179 Amendments of Nicolae ŞTEFĂNUȚĂ related to 2021/0106(COD)
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 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 467 #
Proposal for a regulation
Recital 19
Recital 19
Amendment 473 #
Proposal for a regulation
Recital 20
Recital 20
Amendment 483 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 490 #
Proposal for a regulation
Recital 22
Recital 22
Amendment 499 #
Proposal for a regulation
Recital 23
Recital 23
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 1253 #
Proposal for a regulation
Article 5 – paragraph 1 – point d – point i
Article 5 – paragraph 1 – point d – point i
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 1348 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 1357 #
Proposal for a regulation
Article 5 – paragraph 2 – point a
Article 5 – paragraph 2 – point a
Amendment 1359 #
Proposal for a regulation
Article 5 – paragraph 2 – point b
Article 5 – paragraph 2 – point b
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 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 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 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 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 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 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 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 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 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 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 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 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 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 2293 #
Proposal for a regulation
Article 53 – paragraph 1
Article 53 – paragraph 1
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 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 2404 #
Proposal for a regulation
Article 56 – paragraph 2
Article 56 – paragraph 2
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.