Following 3-day ‘marathon’ talks, the Council presidency and the European Parliament’s negotiators have reached a provisional agreement on the proposal on harmonised rules on artificial intelligence (AI), the so-called artificial intelligence act. The draft regulation aims to ensure that AI systems placed on the European market and used in the EU are safe and respect fundamental rights and EU values. This landmark proposal also aims to stimulate investment and innovation on AI in Europe.

This is a historical achievement, and a huge milestone towards the future! Today’s agreement effectively addresses a global challenge in a fast-evolving technological environment on a key area for the future of our societies and economies. And in this endeavour, we managed to keep an extremely delicate balance: boosting innovation and uptake of artificial intelligence across Europe whilst fully respecting the fundamental rights of our citizens.

Carme Artigas, Spanish secretary of state for digitalisation and artificial intelligence

The AI act is a flagship legislative initiative with the potential to foster the development and uptake of safe and trustworthy AI across the EU’s single market by both private and public actors. The main idea is to regulate AI based on the latter’s capacity to cause harm to society following a ‘risk-based’ approach: the higher the risk, the stricter the rules. As the first legislative proposal of its kind in the world, it can set a global standard for AI regulation in other jurisdictions, just as the GDPR has done, thus promoting the European approach to tech regulation in the world stage.

The main elements of the provisional agreement

Compared to the initial Commission proposal, the main new elements of the provisional agreement can be summarised as follows:

  • rules on high-impact general-purpose AI models that can cause systemic risk in the future, as well as on high-risk AI systems
  • a revised system of governance with some enforcement powers at EU level
  • extension of the list of prohibitions but with the possibility to use remote biometric identification by law enforcement authorities in public spaces, subject to safeguards
  • better protection of rights through the obligation for deployers of high-risk AI systems to conduct a fundamental rights impact assessment prior to putting an AI system into use.

In more concrete terms, the provisional agreement covers the following aspects:

Definitions and scope

To ensure that the definition of an AI system provides sufficiently clear criteria for distinguishing AI from simpler software systems, the compromise agreement aligns the definition with the approach proposed by the OECD.

The provisional agreement also clarifies that the regulation does not apply to areas outside the scope of EU law and should not, in any case, affect member states’ competences in national security or any entity entrusted with tasks in this area. Furthermore, the AI act will not apply to systems which are used exclusively for military or defence purposes. Similarly, the agreement provides that the regulation would not apply to AI systems used for the sole purpose of research and innovation, or for people using AI for non-professional reasons. 

Classification of AI systems as high-risk and prohibited AI practices

The compromise agreement provides for a horizontal layer of protection, including a high-risk classification, to ensure that AI systems that are not likely to cause serious fundamental rights violations or other significant risks are not captured. AI systems presenting only limited risk would be subject to very light transparency obligations, for example disclosing that the content was AI-generated so users can make informed decisions on further use.

A wide range of high-risk AI systems would be authorised, but subject to a set of requirements and obligations to gain access to the EU market. These requirements have been clarified and adjusted by the co-legislators in such a way that they are more technically feasible and less burdensome for stakeholders to comply with, for example as regards the quality of data, or in relation to the technical documentation that should be drawn up by SMEs to demonstrate that their high-risk AI systems comply with the requirements.

Since AI systems are developed and distributed through complex value chains, the compromise agreement includes changes clarifying the allocation of responsibilities and roles of the various actors in those chains, in particular providers and users of AI systems. It also clarifies the relationship between responsibilities under the AI Act and responsibilities that already exist under other legislation, such as the relevant EU data protection or sectorial legislation.

For some uses of AI, risk is deemed unacceptable and, therefore, these systems will be banned from the EU. The provisional agreement bans, for example, cognitive behavioural manipulation, the untargeted scrapping of facial images from the internet or CCTV footage, emotion recognition in the workplace and educational institutions, social scoring, biometric categorisation to infer sensitive data, such as sexual orientation or religious beliefs, and some cases of predictive policing for individuals.

Law enforcement exceptions

Considering the specificities of law enforcement authorities and the need to preserve their ability to use AI in their vital work, several changes to the Commission proposal were agreed relating to the use of AI systems for law enforcement purposes. Subject to appropriate safeguards, these changes are meant to reflect the need to respect the confidentiality of sensitive operational data in relation to their activities. For example, an emergency procedure was introduced allowing law enforcement agencies to deploy a high-risk AI tool that has not passed the conformity assessment procedure in case of urgency. However, a specific mechanism has been also introduced to ensure that fundamental rights will be sufficiently protected against any potential misuses of AI systems.

Moreover, as regards the use of real-time remote biometric identification systems in publicly accessible spaces, the provisional agreement clarifies the objectives where such use is strictly necessary for law enforcement purposes and for which law enforcement authorities should therefore be exceptionally allowed to use such systems. The compromise agreement provides for additional safeguards and limits these exceptions to cases of victims of certain crimes, prevention of genuine, present, or foreseeable threats, such as terrorist attacks, and searches for people suspected of the most serious crimes.

General purpose AI systems and foundation models

New provisions have been added to take into account situations where AI systems can be used for many different purposes (general purpose AI), and where general-purpose AI technology is subsequently integrated into another high-risk system. The provisional agreement also addresses the specific cases of general-purpose AI (GPAI) systems.

Specific rules have been also agreed for foundation models, large systems capable to competently perform a wide range of distinctive tasks, such as generating video, text, images, conversing in lateral language, computing, or generating computer code. The provisional agreement provides that foundation models must comply with specific transparency obligations before they are placed in the market. A stricter regime was introduced for ‘high impact’ foundation models. These are foundation models trained with large amount of data and with advanced complexity, capabilities, and performance well above the average, which can disseminate systemic risks along the value chain.

A new governance architecture

Following the new rules on GPAI models and the obvious need for their enforcement at EU level, an AI Office within the Commission is set up tasked to oversee these most advanced AI models, contribute to fostering standards and testing practices, and enforce the common rules in all member states. A scientific panel of independent experts will advise the AI Office about GPAI models, by contributing to the development of methodologies for evaluating the capabilities of foundation models, advising on the designation and the emergence of high impact foundation models, and monitoring possible material safety risks related to foundation models.

The AI Board, which would comprise member states’ representatives, will remain as a coordination platform and an advisory body to the Commission and will give an important role to Member States on the implementation of the regulation, including the design of codes of practice for foundation models. Finally, an advisory forum for stakeholders, such as industry representatives, SMEs, start-ups, civil society, and academia, will be set up to provide technical expertise to the AI Board.


The fines for violations of the AI act were set as a percentage of the offending company’s global annual turnover in the previous financial year or a predetermined amount, whichever is higher. This would be €35 million or 7% for violations of the banned AI applications, €15 million or 3% for violations of the AI act’s obligations and €7,5 million or 1,5% for the supply of incorrect information. However, the provisional agreement provides for more proportionate caps on administrative fines for SMEs and start-ups in case of infringements of the provisions of the AI act.

The compromise agreement also makes clear that a natural or legal person may make a complaint to the relevant market surveillance authority concerning non-compliance with the AI act and may expect that such a complaint will be handled in line with the dedicated procedures of that authority.

Transparency and protection of fundamental rights

The provisional agreement provides for a fundamental rights impact assessment before a high-risk AI system is put in the market by its deployers. The provisional agreement also provides for increased transparency regarding the use of high-risk AI systems. Notably, some provisions of the Commission proposal have been amended to indicate that certain users of a high-risk AI system that are public entities will also be obliged to register in the EU database for high-risk AI systems.  Moreover, newly added provisions put emphasis on an obligation for users of an emotion recognition system to inform natural persons when they are being exposed to such a system.

Measures in support of innovation

With a view to creating a legal framework that is more innovation-friendly and to promoting evidence-based regulatory learning, the provisions concerning measures in support of innovation have been substantially modified compared to the Commission proposal.

Notably, it has been clarified that AI regulatory sandboxes, which are supposed to establish a controlled environment for the development, testing and validation of innovative AI systems, should also allow for testing of innovative AI systems in real world conditions. Furthermore, new provisions have been added allowing testing of AI systems in real world conditions, under specific conditions and safeguards. To alleviate the administrative burden for smaller companies, the provisional agreement includes a list of actions to be undertaken to support such operators and provides for some limited and clearly specified derogations. 

Entry into force

The provisional agreement provides that the AI act should apply two years after its entry into force, with some exceptions for specific provisions.

Next steps

Following today’s provisional agreement, work will continue at technical level in the coming weeks to finalise the details of the new regulation. The presidency will submit the compromise text to the member states’ representatives (Coreper) for endorsement once this work has been concluded.

The entire text will need to be confirmed by both institutions and undergo legal-linguistic revision before formal adoption by the co-legislators.

Background information

The Commission proposal, presented in April 2021, is a key element of the EU’s policy to foster the development and uptake across the single market of safe and lawful AI that respects fundamental rights.

The proposal follows a risk-based approach and lays down a uniform, horizontal legal framework for AI that aims to ensure legal certainty.  The draft regulation aims to promote investment and innovation in AI, enhance governance and effective enforcement of existing law on fundamental rights and safety, and facilitate the development of a single market for AI applications. It goes hand in hand with other initiatives, including the coordinated plan on artificial intelligence which aims to accelerate investment in AI in Europe. On 6 December 2022, the Council reached an agreement for a general approach (negotiating mandate) on this file and entered interinstitutional talks with the European Parliament (‘trilogues’) in mid-June 2023.

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Press release9 December 2023 Brussels

Commission welcomes political agreement on Artificial Intelligence Act

The Commission welcomes the political agreement reached between the European Parliament and the Council on the Artificial Intelligence Act (AI Act), proposed by the Commission in April 2021.

Ursula von der Leyen, President of the European Commission, said:“Artificial intelligence is already changing our everyday lives. And this is just the beginning. Used wisely and widely, AI promises huge benefits to our economy and society. Therefore, I very much welcome today’s political agreement by the European Parliament and the Council on the Artificial Intelligence Act. The EU’s AI Act is the first-ever comprehensive legal framework on Artificial Intelligence worldwide. So, this is a historic moment. The AI Act transposes European values to a new era. By focusing regulation on identifiable risks, today’s agreement will foster responsible innovation in Europe. By guaranteeing the safety and fundamental rights of people and businesses, it will support the development, deployment and take-up of trustworthy AI in the EU. Our AI Act will make a substantial contribution to the development of global rules and principles for human-centric AI.” 

The European approach to trustworthy AI

The new rules will be applied directly in the same way across all Member States, based on a future-proof definition of AI. They follow a risk-based approach:

Minimal risk: The vast majority of AI systems fall into the category of minimal risk. Minimal risk applications such as AI-enabled recommender systems or spam filters will benefit from a free-pass and absence of obligations, as these systems present only minimal or no risk for citizens’ rights or safety. On a voluntary basis, companies may nevertheless commit to additional codes of conduct for these AI systems.

High-risk: AI systems identified as high-risk will be required to comply with strict requirements, including risk-mitigation systems, high quality of data sets, logging of activity, detailed documentation, clear user information, human oversight, and a high level of robustness, accuracy and cybersecurity. Regulatory sandboxes will facilitate responsible innovation and the development of compliant AI systems.

Examples of such high-risk AI systems include certain critical infrastructures for instance in the fields of water, gas and electricity; medical devices; systems to determine access to educational institutions or for recruiting people; or certain systems used in the fields of law enforcement, border control, administration of justice and democratic processes. Moreover, biometric identification, categorisation and emotion recognition systems are also considered high-risk.

Unacceptable risk: AI systems considered a clear threat to the fundamental rights of people will be banned. This includes AI systems or applications that manipulate human behaviour to circumvent users’ free will, such as toys using voice assistance encouraging dangerous behaviour of minors or systems that allow ‘social scoring’ by governments or companies, and certain applications of predictive policing. In addition, some uses of biometric systems will be prohibited, for example emotion recognition systems used at the workplace and some systems for categorising people or real time remote biometric identification for law enforcement purposes in publicly accessible spaces (with narrow exceptions).

Specific transparency risk: When employing AI systems such as chatbots, users should be aware that they are interacting with a machine. Deep fakes and other AI generated content will have to be labelled as such, and users need to be informed when biometric categorisation or emotion recognition systems are being used. In addition, providers will have to design systems in a way that synthetic audio, video, text and images content is marked in a machine-readable format, and detectable as artificially generated or manipulated.

Companies not complying with the rules will be fined.

General purpose AI

The AI Act introduces dedicated rules for general purpose AI models that will ensure transparency along the value chain. For very powerful models that could pose systemic risks, there will be additional binding obligations related to managing risks and monitoring serious incidents, performing model evaluation and adversarial testing. These new obligations will be operationalised through codes of practices developed by industry, the scientific community, civil society and other stakeholders together with the Commission.

In terms of governance, national competent market surveillance authorities will supervise the implementation of the new rules at national level, while the creation of a new European AI Office within the European Commission will ensure coordination at European level. The new AI Office will also supervise the implementation and enforcement of the new rules on general purpose AI models. Along with the national market surveillance authorities, the AI Office will be the first body globally that enforces binding rules on AI and is therefore expected to become an international reference point. For general purpose models, a scientific panel of independent experts will play a central role by issuing alerts on systemic risks and contributing to classifying and testing the models.

Next Steps

The political agreement is now subject to formal approval by the European Parliament and the Council.

Once the AI Act is adopted, there will be a transitional period before the Regulation becomes applicable. To bridge this time, the Commission will be launching an AI Pact. It will convene AI developers from Europe and around the world who commit on a voluntary basis to implement key obligations of the AI Act ahead of the legal deadlines.

To promote rules on trustworthy AI at international level, the European Union will continue to work in fora such as the G7, the OECD, the Council of Europe, the G20 and the UN. Just recently, we supported the agreement by G7 leaders under the Hiroshima AI process on International Guiding Principles and a voluntary Code of Conduct for Advanced AI systems.


For years, the Commission has been facilitating and enhancing cooperation on AI across the EU to boost its competitiveness and ensure trust based on EU values.

Following the publication of the European Strategy on AI in 2018 and after extensive stakeholder consultation, the High-Level Expert Group on Artificial Intelligence (HLEG) developed Guidelines for Trustworthy AI in 2019, and an Assessment List for Trustworthy AI in 2020. In parallel, the first Coordinated Plan on AI was published in December 2018 as a joint commitment with Member States.

The Commission’s White Paper on AI, published in 2020, set out a clear vision for AI in Europe: an ecosystem of excellence and trust, setting the scene for today’s political agreement. The public consultation on the White Paper on AI elicited widespread participation from across the world. The White Paper was accompanied by a ‘Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics‘ concluding that the current product safety legislation contains a number of gaps that needed to be addressed, notably in the Machinery Directive.

Independent, evidence-based research produced by the Joint Research Centre (JRC) has been fundamental in shaping the EU’s AI policies and ensuring their effective implementation. Through rigorous research and analysis, the JRC has supported the development of the AI Act, informing AI terminology, risk classification, technical requirements and contributing to the ongoing development of harmonised standards.

For More Information

New rules for Artificial Intelligence – Questions and Answers (update available shortly)

New rules for Artificial Intelligence – Facts page

Hiroshima AI Process: Guiding Principles and a Code of Conduct on Artificial Intelligence

Coordinated Plan on Artificial Intelligence

Regulation on Machinery Products

Liability Rules for Artificial Intelligence

European Centre for Algorithmic Transparency, Joint Research Centre