Regulatory Frameworks · Gateway Page

EU AI Act

A structured gateway to Regulation (EU) 2024/1689 — the world’s first comprehensive legal framework for artificial intelligence. The Act entered into force on 1 August 2024, with obligations applying progressively through 2027. Detailed AI governance definitions are available in the dedicated glossary.

Instrument Regulation (EU) 2024/1689
Entry into force 1 August 2024
Full application 2 August 2026
Authority European AI Office
02 · Explore this page

What you’ll find here.

A guided view of the EU AI Act — from risk classification and obligations to the full legal text. Select a topic to jump directly to that section.

03 · Key Highlights

Five essentials for understanding the Regulation.

Drawn from the official text and framed for quick reference. Each point anchors to a detailed section below.

01

First horizontal AI law worldwide.

The first comprehensive legal framework dedicated to artificial intelligence, applicable across all sectors and Member States.

Regulation (EU) 2024/1689
02

Risk-based architecture.

Four tiers determine obligations. Classification is use- and context-based; the same system can sit in different categories.

Articles 5, 6, 50, 95
03

Governance for general-purpose AI.

Documentation, transparency and copyright duties on GPAI providers, with additional obligations for systemic-risk models.

Chapter V · Articles 51–56
04

Phased application 2024 – 2027.

Prohibitions from Feb 2025, GPAI obligations from Aug 2025, full application Aug 2026, Annex I products Aug 2027.

Article 113
05

Penalties up to 7% of turnover.

Breach of Article 5 prohibitions carries fines of up to €35 million or 7% of worldwide annual turnover, whichever is higher.

Article 99
04 · How to Navigate

Two audiences. One unified page.

The structure serves legal and executive readers in parallel. Use the path that fits how you need to work today.

For legal & compliance professionals

Work with the official text.

Every expandable panel contains wording drawn directly from Regulation (EU) 2024/1689, with article-level citations.

Start with the risk classification and prohibited practices, then open the Legal framework section for key provisions and penalties.

For executives & decision-makers

Start with summaries and implications.

Each section leads with a concise summary. Detailed legal text is one click away when your team needs to verify a specific obligation.

Focus on the risk tiers, phased timeline, and fines & penalties — the structural shape of what the Act requires.

05 · Risk Framework
Based on official source

Four categories. Different obligations.

The Regulation distinguishes AI systems by the risk they pose. Classification is use- and context-based. Select any tier to reveal the official wording.

Disclaimer This content is provided for informational purposes only and does not constitute legal advice. Open full legal text
01 Article 5 Unacceptable risk

Prohibited AI practices.

Banned in the EU. AI practices considered a clear threat to safety, livelihoods, or fundamental rights. Exhaustively listed in Article 5.

Article 5(1) · Prohibited AI practices

The following AI practices shall be prohibited. See the full list of eight prohibited practices in the Prohibited AI practices section below.

02 Article 6 · Annex III High risk

High-risk AI systems.

Permitted, subject to strict obligations. Systems with significant potential to affect health, safety or fundamental rights. Classification arises from product-safety integration or Annex III use.

Article 6(1) · Classification rules for high-risk AI systems

Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:

(a) the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I;

(b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.

03 Article 50 Limited risk

Transparency obligations.

Permitted, subject to transparency. AI systems that interact with natural persons, perform biometric categorisation or emotion recognition, or generate synthetic content — including deepfakes.

Article 50(1) · Direct interaction disclosure

Providers shall ensure that AI systems intended to interact directly with natural persons are designed and developed in such a way that the natural persons concerned are informed that they are interacting with an AI system, unless this is obvious from the point of view of a natural person who is reasonably well-informed, observant and circumspect, taking into account the circumstances and the context of use.

04 Article 95 Minimal risk

Voluntary application.

No specific obligations. All other AI systems. The Regulation encourages voluntary application of the requirements for high-risk systems, and the adoption of codes of conduct.

Article 95(1) · Codes of conduct for voluntary application

The AI Office and the Member States shall encourage and facilitate the drawing up of codes of conduct, including related governance mechanisms, intended to foster the voluntary application to AI systems, other than high-risk AI systems, of some or all of the requirements set out in Chapter III, Section 2 taking into account the available technical solutions and industry best practices allowing for the application of such requirements.

06 · Prohibited AI Practices
Official source · Article 5(1)

Eight categories of prohibited AI.

Article 5(1) prohibits specific AI practices altogether. The repeated legal stem is shown once below, followed by the eight categories as a structured legal map.

Shared legal stem · applies to each item

“The placing on the market, the putting into service or the use of an AI system that

The following practices are prohibited
a Manipulation

Subliminal, manipulative or deceptive techniques.

… deploys subliminal techniques beyond a person’s consciousness or purposefully manipulative or deceptive techniques, with the objective, or the effect of materially distorting the behaviour of a person or a group of persons by appreciably impairing their ability to make an informed decision, thereby causing them to take a decision that they would not have otherwise taken in a manner that causes or is reasonably likely to cause that person, another person or group of persons significant harm.

b Exploitation of vulnerabilities

Exploiting age, disability or social/economic vulnerability.

… exploits any of the vulnerabilities of a natural person or a specific group of persons due to their age, disability or a specific social or economic situation, with the objective, or the effect, of materially distorting the behaviour of that person or a person belonging to that group in a manner that causes or is reasonably likely to cause that person or another person significant harm.

c Social scoring

Evaluation or classification based on social behaviour.

… for the evaluation or classification of natural persons or groups of persons over a certain period of time based on their social behaviour or known, inferred or predicted personal or personality characteristics, with the social score leading to either or both: detrimental treatment in contexts unrelated to those in which the data was originally generated, or detrimental treatment that is unjustified or disproportionate to the behaviour or its gravity.

d Predictive policing (profiling)

Risk assessments of criminal offence based solely on profiling.

… for making risk assessments of natural persons in order to assess or predict the risk of a natural person committing a criminal offence, based solely on the profiling of a natural person or on assessing their personality traits and characteristics. This prohibition does not apply to AI systems used to support human assessment already based on objective and verifiable facts directly linked to a criminal activity.

e Facial recognition databases

Untargeted scraping to build or expand databases.

… creates or expands facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage.

f Emotion recognition

Inferring emotions at work and in education.

… to infer emotions of a natural person in the areas of workplace and education institutions, except where the use of the AI system is intended to be put in place or into the market for medical or safety reasons.

g Biometric categorisation

Inferring race, politics, religion, sexual orientation.

… uses biometric categorisation systems that categorise individually natural persons based on their biometric data to deduce or infer their race, political opinions, trade union membership, religious or philosophical beliefs, sex life or sexual orientation. This does not cover labelling or filtering of lawfully acquired biometric datasets in the area of law enforcement.

h Real-time biometric identification

Real-time remote biometric ID in public spaces.

… uses ‘real-time’ remote biometric identification systems in publicly accessible spaces for law enforcement, unless and in so far as such use is strictly necessary for: the targeted search for victims of abduction, trafficking or sexual exploitation and missing persons; the prevention of a specific, substantial and imminent threat or terrorist attack; or the localisation of suspects of specified serious criminal offences.

07 · High-Risk Systems
Based on Article 6 · Annex III

Two routes into high-risk classification.

A system is high-risk when it is either a product-safety component under Annex I, or when it falls within one of the Annex III use-case domains.

Route A · Annex I

Product-safety systems.

AI embedded in products already covered by EU harmonisation legislation — including medical devices, machinery, toys, aviation, lifts, cableways and pressure equipment.

Classification arises when the AI is a safety component and the product requires third-party conformity assessment.

Article 6(1) · Product-safety high-risk classification

Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:

(a) the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I;

(b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.

Route B · Annex III

Use-case systems.

Stand-alone AI systems deployed in high-impact domains — biometrics, critical infrastructure, education, employment, essential services, law enforcement, migration, justice.

The Commission may update Annex III to add or modify use-cases over time.

Annex III · High-risk AI systems referred to in Article 6(2)

High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas:

1. Biometrics, in so far as their use is permitted under relevant Union or national law.

2. Critical infrastructure — as safety components in the management and operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.

3. Education and vocational training — admissions, evaluation of learning outcomes, assessment of appropriate level of education, monitoring during tests.

4. Employment, workers’ management and access to self-employment — recruitment, promotion, termination, task allocation, performance monitoring.

5. Access to and enjoyment of essential private and public services — public assistance benefits, creditworthiness, insurance pricing, emergency call triage.

6. Law enforcement — victim risk assessment, polygraphs, reliability of evidence, profiling in the course of investigations.

7. Migration, asylum and border control — polygraph-like tools, risk assessments, examination of applications.

8. Administration of justice and democratic processes — assistance to judicial authorities, influence on election outcomes.

08 · Phased Application
Based on Article 113

Obligations apply progressively.

The Regulation entered into force on 1 August 2024. Different parts of the Act become applicable on different dates, as set out in Article 113.

Milestone 01
1 Aug 2024

Entry into force

The Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union. The compliance clock starts.

Milestone 02
2 Feb 2025

Prohibitions apply

Chapters I and II shall apply from 2 February 2025. The prohibitions of AI practices under Article 5 take effect across the Union.

Milestone 03
2 Aug 2025

Governance and GPAI obligations

Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the exception of Article 101. This covers notifying authorities, general-purpose AI models, governance, penalties, and confidentiality.

Milestone 04
2 Aug 2026

Full application

The Regulation shall apply from 2 August 2026. The remaining provisions become applicable, including obligations for high-risk AI systems listed in Annex III.

Milestone 05
2 Aug 2027

Annex I high-risk systems

Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027. Obligations for AI systems embedded in products regulated under Annex I harmonisation legislation become applicable.

09 · Fines & Penalties
Based on Article 99

Three tiers of administrative fines.

Non-compliance carries administrative fines indexed to the severity of the breach. Figures below are drawn verbatim from Article 99.

Tier 01 · Highest

€35,000,000administrative fine, up to

or
7%of total worldwide annual turnover

Non-compliance with the prohibition of the AI practices referred to in Article 5 — whichever is higher.

Article 99(3)
Tier 02 · Operator obligations

€15,000,000administrative fine, up to

or
3%of total worldwide annual turnover

Non-compliance with obligations of providers, authorised representatives, importers, distributors, deployers, notified bodies, or transparency obligations under Article 50 — whichever is higher.

Article 99(4)
Tier 03 · Misleading info

€7,500,000administrative fine, up to

or
1%of total worldwide annual turnover

Supply of incorrect, incomplete or misleading information to notified bodies or national competent authorities in reply to a request — whichever is higher.

Article 99(5)
11 · AI Governance Glossary
Dedicated reference page

Definitions on a dedicated page.

The full glossary of AI governance concepts and EU AI Act terminology lives as a standalone, searchable reference.

Primary entry point

AI Governance Glossary

Explore key AI governance concepts, definitions, and legal references under the EU AI Act.

Open Full Glossary
12 · Practitioner Q&A

Ten questions on the EU AI Act in practice.

Each question is structured into a short executive answer, the operative legal basis under Regulation (EU) 2024/1689, and concrete steps to operationalise it. Expand any item to see the full breakdown.

01 Intended purpose

How do you determine the “intended purpose” of an AI system in practice?

Short answer

Intended purpose is the legally binding context defined by the provider — and it must be coherent across documentation, instructions, and marketing. Get this wrong and your risk classification, customer contracts, and oversight design all unravel.

How to operationalise it

  • Document each deployment by domain, output type, user population, environment, and human-override pattern.
  • Use a single, coherent description verbatim across technical documentation, instructions for use, and marketing.
  • State both what the system is for and explicitly what it is not for (e.g., excluded contexts).
  • Test the documented purpose against Annex III; if any use matches, treat as high-risk unless a carve-out applies.
  • Bind customers contractually to respect the documented intended purpose.
  • Trigger re-classification if a customer materially changes the use — they may become providers.
02 Substantial modification

When does a modification become a “substantial modification”?

Short answer

A modification is “substantial” when it either affects high-risk compliance or changes the intended purpose. Either trigger demands a new conformity assessment and may shift provider responsibility downstream.

How to operationalise it

  • Treat as substantial when: new functions move the system into Annex III, decision logic or data sources change in ways affecting safety or rights, architecture changes affect compliance, or intended purpose changes.
  • Treat as not substantial only if pre-planned and explicitly assessed (continuous learning bounds documented in the initial conformity assessment).
  • Run every change through a formal change-control procedure with an impact assessment template.
  • Required questions: Is the change foreseen? Does it alter intended purpose? Could it affect compliance?
  • Route triggered changes to regulatory review and re-conformity assessment for high-risk.
  • Document every decision and rationale — including non-substantial classifications.
03 Reasonably foreseeable misuse

How do you assess “reasonably foreseeable misuse”?

Short answer

Predictable misuse must be addressed through technical design first, not user training. Identify it before deployment, mitigate it in the system itself, and feed real-world incidents back into your risk register.

How to operationalise it

  • Map predictable behaviour for each deployment: workarounds, shortcuts, over-reliance, repurposed outputs, interactions with other systems.
  • Run scenario workshops and red-teaming with engineers, domain experts, and end-users.
  • Quantify each scenario by likelihood and impact on health, safety, and fundamental rights.
  • Prioritise technical and design controls first: input constraints, usage limits, monitoring, alerts, default settings.
  • Document key scenarios and mitigations in instructions for use so deployers can act on them.
  • Feed misuse reports and incident logs into post-market monitoring to update the risk register.
04 Provider · Deployer · Downstream

Who carries which obligations across the AI value chain?

Short answer

The Act assigns distinct duties along the value chain. Providers carry the heaviest compliance load; deployers carry operational duties; importers, distributors, and modifiers can be re-classified as providers if they substantially modify, rebrand, or change intended purpose.

How to operationalise it

  • Map who is provider, deployer, importer, or distributor for each product in each market.
  • Use written agreements to allocate documentation duties, incident reporting, info-sharing, and modification responsibilities.
  • Define explicitly when downstream integrators become providers (substantial modification, new intended purpose).
  • Build modification clauses into vendor and customer contracts requiring notification before any change.
  • Train deployer-side oversight teams on their distinct legal duties — not generic AI awareness.
  • Test role allocation against complex chains: GPAI provider › integrator › reseller › end-deployer.
05 Multiple Annex III matches

How do you classify a system that could fall under multiple Annex III use cases?

Short answer

If any use matches an Annex III category and no narrow carve-out applies, the system is high-risk. Multiple matches don’t dilute the obligation — they aggregate it. Carve-outs require documented justification.

How to operationalise it

  • Classify by intended purpose per deployment, not per system at the abstract level.
  • Multiple Annex III matches mean designing risk management for the most demanding combination — not partial relief.
  • Apply the Art. 6(3) carve-out only if the role is unambiguously narrow, supportive, or preparatory.
  • Confirm the system performs no profiling — that disqualifies the carve-out automatically.
  • Produce a short, lawyer-readable memo for every “not high-risk” decision, tied to intended purpose and technical design.
  • Register systems claiming non-high-risk status as required. Art. 49
06 Risk management system

What does a compliant risk management system look like in practice?

Short answer

Risk management under Article 9 is a continuous lifecycle obligation, not a one-time document. It must integrate technical controls, governance, and post-market feedback — and must demonstrate that residual risk is acceptable.

How to operationalise it

  • Assign risk owners and embed AI risk management in your QMS and product lifecycle.
  • Identify hazards to health, safety, and fundamental rights for each high-risk system, under intended use and foreseeable misuse.
  • Maintain a risk register linked to specific technical and organisational controls, rated by likelihood and impact.
  • Prioritise design-level controls (data quality, model constraints, robustness, logging, explainability, human oversight) over policy or training.
  • Feed incidents, near-misses, and drift observations from post-market monitoring back into the risk register.
  • Document major risk decisions and the rationale for accepting residual risk.
07 Human oversight

How do you operationalise human oversight without it becoming a tick-box exercise?

Short answer

Effective oversight is structural, not procedural. It must be designed into the system, supported by trained competent staff, and measured by override patterns — not by completed checklists.

How to operationalise it

  • Design UI elements that show model confidence, limitations, and key input factors.
  • Make override, disregard, and stop options normal user paths — not exceptional escalations.
  • Define oversight roles in procedures (reviewer, approver) with real authority to block or change decisions.
  • Train assigned humans specifically on system capabilities, failure modes, and automation bias — not generic compliance.
  • Embed mandatory checkpoints for high-impact decisions (credit denial, hiring, welfare benefits) with documented agreement or disagreement rationale.
  • Log overrides, disagreements, and error patterns; use them to refine both the system and the oversight procedure.
08 GPAI integration

How do you manage general-purpose AI (GPAI) models integrated into your systems?

Short answer

Integrating a GPAI model into a product makes you the AI system provider for EU purposes — even if you didn’t train the model. The GPAI provider supports your compliance; you carry the system-level obligations.

How to operationalise it

  • If you integrate a GPAI model into your product, you are typically the provider of the AI system — even if you are not the GPAI model provider.
  • Obtain upstream technical documentation, usage constraints, and systemic-risk information needed for your own risk management, data, robustness, and oversight obligations.
  • Define your system’s intended purpose and high-risk status based on concrete uses (credit scoring vs. chat assistant).
  • Build additional controls (filters, guardrails, logging, oversight) around the GPAI model tailored to that purpose.
  • Use written agreements to secure the technical access and assistance the GPAI provider must provide.
  • For systemic-risk GPAI models, ensure your system-level risk management considers those systemic risks and that you can evidence reliance on the model provider’s obligations.
09 Fundamental rights impact assessment

When is a Fundamental Rights Impact Assessment (FRIA) triggered and how do you run one?

Short answer

FRIA is mandatory for public-sector deployers and certain private deployers in employment, credit, and essential services. It must be done before first use, complement (not replace) the GDPR DPIA, and be notified to the market surveillance authority.

How to operationalise it

  • Determine in-scope status: public body, private provider of public services, or deployer of high-risk AI in Annex III 5(b) or 5(c).
  • Cover at minimum: processes and decisions, frequency and duration of use, affected groups (especially vulnerable), specific rights at stake, mitigation, governance (oversight, complaint handling, redress).
  • Leverage existing GDPR DPIAs as inputs; complement rather than duplicate.
  • Notify the market surveillance authority using the AI Office template.
  • Treat FRIA as a living document — update when purpose, data, users, environment, or risk profile change.
  • Note: separate sector-specific FRIA may apply for real-time remote biometric identification by law enforcement.
10 Third-party suppliers

How do you govern third-party AI systems and suppliers?

Short answer

The Act treats supplier governance as a regulated activity. Contracts must secure documentation, technical access, and incident-reporting flows from upstream providers — and you must absorb modifications and treat open-source components as your own provider obligation.

How to operationalise it

  • Classify suppliers by impact: GPAI providers, model/component vendors, integrators, resellers; prioritise controls on those affecting data, model behaviour, or high-risk classification.
  • Contract for: technical documentation sufficient for your risk management; notification of changes that may amount to substantial modification; incident detection and reporting SLAs; corrective action duties.
  • Allocate the provider/deployer roles explicitly for each integrated component, including the case where a customer becomes a provider through substantial modification.
  • Run onboarding due diligence: evidence of conformity readiness, security, data governance, logging, oversight support.
  • Treat yourself as primary provider for compliance purposes when relying on open-source AI building blocks; produce internal documentation to substitute for absent contractual duties.

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