Article 6 of the Machinery Regulation 2023/1230: how it's decided which machines go into Annex I Part A or Part B
Direct answer: Article 6 of Regulation (EU) 2023/1230 establishes that machinery and related products listed in Annex I, Part A, must undergo the strictest conformity assessment procedures — those in Article 25(2), which require the involvement of a notified body — while those listed in Annex I, Part B, may use the more flexible procedures in Article 25(3). The European Commission decides which Part a machinery category is placed in through delegated acts, applying objective criteria on the probability and severity of harm that this article sets out precisely.
Annex I of Regulation 2023/1230 — which we analyse in detail in a dedicated article of this series — sets out the list of high-risk machinery categories. Article 6 is the rule that explains the procedure and criteria by which a machinery category enters, leaves or changes Part within that Annex. Understanding this mechanism is essential for any manufacturer who wants to anticipate whether their product will be subject to assessment by a notified body, with the higher cost and timeline that entails.
What is the difference between Annex I Part A and Part B?
Annex I, Part A vs. Part B: Part A groups together machinery categories with a serious inherent risk for which, in addition, some aggravating circumstance is present (lack of harmonised standards, recurring residual risks, repeated incorrect application of standards, or methodological uncertainty). Part B groups categories with a serious inherent risk but without those additional aggravating circumstances.
The practical consequence of this distinction is the applicable conformity assessment procedure. Article 6(1) expressly refers to the procedures in Article 25(2) for Part A — which, under Annex VII and the following Annexes of the Regulation, typically require the involvement of a notified body through EU-type examination or full quality assurance — and to those in Article 25(3) for Part B, which in many cases allow internal production control under the manufacturer's sole responsibility, without third-party involvement.
What criteria does the Commission use to assess the risk of a machinery category?
Article 6(4) establishes that the assessment is based on the combination of two factors: the probability of harm occurring and the severity of that harm. To determine both factors, the Commission must take into account, where relevant, the following elements:
- The nature of the hazard inherent to the function of the machinery category, taking into account the intended use and any reasonably foreseeable misuse.
- The severity of the harm a person could suffer, including the degree of reversibility of that harm.
- The number of people potentially affected by the harm.
- The frequency and duration of exposure to the hazard during intended use or reasonably foreseeable misuse.
- The possibilities of avoiding or limiting the harm.
- In the case of safety components, the probability of serious consequences for the safety of exposed persons in the event of the component's failure.
In addition to these criteria, Article 6(5) requires the Commission to consider concrete empirical evidence: indications of harm caused in the past, safety defects detected during market surveillance, information on known accidents and serious "near misses", and data on accidents or damage to health from at least the previous four years, obtained from sources such as the ICSMS system, the Safety Gate rapid alert system, the European Injury Database (EU-IDB), Eurostat's European Statistics on Accidents at Work (ESAW), and the Machinery Administrative Cooperation Group (AdCo).
When is a category included in Part A and when in Part B?
Article 6(7) sets the cut-off rule precisely: a category is included in Part A if, according to the assessment under paragraph 4, it presents a serious potential inherent risk and, in addition, one or more of these four conditions is met:
| Aggravating condition (Art. 6(7)) | Description |
|---|---|
| a) Lack of harmonised standards | There are no harmonised standards or common specifications covering the applicable essential health and safety requirements |
| b) Recurring residual risks | Residual risks exist — even ones that can be mitigated with training or PPE — and the data show recurrence of serious or fatal accidents |
| c) Repeated incorrect application of standards | There is data showing recurring incorrect application of harmonised standards, without market surveillance having succeeded in improving the situation |
| d) Methodological uncertainty | There is a degree of uncertainty in the risk assessment methods applicable to new categories or technologies |
Any other category presenting a serious potential inherent risk, but which does not meet any of these four aggravating conditions, is included in Part B. In other words: serious risk is a necessary condition for being in Annex I, but only the presence of one of these four additional circumstances determines whether the category is subject to the reinforced regime of Part A.
Assuming that every high-risk machine is automatically in Part A. That is not the case: point (d) of Art. 6(7) introduces a relevant nuance for machines with embedded artificial intelligence or self-evolving behaviour, since methodological uncertainty about how to assess their risks can, on its own, justify inclusion in Part A, even where harmonised standards existed for conventional functions of the same machine.
How can a Member State request that a category's classification be reviewed?
The procedure is not static. Article 6(8) allows any Member State that has concerns about the inclusion or non-inclusion of a category in Annex I to immediately inform the Commission, providing the reasons justifying them. The Commission must then carry out the assessment under paragraph 4 without delay, and, following it, may initiate the amendment procedure by delegated act provided for in paragraph 2.
A Member State communicates its concerns to the Commission
It must provide well-founded reasons, typically based on its own accident or market surveillance data.
The Commission carries out the probability and severity assessment
Applying the criteria in Art. 6(4) and consulting experts from the relevant group under Art. 6(3) and Art. 47(4).
The Commission may adopt a delegated act
Adding, removing or moving the category from one Part of Annex I to another, in accordance with Art. 47.
Member States provide periodic data
Every five years (first submission before 14 July 2025), even to confirm that no relevant incidents have occurred.
IgeraIndustria in action: anticipating the impact of a classification change
A manufacturer of press brakes for sheet metal asked its quality department what would happen if the Commission decided to move its machinery category from Part B to Part A of Annex I, following an increase in reported accidents in the sector across Europe. The answer had to anticipate the impact on the conformity assessment procedure and on the marketing timelines for its upcoming models.
How IgeraIndustria resolves it
Question:
"If our category of presses moved from Part B to Part A of Annex I, what changes in the conformity assessment procedure?"
IgeraIndustria answers:
"Under Art. 6(1), categories in Annex I Part A are subject to the procedures in Art. 25(2), which require the involvement of a notified body — EU-type examination or full quality assurance — as opposed to the internal production control that is usually sufficient for Part B under Art. 25(3). In practice, you should budget for an additional third-party certification timeline and the cost associated with the notified body's fees for each new press model."
Do you know if your machine is — or could become — part of Annex I Part A?
IgeraIndustria cross-references your technical file with Annex I and anticipates the applicable assessment procedure.
Try free for 14 days — no card requiredSet up in under 24 hours · Support in English
In summary: Article 6 and Annex I classification
- Part A of Annex I requires conformity assessment with notified body involvement (Art. 25(2)); Part B allows internal control in many cases (Art. 25(3)).
- The Commission decides the classification through delegated acts, after assessing the probability and severity of harm under Art. 6(4).
- A category is placed in Part A if it presents a serious risk and at least one of the four aggravating conditions in Art. 6(7) is present.
- Member States must provide data every five years, and may request a review of the classification at any time.
- Methodological uncertainty about new technologies — including embedded AI — is, on its own, sufficient grounds for inclusion in Part A.
Frequently asked questions about Article 6
Can a machinery category not be in any Part of Annex I?
Yes. Annex I is not exhaustive of all machinery regulated by the Regulation, only of the categories considered to carry a serious inherent risk. Most machinery placed on the EU market does not appear in any Part of Annex I and follows the general conformity assessment procedure — typically internal production control — without the need for notified body involvement.
How often is Annex I updated?
There is no fixed periodicity for updating the Annex itself, but Article 6(9) requires Member States to submit data and information to the Commission every five years, with the first submission before 14 July 2025. This data feeds the assessments that may lead to amendments of the Annex by delegated act at any point in the cycle.
What data sources does the Commission use to decide whether to raise the risk level of a category?
Article 6(5) expressly cites the ICSMS system, safeguard clauses, the Safety Gate rapid alert system, the European Injury Database (EU-IDB), Eurostat's European Statistics on Accidents at Work (ESAW), and the Machinery Administrative Cooperation Group (AdCo), in addition to any other relevant information available.
Do manufacturers take part in the classification process?
Not directly as a formal part of the procedure under Art. 6, which is the responsibility of the Commission and the Member States. However, Article 6(3) requires the Commission to consult experts from the relevant working group before adopting a delegated act, and sector associations typically participate actively in those expert consultations and in related standardisation processes.
How does Article 6 relate to the conformity assessment procedure in Article 25?
Article 6 determines the classification of the machinery category — Part A or Part B of Annex I; Article 25 sets out the full catalogue of conformity assessment procedures (modules from Annexes VI to X) that apply based on that classification. They are two pieces of the same mechanism: first the risk is classified, then the procedure is assigned.
How can IgeraIndustria help monitor changes to Annex I?
IgeraIndustria keeps the current text of Regulation 2023/1230 up to date, including its annexes, and allows you to check at any time whether a product category appears in Annex I and in which Part, together with the corresponding conformity assessment procedure cited precisely.
Get ahead of a classification change in Annex I
IgeraIndustria alerts you if your product category is under review and what the change would mean.
Try free for 14 days — no card requiredSet up in under 24 hours · Support in English
Last updated: July 2026 | Author: Jordi Bassols, Industrial Safety Engineer, COEIC Registered | 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), Article 6 and Annex I. This article is for informational purposes only and does not constitute legal or engineering advice. | IgeraIndustria — try free for 14 days. EUR-Lex — Regulation (EU) 2023/1230 This content is for informational purposes only and does not constitute legal or engineering advice. For the conformity assessment of your machinery, consult a notified body or a qualified industrial safety engineer.