1. 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. 1a. For the purposes of this Regulation, including paragraph 1 of this Article, AI systems that are solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control shall not qualify as safety components. 1b. Notwithstanding paragraph 1a, AI systems the failure or malfunctioning of which would endanger health and safety shall qualify as safety components. 1c. A product that is required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, shall not be considered as fulfilling the condition in paragraph 1, point (b). 2. In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall be considered to be high-risk. 3. By derogation from paragraph 2, an AI system referred to in Annex III shall not be considered to be 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. The first subparagraph shall apply where any of the following conditions is fulfilled: (a) the AI system is intended to perform a narrow procedural task; (b) the AI system is intended to improve the result of a previously completed human activity; (c) the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns and is not meant to replace or influence the previously completed human assessment, without proper human review; or (d) the AI system is intended to perform a preparatory task to an assessment relevant for the purposes of the use cases listed in Annex III. Notwithstanding the first subparagraph, an AI system referred to in Annex III shall always be considered to be high-risk where the AI system performs profiling of natural persons. 4. A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment before that system is placed on the market or put into service.
How this was checked
How high-risk classification works
Verified · last checked Settled, with the evidence a claim at this level needs.
Under the EU AI Act a system is high-risk by either of two routes. It is high-risk where it 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. A product required to undergo that assessment solely because of risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, does not fulfil that second condition. It is also high-risk where it falls within one of the eight areas listed in Annex III, which are, in the order the Annex numbers them, biometrics; critical infrastructure, limited to systems used as safety components in the management and operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity; education and vocational training; employment, workers' management and access to self-employment; access to and enjoyment of essential private services and essential public services and benefits, which is where creditworthiness and life and health insurance pricing sit; law enforcement; migration, asylum and border control management; and the administration of justice and democratic processes. A system in an Annex III area is not high-risk where it does not pose a significant risk of harm to health, safety or fundamental rights, including by not materially influencing the outcome of decision making; that derogation applies only where at least one of four conditions is fulfilled, namely that the system performs a narrow procedural task, improves the result of a previously completed human activity, detects decision-making patterns or deviations from them without replacing or influencing the previous human assessment without proper human review, or performs a preparatory task to an assessment. An Annex III system is always high-risk where it performs profiling of natural persons.
At a glance
The statement laid out, in its own words. The statement above and its sources are what count.
Route one: products under Annex I
- 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
- A product required to undergo that assessment solely because of risks other than risks to health and safety, such as radio spectrum or electromagnetic interference that do not affect health and safety, does not meet that second condition
Route two: the eight areas of Annex III
- Biometrics
- Critical infrastructure, limited to safety components in the management and operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity
- Education and vocational training
- Employment, workers’ management and access to self-employment
- Access to and enjoyment of essential private services and essential public services and benefits, which is where creditworthiness and life and health insurance pricing sit
- Law enforcement
- Migration, asylum and border control management
- Administration of justice and democratic processes
When an Annex III system is not high-risk
- Where it does not pose a significant risk of harm to health, safety or fundamental rights, including by not materially influencing the outcome of decision making
- and only where at least one of four conditions is fulfilled
The four conditions
- It performs a narrow procedural task
- It improves the result of a previously completed human activity
- It detects decision-making patterns or deviations from them, without replacing or influencing the previous human assessment without proper human review
- It performs a preparatory task to an assessment
Profiling
- An Annex III system that performs profiling of natural persons is always high-risk
Where the book relies on it
- The AI Act File, Deciding whether a use is high-risk. About The AI Act File
- Kind of evidence
- documentarySettled by a first-hand source, quoted below with the day it was read.
The evidence
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: [points (a) to (c) elided]. 2. Critical infrastructure: AI systems intended to be used as safety components in the management and operation of critical digital infrastructure, road traffic, or in the supply of water, gas, heating or electricity. 3. Education and vocational training: [points (a) to (d) elided]. 4. Employment, workers' management and access to self-employment: [points (a) and (b) elided]. 5. Access to and enjoyment of essential private services and essential public services and benefits: [point (a) elided]; (b) AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score, with the exception of AI systems used for the purpose of detecting financial fraud; (c) AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance; [point (d) elided]. 6. Law enforcement, in so far as their use is permitted under relevant Union or national law: [points (a) to (e) elided]. 7. Migration, asylum and border control management, in so far as their use is permitted under relevant Union or national law: [points (a) to (d) elided]. 8. Administration of justice and democratic processes: [point (a) elided]; (b) AI systems intended to be used for influencing the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI systems to the output of which natural persons are not directly exposed, such as tools used to organise, optimise or structure political campaigns from an administrative or logistical point of view.
Article 2(2): For AI systems classified as high-risk AI systems in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Article 60a and Articles 102 to 112 shall apply. Articles 57, 58 and 59 shall apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation. Regulation (EU) 2026/1744, Article 1, point (41): in Section A, point 1 is deleted; (b) in Section B, the following point is added: 21. Regulation (EU) 2023/1230 [...]. Regulation (EU) 2026/1744, Article 3, point (1), in the paragraph it inserts into Regulation (EU) 2023/1230: Those requirements shall ensure that the relevant requirements set out in Chapter III, Section 2, and Articles 17, 19, 72 and 73 of Regulation (EU) 2024/1689 are reflected. [...] Those delegated acts shall apply by 2 August 2028.
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