Brussels, 04 November 2021
WK 13239/2021 INIT
LIMITE
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 - FR comments Articles 1-29, Annexes I-IV (doc.
8115/21)
DOCUMENT PARTIALLY ACCESSIBLE TO THE PUBLIC (15.03.2022)
Delegations will find in annex FR comments on Artificial Intelligence Act (Articles 1-29, Annexes I-IV).
WK 13239/2021 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)
(New) This Regulation is without prejudice to
Proposal for a
Article 4(2) of the TEU.
REGULATION OF THE EUROPEAN
(New) This Regulation recognises the
PARLIAMENT AND OF THE COUNCIL
importance
of
justified,
LAYING DOWN HARMONISED RULES
proportionate and controlled use of
ON ARTIFICIAL INTELLIGENCE
AI for important objectives of
(ARTIFICIAL INTELLIGENCE ACT) AND
general public interest of the Union
AMENDING CERTAIN UNION
or of a Member State, such as the
LEGISLATIVE ACTS
protection of the public and
security. The use of AI for such
objectives should be allowed.
(New) The transparency and compliance
obligations established by this
Regulation should not lead to the
publication of information the
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).
secrecy of which is necessary for
the preservation of the public
interest .
(9) For the purposes of this Regulation the notion
of publicly accessible space should be
understood as referring to any
physical place that is accessible to the
public, irrespective of whether the
place in question is privately or
publicly owned. Therefore, the notion
does not cover places that are private
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).
in nature and normally not freely
accessible for third parties, including
law enforcement authorities, unless
those parties have been specifically
invited or authorised, such as homes,
private clubs, offices, warehouses and
factories. Online spaces are not
covered either, as they are not
physical spaces.
This wording does
not
extend
to
correctional
institutions. However, the mere fact COM replied to FR’s question about correctional
that certain conditions for accessing a institutions, saying that it did not consider them
particular space may apply, such as to be publicly accessible spaces. It is believed
admission tickets or age restrictions, that this exclusion needs to appear at least in the
does not mean that the space is not recitals.
publicly accessible within the We suggest either “
correctional institutions” or
meaning
of
this
Regulation. “
prison premisces”.
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).
Consequently, in addition to public
spaces such as streets, relevant parts
of government buildings and most
transport infrastructure, spaces such
as cinemas, theatres, shops and
shopping centres are normally also
publicly accessible. Whether a given
space is accessible to the public
should however be determined on a
case-by-case basis, having regard to
the specificities of the individual
situation at hand.
(12) This Regulation should also apply to Union
institutions, offices, bodies and
agencies when acting as a provider or
user of an AI system.
AI systems
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).
exclusively developed or used for military purposes should be
excluded from the scope of this
Regulation where that use falls
under the exclusive remit of the According to COM, national security is out of the
Common Foreign and Security regulations’s scope by nature. However, several
Policy regulated under Title V of institutions fear that ECJ would interpret it
the Treaty on the European Union differently if this is not expressly mentioned. We
(TEU).
could also be open to another phrasing
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
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).
This Regulation should be
without prejudice to the provisions
regarding the liability of intermediary
service providers set out in Directive
2000/31/EC
of
the
European
Parliament and of the Council [as
amended by the Digital Services Act].
TITLE I
GENERAL PROVISIONS
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
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).
Article 1
Subject matter
This Regulation lays down:
(a)
harmonised rules for the placing on the
market, the putting into service and the use of
artificial intelligence systems (‘AI systems’) in
the Union;
(a)
prohibitions of certain artificial
intelligence practices;
(b)
specific requirements for high-risk AI
systems and obligations for operators of such
systems;
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
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).
(c)
harmonised transparency rules for AI
systems intended to interact with natural
persons, emotion recognition systems and
biometric categorisation systems, and AI
systems used to generate or manipulate image,
audio or video content;
(d)
rules on market monitoring and
surveillance.
New article
The regulation gives a framework and
This Regulation is without prejudice to sets criteria to determine if aaaand how an
Regulation (EU) 2020/852 of the European economica financial activity can be qualified as
Parliament and of the Council of 18 June 2020 “
environmentally sustainable”.is “green” or not.
on the establishment of a framework to The chapter II of this regulation targets
facilitate
sustainable
investment
and
amending Regulation (EU) 2019/2088
8
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).
environmentally sustainable economic activities
and specifically climate change.
Article 2
Scope
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;
9
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).
(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
are themselves products or systems, falling
within the scope of the following acts, only
Article 84 of this Regulation shall apply:
(a)
Regulation (EC) 300/2008;
(b)
Regulation (EU) No 167/2013;
(c)
Regulation (EU) No 168/2013;
(d)
Directive 2014/90/EU;
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
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).
(e)
Directive (EU) 2016/797;
(f)
Regulation (EU) 2018/858;
(g)
Regulation (EU) 2018/1139;
(h)
Regulation (EU) 2019/2144.
3.
This Regulation shall not apply to AI
3. This Regulation shall not apply to AI systems EU has no competence regarding national
systems developed or used exclusively for
whose developed development or use falls security (Article 4 TFEU). However, national
military purposes.
outside the application of Union law, and in security applications are not explicitly excluded
any event, AI systems developed or used
, from the scope of the regulation.
exclusively
for
military for This issue remains unclear, particularly
national security and defence purposes
, regarding
real-time
remote
biometric
identification in public spaces for law
enforcement purposes. Indeed, this type of use of
11
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).
the system is prohibited by the Regulation
(Article 5(d)), except in certain derogatory cases,
which include” the prevention of a terrorist
attack” (Article (d)(ii)). The administrative field
of intelligence is thus clearly identified as a
possible derogatory case.
It is thus important to explicitly exclude
intelligence services from the users covered by
the Regulation.
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
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)
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).
law enforcement and judicial cooperation with
the Union or with one or more Member States.
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
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)
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).
For the purpose of this Regulation, the
following definitions apply:
(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
(2) ‘provider’ means a natural or legal person,
“
with a view to” is a very extensive notion that
person, public authority, agency or other body
public authority, agency or other body that
will cause interpretation problems , and that, in
that develops an AI system or that has an AI
develops an AI system or that has an AI system
certain cases, may be understood as applying to
system developed with a view to placing it on
developed
with a view to
placing itbe placed
R&D or to open source developments.
the market or putting it into service under its
on the market or
putting it into service under its
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
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).
own name or trademark, whether for payment or own name or trademark, whether for payment or
free of charge;
free of charge;
(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,
It might be appropriate for the Commission to
public authority, agency or other body using an
clarify the envisaged cumulative application of
AI system under its authority, except where the
the different definitions provided for in the AI
AI system is used in the course of a personal
Regulation and in the Medical Devices
non-professional activity;
Regulation, in particular. Indeed, FR has
underlined an additional remark concerning the
discrepancies between the definitions of “
user“
and “
operator“ in both of the regulations on AI
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.
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).
and MD, which can result in making impossible
a “cumulative“ application of the requirements of
these two regulations for operators, as initially
envisaged by the Commission.
The definition of “
user“ in this proposal excludes
the layman. However, the Medical Devices
Regulation includes this difference between two
definitions, but this deifference is not taken into
account in this proposal. Thus in AI Regulation:
“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 context of a personal non-
professional activity.
In DM Regulation: “
user“ is any health
professional or lay person who uses a device.
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)
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).
In DM Regulation, “
economic operator“ means
a manufacturer, agent, importer, distributor or the
person referred to in Article 22(1) and 22(3).
(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
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;
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
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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(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;
(8)
‘operator’ means the provider, the user,
This proposal includes the definition of users. It’s
the authorised representative, the importer and
not the case in Medical Devices Regulation, as
the distributor;
there is a distinction between operators and users.
IA Regulation: "
operator" means supplier, user,
authorized
representative,
importer
and
distributor.
(9)
‘placing on the market’ means the first
making available of an AI system on the Union
market;
18
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(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
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,
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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;
(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;
20
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(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
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;
21
Commission proposal (doc. 8115/21 – COM(2021) 206 final)
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(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) ‘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
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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
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;
23
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(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;
(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;
24
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(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;
(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
25
Commission proposal (doc. 8115/21 – COM(2021) 206 final)
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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
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
26
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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
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
27
Commission proposal (doc. 8115/21 – COM(2021) 206 final)
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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;
(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
28
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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.
(38) ‘‘post’ remote biometric identification
system’ means a remote biometric identification
system other than a ‘real-time’ remote biometric
identification system;
29
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(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
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
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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
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
31
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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;
(44) ‘serious incident’ means any incident
that directly or indirectly leads, might have led
or might lead to any of the following:
32
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(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.
Additional paragraph
A number of definitions on identical terms
Where a high-risk AI system related to a
included in Regulation 2017/745/EU on medical
product, to which the legal acts listed in
devices and in Regulation 2017/746/EU on in
Annex II, section A apply, and where the
vitro diagnostic medical devices are different
same term is also defined in the legal acts
from those mentionned in the present proposal.
listed in Annex II, Section A, both definitions All these definitions are not contradictory, but
apply.
which definition applies is not clear for all the
actors involved.
Article 4
Amendments to Annex I
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The Commission is empowered to adopt
delegated acts in accordance with Article 73 to
amend the list of techniques and approaches
listed in Annex I, in order to update that list to
market and technological developments on the
basis of characteristics that are similar to the
techniques and approaches listed therein.
TITLE II
PROHIBITED ARTIFICIAL INTELLIGENCE
PRACTICES
Article 5
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1.
The following artificial intelligence
practices shall be prohibited:
(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
35
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a manner that causes or is likely to cause that
person or another person physical or
psychological harm;
(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
36
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contexts in which the data was originally
generated or collected;
(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
The use of such technology for law enforcement
identification systems in publicly accessible
purposes is no more restricted than its use by the
spaces for the purpose of law enforcement,
private sector. It must therefore be strictly
unless and in as far as such use is strictly
limited,
proportionate to several criteria, and
necessary for one of the following objectives:
not subject to a list of necessary conditions.
(i)
the targeted search for specific potential
victims of crime, including missing children;
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(ii)
the prevention of a specific, substantial
Ongoing work by FR experts
and imminent
threat to the life or physical safety
of natural persons or of a terrorist attack;
(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.
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)
.
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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
point d) shall take into account the following
elements:
(a)
the nature of the situation giving rise to
(a) the nature of the situation giving rise to the Evaluating the probability of damage caused by
the possible use, in particular the seriousness,
possible use, in particular the seriousness, the absence of a system is very difficult to
probability and scale of the harm caused in the
potentiality
probability and scale of the harm achieve in homeland security. The probability
absence of the use of the system;
caused in the absence of the use of the system;
assumes a measurable character, which is not
possible here.
(b)
the consequences of the use of the
(b) the consequences of the use of the system
system for the rights and freedoms of all persons for the rights and freedoms of all persons
concerned, in particular the seriousness,
concerned, in particular the seriousness,
probability and scale of those consequences.
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potentiality probability and scale of those
consequences.
In addition, the use of ‘real-time’ remote
Ongoing work by FR experts
biometric identification systems in publicly
accessible spaces for the purpose of law
enforcement for any of the objectives referred to
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
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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
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
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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.
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,
42
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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
authorised to use those systems for the purpose
of law enforcement.
TITLE III
HIGH-RISK AI SYSTEMS
Chapter 1
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CLASSIFICATION OF AI SYSTEMS AS
HIGH-RISK
Article 6
Classification rules for high-risk AI systems
1.
Irrespective of whether an AI system is
placed on the market or put into service
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;
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(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.
2.
In addition to the high-risk AI systems
2.
In addition to the high-risk AI systems Only AI systems that may present a risk of harm
referred to in paragraph 1, AI systems referred
referred to in paragraph 1, AI systems
, posing a to the health and safety, or a risk of adverse
to in Annex III shall also be considered high-
risk of harm to the health and safety, or a risk impact on fundamental rights should be
risk.
of adverse impact on fundamental rights, considered as high-risk. Furthermore, the same
referred to in Annex III shall also be considered criteria should be applied to draw and amend the
high-risk.
list of Annex III.
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Article 7
Amendments to Annex III
1.
The Commission is empowered to adopt The Commission is empowered to adopt
It is not a question of amending an essential
delegated acts in accordance with Article 73 to
delegated
implementing acts
every XX years,
element of the legislative act, but rather of its
update the list in Annex III by adding high-risk
in accordance with Article 73
XXXX to update
application. Only the Council should therefore
AI systems where both of the following
the list in Annex III by adding high-risk AI
intervene, among the co-legislators.
conditions are fulfilled:
systems where both of the following conditions
Moreover, it is convenient to provide for a fixed
are fulfilled:
periodicity of revision of the list, in order to keep
control over this revision.
If the necessity to be able to modify this annex
rapidly, considering the very important
technological progress in this sector, it is
nevertheless problematic that the Member States
are not associated in the decision process, which
will have very important consequences on the
work of their services. It would be preferable and
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essential to allow the Commission to modify
Annex III by means of implementing acts, thus
allowing prior consultation of the Member
States.
(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.
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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
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
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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;
(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;
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(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,
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:
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(i)
effective measures of redress in relation
to the risks posed by an AI system, with the
exclusion of claims for damages;
(ii)
effective measures to prevent or
substantially minimise those risks.
Chapter 2
REQUIREMENTS FOR HIGH-RISK AI
SYSTEMS
Article 8
Compliance with the requirements
1.
High-risk AI systems shall comply with
the requirements established in this Chapter.
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2.
The intended purpose of the high-risk AI
system and the risk management system referred
to in Article 9 shall be taken into account when
ensuring compliance with those requirements.
(New)
3. When some of the requirements
We should adopt a holistic approach to risk
laid out in articles 8 to 15 may enter into
mitigation. Some of the 7 key requirements
conflict, the development of AI systems can
identified by the HLEG on AI are often at odds,
adopt a balancing approach between them.
leading to unavoidable trade offs; for instance
The balance should be explicit
accuracy
vs
robustness,
privacy
(data
minimization) vs fairness, or accuracy vs fairness
etc. However, the balance made has to be
assumed and could be part of explainibility in
Article 13.1.
Article 9
Risk management system
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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:
(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
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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;
(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
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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
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.
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
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;
(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.
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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.
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.
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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
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
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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
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,
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
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,
(a)
the relevant design choices;
(b)
data collection;
(c)
relevant data preparation processing
operations, such as annotation, labelling,
cleaning, enrichment and aggregation;
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(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;
(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 3. Training, validation and testing data sets shall Practically impossible to be free of errors or
shall be relevant, representative, free of errors
be relevant,
sufficiently representative, free of
complete.
and complete. They shall have the appropriate
errors and complete. They shall have the
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statistical properties, including, where
appropriate statistical properties, including,
applicable, as regards the persons or groups of
where applicable, as regards the persons or
persons on which the high-risk AI system is
groups of persons on which the high-risk AI
intended to be used. These characteristics of the system is intended to be used. These
data sets may be met at the level of individual
characteristics of the data sets may be met at the
data sets or a combination thereof.
level of individual data sets or a combination
thereof
and curated with best proportionate
efforts given the nature of the system and the
state of the art.
4.
Training, validation and testing data sets
shall take into account, to the extent required by
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.
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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
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.
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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.
(New)
7. In order to comply with the
The minimization principle laid out in GDPR
requirements laid out in this article, the
and its interpretation by EDPB shall take into
minimization principle shall be interpreted
account the necessity to retain some training
with consideration for the full life cycle of the evaluation and testing data, during the whole
system.
life cycle of the system.
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
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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
High-risk AI systems shall be designed and In most HR AI systems, it is difficult to fully
and developed in such a way to ensure that their developed in such a way to ensure that their interpret the way that the output has been
operation is sufficiently transparent to enable
operation is sufficiently
as much as possible reached. Full interpretability is often impossible,
users to interpret the system’s output and use it
transparent to enable users to interpret the but we can rely on “best degree of transparency”
appropriately. An appropriate type and degree
system’s output and use it appropriately. An
of transparency shall be ensured, with a view to appropriate type and degree of transparency shall
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achieving compliance with the relevant
be ensured, with a view to achieving compliance
obligations of the user and of the provider set
with the relevant obligations of the user and of
out in Chapter 3 of this Title.
the provider set out in Chapter 3 of this Title
and
to enabling users to understand and use the
system appropriately.
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:
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(a)
the identity and the contact details of the
provider and, where applicable, of its authorised
representative;
(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;
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(iii)
any known or foreseeable circumstance, (iii) any known or foreseeable circumstance, It is too difficult to predict cases of possible
related to the use of the high-risk AI system in
related to the use of the high-risk AI system in misuse
accordance with its intended purpose or under
accordance with its intended purpose or under
conditions of reasonably foreseeable misuse,
conditions of reasonably foreseeable misuse,
which may lead to risks to the health and safety
which may lead to risks to the health and safety
or fundamental rights;
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.
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(c)
the changes to the high-risk AI system
and its performance which have been pre-
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.
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Article 14
Human oversight
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
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when such risks persist notwithstanding the
application of other requirements set out in this
Chapter.
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.
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4.
The measures referred to in paragraph 3
shall enable the individuals to whom human
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
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AI systems used to provide information or
recommendations for decisions to be taken by
natural persons;
(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.
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5.
For high-risk AI systems referred to in
5.
For high-risk AI systems referred to in
Burdensome, we could limit this to one natural
point 1(a) of Annex III, the measures referred to point 1(a) of Annex III, the measures referred to person. In principle, human verification and
in paragraph 3 shall be such as to ensure that, in in paragraph 3 shall be such as to ensure that, in confirmation seems acceptable. However,
addition, no action or decision is taken by the
addition, no action or decision is taken by the
despite COM’s explanation on the “four eyes”
user on the basis of the identification resulting
user on the basis of the identification resulting
rule, this will require some kind of procedural
from the system unless this has been verified
from the system unless this has been verified
formalization in order to be adequately registered
and confirmed by at least two natural persons.
and confirmed by at least two
one natural
in the records. Therefore, it would be relevant to
persons.
leave some latitude to MS in the practical
application of this principle. We believe that in
terms of allocation of human resources and of
practical application of that obligation,
verification by two persons is excessive.
Article 15
Accuracy, robustness and cybersecurity
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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.
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
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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.
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.
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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.
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.
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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
Providers of high-risk AI systems shall:
(a)
ensure that their high-risk AI systems are
compliant with the requirements set out in
Chapter 2 of this Title;
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(b)
have a quality management system in
place which complies with Article 17;
(c)
draw-up the technical documentation of
the high-risk AI system;
(d)
when under their control, keep the logs
automatically generated by their high-risk AI
systems;
(e)
ensure that the high-risk AI system
Ongoing work by FR experts.
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;
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(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
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;
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(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
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:
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(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;
(c)
techniques, procedures and systematic
actions to be used for the development, quality
control and quality assurance of the high-risk AI
system;
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(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;
(f)
systems and procedures for data
management, including data collection, data
analysis, data labelling, data storage, data
filtration, data mining, data aggregation, data
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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;
(i)
procedures related to the reporting of
serious incidents and of malfunctioning in
accordance with Article 62;
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(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;
(m)
an accountability framework setting out
the responsibilities of the management and other
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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
context, any harmonised standards referred to in
Article 40 of this Regulation shall be taken into
account.
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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
mechanisms pursuant to Article 74 of that
Directive.
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Article 19
Conformity assessment
1.
Providers of high-risk AI systems shall
Ongoing work by FR experts.
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
marking of conformity in accordance with
Article 49.
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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
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
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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
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
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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
is known to the provider of the system, that
provider shall immediately inform the national
competent authorities of the Member States in
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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
requirements set out in Chapter 2 of this Title, in
an official Union language determined by the
Member State concerned. Upon a reasoned
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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
manufactured in accordance with those legal
acts and under the name of the product
manufacturer, the manufacturer of the product
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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
1.
Prior to making their systems available
The appointment of an authorised representative
on the Union market, where an importer cannot
on the Union market, where an importer cannot
has to be foreseen where the provider is
be identified, providers established outside the
be identified, providers established outside the
established outside the EU
Union shall, by written mandate, appoint an
Union shall, by written mandate, appoint an
authorised representative which is established in authorised representative which is established in
the Union.
the Union.
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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:
Additional paragraph
The obligations of authorised representative
3. Where a high-risk AI system related to a under Regulation 2017/745/EU on medical
product, to which the legal acts listed in Annex devices and under Regulation 2017/746/EU on in
II, section A apply, is placed on the market or vitro diagnostic medical devices are different
put into service together under the from those mentionned in the present proposal.
responsibility of an authorised representative, All these obligations are not contradictory but the
the authorised representative of the product legal obligations of each economic operator have
shall fulfil the obligations imposed by the to be clearly stated.
present Regulation on the authorised
representative, together with the obligations
imposed in the specific legal act listed in
Annex II, Section A.
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(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
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;
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(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
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
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(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
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.
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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.
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
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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
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.
Additional paragraph
The obligations of importers under Regulation
6. Where a high-risk AI system related to a 2017/745/EU on medical devices and under
product, to which the legal acts listed in Annex Regulation 2017/746/EU on in vitro diagnostic
II, section A apply, is placed on the market medical devices are different from those
under the responsibility of an authorised mentionned in the present proposal. All these
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representative, the authorised representative obligations are not contradictory but the legal
of the product shall fulfil the obligations obligations of each economic operator have to be
imposed by the present Regulation on the clearly stated.
authorised representative, together with the obligations imposed on the authorised
representative in the specific legal act listed in
Annex II, Section A.
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
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the system, as applicable, have complied with
the obligations set out in this Regulation.
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.
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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
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.
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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
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.
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Additional paragraph
The obligations of distributors under Regulation
6. Where a high-risk AI system related to a 2017/745/EU on medical devices and under
product, to which the legal acts listed in Annex Regulation 2017/746/EU on in vitro diagnostic
II, section A apply, is placed on the market medical devices are different from those
under the responsibility of a distributor, the mentionned in the present proposal. All these
distributor of the product shall fulfil the obligations are not contradictory but the legal
obligations imposed by the present Regulation obligations of each economic operator have to be
on the distributor, together with the clearly stated
obligations imposed on the distributor in the
specific legal act listed in Annex II, Section A.
Article 28
Obligations of distributors, importers, users or
any other third-party
1.
Any distributor, importer, user or other
third-party shall be considered a provider for the
purposes of this Regulation and shall be subject
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to the obligations of the provider under Article
16, in any of the following circumstances:
(a)
they place on the market or put into
(a)
they place on the market or put into
service a high-risk AI system under their name
service a high-risk AI system under their name or
or trademark;
trademark
, except in cases where a distributor
or importer enters into an agreement with a
provider whereby the provider is identified as
such on the label and is responsible for
meeting the requirements placed providers in
this Regulation;
(b)
they modify the intended purpose of a
high-risk AI system already placed on the
market or put into service;
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(c)
they make a substantial modification to
(c)
they make a substantial modification to
the high-risk AI system.
the high-risk AI system
, in such a way that
compliance with the applicable requirements
may be affected.
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
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of use accompanying the systems, pursuant to
paragraphs 2 and 5.
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.
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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
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.
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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
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.
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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
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
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TECHNIQUES AND APPROACHES
referred to in Article 3, point 1
(a)
Machine learning approaches, including
supervised, unsupervised and reinforcement
learning, using a wide variety of methods
including deep learning;
(b)
Logic- and knowledge-based
Logic- and knowledge-based approaches,
The proposed definition is too broad. We could
approaches, including knowledge
including knowledge representation, inductive
potentially remove point b completely in order to
representation, inductive (logic) programming,
(logic) programming, knowledge bases,
narrow the definition (or, at least, only for the
knowledge bases, inference and deductive
inference and deductive engines, (symbolic)
applications covered under annex II where we
engines, (symbolic) reasoning and expert
reasoning and expert systems;
already have some sectorial regulations)
systems;
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(c)
Statistical approaches, Bayesian
estimation, search and optimization methods.
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];
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2.
Directive 2009/48/EC of the European
Parliament and of the Council of 18 June 2009
on the safety of toys (OJ L 170, 30.6.2009, p.
1);
3.
Directive 2013/53/EU of the European
Parliament and of the Council of 20 November
2013 on recreational craft and personal
watercraft and repealing Directive 94/25/EC (OJ
L 354, 28.12.2013, p. 90);
4.
Directive 2014/33/EU of the European
Parliament and of the Council of 26 February
2014 on the harmonisation of the laws of the
Member States relating to lifts and safety
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components for lifts (OJ L 96, 29.3.2014, p.
251);
5.
Directive 2014/34/EU of the European
Parliament and of the Council of 26 February
2014 on the harmonisation of the laws of the
Member States relating to equipment and
protective systems intended for use in
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
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Directive 1999/5/EC (OJ L 153, 22.5.2014, p.
62);
7.
Directive 2014/68/EU of the European
Parliament and of the Council of 15 May 2014
on the harmonisation of the laws of the Member
States relating to the making available on the
market of 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);
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9.
Regulation (EU) 2016/425 of the
European Parliament and of the Council of 9
March 2016 on personal protective equipment
and repealing Council Directive 89/686/EEC
(OJ L 81, 31.3.2016, p. 51);
10.
Regulation (EU) 2016/426 of the
European Parliament and of the Council of 9
March 2016 on 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
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
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;
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
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March 2008 on common rules in the field of
civil aviation security and repealing Regulation
(EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72).
2.
Regulation (EU) No 168/2013 of the
European Parliament and of the Council of 15
January 2013 on the approval and market
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);
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4.
Directive 2014/90/EU of the European
Parliament and of the Council of 23 July 2014
on marine equipment and repealing Council
Directive 96/98/EC (OJ L 257, 28.8.2014, p.
146);
5.
Directive (EU) 2016/797 of the
European Parliament and of the Council of 11
May 2016 on the interoperability of the rail
system within the European Union (OJ L 138,
26.5.2016, p. 44).
6.
Regulation (EU) 2018/858 of the
European Parliament and of the Council of 30
May 2018 on the approval and market
surveillance of motor vehicles and their trailers,
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and of systems, components and separate
technical units intended for such vehicles,
amending Regulations (EC) No 715/2007 and
(EC) No 595/2009 and repealing Directive
2007/46/EC (OJ L 151, 14.6.2018, p. 1); 3.
Regulation (EU) 2019/2144 of the European
Parliament and of the Council of 27 November
2019 on type-approval requirements for motor
vehicles and their trailers, and systems,
components and separate technical units
intended for such vehicles, as regards their
general 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
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Parliament and of the Council and Commission
Regulations (EC) No 631/2009, (EU) No
406/2010, (EU) No 672/2010, (EU) No
1003/2010, (EU) No 1005/2010, (EU) No
1008/2010, (EU) No 1009/2010, (EU) No
19/2011, (EU) No 109/2011, (EU) No
458/2011, (EU) No 65/2012, (EU) 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
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1008/2008, (EU) No 996/2010, (EU) No
376/2014 and Directives 2014/30/EU and
2014/53/EU of the European Parliament and of
the Council, and repealing 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.
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ANNEX III
HIGH-RISK AI SYSTEMS REFERRED TO
IN ARTICLE 6(2)
High-risk AI systems pursuant to Article 6(2)
Ongoing work by FR experts.
are the AI systems listed in any of the following
areas:
1.
Biometric identification and
Ongoing work by FR experts.
categorisation of natural persons:
(a)
AI systems intended to be used for the
Ongoing work by FR experts.
‘real-time’ and ‘post’ remote biometric
identification of natural persons;
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2.
Management and operation of critical
Ongoing work by FR experts.
infrastructure:
(a)
AI systems intended to be used as safety
Ongoing work by FR experts.
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;
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(b)
AI systems intended to be used for the
purpose of assessing students in educational and
vocational training institutions and for assessing
participants in tests commonly required for
admission to educational institutions.
4.
Employment, workers management and
access to self-employment:
(a)
AI systems intended to be used for
(a) AI systems intended to be used for Not all task allocation should fall under high risk.
recruitment or selection of natural persons,
recruitment or selection of natural persons,
notably for advertising vacancies, screening or
notably for advertising vacancies, screening or
filtering applications, evaluating candidates in
filtering applications, evaluating candidates in
the course of interviews or tests;
the course of interviews or tests;
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(b)
AI intended to be used for making
AI intended to be used for making decisions on
decisions on promotion and termination of
promotion and termination of work-related
work-related contractual relationships, for task
contractual relationships, for task allocation
allocation and for monitoring and evaluating
based on individual behavior and for
performance and behavior of persons in such
monitoring and evaluating performance and
relationships.
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
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
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
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:
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
(a)
AI systems intended to be used by law
(a)
AI systems intended to be used by law The risk for potential victims of criminal
enforcement authorities for making individual
enforcement authorities for making individual offences does not involve personal data to be
risk assessments of natural persons in order to
risk assessments of natural persons in order to protected (either on the part of the respondent or
assess the risk of a natural person for offending
assess the risk of a natural person for offending the victim).
or reoffending or the risk for potential victims of or reoffending, or the risk for
a natural person
criminal offences;
to become a potential victims of criminal
offences;
(b)
AI systems intended to be used by law
Ongoing work by FR experts.
enforcement authorities as polygraphs and
similar tools or to detect the emotional state of a
natural person;
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(c)
AI systems intended to be used by law
Ongoing work by FR experts.
enforcement authorities to detect deep fakes as
referred to in article 52(3);
(d)
AI systems intended to be used by law
d)
AI systems intended to be used by law
This restriction may question the effectiveness of
enforcement authorities for evaluation of the
enforcement authorities for evaluation of the
criminal investigations, the reliability of
reliability of evidence in the course of
reliability of evidence in the course of
evidence in the judicial field (images, DNA,
investigation or prosecution of criminal
investigation or prosecution of criminal offences etc.).
offences;
without posterior human evaluation;
(e)
AI systems intended to be used by law
Ongoing work by FR experts.
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
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personality traits and characteristics or past
criminal behaviour of natural persons or groups;
(f)
AI systems intended to be used by law
enforcement authorities for profiling of natural
persons as referred to in Article 3(4) of
Directive (EU) 2016/680 in the course of
detection, investigation or prosecution of
criminal offences;
(g)
AI systems intended to be used for crime (g) AI systems intended to be used for crime These systems are not very risky: they either find
analytics regarding natural persons, allowing
analytics regarding natural persons, allowing law an objective link between data or they find none.
law enforcement authorities to search complex
enforcement authorities to search related and Criminal analysis would be restricted by this
related and unrelated large data sets available in unrelated large data sets available in different point. Thus, the analysis of criminal group
different data sources or in different data
data sources or in different data formats in order exchanges, as was the case in the EncroChat case,
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formats in order to identify unknown patterns or to identify
high complex unknown patterns or will be made difficult given the mass of data
discover hidden relationships in the data.
discover hidden relationships in the data.
involved.
The idea of the alternative wording, which shifts
the word ”
complex” to the result of the data
crossing rather than to the complexity of the data
itself, is to reserve this definition of application
to HR to the complex highlighting of certain data
containing an element of predictability/
prospecting (e.g., a tool revealing complex
money laundering operations using numerous
foreign accounts based on known patterns) in
order to exclude from this classification the
”
simple” tools that already exist and that do not
contain any prospecting, but merely search for
identical data that may appear in different
formats (e.g., reading a license plate, etc.)
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reading a license plate; analysis of geolocation
data...).
7.
Migration, asylum and border control
management:
(a)
AI systems intended to be used by
Ongoing work by FR experts.
competent public authorities as polygraphs and
similar tools or to detect the emotional state of a
natural person;
(b)
AI systems intended to be used by
Ongoing work by FR experts.
competent public authorities to assess a risk,
including a security risk, a risk of irregular
immigration, or a health risk, posed by a natural
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person who intends to enter or has entered into
the territory of a Member State;
(c)
AI systems intended to be used by
AI systems intended to be used by competent The detection of false documents is not in itself a
competent public authorities for the verification public authorities for the verification of the high risk. It is a common practice of the security
of the authenticity of travel documents and
authenticity of travel documents and supporting forces concerned and is always corroborated by
supporting documentation of natural persons
documentation of natural persons and detect non- manual analysis.
and detect non-authentic documents by
authentic documents by checking their security
checking their security features;
features
without posterior human evaluation;
(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.
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8.
Administration of justice and democratic
processes:
(a)
AI systems intended to assist a judicial
(a)
AI systems intended to assist a judicial We thank COM for the explanations given, but
authority in researching and interpreting facts
authority in researching and interpreting facts we still believe this is not clear enough to be
and the law and in applying the law to a
and the law and in applying the law to a concrete applied consistently by MS.
concrete set of facts.
set of facts.
ANNEX IV
TECHNICAL DOCUMENTATION referred
to in Article 11(1)
The technical documentation referred to in
Article 11(1) shall contain at least the following
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information, as applicable to the relevant AI
system:
1.
A general description of the AI system
including:
(a)
its intended purpose, the person/s
developing the system the date and the version
of the system;
(b)
how the AI system interacts or can be
used to interact with hardware or software that
is not part of the AI system itself, where
applicable;
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(c)
the versions of relevant software or
firmware and any requirement related to version
update;
(d)
the description of all forms in which the
AI system is placed on the market or put into
service;
(e)
the description of hardware on which the
AI system is intended to run;
(f)
where the AI system is a component of
products, photographs or illustrations showing
external features, marking and internal layout of
those products;
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(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
been used, integrated or modified by the
provider;
(b)
the design specifications of the system,
namely the general logic of the AI system and
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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;
(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;
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(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);
(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
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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;
(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
145
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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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,
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
146
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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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;
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;
147
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.
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entire proposal, please do so in the row containing the title of the proposal (in the 3rd column).
6.
A list of the harmonised standards
applied in full or in part the references of which
have been published in the Official Journal of
the European Union; where no such harmonised
standards have been applied, a detailed
description of the solutions adopted to meet the
requirements set out in Title III, Chapter 2,
including a list of other relevant standards and
technical specifications applied;
7.
A copy of the EU declaration of
conformity;
8.
A detailed description of the system in
place to evaluate the AI system performance in
148
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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the post-market phase in accordance with
Article 61, including the post-market monitoring
plan referred to in Article 61(3).
End
End
149
Document Outline