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THE EVIDENCE GAP · EU MACHINERY REGULATION 2023/1230

For 18 months, AI-driven machinery needs robustness evidence that no standard yet defines.

Regulation (EU) 2023/1230 applies from 20 January 2027, and cybersecurity of a machine’s safety functions becomes mandatory with it. The delegated acts that carry the AI robustness requirements into its Annex III apply by 2 August 2028. Between those two dates an AI policy driving a safety function is in scope and un-specified: the obligation exists, and the AI-specific harmonised standard you would normally test against does not.

That interval is the subject of this page. It is not a countdown to a cliff — it is a window in which the only thing you can bring to a notified body is your own measured evidence, produced against a protocol you chose and can defend.

GAP OPENS · REGULATION APPLIES
20 January 2027
Directly binding in all 27 EU member states
UNTIL IT OPENS — THEN THE GAP RUNS
Annex III delegated acts apply
How the gap opened

Four moves, each dated, each in the Official Journal.

None of this is a forecast. Every step below is a published instrument with a citation, and each is recorded with its primary source and a verification note on the regulatory clock.

  1. — the Regulation applies. Regulation (EU) 2023/1230 replaces Directive 2006/42/EC and binds all 27 member states with no national transposition. Safety components with fully or partially self-evolving machine-learning behaviour are high-risk machinery under Annex I; Annex III requires safety-related control systems to resist deliberate manipulation.
  2. — the AI Act amendment lands. Regulation (EU) 2026/1744 is published in the Official Journal and enters into force on . It moves Regulation (EU) 2023/1230 from Annex I Section A to Section B of the AI Act, so most AI Act high-risk provisions stop applying directly to machinery.
  3. The requirements are redirected, not removed. The same amendment requires the Commission to adopt delegated acts amending Annex III of Regulation (EU) 2023/1230 to carry the AI robustness requirements across. Those apply by .
  4. Article 20(10) bridges the interval — it does not close it. Until harmonised standards or common specifications are referenced under the Machinery Regulation itself, a high-risk AI system that complies with those referenced or adopted under Articles 40 and 41 of Regulation (EU) 2024/1689 is presumed in conformity with the Annex III essential health and safety requirements as regards high-risk AI systems.

“Until harmonised standards or common specifications are referenced or adopted pursuant to this Article as regards high-risk AI systems, high-risk AI systems within the scope of this Regulation which comply with the relevant harmonised standards referenced, or common specifications adopted pursuant to Articles 40 and, respectively, 41 of Regulation (EU) 2024/1689 shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III to this Regulation as regards high-risk AI systems.”

Read that closely and the gap is in the wording. The bridge is conditional on standards existing under the AI Act for the thing you are building. Where one does — and for adversarial robustness of an embodied policy, today, it does not — you inherit a presumption of conformity. Where it does not, the obligation still applies and you are producing the evidence yourself.

The adjacent gap

If you build a humanoid, the standard for your machine is not written either.

Robotics: safety requirements for dynamically stable industrial mobile robots (legged, wheeled, or other forms of locomotion) — Part 1: Robots is the first Type‑C standard aimed at robots that stay upright by continuously controlling balance — the balance-and-fall hazards a legged machine has and a statically stable one does not. It is at Committee Draft. CD registered 8 May 2026; CD consultation opened 12 May 2026. No fixed publication date.

So a humanoid builder placing a machine on the EU market has ISO 10218-1 and -2:2025, and nothing else that speaks to dynamic stability. The two gaps are independent and they overlap: no AI-specific harmonised requirement under the Machinery Regulation until 2 August 2028, and no published Type‑C standard for the machine category at all.

What (EU) 2023/1230 requires

Four things change for AI-driven machinery.

01

AI is a regulated safety function

Safety functions driven by AI, or by fully or partially self-evolving (machine-learning) behaviour, are high-risk machinery under Annex I, Part A. Point 5 names them verbatim: “Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions” (CELEX 32023R1230). Point 6 is the embedded case — machinery placed on the market with that ML safety system inside it, which is what an integrator ships. The safety of what the policy decides is now a regulated property, not an afterthought.

02

Cybersecurity of safety functions is mandatory

Annex III (§1.1.9 protection against corruption, §1.2.1 safety and reliability of control systems) requires safety-related control systems and software to resist both accidental failure and deliberate manipulation. Unintended or malicious modification of safety software must be prevented.

03

Security is a lifecycle duty

Cybersecurity measures and updates must be maintained across the machine’s working life, interventions in safety software logged, and the technical documentation kept for at least 10 years after the machine is placed on the market.

04

High-risk machinery meets a notified body

Annex I Part A high-risk categories — points 5 and 6 for the machine-learning cases — take a third-party conformity-assessment route under Article 25(2) via Article 6(1): a notified body reviews the technical documentation, including the evidence that safety functions resist manipulation. Part B point 19 is the Article 25(3) sibling and is not interchangeable with either point.

Demand → evidence

What the regulation demands, and what Provael emits

Provael does not make you compliant - a conformity assessment is the manufacturer’s and the notified body’s job. It produces the technical, machine-readable robustness evidence that assessment needs, on the AI layer specifically -the layer the other safety stacks do not reach.

Mapping of Machinery Regulation demands to the evidence artifacts Provael emits.
What the regulation demandsThe evidence Provael emits
Robustness evidence for the AI safety functionA measured attack-success rate with a 95% Wilson confidence interval and a benign false-positive control - declared, defensible numbers on your own policy.
Attack-resistance testing17 adversarial attack families, each mapped to an Embodied AI Security Top 10 risk.
Machine-readable findingsSARIF findings that drop straight into GitHub code scanning, plus an Ed25519-signed attestation - a verifiable signature over the evidence bundle.
Conformity documentationA compliance crosswalk (JSON + Markdown) mapping a run to EU AI Act Art. 9 / 15 / 72, ISO 10218:2025, NIST AI RMF and IEC 62443.
Vulnerability handlingA published SECURITY.md with a 90-day coordinated-disclosure policy, and a CycloneDX ML-BOM generated by the tool.
Who this binds

Manufacturers and integrators placing AI-driven machinery on the EU market

Regulation (EU) 2023/1230 binds the manufacturer that places AI-driven machinery - or a safety component with self-evolving behaviour - on the EU market, and the integrator who assembles a machine and places it under their own name.

The honest nuance: if you build the VLA policy or the safety component, but another party places the finished machine on the market, the conformity obligation sits with that manufacturer or integrator - not automatically with you. They will still ask you for the evidence that your component’s safety function resists manipulation. Whether you are the OEM or the component maker, that robustness evidence has to exist before the machine is placed on the market.

Run a Machinery-Reg readiness scan.

Free, public checkpoints only. Send us the open model closest to your stack and we will red-team it in simulation and send back the scorecard and SARIF - a concrete first look at the evidence you will need, no IP touched.