Conseil del'Union européenne
Bruxelles, le 15 février 2022
(OR. fr, en)6239/22
Dossier interinstitutionnel:
2021/0106(COD)

LIMITETELECOM 55
JAI 185
COPEN 47
CYBER 49DATAPROTECT 36
EJUSTICE 21
COSI 44IXIM 31
ENFOPOL 67
FREMP 32
RELEX 183
MI 110COMPET 91
CODEC 154

NOTE
Origine:Destinataire:la présidence
délégations

Nº doc. préc.:

5756/22N° doc. Cion:

8115/21

Objet:

Proposition de Règlement du Parlement européen et du Conseilétablissant des règles harmonisées concernant l'intelligence artificielle(législation sur l'intelligence artificielle) et modifiant certains actes législatifs
de l'Union- Texte de compromis de la présidence - Articles 40-52

I.

INTRODUCTION

1.

La Commission a adopté la proposition de règlement établissant des règles harmoniséesconcernant l’intelligence artificielle (loi sur l’intelligence artificielle, AIA) le 21 avril 2021.

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La présidence slovène a rédigé la première proposition de compromis partiel, qui couvre lesarticles 1 à 7 et les annexes I à III de l’AIA proposée. Cette proposition de compromis
partiel a été présentée au groupe TELECOM le 30 novembre 2021 par la présidence SI et a
fait l’objet d’un examen approfondi lors de la réunion du groupe TELECOM du 11 janvier
2022 sous la présidence française.

3.

La présidence française a repris les travaux de rédaction, dans le cadre desquels la présidence
slovène s’est retirée, et a rédigé les parties suivantes de la première proposition decompromis, couvrant les articles 8 à 15 et l’annexe IV, ainsi que les articles 16 à 29.

4.

La présidence française a maintenant rédigé une autre partie de la première proposition decompromis, couvrant les articles 40 à 52, qui figure à l’annexe du présent document.

5.

La présidence française invite les délégations à examiner les modifications qu’il est
proposé d’apporter aux articles 40 à 52 lors de la réunion du groupe TELECOM du 22
février 2022.

6.

Les modifications apportées au document par rapport à la proposition de la Commission sontsoulignées: les ajouts sont signalés par des caractères gras, les suppressions sont barrées.

II.

PRINCIPAUX CHANGEMENTS

1.

Article 40 — Normes harmonisées
1.1

Un nouvel article 40, paragraphe 2, précisant les objectifs généraux que devront

atteindre les normes élaborées par les organismes de normalisation à la demande de laCommission, a été ajouté. Le nouveau texte prévoit également l’obligation pour laCommission de demander à ces organismes de fournir des preuves de leurs meilleurs efforts
pour atteindre ces objectifs.

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2.

Article 41 — Spécifications communes
2.1

Afin de garantir une plus grande participation des États membres à l’élaboration despécifications communes en ce qui concerne les exigences applicables aux systèmes d’IA à
haut risque au moyen d’actes d’exécution, les modifications apportées à l’article 41,
paragraphe 1, visent à obliger la Commission à consulter le comité d’IA.
2.2. Les modifications apportées à l’article 41, paragraphe 2, ont été introduites pourencadrer l’habilitation de la Commission à adopter des spécifications communes au moyen
d’une référence aux objectifs énumérés à l’article 40, paragraphe 2, récemment ajouté.
3.

Article 42 — Présomption de conformité avec certaines exigences
3.1

Le mot «et» a été remplacé par «ou» à l’article 42, paragraphe 1, afin d’indiquer que

les conditions concernant les données sur la base desquelles les systèmes d’IA à haut risqueont été entrainés et testés ne sont pas cumulables.
4.

Article 43 — Évaluation de la conformité
4.1

L’article 43, paragraphe 2, est toujours en cours de révision afin d’intégrer les retoursd’information reçus de la Banque centrale européenne.
4.2

Le premier alinéa de l’article 43, paragraphe 4, a été supprimé afin d’assurer lacohérence avec le nouvel article 23 bis.
4.3

Le texte du second paragraphe de l'article 43, paragraphe 4, a été déplacé vers ladéfinition de la «modification substantielle» à l'article 3(23).
4.4

Les modifications apportées aux articles 43 (4) et (5) visent à garantir une plus grandeparticipation des États membres au processus des actes délégués par l’intermédiaire du comitéIA.

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5.

Article 45 — Recours contre les décisions des organismes notifiés
5.1

La référence à l’intérêt légitime dans la décision contre laquelle une procédure derecours devrait être ouverte a été supprimée pour tenir compte du fait que ces lois
procédurales sont généralement la prérogative des législateurs nationaux.
6.

Article 47 — Dérogation à la procédure d’évaluation de la conformité
6.1

Le nouvel article 47, paragraphe 1 bis, a été ajouté afin de donner aux autorités

répressives la possibilité de demander une autorisation ex post pour mettre sur le marché ou
mettre en service un système d’IA à haut risque spécifique, conformément à l’article 5,paragraphe 3.
7.

Article 48 — Déclaration UE de conformité
7.1

Les modifications apportées à l’article 48, paragraphe 5, ont été apportées pourgarantir une plus grande participation des États membres au processus des actes délégués parl’intermédiaire du comité de l’IA.
8.

Article 49 — Marquage de conformité CE
8.1

L’ordre des articles 49 (1) et (2) a été modifié afin d’assurer une séquence plus logiquedes exigences.
9.

Article 50 — Conservation des documents
9.1

Le texte de l’article 50 a été déplacé à l’article 18.

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10.

Article 51 — Enregistrement
10.1 Les modifications apportées à l’article 51 sont liées à la suppression des références auterme «autonome» dans les titres du titre VII et de l’article 60, qui sont considérées commepeu claires.

11.

Article 52 — Obligations de transparence pour certains systèmes d’IA
11.1 Le nouveau texte ajouté à la fin de l’article 52, paragraphe 2, concernant des garanties
appropriées pour les droits et libertés des tiers est destiné à assurer l’alignement sur ladernière phrase de l’article 52, paragraphe 3.
11.2 La suppression, à l’article 52, paragraphe 3, de la référence à «l’exercice du droit à laliberté d’expression et du droit à la liberté des arts et des sciences» a été faite parce que cettenotion est déjà implicite dans la formulation «autorisée par la loi», utilisée à l’article 52,
paragraphe 3, deuxième alinéa.
11.3 Le nouvel article 53, paragraphe 3 bis, a été ajouté pour préciser comment et quand
les informations visées aux paragraphes précédents doivent être fournies aux personnes
physiques qui ont été exposées à des systèmes d’IA relevant du titre IV.

12.

Le nouvel article 52 bis a été déplacé à l’article 4 bis et est toujours en cours de réexamen.

____________

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FR/ENAnnex

Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILLAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE(ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNIONLEGISLATIVE ACTS
Chapter 5 (Articles 40-52)

CHAPTER 5
STANDARDS, CONFORMITY ASSESSMENT, CERTIFICATES, REGISTRATION

Article 40
Harmonised standards
1.
High-risk AI systems which are in conformity with harmonised standards or parts thereof thereferences of which have been published in the Official Journal of the European Union shall be
presumed to be in conformity with the requirements set out in Chapter 2 of this Title, to theextent those standards cover those requirements.
2.

When issuing a standardisation request to European standardisation organisationsin accordance with Article 10 of Regulation 1025/2012, the Commission shallspecify that standards are coherent, easy to implement and drafted in such a way thatthey aim to fulfil in particular the following objectives:a)ensure that AI systems placed on the market or put into service in the Union aresafe and respect Union values and strenghten the Union's digital sovereignty;b) promote investment and innovation in AI, as well as competitiveness andgrowth of the Union market;c)enhance multistakeholder governance, representative of all relevant European
stakeholders (e.g. industry, SMEs, civil society, researchers).
d)contribute to strengthening global cooperation on standardisation in the fieldof AI that is consistent with Union values and interests.
The Commission shall request the European standardisation organisations toprovide evidence of their best efforts to fulfil the above objectives.

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FR/ENArticle 41
Common specifications
1.

Where harmonised standards referred to in Article 40 do not exist or where theCommission considers that the relevant harmonised standards are insufficient or that there
is a need to address specific safety or fundamental right concerns, the Commission may,after consulting the AI Board referred to in Article 56, by means of implementing acts,
adopt common specifications in respect of the requirements set out in Chapter 2 of thisTitle. Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 74(2).

2.

The Commission, Wwhen preparing the common specifications referred to in paragraph 1,
the Commission shall fulfil the objectives referred of Article 40(2) and gather the viewsof relevant bodies or expert groups established under relevant sectorial Union law.

3.

High-risk AI systems which are in conformity with the common specifications referred toin paragraph 1 shall be presumed to be in conformity with the requirements set out in
Chapter 2 of this Title, to the extent those common specifications cover thoserequirements.

4.

Where providers do not comply with the common specifications referred to in paragraph 1,
they shall duly justify in the technical documentation referred to in Article 11 that they
have adopted technical solutions that are at least equivalent thereto.
Article 42
Presumption of conformity with certain requirements

1.

Taking into account their intended purpose, hHigh-risk AI systems that have been trained
and tested on data concerning reflecting the specific geographical, behavioural and or
functional setting within which they are intended to be used shall be presumed to be incompliance with the respective requirements set out in Article 10(4).

2.

High-risk AI systems that have been certified or for which a statement of conformity has
been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881 of theEuropean Parliament and of the Council1 and the references of which have been publishedin the Official Journal of the European Union shall be presumed to be in compliance withthe cybersecurity requirements set out in Article 15 of this Regulation in so far as thecybersecurity certificate or statement of conformity or parts thereof cover thoserequirements.

1

Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (theEuropean Union Agency for Cybersecurity) and on information and communications technology cybersecurity
certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 1).

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Conformity assessment1.

For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating thecompliance of a high-risk AI system with the requirements set out in Chapter 2 of thisTitle, the provider has applied harmonised standards referred to in Article 40, or, whereapplicable, common specifications referred to in Article 41, the provider shall follow opt
for one of the following procedures:(a)the conformity assessment procedure based on internal control referred to in Annex
VI; or(b)

the conformity assessment procedure based on assessment of the quality
management system and assessment of the technical documentation, with the
involvement of a notified body, referred to in Annex VII.

Where, in demonstrating the compliance of a high-risk AI system with the requirements set
out in Chapter 2 of this Title, the provider has not applied or has applied only in part
harmonised standards referred to in Article 40, or where such harmonised standards do notexist and common specifications referred to in Article 41 are not available, the provider
shall follow the conformity assessment procedure set out in Annex VII.
For the purpose of the conformity assessment procedure referred to in Annex VII, theprovider may choose any of the notified bodies. However, when the system is intended tobe put into service by law enforcement, immigration or asylum authorities as well as EU
institutions, bodies or agencies, the market surveillance authority referred to in Article
63(5) or (6), as applicable, shall act as a notified body.
2.

For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow
the conformity assessment procedure based on internal control as referred to in Annex VI,
which does not provide for the involvement of a notified body. For high-risk AI systems
referred to in point 5(b) of Annex III, placed on the market or put into service by credit
institutions regulated by Directive 2013/36/EU, the conformity assessment shall be carriedout as part of the procedure referred to in Articles 97 to101 of that Directive.

3.

For high-risk AI systems, to which legal acts listed in Annex II, section A, apply, theprovider shall follow the relevant conformity assessment as required under those legal acts.
The requirements set out in Chapter 2 of this Title shall apply to those high-risk AI systems
and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth paragraph of point
4.6 of Annex VII shall also apply.
For the purpose of that assessment, notified bodies which have been notified under thoselegal acts shall be entitled to control the conformity of the high-risk AI systems with therequirements set out in Chapter 2 of this Title, provided that the compliance of those
notified bodies with requirements laid down in Article 33(4), (9) and (10) has beenassessed in the context of the notification procedure under those legal acts.
Where the legal acts listed in Annex II, section A, enable the manufacturer of the productto opt out from a third-party conformity assessment, provided that that manufacturer hasapplied all harmonised standards covering all the relevant requirements, that manufacturer
may make use of that option only if he has also applied harmonised standards or, where

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applicable, common specifications referred to in Article 41, covering the requirements set
out in Chapter 2 of this Title.
4.

High-risk AI systems shall undergo a new conformity assessment procedure whenever they
are substantially modified, regardless of whether the modified system is intended to befurther distributed or continues to be used by the current user.
For high-risk AI systems that continue to learn after being placed on the market or put into
service, changes to the high-risk AI system and its performance that have been predetermined by the provider at the moment of the initial conformity assessment and are partof the information contained in the technical documentation referred to in point 2(f) ofAnnex IV, shall not constitute a substantial modification.

5.

After consulting the AI Board referred to in Article 56, tThe Commission isempowered to adopt delegated acts in accordance with Article 73 for the purpose of
updating Annexes VI and Annex VII in order to introduce elements of the conformity
assessment procedures that become necessary in light of technical progress.

6.

After consulting the AI Board referred to in Article 56, tThe Commission isempowered to adopt delegated acts to amend paragraphs 1 and 2 in order to subject highrisk AI systems referred to in points 2 to 8 of Annex III to the conformity assessment
procedure referred to in Annex VII or parts thereof. The Commission shall adopt suchdelegated acts taking into account the effectiveness of the conformity assessment
procedure based on internal control referred to in Annex VI in preventing or minimizing
the risks to health and safety and protection of fundamental rights posed by such systems
as well as the availability of adequate capacities and resources among notified bodies.
Article 44
Certificates

1.

Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in
an official Union language determined by the Member State in which the notified body isestablished or in an official Union language otherwise acceptable to the notified body.

2.

Certificates shall be valid for the period they indicate, which shall not exceed five years.
On application by the provider, the validity of a certificate may be extended for further
periods, each not exceeding five years, based on a re-assessment in accordance with theapplicable conformity assessment procedures.

3.

Where a notified body finds that an AI system no longer meets the requirements set out in
Chapter 2 of this Title, it shall, taking account of the principle of proportionality, suspend
or withdraw the certificate issued or impose any restrictions on it, unless compliance withthose requirements is ensured by appropriate corrective action taken by the provider of thesystem within an appropriate deadline set by the notified body. The notified body shallgive reasons for its decision.
Article 45
Appeal against decisions of notified bodies

Member States shall ensure that an appeal procedure against decisions of the notified bodies isavailable to parties having a legitimate interest in that decision.
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Information obligations of notified bodies
1.

2.

3.

Notified bodies shall inform the notifying authority of the following:(a)any Union technical documentation assessment certificates, any supplements to thosecertificates, quality management system approvals issued in accordance with therequirements of Annex VII;(b)

any refusal, restriction, suspension or withdrawal of a Union technicaldocumentation assessment certificate or a quality management system approvalissued in accordance with the requirements of Annex VII;(c)

any circumstances affecting the scope of or conditions for notification;(d)

any request for information which they have received from market surveillanceauthorities regarding conformity assessment activities;(e)on request, conformity assessment activities performed within the scope of theirnotification and any other activity performed, including cross-border activities andsubcontracting.

Each notified body shall inform the other notified bodies of:(a)quality management system approvals which it has refused, suspended or withdrawn,
and, upon request, of quality system approvals which it has issued;(b)

EU technical documentation assessment certificates or any supplements thereto
which it has refused, withdrawn, suspended or otherwise restricted, and, uponrequest, of the certificates and/or supplements thereto which it has issued.

Each notified body shall provide the other notified bodies carrying out similar conformity
assessment activities covering the same artificial intelligence technologies with relevant
information on issues relating to negative and, on request, positive conformity assessment
results.
Article 47
Derogation from conformity assessment procedure1.

By way of derogation from Article 43, any market surveillance authority may authorise theplacing on the market or putting into service of specific high-risk AI systems within the
territory of the Member State concerned, for exceptional reasons of public security or theprotection of life and health of persons, environmental protection and the protection of key
industrial and infrastructural assets. That authorisation shall be for a limited period of time,
while the necessary conformity assessment procedures are being carried out, and shallterminate once those procedures have been completed. The completion of those procedures
shall be undertaken without undue delay.

1a.

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authorisation is requested during or after the use without undue delay.
2.

The authorisation referred to in paragraph 1 shall be issued only if the market surveillanceauthority concludes that the high-risk AI system complies with the requirements of Chapter
2 of this Title. The market surveillance authority shall inform the Commission and theother Member States of any authorisation issued pursuant to paragraph 1.

3.

Where, within 15 calendar days of receipt of the information referred to in paragraph 2, noobjection has been raised by either a Member State or the Commission in respect of an
authorisation issued by a market surveillance authority of a Member State in accordancewith paragraph 1, that authorisation shall be deemed justified.

4.

Where, within 15 calendar days of receipt of the notification referred to in paragraph 2,
objections are raised by a Member State against an authorisation issued by a market
surveillance authority of another Member State, or where the Commission considers theauthorisation to be contrary to Union law or the conclusion of the Member States regarding
the compliance of the system as referred to in paragraph 2 to be unfounded, theCommission shall without delay enter into consultation with the relevant Member State;
the operator(s) concerned shall be consulted and have the possibility to present their views.
In view thereof, the Commission shall decide whether the authorisation is justified or not.
The Commission shall address its decision to the Member State concerned and the relevant
operator or operators.

5.

If the authorisation is considered unjustified, this shall be withdrawn by the market
surveillance authority of the Member State concerned.

6.

By way of derogation from paragraphs 1 to 5, for high-risk AI systems intended to be usedas safety components of devices, or which are themselves devices, covered by Regulation(EU) 2017/745 and Regulation (EU) 2017/746, Article 59 of Regulation (EU) 2017/745
and Article 54 of Regulation (EU) 2017/746 shall apply also with regard to the derogationfrom the conformity assessment of the compliance with the requirements set out in Chapter
2 of this Title.
Article 48
EU declaration of conformity

1.

The provider shall draw up a written or electronically signed EU declaration ofconformity for each AI system and keep it at the disposal of the national competentauthorities for 10 years after the AI system has been placed on the market or put into
service. The EU declaration of conformity shall identify the AI system for which it has
been drawn up. A copy of the EU declaration of conformity shall be given submitted to
the relevant national competent authorities upon request.

2.

The EU declaration of conformity shall state that the high-risk AI system in question meetsthe requirements set out in Chapter 2 of this Title. The EU declaration of conformity shallcontain the information set out in Annex V and shall be translated into an official Union
language or languages required by the Member State(s) in which the high-risk AI system ismade available.

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3.

Where high-risk AI systems are subject to other Union harmonisation legislation which
also requires an EU declaration of conformity, a single EU declaration of conformity shallbe drawn up in respect of all Union legislations applicable to the high-risk AI system. The
declaration shall contain all the information required for identification of the Union
harmonisation legislation to which the declaration relates.

4.

By drawing up the EU declaration of conformity, the provider shall assume responsibility
for compliance with the requirements set out in Chapter 2 of this Title. The provider shallkeep the EU declaration of conformity up-to-date as appropriate.

5.

After consulting the AI Board referred to in Article 56, tThe Commission shall beempowered to adopt delegated acts in accordance with Article 73 for the purpose of
updating the content of the EU declaration of conformity set out in Annex V in order tointroduce elements that become necessary in light of technical progress.
Article 49
CE marking of conformity

1.

The CE marking of conformity referred to in paragraph 1 of this Article shall be
subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
The CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems.
Where that is not possible or not warranted on account of the nature of the high-risk AI
system, it shall be affixed to the packaging or to the accompanying documentation, as
appropriate.

2.

The CE marking referred to in paragraph 1 of this Article shall be subject to the generalprinciples set out in Article 30 of Regulation (EC) No 765/2008. The CE marking shallbe affixed visibly, legibly and indelibly for high-risk AI systems. Where that is notpossible or not warranted on account of the nature of the high-risk AI system, it shallbe affixed to the packaging or to the accompanying documentation, as appropriate.

3.

Where applicable, the CE marking shall be followed by the identification number of thenotified body responsible for the conformity assessment procedures set out in Article 43.
The identification number shall also be indicated in any promotional material which
mentions that the high-risk AI system fulfils the requirements for CE marking.
Article 50
Document retention

The provider shall, for a period ending 10 years after the AI system has been placed on the market
or put into service, keep at the disposal of the national competent authorities:(a)the technical documentation referred to in Article 11;(b)

the documentation concerning the quality management system referred to Article 17;(c)the documentation concerning the changes approved by notified bodies where applicable;(d)the decisions and other documents issued by the notified bodies where applicable;(e)the EU declaration of conformity referred to in Article 48.

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Registration
Before placing on the market or putting into service a high-risk AI system listed in Annex III
referred to in Article 6(23), the provider or, where applicable, the authorised representative shallregister that system in the EU database referred to in Article 60.

TITLE IV
TRANSPARENCY OBLIGATIONS FOR CERTAIN AI SYSTEMS

Article 52
Transparency obligations for certain AI systems
1.

Providers shall ensure that AI systems intended to interact with natural persons aredesigned and developed in such a way that those systems inform that natural persons are
informed that they are interacting with an AI system, unless this is obvious from the pointview of a reasonable person from the circumstances and the context of use. Thisobligation shall not apply to AI systems authorised by law to detect, prevent, investigate
and prosecute criminal offences, unless those systems are available for the public to reporta criminal offence.

2.

Users of an emotion recognition system or a biometric categorisation system shall informof the operation of the system the natural persons exposed thereto. This obligation shall not
apply to AI systems used for biometric categorisation, which are permitted by law todetect, prevent and investigate criminal offences, subject to appropriate safeguards forthe rights and freedoms of third parties.

3.

Users of an AI system that generates or manipulates image, audio or video content that
appreciably resembles existing persons, objects, places or other entities or events andwould falsely appear to a person to be authentic or truthful (‘deep fake’), shall disclose thatthe content has been artificially generated or manipulated.
However, the first subparagraph shall not apply where the use is authorised by law todetect, prevent, investigate and prosecute criminal offences or it is necessary for the
exercise of the right to freedom of expression and the right to freedom of the arts andsciences guaranteed in the Charter of Fundamental Rights of the EU, and subject toappropriate safeguards for the rights and freedoms of third parties.

3a.

The information referred to in paragraphs 1 to 3 shall be provided to natural persons
in a clear and visible manner at the latest at the time of the first interaction or
exposure.

4.

Paragraphs 1, 2 and 3 shall not affect the requirements and obligations set out in Title III ofthis Regulation.

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TITLE IVA
GENERAL PURPOSE AI SYSTEMS

Article 52a
General purpose AI systems
1.

The placing on the market, putting into service or use of general purpose AI
systems shall not, by themselves only, make those systems subject to the provisionsof this Regulation.

2.

Any person who places on the market or puts into service under its own name ortrademark or uses a general purpose AI system made available on the market or
put into service for an intended purpose that makes it subject to the provisions of
this Regulation shall be considered the provider of the AI system subject to theprovisions of this Regulation.

3.

Paragraph 2 shall apply, mutatis mutandis, to any person who integrates a
general purpose AI system made available on the market, with or without
modifying it, into an AI system whose intended purpose makes it subject to theprovisions of this Regulation.

4.

The provisions of this Article shall apply irrespective of whether the general
purpose AI system is open source software or not.

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