Brussels, 03 November 2021
WK 13177/2021 INIT
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TELECOM
WORKING PAPER
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CONTRIBUTION
From:
General Secretariat of the Council
To:
Working Party on Telecommunications and Information Society
Subject:
Artificial Intelligence Act - NL comments Articles 1-29, Annexes I-IV (doc.
8115/21)
Delegations will find in annex NL comments on Artificial Intelligence Act (Articles 1-29, Annexes I-IV).
WK 13177/2021 INIT
LIMITE
EN

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
consolidation of your comments. When adding new provisions, please use the free rows provided for this purpose between the provisions. You can add multiple provisions in one row, if necessary, but
do not add or remove rows. For drafting suggestions (2nd column), please copy the relevant sentence or sentences from a given paragraph or point into the second column and add or remove text.
Please do not use track changes, but highlight your additions in yellow or use strikethrough to indicate deletions. You do not need to copy entire paragraphs or points to indicate your changes, copying
and modifying the relevant sentences is sufficient. For comments on specific provisions, please insert your remarks in the 3rd column in the relevant row. If you wish to make general comments on the
entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
Commission proposal
Drafting Suggestions
Comments
2021/0106 (COD)

General comments:
Proposal for a
NL appreciates the opportunity provided bythe
REGULATION OF THE EUROPEAN
Slovenian Presidency to submit input on Chapter I,
PARLIAMENT AND OF THE COUNCIL
II and III of the proposal for a Artificial Intelligence
Act (hereinafter AI Act), as well as its
LAYING DOWN HARMONISED RULES
corresponding Annexes I, II, III and IIII. Please
ON ARTIFICIAL INTELLIGENCE
note, that the drafting suggestions and/or
(ARTIFICIAL INTELLIGENCE ACT) AND
comments provided below are non-exhaustive: We
AMENDING CERTAIN UNION
are currently still analysing the proposal in -depth
which is why at this point we are only able tp share
LEGISLATIVE ACTS
general comments; the NL comments below hone
in on issues considered to be most pertinent.
We urge, as also mentioned during the Telecom
Council of October 14th, that thoroughness and
quality takes precedence over speed in the process
of coming to a common position. This is a complex
file with potentially far-reaching implications.
1

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
consolidation of your comments. When adding new provisions, please use the free rows provided for this purpose between the provisions. You can add multiple provisions in one row, if necessary, but
do not add or remove rows. For drafting suggestions (2nd column), please copy the relevant sentence or sentences from a given paragraph or point into the second column and add or remove text.
Please do not use track changes, but highlight your additions in yellow or use strikethrough to indicate deletions. You do not need to copy entire paragraphs or points to indicate your changes, copying
and modifying the relevant sentences is sufficient. For comments on specific provisions, please insert your remarks in the 3rd column in the relevant row. If you wish to make general comments on the
entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
Furthermore, at the time of writing, the formation
of a new Dutch government is ongoing. Our
current government is under resignation
1)  The  Netherlands    calls  for  strengther
involvement  of  Member  States  to  amend  Annex  I
and  III  in  the  proposed  AI  Act,  and  therefore  the
flexibility  to  react  to  the  fast  technological
developtments of AI. In our opinion, these annexes
are  essential  elements  of  the  proposed  regulation
and we propose to change art 7 into implementing
acts. Moreover The Netherlands would like to have
removed high risk areas in Annex III, as menioned
in prior draft proposals in this final one it has been
removed. Finally, NL calls for the incorporation of a
consultation  procedure  to  harvest  perspectives  of
non-governmental    stakeholders  such  as  civil
society  and  enterprises  that  have  expertise  about
developments  with  regards  to  techniques,
approaches and areas of high-risk AI, based on best
practices.
2

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
consolidation of your comments. When adding new provisions, please use the free rows provided for this purpose between the provisions. You can add multiple provisions in one row, if necessary, but
do not add or remove rows. For drafting suggestions (2nd column), please copy the relevant sentence or sentences from a given paragraph or point into the second column and add or remove text.
Please do not use track changes, but highlight your additions in yellow or use strikethrough to indicate deletions. You do not need to copy entire paragraphs or points to indicate your changes, copying
and modifying the relevant sentences is sufficient. For comments on specific provisions, please insert your remarks in the 3rd column in the relevant row. If you wish to make general comments on the
entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
2)  The Netherlands takes the position that the AI-
Act  should  be  without  prejudice  to  both  EU  and
national rules governing the context in which the AI-
system  is  used.  For  instance,  according  to  the
principles  of  fair  trial  and  good  administration,
certain decisions that are unilaterally binding must
be  duly  justified.  This  motivation  principle  should
apply  to  any  AI  system  used  by  the  public  sector
and cannot be overridden by the AI Act if this act
does not contain provisions regarding this principle.
3)  The  Netherlands  worries  about  the  current
definition  of  “AI  system”  as  used  in  Article  3  and
Annex  I,  as  it  may  create  an  overbroad  scope  of
application  for  this  regulation.  We  suggest
specifying the scope to AI systems that because of
their  specific  characteristics  warrant  the  extra
measures this regulation prescribes. Our concern is
that the combination of this broad definition of an
AI-system, the extensive list of techniques (annex
I) and the broad definitions of the high-risk areas,
(annex    III)  may  result  in  regulating  algorithmic
3

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
consolidation of your comments. When adding new provisions, please use the free rows provided for this purpose between the provisions. You can add multiple provisions in one row, if necessary, but
do not add or remove rows. For drafting suggestions (2nd column), please copy the relevant sentence or sentences from a given paragraph or point into the second column and add or remove text.
Please do not use track changes, but highlight your additions in yellow or use strikethrough to indicate deletions. You do not need to copy entire paragraphs or points to indicate your changes, copying
and modifying the relevant sentences is sufficient. For comments on specific provisions, please insert your remarks in the 3rd column in the relevant row. If you wish to make general comments on the
entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
systems with minimum risk for fundamental rights.
This  bears  the  risk  to  be  disproportionate,  to
overburden  organizations  (particularly  SMEs),  to
stifle  innovation  and  needs  to  be  considered
carefully.
4) Regarding the definitions in article 3 and the
obligations in articles 16-29: more attention should
be given to clarifying the different roles and
responsibilities organizations have when taking on
more than one role (provider, user, etc). This
applies particularly to the responsibilities
government organizations have when developing in
house and when using AI systems in house.
5) The NL supports a risk-based approach in which
the  requirements  are  proportional  to  the  risk.
Extensive  requirements  apply  to  high-risk  AI
systems to prevent or mitigate the risks (article 9,
Chapter II), such as the obligation to carry out an
ex ante conformity assessment or have it carried out
(article 19, Chapter III). Although we agree that a
certain level of requirements and obligations should
4

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
consolidation of your comments. When adding new provisions, please use the free rows provided for this purpose between the provisions. You can add multiple provisions in one row, if necessary, but
do not add or remove rows. For drafting suggestions (2nd column), please copy the relevant sentence or sentences from a given paragraph or point into the second column and add or remove text.
Please do not use track changes, but highlight your additions in yellow or use strikethrough to indicate deletions. You do not need to copy entire paragraphs or points to indicate your changes, copying
and modifying the relevant sentences is sufficient. For comments on specific provisions, please insert your remarks in the 3rd column in the relevant row. If you wish to make general comments on the
entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
be imposed by the actors, we strongly ask for more
guidance  especially  to  help  SMEs,  start-ups  and
small scale providers and users.  This is important
because those involved do not always have the right
expertise  in  their  companies  available.   It  is
important  to  guide  them  as  much  as  possible,
especially  for  instance  with  the  conformity
assessment  and  administration  burdens.  For
instance guidance can be given  in the form of tools,
roadmaps or checklists.
6) The Netherlands is carefully considering the role
of  those  affected  by  AI  systems:  This  draft
regulation  focuses  on  economic  and  institutional
actors that provide or use AI systems, and focuses
on  governance.  We  are  currently  researching
whether  those  affected  by  AI  systems  in  its
provisions have sufficient access to legal protection
under  this  regulation  combined  with  other
legislation.
7)  The  Netherlands  is  carefully  considering  the
harms in article 5, and whether we have to include
5

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
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do not add or remove rows. For drafting suggestions (2nd column), please copy the relevant sentence or sentences from a given paragraph or point into the second column and add or remove text.
Please do not use track changes, but highlight your additions in yellow or use strikethrough to indicate deletions. You do not need to copy entire paragraphs or points to indicate your changes, copying
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(alternative)  measures  to  further  avoid  unlawful
breaches of human rights, democracy and the rule
of law.
8) Align AI Act with the GDPR : The AI Act overall
currently  lacks  clear  references  to  the  existing
provisions in the GDPR. The AIA would benefit from
clearer  references  to  the  GDPR,  to  increase  legal
certainty and clarity.
9)  Exclude national security: Please explicietly
exclude national security from the scope of this
regulation as it is an exclusive member state
competence.
10) By the use of the word ‘students’ in Annex III
the Cion proposal could suggest only to refer to
vocational and higher education, and lifelong
learning. AI systems are also applied, and perhaps
even more, in primary and secondary education,
and children in this age group (minors up to 17
years) are even more vulnerable. In the
understanding that the AI Act should be applicable
6

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
consolidation of your comments. When adding new provisions, please use the free rows provided for this purpose between the provisions. You can add multiple provisions in one row, if necessary, but
do not add or remove rows. For drafting suggestions (2nd column), please copy the relevant sentence or sentences from a given paragraph or point into the second column and add or remove text.
Please do not use track changes, but highlight your additions in yellow or use strikethrough to indicate deletions. You do not need to copy entire paragraphs or points to indicate your changes, copying
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
to all educational sectors we suggest a minor
redrafting to clarify this. Secondly, the AI Act
should take into account that in education
developments take place such as flexibilisation,
with as a consequence a shift from ‘summative
assessment’ (evaluation of what has been learned,
i.e. learning outcomes) to ‘formative assessment’
(assessment with a view to steer the learning
process), as well as predictive use of AI, with
impact on equal opportunities.
(b) AI systems intended to be used for the purpose
of assessing pupils and students in educational and
vocational training institutions at all levels with a
view to assessing learning outcomes,  steering
the  learning  process  and  for  assessing
participants  in  tests  commonly  required  for
admission to educational institutions.



7

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
consolidation of your comments. When adding new provisions, please use the free rows provided for this purpose between the provisions. You can add multiple provisions in one row, if necessary, but
do not add or remove rows. For drafting suggestions (2nd column), please copy the relevant sentence or sentences from a given paragraph or point into the second column and add or remove text.
Please do not use track changes, but highlight your additions in yellow or use strikethrough to indicate deletions. You do not need to copy entire paragraphs or points to indicate your changes, copying
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
1.
This Regulation applies to:

(a)
providers placing on the market or

putting into service AI systems in the Union,
irrespective of whether those providers are
established within the Union or in a third
country;

(b)
users of AI systems located within the

Union;

(c)
providers and users of AI systems that

are located in a third country, where the output
produced by the system is used in the Union;

2.
For high-risk AI systems that are safety

components of products or systems, or which
10

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).

(h)
Regulation (EU) 2019/2144.

3.
This Regulation shall not apply to AI

systems developed or used exclusively for
military purposes.

4.
This Regulation shall not apply to public

authorities in a third country nor to international
organisations falling within the scope of this
Regulation pursuant to paragraph 1, where those
authorities or organisations use AI systems in
the framework of international agreements for
law enforcement and judicial cooperation with
the Union or with one or more Member States.

12

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
5.
This Regulation shall not affect the

application of the provisions on the liability of
intermediary service providers set out in
Chapter II, Section IV of Directive 2000/31/EC
of the European Parliament and of the Council1
[as to be replaced by the corresponding
provisions of the Digital Services Act].

Article 3

Definitions

For the purpose of this Regulation, the

following definitions apply:

1
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, 17.7.2000, p. 1).
13

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(1)
‘artificial intelligence system’ (AI

system) means software that is developed with
one or more of the techniques and approaches
listed in Annex I and can, for a given set of
human-defined objectives, generate outputs
such as content, predictions, recommendations,
or decisions influencing the environments they
interact with;

(1)
‘provider’ means a natural or legal

person, public authority, agency or other body
that develops an AI system or that has an AI
system developed with a view to placing it on
the market or putting it into service under its
own name or trademark, whether for payment or
free of charge;

14

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
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and modifying the relevant sentences is sufficient. For comments on specific provisions, please insert your remarks in the 3rd column in the relevant row. If you wish to make general comments on the
entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(3)
‘small-scale provider’ means a provider

that is a micro or small enterprise within the
meaning of Commission Recommendation
2003/361/EC2;

(4)
‘user’ means any natural or legal person,

public authority, agency or other body using an
AI system under its authority, except where the
AI system is used in the course of a personal
non-professional activity;

(5)
‘authorised representative’ means any

natural or legal person established in the Union
who has received a written mandate from a
provider of an AI system to, respectively,
perform and carry out on its behalf the

2
Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
15

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
consolidation of your comments. When adding new provisions, please use the free rows provided for this purpose between the provisions. You can add multiple provisions in one row, if necessary, but
do not add or remove rows. For drafting suggestions (2nd column), please copy the relevant sentence or sentences from a given paragraph or point into the second column and add or remove text.
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
obligations and procedures established by this
Regulation;

(6)
‘importer’ means any natural or legal

person established in the Union that places on
the market or puts into service an AI system that
bears the name or trademark of a natural or legal
person established outside the Union;

(7)
‘distributor’ means any natural or legal

person in the supply chain, other than the
provider or the importer, that makes an AI
system available on the Union market without
affecting its properties;

16

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(8)
‘operator’ means the provider, the user,

the authorised representative, the importer and
the distributor;

(9)
‘placing on the market’ means the first

making available of an AI system on the Union
market;

(10)  ‘making available on the market’ means

any supply of an AI system for distribution or
use on the Union market in the course of a
commercial activity, whether in return for
payment or free of charge;

(11)  ‘putting into service’ means the supply

of an AI system for first use directly to the user
17

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
or for own use on the Union market for its
intended purpose;

(12)  ‘intended purpose’ means the use for

which an AI system is intended by the provider,
including the specific context and conditions of
use, as specified in the information supplied by
the provider in the instructions for use,
promotional or sales materials and statements,
as well as in the technical documentation;

(13)  ‘reasonably foreseeable misuse’ means

the use of an AI system in a way that is not in
accordance with its intended purpose, but which
may result from reasonably foreseeable human
behaviour or interaction with other systems;

18

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
Important: In order to guarantee that your comments appear accurately, please do not modify the table format by adding/removing/adjusting/merging/splitting cells and rows. This would hinder the
consolidation of your comments. When adding new provisions, please use the free rows provided for this purpose between the provisions. You can add multiple provisions in one row, if necessary, but
do not add or remove rows. For drafting suggestions (2nd column), please copy the relevant sentence or sentences from a given paragraph or point into the second column and add or remove text.
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(14)  ‘safety component of a product or

system’ means a component of a product or of a
system which fulfils a safety function for that
product or system or the failure or
malfunctioning of which endangers the health
and safety of persons or property;

(15)  ‘instructions for use’ means the

information provided by the provider to inform
the user of in particular an AI system’s intended
purpose and proper use, inclusive of the specific
geographical, behavioural or functional setting
within which the high-risk AI system is
intended to be used;

(16)  ‘recall of an AI system’ means any

measure aimed at achieving the return to the
19

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

Deadline for comments: 26 October 2021
Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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provider of an AI system made available to
users;

(17)  ‘withdrawal of an AI system’ means any

measure aimed at preventing the distribution,
display and offer of an AI system;

(18)  ‘performance of an AI system’ means

the ability of an AI system to achieve its
intended purpose;

(19)  ‘notifying authority’ means the national

authority responsible for setting up and carrying
out the necessary procedures for the assessment,
designation and notification of conformity
assessment bodies and for their monitoring;

20

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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(20)  ‘conformity assessment’ means the

process of verifying whether the requirements
set out in Title III, Chapter 2 of this Regulation
relating to an AI system have been fulfilled;

(21)  ‘conformity assessment body’ means a

body that performs third-party conformity
assessment activities, including testing,
certification and inspection;

(22)  ‘notified body’ means a conformity

assessment body designated in accordance with
this Regulation and other relevant Union
harmonisation legislation;

(23)  ‘substantial modification’ means a

change to the AI system following its placing on
21

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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the market or putting into service which affects
the compliance of the AI system with the
requirements set out in Title III, Chapter 2 of
this Regulation or results in a modification to
the intended purpose for which the AI system
has been assessed;

(24) ‘CE marking of conformity’ (CE

marking) means a marking by which a provider
indicates that an AI system is in conformity with
the requirements set out in Title III, Chapter 2 of
this Regulation and other applicable Union
legislation harmonising the conditions for the
marketing of products (‘Union harmonisation
legislation’) providing for its affixing;

22

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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(25)  ‘post-market monitoring’ means all

activities carried out by providers of AI systems
to proactively collect and review experience
gained from the use of AI systems they place on
the market or put into service for the purpose of
identifying any need to immediately apply any
necessary corrective or preventive actions;

(26)  ‘market surveillance authority’ means

the national authority carrying out the activities
and taking the measures pursuant to Regulation
(EU) 2019/1020;

(27)  ‘harmonised standard’ means a

European standard as defined in Article 2(1)(c)
of Regulation (EU) No 1025/2012;

23

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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(28)  ‘common specifications’ means a

document, other than a standard, containing
technical solutions providing a means to,
comply with certain requirements and
obligations established under this Regulation;

(29)  ‘training data’ means data used for

training an AI system through fitting its
learnable parameters, including the weights of a
neural network;

(30)  ‘validation data’ means data used for

providing an evaluation of the trained AI system
and for tuning its non-learnable parameters and
its learning process, among other things, in
order to prevent overfitting; whereas the
validation dataset can be a separate dataset or
24

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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part of the training dataset, either as a fixed or
variable split;

(31)  ‘testing data’ means data used for

providing an independent evaluation of the
trained and validated AI system in order to
confirm the expected performance of that
system before its placing on the market or
putting into service;

(32)  ‘input data’ means data provided to or

directly acquired by an AI system on the basis
of which the system produces an output;

(33)  ‘biometric data’ means personal data

resulting from specific technical processing
relating to the physical, physiological or
25

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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behavioural characteristics of a natural person,
which allow or confirm the unique identification
of that natural person, such as facial images or
dactyloscopic data;

(34)  ‘emotion recognition system’ means an

AI system for the purpose of identifying or
inferring emotions or intentions of natural
persons on the basis of their biometric data;

(35)  ‘biometric categorisation system’ means

an AI system for the purpose of assigning
natural persons to specific categories, such as
sex, age, hair colour, eye colour, tattoos, ethnic
origin or sexual or political orientation, on the
basis of their biometric data;

26

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(36)  ‘remote biometric identification system’

means an AI system for the purpose of
identifying natural persons at a distance through
the comparison of a person’s biometric data
with the biometric data contained in a reference
database, and without prior knowledge of the
user of the AI system whether the person will be
present and can be identified ;

(37)  ‘‘real-time’ remote biometric

identification system’ means a remote biometric
identification system whereby the capturing of
biometric data, the comparison and the
identification all occur without a significant
delay. This comprises not only instant
identification, but also limited short delays in
order to avoid circumvention.
27

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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(38)  ‘‘post’ remote biometric identification

system’ means a remote biometric identification
system other than a ‘real-time’ remote biometric
identification system;

(39)  ‘publicly accessible space’ means any

physical place accessible to the public,
regardless of whether certain conditions for
access may apply;

(40)  ‘law enforcement authority’ means:

(a)
any public authority competent for the

prevention, investigation, detection or
prosecution of criminal offences or the
execution of criminal penalties, including the
28

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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safeguarding against and the prevention of
threats to public security; or

(b)
any other body or entity entrusted by

Member State law to exercise public authority
and public powers for the purposes of the
prevention, investigation, detection or
prosecution of criminal offences or the
execution of criminal penalties, including the
safeguarding against and the prevention of
threats to public security;

(41) ‘law enforcement’ means activities

carried out by law enforcement authorities for
the prevention, investigation, detection or
prosecution of criminal offences or the
execution of criminal penalties, including the
29

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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safeguarding against and the prevention of
threats to public security;

(42)  ‘national supervisory authority’ means

the authority to which a Member State assigns
the responsibility for the implementation and
application of this Regulation, for coordinating
the activities entrusted to that Member State, for
acting as the single contact point for the
Commission, and for representing the Member
State at the European Artificial Intelligence
Board;

(43)  ‘national competent authority’ means the

national supervisory authority, the notifying
authority and the market surveillance authority;

30

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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(44) ‘serious incident’ means any incident

that directly or indirectly leads, might have led
or might lead to any of the following:

(a)
the death of a person or serious damage

to a person’s health, to property or the
environment,

(b)
a serious and irreversible disruption of

the management and operation of critical
infrastructure.

Article 4

Amendments to Annex I

The Commission is empowered to adopt

delegated acts in accordance with Article 73 to
31

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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(a)
the placing on the market, putting into

service or use of an AI system that deploys
subliminal techniques beyond a person’s
consciousness in order to materially distort a
person’s behaviour in a manner that causes or is
likely to cause that person or another person
physical or psychological harm;

(b)
the placing on the market, putting into

service or use of an AI system that exploits any
of the vulnerabilities of a specific group of
persons due to their age, physical or mental
disability, in order to materially distort the
behaviour of a person pertaining to that group in
a manner that causes or is likely to cause that
person or another person physical or
psychological harm;
33

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(c)
the placing on the market, putting into

service or use of AI systems by public
authorities or on their behalf for the evaluation
or classification of the trustworthiness of natural
persons over a certain period of time based on
their social behaviour or known or predicted
personal or personality characteristics, with the
social score leading to either or both of the
following:

(i)
detrimental or unfavourable treatment of

certain natural persons or whole groups thereof
in social contexts which are unrelated to the
contexts in which the data was originally
generated or collected;

34

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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(ii)
detrimental or unfavourable treatment of

certain natural persons or whole groups thereof
that is unjustified or disproportionate to their
social behaviour or its gravity;

(d)
the use of ‘real-time’ remote biometric

identification systems in publicly accessible
spaces for the purpose of law enforcement,
unless and in as far as such use is strictly
necessary for one of the following objectives:

(i)
the targeted search for specific potential

victims of crime, including missing children;

(ii)
the prevention of a specific, substantial

and imminent threat to the life or physical safety
of natural persons or of a terrorist attack;
35

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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(iii)
the detection, localisation, identification

or prosecution of a perpetrator or suspect of a
criminal offence referred to in Article 2(2) of
Council Framework Decision 2002/584/JHA3
and punishable in the Member State concerned
by a custodial sentence or a detention order for a
maximum period of at least three years, as
determined by the law of that Member State.

2.
The use of ‘real-time’ remote biometric

identification systems in publicly accessible
spaces for the purpose of law enforcement for
any of the objectives referred to in paragraph 1

3
Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States (OJ L 190, 18.7.2002, p.
1).

36

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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Artificial Intelligence Act (Articles 1-29, Annexes I-IV)
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point d) shall take into account the following
elements:

(a)
the nature of the situation giving rise to

the possible use, in particular the seriousness,
probability and scale of the harm caused in the
absence of the use of the system;

(b)
the consequences of the use of the

system for the rights and freedoms of all persons
concerned, in particular the seriousness,
probability and scale of those consequences.

In addition, the use of ‘real-time’ remote

biometric identification systems in publicly
accessible spaces for the purpose of law
enforcement for any of the objectives referred to
37

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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in paragraph 1 point d) shall comply with
necessary and proportionate safeguards and
conditions in relation to the use, in particular as
regards the temporal, geographic and personal
limitations.

3.
As regards paragraphs 1, point (d) and 2,

each individual use for the purpose of law
enforcement of a ‘real-time’ remote biometric
identification system in publicly accessible
spaces shall be subject to a prior authorisation
granted by a judicial authority or by an
independent administrative authority of the
Member State in which the use is to take place,
issued upon a reasoned request and in
accordance with the detailed rules of national
law referred to in paragraph 4. However, in a
38

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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duly justified situation of urgency, the use of the
system may be commenced without an
authorisation and the authorisation may be
requested only during or after the use.

The competent judicial or administrative

authority shall only grant the authorisation
where it is satisfied, based on objective evidence
or clear indications presented to it, that the use
of the ‘real-time’ remote biometric
identification system at issue is necessary for
and proportionate to achieving one of the
objectives specified in paragraph 1, point (d), as
identified in the request. In deciding on the
request, the competent judicial or administrative
authority shall take into account the elements
referred to in paragraph 2.
39

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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4.
A Member State may decide to provide

for the possibility to fully or partially authorise
the use of ‘real-time’ remote biometric
identification systems in publicly accessible
spaces for the purpose of law enforcement
within the limits and under the conditions listed
in paragraphs 1, point (d), 2 and 3. That
Member State shall lay down in its national law
the necessary detailed rules for the request,
issuance and exercise of, as well as supervision
relating to, the authorisations referred to in
paragraph 3. Those rules shall also specify in
respect of which of the objectives listed in
paragraph 1, point (d), including which of the
criminal offences referred to in point (iii)
thereof, the competent authorities may be
40

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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independently from the products referred to in
points (a) and (b), that AI system shall be
considered high-risk where both of the
following conditions are fulfilled:

(a)
the AI system is intended to be used as a

safety component of a product, or is itself a
product, covered by the Union harmonisation
legislation listed in Annex II;

(b)
the product whose safety component is

the AI system, or the AI system itself as a
product, is required to undergo a third-party
conformity assessment with a view to the
placing on the market or putting into service of
that product pursuant to the Union
harmonisation legislation listed in Annex II.
42

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(a)
the AI systems are intended to be used in

any of the areas listed in points 1 to 8 of Annex
III;

(b)
the AI systems pose a risk of harm to the

health and safety, or a risk of adverse impact on
fundamental rights, that is, in respect of its
severity and probability of occurrence,
equivalent to or greater than the risk of harm or
of adverse impact posed by the high-risk AI
systems already referred to in Annex III.

2.
When assessing for the purposes of

paragraph 1 whether an AI system poses a risk
of harm to the health and safety or a risk of
adverse impact on fundamental rights that is
equivalent to or greater than the risk of harm
44

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posed by the high-risk AI systems already
referred to in Annex III, the Commission shall
take into account the following criteria:

(a)
the intended purpose of the AI system;

(b)
the extent to which an AI system has

been used or is likely to be used;

(c)
the extent to which the use of an AI

system has already caused harm to the health
and safety or adverse impact on the fundamental
rights or has given rise to significant concerns in
relation to the materialisation of such harm or
adverse impact, as demonstrated by reports or
documented allegations submitted to national
competent authorities;
45

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(d)
the potential extent of such harm or such

adverse impact, in particular in terms of its
intensity and its ability to affect a plurality of
persons;

(e)
the extent to which potentially harmed or

adversely impacted persons are dependent on
the outcome produced with an AI system, in
particular because for practical or legal reasons
it is not reasonably possible to opt-out from that
outcome;

(f)
the extent to which potentially harmed or

adversely impacted persons are in a vulnerable
position in relation to the user of an AI system,
in particular due to an imbalance of power,
46

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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knowledge, economic or social circumstances,
or age;

(g)
the extent to which the outcome

produced with an AI system is easily reversible,
whereby outcomes having an impact on the
health or safety of persons shall not be
considered as easily reversible;

(h)
the extent to which existing Union

legislation provides for:

(i)
effective measures of redress in relation

to the risks posed by an AI system, with the
exclusion of claims for damages;

47

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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to in Article 9 shall be taken into account when
ensuring compliance with those requirements.

Article 9

Risk management system

1.
A risk management system shall be

established, implemented, documented and
maintained in relation to high-risk AI systems.

2.
The risk management system shall

consist of a continuous iterative process run
throughout the entire lifecycle of a high-risk AI
system, requiring regular systematic updating. It
shall comprise the following steps:

49

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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(a)
identification and analysis of the known

and foreseeable risks associated with each high-
risk AI system;

(b)
estimation and evaluation of the risks

that may emerge when the high-risk AI system
is used in accordance with its intended purpose
and under conditions of reasonably foreseeable
misuse;

(c)
evaluation of other possibly arising risks

based on the analysis of data gathered from the
post-market monitoring system referred to in
Article 61;

50

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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(d)
adoption of suitable risk management

measures in accordance with the provisions of
the following paragraphs.

3.
The risk management measures referred

to in paragraph 2, point (d) shall give due
consideration to the effects and possible
interactions resulting from the combined
application of the requirements set out in this
Chapter 2. They shall take into account the
generally acknowledged state of the art,
including as reflected in relevant harmonised
standards or common specifications.

4.
The risk management measures referred

to in paragraph 2, point (d) shall be such that
any residual risk associated with each hazard as
51

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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well as the overall residual risk of the high-risk
AI systems is judged acceptable, provided that
the high-risk AI system is used in accordance
with its intended purpose or under conditions of
reasonably foreseeable misuse. Those residual
risks shall be communicated to the user.

In identifying the most appropriate risk

management measures, the following shall be
ensured:

(a)
elimination or reduction of risks as far as

possible through adequate design and
development;

52

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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(b)
where appropriate, implementation of

adequate mitigation and control measures in
relation to risks that cannot be eliminated;

(c)
provision of adequate information

pursuant to Article 13, in particular as regards
the risks referred to in paragraph 2, point (b) of
this Article, and, where appropriate, training to
users.

In eliminating or reducing risks related to the

use of the high-risk AI system, due
consideration shall be given to the technical
knowledge, experience, education, training to be
expected by the user and the environment in
which the system is intended to be used.

53

Commission proposal (doc. 8115/21 – COM(2021) 206 final)

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5.
High-risk AI systems shall be tested for

the purposes of identifying the most appropriate
risk management measures. Testing shall ensure
that high-risk AI systems perform consistently
for their intended purpose and they are in
compliance with the requirements set out in this
Chapter.

6.
Testing procedures shall be suitable to

achieve the intended purpose of the AI system
and do not need to go beyond what is necessary
to achieve that purpose.

7.
The testing of the high-risk AI systems

shall be performed, as appropriate, at any point
in time throughout the development process,
and, in any event, prior to the placing on the
54

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market or the putting into service. Testing shall
be made against preliminarily defined metrics
and probabilistic thresholds that are appropriate
to the intended purpose of the high-risk AI
system.

8.
When implementing the risk

management system described in paragraphs 1
to 7, specific consideration shall be given to
whether the high-risk AI system is likely to be
accessed by or have an impact on children.

9.
For credit institutions regulated by

Directive 2013/36/EU, the aspects described in
paragraphs 1 to 8 shall be part of the risk
management procedures established by those
55

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institutions pursuant to Article 74 of that
Directive.

Article 10

Data and data governance

1.
High-risk AI systems which make use of

techniques involving the training of models with
data shall be developed on the basis of training,
validation and testing data sets that meet the
quality criteria referred to in paragraphs 2 to 5.

2.
Training, validation and testing data sets

shall be subject to appropriate data governance
and management practices. Those practices shall
concern in particular,

56

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(a)
the relevant design choices;

(b)
data collection;

(c)
relevant data preparation processing

operations, such as annotation, labelling,
cleaning, enrichment and aggregation;

(d)
the formulation of relevant assumptions,

notably with respect to the information that the
data are supposed to measure and represent;

(e)
a prior assessment of the availability,

quantity and suitability of the data sets that are
needed;

(f)
examination in view of possible biases;

57

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(g)
the identification of any possible data

gaps or shortcomings, and how those gaps and
shortcomings can be addressed.

3.
Training, validation and testing data sets

shall be relevant, representative, free of errors
and complete. They shall have the appropriate
statistical properties, including, where
applicable, as regards the persons or groups of
persons on which the high-risk AI system is
intended to be used. These characteristics of the
data sets may be met at the level of individual
data sets or a combination thereof.

4.
Training, validation and testing data sets

shall take into account, to the extent required by
58

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the intended purpose, the characteristics or
elements that are particular to the specific
geographical, behavioural or functional setting
within which the high-risk AI system is
intended to be used.

5.
To the extent that it is strictly necessary

for the purposes of ensuring bias monitoring,
detection and correction in relation to the high-
risk AI systems, the providers of such systems
may process special categories of personal data
referred to in Article 9(1) of Regulation (EU)
2016/679, Article 10 of Directive (EU)
2016/680 and Article 10(1) of Regulation (EU)
2018/1725, subject to appropriate safeguards for
the fundamental rights and freedoms of natural
persons, including technical limitations on the
59

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re-use and use of state-of-the-art security and
privacy-preserving measures, such as
pseudonymisation, or encryption where
anonymisation may significantly affect the
purpose pursued.

6.
Appropriate data governance and

management practices shall apply for the
development of high-risk AI systems other than
those which make use of techniques involving
the training of models in order to ensure that
those high-risk AI systems comply with
paragraph 2.

Article 11

Technical documentation

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1.
The technical documentation of a high-

risk AI system shall be drawn up before that
system is placed on the market or put into
service and shall be kept up-to date.

The technical documentation shall be drawn up

in such a way to demonstrate that the high-risk
AI system complies with the requirements set
out in this Chapter and provide national
competent authorities and notified bodies with
all the necessary information to assess the
compliance of the AI system with those
requirements. It shall contain, at a minimum, the
elements set out in Annex IV.

2.
Where a high-risk AI system related to a

product, to which the legal acts listed in Annex
61

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II, section A apply, is placed on the market or
put into service one single technical
documentation shall be drawn up containing all
the information set out in Annex IV as well as
the information required under those legal acts.

3.
The Commission is empowered to adopt

delegated acts in accordance with Article 73 to
amend Annex IV where necessary to ensure
that, in the light of technical progress, the
technical documentation provides all the
necessary information to assess the compliance
of the system with the requirements set out in
this Chapter.

Article 12

Record-keeping
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1.
High-risk AI systems shall be designed

and developed with capabilities enabling the
automatic recording of events (‘logs’) while the
high-risk AI systems is operating. Those
logging capabilities shall conform to recognised
standards or common specifications.

2.
The logging capabilities shall ensure a

level of traceability of the AI system’s
functioning throughout its lifecycle that is
appropriate to the intended purpose of the
system.

3.
In particular, logging capabilities shall

enable the monitoring of the operation of the
high-risk AI system with respect to the
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occurrence of situations that may result in the
AI system presenting a risk within the meaning
of Article 65(1) or lead to a substantial
modification, and facilitate the post-market
monitoring referred to in Article 61.

4.
For high-risk AI systems referred to in

paragraph 1, point (a) of Annex III, the logging
capabilities shall provide, at a minimum:

(a)
recording of the period of each use of the

system (start date and time and end date and
time of each use);

(b)
the reference database against which

input data has been checked by the system;

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(c)
the input data for which the search has

led to a match;

(d)
the identification of the natural persons

involved in the verification of the results, as
referred to in Article 14 (5).

Article 13

Transparency and provision of information to
users

1.
High-risk AI systems shall be designed

and developed in such a way to ensure that their
operation is sufficiently transparent to enable
users to interpret the system’s output and use it
appropriately. An appropriate type and degree
of transparency shall be ensured, with a view to
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achieving compliance with the relevant
obligations of the user and of the provider set
out in Chapter 3 of this Title.

2.
High-risk AI systems shall be

accompanied by instructions for use in an
appropriate digital format or otherwise that
include concise, complete, correct and clear
information that is relevant, accessible and
comprehensible to users.

3.
The information referred to in paragraph

2 shall specify:

(a)
the identity and the contact details of the

provider and, where applicable, of its authorised
representative;
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(b)
the characteristics, capabilities and

limitations of performance of the high-risk AI
system, including:

(i)
its intended purpose;

(ii)
the level of accuracy, robustness and

cybersecurity referred to in Article 15 against
which the high-risk AI system has been tested
and validated and which can be expected, and
any known and foreseeable circumstances that
may have an impact on that expected level of
accuracy, robustness and cybersecurity;

(iii)
any known or foreseeable circumstance,

related to the use of the high-risk AI system in
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accordance with its intended purpose or under
conditions of reasonably foreseeable misuse,
which may lead to risks to the health and safety
or fundamental rights;

(iv)
its performance as regards the persons or

groups of persons on which the system is
intended to be used;

(v)
when appropriate, specifications for the

input data, or any other relevant information in
terms of the training, validation and testing data
sets used, taking into account the intended
purpose of the AI system.

(c)
the changes to the high-risk AI system

and its performance which have been pre-
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determined by the provider at the moment of the
initial conformity assessment, if any;

(d)
the human oversight measures referred

to in Article 14, including the technical
measures put in place to facilitate the
interpretation of the outputs of AI systems by
the users;

(e)
the expected lifetime of the high-risk AI

system and any necessary maintenance and care
measures to ensure the proper functioning of
that AI system, including as regards software
updates.

Article 14

Human oversight
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1.
High-risk AI systems shall be designed

and developed in such a way, including with
appropriate human-machine interface tools, that
they can be effectively overseen by natural
persons during the period in which the AI
system is in use.

2.
Human oversight shall aim at preventing

or minimising the risks to health, safety or
fundamental rights that may emerge when a
high-risk AI system is used in accordance with
its intended purpose or under conditions of
reasonably foreseeable misuse, in particular
when such risks persist notwithstanding the
application of other requirements set out in this
Chapter.
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3.
Human oversight shall be ensured

through either one or all of the following
measures:

(a)
identified and built, when technically

feasible, into the high-risk AI system by the
provider before it is placed on the market or put
into service;

(b)
identified by the provider before placing

the high-risk AI system on the market or putting
it into service and that are appropriate to be
implemented by the user.

4.
The measures referred to in paragraph 3

shall enable the individuals to whom human
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oversight is assigned to do the following, as
appropriate to the circumstances:

(a)
fully understand the capacities and

limitations of the high-risk AI system and be
able to duly monitor its operation, so that signs
of anomalies, dysfunctions and unexpected
performance can be detected and addressed as
soon as possible;

(b)
remain aware of the possible tendency of

automatically relying or over-relying on the
output produced by a high-risk AI system
(‘automation bias’), in particular for high-risk
AI systems used to provide information or
recommendations for decisions to be taken by
natural persons;
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(c)
be able to correctly interpret the high-

risk AI system’s output, taking into account in
particular the characteristics of the system and
the interpretation tools and methods available;

(d)
be able to decide, in any particular

situation, not to use the high-risk AI system or
otherwise disregard, override or reverse the
output of the high-risk AI system;

(e)
be able to intervene on the operation of

the high-risk AI system or interrupt the system
through a “stop” button or a similar procedure.

5.
For high-risk AI systems referred to in

point 1(a) of Annex III, the measures referred to
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in paragraph 3 shall be such as to ensure that, in
addition, no action or decision is taken by the
user on the basis of the identification resulting
from the system unless this has been verified
and confirmed by at least two natural persons.

Article 15

Accuracy, robustness and cybersecurity

1.
High-risk AI systems shall be designed

and developed in such a way that they achieve,
in the light of their intended purpose, an
appropriate level of accuracy, robustness and
cybersecurity, and perform consistently in those
respects throughout their lifecycle.

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2.
The levels of accuracy and the relevant

accuracy metrics of high-risk AI systems shall
be declared in the accompanying instructions of
use.

3.
High-risk AI systems shall be resilient as

regards errors, faults or inconsistencies that may
occur within the system or the environment in
which the system operates, in particular due to
their interaction with natural persons or other
systems.

The robustness of high-risk AI systems may be

achieved through technical redundancy
solutions, which may include backup or fail-safe
plans.

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High-risk AI systems that continue to learn after

being placed on the market or put into service
shall be developed in such a way to ensure that
possibly biased outputs due to outputs used as
an input for future operations (‘feedback loops’)
are duly addressed with appropriate mitigation
measures.

4.
High-risk AI systems shall be resilient as

regards attempts by unauthorised third parties to
alter their use or performance by exploiting the
system vulnerabilities.

The technical solutions aimed at ensuring the

cybersecurity of high-risk AI systems shall be
appropriate to the relevant circumstances and
the risks.
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The technical solutions to address AI specific

vulnerabilities shall include, where appropriate,
measures to prevent and control for attacks
trying to manipulate the training dataset (‘data
poisoning’), inputs designed to cause the model
to make a mistake (‘adversarial examples’), or
model flaws.

Chapter 3

OBLIGATIONS OF PROVIDERS AND

USERS OF HIGH-RISK AI SYSTEMS AND
OTHER PARTIES

Article 16

Obligations of providers of high-risk AI systems
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(e)
ensure that the high-risk AI system

undergoes the relevant conformity assessment
procedure, prior to its placing on the market or
putting into service;

(f)
comply with the registration obligations

referred to in Article 51;

(g)
take the necessary corrective actions, if

the high-risk AI system is not in conformity
with the requirements set out in Chapter 2 of
this Title;

(h)
inform the national competent

authorities of the Member States in which they
made the AI system available or put it into
service and, where applicable, the notified body
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of the non-compliance and of any corrective
actions taken;

(i)
to affix the CE marking to their high-risk

AI systems to indicate the conformity with this
Regulation in accordance with Article 49;

(j)
upon request of a national competent

authority, demonstrate the conformity of the
high-risk AI system with the requirements set
out in Chapter 2 of this Title.

Article 17

Quality management system

1.
Providers of high-risk AI systems shall

put a quality management system in place that
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ensures compliance with this Regulation. That
system shall be documented in a systematic and
orderly manner in the form of written policies,
procedures and instructions, and shall include at
least the following aspects:

(a)
a strategy for regulatory compliance,

including compliance with conformity
assessment procedures and procedures for the
management of modifications to the high-risk
AI system;

(b)
techniques, procedures and systematic

actions to be used for the design, design control
and design verification of the high-risk AI
system;

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(c)
techniques, procedures and systematic

actions to be used for the development, quality
control and quality assurance of the high-risk AI
system;

(d)
examination, test and validation

procedures to be carried out before, during and
after the development of the high-risk AI
system, and the frequency with which they have
to be carried out;

(e)
technical specifications, including

standards, to be applied and, where the relevant
harmonised standards are not applied in full, the
means to be used to ensure that the high-risk AI
system complies with the requirements set out
in Chapter 2 of this Title;
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(f)
systems and procedures for data

management, including data collection, data
analysis, data labelling, data storage, data
filtration, data mining, data aggregation, data
retention and any other operation regarding the
data that is performed before and for the
purposes of the placing on the market or putting
into service of high-risk AI systems;

(g)
the risk management system referred to

in Article 9;

(h)
the setting-up, implementation and

maintenance of a post-market monitoring
system, in accordance with Article 61;

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(i)
procedures related to the reporting of

serious incidents and of malfunctioning in
accordance with Article 62;

(j)
the handling of communication with

national competent authorities, competent
authorities, including sectoral ones, providing or
supporting the access to data, notified bodies,
other operators, customers or other interested
parties;

(k)
systems and procedures for record

keeping of all relevant documentation and
information;

(l)
resource management, including security

of supply related measures;
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(m)
an accountability framework setting out

the responsibilities of the management and other
staff with regard to all aspects listed in this
paragraph.

2.
The implementation of aspects referred

to in paragraph 1 shall be proportionate to the
size of the provider’s organisation.

3.
For providers that are credit institutions

regulated by Directive 2013/36/ EU, the
obligation to put a quality management system
in place shall be deemed to be fulfilled by
complying with the rules on internal governance
arrangements, processes and mechanisms
pursuant to Article 74 of that Directive. In that
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context, any harmonised standards referred to in
Article 40 of this Regulation shall be taken into
account.

Article 18

Obligation to draw up technical documentation

1.
Providers of high-risk AI systems shall

draw up the technical documentation referred to
in Article 11 in accordance with Annex IV.

2.
Providers that are credit institutions

regulated by Directive 2013/36/EU shall
maintain the technical documentation as part of
the documentation concerning internal
governance, arrangements, processes and
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mechanisms pursuant to Article 74 of that
Directive.

Article 19

Conformity assessment

1.
Providers of high-risk AI systems shall

ensure that their systems undergo the relevant
conformity assessment procedure in accordance
with Article 43, prior to their placing on the
market or putting into service. Where the
compliance of the AI systems with the
requirements set out in Chapter 2 of this Title
has been demonstrated following that
conformity assessment, the providers shall draw
up an EU declaration of conformity in
accordance with Article 48 and affix the CE
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marking of conformity in accordance with
Article 49.

2.
For high-risk AI systems referred to in

point 5(b) of Annex III that are placed on the
market or put into service by providers that are
credit institutions regulated by Directive
2013/36/EU, the conformity assessment shall be
carried out as part of the procedure referred to in
Articles 97 to101 of that Directive.

Article 20

Automatically generated logs

1.
Providers of high-risk AI systems shall

keep the logs automatically generated by their
high-risk AI systems, to the extent such logs are
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under their control by virtue of a contractual
arrangement with the user or otherwise by law.
The logs shall be kept for a period that is
appropriate in the light of the intended purpose
of high-risk AI system and applicable legal
obligations under Union or national law.

2.
Providers that are credit institutions

regulated by Directive 2013/36/EU shall
maintain the logs automatically generated by
their high-risk AI systems as part of the
documentation under Articles 74 of that
Directive.

Article 21

Corrective actions

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Providers of high-risk AI systems which

consider or have reason to consider that a high-
risk AI system which they have placed on the
market or put into service is not in conformity
with this Regulation shall immediately take the
necessary corrective actions to bring that system
into conformity, to withdraw it or to recall it, as
appropriate. They shall inform the distributors
of the high-risk AI system in question and,
where applicable, the authorised representative
and importers accordingly.

Article 22

Duty of information

Where the high-risk AI system presents a risk

within the meaning of Article 65(1) and that risk
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is known to the provider of the system, that
provider shall immediately inform the national
competent authorities of the Member States in
which it made the system available and, where
applicable, the notified body that issued a
certificate for the high-risk AI system, in
particular of the non-compliance and of any
corrective actions taken.

Article 23

Cooperation with competent authorities

Providers of high-risk AI systems shall, upon

request by a national competent authority,
provide that authority with all the information
and documentation necessary to demonstrate the
conformity of the high-risk AI system with the
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requirements set out in Chapter 2 of this Title, in
an official Union language determined by the
Member State concerned. Upon a reasoned
request from a national competent authority,
providers shall also give that authority access to
the logs automatically generated by the high-
risk AI system, to the extent such logs are under
their control by virtue of a contractual
arrangement with the user or otherwise by law.

Article 24

Obligations of product manufacturers

Where a high-risk AI system related to products

to which the legal acts listed in Annex II,
section A, apply, is placed on the market or put
into service together with the product
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
manufactured in accordance with those legal
acts and under the name of the product
manufacturer, the manufacturer of the product
shall take the responsibility of the compliance of
the AI system with this Regulation and, as far as
the AI system is concerned, have the same
obligations imposed by the present Regulation
on the provider.

Article 25

Authorised representatives

1.
Prior to making their systems available

on the Union market, where an importer cannot
be identified, providers established outside the
Union shall, by written mandate, appoint an
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authorised representative which is established in
the Union.

2.
The authorised representative shall

perform the tasks specified in the mandate
received from the provider. The mandate shall
empower the authorised representative to carry
out the following tasks:

(a)
keep a copy of the EU declaration of

conformity and the technical documentation at
the disposal of the national competent
authorities and national authorities referred to in
Article 63(7);

(b)
provide a national competent authority,

upon a reasoned request, with all the
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information and documentation necessary to
demonstrate the conformity of a high-risk AI
system with the requirements set out in Chapter
2 of this Title, including access to the logs
automatically generated by the high-risk AI
system to the extent such logs are under the
control of the provider by virtue of a contractual
arrangement with the user or otherwise by law;

(c)
cooperate with competent national

authorities, upon a reasoned request, on any
action the latter takes in relation to the high-risk
AI system.

Article 26

Obligations of importers

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1.
Before placing a high-risk AI system on

the market, importers of such system shall
ensure that:

(a)
the appropriate conformity assessment

procedure has been carried out by the provider
of that AI system

(b)
the provider has drawn up the technical

documentation in accordance with Annex IV;

(c)
the system bears the required conformity

marking and is accompanied by the required
documentation and instructions of use.

2.
Where an importer considers or has

reason to consider that a high-risk AI system is
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not in conformity with this Regulation, it shall
not place that system on the market until that AI
system has been brought into conformity.
Where the high-risk AI system presents a risk
within the meaning of Article 65(1), the
importer shall inform the provider of the AI
system and the market surveillance authorities
to that effect.

3.
Importers shall indicate their name,

registered trade name or registered trade mark,
and the address at which they can be contacted
on the high-risk AI system or, where that is not
possible, on its packaging or its accompanying
documentation, as applicable.

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4.
Importers shall ensure that, while a high-

risk AI system is under their responsibility,
where applicable, storage or transport conditions
do not jeopardise its compliance with the
requirements set out in Chapter 2 of this Title.

5.
Importers shall provide national

competent authorities, upon a reasoned request,
with all necessary information and
documentation to demonstrate the conformity of
a high-risk AI system with the requirements set
out in Chapter 2 of this Title in a language
which can be easily understood by that national
competent authority, including access to the
logs automatically generated by the high-risk AI
system to the extent such logs are under the
control of the provider by virtue of a contractual
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arrangement with the user or otherwise by law.
They shall also cooperate with those authorities
on any action national competent authority takes
in relation to that system.

Article 27

Obligations of distributors

1.
Before making a high-risk AI system

available on the market, distributors shall verify
that the high-risk AI system bears the required
CE conformity marking, that it is accompanied
by the required documentation and instruction
of use, and that the provider and the importer of
the system, as applicable, have complied with
the obligations set out in this Regulation.

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2.
Where a distributor considers or has

reason to consider that a high-risk AI system is
not in conformity with the requirements set out
in Chapter 2 of this Title, it shall not make the
high-risk AI system available on the market
until that system has been brought into
conformity with those requirements.
Furthermore, where the system presents a risk
within the meaning of Article 65(1), the
distributor shall inform the provider or the
importer of the system, as applicable, to that
effect.

3.
Distributors shall ensure that, while a

high-risk AI system is under their responsibility,
where applicable, storage or transport conditions
do not jeopardise the compliance of the system
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with the requirements set out in Chapter 2 of
this Title.

4.
A distributor that considers or has reason

to consider that a high-risk AI system which it
has made available on the market is not in
conformity with the requirements set out in
Chapter 2 of this Title shall take the corrective
actions necessary to bring that system into
conformity with those requirements, to
withdraw it or recall it or shall ensure that the
provider, the importer or any relevant operator,
as appropriate, takes those corrective actions.
Where the high-risk AI system presents a risk
within the meaning of Article 65(1), the
distributor shall immediately inform the national
competent authorities of the Member States in
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which it has made the product available to that
effect, giving details, in particular, of the non-
compliance and of any corrective actions taken.

5.
Upon a reasoned request from a national

competent authority, distributors of high-risk AI
systems shall provide that authority with all the
information and documentation necessary to
demonstrate the conformity of a high-risk
system with the requirements set out in Chapter
2 of this Title. Distributors shall also cooperate
with that national competent authority on any
action taken by that authority.

Article 28

Obligations of distributors, importers, users or
any other third-party
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1.
Any distributor, importer, user or other

third-party shall be considered a provider for the
purposes of this Regulation and shall be subject
to the obligations of the provider under Article
16, in any of the following circumstances:

(a)
they place on the market or put into

service a high-risk AI system under their name
or trademark;

(b)
they modify the intended purpose of a

high-risk AI system already placed on the
market or put into service;

(c)
they make a substantial modification to

the high-risk AI system.
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2.
Where the circumstances referred to in

paragraph 1, point (b) or (c), occur, the provider
that initially placed the high-risk AI system on
the market or put it into service shall no longer
be considered a provider for the purposes of this
Regulation.

Article 29

Obligations of users of high-risk AI systems

1.
Users of high-risk AI systems shall use

such systems in accordance with the instructions
of use accompanying the systems, pursuant to
paragraphs 2 and 5.

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2.
The obligations in paragraph 1 are

without prejudice to other user obligations under
Union or national law and to the user’s
discretion in organising its own resources and
activities for the purpose of implementing the
human oversight measures indicated by the
provider.

3.
Without prejudice to paragraph 1, to the

extent the user exercises control over the input
data, that user shall ensure that input data is
relevant in view of the intended purpose of the
high-risk AI system.

4.
Users shall monitor the operation of the

high-risk AI system on the basis of the
instructions of use. When they have reasons to
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consider that the use in accordance with the
instructions of use may result in the AI system
presenting a risk within the meaning of Article
65(1) they shall inform the provider or
distributor and suspend the use of the system.
They shall also inform the provider or
distributor when they have identified any
serious incident or any malfunctioning within
the meaning of Article 62 and interrupt the use
of the AI system. In case the user is not able to
reach the provider, Article 62 shall apply
mutatis mutandis.

For users that are credit institutions regulated by

Directive 2013/36/EU, the monitoring
obligation set out in the first subparagraph shall
be deemed to be fulfilled by complying with the
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rules on internal governance arrangements,
processes and mechanisms pursuant to Article
74 of that Directive.

5.
Users of high-risk AI systems shall keep

the logs automatically generated by that high-
risk AI system, to the extent such logs are under
their control. The logs shall be kept for a period
that is appropriate in the light of the intended
purpose of the high-risk AI system and
applicable legal obligations under Union or
national law.

Users that are credit institutions regulated by

Directive 2013/36/EU shall maintain the logs as
part of the documentation concerning internal
governance arrangements, processes and
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mechanisms pursuant to Article 74 of that
Directive.

6.
Users of high-risk AI systems shall use

the information provided under Article 13 to
comply with their obligation to carry out a data
protection impact assessment under Article 35
of Regulation (EU) 2016/679 or Article 27 of
Directive (EU) 2016/680, where applicable.

ANNEX I

ARTIFICIAL INTELLIGENCE
TECHNIQUES AND APPROACHES
referred to in Article 3, point 1

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(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.

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ANNEX II

LIST OF UNION HARMONISATION
LEGISLATION
Section A – List of Union harmonisation
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
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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);

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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
potentially 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 equipment and repealing
Directive 1999/5/EC (OJ L 153, 22.5.2014, p.
62);

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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
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 pressure 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

European Parliament and of the Council of 9
March 2016 on personal protective equipment
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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 appliances 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 and Regulation (EC) No 1223/2009
and repealing Council Directives 90/385/EEC
and 93/42/EEC (OJ L 117, 5.5.2017, p. 1;
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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).

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).
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2.
Regulation (EU) No 168/2013 of the

European Parliament and of the Council of 15
January 2013 on the approval and market
surveillance 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
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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 motor vehicles and their trailers,
and of systems, components and separate
technical units intended for such vehicles,
amending Regulations (EC) No 715/2007 and
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(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 safety 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
Parliament and of the Council and Commission
Regulations (EC) No 631/2009, (EU) No
406/2010, (EU) No 672/2010, (EU) No
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
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) No
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 establishing 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
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the Council, and repealing Regulations (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.

ANNEX III

HIGH-RISK AI SYSTEMS REFERRED TO
IN ARTICLE 6(2)
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(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 training institutions and for assessing
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
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 persons,
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, for task
allocation and for monitoring and evaluating
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
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 on 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 creditworthiness of natural persons
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
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 first 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
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
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;

(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
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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) 2016/680 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
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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 sets 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 authorities as polygraphs and
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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, posed 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 natural persons
and detect non-authentic documents by
checking their security features;
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(d)
AI systems intended to assist competent

public authorities for the examination of
applications for asylum, visa and residence
permits and associated complaints with regard
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.

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(b)
how the AI system interacts or can be

used to interact with hardware or software that
is not part of the AI system 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;

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(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 instructions;

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
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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 assumptions 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;

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(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 used, 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);
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(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);

(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 requirements set out
in Title III, Chapter 2;

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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(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
compliance 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 under 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,
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
including the degrees of accuracy for specific
persons or groups of persons on 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 intended 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;

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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
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;
139

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