EU AI Act risk classification

How to place an AI system in the EU AI Act's risk tiers, which dates apply after the 2026 Digital Omnibus, and where an implementation partner helps with the classification evidence.

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How do you classify an AI system under the EU AI Act?

A customer, contract or regulator now asks whether your AI system is high-risk, and the answer starts with the tier. Under the EU AI Act, every system falls into one of four levels: unacceptable risk, which is banned, high risk, transparency risk, or minimal or no risk, which the Act does not regulate. The position is set by what the system is used for and by where it sits against Article 5 (prohibited practices), Article 6 (high-risk classification) and Article 50 (transparency duties), not by the underlying technology, so a model that is identical in two products can land in different tiers. The organization owns this decision. No outside party issues the classification, although a consultant or the independent auditor you later engage may test it. Write the reasoning down for each system, including the intended purpose, the deployment context, the Annex III or Annex I category considered, and the conclusion reached.

Two dates in the 2026 amendments change the plan. The ninth prohibition, added by Regulation (EU) 2026/1744, applies from 2 December 2026, so any system with that practice in scope must be stopped or redesigned before then. The Annex III high-risk rules apply from 2 December 2027, and the Annex I product rules from 2 August 2028. Article 50 disclosure and marking duties for chatbots, synthetic content, emotion recognition and deepfakes apply from 2 August 2026, whether or not the system is also high-risk. Confirm each date against the consolidated text on EUR-Lex before you commit a delivery plan to it, because the Commission's own guidance on high-risk examples was still in draft at its last update.

If your system falls in an Annex III area, the Article 6(3) exemption may apply where the system performs a narrow procedural or preparatory task, improves a completed human activity, or detects decision patterns without replacing human assessment. Systems that profile people are always high-risk, so check that point first. A provider that relies on the exemption must document the assessment before market placement and register the system in the EU database. Misclassifying a high-risk system to avoid the rules exposes the provider to fines under Article 80. Ask your legal and product teams to record who approved each classification, when, and what would trigger a re-review, such as a change of use or a new customer sector.

How to work through the classification steps

The sequence moves from the broadest exclusions to the narrowest exemptions, so each step either settles the tier or passes the system to the next check. Every step closes with a written output that a reviewer can audit later.

  1. Check the Article 5 prohibitions first

    Start by testing the system against the nine practices banned under Article 5, including harmful manipulation, social scoring, and sensitive biometric categorisation. Compliance, product, or legal staff can run this check, but the AI system's owner must confirm the intended purpose and any foreseeable misuse. If a practice matches, the system cannot be placed on the EU market, and the record should state the matched prohibition and the date it applies. The 2 February 2025 date covers eight of the prohibitions, and the ninth applies from 2 December 2026. Close the step with a signed note recording that the system is or is not prohibited.

  2. Test the Article 6(1) Annex I product route

    Next, determine whether the AI is a safety component of, or is itself, a product covered by the Annex I harmonisation legislation that requires third-party conformity assessment. Product engineering and regulatory affairs teams usually own this check, because it depends on the product's certification path. A yes answer makes the system high-risk under this route, with rules that apply from 2 August 2028 after the 2026 amendment. Record the Annex I legislation identified and the conformity route it triggers, so the later conformity assessment work starts from a confirmed basis.

  3. Match the system to the Annex III areas

    Compare the intended purpose against the eight Annex III areas, such as biometrics, critical infrastructure, education, employment, credit scoring, insurance pricing, law enforcement, migration, and justice. Business owners describe the use case, and legal or compliance staff map it to the Annex wording. A match makes the system high-risk under Article 6(2), with these rules applying from 2 December 2027. Check the scope again whenever the use case changes, because Article 7 lets the Commission add or remove Annex III use cases within the existing areas by delegated act. The output is a classification record listing each matched area and the date it applies.

  4. Document any Article 6(3) exemption assessment

    If the system matches an Annex III area, test whether it falls under the Article 6(3) exemption, which covers systems that pose no significant risk because they perform a narrow procedural or preparatory task, improve completed human work, or detect decision patterns without replacing human review. Systems that profile natural persons are always high-risk and cannot use this exemption. Providers relying on the exemption must document the assessment before market placement and register the system in the EU database. Treat the Commission's draft guidelines as input to this judgment rather than a final answer. The output is a documented exemption assessment, signed by the provider, or a decision that the system stays high-risk.

  5. Assess Article 50 transparency duties

    Determine whether the system interacts with people, generates synthetic content, performs emotion recognition, or produces deepfakes. These systems face disclosure and marking duties under Article 50 from 2 August 2026, and this applies whether or not they are also high-risk. Product and UX owners can confirm the user-facing behavior, while legal staff confirm which duty applies. A system can carry both high-risk and transparency obligations, so record each one separately. The output is a transparency entry in the classification record that names the disclosure or marking duty and the owner responsible for it.

  6. Determine general-purpose model status under Chapter V

    Finally, establish whether the system is built on, or is itself, a general-purpose AI model. Chapter V applies separate duties to all providers of these models, including documentation, copyright, and training-summary duties, and presumes systemic risk for models trained with more than 10^25 FLOP. Teams that fine-tune or build on a third-party model should confirm with that model's provider what the upstream provider has documented. The output is a short statement of model status and, where relevant, a note on whether the systemic-risk presumption applies. Close the sequence by compiling all step outputs into one dated classification record and schedule a review whenever the intended purpose changes.

What each tier requires and when it applies

Article 5 of the AI Act bans a defined set of practices outright. The Commission counts nine prohibited practices, covering harmful manipulation, exploiting vulnerabilities, social scoring, criminal risk prediction based solely on profiling, untargeted scraping of facial images, emotion recognition at work and in education, sensitive biometric categorisation, real-time remote biometric identification for policing, and non-consensual intimate imagery and child sexual abuse material. Eight of these have applied since 2 February 2025. The ninth, added by Regulation (EU) 2026/1744, applies from 2 December 2026.

  • Legal basis: Article 5, with Chapter I definitions and the Article 113 application dates.
  • Application date: Eight prohibitions from 2 February 2025; the ninth from 2 December 2026.
  • Main duty: Do not place, put into service or use a banned practice. There is no conformity route that makes a banned system lawful.
  • Fine tier: EUR 35 million or 7% of worldwide annual turnover, whichever is higher, under Article 99.
  • Exceptions: Some prohibitions carry narrow law enforcement exceptions, so confirm the exact conditions in the text before relying on one.

Check whether any feature in your product touches a listed practice, including emotion inference in hiring tools, customer analytics that exploit vulnerability, or face matching built on scraped images.

When does the Article 6(3) exemption apply, and what must be documented?

The Article 6(3) exemption lets a provider treat an Annex III system as not high-risk when it poses no significant risk of harm. Three routes qualify: the system performs a narrow procedural or preparatory task, it improves the result of work a human has already completed, or it detects decision patterns without replacing or influencing human assessment that has been properly reviewed. Any system that profiles natural persons is always high-risk, so the exemption cannot be used for profiling tools, whatever the task looks like. Read the conditions narrowly. A screening tool that ranks job applicants is unlikely to fit the preparatory route just because a recruiter makes the final call.

The exemption carries paperwork. A provider that relies on it must document the assessment before the system is placed on the market, and must register the system in the EU database under Articles 6(4) and 49(2). Ask your team to keep a dated record that names the Annex III area, the specific condition relied on, the reasons the system does not pose significant risk, and who approved the decision. Recheck the record whenever the use case, the model or the deployment context changes. Article 80 also exposes providers that misclassify a system to escape obligations to fines under Article 99, so the record is evidence of good faith as well as a compliance step.

The Commission published draft guidelines with practical examples of high-risk and not-high-risk systems on 19 May 2026. Its own page still labeled them draft at the 23 July 2026 update, so confirm the final version on the Commission's AI Act page before you rely on any example in your assessment. An example that fits your system under a draft is not a safe harbor, and your own documented reasoning is what an assessor or market surveillance authority will test.

What changes the classification for your organization

Classification under the AI Act turns on a short set of facts about how a system is built, sold and used. Each factor below shifts the risk tier or the dates that apply, so record the reasoning for each one before you decide the tier.

Intended purpose versus actual use

The provider's stated intended purpose sets the starting point, but an assessor will also ask how the system is used in practice. Document the intended purpose in the instructions for use and the marketing material, then compare it with the deployments you actually observe. If a deployer uses a system for a high-risk task the provider did not foresee, the classification can change. Keep dated records of each purpose review and the evidence that supports it.

Safety component of an Annex I product

Under Article 6(1), an AI system is high-risk when it is a safety component of a product covered by Annex I legislation, or is itself such a product, and that legislation requires third-party conformity assessment. Record which product family the system sits in, who certifies that product, and whether the AI affects its safety function. These rules apply from 2 August 2028 after the 2026 amendment, so the product certification path and the AI Act path must be planned together.

Annex III area and use case

Under Article 6(2), a system is high-risk when it falls within one of the eight Annex III areas, such as employment, credit scoring, education or law enforcement. Map the system to the specific use case listed in the annex, not only to the broad area. Keep a written mapping for each system, including the sub-use case and the decision it informs. Note that the Commission may add or remove use cases by delegated act under Article 7, so review the mapping when the annex changes.

Profiling of natural persons

Under Article 6(3), a system that falls in an Annex III area and profiles people is always high-risk, even if it would otherwise fit the narrow exemption. Profiling means automated processing of personal data to evaluate aspects of a person, such as work performance, economic situation or behavior. Test each system for profiling before relying on any exemption, and keep the test result with the classification file. Assessors will check that this step was not skipped.

Interaction and generated content

Systems that interact with people, generate synthetic content, perform emotion recognition or produce deepfakes fall in the transparency tier. Article 50 disclosure and marking duties apply from 2 August 2026, whether or not the system is also high-risk. Record each user-facing touchpoint, the disclosure shown to the person, and how generated output is marked. A system can carry both a high-risk tier and Article 50 duties, so the transparency record should be kept separately from the high-risk file.

Built on a general-purpose model

A system built on a general-purpose AI model inherits a classification question from two chapters of the Act. The model provider has Chapter V duties, while the system provider must still classify the system itself. Record which model and version the system uses, whether you fine-tune it, and whether the model provider is supplying documentation you can rely on. If your system is built on a provider's own general-purpose model, the AI Office is exclusively competent under Article 75(1) as amended in 2026, so confirm the enforcing authority in your file.

Who classifies, who advises and who decides

Your legal, compliance and product owners hold the classification decision. The organization decides whether each AI system is prohibited, high-risk under Article 6(1) or 6(2), exempt under Article 6(3), subject only to Article 50 transparency duties, or outside the Act, and it must record the reasoning. Where a system is claimed to fall under the Article 6(3) exemption, the provider must document that assessment before market placement and register the system, so the signed record is the central piece of evidence.

  • Named decision owner: A single accountable role, usually the legal or compliance lead with product input, signs each classification and its date.
  • Reasoning on file: The record states the Annex III area or Annex I product legislation, the facts relied on and the rule applied, not only the outcome.
  • Re-review triggers: Changes to intended purpose, data, users or deployment context reopen the classification.
  • Counsel involvement: Borderline cases go to in-house or external counsel, whose written view you retain.
  • Draft guidance: Commission guidelines on high-risk classification were published as drafts on 19 May 2026, so the record should cite them as drafts.

Confirm with your counsel which classifications require a second signature under your governance policy.

Frequently asked questions about AI Act risk classification

How long does AI Act risk classification take for our system inventory?

The time depends mainly on how many systems you have, how well each one is documented, and how many of them touch Annex III use cases such as hiring, credit, insurance or education. A short inventory of tools with clear, documented purposes can be classified quickly. Systems with unclear purposes, vendor-supplied models, or uses that sit close to an Annex III category take longer, because each one needs a written assessment of its intended purpose, its role in decisions about people, and whether an Article 6(3) exemption could apply. Before you plan, confirm the scope in writing: the number of systems, the depth of documentation expected per system, and whether legal review of each assessment is included. The Commission's draft guidelines on high-risk classification, published on 19 May 2026 and still labeled draft, will also shape how the assessments are written.

Do we need a consultant to classify our AI systems?

No law requires an outside consultant to classify your systems. The organization owns the classification and the record of how it was reached. A consultant or implementation partner is most useful when the inventory is large, when systems are built on third-party models, or when the team lacks people who can read Annex III against a product's actual use. DeployOpen prepares systems, documentation and evidence for compliance work, and it does not issue legal opinions or regulatory determinations. If you bring in help, ask for a written scope that names the systems, the outputs (for example, a classification record per system and a register of exemption decisions), and who signs off each conclusion inside your organization.

Can our team classify AI systems in-house?

Yes, and many organizations do. The work is a structured reading of each system against the four Commission risk levels: prohibited practices under Article 5, the two high-risk routes in Article 6, the transparency duties in Article 50, and minimal risk. An internal team needs three things: a current inventory of systems with their purposes and users, access to someone who understands how each system affects people, and legal review for borderline cases such as the Article 6(3) exemption. Keep a written record for every system showing the route, the reasoning and the date. Under Article 6(4), a provider that relies on the Article 6(3) exemption must document the assessment before market placement and register the system, so that record is a compliance item, not a note.

What do product and legal teams need to provide for classification?

Classification is only as accurate as the facts behind it, so product and legal teams supply the inputs. Product teams should describe each system's intended purpose, the decisions or outputs it produces, the people affected, whether a human reviews outputs before they take effect, and whether the system profiles individuals. Legal teams should confirm which Annex III area applies, whether the system is a safety component of a regulated product under Annex I, whether any Article 5 practice is involved, and whether Article 50 disclosure duties apply. Engineering should confirm the model provenance, the data sources and any changes since the last review. Agree on who owns the final classification, who signs it, and how marketing claims about a system are checked against the stated purpose.

Does a model update change the risk classification of a system?

It can. Classification follows the system's intended purpose and its function in use, so a change to the model, the data, the decisions it supports or the population it affects may move a system into a different tier or out of an exemption. A retrained model with the same purpose may not change the tier, but a new use case, a new user group or a removed human review step probably will. Build a trigger into change management: any update to model version, intended purpose or deployment context starts a re-check of the classification record. Ask your vendors to tell you about model changes in writing, because a system you did not build may change under you.

Are open-source AI systems exempt from the AI Act?

Not entirely. Article 2(12) excludes free and open-source AI systems from the Act unless they are placed on the market as high-risk systems, or fall under Article 5 (prohibited practices) or Article 50 (transparency duties). Open-source licensing therefore does not change the classification of a system that is high-risk or prohibited. An organization that deploys an open-source model inside its own operations is still a deployer, and the exclusion does not remove deployer duties where the use is high-risk. Confirm with counsel how the exclusion applies to your specific distribution and deployment model, and record the reasoning in your classification file.

Which AI Act dates apply right now after the 2026 amendment?

As of the Digital Omnibus on AI (Regulation (EU) 2026/1744, entered into force on 27 July 2026), chapters I and II (definitions, AI literacy and prohibitions) have applied since 2 February 2025, and the general-purpose AI chapters since 2 August 2025. The Article 50 transparency duties apply from 2 August 2026. The ninth prohibition, added in 2026, applies from 2 December 2026. The high-risk rules in Chapter III Sections 1 to 3 now apply from 2 December 2027 for Annex III systems and from 2 August 2028 for Annex I product systems. Confirm the current dates against the consolidated EUR-Lex text before you set internal deadlines, because the timeline has changed twice.

How DeployOpen prepares classification evidence

DeployOpen plans and implements self-hosted open-source platforms inside your own infrastructure, and prepares the system records and evidence that support an AI Act risk classification. We do not issue classification opinions or certificates; your organization owns the decision, and independent advisers or auditors review it where needed.

How we scope

  • Written scope lists the AI systems to classify, their intended purposes and the Annex III or Annex I categories to test against.
  • Scope records which role you hold for each system, such as provider, deployer, importer or distributor.
  • Fixed-scope engagements agree deliverables and timelines in writing before any work starts.

How we build

  • We build an AI system inventory with purpose, data sources, affected people and deployment context for each system.
  • We document Article 6(3) exemption assessments with the procedural, preparatory or human-review reasoning for each claim.
  • We configure logging and records in your own environment so the classification rationale stays traceable over time.

How we hand over

  • Deliverables include the classification memo per system, the inventory, and the decision record with its dated assumptions.
  • We flag open questions, such as pending Commission guidance, so your legal and compliance owners can decide them.
  • Handover includes the documents and access your team needs to maintain the classification after the engagement ends.

How we support

  • Ongoing support is available as a retainer for reviewing classifications when systems, purposes or guidance change.
  • Retainers can cover re-classification after a new use case is added or an Annex III list is amended.
  • Your quote follows from the written scope, so ask for the scope, deliverables and exclusions to be stated explicitly.

Sources and further reading

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