63 Amendments of Tomas TOBÉ related to 2021/0106(COD)
Amendment 329 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3 a) The deployment of artificial intelligence is critical for European competitiveness and in particular for the success of small and medium-sized enterprises in industrial sectors. AI solutions can support European companies to optimise production processes, predict machinery failures and develop more efficient and smart services. The potential of AI can however only fully materialise if European industry, and in particular SMEs, are provided with a permissive legislative framework which avoids any overregulation that would funnel resources away from R&D towards unnecessary compliance costs.
Amendment 337 #
Proposal for a regulation
Recital 4
Recital 4
(4) At the same time, depending on the circumstances regarding its specific application and use, artificial intelligence may generate risks and cause harm to public and private interests and rights that are protected by Union law. Such harm might be material or immaterial.
Amendment 352 #
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 and private interests, such as health and safety and the protection of fundamental rights, as recognised and protected by Union law. To achieve that objective, rules regulating the placing on the market and putting into service of certain AI systems should be laid down, thus ensuring the smooth functioning of the internal market and allowing those systems to benefit from the principle of free movement of goods and services. By laying down those rules, this Regulation supports the objective of the Union of being a global leader in the development of secure, trustworthy and ethical artificial intelligence, as stated by the European 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 446 #
Proposal for a regulation
Recital 18
Recital 18
Amendment 462 #
Proposal for a regulation
Recital 19
Recital 19
Amendment 478 #
Proposal for a regulation
Recital 20
Recital 20
Amendment 489 #
Proposal for a regulation
Recital 21
Recital 21
(21) Each uUse of a ‘real-time’ remote biometric identification system in publicly accessible spaces for the purpose of law enforcement should be subject to an express and specific authorisation by a judicial authority or by an independent administrative authority of a Member State. Such authorisation should in principle be obtained prior to the use, except in duly justified situations of urgency, that is, situations where the need to use the systems in question is such as to make it effectively and objectively impossible to obtain an authorisation before commencing the use. In such situations of urgency, the use should be restricted to the absolute minimum necessary and be subject to appropriate safeguards and conditions, as determined in national law and specified in the context of each individual urgent use case by the law enforcement authority itself. In addition, the law enforcement authority should in such situations seek to obtain an authorisation as soon as possible, whilst providing the reasons for not having been able to request it earlier.
Amendment 496 #
Proposal for a regulation
Recital 22
Recital 22
(22) Furthermore, it is appropriate to provide, within the exhaustive framework set by this Regulation that such use in the territory of a Member State in accordance with this Regulation should only be possible where and in as far as the Member State in question has decided to expressly provide for the possibility to authorise such use in its detailed rules of national law. Consequently, Member States remain free under this Regulation not to provide for such a possibility at all or to only provide for such a possibility in respect of some of the objectives capable of justifying authorised use identifiedlimited possibilities in this Rregulationard.
Amendment 506 #
Proposal for a regulation
Recital 23
Recital 23
(23) The use of AI systems for ‘real- time’ remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement necessarily involves the processing of biometric data. The rules of this Regulation that prohibit, subject to certain exceptions, such use, which are based on Article 16 TFEU, should apply as lex specialis in respect of the rules on the processing of biometric data contained in Article 10 of Directive (EU) 2016/680, thus regulating such use and the processing of biometric data involved in an exhaustive manner. Therefore, such use and processing should only be possible in as far as it is compatible with the framework set by this Regulation, without there being scope, outside that framework, for the competent authorities, where they act for purpose of law enforcement, to use such systems and process such data in connection thereto on the grounds listed in Article 10 of Directive (EU) 2016/680. In this context, this Regulation is not intended to provide the legal basis for the processing of personal data under Article 8 of Directive 2016/680. However, the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for purposes other than law enforcement, including by competent authorities, should not be covered by the specific framework regarding such use for the purpose of law enforcement set by this Regulation. Such use for purposes other than law enforcement should therefore not be subject to the requirement of an authorisation under this Regulation and the applicable detailed rules of national law that may give effect to it.
Amendment 529 #
Proposal for a regulation
Recital 28
Recital 28
(28) AI systems could produce adverse outcomes to health and safety of persons, in particular when such systems operate as components of products. Consistently with the objectives of Union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market, it is important that the safety risks that may be generated by a product as a whole due to its digital components, including AI systems, are duly prevented and mitigated. For instance, increasingly autonomous robots, whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments. Similarly, in the health sector where the stakes for life and health are particularly high, increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate. Conversely, industrial robots used in manufacturing processes that operate within a predefined and restricted area entail considerably lower safety risks and are already subject to harmonised safety legislation. The extent of the adverse impact caused by the AI system on the fundamental rights protected by the Charter is of particular relevance when classifying an AI system as high-risk. Those rights include the right to human dignity, respect for private and family life, protection of personal data, freedom of expression and information, freedom of assembly and of association, and non- discrimination, consumer protection, workers’ rights, rights of persons with disabilities, right to an effective remedy and to a fair trial, right of defence and the presumption of innocence, right to good administration. In addition to those rights, it is important to highlight that children have specific rights as enshrined in Article 24 of the EU Charter and in the United Nations Convention on the Rights of the Child (further elaborated in the UNCRC General Comment No. 25 as regards the digital environment), both of which require consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their well-being. The fundamental right to a high level of environmental protection enshrined in the Charter and implemented in Union policies should also be considered when assessing the severity of the harm that an AI system can cause, including in relation to the health and safety of persons.
Amendment 634 #
Proposal for a regulation
Recital 46
Recital 46
(46) Having information on how high- risk AI systems have been developed and how they perform throughout their lifecycle is essential to verify compliance with the requirements under this Regulation. This requires keeping records and the availability of a technical documentation, containing information which is necessary to assess the compliance of the AI system with the relevant requirements. Such information should include the general characteristics, capabilities and limitations of the system, algorithms, data, training, testing and validation processes used as well as documentation on the relevant risk management system. The technical documentation should be kept up to date. The required technical documentation may contain trade secrets in accordance with Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure. Possible trade secrets in the required documentation must be treated and kept in accordance with national legislation put in place in accordance with mentioned directive.
Amendment 675 #
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 couldin exceptional cases, where industry and technical experts consider that pressing and specific safety or fundamental rights concerns cannot be addressed by established standardisation processes, the Commission may adopt common technical specifications in areas where no harmonised standards exist or where they are evidently insufficient. _________________ 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 677 #
Proposal for a regulation
Recital 61 a (new)
Recital 61 a (new)
(61 a) Striving for regulatory alignment on AI with likeminded global partners is key to fostering mutual innovation and cross-border partnerships within the field of AI. Coordination with international standardisation bodies is therefore of great importance.
Amendment 685 #
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 the involvement of a notified body in the conformity assessment should be foreseen, to the extent they are not prohibited.
Amendment 697 #
Proposal for a regulation
Recital 67
Recital 67
(67) High-risk AI systems should bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the internal market. Member States should not create unjustified obstacles to the placing on the market or putting into service of high-risk AI systems that comply with the requirements laid down in this Regulation and bear the CE marking.
Amendment 723 #
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.
Amendment 749 #
Proposal for a regulation
Recital 78
Recital 78
(78) In order to ensure that providers of high-risk AI systems can take into account the experience on the use of high-risk AI systems for improving their systems and the design and development process or can take any possible corrective action in a timely manner, all providers should have a post-market monitoring system in place. This system is also key to ensure that the possible risks emerging from AI systems which continue to ‘learn’ after being placed on the market or put into service can be more efficiently and timely addressed. In this context, providers should also be required to have a system in place to report to the relevant authorities any serious incidents or any breaches to national and Union law protecting fundamental rights resulting from the use of their AI systems.
Amendment 770 #
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 and the content of the EU declaration of conformity in Annex V. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-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 791 #
Proposal for a regulation
Article 1 – paragraph 1 – point c
Article 1 – paragraph 1 – point c
(c) specific requirements for high-risk AI systems and obligations for operators of such systems, unless these systems are already covered by sector-specific regulation;
Amendment 874 #
Proposal for a regulation
Article 2 – paragraph 3 a (new)
Article 2 – paragraph 3 a (new)
3 a. This Regulation shall not apply to AI systems, including their output, specifically developed and put into service for the sole purpose of research and development.
Amendment 908 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) ‘artificial intelligence system’ (AI system) means software that is developed with one or more of the techniques and approaches listed in Annex I and can, for a given set of human-defined objectives,a system that (I) receives machine and/or human-based data and inputs, (II) infers how to achieve a given set of human-defined objectives using learning, reasoning or modelling implemented with the techniques and approaches listed in Annex I, and (III) generates outputs such asin the form of content, predictions, recommendations, or decisions, which influencinge the environments ithey interacts with;
Amendment 1134 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
Amendment 1230 #
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
Amendment 1355 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 1365 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 1383 #
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
Amendment 1459 #
Proposal for a regulation
Article 7
Article 7
Amendment 1460 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
Amendment 1486 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
Amendment 1573 #
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, unless the AI system is covered by New Legislative Framework (NLF) legislation.
Amendment 1676 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. High-risk AI systems which make use of techniques involving the training of models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5, when applicable.
Amendment 1708 #
Proposal for a regulation
Article 10 – paragraph 2 – point g
Article 10 – paragraph 2 – point g
(g) the identification of any possible data gaps or shortcomings, and how those gaps and shortcomings can be addressed.
Amendment 1724 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Training, validation and testing data sets shall be relevant, and representative, free of errors and complete. They shall have the appropriate statistical properties, including, where applicable, as regards the persons or groups of persons on which the high-risk AI system is intended to be used. These characteristics of the data sets may be met at the level of individual data sets or a combination thereof.
Amendment 1762 #
Proposal for a regulation
Article 11 – paragraph 3
Article 11 – paragraph 3
Amendment 1947 #
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. Providers of high-risk AI systems shall draw up the technical documen tation referred to in Article 11 in accordance with Annex IV. When applicable, the technical documentation shall be treated as containing trade secrets as regulated by Directive (EU) 2016/943.
Amendment 1953 #
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Providers of high-risk AI systems shall keep the logs automatically generated by their high-risk AI systems, to the extent such logs are under their control by virtue of a contractual arrangement with the user or otherwise by law. The logs shall be kept for a period that is appropriate in the light of the intended purpose of high-risk AI system and applicable legal obligations under Union or national law. When applicable, the automatically generated logs shall be treated as containing trade secrets as regulated by Directive (EU) 2016/943.
Amendment 2086 #
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
1. Each Member State shall designate or establish a notifying authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring. These procedures shall be developed in cooperation between the notifying authorities of all Member States and shall result in standard procedures implemented equally in all Member States, with a view to removing administrative border barriers and ensuring that the potential of the internal market is realised.
Amendment 2090 #
Proposal for a regulation
Article 30 – paragraph 8
Article 30 – paragraph 8
8. Notifying authorities shall make sure that conformity assessments are carried out in a proportionate manner, avoiding unnecessary burdens for providers and that notified bodies perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure and the degree of complexity of the AI system in question. Particular attention shall be paid to minimising administrative burdens and compliance costs for micro, small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC.
Amendment 2190 #
Proposal for a regulation
Article 43 – paragraph 4 – introductory part
Article 43 – paragraph 4 – introductory part
4. High-risk AI systems shall undergo a new conformity assessment procedure whenever they are substantially modified and the changes could impact performance related to essential requirements, regardless of whether the modified system is intended to be further distributed or continues to be used by the current user.
Amendment 2199 #
Proposal for a regulation
Article 43 – paragraph 5
Article 43 – paragraph 5
Amendment 2206 #
Proposal for a regulation
Article 43 – paragraph 6
Article 43 – paragraph 6
Amendment 2239 #
Proposal for a regulation
Article 50 – paragraph 1 – introductory part
Article 50 – paragraph 1 – introductory part
The provider shall, for a period ending 10five years after the AI system has been placed on the market or put into service, keep at the disposal of the national competent authorities:
Amendment 2243 #
Proposal for a regulation
Article 51
Article 51
Amendment 2563 #
Proposal for a regulation
Article 59 – paragraph 2
Article 59 – paragraph 2
2. Each Member State shall designate a national supervisory authority among the national competent authorities. The national supervisory authority shall act as notifying authority and market surveillance authority unless a Member State has organisational and administrative reasons to designate more than one authority.
Amendment 2591 #
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 providers. Whenever national competent authorities intend to provide guidance and advice with regard to an AI system in areas covered by other Union legislation, the competent national authorities under that Union legislation shall be consulted, as appropriate. Member States mayshall also establish one central contact point for communication with operators.
Amendment 2606 #
Proposal for a regulation
Title VII
Title VII
Amendment 2684 #
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
1. Access to data and documentation in the context of their activities, the market surveillance authorities shall be granted full access to the relevant training, validation and testing datasets used by the provider, including through application programming interfaces (‘API’) or other appropriate technical means and tools enabling remote access.
Amendment 2744 #
Proposal for a regulation
Article 66 – paragraph 3 a (new)
Article 66 – paragraph 3 a (new)
3 a. If the national measure is found to be unjustified, the Member State concerned shall reimburse the operator for the costs and loss of revenue directly attributable to the measure found to be unjustified.
Amendment 2841 #
Proposal for a regulation
Article 71 – paragraph 3 – point b
Article 71 – paragraph 3 – point b
Amendment 2852 #
Proposal for a regulation
Article 71 – paragraph 4
Article 71 – paragraph 4
4. The non-compliance of the AI system with any requirements or obligations under this Regulation, other than those laid down in Articles 5 and 10, shall be subject to administrative fines of up to 201 000 000 EUR or, if the offender is a company, up to 41 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
Amendment 2859 #
Proposal for a regulation
Article 71 – paragraph 5
Article 71 – paragraph 5
5. The supply of incorrect, incomplete or misleading information to notified bodies and national competent authorities in reply to a request shall be subject to administrative fines of up to 10 000 000 EUR or, if the offender is a company, up to 21 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
Amendment 2919 #
Proposal for a regulation
Article 73 – paragraph 2
Article 73 – paragraph 2
2. The delegation of power referred to in Article 4, Article 7(1), Article 11(3), Article 43(5) and (6) and Article 48(5) shall be conferred on the Commission for an indeterminate period of time from [entering into force of the Regulation].
Amendment 2923 #
Proposal for a regulation
Article 73 – paragraph 3
Article 73 – paragraph 3
3. The delegation of power referred to in Article 4, Article 7(1), Article 11(3), Article 43(5) and (6) and Article 48(5) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall take effect the day following that of its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 2931 #
Proposal for a regulation
Article 73 – paragraph 5
Article 73 – paragraph 5
5. Any delegated act adopted pursuant to Article 4, Article 7(1), Article 11(3), Article 43(5) and (6) and Article 48(5) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.
Amendment 2949 #
Proposal for a regulation
Article 83 – paragraph 1 – introductory part
Article 83 – paragraph 1 – introductory part
1. This Regulation shall not apply to the AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex IX that have been placed on the market or put into service before [124 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.
Amendment 2967 #
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, and when necessary, table to the European Parliament and the Council a legislative proposal in this regard.
Amendment 2978 #
Proposal for a regulation
Article 84 – paragraph 3 – point b a (new)
Article 84 – paragraph 3 – point b a (new)
(b a) the levels of investments in research, development and application of AI systems throughout the Union,
Amendment 2979 #
Proposal for a regulation
Article 84 – paragraph 3 – point b b (new)
Article 84 – paragraph 3 – point b b (new)
(b b) the competitiveness of the aggregated European AI ecosystem compared to AI ecosystems in third countries.
Amendment 3004 #
Proposal for a regulation
Article 85 – paragraph 3 – point b
Article 85 – paragraph 3 – point b
(b) Article 71 shall apply from [twelve24 months following the entry into force of this Regulation].
Amendment 3021 #
Proposal for a regulation
Annex I – point c
Annex I – point c
Amendment 3092 #
Proposal for a regulation
Annex III – paragraph 1 – point 2 – point a
Annex III – paragraph 1 – point 2 – point a
(a) AI systems intended to be used as safety components in the management and operation of road traffic and the supply of water, gas, heating and electricity, unless these are regulated in harmonisation legislation or sectorial regulation.
Amendment 3107 #
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 for recruitment or selection of natural persons, notably for advertising vacancies, screening or filtering applications, evaluating candidates in the course of interviews or tests;to make final decisions for recruitment or selection of natural persons.
Amendment 3155 #
Proposal for a regulation
Annex III – paragraph 1 – point 6 – point a a (new)
Annex III – paragraph 1 – point 6 – point a a (new)
(a a) AI systems designed for real-time remote biometric identification in publicly accessible locations for law enforcement purposes.