give  access  to 
non-personal data held in the Union and compliance with such a decision would risk 
putting  the  addressee  in  conflict  with  Union  law  or  with  the  law  of  the  relevant 
Member State, transfer to or access to such data by that third-country authority shall 
take place only:  

(a)  where the third-country system requires the reasons and proportionality of the 
decision to be set out, and it requires the court order or the decision, as the case 
may be, to be specific in character, for instance by establishing a sufficient link 
to certain suspected persons, or infringements; 

(b) 

(c) 

the reasoned objection of the addressee is subject to a review by a competent 
court in the third-country; and  

in that context, the competent court issuing the order or reviewing the decision 
of  an  administrative  authority  is  empowered  under  the  law  of  that  country  to 
take  duly  into  account  the  relevant  legal  interests  of  the  provider  of  the  data 
protected by Union law or the applicable Member State law.  

The  addressee  of  the  decision  shall  ask  the  opinion  of  the  relevant  competent  bodies  or 
authorities, pursuant to this Regulation, in order to determine if these conditions are met. 

(4) 

If the conditions in paragraph 2, or 3 are met, the public sector body, the natural or 
legal person to which the right to re-use data was granted under Chapter 2, the data 

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sharing  provider  or  the  entity  entered  in  the  register  of  recognised  data  altruism 
organisations,  as  the  case  may  be,  shall,    provide  the  minimum  amount  of  data 
permissible  in  response  to  a  request,  based  on  a  reasonable  interpretation  of  the 
request. 

(5) 

The public sector body, the natural or legal person to which the right to re-use data 
was granted under Chapter 2, the data sharing provider and the entity providing data 
altruism  shall  inform  the  data  holder  about  the  existence  of  a  request  of  an 
administrative  authority  in  a  third-country  to  access  its  data,  except  in  cases  where 
the request serves law enforcement purposes and for as long as this is necessary to 
preserve the effectiveness of the law enforcement activity. 

Article 31 
Penalties 

Member  States  shall  lay  down  the  rules  on  penalties  applicable  to  infringements  of  this 
Regulation  and  shall  take  all  measures  necessary  to  ensure  that  they  are  implemented.  The 
penalties  provided  for  shall  be  effective,  proportionate  and  dissuasive.  Member  States  shall 
notify the Commission of those rules and measures by [date of application of the Regulation] 
and shall notify the Commission without delay of any subsequent amendment affecting them. 

Article 32 
Evaluation and review 

By [four  years  after the data  of  application of this  Regulation], the Commission shall carry 
out an evaluation of this Regulation, and submit a report on its main findings to the European 
Parliament  and to the Council as well as to  the  European Economic  and Social Committee. 
Member  States  shall  provide  the  Commission  with  the  information  necessary  for  the 
preparation of that report. 

Article 33 
Amendment to Regulation (EU) No 2018/1724 

In  Annex  II to  Regulation (EU) No 2018/1724,  the following line is  added under  “Starting, 
running and closing a business”: 

Starting, running and closing 
a business 

Notification  as  a  provider  of 
data sharing services 

Confirmation  of  the  receipt 
of notification 

Registration  as  a  European 
Data Altruism Organisation 

Confirmation 
registration 

of 

the 

Article 34 
Transitional arrangements 

Entities providing the data sharing services provided in Article 9(1) on the date of entry into 
force of this Regulation shall comply with the obligations set out in Chapter III by [date - 2 
years after the start date of the application of the Regulation] at the latest. 

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Article 35 
Entry into force and application 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  

It shall apply from [12 months after its entry into force].  

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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