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GuidanceGuidancev1.0.0

Article 6 has two separate routes to high-risk

An AI system can be high-risk in two ways. Either it is itself a product, or a safety component of a product, covered by the Annex I product legislation and that product must undergo third-party conformity assessment (Article 6(1)). Or it falls within one of the use cases listed in Annex III (Article 6(2)). The two routes have their own criteria and their own application dates.

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Address and citation

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Identifier
praxikon:eu:ai-act:guidance:guidance-high-risk-article-6-two-routes
Payload hash (sha256)
5b469bba143ed5b34c1afab440aee9ca78c70f2d513b65ee8c21990ecb393de7

Citation line

Praxikon, "Article 6 has two separate routes to high-risk", praxikon:eu:ai-act:guidance:guidance-high-risk-article-6-two-routes@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 5b469bba143ed5b34c1afab440aee9ca78c70f2d513b65ee8c21990ecb393de7
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

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The obligation this hangs off

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  1. Source

    Official fact on this object, with its locator.

    • Draft guidelines on the classification of high-risk AI systems

      Locator: Draft guidelines on high-risk AI classification (19 May 2026), General principles chapter, section II, paragraph (7); section V, paragraph (448)

      praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines

      Open official source

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    Consequence

What this object is about

2 of 2 shown

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  1. Source

    Official fact on this object, with its locator.

    • Draft guidelines on the classification of high-risk AI systems

      Locator: Draft guidelines on high-risk AI classification (19 May 2026), General principles chapter, section II, paragraph (7); section V, paragraph (448)

      praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines

      Open official source

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    Consequence

What this object states

Official fact

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  • The European Commission's draft guidelines on the classification of high-risk AI of 19 May 2026, which are expressly non-binding, state in paragraph (7) that an AI system is high-risk in two scenarios: first, 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 required to undergo third-party conformity assessment; and second, where it falls within one of the use cases in the areas listed in Annex III. Paragraph (448) of those same draft guidelines notes that the Article 113 application dates have been postponed by the AI Omnibus to 2 December 2027 for the Article 6(2) route and 2 August 2028 for the Article 6(1) route.

    • Locator: Draft guidelines on high-risk AI classification (19 May 2026), General principles chapter, section II, paragraph (7); section V, paragraph (448)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.

  • The two routes are not interchangeable. The Annex I route turns on product legislation and on whether a third party must assess conformity, not on whether the system assesses people. The Annex III route turns on intended purpose and use case. A system can in theory touch both routes, but you must work through them separately. The exemption mechanism also differs: under the draft guidelines the Article 6(3) filter applies only to the Annex III route and not to the Annex I route.

    • Locator: Draft guidelines on high-risk AI classification (19 May 2026), General principles chapter, section II, paragraph (7); section V, paragraph (448)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 each AI system, record in your register which route you assessed and with what outcome. Start with the Annex I question where hardware, machinery, medical devices or toys are involved, and with the Annex III question where the system touches people or access to services. Plan your programme against the earlier of the two dates that applies to you.

    • Locator: Draft guidelines on high-risk AI classification (19 May 2026), General principles chapter, section II, paragraph (7); section V, paragraph (448)praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelinesOpen official source

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Referring to this object

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Reference

Praxikon, "Article 6 has two separate routes to high-risk",
praxikon:eu:ai-act:guidance:guidance-high-risk-article-6-two-routes@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 5b469bba143ed5b34c1afab440aee9ca78c70f2d513b65ee8c21990ecb393de7,
https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-article-6-two-routes
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aguidance%3Aguidance-high-risk-article-6-two-routes&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-article-6-two-routes@1.0.0 (sha256 5b469bba)

BibTeX

@misc{praxikon-eu-ai-act-guidance-guidance-high-risk-article-6-two-routes-1-0-0,
  author       = {{Praxikon}},
  title        = {Article 6 has two separate routes to high-risk},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:guidance:guidance-high-risk-article-6-two-routes},
  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 5b469bba143ed5b34c1afab440aee9ca78c70f2d513b65ee8c21990ecb393de7},
  url          = {https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-article-6-two-routes},
  urldate      = {2026-08-25},
  language     = {en}
}

CSL JSON

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