High-risk AI.Understand your responsibility.

Annex I has two sections with different consequences. Section A products fall under the high-risk framework, subject to the rules coordinating it with product legislation. Section B follows a sectoral route: Article 2(2) limits the directly applicable AI Act provisions, while requirements are integrated into the relevant product rules.

Machinery is in Section B. Regulation (EU) 2023/1230 is the machinery reference following the Omnibus amendment. Article 6(1), Article 60a and Articles 102–112 apply directly to these systems; Articles 57–59 apply to the extent specified in Article 2(2). Do not apply an Annex III compliance checklist to machinery without checking that sectoral route.

Sources: Annex I of the AI Act and the amendment in Regulation (EU) 2026/1744, Article 1, points 2 and 41.

These examples come from the Commission’s draft classification guidelines. They illustrate systems within the listed use cases. They are neither exhaustive nor permission to use a system: Article 5 prohibitions and other applicable law must also be checked.

The Commission also identifies profiling in its admissions and victim-risk examples. That prevents use of the Article 6(3) exemption discussed below. The Annex III document is available through the classification guidelines consultation.

First check that it is an AI system under Article 3(1). Automating a task does not establish that. Intended purpose follows from instructions, documentation and marketing, as well as the contract. A contractual restriction does not cancel a use that you promote. Classification does not follow simply from using a particular model or selling to a particular industry.

Only systems on the Annex III route can use this provision. It does not exempt a system classified under Article 6(1).

The assessment must establish that the system does not pose a significant risk of harm to health, safety or fundamental rights, including that it does not materially influence the outcome of decision-making. The draft takes a narrow approach to this exception. A final human review does not establish it on its own.

The four alternative conditions

At least one of these conditions must apply, together with that overarching test:

• A narrow procedural task. An operation within a process whose limited role does not become the substantive assessment.
• Improving a completed human activity. Working on a result that a person has already produced, rather than replacing their assessment.
• Finding patterns or deviations. Reviewing earlier decisions without replacing or influencing the completed human assessment without proper human review.
• A preparatory task. Preparing an assessment covered by Annex III without materially determining its outcome.

Assess the system in context. If connected components or agents jointly produce an output that materially influences the decision, describing each component as preparatory does not establish an exemption for the combined system.

Profiling rules out the exemption

An Annex III system that profiles natural persons remains high-risk, even if one of the four conditions appears to fit.

The draft uses the three elements of profiling: automated processing, personal data and evaluation of personal aspects. For an AI system, the practical question is usually whether the latter two are present. Ranking a person’s performance, reliability or behaviour requires that examination. A manager’s approval after the ranking does not remove the profiling.

Article 6(4): document the decision before release

A provider relying on the exemption must document its assessment before placing the system on the market or putting it into service. Registration in the EU database under Article 49(2) is still required.

Paragraphs 113–116 of the draft describe what the assessment should explain:

1. The system’s intended purpose.
2. The Annex III use case it would fall within under Article 6(2).
3. The Article 6(3) condition relied on and why it applies.
4. Why the system does not profile natural persons.

The competent authority can request that assessment and review the classification. The draft also encourages deployers to consult the register. Build an explanation that someone outside your development team can examine.

The calendar separates high-risk obligations from transparency obligations and prohibitions. Each date has its own scope. A transitional deadline for systems already on the market is not the general start date for a requirement.

Two of these milestones fall on 2 December, one year apart, and only one of them is about high risk.

The public-authority and Annex X dates belong to specific transitional provisions. They do not replace the general dates for the two Article 6 routes.

The Act sets the requirement. A standard can help you implement it. Publication as a European standard and citation in the Official Journal are separate steps.

Article 11 is the only one of the eight requirements in this table without an associated harmonised draft. It does have a supporting standard, ISO/IEC 25623. That is different from having no standard at all.

EN 18286 has been adopted as a European standard, but its Official Journal citation is still pending at the recorded measurement date. Reading the status column matters as much as reading the standard number.

Harmonised standards are voluntary. Citation and coverage of each requirement determine whether presumption of conformity can be claimed.

Consult the consolidated Act alongside the 2026 amendment.

The draft was published on 19 May 2026. The targeted consultation closed on 23 July 2026, following a four-week extension from 23 June. At the source check, the Commission still expected final adoption by the end of 2026, without specifying an exact date.

The consultation record provides those dates and links to the documents. The regulatory source review used here was recorded on 11 September 2026.

These are draft, non-binding guidelines. They address classification, not proof that a system meets the requirements. Examples may change; the draft also provides for consultation with the AI Board and further stakeholder feedback before adoption.

The draft predates the Omnibus amendment. Where the two differ, the amended Regulation governs: Article 6(5) authorises the Commission to issue guidance, not to replace the Act. This page uses the amended text for the calendar and the machinery regime.