New Machinery Regulation

In the following we answer some questions why the Machinery Directive has been revised, what is the current state of negotiations and what will change in terms of content. Please note that the new Machinery Regulation has not yet been officially published. 

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Last update: 2023-03-15
 

What is the current status?

On December 15, 2022, EU Council and EU Parliament negotiators reached preliminary political agreement on a new Machinery Regulation. This will replace the current Machinery Directive 2006/42/EC.
On January 25, 2023, the Chairman of the Permanent Representatives Committee informed the Chairwomen of the Committee on the Internal Market and Comsumption Protection about the above mentioned political agreement. The letter indicates that, subject to minor legal revisions (numbering, etc.), the currently available text will be adopted accordingly.
On March 02, 2023, the final voting list was submitted to the Internal Market and Consumer Protection Committee (IMCO). After a positive result, the legislative text will be translated into the individual official languages, after which a publication of the regulation in the Official Journal of the EU can take place. 
Currently, the final version is still being worked on. There are already first translations, but they are still in progress.It is expected that a final German version will be published in the next few weeks.

When is the new Machinery Regulation coming?

The negotiations so far have taken place as so-called "informal trilogues". This means that the official decisions, especially in the EU Parliament are still pending. Until the new regulation is actually published in the EU Official Journal, so some time will pass. 
It can be assumed that the official vote will take place in April or May 2023. A final version of the regulation will most likely be available before the vote.
 

Is there a transition period?

The draft Machinery Regulation provides for a key date regulation, i.e. that the current Machinery Directive 2006/42/EC is to be applied until a certain date and then the new Machinery Regulation. Manufacturers thus have time to prepare for the new requirements, but must meet the new requirements by the deadline. It can be assumed that nothing has changed in the key date regulation, although many observers have hoped that an actual transition period will be introduced.
 

From when must the new Machinery Regulation be applied?

The exact date depends on the official publication date of the regulation in the Official Journal of the EU, so currently no exact date can be given. However, it is known that 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 mid/late 2026. 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. 
 

What changes in the content of the new Machinery Regulation compared to the Machinery Directive 2006/42/EC?

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 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 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 768/EU) 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 1.8.2024!
• 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.

Why is the new rule a regulation and no longer a directive?

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. 
 

When will Safexpert - the software for CE marking - be adapted to the new requirements?

We started preliminary work some time ago to enable our customers to carry out conformity assessment procedures in accordance with the new Machinery Regulation as soon as possible after its publication. This is particularly relevant for very complex projects whose date of placing on the market is later than autumn 2026. 

Of course, we will not be able to finalize the functionalities until the official documents are available. Implementing the new requirements in Safexpert has top priority.
 

Conclusion

• The new Machinery Regulation is coming
• Mandatory to apply the new regulation will be from about September 2026. 
• Security is THE topic that manufacturers of networked machines ("smart machines") should prepare for, as requirements will be placed on manufacturers here from other areas of law (Cyber Resilliance Act, Radio Equipment Directive).
• Manufacturers who have organized their processes well according to the current Machinery Directive are well prepared for the new requirements. 
• Users of Safexpert receive promptly after the publication of the official documents with a new CE Guide the necessary assistance to navigate unexcited through the new jungle of regulations. 

Tips & Product recommendations

• Use the time until 2026 to close any knowledge gaps in the organization. We are happy to support you with our seminar offerings.
• If you are already using Safexpert - the software for CE marking - you will have considerable advantages when switching to the new Machinery Regulation! In particular, the automated update monitoring regarding the applied standards makes your life much easier when switching to the new Machinery Regulation!