GuidanceGuidancev1.0.0

Two routes to safety component: intent or consequence

An AI system is a safety component via two alternative routes. Either it is intended to fulfil a safety function, or its failure or malfunctioning endangers health, safety or property.

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Address and citation

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Identifier: praxikon:eu:ai-act:guidance:guidance-high-risk-safety-function-versus-failure-route
Payload hash (sha256): cef01d5437965eec1281d90fe2a0d784862f3905a04f90adbae923fe5b48fc33

Citation line

Praxikon, "Two routes to safety component: intent or consequence", praxikon:eu:ai-act:guidance:guidance-high-risk-safety-function-versus-failure-route@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 cef01d5437965eec1281d90fe2a0d784862f3905a04f90adbae923fe5b48fc33

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.

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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 (34) to (44), including table 1
  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 (34) to (44), including table 1
  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 are a draft document without binding force and read Article 3(14) as two alternative scenarios. In the first scenario the AI system fulfils a safety function, meaning that its intended purpose, as determined by the provider, is to prevent or mitigate risks to the health and safety of persons or property. The draft guidelines note that the mere fact that an AI system is integrated into or operates within a product subject to safety regulation does not in itself mean it fulfils a safety function. In the second scenario the system is a safety component because its failure or malfunctioning could endanger the health and safety of persons or property. The draft guidelines summarise this in a table: the safety function is intent-based and strongly provider-controlled, evidenced by instructions of use, technical documentation and promotional materials, while the failure route is consequence-based and risk-based with lower provider control, evidenced by system architecture, failure modes and effects.
- Locator: Draft guidelines Annex I, points (34) to (44), including table 1praxikon: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.

You can steer the first route, not the second. That is the whole point. A provider determines the intended purpose and can therefore choose not to claim a safety function in the documentation. The draft guidelines close that exit with the failure route, which looks at what happens when things go wrong, regardless of what you wrote down. The guidelines list forms of failure including incorrect outputs such as false positives and false negatives, loss of function or availability, performance instability or drift, timing or latency errors, and misclassification leading to hazardous control decisions. Note the lower bound as well: the likelihood of failure must not be a merely theoretical possibility, and reputational harm, purely financial loss, minor service degradation or inconvenience without a safety hazard do not count.
- Locator: Draft guidelines Annex I, points (34) to (44), including table 1praxikon: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.

Document the two routes separately. For the safety function, record what you communicate as intended purpose in the instructions of use, technical documentation and sales materials, and keep those three consistent. For the failure route, produce a failure mode analysis noting for each failure form whether there is a path to injury or damage to property. That analysis is also your evidence towards a market surveillance authority.
- Locator: Draft guidelines Annex I, points (34) to (44), including table 1praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelinesOpen official source

When this applies

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When this does not apply

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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 routes to safety component: intent or consequence",
praxikon:eu:ai-act:guidance:guidance-high-risk-safety-function-versus-failure-route@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 cef01d5437965eec1281d90fe2a0d784862f3905a04f90adbae923fe5b48fc33,
https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-safety-function-versus-failure-route
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aguidance%3Aguidance-high-risk-safety-function-versus-failure-route&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-safety-function-versus-failure-route@1.0.0 (sha256 cef01d54)

BibTeX

@misc{praxikon-eu-ai-act-guidance-guidance-high-risk-safety-function-versus-failure-route-1-0-0,
  author       = {{Praxikon}},
  title        = {Two routes to safety component: intent or consequence},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:guidance:guidance-high-risk-safety-function-versus-failure-route},
  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 cef01d5437965eec1281d90fe2a0d784862f3905a04f90adbae923fe5b48fc33},
  url          = {https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-safety-function-versus-failure-route},
  urldate      = {2026-08-25},
  language     = {en}
}

CSL JSON

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