+Artikel 6 Classificatieregels voor AI-systemen met een hoog risico
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---+Article 6 1b.
---+Article 6 1c.
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Artikel 6 Classificatieregels voor AI-systemen met een hoog risico

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1. Overzicht

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Artikel 6 1.

Ongeacht of een AI-systeem los van in de punten a) en b) bedoelde producten in de handel wordt gebracht of in gebruik wordt gesteld, wordt een AI-systeem als AI-systeem met een hoog risico beschouwd wanneer aan beide van de volgende voorwaarden is voldaan:

a) 

het AI-systeem is bedoeld om te worden gebruikt als veiligheidscomponent van een product of het AI-systeem is zelf een product dat valt onder de in bijlage I opgenomen harmonisatiewetgeving van de Unie;

b) 

voor het product waarvan het AI-systeem de veiligheidscomponent op grond van punt a) vormt of voor het AI-systeem als product zelf moet een conformiteits-beoordeling door een derde partij worden uitgevoerd met het oog op het in de handel brengen of in gebruik stellen van dat product op grond van de in bijlage I opgenomen harmonisatiewetgeving van de Unie.
Article 6 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.
Article 6 1b.
Notwithstanding paragraph 1a, AI systems the failure or malfunctioning of which would endanger health and safety shall qualify as safety components.
Article 6 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).
Artikel 6 2.
Naast de in lid 1 bedoelde AI-systemen met een hoog risico worden ook AI-systemen zoals bedoeld in bijlage III als AI-systeem met een hoog risico beschouwd.
Artikel 6 3.
In afwijking van lid 2 wordt een in bijlage III bedoeld AI-systeem niet als AI-systeem met een hoog risico beschouwd wanneer het geen significant risico op schade voor de gezondheid, veiligheid of de grondrechten van natuurlijke personen inhoudt, onder meer doordat het de uitkomst van de besluitvorming niet wezenlijk beïnvloedt.

De eerste alinea is van toepassing wanneer aan een van de volgende voorwaarden is voldaan:

a) 

het AI-systeem is bedoeld om een beperkte procedurele taak uit te voeren;

b) 

het AI-systeem is bedoeld om het resultaat van een eerder voltooide menselijke activiteit te verbeteren;

c) 

het AI-systeem is bedoeld om besluitvormingspatronen of afwijkingen van eerdere besluitvormingspatronen op te sporen en is niet bedoeld om de eerder voltooide menselijke beoordeling zonder behoorlijke menselijke toetsing te vervangen of te beïnvloeden, of

d) 

het AI-systeem is bedoeld om een voorbereidende taak uit te voeren voor een beoordeling die relevant is voor de in bijlage III vermelde gebruiksgevallen.

Niettegenstaande de eerste alinea wordt een in bijlage III bedoeld AI-systeem altijd als een AI-systeem met een hoog risico beschouwd indien het AI-systeem profilering van natuurlijke personen uitvoert.
Artikel 6 4.
Een aanbieder die van mening is dat een in bijlage III bedoeld AI-systeem geen hoog risico inhoudt, documenteert zijn beoordeling voordat dat systeem in de handel wordt gebracht of in gebruik wordt gesteld. Die aanbieder is onderworpen aan de registratieverplichting van artikel 49, lid 2. Op verzoek van de nationale bevoegde autoriteiten verstrekt de aanbieder de documentatie van de beoordeling.
Artikel 6 5.
De Commissie verstrekt na raadpleging van de Europese raad voor artificiële intelligentie (de „AI-board”) en uiterlijk op 2 februari 2026 richtsnoeren voor de praktische uitvoering van dit artikel in overeenstemming met artikel 96, samen met een uitgebreide lijst van praktische voorbeelden van gebruiksgevallen van AI-systemen met een hoog risico en zonder hoog risico.
Artikel 6 6.
De Commissie is bevoegd overeenkomstig artikel 97 gedelegeerde handelingen vast te stellen om teneinde lid 3, tweede alinea, van dit artikel te wijzigen door nieuwe voorwaarden toe te voegen aan de daarin vastgelegde voorwaarden, of door hen te wijzigen, indien er concrete en betrouwbare bewijzen zijn voor het bestaan van AI-systemen die onder het toepassingsgebied van bijlage III vallen, maar die geen significant risico inhouden op schade voor de gezondheid, veiligheid of grondrechten van natuurlijke personen.
Artikel 6 7.
De Commissie stelt overeenkomstig artikel 97 gedelegeerde handelingen vast om lid 3, tweede alinea, van dit artikel te wijzigen door de daarin vastgelegde voorwaarden te schrappen, indien er concrete en betrouwbare aanwijzingen zijn dat dit noodzakelijk is om het in deze verordening bepaalde niveau van bescherming van de gezondheid, de veiligheid en de grondrechten te behouden.
Artikel 6 8.
Overeenkomstig de leden 6 en 7 van dit artikel vastgestelde wijzigingen van de in lid 3, tweede alinea, vastgelegde voorwaarden doen geen afbreuk aan het in deze verordening bepaalde algemene niveau van bescherming van de gezondheid, de veiligheid en de grondrechten, en zorgen voor samenhang met de op grond van artikel 7, lid 1, vastgestelde gedelegeerde handelingen en houdenrekening met markt- en technologische ontwikkelingen.

1.1 Referenties

1.2 Geïdentificeerde eisen

1.3 Gerelateerde standaarden

2. Geïdentificeerde eisen

Eisen

3. Gerelateerde standaarden

Standaarden
SCF AI & Autonomous Technologies High Risk Designations

Description

Mechanisms exist to designate Artificial Intelligence (AI) and Autonomous Technologies (AAT) "High Risk" if one (1), or more, of the following criteria are met:
(1) AAT is used as a safety component of a product or service;
(2) AAT poses a significant risk of harm to an individual's health, safety or fundamental rights; and/or
(3) AAT materially influences the outcome of an individual's decision making.

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ Document criteria for high-risk AI use and review before deployment

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ AI risk classification checklist with high-risk criteria

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ Formal AI risk classification policy
∙ High-risk designation process

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ AI risk management framework with formal high-risk designation process
∙ Risk committee review

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ Enterprise AI risk classification framework
∙ Automated risk scoring
∙ Legal/compliance review for high-risk AI
∙ Regulatory compliance mapping (e.g., EU AI Act)

SCR-CMM

Level 0 Not Performed

Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.

Level 1 Performed Informally

SCR-CMM Level 1 criteria definitions are not available for this control:
▪ A reasonable person would conclude this control requires a structured process.
▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality.

Level 2 Planned Tracked

Artificial Intelligence and Autonomous Technology (AAT) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AAT domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with AAT domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AAT domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Artificial Intelligence (AI)-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Asset management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.

Level 3 Well Defined

Artificial Intelligence and Autonomous Technology (AAT) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AAT domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with AAT domain capabilities are well-documented and kept current by process owners.
▪ An Artificial Intelligence Governance (AIG) team, or similar function, is appropriately staffed and supported to implement and maintain AAT domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of AI governance, risk management and compliance operations (e.g., dedicated AI governance platform).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AAT domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to designate AAT "High Risk" if one(1), or more, of the following criteria are met:
(1) AAT is used as a safety component of a product or service;
(2) AAT poses a significant risk of harm to an individual's health, safety or fundamental rights; and/or
(3) AAT materially influences the outcome of an individual's decision making.

Level 4 Quantitatively Controlled

Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.

Level 5 Continuously Improving

Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
SCF High-Risk Technology Assets, Applications and/or Services (TAAS) Categorization

Description

Mechanisms exist to categorize Technology Assets, Applications and/or Services (TAAS) as "High Risk" if it poses a significant risk of harm to an individual's:
(1) Health;
(2) Safety; and/or
(3) Fundamental human rights.

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ Identify systems that could harm people if misused (e.g., safety devices, sensitive personal data)

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ High-risk categorization field in asset inventory
∙ Criteria for high-risk classification

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ High-risk TAAS categorization in CMDB based on potential harm to individuals or society
∙ Enhanced controls for high-risk assets

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ Formal high-risk categorization criteria (e.g., aligned with EU AI Act, safety impact)
∙ Risk-based control baselines for high-risk TAAS

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ Enterprise high-risk asset categorization program integrated with risk management and regulatory obligations
∙ Enhanced assurance for high-risk TAAS

SCR-CMM

Level 0 Not Performed

Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.

Level 1 Performed Informally

SCR-CMM Level 1 criteria definitions are not available for this control:
▪ A reasonable person would conclude this control requires a structured process.
▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality.

Level 2 Planned Tracked

Asset Management (AST) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AST domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with AST domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AST domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Asset management-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Asset management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ The IT department establishes, maintains and updates an inventory that contains a listing of all organizational-owned TAASD, at a minimum covering common devices (e.g., laptops, workstations and servers).

Level 3 Well Defined

Asset Management (AST) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AST domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with AST domain capabilities are well-documented and kept current by process owners.
▪ An IT Asset Management (ITAM) team, or similar function, is appropriately staffed and supported to implement and maintain AST domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of ITAM operations (e.g., ITAM platform, (e.g., Configuration Management Database (CMBD) Asset Management solution).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AST domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to categorize a system and/or service as "High Risk" if it poses a significant risk of harm to an individual's:
(1) Health;
(2) Safety; and/or
(3) Fundamental human rights.

Level 4 Quantitatively Controlled

Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.

Level 5 Continuously Improving

Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.