EU AI Act
Article 25 — Responsibilities along the AI value chain
Article 25 settles who carries the provider obligations when a system passes through more than one pair of hands. A distributor, importer, deployer or other third party becomes the provider, and takes on Article 16 in full, if it puts its name on a high-risk system, substantially modifies one, or turns a system that was not high-risk into one that is.
§ 1 — Who it binds
The three acts that make you a provider
ProviderDeployerImporterDistributor
Any distributor, importer, deployer or other third party that puts its name or trademark on a high-risk system already on the market, substantially modifies one so that it remains high-risk, or modifies the intended purpose of a system — including a general-purpose AI system — so that it becomes high-risk. Article 25(3) separately makes the product manufacturer the provider for safety components of Section A Annex I products supplied under its name.
§ 2 — In practice
What you did, not what you call yourself
Nothing in Article 25(1) turns on what an organisation calls itself. The three triggers are acts: putting your name or trademark on a high-risk system already placed on the market or put into service; making a substantial modification to such a system so that it remains high-risk under Article 6; or modifying the intended purpose of a system — expressly including a general-purpose AI system — that had not been classified as high-risk, so that it becomes high-risk. The first is the one organisations walk into without noticing. White-labelling a licensed tool under your own brand is a commercial decision usually taken for marketing reasons, and it moves the whole of the provider obligations in Article 16 onto the party that took it.
Point (a) carries a clause read as an escape hatch: without prejudice to contractual arrangements stipulating that the obligations are otherwise allocated. What that preserves on its face is the allocation of obligations between the parties. What it does not do on its face is displace the opening words of the paragraph, under which the party shall be considered to be a provider of a high-risk AI system for the purposes of this Regulation — and recital 84 uses the same formula while adding that the provisions apply without prejudice to more specific rules in certain Union harmonisation legislation, giving Article 16(2) of the Medical Devices Regulation as its example. Until the point is tested, the prudent working position is that an indemnity allocates cost between two undertakings and does not decide who a market surveillance authority proceeds against.
The second trigger is where the money is, because substantial modification has a definition most people have not read. Article 3(23) defines it as a change after placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment carried out by the provider, and which affects compliance with Chapter III Section 2 or modifies the intended purpose the system was assessed for. Two things follow. The test is not how large the change is but whether the original provider anticipated it, which is why the pre-determined-changes statement in the instructions for use decides the answer. And retraining is not caught automatically: recital 128 puts changes to the algorithm and performance of systems that continue to learn outside the definition, provided those changes were pre-determined by the provider and assessed at the moment of the conformity assessment. Until the answer comes back, the party’s duties sit in Article 26.
The Digital Omnibus changed this article in two places, and the first is the more useful. Article 25(2) already obliged the initial provider to cooperate closely with new providers and supply information and technical access; it now specifies what that means where relevant — making available technical documentation sufficient to assess compliance with the requirements laid down in Article 16, informing the new providers about known limitations and failure modes, and providing targeted technical access including for testing and validation. The exit survives: the paragraph does not apply where the initial provider clearly specified that its system is not to be changed into a high-risk system, which makes that specification a commercially significant sentence to look for in a licence. Article 25(4) was widened so the written-agreement duty covers a third party supplying an AI model as well as a system, tools, services, components or processes.
Article 25(3) answers a question the value-chain framing tends to obscure. Where a high-risk system is a safety component of a product covered by the Section A Annex I legislation, the product manufacturer is the provider — if the system is placed on the market together with the product under the manufacturer’s name or trademark, or put into service under that name after the product was placed on the market. A supplier selling an AI component into a regulated product is therefore often not the provider of the high-risk system at all, whatever its own documentation assumes. That is the same reasoning as point (a), applied one level up the chain, and it is worth resolving before a supplier builds a programme against obligations it does not carry.
§ 3 — What a weak answer looks like
Answering a legal test with a job title
An organisation that answers a legal test with a job title. Asked whether it is a provider, it says it is a deployer, because that is what the policy register records and what the licence calls it. The article does not ask what you are called; it asks what you did — whose name is on the product, whether the change you made was foreseen in somebody else’s conformity assessment, whether the purpose you put a general-purpose system to was one it had ever been assessed for. The failure is almost never a decision to ignore the provision. It is that the three acts triggering it are performed by brand, data science and product teams for whom no part of the Regulation is a working document.
§ 4 — What discharges it
How a role determination is evidenced
The artefacts an assessor asks to see, and what makes each one sufficient rather than merely present.
01
A dated role determination per system and per release
The question is answered at a moment and the answer moves when the system does. The record names which of the three triggers was tested and what was concluded, dated against a release rather than against a contract signature.
02
The supplier’s statement of pre-determined changes
This is what decides whether a modification was substantial. A party that cannot produce that sentence from its supplier cannot answer the question at all, which makes obtaining it a procurement step rather than an incident-response one.
03
The branding decision, with its date and its approver
Putting a name on a product is a marketing act with a regulatory consequence. The evidence is that somebody who understood the consequence approved the packaging, the interface labelling and the customer-facing name.
04
The Article 25(4) written agreement with each supplier
Not a standard licence. It must specify the information, capabilities, technical access and other assistance needed for the downstream party to comply, based on the generally acknowledged state of the art.
05
Where a supplier disclaimed, the clause being relied on
The cooperation duty falls away where the initial provider clearly specified that its system is not to be changed into a high-risk one. Which side relies on that, and where it is written, is something both should answer identically.
§ 5 — Worked example
Worked example — the module that changed the answer
A large retailer licenses a workforce-scheduling system, high-risk under Annex III point 4, and runs it under the vendor’s brand. Its own data-science team has added a module that adjusts shift recommendations for store-level absence patterns, and the combined arrangement is what stores use. Procurement holds an indemnity covering regulatory non-compliance of the licensed software.
Is the retailer a deployer or a provider?
It turns on a question nobody in the transaction has asked: what the vendor’s conformity assessment foresaw. Point (a) is not engaged, because the retailer has not put its name on anything. Point (b) is live, and the definition asks whether the added module is a change the original assessment did not foresee that affects compliance with Chapter III Section 2 or alters the assessed intended purpose. A module changing how recommendations are produced is very likely to touch the declared accuracy and the oversight design, so unless the vendor’s statement of pre-determined changes anticipates extensions of this kind, the retailer has probably become the provider. If it has, it owes the entire provider list — quality management system, technical documentation, conformity assessment, declaration, marking, registration — for a system it did not build, and the indemnity does not change which party an authority proceeds against. The document that resolves this should have been read before the module was written.
§ 6 — Elsewhere
Where the role gets recorded internally
Where another instrument addresses the same obligation. These are correspondences, not comparisons — the Council does not rank one framework against another.
ISO/IEC 42001 Annex A carries controls addressing responsibilities across the AI system lifecycle and relationships with suppliers and customers. It is where a management system records which role an organisation occupies for a given system.
A correspondence indicates that two instruments address the same underlying obligation. It is not a mapping endorsed by either body, not a statement that one satisfies the other, and not a judgement about which is more demanding.
§ 7 — When it applies
When the reattribution starts to matter
2 December 2027
Annex III standalone high-risk systems. Moved from 2 August 2026 by the Digital Omnibus — a sixteen-month extension driven by undesignated national authorities and the absence of harmonised standards, not by any relaxation of the Section 2 requirements themselves.
2 August 2028
Annex I embedded high-risk systems — medical devices, machinery, vehicles — where AI Act requirements fold into the existing sectoral conformity assessment. Moved from 2 August 2027.
§ 8 — Exposure
Exposure — inherited, and since 2026 direct as well
€15 million or 3% of worldwide annual turnover, whichever is higher
Two distinct exposures. A party that has become a provider under Article 25(1) owes Article 16 and is reached through Article 99(4)(a) exactly as any other provider is. Separately, the Digital Omnibus inserted point (da) into Article 99(4), covering obligations of providers and operators pursuant to Article 25(2) and (4) — so an initial provider that withholds documentation and technical access from a new provider, and a party supplying into a high-risk system without the written agreement Article 25(4) requires, now carry direct exposure at the same ceiling. Article 99(6) gives an SME the lower of the two figures and Article 99(6a) extends that to small mid-cap companies.
§ 9 — provenance
The provision itself
This page sets out what the instrument requires and what discharges it. The official text is the authority — these go straight to it.
- Article 25, and recitals 84 to 90
- Regulation (EU) 2026/1744, replacing Article 113 third paragraph point (c) of Regulation (EU) 2024/1689
- Regulation (EU) 2026/1744, point (38)(b) inserting Article 99(4)(da) and point (38)(c) inserting Article 99(6a); Article 99(4)(a) for the inherited exposure
- Article 25(1) and (3); Article 3(23) for substantial modification; recital 128 for continued learning
- Regulation (EU) 2026/1744, point (12) replacing Article 25(2) and the first subparagraph of Article 25(4)
§ 10 — Also read
Also read
Article 13 — instructions for use
Certification
Assessed on the same standard of evidence
Every Council credential is examined on applied judgement against a published anchor, set out the way the obligations on this page are. The Certified Applied AI Associate, the Council’s flagship, is open to any adult today, its fee waived by a coupon code from the AI-Readiness Check, and the register lists what is open for enrolment.