Milestone in machinery law: What the new EU Machinery Regulation means for companies

For the last 17 years, the Machinery Directive 2006/42/EC has formed the core set of rules for the safety of plant and machinery in the European Economic Area. It will be replaced by the new EU Machinery Regulation. After the European Parliament and the Council have approved the new legislation on 18 April and 22 May respectively, it is expected to come into force in July 2023. The new Regulation will become mandatory after a transitional period of 42 months. The Machinery Regulation aims to further harmonise and update product safety requirements in the EU. This is to take into account emerging risks and challenges that new technologies bring to machinery products and to ensure that they are operated safely.

Who is affected by the EU Machinery Regulation?

In principle, the new Regulation can affect anyone active in the market. For this reason, one should become familiar with the new Regulation as compared with the current Machinery Directive at an early stage. This is set out in in the article “Current developments in machinery law - the Machinery Regulation is coming soon”, by Dr Ulrich Spiegel and Dr Benedikt Rohrßen. Ultimately, only those who meet the requirements of the new Regulation for machinery in question after the transitional period may continue to provide, sell or import them in the EU.

What are the implications of the new EU Machinery Regulation for companies in the machinery and plant engineering sector?

The new Machinery Regulation will bring about a number of detailed changes. The main changes include:

• Currently, machinery with a high risk potential is listed in Annex IV of the Machinery Directive. A machine has a high risk potential if, taking into account its design and intended use, it poses a risk to human health. In the future, this list, which will then be included in Annex I of the new Machinery Regulation, is to be expanded and constantly updated. Any such adjustments will then be made through a delegated act of the EU Commission. Manufacturers should expect that the list of machines with high risk potential will be dynamically updated in the future and that machines will be added to the list in Annex I at short notice.
• In the future, a so-called notified body must be involved in the conformity assessment for CE marking for machinery listed in Annex I Section A.
  Due to the mandatory involvement of such notified bodies, this machinery will incur higher costs for conformity assessments.
• The Machinery Regulation brings new health and safety requirements for Artificial Intelligence (AI) and cyber security. The manufacturer is obliged to ensure reasonable protection against accidental or deliberate attempts at corruption. (Partially) autonomous control systems must be designed in such a way that (i) they do not perform actions beyond the defined task and movement scope and (ii) it is possible to correct the machine at any time in order to maintain its inherent safety (cf. Annex III 1.2.1. of the draft). If the machine uses safety-related AI, it falls under the category of (potentially dangerous) machinery in Annex I. The draft refers to “Machinery that has embedded systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions that have not been placed independently on the market, in respect only of those systems”.
  In terms of content, this should not necessarily mean a tightening of the rules. Particularly in the case of autonomously controlled safety mechanisms (see above), increasing costs should be expected in the context of conformity assessment, simply because the corresponding machinery falls under Annex I (involvement of a notified body).
• The definitions of terms and catalogues of obligations for those actively involved in the market (manufacturers, importers, distributors and authorised representatives) have been revised and adapted to the current state of European law (“New Legislative Framework”)
  The Regulation introduces an explicit obligation for the manufacturer to notify regulators of risks in the field, and there are added obligations on distributors. Overall, the consolidation with the overall legal framework should provide more legal certainty for the industry.
• Digital instruction handbooks (and therefore the abandonment of paper) will be permitted in principle in future. This principle (and above all its restrictions) have been debated until recently. Now, users can only request operating instructions in paper form at the time of purchase. Exceptions also apply to safety information for non-professional users.
  We can now hope that fewer trees will be cut down and less money be spent on paper without compromising product safety.
  
  

Outlook

The exact date for the new Regulation entering into force is not yet known. It is expected for July 2023. A regulation enters into force on the 20th day after its publication in the Official Journal of the EU.