Article 49 of Machinery Regulation 2023/1230: the Commission's power to amend Annex I by delegated act

Direct answer: Article 49 of Regulation (EU) 2023/1230 grants the European Commission the power to amend Annex I —the list of high-risk machinery categories requiring intervention by a notified body— by means of delegated acts, without needing to reopen the ordinary legislative procedure before Parliament and the Council. This means the 2023 list of high-risk machinery is not final: it can grow or change throughout the Regulation's lifetime as new technologies emerge or accident evidence accumulates. In this article we explain what criteria can trigger an expansion of Annex I, what limits this delegation of power has, and how a manufacturer should organise itself to keep track of these changes.

Why does the legislator delegate this power instead of fixing Annex I in a closed form?

Direct answer: a technical annex closed by ordinary law would become obsolete before the Regulation itself even reached full application. The EU's ordinary legislative procedure —Commission proposal, negotiation in Parliament and the Council, trilogues, publication— can take between two and four years. If every update to the high-risk machinery list had to follow that same complete process, Annex I could never react with the speed needed when new risk categories appear, as already happened with machinery fitted with safety-related artificial intelligence, included precisely because the 2023 legislator already anticipated that the technology would keep evolving after the text was adopted.

The delegated act is the legal instrument that Article 290 of the Treaty on the Functioning of the EU reserves precisely for this type of situation: non-essential elements of a legislative act that require agile technical updating, under the political control of Parliament and the Council, but without requiring the full legislative procedure. The list of high-risk machinery categories in Annex I is, in this sense, a technical element, whereas the essential health and safety requirements in Annex III —the substantive core of the Regulation— remain outside the scope of this delegation.

What criteria can justify adding a new category to Annex I?

Article 49 does not grant the Commission unlimited discretion: the amendment must be based on objectifiable technical evidence. The criteria that, in line with the spirit of the Regulation and its regulatory development practice, may justify an expansion are the following.

What controls do Parliament and the Council have over this delegation?

The delegated act is not a power without political control. Article 50 of the Regulation, which governs the exercise of the delegation, establishes a procedure with specific safeguards: the Commission must simultaneously notify the adopted delegated act to the European Parliament and the Council, and both institutions have a period —usually two months, extendable by a further two— to raise objections. If either institution objects within that period, the delegated act does not enter into force. In addition, both Parliament and the Council may revoke the delegation of power at any time, which would require the Commission to return to the ordinary legislative procedure for any future amendment of Annex I.

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How should a manufacturer monitor these changes in practice?

The most reliable way to anticipate this is not to wait for the delegated act to be published in the Official Journal, but to monitor the earlier stages of the process: the Commission publishes draft delegated acts for public consultation for a minimum period of four weeks before their formal adoption, through the European Commission's "Have Your Say" portal. A manufacturer with a product category close to the Annex I risk threshold —for example, machinery with advanced automation components that does not currently qualify as evolving-behaviour AI— should follow these consultations systematically, not just the final outcome.

Case study: the update a press brake manufacturer didn't see coming

A manufacturer of sheet metal press brakes with advanced numerical control in the province of Barcelona —which we will call, anonymised, Conforming Metal S.L.— marketed a model with a camera-based hand-detection system and an image classification algorithm with periodic retraining based on the false positives recorded at each client plant. At the time of its initial design, the technical team considered that the product fitted the standard press brake category in Annex I, without needing to apply the reinforced safety-AI regime, because the vision component was treated as a detection accessory rather than as the core of the safety function. When the Commission clarified, through technical guidance accompanying a revision of Annex I, that continuous retraining systems based on field data had to be treated as evolving-behaviour AI components regardless of whether they were presented as "accessories", Conforming Metal had to retroactively review its technical file for new units in production, thereby avoiding a subsequent inspection classifying the omission as a serious infringement. The lesson from the case is clear: it is not enough to classify the product once at the design stage — the classification must be reviewed every time Annex I is updated.

Frequently asked questions about Article 49

Can the Commission amend any part of the Regulation by delegated act?

No. Article 49 limits the delegation to amending Annex I, the list of high-risk machinery categories. The essential health and safety requirements in Annex III, the penalty regime in Article 50, or any other substantive element of the Regulation can only be amended through the ordinary legislative procedure, with full involvement of Parliament and the Council.

How long does it take for a delegated act to apply once published?

It depends on the specific act, but it is common for an adaptation period to be provided so economic operators can adjust their conformity assessment procedures, in line with the logic of the transitional provisions in Article 52 of the Regulation. In any case, the act cannot enter into force until the Parliament and Council control period expires (usually two months, extendable by a further two) without an objection being raised.

Are manufacturers consulted before Annex I is amended?

Yes, indirectly. Under the 2016 Interinstitutional Agreement on Better Law-Making, the Commission must consult experts designated by the Member States before adopting a delegated act, and it also submits the draft for public consultation for at least four weeks through the "Have Your Say" portal, where manufacturers, sector associations and standardisation bodies can submit comments.

What happens to already-certified machinery if its category is added to Annex I?

Units already lawfully placed on the market before the amendment enters into force can normally remain on the market without needing retroactive recertification, following the same logic as the transitional provisions in Article 52. However, any new unit placed on the market from the date of application of the delegated act must comply with the reinforced procedure, which in practice requires planning the production-line change well in advance.

Can the European Parliament block an amendment to Annex I on its own?

Yes. The Article 50 control procedure grants the European Parliament and the Council an independent right of veto: it is enough for just one of the two institutions to raise objections within the established period for the delegated act not to enter into force, without both institutions needing to agree to object.

Where can a manufacturer check whether a delegated act is being prepared?

The official sources are the European Commission's "Have Your Say" portal, where draft delegated acts are published for public consultation, and the Official Journal of the European Union, where already-adopted acts are published. It is also advisable to follow communications from the Commission's machinery expert group and from manufacturers' sector associations, which often anticipate these changes ahead of formal publication.

Sources: Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery (OJ L 165, 29.6.2023), Articles 49, 50 and 52; Article 290 of the Treaty on the Functioning of the European Union; Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making (2016). This article is for informational purposes only and does not constitute legal advice.