EU Takes Step to Formalize Rules on AI

AI regulation

As originally announced in a press release by the EU.

The European Council president and the European Parliament have reached a provisional agreement on the proposal on harmonised rules on artificial intelligence (AI), labelled as the “EU Artificial Intelligence Act”. The draft regulation aims to ensure that AI systems used by organisations and the public in the European Union are safe, consistent with fundamental human rights and EU values. The rules are also intented to encourage investment and innovation in AI across Europe. The rules will not be activated for at least two years, but this agreement is an important step toward that day.

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, Secretary of State for Digitalisation and Artificial Intelligence for Spain

The legislation takes a risk-based approach to regulation: “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. In this way it is hoped that these AI regulations can become a model for the rest of the world, just as the GDPR rules have done in data protection.

The main elements of the provisional agreement

  • 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


High-risk AI systems 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
  • Untargeted scraping 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
  • Some cases of predictive policing for individuals


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.