GuidanceGuidancev1.0.0

Two cumulative conditions for high-risk under Annex I

An AI system only becomes high-risk under Article 6(1) when two conditions are met at the same time: the system is itself a regulated product or a safety component of one, and that product must undergo third-party conformity assessment.

The official source remains authoritative. This is general information about obligations and not legal advice. See this object on the map

Address and citation

This object has an address of its own that is never renamed or reused. Store the identifier in your own file, not the title or the link.

Identifier: praxikon:eu:ai-act:guidance:guidance-high-risk-annex-i-two-cumulative-conditions
Payload hash (sha256): da0604d8c4d9bc6e309a1ff0bd7cf963a65eac7ddb309e26d69a2ff6533f417e

Citation line

Praxikon, "Two cumulative conditions for high-risk under Annex I", praxikon:eu:ai-act:guidance:guidance-high-risk-annex-i-two-cumulative-conditions@1.0.0, dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0), effective_at 2026-08-08T00:00:00.000Z, known_at 2026-08-14T00:00:00.000Z, sha256 da0604d8c4d9bc6e309a1ff0bd7cf963a65eac7ddb309e26d69a2ff6533f417e

Version: 1.0.0
Legal time (effective_at): 8 August 2026
Knowledge time (known_at): 8 August 2026
Closed on: Not closed
Topics: guidance

Review status: Placed against the official source (8 August 2026). Next check due by 4 February 2027. The check date is the knowledge date of this version; no later recheck has been recorded.

What this object links to

Every relation appears below as a path: from the source with its locator, through the conditions and exceptions of the object carrying the relation, to the consequence. A locator belongs to a statement in the data and not to a relation, so the source is the source anchor of the carrying object.

The obligation this hangs off

1 of 1 shown

The object belongs to this obligation. The source line it hangs off sits there.

Source
Official fact on this object, with its locator.
- Draft guidelines on the classification of high-risk AI systems
  Locator: Draft guidelines Annex I, points (27) and (21)
  praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- ObligationArticles 43-49: conformity assessment, CE and registration
  praxikon:eu:ai-act:obligation:conformity-ce-registration

What this object is about

2 of 2 shown

The object is about this role. Undifferentiated: it does not follow that the duty rests on this role.

Source
Official fact on this object, with its locator.
- Draft guidelines on the classification of high-risk AI systems
  Locator: Draft guidelines Annex I, points (27) and (21)
  praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- ActorDeployer
  praxikon:eu:ai-act:actor:deployer
- ActorProvider of an AI system
  praxikon:eu:ai-act:actor:provider

What this object states

Official fact

Attributable to a named primary source, with a locator. Where they differ, the official source prevails.

The European Commission draft guidelines of 19 May 2026, which are expressly non-binding and not final, read Article 6(1) as two cumulative conditions. First, the AI system must be intended to be used as a safety component of a product, or the AI system must itself be a product, covered by the Union harmonisation legislation listed in Annex I. Second, that product, or the AI system itself where it is the product, must be required to undergo a third-party conformity assessment. The draft guidelines state explicitly that not all AI systems that are components of regulated products are high-risk, but only the subset that satisfies both criteria.
- Locator: Draft guidelines Annex I, points (27) and (21)praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelinesOpen official source

Our interpretation

Our own reading. It can change without the law changing, and it is not the position of a supervisory authority.

This is a filter with two screens, and both must be passed. In practice organisations stop at the first screen and conclude their product is high-risk simply because sectoral product legislation applies to it. That is premature. The second screen, mandatory third-party involvement, removes a substantial share. The reverse also holds: anyone who looks only at the CE route and skips the safety component question will miss systems that only enter through the failure route. You must therefore ask both questions separately and record both answers.
- Locator: Draft guidelines Annex I, points (27) and (21)praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelinesOpen official source

Recommended step

A practical step we consider appropriate. Not an obligation following from the Regulation.

For every AI system in a regulated product, record a two-part classification note: first whether the system is a product or a safety component, then whether a third party must be involved for that product. Keep both answers with their reasoning in your technical documentation, so that during an audit you do not have to reconstruct after the fact why you reached your conclusion.
- Locator: Draft guidelines Annex I, points (27) and (21)praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelinesOpen official source

When this applies

No condition recorded on this object.

When this does not apply

No exception recorded on this object.

Referring to this object

Citation block

Copy this reference into your advice, article or file. The identifier, the version and the hash keep the statement findable later, even once the dataset has moved on.

Reference

Praxikon, "Two cumulative conditions for high-risk under Annex I",
praxikon:eu:ai-act:guidance:guidance-high-risk-annex-i-two-cumulative-conditions@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0),
effective_at 2026-08-08T00:00:00.000Z, known_at 2026-08-08T00:00:00.000Z,
sha256 da0604d8c4d9bc6e309a1ff0bd7cf963a65eac7ddb309e26d69a2ff6533f417e,
https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-annex-i-two-cumulative-conditions
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aguidance%3Aguidance-high-risk-annex-i-two-cumulative-conditions&effective_at=2026-08-08&known_at=2026-08-08&lang=en, accessed 2026-08-25)

Short form

praxikon:eu:ai-act:guidance:guidance-high-risk-annex-i-two-cumulative-conditions@1.0.0 (sha256 da0604d8)

BibTeX

@misc{praxikon-eu-ai-act-guidance-guidance-high-risk-annex-i-two-cumulative-conditions-1-0-0,
  author       = {{Praxikon}},
  title        = {Two cumulative conditions for high-risk under Annex I},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:guidance:guidance-high-risk-annex-i-two-cumulative-conditions},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.1.0, schema 1.4.0},
  note         = {effective_at 2026-08-08T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 da0604d8c4d9bc6e309a1ff0bd7cf963a65eac7ddb309e26d69a2ff6533f417e},
  url          = {https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-annex-i-two-cumulative-conditions},
  urldate      = {2026-08-25},
  language     = {en}
}

CSL JSON

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