New Rules for High-Risk Machinery Under Regulation (EU) 2023/1230

Demystifying Annex I: The New Rules for High-Risk Machinery Under Regulation (EU) 2023/1230

For safety engineers and compliance managers, the old Machinery Directive 2006/42/EC had a very famous section: Annex IV. This list dictated which high-risk machines required strict conformity assessment procedures. However, as the machinery sector has rapidly evolved—introducing new digital technologies, artificial intelligence, and robotics—the European Union recognized that the old risk classifications contained significant gaps.

With the adoption of the new Machinery Regulation (EU) 2023/1230, the notorious Annex IV has been completely restructured and replaced by Annex I.

The new Annex I introduces a crucial split, dividing high-risk machinery into Part A and Part B. If your company manufactures or substantially modifies high-risk equipment, understanding this division is critical to your compliance strategy. Here is exactly how the new rules work.

The Evolution: Why Move to Annex I?

The list of products in the old Annex IV was based on the risks emanating from their intended use or critical protective functions. However, the modern machinery field embraces new ways of designing equipment that present inherently higher risk factors, regardless of intended use—specifically systems with self-evolving behavior (AI).

To properly reflect these new risk factors, the EU created Annex I, which categorizes machinery based on the severity and probability of harm, data dependency, opacity, and autonomy. Furthermore, the European Commission is now empowered to adopt delegated acts to continuously update Annex I, adding or moving categories between Part A and Part B as technological progress and new accident data emerge.

Annex I, Part A: Mandatory Third-Party Assessment

Part A is reserved for categories of machinery or related products that present a serious inherent potential risk, particularly where there is a lack of harmonised standards or a degree of uncertainty in existing risk assessment methods related to new technologies.

If your product falls under Part A, you can no longer self-certify. You are legally required to undergo a stricter, mandatory third-party conformity assessment procedure involving an independent Notified Body.

What is listed in Part A? Currently, Part A includes:

• Removable mechanical transmission devices and their guards.
• Vehicle servicing lifts.
• Portable cartridge-operated fixing and other impact machinery.
• Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions.
• Machinery embedding the aforementioned self-evolving systems (if the system hasn't already been independently placed on the market and assessed).

The Conformity Assessment for Part A: For these products, safety engineers must apply one of the following procedures:

1. EU type-examination (Module B) followed by conformity to type based on internal production control (Module C).
2. Conformity based on full quality assurance (Module H).
3. Conformity based on unit verification (Module G).

Annex I, Part B: The Harmonised Standards Exception

Part B contains the bulk of the traditional high-risk machinery previously found in the old Annex IV. While these products are still considered high-risk, the Regulation offers safety manufacturers a vital path to streamline compliance: internal production control.

What is listed in Part B? Part B includes over 15 categories of heavy and dangerous equipment, such as:

• Circular saws, band-saws, and hand-fed surface planing machinery for woodworking.
• Portable chainsaws for woodworking.
• Presses (including press-brakes) for the cold working of metals.
• Injection or compression plastics-moulding and rubber-moulding machinery with manual loading/unloading.
• Roll-over protective structures (ROPS) and falling-object protective structures (FOPS).
• Logic units to ensure safety functions.

The Conformity Assessment for Part B: If your machinery falls under Part B, you are allowed to apply the internal production control procedure (Module A)—meaning the manufacturer carries out the conformity assessment internally without a Notified Body.

However, there is a massive catch: You can only use Module A if you design and construct the machinery in accordance with the specific harmonised standards or common specifications that cover all the relevant essential health and safety requirements for that specific category.

If you choose not to use these harmonised standards, if the standards do not cover all the risks identified in your iterative risk assessment, or if no such standard exists, you lose the privilege of internal production control. In those cases, you must fall back to the strict third-party procedures required for Part A (Modules B, H, or G).

The Takeaway for Safety Professionals

The transition from Annex IV to Annex I represents a significant tightening of the EU’s grip on high-risk machinery, particularly surrounding artificial intelligence and machine learning.

Safety managers must immediately audit their product lines against the new Annex I. If your products utilize AI-driven safety components (Part A), you must begin budgeting time and resources for mandatory Notified Body assessments. If you manufacture traditional high-risk machinery (Part B), your compliance strategy now hinges entirely on strict adherence to European harmonised standards.