Changes from adopted text to adopted text

RemovedP9_TA(2023)0236

AddedP9_TA(2024)0138

Artificial Intelligence Act

ChangedCommittee on the Internal Market and Consumer Protection,Protection and Committee on Civil Liberties, Justice and Home Affairs

PE731.563

ChangedAmendments adopted by the European Parliament onlegislative 14resolution Juneof 202313 March 2024 on the proposal for a regulation of the European Parliament and of the Council on laying down harmonised rules on artificialArtificial intelligenceIntelligence (Artificial Intelligence Act) and amending certain Union legislativeLegislative actsActs (COM(2021)0206 – C9-0146/2021 – 2021/0106(COD))

(Ordinary legislative procedure: first reading)

RemovedCitation 4 a (new): Having regard to the opinion of the European Central Bank,

Change 1

AddedThe European Parliament,

RemovedCitation 4 b (new): Having regard to the joint opinion of the European Data Protection Board and the European Data Protection Supervisor,

Added– having regard to the Commission proposal to Parliament and the Council (COM(2021)0206),

RemovedRecital 1: (1) The purpose of this Regulation is to promote the uptake of human centric and trustworthy artificial intelligence and to ensure a high level of protection of health, safety, fundamental rights, democracy and rule of law and the environment from harmful effects of artificial intelligence systems in the Union while supporting innovation and improving the functioning of the internal market. This Regulation lays down a uniform legal framework in particular for the development, the placing on the market, the putting into service and the use of artificial intelligence in conformity with Union values and ensures the free movement of AI-based goods and services cross-border, thus preventing Member States from imposing restrictions on the development, marketing and use of Artificial Intelligence systems (AI systems), unless explicitly authorised by this Regulation. Certain AI systems can also have an impact on democracy and rule of law and the environment. These concerns are specifically addressed in the critical sectors and use cases listed in the annexes to this Regulation.

Added– having regard to Article 294(2) and Articles 16 and 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90146/2021),

RemovedRecital 1 a (new): (1a) This Regulation should preserve the values of the Union facilitating the distribution of artificial intelligence benefits across society, protecting individuals, companies, democracy and rule of law and the environment from risks while boosting innovation and employment and making the Union a leader in the field.

Added– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

RemovedRecital 2: (2) AI systems can be easily deployed in multiple sectors of the economy and society, including cross border, and circulate throughout the Union. Certain Member States have already explored the adoption of national rules to ensure that artificial intelligence is trustworthy and safe and is developed and used in compliance with fundamental rights obligations. Differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use AI systems. A consistent and high level of protection throughout the Union should therefore be ensured in order to achieve trustworthy AI, while divergences hampering the free circulation, innovation, deployment and uptake of AI systems and related products and services within the internal market should be prevented, by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on Article 114 of the Treaty on the Functioning of the European Union (TFEU).

Added– having regard to the opinion of the European Central Bank of 29 December 2021,

RemovedRecital 2 a (new): (2a) As artificial intelligence often relies on the processing of large volumes of data, and many AI systems and applications on the processing of personal data, it is appropriate to base this Regulation on Article 16 TFEU, which enshrines the right to the protection of natural persons with regard to the processing of personal data and provides for the adoption of rules on the protection of individuals with regard to the processing of personal data.

Added– having regard to the opinion of the European Economic and Social Committee of 22 September 2021,

RemovedRecital 2 b (new): (2b) The fundamental right to the protection of personal data is safeguarded in particular by Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive 2016/680. Directive 2002/58/EC additionally protects private life and the confidentiality of communications, including providing conditions for any personal and non-personal data storing in and access from terminal equipment. Those legal acts provide the basis for sustainable and responsible data processing, including where datasets include a mix of personal and nonpersonal data. This Regulation does not seek to affect the application of existing Union law governing the processing of personal data, including the tasks and powers of the independent supervisory authorities competent to monitor compliance with those instruments. This Regulation does not affect the fundamental rights to private life and the protection of personal data as provided for by Union law on data protection and privacy and enshrined in the Charter of Fundamental Rights of the European Union (the ‘Charter’).

Added– having regard to the provisional agreement approved by the committees responsible under Rule 74(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 2 February 2024 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

RemovedRecital 2 c (new): (2c) Artificial intelligence systems in the Union are subject to relevant product safety legislation that provides a framework protecting consumers against dangerous products in general and such legislation should continue to apply. This Regulation is also without prejudice to the rules laid down by other Union legal acts related to consumer protection and product safety, including including Regulation (EU) 2017/2394, Regulation (EU) 2019/1020 and Directive 2001/95/EC on general product safety and Directive 2013/11/EU.

Added– having regard to Rule 59 of its Rules of Procedure,

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

Added– having regard to the joint deliberations of the Committee on Internal Market and Consumer Protection and the Committee on Civil Liberties, Justice and Home Affairs under Rule 58 of the Rules of Procedure,

RemovedRecital 2 e (new): (2e) This Regulation should not affect the provisions aiming to improve working conditions in platform work set out in Directive ... [COD 2021/414/EC].

Added– having regard to the opinion of the Committee on Industry, Research and Energy, the Committee on Culture and Education, the Committee on Legal Affairs, the Committee on the Environment, Public Health and Food Safety and the Committee on Transport and Tourism,

RemovedRecital 2 f (new): (2f) This Regulation should help in supporting research and innovation and should not undermine research and development activity and respect freedom of scientific research. It is therefore necessary to exclude from its scope AI systems specifically developed for the sole purpose of scientific research and development and to ensure that the Regulation does not otherwise affect scientific research and development activity on AI systems. Under all circumstances, any research and development activity should be carried out in accordance with the Charter, Union law as well as the national law;

Added– having regard to the report of the Committee on Internal Market and Consumer Protection and the Committee on Civil Liberties, Justice and Home Affairs (A9-0188/2023),

RemovedRecital 3: (3) Artificial intelligence is a fast evolving family of technologies that can and already contributes to a wide array of economic, environmental and societal benefits across the entire spectrum of industries and social activities if developed in accordance with relevant general principles in line with the Charter and the values on which the Union is founded. By improving prediction, optimising operations and resource allocation, and personalising digital solutions available for individuals and organisations, the use of artificial intelligence can provide key competitive advantages to companies and support socially and environmentally beneficial outcomes, for example in healthcare, farming, food safety, education and training, media, sports, culture, infrastructure management, energy, transport and logistics, crisis management, public services, security, justice, resource and energy efficiency, environmental monitoring, the conservation and restoration of biodiversity and ecosystems and climate change mitigation and adaptation.

Added1. Adopts its position at first reading hereinafter set out;

RemovedRecital 3 a (new): (3a) To contribute to reaching the carbon neutrality targets, European companies should seek to utilise all available technological advancements that can assist in realising this goal. Artificial Intelligence is a technology that has the potential of being used to process the ever-growing amount of data created during industrial, environmental, health and other processes. To facilitate investments in AI-based analysis and optimisation tools, this Regulation should provide a predictable and proportionate environment for low-risk industrial solutions.

Added2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

RemovedRecital 4: (4) At the same time, depending on the circumstances regarding its specific application and use, as well as the level of technological development, artificial intelligence may generate risks and cause harm to public or private interests and fundamental rights of natural persons that are protected by Union law. Such harm might be material or immaterial, including physical, psychological, societal or economic harm.

Added3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

RemovedRecital 4 a (new): (4a) Given the major impact that artificial intelligence can have on society and the need to build trust, it is vital for artificial intelligence and its regulatory framework to be developed according to Union values enshrined in Article 2 TEU, the fundamental rights and freedoms enshrined in the Treaties, the Charter, and international human rights law. As a pre-requisite, artificial intelligence should be a human-centric technology. It should not substitute human autonomy or assume the loss of individual freedom and should primarily serve the needs of the society and the common good. Safeguards should be provided to ensure the development and use of ethically embedded artificial intelligence that respects Union values and the Charter.

AddedP9_TC1-COD(2021)0106

RemovedRecital 5: (5) A Union legal framework laying down harmonised rules on artificial intelligence is therefore needed to foster the development, use and uptake of artificial intelligence in the internal market that at the same time meets a high level of protection of public interests, such as health and safety, protection of fundamental rights, democracy and rule of law and the environment, as recognised and protected by Union law. To achieve that objective, rules regulating the placing on the market, the putting into service and the use of certain AI systems should be laid down, thus ensuring the smooth functioning of the internal market and allowing those systems to benefit from the principle of free movement of goods and services. These rules should be clear and robust in protecting fundamental rights, supportive of new innovative solutions, and enabling to a European ecosystem of public and private actors creating AI systems in line with Union values. By laying down those rules as well as measures in support of innovation with a particular focus on SMEs and start-ups, this Regulation supports the objective of promoting the AI made in Europe, of the Union of being a global leader in the development of secure, trustworthy and ethical artificial intelligence, as stated by the European Council33, and it ensures the protection of ethical principles, as specifically requested by the European Parliament34.

AddedPosition of the European Parliament adopted at first reading on 13 March 2024 with a view to the adoption of Regulation (EU) 2024/… of the European Parliament and of the Council laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act)

RemovedRecital 5 a (new): (5a) Furthermore, in order to foster the development of AI systems in line with Union values, the Union needs to address the main gaps and barriers blocking the potential of the digital transformation including the shortage of digitally skilled workers, cybersecurity concerns, lack of investment and access to investment, and existing and potential gaps between large companies, SME’s and start-ups. Special attention should be paid to ensuring that the benefits of AI and innovation in new technologies are felt across all regions of the Union and that sufficient investment and resources are provided especially to those regions that may be lagging behind in some digital indicators.

Added(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2024/1689.)

RemovedRecital 6: (6) The notion of AI system in this Regulation should be clearly defined and closely aligned with the work of international organisations working on artificial intelligence to ensure legal certainty, harmonization and wide acceptance, while providing the flexibility to accommodate the rapid technological developments in this field. Moreover, it should be based on key characteristics of artificial intelligence, such as its learning, reasoning or modelling capabilities, so as to distinguish it from simpler software systems or programming approaches. AI systems are designed to operate with varying levels of autonomy, meaning that they have at least some degree of independence of actions from human controls and of capabilities to operate without human intervention. The term “machine-based” refers to the fact that AI systems run on machines. The reference to explicit or implicit objectives underscores that AI systems can operate according to explicit human-defined objectives or to implicit objectives. The objectives of the AI system may be different from the intended purpose of the AI system in a specific context. The reference to predictions includes content, which is considered in this Regulation a form of prediction as one of the possible outputs produced by an AI system. For the purposes of this Regulation, environments should be understood as the contexts in which the AI systems operate, whereas outputs generated by the AI system, meaning predictions, recommendations or decis…

RemovedRecital 6 a (new): (6a) AI systems often have machine learning capacities that allow them to adapt and perform new tasks autonomously. Machine learning refers to the computational process of optimizing the parameters of a model from data, which is a mathematical construct generating an output based on input data. Machine learning approaches include, for instance, supervised, unsupervised and reinforcement learning, using a variety of methods including deep learning with neural networks. This Regulation is aimed at addressing new potential risks that may arise by delegating control to AI systems, in particular to those AI systems that can evolve after deployment. The function and outputs of many of these AI systems are based on abstract mathematical relationships that are difficult for humans to understand, monitor and trace back to specific inputs. These complex and opaque characteristics (black box element) impact accountability and explainability. Comparably simpler techniques such as knowledge-based approaches, Bayesian estimation or decision-trees may also lead to legal gaps that need to be addressed by this Regulation, in particular when they are used in combination with machine learning approaches in hybrid systems.

RemovedRecital 6 b (new): (6b) AI systems can be used as stand-alone software system, integrated into a physical product (embedded), used to serve the functionality of a physical product without being integrated therein (non-embedded) or used as an AI component of a larger system. If this larger system would not function without the AI component in question, then the entire larger system should be considered as one single AI system under this Regulation.

RemovedRecital 7: (7) The notion of biometric data used in this Regulation is in line with and should be interpreted consistently with the notion of biometric data as defined in Article 4(14) of Regulation (EU) 2016/679 of the European Parliament and of the Council35. Biometrics-based data are additional data resulting from specific technical processing relating to physical, physiological or behavioural signals of a natural person, such as facial expressions, movements, pulse frequency, voice, key strikes or gait, which may or may not allow or confirm the unique identification of a natural person. / (deleted) / (deleted)

RemovedRecital 7 a (new): (7a) The notion of biometric identification as used in this Regulation should be defined as the automated recognition of physical, physiological, behavioural, and psychological human features such as the face, eye movement, facial expressions, body shape, voice, speech, gait, posture, heart rate, blood pressure, odour, keystrokes, psychological reactions (anger, distress, grief, etc.) for the purpose of establishing an individual’s identity by comparing biometric data of that individual to stored biometric data of individuals in a database (one-to-many identification), irrespective of whether the individual has given its consent or not.

RemovedRecital 7 b (new): (7b) The notion of biometric categorisation as used in this Regulation should be defined as assigning natural persons to specific categories or inferring their characteristics and attributes such as gender, sex, age, hair colour, eye colour, tattoos, ethnic or social origin, health, mental or physical ability, behavioural or personality, traits language, religion, or membership of a national minority or sexual or political orientation on the basis of their biometric or biometric-based data, or which can be inferred from such data.

RemovedRecital 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, exlcuding verification systems which merely compare the biometric data of an individual to their previously provided biometric data (one-to-one). Considering their different characteristics and manners in which they are used, as well as the different risks involved, a distinction should be made between ‘real-time’ and ‘post’ remote biometric identification systems. In the case of ‘real-time’ systems, the capturing of the biometric data, the comparison and the identification occur all instantaneously, near-instantaneously or in any event without a significant delay. In this regard, there should be no scope for circumventing the rules of this Regulation on the ‘real-time’ use of the AI systems in question by providing for minor delays. ‘Real-time’ systems involve the use of ‘live’ or ‘near-‘live’ material, such as video footage, generated by a camera or other device with similar functionality. In the case of ‘post’ systems, in contrast, the biometric data have already been captured and the compar…

RemovedRecital 8 a (new): (8a) The identification of natural persons at a distance is understood to distinguish remote biometric identification systems from close proximity individual verification systems using biometric identification means, whose sole purpose is to confirm whether or not a specific natural person presenting themselves for identification is permitted, such as in order to gain access to a service, a device, or premises.

RemovedRecital 9: (9) For the purposes of this Regulation the notion of publicly accessible space should be understood as referring to any physical place that is accessible to the public, irrespective of whether the place in question is privately or publicly owned and regardless of the potential capacity restrictions. Therefore, the notion does not cover places that are private in nature and normally not freely accessible for third parties, including law enforcement authorities, unless those parties have been specifically invited or authorised, such as homes, private clubs, offices, warehouses and factories. Online spaces are not covered either, as they are not physical spaces. However, the mere fact that certain conditions for accessing a particular space may apply, such as admission tickets or age restrictions, does not mean that the space is not publicly accessible within the meaning of this Regulation. Consequently, in addition to public spaces such as streets, relevant parts of government buildings and most transport infrastructure, spaces such as cinemas, theatres, sports grounds, schools, universities, relevant parts of hospitals and banks, amusement parks, festivals, shops and shopping centres are normally also publicly accessible. Whether a given space is accessible to the public should however be determined on a case-by-case basis, having regard to the specificities of the individual situation at hand.

RemovedRecital 9 a (new): (9a) It is important to note that AI systems should make best efforts to respect general principles establishing a high-level framework that promotes a coherent human-centric approach to ethical and trustworthy AI in line with the Charter of Fundamental Rights of the European Union and the values on which the Union is founded, including the protection of fundamental rights, human agency and oversight, technical robustness and safety, privacy and data governance, transparency, non-discrimination and fairness and societal and environmental wellbeing.

RemovedRecital 9 b (new): (9b) ‘AI literacy’ refers to skills, knowledge and understanding that allows providers, users and affected persons, taking into account their respective rights and obligations in the context of this Regulation, to make an informed deployment of AI systems, as well as to gain awareness about the opportunities and risks of AI and possible harm it can cause and thereby promote its democratic control. AI literacy should not be limited to learning about tools and technologies, but should also aim to equip providers and users with the notions and skills required to ensure compliance with and enforcement of this Regulation. It is therefore necessary that the Commission, the Member States as well as providers and users of AI systems, in cooperation with all relevant stakeholders, promote the development of a sufficient level of AI literacy, in all sectors of society, for people of all ages, including women and girls, and that progress in that regard is closely followed.

RemovedRecital 10: (10) In order to ensure a level playing field and an effective protection of rights and freedoms of individuals across the Union and on international level, the rules established by this Regulation should apply to providers of AI systems in a non-discriminatory manner, irrespective of whether they are established within the Union or in a third country, and to deployers of AI systems established within the Union. In order for the Union to be true to its fundamental values, AI systems intended to be used for practices that are considered unacceptable by this Regulation, should equally be deemed to be unacceptable outside the Union because of their particularly harmful effect to fundamental rights as enshrined in the Charter. Therefore it is appropriate to prohibit the export of such AI systems to third countries by providers residing in the Union.

RemovedRecital 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 deployers of AI systems that are established in a third country, to the extent the output produced by those systems is intended to be used in the Union. Nonetheless, to take into account existing arrangements and special needs for cooperation with foreign partners with whom information and evidence is exchanged, this Regulation should not apply to public authorities of a third country and international organisations when acting in the framework of internatio…

RemovedRecital 12: (12) This Regulation should also apply to Union institutions, offices, bodies and agencies when acting as a provider or deployer of an AI system. AI systems exclusively developed or used for military purposes should be excluded from the scope of this Regulation where that use falls under the exclusive remit of the Common Foreign and Security Policy regulated under Title V of the Treaty on the European Union (TEU). This Regulation should be without prejudice to the provisions regarding the liability of intermediary service providers set out in Directive 2000/31/EC of the European Parliament and of the Council [as amended by the Digital Services Act].

RemovedRecital 12 a (new): (12a) Software and data that are openly shared and where users can freely access, use, modify and redistribute them or modified versions thereof, can contribute to research and innovation in the market. Research by the Commission also shows that free and open-source software can contribute between EUR 65 billion to EUR 95 billion to the European Union’s GDP and that it can provide significant growth opportunities for the European economy. Users are allowed to run, copy, distribute, study, change and improve software and data, including models by way of free and open-source licences. To foster the development and deployment of AI, especially by SMEs, start-ups, academic research but also by individuals, this Regulation should not apply to such free and open-source AI components except to the extent that they are placed on the market or put into service by a provider as part of a high-risk AI system or of an AI system that falls under Title II or IV of this Regulation.

RemovedRecital 12 b (new): (12b) Neither the collaborative development of free and open-source AI components nor making them available on open repositories should constitute a placing on the market or putting into service. A commercial activity, within the understanding of making available on the market, might however be characterised by charging a price, with the exception of transactions between micro enterprises, for a free and open-source AI component but also by charging a price for technical support services, by providing a software platform through which the provider monetises other services, or by the use of personal data for reasons other than exclusively for improving the security, compatibility or interoperability of the software.

RemovedRecital 12 c (new): (12c) The developers of free and open-source AI components should not be mandated under this Regulation to comply with requirements targeting the AI value chain and, in particular, not towards the provider that has used that free and open-source AI component. Developers of free and open-source AI components should however be encouraged to implement widely adopted documentation practices, such as model and data cards, as a way to accelerate information sharing along the AI value chain, allowing the promotion of trustworthy AI systems in the Union.

RemovedRecital 13: (13) In order to ensure a consistent and high level of protection of public interests as regards health, safety and fundamental rights as well as democracy and rule of law and the environment, common normative standards for all high-risk AI systems should be established. Those standards should be consistent with the Charter, the European Green Deal, the Joint Declaration on Digital Rights of the Union and the Ethics Guidelines for Trustworthy Artificial Intelligence (AI) of the High-Level Expert Group on Artificial Intelligence, and should be non-discriminatory and in line with the Union’s international trade commitments.

RemovedRecital 14: (14) In order to introduce a proportionate and effective set of binding rules for AI systems, a clearly defined risk-based approach should be followed. That approach should tailor the type and content of such rules to the intensity and scope of the risks that AI systems can generate. It is therefore necessary to prohibit certain unacceptable artificial intelligence practices, to lay down requirements for high-risk AI systems and obligations for the relevant operators, and to lay down transparency obligations for certain AI systems