EU Machinery Regulation 2023/1230

Monitoring of E-STOP, safety gates, light barriers

The EU Machinery Regulation 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. Machine manufacturers now have time in which to meet the new safety requirements on plant and machinery. The Machinery Directive (2006/42/EC) is the current and final version of the Machinery Directive. Application has been mandatory in the EU since 2009.  It is aimed primarily at manufacturers and requires safety to be guaranteed when human and machine interact. If you compare the automation and engineering of today with the technical requirements of 15 years ago, it is clear that the revision of the Directive was more than sensible. 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. The new Machinery Regulation aspires to maintain the high level of safety that was achieved with the implementation of the specifications from the Machinery Directive. This means that you must meet all the specifications of the new Machinery Regulation in your company within the transitional period. Information and implementation of the specifications of the new regulation in terms of risk analysis, instructions for use and technical documentation, as well as conformity assessment and declaration of conformity with subsequent CE marking, mean that companies face an enormous challenge.

The birth of modern machinery safety as we know it today dates back less than 40 years: in 1989, the change was brought about with the Machinery Directive. Since then, machinery safety has been mandatory in Europe. Its provisions have consistently been brought in line with technical developments. The aim has always been to design safe interaction between human and machine, and to promote the standardisation of fundamental and mandatory European machinery safety requirements. Publication of the EU Machinery Regulation 2023/1230 in the Official Journal of the EU on 29 June 2023 has brought the specifications up to the current state of the art. The EU Machinery Regulation becomes legally binding in all EU states on 20 January 2027.

The new regulation continues to cover machinery and related products, but safety components now also include software. It provides greater clarity as to when there is a substantial modification to existing plant and machinery, and therefore a new CE conformity assessment must be conducted. What’s more, it also takes into account the growing importance of Industrial Security and digitisation. Industrial Security is a mandatory element for the safety of machinery, and no longer open to the interpretation of those placing the machine on the market. Manufacturers will need to draw up appropriate Industrial Security concepts. In this respect, Industrial Security is one of the main themes of the Machinery Regulation. Manufacturers of networked machinery should prepare well in this regard. They will also face demands from other areas of legislation.

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.

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