EU Machinery Regulation from 2027

The EU Machinery Regulation 2023/1230 will apply from 20 January 2027. It came into force in all member states on 19 July 2023, twenty days after it was published in the Official Journal of the European Union. The Machinery Regulation contains more specific details and provides greater clarity on previously controversial issues. It also contains new aspects such as the growing importance of Industrial Security and digitisation. Machine manufacturers now have time in which to meet the new safety requirements on plant and machinery.

Why do we have the EU Machinery Regulation, when does it come into force? What are the changes and what are the implications for machine manufacturers? An overview of the key facts:

What is the correct name of the Machinery Regulation?

The official title of the Machinery Regulation is: Regulation (EU) 2023/1230 of the European Parliament and of the Council on machinery.

What is in force until application of the Machinery Regulation becomes mandatory?

The Machinery Directive (2006/42/EC) is the current and final version of the Machinery Directive. Application has been mandatory in the European Union since 2009 and continues to apply until the Machinery Regulation comes into force.

Why do we have the Machinery Regulation?

If you compare today’s technical requirements of automation and engineering with those of 2009, it is clear that the revision of the directive was inevitable. Digitisation and networking, as well as the new related issues of Industrial Security and Artificial Intelligence (AI), are in the process of significantly changing factory halls and the plant and machinery within them. To take account of these changes, the provisions have been brought in line with technical developments.

What is the aim of the Machinery Regulation?

The Machinery Regulation aspires to maintain the high level of safety that was achieved with the implementation of the specifications from the Machinery Directive and to bring it up to date with state-of-the-art technology. The aim is to design safe interaction between human and machine, and to guarantee the standardisation of fundamental and mandatory European Machinery Safety requirements.

To whom does the EU Machinery Regulation apply and what does it cover?

The new regulation continues to cover machinery and related products that are to be operated within the European Union, but safety components now also include software.

From when does the Machinery Regulation apply and what are the transition periods?

The EU Machinery Regulation 2023/1230 was published in the Official Journal of the EU on 29 June 2023. The Machinery Regulation becomes legally binding in all EU states from 20 January 2027 (key date regulation).

What does the Machinery Regulation say?

The new European Machinery Regulation (EU) 2023/1230 contains comprehensive rules on machinery health and safety, including new technologies such as Artificial Intelligence. Key points are safety requirements, new conformity assessment procedures and stricter market surveillance.

What are the most important changes and new developments in the Machinery Regulation?

• Machines subject to inspection
  The list of machines subject to inspection, which was previously in Annex IV of the Machinery Directive 2006/42/EC, has “moved” to Annex I. In Section A it contains a list of high risk machines, for which mandatory inspection and certification through a third party is required. In future, six machine categories will be subject to inspection; application of a harmonised standard does not remove the inspection obligation. This is due to the current developments in Artificial Intelligence. For the six listed product groups, machine manufacturers can no longer self-declare compliance in conjunction with a harmonised standard, as previously. Instead, a named accreditation body must be involved.
   
• Substantial modification
  The regulation has been extended to include a definition of a substantial modification of machinery and the legal consequences of such a modification. A conformity assessment procedure is required for Machinery Safety if a machine undergoes major modifications or when changes are made that affect the machine’s compliance with the statutory provisions for CE marking. If a substantial modification has taken place, the operator becomes the manufacturer – with all the obligations that entails.
   
• Safety components
  The definition of safety components now includes not only physical, digital and/or mixed-type components, but also software.
   
• Digital technologies
  The emergence of new digital technologies such as Artificial Intelligence, the Internet of Things and robotics present new challenges for product safety.
   
• Industrial Security
  In a new section entitled “Protection against corruption”, the Machinery Regulation now also establishes requirements for the cybersecurity of machinery. Cybersecurity threats must not be allowed to compromise the machine’s safety functions. So measures to counteract these threats are no longer open to the interpretation of the person placing the machine on the market, but are a mandatory component. Manufacturers must review their existing safety concepts in this regard!
   
• Digital instructions
  Manufacturers shall be allowed to supply instructions in digital form. Should the customer request it, the manufacturer must supply the instructions in paper format. The EU Declaration of Conformity can also be provided in digital form. Partly completed machinery can be delivered with digital assembly instructions as well as with a digital Declaration of Incorporation.

What does the new Machinery Regulation mean for harmonised standards?

It is still unclear how the process will run with the existing harmonised standards under the Machinery Directive. As it currently stands, these will need to be relisted. With over 750 directly listed standards alone, that means a significant effort over several years. It is currently unclear whether the relevant standards will be available as harmonised standards by the time the EU Machinery Regulation comes into force – on 20 January 2027.

Pilz supports you as a machine manufacturer with a comprehensive package of Machinery Safety services – from safety analysis to validation and CE marking in accordance with the requirements of the Machinery Regulation. Pilz also has the new normative Security requirements in its sights – because Industrial Security ensures the integrity of Safety at the machine. This is why Pilz has added relevant training in Industrial Security to its services package.

• To Safety and Security offer