Compliance

High-Risk AI Under the EU AI Act: Which Systems Are Covered

How to tell whether your AI system is high-risk, and which deadlines actually apply after July 2026.

Author

Dr. Kilian Schmidt

Date

31.7.2026

Updated on

31.7.2026

There are two routes to high-risk status: Article 6(1), as a product or safety component under existing EU product law (Annex I), and Article 6(2), as a use case listed in Annex III.
Annex III names eight areas: biometrics, critical infrastructure, education, employment, access to essential services, law enforcement, migration and border control, and administration of justice and democratic processes.
Annex III contains express carve-outs of its own, including biometric verification, financial fraud detection within creditworthiness assessment, and the verification of travel documents.
Article 6(3) exempts systems that pose no significant risk. Providers relying on it must still document the assessment and register the system. Any system that performs profiling of natural persons is always high-risk.
The deadlines have moved. Under Regulation (EU) 2026/1744, high-risk obligations apply from 2 December 2027 for stand-alone Annex III systems and from 2 August 2028 for product-embedded Annex I systems.

Whether an AI system counts as high-risk decides almost everything else under the EU AI Act. This tier carries the substantive obligations, from conformity assessment through to registration, while most other systems face only transparency duties or none at all. This article covers how the classification works, what the eight Annex III areas actually say, which exemptions apply, and which deadlines are real after the July 2026 amendment.

Updated: Regulation (EU) 2026/1744, the Digital Omnibus on AI, entered into force on 27 July 2026. It amends the EU AI Act and defers the application of the high-risk obligations. Any guidance still pointing to 2 August 2026 for high-risk systems is out of date on that point. The Article 50 transparency obligations largely remain at 2 August 2026.

What are the EU AI Act risk categories?

The EU AI Act regulates by risk rather than by technology. This is commonly described as four tiers, and that maps well onto the structure of the regulation: prohibited practices under Article 5, high-risk systems under Chapter III, systems carrying transparency obligations under Article 50, and everything else with no specific duties. The large majority of commercial AI sits in the lower two tiers. Because the work concentrates on the high-risk tier, classification is the first step in any AI Act programme.

When is an AI system high-risk?

Article 6 sets out two routes.

Route 1 (Article 6(1)): the system is intended to be used as a safety component of a product, or is itself a product, covered by the Union harmonisation legislation listed in Annex I, and that product must undergo a third-party conformity assessment. Both conditions have to be met. Medical devices and toys are the typical examples.

Route 2 (Article 6(2)): the system falls within one of the use cases listed in Annex III. This route captures most software and SaaS companies, so it is the focus here.

Route 1 changed in July 2026. Regulation (EU) 2026/1744 takes AI embedded in products governed by the Machinery Regulation outside the direct scope of the high-risk rules and narrows the definition of a safety component. Medical devices and toys remain in scope. If your system is embedded in machinery, the classification is worth revisiting.

The eight Annex III areas

Annex III is an exhaustive list of use cases. What matters is the function the system performs, not the industry it sits in. The table below summarises the eight headings and the carve-outs that appear expressly in the text.

The eight Annex III areas of the EU AI Act
Area (Annex III)	Systems covered, and express carve-outs
1. Biometricswhere permitted	Remote biometric identification; biometric categorisation according to sensitive or protected attributes; emotion recognition.Not covered: biometric verification whose sole purpose is to confirm that a person is who they claim to be.
2. Critical infrastructure	Safety components in the management and operation of critical digital infrastructure, road traffic, and the supply of water, gas, heating or electricity.
3. Education and vocational training	Determining access, admission or assignment to institutions; evaluating learning outcomes; assessing the appropriate level of education a person will receive; monitoring and detecting prohibited behaviour during tests.
4. Employment, workers management and access to self-employment	Recruitment and selection, including targeted job advertisements, filtering applications and evaluating candidates; decisions on terms of work, promotion and termination; task allocation based on behaviour or personal traits; monitoring and evaluating performance and behaviour.
5. Access to essential private and public services	Evaluating eligibility for essential public assistance benefits and services, including healthcare; evaluating creditworthiness or establishing credit scores; risk assessment and pricing in life and health insurance; evaluating and prioritising emergency calls and triage.Not covered: systems used to detect financial fraud.
6. Law enforcementwhere permitted	Assessing the risk of a person becoming a victim of crime; polygraphs and similar tools; evaluating the reliability of evidence; assessing the risk of offending or re-offending; profiling in the course of detection, investigation or prosecution.
7. Migration, asylum and border controlwhere permitted	Polygraphs and similar tools; assessing security, irregular migration or health risks posed by people entering a Member State; assisting with the examination of asylum, visa and residence permit applications; detecting, recognising or identifying people.Not covered: the verification of travel documents.
8. Administration of justice and democratic processes	Assisting judicial authorities in researching and interpreting facts and the law and applying the law, including in alternative dispute resolution; influencing the outcome of an election or referendum, or voting behaviour.Not covered: systems whose output natural persons are not directly exposed to, such as tools used to organise or structure campaigns administratively or logistically.

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The Article 6(3) exemption

A system in an Annex III area is not high-risk where it does not pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by not materially influencing the outcome of decision making. That applies where any one of the following four conditions is met:

The system is intended to perform a narrow procedural task.
It is intended to improve the result of a previously completed human activity.
It is intended to detect decision-making patterns or deviations from prior patterns, and is not meant to replace or influence the previously completed human assessment without proper human review.
It is intended to perform a preparatory task to an assessment relevant to the Annex III use cases.

Two points get missed. First, an Annex III system is always high-risk where it performs profiling of natural persons, and the exemption does not apply. Second, the exemption is not a free pass. A provider who considers a system not to be high-risk must document that assessment before placing the system on the market under Article 6(4), is subject to the registration obligation in Article 49(2), and must produce the documentation on request. That registration duty was proposed for removal during the Digital Omnibus negotiations and survived, with a lighter process.

Under Article 6(5), the Commission is required to provide guidelines on the practical implementation of Article 6, together with a list of practical examples of high-risk and non-high-risk use cases. Check the current status of those guidelines before finalising an Article 6(3) classification.

What applies if your system is high-risk?

You must demonstrate conformity before placing the system on the market and keep it conformant in operation. The requirements sit in Chapter III Section 2: a risk management system (Article 9), data and data governance (Article 10), technical documentation (Article 11), record-keeping (Article 12), transparency towards deployers (Article 13), human oversight (Article 14), and accuracy, robustness and cybersecurity (Article 15). Provider obligations in Section 3 follow, including a quality management system (Article 17), then conformity assessment (Article 43), the EU declaration of conformity (Article 47), CE marking (Article 48) and registration (Article 49).

A structured way to inventory and classify your systems is an AI risk assessment, ideally embedded in an AI management system aligned to ISO 42001. For the full path to conformity, see our guide to EU AI Act compliance, and for the regulation in the round, the EU AI Act overview.

When do the obligations apply?

EU AI Act application dates as amended by Regulation (EU) 2026/1744
Date	What applies
2 August 2026	Article 50 transparency obligations become applicable. For the machine-readable marking of AI-generated content under Article 50(2), systems placed on the market before this date have a grace period until 2 December 2026.
2 December 2026	End of that grace period. End of the transitional period for the new prohibition on AI generating CSAM and non-consensual intimate imagery.
2 August 2027	Deadline for Member States to establish AI regulatory sandboxes.
2 December 2027	Obligations for stand-alone high-risk systems under Annex III.
2 August 2028	Obligations for product-embedded high-risk systems under Annex I.

The extra runway is a deferral, not a reprieve. The obligations themselves are unchanged, and a risk management system, defensible data governance and auditable technical documentation do not come together in a few weeks. Classifying your systems remains the task to start now, not least because it determines how large the programme is.

Frequently asked questions

How do I know if my AI system is high-risk?

Ask two questions. Is the system a product or safety component under the EU legislation listed in Annex I that requires third-party conformity assessment? And does it perform one of the functions listed in Annex III? If either applies and no carve-out and no Article 6(3) exemption is available, it is high-risk. If the system performs profiling of natural persons, it is high-risk in any case.

What are the eight Annex III areas?

Biometrics; critical infrastructure; education and vocational training; employment, workers management and access to self-employment; access to essential private and public services, including creditworthiness and life and health insurance; law enforcement; migration, asylum and border control management; and administration of justice and democratic processes.

Is every system in an Annex III area automatically high-risk?

No. Annex III contains its own carve-outs, including biometric verification, financial fraud detection within creditworthiness assessment, and the verification of travel documents. Article 6(3) additionally exempts systems that pose no significant risk. The classification must be documented and the system registered regardless. Systems that perform profiling stay high-risk.

Does 2 August 2026 still apply to high-risk AI?

No. Under Regulation (EU) 2026/1744, in force since 27 July 2026, high-risk obligations apply from 2 December 2027 for Annex III systems and from 2 August 2028 for Annex I systems. 2 August 2026 remains relevant for the Article 50 transparency obligations.

What does the amendment mean for AI in machinery?

AI embedded in products governed by the Machinery Regulation falls outside the direct scope of the EU AI Act's high-risk rules. The Commission can, however, impose AI-specific health and safety requirements through delegated acts under the Machinery Regulation. Medical devices and toys remain within the AI Act.

See how Kertos inventories your AI systems, classifies them and prepares you for the high-risk obligations: Book a demo.

Legal status: 30 July 2026. This article is based on Regulation (EU) 2024/1689 as amended by Regulation (EU) 2026/1744. It is general information and does not replace legal advice on individual cases.

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Dr. Kilian Schmidt

CEO & Co-Founder at Kertos

Kilian had a strong focus on legal processes from an early age and began his career at Home24 as a Senior Legal Counsel and Data Protection Officer for the Home24 group. After a stint at Freshfields Bruckhaus Deringer, he moved to TIER Mobility, where he expanded the company's legal and public policy departments from one to 65 cities and from 50 to 800 employees. Driven by the lack of technology in the legal field and confirmed by his consulting work at Gorillas Technologies, he decided to found Kertos to develop the next generation of compliance – made in Europe.

About Kertos

Kertos is the modern backbone of the data protection and compliance activities of scaling companies. We enable our customers to implement integrated data protection and information security processes in accordance with GDPR, ISO 27001, TISAX®, SOC2 and many other standards quickly and cheaply through automation.