Amendments adopted by the European Parliament on 14 June 2023 on the proposal for a regulation of the European Parliament and of the Council on laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union legislative acts (COM(2021)0206 — C9-0146/2021 — 2021/0106(COD))
Date: 2023-06-14
Institutions: Committee on Civil Liberties, Justice and Home Affairs, Committee on Culture and Education, Committee on Industry, Research and Energy, Committee on Legal Affairs, Committee on Transport and Tourism, Committee on the Environment, Climate and Food Safety, Committee on the Internal Market and Consumer Protection, European Parliament
Subjects: EC conformity marking, artificial intelligence, biometrics, data protection, digital technology, innovation, market approval, market supervision, new technology, personal data




C_202400506EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2024/506


23.1.2024






P9_TA(2023)0236
Artificial Intelligence Act
Amendments adopted by the European Parliament on 14 June 2023 on the proposal for a regulation of the European Parliament and of the Council on laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union legislative acts (COM(2021)0206 — C9-0146/2021 — 2021/0106(COD)) (1)

(Ordinary legislative procedure: first reading)
(C/2024/506)


Amendment 1


Proposal for a regulation


Citation 4 a (new)








Text proposed by the Commission




Amendment





 




Having regard to the opinion of the European Central Bank,







Amendment 2


Proposal for a regulation


Citation 4 b (new)








Text proposed by the Commission




Amendment





 




Having regard to the joint opinion of the European Data Protection Board and the European Data Protection Supervisor,







Amendment 3


Proposal for a regulation


Recital 1








Text proposed by the Commission




Amendment











(1)


The purpose of this Regulation is to 
improve
 the functioning of the internal market 
by laying
 down a uniform legal framework in particular for the development, 
marketing and
 use of artificial intelligence in conformity with Union values
. This Regulation pursues a number of overriding reasons of public interest, such as a high level of protection of health, safety and fundamental rights, and it
 ensures the free movement of AI-based goods and services cross-border, thus preventing Member States from imposing restrictions on the development, marketing and use of AI systems, unless explicitly authorised by this Regulation.












(1)


The purpose of this Regulation is 
to promote the uptake of human centric and trustworthy artificial intelligence and to ensure a high level of protection of health, safety, fundamental rights, democracy and rule of law and the environment from harmful effects of artificial intelligence systems in the Union while supporting innovation and improving
 the functioning of the internal market. 
This Regulation lays
 down a uniform legal framework in particular for the development, 
the placing on the market, the putting into service and the
 use of artificial intelligence in conformity with Union values 
and
 ensures the free movement of AI-based goods and services cross-border, thus preventing Member States from imposing restrictions on the development, marketing and use of Artificial Intelligence systems (
AI systems
), unless explicitly authorised by this Regulation. 
Certain AI systems can also have an impact on democracy and rule of law and the environment. These concerns are specifically addressed in the critical sectors and use cases listed in the annexes to this Regulation.











Amendment 4


Proposal for a regulation


Recital 1 a (new)








Text proposed by the Commission




Amendment





 










(1a)






This Regulation should preserve the values of the Union facilitating the distribution of artificial intelligence benefits across society, protecting individuals, companies, democracy and rule of law and the environment from risks while boosting innovation and employment and making the Union a leader in the field.











Amendment 5


Proposal for a regulation


Recital 2








Text proposed by the Commission




Amendment











(2)




Artificial intelligence systems (
AI systems) can be easily deployed in multiple sectors of the economy and society, including cross border, and circulate throughout the Union. Certain Member States have already explored the adoption of national rules to ensure that artificial intelligence is safe and is developed and used in compliance with fundamental rights obligations. Differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use AI systems. A consistent and high level of protection throughout the Union should therefore be ensured, while divergences hampering the free circulation of AI systems and related products and services within the internal market should be prevented, by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on Article 114 of the Treaty on the Functioning of the European Union (TFEU). 
To the extent that this Regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of AI systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the purpose of law enforcement, it is appropriate to base this Regulation, in as far as those specific rules are concerned, on Article 16 of the TFEU. In light of those specific rules and the recourse to Article 16 TFEU, it is appropriate to consult the European Data Protection Board.














(2)


AI systems can be easily deployed in multiple sectors of the economy and society, including cross border, and circulate throughout the Union. Certain Member States have already explored the adoption of national rules to ensure that artificial intelligence is 
trustworthy and
 safe and is developed and used in compliance with fundamental rights obligations. Differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use AI systems. A consistent and high level of protection throughout the Union should therefore be ensured 
in order to achieve trustworthy AI
, while divergences hampering the free circulation
, innovation, deployment and uptake
 of AI systems and related products and services within the internal market should be prevented, by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on Article 114 of the Treaty on the Functioning of the European Union (TFEU).









Amendment 6


Proposal for a regulation


Recital 2 a (new)








Text proposed by the Commission




Amendment





 










(2a)






As artificial intelligence often relies on the processing of large volumes of data, and many AI systems and applications on the processing of personal data, it is appropriate to base this Regulation on Article 16 TFEU, which enshrines the right to the protection of natural persons with regard to the processing of personal data and provides for the adoption of rules on the protection of individuals with regard to the processing of personal data.











Amendment 7


Proposal for a regulation


Recital 2 b (new)








Text proposed by the Commission




Amendment





 










(2b)






The fundamental right to the protection of personal data is safeguarded in particular by Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive 2016/680. Directive 2002/58/EC additionally protects private life and the confidentiality of communications, including providing conditions for any personal and non-personal data storing in and access from terminal equipment. Those legal acts provide the basis for sustainable and responsible data processing, including where datasets include a mix of personal and nonpersonal data. This Regulation does not seek to affect the application of existing Union law governing the processing of personal data, including the tasks and powers of the independent supervisory authorities competent to monitor compliance with those instruments. This Regulation does not affect the fundamental rights to private life and the protection of personal data as provided for by Union law on data protection and privacy and enshrined in the Charter of Fundamental Rights of the European Union (the ‘Charter’).











Amendment 8


Proposal for a regulation


Recital 2 c (new)








Text proposed by the Commission




Amendment





 










(2c)






Artificial intelligence systems in the Union are subject to relevant product safety legislation that provides a framework protecting consumers against dangerous products in general and such legislation should continue to apply. This Regulation is also without prejudice to the rules laid down by other Union legal acts related to consumer protection and product safety, including including Regulation (EU) 2017/2394, Regulation (EU) 2019/1020 and Directive 2001/95/EC on general product safety and Directive 2013/11/EU.











Amendment 9


Proposal for a regulation


Recital 2 d (new)








Text proposed by the Commission




Amendment





 










(2d)






In accordance with Article 114(2) TFEU, this Regulation complements and should not undermine the rights and interests of employed persons. This Regulation should therefore not affect Union law on social policy and national labour law and practice, that is any legal and contractual provision concerning employment conditions, working conditions, including health and safety at work and the relationship between employers and workers, including information, consultation and participation. This Regulation should not affect the exercise of fundamental rights as recognised in the Member States and at Union level, including the right or freedom to strike or to take other action covered by the specific industrial relations systems in Member States, in accordance with national law and/or practice. Nor should it affect concertation practices, the right to negotiate, to conclude and enforce collective agreement or to take collective action in accordance with national law and/or practice. It should in any event not prevent the Commission from proposing specific legislation on the rights and freedoms of workers affected by AI systems.











Amendment 10


Proposal for a regulation


Recital 2 e (new)








Text proposed by the Commission




Amendment





 










(2e)






This Regulation should not affect the provisions aiming to improve working conditions in platform work set out in Directive … [COD 2021/414/EC].











Amendment 11


Proposal for a regulation


Recital 2 f (new)








Text proposed by the Commission




Amendment





 










(2f)






This Regulation should help in supporting research and innovation and should not undermine research and development activity and respect freedom of scientific research. It is therefore necessary to exclude from its scope AI systems specifically developed for the sole purpose of scientific research and development and to ensure that the Regulation does not otherwise affect scientific research and development activity on AI systems. Under all circumstances, any research and development activity should be carried out in accordance with the Charter, Union law as well as the national law;











Amendment 12


Proposal for a regulation


Recital 3








Text proposed by the Commission




Amendment











(3)


Artificial intelligence is a fast evolving family of technologies that can 
contribute
 to a wide array of economic and societal benefits across the entire spectrum of industries and social activities. By improving prediction, optimising operations and resource allocation, and personalising digital solutions available for individuals and organisations, the use of artificial intelligence can provide key competitive advantages to companies and support socially and environmentally beneficial outcomes, for example in healthcare, farming, education and training, infrastructure management, energy, transport and logistics, public services, security, justice, resource and energy efficiency, and climate change mitigation and adaptation.












(3)


Artificial intelligence is a fast evolving family of technologies that can 
and already contributes
 to a wide array of economic
, environmental
 and societal benefits across the entire spectrum of industries and social activities 
if developed in accordance with relevant general principles in line with the Charter and the values on which the Union is founded
. By improving prediction, optimising operations and resource allocation, and personalising digital solutions available for individuals and organisations, the use of artificial intelligence can provide key competitive advantages to companies and support socially and environmentally beneficial outcomes, for example in healthcare, farming, 
food safety,
 education and training
, media, sports, culture
, infrastructure management, energy, transport and logistics
, crisis management
, public services, security, justice, resource and energy efficiency, 
environmental monitoring, the conservation and restoration of biodiversity and ecosystems
 and climate change mitigation and adaptation.









Amendment 13


Proposal for a regulation


Recital 3 a (new)








Text proposed by the Commission




Amendment





 










(3a)






To contribute to reaching the carbon neutrality targets, European companies should seek to utilise all available technological advancements that can assist in realising this goal. Artificial Intelligence is a technology that has the potential of being used to process the ever-growing amount of data created during industrial, environmental, health and other processes. To facilitate investments in AI-based analysis and optimisation tools, this Regulation should provide a predictable and proportionate environment for low-risk industrial solutions.











Amendment 14


Proposal for a regulation


Recital 4








Text proposed by the Commission




Amendment











(4)


At the same time, depending on the circumstances regarding its specific application and use, artificial intelligence may generate risks and cause harm to public interests and rights that are protected by Union law. Such harm might be material or immaterial.












(4)


At the same time, depending on the circumstances regarding its specific application and use, 
as well as the level of technological development,
 artificial intelligence may generate risks and cause harm to public 
or private
 interests and 
fundamental
 rights 
of natural persons
 that are protected by Union law. Such harm might be material or immaterial
, including physical, psychological, societal or economic harm
.









Amendment 15


Proposal for a regulation


Recital 4 a (new)








Text proposed by the Commission




Amendment





 










(4a)






Given the major impact that artificial intelligence can have on society and the need to build trust, it is vital for artificial intelligence and its regulatory framework to be developed according to Union values enshrined in Article 2 TEU, the fundamental rights and freedoms enshrined in the Treaties, the Charter, and international human rights law. As a pre-requisite, artificial intelligence should be a human-centric technology. It should not substitute human autonomy or assume the loss of individual freedom and should primarily serve the needs of the society and the common good. Safeguards should be provided to ensure the development and use of ethically embedded artificial intelligence that respects Union values and the Charter.











Amendment 16


Proposal for a regulation


Recital 5








Text proposed by the Commission




Amendment











(5)


A Union legal framework laying down harmonised rules on artificial intelligence is therefore needed to foster the development, use and uptake of artificial intelligence in the internal market that at the same time meets a high level of protection of public interests, such as health and safety 
and the
 protection of fundamental rights, as recognised and protected by Union law. To achieve that objective, rules regulating the placing on the market 
and
 putting into service of certain AI systems should be laid down, thus ensuring the smooth functioning of the internal market and allowing those systems to benefit from the principle of free movement of goods and services. By laying down those rules, this Regulation supports the objective of the Union of being a global leader in the development of secure, trustworthy and ethical artificial intelligence, as stated by the European Council (33), and it ensures the protection of ethical principles, as specifically requested by the European Parliament (34).












(5)


A Union legal framework laying down harmonised rules on artificial intelligence is therefore needed to foster the development, use and uptake of artificial intelligence in the internal market that at the same time meets a high level of protection of public interests, such as health and safety, protection of fundamental rights
, democracy and rule of law and the environment
, as recognised and protected by Union law. To achieve that objective, rules regulating the placing on the market
, the
 putting into service 
and the use
 of certain AI systems should be laid down, thus ensuring the smooth functioning of the internal market and allowing those systems to benefit from the principle of free movement of goods and services. 
These rules should be clear and robust in protecting fundamental rights, supportive of new innovative solutions, and enabling to a European ecosystem of public and private actors creating AI systems in line with Union values.
 By laying down those rules 
as well as measures in support of innovation with a particular focus on SMEs and start-ups
, this Regulation supports the objective 
of promoting the AI made in Europe,
 of the Union of being a global leader in the development of secure, trustworthy and ethical artificial intelligence, as stated by the European Council (33), and it ensures the protection of ethical principles, as specifically requested by the European Parliament (34).









Amendment 17


Proposal for a regulation


Recital 5 a (new)








Text proposed by the Commission




Amendment





 










(5a)






Furthermore, in order to foster the development of AI systems in line with Union values, the Union needs to address the main gaps and barriers blocking the potential of the digital transformation including the shortage of digitally skilled workers, cybersecurity concerns, lack of investment and access to investment, and existing and potential gaps between large companies, SME’s and start-ups. Special attention should be paid to ensuring that the benefits of AI and innovation in new technologies are felt across all regions of the Union and that sufficient investment and resources are provided especially to those regions that may be lagging behind in some digital indicators.











Amendment 18


Proposal for a regulation


Recital 6








Text proposed by the Commission




Amendment











(6)


The notion of AI system should be clearly defined to ensure legal certainty, while providing the flexibility to accommodate 
future
 technological developments
. The definition
 should be based on 
the key functional
 characteristics of 
the software
, 
in particular the ability, for a given set of human-defined objectives, to generate outputs
 such as 
content, predictions, recommendations, or decisions which influence the environment with which the system interacts, be it in a physical or digital dimension
. AI systems 
can be
 designed to operate with varying levels of autonomy and 
be used on a stand-alone basis or as a component of a product, irrespective of whether the system is physically integrated into the product (embedded) or serve the functionality of the product
 without 
being integrated therein (non-embedded). The definition of
 AI system 
should be complemented by a list of
 specific 
techniques and approaches used for its development
, which should be 
kept up-to–date in the light of market and technological developments through the adoption of delegated acts
 by the 
Commission to amend that list
.












(6)


The notion of AI system 
in this Regulation
 should be clearly defined 
and closely aligned with the work of international organisations working on artificial intelligence
 to ensure legal certainty
, harmonization and wide acceptance
, while providing the flexibility to accommodate 
the rapid
 technological developments 
in this field. Moreover, it
 should be based on 
key
 characteristics of 
artificial intelligence
, such as 
its learning, reasoning or modelling capabilities, so as to distinguish it from simpler software systems or programming approaches
. AI systems 
are
 designed to operate with varying levels of autonomy
, meaning that they have at least some degree of independence of actions from human controls
 and 
of capabilities to operate
 without 
human intervention. The term ‘machine-based’ refers to the fact that AI systems run on machines. The reference to explicit or implicit objectives underscores that AI systems can operate according to explicit human-defined objectives or to implicit objectives. The objectives of the
 AI system 
may be different from the intended purpose of the AI system in a
 specific 
context. The reference to predictions includes content
, which 
is considered in this Regulation a form of prediction as one of the possible outputs produced by an AI system. For the purposes of this Regulation, environments
 should be 
understood as the contexts in which the AI systems operate, whereas outputs generated
 by the 
AI system, meaning predictions, recommendations or decisions, respond to the objectives of the system, on the basis of inputs from said environment
. 
Such output further influences said environment, even by merely introducing new information to it.











Amendment 19


Proposal for a regulation


Recital 6 a (new)








Text proposed by the Commission




Amendment





 










(6a)






AI systems often have machine learning capacities that allow them to adapt and perform new tasks autonomously. Machine learning refers to the computational process of optimizing the parameters of a model from data, which is a mathematical construct generating an output based on input data. Machine learning approaches include, for instance, supervised, unsupervised and reinforcement learning, using a variety of methods including deep learning with neural networks. This Regulation is aimed at addressing new potential risks that may arise by delegating control to AI systems, in particular to those AI systems that can evolve after deployment. The function and outputs of many of these AI systems are based on abstract mathematical relationships that are difficult for humans to understand, monitor and trace back to specific inputs. These complex and opaque characteristics (black box element) impact accountability and explainability. Comparably simpler techniques such as knowledge-based approaches, Bayesian estimation or decision-trees may also lead to legal gaps that need to be addressed by this Regulation, in particular when they are used in combination with machine learning approaches in hybrid systems.











Amendment 20


Proposal for a regulation


Recital 6 b (new)








Text proposed by the Commission




Amendment





 










(6b)






AI systems can be used as stand-alone software system, integrated into a physical product (embedded), used to serve the functionality of a physical product without being integrated therein (non-embedded) or used as an AI component of a larger system. If this larger system would not function without the AI component in question, then the entire larger system should be considered as one single AI system under this Regulation.











Amendment 21


Proposal for a regulation


Recital 7








Text proposed by the Commission




Amendment











(7)


The notion of biometric data used in this Regulation is in line with and should be interpreted consistently with the notion of biometric data as defined in Article 4(14) of Regulation (EU) 2016/679 of the European Parliament and of the Council (35)

, Article 3(18) of Regulation (EU) 2018/1725 of the European Parliament and of the Council



 (36)



and Article 3(13) of Directive (EU) 2016/680 of the European Parliament and of the Council



 (37)

.












(7)


The notion of biometric data used in this Regulation is in line with and should be interpreted consistently with the notion of biometric data as defined in Article 4(14) of Regulation (EU) 2016/679 of the European Parliament and of the Council (35)

. Biometrics-based data are additional data resulting from specific technical processing relating to physical, physiological or behavioural signals of a natural person, such as facial expressions, movements, pulse frequency, voice, key strikes or gait, which may or may not allow or confirm the unique identification of a natural person
.









Amendment 22


Proposal for a regulation


Recital 7 a (new)








Text proposed by the Commission




Amendment





 










(7a)






The notion of biometric identification as used in this Regulation should be defined as the automated recognition of physical, physiological, behavioural, and psychological human features such as the face, eye movement, facial expressions, body shape, voice, speech, gait, posture, heart rate, blood pressure, odour, keystrokes, psychological reactions (anger, distress, grief, etc.) for the purpose of establishing an individual’s identity by comparing biometric data of that individual to stored biometric data of individuals in a database (one-to-many identification), irrespective of whether the individual has given its consent or not.











Amendment 23


Proposal for a regulation


Recital 7 b (new)








Text proposed by the Commission




Amendment





 










(7b)






The notion of biometric categorisation as used in this Regulation should be defined as assigning natural persons to specific categories or inferring their characteristics and attributes such as gender, sex, age, hair colour, eye colour, tattoos, ethnic or social origin, health, mental or physical ability, behavioural or personality, traits language, religion, or membership of a national minority or sexual or political orientation on the basis of their biometric or biometric-based data, or which can be inferred from such data.











Amendment 24


Proposal for a regulation


Recital 8








Text proposed by the Commission




Amendment











(8)


The notion of remote biometric identification system as used in this Regulation should be defined functionally, as an AI system intended for the identification of 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 whether the targeted person will be present and can be identified, irrespectively of the particular technology, processes or types of biometric data used. Considering their different characteristics and manners in which they are used, as well as the different risks involved, a distinction should be made between ‘real-time’ and ‘post’ remote biometric identification systems. In the case of ‘real-time’ systems, the capturing of the biometric data, the comparison and the identification occur all instantaneously, near-instantaneously or in any event without a significant delay. In this regard, there should be no scope for circumventing the rules of this Regulation on the ‘real-time’ use of the AI systems in question by providing for minor delays. ‘Real-time’ systems involve the use of ‘live’ or ‘near-‘live’ material, such as video footage, generated by a camera or other device with similar functionality. In the case of ‘post’ systems, in contrast, the biometric data have already been captured and the comparison and identification occur only after a significant delay. This involves material, such as pictures or video footage generated by closed circuit television cameras or private devices, which has been generated before the use of the system in respect of the natural persons concerned.












(8)


The notion of remote biometric identification system as used in this Regulation should be defined functionally, as an AI system intended for the identification of 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 whether the targeted person will be present and can be identified, irrespectively of the particular technology, processes or types of biometric data used
, exlcuding verification systems which merely compare the biometric data of an individual to their previously provided biometric data (one-to-one)
. Considering their different characteristics and manners in which they are used, as well as the different risks involved, a distinction should be made between ‘real-time’ and ‘post’ remote biometric identification systems. In the case of ‘real-time’ systems, the capturing of the biometric data, the comparison and the identification occur all instantaneously, near-instantaneously or in any event without a significant delay. In this regard, there should be no scope for circumventing the rules of this Regulation on the ‘real-time’ use of the AI systems in question by providing for minor delays. ‘Real-time’ systems involve the use of ‘live’ or ‘near-‘live’ material, such as video footage, generated by a camera or other device with similar functionality. In the case of ‘post’ systems, in contrast, the biometric data have already been captured and the comparison and identification occur only after a significant delay. This involves material, such as pictures or video footage generated by closed circuit television cameras or private devices, which has been generated before the use of the system in respect of the natural persons concerned. 
Given that the notion of biometric identification is independent from the individual’s consent, this definition applies even when warning notices are placed in the location that is under surveillance of the remote biometric identification system, and is not de facto annulled by pre-enrolment.











Amendment 25


Proposal for a regulation


Recital 8 a (new)








Text proposed by the Commission




Amendment





 










(8a)






The identification of natural persons at a distance is understood to distinguish remote biometric identification systems from close proximity individual verification systems using biometric identification means, whose sole purpose is to confirm whether or not a specific natural person presenting themselves for identification is permitted, such as in order to gain access to a service, a device, or premises.











Amendment 26


Proposal for a regulation


Recital 9








Text proposed by the Commission




Amendment











(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 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. However, the mere fact that certain conditions for accessing a particular space may apply, such as admission tickets or age restrictions, does not mean that the space is not publicly accessible within the meaning of this Regulation. 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.












(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 
and regardless of the potential capacity restrictions
. Therefore, the notion does not cover places that are private 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. However, the mere fact that certain conditions for accessing a particular space may apply, such as admission tickets or age restrictions, does not mean that the space is not publicly accessible within the meaning of this Regulation. Consequently, in addition to public spaces such as streets, relevant parts of government buildings and most transport infrastructure, spaces such as cinemas, theatres, 
sports grounds, schools, universities, relevant parts of hospitals and banks, amusement parks, festivals,
 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.









Amendment 27


Proposal for a regulation


Recital 9 a (new)








Text proposed by the Commission




Amendment





 










(9a)






It is important to note that AI systems should make best efforts to respect general principles establishing a high-level framework that promotes a coherent human-centric approach to ethical and trustworthy AI in line with the Charter of Fundamental Rights of the European Union and the values on which the Union is founded, including the protection of fundamental rights, human agency and oversight, technical robustness and safety, privacy and data governance, transparency, non-discrimination and fairness and societal and environmental wellbeing.











Amendment 28


Proposal for a regulation


Recital 9 b (new)








Text proposed by the Commission




Amendment





 










(9b)






‘AI literacy’ refers to skills, knowledge and understanding that allows providers, users and affected persons, taking into account their respective rights and obligations in the context of this Regulation, to make an informed deployment of AI systems, as well as to gain awareness about the opportunities and risks of AI and possible harm it can cause and thereby promote its democratic control. AI literacy should not be limited to learning about tools and technologies, but should also aim to equip providers and users with the notions and skills required to ensure compliance with and enforcement of this Regulation. It is therefore necessary that the Commission, the Member States as well as providers and users of AI systems, in cooperation with all relevant stakeholders, promote the development of a sufficient level of AI literacy, in all sectors of society, for people of all ages, including women and girls, and that progress in that regard is closely followed.











Amendment 29


Proposal for a regulation


Recital 10








Text proposed by the Commission




Amendment











(10)


In order to ensure a level playing field and an effective protection of rights and freedoms of individuals across the Union, the rules established by this Regulation should apply to providers of AI systems in a non-discriminatory manner, irrespective of whether they are established within the Union or in a third country, and to 
users
 of AI systems established within the Union.












(10)


In order to ensure a level playing field and an effective protection of rights and freedoms of individuals across the Union 
and on international level
, the rules established by this Regulation should apply to providers of AI systems in a non-discriminatory manner, irrespective of whether they are established within the Union or in a third country, and to 
deployers
 of AI systems established within the Union. 
In order for the Union to be true to its fundamental values, AI systems intended to be used for practices that are considered unacceptable by this Regulation, should equally be deemed to be unacceptable outside the Union because of their particularly harmful effect to fundamental rights as enshrined in the Charter. Therefore it is appropriate to prohibit the export of such AI systems to third countries by providers residing in the Union.











Amendment 30


Proposal for a regulation


Recital 11








Text proposed by the Commission




Amendment











(11)


In light of their digital nature, certain AI systems should fall within the scope of this Regulation even when they are neither placed on the market, nor put into service, nor used in the Union. This is the case for example of an operator established in the Union that contracts certain services to an operator established outside the Union in relation to an activity to be performed by an AI system that would qualify as high-risk and whose effects impact natural persons located in the Union. In those circumstances, the AI system used by the operator outside the Union could process data lawfully collected in and transferred from the Union, and provide to the contracting operator in the Union the output of that AI system resulting from that processing, without that AI system being placed on the market, put into service or used in the Union. To prevent the circumvention of this Regulation and to ensure an effective protection of natural persons located in the Union, this Regulation should also apply to providers and users of AI systems that are established in a third country, to the extent the output produced by those systems is used in the Union. Nonetheless, to take into account existing arrangements and special needs for cooperation with foreign partners with whom information and evidence is exchanged, this Regulation should not apply to public authorities of a third country and international organisations when acting in the framework of international agreements concluded at national or European level for law enforcement and judicial cooperation with the Union or with its Member States. Such agreements have been concluded bilaterally between Member States and third countries or between the European Union, Europol and other EU agencies and third countries and international organisations.












(11)


In light of their digital nature, certain AI systems should fall within the scope of this Regulation even when they are neither placed on the market, nor put into service, nor used in the Union. This is the case for example of an operator established in the Union that contracts certain services to an operator established outside the Union in relation to an activity to be performed by an AI system that would qualify as high-risk and whose effects impact natural persons located in the Union. In those circumstances, the AI system used by the operator outside the Union could process data lawfully collected in and transferred from the Union, and provide to the contracting operator in the Union the output of that AI system resulting from that processing, without that AI system being placed on the market, put into service or used in the Union. To prevent the circumvention of this Regulation and to ensure an effective protection of natural persons located in the Union, this Regulation should also apply to providers and users 
deployers
 of AI systems that are established in a third country, to the extent the output produced by those systems is 
intended to be
 used in the Union. Nonetheless, to take into account existing arrangements and special needs for cooperation with foreign partners with whom information and evidence is exchanged, this Regulation should not apply to public authorities of a third country and international organisations when acting in the framework of international agreements concluded at national or European level for law enforcement and judicial cooperation with the Union or with its Member States. Such agreements have been concluded bilaterally between Member States and third countries or between the European Union, Europol and other EU agencies and third countries and international organisations. 
This exception should nevertheless be limited to trusted countries and international organisation that share Union values.











Amendment 31


Proposal for a regulation


Recital 12








Text proposed by the Commission




Amendment











(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 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 Common Foreign and Security Policy regulated under Title V of the Treaty on the European Union (TEU). 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].












(12)


This Regulation should also apply to Union institutions, offices, bodies and agencies when acting as a provider or 
deployer
 of an AI system. AI systems 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 Common Foreign and Security Policy regulated under Title V of the Treaty on the European Union (TEU). 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].









Amendment 32


Proposal for a regulation


Recital 12 a (new)








Text proposed by the Commission




Amendment





 










(12a)






Software and data that are openly shared and where users can freely access, use, modify and redistribute them or modified versions thereof, can contribute to research and innovation in the market. Research by the Commission also shows that free and open-source software can contribute between EUR 65 billion to EUR 95 billion to the European Union’s GDP and that it can provide significant growth opportunities for the European economy. Users are allowed to run, copy, distribute, study, change and improve software and data, including models by way of free and open-source licences. To foster the development and deployment of AI, especially by SMEs, start-ups, academic research but also by individuals, this Regulation should not apply to such free and open-source AI components except to the extent that they are placed on the market or put into service by a provider as part of a high-risk AI system or of an AI system that falls under Title II or IV of this Regulation.











Amendment 33


Proposal for a regulation


Recital 12 b (new)








Text proposed by the Commission




Amendment





 










(12b)






Neither the collaborative development of free and open-source AI components nor making them available on open repositories should constitute a placing on the market or putting into service. A commercial activity, within the understanding of making available on the market, might however be characterised by charging a price, with the exception of transactions between micro enterprises, for a free and open-source AI component but also by charging a price for technical support services, by providing a software platform through which the provider monetises other services, or by the use of personal data for reasons other than exclusively for improving the security, compatibility or interoperability of the software.











Amendment 34


Proposal for a regulation


Recital 12 c (new)








Text proposed by the Commission




Amendment





 










(12c)






The developers of free and open-source AI components should not be mandated under this Regulation to comply with requirements targeting the AI value chain and, in particular, not towards the provider that has used that free and open-source AI component. Developers of free and open-source AI components should however be encouraged to implement widely adopted documentation practices, such as model and data cards, as a way to accelerate information sharing along the AI value chain, allowing the promotion of trustworthy AI systems in the Union.











Amendment 35


Proposal for a regulation


Recital 13








Text proposed by the Commission




Amendment











(13)


In order to ensure a consistent and high level of protection of public interests as regards health, safety and fundamental rights, common normative standards for all high-risk AI systems should be established. Those standards should be consistent with the Charter 
of fundamental rights of the European Union (the Charter)
 and should be non-discriminatory and in line with the Union’s international trade commitments.












(13)


In order to ensure a consistent and high level of protection of public interests as regards health, safety and fundamental rights 
as well as democracy and rule of law and the environment
, common normative standards for all high-risk AI systems should be established. Those standards should be consistent with the Charter, 
the European Green Deal, the Joint Declaration on Digital Rights of the Union and the Ethics Guidelines for Trustworthy Artificial Intelligence (AI) of the High-Level Expert Group on Artificial Intelligence,
 and should be non-discriminatory and in line with the Union’s international trade commitments.









Amendment 36


Proposal for a regulation


Recital 14








Text proposed by the Commission




Amendment











(14)


In order to introduce a proportionate and effective set of binding rules for AI systems, a clearly defined risk-based approach should be followed. That approach should tailor the type and content of such rules to the intensity and scope of the risks that AI systems can generate. It is therefore necessary to prohibit certain artificial intelligence practices, to lay down requirements for high-risk AI systems and obligations for the relevant operators, and to lay down transparency obligations for certain AI systems.












(14)


In order to introduce a proportionate and effective set of binding rules for AI systems, a clearly defined risk-based approach should be followed. That approach should tailor the type and content of such rules to the intensity and scope of the risks that AI systems can generate. It is therefore necessary to prohibit certain 
unacceptable
 artificial intelligence practices, to lay down requirements for high-risk AI systems and obligations for the relevant operators, and to lay down transparency obligations for certain AI systems









Amendment 37


Proposal for a regulation


Recital 15








Text proposed by the Commission




Amendment











(15)


Aside from the many beneficial uses of artificial intelligence, that technology can also be misused and provide novel and powerful tools for manipulative, exploitative and social control practices. Such practices are particularly harmful and should be prohibited because they contradict Union values of respect for human dignity, freedom, equality, democracy and the rule of law and Union fundamental rights, including the right to non-discrimination, data protection and privacy and the rights of the child.












(15)


Aside from the many beneficial uses of artificial intelligence, that technology can also be misused and provide novel and powerful tools for manipulative, exploitative and social control practices. Such practices are particularly harmful 
and abusive
 and should be prohibited because they contradict Union values of respect for human dignity, freedom, equality, democracy and the rule of law and Union fundamental rights, including the right to non-discrimination, data protection and privacy and the rights of the child.









Amendment 38


Proposal for a regulation


Recital 16








Text proposed by the Commission




Amendment











(16)


The placing on the market, putting into service or use of certain AI systems 
intended to distort
 human behaviour, whereby physical or psychological harms are likely to occur, should be forbidden. Such AI systems deploy subliminal components individuals cannot perceive or exploit vulnerabilities of 
children and people
 due to their age, physical or mental incapacities. They do so with the intention to materially 
distort
 the behaviour of a person and in a manner that causes or is likely to cause harm to that or another person. The intention may not be presumed if the distortion 
of human behaviour
 results from factors external to the AI system which are outside of the control of the provider or the user. Research for legitimate purposes in relation to such AI systems should not be stifled by the prohibition, if such research does not amount to use of the AI system in human-machine relations that exposes natural persons to harm and such research is carried out in accordance with recognised ethical standards for scientific research.












(16)


The placing on the market, putting into service or use of certain AI systems 
with the objective to or the effect of materially distorting
 human behaviour, whereby physical or psychological harms are likely to occur, should be forbidden. 
This limitation should be understood to include neuro-technologies assisted by AI systems that are used to monitor, use, or influence neural data gathered through brain-computer interfaces insofar as they are materially distorting the behaviour of a natural person in a manner that causes or is likely to cause that person or another person significant harm.
 Such AI systems deploy subliminal components individuals cannot perceive or exploit vulnerabilities of 
individuals
 and 
specific groups of persons
 due to their 
known or predicted personality traits,
 age, physical or mental incapacities
, social or economic situation
. They do so with the intention to 
or the effect of
 materially 
distorting
 the behaviour of a person and in a manner that causes or is likely to cause 
significant
 harm to that or another person 
or groups of persons, including harms that may be accumulated over time.
 The intention 
to distort the behaviour
 may not be presumed if the distortion results from factors external to the AI system which are outside of the control of the provider or the user
, such as factors that may not be reasonably foreseen and mitigated by the provider or the deployer of the AI system. In any case, it is not necessary for the provider or the deployer to have the intention to cause the significant harm, as long as such harm results from the manipulative or exploitative AI-enabled practices. The prohibitions for such AI practices is complementary to the provisions contained in Directive 2005/29/EC, according to which unfair commercial practices are prohibited, irrespective of whether they carried out having recourse to AI systems or otherwise. In such setting, lawful commercial practices, for example in the field of advertising, that are in compliance with Union law should not in themselves be regarded as violating prohibition.
 Research for legitimate purposes in relation to such AI systems should not be stifled by the prohibition, if such research does not amount to use of the AI system in human-machine relations that exposes natural persons to harm and such research is carried out in accordance with recognised ethical standards for scientific research 
and on the basis of specific informed consent of the individuals that are exposed to them or, where applicable, of their legal guardian.











Amendment 39


Proposal for a regulation


Recital 16 a (new)








Text proposed by the Commission




Amendment





 










(16a)






AI systems that categorise natural persons by assigning them to specific categories, according to known or inferred sensitive or protected characteristics are particularly intrusive, violate human dignity and hold great risk of discrimination. Such characteristics include gender, gender identity, race, ethnic origin, migration or citizenship status, political orientation, sexual orientation, religion, disability or any other grounds on which discrimination is prohibited under Article 21 of the Charter of Fundamental Rights of the European Union, as well as under Article 9 of Regulation (EU)2016/769. Such systems should therefore be prohibited.











Amendment 40


Proposal for a regulation


Recital 17








Text proposed by the Commission




Amendment











(17)


AI systems providing social scoring of natural persons for general purpose 
by public authorities or on their behalf
 may lead to discriminatory outcomes and the exclusion of certain groups. They 
may
 violate the right to dignity and non-discrimination and the values of equality and justice. Such AI systems evaluate or classify 
the trustworthiness of
 natural persons based on their social behaviour in multiple contexts or known or predicted personal or personality characteristics. The social score obtained from such AI systems may lead to the detrimental or unfavourable treatment of natural persons or whole groups thereof in social contexts, which are unrelated to the context in which the data was originally generated or collected or to a detrimental treatment that is disproportionate or unjustified to the gravity of their social behaviour. Such AI systems should be therefore prohibited.












(17)


AI systems providing social scoring of natural persons for general purpose may lead to discriminatory outcomes and the exclusion of certain groups. They violate the right to dignity and non-discrimination and the values of equality and justice. Such AI systems evaluate or classify natural persons 
or groups
 based on 
multiple data points and time occurrences related to
 their social behaviour in multiple contexts or known
, inferred
 or predicted personal or personality characteristics. The social score obtained from such AI systems may lead to the detrimental or unfavourable treatment of natural persons or whole groups thereof in social contexts, which are unrelated to the context in which the data was originally generated or collected or to a detrimental treatment that is disproportionate or unjustified to the gravity of their social behaviour. Such AI systems should be therefore prohibited.









Amendment 41


Proposal for a regulation


Recital 18








Text proposed by the Commission




Amendment











(18)


The use of AI systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces 
for the purpose of law enforcement is considered
 particularly intrusive 
in
 the rights and freedoms of the concerned persons, 
to the extent that it may
 affect the private life of a large part of the population, evoke a feeling of constant surveillance and indirectly dissuade the exercise of the freedom of assembly and other fundamental rights. In addition, the immediacy of the impact and the limited opportunities for further checks or corrections in relation to the use of such systems operating in ‘real-time’ carry heightened risks for the rights and freedoms of the persons that are concerned by law enforcement activities.












(18)


The use of AI systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces 
is
 particularly intrusive 
to
 the rights and freedoms of the concerned persons, 
and can ultimately
 affect the private life of a large part of the population, evoke a feeling of constant surveillance
, give parties deploying biometric identification in publicly accessible spaces a position of uncontrollable power
 and indirectly dissuade the exercise of the freedom of assembly and other fundamental rights 
at the core to the Rule of Law. Technical inaccuracies of AI systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. This is particularly relevant when it comes to age, ethnicity, sex or disabilities
. In addition, the immediacy of the impact and the limited opportunities for further checks or corrections in relation to the use of such systems operating in ‘real-time’ carry heightened risks for the rights and freedoms of the persons that are concerned by law enforcement activities. 
The use of those systems in publicly accessible places should therefore be prohibited. Similarly, AI systems used for the analysis of recorded footage of publicly accessible spaces through ‘post’ remote biometric identification systems should also be prohibited, unless there is pre-judicial authorisation for use in the context of law enforcement, when strictly necessary for the targeted search connected to a specific serious criminal offense that already took place, and only subject to a pre-judicial authorisation.











Amendment 42


Proposal for a regulation


Recital 19








Text proposed by the Commission




Amendment













(19)






The use of those systems for the purpose of law enforcement should therefore be prohibited, except in three exhaustively listed and narrowly defined situations, where the use is strictly necessary to achieve a substantial public interest, the importance of which outweighs the risks. Those situations involve the search for potential victims of crime, including missing children; certain threats to the life or physical safety of natural persons or of a terrorist attack; and the detection, localisation, identification or prosecution of perpetrators or suspects of the criminal offences referred to in Council Framework Decision 2002/584/JHA



 (38)



if those criminal offences are punishable in the Member State concerned by a custodial sentence or a detention order for a maximum period of at least three years and as they are defined in the law of that Member State. Such threshold for the custodial sentence or detention order in accordance with national law contributes to ensure that the offence should be serious enough to potentially justify the use of ‘real-time’ remote biometric identification systems. Moreover, of the 32 criminal offences listed in the Council Framework Decision 2002/584/JHA, some are in practice likely to be more relevant than others, in that the recourse to ‘real-time’ remote biometric identification will foreseeably be necessary and proportionate to highly varying degrees for the practical pursuit of the detection, localisation, identification or prosecution of a perpetrator or suspect of the different criminal offences listed and having regard to the likely differences in the seriousness, probability and scale of the harm or possible negative consequences.










deleted







Amendment 43


Proposal for a regulation


Recital 20








Text proposed by the Commission




Amendment













(20)






In order to ensure that those systems are used in a responsible and proportionate manner, it is also important to establish that, in each of those three exhaustively listed and narrowly defined situations, certain elements should be taken into account, in particular as regards the nature of the situation giving rise to the request and the consequences of the use for the rights and freedoms of all persons concerned and the safeguards and conditions provided for with the use. In addition, the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement should be subject to appropriate limits in time and space, having regard in particular to the evidence or indications regarding the threats, the victims or perpetrator. The reference database of persons should be appropriate for each use case in each of the three situations mentioned above.










deleted







Amendment 44


Proposal for a regulation


Recital 21








Text proposed by the Commission




Amendment













(21)






Each use of a ‘real-time’ remote biometric identification system in publicly accessible spaces for the purpose of law enforcement should be subject to an express and specific authorisation by a judicial authority or by an independent administrative authority of a Member State. Such authorisation should in principle be obtained prior to the use, except in duly justified situations of urgency, that is, situations where the need to use the systems in question is such as to make it effectively and objectively impossible to obtain an authorisation before commencing the use. In such situations of urgency, the use should be restricted to the absolute minimum necessary and be subject to appropriate safeguards and conditions, as determined in national law and specified in the context of each individual urgent use case by the law enforcement authority itself. In addition, the law enforcement authority should in such situations seek to obtain an authorisation as soon as possible, whilst providing the reasons for not having been able to request it earlier.










deleted







Amendment 45


Proposal for a regulation


Recital 22








Text proposed by the Commission




Amendment













(22)






Furthermore, it is appropriate to provide, within the exhaustive framework set by this Regulation that such use in the territory of a Member State in accordance with this Regulation should only be possible where and in as far as the Member State in question has decided to expressly provide for the possibility to authorise such use in its detailed rules of national law. Consequently, Member States remain free under this Regulation not to provide for such a possibility at all or to only provide for such a possibility in respect of some of the objectives capable of justifying authorised use identified in this Regulation.










deleted







Amendment 46


Proposal for a regulation


Recital 23








Text proposed by the Commission




Amendment













(23)






The use of AI systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement necessarily involves the processing of biometric data. The rules of this Regulation that prohibit, subject to certain exceptions, such use, which are based on Article 16 TFEU, should apply as lex specialis in respect of the rules on the processing of biometric data contained in Article 10 of Directive (EU) 2016/680, thus regulating such use and the processing of biometric data involved in an exhaustive manner. Therefore, such use and processing should only be possible in as far as it is compatible with the framework set by this Regulation, without there being scope, outside that framework, for the competent authorities, where they act for purpose of law enforcement, to use such systems and process such data in connection thereto on the grounds listed in Article 10 of Directive (EU) 2016/680. In this context, this Regulation is not intended to provide the legal basis for the processing of personal data under Article 8 of Directive 2016/680. However, the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for purposes other than law enforcement, including by competent authorities, should not be covered by the specific framework regarding such use for the purpose of law enforcement set by this Regulation. Such use for purposes other than law enforcement should therefore not be subject to the requirement of an authorisation under this Regulation and the applicable detailed rules of national law that may give effect to it.










deleted







Amendment 47


Proposal for a regulation


Recital 24








Text proposed by the Commission




Amendment











(24)


Any processing of biometric data and other personal data involved in the use of AI systems for biometric identification, other than in connection to the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces 
for the purpose of law enforcement
 as regulated by this Regulation
, including where those systems are used by competent authorities in publicly accessible spaces for other purposes than law enforcement,
 should continue to comply with all requirements resulting from Article 9(1) of Regulation (EU) 2016/679, Article 10(1) of Regulation (EU) 2018/1725 and Article 10 of Directive (EU) 2016/680, as applicable.












(24)


Any processing of biometric data and other personal data involved in the use of AI systems for biometric identification, other than in connection to the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces as regulated by this Regulation should continue to comply with all requirements resulting from Article 9(1) of Regulation (EU) 2016/679, Article 10(1) of Regulation (EU) 2018/1725 and Article 10 of Directive (EU) 2016/680, as applicable.









Amendment 48


Proposal for a regulation


Recital 25








Text proposed by the Commission




Amendment











(25)


In accordance with Article 6a of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, as annexed to the TEU and to the TFEU, Ireland is not bound by the rules laid down in Article 5(1), point (d), 
(2) and (3)
 of this Regulation adopted on the basis of Article 16 of the TFEU which relate to the processing of personal data by the Member States when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU, where Ireland is not bound by the rules governing the forms of judicial cooperation in criminal matters or police cooperation which require compliance with the provisions laid down on the basis of Article 16 of the TFEU.












(25)


In accordance with Article 6a of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, as annexed to the TEU and to the TFEU, Ireland is not bound by the rules laid down in Article 5(1), point (d), of this Regulation adopted on the basis of Article 16 of the TFEU which relate to the processing of personal data by the Member States when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU, where Ireland is not bound by the rules governing the forms of judicial cooperation in criminal matters or police cooperation which require compliance with the provisions laid down on the basis of Article 16 of the TFEU.









Amendment 49


Proposal for a regulation


Recital 26








Text proposed by the Commission




Amendment











(26)


In accordance with Articles 2 and 2a of Protocol No 22 on the position of Denmark, annexed to the TEU and TFEU, Denmark is not bound by rules laid down in Article 5(1), point (d)
, (2) and (3)
 of this Regulation adopted on the basis of Article 16 of the TFEU, or subject to their application, which relate to the processing of personal data by the Member States when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU.












(26)


In accordance with Articles 2 and 2a of Protocol No 22 on the position of Denmark, annexed to the TEU and TFEU, Denmark is not bound by rules laid down in Article 5(1), point (d) of this Regulation adopted on the basis of Article 16 of the TFEU, or subject to their application, which relate to the processing of personal data by the Member States when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU.









Amendment 50


Proposal for a regulation


Recital 26 a (new)








Text proposed by the Commission




Amendment





 










(26a)






AI systems used by law enforcement authorities or on their behalf to make predictions, profiles or risk assessments based on profiling of natural persons or data analysis based on personality traits and characteristics, including the person’s location, or past criminal behaviour of natural persons or groups of persons for the purpose of predicting the occurrence or reoccurrence of an actual or potential criminal offence(s) or other criminalised social behaviour or administrative offences, including fraud-predicition systems, hold a particular risk of discrimination against certain persons or groups of persons, as they violate human dignity as well as the key legal principle of presumption of innocence. Such AI systems should therefore be prohibited.











Amendment 51


Proposal for a regulation


Recital 26 b (new)








Text proposed by the Commission




Amendment





 










(26b)






The indiscriminate and untargeted scraping of biometric data from social media or CCTV footage to create or expand facial recognition databases add to the feeling of mass surveillance and can lead to gross violations of fundamental rights, including the right to privacy. The use of AI systems with this intended purpose should therefore be prohibited.











Amendment 52


Proposal for a regulation


Recital 26 c (new)








Text proposed by the Commission




Amendment





 










(26c)






There are serious concerns about the scientific basis of AI systems aiming to detect emotions, physical or physiological features such as facial expressions, movements, pulse frequency or voice. Emotions or expressions of emotions and perceptions thereof vary considerably across cultures and situations, and even within a single individual. Among the key shortcomings of such technologies, are the limited reliability (emotion categories are neither reliably expressed through, nor unequivocally associated with, a common set of physical or physiological movements), the lack of specificity (physical or physiological expressions do not perfectly match emotion categories) and the limited generalisability (the effects of context and culture are not sufficiently considered). Reliability issues and consequently, major risks for abuse, may especially arise when deploying the system in real-life situations related to law enforcement, border management, workplace and education institutions. Therefore, the placing on the market, putting into service, or use of AI systems intended to be used in these contexts to detect the emotional state of individuals should be prohibited.











Amendment 53


Proposal for a regulation


Recital 26 d (new)








Text proposed by the Commission




Amendment





 










(26d)






Practices that are prohibited by Union legislation, including data protection law, non-discrimination law, consumer protection law, and competition law, should not be affected by this Regulation











Amendment 54


Proposal for a regulation


Recital 27








Text proposed by the Commission




Amendment











(27)


High-risk AI systems should only be placed on the Union market 
or
 put into service if they comply with certain mandatory requirements. Those requirements should ensure that high-risk AI systems available in the Union or whose output is otherwise used in the Union do not pose unacceptable risks to important Union public interests as recognised and protected by Union law. AI systems identified as high-risk should be limited to those that have a significant harmful impact on the health, safety and fundamental rights of persons in the Union and such limitation minimises any potential restriction to international trade, if any.












(27)


High-risk AI systems should only be placed on the Union market, put into service 
or used
 if they comply with certain mandatory requirements. Those requirements should ensure that high-risk AI systems available in the Union or whose output is otherwise used in the Union do not pose unacceptable risks to important Union public interests as recognised and protected by Union law
, including fundamental rights, democracy, the rule or law or the environment. In order to ensure alignment with sectoral legislation and avoid duplications, requirements for high-risk AI systems should take into account sectoral legislation laying down requirements for high-risk AI systems included in the scope of this Regulation, such as Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In Vitro Diagnostic Devices or Directive 2006/42/EC on Machinery
. AI systems identified as high-risk should be limited to those that have a significant harmful impact on the health, safety and fundamental rights of persons in the Union and such limitation minimises any potential restriction to international trade, if any. 
Given the rapid pace of technological development, as well as the potential changes in the use of AI systems, the list of high-risk areas and use-cases in Annex III should nonetheless be subject to permanent review through the exercise of regular assessment.











Amendment 55


Proposal for a regulation


Recital 28








Text proposed by the Commission




Amendment











(28)


AI systems could 
produce
 adverse 
outcomes
 to health and safety of persons, in particular when such systems operate as components of products. Consistently with the objectives of Union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market, it is important that the safety risks that may be generated by a product as a whole due to its digital components, including AI systems, are duly prevented and mitigated. For instance, increasingly autonomous robots, whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments. Similarly, in the health sector where the stakes for life and health are particularly high, increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate. 
The extent of the adverse impact caused by the AI system on the fundamental rights protected by the Charter is of particular relevance when classifying an AI system as high-risk. Those rights include the right to human dignity, respect for private and family life, protection of personal data, freedom of expression and information, freedom of assembly and of association, and non-discrimination, consumer protection, workers’ rights, rights of persons with disabilities, right to an effective remedy and to a fair trial, right of defence and the presumption of innocence, right to good administration. In addition to those rights, it is important to highlight that children have specific rights as enshrined in Article 24 of the EU Charter and in the United Nations Convention on the Rights of the Child (further elaborated in the UNCRC General Comment No. 25 as regards the digital environment), both of which require consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their well-being. The fundamental right to a high level of environmental protection enshrined in the Charter and implemented in Union policies should also be considered when assessing the severity of the harm that an AI system can cause, including in relation to the health and safety of persons.














(28)


AI systems could 
have an
 adverse 
impact
 to health and safety of persons, in particular when such systems operate as 
safety
 components of products. Consistently with the objectives of Union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market, it is important that the safety risks that may be generated by a product as a whole due to its digital components, including AI systems, are duly prevented and mitigated. For instance, increasingly autonomous robots, whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments. Similarly, in the health sector where the stakes for life and health are particularly high, increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate.









Amendment 56


Proposal for a regulation


Recital 28 a (new)








Text proposed by the Commission




Amendment





 










(28a)






The extent of the adverse impact caused by the AI system on the fundamental rights protected by the Charter is of particular relevance when classifying an AI system as high-risk. Those rights include the right to human dignity, respect for private and family life, protection of personal data, freedom of expression and information, freedom of assembly and of association, and non-discrimination, right to education consumer protection, workers’ rights, rights of persons with disabilities, gender equality, intellectual property rights, right to an effective remedy and to a fair trial, right of defence and the presumption of innocence, right to good administration. In addition to those rights, it is important to highlight that children have specific rights as enshrined in Article 24 of the EU Charter and in the United Nations Convention on the Rights of the Child (further elaborated in the UNCRC General Comment No. 25 as regards the digital environment), both of which require consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their well-being. The fundamental right to a high level of environmental protection enshrined in the Charter and implemented in Union policies should also be considered when assessing the severity of the harm that an AI system can cause, including in relation to the health and safety of persons or to the environment.











Amendment 57


Proposal for a regulation


Recital 29








Text proposed by the Commission




Amendment











(29)


As regards high-risk AI systems that are safety components of products or systems, or which are themselves products or systems falling within the scope of Regulation (EC) No 300/2008 of the European Parliament and of the Council (39), Regulation (EU) No 167/2013 of the European Parliament and of the Council (40), Regulation (EU) No 168/2013 of the European Parliament and of the Council (41), Directive 2014/90/EU of the European Parliament and of the Council (42), Directive (EU) 2016/797 of the European Parliament and of the Council (43), Regulation (EU) 2018/858 of the European Parliament and of the Council (44), Regulation (EU) 2018/1139 of the European Parliament and of the Council (45), and Regulation (EU) 2019/2144 of the European Parliament and of the Council (46), it is appropriate to amend those acts to ensure that the Commission takes into account, on the basis of the technical and regulatory specificities of each sector, and without interfering with existing governance, conformity assessment and enforcement mechanisms and authorities established therein, the mandatory requirements for high-risk AI systems laid down in this Regulation when adopting any relevant future delegated or implementing acts on the basis of those acts.












(29)


As regards high-risk AI systems that are safety components of products or systems, or which are themselves products or systems falling within the scope of Regulation (EC) No 300/2008 of the European Parliament and of the Council (39), Regulation (EU) No 167/2013 of the European Parliament and of the Council (40), Regulation (EU) No 168/2013 of the European Parliament and of the Council (41), Directive 2014/90/EU of the European Parliament and of the Council (42), Directive (EU) 2016/797 of the European Parliament and of the Council (43), Regulation (EU) 2018/858 of the European Parliament and of the Council (44), Regulation (EU) 2018/1139 of the European Parliament and of the Council (45), and Regulation (EU) 2019/2144 of the European Parliament and of the Council (46), it is appropriate to amend those acts to ensure that the Commission takes into account, on the basis of the technical and regulatory specificities of each sector, and without interfering with existing governance, conformity assessment
, market surveillance
 and enforcement mechanisms and authorities established therein, the mandatory requirements for high-risk AI systems laid down in this Regulation when adopting any relevant future delegated or implementing acts on the basis of those acts.









































Amendment 58


Proposal for a regulation


Recital 30








Text proposed by the Commission




Amendment











(30)


As regards AI systems that are safety components of products, or which are themselves products, falling within the scope of certain Union harmonisation 
legislation,
 it is appropriate to classify them as high-risk under this Regulation if the product in question undergoes the conformity assessment procedure with a third-party conformity assessment body pursuant to that relevant Union harmonisation 
legislation.
 In particular, such products are machinery, toys, lifts, equipment and protective systems intended for use in potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft equipment, cableway installations, appliances burning gaseous fuels, medical devices, and in vitro diagnostic medical devices.












(30)


As regards AI systems that are safety components of products, or which are themselves products, falling within the scope of certain Union harmonisation 
law listed in Annex II,
 it is appropriate to classify them as high-risk under this Regulation if the product in question undergoes the conformity assessment procedure 
in order to ensure compliance with essential safety requirements
 with a third-party conformity assessment body pursuant to that relevant Union harmonisation 
law.
 In particular, such products are machinery, toys, lifts, equipment and protective systems intended for use in potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft equipment, cableway installations, appliances burning gaseous fuels, medical devices, and in vitro diagnostic medical devices.









Amendment 59


Proposal for a regulation


Recital 31








Text proposed by the Commission




Amendment











(31)


The classification of an AI system as high-risk pursuant to this Regulation should not 
necessarily
 mean that the product whose safety component is the AI system, or the AI system itself as a product, is considered ‘high-risk’ under the criteria established in the relevant Union harmonisation 
legislation
 that applies to the product. This is notably the case for Regulation (EU) 2017/745 of the European Parliament and of the Council (47) and Regulation (EU) 2017/746 of the European Parliament and of the Council (48), where a third-party conformity assessment is provided for medium-risk and high-risk products.












(31)


The classification of an AI system as high-risk pursuant to this Regulation should not mean that the product whose safety component is the AI system, or the AI system itself as a product, is considered ‘high-risk’ under the criteria established in the relevant Union harmonisation 
law
 that applies to the product. This is notably the case for Regulation (EU) 2017/745 of the European Parliament and of the Council (47) and Regulation (EU) 2017/746 of the European Parliament and of the Council (48), where a third-party conformity assessment is provided for medium-risk and high-risk products.









Amendment 60


Proposal for a regulation


Recital 32








Text proposed by the Commission




Amendment











(32)


As regards stand-alone AI systems, meaning high-risk AI systems other than those that are safety components of products, or which are themselves products, it is appropriate to classify them as high-risk if, in the light of their intended purpose, they pose a 
high
 risk of harm to the health and safety or the fundamental rights of persons
, taking into account both the
 severity 
of the possible harm and its
 probability of occurrence and 
they are used in a number of specifically pre-defined areas specified in the Regulation
. The identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk AI systems.












(32)


As regards stand-alone AI systems, meaning high-risk AI systems other than those that are safety components of products, or which are themselves products 
and that are listed in one of the areas and use cases in Annex III
, it is appropriate to classify them as high-risk if, in the light of their intended purpose, they pose a 
significant
 risk of harm to the health and safety or the fundamental rights of persons 
and, where the AI system is used as a safety component of a critical infrastructure, to the environment . Such significant risk of harm should be identified by assessing on the one hand the effect of such risk with respect to its level of
 severity
, intensity,
 probability of occurrence and 
duration combined altogether and on the other hand whether the risk can affect an individual, a plurality of persons or a particular group of persons. Such combination could for instance result in a high severity but low probability to affect a natural person, or a high probability to affect a group of persons with a low intensity over a long period of time, depending on the context
. The identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk AI systems.









Amendment 61


Proposal for a regulation


Recital 32 a (new)








Text proposed by the Commission




Amendment





 










(32a)






Providers whose AI systems fall under one of the areas and use cases listed in Annex III that consider their system does not pose a significant risk of harm to the health, safety, fundamental rights or the environment should inform the national supervisory authorities by submitting a reasoned notification. This could take the form of a one-page summary of the relevant information on the AI system in question, including its intended purpose and why it would not pose a significant risk of harm to the health, safety, fundamental rights or the environment. The Commission should specify criteria to enable companies to assess whether their system would pose such risks, as well as develop an easy to use and standardised template for the notification. Providers should submit the notification as early as possible and in any case prior to the placing of the AI system on the market or its putting into service, ideally at the development stage, and they should be free to place it on the market at any given time after the notification. However, if the authority estimates the AI system in question was misclassified, it should object to the notification within a period of three months. The objection should be substantiated and duly explain why the AI system has been misclassified. The provider should retain the right to appeal by providing further arguments. If after the three months there has been no objection to the notification, national supervisory authorities could still intervene if the AI system presents a risk at national level, as for any other AI system on the market. National supervisory authorities should submit annual reports to the AI Office detailing the notifications received and the decisions taken.











Amendment 62


Proposal for a regulation


Recital 33








Text proposed by the Commission




Amendment













(33)






Technical inaccuracies of AI systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. This is particularly relevant when it comes to age, ethnicity, sex or disabilities. Therefore, ‘real-time’ and ‘post’ remote biometric identification systems should be classified as high-risk. In view of the risks that they pose, both types of remote biometric identification systems should be subject to specific requirements on logging capabilities and human oversight.










deleted







Amendment 63


Proposal for a regulation


Recital 33 a (new)








Text proposed by the Commission




Amendment





 










(33a)






As biometric data constitute a special category of sensitive personal data in accordance with Regulation 2016/679, it is appropriate to classify as high-risk several critical use-cases of biometric and biometrics-based systems. AI systems intended to be used for biometric identification of natural persons and AI systems intended to be used to make inferences about personal characteristics of natural persons on the basis of biometric or biometrics-based data, including emotion recognition systems, with the exception of those which are prohibited under this Regulation should therefore be classified as high-risk. This should not include AI systems intended to be used for biometric verification, which includes authentication, whose sole purpose is to confirm that a specific natural person is the person he or she claims to be and to confirm the identity of a natural person for the sole purpose of having access to a service, a device or premises (one-to-one verification). Biometric and biometrics-based systems which are provided for under Union law to enable cybersecurity and personal data protection measures should not be considered as posing a significant risk of harm to the health, safety and fundamental rights.











Amendment 64


Proposal for a regulation


Recital 34








Text proposed by the Commission




Amendment











(34)


As regards the management and operation of critical infrastructure, it is appropriate to classify as high-risk the AI systems intended to be used as safety components in the management and operation of 
road traffic and
 the supply of water, gas, heating 
and
 electricity, since their failure or malfunctioning may put at risk the life and health of persons at large scale and lead to appreciable disruptions in the ordinary conduct of social and economic activities.












(34)


As regards the management and operation of critical infrastructure, it is appropriate to classify as high-risk the AI systems intended to be used as safety components in the management and operation of the supply of water, gas, heating electricity 
and critical digital infrastructure
, since their failure or malfunctioning may 
infringe the security and integrity of such critical infrastructure or
 put at risk the life and health of persons at large scale and lead to appreciable disruptions in the ordinary conduct of social and economic activities. 
Safety components of critical infrastructure, including critical digital infrastructure, are systems used to directly protect the physical integrity of critical infrastructure or health and safety of persons and property. Failure or malfunctioning of such components might directly lead to risks to the physical integrity of critical infrastructure and thus to risks to the health and safety of persons and property. Components intended to be used solely for cybersecurity purposes should not qualify as safety components. Examples of such safety components may include systems for monitoring water pressure or fire alarm controlling systems in cloud computing centres.











Amendment 65


Proposal for a regulation


Recital 35








Text proposed by the Commission




Amendment











(35)


AI systems used in education or vocational training, notably for determining access or assigning persons to educational and vocational training institutions or to evaluate persons on tests as part of or as a precondition for their education should be 
considered high-risk
, since they may determine the educational and professional course of a person’s life and therefore affect their ability to secure their livelihood. When improperly designed and used, such systems may violate the right to education and training as well as the right not to be discriminated against and perpetuate historical patterns of discrimination.












(35)




Deployment of AI systems in education is important in order to help modernise entire education systems, to increase educational quality, both offline and online and to accelerate digital education, thus also making it available to a broader audience .
 AI systems used in education or vocational training, notably for determining access 
or materially influence decisions on admission
 or assigning persons to educational and vocational training institutions or to evaluate persons on tests as part of or as a precondition for their education 
or to assess the appropriate level of education for an individual and materially influence the level of education and training that individuals will receive or be able to access or to monitor and detect prohibited behaviour of students during tests
 should be 
classified as high-risk AI systems
, since they may determine the educational and professional course of a person’s life and therefore affect their ability to secure their livelihood. When improperly designed and used, such systems 
can be particularly intrusive and
 may violate the right to education and training as well as the right not to be discriminated against and perpetuate historical patterns of discrimination
, for example against women, certain age groups, persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation
.









Amendment 66


Proposal for a regulation


Recital 36








Text proposed by the Commission




Amendment











(36)


AI systems used in employment, workers management and access to self-employment, notably for the recruitment and selection of persons, for making decisions 
on
 promotion and termination and for task allocation, monitoring or evaluation of persons in work-related contractual relationships, should also be classified as high-risk, since those systems may appreciably impact future career prospects 
and
 livelihoods of these persons. Relevant work-related contractual relationships should involve employees and persons providing services through platforms as referred to in the Commission Work Programme 2021
. Such persons should in principle not be considered users within the meaning of this Regulation
. Throughout the recruitment process and in the evaluation, promotion, or retention of persons in work-related contractual relationships, such systems may perpetuate historical patterns of discrimination, for example against women, certain age groups, persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation. AI systems used to monitor the performance and behaviour of these persons may also impact their rights to data protection and privacy.












(36)


AI systems used in employment, workers management and access to self-employment, notably for the recruitment and selection of persons, for making decisions 
or materially influence decisions on initiation,
 promotion and termination and for 
personalised
 task allocation 
based on individual behaviour, personal traits or biometric data
, monitoring or evaluation of persons in work-related contractual relationships, should also be classified as high-risk, since those systems may appreciably impact future career prospects, livelihoods of these persons 
and workers’ rights
. Relevant work-related contractual relationships should 
meaningfully
 involve employees and persons providing services through platforms as referred to in the Commission Work Programme 2021. Throughout the recruitment process and in the evaluation, promotion, or retention of persons in work-related contractual relationships, such systems may perpetuate historical patterns of discrimination, for example against women, certain age groups, persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation. AI systems used to monitor the performance and behaviour of these persons may also 
undermine the essence of their fundamental
 rights to data protection and privacy. 
This Regulation applies without prejudice to Union and Member State competences to provide for more specific rules for the use of AI-systems in the employment context.











Amendment 67


Proposal for a regulation


Recital 37








Text proposed by the Commission




Amendment











(37)


Another area in which the use of AI systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people to fully participate in society or to improve one’s standard of living. In particular, AI systems used to evaluate the credit score or creditworthiness of natural persons should be classified as high-risk AI systems, since they determine those persons’ access to financial resources or essential services such as housing, electricity, and telecommunication services. AI systems used for this purpose may lead to discrimination of persons or groups and perpetuate historical patterns of discrimination, for example based on racial or ethnic origins, disabilities, age, sexual orientation, or create new forms of discriminatory impacts. 
Considering the very limited scale of the impact and the available alternatives on the market
, 
it is appropriate to exempt
 AI systems for the purpose of 
creditworthiness assessment and credit scoring when put into service by small-scale providers for their own use
. Natural persons applying for or receiving public assistance benefits and services from public authorities are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. If AI systems are used for determining whether such benefits and services should be denied, reduced, revoked or reclaimed by authorities, they may have a significant impact on persons’ livelihood and may infringe their fundamental rights, such as the right to social protection, non-discrimination, human dignity or an effective remedy. Those systems should therefore be classified as high-risk. Nonetheless, this Regulation should not hamper the development and use of innovative approaches in the public administration, which would stand to benefit from a wider use of compliant and safe AI systems, provided that those systems do not entail a high risk to legal and natural persons. Finally, AI systems used to dispatch or establish priority in the dispatching of emergency first response services should also be classified as high-risk since they make decisions in very critical situations for the life and health of persons and their property.












(37)


Another area in which the use of AI systems deserves special consideration is the access to and enjoyment of certain essential private and public services, 
including healthcare services, and essential services, including but not limited to housing, electricity, heating/cooling and internet,
 and benefits necessary for people to fully participate in society or to improve one’s standard of living. In particular, AI systems used to evaluate the credit score or creditworthiness of natural persons should be classified as high-risk AI systems, since they determine those persons’ access to financial resources or essential services such as housing, electricity, and telecommunication services. AI systems used for this purpose may lead to discrimination of persons or groups and perpetuate historical patterns of discrimination, for example based on racial or ethnic origins, 
gender,
 disabilities, age, sexual orientation, or create new forms of discriminatory impacts. 
However, AI systems provided for by Union law for the purpose of detecting fraud in the offering of financial services should not be considered as high-risk under this Regulation.
 Natural persons applying for or receiving public assistance benefits and services from public authorities
, including healthcare services and essential services, including but not limited to housing, electricity, heating/cooling and internet,
 are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. If AI systems are used for determining whether such benefits and services should be denied, reduced, revoked or reclaimed by authorities, they may have a significant impact on persons’ livelihood and may infringe their fundamental rights, such as the right to social protection, non-discrimination, human dignity or an effective remedy. Similarly, AI systems intended to be used 
to make decisions or materially influence decisions on the eligibility of natural persons for health and life insurance may also have a significant impact on persons’ livelihood and may infringe their fundamental rights such as by limiting access to healthcare or by perpetuating discrimination based on personal characteristics.
 Those systems should therefore be classified as high-risk. Nonetheless, this Regulation should not hamper the development and use of innovative approaches in the public administration, which would stand to benefit from a wider use of compliant and safe AI systems, provided that those systems do not entail a high risk to legal and natural persons. Finally, AI systems used 
to evaluate and classify emergency calls by natural persons or
 to dispatch or establish priority in the dispatching of emergency first response services should also be classified as high-risk since they make decisions in very critical situations for the life and health of persons and their property.









Amendment 68


Proposal for a regulation


Recital 37 a (new)








Text proposed by the Commission




Amendment





 










(37a)






Given the role and responsibility of police and judicial authorities, and the impact of decisions they take for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, some specific use-cases of AI applications in law enforcement has to be classified as high-risk, in particular in instances where there is the potential to significantly affect the lives or the fundamental rights of individuals.











Amendment 69


Proposal for a regulation


Recital 38








Text proposed by the Commission




Amendment











(38)


Actions by law enforcement authorities involving certain uses of AI systems are characterised by a significant degree of power imbalance and may lead to surveillance, arrest or deprivation of a natural person’s liberty as well as other adverse impacts on fundamental rights guaranteed in the Charter. In particular, if the AI system is not trained with high quality data, does not meet adequate requirements in terms of its accuracy or robustness, or is not properly designed and tested before being put on the market or otherwise put into service, it may single out people in a discriminatory or otherwise incorrect or unjust manner. Furthermore, the exercise of important procedural fundamental rights, such as the right to an effective remedy and to a fair trial as well as the right of defence and the presumption of innocence, could be hampered, in particular, where such AI systems are not sufficiently transparent, explainable and documented. It is therefore appropriate to classify as high-risk a number of AI systems intended to be used in the law enforcement context where accuracy, reliability and transparency is particularly important to avoid adverse impacts, retain public trust and ensure accountability and effective redress. In view of the nature of the activities in question and the risks relating thereto, those high-risk AI systems should include in particular AI systems intended to be used by law enforcement authorities 
for individual risk assessments
, polygraphs and similar tools 
or to detect the emotional state of natural person, to detect ‘deep fakes’
, for the evaluation of the reliability of evidence in criminal proceedings
, for predicting the occurrence or reoccurrence of an actual or potential criminal offence based on profiling of natural persons, or assessing personality traits and characteristics or past criminal behaviour of natural persons or groups
, for profiling in the course of detection, investigation or prosecution of criminal offences, as well as for crime analytics regarding natural persons. AI systems specifically intended to be used for administrative proceedings by tax and customs authorities should not be 
considered
 high-risk AI systems used by law enforcement authorities for the purposes of prevention, detection, investigation and prosecution of criminal offences.












(38)


Actions by law enforcement authorities involving certain uses of AI systems are characterised by a significant degree of power imbalance and may lead to surveillance, arrest or deprivation of a natural person’s liberty as well as other adverse impacts on fundamental rights guaranteed in the Charter. In particular, if the AI system is not trained with high quality data, does not meet adequate requirements in terms of 
its performance,
 its accuracy or robustness, or is not properly designed and tested before being put on the market or otherwise put into service, it may single out people in a discriminatory or otherwise incorrect or unjust manner. Furthermore, the exercise of important procedural fundamental rights, such as the right to an effective remedy and to a fair trial as well as the right of defence and the presumption of innocence, could be hampered, in particular, where such AI systems are not sufficiently transparent, explainable and documented. It is therefore appropriate to classify as high-risk a number of AI systems intended to be used in the law enforcement context where accuracy, reliability and transparency is particularly important to avoid adverse impacts, retain public trust and ensure accountability and effective redress. In view of the nature of the activities in question and the risks relating thereto, those high-risk AI systems should include in particular AI systems intended to be used by 
or on behalf of
 law enforcement authorities 
or by Union agencies
, 
offices or bodies in support of law enforcement authorities, as
 polygraphs and similar tools 
insofar as their use is permitted under relevant Union and national law
, for the evaluation of the reliability of evidence in criminal proceedings, for profiling in the course of detection, investigation or prosecution of criminal offences, as well as for crime analytics regarding natural persons. AI systems specifically intended to be used for administrative proceedings by tax and customs authorities should not be 
classified as
 high-risk AI systems used by law enforcement authorities for the purposes of prevention, detection, investigation and prosecution of criminal offences. 
The use of AI tools by law enforcement and judicial authorities should not become a factor of inequality, social fracture or exclusion. The impact of the use of AI tools on the


defence rights of suspects should not be ignored, notably the difficulty in obtaining meaningful information on their functioning and the consequent difficulty in challenging their results in court, in particular by individuals under investigation.











Amendment 70


Proposal for a regulation


Recital 39








Text proposed by the Commission




Amendment











(39)


AI systems used in migration, asylum and border control management affect people who are often in particularly vulnerable position and who are dependent on the outcome of the actions of the competent public authorities. The accuracy, non-discriminatory nature and transparency of the AI systems used in those contexts are therefore particularly important to guarantee the respect of the fundamental rights of the affected persons, notably their rights to free movement, non-discrimination, protection of private life and personal data, international protection and good administration. It is therefore appropriate to classify as high-risk AI systems intended to be used by 
the
 competent public authorities charged with tasks in the fields of migration, asylum and border control management as polygraphs and similar tools 
or to detect the emotional state of a natural person;
 for assessing certain risks posed by natural persons entering the territory of a Member State or applying for visa or asylum; for verifying the authenticity of the relevant documents of natural persons; for assisting competent public authorities for the examination 
of
 applications for asylum, visa and residence permits and associated complaints with regard to the objective to establish the eligibility of the natural persons applying for a status. AI systems in the area of migration, asylum and border control management covered by this Regulation should comply with the relevant procedural requirements set by the Directive 2013/32/EU of the European Parliament and of the Council (49), the Regulation (EC) No 810/2009 of the European Parliament and of the Council (50) and other relevant legislation.












(39)


AI systems used in migration, asylum and border control management affect people who are often in particularly vulnerable position and who are dependent on the outcome of the actions of the competent public authorities. The accuracy, non-discriminatory nature and transparency of the AI systems used in those contexts are therefore particularly important to guarantee the respect of the fundamental rights of the affected persons, notably their rights to free movement, non-discrimination, protection of private life and personal data, international protection and good administration. It is therefore appropriate to classify as high-risk AI systems intended to be used by 
or on behalf of
 competent public authorities 
or by Union agencies, offices or bodies
 charged with tasks in the fields of migration, asylum and border control management as polygraphs and similar tools 
insofar as their use is permitted under relevant Union and national law,
 for assessing certain risks posed by natural persons entering the territory of a Member State or applying for visa or asylum; for verifying the authenticity of the relevant documents of natural persons; for assisting competent public authorities for the examination 
and assessment of the veracity of evidence in relation to
 applications for asylum, visa and residence permits and associated complaints with regard to the objective to establish the eligibility of the natural persons applying for a status
; for monitoring, surveilling or processing personal data in the context of border management activities, for the purpose of detecting, recognising or identifying natural persons; for the forecasting or prediction of trends related to


migration movements and border crossings
. AI systems in the area of migration, asylum and border control management covered by this Regulation should comply with the relevant procedural requirements set by the Directive 2013/32/EU of the European Parliament and of the Council (49), the Regulation (EC) No 810/2009 of the European Parliament and of the Council (50) and other relevant legislation. 
The use of AI systems in migration, asylum and border control management should in no circumstances be used by Member States or Union institutions, agencies or bodies as a means to circumvent their international obligations under the Convention of 28 July 1951 relating to the Status of Refugees as amended by the Protocol of 31 January 1967, nor should they be used to in any way infringe on the principle of non-refoulement, or or deny safe and effective legal avenues into the territory of the Union, including the right to international protection.











Amendment 71


Proposal for a regulation


Recital 40








Text proposed by the Commission




Amendment











(40)


Certain AI systems intended for the administration of justice and democratic processes should be classified as high-risk, considering their potentially significant impact on democracy, rule of law, individual freedoms as well as the right to an effective remedy and to a fair trial. In particular, to address the risks of potential biases, errors and opacity, it is appropriate to qualify as high-risk AI systems intended to assist judicial authorities in researching and interpreting facts and the law and in applying the law to a concrete set of facts. Such qualification should not extend, however, to AI systems intended for purely ancillary administrative activities that do not affect the actual administration of justice in individual cases, such as anonymisation or pseudonymisation of judicial decisions, documents or data, communication between personnel, administrative tasks or allocation of resources.












(40)


Certain AI systems intended for the administration of justice and democratic processes should be classified as high-risk, considering their potentially significant impact on democracy, rule of law, individual freedoms as well as the right to an effective remedy and to a fair trial. In particular, to address the risks of potential biases, errors and opacity, it is appropriate to qualify as high-risk AI systems intended to 
be used by a judicial authority or administrative body or on their behalf to
 assist judicial authorities 
or administrative bodies
 in researching and interpreting facts and the law and in applying the law to a concrete set of facts 
or used in a similar way in alternative dispute resolution. The use of artificial intelligence tools can support, but should not replace the decision-making power of judges or judicial independence, as the final decision-making must remain a human-driven activity and decision
. Such qualification should not extend, however, to AI systems intended for purely ancillary administrative activities that do not affect the actual administration of justice in individual cases, such as anonymisation or pseudonymisation of judicial decisions, documents or data, communication between personnel, administrative tasks or allocation of resources.









Amendment 72


Proposal for a regulation


Recital 40 a (new)








Text proposed by the Commission




Amendment





 










(40a)






In order to address the risks of undue external interference to the right to vote enshrined in Article 39 of the Charter, and of disproportionate effects on democratic processes, democracy, and the rule of law, AI systems intended to be used to influence the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda should be classified as high-risk AI systems. with the exception of AI systems whose output natural persons are not directly exposed to, such as tools used to organise, optimise and structure political campaigns from an administrative and logistical point of view.











Amendment 73


Proposal for a regulation


Recital 40 b (new)








Text proposed by the Commission




Amendment





 










(40b)






Considering the scale of natural persons using the services provided by social media platforms designated as very large online platforms, such online platforms can be used in a way that strongly influences safety online, the shaping of public opinion and discourse, election and democratic processes and societal concerns. It is therefore appropriate that AI systems used by those online platforms in their recommender systems are subject to this Regulation so as to ensure that the AI systems comply with the requirements laid down under this Regulation, including the technical requirements on data governance, technical documentation and traceability, transparency, human oversight, accuracy and robustness. Compliance with this Regulation should enable such very large online platforms to comply with their broader risk assessment and risk-mitigation obligations in Article 34 and 35 of Regulation EU 2022/2065. The obligations in this Regulation are without prejudice to Regulation (EU) 2022/2065 and should complement the obligations required under the Regulation (EU) 2022/2065 when the social media platform has been designated as a very large online platform. Given the European-wide impact of social media platforms designated as very large online platforms, the authorities designated under Regulation (EU) 2022/2065 should act as enforcement authorities for the purposes of enforcing this provision.











Amendment 74


Proposal for a regulation


Recital 41








Text proposed by the Commission




Amendment











(41)


The fact that an AI system is classified as high risk under this Regulation should not be interpreted as indicating that the use of the system is necessarily lawful under other acts of Union law or under national law compatible with Union law, such as on the protection of personal data, 
on the use of polygraphs and similar tools or other systems to detect the emotional state of natural persons.
 Any such use should continue to occur solely in accordance with the applicable requirements resulting from the Charter and from the applicable acts of secondary Union law and national law. 
This Regulation should not be understood as providing for the legal ground for processing of personal data, including special categories of personal data, where relevant.














(41)


The fact that an AI system is classified as 
a
 high risk 
AI system
 under this Regulation should not be interpreted as indicating that the use of the system is necessarily lawful 
or unlawful
 under other acts of Union law or under national law compatible with Union law, such as on the protection of personal data, Any such use should continue to occur solely in accordance with the applicable requirements resulting from the Charter and from the applicable acts of secondary Union law and national law.









Amendment 75


Proposal for a regulation


Recital 41 a (new)








Text proposed by the Commission




Amendment





 










(41a)






A number of legally binding rules at European, national and international level already apply or are relevant to AI systems today, including but not limited to EU primary law (the Treaties of the European Union and its Charter of Fundamental Rights), EU secondary law (such as the General Data Protection Regulation, the Product Liability Directive, the Regulation on the Free Flow of Non-Personal Data, anti-discrimination Directives, consumer law and Safety and Health at Work Directives), the UN Human Rights treaties and the Council of Europe conventions (such as the European Convention on Human Rights), and national law. Besides horizontally applicable rules, various domain-specific rules exist that apply to particular AI applications (such as for instance the Medical Device Regulation in the healthcare sector).











Amendment 76


Proposal for a regulation


Recital 42








Text proposed by the Commission




Amendment











(42)


To mitigate the risks from high-risk AI systems placed or otherwise put into service on the Union market for 
users
 and affected persons, certain mandatory requirements should apply, taking into account the intended purpose 
of the use
 of the system and according to the risk management system to be established by the provider.












(42)


To mitigate the risks from high-risk AI systems placed or otherwise put into service on the Union market for 
deployers
 and affected persons, certain mandatory requirements should apply, taking into account the intended purpose
, the reasonably foreseeable misuse
 of the system and according to the risk management system to be established by the provider. 
These requirements should be objective-driven, fit for purpose, reasonable and effective, without adding undue regulatory burdens or costs on operators.











Amendment 77


Proposal for a regulation


Recital 43








Text proposed by the Commission




Amendment











(43)


Requirements should apply to high-risk AI systems as regards the quality of data sets used, technical documentation and record-keeping, transparency and the provision of information to 
users
, human oversight, and robustness, accuracy and cybersecurity. Those requirements are necessary to effectively mitigate the risks for health, safety and fundamental rights, as applicable in the light of the intended purpose of the system, and no other less trade restrictive measures are reasonably available, thus avoiding unjustified restrictions to trade.












(43)


Requirements should apply to high-risk AI systems as regards the quality 
and relevance
 of data sets used, technical documentation and record-keeping, transparency and the provision of information to 
deployers
, human oversight, and robustness, accuracy and cybersecurity. Those requirements are necessary to effectively mitigate the risks for health, safety and fundamental rights, as 
well as the environment, democracy and rule of law, as
 applicable in the light of the intended purpose 
or reasonably foreseeable misuse
 of the system, and no other less trade restrictive measures are reasonably available, thus avoiding unjustified restrictions to trade.









Amendment 78


Proposal for a regulation


Recital 44








Text proposed by the Commission




Amendment











(44)




High
 data quality 
is essential for
 the performance of many AI systems, especially when techniques involving the training of models are used, with a view to ensure that the high-risk AI system performs as intended and safely and it does not become 
the
 source of discrimination prohibited by Union law. High quality training, validation and testing data sets require the implementation of appropriate data governance and management practices. Training, validation and testing data sets should be sufficiently relevant, representative 
and free of errors and
 complete in view of the intended purpose of the system. They should also have the appropriate statistical properties, including as regards the persons or groups of persons 
on which
 the high-risk AI system is intended to be used. In particular, training, validation and testing data sets should take into account, to the extent required in the light of their intended purpose, the features, characteristics or elements that are particular to the specific geographical, behavioural or functional setting or context within which the AI system is intended to be used. In order to protect the right of others from the discrimination that might result from the bias in AI systems, the providers 
shouldbe
 able to process also special categories of personal data, as a matter of substantial public interest, in order to ensure the bias 
monitoring,
 detection and correction in relation to high-risk AI systems.












(44)




Access to
 data 
of high
 quality 
plays a vital role in providing structure and in ensuring
 the performance of many AI systems, especially when techniques involving the training of models are used, with a view to ensure that the high-risk AI system performs as intended and safely and it does not become 
a
 source of discrimination prohibited by Union law. High quality training, validation and testing data sets require the implementation of appropriate data governance and management practices. Training
, and where applicable,
 validation and testing data sets, 
including the labels,
 should be sufficiently relevant, representative, 
appropriately vetted for
 errors and 
as
 complete 
as possible
 in view of the intended purpose of the system. They should also have the appropriate statistical properties, including as regards the persons or groups of persons 
in relation to whom
 the high-risk AI system is intended to be used
, with specific attention to the mitigation of possible biases in the datasets, that might lead to risks to fundamental rights or discriminatory outcomes for the persons affected by the high-risk AI system. Biases can for example be inherent in underlying datasets, especially when historical data is being used, introduced by the developers of the algorithms, or generated when the systems are implemented in real world settings. Results provided by AI systems are influenced by such inherent biases that are inclined to gradually increase and thereby perpetuate and amplify existing discrimination, in particular for persons belonging to certain vulnerable or ethnic groups, or racialised communities.
 In particular, training, validation and testing data sets should take into account, to the extent required in the light of their intended purpose, the features, characteristics or elements that are particular to the specific geographical, 
contextal
, behavioural or functional setting or context within which the AI system is intended to be used. In order to protect the right of others from the discrimination that might result from the bias in AI systems, the providers should, 
exceptionally and following the application of all applicable conditions laid down under this Regulation and in Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725,
 be able to process also special categories of personal data, as a matter of substantial public interest, in order to ensure the negative bias detection and correction in relation to high-risk AI systems. 
Negative bias should be understood as bias that create direct or indirect discriminatory effect against a natural person The requirements related to data governance can be complied with by having recourse to third-parties that offer certified compliance services including verification of data governance, data set integrity, and data training, validation and testing practices.











Amendment 79


Proposal for a regulation


Recital 45








Text proposed by the Commission




Amendment











(45)


For the development of high-risk AI systems, certain actors, such as providers, notified bodies and other relevant entities, such as digital innovation hubs, testing experimentation facilities and researchers, should be able to access and use high quality datasets within their respective fields of activities which are related to this Regulation. European common data spaces established by the Commission and the facilitation of data sharing between businesses and with government in the public interest will be instrumental to provide trustful, accountable and non-discriminatory access to high quality data for the training, validation and testing of AI systems. For example, in health, the European health data space will facilitate non-discriminatory access to health data and the training of artificial intelligence algorithms on those datasets, in a privacy-preserving, secure, timely, transparent and trustworthy manner, and with an appropriate institutional governance. Relevant competent authorities, including sectoral ones, providing or supporting the access to data may also support the provision of high-quality data for the training, validation and testing of AI systems.












(45)


For the development 
and assessment
 of high-risk AI systems, certain actors, such as providers, notified bodies and other relevant entities, such as digital innovation hubs, testing experimentation facilities and researchers, should be able to access and use high quality datasets within their respective fields of activities which are related to this Regulation. European common data spaces established by the Commission and the facilitation of data sharing between businesses and with government in the public interest will be instrumental to provide trustful, accountable and non-discriminatory access to high quality data for the training, validation and testing of AI systems. For example, in health, the European health data space will facilitate non-discriminatory access to health data and the training of artificial intelligence algorithms on those datasets, in a privacy-preserving, secure, timely, transparent and trustworthy manner, and with an appropriate institutional governance. Relevant competent authorities, including sectoral ones, providing or supporting the access to data may also support the provision of high-quality data for the training, validation and testing of AI systems.









Amendment 80


Proposal for a regulation


Recital 45 a (new)








Text proposed by the Commission




Amendment





 










(45a)






The right to privacy and to protection of personal data must be guaranteed throughout the entire lifecycle of the AI system. In this regard, the principles of data minimisation and data protection by design and by default, as set out in Union data protection law, are essential when the processing of data involves significant risks to the fundamental rights of individuals. Providers and users of AI systems should implement state-of-the-art technical and organisational measures in order to protect those rights. Such measures should include not only anonymisation and encryption, but also the use of increasingly available technology that permits algorithms to be brought to the data and allows valuable insights to be derived without the transmission between parties or unnecessary copying of the raw or structured data themselves.











Amendment 81


Proposal for a regulation


Recital 46








Text proposed by the Commission




Amendment











(46)


Having information on how high-risk AI systems have been developed and how they perform throughout their 
lifecycle
 is essential to verify compliance with the requirements under this Regulation. This requires keeping records and the availability of a technical documentation, containing information which is necessary to assess the compliance of the AI system with the relevant requirements. Such information should include the general characteristics, capabilities and limitations of the system, algorithms, data, training, testing and validation processes used as well as documentation on the relevant risk management system. The technical documentation should be kept up to date.












(46)


Having 
comprehensible
 information on how high-risk AI systems have been developed and how they perform throughout their 
lifetime
 is essential to verify compliance with the requirements under this Regulation. This requires keeping records and the availability of a technical documentation, containing information which is necessary to assess the compliance of the AI system with the relevant requirements. Such information should include the general characteristics, capabilities and limitations of the system, algorithms, data, training, testing and validation processes used as well as documentation on the relevant risk management system. The technical documentation should be kept up to date 
appropriately throughout the lifecycle of the AI system
. 
AI systems can have a large important environmental impact and high energy consumption during their lifecyle. In order to better apprehend the impact of AI systems on the environment, the technical documentation drafted by providers should include information on the energy consumption of the AI system, including the consumption during development and expected consumption during use. Such information should take into account the relevant Union and national legislation. This reported information should be comprehensible, comparable and verifiable and to that end, the Commission should develop guidelines on a harmonised metholodogy for calculation and reporting of this information. To ensure that a single documentation is possible, terms and definitions related to the required documentation and any required documentation in the relevant Union legislation should be aligned as much as possible.











Amendment 82


Proposal for a regulation


Recital 46 a (new)








Text proposed by the Commission




Amendment





 










(46a)






AI systems should take into account state-of-the art methods and relevant applicable standards to reduce the energy use, resource use and waste, as well as to increase their energy efficiency and the overall efficiency of the system. The environmental aspects of AI systems that are significant for the purposes of this Regulation are the energy consumption of the AI system in the development, training and deployment phase as well as the recording and reporting and storing of this data. The design of AI systems should enable the measurement and logging of the consumption of energy and resources at each stage of development, training and deployment. The monitoring and reporting of the emissions of AI systems must be robust, transparent, consistent and accurate. In order to ensure the uniform application of this Regulation and stable legal ecosystem for providers and deployers in the Single Market, the Commission should develop a common specification for the methodology to fulfil the reporting and documentation requirement on the consumption of energy and resources during development, training and deployment. Such common specifications on measurement methodology can develop a baseline upon which the Commission can better decide if future regulatory interventions are needed, upon conducting an impact assessment that takes into account existing law.











Amendment 83


Proposal for a regulation


Recital 46 b (new)








Text proposed by the Commission




Amendment





 










(46b)






In order to achieve the objectives of this Regulation, and contribute to the Union’s environmental objectives while ensuring the smooth functioning of the internal market, it may be necessary to establish recommendations and guidelines and, eventually, targets for sustainability. For that purpose the Commission is entitled to develop a methodology to contribute towards having Key Performance Indicators (KPIs) and a reference for the Sustainable Development Goals (SDGs). The goal should be in the first instance to enable fair comparison between AI implementation choices providing incentives to promote using more efficient AI technologies addressing energy and resource concerns. To meet this objective this Regulation should provide the means to establish a baseline collection of data reported on the emissions from development and training and for deployment.











Amendment 84


Proposal for a regulation


Recital 47 a (new)








Text proposed by the Commission




Amendment





 










(47a)






Such requirements on transparency and on the explicability of AI decision-making should also help to counter the deterrent effects of digital asymmetry and so-called ‘dark patterns’ targeting individuals and their informed consent.











Amendment 85


Proposal for a regulation


Recital 49








Text proposed by the Commission




Amendment











(49)


High-risk AI systems should perform consistently throughout their lifecycle and meet an appropriate level of accuracy, robustness and cybersecurity in accordance with the generally acknowledged state of the art. 
The
 level of 
accuracy and accuracy
 metrics should be communicated to the 
users
.












(49)


High-risk AI systems should perform consistently throughout their lifecycle and meet an appropriate level of accuracy, robustness and cybersecurity in accordance with the generally acknowledged state of the art. 
Performance metrics and their expected level should be defined with the primary objective to mitigate risks and negative impact of the AI system. The expected
 level of 
performance
 metrics should be communicated 
in a clear, transparent, easily understandable and intelligible way
 to the 
deployers
. 
The declaration of performance metrics cannot be considered proof of future levels, but relevant methods need to be applied to ensure consistent levels during use While standardisation organisations exist to establish standards, coordination on benchmarking is needed to establish how these standardised requirements and characteristics of AI systems should be measured. The European Artificial Intelligence Office should bring together national and international metrology and benchmarking authorities and provide non-binding guidance to address the technical aspects of how to measure the appropriate levels of performance and robustness.











Amendment 86


Proposal for a regulation


Recital 50








Text proposed by the Commission




Amendment











(50)


The technical robustness is a key requirement for high-risk AI systems. They should be resilient against risks connected to the limitations of the system (e.g. errors, faults, inconsistencies, unexpected situations) as well as against malicious actions that may compromise the security of the AI system and result in harmful or otherwise undesirable behaviour. Failure to protect against these risks could lead to safety impacts or negatively affect the fundamental rights, for example due to erroneous decisions or wrong or biased outputs generated by the AI system.












(50)


The technical robustness is a key requirement for high-risk AI systems. They should be resilient against risks connected to the limitations of the system (e.g. errors, faults, inconsistencies, unexpected situations) as well as against malicious actions that may compromise the security of the AI system and result in harmful or otherwise undesirable behaviour. Failure to protect against these risks could lead to safety impacts or negatively affect the fundamental rights, for example due to erroneous decisions or wrong or biased outputs generated by the AI system. 
Users of the AI system should take steps to ensure that the possible trade-off between robustness and accuracy does not lead to discriminatory or negative outcomes for minority subgroups.











Amendment 87


Proposal for a regulation


Recital 51








Text proposed by the Commission




Amendment











(51)


Cybersecurity plays a crucial role in ensuring that AI systems are resilient against attempts to alter their use, behaviour, performance or compromise their security properties by malicious third parties exploiting the system’s vulnerabilities. Cyberattacks against AI systems can leverage AI specific assets, such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks), or exploit vulnerabilities in the AI system’s digital assets or the underlying ICT infrastructure. To ensure a level of cybersecurity appropriate to the risks, suitable measures should therefore be taken by the providers of high-risk AI systems, also taking into account as appropriate the underlying ICT infrastructure.












(51)


Cybersecurity plays a crucial role in ensuring that AI systems are resilient against attempts to alter their use, behaviour, performance or compromise their security properties by malicious third parties exploiting the system’s vulnerabilities. Cyberattacks against AI systems can leverage AI specific assets, such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks 
or confidentiality attacks
), or exploit vulnerabilities in the AI system’s digital assets or the underlying ICT infrastructure. To ensure a level of cybersecurity appropriate to the risks, suitable measures should therefore be taken by the providers of high-risk AI systems, 
as well as the notified bodies, competent national authorities and market surveillance authorities,
 also taking into account as appropriate the underlying ICT infrastructure. 
High-risk AI should be accompanied by security solutions and patches for the lifetime of the product, or in case of the absence of dependence on a specific product, for a time that needs to be stated by the manufacturer.











Amendment 88


Proposal for a regulation


Recital 53 a (new)








Text proposed by the Commission




Amendment





 










(53a)






As signatories to the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD), the Union and the Member States are legally obliged to protect persons with disabilities from discrilmination and promote their equality, to ensure that persons with disabilities have access, on an equal basis wirh others, to information and communications technologies and systems, and to ensure respect for privacy for persons with disabilities. Given the growing importance and use of AI systems, the application of universal design principles to all new technologies and services should ensure full, equal, and unrestricted access for everyone potentially affected by or using AI technologies, including persons with disabilities, in a way that takes full account of their inherent dignity and diversity. It is therefore essential that Providers ensure full compliance with accessibility requirements, including Directive (EU) 2016/2102 and Directive (EU) 2019/882. Providers should ensure compliance with these requirements by design. Therefore, the necessary measures should be integrated as much as possible into the design of the high-risk AI system.











Amendment 89


Proposal for a regulation


Recital 54








Text proposed by the Commission




Amendment











(54)


The provider should establish a sound quality management system, ensure the accomplishment of the required conformity assessment procedure, draw up the relevant documentation and establish a robust post-market monitoring system. Public authorities which put into service high-risk AI systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level, as appropriate, taking into account the specificities of the sector and the competences and organisation of the public authority in question.












(54)


The provider should establish a sound quality management system, ensure the accomplishment of the required conformity assessment procedure, draw up the relevant documentation and establish a robust post-market monitoring system
. For providers that have already in place quality management systems based on standards such as ISO 9001 or other relevant standards, no duplicative quality management system in full should be expected but rather an adaptation of their existing systems to certain aspects linked to compliance with specific requirements of this Regulation. This should also be reflected in future standardization activities or guidance adopted by the Commission in this respect
. Public authorities which put into service high-risk AI systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level, as appropriate, taking into account the specificities of the sector and the competences and organisation of the public authority in question.









Amendment 90


Proposal for a regulation


Recital 56








Text proposed by the Commission




Amendment











(56)


To enable enforcement of this Regulation and create a level-playing field for operators, and taking into account the different forms of making available of digital products, it is important to ensure that, under all circumstances, a person established in the Union can provide authorities with all the necessary information on the compliance of an AI system. Therefore, prior to making their AI systems available in the Union, 
where an importer cannot be identified,
 providers established outside the Union shall, by written mandate, appoint an authorised representative established in the Union.












(56)


To enable enforcement of this Regulation and create a level-playing field for operators, and taking into account the different forms of making available of digital products, it is important to ensure that, under all circumstances, a person established in the Union can provide authorities with all the necessary information on the compliance of an AI system. Therefore, prior to making their AI systems available in the Union, providers established outside the Union shall, by written mandate, appoint an authorised representative established in the Union.









Amendment 91


Proposal for a regulation


Recital 58








Text proposed by the Commission




Amendment











(58)


Given the nature of AI systems and the risks to safety and fundamental rights possibly associated with their use, including as 
regard
 the need to ensure proper monitoring of the performance of an AI system in a real-life setting, it is appropriate to set specific responsibilities for 
users. Users
 should in particular use high-risk AI systems in accordance with the instructions of use and certain other obligations should be provided for with regard to monitoring of the functioning of the AI systems and with regard to record-keeping, as appropriate.












(58)


Given the nature of AI systems and the risks to safety and fundamental rights possibly associated with their use, including as 
regards
 the need to ensure proper monitoring of the performance of an AI system in a real-life setting, it is appropriate to set specific responsibilities for 
deployers. Deployers
 should in particular use high-risk AI systems in accordance with the instructions of use and certain other obligations should be provided for with regard to monitoring of the functioning of the AI systems and with regard to record-keeping, as appropriate.









Amendment 92


Proposal for a regulation


Recital 58 a (new)








Text proposed by the Commission




Amendment





 










(58a)






Whilst risks related to AI systems can result from the way such systems are designed, risks can as well stem from how such AI systems are used. Deployers of high-risk AI system therefore play a critical role in ensuring that fundamental rights are protected, complementing the obligations of the provider when developing the AI system. Deployers are best placed to understand how the high-risk AI system will be used concretely and can therefore identify potential significant risks that were not foreseen in the development phase, due to a more precise knowledge of the context of use, the people or groups of people likely to be affected, including marginalised and vulnerable groups. Deployers should identify appropriate governance structures in that specific context of use, such as arrangements for human oversight, complaint-handling procedures and redress procedures, because choices in the governance structures can be instrumental in mitigating risks to fundamental rights in concrete use-cases. In order to efficiently ensure that


fundamental rights are protected, the deployer of high-risk AI systems should therefore carry out a fundamental rights impact assessment prior to putting it into use. The impact assessment should be accompanied by a detailed plan describing the measures or tools that will help mitigating the risks to fundamental rights identified at the latest from the time of putting it into use. If such plan cannot be identified, the deployer should refrain from putting the system into use. When performing this impact assessment, the deployer should notify the national supervisory authority and, to the best extent possible relevant stakeholders as well as representatives of groups of persons likely to be affected by the AI system in order to collect relevant information which is deemed necessary to perform the impact assessment and are encouraged to make the summary of their fundamental rights impact assessment publicly available on their online website. This obligations should not apply to SMEs which, given the lack of resrouces, might find it difficult to perform such consultation. Nevertheless, they should also strive to invole such representatives when carrying out their fundamental rights impact assessment.In addition, given the potential impact and the need for democratic oversight and scrutiny, deployers of high-risk AI systems that are public authorities or Union institutions, bodies, offices and agencies, as well deployers who are undertakings designated as a gatekeeper under Regulation (EU) 2022/1925 should be required to register the use of any high-risk AI system in a public database. Other deployers may voluntarily register.











Amendment 93


Proposal for a regulation


Recital 59








Text proposed by the Commission




Amendment











(59)


It is appropriate to envisage that the 
user
 of the AI system should be the natural or legal person, public authority, agency or other body under whose authority the AI system is operated except where the use is made in the course of a personal non-professional activity.












(59)


It is appropriate to envisage that the 
deployer
 of the AI system should be the natural or legal person, public authority, agency or other body under whose authority the AI system is operated except where the use is made in the course of a personal non-professional activity.









Amendment 94


Proposal for a regulation


Recital 60








Text proposed by the Commission




Amendment











(60)


In the light of 
the
 complexity of the 
artificial intelligence
 value chain, relevant third parties, notably 
the ones
 involved in the sale and the supply of software
, software
 tools 
and
 components, pre-trained models 
and data
, or providers of network services, should cooperate, as appropriate, with providers 
and users
 to enable their compliance 
with the obligations under this Regulation and with competent authorities established
 under this Regulation.












(60)




Within the AI value chain multiple entities often supply tools and services but also components or processes that are then incorporated by the provider into the AI system, including in relation to data collection and pre-processing, model training, model retraining, model testing and evaluation, integration into software, or other aspects of model development. The involved entities may make their offering commercially available directly or indirectly, through interfaces, such as Application Programming Interfaces (API), and distributed under free and open source licenses but also more and more by AI workforce platforms, trained parameters resale, DIY kits to build models or the offering of paying access to a model serving architecture to develop and train models.
 In the light of 
this
 complexity of the 
AI
 value chain, 
all
 relevant third parties, 
in particular those that are
 involved in the 
development,
 sale and the 
commercial
 supply of software tools, components, pre-trained models 
or data incorporated into the AI system
, or providers of network services, should 
without compromising their own intellectual property rights or trade secrets, make available the required information, training or expertise and
 cooperate, as appropriate, with providers to enable their 
control over all
 compliance 
relevant aspects of the AI system that falls
 under this Regulation. 
To allow a cost-effective AI value chain governance, the level of control shall be explicitly disclosed by each third party that supplies the provider with a tool, service, component or process that is later incorporated by the provider into the AI system.











Amendment 95


Proposal for a regulation


Recital 60 a (new)








Text proposed by the Commission




Amendment





 










(60a)






Where one party is in a stronger bargaining position, there is a risk that that party could leverage such position to the detriment of the other contracting party when negotiating the supply of tools, services, components or processes that are used or integrated in a high risk AI system or the remedies for the breach or the termination of related obligations. Such contractual imbalances particularly harm micro, small and medium-sized enterprises as well as start-ups, unless they are owned or sub-contracted by an enterprise which is able to compensate the sub-contractor appropriately, as they are without a meaningful ability to negotiate the conditions of the contractual agreement, and may have no other choice than to accept ‘take-it-or-leave-it’ contractual terms. Therefore, unfair contract terms regulating the supply of tools, services, components or processes that are used or integrated in a high risk AI system or the remedies for the breach or the termination of related obligations should not be binding to such micro, small or medium-sized enterprises and start-ups when they have been unilaterally imposed on them.











Amendment 96


Proposal for a regulation


Recital 60 b (new)








Text proposed by the Commission




Amendment





 










(60b)






Rules on contractual terms should take into account the principle of contractual freedom as an essential concept in business-to-business relationships. Therefore, not all contractual terms should be subject to an unfairness test, but only to those terms that are unilaterally imposed on micro, small and medium-sized enterprises and start-ups. This concerns ‘take-it-or-leave-it’ situations where one party supplies a certain contractual term and the micro, small or medium-sized enterprise and start-up cannot influence the content of that term despite an attempt to negotiate it. A contractual term that is simply provided by one party and accepted by the micro, small, medium-sized enterprise or a start-up or a term that is negotiated and subsequently agreed in an amended way between contracting parties should not be considered as unilaterally imposed.











Amendment 97


Proposal for a regulation


Recital 60 c (new)








Text proposed by the Commission




Amendment





 










(60c)






Furthermore, the rules on unfair contractual terms should only apply to those elements of a contract that are related to supply of tools, services, components or processes that are used or integrated in a high risk AI system or the remedies for the breach or the termination of related obligations. Other parts of the same contract, unrelated to these elements, should not be subject to the unfairness test laid down in this Regulation.











Amendment 98


Proposal for a regulation


Recital 60 d (new)








Text proposed by the Commission




Amendment





 










(60d)






Criteria to identify unfair contractual terms should be applied only to excessive contractual terms, where a stronger bargaining position is abused. The vast majority of contractual terms that are commercially more favourable to one party than to the other, including those that are normal in business-to-business contracts, are a normal expression of the principle of contractual freedom and continue to apply. If a contractual term is not included in the list of terms that are always considered unfair, the general unfairness provision applies. In this regard, the terms listed as unfair terms should serve as a yardstick to interpret the general unfairness provision.











Amendment 99


Proposal for a regulation


Recital 60 e (new)








Text proposed by the Commission




Amendment





 










(60e)






Foundation models are a recent development, in which AI models are developed from algorithms designed to optimize for generality and versatility of output. Those models are often trained on a broad range of data sources and large amounts of data to accomplish a wide range of downstream tasks, including some for which they were not specifically developed and trained. The foundation model can be unimodal or multimodal, trained through various methods such as supervised learning or reinforced learning. AI systems with specific intended purpose or general purpose AI systems can be an implementation of a foundation model, which means that each foundation model can be reused in countless downstream AI or general purpose AI systems. These models hold growing importance to many downstream applications and systems.











Amendment 100


Proposal for a regulation


Recital 60 f (new)








Text proposed by the Commission




Amendment





 










(60f)






In the case of foundation models provided as a service such as through API access, the cooperation with downstream providers should extend throughout the time during which that service is provided and supported, in order to enable appropriate risk mitigation, unless the provider of the foundation model transfers the training model as well as extensive and appropriate information on the datasets and the development process of the system or restricts the service, such as the API access, in such a way that the downstream provider is able to fully comply with this Regulation without further support from the original provider of the foundation model.











Amendment 101


Proposal for a regulation


Recital 60 g (new)








Text proposed by the Commission




Amendment





 










(60g)






In light of the nature and complexity of the value chain for AI system, it is essential to clarify the role of actors contributing to the development of AI systems. There is significant uncertainty as to the way foundation models will evolve, both in terms of typology of models and in terms of self-governance. Therefore, it is essential to clarify the legal situation of providers of foundation models. Combined with their complexity and unexpected impact, the downstream AI provider’s lack of control over the foundation model’s development and the consequent power imbalance and in order to ensure a fair sharing of responsibilities along the AI value chain, such models should be subject to proportionate and more specific requirements and obligations under this Regulation, namely foundation models should assess and mitigate possible risks and harms through appropriate design, testing and analysis, should implement data governance measures, including assessment of biases, and should comply with technical design requirements to ensure appropriate levels of performance, predictability, interpretability, corrigibility, safety and cybersecurity and should comply with environmental standards. These obligations should be accompanied by standards. Also, foundation models should have information obligations and prepare all necessary technical documentation for potential downstream providers to be able to comply with their obligations under this Regulation. Generative foundation models should ensure transparency about the fact the content is generated by an AI system, not by humans. These specific requirements and obligations do not amount to considering foundation models as high risk AI systems, but should guarantee that the objectives of this Regulation to ensure a high level of protection of fundamental rights, health and safety, environment, democracy and rule of law are achieved. Pre-trained models developed for a narrower, less general, more limited set of applications that cannot be adapted for a wide range of tasks such as simple multi-purpose AI systems should not be considered foundation models for the purposes of this Regulation, because of their greater interpretability which makes their behaviour less unpredictable.











Amendment 102


Proposal for a regulation


Recital 60 h (new)








Text proposed by the Commission




Amendment





 










(60h)






Given the nature of foundation models, expertise in conformity assessment is lacking and third-party auditing methods are still under development . The sector itself is therefore developing new ways to assess fundamental models that fulfil in part the objective of auditing (such as model evaluation, red-teaming or machine learning verification and validation techniques). Those internal assessments for foundation models should be should be broadly applicable (e.g. independent of distribution channels, modality, development methods), to address risks specific to such models taking into account industry state-of-the-art practices and focus on developing sufficient technical understanding and control over the model, the management of reasonably foreseeable risks, and extensive analysis and testing of the model through appropriate measures, such as by the involvement of independent evaluators. As foundation models are a new and fast-evolving development in the field of artificial intelligence, it is appropriate for the Commission and the AI Office to monitor and periodically asses the legislative and governance framework of such models and in particular of generative AI systems based on such models, which raise significant questions related to the generation of content in breach of Union law, copyright rules, and potential misuse. It should be clarified that this Regulation should be without prejudice to Union law on copyright and related rights, including Directives 2001/29/EC, 2004/48/ECR and (EU) 2019/790 of the European Parliament and of the Council.











Amendment 103


Proposal for a regulation


Recital 61








Text proposed by the Commission




Amendment











(61)


Standardisation should play a key role to provide technical solutions to providers to ensure compliance with this Regulation. Compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (54) should be a means for providers to demonstrate conformity with the requirements of this Regulation. 
However, the Commission could adopt common technical specifications in areas where no harmonised
 standards 
exist or where they are insufficient
.












(61)


Standardisation should play a key role to provide technical solutions to providers to ensure compliance with this Regulation. Compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (54) should be a means for providers to demonstrate conformity with the requirements of this Regulation. 
To ensure the effectiveness of standards as policy tool for the Union and considering the importance of
 standards 
for ensuring conformity with the requirements of this Regulation and for the competitiveness of undertakings, it is necessary to ensure a balanced representation of interests by involving all relevant stakeholders in the development of standards
. 
The standardisation process should be transparent in terms of legal and natural persons participating in the standardisation activities.











Amendment 104


Proposal for a regulation


Recital 61 a (new)








Text proposed by the Commission




Amendment





 










(61a)






In order to facilitate compliance, the first standardisation requests should be issued by the Commission two months after the entry into force of this Regulation at the latest. This should serve to improve legal certainty, thereby promoting investment and innovation in AI, as well as competitiveness and growth of the Union market, while enhancing multistakeholder governance representing all relevant European stakeholders such as the AI Office, European standardisation organisations and bodies or experts groups established under relevant sectorial Union law as well as industry, SMEs, start-ups, civil society, researchers and social partners, and should ultimately facilitate global cooperation on standardisation in the field of AI in a manner consistent with Union values. When preparing the standardisation request, the Commission should consult the AI Office and the AI advisory Forum in order to collect relevant expertise.











Amendment 105


Proposal for a regulation


Recital 61 b (new)








Text proposed by the Commission




Amendment





 










(61b)






When AI systems are intended to be used at the workplace, harmonised standards should be limited to technical specifications and procedures.











Amendment 106


Proposal for a regulation


Recital 61 c (new)








Text proposed by the Commission




Amendment





 










(61c)






The Commission should be able to adopt common specifications under certain conditions, when no relevant harmonised standard exists or to address specific fundamental rights concerns. Through the whole drafting process, the Commission should regularly consult the AI Office and its advisory forum, the European standardisation organisations and bodies or expert groups established under relevant sectorial Union law as well as relevant stakeholders, such as industry, SMEs, start-ups, civil society, researchers and social partners.











Amendment 107


Proposal for a regulation


Recital 61 d (new)








Text proposed by the Commission




Amendment





 










(61d)






When adopting common specifications, the Commission should strive for regulatory alignment of AI with likeminded global partners, which is key to fostering innovation and cross-border partnerships within the field of AI, as coordination with likeminded partners in international standardisation bodies is of great importance.











Amendment 108


Proposal for a regulation


Recital 62








Text proposed by the Commission




Amendment











(62)


In order to ensure a high level of trustworthiness of high-risk AI systems, those systems should be subject to a conformity assessment prior to their placing on the market or putting into service.












(62)


In order to ensure a high level of trustworthiness of high-risk AI systems, those systems should be subject to a conformity assessment prior to their placing on the market or putting into service. 
To increase the trust in the value chain and to give certainty to businesses about the performance of their systems, third-parties that supply AI components may voluntarily apply for a third-party conformity assessment.











Amendment 109


Proposal for a regulation


Recital 64








Text proposed by the Commission




Amendment











(64)


Given the 
more extensive
 experience of professional pre-market certifiers in the field of product safety and the different nature of risks involved, it is appropriate to limit, at least in an initial phase of application of this Regulation, the scope of application of third-party conformity assessment for high-risk AI systems other than those related to products. Therefore, the conformity assessment of such systems should be carried out as a general rule by the provider under its own responsibility, with the only exception of AI systems intended to be used for the remote biometric identification of persons, for which the involvement of a notified body in the conformity assessment should be foreseen, to the extent they are not prohibited.












(64)


Given the 
complexity of high-risk AI systems and the risks that are associated to them, it is essential to develop a more adequate capacity for the application of third party conformity assessment for high-risk AI systems. However, given the current
 experience of professional pre-market certifiers in the field of product safety and the different nature of risks involved, it is appropriate to limit, at least in an initial phase of application of this Regulation, the scope of application of third-party conformity assessment for high-risk AI systems other than those related to products. Therefore, the conformity assessment of such systems should be carried out as a general rule by the provider under its own responsibility, with the only exception of AI systems intended to be used for the remote biometric identification of persons, 
or AI systems intended to be used to make inferences about personal characteristics of natural persons on the basis of biometric or biometrics-based data, including emotion recognition systems
 for which the involvement of a notified body in the conformity assessment should be foreseen, to the extent they are not prohibited









Amendment 110


Proposal for a regulation


Recital 65








Text proposed by the Commission




Amendment











(65)


In order to carry out third-party conformity 
assessment for AI systems intended to be used for the remote biometric identification of persons
, notified bodies should be designated under this Regulation by the national competent authorities, provided they are compliant with a set of requirements, notably on independence, competence 
and
 absence of conflicts of interests.












(65)


In order to carry out third-party conformity 
assessments when so required
, notified bodies should be designated under this Regulation by the national competent authorities, provided they are compliant with a set of requirements, notably on independence, competence, absence of conflicts of interests 
and minimum cybersecurity requirements
. 
Member States should encourage the designation of a sufficient number of conformity assessment bodies, in order to make the certification feasible in a timely manner. The procedures of assessment, designation, notification and monitoring of conformity assessment bodies should be implemented as uniformly as possible in Member States, with a view to removing administrative border barriers and ensuring that the potential of the internal market is realised.











Amendment 111


Proposal for a regulation


Recital 65 a (new)








Text proposed by the Commission




Amendment





 










(65a)






In line with Union commitments under the World Trade Organization Agreement on Technical Barriers to Trade, it is adequate to maximise the acceptance of test results produced by competent conformity assessment bodies, independent of the territory in which they are established, where necessary to demonstrate conformity with the applicable requirements of the Regulation. The Commission should actively explore possible international instruments for that purpose and in particular pursue the possible establishment of mutual recognition agreements with countries which are on a comparable level of technical development, and have compatible approach concerning AI and conformity assessment.











Amendment 112


Proposal for a regulation


Recital 66








Text proposed by the Commission




Amendment











(66)


In line with the commonly established notion of substantial modification for products regulated by Union harmonisation legislation, it is appropriate that an AI system undergoes a new conformity assessment whenever 
a
 change occurs which 
may
 affect the compliance of the system with this Regulation or when the intended purpose of the system changes. In addition, as regards AI systems which continue to ‘learn’ after being placed on the market or put into service (i.e. they automatically adapt how functions are carried out), it is necessary to provide rules establishing that changes to the algorithm and its performance that have been pre-determined by the provider and assessed at the moment of the conformity assessment should not constitute a substantial modification.












(66)


In line with the commonly established notion of substantial modification for products regulated by Union harmonisation legislation, it is appropriate that an 
high-risk
 AI system undergoes a new conformity assessment whenever 
an unplanned
 change occurs which 
goes beyond controlled or predetermined changes by the provider including continuous learning and which may create a new unacceptable risk and significantly
 affect the compliance of the 
high-risk AI
 system with this Regulation or when the intended purpose of the system changes. In addition, as regards AI systems which continue to ‘learn’ after being placed on the market or put into service (i.e. they automatically adapt how functions are carried out), it is necessary to provide rules establishing that changes to the algorithm and its performance that have been pre-determined by the provider and assessed at the moment of the conformity assessment should not constitute a substantial modification. 
The same should apply to updates of the AI system for security reasons in general and to protect against evolving threats of manipulation of the system, provided that they do not amount to a substantial modification











Amendment 113


Proposal for a regulation


Recital 67








Text proposed by the Commission




Amendment











(67)


High-risk AI systems should bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the internal market. Member States should not create unjustified obstacles to the placing on the market or putting into service of high-risk AI systems that comply with the requirements laid down in this Regulation and bear the CE marking.












(67)


High-risk AI systems should bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the internal market
. For physical high-risk AI systems, a physical CE marking should be affixed, and may be complemented by a digital CE marking. For digital only high-risk AI systems, a digital CE marking should be used
. Member States should not create unjustified obstacles to the placing on the market or putting into service of high-risk AI systems that comply with the requirements laid down in this Regulation and bear the CE marking.









Amendment 114


Proposal for a regulation


Recital 68








Text proposed by the Commission




Amendment











(68)


Under certain conditions, rapid availability of innovative technologies may be crucial for health and safety of persons and for society as a whole. It is thus appropriate that under exceptional reasons of 
public security or
 protection of life and health of natural persons and the protection of 
industrial and commercial property
, Member States could authorise the placing on the market or putting into service of AI systems which have not undergone a conformity assessment.












(68)


Under certain conditions, rapid availability of innovative technologies may be crucial for health and safety of persons
, the environment and climate change
 and for society as a whole. It is thus appropriate that under exceptional reasons of protection of life and health of natural persons
, environmental protection
 and the protection of 
critical infrastructure
, Member States could authorise the placing on the market or putting into service of AI systems which have not undergone a conformity assessment.









Amendment 115


Proposal for a regulation


Recital 69








Text proposed by the Commission




Amendment











(69)


In order to facilitate the work of the Commission and the Member States in the artificial intelligence field as well as to increase the transparency towards the public, providers of high-risk AI systems other than those related to products falling within the scope of relevant existing Union harmonisation legislation, should be required to register their high-risk AI system in a EU database, to be established and managed by the Commission. The Commission should be the controller of that database, in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (55). In order to ensure the full functionality of the database, when deployed, the procedure for setting the database should include the elaboration of functional specifications by the Commission and an independent audit report.












(69)


In order to facilitate the work of the Commission and the Member States in the artificial intelligence field as well as to increase the transparency towards the public, providers of high-risk AI systems other than those related to products falling within the scope of relevant existing Union harmonisation legislation, should be required to register their high-risk AI system 
and foundation models
 in a EU database, to be established and managed by the Commission
. This database should be freely and publicly accessible, easily understandable and machine-readable. The database should also be user-friendly and easily navigable, with search functionalities at minimum allowing the general public to search the database for specific high-risk systems, locations, categories of risk under Annex IV and keywords. Deployers who are public authorities or Union institutions, bodies, offices and agencies or deployers acting on their behalf and deployers who are undertakings designated as a gatekeeper under Regulation (EU)2022/1925 should also register in the EU database before putting into service or using a high-risk AI system for the first time and following each substantial modification. Other deployers should be entitled to do so voluntarily. Any substantial modification of high-risk AI systems shall also be registered in the EU database
. The Commission should be the controller of that database, in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (55). In order to ensure the full functionality of the database, when deployed, the procedure for setting the database should include the elaboration of functional specifications by the Commission and an independent audit report. 
The Commission should take into account cybersecurity and hazard-related risks when carrying out its tasks as data controller on the EU database. In order to maximise the availability and use of the database by the public, the database, including the information made available through it, should comply with requirements under the Directive 2019/882.











Amendment 116


Proposal for a regulation


Recital 71








Text proposed by the Commission




Amendment











(71)


Artificial intelligence is a rapidly developing family of technologies that requires 
novel forms of
 regulatory oversight and a safe space for experimentation, while ensuring responsible innovation and integration of appropriate safeguards and risk mitigation measures. To ensure a legal framework that is 
innovation-friendly,
 future-proof and resilient to disruption, 
national competent authorities from one or more
 Member States should 
be encouraged to
 establish artificial intelligence regulatory 
sandboxes
 to facilitate the development and testing of innovative AI systems under strict regulatory oversight before these systems are placed on the market or otherwise put into service.












(71)


Artificial intelligence is a rapidly developing family of technologies that requires regulatory oversight and a safe 
and controlled
 space for experimentation, while ensuring responsible innovation and integration of appropriate safeguards and risk mitigation measures. To ensure a legal framework that 
promotes innovation,
 is future-proof, and resilient to disruption, Member States should establish 
at least one
 artificial intelligence regulatory 
sandbox
 to facilitate the development and testing of innovative AI systems under strict regulatory oversight before these systems are placed on the market or otherwise put into service. 
It is indeed desirable for the establishment of regulatory sandboxes, whose establishment is currently left at the discretion of Member States, as a next step to be made mandatory with established criteria. That mandatory sandbox could also be established jointly with one or several other Member States, as long as that sandbox would cover the respective national level of the involved Member States. Additional sandboxes may also be established at different levels, including cross Member States, in order to facilitate cross-border cooperation and synergies. With the exception of the mandatory sandbox at national level, Member States should also be able to establish virtual or hybrid sandboxes. All regulatory sandboxes should be able to accommodate both physical and virtual products. Establishing authorities should also ensure that the regulatory sandboxes have the adequate financial and human resources for their functioning.











Amendment 117


Proposal for a regulation


Recital 72








Text proposed by the Commission




Amendment











(72)


The objectives of the regulatory sandboxes should be 
to foster AI innovation by
 establishing 
a controlled experimentation and testing environment in the development and pre-marketing phase with a view to ensuring compliance of the innovative
 AI systems with this Regulation 
and other
 relevant Union and Member States legislation; to enhance legal certainty 
for innovators and the competent
 authorities
’ oversight and understanding of the opportunities, emerging risks and the impacts of AI use,
 and to 
accelerate access to markets, including by removing barriers for small and medium enterprises (SMEs) and start-ups
. To ensure uniform implementation across the Union and economies of scale, it is appropriate to establish common rules for the regulatory sandboxes’ implementation and a framework for cooperation between the relevant authorities involved in the supervision of the sandboxes. 
This Regulation should provide the legal basis for the use of personal data collected for other purposes for developing certain AI systems in the public interest within the AI regulatory sandbox, in line with Article 6(4) of Regulation (EU) 2016/679, and Article 6 of Regulation (EU) 2018/1725, and without prejudice to Article 4(2) of Directive (EU) 2016/680. Participants in the sandbox
 should ensure 
appropriate safeguards and cooperate with the competent authorities, including by following their guidance and acting expeditiously and in good faith to mitigate any high-risks to safety and fundamental rights that may arise during
 the development and 
experimentation in the sandbox. The conduct of the participants in the sandbox should be taken into account when competent authorities decide whether to impose an administrative fine under Article 83(2) of Regulation 2016/679 and Article 57 of Directive 2016/680.














(72)


The objectives of the regulatory sandboxes should be
: for the
 establishing 
authorities to increase their understanding of technical developments, improve supervisory methods and provide guidance to
 AI systems 
developers and providers to achieve regulatory compliance
 with this Regulation 
or where
 relevant
, other applicable
 Union and Member States legislation
, as well as with the Charter of Fundamental Rights
; 
for the prospective providers to allow and facilitate the testing and development of innovative solutions related to AI systems in the pre-marketing phase
 to enhance legal certainty
, to allow for more regulatory learning by establishing
 authorities 
in a controlled environment to develop better guidance
 and to 
identify possible future improvements of the legal framework through the ordinary legislative procedure. Any significant risks identified during the development and testing of such AI systems should result in immediate mitigation and, failing that, in the suspension of the development and testing process until such mitigation takes place
. To ensure uniform implementation across the Union and economies of scale, it is appropriate to establish common rules for the regulatory sandboxes’ implementation and a framework for cooperation between the relevant authorities involved in the supervision of the sandboxes. 
Member States
 should ensure 
that regulatory sandboxes are widely available throughout the Union, while the participation should remain voluntary. It is especially important to ensure that SMEs and startups can easily access these sandboxes, are actively involved and participate in
 the development and 
testing of innovative AI systems, in order to be able to contribute with their knowhow and experience.











Amendment 118


Proposal for a regulation


Recital 72 a (new)








Text proposed by the Commission




Amendment





 










(72a)






This Regulation should provide the legal basis for the use of personal data collected for other purposes for developing certain AI systems in the public interest within the AI regulatory sandbox only under specified conditions in line with Article 6(4) of Regulation (EU) 2016/679, and Article 6 of Regulation (EU) 2018/1725, and without prejudice to Article 4(2) of Directive (EU) 2016/680. Prospective providers in the sandbox should ensure appropriate safeguards and cooperate with the competent authorities, including by following their guidance and acting expeditiously and in good faith to mitigate any high-risks to safety, health and the environment and fundamental rights that may arise during the development and experimentation in the sandbox. The conduct of the prospective providers in the sandbox should be taken into account when competent authorities decide over the temporary or permanent suspension of their participation in the sandbox whether to impose an administrative fine under Article 83(2) of Regulation 2016/679 and Article 57 of Directive 2016/680.











Amendment 119


Proposal for a regulation


Recital 72 b (new)








Text proposed by the Commission




Amendment





 










(72b)






To ensure that Artificial Intelligence leads to socially and environmentally beneficial outcomes, Member States should support and promote research and development of AI in support of socially and environmentally beneficial outcomes by allocating sufficient resources, including public and Union funding, and giving priority access to regulatory sandboxes to projects led by civil society. Such projects should be based on the principle of interdisciplinary cooperation between AI developers, experts on inequality and non-discrimination, accessibility, consumer, environmental, and digital rights, as well as academics











Amendment 120


Proposal for a regulation


Recital 73








Text proposed by the Commission




Amendment











(73)


In order to promote and protect innovation, it is important that the interests of small-scale providers and users of AI systems are taken into particular account. To this objective, Member States should develop initiatives, which are targeted at those operators, including on awareness raising and information communication. Moreover, the specific interests and needs of small-scale providers shall be taken into account when Notified Bodies set conformity assessment fees. Translation costs related to mandatory documentation and communication with authorities may constitute a significant cost for providers and other operators, notably those of a smaller scale. Member States should possibly ensure that one of the languages determined and accepted by them for relevant providers’ documentation and for communication with operators is one which is broadly understood by the largest possible number of cross-border users.












(73)


In order to promote and protect innovation, it is important that the interests of small-scale providers and users of AI systems are taken into particular account. To this objective, Member States should develop initiatives, which are targeted at those operators, including on 
AI literacy,
 awareness raising and information communication
. Member States shall utilise existing channels and where appropriate, establish new dedicated channels for communication with SMEs, start-ups, user and other innovators to provide guidance and respond to queries about the implementation of this Regulation. Such existing channels could include but are not limited to ENISA’s Computer Security Incident Response Teams, National Data Protection Agencies, the AI-on demand platform, the European Digital Innovation Hubs and other relevant instruments funded by EU programmes as well as the Testing and Experimentation Facilities established by the Commission and the Member States at national or Union level. Where appropriate, these channels shall work together to create synergies and ensure homogeneity in their guidance to start-ups, SMEs and users
. Moreover, the specific interests and needs of small-scale providers shall be taken into account when Notified Bodies set conformity assessment fees. 
The Commission shall regularly assess the certification and compliance costs for SMEs and start-ups, including through transparent consultations with SMEs, start-ups and users and shall work with Member States to lower such costs. For example,
 translation costs related to mandatory documentation and communication with authorities may constitute a significant cost for providers and other operators, notably those of a smaller scale. Member States should possibly ensure that one of the languages determined and accepted by them for relevant providers’ documentation and for communication with operators is one which is broadly understood by the largest possible number of cross-border users. 
Medium-sized enterprises which recently changed from the small to medium-size category within the meaning of the Annex to Recommendation 2003/361/EC (Article 16) shall have access to these initiatives and guidance for a period of time deemed appropriate by the Member States, as these new medium-sized enterprises may sometimes lack the legal resources and training necessary to ensure proper understanding and compliance with provisions.











Amendment 121


Proposal for a regulation


Recital 74








Text proposed by the Commission




Amendment











(74)


In order to minimise the risks to implementation resulting from lack of knowledge and expertise in the market as well as to facilitate compliance of providers and notified bodies with their obligations under this Regulation, the AI-on demand platform, the European Digital Innovation Hubs and the Testing and Experimentation Facilities established by the Commission and the Member States at national or EU level should 
possibly
 contribute to the implementation of this Regulation. Within their respective mission and fields of competence, they may provide in particular technical and scientific support to providers and notified bodies.












(74)


In order to minimise the risks to implementation resulting from lack of knowledge and expertise in the market as well as to facilitate compliance of providers and notified bodies with their obligations under this Regulation, the AI-on demand platform, the European Digital Innovation Hubs and the Testing and Experimentation Facilities established by the Commission and the Member States at national or EU level should contribute to the implementation of this Regulation. Within their respective mission and fields of competence, they may provide in particular technical and scientific support to providers and notified bodies.









Amendment 122


Proposal for a regulation


Recital 76








Text proposed by the Commission




Amendment











(76)


In order to 
facilitate a smooth
, effective and harmonised implementation of this Regulation 
a European
 Artificial Intelligence 
Board
 should be established. The 
Board
 should be responsible for a number of advisory tasks, including issuing opinions, recommendations, advice or guidance on matters related to the implementation of this Regulation
, including on technical specifications or existing standards regarding the requirements established in
 this Regulation 
and providing advice to and assisting the Commission on specific questions related to artificial intelligence
.












(76)


In order to 
avoid fragmentation, to ensure the optimal functioning of the Single market
, 
to ensure
 effective and harmonised implementation of this Regulation
, to achieve a high level of trustworthiness and of protection of health and safety, fundamental rights, the environment, democracy and the rule of law across the Union with regards to
 AI 
systems, to actively support national supervisory authorities, Union institutions, bodies, offices and agencies in matters pertaining to this Regulation, and to increase the uptake of artificial intelligence throughout the Union, an European Union Artificial Intelligence Office
 should be established. The 
AI Office should have legal personality, should act in full independence,
 should be responsible for a number of advisory 
and coordination
 tasks, including issuing opinions, recommendations, advice or guidance on matters related to the implementation of this Regulation 
and should be adequately funded and staffed. Member States should provide the strategic direction and control of the AI Office through the management board of the AI Office, alongside the Commission, the EDPS, the FRA, and ENISA. An executive director should be responsible for managing the activities of the secretariat of the AI office and for representing the AI office. Stakeholders should formally participate in the work of the AI Office through an advisory forum that should ensure varied and balanced stakeholder representation and should advise the AI Office on matters pertaining to this Regulation. In case the establishment of the AI Office prove not to be sufficient to ensure a fully consistent application of
 this Regulation 
at Union level as well as efficient cross-border enforcement measures, the creation of an AI agency should be considered
.









Amendment 123


Proposal for a regulation


Recital 77








Text proposed by the Commission




Amendment











(77)




Member States hold a key role in the application and enforcement of this Regulation. In this respect,
 each Member State should designate 
one or more
 national 
competent authorities
 for the purpose of supervising the application and implementation of this Regulation. In order to increase organisation efficiency on the side of Member States and to set an official point of contact vis-à-vis the public and other counterparts at Member State and Union levels
, in each Member State one national authority should be designated as
 national supervisory authority.












(77)


Each Member State should designate 
a
 national 
supervisory authority
 for the purpose of supervising the application and implementation of this Regulation
. It should also represent its Member State at the management board of the AI Office
. In order to increase organisation efficiency on the side of Member States and to set an official point of contact vis-à-vis the public and other counterparts at Member State and Union levels
. Each
 national supervisory authority 
should act with complete independence in performing its tasks and exercising its powers in accordance with this Regulation
.









Amendment 124


Proposal for a regulation


Recital 77 a (new)








Text proposed by the Commission




Amendment





 










(77a)






The national supervisory authorities should monitor the application of the provisions pursuant to this Regulation and contribute to its consistent application throughout the Union. For that purpose, the national supervisory authorities should cooperate with each other, with the relevant national competent authorities, the Commission, and with the AI Office.











Amendment 125


Proposal for a regulation


Recital 77 b (new)








Text proposed by the Commission




Amendment





 










(77b)






The member or the staff of each national supervisory authority should, in accordance with Union or national law, be subject to a duty of professional secrecy both during and after their term of office, with regard to any confidential information which has come to their knowledge in the course of the performance of their tasks or exercise of their powers. During their term of office, that duty of professional secrecy should in particular apply to trade secrets and to reporting by natural persons of infringements of this Regulation











Amendment 126


Proposal for a regulation


Recital 78








Text proposed by the Commission




Amendment











(78)


In order to ensure that providers of high-risk AI systems can take into account the experience on the use of high-risk AI systems for improving their systems and the design and development process or can take any possible corrective action in a timely manner, all providers should have a post-market monitoring system in place. This system is also key to ensure that the possible risks emerging from AI systems which continue to ‘learn’ after being placed on the market or put into service can be more efficiently and timely addressed. In this context, providers should also be required to have a system in place to report to the relevant authorities any serious incidents or any breaches to national and Union law protecting fundamental rights resulting from the use of their AI systems.












(78)


In order to ensure that providers of high-risk AI systems can take into account the experience on the use of high-risk AI systems for improving their systems and the design and development process or can take any possible corrective action in a timely manner, all providers should have a post-market monitoring system in place. This system is also key to ensure that the possible risks emerging from AI systems which continue to ‘learn’
or evolve
 after being placed on the market or put into service can be more efficiently and timely addressed. In this context, providers should also be required to have a system in place to report to the relevant authorities any serious incidents or any breaches to national and Union law
, including those
 protecting fundamental 
rights and consumer
 rights resulting from the use of their AI systems 
and take appropriate corrective actions
. 
Deployers should also report to the relevant authorities, any serious incidents or breaches to national and Union law resulting from the use of their AI system when they become aware of such serious incidents or breaches.











Amendment 127


Proposal for a regulation


Recital 79








Text proposed by the Commission




Amendment











(79)


In order to ensure an appropriate and effective enforcement of the requirements and obligations set out by this Regulation, which is Union harmonisation legislation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 should apply in its entirety. Where necessary for their mandate, national public authorities or bodies, which supervise the application of Union law protecting fundamental rights, including equality bodies, should also have access to any documentation created under this Regulation.












(79)


In order to ensure an appropriate and effective enforcement of the requirements and obligations set out by this Regulation, which is Union harmonisation legislation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 should apply in its entirety. 
For the purpose of this Regulation, national supervisory authorities should act as market surveillance authorities for AI systems covered by this Regulation except for AI systems covered by Annex II of this Regulation. For AI systems covered by legal acts listed in the Annex II, the competent authorites under those legal acts should remain the lead authority. National supervisory authorities and competent authorities in the legal acts listed in Annex II should work together whenever necessary. When appropriate, the competent authorities in the legal acts listed in Annex II should send competent staff to the national supervisory authority in order to assist in the performance of its tasks. For the purpose of this Regulation, national supervisory authorities should have the same powers and obligations as market surveillance authorities under Regulation (EU) 2019/1020.
 Where necessary for their mandate, national public authorities or bodies, which supervise the application of Union law protecting fundamental rights, including equality bodies, should also have access to any documentation created under this Regulation. 
After having exhausted all other reasonable ways to assess/verify the conformity and upon a reasoned request, the national supervisory authority should be granted access to the training, validation and testing datasets, the trained and training model of the high-risk AI system, including its relevant model parameters and their execution /run environment. In cases of simpler software systems falling under this Regulation that are not based on trained models, and where all other ways to verify conformity have been exhausted, the national supervisory authority may exceptionally have access to the source code, upon a reasoned request. Where the national supervisory authority has been granted access to the training, validation and testing datasets in accordance with this Regulation, such access should be achieved through appropriate technical means and


tools, including on site access and in exceptional circumstances, remote access. The national supervisory authority should treat any information, including source code, software, and data as applicable, obtained as confidential information and respect relevant Union law on the protection of intellectual property and trade secrets. The national supervisory authority should delete any information obtained upon the completion of the investigation.











Amendment 128


Proposal for a regulation


Recital 80








Text proposed by the Commission




Amendment











(80)


Union 
legislation
 on financial services includes internal governance and risk management rules and requirements which are applicable to regulated financial institutions in the course of provision of those services, including when they make use of AI systems. In order to ensure coherent application and enforcement of the obligations under this Regulation and relevant rules and requirements of the Union financial services 
legislation
, the authorities responsible for the supervision and enforcement of the financial services 
legislation
, including where applicable the European Central Bank, should be designated as competent authorities for the purpose of supervising the implementation of this Regulation, including for market surveillance activities, as regards AI systems provided or used by regulated and supervised financial institutions. To further enhance the consistency between this Regulation and the rules applicable to credit institutions regulated under Directive 2013/36/EU of the European Parliament and of the Council (56), it is also appropriate to integrate the conformity assessment procedure and some of the providers’ procedural obligations in relation to risk management, post marketing monitoring and documentation into the existing obligations and procedures under Directive 2013/36/EU. In order to avoid overlaps, limited derogations should also be envisaged in relation to the quality management system of providers and the monitoring obligation placed on 
users
 of high-risk AI systems to the extent that these apply to credit institutions regulated by Directive 2013/36/EU.












(80)


Union 
law
 on financial services includes internal governance and risk management rules and requirements which are applicable to regulated financial institutions in the course of provision of those services, including when they make use of AI systems. In order to ensure coherent application and enforcement of the obligations under this Regulation and relevant rules and requirements of the Union financial services 
law
, the 
competent
 authorities responsible for the supervision and enforcement of the financial services 
law
, including where applicable the European Central Bank, should be designated as competent authorities for the purpose of supervising the implementation of this Regulation, including for market surveillance activities, as regards AI systems provided or used by regulated and supervised financial institutions. To further enhance the consistency between this Regulation and the rules applicable to credit institutions regulated under Directive 2013/36/EU of the European Parliament and of the Council (56), it is also appropriate to integrate the conformity assessment procedure and some of the providers’ procedural obligations in relation to risk management, post marketing monitoring and documentation into the existing obligations and procedures under Directive 2013/36/EU. In order to avoid overlaps, limited derogations should also be envisaged in relation to the quality management system of providers and the monitoring obligation placed on 
deployers
 of high-risk AI systems to the extent that these apply to credit institutions regulated by Directive 2013/36/EU.









Amendment 129


Proposal for a regulation


Recital 80 a (new)








Text proposed by the Commission




Amendment





 










(80a)






Given the objectives of this Regulation, namely to ensure an equivalent level of protection of health, safety and fundamental rights of natural persons, to ensure the protection of the rule of law and democracy, and taking into account that the mitigation of the risks of AI system against such rights may not be sufficiently achieved at national level or may be subject to diverging interpretation which could ultimately lead to an uneven level of protection of natural persons and create market fragmentation, the national supervisory authorities should be empowered to conduct joint investigations or rely on the union safeguard procedure provided for in this Regulation for effective enforcement. Joint investigations should be initiated where the national supervisory authority have sufficient reasons to believe that an infringement of this Regulation amount to a widespread infringement or a widespread infringement with a Union dimension, or where the AI system or foundation model presents a risk which affects or is likely to affect at least 45 million individuals in more than one Member State.











Amendment 130


Proposal for a regulation


Recital 82








Text proposed by the Commission




Amendment











(82)


It is important that AI systems related to products that are not high-risk in accordance with this Regulation and thus are not required to comply with the requirements set out 
herein
 are nevertheless safe when placed on the market or put into service. To contribute to this objective, the Directive 2001/95/EC of the European Parliament and of the Council (57) would apply as a safety net.












(82)


It is important that AI systems related to products that are not high-risk in accordance with this Regulation and thus are not required to comply with the requirements set out 
for high-risk AI systems
 are nevertheless safe when placed on the market or put into service. To contribute to this objective, the Directive 2001/95/EC of the European Parliament and of the Council (57) would apply as a safety net.









Amendment 131


Proposal for a regulation


Recital 83








Text proposed by the Commission




Amendment











(83)


In order to ensure trustful and constructive cooperation of competent authorities on Union and national level, all parties involved in the application of this Regulation should 
respect
 the confidentiality of information and data obtained in carrying out their tasks.












(83)


In order to ensure trustful and constructive cooperation of competent authorities on Union and national level, all parties involved in the application of this Regulation should 
aim for transparency and openness while respecting
 the confidentiality of information and data obtained in carrying out their tasks 
by putting in place technical and organisational measures to protect the security and confidentiality of the information obtained carrying out their activities including for intellectual property rights and public and national security interests
. 
Where the activities of the Commission, national competent authorities and notified bodies pursuant to this Regulation results in a breach of intellectual property rights, Member States should provide for adequate measures and remedies to ensure the enforcement of intellectual property rights in application of Directive 2004/48/EC.











Amendment 132


Proposal for a regulation


Recital 84








Text proposed by the Commission




Amendment











(84)


Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement. For certain specific infringements
, Member States
 should take into account 
the margins and criteria set out in this Regulation
. The European Data Protection Supervisor should have the power to impose fines on Union institutions, agencies and bodies falling within the scope of this Regulation.












(84)




Compliance with this Regulation should be enforceable by means of the imposition of fines by the national supervisory authority when carrying out proceedings under the procedure laid down in this Regulation.
 Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement. 
In order to strengthen and harmonise administrative penalties for infringement of this Regulation, the upper limits for setting the administrative fines
 for certain specific infringements 
should be laid down
;
. When assessing the amount of the fines, national competent authorities
 should
, in each individual case,
 take into account 
all relevant circumstances of the specific situation, with due regard in particular to the nature, gravity and duration of the infringement and of its consequences and to the provider’s size, in particular if the provider is a SME or a start-up
. The European Data Protection Supervisor should have the power to impose fines on Union institutions, agencies and bodies falling within the scope of this Regulation. 
The penalties and litigation costs under this Regulation should not be subject to contractual clauses or any other arrangements.











Amendment 133


Proposal for a regulation


Recital 84 a (new)








Text proposed by the Commission




Amendment





 










(84a)






As the rights and freedoms of natural and legal persons and groups of natural persons can be seriously undermined by AI systems, it is essential that natural and legal persons or groups of natural persons have meaningful access to reporting and redress mechanisms and to be entitled to access proportionate and effective remedies. They should be able to report infringments of this Regulation to their national supervisory authority and have the right to lodge a complaint against the providers or deployers of AI systems. Where applicable, deployers should provide internal complaints mechanisms to be used by natural and legal persons or groups of natural persons. Without prejudice to any other administrative or non-judicial remedy, natural and legal persons and groups of natural persons should also have the right to an effective judicial remedy with regard to a legally binding decision of a national supervisory authority concerning them or, where the national supervisory authority does not handle a complaint, does not inform the complainant of the progress or preliminary outcome of the complaint lodged or does not comply with its obligation to reach a final decision, with regard to the complaint.











Amendment 134


Proposal for a regulation


Recital 84 b (new)








Text proposed by the Commission




Amendment





 










(84b)






Affected persons should always be informed that they are subject to the use of a high-risk AI system, when deployers use a high-risk AI system to assist in decision-making or make decisions related to natural persons. This information can provide a basis for affected persons to exercise their right to an explanation under this Regulation.When deployers provide an explanation to affected persons under this Regulation, they should take into account the level of expertise and knowledge of the average consumer or individual.











Amendment 135


Proposal for a regulation


Recital 84 c (new)








Text proposed by the Commission




Amendment





 










(84c)






Union law on the protection of whistleblowers (Directive (EU) 2019/1937) has full application to academics, designers, developers, project contributors, auditors, product managers, engineers and economic operators acquiring information on breaches of Union law by a provider of AI system or its AI system.











Amendment 136


Proposal for a regulation


Recital 85








Text proposed by the Commission




Amendment











(85)


In order to ensure that the regulatory framework can be adapted where necessary, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend 
the techniques and approaches referred to in Annex I to define AI systems,
 the Union harmonisation legislation listed in Annex II, the high-risk AI systems listed in Annex III, the provisions regarding technical documentation listed in Annex IV, the content of the EU declaration of conformity in Annex V, the provisions regarding the conformity assessment procedures in Annex VI and VII and the provisions establishing the high-risk AI systems to which the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation should apply. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (58). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.












(85)


In order to ensure that the regulatory framework can be adapted where necessary, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the Union harmonisation legislation listed in Annex II, the high-risk AI systems listed in Annex III, the provisions regarding technical documentation listed in Annex IV, the content of the EU declaration of conformity in Annex V, the provisions regarding the conformity assessment procedures in Annex VI and VII and the provisions establishing the high-risk AI systems to which the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation should apply. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (58)

. These consultations should involve the participation of a balanced selection of stakeholders, including consumer organisations, civil society, associations representing affected persons, businesses representatives from different sectors and sizes, as well as researchers and scientists
. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.









Amendment 137


Proposal for a regulation


Recital 85 a (new)








Text proposed by the Commission




Amendment





 










(85a)






Given the rapid technological developments and the required technical expertise in conducting the assessment of high-risk AI systems, the Commission should regularly review the implementation of this Regulation, in particular the prohibited AI systems, the transparency obligations and the list of high-risk areas and use cases, at least every year, while consulting the AI office and the relevant stakeholders.











Amendment 138


Proposal for a regulation


Recital 87 a (new)








Text proposed by the Commission




Amendment





 










(87a)






As reliable information on the resource and energy use, waste production and other environmental impact of AI systems and related ICT technology, including software, hardware and in particular data centres, is limited, the Commission should introduce of an adequate methodology to measure the environmental impact and effectiveness of this Regulation in light of the Union environmental and climate objectives.











Amendment 139


Proposal for a regulation


Recital 89








Text proposed by the Commission




Amendment











(89)


The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42(2) of Regulation (EU) 2018/1725 and delivered an opinion on […]”.












(89)


The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42(2) of Regulation (EU) 2018/1725 and delivered an opinion on 
18 June 2021
.









Amendment 140


Proposal for a regulation


Article 1 — paragraph 1 (new)








Text proposed by the Commission




Amendment





 










1.





The purpose of this Regulation is to promote the uptake of human-centric and trustworthy artificial intelligence and to ensure a high level of protection of health, safety, fundamental rights, democracy and the rule of law, and the environment from harmful effects of artificial intelligence systems in the Union while supporting innovation;










Amendment 141


Proposal for a regulation


Article 1 — paragraph 1 — point d








Text proposed by the Commission




Amendment











(d)


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)


harmonised transparency rules for 
certain
 AI systems;









Amendment 142


Proposal for a regulation


Article 1 — paragraph 1 — point e








Text proposed by the Commission




Amendment











(e)


rules on market monitoring 
and
 surveillance.












(e)


rules on market monitoring
, market
 surveillance 
governance and enforcement;











Amendment 143


Proposal for a regulation


Article 1 — paragraph 1 — point e a (new)








Text proposed by the Commission




Amendment





 










(ea)






measures to support innovation, with a particular focus on SMEs and start-ups, including on setting up regulatory sandboxes and targeted measures to reduce the regulatory burden on SMEs’s and start-ups;











Amendment 144


Proposal for a regulation


Article 1 — paragraph 1 — point e b (new)








Text proposed by the Commission




Amendment





 










(eb)






rules for the establishment and functioning of the Union’s Artificial Intelligence Office (AI Office).











Amendment 145


Proposal for a regulation


Article 2 — paragraph 1 — point b








Text proposed by the Commission




Amendment











(b)




users
 of AI systems located within the Union;












(b)




deployers
 of AI systems 
that have their place of establishment or who are
 located within the Union;









Amendment 146


Proposal for a regulation


Article 2 — paragraph 1 — point c








Text proposed by the Commission




Amendment











(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;












(c)


providers and 
deployers
 of AI systems that 
have their place of establishment or who
 are located in a third country, where 
either Member State law applies by virtue of a public international law or
 the output produced by the system is 
intended to be
 used in the Union;









Amendment 147


Proposal for a regulation


Article 2 — paragraph 1 — point c a (new)








Text proposed by the Commission




Amendment





 










(ca)






providers placing on the market or putting into service AI systems referred to in Article 5 outside the Union where the provider or distributor of such systems is located within the Union;











Amendment 148


Proposal for a regulation


Article 2 — paragraph 1 — point c b (new)








Text proposed by the Commission




Amendment





 










(cb)






importers and distributors of AI systems as well as authorised representatives of providers of AI systems, where such importers, distributors or authorised representatives have their establishment or are located in the Union;











Amendment 149


Proposal for a regulation


Article 2 — paragraph 1 — point c c (new)








Text proposed by the Commission




Amendment





 










(cc)






affected persons as defined in Article 3(8a) that are located in the Union and whose health, safety or fundamental rights are adversely impacted by the use of an AI system that is placed on the market or put into service within the Union.











Amendment 150


Proposal for a regulation


Article 2 — paragraph 2 — introductory part








Text proposed by the Commission




Amendment






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:




2.   For high-risk AI systems that are safety components of products or systems, or which are themselves products or systems 
and that fall,
 within the scope of 
harmonisation legislation listed in Annex II — Section B
, only Article 84 of this Regulation shall apply;






Amendment 151


Proposal for a regulation


Article 2 — paragraph 2 — point a








Text proposed by the Commission




Amendment













(a)






Regulation (EC) 300/2008;










deleted







Amendment 152


Proposal for a regulation


Article 2 — paragraph 2 — point b








Text proposed by the Commission




Amendment













(b)






Regulation (EU) No 167/2013;










deleted







Amendment 153


Proposal for a regulation


Article 2 — paragraph 2 — point c








Text proposed by the Commission




Amendment













(c)






Regulation (EU) No 168/2013;










deleted







Amendment 154


Proposal for a regulation


Article 2 — paragraph 2 — point d








Text proposed by the Commission




Amendment













(d)






Directive 2014/90/EU;










deleted







Amendment 155


Proposal for a regulation


Article 2 — paragraph 2 — point e








Text proposed by the Commission




Amendment













(e)






Directive (EU) 2016/797;










deleted







Amendment 156


Proposal for a regulation


Article 2 — paragraph 2 — point f








Text proposed by the Commission




Amendment













(f)






Regulation (EU) 2018/858;










deleted







Amendment 157


Proposal for a regulation


Article 2 — paragraph 2 — point g








Text proposed by the Commission




Amendment













(g)






Regulation (EU) 2018/1139;










deleted







Amendment 158


Proposal for a regulation


Article 2 — paragraph 2 — point h








Text proposed by the Commission




Amendment













(h)






Regulation (EU) 2019/2144.










deleted







Amendment 159


Proposal for a regulation


Article 2 — paragraph 4








Text proposed by the Commission




Amendment






4.   This Regulation shall not apply to public authorities in a third country nor to international organisations falling within the scope of this Regulation pursuant to paragraph 1, where those authorities or organisations use AI systems in the framework of international agreements for law enforcement and judicial cooperation with the Union or with one or more Member States.




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 
cooperation or
 agreements for law enforcement and judicial cooperation with the Union or with one or more Member States 
and are subject of a decision of the Commission adopted in accordance with Article 36 of Directive (EU)2016/680 or Article 45 of Regulation 2016/679 (adequacy decision) or are part of an international agreement concluded between the Union and that third country or international organisation pursuant to Article 218 TFUE providing adequate safeguards with respect to the protection of privacy and fundamental rights and freedoms of individuals;








Amendment 160


Proposal for a regulation


Article 2 — paragraph 5 a (new)








Text proposed by the Commission




Amendment





 





5a.
   
Union law on the protection of personal data, privacy and the confidentiality of communications applies to personal data processes in connection with the rights and obligations laid down in this Regulation. This Regulation shall not affect Regulations (EU) 2016/679 and (EU) 2018/1725 and Directives 2002/58/EC and (EU) 2016/680, without prejudice to arrangements provided for in Article 10(5) and Article 54 of this Regulation.;








Amendment 161


Proposal for a regulation


Article 2 — paragraph 5 b (new)








Text proposed by the Commission




Amendment





 





5b.
   
This Regulation is without prejudice to the rules laid down by other Union legal acts related to consumer protection and product safety;








Amendment 162


Proposal for a regulation


Article 2 — paragraph 5 c (new)








Text proposed by the Commission




Amendment





 





5c.
   
This regulation shall not preclude Member States or the Union from maintaining or introducing laws, regulations or administrative provisions which are more favourable to workers in terms of protecting their rights in respect of the use of AI systems by employers, or to encourage or allow the application of collective agreements which are more favourable to workers.








Amendment 163


Proposal for a regulation


Article 2 — paragraph 5 d (new)








Text proposed by the Commission




Amendment





 





5d.
   
This Regulation shall not apply to research, testing and development activities regarding an AI system prior to this system being placed on the market or put into service, provided that these activities are conducted respecting fundamental rights and the applicable Union law. The testing in real world conditions shall not be covered by this exemption.The Commission is empowered to may adopt delegated acts in accordance with Article 73 that clarify the application of this paragraph to specify this exemption to prevent its existing and potential abuse. The AI Office shall provide guidance on the governance of research and development pursuant to Article 56, also aiming to coordinate its application by the national supervisory authorities;








Amendment 164


Proposal for a regulation


Article 2 — paragraph 5 e (new)








Text proposed by the Commission




Amendment





 





5e.
   
This Regulation shall not apply to AI components provided under free and open-source licences except to the extent they are placed on the market or put into service by a provider as part of a high-risk AI system or of an AI system that falls under Title II or IV. This exemption shall not apply to foundation models as defined in Art 3.








Amendment 165


Proposal for a regulation


Article 3 — paragraph 1 — point 1








Text proposed by the Commission




Amendment











(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)


‘‘artificial intelligence system’ (AI system) means 
a machine-based system that is designed to operate with varying levels of autonomy and that can, for explicit or implicit objectives, generate outputs such as predictions, recommendations, or decisions, that influence physical or virtual environments;











Amendment 166


Proposal for a regulation


Article 3 — paragraph 1 — point 1 a (new)








Text proposed by the Commission




Amendment





 










(1a)





‘risk’ means the combination of the probability of an occurrence of harm and the severity of that harm;










Amendment 167


Proposal for a regulation


Article 3 — paragraph 1 — point 1 b (new)








Text proposed by the Commission




Amendment





 










(1b)





‘significant risk’ means a risk that is significant as a result of the combination of its severity, intensity, probability of occurrence, and duration of its effects, and its the ability to affect an individual, a plurality of persons or to affect a particular group of persons;










Amendment 168


Proposal for a regulation


Article 3 — paragraph 1 — point 1 c (new)








Text proposed by the Commission




Amendment





 










(1c)





‘foundation model’ means an AI system model that is trained on broad data at scale, is designed for generality of output, and can be adapted to a wide range of distinctive tasks;










Amendment 169


Proposal for a regulation


Article 3 — paragraph 1 — point 1 d (new)








Text proposed by the Commission




Amendment





 










(1d)





‘general purpose AI system’ means an AI system that can be used in and adapted to a wide range of applications for which it was not intentionally and specifically designed;










Amendment 170


Proposal for a regulation


Article 3 — paragraph 1 — point 1 e (new)








Text proposed by the Commission




Amendment





 










(1e)





‘large training runs’ means the production process of a powerful AI model that require computing resources above a very high threshold;










Amendment 171


Proposal for a regulation


Article 3 — paragraph 1 — point 3








Text proposed by the Commission




Amendment













(3)





‘small-scale provider’ means a provider that is a micro or small enterprise within the meaning of Commission Recommendation 2003/361/EC

 (61)

;









deleted







Amendment 172


Proposal for a regulation


Article 3 — paragraph 1 — point 4








Text proposed by the Commission




Amendment











(4)


‘
user
’ means any natural or legal person, public authority, agency or other body using an AI system under its authority, except where the AI system is used in the course of a personal non-professional activity;












(4)


‘
deployer
’ means any natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity;









Amendment 173


Proposal for a regulation


Article 3 — paragraph 1 — point 8








Text proposed by the Commission




Amendment











(8)


‘operator’ means the provider, the 
user
, the authorised representative, the importer and the distributor;












(8)


‘operator’ means the provider, 
the deployer
, the authorised representative, the importer and the distributor;









Amendment 174


Proposal for a regulation


Article 3 — paragraph 1 — point 8 a (new)








Text proposed by the Commission




Amendment





 










(8a)





‘affected person’ means any natural person or group of persons who are subject to or otherwise affected by an AI system;










Amendment 175


Proposal for a regulation


Article 3 — paragraph 1 — point 11








Text proposed by the Commission




Amendment











(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;












(11)


‘putting into service’ means the supply of an AI system for first use directly to the 
deployer
 or for own use on the Union market for its intended purpose;









Amendment 176


Proposal for a regulation


Article 3 — paragraph 1 — point 13








Text proposed by the Commission




Amendment











(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;












(13)


‘reasonably foreseeable misuse’ means the use of an AI system in a way that is not in accordance with its intended purpose 
as indicated in instructions for use established by the provider
, but which may result from reasonably foreseeable human behaviour or interaction with other systems
, including other AI systems
;









Amendment 177


Proposal for a regulation


Article 3 — paragraph 1 — point 14








Text proposed by the Commission




Amendment











(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
;












(14)


‘safety component of a product or system’ means, 
in line with Union harmonisation law listed in Annex II,
 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;









Amendment 178


Proposal for a regulation


Article 3 — paragraph 1 — point 15








Text proposed by the Commission




Amendment











(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;












(15)


‘instructions for use’ means the information provided by the provider to inform the 
deployer
 of in particular an AI system’s intended purpose and proper use, 
as well as information on any precautions to be taken;
 inclusive of the specific geographical, behavioural or functional setting within which the high-risk AI system is intended to be used;









Amendment 179


Proposal for a regulation


Article 3 — paragraph 1 — point 16








Text proposed by the Commission




Amendment











(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
;












(16)


‘recall of an AI system’ means any measure aimed at achieving the return to the provider of an AI system 
that has been
 made available to 
deployers
;









Amendment 180


Proposal for a regulation


Article 3 — paragraph 1 — point 20








Text proposed by the Commission




Amendment











(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;












(20)


‘conformity assessment’ means the process of 
demonstrating
 whether the requirements set out in Title III, Chapter 2 of this Regulation relating to an AI system have been fulfilled;









Amendment 181


Proposal for a regulation


Article 3 — paragraph 1 — point 22








Text proposed by the Commission




Amendment











(22)


‘notified body’ means a conformity assessment body 
designated
 in accordance with this Regulation and other relevant Union harmonisation legislation;












(22)


‘notified body’ means a conformity assessment body 
notified
 in accordance with this Regulation and other relevant Union harmonisation legislation;









Amendment 182


Proposal for a regulation


Article 3 — paragraph 1 — point 23








Text proposed by the Commission




Amendment











(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)


‘substantial modification’ means a 
modification or a series of modifications of
 the AI system 
after
 its placing on the market or putting into service which 
is not foreseen or planned in the initial risk assessment by the provider and as a result of which
 the compliance of the AI system with the requirements set out in Title III, Chapter 2 of this Regulation 
is affected
 or results in a modification to the intended purpose for which the AI system has been assessed;









Amendment 183


Proposal for a regulation


Article 3 — paragraph 1 — point 24








Text proposed by the Commission




Amendment











(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;












(24)


‘CE marking of conformity’ (CE marking) means a 
physical or digital
 marking by which a provider indicates that an 
AI system or a product with an embedded
 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;









Amendment 184


Proposal for a regulation


Article 3 — paragraph 1 — point 29








Text proposed by the Commission




Amendment











(29)


‘training data’ means data used for training an AI system through fitting its learnable parameters
, including the weights of a neural network
;












(29)


‘training data’ means data used for training an AI system through fitting its learnable parameters;









Amendment 185


Proposal for a regulation


Article 3 — paragraph 1 — point 30








Text proposed by the Commission




Amendment











(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;












(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 
underfitting or
 overfitting; whereas the validation dataset 
is
 a separate dataset or part of the training dataset, either as a fixed or variable split;









Amendment 186


Proposal for a regulation


Article 3 — paragraph 1 — point 33








Text proposed by the Commission




Amendment











(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
;












(33)


‘biometric data’ means 
biometric data as defined in Article 4, point (14) of Regulation (EU) 2016/679;











Amendment 187


Proposal for a regulation


Article 3 — paragraph 1 — point 33 a (new)








Text proposed by the Commission




Amendment





 










(33a)





‘biometric-based data’ means data resulting from specific technical processing relating to physical, physiological or behavioural signals of a natural person;










Amendment 188


Proposal for a regulation


Article 3 — paragraph 1 — point 33 b (new)








Text proposed by the Commission




Amendment





 










(33b





) ‘biometric identification’ means the automated recognition of physical, physiological, behavioural, and psychological human features for the purpose of establishing an individual’s identity by comparing biometric data of that individual to stored biometric data of individuals in a database (one-to-many identification);










Amendment 189


Proposal for a regulation


Article 3 — paragraph 1 — point 33 c (new)








Text proposed by the Commission




Amendment





 










(33c)





‘biometric verification’ means the automated verification of the identity of natural persons by comparing biometric data of an individual to previously provided biometric data (one-to-one verification, including authentication);










Amendment 190


Proposal for a regulation


Article 3 — paragraph 1 — point 33 d (new)








Text proposed by the Commission




Amendment





 










(33d)





‘special categories of personal data’ means the categories of personal data referred to in Article 9(1) of Regulation (EU)2016/679;










Amendment 191


Proposal for a regulation


Article 3 — paragraph 1 — point 34








Text proposed by the Commission




Amendment











(34)


‘emotion recognition system’ means an AI system for the purpose of identifying or inferring emotions or intentions of 
natural persons
 on the basis of their biometric data;












(34)


‘emotion recognition system’ means an AI system for the purpose of identifying or inferring emotions
, thoughts, states of mind
 or intentions of 
individuals or groups
 on the basis of their biometric 
and biometric-based
 data;









Amendment 192


Proposal for a regulation


Article 3 — paragraph 1 — point 35








Text proposed by the Commission




Amendment











(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;












(35)


‘biometric categorisation’ means assigning natural persons to specific categories, 
or inferring their characteristics and attributes
 on the basis of their biometric 
or biometric-based
 data, 
or which can be inferred from such data
;









Amendment 193


Proposal for a regulation


Article 3 — paragraph 1 — point 36








Text proposed by the Commission




Amendment











(36)


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












(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 
deployer
 of the AI system whether the person will be present and can be identified
, excluding verification systems;











Amendment 194


Proposal for a regulation


Article 3 — paragraph 1 — point 37








Text proposed by the Commission




Amendment











(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.












(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 delays in order to avoid circumvention;









Amendment 195


Proposal for a regulation


Article 3 — paragraph 1 — point 39








Text proposed by the Commission




Amendment











(39)


‘publicly accessible space’ means any physical place accessible to the public, regardless of whether certain conditions for access may apply;












(39)


‘publicly accessible space’ means any 
publicly or privately owned
 physical place accessible to the public, regardless of whether certain conditions for access may apply
, and regardless of the potential capacity restrictions
;









Amendment 196


Proposal for a regulation


Article 3 — paragraph 1 — point 41








Text proposed by the Commission




Amendment











(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;












(41)


‘law enforcement’ means activities carried out by law enforcement authorities 
or on their behalf
 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;









Amendment 197


Proposal for a regulation


Article 3 — paragraph 1 — point 42








Text proposed by the Commission




Amendment











(42)


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












(42)


‘national supervisory authority’ means 
a public (AM 69)
 authority to which a Member State assigns the responsibility for the implementation and application of this Regulation, for coordinating the activities entrusted to that Member State, for acting as the single contact point for the Commission, and for representing the Member State 
in the management
 Board 
of the AI Office
;









Amendment 198


Proposal for a regulation


Article 3 — paragraph 1 — point 43








Text proposed by the Commission




Amendment











(43)


‘national competent authority’ means the national 
supervisory authority, the notifying authority and the market surveillance authority
;












(43)


‘national competent authority’ means 
any of
 the national 
authorities which are responsible for the enforcement of this Regulation;











Amendment 199


Proposal for a regulation


Article 3 — paragraph 1 — point 44 — introductory part








Text proposed by the Commission




Amendment











(44)


‘serious incident’ means any incident that directly or indirectly leads, might have led or might lead to any of the following:












(44)


‘serious incident’ means any incident 
or malfunctioning of an AI system
 that directly or indirectly leads, might have led or might lead to any of the following:














(a)


the death of a person or serious damage to a person’s health, 
to property or the environment,














(a)


the death of a person or serious damage to a person’s health,














(b)


a serious disruption of the management and operation of critical infrastructure.












(b)


a serious disruption of the management and operation of critical infrastructure,








 










(ba)






a breach of fundamental rights protected under Union law,










 










(bb)






serious damage to property or the environment.











Amendment 200


Proposal for a regulation


Article 3 — paragraph 1 — point 44 a (new)








Text proposed by the Commission




Amendment





 










(44a)





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










Amendment 201


Proposal for a regulation


Article 3 — paragraph 1 — point 44 b (new)








Text proposed by the Commission




Amendment





 










(44b)





‘non-personal data’ means data other than personal data;










Amendment 202


Proposal for a regulation


Article 3 — paragraph 1 — point 44 c (new)








Text proposed by the Commission




Amendment





 










(44c)





‘profiling’ means any form of automated processing of personal data as defined in point (4) of Article 4 of Regulation (EU) 2016/679; or in the case of law enforcement authorities — in point 4 of Article 3 of Directive (EU) 2016/680 or, in the case of Union institutions, bodies, offices or agencies, in point 5 Article 3 of Regulation (EU) 2018/1725;










Amendment 203


Proposal for a regulation


Article 3 — paragraph 1 — point 44 d (new)








Text proposed by the Commission




Amendment





 










(44d)





‘deep fake’ means manipulated or synthetic audio, image or video content that would falsely appear to be authentic or truthful, and which features depictions of persons appearing to say or do things they did not say or do, produced using AI techniques, including machine learning and deep learning;










Amendment 204


Proposal for a regulation


Article 3 — paragraph 1 — point 44 e (new)








Text proposed by the Commission




Amendment





 










(44e)





‘widespread infringement’ means any act or omission contrary to Union law that protects the interest of individuals:









 










(a)






which has harmed or is likely to harm the collective interests of individuals residing in at least two Member States other than the Member State, in which:










 








 










(i)






the act or omission originated or took place;














 








 










(ii)






the provider concerned, or, where applicable, its authorised representative is established; or,














 








 










(iii)






the deployer is established, when the infringement is committed by the deployer;














 










(b)






which protects the interests of individuals, that have caused, cause or are likely to cause harm to the collective interests of individuals and that have common features, including the same unlawful practice, the same interest being infringed and that are occurring concurrently, committed by the same operator, in at least three Member States;











Amendment 205


Proposal for a regulation


Article 3 — paragraph 1 — point 44 f (new)








Text proposed by the Commission




Amendment





 










(44f)





‘widespread infringement with a Union dimension’ means a widespread infringement that has harmed or is likely to harm the collective interests of individuals in at least two-thirds of the Member States, accounting, together, for at least two-thirds of the population of the Union;










Amendment 206


Proposal for a regulation


Article 3 — paragraph 1 — point 44 g (new)








Text proposed by the Commission




Amendment





 










(44g)





‘regulatory sandbox’ means a controlled environment established by a public authority that facilitates the safe development, testing and validation of innovative AI systems for a limited time before their placement on the market or putting into service pursuant to a specific plan under regulatory supervision;










Amendment 207


Proposal for a regulation


Article 3 — paragraph 1 — point 44 h (new)








Text proposed by the Commission




Amendment





 










(44h)





‘critical infrastructure’ means an asset, a facility, equipment, a network or a system, or a part of an asset, a facility, equipment, a network or a system, which is necessary for the provision of an essential service within the meaning of Article 2(4) of Directive (EU) 2022/2557;










Amendment 208


Proposal for a regulation


Article 3 — paragraph 1 — point 44 k (new)








Text proposed by the Commission




Amendment





 










(44k)





‘social scoring’ means evaluating or classifying natural persons based on their social behaviour, socio-economic status or known or predicted personal or personality characteristics;










Amendment 209


Proposal for a regulation


Article 3 — paragraph 1 — point 44 l (new)








Text proposed by the Commission




Amendment





 










(44l)





‘social behaviour’ means the way a natural person interacts with and influences other natural persons or society;










Amendment 210


Proposal for a regulation


Article 3 — paragraph 1 — point 44 m (new)








Text proposed by the Commission




Amendment





 










(44m)





‘state of the art’ means the developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience;










Amendment 211


Proposal for a regulation


Article 3 — paragraph 1 — point 44 n (new)








Text proposed by the Commission




Amendment





 










(44n)





‘testing in real world conditions’ means the temporary testing of an AI system for its intended purpose in real world conditions outside of a laboratory or otherwise simulated environment;










Amendment 212


Proposal for a regulation


Article 4








Text proposed by the Commission




Amendment







Article 4






deleted








Amendments to Annex I




 






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.




 





Amendment 213


Proposal for a regulation


Article 4 a (new)








Text proposed by the Commission




Amendment





 




Article 4 a






 




General principles applicable to all AI systems






 





1.
   
All operators falling under this Regulation shall make their best efforts to develop and use AI systems or foundation models in accordance with the following general principles establishing a high-level framework that promotes a coherent human-centric European approach to ethical and trustworthy Artificial Intelligence, which is fully in line with the Charter as well as the values on which the Union is founded:







 










a)






‘human agency and oversight’ means that AI systems shall be developed and used as a tool that serves people, respects human dignity and personal autonomy, and that is functioning in a way that can be appropriately controlled and overseen by humans;










 










b)






‘technical robustness and safety’ means that AI systems shall be developed and used in a way to minimize unintended and unexpected harm as well as being robust in case of unintended problems and being resilient against attempts to alter the use or performance of the AI system so as to allow unlawful use by malicious third parties;










 










c)






‘privacy and data governance’ means that AI systems shall be developed and used in compliance with existing privacy and data protection rules, while processing data that meets high standards in terms of quality and integrity;










 










d)






‘transparency’ means that AI systems shall be developed and used in a way that allows appropriate traceability and explainability, while making humans aware that they communicate or interact with an AI system as well as duly informing users of the capabilities and limitations of that AI system and affected persons about their rights;.










 










e)






‘diversity, non-discrimination and fairness’ means that AI systems shall be developed and used in a way that includes diverse actors and promotes equal access, gender equality and cultural diversity, while avoiding discriminatory impacts and unfair biases that are prohibited by Union or national law;










 










f)






‘social and environmental well-being’ means that AI systems shall be developed and used in a sustainable and environmentally friendly manner as well as in a way to benefit all human beings, while monitoring and assessing the long-term impacts on the individual, society and democracy.










 





2.
   
Paragraph 1 is without prejudice to obligations set up by existing Union and national law. For high-risk AI systems, the general principles are translated into and complied with by providers or deployers by means of the requirements set out in Articles 8 to 15, and the relevant obligations laid down in Chapter 3 of Title III of this Regulation. For foundation models, the general principles are translated into and complied with by providers by means of the requirements set out in Articles 28 to 28b. For all AI systems, the application of the principles referred to in paragraph 1 can be achieved, as applicable, through the provisions of Article 28, Article 52, or the application of harmonised standards, technical specifications, and codes of conduct as referred to in Article 69,without creating new obligations under this Regulation.







 





3.
   
The Commission and the AI Office shall incorporate these guiding principles in standardisation requests as well as recommendations consisting in technical guidance to assist providers and deployers on how to develop and use AI systems. European Standardisation Organisations shall take the general principles referred to in paragraph 1of this Article into account as outcome-based objectives when developing the appropriate harmonised standards for high risk AI systems as referred to in Article 40(2b).








Amendment 214


Proposal for a regulation


Article 4 b (new)








Text proposed by the Commission




Amendment





 




Article 4 b






 




AI literacy






 





1.
   
When implementing this Regulation, the Union and the Member States shall promote measures for the development of a sufficient level of AI literacy, across sectors and taking into account the different needs of groups of providers, deployers and affected persons concerned, including through education and training, skilling and reskilling programmes and while ensuring proper gender and age balance, in view of allowing a democratic control of AI systems







 





2.
   
Providers and deployers of AI systems shall take measures to ensure a sufficient level of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their technical knowledge, experience, education and training and the context the AI systems are to be used in, and considering the persons or groups of persons on which the AI systems are to be used.







 





3.
   
Such literacy measures shall consist, in particular, of the teaching of basic notions and skills about AI systems and their functioning, including the different types of products and uses, their risks and benefits.







 





4.
   
A sufficient level of AI literacy is one that contributes, as necessary, to the ability of providers and deployers to ensure compliance and enforcement of this Regulation.








Amendment 215


Proposal for a regulation


Article 5 — paragraph 1 — point a








Text proposed by the Commission




Amendment











(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;












(a)


the placing on the market, putting into service or use of an AI system that deploys subliminal techniques beyond a person’s consciousness 
or purposefully manipulative or deceptive techniques, with the objective to or the effect of
 materially 
distorting
 a person’s 
or a group of persons’
 behaviour 
by appreciably impairing the person’s ability to make an informed decision, thereby causing the person to take a decision that that person would not have otherwise taken
 in a manner that causes or is likely to cause that person, another person 
or group of persons significant
 harm;








 




The prohibition of AI system that deploys subliminal techniques referred to in the first sub-paragraph shall not apply to AI systems intended to be used for approved therapeutical purposes on the basis of specific informed consent of the individuals that are exposed to them or, where applicable, of their legal guardian;







Amendment 216


Proposal for a regulation


Article 5 — paragraph 1 — point b








Text proposed by the Commission




Amendment











(b)


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












(b)


the placing on the market, putting into service or use of an AI system that exploits any of the vulnerabilities of a 
person or a
 specific group of persons
, including characteristics of such person’s or a such group’s known or predicted personality traits or social or economic situation
 age, physical or mental 
ability with the objective or to the effect of
 materially 
distorting
 the behaviour of 
that person or
 a person pertaining to that group in a manner that causes or is likely to cause that person or another person 
significant
 harm;;









Amendment 217


Proposal for a regulation


Article 5 — paragraph 1 — point b a (new)








Text proposed by the Commission




Amendment





 










(b a)






the placing on the market, putting into service or use of biometric categorisation systems that categorise natural persons according to sensitive or protected attributes or characteristics or based on the inference of those attributes or characteristics. This prohibition shall not apply to AI systems intended to be used for approved therapeutical purposes on the basis of specific informed consent of the individuals that are exposed to them or, where applicable, of their legal guardian.











Amendment 218


Proposal for a regulation


Article 5 — paragraph 1 — point c — introductory part








Text proposed by the Commission




Amendment











(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:












(c)


the placing on the market, putting into service or use of AI systems for the 
social scoring
 evaluation or classification of natural persons 
or groups thereof
 over a certain period of time based on their social behaviour or known
, inferred
 or predicted personal or personality characteristics, with the social score leading to either or both of the following:









Amendment 219


Proposal for a regulation


Article 5 — paragraph 1 — point c — point i








Text proposed by the Commission




Amendment











(i)


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












(i)


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









Amendment 220


Proposal for a regulation


Article 5 — paragraph 1 — point d — introductory part








Text proposed by the Commission




Amendment











(d)


the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces 
for the purpose of law enforcement, unless and in as far as such use is strictly necessary for one of the following objectives:














(d)


the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces;









Amendment 221


Proposal for a regulation


Article 5 — paragraph 1 — point d — point i








Text proposed by the Commission




Amendment













(i)






the targeted search for specific potential victims of crime, including missing children;










deleted







Amendment 222


Proposal for a regulation


Article 5 — paragraph 1 — point d — point ii








Text proposed by the Commission




Amendment













(ii)






the prevention of a specific, substantial and imminent threat to the life or physical safety of natural persons or of a terrorist attack;










deleted







Amendment 223


Proposal for a regulation


Article 5 — paragraph 1 — point d — point iii








Text proposed by the Commission




Amendment













(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/JHA

 (62)

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.










deleted







Amendment 224


Proposal for a regulation


Article 5 — paragraph 1 — point d a (new)








Text proposed by the Commission




Amendment





 










(d a)






the placing on the market, putting into service or use of an AI system for making risk assessments of natural persons or groups thereof in order to assess the risk of a natural person for offending or reoffending or for predicting the occurrence or reoccurrence of an actual or potential criminal or administrative offence based on profiling of a natural person or on assessing personality traits and characteristics, including the person’s location, or past criminal behaviour of natural persons or groups of natural persons;











Amendment 225


Proposal for a regulation


Article 5 — paragraph 1 — point d b (new)








Text proposed by the Commission




Amendment





 










(d b)






The placing on the market, putting into service or use of AI systems that create or expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage;











Amendment 226


Proposal for a regulation


Article 5 — paragraph 1 — point d c (new)








Text proposed by the Commission




Amendment





 










dc)






the placing on the market, putting into service or use of AI systems to infer emotions of a natural person in the areas of law enforcement, border management, in workplace and education institutions.











Amendment 227


Proposal for a regulation


Article 5 — paragraph 1 — point d d (new)








Text proposed by the Commission




Amendment





 










(d d)






the putting into service or use of AI systems for the analysis of recorded footage of publicly accessible spaces through ‘post’ remote biometric identification systems, unless they are subject to a pre-judicial authorisation in accordance with Union law and strictly necessary for the targeted search connected to a specific serious criminal offense as defined in Article 83(1) of TFEU that already took place for the purpose of law enforcement.











Amendment 228


Proposal for a regulation


Article 5 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 





1 a.
   
This Article shall not affect the prohibitions that apply where an artificial intelligence practice infringes another Union law, including Union law on data protection, non discrimination, consumer protection or competition;








Amendment 229


Proposal for a regulation


Article 5 — paragraph 2








Text proposed by the Commission




Amendment








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:







deleted














(a)






the nature of the situation giving rise to the possible use, in particular the seriousness, probability and scale of the harm caused in the absence of the use of the system;








 












(b)






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








 






In addition, the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement for any of the objectives referred to 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.




 





Amendment 230


Proposal for a regulation


Article 5 — paragraph 3








Text proposed by the Commission




Amendment








3.
   
As regards paragraphs 1, point (d) and 2, each individual use for the purpose of law enforcement of a ‘real-time’ remote biometric identification system in publicly accessible spaces shall be subject to a prior authorisation granted by a judicial authority or by an independent administrative authority of the Member State in which the use is to take place, issued upon a reasoned request and in accordance with the detailed rules of national law referred to in paragraph 4. However, in a 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.







deleted








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




 





Amendment 231


Proposal for a regulation


Article 5 — paragraph 4








Text proposed by the Commission




Amendment








4.
   
A Member State may decide to provide for the possibility to fully or partially authorise the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement within the limits and under the conditions listed in paragraphs 1, point (d), 2 and 3. That Member State shall lay down in its national law the necessary detailed rules for the request, issuance and exercise of, as well as supervision relating to, the authorisations referred to in paragraph 3. Those rules shall also specify in respect of which of the objectives listed in paragraph 1, point (d), including which of the criminal offences referred to in point (iii) thereof, the competent authorities may be authorised to use those systems for the purpose of law enforcement.







deleted







Amendment 232


Proposal for a regulation


Article 6 — paragraph 1 — point a








Text proposed by the Commission




Amendment











(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;












(a)


the AI system is intended to be used as a safety component of a product, 
or the AI system
 is itself a product, covered by the Union harmonisation 
law
 listed in Annex II;









Amendment 233


Proposal for a regulation


Article 6 — paragraph 1 — point b








Text proposed by the Commission




Amendment











(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.












(b)


the product whose safety component 
pursuant to point (a)
 is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment 
related to risks for health and safety,
 with a view to the placing on the market or putting into service of that product pursuant to the Union harmonisation 
law
 listed in Annex II;









Amendment 234


Proposal for a regulation


Article 6 — paragraph 2








Text proposed by the Commission




Amendment






2.   In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall 
also
 be considered high-risk.




2.   In addition to the high-risk AI systems referred to in paragraph 1, AI systems 
falling under one or more of the critical areas and use cases
 referred to in Annex III shall 
be considered high-risk if they pose a significant risk of harm to the health, safety or fundamental rights of natural persons. Where an AI system falls under Annex III point 2, it shall
 be considered 
to be
 high-risk 
if it poses a significant risk of harm to the environment
.





 




The Commission shall, six months prior to the entry into force of this Regulation, after consulting the AI Office and relevant stakeholders, provide guidelines clearly specifying the circumstances where the output of AI systems referred to in Annex III would pose a significant risk of harm to the health, safety or fundamental rights of natural persons or cases in which it would not.







Amendment 235


Proposal for a regulation


Article 6 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
Where providers falling under one or more of the critical areas and use cases referred to in Annex III consider that their AI system does not pose a significant risk as described in paragraph 2, they shall submit a reasoned notification to the national supervisory authority that they are not subject to the requirements of Title III Chapter 2 of this Regulation. Where the AI system is intended to be used in two or more Member States, that notification shall be addressed to the AI Office. Without prejudice to Article 65, the national supervisory authority shall review and reply to the notification, directly or via the AI Office, within three months if they deem the AI system to be misclassified.








Amendment 236


Proposal for a regulation


Article 6 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 b.
   
Providers that misclassify their AI system as not subject to the requirements of Title III Chapter 2 of this Regulation and place it on the market before the deadline for objection by national supervisory authorities shall be subject to fines pursuant to Article 71.








Amendment 237


Proposal for a regulation


Article 6 — paragraph 2 b (new)








Text proposed by the Commission




Amendment





 





2 c.
   
National supervisory authorities shall submit a yearly report to the AI Office detailing the number of notifications received, the related high-risk areas at stake and the decisions taken concerning received notifications








Amendment 238


Proposal for a regulation


Article 7 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment






1.   The Commission is empowered to adopt delegated acts in accordance with Article 73 to 
update the list in
 Annex III by adding high-risk AI systems where 
both of the following conditions are fulfilled:






1.   The Commission is empowered to adopt delegated acts in accordance with Article 73 to 
amend
 Annex III by adding 
or modifying areas or use-cases of
 high-risk AI systems where 
these pose a significant risk of harm to health and safety, or an adverse impact on fundamental rights, to the environment, or to democracy and the rule of law, and that risk 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.








Amendment 239


Proposal for a regulation


Article 7 — paragraph 1 — point a








Text proposed by the Commission




Amendment













(a)






the AI systems are intended to be used in any of the areas listed in points 1 to 8 of Annex III;










deleted







Amendment 240


Proposal for a regulation


Article 7 — paragraph 1 — point b








Text proposed by the Commission




Amendment













(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.










deleted







Amendment 241


Proposal for a regulation


Article 7 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 





1 a.
   
The Commission is also empowered to adopt delegated acts in accordance with Article 73 to remove use-cases of high-risk AI systems from the list in Annex III if the conditions referred to in paragraph 1 no longer apply;








Amendment 242


Proposal for a regulation


Article 7 — paragraph 2 — introductory part








Text proposed by the Commission




Amendment






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:




2.   When assessing 
an AI system
 for the purposes of paragraph 1 
and 1a
 the Commission shall take into account the following criteria:






Amendment 243


Proposal for a regulation


Article 7 — paragraph 2 — point a a (new)








Text proposed by the Commission




Amendment





 










(a a)






the general capabilities and functionalities of the AI system independent of its intended purpose;











Amendment 244


Proposal for a regulation


Article 7 — paragraph 2 — point b a (new)








Text proposed by the Commission




Amendment





 










(b a)






the nature and amount of the data processed and used by the AI system;











Amendment 245


Proposal for a regulation


Article 7 — paragraph 2 — point b b (new)








Text proposed by the Commission




Amendment





 










(b b)






the extent to which the AI system acts autonomously;











Amendment 246


Proposal for a regulation


Article 7 — paragraph 2 — point c








Text proposed by the Commission




Amendment











(c)


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












(c)


the extent to which the use of an AI system has already caused harm to health and safety
, has had an
 adverse impact on fundamental rights
, the environment, democracy and the rule of law
 or has given rise to significant concerns in relation to the 
likelihood
 of such harm or adverse impact, as demonstrated 
for example
 by reports or documented allegations submitted to national 
supervisory
 authorities
, to the Commission, to the AI Office, to the EDPS, or to the European Union Agency for Fundamental Rights
;









Amendment 247


Proposal for a regulation


Article 7 — paragraph 2 — point d








Text proposed by the Commission




Amendment











(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;












(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 
or to disproportionately affect a particular group of persons
;









Amendment 248


Proposal for a regulation


Article 7 — paragraph 2 — point e








Text proposed by the Commission




Amendment











(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
;












(e)


the extent to which potentially harmed or adversely impacted persons are dependent on the 
output
 produced 
involving
 an AI system
, and that output is purely accessory in respect of the relevant action or decision to be taken
, in particular because for practical or legal reasons it is not reasonably possible to opt-out from that 
output
;









Amendment 249


Proposal for a regulation


Article 7 — paragraph 2 — point e a (new)








Text proposed by the Commission




Amendment





 










(e a)






the potential misuse and malicious use of the AI system and of the technology underpinning it;











Amendment 250


Proposal for a regulation


Article 7 — paragraph 2 — point f








Text proposed by the Commission




Amendment











(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;












(f)


the extent to which 
there is an imbalance of power, or the
 potentially harmed or adversely impacted persons are in a vulnerable position in relation to the user of an AI system, in particular due to 
status, authority
, knowledge, economic or social circumstances, or age;









Amendment 251


Proposal for a regulation


Article 7 — paragraph 2 — point g








Text proposed by the Commission




Amendment











(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;












(g)


the extent to which the outcome produced 
involving
 an AI system is easily reversible 
or remedied
, whereby outcomes having an 
adverse
 impact on health, safety
, fundamental rights
 of persons
, the environment, or on democracy and rule of law
 shall not be considered as easily reversible;









Amendment 252


Proposal for a regulation


Article 7 — paragraph 2 — point g a (new)








Text proposed by the Commission




Amendment





 










(g a)






the extent of the availability and use of effective technical solutions and mechanisms for the control, reliability and corrigibility of the AI system;











Amendment 253


Proposal for a regulation


Article 7 — paragraph 2 — point g b (new)








Text proposed by the Commission




Amendment





 










(g b)






the magnitude and likelihood of benefit of the deployment of the AI system for individuals, groups, or society at large, including possible improvements in product safety;











Amendment 254


Proposal for a regulation


Article 7 — paragraph 2 — point g c (new)








Text proposed by the Commission




Amendment





 










(g c)






the extent of human oversight and the possibility for a human to intercede in order to override a decision or recommendations that may lead to potential harm;











Amendment 255


Proposal for a regulation


Article 7 — paragraph 2 — point h –








Text proposed by the Commission




Amendment











(i)


effective measures of redress in relation to the 
risks posed
 by an AI system, with the exclusion of claims for damages;












(h)


the extent to which existing Union law provides for:








 








 








(i)


effective measures of redress in relation to the 
damage caused
 by an AI system, with the exclusion of claims for 
direct or indirect
 damages;












 








 








(ii)


effective measures to prevent or substantially minimise those risks.













Amendment 256


Proposal for a regulation


Article 7 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
When assessing an AI system for the purposes of paragraphs 1 or 1a the Commission shall consult the AI Office and, where relevant, representatives of groups on which an AI system has an impact, industry, independent experts, the social partners, and civil society organisations. The Commission shall also organise public consultations in this regard and shall make the results of those consultations and of the final assessment publicly available;








Amendment 257


Proposal for a regulation


Article 7 — paragraph 2 b (new)








Text proposed by the Commission




Amendment





 





2 b.
   
The AI Office, national supervisory authorities or the European Parliament may request the Commission to reassess and recategorise the risk categorisation of an AI systemin accordance with paragraphs 1 and 1a. The Commission shall give reasons for its decision and make them public.








Amendment 258


Proposal for a regulation


Article 8 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 





1 a.
   
In complying with the requirement established in this Chapter, due account shall be taken of guidelines developed as referred to in Article 82b, the generally acknowledged state of the art, including as reflected in the relevant harmonised standards and common specifications as referred to in articles 40 and 41 or those already set out in Union harmonisation law;.








Amendment 259


Proposal for a regulation


Article 8 — paragraph 2








Text proposed by the Commission




Amendment






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.




2.   The intended purpose of the high-risk AI system
, the reasonably foreseeable misuses
 and the risk management system referred to in Article 9 shall be taken into account when ensuring compliance with those requirements.






Amendment 260


Proposal for a regulation


Article 8 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
As long as the requirements of Title III, Chapters 2 and 3 or Title VIII, Chapters 1, 2 and 3 for high-risk AI systems are addressed by Union harmonisation law listed in Annex II, Section A, the requirements or obligations of those Chapters of this Regulation shall be deemed to be fulfilled, as long as they include the AI component. Requirements of Chapters 2 and 3 of Title III or Title VIII, Chapters 1, 2 and 3 for high-risk AI systems not addressed by Union harmonisation law listed in Annex II Section A, shall be incorporated into that Union harmonisation law, where applicable. The relevant conformity assessment shall be carried out as part of the procedures laid out under Union harmonisation law listed in Annex II, Section A.








Amendment 261


Proposal for a regulation


Article 9 — paragraph 1








Text proposed by the Commission




Amendment






1.   A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.




1.   A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems
, throughout the entire lifecycle of the AI system
. 
The risk management system can be integrated into, or a part of, already existing risk management procedures relating to the relevant Union sectoral law insofar as it fulfils the requirements of this article.








Amendment 262


Proposal for a regulation


Article 9 — paragraph 2 — introductory part








Text proposed by the Commission




Amendment






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:




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 
review and
 updating 
of the risk management process, to ensure its continuing effectiveness, and documentation of any significant decisions and actions taken subject to this Article
. It shall comprise the following steps:






Amendment 263


Proposal for a regulation


Article 9 — paragraph 2 — point a








Text proposed by the Commission




Amendment











(a)


identification 
and analysis
 of the known and foreseeable risks 
associated with each
 high-risk AI system;












(a)


identification
, estimation and evaluation
 of the known and 
the reasonably
 foreseeable risks 
that the
 high-risk AI system 
can pose to the health or safety of natural persons, their fundamental rights including equal access and opportunities, democracy and rule of law or the environement when the high-risk AI system is used in accordance with its intended purpose and under conditions of reasonably foreseeable misuse
;









Amendment 264


Proposal for a regulation


Article 9 — paragraph 2 — point b








Text proposed by the Commission




Amendment













(b)






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










deleted







Amendment 265


Proposal for a regulation


Article 9 — paragraph 2 — point c








Text proposed by the Commission




Amendment











(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;












(c)


evaluation of 
emerging significant
 risks 
as described in point (a) and identified
 based on the analysis of data gathered from the post-market monitoring system referred to in Article 61;









Amendment 266


Proposal for a regulation


Article 9 — paragraph 2 — point d








Text proposed by the Commission




Amendment











(d)


adoption of 
suitable
 risk management measures in accordance with the provisions of the following paragraphs.












(d)


adoption of 
appropriate and targeted
 risk management measures 
designed to address the risks identified pursuant to points a and b of this paragraph
 in accordance with the provisions of the following paragraphs









Amendment 267


Proposal for a regulation


Article 9 — paragraph 3








Text proposed by the Commission




Amendment






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




3.   The risk management measures referred to in paragraph 2, point 
(d)
 shall give due consideration to the effects and possible interactions resulting from the combined application of the requirements set out in this Chapter 2
, with a view to mitigate risks effectively while ensuring an appropriate and proportionate implementation
 of the 
requirements
.






Amendment 268


Proposal for a regulation


Article 9 — paragraph 4 — introductory part








Text proposed by the Commission




Amendment






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
.




4.   The risk management measures referred to in paragraph 2, point 
(d)
 shall be such that 
relevant
 residual risk associated with each hazard as well as the overall residual risk of the high-risk AI systems is 
reasonably
 judged 
to be
 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 
and the reasoned judgements made
 shall be communicated to the 
deployer
.





 




In identifying the most appropriate risk management measures, the following shall be ensured:







Amendment 269


Proposal for a regulation


Article 9 — paragraph 4 — subparagraph 1 — point a








Text proposed by the Commission




Amendment











(a)


elimination or reduction of risks as far as 
possible
 through adequate design and development;












(a)


elimination or reduction of 
identified
 risks as far as 
technically feasible
 through adequate design and development 
of the high-risk AI system, involving when relevant, experts and external stakeholders
;









Amendment 270


Proposal for a regulation


Article 9 — paragraph 4 — subparagraph 1 — point b








Text proposed by the Commission




Amendment











(b)


where appropriate, implementation of adequate mitigation and control measures 
in relation to
 risks that cannot be eliminated;












(b)


where appropriate, implementation of adequate mitigation and control measures 
addressing significant
 risks that cannot be eliminated;









Amendment 271


Proposal for a regulation


Article 9 — paragraph 4 — subparagraph 1 — point c








Text proposed by the Commission




Amendment











(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
.












(c)


provision of 
the required
 information pursuant to Article 13, and, where appropriate, training to 
deployers
.









Amendment 272


Proposal for a regulation


Article 9 — paragraph 4 — subparagraph 2








Text proposed by the Commission




Amendment





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
.


In eliminating or reducing risks related to the use of the high-risk AI system, 
providers shall take into
 due consideration the technical knowledge, experience, education 
and
 training 
the deployer may need, including in relation to the presumable context of use
.





Amendment 273


Proposal for a regulation


Article 9 — paragraph 5








Text proposed by the Commission




Amendment






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.




5.   High-risk AI systems shall be tested for the purposes of identifying the most appropriate 
and targeted
 risk management measures 
and weighing any such measures against the potential benefits and intended goals of the system
. 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.






Amendment 274


Proposal for a regulation


Article 9 — paragraph 6








Text proposed by the Commission




Amendment






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
.




6.   Testing procedures shall be suitable to achieve the intended purpose of the AI system.






Amendment 275


Proposal for a regulation


Article 9 — paragraph 7








Text proposed by the Commission




Amendment






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.




7.   The testing of the high-risk AI systems shall be performed, prior to the placing on the market or the putting into service. Testing shall be made against 
prior
 defined metrics, and probabilistic thresholds that are appropriate to the intended purpose 
or reasonably foreseeable misuse
 of the high-risk AI system.






Amendment 276


Proposal for a regulation


Article 9 — paragraph 8








Text proposed by the Commission




Amendment






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




8.   When implementing the risk management system described in paragraphs 1 to 7, 
providers shall give
 specific consideration to whether the high-risk AI system is likely to 
adversely
 impact 
vulnerable groups of people or
 children.






Amendment 277


Proposal for a regulation


Article 9 — paragraph 9








Text proposed by the Commission




Amendment






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
.




9.   For 
providers and AI systems already covered by Union law that require them to establish a specific risk management, including
 credit institutions regulated by Directive 2013/36/EU, the aspects described in paragraphs 1 to 8 shall be part of 
or combined with
 the risk management procedures established by 
that Union law
.






Amendment 278


Proposal for a regulation


Article 10 — paragraph 1








Text proposed by the Commission




Amendment






1.   High-risk AI systems which make use of techniques involving the training of models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5.




1.   High-risk AI systems which make use of techniques involving the training of models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5 
as far as this is technically feasible according to the specific market segment or scope of application
.





 




Techniques that do not require labelled input data such as unsupervised learning and reinforcement learning shall be developed on the basis of data sets such as for testing and verification that meet the quality criteria referred to in paragraphs 2 to 5.







Amendment 279


Proposal for a regulation


Article 10 — paragraph 2 — introductory part








Text proposed by the Commission




Amendment






2.   Training, validation and testing data sets shall be subject to 
appropriate
 data governance 
and management practices
. Those 
practices
 shall concern in particular,




2.   Training, validation and testing data sets shall be subject to data governance 
appropriate for the context of use as well as the intended purpose of the AI system
. Those 
measures
 shall concern in particular,






Amendment 280


Proposal for a regulation


Article 10 — paragraph 2 — point a a (new)








Text proposed by the Commission




Amendment





 










(a a)






transparency as regards the original purpose of data collection;











Amendment 281


Proposal for a regulation


Article 10 — paragraph 2 — point b








Text proposed by the Commission




Amendment











(b)


data collection;












(b)


data collection 
processes
;









Amendment 282


Proposal for a regulation


Article 10 — paragraph 2 — point c








Text proposed by the Commission




Amendment











(c)




relevant
 data preparation processing operations, such as annotation, labelling, cleaning, enrichment and aggregation;












(c)


data preparation processing operations, such as annotation, labelling, cleaning, 
updating
 enrichment and aggregation;









Amendment 283


Proposal for a regulation


Article 10 — paragraph 2 — point d








Text proposed by the Commission




Amendment











(d)


the formulation of 
relevant
 assumptions, notably with respect to the information that the data are supposed to measure and represent;












(d)


the formulation of assumptions, notably with respect to the information that the data are supposed to measure and represent;









Amendment 284


Proposal for a regulation


Article 10 — paragraph 2 — point e








Text proposed by the Commission




Amendment











(e)




a prior
 assessment of the availability, quantity and suitability of the data sets that are needed;












(e)




an
 assessment of the availability, quantity and suitability of the data sets that are needed;









Amendment 285


Proposal for a regulation


Article 10 — paragraph 2 — point f








Text proposed by the Commission




Amendment











(f)


examination in view of possible biases;












(f)


examination in view of possible biases 
that are likely to affect the health and safety of persons, negatively impact fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations (‘feedback loops’) and appropriate measures to detect, prevent and mitigate possible biases
;









Amendment 286


Proposal for a regulation


Article 10 — paragraph 2 — point f a (new)








Text proposed by the Commission




Amendment





 










(f a)






appropriate measures to detect, prevent and mitigate possible biases











Amendment 287


Proposal for a regulation


Article 10 — paragraph 2 — point g








Text proposed by the Commission




Amendment











(g)


the identification of 
any possible
 data gaps or shortcomings, and how those gaps and shortcomings can be addressed.












(g)


the identification of 
relevant
 data gaps or shortcomings 
that prevent compliance with this Regulation
, and how those gaps and shortcomings can be addressed;









Amendment 288


Proposal for a regulation


Article 10 — paragraph 3








Text proposed by the Commission




Amendment






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




3.   Training 
datasets, and where they are used
, validation and testing 
datasets, including the labels,
 shall be relevant, 
sufficiently
 representative
, appropriately vetted for
 errors and 
be as
 complete 
as possible in view of the intended purpose
. They shall have the appropriate statistical properties, including, where applicable, as regards the persons or groups of persons 
in relation to whom
 the high-risk AI system is intended to be used. These characteristics of the 
datasets shall
 be met at the level of individual 
datasets
 or a combination thereof.






Amendment 289


Proposal for a regulation


Article 10 — paragraph 4








Text proposed by the Commission




Amendment






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.




4.   
Datasets
 shall take into account, to the extent required by the intended purpose 
or reasonably foreseeable misuses of the AI system
, the characteristics or elements that are particular to the specific geographical, 
contextual
 behavioural or functional setting within which the high-risk AI system is intended to be used.






Amendment 290


Proposal for a regulation


Article 10 — paragraph 5








Text proposed by the Commission




Amendment






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
.




5.   To the extent that it is strictly necessary for the purposes of ensuring 
negative
 bias detection and correction in relation to the high-risk AI systems, the providers of such systems may 
exceptionally
 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
. In particular, all the following conditions shall apply in order for this processing to occur:










(a)






the bias detection and correction cannot be effectively fulfilled by processing synthetic or anonymised data;











 










(b)






the data are pseudonymised;










 










(c)






the provider takes appropriate technical and organisational
 measures 
to ensure that the data processed for
 the purpose 
of this paragraph are secured, protected, subject to suitable safeguards and only authorised persons have access to those data with appropriate confidentiality obligations;










 










(d)






the data processed for the purpose of this paragraph are not to be transmitted, transferred or otherwise accessed by other parties;










 










(e)






the data processed for the purpose of this paragraph are protected by means of appropriate technical and organisational measures and deleted once the bias has been corrected or the personal data has reached the end of its retention period;










 










(f)






effective and appropriate measures are in place to ensure availability, security and resilience of processing systems and services against technical or physical incidents;










 










(g)






effective and appropriate measures are in place to ensure physical security of locations where the data are stored and processed, internal IT and IT security governance and management, certification of processes and products;










 




Providers having recourse to this provision shall draw up documentation explaining why the processing of special categories of personal data was necessary to detect and correct biases
.





Amendment 291


Proposal for a regulation


Article 10 — paragraph 6 a (new)








Text proposed by the Commission




Amendment





 





6 a.
   
Where the provider cannot comply with the obligations laid down in this Article because that provider does not have access to the data and the data is held exclusively by the deployer, the deployer may, on the basis of a contract, be made responsible for any infringement of this Article.








Amendment 292


Proposal for a regulation


Article 11 — paragraph 1 — subparagraph 1








Text proposed by the Commission




Amendment





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.


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 
supervisory
 authorities and notified bodies with 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 
or, in the case of SMEs and start-ups, any equivalent documentation meeting the same objectives, subject to approval of the competent national authority
.





Amendment 293


Proposal for a regulation


Article 11 — paragraph 2








Text proposed by the Commission




Amendment






2.   Where a high-risk AI system related to a product, to which the legal acts listed in Annex 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.




2.   Where a high-risk AI system related to a product, to which the legal acts listed in Annex 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 
paragraph 1
 as well as the information required under those legal acts.






Amendment 294


Proposal for a regulation


Article 11 — paragraph 3 a (new)








Text proposed by the Commission




Amendment





 





3 a.
   
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.








Amendment 295


Proposal for a regulation


Article 12 — paragraph 1








Text proposed by the Commission




Amendment






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.




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 
the state of the art and
 recognised standards or common specifications.






Amendment 296


Proposal for a regulation


Article 12 — paragraph 2








Text proposed by the Commission




Amendment






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.




2.   
In order to
 ensure a level of traceability of the AI system’s functioning throughout its 
entire lifetime
 that is appropriate to the intended purpose of the system
, the logging capabilities shall facilitate the monitoring of operations as referred to in Article 29(4) as well as the post market monitoring referred to in Article 61
. 
In particular, they shall enable the recording of events relevant for the identification of situations that may:







 










(a)






result in the AI system presenting a risk within the meaning of Article65(1); or










 










(b)






lead to a substantial modification of the AI system.











Amendment 297


Proposal for a regulation


Article 12 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
High-risk AI systems shall be designed and developed with, the logging capabilities enabling the recording of energy consumption, the measurement or calculation of resource use and environmental impact of the high-risk AI system during all phases of the system’s lifecycle.








Amendment 298


Proposal for a regulation


Article 12 — paragraph 3








Text proposed by the Commission




Amendment








3.
   
In particular, logging capabilities shall enable the monitoring of the operation of the high-risk AI system with respect to the 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.







deleted







Amendment 299


Proposal for a regulation


Article 13 — title








Text proposed by the Commission




Amendment





Transparency and provision of information 
to users




Transparency and provision of information





Amendment 300


Proposal for a regulation


Article 13 — paragraph 1








Text proposed by the Commission




Amendment






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




1.   High-risk AI systems shall be designed and developed in such a way to ensure that their operation is sufficiently transparent to enable 
providers and
 users to 
reasonably understand
 the system’s 
functioning
. Appropriate transparency shall be ensured 
in accordance with the intended purpose of the AI system
, with a view to achieving compliance with the relevant obligations of the provider 
and user
 set out in Chapter 3 of this Title.





 




Transparency shall thereby mean that, at the time the high-risk AI system is placed on the market, all technical means available in accordance with the generally acknowledged state of art are used to ensure that the AI system’s output is interpretable by the provider and the user. The user shall be enabled to understand and use the AI system appropriately by generally knowing how the AI system works and what data it processes, allowing the user to explain the decisions taken by the AI system to the affected person pursuant to Article 68(c).







Amendment 301


Proposal for a regulation


Article 13 — paragraph 2








Text proposed by the Commission




Amendment






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.




2.   High-risk AI systems shall be accompanied by 
intelligible
 instructions for use in an appropriate digital format or 
made
 otherwise 
available in a durable medium
 that include concise, 
correct, clear and to the extent possible
 complete information that 
helps operating and maintaining the AI system as well as supporting informed decision-making by users and is reasonably
 relevant, accessible and comprehensible to users .






Amendment 302


Proposal for a regulation


Article 13 — paragraph 3 — introductory part








Text proposed by the Commission




Amendment






3.   
The
 information referred to in paragraph 2 shall specify:




3.   
To achieve the outcomes referred to in paragraph 1,
 information referred to in paragraph 2 shall specify:






Amendment 303


Proposal for a regulation


Article 13 — paragraph 3 — point a








Text proposed by the Commission




Amendment











(a)


the identity and the contact details of the provider and, where applicable, of its authorised 
representative
;












(a)


the identity and the contact details of the provider and, where applicable, of its authorised 
representatives
;









Amendment 304


Proposal for a regulation


Article 13 — paragraph 3 — point a a (new)








Text proposed by the Commission




Amendment





 










(aa)






where it is not the same as the provider, the identity and the contact details of the entity that carried out the conformity assessment and, where applicable, of its authorised representative;











Amendment 305


Proposal for a regulation


Article 13 — paragraph 3 — point b — introductory part








Text proposed by the Commission




Amendment











(b)


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












(b)


the characteristics, capabilities and limitations of performance of the high-risk AI system, including
, where appropriate
:









Amendment 306


Proposal for a regulation


Article 13 — paragraph 3 — point b — point ii








Text proposed by the Commission




Amendment











(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;












(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 
clearly
 known and foreseeable circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity;









Amendment 307


Proposal for a regulation


Article 13 — paragraph 3 — point b — point iii








Text proposed by the Commission




Amendment











(iii)


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












(iii)


any 
clearly
 known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety, fundamental rights 
or the environment, including, where appropriate, illustrative examples of such limitations and of scenarios for which the system should not be used
;









Amendment 308


Proposal for a regulation


Article 13 — paragraph 3 — point b — point iii a (new)








Text proposed by the Commission




Amendment





 










(iiia)






the degree to which the AI system can provide an explanation for decisions it takes;











Amendment 309


Proposal for a regulation


Article 13 — paragraph 3 — point b — point v








Text proposed by the Commission




Amendment











(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.












(v)




relevant information about user actions that may influence system performance, including type or quality of
 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.









Amendment 310


Proposal for a regulation


Article 13 — paragraph 3 — point e








Text proposed by the Commission




Amendment











(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.












(e)


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









Amendment 311


Proposal for a regulation


Article 13 — paragraph 3 — point e a (new)








Text proposed by the Commission




Amendment





 










(ea)






a description of the mechanisms included within the AI system that allows users to properly collect, store and interpret the logs in accordance with Article 12(1).











Amendment 312


Proposal for a regulation


Article 13 — paragraph 3 — point e b (new)








Text proposed by the Commission




Amendment





 










(eb)






The information shall be provided at least in the language of the country where the AI system is used.











Amendment 313


Proposal for a regulation


Article 13 — paragraph 3 a (new)








Text proposed by the Commission




Amendment





 





3a.
   
In order to comply with the obligations laid down in this Article, providers and users shall ensure a sufficient level of AI literacy in line with Article 4b.








Amendment 314


Proposal for a regulation


Article 14 — paragraph 1








Text proposed by the Commission




Amendment






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.




1.   High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they be effectively overseen by natural persons 
as proportionate to the risks associated with those systems. Natural persons in charge of ensuring human oversight shall have sufficient level of AI literacy in accordance with Article 4b and the necessary support and authority to exercise that function,
 during the period in which the AI system is in use 
and to allow for thorough investigation after an incident
.






Amendment 315


Proposal for a regulation


Article 14 — paragraph 2








Text proposed by the Commission




Amendment






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




2.   Human oversight shall aim at preventing or minimising the risks to health, safety, fundamental rights 
or environment
 that may emerge when a high-risk AI system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, in particular when such risks persist notwithstanding the application of other requirements set out in this Chapter 
and where decisions based solely on automated processing by AI systems produce legal or otherwise significant effects on the persons or groups of persons on which the system is to be used
.






Amendment 316


Proposal for a regulation


Article 14 — paragraph 3 — introductory part








Text proposed by the Commission




Amendment






3.   Human oversight shall be ensured through either one or all of the following measures:




3.   Human oversight 
shall take into account the specific risks, the level of automation, and context of the AI system and
 shall be ensured through either one or all of the following 
types of
 measures:






Amendment 317


Proposal for a regulation


Article 14 — paragraph 4 — introductory part








Text proposed by the Commission




Amendment






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:




4.   
For the purpose of implementing paragraphs 1 to 3, the high-risk AI system
 shall 
be provided to the user in such a way that natural persons
 to whom human oversight is assigned 
are enabled
, as appropriate 
and proportionate
 to the circumstances:






Amendment 318


Proposal for a regulation


Article 14 — paragraph 4 — point a








Text proposed by the Commission




Amendment











(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;












(a)




be aware of and sufficiently
 understand the 
relevant
 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;









Amendment 319


Proposal for a regulation


Article 14 — paragraph 4 — point e








Text proposed by the Commission




Amendment











(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.












(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 
that allows the system to come to a halt in a safe state, except if the human interference increases the risks or would negatively impact the performance in consideration of generally acknowledged state-of-the-art
.









Amendment 320


Proposal for a regulation


Article 14 — paragraph 5








Text proposed by the Commission




Amendment






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




5.   For high-risk AI systems referred to in point1(a) of Annex III, the measures referred to in paragraph 3 shall be such as to ensure that, in addition, no action or decision is taken by the user on the basis of the identification resulting from the system unless this has been verified and confirmed by at least two natural persons 
with the necessary competence, training and authority
.






Amendment 321


Proposal for a regulation


Article 15 — paragraph 1








Text proposed by the Commission




Amendment






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.




1.   High-risk AI systems shall be designed and developed 
following the principle of security by design and by default.
 In the light of their intended purpose, 
they should achieve
 an appropriate level of accuracy, robustness
, safety,
 and cybersecurity, and perform consistently in those respects throughout their lifecycle. 
Compliance with these requirements shall include implementation of state-of-the-art measures, according to the specific market segment or scope of application.








Amendment 322


Proposal for a regulation


Article 15 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 





1 a.
   
To address the technical aspects of how to measure the appropriate levels of accuracy and robustness set out in paragraph 1 of this Article, the AI Office shall bring together national and international metrology and benchmarking authorities and provide non-binding guidance on the matter as set out in Article 56, paragraph 2, point (a).








Amendment 323


Proposal for a regulation


Article 15 — paragraph 1 b (new)








Text proposed by the Commission




Amendment





 





1b.
   
To address any emerging issues across the internal market with regard to cybersecurity, the European Union Agency for Cybersecurity (ENISA) shall be involved alongside the European Artificial Intelligence Board as set out Article 56, paragraph 2, point (b).








Amendment 324


Proposal for a regulation


Article 15 — paragraph 2








Text proposed by the Commission




Amendment






2.   The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be declared in the accompanying instructions of use.




2.   The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be declared in the accompanying instructions of use. 
The language used shall be clear, free of misunderstandings or misleading statements.








Amendment 325


Proposal for a regulation


Article 15 — paragraph 3 — subparagraph 1








Text proposed by the Commission




Amendment





High-risk AI systems shall be resilient as 
regards
 errors, faults or inconsistencies that may occur within the system or the environment in which the system operates, in particular due to their interaction with natural persons or other systems.




Technical and organisational measures shall be taken to ensure that
 high-risk AI systems shall be 
as
 resilient as 
possible regarding
 errors, faults or inconsistencies that may occur within the system or the environment in which the system operates, in particular due to their interaction with natural persons or other systems.





Amendment 326


Proposal for a regulation


Article 15 — paragraph 3 — subparagraph 2








Text proposed by the Commission




Amendment





The robustness of high-risk AI systems may be achieved through technical redundancy solutions, which may include backup or fail-safe plans.


The robustness of high-risk AI systems may be achieved 
by the appropriate provider with input from the user, where necessary,
 through technical redundancy solutions, which may include backup or fail-safe plans.





Amendment 327


Proposal for a regulation


Article 15 — paragraph 3 — subparagraph 3








Text proposed by the Commission




Amendment





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.


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 
influencing
 input for future operations (‘feedback loops’) 
and malicious manipulation of inputs used in learning during operation
 are duly addressed with appropriate mitigation measures.





Amendment 328


Proposal for a regulation


Article 15 — paragraph 4 — subparagraph 1








Text proposed by the Commission




Amendment





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.


High-risk AI systems shall be resilient as regards 
to
 attempts by unauthorised third parties to alter their use
, behaviour, outputs
 or performance by exploiting the system vulnerabilities.





Amendment 329


Proposal for a regulation


Article 15 — paragraph 4 — subparagraph 3








Text proposed by the Commission




Amendment





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.


The technical solutions to address AI specific vulnerabilities shall include, where appropriate, measures to prevent
, detect, respond to, resolve
 and control for attacks trying to manipulate the training dataset (‘data poisoning’), 
or pre-trained components used in training (‘model poisoning’) ,
 inputs designed to cause the model to make a mistake (‘adversarial examples’
or ‘model evasion’
), 
confidentiality attacks
 or model flaws
, which could lead to harmful decision-making
.





Amendment 330


Proposal for a regulation


Title III — Chapter 3 — title








Text proposed by the Commission




Amendment





OBLIGATIONS OF PROVIDERS AND 
USERS
 OF HIGH-RISK AI SYSTEMS 
and other parties




OBLIGATIONS OF PROVIDERS AND 
DEPLOYERS
 OF HIGH-RISK AI SYSTEMS 
AND OTHER PARTIES







Amendment 331


Proposal for a regulation


Article 16 — title








Text proposed by the Commission




Amendment





Obligations of providers of high-risk AI systems


Obligations of providers 
and deployers
 of high-risk AI systems 
and other parties







Amendment 332


Proposal for a regulation


Article 16 — paragraph 1 — point a








Text proposed by the Commission




Amendment











(a)


ensure that their high-risk AI systems are compliant with the requirements set out in Chapter 2 of this Title;












(a)


ensure that their high-risk AI systems are compliant with the requirements set out in Chapter 2 of this Title 
before placing them on the market or putting them into service
;









Amendment 333


Proposal for a regulation


Article 16 — paragraph 1 — point a a (new)








Text proposed by the Commission




Amendment





 










(a a)






indicate their name, registered trade name or registered trade mark, and their address and contact information on the high-risk AI system or, where that is not possible, on its accompanying documentation, as appropriate;











Amendment 334


Proposal for a regulation


Article 16 — paragraph 1 — point a b (new)








Text proposed by the Commission




Amendment





 










(a b)






ensure that natural persons to whom human oversight of high-risk AI systems is assigned are specifically made aware of the risk of automation or confirmation bias;











Amendment 335


Proposal for a regulation


Article 16 — paragraph 1 — point a c (new)








Text proposed by the Commission




Amendment





 










(a c)






provide specifications for the input data, or any other relevant information in terms of the datasets used, including their limitation and assumptions, taking into account the intended purpose and the foreseeable and reasonably foreseeable misuses of the AI system;











Amendment 336


Proposal for a regulation


Article 16 — paragraph 1 — point c








Text proposed by the Commission




Amendment











(c)


draw-up the technical documentation of the high-risk AI system;












(c)


draw-up 
and keep
 the technical documentation of the high-risk AI system 
referred to in Article 11
;









Amendment 337


Proposal for a regulation


Article 16 — paragraph 1 — point d








Text proposed by the Commission




Amendment











(d)


when under their control, keep the logs automatically generated by their high-risk AI systems;












(d)


when under their control, keep the logs automatically generated by their high-risk AI systems 
that are required for ensuring and demonstrating compliance with this Regulation, in accordance with Article 20
;









Amendment 338


Proposal for a regulation


Article 16 — paragraph 1 — point e








Text proposed by the Commission




Amendment











(e)


ensure that the high-risk AI system undergoes the relevant conformity assessment procedure, prior to its placing on the market or putting into service;












(e)


ensure that the high-risk AI system undergoes the relevant conformity assessment procedure, prior to its placing on the market or putting into service
, in accordance with Article 43
;









Amendment 339


Proposal for a regulation


Article 16 — paragraph 1 — point e a (new)








Text proposed by the Commission




Amendment





 










(e a)






draw up an EU declaration of conformity in accordance with Article 48;











Amendment 340


Proposal for a regulation


Article 16 — paragraph 1 — point e b (new)








Text proposed by the Commission




Amendment





 










(e b)






affix the CE marking to the high-risk AI system to indicate conformity with this Regulation, in accordance with Article 49;











Amendment 341


Proposal for a regulation


Article 16 — paragraph 1 — point g








Text proposed by the Commission




Amendment











(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
;












(g)


take the necessary corrective actions 
as referred to in Article 21 and provide information in that regard
;









Amendment 342


Proposal for a regulation


Article 16 — paragraph 1 — point h








Text proposed by the Commission




Amendment













(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;










deleted







Amendment 343


Proposal for a regulation


Article 16 — paragraph 1 — point i








Text proposed by the Commission




Amendment













(i)






to affix the CE marking to their high-risk AI systems to indicate the conformity with this Regulation in accordance with Article 49;










deleted







Amendment 344


Proposal for a regulation


Article 16 — paragraph 1 — point j








Text proposed by the Commission




Amendment











(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.












(j)


upon 
a reasoned
 request of a national 
supervisory
 authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Chapter 2 of this Title.









Amendment 345


Proposal for a regulation


Article 16 — paragraph 1 — point j a (new)








Text proposed by the Commission




Amendment





 










(j a)






ensure that the high-risk AI system complies with accessibility requirements.











Amendment 346


Proposal for a regulation


Article 17 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment






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:




1.   Providers of high-risk AI systems shall 
have
 a quality management system in place that ensures compliance with this Regulation. 
It
 shall be documented in a systematic and orderly manner in the form of written policies, procedures 
or
 instructions, and 
can be incorporated into an existing quality management system under Union sectoral legislative acts. It
 shall include at least the following aspects:






Amendment 347


Proposal for a regulation


Article 17 — paragraph 1 — point a








Text proposed by the Commission




Amendment













(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;










deleted







Amendment 348


Proposal for a regulation


Article 17 — paragraph 1 — point e








Text proposed by the Commission




Amendment











(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;












(e)


technical specifications, including standards, to be applied and, where the relevant harmonised standards are not applied in full, 
or do not cover all of the relevant requirements,
 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;









Amendment 349


Proposal for a regulation


Article 17 — paragraph 1 — point f








Text proposed by the Commission




Amendment











(f)


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












(f)


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









Amendment 350


Proposal for a regulation


Article 17 — paragraph 1 — point j








Text proposed by the Commission




Amendment











(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
;












(j)


the handling of communication with 
relevant
 competent authorities, including sectoral ones;









Amendment 351


Proposal for a regulation


Article 17 — paragraph 2








Text proposed by the Commission




Amendment






2.   The implementation of aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s organisation.




2.   The implementation of aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s organisation. 
Providers shall in any event respect the degree of rigour and the level of protection required to ensure compliance of their AI systems with this Regulation.








Amendment 352


Proposal for a regulation


Article 18 — title








Text proposed by the Commission




Amendment







Obligation to draw up technical documentation






deleted







Amendment 353


Proposal for a regulation


Article 18 — paragraph 1








Text proposed by the Commission




Amendment








1.
   
Providers of high-risk AI systems shall draw up the technical documentation referred to in Article 11 in accordance with Annex IV.







deleted







Amendment 354


Proposal for a regulation


Article 18 — paragraph 2








Text proposed by the Commission




Amendment








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.







deleted







Amendment 355


Proposal for a regulation


Article 19








Text proposed by the Commission




Amendment







Article 19






deleted








Conformity assessment




 







1.
   
Providers of high-risk AI systems shall ensure that their systems undergo the relevant conformity assessment procedure in accordance with Article 43, prior to their placing on the market or putting into service. Where the compliance of the AI systems with the requirements set out in Chapter 2 of this Title has been demonstrated following that conformity assessment, the providers shall draw up an EU declaration of conformity in accordance with Article 48 and affix the CE marking of conformity in accordance with Article 49.





 







2.
   
For high-risk AI systems referred to in point 5(b) of Annex III that are placed on the market or put into service by providers that are credit institutions regulated by Directive 2013/36/EU, the conformity assessment shall be carried out as part of the procedure referred to in Articles 97 to101 of that Directive.





 





Amendment 356


Proposal for a regulation


Article 20 — paragraph 1








Text proposed by the Commission




Amendment






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
 appropriate 
in the light of
 the intended purpose of high-risk AI system 
and applicable legal obligations under Union or national law
.




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
. Without prejudice to applicable Union or national law,
 the logs shall be kept for a period 
of at least 6 months. The retention period shall be in accordance with industry standards and
 appropriate 
to
 the intended purpose of high-risk AI system.






Amendment 357


Proposal for a regulation


Article 21 — paragraph 1








Text proposed by the Commission




Amendment





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




Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective actions to bring that system into conformity, to withdraw it
, to disable it
 or to recall it, as appropriate.




 




In the cases referred to in the first paragraph, providers shall immediately inform:






 










a.






the distributors;










 










b.






the importers;










 










c.






the national competent authorities of the Member States in which they made the AI system available or put it into service; and










 










d.






where possible, the deployer.











Amendment 358


Proposal for a regulation


Article 21 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 




The providers shall also inform the authorised representative, if one was appointed in accordance with Article 25, and the notified body if the high-risk AI system had to undergo a third-party conformity assessment in accordance with Article 43. Where applicable, they shall also investigate the causes in collaboration with the deployer.







Amendment 359


Proposal for a regulation


Article 22 — paragraph 1








Text proposed by the Commission




Amendment





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 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.


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





Amendment 360


Proposal for a regulation


Article 22 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 




In the cases referred to inthe first paragraph, providers of the high-risk AI system shall immediately inform:






 










a)






the distributors;










 










b)






the importers;










 










c)






the national competent authorities of the Member States in which they made the AI system available or put it into service; and










 










d)






where possible, the deployers.











Amendment 361


Proposal for a regulation


Article 22 — paragraph 1 b (new)








Text proposed by the Commission




Amendment





 




The providers shall also inform the authorised representative, if one was appointed in accordance with Article 25.







Amendment 362


Proposal for a regulation


Article 23 — title








Text proposed by the Commission




Amendment





Cooperation with competent authorities


Cooperation with competent authorities
, the Office and the Commission







Amendment 363


Proposal for a regulation


Article 23 — paragraph 1








Text proposed by the Commission




Amendment





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 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.




Providers 
and where applicable, deployers
 of high-risk AI systems shall, upon 
a reasoned
 request by a national competent authority 
or where applicable, by the AI Office or the Commission
, provide 
them
 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.





Amendment 364


Proposal for a regulation


Article 23 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 




Upon a reasoned request by a national competent authority or, where applicable, by the Commission, providers and, where applicable, deployers shall also give the requesting national competent authority or the Commission, as applicable, access to the logs automatically generated by the high-risk AI system, to the extent such logs are under their control.







Amendment 365


Proposal for a regulation


Article 23 — paragraph 1 b (new)








Text proposed by the Commission




Amendment





 




Any information obtained by a national competent authority or by the Commission pursuant to the provisions of this Article shall be considered a trade secret and be treated in compliance with the confidentiality obligations set out in Article 70.







Amendment 366


Proposal for a regulation


Article 25 — paragraph 1








Text proposed by the Commission




Amendment






1.   Prior to making their systems available on the Union market
, where an importer cannot be identified
, providers established outside the Union shall, by written mandate, appoint an authorised representative which is established in the Union.




1.   Prior to making their systems available on the Union market, providers established outside the Union shall, by written mandate, appoint an authorised representative which is established in the Union.






Amendment 367


Proposal for a regulation


Article 25 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 





1 a.
   
The authorised representative shall reside or be established in one of the Member States where the activities pursuant to Article 2, paragraphs 1(cb) are taking place.








Amendment 368


Proposal for a regulation


Article 25 — paragraph 1 b (new)








Text proposed by the Commission




Amendment





 





1 b.
   
The provider shall provide its authorised representative with the necessary powers and resources to comply with its tasks under this Regulation.








Amendment 369


Proposal for a regulation


Article 25 — paragraph 2 — introductory part








Text proposed by the Commission




Amendment






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:




2.   The authorised representative shall perform the tasks specified in the mandate received from the provider. 
It shall provide a copy of the mandate to the market surveillance authorities upon request, in one of the official languages of the institution of the Union determined by the national competent authority. For the purpose of this Regulation,
 the mandate shall empower the authorised representative to carry out the following tasks:






Amendment 370


Proposal for a regulation


Article 25 — paragraph 2 — point a








Text proposed by the Commission




Amendment











(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)
;












(a)




ensure that
 the EU declaration of conformity and the technical documentation 
have been drawn up and that an appropriate conformity assessment procedure has been carried out by the provider
;









Amendment 371


Proposal for a regulation


Article 25 — paragraph 2 — point a a (new)








Text proposed by the Commission




Amendment





 










(a a)






keep at the disposal of the national competent authorities and national authorities referred to in Article 63(7), a copy of the EU declaration of conformity, the technical documentation and, if applicable, the certificate issued by the notified body;











Amendment 372


Proposal for a regulation


Article 25 — paragraph 2 — point b








Text proposed by the Commission




Amendment











(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
;












(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;









Amendment 373


Proposal for a regulation


Article 25 — paragraph 2 — point c








Text proposed by the Commission




Amendment











(c)


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












(c)


cooperate with national 
supervisory
 authorities, upon a reasoned request, on any action the 
authority
 takes to 
reduce and mitigate the risks posed by
 the high-risk AI system;









Amendment 374


Proposal for a regulation


Article 25 — paragraph 2 — point c a (new)








Text proposed by the Commission




Amendment





 










(c a)






where applicable, comply with the registration obligations referred in Article 51, or, if the registration is carried out by the provider itself, ensure that the information referred to in point 3 of Annex VIII is correct.











Amendment 375


Proposal for a regulation


Article 25 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
The authorised representative shall be mandated to be addressed, in addition to or instead of the provider, by, in particular, the national supervisory authority or the national competent authorities, on all issues related to ensuring compliance with this Regulation.








Amendment 376


Proposal for a regulation


Article 25 — paragraph 2 b (new)








Text proposed by the Commission




Amendment





 





2 b.
   
The authorised representative shall terminate the mandate if it considers or has reason to consider that the provider acts contrary to its obligations under this Regulation. In such a case, it shall also immediately inform the national supervisory authority of the Member State in which it is established, as well as, where applicable, the relevant notified body, about the termination of the mandate and the reasons thereof.








Amendment 377


Proposal for a regulation


Article 26 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment






1.   Before placing a high-risk AI system on the market, importers of such system shall ensure that:




1.   Before placing a high-risk AI system on the market, importers of such system shall ensure that 
such a system is in conformity with this Regulation by ensuring that
:






Amendment 378


Proposal for a regulation


Article 26 — paragraph 1 — point a








Text proposed by the Commission




Amendment











(a)


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












(a)


the 
relevant
 conformity assessment procedure 
referred to in Article 43
 has been carried out by the provider of that AI system









Amendment 379


Proposal for a regulation


Article 26 — paragraph 1 — point b








Text proposed by the Commission




Amendment











(b)


the provider has drawn up the technical documentation in accordance with Annex IV;












(b)


the provider has drawn up the technical documentation in accordance with 
Article 11 and
 Annex IV;









Amendment 380


Proposal for a regulation


Article 26 — paragraph 1 — point c a (new)








Text proposed by the Commission




Amendment





 










(c a)






where applicable, the provider has appointed an authorised representative in accordance with Article 25(1).











Amendment 381


Proposal for a regulation


Article 26 — paragraph 2








Text proposed by the Commission




Amendment






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.




2.   Where an importer considers or has reason to consider that a high-risk AI system is not in conformity with this Regulation, 
or is counterfeit, or accompanied by falsified documentation
 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.






Amendment 382


Proposal for a regulation


Article 26 — paragraph 3








Text proposed by the Commission




Amendment






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.




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 
and
 on its packaging or its accompanying documentation, 
where
 applicable.






Amendment 383


Proposal for a regulation


Article 26 — paragraph 5








Text proposed by the Commission




Amendment






5.   Importers shall provide national competent authorities, upon a reasoned request, with all necessary information and documentation to demonstrate the conformity of a high-risk AI system with the requirements set out in Chapter 2 of this Title in a language which can be easily understood by 
that national competent authority
, including access to the logs automatically generated by the high-risk AI system to the extent such logs are under the control of the provider 
by virtue of a contractual 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.






5.   Importers shall provide national competent authorities, upon a reasoned request, with all 
the
 necessary information and documentation to demonstrate the conformity of a high-risk AI system with the requirements set out in Chapter 2 of this Title in a language which can be easily understood by 
them
, 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 
in accordance with Article 20
.






Amendment 384


Proposal for a regulation


Article 26 — paragraph 5 a (new)








Text proposed by the Commission




Amendment





 





5 a.
   
Importers shall cooperate with national competent authorities on any action those authorities take to reduce and mitigate the risks posed by the high-risk AI system.








Amendment 385


Proposal for a regulation


Article 27 — paragraph 1








Text proposed by the Commission




Amendment






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




1.   Before making a high-risk AI system available on the market, distributors shall verify that the high-risk AI system bears the required CE conformity marking, that it is accompanied by the required documentation and instruction of use, and that the provider and the importer of the system, as applicable, have complied with 
their
 obligations set out in this Regulation 
in Articles 16 and 26 respectively
.






Amendment 386


Proposal for a regulation


Article 27 — paragraph 2








Text proposed by the Commission




Amendment






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.




2.   Where a distributor considers or has reason to consider
, on the basis of the information in its possession
 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, 
the relevant national competent authority,
 as applicable, to that effect.






Amendment 387


Proposal for a regulation


Article 27 — paragraph 4








Text proposed by the Commission




Amendment






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




4.   A distributor that considers or has reason to consider
, on the basis of the information in its possession,
 that a high-risk AI system which it has made available on the market is not in conformity with the requirements set out in Chapter 2 of this Title shall take the corrective actions necessary to bring that system into conformity with those requirements, to withdraw it or recall it or shall ensure that the provider, the importer or any relevant operator, as appropriate, takes those corrective actions. Where the high-risk AI system presents a risk within the meaning of Article 65(1), the distributor shall immediately inform the 
provider or importer of the system and 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.






Amendment 388


Proposal for a regulation


Article 27 — paragraph 5








Text proposed by the Commission




Amendment






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.






5.   Upon a reasoned request from a national competent authority, distributors of 
the
 high-risk AI system shall provide that authority with all the information and documentation 
in their possession or available to them, in accordance with the obligations of distributors as outlined in paragraph 1, that are
 necessary to demonstrate the conformity of a high-risk system with the requirements set out in Chapter 2 of this Title.






Amendment 389


Proposal for a regulation


Article 27 — paragraph 5 a (new)








Text proposed by the Commission




Amendment





 





5 a.
   
Distributors shall cooperate with national competent authorities on any action those authorities take to reduce and mitigate the risks posed by the high-risk AI system.








Amendment 390


Proposal for a regulation


Article 28 — title








Text proposed by the Commission




Amendment







Obligations of
 distributors, importers, 
users or any
 other 
third-party






Responsibilities along the AI value chain of providers,
 distributors, importers, 
deployers or
 other 
third parties







Amendment 391


Proposal for a regulation


Article 28 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment






1.   Any distributor, importer, 
user
 or other third-party shall be considered a provider for the purposes of this Regulation and shall be subject to the obligations of the provider under Article 16, in any of the following circumstances:




1.   Any distributor, importer, 
deployer
 or other third-party shall be considered a provider 
of a high-risk AI system
 for the purposes of this Regulation and shall be subject to the obligations of the provider under Article 16, in any of the following circumstances:






Amendment 392


Proposal for a regulation


Article 28 — paragraph 1 — point a








Text proposed by the Commission




Amendment











(a)


they 
place
 on the market or put into service 
a high-risk AI system under their name or trademark;














(a)


they 
put their name or trademarkt on a high-risk AI system already placed
 on the market or put into service;









Amendment 393


Proposal for a regulation


Article 28 — paragraph 1 — point b








Text proposed by the Commission




Amendment











(b)


they 
modify the intended purpose of
 a high-risk AI system already placed on the market or put into service;












(b)


they 
make a substantial modification to
 a high-risk AI system 
that has
 already 
been
 placed on the market or 
has already been
 put into service 
and in a way that it remains a high-risk AI system in accordance with Article 6
;









Amendment 394


Proposal for a regulation


Article 28 — paragraph 1 — point b a (new)








Text proposed by the Commission




Amendment





 










(b a)






they make a substantial modification to an AI system, including a general purpose AI system, which has not been classified as high-risk and has already been placed on the market or put into service in such manner that the AI system becomes a high risk AI system in accordance with Article 6











Amendment 395


Proposal for a regulation


Article 28 — paragraph 2








Text proposed by the Commission




Amendment






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.




2.   Where the circumstances referred to in paragraph 1, point 
(a) to (ba)
 occur, the provider that initially placed the AI system on the market or put it into service shall no longer be considered a provider 
of that specific AI system
 for the purposes of this Regulation. 
This former provider shall provide the new provider with the technical documentation and all other relevant and reasonably expected information capabilities of the AI system, technical access or other assistance based on the generally acknowledged state of the art that are required for the fulfilment of the obligations set out in this Regulation.







 




This paragraph shall also apply to providers of foundation models as defined in Article 3 when the foundation model is directly integrated in an high-risk AI system.







Amendment 396


Proposal for a regulation


Article 28 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
The provider of a high risk AI system and the third party that supplies tools, services, components or processes that are used or integrated in the high risk AI system shall, by written agreement specify the information, capabilities, technical access, and or other assistance, based on the generally acknowledged state of the art, that the third party is required to provide in order to enable the provider of the high risk AI system to fully comply with the obligations under this Regulation.







 




The Commission shall develop and recommend non-binding model contractual terms between providers of high-risk AI systems and third parties that supply tools, services, components or processes that are used or integrated in high-risk AI systems in order to assist both parties in drafting and negotiating contracts with balanced contractual rights and obligations, consistent with each party’s level of control. When developing non-binding model contractual terms, the Commission shall take into account possible contractual requirements applicable in specific sectors or business cases. The non-binding contractual terms shall be published and be available free of charge in an easily usable electronic format on the AI Office’s website.







Amendment 397


Proposal for a regulation


Article 28 — paragraph 2 b (new)








Text proposed by the Commission




Amendment





 





2 b.
   
For the purposes of this Article, trade secrets shall be preserved and shall only be disclosed provided that all specific necessary measures pursuant to Directive (EU) 2016/943 are taken in advance to preserve their confidentiality, in particular with respect to third parties. Where necessary, appropriate technical and organizational arrangements can be agreed to protect intellectual property rights or trade secrets.








Amendment 398


Proposal for a regulation


Article 28 a (new)








Text proposed by the Commission




Amendment





 




Article 28 a






 




Unfair contractual terms unilaterally imposed on an SME or startup






 





1.
   
A contractual term concerning the supply of tools, services, components or processes that are used or integrated in a high risk AI system or the remedies for the breach or the termination of related obligations which has been unilaterally imposed by an enterprise on a SME or startup shall not be binding on the latter enterprise if it is unfair.







 





2.
   
A contractual term is not to be considered unfair where it arises from applicable Union law.







 





3.
   
A contractual term is unfair if it is of such a nature that it objectively impairs the ability of the party upon whom the term has been unilaterally imposed to protect its legitimate commercial interest in the information in question or its use grossly deviates from good commercial practice in the supply of tools, services, components or processes that are used or integrated in a high-risk AI system, contrary to good faith and fair dealing or creates a significant imbalance between the rights and the obligations of the parties in the contract. A contractual term is also unfair if it has the effect of shifting penalties referred to in Article 71 or associated litigation costs across parties to the contract, as referred to in Article 71(8).







 





4.
   
A contractual term is unfair for the purposes of this Article if its object or effect is to:







 










(a)






exclude or limit the liability of the party that unilaterally imposed the term for intentional acts or gross negligence;










 










(b)






exclude the remedies available to the party upon whom the term has been unilaterally imposed in the case of non-performance of contractual obligations or the liability of the party that unilaterally imposed the term in the case of a breach of those obligations;










 










(c)






give the party that unilaterally imposed the term the exclusive right to determine whether the technical documentation, information supplied are in conformity with the contract or to interpret any term of the contract.










 





5.
   
A contractual term shall be considered to be unilaterally imposed within the meaning of this Article if it has been supplied by one contracting party and the other contracting party has not been able to influence its content despite an attempt to negotiate it. The contracting party that supplied a contractual term shall bears the burden of proving that that term has not been unilaterally imposed.







 





6.
   
Where the unfair contractual term is severable from the remaining terms of the contract, those remaining terms shall remain binding. The party that supplied the contested term shall not argue that the term is an unfair term.







 





7.
   
This Article shall apply to all new contracts entered into force after … [date of entry into force of this Regulation]. Businesses shall review existing contractual obligations that are subject to this Regulation by …[three years after the date of entry into force of this Regulation].







 





8.
   
Given the rapidity in which innovations occur in the markets, the list of unfair contractual terms within Article 28a shall be reviewed regularly by the Commission and be updated to new business practices if necessary.








Amendment 399


Proposal for a regulation


Article 28 b (new)








Text proposed by the Commission




Amendment





 




Article 28 b






 




Obligations of the provider of a foundation model






 





1.
   
A provider of a foundation model shall, prior to making it available on the market or putting it into service, ensure that it is compliant with the requirements set out in this Article, regardless of whether it is provided as a standalone model or embedded in an AI system or a product, or provided under free and open source licences, as a service, as well as other distribution channels.







 





2.
   
For the purpose of paragraph 1, the provider of a foundation model shall:







 










(a)






demonstrate through appropriate design, testing and analysis the identification, the reduction and mitigation of reasonably foreseeable risks to health, safety, fundamental rights, the environment and democracy and the rule of law prior and throughout development with appropriate methods such as with the involvement of independent experts, as well as the documentation of remaining non-mitigable risks after development










 










(b)






process and incorporate only datasets that are subject to appropriate data governance measures for foundation models, in particular measures to examine the suitability of the data sources and possible biases and appropriate mitigation










 










(c)






design and develop the foundation model in order to achieve throughout its lifecycle appropriate levels of performance, predictability, interpretability, corrigibility, safety and cybersecurity assessed through appropriate methods such as model evaluation with the involvement of independent experts, documented analysis, and extensive testing during conceptualisation, design, and development;










 










(d)






design and develop the foundation model, making use of applicable standards to reduce energy use, resource use and waste, as well as to increase energy efficiency, and the overall efficiency of the system, whithout prejudice to relevant existing Union and national law. This obligation shall not apply before the standards referred to in Article 40 are published. Foundation models shall be designed with capabilities enabling the measurement and logging of the consumption of energy and resources, and, where technically feasible, other environmental impact the deployment and use of the systems may have over their entire lifecycle;










 










(e)






draw up extensive technical documentation and intelligible instructions for use, in order to enable the downstream providers to comply with their obligations pursuant to Articles 16 and 28(1);.










 










(f)






establish a quality management system to ensure and document compliance with this Article, with the possibility to experiment in fulfilling this requirement,










 










(g)






register that foundation model in the EU database referred to in Article 60, in accordance with the instructions outlined in Annex VIII point C.










 




When fulfilling those requirements, the generally acknowledged state of the art shall be taken into account, including as reflected in relevant harmonised standards or common specifications, as well as the latest assessment and measurement methods, reflected in particular in benchmarking guidance and capabilities referred to in Article 58a;






 





3.
   
Providers of foundation models shall, for a period ending 10 years after their foundation models have been placed on the market or put into service, keep the technical documentation referred to in paragraph 2(e) at the disposal of the national competent authorities







 





4.
   
Providers of foundation models used in AI systems specifically intended to generate, with varying levels of autonomy, content such as complex text, images, audio, or video (‘generative AI’) and providers who specialise a foundation model into a generative AI system, shall in addition







 










a)






comply with the transparency obligations outlined in Article 52 (1),










 










b)






train, and where applicable, design and develop the foundation model in such a way as to ensure adequate safeguards against the generation of content in breach of Union law in line with the generally-acknowledged state of the art, and without prejudice to fundamental rights, including the freedom of expression,










 










c)






without prejudice to Union or national or Union legislation on copyright, document and make publicly available a sufficiently detailed summary of the use of training data protected under copyright law.











Amendment 400


Proposal for a regulation


Article 29 — paragraph 1








Text proposed by the Commission




Amendment






1.   
Users
 of high-risk AI systems shall use such systems in accordance with the instructions of use accompanying the systems, pursuant to paragraphs 2 and 5.




1.   
Deployers
 of high-risk AI systems shall 
take appropriate technical and organisational measures to ensure they
 use such systems in accordance with the instructions of use accompanying the systems, pursuant to paragraphs 2 and 5 
of this Article
.






Amendment 401


Proposal for a regulation


Article 29 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 





1 a.
   
To the extent deployers exercise control over the high-risk AI system, they shall







 










i)






implement human oversight according to the requirements laid down in this Regulation










 










(ii)






ensure that the natural persons assigned to ensure human oversight of the high-risk AI systems are competent, properly qualified and trained, and have the necessary resources in order to ensure the effective supervision of the AI system in accordance with Article 14










 










(iii)






ensure that relevant and appropriate robustness and cybersecurity measures are regularly monitored for effectiveness and are regularly adjusted or updated.











Amendment 402


Proposal for a regulation


Article 29 — paragraph 2








Text proposed by the Commission




Amendment






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.




2.   The obligations in paragraph 1 and 
1a,
 are without prejudice to other 
deployer
 obligations under Union or national law and to the 
deployer’s
 discretion in organising its own resources and activities for the purpose of implementing the human oversight measures indicated by the provider.






Amendment 403


Proposal for a regulation


Article 29 — paragraph 3








Text proposed by the Commission




Amendment






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.




3.   Without prejudice to paragraph 1 
and 1a,
 to the extent the 
deployer
 exercises control over the input data, that 
deployer
 shall ensure that input data is relevant 
and sufficiently representative
 in view of the intended purpose of the high-risk AI system.






Amendment 404


Proposal for a regulation


Article 29 — paragraph 4 — introductory part








Text proposed by the Commission




Amendment






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.




4.   
Deployers
 shall monitor the operation of the high-risk AI system on the basis of the instructions of use 
and when relevant, inform providers in accordance with Article 61
. 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
, without undue delay,
 inform the provider or distributor 
and relevant national supervisory authorities
 and suspend the use of the system. They shall also 
immediately
 inform 
first
 the provider
, and then the importer
 or distributor 
and relevant national supervisory authorities
 when they have identified any serious incident or any malfunctioning within the meaning of Article 62 and interrupt the use of the AI system. If the 
deployer
 is not able to reach the provider, Article 62 shall apply mutatis mutandis.






Amendment 405


Proposal for a regulation


Article 29 — paragraph 4 — subparagraph 1








Text proposed by the Commission




Amendment





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.


For 
deployers
 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.





Amendment 406


Proposal for a regulation


Article 29 — paragraph 5 — introductory part








Text proposed by the Commission




Amendment






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
.




5.   
Deployers
 of high-risk AI systems shall keep the logs automatically generated by that high-risk AI system, to the extent 
that
 such logs are under their control 
and are required for ensuring and demonstrating compliance with this Regulation, for ex-post audits of any reasonably foreseeable malfunction, incidents or misuses of the system, or for ensuring and monitoring for the proper functioning of the system throughout its lifecycle
. 
Without prejudice to applicable Union or national law,
 the logs shall be kept for a period 
of at least six months. The retention period shall be in accordance with industry standards and
 appropriate 
to
 the intended purpose of the high-risk AI system.






Amendment 407


Proposal for a regulation


Article 29 — paragraph 5 — subparagraph 1








Text proposed by the Commission




Amendment







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.




Deployers
 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.





Amendment 408


Proposal for a regulation


Article 29 — paragraph 5 a (new)








Text proposed by the Commission




Amendment





 





5 a.
   
Prior to putting into service or use a high-risk AI system at the workplace, deployers shall consult workers representatives with a view to reaching an agreement in accordance with Directive 2002/14/EC and inform the affected employees that they will be subject to the system.








Amendment 409


Proposal for a regulation


Article 29 — paragraph 5 b (new)








Text proposed by the Commission




Amendment





 





5 b.
   
Deployers of high-risk AI systems that are public authorities or Union institutions, bodies, offices and agencies or undertakings referred to in Article 51(1a)(b) shall comply with the registration obligations referred to in Article 51.








Amendment 410


Proposal for a regulation


Article 29 — paragraph 6








Text proposed by the Commission




Amendment






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
.




6.   
Where applicable, deployers
 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, 
a summary of which shall be published, having regard to the specific use and the specific context in which the AI system is intended to operate
. 
Deployers may revert in part to those data protection impact assessments for fulfilling some of the obligations set out in this article, insofar as the data protection impact assesment fulfill those obligations.








Amendment 411


Proposal for a regulation


Article 29 — paragraph 6 a (new)








Text proposed by the Commission




Amendment





 





6 a.
   
Without prejudice to Article 52, deployers of high-risk AI systems referred to in Annex III, which make decisions or assist in making decisions related to natural persons, shall inform the natural persons that they are subject to the use of the high-risk AI system. This information shall include the intended purpose and the type of decisions it makes. The deployer shall also inform the natural person about its right to an explanation referred to in Article 68c.








Amendment 412


Proposal for a regulation


Article 29 — paragraph 6 b (new)








Text proposed by the Commission




Amendment





 





6 b.
   
Deployers shall cooperate with the relevant national competent authorities on any action those authorities take in relation with the high-risk system in order to implement this Regulation.








Amendment 413


Proposal for a regulation


Article 29 a (new)








Text proposed by the Commission




Amendment





 




Article 29 a






 




Fundamental rights impact assessment for high-risk AI systems






 




Prior to putting a high-risk AI system as defined in Article 6(2) into use, with the exception of AI systems intended to be used in area 2 of Annex III, deployers shall conduct an assessment of the systems’ impact in the specific context of use. This assessment shall include, at a minimum, the following elements:






 










(a)






a clear outline of the intended purpose for which the system will be used;










 










(b)






a clear outline of the intended geographic and temporal scope of the system’s use;










 










(c)






categories of natural persons and groups likely to be affected by the use of the system;










 










(d)






verification that the use of the system is compliant with relevant Union and national law on fundamental rights;










 










(e)






the reasonably foreseeable impact on fundamental rights of putting the high-risk AI system into use;










 










(f)






specific risks of harm likely to impact marginalised persons or vulnerable groups;










 










(g)






the reasonably foreseeable adverse impact of the use of the system on the environment;










 










(h)






a detailed plan as to how the harms and the negative impact on fundamental rights identified will be mitigated.










 










(j)






the governance system the deployer will put in place, including human oversight, complaint-handling and redress.










 





2.
   
If a detailed plan to mitigate the risks outlined in the course of the assessment outlined in paragraph 1 cannot be identified, the deployer shall refrain from putting the high-risk AI system into use and inform the provider and the National supervisory authority without undue delay. National supervisory authorities, pursuant to Articles 65 and 67, shall take this information into account when investigating systems which present a risk at national level.







 





3.
   
The obligation outlined under paragraph 1 applies for the first use of the high-risk AI system. The deployer may, in similar cases, draw back on previously conducted fundamental rights impact assessment or existing assessment carried out by providers. If, during the use of the high-risk AI system, the deployer considers that the criteria listed in paragraph 1 are not longer met, it shall conduct a new fundamental rights impact assessment.







 





4.
   
In the course of the impact assessment, the deployer, with the exception of SMEs, shall shall notify national supervisory authority and relevant stakeholders and shall, to best extent possible, involve representatives of the persons or groups of persons that are likely to be affected by the high-risk AI system, as identified in paragraph 1, including but not limited to: equality bodies, consumer protection agencies, social partners and data protection agencies, with a view to receiving input into the impact assessment. The deployer shall allow a period of six weeks for bodies to respond. SMEs may voluntarily apply the provisions laid down in this paragraph.







 




In the case referred to in Article 47(1), public authorities may be exempted from this obligations.






 





5.
   
The deployer that is a public authority or an undertaking referred to in Article 51(1a) (b) shall publish a summary of the results of the impact assessment as part of the registration of use pursuant to their obligation under Article 51(2).







 





6.
   
Where the deployer is already required to carry out a data protection impact assessment under Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the fundamental rights impact assessment referred to in paragraph 1 shall be conducted in conjunction with the data protection impact assessment. The data protection impact assessment shall be published as an addendum.








Amendment 414


Proposal for a regulation


Article 30 — paragraph 1








Text proposed by the Commission




Amendment






1.   Each Member State shall designate or establish a notifying 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.




1.   Each Member State shall designate or establish a notifying 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. 
Those procedures shall be developed in cooperation between the notifying authorities of all Member States.








Amendment 415


Proposal for a regulation


Article 30 — paragraph 7








Text proposed by the Commission




Amendment






7.   Notifying authorities shall have a sufficient number of competent personnel at their disposal for the proper performance of their tasks.




7.   Notifying authorities shall have a sufficient number of competent personnel at their disposal for the proper performance of their tasks. 
Where applicable, competent personnel shall have the necessary expertise, such as a degree in an appropriate legal field, in the supervision of fundamental rights enshrined in the Charter of Fundamental Rights of the European Union.








Amendment 416


Proposal for a regulation


Article 30 — paragraph 8








Text proposed by the Commission




Amendment






8.   Notifying authorities shall make sure that conformity assessments are carried out in a proportionate manner, avoiding unnecessary burdens for providers and that notified bodies perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure and the degree of complexity of the AI system in question.




8.   Notifying authorities shall make sure that conformity assessments are carried out in a proportionate 
and timely
 manner, avoiding unnecessary burdens for providers, and that notified bodies perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure and the degree of complexity of the AI system in question. 
Particular attention shall be paid to minimising administrative burdens and compliance costs for micro and small enterprises as defined in the Annex to Commission Recommendation 2003/361/EC.








Amendment 417


Proposal for a regulation


Article 32 — paragraph 1








Text proposed by the Commission




Amendment






1.   Notifying authorities 
may
 notify only conformity assessment bodies which have satisfied the requirements laid down in Article 33.




1.   Notifying authorities 
shall
 notify only conformity assessment bodies which have satisfied the requirements laid down in Article 33.






Amendment 418


Proposal for a regulation


Article 32 — paragraph 2








Text proposed by the Commission




Amendment






2.   Notifying authorities shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.




2.   Notifying authorities shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission 
of each conformity assessment body referred to in paragraph 1
.






Amendment 419


Proposal for a regulation


Article 32 — paragraph 3








Text proposed by the Commission




Amendment






3.   The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and the artificial intelligence technologies concerned.




3.   The notification 
referred to in paragraph 2
 shall include full details of the conformity assessment activities, the conformity assessment module or modules and the artificial intelligence technologies concerned
, as well as the relevant attestation of competence
.






Amendment 420


Proposal for a regulation


Article 32 — paragraph 4








Text proposed by the Commission




Amendment






4.   The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within one month of a notification.




4.   The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within 
two weeks of the validation of the
 notification 
where it includes an accreditation certificate referred to in Article 31(2), or within two months of the notification where it incudes documentary evidence referred to in Article 31(3
.






Amendment 421


Proposal for a regulation


Article 32 — paragraph 4 a (new)








Text proposed by the Commission




Amendment





 





4 a.
   
Where objections are raised, the Commission shall without delay enter into consultation with the relevant Member States and the conformity assessment body. 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 conformity assessment body.








Amendment 422


Proposal for a regulation


Article 32 — paragraph 4 b (new)








Text proposed by the Commission




Amendment





 





4 b.
   
Member States shall notify the Commission and the other Member States of conformity assessment bodies.








Amendment 423


Proposal for a regulation


Article 33 — paragraph 2








Text proposed by the Commission




Amendment






2.   Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks.




2.   Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks 
as well as the minimum cybersecurity requirements set out for public administration entities identified as operators of essential services pursuant to Directive (EU 2022/2555
.






Amendment 424


Proposal for a regulation


Article 33 — paragraph 4








Text proposed by the Commission




Amendment






4.   Notified bodies shall be independent of the provider of a high-risk AI system in relation to which it performs conformity assessment activities. Notified bodies shall also be independent of any other operator having an economic interest in the high-risk AI system that is assessed, as well as of any competitors of the provider.




4.   Notified bodies shall be independent of the provider of a high-risk AI system in relation to which it performs conformity assessment activities. Notified bodies shall also be independent of any other operator having an economic interest in the high-risk AI system that is assessed, as well as of any competitors of the provider. 
This shall not preclude the use of assessed AI systems that are necessary for the operations of the conformity assessment body or the use of such systems for personal purposes.








Amendment 425


Proposal for a regulation


Article 33 — paragraph 4 a (new)








Text proposed by the Commission




Amendment





 





4 a.
   
A conformity assessment pursuant to paragraph 1 shall be performed by employees of notified bodies who have not provided any other other service related to the matter assessed than the conformity assessment to the provider of a high-risk AI system nor to any legal person connected to that provider in the 12 months’ period before the assessment and have committed to not providing them with such services in the 12 month period following the completion of the assessment.








Amendment 426


Proposal for a regulation


Article 33 — paragraph 6








Text proposed by the Commission




Amendment






6.   Notified bodies shall have documented procedures in place ensuring that their personnel, committees, subsidiaries, subcontractors and any associated body or personnel of external bodies respect the confidentiality of the information which comes into their possession during the performance of conformity assessment activities, except when disclosure is required by law. The staff of notified bodies shall be bound to observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation, except in relation to the notifying authorities of the Member State in which their activities are carried out.




6.   Notified bodies shall have documented procedures in place ensuring that their personnel, committees, subsidiaries, subcontractors and any associated body or personnel of external bodies respect the confidentiality of the information which comes into their possession during the performance of conformity assessment activities, except when disclosure is required by law. The staff of notified bodies shall be bound to observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation, except in relation to the notifying authorities of the Member State in which their activities are carried out. 
Any information and documentation obtained by notified bodies pursuant to the provisions of this Article shall be treated in compliance with the confidentiality obligations set out in Article 70.








Amendment 427


Proposal for a regulation


Article 34 — paragraph 3








Text proposed by the Commission




Amendment






3.   Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider.




3.   Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. 
Notified bodies shall make a list of their subsidiaries publicly available.








Amendment 428


Proposal for a regulation


Article 34 — paragraph 4








Text proposed by the Commission




Amendment






4.   Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the 
assessment
 of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.




4.   Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the 
verification
 of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.






Amendment 429


Proposal for a regulation


Article 35 — title








Text proposed by the Commission




Amendment





Identification numbers and lists of notified bodies 
designated under this Regulation




Identification numbers and lists of notified bodies





Amendment 430


Proposal for a regulation


Article 36 — paragraph 1








Text proposed by the Commission




Amendment






1.   Where a notifying authority has suspicions or has been informed that a notified body no longer meets the requirements laid down in Article 33, or that it is failing to fulfil its obligations, that authority shall without delay investigate the matter with the utmost diligence. In that context, it shall inform the notified body concerned about the objections raised and give it the possibility to make its views known. If the notifying authority comes to the conclusion that the notified body 
investigation
 no longer meets the requirements laid down in Article 33 or that it is failing to fulfil its obligations, it shall restrict, suspend or withdraw the notification as appropriate, depending on the seriousness of the failure. It shall also immediately inform the Commission and the other Member States accordingly.




1.   Where a notifying authority has suspicions or has been informed that a notified body no longer meets the requirements laid down in Article 33, or that it is failing to fulfil its obligations, that authority shall without delay investigate the matter with the utmost diligence. In that context, it shall inform the notified body concerned about the objections raised and give it the possibility to make its views known. If the notifying authority comes to the conclusion that the notified body no longer meets the requirements laid down in Article 33 or that it is failing to fulfil its obligations, it shall restrict, suspend or withdraw the notification as appropriate, depending on the seriousness of the failure. It shall also immediately inform the Commission and the other Member States accordingly.






Amendment 431


Proposal for a regulation


Article 36 — paragraph 2








Text proposed by the Commission




Amendment






2.   In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that notified body are either taken over by another notified body or kept available for the responsible notifying authorities at their request.




2.   In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that notified body are either taken over by another notified body or kept available for the responsible notifying authorities
, and market surveillance authority
 at their request.






Amendment 432


Proposal for a regulation


Article 37 — paragraph 1








Text proposed by the Commission




Amendment






1.   The Commission shall, where necessary, investigate all cases where there are reasons to doubt 
whether
 a notified body 
complies with the
 requirements 
laid down in Article 33
.




1.   The Commission shall, where necessary, investigate all cases where there are reasons to doubt 
the competence of
 a notified body 
or the continued fulfilment by a notified body of the applicable
 requirements 
and responsibilities
.






Amendment 433


Proposal for a regulation


Article 37 — paragraph 2








Text proposed by the Commission




Amendment






2.   The Notifying authority shall provide the Commission, on request, with all relevant information relating to the notification of the notified body concerned.




2.   The Notifying authority shall provide the Commission, on request, with all relevant information relating to the notification 
or the maintenance of the competence
 of the notified body concerned.






Amendment 434


Proposal for a regulation


Article 37 — paragraph 3








Text proposed by the Commission




Amendment






3.   The Commission shall ensure that all 
confidential
 information obtained in the course of its investigations pursuant to this Article is treated confidentially.




3.   The Commission shall ensure that all 
sensitive
 information obtained in the course of its investigations pursuant to this Article is treated confidentially.






Amendment 435


Proposal for a regulation


Article 37 — paragraph 4








Text proposed by the Commission




Amendment






4.   Where the Commission ascertains that a notified body does not meet or no longer meets the requirements 
laid down in Article 33
, it shall 
adopt a reasoned decision requesting
 the notifying Member State to take the necessary corrective measures, including withdrawal of notification if necessary. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 74(2).




4.   Where the Commission ascertains that a notified body does not meet or no longer meets the requirements 
for its notification
, it shall 
inform
 the notifying Member State 
accordingly and request it
 to take the necessary corrective measures, including 
suspension or
 withdrawal of 
the
 notification if necessary. 
Where the Member State fails to take the necessary corrective measures, the Commission may, by means of an implementing act, suspend, restrict or withdraw the designation.
 That implementing act shall be adopted in accordance with the examination procedure referred to in Article 74(2).






Amendment 436


Proposal for a regulation


Article 38 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
The Commission shall provide for the exchange of knowledge and best practices between the Member States' national authorities responsible for notification policy.








Amendment 437


Proposal for a regulation


Article 40 — paragraph 1








Text proposed by the Commission




Amendment





High-risk AI systems which are in conformity with harmonised standards or parts thereof the references 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 the extent those standards cover those requirements.


High-risk AI systems 
and foundation models
 which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union 
in accordance with Regulation (EU) 1025/2012
 shall be presumed to be in conformity with the requirements set out in Chapter 2 of this Title 
or Article 28b
, to the extent those standards cover those requirements.





Amendment 438


Proposal for a regulation


Article 40 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 




The Commission shall issue standardisation requests covering all requirements of this Regulation, in accordance with Article 10 of Regulation EU (No)1025/2012 by… [two months after the date of entry into force of this Regulation]. When preparing standardisation request, the Commission shall consult the AI Office and the Advisory Forum;







Amendment 439


Proposal for a regulation


Article 40 — paragraph 1 b (new)








Text proposed by the Commission




Amendment





 




When issuing a standardisation request to European standardisation organisations, the Commission shall specify that standards have to be consistent, including with the sectorial law listed in Annex II, and aimed at ensuring that AI systems or foundation models placed on the market or put into service in the Union meet the relevant requirements laid down in this Regulation;







Amendment 440


Proposal for a regulation


Article 40 — paragraph 1 c (new)








Text proposed by the Commission




Amendment





 




The actors involved in the standardisation process shall take into account the general principles for trustworthy AI set out in Article 4(a), seek to promote investment and innovation in AI as well as competitiveness and growth of the Union market, and contribute to strengthening global cooperation on standardisation and taking into account existing international standards in the field of AI that are consistent with Union values, fundamental rights and interests, and ensure a balanced representation of interests and effective participation of all relevant stakeholders in accordance with Articles 5, 6, and 7 of Regulation (EU) No 1025/2012







Amendment 441


Proposal for a regulation


Article 41 — paragraph 1








Text proposed by the Commission




Amendment








1.
   
Where harmonised standards referred to in Article 40 do not exist or where the Commission 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, by means of implementing acts, adopt common specifications in respect of the requirements set out in Chapter 2 of this Title. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2).







deleted







Amendment 442


Proposal for a regulation


Article 41 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 





1 a.
   
The Commission may, by means of implementing act adopted in accordance with the examination procedure referred to in Article 74(2) and after consulting the AI Office and the AI Advisory Forum, adopt common specifications in respect of the requirements set out in Chapter 2 of this Title or Article 28b wherein all of the following conditions are fulfilled:







 










(a)






there is no reference to harmonised standards already published in the Official Journal of the European Union related to the essential requirement(s), unless the harmonised standard in question is an existing standard that must be revised;










 










(b)






the Commission has requested one or more European standardisation organisations to draft a harmonised standard for the essential requirement(s) set out in Chapter 2;










 










(c)






the request referred to in point (b) has not been accepted by any of the European standardisation organisations; or there are undue delays in the establishment of an appropriate harmonised standard; or the standard provided does not satisfy the requirements of the relevant Union law, or does not comply with the request of the Commission.











Amendment 443


Proposal for a regulation


Article 41 — paragraph 1 b (new)








Text proposed by the Commission




Amendment





 





1 b.
   
Where the Commission considers there to be a need to address specific fundamental rights concerns, common specifications adopted by the Commission in accordance with paragraph 1a shall also address those specific fundamental rights concerns.








Amendment 444


Proposal for a regulation


Article 41 — paragraph 1 c (new)








Text proposed by the Commission




Amendment





 





1 c.
   
The Commission shall develop common specifications for the methodology to fulfil the reporting and documentation requirement on the consumption of energy and resources during development, training and deployment of the high risk AI system.








Amendment 445


Proposal for a regulation


Article 41 — paragraph 2








Text proposed by the Commission




Amendment






2.   The Commission, 
when preparing
 the common specifications referred to in 
paragraph 1
, shall 
gather the views of
 relevant bodies or expert groups established under relevant sectorial Union law.




2.   The Commission 
shall, throughout the whole process of drafting
 the common specifications referred to in 
paragraphs 1a and 1b
, 
regularly consult the AI Office and the Advisory Forum, the European standardisation organisations and bodies or expert groups established under
 relevant 
sectorial Union law as well as other relevant stakeholders. The Commission shall fulfil the objectives referred to in Article 40 (1c) and duly justify why it decided to resort to common specifications.







 




Where the Commission intends to adopt common specifications pursuant to paragraph 1a of this Article, it shall also clearly identify the specific fundamental rights concern to be addressed.






 




When adopting common specifications pursuant to paragraphs 1a and 1b of this Article, the Commission shall take into account the opinion issued by the AI Office referred to in Article 56e(b) of this Regulation. Where the Commission decides not to follow the opinion of the AI Office, it shall provide a reasoned explanation to the AI Office.







Amendment 446


Proposal for a regulation


Article 41 — paragraph 3








Text proposed by the Commission




Amendment






3.   High-risk AI systems which are in conformity with the common specifications referred to in 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 those requirements.




3.   High-risk AI systems which are in conformity with the common specifications referred to in paragraph 
1a and 1b
 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 those requirements






Amendment 447


Proposal for a regulation


Article 41 — paragraph 3 a (new)








Text proposed by the Commission




Amendment





 





3 a.
   
Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the publication of its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal acts referred to in paragraph 1 and 1b, or parts thereof which cover the same requirements set out in Chapter 2 of this Title.








Amendment 448


Proposal for a regulation


Article 41 — paragraph 4








Text proposed by the Commission




Amendment






4.   Where providers do not comply with the common specifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that 
are
 at least equivalent thereto.




4.   Where providers 
of high-risk AI systems
 do not comply with the common specifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that 
meet the requirements referred to in Chapter II to a level
 at least equivalent thereto;






Amendment 449


Proposal for a regulation


Article 42 — paragraph 1








Text proposed by the Commission




Amendment






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




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






Amendment 450


Proposal for a regulation


Article 43 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment






1.   For high-risk AI systems listed in point 1 of Annex III, 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 applied harmonised standards referred to in Article 40, or, where applicable, common specifications referred to in Article 41, the provider shall 
follow
 one of the following procedures:




1.   For high-risk AI systems listed in point 1 of Annex III, 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 applied harmonised standards referred to in Article 40, or, where applicable, common specifications referred to in Article 41, the provider shall 
opt for
 one of the following procedures;






Amendment 451


Proposal for a regulation


Article 43 — paragraph 1 — point a








Text proposed by the Commission




Amendment











(a)


the conformity assessment procedure based on internal control referred to in Annex VI;












(a)


the conformity assessment procedure based on internal control referred to in Annex VI; 
or











Amendment 452


Proposal for a regulation


Article 43 — paragraph 1 — point b








Text proposed by the Commission




Amendment











(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.












(b)


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









Amendment 453


Proposal for a regulation


Article 43 — paragraph 1 — subparagraph 1








Text proposed by the Commission




Amendment







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 not exist and common specifications referred to in Article 41 are not available, the provider 
shall follow the conformity assessment procedure set out in Annex VII
.


In demonstrating the compliance of a high-risk AI system with the requirements set out in Chapter 2 of this Title, the provider 
shall follow the conformity assessment procedure set out in Annex VII in the following cases:






 










(a)






where
 harmonised standards referred to in Article 40, 
the reference number of which has been published in the Official Journal of the European Union, covering all relevant safety requirements for the AI system,
 do not exist and common specifications referred to in Article 41 are not available;








 










(b)






where the technical specifications referred to in point (a) exist but
 the provider 
has not applied them or has applied them only in part;










 










(c)






where one or more of the technical specifications referred to in point (a) has been published with a restriction and only on the part of the standard that was restricted;










 










(d)






when the provider considers that the nature, design, construction or purpose of the AI system necessitate third party verification, regardless of its risk level
.









Amendment 454


Proposal for a regulation


Article 43 — paragraph 1 — subparagraph 2








Text proposed by the Commission




Amendment





For the purpose of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the notified bodies. However, when the system is intended to be 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.


For the purpose of 
carrying out
 the conformity assessment procedure referred to in Annex VII, the provider may choose any of the notified bodies. However, when the system is intended to be 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.





Amendment 455


Proposal for a regulation


Article 43 — paragraph 4 — introductory part








Text proposed by the Commission




Amendment






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 be further distributed or continues to be used by the current 
user.






4.   High-risk AI systems 
that have already been subject to a conformity assessment procedure
 shall undergo a new conformity assessment procedure whenever they are substantially modified, regardless of whether the modified system is intended to be further distributed or continues to be used by the current 
deployer;








Amendment 456


Proposal for a regulation


Article 43 — paragraph 4 a (new)








Text proposed by the Commission




Amendment





 





4 a.
   
The specific interests and needs of SMEs shall be taken into account when setting the fees for third-party conformity assessment under this Article, reducing those fees proportionately to their size and market share;








Amendment 457


Proposal for a regulation


Article 43 — paragraph 5








Text proposed by the Commission




Amendment






5.   The Commission is empowered 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.




5.   The Commission is empowered 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. 
When preparing such delegated acts, the Commission shall consult the AI Office and the stakeholders affected;








Amendment 458


Proposal for a regulation


Article 43 — paragraph 6








Text proposed by the Commission




Amendment






6.   The Commission is empowered to adopt delegated acts to amend paragraphs 1 and 2 in order to subject high-risk 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 such delegated 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.




6.   The Commission is empowered to adopt delegated acts to amend paragraphs 1 and 2 in order to subject high-risk 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 such delegated 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. 
When preparing such delegated acts, the Commission shall consult the AI Office and the stakeholders affected;








Amendment 459


Proposal for a regulation


Article 44 — paragraph 1








Text proposed by the Commission




Amendment






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 is established or in 
an
 official Union 
language
 otherwise acceptable to the notified body.




1.   Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in 
one or several
 official Union 
languages
 determined by the Member State in which the notified body is established or in 
one or several
 official Union 
languages
 otherwise acceptable to the notified body;






Amendment 460


Proposal for a regulation


Article 44 — paragraph 2








Text proposed by the Commission




Amendment






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 the applicable conformity assessment procedures.




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






Amendment 461


Proposal for a regulation


Article 44 — paragraph 3








Text proposed by the Commission




Amendment






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 with those requirements is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The notified body shall give reasons for its decision.




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 suspend or withdraw the certificate issued or impose any restrictions on it, unless compliance with those requirements is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The notified body shall give reasons for its decision.






Amendment 462


Proposal for a regulation


Article 45 — paragraph 1








Text proposed by the Commission




Amendment





Member States shall ensure that an appeal procedure against decisions of the notified bodies is available to parties having a legitimate interest in that decision.


Member States shall ensure that an appeal procedure against decisions of the notified bodies
, including on issued conformity certificates
 is available to parties having a legitimate interest in that decision.





Amendment 463


Proposal for a regulation


Article 46 — paragraph 3








Text proposed by the Commission




Amendment






3.   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.




3.   Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities with relevant information on issues relating to negative and, on request, positive conformity assessment results.






Amendment 464


Proposal for a regulation


Article 47 — paragraph 1








Text proposed by the Commission




Amendment






1.   By way of derogation from Article 43, any 
market surveillance
 authority may authorise the placing 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
 the protection 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 shall terminate once those procedures have been completed. The completion of those procedures shall be undertaken without undue delay.




1.   By way of derogation from Article 43, any 
national supervisory
 authority may 
request a judicial authority to
 authorise the placing 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 the protection of life and health of persons, environmental protection and the protection of 
critical infrastructure
. That authorisation shall be for a limited period of time, while the necessary conformity assessment procedures are being carried out, and shall terminate once those procedures have been completed. The completion of those procedures shall be undertaken without undue delay;






Amendment 465


Proposal for a regulation


Article 47 — paragraph 2








Text proposed by the Commission




Amendment






2.   The authorisation referred to in paragraph 1 shall be issued only if the 
market surveillance
 authority 
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 the other Member States of any authorisation issued pursuant to paragraph 1.




2.   The authorisation referred to in paragraph 1 shall be issued only if the 
national supervisory
 authority 
and judicial authority conclude
 that the high-risk AI system complies with the requirements of Chapter 2 of this Title. The 
national supervisory
 authority shall inform the Commission
, the AI office,
 and the other Member States of any 
request made and any subsequent
 authorisation issued pursuant to paragraph 1;






Amendment 466


Proposal for a regulation


Article 47 — paragraph 3








Text proposed by the Commission




Amendment






3.   Where, within 15 calendar days of receipt of the information referred to in paragraph 2, no objection 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 accordance with paragraph 1, that authorisation shall be deemed justified.




3.   Where, within 15 calendar days of receipt of the information referred to in paragraph 2, no objection has been raised by either a Member State or the Commission in respect 
to the request of the national supervisory authority for
 an authorisation issued by a 
national supervisory
 authority of a Member State in accordance with paragraph 1, that authorisation shall be deemed justified;






Amendment 467


Proposal for a regulation


Article 47 — paragraph 4








Text proposed by the Commission




Amendment






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 the authorisation 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, the Commission 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.






4.   Where, within 15 calendar days of receipt of the notification referred to in paragraph 2, objections are raised by a Member State against 
a request
 issued by a 
national supervisory
 authority of another Member State, or where the Commission considers the authorisation 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, the Commission shall without delay enter into consultation with the relevant Member State 
and the AI Office
; 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
(s);








Amendment 468


Proposal for a regulation


Article 47 — paragraph 5








Text proposed by the Commission




Amendment






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




5.   If the authorisation is considered unjustified, this shall be withdrawn by the 
national supervisory
 authority of the Member State concerned;






Amendment 469


Proposal for a regulation


Article 48 — paragraph 1








Text proposed by the Commission




Amendment






1.   The provider shall draw up a written EU declaration of conformity for each AI system and keep it at the disposal of the national competent authorities 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 to
 the relevant national competent authorities upon request.




1.   The provider shall draw up a written 
machine readable, physical or electronic
 EU declaration of conformity for each 
high-risk
 AI system and keep it at the disposal of 
the national supervisory authority and
 the national competent authorities for 10 years after the AI 
high-risk
 system has been placed on the market or put into service. A copy of the EU declaration of conformity shall be 
submitted to the national supervisory authority and
 the relevant national competent authorities upon request;






Amendment 470


Proposal for a regulation


Article 48 — paragraph 2








Text proposed by the Commission




Amendment






2.   The EU declaration of conformity shall state that the high-risk AI system in question meets the requirements set out in Chapter 2 of this Title. The EU declaration of conformity shall contain 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 is made available.




2.   The EU declaration of conformity shall state that the high-risk AI system in question meets the requirements set out in Chapter 2 of this Title. The EU declaration of conformity shall contain 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 is 
placed on the market or
 made available;






Amendment 471


Proposal for a regulation


Article 48 — paragraph 3








Text proposed by the Commission




Amendment






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 
shall
 be 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.




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 
may
 be 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.






Amendment 472


Proposal for a regulation


Article 48 — paragraph 5








Text proposed by the Commission




Amendment






5.   The Commission shall be empowered 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 to introduce elements that become necessary in light of technical progress.




5.   
After consulting the AI Office,
 the Commission shall be empowered 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 to introduce elements that become necessary in light of technical progress;






Amendment 473


Proposal for a regulation


Article 49 — paragraph 1








Text proposed by the Commission




Amendment






1.   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.




1.   The 
physical
 CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems 
before the high-risk AI system is placed on the market
 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. 
It may be followed by a pictogram or any other marking indicating a special risk of use;








Amendment 474


Proposal for a regulation


Article 49 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 





1 a.
   
For digital only high-risk AI systems, a digital CE marking shall be used, only if it can be easily accessed via the interface from which the AI system is accessed or via an easily accessible machine-readable code or other electronic means.








Amendment 475


Proposal for a regulation


Article 49 — paragraph 3








Text proposed by the Commission




Amendment






3.   Where applicable, the CE marking shall be followed by the identification number of the notified 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.




3.   Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 43. The identification number 
of the notified body shall be affixed by the body itself or, under its instructions, by the provider’s authorised representative. 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;






Amendment 476


Proposal for a regulation


Article 49 — paragraph 3 a (new)








Text proposed by the Commission




Amendment





 





3 a.
   
Where high-risk AI systems are subject to other Union law which also provides for the affixing of the CE marking, the CE marking shall indicate that the high-risk AI system also fulfil the requirements of that other law.








Amendment 477


Proposal for a regulation


Article 50 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment





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:


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 
supervisory authority and the national
 competent authorities:





Amendment 478


Proposal for a regulation


Article 51 — paragraph 1








Text proposed by the Commission




Amendment





Before placing on the market or putting into service a high-risk AI system referred to in Article 6(2), the provider or, where applicable, the authorised representative shall register that system in the EU database referred to in Article 60.


Before placing on the market or putting into service a high-risk AI system referred to in Article 6(2) the provider or, where applicable, the authorised representative shall register that system in the EU database referred to in Article 60
, in accordance with Article 60(2);







Amendment 479


Proposal for a regulation


Article 51 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 




Before putting into service or using a high-risk AI system in accordance with Article 6(2), the following categories of deployers shall register the use of that AI system in the EU database referred to in Article 60:






 










a)






deployers who are public authorities or Union institutions, bodies, offices or agencies or deployers acting on their behalf;










 










b)






deployers who are undertakings designated as a gatekeeper under Regulation (EU) 2022/1925.











Amendment 480


Proposal for a regulation


Article 51 — paragraph 1 b (new)








Text proposed by the Commission




Amendment





 




Deployers who do not fall under subparagraph 1a. shall be entitled to voluntarily register the use of a high-risk AI system referred to in Article 6(2) in the EU database referred to in Article 60.







Amendment 481


Proposal for a regulation


Article 51 — paragraph 1 c (new)








Text proposed by the Commission




Amendment





 




An updated registration entry must be completed immediately following each substantial modification.







Amendment 482


Proposal for a regulation


Title IV








Text proposed by the Commission




Amendment





TRANSPARENCY OBLIGATIONS 
FOR CERTAIN AI SYSTEMS




TRANSPARENCY OBLIGATIONS





Amendment 483


Proposal for a regulation


Article 52 — title








Text proposed by the Commission




Amendment





Transparency obligations 
for certain AI systems




Transparency obligations





Amendment 484


Proposal for a regulation


Article 52 — paragraph 1








Text proposed by the Commission




Amendment






1.   Providers shall ensure that AI systems intended to interact with natural persons are designed and developed in such a way that natural 
persons are informed
 that they are interacting with an AI system, unless this is obvious from the circumstances and the context of use. 
This obligation
 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 report a criminal offence.




1.   Providers shall ensure that AI systems intended to interact with natural persons are designed and developed in such a way that 
the AI system, the provider itself or the user informs the
 natural 
person exposed to an AI system
 that they are interacting with an AI system 
in a timely, clear and intelligible manner
, unless this is obvious from the circumstances and the context of use.





 




Where appropriate and relevant, this information
 shall 
also include which functions are AI enabled, if there is human oversight, and who is responsible for the decision-making process, as well as the existing rights and processes that, according to Union and national law, allow natural persons or their representatives to object against the application of such systems to them and to seek judicial redress against decisions taken by or harm caused by AI systems, including their right to seek an explanation. This obligation 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 report a criminal offence.





Amendment 485


Proposal for a regulation


Article 52 — paragraph 2








Text proposed by the Commission




Amendment






2.   Users of an emotion recognition system or a biometric categorisation system shall inform of 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 to detect, prevent and investigate criminal offences.




2.   Users of an emotion recognition system or a biometric categorisation system 
which is not prohibited pursuant to Article 5
 shall inform 
in a timely, clear and intelligible manner
 of the operation of the system the natural persons exposed thereto 
and obtain their consent prior to the processing of their biometric and other personal data in accordance with Regulation (EU) 2016/679, Regulation (EU) 2016/1725 and Directive (EU) 2016/280, as applicable
. This obligation shall not apply to AI systems used for biometric categorisation, which are permitted by law to detect, prevent and investigate criminal offences.






Amendment 486


Proposal for a regulation


Article 52 — paragraph 3 — subparagraph 1








Text proposed by the Commission




Amendment






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 and
 would falsely appear 
to a person
 to be authentic or truthful (‘deep fake’), shall disclose that the content has been artificially generated or manipulated.




3.   Users of an AI system that generates or manipulates 
text
, audio or 
visual
 content that would falsely appear to be authentic or truthful 
and which features depictions of people appearing to say or do things they did not say or do, without their consent
 (‘deep fake’), shall disclose 
in an appropriate, timely, clear and visible manner
 that the content has been artificially generated or manipulated
, as well as, whenever possible, the name of the natural or legal person that generated or manipulated it
. 
Disclosure shall mean labelling the content in a way that informs that the content is inauthentic and that is clearly visible for the recipient of that content. To label the content, users shall take into account the generally acknowledged state of the art and relevant harmonised standards and specifications.








Amendment 487


Proposal for a regulation


Article 52 — paragraph 3 — subparagraph 2








Text proposed by the Commission




Amendment







However, the first subparagraph
 shall not apply where the use is authorised by law 
to detect, 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 and sciences guaranteed in the Charter of Fundamental Rights of the EU, and subject to appropriate safeguards for the rights and freedoms of third parties.





3a.
   
Paragraph 3
 shall not apply where the use 
of an AI system that generates or manipulates text, audio or visual content
 is authorized by law or 
if
 it is necessary for the exercise of the right to freedom of expression and the right to freedom of the arts and sciences guaranteed in the Charter of Fundamental Rights of the EU, and subject to appropriate safeguards for the rights and freedoms of third parties. 
Where the content forms part of an evidently creative, satirical, artistic or fictional cinematographic, video games visuals and analogous work or programme, transparency obligations set out in paragraph 3 are limited to disclosing of the existence of such generated or manipulated content in an appropriate clear and visible manner that does not hamper the display of the work and disclosing the applicable copyrights, where relevant. It shall also not prevent law enforcement authorities from using AI systems intended to detect deep fakes and prevent, investigate and prosecute criminal offences linked with their use








Amendment 488


Proposal for a regulation


Article 52 — paragraph 3 b (new)








Text proposed by the Commission




Amendment





 





3b.
   
The information referred to in paragraphs 1 to 3 shall be provided to the natural persons at the latest at the time of the first interaction or exposure. It shall be accessible to vulnerable persons, such as persons with disabilities or children, complete, where relevant and appropriate, with intervention or flagging procedures for the exposed natural person taking into account the generally acknowledged state of the art and relevant harmonised standards and common specifications.








Amendment 489


Proposal for a regulation


Article 53 — paragraph 1








Text proposed by the Commission




Amendment






1.   AI regulatory 
sandboxes established by one or more Member States competent authorities or the European Data Protection Supervisor
 shall 
provide a controlled environment that facilitates the development, testing and validation of innovative AI systems for a limited time before their placement
 on the 
market or putting into service pursuant to a specific plan. This shall take place under the direct supervision and guidance by the competent authorities with a view to ensuring compliance with the requirements
 of this Regulation 
and, where relevant,
 other 
Union and
 Member States 
legislation supervised within the sandbox.






1.   
Member States shall establish at least one
 AI regulatory 
sandbox at national level, which
 shall 
be operational at the latest
 on the 
day of the entry into application
 of this Regulation 
This sandbox can also be established jointly with one or several
 other Member States;






Amendment 490


Proposal for a regulation


Article 53 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 





1 a.
   
Additional AI regulatory sandboxes at regional or local levels or jointly with other Member States may also be established;








Amendment 491


Proposal for a regulation


Article 53 — paragraph 1 b (new)








Text proposed by the Commission




Amendment





 





1 b.
   
The Commission and the European Data Protection Supervisor, on their own, jointly or in collaboration with one or more Member States may also establish AI regulatory sandboxes at Union level;








Amendment 492


Proposal for a regulation


Article 53 — paragraph 1 c (new)








Text proposed by the Commission




Amendment





 





1 c.
   
Establishing authorities shall allocate sufficient resources to comply with this Article effectively and in a timely manner;








Amendment 493


Proposal for a regulation


Article 53 — paragraph 1 d (new)








Text proposed by the Commission




Amendment





 





1 d.
   
AI regulatory sandboxes shall, in accordance with criteria set out in Article 53a, provide for a controlled environment that fosters innovation and facilitates the development, testing and validation of innovative AI systems for a limited time before their placement on the market or putting into service pursuant to a specific plan agreed between the prospective providers and the establishing authority;








Amendment 494


Proposal for a regulation


Article 53 — paragraph 1 e (new)








Text proposed by the Commission




Amendment





 





1 e.
   
The establishment of AI regulatory sandboxes shall aim to contribute to the following objectives:







 










a)






for the competent authorities to provide guidance to AI systems prospective providers providers to achieve regulatory compliance with this Regulation or where relevant other applicable Union and Member States legislation;










 










b)






for the prospective providers to allow and facilitate the testing and development of innovative solutions related to AI systems;










 










c)






regulatory learning in a controlled environment.











Amendment 495


Proposal for a regulation


Article 53 — paragraph 1 f (new)








Text proposed by the Commission




Amendment





 





1 f.
   
Establishing authorities shall provide guidance and supervision within the sandbox with a view to identify risks, in particular to fundamental rights, democracy and rule of law, health and safety and the environment, test and demonstrate mitigation measures for identified risks, and their effectiveness and ensure compliance with the requirements of this Regulation and, where relevant, other Union and Member States legislation;








Amendment 496


Proposal for a regulation


Article 53 — paragraph 1 f (new)








Text proposed by the Commission




Amendment





 





1 g.
   
Establishing authorities shall provide sandbox prospective providers who develop high-risk AI systems with guidance and supervision on how to fulfil the requirements set out in this Regulation, so that the AI systems may exit the sandbox being in presumption of conformity with the specific requirements of this Regulation that were assessed within the sandbox. Insofar as the AI system complies with the requirements when exiting the sandbox, it shall be presumed to be in conformity with this regulation. In this regard, the exit reports created by the establishing authority shall be taken into account by market surveillance authorities or notified bodies, as applicable, in the context of conformity assessment procedures or market surveillance checks;








Amendment 497


Proposal for a regulation


Article 53 — paragraph 2








Text proposed by the Commission




Amendment






2.   
Member States
 shall ensure that to the extent the innovative AI systems involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the national data protection authorities and those other national authorities are associated to the operation of the AI regulatory sandbox.




2.   
Establishing authorities
 shall ensure that, to the extent the innovative AI systems involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to 
personal
 data, the national data protection authorities
, or in cases referred to in paragraph 1b the EDPS,
 and those other national authorities are associated to the operation of the AI regulatory sandbox 
and involved in the supervision of those aspects to the full extent of their respective tasks and powers;








Amendment 498


Proposal for a regulation


Article 53 — paragraph 3








Text proposed by the Commission




Amendment






3.   The AI regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. Any significant risks to 
health and safety and
 fundamental rights identified during the development and testing of such systems shall result in immediate mitigation 
and, failing that, in the suspension of the development and
 testing process 
until such
 mitigation 
takes place.






3.   The AI regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities
, including at regional or local level
. Any significant risks to fundamental rights
, democracy and rule of law, health and safety or the environment
 identified during the development and testing of such 
AI
 systems shall result in immediate 
and adequate
 mitigation
. Competent authorities shall have the power to temporarily or permanently suspend the
 testing process
, or participation in the sandbox if no effective
 mitigation 
is possible and inform the AI office of such decision;








Amendment 499


Proposal for a regulation


Article 53 — paragraph 4








Text proposed by the Commission




Amendment






4.   
Participants
 in the AI regulatory sandbox shall remain liable under applicable Union and Member States liability legislation for any harm inflicted on third parties as a result 
from
 the experimentation taking place in the sandbox.




4.   
Prospective providers
 in the AI regulatory sandbox shall remain liable under applicable Union and Member States liability legislation for any harm inflicted on third parties as a result 
of
 the experimentation taking place in the sandbox. 
However, provided that the prospective provider(s) respect the specific plan referred to in paragraph 1c and the terms and conditions for their participation and follow in good faith the guidance given by the establishing authorities, no administrative fines shall be imposed by the authorities for infringements of this Regulation;








Amendment 500


Proposal for a regulation


Article 53 — paragraph 5








Text proposed by the Commission




Amendment






5.   
Member States’ competent
 authorities 
that have established AI regulatory sandboxes
 shall coordinate their activities and cooperate within the framework of the 
European Artificial Intelligence Board. They shall submit annual reports to the Board and the Commission on the results from the implementation of those scheme, including good practices, lessons learnt and recommendations on their setup and, where relevant, on the application of this Regulation and other Union legislation supervised within the sandbox.






5.   
Establishing
 authorities shall coordinate their activities and cooperate within the framework of the 
AI office;








Amendment 501


Proposal for a regulation


Article 53 — paragraph 5 a (new)








Text proposed by the Commission




Amendment





 





5 a.
   
Establishing authorities shall inform the AI Office of the establishment of a sandbox and may ask for support and guidance. A list of planned and existing sandboxes shall be made publicly available by the AI office and kept up to date in order to encourage more interaction in the regulatory sandboxes and transnational cooperation;








Amendment 502


Proposal for a regulation


Article 53 — paragraph 5 b (new)








Text proposed by the Commission




Amendment





 





5 b.
   
Establishing authorities shall submit to the AI office and, unless the Commission is the sole establishing authority, to the Commission, annual reports, starting one year after the establishment of the sandbox and then every year until its termination and a final report. Those reports shall provide information on the progress and results of the implementation of those sandboxes, including best practices, incidents, lessons learnt and recommendations on their setup and, where relevant, on the application and possible revision of this Regulation and other Union law supervised within the sandbox. Those annual reports or abstracts thereof shall be made available to the public, online;








Amendment 503


Proposal for a regulation


Article 53 — paragraph 6








Text proposed by the Commission




Amendment






6.   The 
modalities and the conditions of the operation of the AI
 regulatory sandboxes
, including the eligibility criteria and the procedure for the application, selection, participation and exiting from the sandbox, and the rights and obligations of the participants
 shall 
be set out in implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2).






6.   The 
Commission shall develop a single and dedicated interface containing all relevant information related to sandboxes, together with a single contact point at Union level to interact with the
 regulatory sandboxes 
and to allow stakeholders to raise enquiries with competent authorities, and to seek non-binding guidance on the conformity of innovative products, services, business models embedding AI technologies;







 




The Commission
 shall 
proactively coordinate with national, regional and also local authorities, where relevant;







Amendment 504


Proposal for a regulation


Article 53 — paragraph 6 a (new)








Text proposed by the Commission




Amendment





 





6 a.
   
For the purpose of paragraph 1 and 1a, the Commission shall play a complementary role, enabling Member States to build on their expertise and, on the other hand, assisting and providing technical understanding and resources to those Member States that seek guidance on the set-up and running of these regulatory sandboxes;








Amendment 505


Proposal for a regulation


Article 53 a (new)








Text proposed by the Commission




Amendment





 




Article 53 a






 




Modalities and functioning of AI regulatory sandboxes






 





1.
   
In order to avoid fragmentation across the Union, the Commission, in consultation with the AI office, shall adopt a delegated act detailing the modalities for the establishment, development, implementation, functioning and supervision of the AI regulatory sandboxes, including the eligibility criteria and the procedure for the application, selection, participation and exiting from the sandbox, and the rights and obligations of the participants based on the provisions set out in this Article;







 





2.
   
The Commission is empowered to adopt delegated acts in accordance with the procedure referred to in Article 73, no later than 12 months following the entry into force of this Regulation and shall ensure that:







 










a)






regulatory sandboxes are open to any applying prospective provider of an AI system who fulfils eligibility and selection criteria. The criteria for accessing to the regulatory sandbox are transparent and fair and establishing authorities inform applicants of their decision within 3 months of the application;










 










b)






regulatory sandboxes allow broad and equal access and keep up with demand for participation;










 










c)






access to the AI regulatory sandboxes is free of charge for SMEs and start-ups without prejudice to exceptional costs that establishing authorities may recover in a fair and proportionate manner;










 










d)






regulatory sandboxes facilitate the involvement of other relevant actors within the AI ecosystem, such as notified bodies and standardisation organisations (SMEs, start-ups, enterprises, innovators, testing and experimentation facilities, research and experimentation labs and digital innovation hubs, centers of excellence, individual researchers), in order to allow and facilitate cooperation with the public and private sector;










 










e)






they allow prospective providers to to fulfil, in a controlled environment, the conformity assessment obligations of this Regulation or the voluntary application of the codes of conduct referred to in Article 69;










 










f)






procedures, processes and administrative requirements for application, selection, participation and exiting the sandbox are simple, easily intelligible, clearly communicated in order to facilitate the participation of SMEs and start-ups with limited legal and administrative capacities and are streamlined across the Union, in order to avoid fragmentation and that participation in a regulatory sandbox established by a Member State, by the Commission, or by the EDPS is mutually and uniformly recognised and carries the same legal effects across the Union;










 










g)






participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of the project.










 










h)






the sandboxes shall facilitate the development of tools and infrastructure for testing, benchmarking, assessing and explaining dimensions of AI systems relevant to sandboxes, such as accuracy, robustness and cybersecurity as well as minimisation of risks to fundamental rights, environment and the society at large










 





3.
   
Prospective providers in the sandboxes, in particular SMEs and start-ups, shall be facilitated access to pre-deployment services such as guidance on the implementation of this Regulation, to other value-adding services such as help with standardisation documents and certification and consultation, and to other Digital Single Market initiatives such as Testing & Experimentation Facilities, Digital Hubs, Centres of Excellence, and EU benchmarking capabilities;








Amendment 506


Proposal for a regulation


Article 54 — title








Text proposed by the Commission




Amendment





Further processing of 
personal
 data for developing certain AI systems in the public interest in the AI regulatory sandbox


Further processing of data for developing certain AI systems in the public interest in the AI regulatory sandbox





Amendment 507


Proposal for a regulation


Article 54 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment






1.   In the AI regulatory sandbox personal data lawfully collected for other purposes 
shall
 be processed for the purposes of developing and testing certain 
innovative
 AI systems in the sandbox 
under
 the following conditions:




1.   In the AI regulatory sandbox personal data lawfully collected for other purposes 
may
 be processed 
solely
 for the purposes of developing and testing certain AI systems in the sandbox 
when all of
 the following conditions 
are met
:






Amendment 508


Proposal for a regulation


Article 54 — paragraph 1 — point a — introductory part








Text proposed by the Commission




Amendment











(a)




the innovative
 AI systems shall be developed for safeguarding substantial public interest in one or more of the following areas:












(a)


AI systems shall be developed for safeguarding substantial public interest in one or more of the following areas:








 








 










(ii)






public safety and public health, including disease detection, diagnosis prevention, control and treatment;














 








 










(iii)






a high level of protection and improvement of the quality of the environment, protection of biodiversity, pollution as well as climate change mitigation and adaptation;














 








 










(iii a)






safety and resilience of transport systems, critical infrastructure and networks.















Amendment 509


Proposal for a regulation


Article 54 — paragraph 1 — point a — point i








Text proposed by the Commission




Amendment













(i)






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, under the control and responsibility of the competent authorities. The processing shall be based on Member State or Union law;










deleted







Amendment 510


Proposal for a regulation


Article 54 — paragraph 1 — point c








Text proposed by the Commission




Amendment











(c)


there are effective monitoring mechanisms to identify if any high risks to the 
fundamental
 rights of the data subjects may arise during the sandbox experimentation as well as response mechanism to promptly mitigate those risks and, where necessary, stop the processing;












(c)


there are effective monitoring mechanisms to identify if any high risks to the rights 
and freedoms
 of the data subjects
, as referred to in Article 35 of Regulation (EU) 2016/679 and in Article 35 of Regulation (EU) 2018/1725
 may arise during the sandbox experimentation as well as response mechanism to promptly mitigate those risks and, where necessary, stop the processing;









Amendment 511


Proposal for a regulation


Article 54 — paragraph 1 — point d








Text proposed by the Commission




Amendment











(d)


any personal data to be processed in the context of the sandbox are in a functionally separate, isolated and protected data processing environment under the control of the 
participants
 and only authorised persons have access to that data;












(d)


any personal data to be processed in the context of the sandbox are in a functionally separate, isolated and protected data processing environment under the control of the 
prospective provider
 and only authorised persons have access to that 
those
 data;









Amendment 512


Proposal for a regulation


Article 54 — paragraph 1 — point f








Text proposed by the Commission




Amendment











(f)


any processing of personal data in the context of the sandbox do not lead to measures or decisions affecting the data subjects;












(f)


any processing of personal data in the context of the sandbox do not lead to measures or decisions affecting the data subjects 
nor affect the application of their rights laid down in Union law on the protection of personal data
;









Amendment 513


Proposal for a regulation


Article 54 — paragraph 1 — point g








Text proposed by the Commission




Amendment











(g)


any personal data processed in the context of the sandbox are deleted once the participation in the sandbox has terminated or the personal data has reached the end of its retention period;












(g)


any personal data processed in the context of the sandbox are 
protected by means of appropriate technical and organisational measures and
 deleted once the participation in the sandbox has terminated or the personal data has reached the end of its retention period;









Amendment 514


Proposal for a regulation


Article 54 — paragraph 1 — point h








Text proposed by the Commission




Amendment











(h)


the logs of the processing of personal data in the context of the sandbox are kept for the duration of the participation in the sandbox 
and 1 year after its termination, solely for the purpose of and only as long as necessary for fulfilling accountability and documentation obligations under this Article or other application Union or Member States legislation
;












(h)


the logs of the processing of personal data in the context of the sandbox are kept for the duration of the participation in the sandbox;









Amendment 515


Proposal for a regulation


Article 54 — paragraph 1 — point j








Text proposed by the Commission




Amendment











(j)


a short summary of the AI 
project
 developed in the sandbox, its objectives and expected results published on the website of the competent authorities.












(j)


a short summary of the AI 
system
 developed in the sandbox, its objectives
, hypotheses,
 and expected results, published on the website of the competent authorities;









Amendment 516


Proposal for a regulation


Article 54 a (new)








Text proposed by the Commission




Amendment





 




Article 54 a






 




Promotion of AI research and development in support of socially and environmentally beneficial outcomes






 





1.
   
Member States shall promote research and development of AI solutions which support socially and environmentally beneficial outcomes, including but not limited to development of AI-based solutions to increase accessibility for persons with disabilities, tackle socio-economic inequalities, and meet sustainability and environmental targets, by:







 










(a)






providing relevant projects with priority access to the AI regulatory sandboxes to the extent that they fulfil the eligibility conditions;










 










(b)






earmarking public funding, including from relevant EU funds, for AI research and development in support of socially and environmentally beneficial outcomes;










 










(c)






organising specific awareness raising activities about the application of this Regulation, the availability of and application procedures for dedicated funding, tailored to the needs of those projects;










 










(d)






where appropriate, establishing accessible dedicated channels, including within the sandboxes, for communication with projects to provide guidance and respond to queries about the implementation of this Regulation.










 




Member States shall support civil society and social stakeholders to lead or participate in such projects;







Amendment 517


Proposal for a regulation


Article 55 — title








Text proposed by the Commission




Amendment





Measures for 
small-scale providers
 and users


Measures for 
SMEs, start-ups
 and users





Amendment 518


Proposal for a regulation


Article 55 — paragraph 1 — point a








Text proposed by the Commission




Amendment











(a)


provide 
small-scale providers
 and start-ups with priority access to the AI regulatory sandboxes to the extent that they fulfil the eligibility conditions;












(a)


provide 
SMEs
 and start-ups
, established in the Union,
 with priority access to the AI regulatory sandboxes, to the extent that they fulfil the eligibility conditions;









Amendment 519


Proposal for a regulation


Article 55 — paragraph 1 — point b








Text proposed by the Commission




Amendment











(b)


organise specific awareness raising activities 
about
 the application of this Regulation tailored to the needs of 
the small-scale providers
 and users;












(b)


organise specific awareness raising 
and enhanced digital skills development
 activities 
on
 the application of this Regulation tailored to the needs of 
SMEs, start-ups
 and users;









Amendment 520


Proposal for a regulation


Article 55 — paragraph 1 — point c








Text proposed by the Commission




Amendment











(c)


where appropriate, establish 
a
 dedicated 
channel
 for communication with 
small-scale providers and user
 and other innovators to provide guidance and respond to queries about the implementation of this Regulation.












(c)




utilise existing dedicated channels and
 where appropriate, establish 
new
 dedicated 
channels
 for communication with 
SMEs, start-ups, users
 and other innovators to provide guidance and respond to queries about the implementation of this Regulation;









Amendment 521


Proposal for a regulation


Article 55 — paragraph 1 — point c a (new)








Text proposed by the Commission




Amendment





 










(ca)






foster the participation of SMEs and other relevant stakeholders in the standardisation development process.











Amendment 522


Proposal for a regulation


Article 55 — paragraph 2








Text proposed by the Commission




Amendment






2.   The specific interests and needs of the 
small-scale providers
 shall be taken into account when setting the fees for conformity assessment under Article 43, reducing those fees proportionately to their size and market 
size
.




2.   The specific interests and needs of the 
SMEs, start-ups and users
 shall be taken into account when setting the fees for conformity assessment under Article 43, reducing those fees proportionately to 
development stage,
 their 
size, market
 size and market 
demand
. 
The Commission shall regularly assess the certification and compliance costs for SMEs and start-ups, including through transparent consultations with SMEs, start-ups and users and shall work with Member States to lower such costs where possible. The Commission shall report on these findings to the European Parliament and to the Council as part of the report on the evaluation and review of this Regulation provided for in Article 84(2).








Amendment 523


Proposal for a regulation


Article 56 — SECTION 1 — Title








Text proposed by the Commission




Amendment





 




Title






 




SECTION 1: General provisions on the European Artificial Intelligence Office







Amendment 524


Proposal for a regulation


Article 56 — title








Text proposed by the Commission




Amendment





Establishment of the European Artificial Intelligence 
Board




Establishment of the European Artificial Intelligence 
Office







Amendment 525


Proposal for a regulation


Article 56 — paragraph 1








Text proposed by the Commission




Amendment






1.   
A
‘European Artificial Intelligence 
Board
’ (the ‘
Board
’) is established.




1.   
The
‘European Artificial Intelligence 
Office
’ (the ‘
AI Office
’) is 
hereby
 established. 
The AI Office shall be an independent body of the Union. It shall have legal personality.








Amendment 526


Proposal for a regulation


Article 56 — paragraph 2 — introductory part








Text proposed by the Commission




Amendment






2.   The 
Board
 shall 
provide advice and assistance to the Commission in order to:






2.   The 
AI Office
 shall 
have a secretariat, and shall be adequately funded and staffed for the purpose of performing its tasks pursuant to this Regulation.








Amendment 527


Proposal for a regulation


Article 56 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
The seat of the AI Office shall be in Brussels.








Amendment 528


Proposal for a regulation


Article 56 a (new)








Text proposed by the Commission




Amendment





 





Article 56 a





Structure





The administrative and management structure of the AI Office shall comprise:










(a)






a management board, including a chair














(b)






a secretariat managed by an executive director;














(c)






an advisory forum.












Amendment 529


Proposal for a regulation


Article 56 b (new)








Text proposed by the Commission




Amendment





 




Article 56 b






 




Tasks of the AI Office






 




The AI Office shall carry out the following tasks:






 










a)






support, advise, and cooperate with Member States, national supervisory authorities, the Commission and other Union institutions, bodies, offices and agencies with regard to the implementation of this Regulation;










 










b)






monitor and ensure the effective and consistent application of this Regulation, without prejudice to the tasks of national supervisory authorities;










 










c)






contribute to the coordination among national supervisory authorities responsible for the application of this Regulation,










 










d)






serve as a mediator in discussions about serious disagreements that may arise between competent authorities regarding the application of the Regulation










 










e)






coordinate joint investigations, pursuant to Article 66a;










 










f)






contribute to the effective cooperation with the competent authorities of third countries and with international organisations,










 










g)






collect and share Member States’ expertise and best practices and to assist Member States national supervisory authorities and the Commission in developing the organizational and technical expertise required for the implementation of this Regulation, including by means of facilitating the creation and maintenance of a Union pool of experts










 










h)






examine, on its own initiative or upon the request of its management board or the Commission, questions relating to the implementation of this Regulation and to issue opinions, recommendations or written contributions including with regard to:










 








 










(i)






technical specifications or existing standards;














 








 










(ii)






the Commission’s guidelines














 








 










(iii)






codes of conduct and the application thereof, in close cooperation with industry and other relevant stakeholders;














 








 










(iv)






the possible revision of the Regulation, the preparation of the delegated acts, and possible alignments of this Regulation with the legal acts listed in Annex II;














 








 










(v)






trends, such as European global competitiveness in artificial intelligence, the uptake of artificial intelligence in the Union, the development of digital skills, and emerging systemic threats relating to artificial intelligence














 








 










(vi)






guidance on how this Regulation applies to the ever evolving typology of AI value chains, in particular on the resulting implications in terms of accountability of all the entities involved














 










i)






issue:










 








 










(i)






an annual report that includes an evaluation of the implementation of this Regulation, a review of serious incident reports as referred to in Article 62 and the functioning of the database referred to in Article 60 and














 








 










(ii)






recommendations to the Commission on the categorisation of prohibited practices, high-risk AI systems referred to in Annex III, the codes of conduct referred to in Article 69, and the application of the general principles outlines in Article 4a














 










j)






assist authorities in the establishment and development of regulatory sandboxes and to facilitate cooperation among regulatory sandboxes;










 










k)






organise meetings with Union agencies and governance bodies whose tasks are related to artificial intelligence and the implementation of this Regulation;










 










l)






organise quarterly consultations with the advisory forum, and, where appropriate, public consultations with other stakeholders, and to make the results of those consultations public on its website;










 










m)






promote public awareness and understanding of the benefits, risks, safeguards and rights and obligations in relation to the use of AI systems;










 










n)






facilitate the development of common criteria and a shared understanding among market operators and competent authorities of the relevant concepts provided for in this Regulation;










 










o)






provide monitoring of foundation models and to organise a regular dialogue with the developers of foundation models with regard to their compliance as well as AI systems that make use of such AI models










 










p)






provide interpretive guidance on how the AI Act applies to the ever evolving typology of AI value chains, and what the resulting implications in terms of accountability of all the entities involved will be under the different scenarios based on the generally acknowledged state of the art, including as reflected in relevant harmonized standards;










 










q)






provide particular oversight and monitoring and institutionalize regular dialogue with the providers of foundation models about the compliance of foundation models as well as AI systems that make use of such AI models with Article 28b of this Regulation, and about industry best practices for self-governance. Any such meeting shall be open to national supervisory authorities, notified bodies and market surveillance authorities to attend and contribute










 










r)






issue and periodically update guidelines on the thresholds that qualify training a foundation model as a large training run, record and monitor known instances of large training runs, and issue an annual report on the state of play in the development, proliferation, and use of foundation models alongside policy options to address risks and opportunities specific to foundation models.










 










s)






promote AI literacy pursuant to Article 4b.











Amendment 530


Proposal for a regulation


Article 56 c (new)








Text proposed by the Commission




Amendment





 




Article 56 c






 




Accountability, independence, and transparency






 





1.
   
The AI Office shall:







 










a.






be accountable to the European Parliament and to the Council in accordance with this Regulation;










 










b.






act independently when carrying out its tasks or exercising its powers; and










 










c.






ensure a high level of transparency concerning its activities and develop good administrative practices in that regard.










 




Regulation (EC) No 1049/2001 shall apply to documents held by the AI Office.







Amendment 531


Proposal for a regulation


Article — 57 a (new) — SECTION 2 — title








Text proposed by the Commission




Amendment





 




Title






 




SECTION 2: Management Board







Amendment 532


Proposal for a regulation


Article — 57 a (new)








Text proposed by the Commission




Amendment





 




Article — 57 a






 




Composition of the management board






 





1.
   
The management board shall be composed of the following members:







 










(a)






one representative of each Member State’s national supervisory authority;










 










(b)






one representative from the Commission;










 










(c)






one representative from the European Data Protection Supervisor (EDPS);










 










(d)






one representative from the European Union Agency for Cybersecurity (ENISA);










 










(e)






one representative from the Fundamental Rights Agency (FRA)










 




Each representative of a national supervisory authority shall have one vote. The representatives of the Commission, the EDPS, the ENISA and the FRA shall not have voting rights. Each member shall have a substitute. The appointment of members and substitute members of the management board shall take into account the need to gender balance. The members of the management board and their substitute members shall be made public.






 





2.
   
The members and substitutes members of the management board shall not hold conflicting positions or commercial interests with regard to any topic related to the application of this Regulation.







 





3.
   
The rules for the meetings and voting of the management board and the appointment and removal of the Executive Director shall be laid down in the rules of procedure referred to in Article — 57 b, point (a).








Amendment 533


Proposal for a regulation


Article — 57 b (new)








Text proposed by the Commission




Amendment





 




Article — 57 b






 




Functions of the management board






 





1.
   
The management board shall have the following tasks:







 










(a)






to make strategic decisions on the activities of the AI Office and to adopt its rules of procedure by a two-thirds majority of its members;










 










(b)






to implement its rules of procedure;










 










(c)






to adopt the AI Office’s single programming document as well as it annual public report and transmit both to the European Parliament, to the Council, to the Commission, and to the Court of Auditors;










 










(d)






to adopt the AI Office’s budget;










 










(e)






to appoint the executive director and, where relevant, to extend or curtail the executive director’s term of office or remove him or her from office;










 










(f)






to decide on the establishment of the AI Office’s internal structures and, where necessary, the modification of those internal structures necessary for the fulfilment of the AI Office tasks;











Amendment 534


Proposal for a regulation


Article — 57 c (new)








Text proposed by the Commission




Amendment





 





Article — 57 c





Chair of the management board






1.
   
The management board shall elect a Chair and two deputy Chairs from among its voting members, by simple majority.






2.
   
The term of office of the Chair and of the deputy Chairs shall be four years. The terms of the Chair and of the deputy Chairs renewable once.









Amendment 535


Proposal for a regulation


Article 57 — SECTION 3 — title








Text proposed by the Commission




Amendment







Structure of the Board






Secretariat







Amendment 536


Proposal for a regulation


Article 57 — paragraph 1








Text proposed by the Commission




Amendment






1.   The 
Board
 shall be 
composed of the national supervisory authorities
, who shall be 
represented by the head or equivalent high-level official of that authority,
 and the 
European Data Protection Supervisor.
 Other 
national authorities may be invited to the meetings, where the issues discussed are of relevance for them.






1.   The 
activities of the secretariat
 shall be 
managed by an executive director. The executive director
 shall be 
accountable to the management board. Without prejudice to the respective powers of the management board
 and the 
Union institutions, the executive director shall neither seek nor take instructions from any government or from any
 other 
body








Amendment 537


Proposal for a regulation


Article 57 — paragraph 2








Text proposed by the Commission




Amendment






2.   The 
Board
 shall 
adopt its rules of procedure by a simple majority of its members, following the consent
 of the 
Commission. The rules of procedure shall also contain the operational aspects related to the execution of the Board’s tasks as listed in Article 58
. 
The Board may establish sub-groups as appropriate for the purpose of examining specific questions.






2.   The 
executive director
 shall 
attend hearings on any matter linked to the AI Office's activities and shall report on the performance
 of the 
executive director’s duties when invited to do so by the European Parliament or the Council
.






Amendment 538


Proposal for a regulation


Article 57 — paragraph 3








Text proposed by the Commission




Amendment






3.   The 
Board
 shall 
be chaired by the Commission. The Commission shall convene the meetings and prepare the agenda in accordance with the tasks of the Board pursuant to this Regulation and with its rules of procedure. The Commission shall provide administrative and analytical support for the activities of the Board pursuant to this Regulation.






3.   The 
executive director
 shall 
represent the AI Office, including in international fora for cooperation with regard to artificial intelligence;








Amendment 539


Proposal for a regulation


Article 57 — paragraph 4








Text proposed by the Commission




Amendment






4.   The Board 
may invite external experts and observers to attend its meetings and may hold exchanges with interested third parties to inform its
 activities 
to an appropriate extent. To that end the Commission may facilitate exchanges between the
 Board 
and other Union bodies, offices, agencies and advisory groups.






4.   The 
secretariat shall provide the management
 board 
and the advisory forum with the analytical, administrative and logistical support necessary to fulfil the tasks of the AI Office, including by:







 










(a)






Implementing the decisions, programmes and
 activities 
adopted by the management
 board;








 










(b)






preparing each year the draft single programming document, the draft budget, the annual activity report on the AI Office, the draft opinions and the draft positions of the AI Office, and submit them to the management board










 










(c)






Coordinating with international fora for cooperation on artificial intelligence;











Amendment 540


Proposal for a regulation


Article 58 — SECTION 4 — title








Text proposed by the Commission




Amendment







Tasks of the Board






Advisory Forum







Amendment 541


Proposal for a regulation


Article 58 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment







When providing advice and assistance to the Commission in the context of Article 56(2), the Board
 shall in particular:




The advisory forum
 shall 
provide the AI Office with stakeholder input in matters relating to this Regulation,
 in particular 
with regard to the tasks set out in Article 56b point (l).







Amendment 542


Proposal for a regulation


Article 58 — paragraph 2 (new)








Text proposed by the Commission




Amendment





 




The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry, start-ups, SMEs, civil society, the social partners and academia. The membership of the advisory forum shall be balanced with regard to commercial and non-commercial interests and, within the category of commercial interests, with regards to SMEs and other undertakings.







Amendment 543


Proposal for a regulation


Article 58 — paragraph 3 (new)








Text proposed by the Commission




Amendment





 




The management board shall appoint the members of the advisory forum in accordance with the selection procedure established in the AI Office’s rules of procedure and taking into account the need for transparency and in accordance with the criteria set out in paragraph 2;







Amendment 544


Proposal for a regulation


Article 58 — paragraph 4 (new)








Text proposed by the Commission




Amendment





 




The term of office of the members of the advisory forum shall be two years, which may be extended by up to no more than four years.







Amendment 545


Proposal for a regulation


Article 58 — paragraph 5 (new)








Text proposed by the Commission




Amendment





 




The European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI) shall be permanent members of the Advisory Forum. The Joint Research Centre shall be permanent member, without voting rights.







Amendment 546


Proposal for a regulation


Article 58 — paragraph 6 (new)








Text proposed by the Commission




Amendment





 




The advisory forum shall draw up its rules of procedure. It shall elect two co-Chairs from among its members, in accordance with criteria set out in paragraph 2. The term of office of the co-Chairs shall be two years, renewable once.







Amendment 547


Proposal for a regulation


Article 58 — paragraph 7 (new)








Text proposed by the Commission




Amendment





 




The advisory forum shall hold meetings at least four times a year. The advisory forum may invite experts and other stakeholders to its meetings. The executive director may attend, ex officio, the meetings of the advisory forum.







Amendment 548


Proposal for a regulation


Article 58 — paragraph 8 (new)








Text proposed by the Commission




Amendment





 




In fulfilling its role as set out in paragraph 1, the advisory forum may prepare opinions, recommendations and written contributions.







Amendment 549


Proposal for a regulation


Article 58 — paragraph 9 (new)








Text proposed by the Commission




Amendment





 




The advisory forum may establish standing or temporary subgroups as appropriate for the purpose of examining specific questions related to the objectives of this Regulation.







Amendment 550


Proposal for a regulation


Article 58 — paragraph 10 (new)








Text proposed by the Commission




Amendment





 




The advisory forum shall prepare an annual report of its activities. That report shall be made publicly available.







Amendment 551


Proposal for a regulation


Article 58 a — SECTION 5 — title








Text proposed by the Commission




Amendment





 




European Authorities on benchmarking







Amendment 552


Proposal for a regulation


Article 58 a (new)








Text proposed by the Commission




Amendment





 





Article 58 a





Benchmarking





The European authorities on benchmarking referred to in Article 15 (1a) and the AI Office shall, in close cooperation with international partners, jointly develop cost-effective guidance and capabilities to measure and benchmark aspects of AI systems and AI components, and in particular of foundation models relevant to the compliance and enforcement of this Regulation based on the generally acknowledged state of the art, including as reflected in relevant harmonized standards.








Amendment 553


Proposal for a regulation


Article 59 — title








Text proposed by the Commission




Amendment





Designation of national 
competent
 authorities


Designation of national 
supervisory
 authorities





Amendment 554


Proposal for a regulation


Article 59 — paragraph 1








Text proposed by the Commission




Amendment






1.   
National competent authorities shall be established or designated by
 each Member State 
for the purpose of ensuring the application and implementation of this Regulation.
 National 
competent authorities
 shall be organised so as to safeguard the objectivity and impartiality of 
their
 activities and tasks.




1.   Each Member State 
shall designate one
 national 
supervisory authority, which
 shall be organised so as to safeguard the objectivity and impartiality of 
its
 activities and tasks 
by …[three months after the date of entry into force of this Regulation]
.






Amendment 555


Proposal for a regulation


Article 59 — paragraph 2








Text proposed by the Commission




Amendment






2.   
Each Member State shall designate a
 national supervisory authority 
among the national
 competent authorities. The national supervisory authority shall act as 
notifying authority and
 market surveillance authority 
unless a Member State has organisational and administrative reasons to designate more than one authority
.




2.   
The
 national supervisory authority 
shall ensure the application and implementation of this Regulation. With regard to high-risk AI systems, related to products to which legal acts listed in Annex II apply, the
 competent authorities 
designated under those legal acts shall continue to lead the administrative procedures. However, to the extent a case involves aspects exclusively covered by this Regulation, those competent authorities shall be bound by the measures related to those aspects issued by the national supervisory authority designated under this Regulation
. The national supervisory authority shall act as market surveillance authority.






Amendment 556


Proposal for a regulation


Article 59 — paragraph 3








Text proposed by the Commission




Amendment






3.   Member States shall 
inform
 the Commission 
of their designation or designations and, where applicable, the reasons for designating more than one
 authority.




3.   Member States shall 
make publicly available and communicate to the AI Office and
 the Commission 
the national supervisory authority and information on how it can be contacted, by… [three months after the date of entry into force of this Regulation]. The national supervisory
 authority 
shall act as single point of contact for this Regulation and should be contactable though electronic communications means
.






Amendment 557


Proposal for a regulation


Article 59 — paragraph 4








Text proposed by the Commission




Amendment






4.   Member States shall ensure that national 
competent authorities are
 provided with adequate financial and human resources to fulfil their tasks under this Regulation. In particular, national 
competent authorities
 shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of artificial intelligence technologies, data and data computing, fundamental rights, health and safety risks and knowledge of existing standards and legal requirements.




4.   Member States shall ensure that 
the
 national 
supervisory authority is
 provided with adequate 
technical,
 financial and human resources
, and infrastructure
 to fulfil their tasks 
effectively
 under this Regulation. In particular, 
the
 national 
supervisory authority
 shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of artificial intelligence technologies, data and data computing, 
personal data protection, cybersecurity, competition law,
 fundamental rights, health and safety risks and knowledge of existing standards and legal requirements. 
Member States shall assess and, if deemed necessary, update competence and resource requirements referred to in this paragraph on an annual basis.








Amendment 558


Proposal for a regulation


Article 59 — paragraph 4 a (new)








Text proposed by the Commission




Amendment





 





4 a.
   
Each national supervisory authority shall exercise their powers and carry out their duties independently, impartially and without bias. The members of each national supervisory authority, in the performance of their tasks and exercise of their powers under this Regulation, shall neither seek nor take instructions from any body and shall refrain from any action incompatible with their duties.








Amendment 559


Proposal for a regulation


Article 59 — paragraph 4 b (new)








Text proposed by the Commission




Amendment





 





4 b.
   
National supervisory authorities shall satisfy the minimum cybersecurity requirements set out for public administration entities identified as operators of essential services pursuant to Directive (EU) 2022/2555.








Amendment 560


Proposal for a regulation


Article 59 — paragraph 4 c (new)








Text proposed by the Commission




Amendment





 





4 c.
   
When performing their tasks, the national supervisory authority shall act in compliance with the confidentiality obligations set out in Article 70.








Amendment 561


Proposal for a regulation


Article 59 — paragraph 5








Text proposed by the Commission




Amendment






5.   Member States shall report to the Commission on an annual basis on the status of the financial and human resources of the national 
competent authorities
 with an assessment of their adequacy. The Commission shall transmit that information to the 
Board
 for discussion and possible recommendations.




5.   Member States shall report to the Commission on an annual basis on the status of the financial and human resources of the national 
supervisory authority
 with an assessment of their adequacy. The Commission shall transmit that information to the 
AI Office
 for discussion and possible recommendations.






Amendment 562


Proposal for a regulation


Article 59 — paragraph 6








Text proposed by the Commission




Amendment








6.
   
The Commission shall facilitate the exchange of experience between national competent authorities.







deleted







Amendment 563


Proposal for a regulation


Article 59 — paragraph 7








Text proposed by the Commission




Amendment






7.   National 
competent
 authorities may provide guidance and advice on the implementation of this Regulation, including to 
small-scale providers
. Whenever national 
competent authorities
 intend to provide guidance and advice with regard to an AI system in areas covered by other Union legislation, the competent national authorities under that Union legislation 
shall be consulted
, as appropriate. 
Member States may also establish one central contact point for communication with operators.






7.   National 
supervisory
 authorities may provide guidance and advice on the implementation of this Regulation, including to 
SMEs and start-ups, taking into account the AI Office or the Commission’s guidance and advice
. Whenever 
the
 national 
supervisory authority
 intend to provide guidance and advice with regard to an AI system in areas covered by other Union 
law
, the 
guidance shall be drafted in consultation with the
 competent national authorities under that Union 
law
, as appropriate.






Amendment 564


Proposal for a regulation


Article 59 — paragraph 8








Text proposed by the Commission




Amendment






8.   When Union institutions, agencies and bodies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as the competent authority for their supervision.




8.   When Union institutions, agencies and bodies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as the competent authority for their supervision 
and coordination
.






Amendment 565


Proposal for a regulation


Article 59 a (new)








Text proposed by the Commission




Amendment





 




Article 59 a






 




Cooperation mechanism between national supervisory authorities in cases involving two or more Member States






 





1.
   
Each national supervisory authority shall perform its tasks and powers conferred on in accordance with this Regulation on the territory of its own Member State.







 





2.
   
In the event of a case involving two or more national supervisory authorities, the national supervisory authority of the Member State where the infringement took place shall be considered the lead supervisory authority.







 





3.
   
In the cases referred to in paragraph 2, the relevant supervisory authorities shall cooperate and exchange all relevant information in due time. National supervisory authorities shall cooperate in order to reach a consensus.








Amendment 566


Proposal for a regulation


Title VII








Text proposed by the Commission




Amendment





VII EU DATABASE FOR 
STAND-ALONE
 HIGH-RISK AI SYSTEMS


EU DATABASE FOR HIGH-RISK AI SYSTEMS





Amendment 567


Proposal for a regulation


Article 60 — title








Text proposed by the Commission




Amendment





EU database for 
stand-alone
 high-risk AI systems


EU database for high-risk AI systems





Amendment 568


Proposal for a regulation


Article 60 — paragraph 1








Text proposed by the Commission




Amendment






1.   The Commission shall, in collaboration with the Member States, set up and maintain a EU database containing information referred to in 
paragraph 2
 concerning high-risk AI systems referred to in Article 
6(2)
 which are registered in accordance with Article 51.




1.   The Commission shall, in collaboration with the Member States, set up and maintain a 
public
 EU database containing information referred to in 
paragraphs 2 and 2a
 concerning high-risk AI systems referred to in Article 
6 (2)
 which are registered in accordance with Article 51.






Amendment 569


Proposal for a regulation


Article 60 — paragraph 2








Text proposed by the Commission




Amendment






2.   The data listed in Annex VIII shall be entered into the EU database by the providers. 
The Commission shall provide them with technical and administrative support.






2.   The data listed in Annex VIII
, Section A,
 shall be entered into the EU database by the providers.






Amendment 570


Proposal for a regulation


Article 60 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
The data listed in Annex VIII, Section B, shall be entered into the EU database by the deployers who are or who act on behalf of public authorities or Union institutions, bodies, offices or agencies and by deployers who are undertakings referred to in Article 51(1a) and (1b).








Amendment 571


Proposal for a regulation


Article 60 — paragraph 3








Text proposed by the Commission




Amendment






3.   Information contained in the EU database shall be 
accessible
 to the public.




3.   Information contained in the EU database shall be 
freely available
 to the public
, user-friendly and accessible, easily navigable and machine-readable containing structured digital data based on a standardised protocol
.






Amendment 572


Proposal for a regulation


Article 60 — paragraph 4








Text proposed by the Commission




Amendment






4.   The EU database shall contain personal data only insofar as necessary for collecting and processing information in accordance with this Regulation. That information shall include the names and contact details of natural persons who are responsible for registering the system and have the legal authority to represent the provider.




4.   The EU database shall contain personal data only insofar as necessary for collecting and processing information in accordance with this Regulation. That information shall include the names and contact details of natural persons who are responsible for registering the system and have the legal authority to represent the provider 
or the deployer which is a public authority or Union institution, body, office or agency or a deployer acting on their behalf or a deployer which is an undertaking referred to in Article 51(1a)(b) and (1b)
.






Amendment 573


Proposal for a regulation


Article 60 — paragraph 5








Text proposed by the Commission




Amendment






5.   The Commission shall be the controller of the EU database. It shall also ensure to providers adequate technical and administrative support.




5.   The Commission shall be the controller of the EU database. It shall also ensure to providers 
and deployers
 adequate technical and administrative support.





 




The database shall comply with the accessibility requirements of Annex I to Directive (EU) 2019/882.







Amendment 574


Proposal for a regulation


Article 61 — paragraph 2








Text proposed by the Commission




Amendment






2.   The post-market monitoring system shall actively and systematically collect, document and analyse relevant data provided by 
users
 or collected through other sources on the performance of high-risk AI systems throughout their lifetime, and allow the provider to evaluate the continuous compliance of AI systems with the requirements set out in Title III, Chapter 2.




2.   The post-market monitoring system shall actively and systematically collect, document and analyse relevant data provided by 
deployers
 or collected through other sources on the performance of high-risk AI systems throughout their lifetime, and allow the provider to evaluate the continuous compliance of AI systems with the requirements set out in Title III, Chapter 2. 
Where relevant, post-market monitoring shall include an analysis of the interaction with other AI systems environment, including other devices and software taking into account the rules applicable from areas such as data protection, intellectual property rights and competition law.








Amendment 575


Proposal for a regulation


Article 61 — paragraph 3








Text proposed by the Commission




Amendment






3.   The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring plan shall be part of the technical documentation referred to in Annex IV. The Commission shall adopt an implementing act laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be included in the plan.




3.   The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring plan shall be part of the technical documentation referred to in Annex IV. The Commission shall adopt an implementing act laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be included in the plan 
by [twelve months after the date of entry into force of this Regulation]
.






Amendment 576


Proposal for a regulation


Article 62 — title








Text proposed by the Commission




Amendment





Reporting of serious incidents 
and of malfunctioning




Reporting of serious incidents





Amendment 577


Proposal for a regulation


Article 62 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment






1.   Providers of high-risk AI systems placed on the Union market shall report any serious incident 
or any malfunctioning
 of those systems which constitutes a breach of obligations under Union law intended to protect fundamental rights to the 
market surveillance authorities
 of the Member States where that incident or breach occurred.




1.   Providers 
and, where deployers have identified a serious incident, deployers
 of high-risk AI systems placed on the Union market shall report any serious incident of those systems which constitutes a breach of obligations under Union law intended to protect fundamental rights to the 
national supervisory authority
 of the Member States where that incident or breach occurred.






Amendment 578


Proposal for a regulation


Article 62 — paragraph 1 — subparagraph 1








Text proposed by the Commission




Amendment





Such notification shall be made 
immediately
 after the provider has established a causal link between the AI system and the incident 
or malfunctioning
 or the reasonable likelihood of such a link, and, in any event, not later than 
15 days
 after the 
providers
 becomes aware of the serious incident 
or of the malfunctioning
.


Such notification shall be made 
without undue delay
 after the provider
, or, where applicable the deployer,
 has established a causal link between the AI system and the incident or the reasonable likelihood of such a link, and, in any event, not later than 
72 hours
 after the 
provider or, where applicable, the deployer
 becomes aware of the serious incident.





Amendment 579


Proposal for a regulation


Article 62 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 





1 a.
   
Upon establishing a causal link between the AI system and the serious incident or the reasonable likelihood of such a link, providers shall take appropriate corrective actions pursuant to Article 21.








Amendment 580


Proposal for a regulation


Article 62 — paragraph 2








Text proposed by the Commission




Amendment






2.   Upon receiving a notification related to a breach of obligations under Union law intended to protect fundamental rights, the 
market surveillance
 authority shall inform the national public authorities or bodies referred to in Article 64(3). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1. That guidance shall be issued 
12 months after
 the entry into force of this Regulation
, at the latest
.




2.   Upon receiving a notification related to a breach of obligations under Union law intended to protect fundamental rights, the 
national supervisory
 authority shall inform the national public authorities or bodies referred to in Article 64(3). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1. That guidance shall be issued 
by [
the entry into force of this Regulation
] and shall be assessed regularly
.






Amendment 581


Proposal for a regulation


Article 62 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
The national supervisory authority shall take appropriate measures within 7 days from the date it received the notification referred to in paragraph 1. Where the infringement takes place or is likely to take place in other Member States, the national supervisory authority shall notify the AI Office and the relevant national supervisory authorities of these Member States.








Amendment 582


Proposal for a regulation


Article 62 — paragraph 3








Text proposed by the Commission




Amendment






3.   For high-risk AI systems referred to in 
point 5(b) of
 Annex III 
which
 are placed on the market or put into service by providers that are 
credit institutions regulated by Directive 2013/36/EU and for high-risk AI systems which are safety components of devices, or are themselves devices, covered by
 Regulation 
(EU) 2017/745 and Regulation (EU) 2017/746
, the notification of serious incidents 
or malfunctioning shall be limited to those that that constitute
 a breach of 
obligations under Union law intended to protect
 fundamental rights.




3.   For high-risk AI systems referred to in Annex III 
that
 are placed on the market or put into service by providers that are 
subject to Union legislative instruments laying down reporting obligations equivalent to those set out in this
 Regulation, the notification of serious incidents 
constituting
 a breach of fundamental rights 
under Union law shall be transferred to the national supervisory authority
.






Amendment 583


Proposal for a regulation


Article 62 — paragraph 3 a (new)








Text proposed by the Commission




Amendment





 





3 a.
   
National supervisory authorities shall on an annual basis notify the AI Office of the serious incidents reported to them in accordance with this Article.








Amendment 584


Proposal for a regulation


Article 63 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment






1.   Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. However, for the purpose of the effective enforcement of this Regulation:




1.   Regulation (EU) 2019/1020 shall apply to AI systems 
and foundation models
 covered by this Regulation. However, for the purpose of the effective enforcement of this Regulation:






Amendment 585


Proposal for a regulation


Article 63 — paragraph 1 — point b a (new)








Text proposed by the Commission




Amendment





 










(b a)






the national supervisory authorities shall act as market surveillance authorities under this Regulation and have the same powers and obligations as market surveillance authorities under Regulation (EU) 2019/1020.











Amendment 586


Proposal for a regulation


Article 63 — paragraph 2








Text proposed by the Commission




Amendment






2.   The national supervisory authority shall report to the Commission 
on a regular basis
 the outcomes of relevant market surveillance activities. The national supervisory authority shall report, without delay, to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union law on competition rules.




2.   The national supervisory authority shall report to the Commission 
and the AI Office annually
 the outcomes of relevant market surveillance activities. The national supervisory authority shall report, without delay, to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union law on competition rules.






Amendment 587


Proposal for a regulation


Article 63 — paragraph 3 a (new)








Text proposed by the Commission




Amendment





 





3 a.
   
For the purpose of ensuring the effective enforcement of this Regulation, national supervisory authorities may:







 










(a)






carry out unannounced on-site and remote inspections of high-risk AI systems;










 










(b)






acquire samples related to high-risk AI systems, including through remote inspections, to reverse-engineer the AI systems and to acquire evidence to identify non-compliance.











Amendment 588


Proposal for a regulation


Article 63 — paragraph 5








Text proposed by the Commission




Amendment






5.   For AI systems 
listed in point 1(a) in so far as the systems
 are used for law enforcement purposes
, points 6 and 7 of Annex III
, Member States shall designate as market surveillance authorities for the purposes of this Regulation 
either
 the competent data protection supervisory authorities under Directive (EU) 2016/680
, or Regulation 2016/679 or the national competent authorities supervising the activities of the law enforcement, immigration or asylum authorities putting into service or using those systems
.




5.   For AI systems 
that
 are used for law enforcement purposes, Member States shall designate as market surveillance authorities for the purposes of this Regulation the competent data protection supervisory authorities under Directive (EU) 2016/680.






Amendment 589


Proposal for a regulation


Article 63 — paragraph 7








Text proposed by the Commission




Amendment






7.   
Member States shall facilitate the coordination between market surveillance
 authorities designated under this Regulation 
and
 other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed in Annex II or other Union legislation that might be relevant for the high-risk AI systems referred to in Annex III.




7.   
National supervisory
 authorities designated under this Regulation 
shall coordinate with
 other relevant national authorities or bodies which supervise the application of Union harmonisation 
law
 listed in Annex II or other Union 
law
 that might be relevant for the high-risk AI systems referred to in Annex III.






Amendment 590


Proposal for a regulation


Article 64 — paragraph 1








Text proposed by the Commission




Amendment






1.   
Access to data and documentation
 in the context of their activities, 
the market surveillance authorities
 shall be granted full access to the training, validation and testing datasets used by the provider, 
including
 through 
application programming interfaces (‘API’) or other
 appropriate technical means and tools 
enabling remote access
.




1.   In the context of their activities, 
and upon their reasoned request the national supervisory authority
 shall be granted full access to the training, validation and testing datasets used by the provider, 
or, where relevant, the deployer, that are relevant and strictly necessary for the purpose of its request
 through appropriate technical means and tools.






Amendment 591


Proposal for a regulation


Article 64 — paragraph 2








Text proposed by the Commission




Amendment






2.   Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Title III, Chapter 2 and upon a reasoned request, the 
market surveillance authorities
 shall be granted access to the 
source code
 of the AI system.




2.   Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Title III, Chapter 2
, after all other reasonable ways to verify conformity including paragraph 1 have been exhausted and have proven to be insufficient,
 and upon a reasoned request, the 
national supervisory authority
 shall be granted access to the 
training and trained models
 of the AI system
, including its relevant model parameters
. 
All information in line with Article 70 obtained shall be treated as confidential information and shall be subject to existing Union law on the protection of intellectual property and trade secrets and shall be deleted upon the completion of the investigation for which the information was requested.








Amendment 592


Proposal for a regulation


Article 64 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
Paragraphs 1 and 2 are without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation (EU) 2019/1020.








Amendment 593


Proposal for a regulation


Article 64 — paragraph 3








Text proposed by the Commission




Amendment






3.   National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights in relation to the use of high-risk AI systems referred to in Annex III shall have the power to request and access any documentation created or maintained under this Regulation when access to that documentation is necessary for the fulfilment of the competences under their mandate within the limits of their jurisdiction. The relevant public authority or body shall inform the 
market surveillance
 authority of the Member State concerned of any such request.




3.   National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights in relation to the use of high-risk AI systems referred to in Annex III shall have the power to request and access any documentation created or maintained under this Regulation when access to that documentation is necessary for the fulfilment of the competences under their mandate within the limits of their jurisdiction. The relevant public authority or body shall inform the 
national supervisory
 authority of the Member State concerned of any such request.






Amendment 594


Proposal for a regulation


Article 64 — paragraph 4








Text proposed by the Commission




Amendment






4.   By 3 months after the entering into force of this Regulation, each Member State shall identify the public authorities or bodies referred to in paragraph 3 and make a list publicly available on the website of the national supervisory authority. 
Member States
 shall notify the list to the Commission and all other 
Member States
 and keep the list up to date.




4.   By 3 months after the entering into force of this Regulation, each Member State shall identify the public authorities or bodies referred to in paragraph 3 and make a list publicly available on the website of the national supervisory authority. 
National supervisory authorities
 shall notify the list to the Commission, 
the AI Office,
 and all other 
national supervisory authorities
 and keep the list up to date. 
The Commission shall publish in a dedicated website the list of all the competent authorities designated by the Member States in accordance with this Article.








Amendment 595


Proposal for a regulation


Article 64 — paragraph 5








Text proposed by the Commission




Amendment






5.   Where the documentation referred to in paragraph 3 is insufficient to ascertain whether a breach of obligations under Union law intended to protect fundamental rights has occurred, the public authority or body referred to paragraph 3 may make a reasoned request to the 
market surveillance
 authority to organise testing of the high-risk AI system through technical means. The 
market surveillance
 authority shall organise the testing with the close involvement of the requesting public authority or body within reasonable time following the request.




5.   Where the documentation referred to in paragraph 3 is insufficient to ascertain whether a breach of obligations under Union law intended to protect fundamental rights has occurred, the public authority or body referred to 
in
 paragraph 3 may make a reasoned request to the 
national supervisory
 authority, to organise testing of the high-risk AI system through technical means. The 
national supervisory
 authority shall organise the testing with the close involvement of the requesting public authority or body within reasonable time following the request.






Amendment 596


Proposal for a regulation


Article 65 — paragraph 1








Text proposed by the Commission




Amendment






1.   AI systems presenting a risk shall be understood as 
a product presenting a risk defined in Article 3, point 19 of Regulation (EU) 2019/1020 insofar as risks to the
 health 
or
 safety 
or to the protection of
 fundamental rights of persons are concerned.




1.   AI systems presenting a risk shall be understood as 
an AI system having the potential to affect adversely
 health 
and
 safety, fundamental rights of persons 
in general, including in the workplace, protection of consumers, the environment, public security, or democracy or the rule of law and other public interests, that are protected by the applicable Union harmonisation law, to a degree which goes beyond that considered reasonable and acceptable in relation to its intended purpose or under the normal or reasonably foreseeable conditions of use of the system
 are concerned
, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements
.






Amendment 597


Proposal for a regulation


Article 65 — paragraph 2 — introductory part








Text proposed by the Commission




Amendment






2.   Where the 
market surveillance
 authority of a Member State has sufficient reasons to consider that an AI system presents a risk as referred to in paragraph 1, 
they
 shall carry out an evaluation of the AI system concerned in respect of its compliance with all the requirements and obligations laid down in this Regulation. When risks 
to the protection of
 fundamental rights are present, the 
market surveillance
 authority shall also inform the relevant national public authorities or bodies referred to in Article 64(3). The relevant operators shall cooperate as necessary with the 
market surveillance authorities
 and the other national public authorities or bodies referred to in Article 64(3).




2.   Where the 
national supervisory
 authority of a Member State has sufficient reasons to consider that an AI system presents a risk as referred to in paragraph 1, 
it
 shall carry out an evaluation of the AI system concerned in respect of its compliance with all the requirements and obligations laid down in this Regulation. When risks to fundamental rights are present, the 
national supervisory
 authority shall also 
immediately
 inform 
and fully cooperate with
 the relevant national public authorities or bodies referred to in Article 64(3); 
Where there is sufficient reason to consider that that an AI system exploits the vulnerabilities of vulnerable groups or violates their rights intentionally or unintentionally, the national supervisory authority shall have the duty to investigate the design goals, data inputs, model selection, implementation and outcomes of the AI system .
 The relevant operators shall cooperate as necessary with the 
national supervisory authority
 and the other national public authorities or bodies referred to in Article 64(3);






Amendment 598


Proposal for a regulation


Article 65 — paragraph 2 — subparagraph 1








Text proposed by the Commission




Amendment





Where, in the course of that evaluation, the 
market surveillance
 authority finds that the AI system does not comply with the requirements and obligations laid down in this Regulation, it shall without delay require the relevant operator to take all appropriate corrective actions to bring the AI system into compliance, to withdraw the AI system from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.


Where, in the course of that evaluation, the 
national supervisory
 authority 
or, where relevant, the national public authority referred to in Article 64(3)
 finds that the AI system does not comply with the requirements and obligations laid down in this Regulation, it shall without delay require the relevant operator to take all appropriate corrective actions to bring the AI system into compliance, to withdraw the AI system from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe 
and in any event no later than fifteen working days or as provided for in the relevant Union harmonisation law as applicable







Amendment 599


Proposal for a regulation


Article 65 — paragraph 2 — subparagraph 2








Text proposed by the Commission




Amendment





The 
market surveillance
 authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU) 2019/1020 shall apply to the measures referred to in the second subparagraph.


The 
national supervisory
 authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU) 2019/1020 shall apply to the measures referred to in the second subparagraph.





Amendment 600


Proposal for a regulation


Article 65 — paragraph 3








Text proposed by the Commission




Amendment






3.   Where the 
market surveillance
 authority considers that non-compliance is not restricted to its national territory, it shall inform the Commission 
and
 the other Member States of the results of the evaluation and of the actions which it has required the operator to take.




3.   Where the 
national supervisory
 authority considers that non-compliance is not restricted to its national territory, it shall inform the Commission
, the AI Office and the national supervisory authority of
 the other Member States 
without undue delay
 of the results of the evaluation and of the actions which it has required the operator to take.






Amendment 601


Proposal for a regulation


Article 65 — paragraph 5








Text proposed by the Commission




Amendment






5.   Where the operator of an AI system does not take adequate corrective action within the period referred to in paragraph 2, the 
market surveillance
 authority shall take all appropriate provisional measures to prohibit or restrict the AI system's being made available on its national market, to withdraw the 
product
 from that market or to recall it. That authority shall inform the Commission 
and
 the other Member States
, without delay,
 of those measures.




5.   Where the operator of an AI system does not take adequate corrective action within the period referred to in paragraph 2, the 
national supervisory
 authority shall take all appropriate provisional measures to prohibit or restrict the AI system's being made available on its national market 
or put into service
, to withdraw the 
AI system
 from that market or to recall it. That authority shall 
immediately
 inform the Commission
, the AI Office and the national supervisory authority of
 the other Member States of those measures.






Amendment 602


Proposal for a regulation


Article 65 — paragraph 6 — introductory part








Text proposed by the Commission




Amendment






6.   The information referred to in paragraph 5 shall include all available details, in particular the data necessary for the identification of the non-compliant AI system, the origin of the AI system, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant operator. In particular, the 
market surveillance authorities
 shall indicate whether the non-compliance is due to one or more of the following:




6.   The information referred to in paragraph 5 shall include all available details, in particular the data necessary for the identification of the non-compliant AI system, the origin of the AI system 
and the supply chain
, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant operator. In particular, the 
national supervisory authority
 shall indicate whether the non-compliance is due to one or more of the following:






Amendment 603


Proposal for a regulation


Article 65 — paragraph 6 — point a








Text proposed by the Commission




Amendment











(a)


a failure of the AI system to meet requirements set out 
in Title III, Chapter 2
;












(a)


a failure of the 
high-risk
 AI system to meet requirements set out 
this Regulation
;









Amendment 604


Proposal for a regulation


Article 65 — paragraph 6 — point b a (new)








Text proposed by the Commission




Amendment





 










(b a)






non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5;











Amendment 605


Proposal for a regulation


Article 65 — paragraph 6 — point b b (new)








Text proposed by the Commission




Amendment





 










(b b)






non-compliance with provisions set out in Article 52.











Amendment 606


Proposal for a regulation


Article 65 — paragraph 7








Text proposed by the Commission




Amendment






7.   The 
market surveillance
 authorities of the Member States other than the 
market surveillance
 authority of the Member State initiating the procedure shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the AI system concerned, and, in the event of disagreement with the notified national measure, of their objections.




7.   The 
national supervisory
 authorities of the Member States other than the 
national supervisory
 authority of the Member State initiating the procedure shall without delay inform the Commission
, the AI Office
 and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the AI system concerned, and, in the event of disagreement with the notified national measure, of their objections.






Amendment 607


Proposal for a regulation


Article 65 — paragraph 8








Text proposed by the Commission




Amendment






8.   Where, within three months of receipt of the information referred to in paragraph 5, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified. This is without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation (EU) 2019/1020.




8.   Where, within three months of receipt of the information referred to in paragraph 5, no objection has been raised by either a 
national supervisory authority of a
 Member State or the Commission in respect of a provisional measure taken by a 
national supervisory authority of another
 Member State, that measure shall be deemed justified. This is without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation (EU) 2019/1020. 
The period referred to in the first sentence of this paragraph shall be reduced to thirty days in the event of non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5.








Amendment 608


Proposal for a regulation


Article 65 — paragraph 9








Text proposed by the Commission




Amendment






9.   The 
market surveillance
 authorities of all Member States shall ensure that appropriate restrictive measures are taken in respect of the 
product
 concerned, such as withdrawal of the 
product
 from their market, without delay.




9.   The 
national supervisory
 authorities of all Member States shall ensure that appropriate restrictive measures are taken in respect of the 
AI system
 concerned, such as withdrawal of the 
AI system
 from their market, without delay.






Amendment 609


Proposal for a regulation


Article 65 — paragraph 9 a (new)








Text proposed by the Commission




Amendment





 





9 a.
   
National supervisory authorities shall annually report to the AI Office about the use of prohibited practices that occurred during that year and about the measures taken to eliminate or mitigate the risks in accordance with this Article.








Amendment 610


Proposal for a regulation


Article 66 — paragraph 1








Text proposed by the Commission




Amendment






1.   Where, within three months of receipt of the notification referred to in Article 65(5), objections are raised by a Member State against a measure taken by another 
Member State
, or where the Commission considers the measure to be contrary to Union law, the Commission shall without delay enter into consultation with the relevant Member State and operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not within 
9
 months from the notification referred to in Article 65(5) and notify such decision to the Member State concerned.




1.   Where, within three months of receipt of the notification referred to in Article 65(5), 
or 30 days in the case of non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5,
 objections are raised by 
the national supervisory authority of
 a Member State against a measure taken by another 
national supervisory authority,
 or where the Commission considers the measure to be contrary to Union law, the Commission shall without delay enter into consultation with 
the national supervisory authority of
 the relevant Member State and operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not within 
three
 months
, or 60 days in the case of non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5, starting
 from the notification referred to in Article 65(5) and notify such decision to the 
national supervisory authority of the
 Member State concerned. 
The Commission shall also inform all other national supervisory authorities of such decision.








Amendment 611


Proposal for a regulation


Article 66 — paragraph 2








Text proposed by the Commission




Amendment






2.   If the national measure is considered justified, all 
Member States
 shall take the measures necessary to ensure that the non-compliant AI system is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw the measure.




2.   If the national measure is considered justified, all 
national supervisory authorities designated under this Regulation
 shall take the measures necessary to ensure that the non-compliant AI system is withdrawn from their market 
without delay
, and shall inform the Commission 
and the AI Office
 accordingly. If the national measure is considered unjustified, the 
national supervisory authority of the
 Member State concerned shall withdraw the measure.






Amendment 612


Proposal for a regulation


Article 66 a (new)








Text proposed by the Commission




Amendment





 





Article 66 a





Joint investigations





Where a national supervisory authority has reasons to suspect that the infringement by a provider or a deployer of a high-risk AI system or foundation model to this Regulation amount to a widespread infringement with a Union dimension, or affects or is likely affect at least 45 million individuals, in more than one Member State, that national supervisory authority shall inform the AI Office and may request the national supervisory authorities of the Member States where such infringement took place to start a joint investigation. The AI Office shall provide central coordination to the joint investigation. Investigation powers shall remain within the competence of the national supervisory authorities.








Amendment 613


Proposal for a regulation


Article 67 — paragraph 1








Text proposed by the Commission




Amendment






1.   Where, having performed an evaluation under Article 65, 
the market surveillance
 authority of a Member State finds that although an AI system is in compliance with this Regulation, it presents a risk to the health or safety of persons, to the compliance with obligations under Union or national law intended to protect fundamental rights or to other aspects of public interest protection, it shall require the relevant operator to take all appropriate measures to ensure that the AI system concerned, when placed on the market or put into service, no longer presents that risk
, to withdraw the AI system from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe
.




1.   Where, having performed an evaluation under Article 65, 
in full cooperation with the relevant national public authority referred to in Article 64(3), the national supervisory
 authority of a Member State finds that although an AI system is in compliance with this Regulation, it presents a 
serious
 risk to the health or safety of persons, to the compliance with obligations under Union or national law intended to protect fundamental rights
, or the environment or the democracy and rule of law
 or to other aspects of public interest protection, it shall require the relevant operator to take all appropriate measures to ensure that the AI system concerned, when placed on the market or put into service, no longer presents that risk.






Amendment 614


Proposal for a regulation


Article 67 — paragraph 2








Text proposed by the Commission




Amendment






2.   The provider or other relevant operators shall ensure that corrective action is taken in respect of all the AI systems concerned that they have made available on the market throughout the Union within the timeline prescribed by the 
market surveillance
 authority of the Member State referred to in paragraph 1.




2.   The provider or other relevant operators shall ensure that corrective action is taken in respect of all the AI systems concerned that they have made available on the market throughout the Union within the timeline prescribed by the 
national supervisory authority
 authority of the Member State referred to in paragraph 1.






Amendment 615


Proposal for a regulation


Article 67 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
Where the provider or other relevant operators fail to take corrective action as referred to in paragraph 2 and the AI system continues to present a risk as referred to in paragraph 1, the national supervisory authority may require the relevant operator to withdraw the AI system from the market or to recall it within a reasonable period, commensurate with the nature of the risk.








Amendment 616


Proposal for a regulation


Article 67 — paragraph 3








Text proposed by the Commission




Amendment






3.   The 
Member State
 shall immediately inform the Commission and the other 
Member States
. That information shall include all available details, in particular the data necessary for the identification of the AI system concerned, the origin and the supply chain of the AI system, the nature of the risk involved and the nature and duration of the national measures taken.




3.   The 
national supervisory authority
 shall immediately inform the Commission
, the AI Office
 and the other 
national supervisory authorities
. That information shall include all available details, in particular the data necessary for the identification of the AI system concerned, the origin and the supply chain of the AI system, the nature of the risk involved and the nature and duration of the national measures taken.






Amendment 617


Proposal for a regulation


Article 67 — paragraph 4








Text proposed by the Commission




Amendment






4.   The Commission shall without delay enter into consultation with the 
Member States
 and the relevant operator and shall evaluate the national measures taken. On the basis of the results of that evaluation, the 
Commission
 shall decide whether the measure is justified or not and, where necessary, propose appropriate measures.




4.   The Commission
, in consultation with the AI Office
 shall without delay enter into consultation with the 
national supervisory authorities concerned
 and the relevant operator and shall evaluate the national measures taken. On the basis of the results of that evaluation, the 
AI Office
 shall decide whether the measure is justified or not and, where necessary, propose appropriate measures.






Amendment 618


Proposal for a regulation


Article 67 — paragraph 5








Text proposed by the Commission




Amendment






5.   The Commission shall 
address
 its decision to the Member States.




5.   The Commission
, in consultation with the AI Office
 shall 
immediately communicate
 its decision to the 
national supervisory authorities of the
 Member States 
concerned and to the relevant operators
. 
It shall also inform the decision to all other national supervisory authorities.








Amendment 619


Proposal for a regulation


Article 67 — paragraph 5 a (new)








Text proposed by the Commission




Amendment





 





5 a.
   
The Commission shall adopt guidelines to help national competent authorities to identify and rectify, where necessary, similar problems arising in other AI systems.








Amendment 620


Proposal for a regulation


Article 68 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment






1.   Where the 
market surveillance
 authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the non-compliance concerned:




1.   Where the 
national supervisory
 authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the non-compliance concerned:






Amendment 621


Proposal for a regulation


Article 68 — paragraph 1 — point a








Text proposed by the Commission




Amendment











(a)


the 
conformity
 marking has been affixed in violation of Article 49;












(a)


the 
CE
 marking has been affixed in violation of Article 49;









Amendment 622


Proposal for a regulation


Article 68 — paragraph 1 — point b








Text proposed by the Commission




Amendment











(b)


the 
conformity
 marking has not been affixed;












(b)


the 
CE
 marking has not been affixed;









Amendment 623


Proposal for a regulation


Article 68 — paragraph 1 — point e a (new)








Text proposed by the Commission




Amendment





 










(e a)






the technical documentation is not available;











Amendment 624


Proposal for a regulation


Article 68 — paragraph 1 — point e b (new)








Text proposed by the Commission




Amendment





 










(e b)






the registration in the EU database has not been carried out;











Amendment 625


Proposal for a regulation


Article 68 — paragraph 1 — point e c (new)








Text proposed by the Commission




Amendment





 










(e c)






where applicable, the authorised representative has not been appointed.











Amendment 626


Proposal for a regulation


Article 68 — paragraph 2








Text proposed by the Commission




Amendment






2.   Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take 
all
 appropriate measures to restrict or prohibit the high-risk AI system being made available on the market or ensure that it is recalled or withdrawn from the market.




2.   Where the non-compliance referred to in paragraph 1 persists, the 
national supervisory authority of the
 Member State concerned shall take appropriate 
and proportionate
 measures to restrict or prohibit the high-risk AI system being made available on the market or ensure that it is recalled or withdrawn from the market 
without delay
. 
The national supervisory authority of the Member State concerned shall immediately inform the AI Office of the non-compliance and the measures taken.








Amendment 627


Proposal for a regulation


Article 68 — Chapter 3a (new)








Text proposed by the Commission




Amendment





 










3 a.





Remedies










Amendment 628


Proposal for a regulation


Article 68 a (new)








Text proposed by the Commission




Amendment





 




Article 68 a






 




Right to lodge a complaint with a national supervisory authority






 





1.
   
Without prejudice to any other administrative or judicial remedy, every natural persons or groups of natural persons shall have the right to lodge a complaint with a national supervisory authority, in particular in the Member State of his or her habitual residence, place of work or place of the alleged infringement if they consider that the AI system relating to him or her infringes this Regulation.







 





2.
   
The national supervisory authority with which the complaint has been lodged shall inform the complainant on the progress and the outcome of the complaint including the possibility of a judicial remedy pursuant to Article 78.








Amendment 629


Proposal for a regulation


Article 68 b (new)








Text proposed by the Commission




Amendment





 




Article 68 b






 




Right to an effective judicial remedy against a national supervisory authority






 





1.
   
Without prejudice to any other administrative or non-judicial remedy, each natural or legal person shall have the right to an effective judicial remedy against a legally binding decision of a national supervisory authority concerning them.







 





2.
   
Without prejudice to any other administrative or non-judicial remedy, each natural or legal person shall have the right to a an effective judicial remedy where the national supervisory authority which is competent pursuant to Articles 59 does not handle a complaint or does not inform the data subject within three months on the progress or outcome of the complaint lodged pursuant to Article 68a.







 





3.
   
Proceedings against a national supervisory authority shall be brought before the courts of the Member State where the national supervisory authority is established.







 





4.
   
Where proceedings are brought against a decision of a national supervisory authority which was preceded by an opinion or a decision of the Commission in the union safeguard procedure, the supervisory authority shall forward that opinion or decision to the court.








Amendment 630


Proposal for a regulation


Article 68 c (new)








Text proposed by the Commission




Amendment





 




Article 68 c






 




A right to explanation of individual decision-making






 





1.
   
Any affected person subject to a decision which is taken by the deployer on the basis of the output from an high-risk AI system which produces legal effects or similarly significantly affects him or her in a way that they consider to adversely impact their health, safety, fundamental rights, socio-economic well-being or any other of the rights deriving from the obligations laid down in this Regulation, shall have the right to request from the deployer clear and meaningful explanation pursuant to Article 13(1) on the role of the AI system in the decision-making procedure, the main parameters of the decision taken and the related input data.







 





2.
   
Paragraph 1 shall not apply to the use of AI systems for which exceptions from, or restrictions to, the obligation under paragraph 1 follow from Union or national law are provided in so far as such exception or restrictions respect the essence of the fundamental rights and freedoms and is a necessary and proportionate measure in a democratic society.







 





3.
   
This Article shall apply without prejudice to Articles 13, 14, 15, and 22 of the Regulation 2016/679.








Amendment 631


Proposal for a regulation


Article 68 d (new)








Text proposed by the Commission




Amendment





 




Article 68 d






 




Amendment to Directive (EU) 2020/1828






 




In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council



 (1a)



, the following point is added:






 











‘(67a)





Regulation xxxx/xxxx of the European Parliament and of the Council [laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union legislative acts (OJ L …)]’.











Amendment 632


Proposal for a regulation


Article 68 e (new)








Text proposed by the Commission




Amendment





 





Article 68 e





Reporting of breaches and protection of reporting persons





Directive (EU) 2019/1937 of the European Parliament and of the Council shall apply to the reporting of breaches of this Regulation and the protection of persons reporting such breaches.








Amendment 633


Proposal for a regulation


Article 69 — paragraph 1








Text proposed by the Commission




Amendment






1.   The Commission and the Member States shall encourage and facilitate the drawing up of codes of conduct intended to foster the voluntary application to AI systems other than high-risk AI systems of the requirements set out in Title III, Chapter 2 on the basis of technical specifications and solutions that are appropriate means of ensuring compliance with such requirements in light of the intended purpose of the systems.




1.   The Commission, 
the AI Office
 and the Member States shall encourage and facilitate the drawing up of codes of conduct intended
, including where they are drawn up in order to demonstrate how AI systems respect the principles set out in Article 4a and can thereby be considered trustworthy,
 to foster the voluntary application to AI systems other than high-risk AI systems of the requirements set out in Title III, Chapter 2 on the basis of technical specifications and solutions that are appropriate means of ensuring compliance with such requirements in light of the intended purpose of the systems.






Amendment 634


Proposal for a regulation


Article 69 — paragraph 2








Text proposed by the Commission




Amendment






2.   
The Commission and the Board shall encourage and facilitate the drawing up of
 codes of 
conduct
 intended to foster the voluntary 
application to
 AI systems 
of requirements related for example
 to environmental sustainability
, accessibility for persons with a disability, stakeholders participation in the design and development of the AI systems and diversity of development teams on the basis of clear objectives and key performance indicators to measure the achievement of those objectives
.




2.   Codes of 
conduct
 intended to foster the voluntary 
compliance with the principles underpinning trustworthy AI systems, shall, in particular:







 










(a)






aim for a sufficient level of AI literacy among their staff and other persons dealing with the operation and use of
 AI systems 
in order to observe such principles;










 










(b)






assess to what extent their AI systems may affect vulnerable persons or groups of persons, including children, the elderly, migrants and persons with disabilities or whether measures could be put in place in order to increase accessibility, or otherwise support such persons or groups of persons;










 










(c)






consider the way in which the use of their AI systems may have an impact or can increase diversity, gender balance and equality;










 










(d)






have regard to whether their AI systems can be used in a way that, directly or indirectly, may residually or significantly reinforce existing biases or inequalities;










 










(e)






reflect on the need and relevance of having in place diverse development teams in view of securing an inclusive design of their systems;










 










(f)






give careful consideration to whether their systems can have a negative societal impact, notably concerning political institutions and democratic processes;










 










(g)






evaluate how AI systems can contribute
 to environmental sustainability 
and in particular to the Union’s commitments under the European Green Deal and the European Declaration on Digital Rights and Principles
.









Amendment 635


Proposal for a regulation


Article 69 — paragraph 3








Text proposed by the Commission




Amendment






3.   Codes of conduct may be drawn up by individual providers of AI systems or by organisations representing them or by both, including with the involvement of users and any interested stakeholders and their representative organisations. Codes of conduct may cover one or more AI systems taking into account the similarity of the intended purpose of the relevant systems.




3.   Codes of conduct may be drawn up by individual providers of AI systems or by organisations representing them or by both, including with the involvement of users and any interested stakeholders
, including scientific researchers,
 and their representative 
organisations, in particular trade unions, and consumer
 organisations. Codes of conduct may cover one or more AI systems taking into account the similarity of the intended purpose of the relevant systems. 
Providers adopting codes of conduct will designate at least one natural person responsible for internal monitoring.








Amendment 636


Proposal for a regulation


Article 69 — paragraph 4








Text proposed by the Commission




Amendment






4.   The Commission and the Board shall take into account the specific interests and needs of 
the small-scale providers
 and start-ups when encouraging and facilitating the drawing up of codes of conduct.




4.   The Commission and the 
AI Office
 shall take into account the specific interests and needs of 
SMEs
 and start-ups when encouraging and facilitating the drawing up of codes of conduct.






Amendment 637


Proposal for a regulation


Article 70 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment






1.   National competent authorities and notified bodies involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular:




1.   
The Commission,
 national competent authorities and notified bodies
, the AI Office and any other natural or legal person
 involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular;






Amendment 638


Proposal for a regulation


Article 70 — paragraph 1 — point a








Text proposed by the Commission




Amendment











(a)


intellectual property rights, and confidential business information or trade secrets of a natural or legal person, including source code, except the cases referred to in Article 5 of Directive 2016/943 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure apply.












(a)


intellectual property rights, and confidential business information or trade secrets of a natural or legal person
, in accordance with the provisions of Directives 2004/48/EC and 2016/943/EC
, including source code, except the cases referred to in Article 5 of Directive 2016/943 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure apply;









Amendment 639


Proposal for a regulation


Article 70 — paragraph 1 — point b a (new)








Text proposed by the Commission




Amendment





 










(b a)






public and national security interests











Amendment 640


Proposal for a regulation


Article 70 — paragraph 1 a (new)








Text proposed by the Commission




Amendment





 





1 a.
   
The authorities involved in the application of this Regulation pursuant to paragraph 1 shall minimise the quantity of data requested for disclosure to the data that is strictly necessary for the perceived risk and the assessment of that risk. They shall delete the data as soon as it is no longer needed for the purpose it was requested for. They shall put in place adequate and effective cybersecurity, technical and organisational measures to protect the security and confidentiality of the information and data obtained in carrying out their tasks and activities;








Amendment 641


Proposal for a regulation


Article 70 — paragraph 2 — introductory part








Text proposed by the Commission




Amendment






2.   Without prejudice to 
paragraph 1
, information exchanged on a confidential basis between the national competent authorities and between national competent authorities and the Commission shall not be disclosed without the prior consultation of the originating national competent authority and the 
user
 when high-risk AI systems referred to in points 1, 6 and 7 of Annex III are used by law enforcement, immigration or asylum authorities, when such disclosure would jeopardise public 
and
 national security 
interests.






2.   
Without prejudice to paragraphs 1 and 1a
, information exchanged on a confidential basis between the national competent authorities and between national competent authorities and the Commission shall not be disclosed without the prior consultation of the originating national competent authority and the 
deployer
 when high-risk AI systems referred to in points 1, 6 and 7 of Annex III are used by law enforcement, immigration or asylum authorities, when such disclosure would jeopardise public 
or
 national security.






Amendment 642


Proposal for a regulation


Article 70 — paragraph 3








Text proposed by the Commission




Amendment






3.   Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to the exchange of information and the dissemination of warnings, nor the obligations of the parties concerned to provide information under criminal law of the Member States.




3.   Paragraphs 1
, 1a
 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to the exchange of information and the dissemination of warnings, nor the obligations of the parties concerned to provide information under criminal law of the Member States;






Amendment 643


Proposal for a regulation


Article 70 — paragraph 4








Text proposed by the Commission




Amendment






4.   The Commission and Member States may exchange, where necessary, confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.




4.   The Commission and Member States may exchange, where 
strictly
 necessary 
and in accordance with relevant provisions of international and trade agreements
, confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.






Amendment 644


Proposal for a regulation


Article 71 — title








Text proposed by the Commission




Amendment





Penalties 
and fines




Penalties





Amendment 645


Proposal for a regulation


Article 71 — paragraph 1








Text proposed by the Commission




Amendment






1.   In compliance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties, 
including administrative fines,
 applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are properly and effectively implemented. The penalties provided for shall be effective, proportionate, and dissuasive. They shall take into 
particular
 account the interests of 
small-scale providers and start-up
 and their economic viability.




1.   In compliance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties, applicable to infringements of this Regulation 
by any operator,
 and shall take all measures necessary to ensure that they are properly and effectively implemented 
and aligned with the guidelines issued by the Commission and the AI Office pursuant to Article 82b
. The penalties provided for shall be effective, proportionate, and dissuasive. They shall take into account the interests of 
SMEs and start-ups
 and their economic viability;






Amendment 646


Proposal for a regulation


Article 71 — paragraph 2








Text proposed by the Commission




Amendment






2.   The Member States shall notify the Commission of those rules and of those measures and shall notify 
it
, without delay, of any subsequent amendment affecting them.




2.   The Member States shall notify the Commission 
and the Office by [12 months after the date of entry into force of this Regulation]
 of those rules and of those measures and shall notify 
them
, without delay, of any subsequent amendment affecting them.






Amendment 647


Proposal for a regulation


Article 71 — paragraph 3 — introductory part








Text proposed by the Commission




Amendment






3.   
The following infringements
 shall be subject to administrative fines of up to 
30 000 000 
 EUR or, if the offender is company, up to 
6
 % of its total worldwide annual turnover for the preceding financial year, whichever is higher:




3.   
Non compliance with the prohibition of the artificial intelligence practices referred to in Article 5
 shall be subject to administrative fines of up to 
40 000 000 
 EUR or, if the offender is 
a
 company, up to 
7
 % of its total worldwide annual turnover for the preceding financial year, whichever is higher:






Amendment 648


Proposal for a regulation


Article 71 — paragraph 3 — point a








Text proposed by the Commission




Amendment













(a)






non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5;










deleted







Amendment 649


Proposal for a regulation


Article 71 — paragraph 3 — point b








Text proposed by the Commission




Amendment













(b)






non-compliance of the AI system with the requirements laid down in Article 10.










deleted







Amendment 650


Proposal for a regulation


Article 71 — paragraph 3 a (new)








Text proposed by the Commission




Amendment





 





3 a.
   
Non-compliance of the AI system with the requirements laid down in Article 10 and 13 shall be subject to administrative fines of up to EUR 20 000 000  or, if the offender is a company, up to 4 % of its total worldwide annual turnover for the preceding financial year, whichever is the higher.








Amendment 651


Proposal for a regulation


Article 71 — paragraph 4








Text proposed by the Commission




Amendment






4.   
The
 non-compliance of the AI system with any requirements or obligations under this Regulation, other than those laid down in Articles 5 
and 10
, shall be subject to administrative fines of up to 
20 000 000 
 EUR or, if the offender is a company, up to 
4 %
 of its total worldwide annual turnover for the preceding financial year, whichever is higher.




4.   Non-compliance of the AI system 
or foundation model
 with any requirements or obligations under this Regulation, other than those laid down in Articles 5
, 10 and 13
, shall be subject to administrative fines of up to 
EUR 10 000 000 
 or, if the offender is a company, up to 
2 %
 of its total worldwide annual turnover for the preceding financial year, whichever is higher;






Amendment 652


Proposal for a regulation


Article 71 — paragraph 5








Text proposed by the Commission




Amendment






5.   The supply of incorrect, incomplete or misleading information to notified bodies and national competent authorities in reply to a request shall be subject to administrative fines of up to 
10 000 000 
 EUR or, if the offender is a company, up to 
2
 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.




5.   The supply of incorrect, incomplete or misleading information to notified bodies and national competent authorities in reply to a request shall be subject to administrative fines of up to 
5 000 000 
 EUR or, if the offender is a company, up to 
1
 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.






Amendment 653


Proposal for a regulation


Article 71 — paragraph 6 — introductory part








Text proposed by the Commission




Amendment






6.   
When
 deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following:




6.   
Fines may be imposed in addition to or instead of non-monetary measures such as orders or warnings. When
 deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following;






Amendment 654


Proposal for a regulation


Article 71 — paragraph 6 — point a








Text proposed by the Commission




Amendment











(a)


the nature, gravity and duration of the infringement and of its consequences;












(a)


the nature, gravity and duration of the infringement and of its consequences
, taking into account the purpose of the AI system, as well as, where appropriate, the number of affected persons and the level of damage suffered by them
;









Amendment 655


Proposal for a regulation


Article 71 — paragraph 6 — point b








Text proposed by the Commission




Amendment











(b)


whether administrative fines have been already applied by other 
market surveillance
 authorities to the same operator for the same infringement.












(b)


whether administrative fines have been already applied by other 
national supervisory
 authorities 
of one or more Member States
 to the same operator for the same infringement;









Amendment 656


Proposal for a regulation


Article 71 — paragraph 6 — point c








Text proposed by the Commission




Amendment











(c)


the size and 
market share
 of the operator committing the infringement;












(c)


the size and 
annual turnover
 of the operator committing the infringement;









Amendment 657


Proposal for a regulation


Article 71 — paragraph 6 — point c a (new)








Text proposed by the Commission




Amendment





 










(c a)






any action taken by the operator to mitigate the harm of damage suffered by the affected persons;











Amendment 658


Proposal for a regulation


Article 71 — paragraph 6 — point c b (new)








Text proposed by the Commission




Amendment





 










(c b)






the intentional or negligent character of the infringement;











Amendment 659


Proposal for a regulation


Article 71 — paragraph 6 — point c c (new)








Text proposed by the Commission




Amendment





 










(c c)






the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;











Amendment 660


Proposal for a regulation


Article 71 — paragraph 6 — point c d (new)








Text proposed by the Commission




Amendment





 










(c d)






the degree of responsibility of the operator taking into account the technical and organisational measures implemented by them;











Amendment 661


Proposal for a regulation


Article 71 — paragraph 6 — point c e (new)








Text proposed by the Commission




Amendment





 










(c e)






the manner in which the infringement became known to the national competent authorities, in particular whether, and if so to what extent, the operator notified the infringement;











Amendment 662


Proposal for a regulation


Article 71 — paragraph 6 — point c f (new)








Text proposed by the Commission




Amendment





 










(c f)






adherence to approved codes of conduct or approved certification mechanisms;











Amendment 663


Proposal for a regulation


Article 71 — paragraph 6 — point c g (new)








Text proposed by the Commission




Amendment





 










(c g)






any relevant previous infringements by the operator;











Amendment 664


Proposal for a regulation


Article 71 — paragraph 6 — point c h (new)








Text proposed by the Commission




Amendment





 










(c h)






any other aggravating or mitigating factor applicable to the circumstances of the case.











Amendment 665


Proposal for a regulation


Article 71 — paragraph 7








Text proposed by the Commission




Amendment






7.   Each Member State shall lay down rules on 
whether and to what extent
 administrative fines 
may
 be imposed on public authorities and bodies established in that Member State.




7.   each Member State shall lay down rules on administrative fines 
to
 be imposed on public authorities and bodies established in that Member State;






Amendment 666


Proposal for a regulation


Article 71 — paragraph 8 a (new)








Text proposed by the Commission




Amendment





 





8 a.
   
The penalties referred to in this article as well as the associated litigation costs and indemnification claims may not be the subject of contractual clauses or other form of burden-sharing agreements between providers and distributors, importers, deployers, or any other third parties;








Amendment 667


Proposal for a regulation


Article 71 — paragraph 8 b (new)








Text proposed by the Commission




Amendment





 





8 b.
   
National supervisory authorities shall, on an annual basis, report to the AI Office about the fines they have issued during that year, in accordance with this Article;








Amendment 668


Proposal for a regulation


Article 71 — paragraph 8 c (new)








Text proposed by the Commission




Amendment





 





8 c.
   
The exercise by competent authorities of their powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and national law, including judicial remedy and due process;








Amendment 669


Proposal for a regulation


Article 72 — paragraph 1 — point a








Text proposed by the Commission




Amendment











(a)


the nature, gravity and duration of the infringement and of its consequences;












(a)


the nature, gravity and duration of the infringement and of its consequences;
, taking into account the purpose of the AI system concerned as well as the number of affected persons and the level of damage suffered by them, and any relevant previous infringement;











Amendment 670


Proposal for a regulation


Article 72 — paragraph 1 — point a a (new)








Text proposed by the Commission




Amendment





 










(a a)






any action taken by the Union institution, agency or body to mitigate the damage suffered by affected persons;











Amendment 671


Proposal for a regulation


Article 72 — paragraph 1 — point a b (new)








Text proposed by the Commission




Amendment





 










(a b)






the degree of responsibility of the Union institution, agency or body, taking into account technical and organisational measures implemented by them;











Amendment 672


Proposal for a regulation


Article 72 — paragraph 1 — point b








Text proposed by the Commission




Amendment











(b)


the cooperation with the European Data Protection Supervisor in order to remedy the infringement and mitigate the possible adverse effects of the infringement, including compliance with any of the measures previously ordered by the European Data Protection Supervisor against the Union institution or agency or body concerned with regard to the same subject matter;












(b)


the 
degree of
 cooperation with the European Data Protection Supervisor in order to remedy the infringement and mitigate the possible adverse effects of the infringement, including compliance with any of the measures previously ordered by the European Data Protection Supervisor against the Union institution or agency or body concerned with regard to the same subject matter;









Amendment 673


Proposal for a regulation


Article 72 — paragraph 1 — point c a (new)








Text proposed by the Commission




Amendment





 










(c a)






the manner in which the infringement became known to the European Data Protection Supervisor, in particular whether, and if so to what extent, the Union institution or body notified the infringement;











Amendment 674


Proposal for a regulation


Article 72 — paragraph 1 — point c b (new)








Text proposed by the Commission




Amendment





 










(c b)






the annual budget of the body;











Amendment 675


Proposal for a regulation


Article 72 — paragraph 2 — introductory part








Text proposed by the Commission




Amendment






2.   
The following infringements
 shall be subject to administrative fines of up to 
500 000  EUR
:




2.   
Non compliance with the prohibition of the artificial intelligence practices referred to in Article 5
 shall be subject to administrative fines of up to 
EUR 1 500 000 .








Amendment 676


Proposal for a regulation


Article 72 — paragraph 2 — point a








Text proposed by the Commission




Amendment













(a)






non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5;










deleted







Amendment 677


Proposal for a regulation


Article 72 — paragraph 2 a (new)








Text proposed by the Commission




Amendment





 





2 a.
   
non-compliance of the AI system with the requirements laid down in Article 10 shall be subject to administrative fines of up to 1 000 000  EUR.








Amendment 678


Proposal for a regulation


Article 72 — paragraph 3








Text proposed by the Commission




Amendment






3.   The non-compliance of the AI system with any requirements or obligations under this Regulation, other than those laid down in Articles 5 and 10, shall be subject to administrative fines of up to 
250 000  EUR.






3.   the non-compliance of the AI system with any requirements or obligations under this Regulation, other than those laid down in Articles 5 and 10, shall be subject to administrative fines of up to 
EUR 750 000 .








Amendment 679


Proposal for a regulation


Article 72 — paragraph 6








Text proposed by the Commission




Amendment






6.   Funds collected by imposition of fines in this Article shall 
be the income of
 the general budget of the Union.




6.   Funds collected by imposition of fines in this Article shall 
contribute to
 the general budget of the Union. 
The fines shall not affect the effective operation of the Union institution, body or agency fined.








Amendment 680


Proposal for a regulation


Article 72 — paragraph 6 a (new)








Text proposed by the Commission




Amendment





 





6 a.
   
the European Data Protection Supervisor shall, on an annual basis, notify the AI Office of the fines it has imposed pursuant to this Article.








Amendment 681


Proposal for a regulation


Article 73 — paragraph 2








Text proposed by the Commission




Amendment






2.   The 
delegation of
 power referred to in Article 4, Article 7(1), Article 11(3), Article 43(5) and (6) and Article 48(5) shall be conferred on the Commission for 
an indeterminate
 period of 
time
 from [
entering
 into force of the Regulation].




2.   The power 
to adopt delegated acts
 referred to in Article 4, Article 7(1), Article 11(3), Article 43(5) and (6) and Article 48(5) shall be conferred on the Commission for 
a
 period of 
five years
 from … [
the date of entry
 into force of the Regulation].
The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.








Amendment 682


Proposal for a regulation


Article 73 — paragraph 3 a (new)








Text proposed by the Commission




Amendment





 





3 a.
   
Before adopting a delegated act, the Commission shall consult with the relevant institutions, the Office, the Advisory Forum and other relevant stakeholders in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.







 




Once the Commission decides to draft a delegated act, it shall notify the European Parliament of this fact. This notification does not place an obligation on the Commission to adopt the said act.







Amendment 683


Proposal for a regulation


Article 81 a (new)








Text proposed by the Commission




Amendment





 




Article 81 a






 




Amendment to Regulation (EU) 2019/1020






 




Regulation (EU) 2019/1020 is amended as follows:






 




in Article 14(4), the following paragraph is added:






 










‘(l).






the power to implement the powers provided for in this Article remotely, where applicable;’











Amendment 684


Proposal for a regulation


Article 82 a (new)








Text proposed by the Commission




Amendment





 





Article 82 a





Better Regulation





in taking into account the requirements of this Regulation pursuant to the Amendments in Articles 75, 76, 77, 78, 79, 80, 81, and 82, the Commission shall conduct an analysis and consult relevant stakeholders to determine potential gaps as well as overlaps between existing sectoral legislation and the provisions of this Regulation.








Amendment 685


Proposal for a regulation


Article 82 b (new)








Text proposed by the Commission




Amendment





 




Article 82 b






 




Guidelines from the Commission on the implementation of this Regulation






 





1.
   
The Commission shall develop, in consultation with the AI office, guidelines on the practical implementation of this Regulation, and in particular on:







 










(a)






the application of the requirements referred to in Articles 8 — 15 and Article 28 to 28b;










 










(b)






the prohibited practices referred to in Article 5;










 










(c)






the practical implementation of the provisions related to substantial modification;










 










(d)






the practical circumstances where the output of an AI system referred to in Annex III would pose a significant risk of harm to the health, safety or fundamental rights of natural persons as referred to in Article 6, paragraph 2, including examples in relation to high risk AI systems referred to in Annex III;










 










(e)






the practical implementation of transparency obligations laid down in Article 52;










 










(f)






the development of codes of conduct referred to in Article 69;










 










(g)






the relationship of this Regulation with other relevant Union law, including as regards consistency in their enforcement.










 










(h)






the practical implementation of Article 12, Article 28b on environmental impact of foundation models and Annex IV 3(b), particularly the measurement and logging methods to enable calculations and reporting of the environmental impact of systems to comply with the obligations in this Regulation, including carbon footprint and energy efficiency, taking into account state-of-the-art methods and economies of scale.










 




When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs including start-ups, local public authorities and sectors most likely to be affected by this Regulation.






 





2.
   
Upon request of the Member States or the AI Office, or on its own initiative, the Commission shall update already adopted guidelines when deemed necessary.








Amendment 686


Proposal for a regulation


Article 83 — paragraph 1 — introductory part








Text proposed by the Commission




Amendment






1.   
This Regulation shall not apply to
 the AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex IX that have been placed on the market or put into service 
before [12 months after
 the date of 
application
 of this Regulation 
referred to in Article 85(2)], unless the replacement or amendment of those legal acts leads to a significant change in the design or intended purpose of the AI system or AI systems concerned.






1.   
Operators of
 the AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex IX that have been placed on the market or put into service 
prior to … [
the date of 
entry into force
 of this Regulation
] shall take the necessary steps to comply with the requirements laid down in this Regulation by … [four years after the date of entry into force of this Regulation]
.






Amendment 687


Proposal for a regulation


Article 83 — paragraph 1 — subparagraph 1








Text proposed by the Commission




Amendment





The requirements laid down in this Regulation shall be taken into account
, where applicable,
 in the evaluation of each large-scale IT systems established by the legal acts listed in Annex IX to be undertaken as provided for in those respective acts.


The requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT systems established by the legal acts listed in Annex IX to be undertaken as provided for in those respective acts 
and whenever those legal acts are replaced or amended.







Amendment 688


Proposal for a regulation


Article 83 — paragraph 2








Text proposed by the Commission




Amendment






2.   This Regulation shall apply to 
the
 high-risk AI systems, other than the ones referred to in paragraph 1, that have been placed on the market or put into service before [date of application of this Regulation referred to in Article 85(2)], only if, from that date, those systems are subject to 
significant changes in their design or
 intended 
purpose.






2.   This Regulation shall apply to 
operators of
 high-risk AI systems, other than the ones referred to in paragraph 1, that have been placed on the market or put into service before [date of application of this Regulation referred to in Article 85(2)], only if, from that date, those systems are subject to 
substantial modifications as defined in Article 3(23). In the case of high-risk AI systems
 intended 
to be used by public authorities, providers and deployers of such systems shall take the necessary steps to comply with the requirements of the present Regulation [two years after the date of entry into force of this Regulation]
.






Amendment 689


Proposal for a regulation


Article 84 — paragraph 1








Text proposed by the Commission




Amendment






1.   The Commission shall assess the need for amendment of the list in Annex III once a year following the entry into force of this Regulation.




1.   
After consulting the AI Office,
 the Commission shall assess the need for amendment of the list in Annex III
, including the extension of existing area headings or addition of new area headings in that Annex the list of prohibited AI practices in Article 5, and the list of AI systems requiring additional transparency measures in Article 52
 once a year following the entry into force of this Regulation 
and following a recommendation of the Office.







 




the Commission shall submit the findings of that assessment to the European Parliament and the Council.







Amendment 690


Proposal for a regulation


Article 84 — paragraph 2








Text proposed by the Commission




Amendment






2.   By [
three
 years after the date of application of this Regulation referred to in Article 85(2)] and every 
four
 years thereafter, the Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The reports shall be made public.




2.   By … [
two
 years after the date of application of this Regulation referred to in Article 85(2)] and every 
two
 years thereafter, the Commission
, together with the AI office,
 shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The reports shall be made public.






Amendment 691


Proposal for a regulation


Article 84 — paragraph 3 — point a








Text proposed by the Commission




Amendment











(a)


the status of the financial and human resources of the national competent authorities in order to effectively perform the tasks assigned to them under this Regulation;












(a)


the status of the financial
, technical
 and human resources of the national competent authorities in order to effectively perform the tasks assigned to them under this Regulation;









Amendment 692


Proposal for a regulation


Article 84 — paragraph 3 — point b a (new)








Text proposed by the Commission




Amendment





 










(b a)






the level of the development of harmonised standards and common specifications for Artificial Intelligence;











Amendment 693


Proposal for a regulation


Article 84 — paragraph 3 — point b b (new)








Text proposed by the Commission




Amendment





 










(b b)






the levels of investments in research, development and application of AI systems throughout the Union;











Amendment 694


Proposal for a regulation


Article 84 — paragraph 3 — point b c (new)








Text proposed by the Commission




Amendment





 










(b c)






the competitiveness of the aggregated European AI sector compared to AI sectors in third countries;











Amendment 695


Proposal for a regulation


Article 84 — paragraph 3 — point b d (new)








Text proposed by the Commission




Amendment





 










(b d)






the impact of the Regulation with regards to the resource and energy use, as well as waste production and other environmental impact;











Amendment 696


Proposal for a regulation


Article 84 — paragraph 3 — point b e (new)








Text proposed by the Commission




Amendment





 










(b e)






the implementation of the coordinated plan on AI, taking into account the different level of progress among Member States and identifying existing barriers to innovation in AI;











Amendment 697


Proposal for a regulation


Article 84 — paragraph 3 — point b f (new)








Text proposed by the Commission




Amendment





 










(b f)






the update of the specific requirements regarding the sustainability of AI systems and foundation models, building on the reporting and documentation requirement in Annex IV and in Article 28b;











Amendment 698


Proposal for a regulation


Article 84 — paragraph 3 — point b g (new)








Text proposed by the Commission




Amendment





 










(b g)






the legal regime governing foundation models;











Amendment 699


Proposal for a regulation


Article 84 — paragraph 3 — point b h (new)








Text proposed by the Commission




Amendment





 










(b h)






the list of unfair contractual terms within Article 28a taking into account new business practices if necessary;











Amendment 700


Proposal for a regulation


Article 84 — paragraph 3 a (new)








Text proposed by the Commission




Amendment





 





3 a.
   
By … [two years after the date of entry into application of this Regulation referred to in Article 85(2)] the Commission shall evaluate the functioning of the AI office, whether the office has been given sufficient powers and competences to fulfil its tasks and whether it would be relevant and needed for the proper implementation and enforcement of this Regulation to upgrade the Office and its enforcement competences and to increase its resources. The Commission shall submit this evaluation report to the European Parliament and to the Council.








Amendment 701


Proposal for a regulation


Article 84 — paragraph 4








Text proposed by the Commission




Amendment






4.   Within [
three years
 after the date of application of this Regulation referred to in Article 85(2)] and every 
four
 years thereafter, the Commission shall evaluate the impact and effectiveness of codes of conduct to foster the application of the requirements set out in Title III, Chapter 2 and possibly other additional requirements for AI systems other than high-risk AI systems.




4.   Within … [
one year
 after the date of application of this Regulation referred to in Article 85(2)] and every 
two
 years thereafter, the Commission shall evaluate the impact and effectiveness of codes of conduct to foster the application of the requirements set out in Title III, Chapter 2 and possibly other additional requirements for AI systems other than high-risk AI systems;






Amendment 702


Proposal for a regulation


Article 84 — paragraph 5








Text proposed by the Commission




Amendment






5.   For the purpose of paragraphs 1 to 4 the 
Board
, the Member States and national competent authorities shall provide the Commission with information on its request.




5.   For the purpose of paragraphs 1 to 4 the 
AI Office
, the Member States and national competent authorities shall provide the Commission with information on its request 
without undue delay.








Amendment 703


Proposal for a regulation


Article 84 — paragraph 6








Text proposed by the Commission




Amendment






6.   In carrying out the evaluations and reviews referred to in paragraphs 1 to 4 the Commission shall take into account the positions and findings of the 
Board,
 of the European Parliament, of the Council, and of other relevant bodies or sources.




6.   in carrying out the evaluations and reviews referred to in paragraphs 1 to 4 the Commission shall take into account the positions and findings of the 
-AI Office
 of the European Parliament, of the Council, and of other relevant bodies or sources 
and shall consult relevant stakeholders
. 
The result of such consultation shall be attached to the report;








Amendment 704


Proposal for a regulation


Article 84 — paragraph 7








Text proposed by the Commission




Amendment






7.   The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into account developments in technology and in the light of the state of progress in the information society.




7.   the Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into account developments in technology
, the effect of AI systems on health and safety, fundamental rights, the environment, equality, and accessibility for persons with disabilities, democracy and rule of law
 and in the light of the state of progress in the information society.






Amendment 705


Proposal for a regulation


Article 84 — paragraph 7 a (new)








Text proposed by the Commission




Amendment





 





7 a.
   
To guide the evaluations and reviews referred to in paragraphs 1 to 4 of this Article, the Office shall undertake to develop an objective and participative methodology for the evaluation of risk level based on the criteria outlined in the relevant articles and inclusion of new systems in: the list in Annex III, including the extension of existing area headings or addition of new area headings in that Annex; the list of prohibited practices laid down in Article 5; and the list of AI systems requiring additional transparency measures pursuant to Article 52.








Amendment 706


Proposal for a regulation


Article 84 — paragraph 7 b (new)








Text proposed by the Commission




Amendment





 





7 b.
   
Any amendment to this Regulation pursuant to paragraph 7 of this Article, or relevant future delegated or implementing acts, which concern sectoral legislation listed in Annex II Ssection B, shall take into account the regulatory specificities of each sector, and existing governance, conformity assessment and enforcement mechanisms and authorities established therein.








Amendment 707


Proposal for a regulation


Article 84 — paragraph 7 c (new)








Text proposed by the Commission




Amendment





 





7 c.
   
By … [five years from the date of application of this Regulation], the Commission shall carry out an assessment of the enforcement of this Regulation and shall report it to the European Parliament, the Council and the European Economic and Social Committee, taking into account the first years of application of the Regulation. On the basis of the findings that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation with regard to the structure of enforcement and the need for an Union agency to resolve any identified shortcomings.








Amendment 708


Proposal for a regulation


Annex I








Text proposed by the Commission




Amendment







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






deleted














(a)






Machine learning approaches, including supervised, unsupervised and reinforcement learning, using a wide variety of methods including deep learning;








 












(b)






Logic- and knowledge-based approaches, including knowledge representation, inductive (logic) programming, knowledge bases, inference and deductive engines, (symbolic) reasoning and expert systems;








 












(c)






Statistical approaches, Bayesian estimation, search and optimization methods.








 





Amendment 709


Proposal for a regulation


Annex III — paragraph 1 — introductory part








Text proposed by the Commission




Amendment





High-risk AI systems pursuant to Article 6(2) 
are the AI systems listed in any of the following areas
:




The AI systems specifically refered to in under points 1 to 8a stand for critical use cases and are each considered to be
 high-risk AI systems pursuant to Article 6(2)
, provided that they fulfil the criteria set out in that Article
:





Amendment 710


Proposal for a regulation


Annex III — paragraph 1 — point 1 — introductory part








Text proposed by the Commission




Amendment











1.


Biometric 
identification and categorisation of natural persons:














1.


Biometric 
and biometrics-based systems











Amendment 711


Proposal for a regulation


Annex III — paragraph 1 — point 1 — point a








Text proposed by the Commission




Amendment











(a)


AI systems intended to be used for 
the ‘real-time’ and ‘post’ remote
 biometric identification of natural persons;












(a)


AI systems intended to be used for biometric identification of natural persons
, with the exception of those mentioned in Article 5
;









Amendment 712


Proposal for a regulation


Annex III — paragraph 1 — point 1 — point a a (new)








Text proposed by the Commission




Amendment





 










(a a)






AI systems intended to be used to make inferences about personal characteristics of natural persons on the basis of biometric or biometrics-based data, including emotion recognition systems, with the exception of those mentioned in Article 5;










 




Point 1 shall not include AI systems intended to be used for biometric verification whose sole purpose is to confirm that a specific natural person is the person he or she claims to be.







Amendment 713


Proposal for a regulation


Annex III — paragraph 1 — point 2 — point a








Text proposed by the Commission




Amendment











(a)


AI systems intended to be used as safety components in the management and operation of road traffic 
and the supply of water, gas, heating and electricity
.












(a)


AI systems intended to be used as safety components in the management and operation of road
, rail and air
 traffic 
unless they are regulated in harmonisation or sectoral law
.









Amendment 714


Proposal for a regulation


Annex III — paragraph 1 — point 2 — point a a (new)








Text proposed by the Commission




Amendment





 










(a a)






AI systems intended to be used as safety components in the management and operation of the supply of water, gas, heating, electricity and critical digital infrastructure;











Amendment 715


Proposal for a regulation


Annex III — paragraph 1 — point 3 — point a








Text proposed by the Commission




Amendment











(a)


AI systems intended to be used for the purpose of determining access or assigning natural persons to educational and vocational training institutions;












(a)


AI systems intended to be used for the purpose of determining access 
or materially influence decisions on admission
 or assigning natural persons to educational and vocational training institutions;









Amendment 716


Proposal for a regulation


Annex III — paragraph 1 — point 3 — point b








Text proposed by the Commission




Amendment











(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.












(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 
those
 institutions;









Amendment 717


Proposal for a regulation


Annex III — paragraph 1 — point 3 — point b a (new)








Text proposed by the Commission




Amendment





 










(b a)






AI systems intended to be used for the purpose of assessing the appropriate level of education for an individual and materially influencing the level of education and vocational training that individual will receive or will be able to access;











Amendment 718


Proposal for a regulation


Annex III — paragraph 1 — point 3 — point b b (new)








Text proposed by the Commission




Amendment





 










(b b)






AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the context of/within education and vocational training institutions;











Amendment 719


Proposal for a regulation


Annex III — paragraph 1 — point 4 — point a








Text proposed by the Commission




Amendment











(a)


AI systems intended to be used for recruitment or selection of natural persons, notably for 
advertising vacancies
, screening or filtering applications, evaluating candidates in the course of interviews or tests;












(a)


AI systems intended to be used for recruitment or selection of natural persons, notably for 
placing targeted job advertisements
 screening or filtering applications, evaluating candidates in the course of interviews or tests;









Amendment 720


Proposal for a regulation


Annex III — paragraph 1 — point 4 — point b








Text proposed by the Commission




Amendment











(b)


AI intended to be used 
for making
 decisions 
on
 promotion and termination of work-related contractual relationships, 
for
 task allocation 
and
 for monitoring and evaluating performance and behavior of persons in such relationships.












(b)


AI 
systems
 intended to be used 
to make or materially influence
 decisions 
affecting the initiation,
 promotion and termination of work-related contractual relationships, task allocation 
based on individual behaviour or personal traits or characteristics, or
 for monitoring and evaluating performance and behavior of persons in such relationships;









Amendment 721


Proposal for a regulation


Annex III — paragraph 1 — point 5 — point a








Text proposed by the Commission




Amendment











(a)


AI systems intended to be used by 
public authorities
 or on behalf of public authorities to evaluate the eligibility of natural persons for public assistance benefits and services, as well as to grant, reduce, revoke, or reclaim such benefits and services;












(a)


AI systems intended to be used by or on behalf of public authorities to evaluate the eligibility of natural persons for public assistance benefits and services, 
including healthcare services and essential services, including but not limited to housing, electricity, heating/cooling and internet,
 as well as to grant, reduce, revoke, 
increase
 or reclaim such benefits and services;









Amendment 722


Proposal for a regulation


Annex III — paragraph 1 — point 5 — point b








Text proposed by the Commission




Amendment











(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;














(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 
used for the purpose of detecting financial fraud;











Amendment 723


Proposal for a regulation


Annex III — paragraph 1 — point 5 — point b a (new)








Text proposed by the Commission




Amendment





 










(b a)






AI systems intended to be used for making decisions or materially influencing decisions on the eligibility of natural persons for health and life insurance;











Amendment 724


Proposal for a regulation


Annex III — paragraph 1 — point 5 — point c








Text proposed by the Commission




Amendment











(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.












(c)


AI systems intended 
to evaluate and classify emergency calls by natural persons or
 to be used to dispatch, or to establish priority in the dispatching of emergency first response services, including by 
police and law enforcement,
 firefighters and medical aid
, as well as of emergency healthcare patient triage systems;











Amendment 725


Proposal for a regulation


Annex III — paragraph 1 — point 6 — point a








Text proposed by the Commission




Amendment













(a)






AI systems intended to be used by law enforcement authorities for making individual risk assessments of natural persons in order to assess the risk of a natural person for offending or reoffending or the risk for potential victims of criminal offences;










deleted







Amendment 726


Proposal for a regulation


Annex III — paragraph 1 — point 6 — point b








Text proposed by the Commission




Amendment











(b)


AI systems intended to be used by law enforcement authorities as polygraphs and similar tools 
or to detect the emotional state of a natural person;














(b)


AI systems intended to be used by 
or on behalf of law enforcement authorities, or by Union agencies, offices or bodies in support of
 law enforcement authorities as polygraphs and similar tools, 
insofar as their use is permitted under relevant Union and national law;











Amendment 727


Proposal for a regulation


Annex III — paragraph 1 — point 6 — point c








Text proposed by the Commission




Amendment













(c)






AI systems intended to be used by law enforcement authorities to detect deep fakes as referred to in article 52(3);










deleted







Amendment 728


Proposal for a regulation


Annex III — paragraph 1 — point 6 — point d








Text proposed by the Commission




Amendment











(d)


AI systems intended to be used by law enforcement authorities 
for evaluation of
 the reliability of evidence in the course of investigation or prosecution of criminal offences;












(d)


AI systems intended to be used by 
or on behalf of law enforcement authorities, or by Union agencies, offices or bodies in support of
 law enforcement authorities 
to evaluate
 the reliability of evidence in the course of investigation or prosecution of criminal offences;









Amendment 729


Proposal for a regulation


Annex III — paragraph 1 — point 6 — point e








Text proposed by the Commission




Amendment













(e)






AI systems intended to be used by law enforcement authorities for predicting the occurrence or reoccurrence of an actual or potential criminal offence based on profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 or assessing personality traits and characteristics or past criminal behaviour of natural persons or groups;










deleted







Amendment 730


Proposal for a regulation


Annex III — paragraph 1 — point 6 — point f








Text proposed by the Commission




Amendment











(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;












(f)


AI systems intended to be used by 
or on behalf of law enforcement authorities or by Union agencies, offices or bodies in support of
 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 
or, in the case of Union agencies, offices or bodies, as referred to in Article 3(5) of Regulation (EU) 2018/1725
;









Amendment 731


Proposal for a regulation


Annex III — paragraph 1 — point 6 — point g








Text proposed by the Commission




Amendment











(g)


AI systems intended to be used for crime analytics regarding natural persons, allowing law enforcement authorities to search complex related and unrelated large data sets available in different data sources or in different data formats in order to identify unknown patterns or discover hidden relationships in the data.












(g)


AI systems intended to be used 
by or on behalf of law enforcement authorities or by Union agencies, offices or bodies in support of law enforcement authorities
 for crime analytics regarding natural persons, allowing law enforcement authorities to search complex related and unrelated large data sets available in different data sources or in different data formats in order to identify unknown patterns or discover hidden relationships in the data.









Amendment 732


Proposal for a regulation


Annex III — paragraph 1 — point 7 — point a








Text proposed by the Commission




Amendment











(a)


AI systems intended to be used by competent public authorities as polygraphs and similar tools 
or to detect the emotional state of a natural person;














(a)


AI systems intended to be used by 
or on behalf of
 competent public authorities 
or by Union agencies, offices or bodies
 as polygraphs and similar tools 
insofar as their use is permitted under relevant Union or national law











Amendment 733


Proposal for a regulation


Annex III — paragraph 1 — point 7 — point b








Text proposed by the Commission




Amendment











(b)


AI systems intended to be used by competent public authorities to assess a risk, including a security risk, a risk of irregular immigration, or a health risk, posed by a natural person who intends to enter or has entered into the territory of a Member State;












(b)


AI systems intended to be used by 
or on behalf of
 competent public 
authorities or by Union agencies, offices or bodies
 to assess a risk, including a security risk, a risk of irregular immigration, or a health risk, posed by a natural person who intends to enter or has entered into the territory of a Member State;









Amendment 734


Proposal for a regulation


Annex III — paragraph 1 — point 7 — point c








Text proposed by the Commission




Amendment











(c)


AI systems intended to be used by competent public authorities for the verification of the authenticity of travel documents and supporting documentation of natural persons and detect non-authentic documents by checking their security features;












(c)


AI systems intended to be used by 
or on behalf of
 competent public 
authorities or by Union agencies, offices or bodies
 for the verification of the authenticity of travel documents and supporting documentation of natural persons and detect non-authentic documents by checking their security features;









Amendment 735


Proposal for a regulation


Annex III — paragraph 1 — point 7 — point d








Text proposed by the Commission




Amendment











(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.












(d)


AI systems intended 
to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies
 to assist competent public authorities for the examination 
and assessment of the veracity of evidence in relation to
 applications for asylum, visa and residence permits and associated complaints with regard to the eligibility of the natural persons applying for a status;









Amendment 736


Proposal for a regulation


Annex III — paragraph 1 — point 7 — point d a (new)








Text proposed by the Commission




Amendment





 










(d a)






AI systems intended to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies in migration, asylum and border control management to monitor, surveil or process data in the context of border management activities, for the purpose of detecting, recognising or identifying natural persons;











Amendment 737


Proposal for a regulation


Annex III — paragraph 1 — point 7 — point d b (new)








Text proposed by the Commission




Amendment





 










(d b)






AI systems intended to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies in migration, asylum and border control management for the forecasting or prediction of trends related to migration movement and border crossing;











Amendment 738


Proposal for a regulation


Annex III — paragraph 1 — point 8 — point a








Text proposed by the Commission




Amendment











(a)


AI systems intended to assist a judicial authority in researching and interpreting facts and the law and in applying the law to a concrete set of facts.












(a)


AI systems intended 
to be used by a judicial authority ot administrative body or on their behalf
 to assist a judicial authority 
or administrative body
 in researching and interpreting facts and the law and in applying the law to a concrete set of facts 
or used in a similar way in alternative dispute resolution
.









Amendment 739


Proposal for a regulation


Annex III — paragraph 1 — point 8 — point a a (new)








Text proposed by the Commission




Amendment





 










(a a)






AI systems intended to be used for influencing the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI systems whose output natural persons are not directly exposed to, such as tools used to organise, optimise and structure political campaigns from an administrative and logistic point of view.











Amendment 740


Proposal for a regulation


Annex III — paragraph 1 — point 8 — point a b (new)








Text proposed by the Commission




Amendment





 










(a b)






AI systems intended to be used by social media platforms that have been designated as very large online platforms within the meaning of Article 33 of Regulation EU 2022/2065, in their recommender systems to recommend to the recipient of the service user-generated content available on the platform.











Amendment 741


Proposal for a regulation


Annex IV — paragraph 1 — point 1 — point a








Text proposed by the Commission




Amendment











(a)


its intended purpose, the 
person/s developing the system the date
 and the version of the system;












(a)


its intended purpose, the 
name of the provider
 and the version of the system 
reflecting its relation to previous and, where applicable, more recent, versions in the succession of revisions
;









Amendment 742


Proposal for a regulation


Annex IV — paragraph 1 — point 1 — point a a (new)








Text proposed by the Commission




Amendment





 










(a a)






the nature of data likely or intended to be processed by the system and, in the case of personal data, the categories of natural persons and groups likely or intended to be affected;











Amendment 743


Proposal for a regulation


Annex IV — paragraph 1 — point 1 — point b








Text proposed by the Commission




Amendment











(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;












(b)


how the AI system 
can interact
 or can be used to interact with hardware or software
, including other AI systems, that are
 not part of the AI system itself, where applicable;









Amendment 744


Proposal for a regulation


Annex IV — paragraph 1 — point 1 — point c








Text proposed by the Commission




Amendment











(c)


the versions of relevant software or firmware and any requirement related to version update;












(c)


the versions of relevant software or firmware and
, where applicable, information for the deployer on
 any requirement related to version update;









Amendment 745


Proposal for a regulation


Annex IV — paragraph 1 — point 1 — point d








Text proposed by the Commission




Amendment











(d)


the description of 
all forms in which
 the AI system 
is
 placed on the market or put into service;












(d)


the description of 
the various configurations and variants of
 the AI system 
which are intended to be
 placed on the market or put into service;









Amendment 746


Proposal for a regulation


Annex IV — paragraph 1 — point 1 — point f a (new)








Text proposed by the Commission




Amendment





 










(f a)






the description of the deployer interface;











Amendment 747


Proposal for a regulation


Annex IV — paragraph 1 — point 1 — point g








Text proposed by the Commission




Amendment











(g)


instructions of use for the 
user
 and, where applicable installation instructions;












(g)


instructions of use for the 
deployer in accordance with Article 13(2) and (3) as well as 14(4)(e)
 and, where applicable installation instructions;









Amendment 748


Proposal for a regulation


Annex IV — paragraph 1 — point 1 — point g a (new)








Text proposed by the Commission




Amendment





 










(g a)






a detailed and easily intellegible description of the system’s main optimisation goal or goals;











Amendment 749


Proposal for a regulation


Annex IV — paragraph 1 — point 1 — point g b (new)








Text proposed by the Commission




Amendment





 










(g b)






a detailed and easily intellegible description of the system’s expected output and expected output quality;











Amendment 750


Proposal for a regulation


Annex IV — paragraph 1 — point 1 — point g c (new)








Text proposed by the Commission




Amendment





 










(g c)






detailed and easily intellegible instructions for interpreting the system’s output;











Amendment 751


Proposal for a regulation


Annex IV — paragraph 1 — point 1 — point g d (new)








Text proposed by the Commission




Amendment





 










(g d)






examples of scenarios for which the system should not be used;











Amendment 752


Proposal for a regulation


Annex IV — paragraph 1 — point 2 — point b








Text proposed by the Commission




Amendment











(b)




the
 design specifications 
of the system, namely the general
 logic of the AI system 
and of the algorithms
; the key design choices including the rationale and assumptions made, also with regard to persons or groups of persons on which the system is intended to be used; the main classification choices; what the system is designed to optimise for and the relevance of the different parameters; the decisions about any possible trade-off made regarding the technical solutions adopted to comply with the requirements set out in Title III, Chapter 2;












(b)




a description of the architecture,
 design specifications
, algorithms and the data structures including a decomposition of its components and interfaces, how they relate to one another and how they provide for the overall processing or
 logic of the AI system; 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;









Amendment 753


Proposal for a regulation


Annex IV — paragraph 1 — point 2 — point c








Text proposed by the Commission




Amendment











(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;














(c)




deleted











Amendment 754


Proposal for a regulation


Annex IV — paragraph 1 — point 2 — point e








Text proposed by the Commission




Amendment











(e)


assessment of the human oversight measures needed in accordance with Article 14, including an assessment of the technical measures needed to facilitate the interpretation of the outputs of AI systems by the 
users
, in accordance with Articles 13(3)(d);












(e)


assessment of the human oversight measures needed in accordance with Article 14, including an assessment of the technical measures needed to facilitate the interpretation of the outputs of AI systems by the 
deployers
, in accordance with Articles 13(3)(d);









Amendment 755


Proposal for a regulation


Annex IV — paragraph 1 — point 2 — point g








Text proposed by the Commission




Amendment











(g)


the validation and testing procedures used, including information about the validation and testing data used and their main characteristics; metrics used to measure accuracy, robustness
, cybersecurity
 and compliance with other relevant requirements set out in Title III, Chapter 2 as well as potentially discriminatory impacts; test logs and all test reports dated and signed by the responsible persons, including with regard to pre-determined changes as referred to under point (f).












(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 and compliance with other relevant requirements set out in Title III, Chapter 2 as well as potentially discriminatory impacts; test logs and all test reports dated and signed by the responsible persons, including with regard to pre-determined changes as referred to under point (f).









Amendment 756


Proposal for a regulation


Annex IV — paragraph 1 — point 2 — point g a (new)








Text proposed by the Commission




Amendment





 










(g a)






cybersecurity measures put in place.











Amendment 757


Proposal for a regulation


Annex IV — paragraph 1 — point 3








Text proposed by the Commission




Amendment











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 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;












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 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 
deployers
; specifications on input data, as appropriate;









Amendment 758


Proposal for a regulation


Annex IV — paragraph 1 — point 3 a (new)








Text proposed by the Commission




Amendment





 










3 a.





A description of the appropriateness of the performance metrics for the specific AI system;










Amendment 759


Proposal for a regulation


Annex IV — paragraph 1 — point 3 b (new)








Text proposed by the Commission




Amendment





 










3 b.





Information about the energy consumption of the AI system during the development phase and the expected energy consumption during use, taking into account, where applicable, relevant Union and national law;










Amendment 760


Proposal for a regulation


Annex IV — paragraph 1 — point 5








Text proposed by the Commission




Amendment











5.


A description of any change made to the system through its lifecycle;












5.


A description of any 
relevant
 change made 
by providers
 to the system through its 
lifecycle
;









Amendment 761


Proposal for a regulation


Annex IV — paragraph 1 — point 6








Text proposed by the Commission




Amendment











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;












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 
or common
 specifications applied;









Amendment 762


Proposal for a regulation


Annex V — paragraph 1 — point 4 a (new)








Text proposed by the Commission




Amendment





 










4 a.





Where an AI system involves the processing of personal data, a statement that that AI system complies with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680.










Amendment 763


Proposal for a regulation


Annex V — paragraph 1 — point 7








Text proposed by the Commission




Amendment











7.


Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.












7.


Place and date of issue of the declaration
, signature
, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.









Amendment 764


Proposal for a regulation


Annex VII — point 4 — point 4.5








Text proposed by the Commission




Amendment











4.5.


Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Title III, Chapter 2 and upon a reasoned request, the notified body shall also be granted access to the 
source code
 of the AI system.












4.5.


Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Title III, Chapter 2
, after all other reasonable ways to verify conformity have been exhausted and have proven to be insufficient,
 and upon a reasoned request, the notified body shall also be granted access to the 
training and trained models
 of the AI system
, including its relevant parameters
. 
Such access shall be subject to existing Union law on the protection of intellectual property and trade secrets. They shall take technical and organisational measures to ensure the protection of intellectual property and trade secrets.











Amendment 765


Proposal for a regulation


Annex VIII — paragraph 1








Text proposed by the Commission




Amendment





The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51.




Section A -
 The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51 
(1)
.





Amendment 766


Proposal for a regulation


Annex VIII — point 4 a (new)








Text proposed by the Commission




Amendment





 










4 a.





Foundation model trade name and any additional unambiguous refernce allowing identification and traceability










Amendment 767


Proposal for a regulation


Annex VIII — point 5








Text proposed by the Commission




Amendment











5.


Description of the intended purpose of the AI system;












5.




A simple and comprehensible
 description of








 










a.




the intended purpose of the AI system;








 










b.






the components and functions supported through AI;










 










c.






a basic explanation of the logic of the AI system











Amendment 768


Proposal for a regulation


Annex VIII — point 5 a (new)








Text proposed by the Commission




Amendment





 










5 a.





where applicable, the categories and nature of data likely or foreseen to be processed by the AI system.










Amendment 769


Proposal for a regulation


Annex VIII — point 11








Text proposed by the Commission




Amendment













11.





Electronic instructions for use; this information shall not be provided for high-risk AI systems in the areas of law enforcement and migration, asylum and border control management referred to in Annex III, points 1, 6 and 7.









deleted







Amendment 770


Proposal for a regulation


ANNEX VIII — SECTION B (new)








Text proposed by the Commission




Amendment





 




SECTION B — The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51 (1a) (a) and (1b).






 










1.





the name, address and contact details of the deployer;









 










2.





the name, address and contact details of the person submitting information on behalf of the deployer;









 










3.





the high risk AI system trade name and any additional unambiguous reference allowing identification and traceability of the AI system used;









 










4.





a) A simple and comprehensible description of the intended use of the AI system, including the specific outcomes sought through the use of the systemn, the geographic and temporal scope of application









 










b.






Where applicable, the categories and nature of data to be processed by the AI system;










 










c.






Arrangements for human oversight and governance










 










d.






Where relevant, the bodies or natural persons responsible for decisions taken or supported by the AI system;










 










5.





a summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 29a









 










6.





The URL of the entry of the AI system in the EU database by its provider









 










7.





A summary of the data protection impact assessment carried out in accordance with Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680 as specified in paragraph 6 of Article 29 of this Regulation, where applicable.










Amendment 771


Proposal for a regulation


Annex VIII — Section C (new)








Text proposed by the Commission




Amendment





 




Section C — The following information shall be provided and thereafter kept up to date with regard to foundation models to be registered in accordance with Article 28b (e).






 










1.





Name, address and contact details of the provider;









 










2.





Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person;









 










3.





Name, address and contact details of the authorised representative, where applicable;









 










4.





Trade name and any additional unambiguous reference allowing the identification of the foundation model









 










5.





Description of the data sources used in the development of the foundational model









 










6.





Description of the capabilities and limitations of the foundation model, including the reasonably foreseeable risks and the measures that have been taken to mitigate them as well as remaining non-mitigated risks with an explanation on the reason why they cannot be mitigated









 










7.





Description of the training resources used by the foundation model including computing power required, training time, and other relevant information related to the size and power of the model 8. Description of the model’s performance, including on public benchmarks or state of the art industry benchmarks









 










8.





Description of the results of relevant internal and external testing and optimisation of the model









 










9.





Member States in which the foundation model is or has been placed on the market, put into service or made available in the Union;









 










10.





URL for additional information (optional).











(1)  The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A9-0188/2023).

(33)  European Council, Special meeting of the European Council (1 and 2 October 2020) — Conclusions, EUCO 13/20, 2020, p. 6.

(34)  European Parliament resolution of 20 October 2020 with recommendations to the Commission on a framework of ethical aspects of artificial intelligence, robotics and related technologies, 2020/2012(INL).

(33)  European Council, Special meeting of the European Council (1 and 2 October 2020) — Conclusions, EUCO 13/20, 2020, p. 6.

(34)  European Parliament resolution of 20 October 2020 with recommendations to the Commission on a framework of ethical aspects of artificial intelligence, robotics and related technologies, 2020/2012(INL).

(35)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

(36)  
            
Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39)



(37)  
            
Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (Law Enforcement Directive) (OJ L 119, 4.5.2016, p. 89).



(35)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

(38)  
            
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).



(39)  Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72).

(40)  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).

(41)  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).

(42)  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).

(43)  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).

(44)  Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).

(45)  Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of 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).

(46)  Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 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).

(39)  Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72).

(40)  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).

(41)  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).

(42)  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).

(43)  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).

(44)  Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).

(45)  Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of 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).

(46)  Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 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).

(47)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

(48)  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).

(47)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

(48)  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).

(49)  Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60).

(50)  Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1).

(49)  Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60).

(50)  Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1).

(54)  Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

(54)  Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

(55)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

(55)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

(56)  Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).

(56)  Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).

(57)  Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4).

(57)  Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4).

(58)  
            OJ L 123, 12.5.2016, p. 1.

(58)  
            OJ L 123, 12.5.2016, p. 1.

(61)  
            
Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).



(62)  
            
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).



(1a)  
            
Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p. 1).




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