Activities of Dragoş TUDORACHE related to 2021/0106(COD)
Plenary speeches (4)
Artificial Intelligence Act (debate)
Artificial Intelligence Act (debate)
Artificial Intelligence Act (A9-0188/2023 - Brando Benifei, Dragoş Tudorache) (vote)
Artificial Intelligence Act (A9-0188/2023 - Brando Benifei, Dragoş Tudorache) (vote)
Reports (1)
REPORT 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
Amendments (361)
Amendment 311 #
Proposal for a regulation
Citation 5 a (new)
Citation 5 a (new)
Having regard to the opinion of the European Central Bank,
Amendment 348 #
Proposal for a regulation
Recital 5
Recital 5
(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 as well as measures in support of innovation with a particular focus on SMEs and start-ups, 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 Council33 , and it ensures the protection of ethical principles, as specifically requested by the European Parliament34 . _________________ 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).
Amendment 374 #
Proposal for a regulation
Recital 8
Recital 8
(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. The notion of remote biometric identification system shall not include verification or authentification systems whose sole purpose is to confirm that a specific natural person is the person he or she claims to be, and systems that are used to confirm the identity of a natural person for the sole purpose of having access to a service, a device or premises.
Amendment 375 #
Proposal for a regulation
Recital 8
Recital 8
(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. The notion of remote biometric identification system shall not include authentification and verification systems whose purpose is to confirm, based on prior consent, that a specific natural person is the person he or she claims to be or to confirm the identity of a natural person for the purpose of having access to a service, a device or premises.
Amendment 393 #
Proposal for a regulation
Recital 11
Recital 11
(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. This exception should nevertheless be limited to trusted countries and international organizations that share the Union’s values.
Amendment 428 #
Proposal for a regulation
Recital 16
Recital 16
(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. SuchIn particular, AI systems that deploy subliminal components individualthat natural persons cannot perceive or, that exploit the vulnerabilities of children and people due to their age, physical or mental incapacities. They do soany groups,or that use purposefully manipulative techniques 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 or to their rights or to the values of the Union should be prohibited. 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.
Amendment 434 #
Proposal for a regulation
Recital 17
Recital 17
(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 using trustworthiness, good citizenship, patriotism, deviancy, or any other such metric as a proxi. 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. This detrimental treatment can also be effected by providing undue and unjustified privileges to groups of people based on their social score. Such AI systems should be therefore prohibited.
Amendment 443 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17 a) AI systems used by law enforcement authorities or on their behalf to predict the probability of a natural person to offend or to reoffend, based on profiling and individual risk-assessment 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 450 #
Proposal for a regulation
Recital 18
Recital 18
(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. The use of those systems in publicly accessible places should therefore be prohibited.
Amendment 451 #
Proposal for a regulation
Recital 18
Recital 18
(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. The use of those systems in publicly accessible places should therefore be prohibited.
Amendment 464 #
Proposal for a regulation
Recital 19
Recital 19
Amendment 467 #
Proposal for a regulation
Recital 19
Recital 19
Amendment 473 #
Proposal for a regulation
Recital 20
Recital 20
Amendment 477 #
Proposal for a regulation
Recital 20
Recital 20
Amendment 483 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 486 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 490 #
Proposal for a regulation
Recital 22
Recital 22
Amendment 494 #
Proposal for a regulation
Recital 22
Recital 22
Amendment 497 #
Proposal for a regulation
Recital 23
Recital 23
Amendment 499 #
Proposal for a regulation
Recital 23
Recital 23
Amendment 511 #
Proposal for a regulation
Recital 24
Recital 24
(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.
Amendment 512 #
Proposal for a regulation
Recital 24
Recital 24
(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.
Amendment 527 #
(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 or to Union values as enshrined in Article 2 TEU and such limitation minimises any potential restriction to international trade, if any.
Amendment 538 #
Proposal for a regulation
Recital 32
Recital 32
(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 or to Union values as enshrined in Article 2 TEU, 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. Such systems should be classified as high-risk only insofar as they are built and operated with biometric, biometrics- based, or personal data or they influence decisions of natural persons or make decisions or influence decisions affecting natural persons. This ensures that, when referencing AI systems in pre-defined areas of human activity, this Regulation does not inadvertently apply to AI systems that can have no impact on the health, safety, fundamental rights of natural persons or the values of the Union as enshrined in Article 2 TEU.
Amendment 546 #
Proposal for a regulation
Recital 33
Recital 33
(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, except for verification or authentification systems whose sole purpose is to confirm that a specific natural person is the person he or she claims to be, and systems that are used to confirm the identity of a natural person for the sole purpose of having access to a service, a device or premises. 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.
Amendment 554 #
Proposal for a regulation
Recital 34
Recital 34
(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, and internet, 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.
Amendment 561 #
Proposal for a regulation
Recital 36
Recital 36
(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 personalised task allocation based on personal 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 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.
Amendment 576 #
Proposal for a regulation
Recital 37
Recital 37
(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 providerSMEs and start-ups 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.
Amendment 582 #
Proposal for a regulation
Recital 38
Recital 38
(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.
Amendment 583 #
Proposal for a regulation
Recital 38
Recital 38
(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.
Amendment 602 #
Proposal for a regulation
Recital 40 a (new)
Recital 40 a (new)
(40 a) When the “deep fake” content forms part of an evidently artistic, creative, or fictional cinematographic and analogous work, or when the “AI authors” generate content that undergoes human review and for the publication of which a natural or legal person established in the Union is liable or holds editorial responsibility, the AI systems should not be considered high-risk but should nevertheless be subject to adequate transparency requirements, where appropriate.
Amendment 606 #
Proposal for a regulation
Recital 40 b (new)
Recital 40 b (new)
(40 b) Subliminal techniques are techniques that expose natural persons to sensorial stimuli that the natural persons cannot consciously perceive but that are assumed to register in the brain unconsciously, such as flashing images or text for fractions of a second or playing sounds outside the range of perceptible hearing. AI systems deploying such techniques should be prohibited, because these techniques are by their very nature intended to be manipulative. Nevertheless, exceptions are warranted for AI systems using subliminal techniques for research and therapeutical purposes, based on the consent of the natural persons that are being exposed to them. In such limited cases, the AI systems should be considered high-risk and comply with the requirements for high-risk AI systems as set forth in this Regulation.
Amendment 613 #
Proposal for a regulation
Recital 42
Recital 42
(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. These requirements should be objective-driven, fit to purpose, reasonable and effective, without adding undue regulatory burdens or costs on operators.
Amendment 662 #
Proposal for a regulation
Recital 56
Recital 56
(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.
Amendment 663 #
Proposal for a regulation
Recital 58
Recital 58
(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. Given the potential impact and the need for democratic oversight and scrutiny, users of high-risk AI systems that are public authorities or Union institutions, bodies, offices and agencies should be required to conduct a fundamental rights impact assessment prior to commencing the use of a high-risk AI system should be required to register the use of any high- risk AI systems in a public database.
Amendment 674 #
Proposal for a regulation
Recital 61
Recital 61
(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 Council54 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 insufficientand are not expected to be published within a reasonable period or where they are insufficient, only after consulting the Artificial Intelligence Board, the European standardisation organisations as well as the relevant stakeholders. The Commission should duly justify why it decided not to use harmonised standards. _________________ 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).
Amendment 683 #
Proposal for a regulation
Recital 64
Recital 64
(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 and AI systems intended to be used to make inferences on the basis of biometric data that produce legal effects or affect the rights and freedoms of natural persons. For those types of AI systems the involvement of a notified body in the conformity assessment should be foreseen, to the extent they are not prohibited..
Amendment 688 #
Proposal for a regulation
Recital 65
Recital 65
(65) In order to carry out third-party conformity assessment for AI systems intended to be used for the remote biometric identification of personss 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 and absence of conflicts of interests.
Amendment 698 #
Proposal for a regulation
Recital 68
Recital 68
Amendment 713 #
Proposal for a regulation
Recital 70
Recital 70
(70) Certain AI systems intended to interact with natural persons or to generate content may pose specific risks of impersonation or deception irrespective of whether they qualify as high-risk or not. In certain circumstances, the use of these systems should therefore be subject to specific transparency obligations without prejudice to the requirements and obligations for high-risk AI systems. In particular, natural persons should be notified that they are interacting with an AI system, unless this is obvious from the circumstances and the context of use or where the content is part of an obviously artistic, creative or fictional cinematographic work. Moreover, natural persons should be notified when they are exposed to an emotion recognition system or a biometric categorisation system. Such information and notifications should be provided in accessible formats for persons with disabilities. Further, users, who use an AI system to generate or manipulate image, audio or video content that appreciably resembles existing persons, places or events and would falsely appear to a person to be authentic, should disclose, in an appropriate, clear and visible manner, that the content has been artificially created or manipulated by labelling the artificial intelligence output accordingly and disclosing its artificial origin.
Amendment 720 #
Proposal for a regulation
Recital 71
Recital 71
(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. Member States should ensure that the regulatory sandboxes have the adequate financial and human resources for their proper functioning.
Amendment 733 #
Proposal for a regulation
Recital 73
Recital 73
(73) In order to promote and protect innovation, it is important that the interests of small-scaletart-ups and SME 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 providerSMEs and start-ups 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.
Amendment 739 #
Proposal for a regulation
Recital 76
Recital 76
(76) In order to facilitate a smooth,ensure an 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, to achieve a high level of trustworthiness and of protection of health, safety, fundamental rights and the Union values enshrined in Article 2 TEU across the Union with regards to artificial intelligence systems, to actively support Member States, Union institutions, bodies, offices and agencies in matters pertaining to this Regulation, to reduce the fragmentation of the internal market, 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, 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, and the FRA. An executive director should be responsible for the coordination of the AI Office’s operations and for the implementation of its work programme. Industry,start-ups and SMEs, and civil society should formally participate in the work of the AI Office through an advisory forum that should ensure varied stakeholder representation and should advise the AI Office on matters pertaining to this Regulation.
Amendment 741 #
Proposal for a regulation
Recital 76
Recital 76
(76) In order to facilitate a smooth, effective and harmonised implementation of this Regulation a European Artificial Intelligence Board should be established as a body of the Union and should have legal personality. 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 and the national competent authorities on specific questions related to artificial intelligence.
Amendment 759 #
Proposal for a regulation
Recital 81
Recital 81
(81) The development of AI systems other than high-risk AI systems in accordance with the requirements of this Regulation may lead to a larger uptake of trustworthy artificial intelligence in the Union. Providers of non-high-risk AI systems should be encouraged to create codes of conduct intended to foster the voluntary application of the mandatory requirements applicable to high-risk AI systems or risk-appropriate codes of conduct that sufficiently increase trust in the underlying technology that is not high-risk. Providers should also be encouraged to apply on a voluntary basis additional requirements related, for example, to environmental sustainability, accessibility to persons with disability, stakeholders’ participation in the design and development of AI systems, and diversity of the development teams. The Commission may develop initiatives, including of a sectorial nature, to facilitate the lowering of technical barriers hindering cross-border exchange of data for AI development, including on data access infrastructure, semantic and technical interoperability of different types of data.
Amendment 773 #
Proposal for a regulation
Recital 85
Recital 85
(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 with industry, civil society, other stakeholders, and 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-Making58 . 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. _________________ 58 OJ L 123, 12.5.2016, p. 1.
Amendment 796 #
Proposal for a regulation
Article 1 – paragraph 1 – point d
Article 1 – paragraph 1 – point d
(d) harmonised transparency rules for certain 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;
Amendment 797 #
Proposal for a regulation
Article 1 – paragraph 1 – point e
Article 1 – paragraph 1 – point e
(e) rules on market monitoring and, market surveillance and governance; .
Amendment 802 #
Proposal for a regulation
Article 1 – paragraph 1 – point e a (new)
Article 1 – paragraph 1 – point e a (new)
(e a) measures in support of innovation with a particular focus on SMEs and start-ups, including the setting up of regulatory sandboxes and the reduction of regulatory burdens.
Amendment 803 #
Proposal for a regulation
Article 1 – paragraph 1 – point e a (new)
Article 1 – paragraph 1 – point e a (new)
(e a) rules for the establishment and functioning of the European Union Artificial Intelligence Office;
Amendment 805 #
Proposal for a regulation
Article 1 – paragraph 1 – point e b (new)
Article 1 – paragraph 1 – point e b (new)
(e b) measures in support of innovation, including the setting up of regulatory sandboxes, and measures to reduce the regulatory burden on SMEs and start-ups.
Amendment 827 #
Proposal for a regulation
Article 2 – paragraph 1 – point c
Article 2 – paragraph 1 – point c
(c) providers and users of AI systems thatwho are locatestablished in a third country, where the output produced by the system is used in the Union;
Amendment 844 #
Proposal for a regulation
Article 2 – paragraph 2 – introductory part
Article 2 – paragraph 2 – introductory part
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,classified as high- risk AI in accordance with Article 6 related to products covered by Union harmonisation legislation listed in Annex II, section B only Article 84 of this Regulation shall apply:.
Amendment 845 #
Proposal for a regulation
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
Amendment 847 #
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
Amendment 849 #
Proposal for a regulation
Article 2 – paragraph 2 – point c
Article 2 – paragraph 2 – point c
Amendment 851 #
Proposal for a regulation
Article 2 – paragraph 2 – point d
Article 2 – paragraph 2 – point d
Amendment 853 #
Proposal for a regulation
Article 2 – paragraph 2 – point e
Article 2 – paragraph 2 – point e
Amendment 856 #
Proposal for a regulation
Article 2 – paragraph 2 – point f
Article 2 – paragraph 2 – point f
Amendment 857 #
Proposal for a regulation
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
Amendment 860 #
Proposal for a regulation
Article 2 – paragraph 2 – point h
Article 2 – paragraph 2 – point h
Amendment 883 #
Proposal for a regulation
Article 2 – paragraph 4
Article 2 – paragraph 4
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. 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 TFEU adducing adequate safeguards with respect to the protection of privacy and fundamental rights and freedoms of individuals;
Amendment 902 #
Proposal for a regulation
Article 2 a (new)
Article 2 a (new)
Article 2 a Metaverse environments 1. This regulation shall apply, mutatis mutandis, to operators of AI systems operating in virtual environments that can be accessed by natural persons in the Union that fulfil all the following criteria (‘metaverse environments’): (i) they require natural persons to have a uniquely identifiable and permanent representation within the virtual environment that is legally and economically connected to them via an official identity document, a digital identity, a digital wallet, or equivalent; (ii) they are built for social and economic interaction on a large scale; (iii) they allow natural persons to behave and interact virtually in manners that are consistent with their real-world behaviours and interactions and that can be analysed to infer real-world characteristics, including personal data; (iv) they allow natural persons to engage in real-world financial transactions, including through blockchain-backed digital currencies and non-fungible tokens; (v) they allow for such interactions between natural persons as to make possible risks to the health, safety, or fundamental rights of natural persons or to bring prejudice to the values of the Union as enshrined in Article 2 TEU.
Amendment 937 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
Amendment 940 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3 b (new)
Article 3 – paragraph 1 – point 3 b (new)
(3 b) ‘significant harm‘ means a material harm to a person's life, health and safety or fundamental rights or entities or society at large whose severity is exceptional. The severity is in particular exceptional when the harm is hardly reversible, the outcome has a material adverse impact on health or safety of a person or the impacted person is dependent on the outcome;
Amendment 1009 #
Proposal for a regulation
Article 3 – paragraph 1 – point 24
Article 3 – paragraph 1 – point 24
(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 1028 #
Proposal for a regulation
Article 3 – paragraph 1 – point 33 a (new)
Article 3 – paragraph 1 – point 33 a (new)
(33 a) ‘subliminal techniques’ means techniques that use sensorial stimuli such as images, text, or sounds, that are below the limits of conscious human sensorial perception;
Amendment 1037 #
Proposal for a regulation
Article 3 – paragraph 1 – point 34
Article 3 – paragraph 1 – point 34
(34) ‘emotion recognition system’ means an AI system for the purpose of identifying or inferring emotions, thoughts or intentions of natural persons on the basis of their biometric or biometrics-based data;
Amendment 1044 #
Proposal for a regulation
Article 3 – paragraph 1 – point 35
Article 3 – paragraph 1 – point 35
(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, or inferring their characteristics and attributes on the basis of their biometric or biometrics-based data;
Amendment 1047 #
Proposal for a regulation
Article 3 – paragraph 1 – point 35 a (new)
Article 3 – paragraph 1 – point 35 a (new)
(35 a) ‘remote biometric categorisation system’ means a biometric categorisation system capable of categorising natural persons at a distance;
Amendment 1051 #
Proposal for a regulation
Article 3 – paragraph 1 – point 36
Article 3 – paragraph 1 – point 36
(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 , , excluding authentification and verification systems whose sole purpose is to confirm, based on prior consent, that a specific natural person is the person he or she claims to be or to confirm the identity of a natural person for the sole purpose of having access to a service, a device or premises;
Amendment 1052 #
Proposal for a regulation
Article 3 – paragraph 1 – point 36
Article 3 – paragraph 1 – point 36
(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 , excluding verification/authentification systems whose sole purpose is to confirm that a specific natural person is the person he or she claims to be, and systems that are used to confirm the identity of a natural person for the sole purpose of having access to a service, a device or premises;
Amendment 1078 #
Proposal for a regulation
Article 3 – paragraph 1 – point 42
Article 3 – paragraph 1 – point 42
(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 atin the European Artificial Intelligence Boardmanagement board of the AI Office;
Amendment 1103 #
Proposal for a regulation
Article 3 – paragraph 1 – point 44 a (new)
Article 3 – paragraph 1 – point 44 a (new)
(44 a) ‘regulatory sandbox’ means a facility that provides a controlled environment 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;
Amendment 1111 #
Proposal for a regulation
Article 3 – paragraph 1 – point 44 b (new)
Article 3 – paragraph 1 – point 44 b (new)
(44 b) ‘deep fake’ means 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.
Amendment 1136 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
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, after an adequate and transparent consultation process involving the relevant stakeholders, to amend the list of techniques and approaches listed in Annex I within the scope of the definition of an AI system as provided for in Article 3(1), in order to update that list to market and technological developments on the basis of transparent characteristics that are similar to the techniques and approaches listed therein. Providers and users of AI systems should be given 24 months to comply with any amendment to Annex I.
Amendment 1163 #
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(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 ano, with the exception of AI systems using such techniques for scientific research and for approved therapeutical purposes on the basis of explicit consent of the natural persons that are exposed to them, which systems shall be classified as high risk for ther person physical or psychological harmurposes of this Regulation;
Amendment 1172 #
Proposal for a regulation
Article 5 – paragraph 1 – point a a (new)
Article 5 – paragraph 1 – point a a (new)
Amendment 1185 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(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;
Amendment 1197 #
Proposal for a regulation
Article 5 – paragraph 1 – point c – introductory part
Article 5 – paragraph 1 – point c – introductory part
(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 certainn extended period of time based on their social behaviour or known or predicted personal or personality characteristics, (social scoring),with the social score leading to either or both of the following:
Amendment 1208 #
Proposal for a regulation
Article 5 – paragraph 1 – point c – point i
Article 5 – paragraph 1 – point c – point i
(i) detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts whichthat are unrelated to the contexts in which the data was originally generated or collected;
Amendment 1220 #
Proposal for a regulation
Article 5 – paragraph 1 – point c – point ii a (new)
Article 5 – paragraph 1 – point c – point ii a (new)
(ii a) privileged 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 1223 #
Proposal for a regulation
Article 5 – paragraph 1 – point c a (new)
Article 5 – paragraph 1 – point c a (new)
(c a) the placing on the market, putting into service or use of an AI system for making individual risk assessments of natural persons 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 offence based on profiling of a natural person or on assessing personality traits and characteristics or past criminal behaviour of natural persons or groups of natural persons;
Amendment 1233 #
Proposal for a regulation
Article 5 – paragraph 1 – point d – introductory part
Article 5 – paragraph 1 – point d – introductory part
(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:
Amendment 1234 #
Proposal for a regulation
Article 5 – paragraph 1 – point d – introductory part
Article 5 – paragraph 1 – point d – introductory part
(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:.
Amendment 1253 #
Proposal for a regulation
Article 5 – paragraph 1 – point d – point i
Article 5 – paragraph 1 – point d – point i
Amendment 1254 #
Proposal for a regulation
Article 5 – paragraph 1 – point d – point i
Article 5 – paragraph 1 – point d – point i
Amendment 1260 #
Proposal for a regulation
Article 5 – paragraph 1 – point d – point ii
Article 5 – paragraph 1 – point d – point ii
Amendment 1263 #
Proposal for a regulation
Article 5 – paragraph 1 – point d – point ii
Article 5 – paragraph 1 – point d – point ii
Amendment 1273 #
Proposal for a regulation
Article 5 – paragraph 1 – point d – point iii
Article 5 – paragraph 1 – point d – point iii
Amendment 1274 #
Proposal for a regulation
Article 5 – paragraph 1 – point d – point iii
Article 5 – paragraph 1 – point d – point iii
Amendment 1348 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 1354 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 1356 #
Proposal for a regulation
Article 5 – paragraph 2 – point a
Article 5 – paragraph 2 – point a
Amendment 1357 #
Proposal for a regulation
Article 5 – paragraph 2 – point a
Article 5 – paragraph 2 – point a
Amendment 1358 #
Proposal for a regulation
Article 5 – paragraph 2 – point b
Article 5 – paragraph 2 – point b
Amendment 1359 #
Proposal for a regulation
Article 5 – paragraph 2 – point b
Article 5 – paragraph 2 – point b
Amendment 1361 #
Proposal for a regulation
Article 5 – paragraph 2 – subparagraph 1
Article 5 – paragraph 2 – subparagraph 1
Amendment 1362 #
Proposal for a regulation
Article 5 – paragraph 2 – subparagraph 1
Article 5 – paragraph 2 – subparagraph 1
Amendment 1364 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 1367 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 1375 #
Proposal for a regulation
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Amendment 1376 #
Proposal for a regulation
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Amendment 1381 #
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
Amendment 1387 #
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
Amendment 1435 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
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, with the exception of those AI systems that are not safety components of a product and that fulfil both of the following conditions: (a) they are not developed with and do not use biometric data, biometrics-based data, or personal data as inputs; (b) they are not intended to influence decisions of natural persons or to make decisions or to assist in the making of decisions affecting natural persons.
Amendment 1466 #
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
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, after an adequate and transparent consultation process involving the relevant stakeholders, to update the list in Annex III by withdrawing areas from that list or by adding critical areas. For additions both of the following conditions arneed to be fulfilled:
Amendment 1520 #
Proposal for a regulation
Article 7 – paragraph 2 – point e a (new)
Article 7 – paragraph 2 – point e a (new)
(e a) the potential misuse and malicious use of the AI system and of the technology underpinning it;
Amendment 1538 #
Proposal for a regulation
Article 7 – paragraph 2 – point h – introductory part
Article 7 – paragraph 2 – point h – introductory part
(h) the extent to which existing Union legislation, in particular the GDPR, provides for:
Amendment 1549 #
Proposal for a regulation
Article 7 – paragraph 2 a (new)
Article 7 – paragraph 2 a (new)
2 a. The Commission shall provide a transitional period of at least 24 months following each update of Annex III.
Amendment 1555 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. High-risk AI systems shall comply with the requirements established in this Chapter, taking into account the generally acknowledged state of the art, including as reflected in relevant harmonised standards or common specifications.
Amendment 1558 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. H1. Operators of high-risk AI systems shall comply with the requirements established in this Chapter.
Amendment 1559 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
Amendment 1572 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems. The risk management system can be integrated into, or a part of, already existing risk management procedures insofar as it fulfils the requirements of this article.
Amendment 1584 #
Proposal for a regulation
Article 9 – paragraph 2 – point a
Article 9 – paragraph 2 – point a
(a) identification and analysis of the known and reasonably foreseeable risks associated with each high-risk AI system with respect to health, safety, fundamental rights, and the values of the Union as enshrined in Article 2 TEU;
Amendment 1601 #
Proposal for a regulation
Article 9 – paragraph 2 – point d
Article 9 – paragraph 2 – point d
(d) adoption of suitable risk management measureappropriate and targeted risk management measures to address identified significant risks in accordance with the provisions of the following paragraphs.
Amendment 1614 #
Proposal for a regulation
Article 9 – paragraph 4 – introductory part
Article 9 – paragraph 4 – introductory part
4. The risk management measures referred to in paragraph 2, point (d) shall be such that any relevant 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.
Amendment 1629 #
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – point c
Article 9 – paragraph 4 – subparagraph 1 – point c
(c) provision of adequate information pursuant to Article 13, in particular as regards the risks referred to in paragraph 2, point (a) and (b) of this Article, and, where appropriate, training to users.
Amendment 1653 #
Proposal for a regulation
Article 9 – paragraph 7
Article 9 – paragraph 7
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.
Amendment 1659 #
Proposal for a regulation
Article 9 – paragraph 8
Article 9 – paragraph 8
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 or natural persons suffering from disabilities that render them legally unable to give their consent.
Amendment 1683 #
Proposal for a regulation
Article 10 – paragraph 2 – introductory part
Article 10 – paragraph 2 – introductory part
2. Training, validation and testing data sets shall be subject to appropriate data governance and management practices appropriate for the context of the use as well as the intended purpose of the AI system. Those practices shall concern in particular,
Amendment 1693 #
Proposal for a regulation
Article 10 – paragraph 2 – point c
Article 10 – paragraph 2 – point c
(c) relevant data preparation processing operations, such as annotation, labelling, cleaning, enrichment and aggregation;
Amendment 1706 #
Proposal for a regulation
Article 10 – paragraph 2 – point g
Article 10 – paragraph 2 – point g
(g) the identification of relevanyt possible data gaps or shortcomings, and how those gaps and shortcomings can be addressed.
Amendment 1707 #
Proposal for a regulation
Article 10 – paragraph 2 – point g
Article 10 – paragraph 2 – point g
(g) the identification of any possiblesignificant data gaps or shortcomings, and how those gaps and shortcomings can be addressed.
Amendment 1715 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Training, validation and testing data sets shall be relevant, representative, free of errors and completeHigh-risk AI systems shall be designed and developed with the best efforts to ensure that training, validation and testing data sets shall be relevant, representative, and to the best extent possible, free of errors and complete in accordance with industry standards. 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.
Amendment 1754 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
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 or equivalent documentation meeting the same objectives, subject to the approval of the competent authority.
Amendment 1759 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
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 IVparagraph 1 as well as the information required under those legal acts.
Amendment 1778 #
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
Amendment 1793 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
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 helps supporting informed decision-making by users and is relevant, accessible and comprehensible to users.
Amendment 1808 #
Proposal for a regulation
Article 13 – paragraph 3 – point e a (new)
Article 13 – paragraph 3 – point e a (new)
(e a) a description of the mechanisms included within the AI system that allow users to properly collect, store and interpret the logs in accordance with Article 12(1).
Amendment 1832 #
Proposal for a regulation
Article 14 – paragraph 4 – point a
Article 14 – paragraph 4 – point a
(a) fulto be aware of and sufficiently 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;
Amendment 1833 #
Proposal for a regulation
Article 14 – paragraph 4 – point b
Article 14 – paragraph 4 – point b
(b) remain aware of the possible tendency of automatically relying or over- relying on the output produced by a high- risk AI system (‘automation bias’), in particular for high-risk AI systems used to provide information or recommendations for decisions to be taken by natural persons;
Amendment 1838 #
Proposal for a regulation
Article 14 – paragraph 4 – point d
Article 14 – paragraph 4 – point d
(d) to be able to decide, in any particular situation, not to use the high-risk AI system or otherwise disregard, override or reverse the output of the high-risk AI system;
Amendment 1856 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The levels of accuracy and the relevant accuracy metrics of high-risk AI systemsrange of expected performance and the operational factors that affect that performance shall be declared in the accompanying instructions of use.
Amendment 1858 #
Proposal for a regulation
Article 15 – paragraph 3 – introductory part
Article 15 – paragraph 3 – introductory part
3. High-risk AI systems shall be resilientdesigned and developed with safety and security-by-design mechanism so that they achieve, in the light of their intended purpose, an appropriate level of cyber resilience as regards to 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 1863 #
Proposal for a regulation
Article 15 – paragraph 3 – subparagraph 2
Article 15 – paragraph 3 – subparagraph 2
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 aninfluencing input for future operations (‘feedback loops’) are duly addressed with appropriate mitigation measures.
Amendment 1867 #
Proposal for a regulation
Article 15 – paragraph 4 – subparagraph 1
Article 15 – paragraph 4 – subparagraph 1
The technical solutions aimed at ensuring and organisational measures designed to uphold the cybersecurity of high-risk AI systems shall be appropriate to the relevant circumstances and the risks.
Amendment 1887 #
Proposal for a regulation
Article 16 – paragraph 1 – point c
Article 16 – paragraph 1 – point c
(c) draw-up the technical documentation of the high-risk AI system referred to in Article 18;
Amendment 1891 #
Proposal for a regulation
Article 16 – paragraph 1 – point d
Article 16 – paragraph 1 – point d
(d) when under their control, keep the logs automatically generated by their high- risk AI systems as referred to in Article 20;
Amendment 1893 #
Proposal for a regulation
Article 16 – paragraph 1 – point e
Article 16 – paragraph 1 – point e
(e) ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its placing on the market or putting into service;
Amendment 1899 #
Proposal for a regulation
Article 16 – paragraph 1 – point g
Article 16 – paragraph 1 – point g
(g) take the necessary corrective actions as referred to in Article 21, if the high-risk AI system is not in conformity with the requirements set out in Chapter 2 of this Title;
Amendment 1914 #
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
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 andor instructions, and shall include at least the following aspects:
Amendment 1965 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
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 competentmarket surveillance 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.
Amendment 1967 #
Proposal for a regulation
Article 23 – title
Article 23 – title
Cooperation with competent authorities, the AI Office and the Commission
Amendment 1970 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
Providers of high-risk AI systems and where applicable, users shall, upon request by a national competent authority, provide that 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. 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.
Amendment 1974 #
Upon a reasoned request by a national competent authority or, where applicable, by the Commission, providers and, where applicable, users 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 by virtue of a contractual arrangement with the user or otherwise by law. The national competent authorities or, where applicable, the Commission, shall keep confidential all trade secrets contained in the information received, in accordance with Article 70(2).
Amendment 1981 #
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
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.
Amendment 2011 #
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
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 well as the market surveillance authorities, as applicable, to that effect.
Amendment 2012 #
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
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 market surveillance authority and the provider or the importer of the system, as applicable, to that effect.
Amendment 2015 #
Proposal for a regulation
Article 27 – paragraph 4
Article 27 – paragraph 4
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 provider or the importer of the system as well as 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 2019 #
Proposal for a regulation
Article 27 – paragraph 5
Article 27 – paragraph 5
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 in its possession or available to it, in accordance with the obligations of distributors as outlined by this Regulation, that are 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.
Amendment 2033 #
Proposal for a regulation
Article 28 – paragraph 2 a (new)
Article 28 – paragraph 2 a (new)
2 a. Providers that initially placed the high-risk AI system on the market or put it into service shall cooperate closely with distributors, importers, users, or other third-parties to supply them with the necessary information or documentation in their possession that is required for the fulfilment of the obligations set out in this Regulation, in particular at the moment when such distributors, importers, users or other third-parties become the new providers as determined in paragraph 1 and the initial providers are no longer considered a provider for the purposes of this Regulation as determined in paragraph 2.
Amendment 2039 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Users of high-risk AI systems shall use such systems and implement human oversight in accordance with the instructions of use accompanying the systems, pursuant to paragraphs 2 and 5 of this article.
Amendment 2040 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Users of high-risk AI systems shall use such systems and implement human oversight in accordance with the instructions of use accompanying the systems, pursuant to paragraphs 2 and 5.
Amendment 2044 #
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
1 a. Users shall assign human oversight to natural persons who have the necessary competence, training and authority.
Amendment 2049 #
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
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. To the extent the user exercises control over the high-risk AI system, that user shall also ensure that relevant and appropriate robustness and cybersecurity measures are in place and are regularly adjusted or updated.
Amendment 2050 #
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
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. To the extent the user exercises control over the high-risk AI system, that user shall also ensure that relevant and appropriate robustness and cybersecurity measures are in place and are regularly adjusted or updated.
Amendment 2062 #
Proposal for a regulation
Article 29 – paragraph 5 a (new)
Article 29 – paragraph 5 a (new)
5 a. Users of high-risk AI systems that are public authorities or Union institutions, bodies, offices and agencies shall conduct a fundamental rights impact assessment prior to commencing the use of a high-risk AI system;
Amendment 2125 #
Proposal for a regulation
Article 40 – paragraph 1 a (new)
Article 40 – paragraph 1 a (new)
The Commission shall issue standardisation requests covering all essential requirements of this Regulation in accordance with Article 10 of Regulation 1025/2012 no later than 6 months after the date of entry into force of this Regulation.
Amendment 2131 #
Proposal for a regulation
Article 41 – paragraph 1
Article 41 – paragraph 1
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 Titleshall issue a standardisation request to one or several of the European standardization organizations in accordance with Article 10 of Regulation 1025/2012 and may, by means of implementing acts, adopt common specifications in respect of the requirements set out in Chapter 2 of this Title, which shall only be valid until the requested harmonised standards have been elaborated and published in the Official Journal of the European Union. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2).
Amendment 2133 #
Proposal for a regulation
Article 41 – paragraph 1
Article 41 – paragraph 1
1. Where harmonised standards referred to in Article 40 do not exist and are not expected to be published within a reasonable period 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).
Amendment 2138 #
Proposal for a regulation
Article 41 – paragraph 1 a (new)
Article 41 – paragraph 1 a (new)
1 a. When deciding to draft and adopt common specifications, the Commission shall consult the Board, the European standardisation organisations as well as the relevant stakeholders, and duly justify why it decided not to use harmonised standards. The abovementioned organisations shall be regularly consulted while the Commission is in the process of drafting the common specifications.
Amendment 2139 #
Proposal for a regulation
Article 41 – paragraph 2
Article 41 – paragraph 2
2. The Commission, when preparing the common specifications referred to in paragraph 1, shall gather the views of relevant stakeholders, including industry, start-ups, and SMEs, and of relevant bodies or expert groups established under relevant sectorial Union law.
Amendment 2141 #
Proposal for a regulation
Article 41 – paragraph 2
Article 41 – paragraph 2
2. The Commission, when preparing the common specifications referred to in paragraph 1, shall gather the views of stakeholders, including SMEs and start- ups, relevant bodies or expert groups established under relevant sectorial Union law.
Amendment 2150 #
Proposal for a regulation
Article 41 – paragraph 4 a (new)
Article 41 – paragraph 4 a (new)
4 a. If harmonised standards referred to in Article 40 are developed and the references to them are published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 in the future, the relevant common specifications shall no longer apply.
Amendment 2191 #
Proposal for a regulation
Article 43 – paragraph 4 – introductory part
Article 43 – paragraph 4 – introductory part
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 whetherif the modified system is intended to be further distributed or continues to be used by the current user.
Amendment 2193 #
Proposal for a regulation
Article 43 – paragraph 4 – subparagraph 1
Article 43 – paragraph 4 – subparagraph 1
For high-risk AI systems that continue to learn after being placed on the market or put into service, changes to the high-risk AI system and its performance that have been pre-determined by the provider at the moment of the initial conformity assessment and are part of the information contained in the technical documentation referred to in point 2(f) of Annex IV, shall 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 as long as the update does not include significant changes to the functionality of the system.
Amendment 2201 #
Proposal for a regulation
Article 43 – paragraph 5
Article 43 – paragraph 5
5. TAfter consulting the AI Board referred to in Article 56 and after providing substantial evidence, followed by thorough consultation and the involvement of the affected stakeholders, 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.
Amendment 2208 #
Proposal for a regulation
Article 43 – paragraph 6
Article 43 – paragraph 6
Amendment 2232 #
Proposal for a regulation
Article 49 – paragraph 1
Article 49 – paragraph 1
1. The physical 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.
Amendment 2234 #
Proposal for a regulation
Article 49 – paragraph 1 a (new)
Article 49 – paragraph 1 a (new)
1 a. A digital CE marking may be used instead of or additionally to the physical marking if it can be accessed via the display of the product or via a machine- readable code or other electronic means.
Amendment 2252 #
Proposal for a regulation
Article 51 – paragraph 1 a (new)
Article 51 – paragraph 1 a (new)
Before putting into service or using a high-risk AI system in one of the areas listed in Annex III, users who are public authorities or Union institutions, bodies, offices or agencies or users acting on their behalf shall register in the EU database referred to in Article 60.
Amendment 2263 #
Proposal for a regulation
Article 52 – paragraph 1
Article 52 – paragraph 1
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.
Amendment 2267 #
Proposal for a regulation
Article 52 – paragraph 2
Article 52 – paragraph 2
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.
Amendment 2268 #
Proposal for a regulation
Article 52 – paragraph 2
Article 52 – paragraph 2
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.
Amendment 2271 #
Proposal for a regulation
Article 52 – paragraph 3 – introductory part
Article 52 – paragraph 3 – introductory part
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, in an appropriate, clear and visible manner, that the content has been artificially generated or manipulated.
Amendment 2276 #
Proposal for a regulation
Article 52 – paragraph 3 – subparagraph 1
Article 52 – paragraph 3 – subparagraph 1
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.
Amendment 2278 #
Proposal for a regulation
Article 52 – paragraph 3 – subparagraph 1
Article 52 – paragraph 3 – subparagraph 1
However, the first subparagraph shall not apply where the use is authorised by law to detectcontent is part of an obviously artistic, pcrevent, investigate and prosecute criminal offencesative or fictional cinematographic work 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.
Amendment 2293 #
Proposal for a regulation
Article 53 – paragraph 1
Article 53 – paragraph 1
Amendment 2294 #
Proposal for a regulation
Article 53 – paragraph 1
Article 53 – paragraph 1
1. AI regulatory sandboxes established by one or more Member States competent authorities or the European Data Protection Supervisorthe European Commission, one or more Member States, or other competent entities 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 ensuringin collaboration with and guidance by the European Commission or the competent authorities in order to identify risks to health and safety and fundamental rights, test mitigation measures for identified risks, demonstrate prevention of these risks and otherwise ensure compliance with the requirements of this Regulation and, where relevant, other Union and Member States legislation supervised within the sandbox.
Amendment 2298 #
Proposal for a regulation
Article 53 – paragraph 1 a (new)
Article 53 – paragraph 1 a (new)
1 a. AI regulatory sandboxes established by one or more Member States, by local, regional, or national competent authorities, by the Commission or by 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.
Amendment 2330 #
Proposal for a regulation
Article 53 – paragraph 5
Article 53 – paragraph 5
5. Member States’National competent authorities that have established AI regulatory sandboxes shall coordinate their activities and cooperate within the framework of the European Artificial Intelligence BoardAI Office. They shall submit annual reports to the BoardAI Office and the Commission on the results ofrom the implementation of those scheme, including good practices, incidents, lessons learnt and recommendations on their setup and, where relevant, on the application of this Regulation and other Union legislation supervised within the sandbox. Those reports or abstracts thereof shall be made available to the public in order to further enable innovation in the Union.
Amendment 2333 #
Proposal for a regulation
Article 53 – paragraph 5 a (new)
Article 53 – paragraph 5 a (new)
5 a. Regulatory sandboxes shall allow and facilitate the testing of possible adaptations of the regulatory framework governing artificial intelligence in order to enhance innovation or reduce compliance costs, without prejudice to the provisions of this Regulation or to the health, safety, fundamental rights of natural persons or to the values of the Union as enshrined in Article 2 TEU. The results and lessons learned from such tests shall be submitted to the AI Office and the Commission.
Amendment 2334 #
Proposal for a regulation
Article 53 – paragraph 6
Article 53 – paragraph 6
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). no later than 12 months following the entry into force of this Regulation and shall ensure, inter alia: (a) that they allow start-ups to use their participation in the sandbox in order to fulfil, in a guided environment with significantly reduced costs, the conformity assessment obligations of this Regulation or the voluntary application of the codes of conduct referred to in Article 69; (b) that adequate resources are dedicated to the establishment and functioning of the regulatory sandboxes so that the regulatory sandboxes can ensure broad access and keep up with demand for participation without creating disincentivising backlogs or delays; (c)that procedures, processes, and bureaucratic requirements for application, selection, participation, and exiting the sandbox are simple, easily intelligible, clearly communicated, and streamlined so as to facilitate the participation of startups with limited legal and bureaucratic capacities; (d) that procedures, processes, and bureaucratic requirements for application, selection, participation, and exiting the sandbox are streamlined across the Union and that participation in a regulatory sandbox established by a Member State by virtue of its obligation in paragraph 1 or by the Commission is uniformly recognised and carries the same legal effects across the Union.
Amendment 2341 #
Proposal for a regulation
Article 53 – paragraph 6 a (new)
Article 53 – paragraph 6 a (new)
6 a. The Commission shall draw up guidelines for the proper establishment, development, implementation, functioning, and supervision of regulatory sandboxes.
Amendment 2347 #
Proposal for a regulation
Article 54 – paragraph 1 – introductory part
Article 54 – paragraph 1 – introductory part
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 underwhen all of the following conditions are met:
Amendment 2352 #
Proposal for a regulation
Article 54 – paragraph 1 – point a – point i
Article 54 – paragraph 1 – point a – point i
(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;
Amendment 2365 #
Proposal for a regulation
Article 54 – paragraph 1 – point j
Article 54 – paragraph 1 – point j
(j) a short summary of the AI project developed in the sandbox, its objectives, hypotheses and expected results, and non- confidential testing results, is published on the website of the competent authorities.
Amendment 2372 #
Proposal for a regulation
Article 55 – title
Article 55 – title
Measures for small-scale providerSMEs, start-ups and users
Amendment 2375 #
Proposal for a regulation
Article 55 – paragraph 1 – point a
Article 55 – paragraph 1 – point a
(a) provide small-scale providerSMEs and start-ups with priority access to the AI regulatory sandboxes to the extent that they fulfil the eligibility conditions;
Amendment 2377 #
Proposal for a regulation
Article 55 – paragraph 1 – point b
Article 55 – paragraph 1 – point b
(b) organise specific awareness raising activities about the application of this Regulation tailored to the needs of the small-scale providerSMEs, sart-ups and users;
Amendment 2379 #
(c) where appropriate, establish a dedicated channel for communication with small-scale providers andSMEs, start-ups, users and other innovators to provide guidance and respond to queries about the implementation of this Regulation.
Amendment 2381 #
Proposal for a regulation
Article 55 – paragraph 1 – point c a (new)
Article 55 – paragraph 1 – point c a (new)
(c a) support SME's increased participation in the standardisation development process;
Amendment 2387 #
Proposal for a regulation
Article 55 – paragraph 2
Article 55 – paragraph 2
2. The specific interests and needs of the small-scale providerSMEs and start-ups 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.
Amendment 2392 #
Proposal for a regulation
Title VI – Chapter 1 – title
Title VI – Chapter 1 – title
1 European Artificial Intelligence BoardOffice
Amendment 2394 #
Proposal for a regulation
Article 56 – title
Article 56 – title
Establishment of the European Artificial Intelligence BoardOffice
Amendment 2397 #
Proposal for a regulation
Article 56 – paragraph 1
Article 56 – paragraph 1
Amendment 2400 #
Proposal for a regulation
Article 56 – paragraph 1
Article 56 – paragraph 1
1. A ‘European Artificial Intelligence Board’ (the ‘Board’) is established as a body of the Union and shall have legal personality.
Amendment 2404 #
Proposal for a regulation
Article 56 – paragraph 2
Article 56 – paragraph 2
Amendment 2405 #
Proposal for a regulation
Article 56 – paragraph 2 – introductory part
Article 56 – paragraph 2 – introductory part
2. The Board shall provide advice and assistance to the Commission and to the national supervisory authorities in order to:
Amendment 2408 #
Proposal for a regulation
Article 56 – paragraph 2 – point b
Article 56 – paragraph 2 – point b
(b) coordinate and contribute toprovide guidance and analysis by the Commission and the national supervisory authorities and other competent authorities on emerging issues across the internal market with regard to matters covered by this Regulation;
Amendment 2410 #
Proposal for a regulation
Article 56 – paragraph 2 – point c
Article 56 – paragraph 2 – point c
(c) contribute to the effective and consistent application of this Regulation and assist the national supervisory authorities and the Commission in ensuring the consistent application of this Regulationthat regard.
Amendment 2414 #
(c a) contribute to the effective cooperation with the competent authorities of third countries and with international organisations.
Amendment 2421 #
Proposal for a regulation
Article 56 a (new)
Article 56 a (new)
Article 56 a SECTION 1:General provisions An independent ‘European Artificial Intelligence Office’ (the ‘AI Office’) is hereby established. The European Union Artificial Intelligence Office shall bean Office of the Union, shall have legal personality, and shall be adequately funded and staffed. The Office shall enjoy in all the Member States the most extensive legal capacity accorded to legal persons under their laws. Or.
Amendment 2422 #
Proposal for a regulation
Article 56 b (new)
Article 56 b (new)
Article 56 b Mandate 1. The AI Office shall carry out the tasks assigned to it under this Regulation for the purpose of achieving a high level of trustworthiness and of protection of health, safety, fundamental rights and the Union values enshrined in Article 2 TEU across the Union with regards to artificial intelligence systems, including by actively supporting Member States, Union institutions, bodies, offices and agencies in matters pertaining to this Regulation. The AI Office shall act as a reference point for advice and expertise on artificial intelligence for Union institutions, bodies, offices and agencies, for Member States and their national supervisory authorities, as well as for other relevant Union stakeholders. 2. The AI Office shall contribute to reducing the fragmentation of the internal market and to increasing the uptake of artificial intelligence throughout the Union by carrying out the tasks assigned to it under this Regulation. 3. When carrying out its tasks, the AI Office shall act independently while avoiding the duplication of Member State activities and taking into consideration Member State competences. 4. The AI Office shall organise consultations with stakeholders twice a year to assess the evolution of trends in technology, issues related to the implementation and the effectiveness of this Regulation, regulatory gaps or loopholes observed in practice. Such stakeholders shall include representatives from industry, start-ups and SMEs, civil society organisations, such as NGOs, consumer associations, the social partners and academia. 5. The AI Office may consult national authorities, such as national equality bodies, where the issues discussed are of relevance for them. The AI Office may also consult, where appropriate, external experts and observers and interested third parties, including stakeholders such as those referred to in paragraph 5, and may hold exchanges with them. 6. The AI Office shall cooperate with Union institutions, bodies, offices, agencies and advisory groups and shall make the results of that cooperation publicly available.
Amendment 2423 #
Proposal for a regulation
Article 56 c (new)
Article 56 c (new)
Article 56 c Accountability, transparency, and independence 1. The AI Office shall be accountable to the European Parliament and to the Council in accordance with this Regulation. 2. The AI Office shall develop good administrative practices in order to ensure the highest possible level of transparency concerning its activities. Regulation (EC) No 1049/2001 shall apply to documents held by the AI Office. 3. The AI Office shall fulfil its tasks in complete independence.
Amendment 2424 #
Proposal for a regulation
Article 56 d (new)
Article 56 d (new)
Article 56 d Administrative and management structure 1. The administrative and management structure of the AI Office shall comprise: (a) a management board (b) an executive director (c) an advisory forum (d) where appropriate, other advisory bodies established by the management board to support the AI Office in technical or scientific matters related to this Regulation.
Amendment 2425 #
Proposal for a regulation
Article 56 e (new)
Article 56 e (new)
Article 56 e Objectives 1. The AI Office shall: (a) contribute to the uptake of artificial intelligence in the Union, including through supporting innovation and the development of regulatory sandboxes provided for in this Regulation; (b) contribute to a high level of trustworthiness and of protection of health, safety, fundamental rights and the Union values enshrined in Article 2 TEU with regard to artificial intelligence systems in the Union; (c) contribute to the effective cooperation of the national supervisory authorities and the Commission with regard to matters covered by this Regulation; (d) provide forecasts, guidance, and analysis to the Commission, Member States, and to the national supervisory authorities and other competent authorities on emerging issues across the internal market with regard to matters covered by this Regulation and related issues; (e) contribute to the effective and consistent application of this Regulation and assist Member States, the national supervisory authorities, and the Commission in this regard; (f) contribute to the effective cooperation with the competent authorities of third countries and with international organisations; (g) contribute to the development, promotion, and adoption of harmonized standards, common specifications, common benchmarking standards, and voluntary codes of conduct; (h) contribute to the effective and consistent enforcement of this Regulation throughout the Union, including by issuing binding decisions with regard to cases involving two or more Member States asset out in Article 59b.
Amendment 2427 #
Proposal for a regulation
Article 57
Article 57
Amendment 2439 #
Proposal for a regulation
Article 57 – paragraph 1 a (new)
Article 57 – paragraph 1 a (new)
1 a. The Board shall act independently when performing its tasks or exercising its powers.
Amendment 2464 #
Proposal for a regulation
Article 57 – paragraph 4
Article 57 – paragraph 4
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 t, and hold consultations with relevant stakeholders and ensure appropriate participation. The Commission may facilitate exchanges between the Board and other Union bodies, offices, agencies and advisory. The Commission may facilitate exchanges between the Board and other Union bodies, offices, agencies and advisory groups.
Amendment 2471 #
Proposal for a regulation
Article 57 a (new)
Article 57 a (new)
Article 57 a Composition of the management board 1. The management board shall be composed of one representative of each Member State, the Commission, and the European Data Protection Supervisor, and the Fundamental Rights Agency. Each Member State and the Commission shall have one vote. The EDPS and the FRA shall not have voting rights. 2. Each member of the management board shall have an alternate. That alternate shall represent the member in the member’s absence. 3. The Commission and the Member States shall aim to achieve gender balance on the management board. 4. The list of the members and alternate members of the management board shall be made public and shall be updated by the AI Office on its web site. 5. The term of office of the members of the management board and their alternates shall be four years. That term shall be renewable once.
Amendment 2472 #
Proposal for a regulation
Article 57 b (new)
Article 57 b (new)
Amendment 2473 #
Proposal for a regulation
Article 57 c (new)
Article 57 c (new)
Amendment 2474 #
Proposal for a regulation
Article 57 c (new)
Article 57 c (new)
Article 57 c Chair of the management board 1. The management board shall elect a Chair and a deputy Chair from among its voting members by simple majority. The term of office of the Chair and of the deputy Chair shall be three years. The terms of the Chair and of the deputy Chair may be renewed once. The Deputy Chair shall replace the Chair ex officio if the Chair is unable to attend to his or her duties.
Amendment 2475 #
Proposal for a regulation
Article 57 d (new)
Article 57 d (new)
Article 57 d Voting rules of the management board 1. The management board shall take its decisions by a majority of its members, unless otherwise provided for in this Regulation. 2. A majority of two-thirds of the members of the management board shall be required for the adoption of the single programming document and of the annual budget and for the appointment, extension of the term of office or removal of the executive director. 3. Each member shall have one vote. In the absence of a member, their alternate shall be entitled to exercise the member’s right to vote. 4. The Chair of the management board shall take part in the voting. 5. The executive director shall not take part in the voting. 6. The management board’s rules of procedure shall establish more detailed voting arrangements, in particular the circumstances in which a member may act on behalf of another member.
Amendment 2477 #
Proposal for a regulation
Article 58 – title
Article 58 – title
Tasks of the Board
Amendment 2484 #
Proposal for a regulation
Article 58 – paragraph 1 – introductory part
Article 58 – paragraph 1 – introductory part
When providing advice and assistance to the Commission and to the national supervisory authorities in the context of Article 56(2), the Board shall in particular:
Amendment 2486 #
Proposal for a regulation
Article 58 – paragraph 1 – introductory part
Article 58 – paragraph 1 – introductory part
Amendment 2493 #
Proposal for a regulation
Article 58 – paragraph 1 – point a a (new)
Article 58 – paragraph 1 – point a a (new)
(a a) issue opinions, recommendations or written contributions on matters related to the implementation of this Regulation;
Amendment 2494 #
Proposal for a regulation
Article 58 – paragraph 1 – point a b (new)
Article 58 – paragraph 1 – point a b (new)
(a b) examine, on its own initiative or on request of its management board, any question covering the application of this Regulation and issue guidelines, recommendations and best practices with a view to ensuring the consistent implementation of this Regulation;
Amendment 2495 #
Proposal for a regulation
Article 58 – paragraph 1 – point a c (new)
Article 58 – paragraph 1 – point a c (new)
(a c) provide the Commission, in the cases referred to in Article 68a (1)(a) and(1)(b), with all the available information at its disposal, including market studies, impact assessments, and analyses referred to in paragraph (f) of this article, to prepare the decision for triggering the Commission's intervention and opening of proceedings pursuant to Article 68a;
Amendment 2496 #
Proposal for a regulation
Article 58 – paragraph 1 – point a d (new)
Article 58 – paragraph 1 – point a d (new)
(a d) assist Member States in developing the organizational and technical expertise required for the implementation of this Regulation;
Amendment 2497 #
Proposal for a regulation
Article 58 – paragraph 1 – point b
Article 58 – paragraph 1 – point b
(b) contribute to uniform administrative practices in the Member States, including for the functioning of regulatory sandboxes referred to in Article 53by assisting Member States, the Commission, and, where applicable, other authorities in the establishment, development, and functioning of regulatory sandboxes referred to in Article 53, including by providing input and support in drafting the delegated acts referred to in Article 53(6);
Amendment 2498 #
Proposal for a regulation
Article 58 – paragraph 1 – point b
Article 58 – paragraph 1 – point b
(b) contribute to uniform administrative practices in the Member States, including for the assessment , establishing, managing with the meaning of fostering cooperation and guaranteeing consistency among regulatory sandboxes, and functioning of regulatory sandboxes referred to in Article 53, Article54 and Annex IXa;
Amendment 2501 #
Proposal for a regulation
Article 58 – paragraph 1 – point b a (new)
Article 58 – paragraph 1 – point b a (new)
(b a) Support innovation by coordinating the exchange of information and good practices and by facilitating the cooperation among regulatory sandboxes established according to Article 53 and by making available on its website the information referred to in Article 53 (5).
Amendment 2502 #
Proposal for a regulation
Article 58 – paragraph 1 – point c – introductory part
Article 58 – paragraph 1 – point c – introductory part
(c) issue opinions, recommendations or, written contributions, or studies on matters related to the implementation of this Regulation,technical specifications or existing standards regarding the requirements set out in Title III, Chapter 2 and on the use of harmonised standards or common specifications referred to in paArticular les 40and 41;
Amendment 2505 #
Proposal for a regulation
Article 58 – paragraph 1 – point c – point i
Article 58 – paragraph 1 – point c – point i
Amendment 2506 #
Proposal for a regulation
Article 58 – paragraph 1 – point c – point ii
Article 58 – paragraph 1 – point c – point ii
Amendment 2507 #
Proposal for a regulation
Article 58 – paragraph 1 – point c – point iii
Article 58 – paragraph 1 – point c – point iii
Amendment 2513 #
Proposal for a regulation
Article 58 – paragraph 1 – point c a (new)
Article 58 – paragraph 1 – point c a (new)
(c a) carry out annual reviews and analyses of the complaints sent to and findings made by national competent authorities, of the serious incidents reports referred to in Article 62, and of the new registration in the EU Database referred to in Article 60 to identify trends and potential emerging issues threatening the future health and safety and fundamental rights of citizens that are not adequately addressed by this Regulation;
Amendment 2516 #
Proposal for a regulation
Article 58 – paragraph 1 – point c a (new)
Article 58 – paragraph 1 – point c a (new)
(c a) support the Commission and the Member States in the preparation of guidance documents, including the guidelines concerning the setting of administrative fines referred to in Article 71;
Amendment 2519 #
Proposal for a regulation
Article 58 – paragraph 1 – point c b (new)
Article 58 – paragraph 1 – point c b (new)
(c b) encourage, facilitate and support the drawing up of risk-commensurate codes of conduct intended to foster the voluntary application to AI systems of those codes of conduct in close cooperation with industry and other relevant stakeholders in accordance with Article 69;
Amendment 2521 #
Proposal for a regulation
Article 58 – paragraph 1 – point c b (new)
Article 58 – paragraph 1 – point c b (new)
(c b) coordinate among national competent authorities; issue guidelines, recommendations and best practices with a view to ensuring the consistent implementation of this Regulation;
Amendment 2523 #
Proposal for a regulation
Article 58 – paragraph 1 – point c c (new)
Article 58 – paragraph 1 – point c c (new)
(c c) carry out periodic in-depth horizon-scanning, foresight, and market monitoring exercises to analyse trends and emerging issues in respect of this Regulation, with a particular focus on emerging technologies and their interaction with artificial intelligence, European global competitiveness in artificial intelligence, the uptake of artificial intelligence technologies, the development of digital skills, and emerging systemic threats related to artificial intelligence, including those referred to in Article 68a (1)(a) and (1)(b);
Amendment 2526 #
Proposal for a regulation
Article 58 – paragraph 1 – point c c (new)
Article 58 – paragraph 1 – point c c (new)
(c c) promote the cooperation and effective bilateral and multilateral exchange of information and best practices between the national supervisory authorities;
Amendment 2528 #
Proposal for a regulation
Article 58 – paragraph 1 – point c d (new)
Article 58 – paragraph 1 – point c d (new)
(c d) cooperate with the European Data Protection Board and with the FRA to provide guidance in relation to the respect of fundamental rights, in particular the right to non-discrimination and to equal treatment, the right to privacy and the protection of personal data;
Amendment 2529 #
Proposal for a regulation
Article 58 – paragraph 1 – point c d (new)
Article 58 – paragraph 1 – point c d (new)
Amendment 2533 #
Proposal for a regulation
Article 58 – paragraph 1 – point c e (new)
Article 58 – paragraph 1 – point c e (new)
(c e) carry out biannual horizon scanning and foresight exercises to extrapolate the impact the trends and emerging issues can have on the Union;
Amendment 2534 #
Proposal for a regulation
Article 58 – paragraph 1 – point c e (new)
Article 58 – paragraph 1 – point c e (new)
(c e) promote public awareness and understanding of the benefits, risks, rules and safeguards and rights in relation to the use of AI systems;
Amendment 2538 #
Proposal for a regulation
Article 58 – paragraph 1 – point c f (new)
Article 58 – paragraph 1 – point c f (new)
(c f) promote the cooperation and effective bilateral and multilateral exchange of information and best practices between the national supervisory authorities;
Amendment 2539 #
Proposal for a regulation
Article 58 – paragraph 1 – point c f (new)
Article 58 – paragraph 1 – point c f (new)
(c f) promote public awareness and understanding of the benefits, rules and safeguards and rights in relation to the use of AI systems.
Amendment 2540 #
Proposal for a regulation
Article 58 – paragraph 1 – point c g (new)
Article 58 – paragraph 1 – point c g (new)
(c g) facilitate cooperation between the supervisory authorities of Member States and other supervisory authorities that might be responsible for the enforcement of this Regulation;
Amendment 2543 #
Proposal for a regulation
Article 58 – paragraph 1 – point c h (new)
Article 58 – paragraph 1 – point c h (new)
(c h) support capacity and expertise building in supervisory authorities that are responsible for the enforcement of this Regulation;
Amendment 2544 #
Proposal for a regulation
Article 58 – paragraph 1 – point c i (new)
Article 58 – paragraph 1 – point c i (new)
(c i) advise the Commission on the possible amendment of the Annexes by means of delegated acts in accordance with Article 73, in particular the annex listing high-risk AI systems;
Amendment 2545 #
Proposal for a regulation
Article 58 – paragraph 1 – point c j (new)
Article 58 – paragraph 1 – point c j (new)
(c j) ensure that the national supervisory authorities actively cooperate in the implementation of this Regulation;
Amendment 2546 #
Proposal for a regulation
Article 58 – paragraph 1 – point c k (new)
Article 58 – paragraph 1 – point c k (new)
(c k) adopt binding decisions for national competent authorities in cases of serious disagreements pursuant to article 59a (5);
Amendment 2547 #
Proposal for a regulation
Article 58 – paragraph 1 – point c l (new)
Article 58 – paragraph 1 – point c l (new)
(c l) promote the development of a common European approach to benchmarking by cooperating with national metrology and benchmarking authorities and by issuing opinions, recommendations, written contributions, or studies with a view to ensure consistent and harmonised European benchmarking standards;
Amendment 2548 #
Proposal for a regulation
Article 58 – paragraph 1 – point c m (new)
Article 58 – paragraph 1 – point c m (new)
(c m) provide guidance in relation to children’s rights, applicable law and minimum standards to meet the objectives of this Regulation that pertain to children;
Amendment 2549 #
Proposal for a regulation
Article 58 – paragraph 1 – point c n (new)
Article 58 – paragraph 1 – point c n (new)
(c n) promote and support the accessible development and use of artificial intelligence systems, in accordance with the provisions of Directive (EU) 2019/882;
Amendment 2552 #
Proposal for a regulation
Article 58 a (new)
Article 58 a (new)
Amendment 2555 #
Proposal for a regulation
Article 58 b (new)
Article 58 b (new)
Amendment 2572 #
Proposal for a regulation
Article 59 – paragraph 4
Article 59 – paragraph 4
4. Member States shall ensure that national competent authorities are provided with adequate financial, technical 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.
Amendment 2581 #
Proposal for a regulation
Article 59 – paragraph 5
Article 59 – paragraph 5
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 BoardAI Office for discussion and possible recommendations.
Amendment 2584 #
Proposal for a regulation
Article 59 – paragraph 6
Article 59 – paragraph 6
6. The Commission and the board shall facilitate the exchange of experience between national competent authorities.
Amendment 2589 #
Proposal for a regulation
Article 59 – paragraph 7
Article 59 – paragraph 7
7. National competent authorities may provide guidance and advice on the implementation of this Regulation, including to small-scale providerSMEs and start-ups. 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 mayshall also establish one central contact point for communication with operators and other stakeholders.
Amendment 2593 #
Proposal for a regulation
Article 59 – paragraph 8
Article 59 – paragraph 8
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 2597 #
Proposal for a regulation
Article 59 a (new)
Article 59 a (new)
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 provider or the user of the concerned AI system is established or where the authorised representative is appointed shall be considered to be the lead national supervisory authority. 3. In the cases referred to in paragraph 2,the relevant national supervisory authorities shall cooperate and exchange all relevant information in due time. National supervisory authorities shall cooperate in order to reach a consensus. 4. In the case of a serious disagreement between two or more national supervisory authorities, the national supervisory authorities shall notify the AI Office and communicate without delay all relevant information related to the case to the AI Office. 5. The AI Office shall, within three months of receipt of the notification referred to in paragraph 4, issue a binding decision to the national supervisory authorities.
Amendment 2615 #
Proposal for a regulation
Article 60 – paragraph 1
Article 60 – paragraph 1
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)in one of the areas listed in Annex III which are registered in accordance with Article 51 and their uses by public authorities and Union institutions, bodies, offices or agencies or on their behalf.
Amendment 2627 #
Proposal for a regulation
Article 60 – paragraph 4
Article 60 – paragraph 4
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 user, if the user is a public authority or a Union institution, body, office or agency or a user acting on their behalf.
Amendment 2655 #
Proposal for a regulation
Article 62 – paragraph 1 – introductory part
Article 62 – paragraph 1 – introductory part
1. Providers and, where applicable, users 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.
Amendment 2657 #
Proposal for a regulation
Article 62 – paragraph 1 – subparagraph 1
Article 62 – paragraph 1 – subparagraph 1
Such notification shall be made immediatwithout undue delay 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 day72 hours after the providers becomes aware of the serious incident or of the malfunctioning.
Amendment 2673 #
Proposal for a regulation
Article 62 – paragraph 3 a (new)
Article 62 – paragraph 3 a (new)
3 a. National supervisory authorities shall on an annual basis notify the Board of the serious incidents and malfunctioning reported to them in accordance with this Article.
Amendment 2674 #
Proposal for a regulation
Article 63 – paragraph 2
Article 63 – paragraph 2
2. The national supervisory authority shall report annually 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.
Amendment 2688 #
Proposal for a regulation
Article 64 – paragraph 2
Article 64 – paragraph 2
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 have been exhausted and have proven to be insufficient, and upon a reasoned request, the market surveillance authorities or, where applicable, the Commission, shall be granted access to the source code of the AI system. Such access shall be subject to existing Union law on the protection of intellectual property and trade secrets.
Amendment 2689 #
Proposal for a regulation
Article 64 – paragraph 2
Article 64 – paragraph 2
2. WhereMarket surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned request and only when the following cumulative conditions are fulfilled: a) Access to source code is necessary to assess the conformity of thea 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. b) testing/auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.
Amendment 2715 #
Proposal for a regulation
Article 65 – paragraph 2 – introductory part
Article 65 – paragraph 2 – introductory part
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).
Amendment 2722 #
Proposal for a regulation
Article 65 – paragraph 3
Article 65 – paragraph 3
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 without undue delay of the results of the evaluation and of the actions which it has required the operator to take.
Amendment 2723 #
Proposal for a regulation
Article 65 – paragraph 3
Article 65 – paragraph 3
3. Where the market surveillance authority considers that non-compliance is not restricted to its national territory, it shall inform the Commission, the AI Office and the other Member States of the results of the evaluation and of the actions which it has required the operator to take.
Amendment 2726 #
Proposal for a regulation
Article 65 – paragraph 5
Article 65 – paragraph 5
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 informnotify the Commission and the other Member States, without delay, of those measures.
Amendment 2727 #
Proposal for a regulation
Article 65 – paragraph 6 – introductory part
Article 65 – paragraph 6 – introductory part
6. The informnotification referred to in paragraph 5 shall include all available details, in particular the datainformation 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:
Amendment 2730 #
Proposal for a regulation
Article 65 – paragraph 6 – point b a (new)
Article 65 – paragraph 6 – point b a (new)
(b a) non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5;
Amendment 2731 #
Proposal for a regulation
Article 65 – paragraph 6 – point b b (new)
Article 65 – paragraph 6 – point b b (new)
(b b) non-compliance with provisions set out in Article 52;
Amendment 2735 #
Proposal for a regulation
Article 65 – paragraph 8
Article 65 – paragraph 8
8. Where, within three months of receipt of the informnotification 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. The period referred to in the first sentence of this paragraph shall be reduced to 30 days in the case of non- compliance with the prohibition of the artificial intelligence practices referred to in Article 5.
Amendment 2737 #
Proposal for a regulation
Article 65 – paragraph 9
Article 65 – paragraph 9
9. The market surveillance authorities of all Member States shall ensure that appropriate restrictive measures are taken in respect of the productAI system concerned, such as withdrawal of the product from their market, without delay.
Amendment 2739 #
Proposal for a regulation
Article 66 – paragraph 1
Article 66 – paragraph 1
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 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’s market surveillance authority 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, 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 Member State concerned. The Commission shall also inform all other Member States of such decision.
Amendment 2748 #
Proposal for a regulation
Article 67 – paragraph 1
Article 67 – paragraph 1
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, or 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.
Amendment 2753 #
Proposal for a regulation
Article 67 – paragraph 2 a (new)
Article 67 – paragraph 2 a (new)
Amendment 2755 #
Proposal for a regulation
Article 67 – paragraph 3
Article 67 – paragraph 3
3. The Member State shall immediately inform the Commission, the AI Office, 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.
Amendment 2758 #
Proposal for a regulation
Article 67 – paragraph 4
Article 67 – paragraph 4
4. The Commission shall without delay enter into consultation with the Member States concerned 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.
Amendment 2762 #
5. The Commission shall address its decision to the Member States concerned, and inform all other Member States.
Amendment 2769 #
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all 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.
Amendment 2772 #
Proposal for a regulation
Article 68 a (new)
Article 68 a (new)
Amendment 2779 #
Proposal for a regulation
Article 68 b (new)
Article 68 b (new)
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 data subject shall have the right to a an effective judicial remedy where the national supervisory authority does not handle a complaint, does not inform the complainant on the progress or preliminary outcome of the complaint lodged within three months pursuant to Article 68a(3) or does not comply with its obligation to reach a final decision on the complaint within six months pursuant to Article 68a(4) or its obligations under Article 65. 3. Proceedings against a supervisory authority shall be brought before the courts of the Member State where the national supervisory authority is established.
Amendment 2786 #
Proposal for a regulation
Article 69 – paragraph 1
Article 69 – paragraph 1
1. The Commission, AI Office, 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 ofdevelopment and use of safe and trustworthy AI for AI systems other than high-risk AI systems. These codes of conduct should be voluntary and should be based on 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 but be adapted in light of the intended purpose of the systems. and of the lower risk involved
Amendment 2787 #
Proposal for a regulation
Article 69 – paragraph 1
Article 69 – paragraph 1
1. The Commission and the Member Statesboard 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.
Amendment 2790 #
Proposal for a regulation
Article 69 – paragraph 2
Article 69 – paragraph 2
2. The Commission and the BoardAI Office 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.
Amendment 2791 #
Proposal for a regulation
Article 69 – paragraph 3
Article 69 – paragraph 3
3. Codes of conduct may be drawn up by individual providers of AI systems or by organisations representing them or by bothe Commission or the AI Office, 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.
Amendment 2792 #
Proposal for a regulation
Article 69 – paragraph 4
Article 69 – paragraph 4
4. The Commission and the BoardAI Office 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.
Amendment 2793 #
Proposal for a regulation
Article 69 – paragraph 4
Article 69 – paragraph 4
4. The Commission and the Board shall take into account the specific interests and needs of the small-scale providerSMEs and start-ups when encouraging and facilitating the drawing up of codes of conduct.
Amendment 2796 #
Proposal for a regulation
Article 70 – paragraph 1 – introductory part
Article 70 – paragraph 1 – introductory part
1. National competent authorities and, notified bodies involved in the application of this Regulation shall respect, the Commission, the Board, and any other natural or legal person involved in the application of this Regulation shall, in accordance with Union or national law, put appropriate technical and organisational measures in place to ensure the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular:
Amendment 2798 #
Proposal for a regulation
Article 70 – paragraph 1 – introductory part
Article 70 – paragraph 1 – introductory part
1. NThe Commission, the AI Office, 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:
Amendment 2820 #
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
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 and size of small-scale providers and start- ups and their economic viability.
Amendment 2821 #
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
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 size and interests of small-scale providerSMEs and start-ups and their economic viability.
Amendment 2827 #
Proposal for a regulation
Article 71 – paragraph 2
Article 71 – paragraph 2
2. The Member States shall without delay notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.
Amendment 2831 #
Proposal for a regulation
Article 71 – paragraph 3 – introductory part
Article 71 – paragraph 3 – introductory part
3. The following infringementsNon-compliance with the prohibition of the artificial intelligence practices referred to in Article 5 shall be subject to administrative fines of up to 30 000 000 EUR or, if the offender is a company, up to 6 % of its total worldwide annual turnover for the preceding financial year, whichever is higher:;
Amendment 2839 #
Proposal for a regulation
Article 71 – paragraph 3 – point a
Article 71 – paragraph 3 – point a
Amendment 2842 #
Proposal for a regulation
Article 71 – paragraph 3 – point b
Article 71 – paragraph 3 – point b
Amendment 2845 #
Proposal for a regulation
Article 71 – paragraph 3 a (new)
Article 71 – paragraph 3 a (new)
3 a. Non-compliance of the AI system with the requirements laid down in Article 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.
Amendment 2853 #
Proposal for a regulation
Article 71 – paragraph 4
Article 71 – paragraph 4
4. The nNon-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 210 000 000 EUR or, if the offender is a company, up to 42 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
Amendment 2864 #
Proposal for a regulation
Article 71 – paragraph 6 – point b
Article 71 – paragraph 6 – point b
(b) whether administrative fines have been already applied by other market surveillance authorities of one or more Member States to the same operator for the same infringement.
Amendment 2866 #
Proposal for a regulation
Article 71 – paragraph 6 – point c
Article 71 – paragraph 6 – point c
(c) the size, the annual turnover and market share of the operator committing the infringement;
Amendment 2876 #
Proposal for a regulation
Article 71 – paragraph 7
Article 71 – paragraph 7
7. Each Member State shall lay down rules on whether and to what extent administrative fines mayto be imposed on public authorities and bodies established in that Member State, with a view to ensure compliance with this Regulation.
Amendment 2881 #
Proposal for a regulation
Article 71 – paragraph 8 a (new)
Article 71 – paragraph 8 a (new)
Amendment 2895 #
Proposal for a regulation
Article 72 – paragraph 2 – introductory part
Article 72 – paragraph 2 – introductory part
2. The following infringementsNon-compliance with the prohibition of the artificial intelligence practices referred to in Article 5 shall be subject to administrative fines of up to 51.000 000 EUR:;
Amendment 2901 #
Proposal for a regulation
Article 72 – paragraph 2 – point a
Article 72 – paragraph 2 – point a
Amendment 2904 #
Proposal for a regulation
Article 72 – paragraph 2 – point b
Article 72 – paragraph 2 – point b
Amendment 2906 #
Proposal for a regulation
Article 72 – paragraph 2 a (new)
Article 72 – paragraph 2 a (new)
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 500 000 EUR.
Amendment 2910 #
Proposal for a regulation
Article 72 – paragraph 3
Article 72 – paragraph 3
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 25300 000 EUR.
Amendment 2925 #
Proposal for a regulation
Article 73 – paragraph 3 a (new)
Article 73 – paragraph 3 a (new)
3 a. Prior to adopting a delegated act pursuant to Article 4, Article 7(1), Article 11(3), Article 43(5) and (6), and Article48(5) the Commission shall consult the AI Office.
Amendment 2926 #
Proposal for a regulation
Article 73 – paragraph 3 b (new)
Article 73 – paragraph 3 b (new)
Amendment 2928 #
Proposal for a regulation
Article 73 – paragraph 4
Article 73 – paragraph 4
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to, the Council, and the AI Office.
Amendment 2942 #
Proposal for a regulation
Article 82 a (new)
Article 82 a (new)
Article 82 a Sound 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 in order to avoid duplication, overregulation, and the creation of loopholes.
Amendment 2946 #
Proposal for a regulation
Article 83 – paragraph 1 – introductory part
Article 83 – paragraph 1 – introductory part
1. This Regulation shall not apply toOperators 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 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 shall take the necessary steps to comply with the requirements of the present Regulation within 4 years of its entry into force.
Amendment 2952 #
Proposal for a regulation
Article 83 – paragraph 1 – subparagraph 1
Article 83 – paragraph 1 – subparagraph 1
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 and whenever those legal acts are replaced or amended.
Amendment 2957 #
Proposal for a regulation
Article 83 – paragraph 2
Article 83 – paragraph 2
2. This Regulation shall apply to theOperators 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 significant changes shall take the necessary steps to comply with the requirements of the present Regulation within 2 years of its entry into force or at the time when such systems are subject to a substantial modification in their design or intended purpose.
Amendment 2962 #
Proposal for a regulation
Article 83 – paragraph 2
Article 83 – paragraph 2
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 changesubstantial modification in their design or intended purpose as defined in Article 3(23) .
Amendment 2968 #
Proposal for a regulation
Article 84 – paragraph 1
Article 84 – paragraph 1
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. The findings of that assessment shall be presented to the European Parliament and the Council.
Amendment 2970 #
Proposal for a regulation
Article 84 – paragraph 1
Article 84 – paragraph 1
1. TIn consultation with the AI Office, the Commissions shall assess the need for amendment of the list in Annex III once a year following the entry into force of this Regulation.
Amendment 2972 #
Proposal for a regulation
Article 84 – paragraph 1 a (new)
Article 84 – paragraph 1 a (new)
Amendment 2974 #
Proposal for a regulation
Article 84 – paragraph 3 – point a
Article 84 – paragraph 3 – point a
(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 2976 #
Proposal for a regulation
Article 84 – paragraph 3 – point b
Article 84 – paragraph 3 – point b
(b) the state of penalties, and notably administrative fines as referred to in Article 71(1), applied by Member States to infringements of the provisions of this Regulation.
Amendment 2977 #
Proposal for a regulation
Article 84 – paragraph 3 – point b a (new)
Article 84 – paragraph 3 – point b a (new)
(b a) the state of the development of harmonised standards and common specifications for Artificial Intelligence;
Amendment 2981 #
Proposal for a regulation
Article 84 – paragraph 4
Article 84 – paragraph 4
4. Within [threone years after the date of application of this Regulation referred to in Article 85(2)] and every fourtwo 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 2983 #
Proposal for a regulation
Article 84 – paragraph 5
Article 84 – paragraph 5
5. For the purpose of paragraphs 1 to 4 the BoardAI Office, the Member States and national competent authorities shall provide the Commission with information on its request.
Amendment 2989 #
Proposal for a regulation
Article 84 – paragraph 6
Article 84 – paragraph 6
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 BoardAI Office, of the European Parliament, of the Council, and of other relevant bodies or sources.
Amendment 3008 #
Proposal for a regulation
Article 85 – paragraph 3 b (new)
Article 85 – paragraph 3 b (new)
Amendment 3047 #
Proposal for a regulation
Annex III – paragraph 1 – point 1 – introductory part
Annex III – paragraph 1 – point 1 – introductory part
1. 1.Biometric identification and categorisation of natural persons:and biometrics-based systems: (a) AI systems intended to be used for the ‘real-time’ and ‘post’ remote biometric identification of natural persons; (b) AI systems intended to be used for the remote biometric categorisation of natural persons in publicly-accessible spaces; (c) AI systems intended to be used for emotion recognition in natural persons;
Amendment 3056 #
Proposal for a regulation
Annex III – paragraph 1 – point 1 – point a
Annex III – paragraph 1 – point 1 – point a
Amendment 3110 #
Proposal for a regulation
Annex III – paragraph 1 – point 4 – point a
Annex III – paragraph 1 – point 4 – point a
(a) AI systems intended to be used forin recruitment or selection of natural persons, notably for advertising vacancies, screening or filtering applications, or evaluating candidates in the course of interviews or tests;
Amendment 3117 #
Proposal for a regulation
Annex III – paragraph 1 – point 4 – point b
Annex III – paragraph 1 – point 4 – point b
(b) AI systems intended to be used for making decisions or to assist in making decisions on promotion and termination of work-related contractual relationships,; for personalized task allocation based on biometrics, biometrics-based, or personal data; and for monitoring and evaluating performance and behaviour of natural persons in such relationships.
Amendment 3125 #
Proposal for a regulation
Annex III – paragraph 1 – point 5 – point a
Annex III – paragraph 1 – point 5 – point a
(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, increase, or reclaim such benefits and services;
Amendment 3154 #
Proposal for a regulation
Annex III – paragraph 1 – point 6 – point a
Annex III – paragraph 1 – point 6 – point a
(a) AI systems intended to be used by law enforcement authorities or on their behalf 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;
Amendment 3163 #
Proposal for a regulation
Annex III – paragraph 1 – point 6 – point b
Annex III – paragraph 1 – point 6 – point b
(b) AI systems intended to be used by law enforcement authorities or on behalf of law enforcement authorities as polygraphs and similar tools or to detect the emotional state of a natural person;
Amendment 3164 #
Proposal for a regulation
Annex III – paragraph 1 – point 6 – point b
Annex III – paragraph 1 – point 6 – point b
(b) AI systems intended to be used by law enforcement authorities or on their behalf as polygraphs and similar tools or to detect the emotional state of a natural person;
Amendment 3166 #
Proposal for a regulation
Annex III – paragraph 1 – point 6 – point c
Annex III – paragraph 1 – point 6 – point c
(c) AI systems intended to be used by law enforcement authorities or on behalf of law enforcement authorities to detect deep fakes as referred to in article 52(3);
Amendment 3168 #
Proposal for a regulation
Annex III – paragraph 1 – point 6 – point c
Annex III – paragraph 1 – point 6 – point c
(c) AI systems intended to be used by law enforcement authorities or on their behalf to detect deep fakes as referred to in article 52(3);
Amendment 3169 #
Proposal for a regulation
Annex III – paragraph 1 – point 6 – point d
Annex III – paragraph 1 – point 6 – point d
(d) AI systems intended to be used by law enforcement authorities or on behalf of law enforcement authorities for evaluation of the reliability of evidence in the course of investigation or prosecution of criminal offences;
Amendment 3172 #
Proposal for a regulation
Annex III – paragraph 1 – point 6 – point d
Annex III – paragraph 1 – point 6 – point d
(d) AI systems intended to be used by law enforcement authorities or on their behalf for evaluation of the reliability of evidence in the course of investigation or prosecution of criminal offences;
Amendment 3177 #
Proposal for a regulation
Annex III – paragraph 1 – point 6 – point e
Annex III – paragraph 1 – point 6 – point e
Amendment 3182 #
Proposal for a regulation
Annex III – paragraph 1 – point 6 – point f
Annex III – paragraph 1 – point 6 – point f
(f) AI systems intended to be used by law enforcement authorities or on behalf 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;
Amendment 3184 #
Proposal for a regulation
Annex III – paragraph 1 – point 6 – point f
Annex III – paragraph 1 – point 6 – point f
(f) AI systems intended to be used by law enforcement authorities or on their behalf 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;
Amendment 3188 #
Proposal for a regulation
Annex III – paragraph 1 – point 6 – point g
Annex III – paragraph 1 – point 6 – point g
(g) AI systems intended to be used by law enforcement authorities or on their behalf 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 3195 #
Proposal for a regulation
Annex III – paragraph 1 – point 7 – point a
Annex III – paragraph 1 – point 7 – point a
(a) AI systems intended to be used by competent public authorities or on their behalf as polygraphs and similar tools or to detect the emotional state of a natural person;
Amendment 3196 #
Proposal for a regulation
Annex III – paragraph 1 – point 7 – point a
Annex III – paragraph 1 – point 7 – point a
(a) AI systems intended to be used by competent public authorities or on their behalf as polygraphs and similar tools or to detect the emotional state of a natural person;
Amendment 3204 #
Proposal for a regulation
Annex III – paragraph 1 – point 7 – point b
Annex III – paragraph 1 – point 7 – point b
(b) AI systems intended to be used by competent public authorities or on their behalf 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 3205 #
Proposal for a regulation
Annex III – paragraph 1 – point 7 – point b
Annex III – paragraph 1 – point 7 – point b
(b) AI systems intended to be used by competent public authorities or on their behalf 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 3207 #
Proposal for a regulation
Annex III – paragraph 1 – point 7 – point c
Annex III – paragraph 1 – point 7 – point c
(c) AI systems intended to be used by competent public authorities or on their behalf 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 3208 #
Proposal for a regulation
Annex III – paragraph 1 – point 7 – point c
Annex III – paragraph 1 – point 7 – point c
(c) AI systems intended to be used by competent public authorities or on their behalf 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 3213 #
Proposal for a regulation
Annex III – paragraph 1 – point 7 – point d
Annex III – paragraph 1 – point 7 – point d
(d) AI systems intended to be used by competent public authorities or on their behalf or to assist competent public authorities forin 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.
Amendment 3214 #
Proposal for a regulation
Annex III – paragraph 1 – point 7 – point d
Annex III – paragraph 1 – point 7 – point d
(d) AI systems intended to assist competent public authorities or on their behalf 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.
Amendment 3216 #
Proposal for a regulation
Annex III – paragraph 1 – point 7 – point d
Annex III – paragraph 1 – point 7 – point d
(d) AI systems intended to assistbe used by 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.
Amendment 3230 #
Proposal for a regulation
Annex III – paragraph 1 – point 8 – point a
Annex III – paragraph 1 – point 8 – point a
(a) AI systems intended to be used by a judicial authority or administrative body or on their behalf or to assist a judicial authority or administrative body in researching and interpreting facts andor the law and in applying the law to a concrete set of facts.
Amendment 3233 #
Proposal for a regulation
Annex III – paragraph 1 – point 8 – point a
Annex III – paragraph 1 – point 8 – point a
(a) AI systems intended to assist abe used by judicial authority in researching andies or on their behalf in interpreting facts andor the law and infor applying the law to a concrete set of facts.
Amendment 3235 #
Proposal for a regulation
Annex III – paragraph 1 – point 8 – point a a (new)
Annex III – paragraph 1 – point 8 – point a a (new)
(a a) AI systems used by political parties, political candidates, public authorities, or on their behalf for influencing natural persons in the exercise of their vote in local, national, or European Parliament elections;
Amendment 3237 #
Proposal for a regulation
Annex III – paragraph 1 – point 8 a (new)
Annex III – paragraph 1 – point 8 a (new)
8 a. Other applications: (a) AI systems intended to be used to generate, on the basis of limited human input, complex text content that would falsely appear to a person to be human generated and authentic, such as news articles, opinion articles, novels, scripts, and scientific articles, with the exception of AI systems used exclusively for content that undergoes human review and for the publication of which a natural or legal person established in the Union is liable or holds editorial responsibility; (b) AI systems intended to be used to generate or manipulate audio or video content that features existing natural persons appearing to say or do something they have never said or done, with the exception of AI systems used exclusively for content that forms part of an evidently artistic, creative or fictional cinematographic and analogous work; (c)AI systems that deploy subliminal techniques for scientific research and for therapeutical purposes;
Amendment 3279 #
Proposal for a regulation
Annex IV – paragraph 1 – point 5
Annex IV – paragraph 1 – point 5
5. A description of relevanyt changes made by providers to the system through its lifecycle;
Amendment 3280 #
Proposal for a regulation
Annex IV – paragraph 1 – point 5
Annex IV – paragraph 1 – point 5
5. A description of any relevant change made to the system through its lifecycle;
Amendment 3281 #
Proposal for a regulation
Annex IV – paragraph 1 – point 6
Annex IV – paragraph 1 – point 6
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 common specifications or other relevant standards and technical specifications applied;
Amendment 3286 #
Proposal for a regulation
Annex VII – point 4 – point 4.5
Annex VII – point 4 – point 4.5
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 source code of the AI system. Such access shall be subject to existing Union law on the protection of intellectual property and trade secrets.
Amendment 3294 #
Proposal for a regulation
Annex VIII – paragraph 1 a (new)
Annex VIII – paragraph 1 a (new)
1a.The following information shall be provided and updated with regard to high risk AI systems to be registered in accordance with Article 51(2) by users who are or act on behalf of public authorities or Union institutions, bodies, offices or agencies: 1. the name, address and contact details of the user; 2. the name, address and contact details of any person submitting information on behalf of the user; 3. the high-risk AI system trade name and any additional unambiguous reference allowing identification and traceability of the AI system used; 4. description of the intended use of the AI system, including the specific outcomes sought through the use of the system; 5. a summary of the findings of the fundamental rights impact assessment conducted in accordance with the obligation of public authorities or Union institutions, agencies, offices or bodies set out in this Regulation; 6. 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; 6. a declaration of conformity with the applicable data protection rules.