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Eaton: Machinery directive, Maschinenrichtlinie 2006/42/EC

On 04/21/2021, the EU Commission issued a proposal to revise the current machinery directive 2006/42/EC. The proposal was issued because the directive does not reflect the current state of technology in some areas, particularly relating to digitalisation. The draft also intends to bring the machinery directive in line with the New Legislative Framework (NLF 768/2008/EC) and become a regulation.          

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How does legislation work in Europe?

Basically, the EU Commission issues directives that are then approved by the EU Council. Committees such as the CEN or CENELEC draw up EU standards for 34 European member states. Each member state has an appropriate committee set up to deal with aspects such as health, safety and social issues at work. Adopted EU directives such as machinery directive 2006/42/EC or EMC directive 2014/30/EU are transposed into national law by governments. Law enforcement authorities draw up supporting documentation and then enforce these laws.     

What is the machinery directive?

The currently applicable machinery directive was revised in 2006 and came into force on December 29, 2009. The directive is based on the first version introduced in 1989 and regulates machines that are put into circulation within the European Economic Area, Switzerland and Liechtenstein, as well as in Turkey, Norway and Iceland. The aim of the directive is to ensure that, within the European single market, only products meeting the same basic safety standards are placed on the market. The directive contains 29 articles in the main body and 11 annexes. The European Commission also provides guidelines on how to apply the machinery directive.           

EU member states are obliged to implement the directive through national laws and regulations. 

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Machinery regulation or machinery directive?

The revision of the currently applicable machinery directive 2006/42/EC, published on 04/21/2021, is intended to bring the directive in line with the EU machinery regulation and the New Legislative Framework (NLF). EU institutions use the NLF to define basic health and safety requirements for products through directives and regulations, in doing so the technical content of these requirements is achieved through a harmonisation of standards throughout Europe.            

An overview of the most important changes to the machinery regulation:

  • Annex I lists high-risk machines.
  • Machinery referred to in Annex I will be subject to special conformity evaluation procedures.
  • It includes a new artificial intelligence (AI) regulation that addresses the security risks of AI systems and seeks to ensure the safe integration of these systems into the machine. It includes a new artificial intelligence (AI) regulation that addresses the security risks of AI systems and seeks to ensure the safe integration of these systems into the machine.
  • Digital documentation is now permitted. Digital documentation is now permitted. Anyone who purchases a machine can request a printed version of the operating instructions free of charge.
  • Two new terms are defined: "substantial modification" and "artificial intelligence system."

When will the machinery regulation take effect?

The member states and European Parliament still need to approve the proposal issued by the EU Commission. As a result, it is expected that the next version of the machinery directive or the new machinery regulation will be published in the next one to three years. After publication, the regulation then becomes a national law in the member states. Considering the relevant transition periods, it is likely that the previous machinery directive 2006/42/EC will still be applicable until around 2025.

 

What impact does the new Machinery Regulation have on operating instructions?

The replacement of the Machinery Directive by the Machinery Regulation also affects your operating instructions. For example: the Machinery Regulation mentions that instructions can be provided in digital form. This infographic shows you exactly what the differences are.

Machinery Directive becomes Machinery Regulations

The Change of the Machinery Directive 2006/42/EC to the Machinery Regulations as well as the update EN ISO 13849-1 and EN IEC 61061 in 2021 and 2022 and how this effect machine and system builder are described in the white paper.

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