GuidanceGuidancev1.0.0

Annex I lists legislation, not products

Annex I contains no list of high-risk products but an exhaustive list of harmonisation legislation. The AI Act does not extend the scope of that product legislation and does not change a product's risk profile.

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-lists-legislation-not-products
Payload hash (sha256): 3fd1da47cb4c99a33d5e7595a433bec0d9a5c1686b866fc247c7b1bb499b6864

Citation line

Praxikon, "Annex I lists legislation, not products", praxikon:eu:ai-act:guidance:guidance-high-risk-annex-i-lists-legislation-not-products@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 3fd1da47cb4c99a33d5e7595a433bec0d9a5c1686b866fc247c7b1bb499b6864

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 (23) to (26)
  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 (23) to (26)
  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 draft guidelines of 19 May 2026, published for consultation and expressly non-binding, clarify that Annex I AI Act does not list individual products to be classified as high-risk, but Union harmonisation legislation regulating the safety aspects of certain products. Whether an AI system falls within the scope of Annex I therefore depends on whether the system, or the product of which it is a safety component, falls within the material scope of one of the listed legislative acts. According to the draft guidelines the list in Annex I is exhaustive; products can only be added or removed by amending the scope of the harmonisation legislation itself or by adding new harmonisation legislation to Annex I. The draft guidelines also state that through Article 6(1) the AI Act does not itself extend the scope of harmonisation legislation to new or additional products, and that the AI Act does not determine or change the risk profile of a product but builds on the sectoral risk classification. Products mentioned include machinery, toys, lifts, equipment and protective systems for potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft, cableway installations, appliances burning gaseous fuels, medical devices, in vitro diagnostic medical devices, and products in the automotive and aviation sectors.
- Locator: Draft guidelines Annex I, points (23) to (26)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.

Your starting point is therefore not the AI Act but your existing product file. The question is not whether your product appears on an AI list, because no such list exists. The question is whether your product already fell under one of the listed regulations or directives before AI was added to it. If not, this route does not bring you into the high-risk regime, however advanced the AI system is. The draft guidelines do note that for this classification the concept of safety component may be read as excluding public interests in the sectoral legislation that go beyond health, safety and fundamental rights, such as risks relating to radio spectrum use or electromagnetic compatibility. Those interests therefore do not contribute to the qualification.
- Locator: Draft guidelines Annex I, points (23) to (26)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.

Start your classification with an inventory of the product legislation that already applies to your portfolio today, and record per product line which regulation or directive covers you. That overview is reusable and prevents you from redoing the entire analysis for each AI feature.
- Locator: Draft guidelines Annex I, points (23) to (26)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, "Annex I lists legislation, not products",
praxikon:eu:ai-act:guidance:guidance-high-risk-annex-i-lists-legislation-not-products@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 3fd1da47cb4c99a33d5e7595a433bec0d9a5c1686b866fc247c7b1bb499b6864,
https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-annex-i-lists-legislation-not-products
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aguidance%3Aguidance-high-risk-annex-i-lists-legislation-not-products&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-lists-legislation-not-products@1.0.0 (sha256 3fd1da47)

BibTeX

@misc{praxikon-eu-ai-act-guidance-guidance-high-risk-annex-i-lists-legislation-not-products-1-0-0,
  author       = {{Praxikon}},
  title        = {Annex I lists legislation, not products},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:guidance:guidance-high-risk-annex-i-lists-legislation-not-products},
  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 3fd1da47cb4c99a33d5e7595a433bec0d9a5c1686b866fc247c7b1bb499b6864},
  url          = {https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-annex-i-lists-legislation-not-products},
  urldate      = {2026-08-25},
  language     = {en}
}

CSL JSON

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    "URL": "https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-annex-i-lists-legislation-not-products",
    "language": "en",
    "issued": {
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    "accessed": {
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    "note": "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 3fd1da47cb4c99a33d5e7595a433bec0d9a5c1686b866fc247c7b1bb499b6864; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aguidance%3Aguidance-high-risk-annex-i-lists-legislation-not-products&effective_at=2026-08-08&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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