New Machinery Regulation

On 18 April 2023, the new Machinery Regulation (EU) 2023/1230 was adopted by a large majority in the EU Parliament, and on 22 May the European Council also gave its final approval. On 14 June 2023, the Presidents of the EU Council and Parliament also signed off on it, and the final publication in the EU Official Journal was on 29 June 2023. Many observers had hoped that a transitional period would be introduced after all. However, the final publication now makes it clear that there is no such thing.

The Machinery Regulation (EU) 2023/1230 provides for a key date regulation, i.e. the current Machinery Directive 2006/42/EC is to be applied until 2027-01-20 and the new Machinery Regulation thereafter. Manufacturers therefore have time to prepare for the new requirements, but must meet the new requirements by the deadline.

The negotiators have agreed that the new regulation is to be applied 42 months after its entry into force (= usually 20 days after publication in the Official Journal of the EU). This means that the new requirements must be applied from January 20, 2027. However, companies must already deal with the new requirements before the effective date, as from the effective date the declaration of conformity, technical documentation, etc. must already have been prepared in accordance with the new regulation. 

Some sections of the new regulation must already be applied before 2027-01-20. This primarily affects the member states as well as the EU Commission:

• Chapter V (Notification of conformity assessment bodies): applies from 2024-01-20;
• Article 50 (1.) (Member State sanctions): applies from 2023-10-20;
• Article 6 (7.) (Certain categories of machinery in Annex I), Article 48 (Committee procedure) and Article 52 (Transitional provisions): applicable from 2023-07-19;
• Articles 6 (2.) - (6.) and 11 (delegated acts), 47 (exercise of delegation) and 53(3.) (Commission report on evaluation and review): applicable from 2024-07-20.
   

In fact, this is a (binary) key date regulation. The relevant date is the date of placing on the market. This means that if manufacturers are working on a complex project that will not be placed on the market until after 20 January 2027, they should already apply the new Machinery Regulation; in all other cases, they should apply the Machinery Directive. In other words: All machines delivered before 20 January 2027 will receive a declaration of conformity in accordance with the Machinery Directive, all products after this date will receive a declaration of conformity in accordance with the Machinery Regulation. 

Of course, manufacturers can already fulfil additional requirements (e.g. with regard to security). A mixture of formal requirements (e.g. conformity assessment procedures) is not envisaged.

Please note that the following is only a rough overview of some of the changes in content. To list all changes in detail would go beyond the scope of a technical paper. 

• The order of articles and appendices will change. While this is in principle purely editorial, users of the Machinery Directive will nevertheless have to get used to new terminology. For example, machinery for which a notified body had to be involved in the conformity assessment procedure under certain circumstances was previously named "Annex IV machinery" after the name-giving Annex IV. This will, for example, be regulated in Annex I in the future. The term "high-risk machine", which was originally intended in one of the drafts, does not appear in the final compromise text. Nevertheless, we use this term below for better readability.
• Terminology: Different terminologies were still used in the different negotiation documents (e.g., "machine" or "machine product").
  • The new regulation 2023/1230 refers to "machinery and related products" ("machinery and related products") in Article 2 (Scope). In our view, this is welcome. In the Machinery Directive 2006/42/EC (and in the associated Guide), there was unnecessary confusion for users due to the double meaning of the term "machinery". In the 2006/42/EC Directive, the term "machinery" was used both as an umbrella term (for all products within the scope of the Machinery Directive except partly completed machinery) and for "machinery in the strict sense", i.e. machinery as defined in Article 2a (2006/42/EC). Users of the Machinery Directive needed to know that when it came to certain obligations for machinery, it was always the umbrella term that was meant (i.e. also including chains, ropes, belts, etc.)
  • The new Machinery Regulation (EU) 2023/1230 defines the term "machine" in one place and subsumes under "related products" interchangeable devices, safety components, load handling attachments, chains, ropes, belts, as well as removable cardan shafts. That is, whenever the conformity assessment procedure is involved, the Machinery Regulation consistently refers to "machinery and related products" or "partly completed machinery". Thus, a double use of the term is no longer necessary, even if this makes the text read a bit bulky in some places.
  • Total: It changes thereby purely content not much, by the more consistent use of the word group  "machine and related products" the new document but - in some places - a little more readable.
• The procedure for "High risk machinery" (formerly "Annex IV machinery", see above) is changed. In the future, with regard to high-risk machines, a distinction will be made between two sub-types (type A and type B), for which different procedures (different conformity assessment modules in accordance with Decision Nr. 768/2008/EC) will have to be applied. Specifically, three different procedures will be applied - depending on the classification from Annex I:
  • Module A (Internal Production Control), Module B (EU Type Examination) in combination with Module C (Conformity to Type based on Internal Production Control), Module H (Full Quality Assurance), Module G (Unit Verification)
  • Manufacturers of machines that do not fall under Annex I of the new regulation perform - as before - the conformity assessment procedure based on internal production control (Module A). 
  • For manufacturers of "high risk machinery", a distinction is made between Part A or Part B of Annex I of the Machinery Regulation.
  • Conformity assessment procedures for Annex I, Part A products:
    • Module B in combination with Module C
    • Module H
    • Module G
  • Conformity assessment procedures for Annex I, Part B products:
    • In principle, the same applies as for products under Part A, but:
    • when harmonized standards are applied, the Contrôle interne de fabrication (Module A) procedure may also be used for products according to Annex I, B.
• Newly added is the explicit mention of after-market obligations for manufacturers. Specifically, Article 10, paragraph 9 of the new regulation requires that they "shall immediately take (...) actions" to either bring into conformity with the regulation, notify national authorities if necessary or - if appropriate - withdraw the product from the market or carry out a recall. However, the (now) explicit mention of these obligations in the Machinery Regulation does not mean, of course, that it is not already mandatory to take immediate action in the event of unsafe machinery in the field! More detailed information on the extremely important and unfortunately often neglected complex of topics "aftermarket obligations" is covered in our seminar recall management and product monitoring.
• A requirement of the EU Parliament was the introduction of a digital instruction manual comes, but with restrictions. Although it is now possible to include digital instructions, but with some restrictions, for example:
  • The digital instructions must be downloadable and printable 
  • On request, printed operating instructions must still be handed over. The legislator now provides a period of one month here.
  • For "non-professional users", it is mandatory to provide safety information in paper form
• The topic of "Security" becomes a manufacturer's obligation due to the new Machinery Regulation. In particular, the completely new point 1.1.9 (which is sure to cause much discussion) from Annex III of the new Machinery Regulation, which defines requirements with regard to the protection against interference (Protection against corruption). The new Machinery Regulation requires here that the linking of a device (probably USB sticks or other data media are meant) as well as the linking with "remote devices", i.e. via the Internet, must not lead to dangerous situations. It should be noted that not only the new point 1.1.9 deals with security aspects, but that other sections (e.g. 1.2.1 a, d, f) also contain new requirements regarding the resilience of controls. In particular, it should be emphasized at this point that the regulation distinguishes between unintentional and intentional corruption. While the former mainly refers to employees who make changes without malicious intent, intentional corruption refers in particular to hacking, which can also take place by deliberately influencing employees (social engineering). You can find more information about this in our detailed Security by Design article or in our related Seminar.  The new requirements are in line with the EU's cyber strategy, which is also manifested by requirements on manufacturers due to the Cyber Resilliance Acts as well as regarding amended requirements of the Radio Equipment Directive. Attention! The security requirements of the Radio Equipment Directive are mandatory already from 1.8.2025!
• Another key change in the essential requirements (now Annex III) concerns Artificial Intelligence, or, as the new regulation somewhat cryptically puts it (probably to anticipate any overlap with the EU's AI Act) "Self-Evolving Behaviour". For example, the general principles of Annex III mention that the risk assessment of self-evolving machines must take into account the risks arising from this autonomous behavior. From our point of view, this is not a big change, since such behavior must also be considered in the risk assessment (if relevant). More interesting in this context are some passages in Annex III (e.g. 1.1.6 f, 1.2.1 d, 1.2.1 ii a and b, 1.2.1, iii c) in which explicit requirements regarding "self-evolving behavior" are specified.

Currently, machinery safety in Europe is regulated by Directive 2006/42/EC (Machinery Directive). By establishing the European requirements as a directive, member states had more flexibility in meeting the directive's objectives. However, this has also led to different interpretations and thus, in part, to legal uncertainties for users of the directive, such as manufacturers. If these exported their machines or plants e.g. into different countries of the EU and there by local authorities details interpreted sometimes somewhat differently.

With the aim of reducing the administrative burden, the directive has now been replaced by a regulation. This must be applied directly in all member states. This means that different national interpretations should be significantly reduced and thus the legal clarity is improved. In addition, the administrative burden for economic operators, such as manufacturers, should also be reduced. 

From version Safexpert 9.1(released in April 2024), the CE software will have a new CE Guide in accordance with Machinery Regulation (EU) 2023/1230. This guide is based on the proven structure of the existing CE Guides and, like them, guides users conveniently and reliably through all the steps required for the declaration of conformity.

This means that customers can already create and edit projects for machinery placed on the market from 20 January 2027.

There are currently over 800 harmonised standards listed in the EU Official Journal in accordance with the Machinery Directive 2006/42/EC. However, as the new Machinery Regulation will result in amended or new health and safety requirements (EHSRs for short), all documents must be reviewed and, if necessary, adapted to the new requirements.

As things stand, the EU Commission will also fully certify the presumption of conformity under the Machinery Regulation for all standards that are currently listed in the EU Official Journal under the Machinery Directive - provided they cover the same requirements. For the new requirements added under the Machinery Regulation, the CEN/CENELEC Technical Committees must carry out a review to determine the extent to which individual standards need to be adapted. The aim is to have an implementing decision with a complete list of harmonised standards in accordance with the Machinery Regulation by the end of 2026 (shortly before the deadline of 20 January 2027).

The EU Commission's standardisation mandate is to be adopted by the European standardisation organisations in 2024. This includes the creation of harmonised standards specifically for the new requirements of the Machinery Regulation, such as artificial intelligence and cyber resilience. In addition to the existing Annex ZA (reference of a European standard to the EHSRs to be covered by Directive 2006/42/EC), new publications of European standards that (still) cover the requirements of both sets of regulations will also contain an Annex ZB for Machinery Regulation (EU) 2023/1230. Further information on the status of the harmonised standards can be found in the technical article "New Machinery Regulation: Status of harmonised standards"