EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 21.4.2021  
COM(2021) 206 final  
ANNEXES 1 to 9  
 
ANNEXES  
to the  
Proposal for a Regulation of the European Parliament and of the Council  
LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE 
(ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION 
LEGISLATIVE ACTS     
     
 
{SEC(2021)  167 final}  - {SWD(2021)  84 final}  - {SWD(2021)  85 final}    
EN 1  EN ANNEX I 
ARTIFICIAL INTELLIGENCE TECHNIQUES AND APPROACHES  
referred to in Article 3, point 1  
(a) Machine learning approaches, including supervised, unsupervised and reinforcement 
learning, using a wide variety of methods including deep learning;  
(b) Logic - and knowledge -based approaches, including knowledge representation, 
inductive (logic) programming, knowledge bases, inference and deductive engines, 
(symbolic) reasoning and expert systems;  
(c) Statistical approaches, Bayesian estimation, search and optimization methods.   
EN 2  EN ANNEX II  
LIST OF UNION HARMONISATION LEGISLATION  
Section A – List of Union harmonisa tion legislation based on the New Legislative 
Framework  
1. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 
2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24) 
[as repealed by the Machinery Regulation];  
2. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 
2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1);  
3. Directive 2013/53/EU of the European Parliament and of the Council of 20 
November 2013 on recreational craft and personal watercraft and repealing Directive 
94/25/EC (OJ L 354, 28.12.2013, p. 90);  
4. Directive 2014/33/EU of the European Parliament and of the Council of 26 February 
2014 on the harmonisation of the laws of the Member States relating to lifts and 
safety components for lifts (OJ L 96, 29.3.2014, p. 251);  
5. Directive 2014/34/EU of the European Parliament and of the Council of 26 February 
2014 on the harmonisation of the laws of the Member States relating to equipment 
and protective systems intended for use in potentiall y explosive atmospheres (OJ L 
96, 29.3.2014, p. 309);  
6. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 
2014 on the harmonisation of the laws of the Member States relating to the making 
available on the market of radio equipmen t and repealing Directive 1999/5/EC (OJ L 
153, 22.5.2014, p. 62);  
7. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 
2014 on the harmonisation of the laws of the Member States relating to the making 
available on the market of pres sure equipment (OJ L 189, 27.6.2014, p. 164);  
8. Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 
2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 
31.3.2016, p. 1);  
9. Regulation (EU) 2016/425 of the Eur opean Parliament and of the Council of 9 March 
2016 on personal protective equipment and repealing Council Directive 89/686/EEC 
(OJ L 81, 31.3.2016, p. 51);  
10. Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 
2016 on appliance s burning gaseous fuels and repealing Directive 2009/142/EC (OJ 
L 81, 31.3.2016, p. 99);  
11. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 
2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 
178/2002 a nd Regulation (EC) No 1223/2009 and repealing Council Directives 
90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1;  
12. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 
2017 on in vitro diagnostic medical devices and repealing  Directive 98/79/EC and 
Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).   
EN 3  EN Section B. List of other Union harmonisation legislation  
1. Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 
March 2008 on  common rules in the field of civil aviation security and repealing 
Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72).  
2. Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 
January 2013 on the approval and market surveillanc e of two - or three -wheel 
vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52);  
3. Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 
February 2013 on the approval and market surveillance of agricultural and forestry 
vehicles (OJ L 60, 2.3.2013, p. 1);  
4. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 
on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 
28.8.2014, p. 146);  
5. Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 
2016 on the interoperability of the rail system within the European Union (OJ L 138, 
26.5.2016, p. 44).  
6. Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 
2018 on the approval and market surveillance of m otor 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, p. 1); 3. Regulation ( EU) 2019/2144 of 
the European Parliament and of the Council of 27 November 2019 on type -approval 
requirements for motor vehicles and their trailers, and systems, components and 
separate technical units intended for such vehicles, as regards their general s afety and 
the protection of vehicle occupants and vulnerable road users, amending Regulation 
(EU) 2018/858 of the European Parliament and of the Council and repealing 
Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the 
European Parliam ent and of the Council and Commission Regulations (EC) No 
631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 
1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 
109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) N o 130/2012, (EU) No 
347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 
16.12.2019, p. 1);  
7. Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 
2018 on common rules in the field of civil aviation and esta blishing a European 
Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) 
No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU 
and 2014/53/EU of the European Parliament and of the Council, and repealing 
Regula tions (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament 
and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, 
p. 1), in so far as the design, production and placing on the market of aircrafts 
referred to in points (a) and (b) of Article 2(1) thereof, where it concerns unmanned 
aircraft and their engines, propellers, parts and equipment to control them remotely, 
are concerned.   
EN 4  EN ANNEX III  
HIGH -RISK AI SYSTEMS  REFERRED TO IN ARTICLE 6(2)  
High -risk AI  systems pursuant to Article 6(2) are the AI systems listed in any of the following  
areas : 
1. Biometric identification and categorisation of natural persons:  
(a) AI systems intended to be used for the ‘real -time’ and ‘post’ remote biometric 
identification of natu ral persons;  
2. Management and operation of critical infrastructure:  
(a) AI systems intended to be used as safety components in the management and 
operation of road traffic and the supply of water, gas, heating and electricity.  
3. Education and vocational training:  
(a) AI systems intended to be used for the purpose of determining access or 
assigning natural persons to educational and vocational training institutions;  
(b) AI systems intended to be used for the purpose of assessing students in 
educational and vocational train ing institutions and for assessing participants in 
tests commonly required for admission to educational institutions.  
4. Employment, workers management  and access to self -employment:  
(a) AI systems intended to be used for recruitment or selection of natural perso ns, 
notably for advertising vacancies, screening or filtering applications, evaluating 
candidates in the course of interviews or tests;   
(b) AI intended to be used for making decisions on promotion and termination of 
work -related contractual relationships, fo r task allocation and for monitoring 
and evaluating performance and behavior of persons in such relationships.  
5. Access to and enjoyment of essential private services and public services and 
benefits:  
(a) AI systems intended to be used by public authorities or o n behalf of public 
authorities to evaluate the eligibility of natural persons for public assistance 
benefits and services, as well as to grant, reduce, revoke, or reclaim such 
benefits and services;  
(b) AI systems intended to be used to evaluate the creditwort hiness of natural 
persons or establish their credit score, with the exception of AI systems put into 
service  by small scale providers for their own use;  
(c) AI systems intended to be used to dispatch, or to establish priority in the 
dispatching of emergency f irst response services, including by firefighters and 
medical aid.  
6.  Law enforcement:  
(a) AI systems intended to be used by law enforcement authorities for making 
individual risk assessments of natural persons in order to assess the risk of a 
natural person for  offending or reoffending or the risk for potential victims of 
criminal offences;  
(b) AI systems intended to be used by law enforcement authorities as polygraphs 
and similar tools or to detect the emotional state of a natural person;   
EN 5  EN (c) AI systems intended to be used by law enforcement authorities to detect deep 
fakes as referred to in article 52(3);  
(d) AI systems intended to be used by law enforcement authorities for evaluation 
of the reliability of evidence in the course of investigation or prosecution of 
criminal offences;  
(e) AI systems intended to be used by law enforcement authorities for predicting 
the  occurrence  or reoccurrence of an actual or potential criminal offence 
based on profiling of natural persons as referred to in Article 3(4) of Directive 
(EU) 2016/6 80 or assessing personality traits and characteristics or past 
criminal behaviour of natural persons or groups;  
(f) AI systems intended to be used by law enforcement authorities for profiling of 
natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in the 
course of detection, investigation or prosecution of criminal offences;  
(g) AI systems intended to be used for crime analytics regarding natural persons, 
allowing law enforcement authorities to search complex related and unrelated 
large data se ts available in different data sources or in different data formats in 
order to identify unknown patterns or discover hidden relationships in the data.  
7. Migration, asylum and border control management:  
(a) AI systems intended to be used by competent public auth orities as polygraphs 
and similar tools or to detect the emotional state of a natural person;  
(b) AI systems intended to be used by competent public authorities to assess a risk, 
including a security risk, a risk of irregular immigration, or a health risk, pos ed 
by a natural person who intends to enter or has entered into the territory of a 
Member State;  
(c) AI systems intended to be used by competent public authorities for the 
verification of the authenticity of travel documents and supporting 
documentation of na tural persons and detect non -authentic documents by 
checking their security features;  
(d) AI systems intended to assist competent public authorities for the examination 
of applications for asylum, visa and residence permits and associated 
complaints with regar d to the eligibility of the natural persons applying for a 
status.  
8. Administration of justice and democratic processes:  
(a) AI systems intended to assist a judicial authority in researching and 
interpreting facts and the law and in applying the law to a concrete set of facts.   
EN 6  EN ANNEX IV  
TECHNICAL DOCUMENTATION referred to in Article 11(1)  
The technical documentation referred to in Article 11(1) shall contain at least the following 
information, as applicable to the relevant AI system:  
1. A general description of the AI system including:  
(a) its intended purpose, the person/s developing the system the date and the 
version of the system;  
(b) how the AI system interacts or can be used to interact with hardware or 
software that is not part of the AI syst em itself, where applicable;  
(c) the versions of relevant software or firmware and any requirement related to 
version update;  
(d) the description of all forms in which the AI system is placed on the market or 
put into service;  
(e) the description of hardware on which the AI system is intended to run;  
(f) where the AI system is a component of products, photographs or illustrations 
showing external features, marking and internal layout of those products;  
(g) instructions of use for the user and, where applicable installation ins tructions;  
2. A detailed description of the elements of the AI system and of the process for its 
development, including:  
(a) the methods and steps performed for the development of the AI system, 
including, where relevant, recourse to pre -trained systems or tools provided by 
third parties and how these have been used, integrated or modified by the 
provider;  
(b) the design specifications of the system, namely the general logic of the AI 
system and of the algorithms; the key design choices including the rationale 
and ass umptions made, also with regard to persons or groups of persons on 
which the system is intended to be used; the main classification choices; what 
the system is designed to optimise for and the relevance of the different 
parameters; the decisions about any possible trade -off made regarding the 
technical solutions adopted to comply with the requirements set out in Title III, 
Chapter 2;  
(c) the description of the system architecture explaining how software components 
build on or feed into each other and integrate into the overall processing; the 
computational resources used to develop, train, test and validate the AI system;  
(d) where relevant, the data requirements in terms of datasheets describing the 
training methodologies and techniques and the training data sets u sed, 
including information about the provenance of those data sets, their scope and 
main characteristics; how the data was obtained and selected; labelling 
procedures (e.g. for supervised learning), data cleaning methodologies (e.g. 
outliers detection);  
(e) assessment of the human oversight measures needed in accordance with Article 
14, including an assessment of the technical measures needed to facilitate the 
interpretation of the outputs of AI systems by the users, in accordance with 
Articles 13(3)(d);   
EN 7  EN (f) where applicable, a detailed description of pre -determined changes  to the AI 
system and its performance, together with all the relevant information related 
to the technical solutions adopted to ensure continuous compliance of the AI 
system with the relevant req uirements set out in Title III, Chapter 2;  
(g) the validation and testing procedures used, including information about the 
validation and testing data used and their main characteristics; metrics used to 
measure accuracy, robustness, cybersecurity and complian ce with other 
relevant requirements set out in Title III, Chapter 2 as well as potentially 
discriminatory impacts; test logs and all test reports dated and signed by the 
responsible persons, including with regard to pre -determined changes as 
referred to un der point (f).  
3. Detailed information about the monitoring, functioning and control of the AI system, 
in particular with regard to: its capabilities and limitations in performance, including 
the degrees of accuracy for specific persons or groups of persons o n which the 
system is intended to be used and the overall expected level of accuracy in relation to 
its intended purpose; the foreseeable unintended outcomes and sources of risks to 
health and safety, fundamental rights and discrimination in view of the in tended 
purpose of the AI system; the human oversight measures needed in accordance with 
Article 14, including the technical measures put in place to facilitate the 
interpretation of the outputs of AI systems by the users; specifications on input data, 
as appropriate;  
4. A detailed description of the risk management system in accordance with Article 9;  
5. A description of any change made to the system through its lifecycle;  
6. A list of the harmonised standards applied in full or in part the references of which 
have been published in the Official Journal of the European Union; where no such 
harmonised standards have been applied, a detailed description of the solutions 
adopted to meet the requirements set out in Title III, Chapter 2, including a list of 
other relevant  standards and technical specifications applied;  
7. A copy of the EU declaration of conformity;  
8. A detailed description of the system in place to evaluate the AI system performance 
in the post -market phase in accordance with Article 61, including the post-market 
monitoring plan referred to in Article 61(3).   
EN 8  EN ANNEX V  
EU DECLARATION OF CONFORMITY  
The EU declaration of conformity referred to in Article 48, shall contain all of the following 
information:  
1. AI system name and type and any a dditional unambiguous reference allowing 
identification and traceability of the AI system;  
2. Name and address of the provider or, where applicable, their authorised 
representative;  
3. A statement that the EU declaration of conformity is issued under the sole 
responsibility of the provider;  
4. A statement that the AI system in question is in conformity with this Regulation and, 
if applicable, with any other relevant Union legislation that provides for the issuing 
of an EU declaration of conformity;  
5. References to any  relevant harmonised standards used or any other common 
specification in relation to which conformity is declared;  
6. Where applicable, the name and identification number of the notified body, a 
description of the conformity assessment procedure performed and  identification of 
the certificate issued;  
7. Place and date of issue of the declaration, name and function of the person who 
signed it as well as an indication for, and on behalf of whom, that person signed, 
signature.   
EN 9  EN ANNEX VI  
CONFORMITY  ASSESSMENT PROCEDURE BASED ON INTERNAL CONTROL  
1. The conformity assessment procedure based on internal control is the conformity 
assessment procedure based on points 2 to 4.  
2. The provider verifies that the established quality management system is in 
complian ce with the requirements of Article 17.  
3. The provider examines the information contained in the technical documentation in 
order to assess the compliance of the AI system with the relevant essential 
requirements set out in Title III, Chapter 2.  
4. The provide r also verifies that the design and development process of the AI system 
and its post -market monitoring as referred to in Article 61 is consistent with the 
technical documentation.   
EN 10  EN ANNEX VII  
CONFORMITY BASED ON ASSESSMENT OF QUALITY MAN AGEMENT 
SYSTEM AND ASSESSMENT OF TECHNICAL DOCUMENTATION  
1. Introduction  
Conformity based on assessment of quality management system and assessment of 
the technical documentation is the conformity assessment procedure based on points 
2 to 5.  
2. Overview  
The app roved quality management system for the design, development and testing of 
AI systems pursuant to Article 17 shall be examined in accordance with point 3 and 
shall be subject to surveillance as specified in point 5. The technical documentation 
of the AI sy stem shall be examined in accordance with point 4.  
3. Quality management system  
3.1. The application of the provider shall include:  
(a) the name and address of the provider and, if the application is lodged by the 
authorised representative, their name and address as well;  
(b) the list of AI systems covered under the same quality management system;  
(c) the technical documentation for each AI system covered under the same quality 
management system;  
(d) the documentation concerning the quality management system which shall 
cover all  the aspects listed under Article 17;  
(e) a description of the procedures in place to ensure that the quality management 
system remains adequate and effective;  
(f) a written declaration that the same application has not been lodged with any 
other notified body.  
3.2. The quality management system shall be assessed by the notified body, which shall 
determine whether it satisfies the requirements referred to in Article 17.  
The decision shall be notified to the provider or its authorised representative.  
The notification s hall contain the conclusions of the assessment of the quality 
management system and the reasoned assessment decision.  
3.3. The quality management system as approved shall continue to be implemented and 
maintained by the provider so that it remains adequate and efficient.  
3.4. Any intended change to the approved quality management system or the list of AI 
systems covered by the latter shall be brought to the attention of the notified body by 
the provider.  
The proposed changes shall be examined by the notified body, wh ich shall decide 
whether the modified quality management system continues to satisfy the 
requirements referred to in point 3.2 or whether a reassessment is necessary.  
The notified body shall notify the provider of its decision. The notification shall 
conta in the conclusions of the examination of the changes and the reasoned 
assessment decision.  
4. Control of the technical documentation.   
EN 11  EN 4.1. In addition to the application referred to in point 3, an application with a notified 
body of their choice shall be lodged by  the provider for the assessment of the 
technical documentation relating to the AI system which the provider intends to 
place on the market or put into service and which is covered by the quality 
management system referred to under point 3.  
4.2. The application  shall include:  
(a) the name and address of the provider;  
(b) a written declaration that the same application has not been lodged with any 
other notified body;  
(c) the technical documentation referred to in Annex IV.  
4.3. The technical documentation shall be examined by th e notified body. To this 
purpose, the notified body shall be granted full access to the training and testing 
datasets used by the provider, including through application programming interfaces 
(API) or other appropriate means and tools enabling remote acce ss. 
4.4. In examining the technical documentation, the notified body may require that the 
provider supplies further evidence or carries out further tests so as to enable a proper 
assessment of conformity of the AI system with the requirements set out in Title I II, 
Chapter 2. Whenever the notified body is not satisfied with the tests carried out by 
the provider, the notified body shall directly carry out adequate tests, as appropriate.  
4.5. Where necessary to assess the conformity of the high -risk AI system with the 
requirements set out in Title III, Chapter 2 and upon a reasoned request, the notified 
body shall also be granted access to the source code of the AI system . 
4.6. The decision shall be notified to the provider or its authorised representative. The 
notification shall contain the conclusions of the assessment of the technical 
documentation and the reasoned assessment decision.  
Where the AI system is in conformity with the requirements set out in Title III, 
Chapter 2, an EU technical documentation assessment certif icate shall be issued by 
the notified body. The certificate shall indicate the name and address of the provider, 
the conclusions of the examination, the conditions (if any) for its validity and the 
data necessary for the identification of the AI system.  
The certificate and its annexes shall contain all relevant information to allow the 
conformity of the AI system to be evaluated, and to allow for control of the AI 
system while in use, where applicable.  
Where the AI system is not in conformity with the requi rements set out in Title III, 
Chapter 2, the notified body shall refuse to issue an EU technical documentation 
assessment certificate and shall inform the applicant accordingly, giving detailed 
reasons for its refusal.  
Where the AI system does not meet the  requirement relating to the data used to train 
it, re -training of the AI system will be needed prior to the application for a new 
conformity assessment. In this case, the reasoned assessment decision of the notified 
body refusing to issue the EU technical  documentation assessment certificate shall 
contain specific considerations on the quality data used to train the AI system, 
notably on the reasons for non -compliance.  
4.7. Any change to the AI system that could affect the compliance of the AI system with 
the requirements or its intended purpose shall be approved by the notified body  
EN 12  EN which issued the EU technical documentation assessment certificate. The provider 
shall inform such notified body of its intention to introduce any of the above -
mentioned changes or  if it becomes otherwise aware of the occurrence of such 
changes. The intended changes shall be assessed by the notified body which shall 
decide whether those changes require a new conformity assessment in accordance 
with Article 43(4) or whether they coul d be addressed by means of a supplement to 
the EU technical documentation assessment certificate. In the latter case, the notified 
body shall assess the changes, notify the provider of its decision and, where the 
changes are approved, issue to the provider  a supplement to the EU technical 
documentation assessment certificate.  
5. Surveillance of the approved quality management system.  
5.1. The purpose of the surveillance carried out by the notified body referred to in Point 3 
is to make sure that the provider duly f ulfils the terms and conditions of the approved 
quality management system.  
5.2. For assessment purposes, the provider shall allow the notified body to access the 
premises where the design, development, testing of the AI systems is taking place. 
The provider sha ll further share with the notified body all necessary information.  
5.3. The notified body shall carry out periodic audits to make sure that the provider 
maintains and applies the quality management system and shall provide the provider 
with an audit report. In the context of those audits, the notified body may carry out 
additional tests of the AI systems for which an EU technical documentation 
assessment certificate was issued.   
EN 13  EN ANNEX VIII  
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF H IGH -
RISK AI SYSTEMS IN ACCORDANCE WITH ARTICLE 51  
The following information shall be provided and thereafter kept up to date with regard to 
high-risk AI systems to be registered in accordance with Article 51.  
1. Name, address and contact details of the provid er; 
2. Where submission of information is carried out by another person on behalf of the 
provider, the name, address and contact details of that person;  
3. Name, address and contact details of the authorised representative, where applicable;  
4. AI system trade name  and any additional unambiguous reference allowing 
identification and traceability of the AI system;  
5. Description of the intended purpose of the AI system;  
6. Status of the AI system (on the market, or in service; no longer placed on the 
market/in service, rec alled);  
7. Type, number and expiry date of the certificate issued by the notified body and the 
name or identification number of that notified body, when applicable;  
8. A scanned copy of the certificate referred to in point 7, when applicable;  
9. Member States in wh ich the AI system is or has been placed on the market, put into 
service or made available in the Union;  
10. A copy of the EU declaration of conformity referred to in Article 48;  
11. Electronic instructions for use; this information shall not be provided for high -risk AI 
systems in the areas of law enforcement and migration, asylum and border control 
management referred to in Annex III, points 1, 6 and 7.  
12. URL for additional information (optional).   
EN 14  EN ANNEX IX  
UNION LEGISLATION ON  LARGE -SCALE IT SYSTEMS IN THE AREA OF 
FREEDOM, SECURITY AN D JUSTICE  
1. Schengen Information System  
(a) Regulation (EU) 2018/1860 of the European Parliament and of the Council of 
28 November 2018 on the use of the Schengen Information System for the 
return of illegally staying t hird-country nationals (OJ L 312, 7.12.2018, p. 1).  
(b) Regulation (EU) 2018/1861 of the European Parliament and of the Council of 
28 November 2018 on the establishment, operation and use of the Schengen 
Information System (SIS) in the field of border checks, and amending the 
Convention implementing the Schengen Agreement, and amending and 
repealing Regulation (EC) No 1987/2006 (OJ L 312, 7.12.2018, p. 14)  
(c) Regulation (EU) 2018/1862 of the European Parliament and of the Council of 
28 November 2018 on the establi shment, operation and use of the Schengen 
Information System (SIS) in the field of police cooperation and judicial 
cooperation in criminal matters, amending and repealing Council Decision 
2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the Euro pean 
Parliament and of the Council and Commission Decision 2010/261/EU (OJ L 
312, 7.12.2018, p. 56).  
2. Visa Information System  
(a) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND 
OF THE COUNCIL amending Regulation (EC) No 767/2008, Regulation (EC) 
No 810/2009, Regulation (EU) 2017/2226, Regulation (EU) 2016/399, 
Regulation XX/2018 [Interoperability Regulation], and Decision 2004/512/EC 
and repealing Council Decision 2008/633/JHA - COM(2018) 302 final. To be 
updated once the Regulation is adopted (April /May 2021) by the co -legislators.  
3. Eurodac  
(a) Amended proposal for a REGULATION OF THE EUROPEAN 
PARLIAMENT AND OF THE COUNCIL on the establishment of 'Eurodac' 
for the comparison of biometric data for the effective application of Regulation 
(EU) XXX/XXX [Regul ation on Asylum and Migration Management] and of 
Regulation (EU) XXX/XXX [Resettlement Regulation], for identifying an 
illegally staying third -country national or stateless person and on requests for 
the comparison with Eurodac data by Member States' law e nforcement 
authorities and Europol for law enforcement purposes and amending 
Regulations (EU) 2018/1240 and (EU) 2019/818 – COM(2020) 614 final.  
4. Entry/Exit System  
(a) Regulation (EU) 2017/2226 of the European Parliament and of the Council of 
30 November 2017 establishing an Entry/Exit System (EES) to register entry 
and exit data and refusal of entry data of third -country nationals crossing the 
external borders of the Member States and determining the conditions for 
access to the EES for law enforcement purpose s, and amending the Convention 
implementing the Schengen Agreement and Regulations (EC) No 767/2008 
and (EU) No 1077/2011 (OJ L 327, 9.12.2017, p. 20).  
5. European Travel Information and Authorisation System   
EN 15  EN (a) Regulation (EU) 2018/1240 of the European Parliamen t and of the Council of 
12 September 2018 establishing a European Travel Information and 
Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, 
(EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ 
L 236, 19.9.2018, p. 1) .  
(b) Regulation (EU) 2018/1241 of the European Parliament and of the Council of 
12 September 2018 amending Regulation (EU) 2016/794 for the purpose of 
establishing a European Travel Information and Authorisation System (ETIAS) 
(OJ L 236, 19.9.2018, p. 72).  
6. European Criminal Records Information System on third -country nationals and 
stateless persons  
(a) Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 
April 2019 establishing a centralised system for the identification of Member 
States h olding conviction information on third -country nationals and stateless 
persons (ECRIS -TCN) to supplement the European Criminal Records 
Information System and amending Regulation (EU) 2018/1726 (OJ L 135, 
22.5.2019, p. 1).  
7. Interoperability  
(a) Regulation (EU)  2019/817 of the European Parliament and of the Council of 20 
May 2019 on establishing a framework for interoperability between EU 
information systems in the field of borders and visa (OJ L 135, 22.5.2019, p. 
27). 
(b) Regulation (EU) 2019/818 of the European P arliament and of the Council of 20 
May 2019 on establishing a framework for interoperability between EU 
information systems in the field of police and judicial cooperation, asylum and 
migration (OJ L 135, 22.5.2019, p. 85).   
EN 16  EN