Machinery Directive

Official title of the Machinery Directive: Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast). It has applied since 29.12.2009. Irrespective of the place and date of manufacture, all machinery used in the European Economic Area for the first time from 01.01.1995 is subject to the EU Machinery Directive and as such must be CE certified.

The Machinery Directive is one of the most important pieces of legislation for harmonising the essential safety requirements for machinery within the European Union. It describes standardised health and safety requirements for interaction between human and machine. The Directive promotes the free movement of machinery within the single market and guarantees a high level of protection for EU workers and citizens.

Machinery safety is the basis for effective, accident-free cooperation between human and machine. New approaches and issues, such as digitalisation for example, require ongoing development of the directives and standards applicable today. In his keynote speech, Klaus Stark explains where that journey might lead.

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In Europe, the Machinery Directive 2006/42/EC is the main legal basis for any company that designs, builds or sells machines. Machines that are imported into the area of European jurisdiction also have to meet the requirements of the Machinery Directive. The current Machinery Directive 2006/42/EC was published in 2006 and has been mandatory since 29 December 2009.

The EU Commission checks the provisions and directives regularly to ensure they are adapted to the new requirements and developments. The Machinery Directive needs updating to improve safety levels further, to take more account of security aspects and to stay abreast of technological developments such as Industrie 4.0. The proposed revision:

• Aligns the directive with harmonised EU legislation on product health and safety and
• tackles the challenges that may arise from technical progress in digitalisation.

The draft is currently available in English: “Regulation of the European Parliament and of the Council on Machinery Products”. Other language versions are to follow. The draft is available publicly for download and comment from the European Union website from the period 26 April 2021 – 2 August 2021.

Here’s a summary of some of the planned changes for the new EU Machinery Regulation:  

• Machines subject to inspection: The catalogue of machines subject to inspection has been extended. What’s more, in the case of machines subject to inspection, it shall no longer be possible for manufacturers to carry out the conformity assessment procedure entirely on their own when harmonised standards are applied.
• Substantial modification: The regulation has been extended to include the definition of a substantial modification of machinery and the legal consequences of such a modification. For machinery safety, a conformity assessment procedure is required if a machine undergoes substantial modifications or if modifications are carried out that affect the machine’s compliance with the statutory provisions for CE marking (Article 14).
• Safety components: The definition of safety components now also includes software that provides a safety function (Article 6).
• Digital instructions: Manufacturers shall be allowed to supply instructions in digital form. Should the customer request it, the manufacturer shall supply the instructions in paper format.
• Technical specifications: Presumption of conformity shall also be enabled in the event of conformity with technical specifications or parts thereof (Article 17). 

Artificial intelligence:  

A separate draft of the EU regulation on artificial intelligence was published at the same time as the Commission’s draft. This is intended to cover all products with AI and use thereof. No additional safety requirements should be required; the definition will just be more precise. The argument is that the effects of AI functions are already covered through existing conformity assessment procedures and the definition of the intended use.  

Further steps:

Once the period for comment has passed, the planned changes are to be discussed in the co-decision procedure in the European Council and European Parliament.  

Incidentally, regulations no longer need to be incorporated into domestic legislation in each country, and so apply from the moment they are published in the EU Official Journal. The EU regulations on artificial intelligence will be negotiated at the same time in the co-decision procedure.   

Planned transitional provisions:

The transitional provisions for the EU Machinery Regulation currently provide for the following (Article 49/50): The switch from the old Machinery Directive 2006/42/EC to the new EU Machinery Regulation will take place 30 months after the date of entry into force. However, there is to be a time limit on making machinery available on the market under the existing law, and not just on placing it on the market. That would mean that one year after the entry into force, distributors could no longer continue to market goods they have in stock, even though they were placed on the market correctly in accordance with the old directive!  

It is still unclear how the process will run with the existing harmonised standards under the Machinery Directive. Neither has it been established which of the planned updates will actually make it into the new EU Machinery Regulation. Nonetheless, machine builders should follow developments with increased vigilance from now on. Pilz will keep an eye on the ball for you!

For the purposes of the Directive, machinery means an assembly consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application.

The following are also considered as machinery for the purposes of the Machinery Directive:

• Assembly of machines or complex plants. Complex plants include production lines, special purpose machinery made up of several machines, interlinked machinery
• Safety components: The issue of which components are classified as safety components is very controversial. As yet there is no discernible, consistent trend
• Interchangeable equipment that can modify the basic functions of a machine
• Partly completed machinery

In addition to the machinery listed above there is also a list of exceptions for machinery, which would fall under the scope of the Directive by definition, but for which other statutory provisions generally apply.

The practical "Guide to application of the Machinery Directive 2006/42/EC" is used to interpret the text of the Directive. Version 2.2 has been published and can be downloaded from the European Commission's website. The main differences between the current version and the previous Version 2.1 are the additions and clarifications, particularly with regard to the terms “safety components” and “partly completed machinery”, plus some edits to guarantee coherence with the guidelines for the Low Voltage Directive.

A short section about the safety-related requirements has been added in the section entitled “Mode selection” (§204). Two new paragraphs have also been added regarding machinery control units (§417) and safety components which are considered to be logic units (§418).

Related standards:

• EN ISO 13849-1
• EN IEC 62061

Further information:

• European aspects of the Machinery Directive
• EU information regarding the Machinery Directive
• Consulting, engineering and training on machinery safety and CE marking

Navigating the jungle of standards! The poster on “Safeguards for plant and machinery – Important harmonised standards according to the Machinery Directive” clearly presents the A/B and C standards. At the same time you get a condensed overview of our safety-related products.

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You can also order a printed copy of the poster from us directly.