New European Machinery Regulation replaces Machinery Directive

The new European Machinery Regulation has been finalized. What are the principal changes and transition periods?

The regulation was approved by the European Parliament on 18 April 2023 and the European Council on 22 May. The Machinery Regulation is now expected to be published in the Official Journal of the European Union in June of this year and to enter into force 20 days later. However, its application will not become mandatory for economic operators until 42 months after its entry into force. Until then, the current Machinery Directive 2006/42/EC must continue to be applied.

In Germany, a national implementing act for the Machinery Regulation is pending and in progress. This act will include provisions governing the official language and penalties for violation of the Regulation.

Structural and technical changes

The European Machinery Regulation consists of 52 articles of the regulation itself and ten applicable annexes. On the one hand, the procedures affecting the Member States and the Commission have been brought into line with the “New Legislative Framework”. Furthermore, the procedures by which the economic operators attain conformity are set out in great detail and conclusively.

At the same time, technical content has been tightened up and adapted. In addition to articles being structured more comprehensibly, the subdivision of the new Annex I governing machines presenting a serious inherent potential risk is worthy of mention, as is the implementation of the topics of artificial intelligence and cybersecurity. The latter are covered by the Machinery Regulation itself, which can be applied directly to them without reference to further legal acts.

The annexes have been re-ordered. The present Annex I, containing essential health and safety requirements, becomes Annex III. The present Annex IV, containing a list of machinery and products for which third-party certification is mandatory, becomes Annex I.

What are the highlights of the new regulation?

• Delegated acts: the European Commission may, in accordance with a defined procedure and after consulting the standards organizations CEN or CENELEC draw up acts in order to regulate matters which it considers neglected where they have not been addressed in standards by the standards organizations within a time frame previously specified.
• The Machinery Regulation has been decoupled from the planned AI Regulation; major fundamental points concerning artificial intelligence are addressed with respect to machinery in the Machinery Regulation.
• The term “economic operator” is new: this is defined as manufacturer, authorized representative of the manufacturer in the EU, importer or seller.
• The procedure for the “substantial modification” of machinery which has been followed for some time in Germany has been implemented in the regulation. Briefly: a “significant modification” exists when the safety technology implemented in a machine is no longer sufficient to counter new hazards arising following the machine’s modification.
• The new Annex I covering machinery and products presenting a serious inherent potential risk consists of two parts. Part A covers machinery and products that always require type examination by a notified body. Vehicle servicing lift machinery, removable mechanical transmission devices including their guards, safety components with fully or partially self-evolving behaviour and portable cartridge-operated fixing and other impact machinery must pass a third-party inspection. Part B describes machinery and products for which manufacturers may continue to declare conformity without involving a notified body, provided they apply harmonized European standards that cover all risks.
• Requirements for machinery with fully or partially self-evolving behaviour or logic are included within the section covering control systems.
• Autonomous mobile machinery is covered in an almost completely new section in Annex III.
• E-bikes, e-scooters and other personal transportation devices are classified as machinery; filter systems for air purification in drivers’ cabs are now deemed to be safety components.

In summary, the essence of the new European Machinery Regulation may be considered a positive achievement and as well integrated into current EU legislation. Further discussions will be needed to determine whether the aspects incorporated into the regulation prove effective in practice and implementation is unequivocally successful.

Christoph Preuße, Spokesperson of the DGUV Machinery safety working group
German Social Accident Insurance Institution for the woodworking and metalworking industries
c.preusse@bghm.de