ChangeUpcomingv1.0.0

High-risk AI embedded in regulated products

AI as a safety component of products under Annex I follows on 2 August 2028.

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:change:2028-08-02-annex-i-high-risk-applicable
Payload hash (sha256): 139fd5e6f94a689f8d05a09f4653fbe7cab49b5d6ca99447ab28a3373a68e89a

Citation line

Praxikon, "High-risk AI embedded in regulated products", praxikon:eu:ai-act:change:2028-08-02-annex-i-high-risk-applicable@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 139fd5e6f94a689f8d05a09f4653fbe7cab49b5d6ca99447ab28a3373a68e89a

Version: 1.0.0
Legal time (effective_at): 27 July 2026
Knowledge time (known_at): 8 August 2026
Closed on: Not closed
Application date: 2 August 2028
Topics: high-risk, timeline

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

2 of 2 shown

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

Source
Official fact on this object, with its locator.
- Digital Omnibus on AI 2026/1744
  Locator: Regulation (EU) 2026/1744, amended application dates under Article 113
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- ObligationAnnex III: high-risk AI
  praxikon:eu:ai-act:obligation:annex-iii-high-risk
- ObligationArticles 43-49: conformity assessment, CE and registration
  praxikon:eu:ai-act:obligation:conformity-ce-registration

What this object is about

1 of 1 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.
- Digital Omnibus on AI 2026/1744
  Locator: Regulation (EU) 2026/1744, amended application dates under Article 113
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- 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.

For AI systems under Article 6(1) and Annex I, that is AI as a safety component of products already covered by EU product legislation, the high-risk requirements apply from 2 August 2028.
- Locator: Regulation (EU) 2026/1744, amended application dates under Article 113praxikon:eu:ai-act:source:reg-eu-2026-1744Open 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, "High-risk AI embedded in regulated products",
praxikon:eu:ai-act:change:2028-08-02-annex-i-high-risk-applicable@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0),
effective_at 2026-07-27T00:00:00.000Z, known_at 2026-08-08T00:00:00.000Z,
sha256 139fd5e6f94a689f8d05a09f4653fbe7cab49b5d6ca99447ab28a3373a68e89a,
https://www.praxikon.com/en/verkenner/change/2028-08-02-annex-i-high-risk-applicable
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Achange%3A2028-08-02-annex-i-high-risk-applicable&effective_at=2026-07-27&known_at=2026-08-08&lang=en, accessed 2026-08-23)

Short form

praxikon:eu:ai-act:change:2028-08-02-annex-i-high-risk-applicable@1.0.0 (sha256 139fd5e6)

BibTeX

@misc{praxikon-eu-ai-act-change-2028-08-02-annex-i-high-risk-applicable-1-0-0,
  author       = {{Praxikon}},
  title        = {High-risk AI embedded in regulated products},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:change:2028-08-02-annex-i-high-risk-applicable},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.1.0, schema 1.4.0},
  note         = {effective_at 2026-07-27T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 139fd5e6f94a689f8d05a09f4653fbe7cab49b5d6ca99447ab28a3373a68e89a},
  url          = {https://www.praxikon.com/en/verkenner/change/2028-08-02-annex-i-high-risk-applicable},
  urldate      = {2026-08-23},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:change:2028-08-02-annex-i-high-risk-applicable@1.0.0",
    "type": "dataset",
    "title": "High-risk AI embedded in regulated products",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:change:2028-08-02-annex-i-high-risk-applicable",
    "URL": "https://www.praxikon.com/en/verkenner/change/2028-08-02-annex-i-high-risk-applicable",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          8
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          8,
          23
        ]
      ]
    },
    "note": "dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0; schema 1.4.0; effective_at 2026-07-27T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 139fd5e6f94a689f8d05a09f4653fbe7cab49b5d6ca99447ab28a3373a68e89a; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Achange%3A2028-08-02-annex-i-high-risk-applicable&effective_at=2026-07-27&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

How to verify a reference later is set out in the methodology. Terms

For agents and integrations

This page and the machine output come from the same object and the same two time axes.

Open as JSON Open as JSON-LD Read the methodology