Summary: Since 27 July 2026, the “Digital Omnibus on AI” (Regulation (EU) 2026/1744) has been in force. It moves the Machinery Regulation (Regulation (EU) 2023/1230) in Annex I of the AI Act from Section A to Section B — that concerns the AI Act’s own annex, not Annex I of the Machinery Regulation itself. The AI-specific safety requirements for machinery instead migrate into Annex III of the Machinery Regulation via a delegated act, due by 2 August 2028 at the latest. The Machinery Regulation’s regular date of application — 20 January 2027 — is untouched by any of this. If you’ve been mixing up both regulations and the Omnibus, you’re not alone.
Why three deadlines are circulating right now
Search “Machinery Regulation AI Act deadline” in the summer of 2026 and you’ll find at least three dates that all sound plausible: 2 August 2027, 2 December 2027, 2 August 2028. Add a fourth fixed point that actually matters most to machine builders: 20 January 2027. The confusion has a concrete trigger: the Digital Omnibus on AI, which entered into force on 27 July 2026 and changed the AI Act’s original treatment of machinery. This article sorts the deadlines by legal basis, EUR-Lex evidence, and who is actually affected — so it’s clear which date matters for which question.
The Machinery Regulation: what applies when
The Machinery Regulation (EU) 2023/1230 entered into force on 19 July 2023, but did not become fully applicable at that point. Individual articles applied earlier; the regulatory core follows only in 2027:
| Date | What applies from this date |
|---|---|
| 19 July 2023 | Entry into force; individual articles apply immediately (incl. Art. 6(7), 48, 52) |
| 20 January 2024 | Art. 26–42 — provisions on notified bodies |
| 20 July 2024 | Art. 6(2)–(6), (8), (11), 47, 53(3) |
| 20 January 2027 | The regulation’s regulatory core — the date that matters for most manufacturers |
Until 19 January 2027, the old Machinery Directive 2006/42/EC continues to apply in parallel — a transitional regime with no regulatory gap, not a “countdown to nothing.” This structure is confirmed consistently by the EUR-Lex summary and several independent technical sources (including Pilz, TÜV Rheinland).
Annex I of the Machinery Regulation distinguishes two classes: Part A requires mandatory conformity assessment by a notified body (third-party assessment is compulsory); Part B is also classified as high-risk but permits self-certification provided the relevant harmonised standards are met. Two entries in Part A are relevant to AI: Item 5 — safety components with fully or partially self-evolving behaviour using machine-learning approaches that ensure safety functions — and Item 6 — machinery incorporating such embedded systems, in relation to those systems specifically. Recital 54 of the Machinery Regulation justifies their inclusion explicitly with “data dependency, opacity, autonomy and connectivity” of such systems. The Digital Omnibus has changed nothing about these two items — more on that below.
The AI Act: the staggered start of application
The AI Act (EU) 2024/1689 does not enter into force fully on a single date, but in four waves (Art. 113, original version):
| Date | What takes effect |
|---|---|
| 2 February 2025 | Chapters I+II — including prohibited practices |
| 2 August 2025 | Chapter III Section 4, V, VII, XII + Art. 78 — notified bodies, governance |
| 2 August 2026 | General start of application (catch-all rule) |
| 2 August 2027 | Art. 6(1) — obligations for AI as a safety component in products under Annex I, originally including the Machinery Regulation |
That last line is exactly where the Digital Omnibus intervenes.
What the Digital Omnibus actually changed on 27 July 2026
Two clarifications that get lost in most short summaries:
1. Two dates, two events. The political trilogue agreement on the machinery-specific carve-out landed on 7 May 2026 — which is why “May 2026” circulates as the reference date. The formal legal act, Regulation (EU) 2026/1744, was published in the Official Journal only on 24 July 2026 and entered into force on 27 July 2026. For the question “is this already in effect,” 27 July 2026 is what counts, not the May date.
2. Which Annex I is meant. This is the point that causes the most confusion: the widely cited shift “from Part A to Part B” does not concern Annex I of the Machinery Regulation (there, Items 5 and 6 remain unchanged in Part A, still subject to mandatory third-party assessment). It concerns Annex I of the AI Act — the list of harmonisation legislation whose scope overlaps with the AI Act, divided into Section A (full AI Act obligation cascade) and Section B (reduced set of obligations). The Machinery Regulation, as a legal act, was moved there from Section A to Section B. Recital 42 of Regulation (EU) 2026/1744 puts it this way: “it is appropriate to move to a sectoral approach by moving Regulation (EU) 2023/1230 from Section A to Section B of Annex I to Regulation (EU) 2024/1689.”
Practical consequence: the full horizontal obligation cascade from Chapter III of the AI Act no longer applies automatically to machinery AI via the Annex I mechanism. Instead, the AI-specific health and safety requirements migrate into a sector-specific place — the Machinery Regulation’s own Annex III — via a delegated act which, per Recital 42, is meant to be applicable “by 2 August 2028.” That is the origin of the fourth circulating date, 2 August 2028.
A side finding that does not concern the Machinery Regulation itself but often turns up in the same search results: the same Omnibus also shifts the general high-risk deadline for standalone Annex III AI systems under Art. 6(2) of the AI Act from 2 August 2026 to 2 December 2027 (Recital 40). This is a separate mechanism — it concerns standalone high-risk AI systems, not AI as an embedded safety component of machinery under the Annex I route. Conflating the two dates is the most common mistake currently seen in forums and LinkedIn comments.
What this means in practice for Annex III of the Machinery Regulation
Annex III of the Machinery Regulation — the essential health and safety requirements for design and construction — has already been expanded relative to the old Directive to cover AI, cybersecurity, human-robot collaboration, IoT connectivity, effects of software updates, and functional safety. The delegated act from the Digital Omnibus package will supplement this annex further with AI-specific requirements by 2 August 2028. The draft of that delegated act had not been published as of this article’s writing — once it is, that’s the next trigger for a content update to this piece.
Practical example: where this distinction actually bites
From twelve years of customer support and complaint handling at an injection-moulding-machine OEM, a familiar pattern: as soon as an image-based inspection system — say, a camera that detects part defects and stops the process on an anomaly — stops working with fixed programmed thresholds and instead runs a trained model, the question arises immediately: is this a “safety component with self-evolving behaviour” within the meaning of Annex I Item 5? The answer hinges on whether the system actually ensures a safety function (e.g. triggering an emergency stop) or “merely” makes a quality decision that is not a safety function. This distinction had to be made before the Digital Omnibus too — and it still does, because nothing changed for Items 5/6. What the Omnibus changes is which additional AI Act obligations apply alongside the Machinery Regulation — and the answer, as of 27 July 2026, is: markedly fewer than originally planned, but potentially more within the Machinery Regulation itself down the line.
Checklist: five steps to work out where your machine stands
- Does the affected system fall under Annex I Item 5 or 6 of the Machinery Regulation? Check whether a safety component with ML-based, (partially) self-evolving behaviour ensures a safety function — not whether AI appears somewhere in the product.
- Is placing on the market planned before or after 20 January 2027? Before that date, the old Machinery Directive 2006/42/EC still applies; after it, the Machinery Regulation.
- Check whether your product/category is still listed in Section A or in Section B of Annex I of the AI Act — for the Machinery Regulation this has been Section B since 27 July 2026, with a correspondingly reduced horizontal AI Act obligation cascade.
- Watch the delegated act on Annex III of the Machinery Regulation. This is where AI-specific requirements will become concrete — target application date 2 August 2028, draft still pending.
- Document the review date. In a legal framework this much in motion, a date stamp in the technical documentation (“reviewed as of DD.MM.YYYY”) is worth more than a one-off assessment with no timestamp.
Ongoing design projects spanning the cutoff date
A project that begins today under the old Machinery Directive but is only placed on the market after 20 January 2027 falls under the new Machinery Regulation from that point on — no longer under the Directive under which the design work started. For projects with AI components, the classification under Annex I Item 5/6 described above comes on top of that. Anyone who checks this too late risks a declaration of conformity that rests on the wrong legal basis by the time of delivery.
FAQ
Does the AI Act now apply to machinery too? Yes, but no longer via the full horizontal obligation cascade from Annex I Section A — since 27 July 2026 the Machinery Regulation is classified there under Section B, with a sector-specific approach via Annex III of the Machinery Regulation itself.
Which deadline applies now: 2 August 2027, 2 December 2027, or 2 August 2028? For machinery with AI safety components, the 2 August 2027 deadline has been superseded by the sector-specific approach; the relevant date is the 2 August 2028 target for the delegated act on Annex III of the Machinery Regulation. 2 December 2027 concerns standalone high-risk AI systems (Art. 6(2) of the AI Act), not the machinery-specific route.
Does the Digital Omnibus change anything in Annex I of the Machinery Regulation itself? No. Items 5 and 6 in Part A remain unchanged, including the requirement for third-party assessment by a notified body. What was moved is Annex I of the AI Act, not of the Machinery Regulation.
What applies to a project that’s running now and will only be finished in 2027? What matters is the point of placing on the market, not the start of design. After 20 January 2027, the Machinery Regulation applies.
Are there already harmonised standards to rely on? For the Machinery Regulation, standardisation request C(2025) 129 to CEN/CENELEC is underway, with a phase-1 milestone of 20 January 2026. For the AI Act standards (JTC 21), no standard had been published in the Official Journal as of this article’s writing — so there is not yet a presumption of conformity under Art. 40 of the AI Act.
For your specific case
This overview does not replace legal advice or a binding classification for an individual case. Whether a specific system falls under Annex I Item 5/6 and which conformity assessment follows from that should be discussed with your notified body or legal department.
Sources
- Regulation (EU) 2023/1230 – Machinery Regulation, EUR-Lex Summary
- Regulation (EU) 2024/1689 – AI Act, Art. 113 (activeMind.legal)
- Regulation (EU) 2024/1689 – AI Act, Art. 113 (artificialintelligenceact.eu)
- Regulation (EU) 2026/1744 – Digital Omnibus on AI, Official Journal full text
- Gibson Dunn: EU AI Act Omnibus Agreement – Postponed High-Risk Deadlines
- Pilz: Machinery Regulation – Overview
- TÜV: New Machinery Regulation EU 2023/1230
- Baker McKenzie: Machinery Regulation – Product Risk Radar
- CEN-CENELEC: Artificial Intelligence – Areas of Work
- KLA Digital: JTC 21 Standards Tracker
More background: About me – 20 years in precision manufacturing, Meister, now software engineer.