EU AI Act Article 6 High-Risk Classification Rules

Article 6 sets two routes for classifying a system as high-risk. Under Article 6(1), an AI system must be intended as a safety component of a product, or be a product itself, covered by Union harmonisation legislation in Annex I; the relevant product must also require third-party conformity assessment under that legislation. Both conditions are necessary. The AI component’s presence in a regulated product is not by itself enough. Regulation (EU) 2026/1744 clarified “safety component.” AI used solely for non-safety user assistance, performance optimisation, service efficiency, automation, convenience, or quality control does not qualify on that basis. A system whose failure or malfunction would endanger health and safety does qualify. A third-party product assessment required solely for a non-health or non-safety risk, such as radio-spectrum interference, does not satisfy Article 6(1)(b). The product-specific route thus turns on intended purpose, safety function, and the relevant product law. Article 6(2) establishes the other route: AI systems intended for an Annex III use case are high-risk, subject to Article 6(3). The narrow exception requires no significant risk of harm and one of the stated functions, such as a narrow procedural or preparatory task. The system is always high-risk under this provision if it performs profiling of natural persons. A provider that concludes an Annex III system is not high-risk must document the assessment and complete the applicable registration. The legal classification and the application date are separate questions. Regulation (EU) 2026/1744 is in force and defers the main Chapter III requirements for Article 6(2)/Annex III systems to December 2, 2027, and for Article 6(1)/Annex I systems to August 2, 2028. It also contains transitional provisions for certain systems. Teams should assess the system against the current legal text and separately record which obligations apply when. This is informational, not legal advice.