Regulation (EU) 2024/1689 · updated after the Digital Omnibus

The EU AI Act explained: what it is, who it applies to and what you must do

The EU AI Act is the EU's law on artificial intelligence: four risk tiers, duties by role. Prohibitions, AI literacy, GPAI rules and Article 50 already apply; high-risk obligations from 02.12.2027.

Last reviewed · against the consolidated text and Commission guidance

113
articles, plus 14 annexes
4
risk tiers: prohibited, high, limited, minimal
02.08.2026
Article 50 transparency, in force
02.12.2027
high-risk (Annex III) obligations apply
The regulation

What is the EU AI Act?

Regulation (EU) 2024/1689, the EU AI Act, is a product-safety style law. It targets AI systems, not AI as a technology, and sorts them by the harm they can do:

Prohibited8 practices banned, 2 more from 02.12.2026Art. 5
High-risk8 Annex III areas, and AI inside regulated productsArt. 6Annex IAnnex III
Limited riskChatbots, generated content, deepfakes, emotion recognitionArt. 50
Minimal riskNo tier-specific duties
General-purpose AI models: their own chapter, Art. 51–56

In force since 01.08.2024, it applies in stages, so “is it in force?” has a different answer per chapter. The Digital Omnibus (Regulation (EU) 2026/1744, in force since 27.07.2026) moved the high-risk dates and added two prohibitions. Article 50 stayed put.

Scope

Who does the EU AI Act apply to?

Article 3 names six operator roles, and yours decides which articles you owe. Like the GDPR, the Act reaches beyond the EU whenever a system's output is used in the Union.

Art. 3(3)

Provider

Develops an AI system or GPAI model, or has one developed, and places it on the market or puts it into service under its own name or trademark, paid or free.

Owes: The most: Articles 8 to 15 for high-risk systems, conformity assessment, CE marking, registration, post-market monitoring, and Article 50(1) and (2).

Art. 3(4)

Deployer

Uses an AI system under its own authority at work: an HR screening tool, a bank's credit model, a clinic's triage software.

Owes: Article 26: use as instructed, assign human oversight, keep logs, inform workers and affected people. A FRIA where Article 27 applies; Article 50(4) deepfake disclosure.

Art. 3(6)

Importer

Established in the EU and places on the market a system bearing the name of a provider established outside the EU.

Owes: Article 23: before placing it on the market, verify the provider's conformity assessment, documentation and authorised representative.

Art. 3(7)

Distributor

Makes a system available on the EU market without being its provider or importer: resellers, marketplaces, integrators who do not rebrand.

Owes: Article 24: check the CE marking, declaration of conformity and instructions for use; withhold a system that does not conform.

Not sure which you are? Provider or deployer walks the Article 25 triggers; the free check asks the role question first.

Timeline

When does the EU AI Act apply? The key dates

The Act applies chapter by chapter: four milestones have passed, the high-risk obligations are ahead. Every date comes from the regulatory registry the product runs on.

DateWhat appliesArticles
01.08.2024In forceThe Act enters into forceRegulation (EU) 2024/1689 became binding law on publication in the Official Journal. Nothing applied yet: each chapter applies from the dates below.Art. 113
02.02.2025In forceProhibited practices and AI literacy applyThe bans (social scoring, emotion recognition at work and in education, untargeted facial scraping and the rest) and the duty to make staff AI-literate, for every provider and deployer, whatever the tier.Art. 5Art. 4
02.08.2025In forceGPAI obligations, governance and penalties applyGPAI model providers owe documentation, copyright and training-data transparency; models with systemic risk owe more. Penalties and national authorities started the same day.Art. 53Art. 55Art. 99
02.08.2026In forceArticle 50 transparency duties applyChatbots say they are AI, generated content is marked, deepfakes are disclosed. The Digital Omnibus did not move this date.Art. 50
02.12.2026AheadTwo new Article 5 prohibitions applyRegulation (EU) 2026/1744 adds bans on AI nudification tools and on AI-generated child sexual abuse material.Art. 5
02.12.2027AheadHigh-risk (Annex III) obligations applyThe bulk of the Act: risk management, data governance, technical documentation, human oversight, conformity assessment, CE marking, registration and the deployer duties. Deferred from 02.08.2026 by Regulation (EU) 2026/1744, in force since 27.07.2026.Art. 6Art. 8–15Art. 26
02.08.2028AheadAI in Annex I regulated products appliesHigh-risk AI that is a safety component of a product under EU product law, such as machinery, medical devices, vehicles and toys. Deferred from 02.08.2027.Art. 6(1)

Systems on the market before the high-risk date fall under the transitional rules in Art. 111. The free tracker shows original and Omnibus dates side by side.

Classification

What counts as high-risk AI?

Two routes into the tier, one filter out: Annex III's eight areas of use, safety components of Annex I products, and the Article 6(3) filter, which profiling overrides.

Annex III: the eight areas

  1. 1Biometrics
  2. 2Critical infrastructure
  3. 3Education and vocational training
  4. 4Employment, workers management and access to self-employment
  5. 5Access to essential private and public services and benefitsEligibility for essential public assistance benefits and services, including healthcare · Creditworthiness / credit scoring (excluding fraud detection) · Risk assessment and pricing in life and health insurance · Emergency call classification and dispatch, including emergency healthcare patient triage
  6. 6Law enforcement
  7. 7Migration, asylum and border control
  8. 8Administration of justice and democratic processes
Art. 6(1)

Annex I: AI inside regulated products

A safety component of a product under the Annex I product laws (machinery, medical devices, in-vitro diagnostics, lifts, toys, vehicles, aviation), where that law requires third-party conformity assessment.
Art. 6(3)

The filter: no significant risk

An Annex III system is not high-risk if it only:
  • performs a narrow procedural task
  • improves a completed human activity
  • detects decision patterns without replacing the assessment
  • does preparatory work
The provider documents this before placing it on the market. Profiling of natural persons overrides the filter.
Art. 8–15

What high-risk means in practice

Risk management, data governance, Annex IV documentation, logging, deployer instructions, human oversight, accuracy and cybersecurity. Then conformity assessment, CE marking and registration, all before the system is placed on the market.

Deeper in the help centre: the Annex III areas and the Article 6(3) exception.

Three questions

What is your AI system's risk tier?

A first orientation in under a minute, one system at a time. The result names the tier and the articles that follow.

  1. Question 1
    Art. 5
    Does the system do anything Article 5 prohibits?

    Social scoring, untargeted facial-image scraping, emotion recognition at work or in education, real-time remote biometric identification in public spaces for law enforcement (outside the narrow exceptions), plus the two bans the Digital Omnibus added: AI nudification and AI-generated child sexual abuse material.

Obligations by role

Provider vs deployer: who owes what

One high-risk system, two obligation lists. In the rules Veritome ships, its deployer carries 13 obligations and its provider 25, out of 87 EU AI Act requirements the engine models.

ObligationProviderDeployerImporterDistributor
Art. 9Risk management system●○○○
Art. 10Data and data governance●○○○
Art. 11Technical documentation (Annex IV)●○○○
Art. 12Record-keeping and automatic logging●●○○
Art. 13Transparency and instructions for deployers●○○○
Art. 14Human oversight●●○○
Art. 15Accuracy, robustness and cybersecurity●○○○
Art. 17Quality management system●○○○
Art. 23–24Verify the provider's conformity before supply○○●●
Art. 26Deployer duties: use as instructed, oversight, logs, worker notice○●○○
Art. 27Fundamental rights impact assessment (FRIA)○●○○
Art. 43Conformity assessment and CE marking●○○○
Art. 49Registration in the EU database●●○○
Art. 50Transparency to people (chatbots, generated content, deepfakes)●●○○
Art. 72–73Post-market monitoring and serious-incident reporting●●○○

Importers and distributors owe the verification duties in Art. 23 and Art. 24. Any of the four becomes the provider under Art. 25 by rebranding a high-risk system, changing its intended purpose or substantially modifying it.

Transparency

Article 50: the duties that reach almost everyone

On top of the risk tier, based on how the AI touches people. Applies since 02.08.2026; the Digital Omnibus did not defer it.

Art. 50(1)

Tell people they are talking to AI

Chatbots and voice assistants must make the AI interaction clear unless it is obvious from the context.
Art. 50(2)

Mark generated content

Providers of generative systems mark synthetic audio, image, video and text in a machine-readable, detectable way.
Art. 50(3)

Disclose emotion recognition

Deployers of emotion-recognition or biometric-categorisation systems tell the people exposed to them.
Art. 50(4)

Disclose deepfakes

Deployers always disclose deepfakes. AI-written text published on matters of public interest is disclosed too, unless a human takes editorial responsibility.
Enforcement

What are the penalties?

Article 99 sets three bands: the higher of amount or percentage applies, the lower for SMEs and start-ups. National market-surveillance authorities enforce for AI systems; the Commission's AI Office for GPAI models.

InfringementMaximum fine
Prohibited practices (Art. 5)€35m or 7% of worldwide annual turnover
Most other obligations (e.g. high-risk duties)€15m or 3% of worldwide annual turnover
Incorrect/incomplete/misleading info to authorities€7.5m or 1% of worldwide annual turnover

These are maximums. Authorities weigh the nature and duration of the breach, intent, and what the operator did about it (Art. 99(7)). More in penalties and enforcement.

The path

How to comply with the EU AI Act: six phases

The work runs in this order, as do the product's six gated phases. You cannot register what you have not assessed, or assess what you have not classified.

  1. 01ClassifyWork through role, risk and prohibited-use — to review and confirm
  2. 02Scope & literacyApplicable obligations derived + Art. 4 AI literacy
  3. 03Build & documentRisk management, data governance, oversight & tech docs
  4. 04Conformity assessmentConformity assessment, declaration and CE marking
  5. 05RegisterEU database registration before market placement
  6. 06Operate & monitorPost-market monitoring, incident reporting, retention
Alongside

The EU AI Act and the GDPR

Both apply at once. A high-risk system processing personal data owes an Annex IV file and, usually, a DPIA; Article 26(9) sends deployers to the GDPR.

Where they overlap, one piece of work can serve both:

  • the Article 27 FRIA and the GDPR Article 35 DPIA answer overlapping questions
  • the Article 13 information a provider hands over feeds the deployer's DPIA
  • GDPR Article 22 (solely automated decisions) sits next to the Article 26(11) duty to inform affected people

How Veritome models the five frameworks as one register shows which records are credited in more than one.

Straight answers

EU AI Act: frequently asked questions

What is the EU AI Act?

The EU AI Act is Regulation (EU) 2024/1689, the European Union's law on artificial intelligence. It sorts AI systems into four risk tiers (prohibited, high-risk, limited-risk and minimal-risk) and attaches obligations to each tier and to each operator role: provider, deployer, importer and distributor. It has 113 articles and 14 annexes and has been in force since 01.08.2024.

Who does the EU AI Act apply to?

Anyone who places an AI system on the EU market or uses one in the EU in a professional capacity: providers (who build or brand it), deployers (who use it), importers and distributors. Like the GDPR it reaches organisations outside the EU whenever the system's output is used in the Union. Purely personal, non-professional use is out of scope.

What is the difference between a provider and a deployer?

A provider develops the system, or has it developed, and places it on the market under its own name; a deployer uses it under its own authority. Providers carry Articles 8 to 15 and the conformity route, deployers Article 26. A deployer that rebrands a high-risk system, changes its intended purpose or substantially modifies it becomes the provider (Article 25).

When does the EU AI Act apply?

In stages. Prohibited practices and AI-literacy duties have applied since 02.02.2025; GPAI model obligations and the penalty regime since 02.08.2025; Article 50 transparency since 02.08.2026. Two new Article 5 prohibitions apply from 02.12.2026. High-risk (Annex III) obligations apply from 02.12.2027 and AI in Annex I regulated products from 02.08.2028. Both were deferred by Regulation (EU) 2026/1744, the Digital Omnibus, in force since 27.07.2026.

What counts as a high-risk AI system?

Two routes. Annex III lists eight areas: biometrics, critical infrastructure, education, employment, essential services such as credit and insurance, law enforcement, migration and border control, justice and democratic processes. Article 6(1) adds safety components of products under the Annex I laws, such as medical devices or machinery. Under Article 6(3) a provider may document that an Annex III system poses no significant risk, unless it profiles natural persons.

What are the penalties for non-compliance?

Prohibited practices (Art. 5): up to €35m or 7% of worldwide annual turnover, whichever is higher. Most other obligations (e.g. high-risk duties): up to €15m or 3% of worldwide annual turnover, whichever is higher. Incorrect/incomplete/misleading info to authorities: up to €7.5m or 1% of worldwide annual turnover, whichever is higher. For SMEs and start-ups the lower of the two figures applies (Art. 99(6)).

Does the EU AI Act apply to AI tools we use but did not build?

Yes, as a deployer. Using a third-party recruitment screener, credit model or chatbot at work brings Article 26: follow the provider's instructions, assign human oversight, keep the logs, tell workers and affected people. Public bodies and certain private deployers also run an Article 27 fundamental rights impact assessment before first use.

Are SMEs exempt from the EU AI Act?

No. The obligations apply regardless of size. SMEs get proportionality: fines capped at the lower of amount or percentage (Art. 99(6)), priority sandbox access (Art. 62), simplified technical-documentation forms for microenterprises and lighter quality-management expectations. Classification and the core high-risk duties are the same.