Proposal for a REGULATION
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON
ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN
UNION LEGISLATIVE ACTS
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16 and 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Central Bank,
Having regard to the joint opinion of the European Data Protection Board and the European Data Protection Supervisor,
Having regard to the opinion of the European Economic and Social Committee,
Having regard to the opinion of the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure,
(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.
(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.
(2) Artificial intelligence systems (AI systems) can be easily deployed in multiple sectors of the economy and society, including cross border, and circulate throughout the Union. Certain Member States have already explored the adoption of national rules to ensure that artificial intelligence is 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).
(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.
(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’).
(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.
(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.
(2e) This Regulation should not affect the provisions aiming to improve working conditions in platform work set out in Directive ... [COD 2021/414/EC].
(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;
(3) Artificial intelligence is a fast evolving family of technologies that can and already contribute 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.
(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.
(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.
(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.
(5) A Union legal framework laying down harmonised rules on artificial intelligence is therefore needed to foster the development, use and uptake of artificial intelligence in the internal market that at the same time meets a high level of protection of public interests, such as health and safety protection of fundamental rights, democracy and rule of law and the environment, as recognised and protected by Union law. To achieve that objective, rules regulating the placing on the market, the putting into service and the use of certain AI systems should be laid down, thus ensuring the smooth functioning of the internal market and allowing those systems to benefit from the principle of free movement of goods and services. These rules should be clear and robust in protecting fundamental rights, supportive of new innovative solutions, and enabling to a European ecosystem of public and private actors creating AI systems in line with Union values. By laying down those rules, as well as measures in support of innovation with a particular focus on SMEs and start-ups, this Regulation supports the objective of promoting the AI made in Europe, of the Union of being a global leader in the development of secure, trustworthy and ethical artificial intelligence, as stated by the European Council, and it ensures the protection of ethical principles, as specifically requested by the European Parliament.
(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.
(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 the key characteristics of artificial intelligence such as its learning, reasoning or modelling capabilities, so as to distinguish it from simpler software systems or programming approaches.. AI systems are designed to operate with varying levels of autonomy, meaning that they have at least some degree of independence of actions from human controls and of capabilities to operate without human intervention. The term “machine-based” refers to the fact that AI systems run on machines. The reference to explicit or implicit objectives underscores that AI systems can operate according to explicit human-defined objectives or to implicit objectives. The objectives of the AI system may be different from the intended purpose of the AI system in a specific context. The reference to predictions includes content, which is considered in this Regulation a form of prediction as one of the possible outputs produced by an AI system. For the purposes of this Regulation, environments should be understood as the contexts in which the AI systems operate, whereas outputs generated by the AI system, meaning predictions, recommendations or decisions, respond to the objectives of the system, on the basis of inputs from said environment. Such output further influences said environment, even by merely introducing new information to it.
(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.
(6b) AI systems can be used as standalone 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.
(7) The notion of biometric data used in this Regulation is in line with and should be interpreted consistently with the notion of biometric data as defined in Article 4(14) of Regulation (EU) 2016/679 of the European Parliament and of the Council, 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.
(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.
(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.
(8) The notion of remote biometric identification system as used in this Regulation should be defined functionally, as an AI system intended for the identification of natural persons at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference database, and without prior knowledge whether the targeted person will be present and can be identified, irrespectively of the particular technology, processes or types of biometric data used, exlcuding verification systems which merely compare the biometric data of an individual to their previously provided biometric data (one-to-one). Considering their different characteristics and manners in which they are used, as well as the different risks involved, a distinction should be made between ‘real-time’ and ‘post’ remote biometric identification systems. In the case of ‘real-time’ systems, the capturing of the biometric data, the comparison and the identification occur all instantaneously, near-instantaneously or in any event without a significant delay. In this regard, there should be no scope for circumventing the rules of this Regulation on the ‘real-time’ use of the AI systems in question by providing for minor delays. ‘Real-time’ systems involve the use of ‘live’ or ‘near-‘live’ material, such as video footage, generated by a camera or other device with similar functionality. In the case of ‘post’ systems, in contrast, the biometric data have already been captured and the comparison and identification occur only after a significant delay. This involves material, such as pictures or video footage generated by closed circuit television cameras or private devices, which has been generated before the use of the system in respect of the natural persons concerned. Given that the notion of biometric identification is independent from the individual’s consent, this definition applies even when warning notices are placed in the location that is under surveillance of the remote biometric identification system, and is not de facto annulled by pre-enrolment.
(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.
(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-bycase basis, having regard to the specificities of the individual situation at hand.
(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, nondiscrimination and fairness and societal and environmental wellbeing.
(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.
(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.