Chapter III · High-risk AI systems
Article 46 — Derogation from conformity assessment procedure
Official text
Each paragraph records where its wording comes from. Only text reproduced unchanged from the Official Journal is authentic; consolidated text is editorial and has no legal value. Paragraphs, subparagraphs and points each have their own link.
By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the Member State concerned, for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That authorisation shall be for a limited period while the necessary conformity assessment procedures are being carried out, taking into account the exceptional reasons justifying the derogation. The completion of those procedures shall be undertaken without undue delay.
Authentic — as published in the Official Journal
In a duly justified situation of urgency for exceptional reasons of public security or in the case of specific, substantial and imminent threat to the life or physical safety of natural persons, law-enforcement authorities or civil protection authorities may put a specific high-risk AI system into service without the authorisation referred to in paragraph 1, provided that such authorisation is requested during or after the use without undue delay. If the authorisation referred to in paragraph 1 is refused, the use of the high-risk AI system shall be stopped with immediate effect and all the results and outputs of such use shall be immediately discarded.
Authentic — as published in the Official Journal
The authorisation referred to in paragraph 1 shall be issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The market surveillance authority shall inform the Commission and the other Member States of any authorisation issued pursuant to paragraphs 1 and 2. This obligation shall not cover sensitive operational data in relation to the activities of law-enforcement authorities.
Authentic — as published in the Official Journal
Where, within 15 calendar days of receipt of the information referred to in paragraph 3, no objection has been raised by either a Member State or the Commission in respect of an authorisation issued by a market surveillance authority of a Member State in accordance with paragraph 1, that authorisation shall be deemed justified.
Authentic — as published in the Official Journal
Where, within 15 calendar days of receipt of the notification referred to in paragraph 3, objections are raised by a Member State against an authorisation issued by a market surveillance authority of another Member State, or where the Commission considers the authorisation to be contrary to Union law, or the conclusion of the Member States regarding the compliance of the system as referred to in paragraph 3 to be unfounded, the Commission shall, without delay, enter into consultations with the relevant Member State. The operators concerned shall be consulted and have the possibility to present their views. Having regard thereto, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant operators.
Authentic — as published in the Official Journal
Where the Commission considers the authorisation unjustified, it shall be withdrawn by the market surveillance authority of the Member State concerned.
Authentic — as published in the Official Journal
For high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply.
Authentic — as published in the Official Journal
The formal analysis of Article 46
Article 6 is formalised first. The remaining articles follow.
Article 46 is formalised node by node: each rule as a deontic position with its operator, each exception with its rank, each predicate resolved against the definitions in Article 3.
What members get, per article
- the rule logic: every norm as a formal position, with the defeater chain that decides which exception wins
- the competency questions and their answers, every unanswered one marked as a gap and named
- the ontology: predicates bound to AISV (AI Standardisation Vocabulary) and to the definitions they depend on, exportable as JSON-LD and OWL
- the documentation: the Article 6(4) assessment record generated from a fact set, with its derivation and the version of the law it was decided against
Built for providers claiming the 6(3) derogation, for the counsel who has to defend that claim, and for the auditor who reads it afterwards.
Access is invite-only and opening in stages. Article 6 is formalised first; the remaining articles follow.
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Commentary in preparation
The official text above is complete. The editorial layer for this article — duties, the roles bound by them, the AISV concepts that model them, and the European standards written to support them — is in preparation, in the same form as the articles already published.
See the published articles