We will summarize the terms of the Machinery Directive 2006/42/EC in 8 simple points, examine when it applies, and see how it functions in Italy for the production of new machinery or for the use of work equipment built before and after the Directive was implemented.
1. What is the Machinery Directive?
Directive 2006/42/EC is the version of the Machinery Directive currently in force; the first version was drafted in 1989 (Directive 89/392/EEC) and subsequently revised in 1998 (Directive 98/37/EC).
The main purposes of the Machinery Directive are as follows:
- to harmonize the health and safety requirements applicable to machinery, based on a high level of health and safety protection
- to guarantee the free movement of machinery within the European market.
2. Field of application of the Machinery Directive
The general categories of products covered by the Directive are listed below:
- interchangeable equipment
- safety components
- lifting apparatus
- chains, ropes and straps designed and made for lifting purposes and serving as an integral part of lifting machinery or lifting accessories
- removable mechanical transmission devices
- partly completed machinery
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3. What is meant by machinery?
The Machinery Directive provides the following definition of “machinery” in
Article 2 Point 1: “An assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application”.
The Directive then extends the concept of machinery in further ways, also defining machinery as:
- an assembly referred to in the first point, missing only the components to connect it on-site or to sources of energy and motion
- an assembly referred to in the first and second points, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or structure
- assemblies of machinery, referred to in the three previous points, or partly completed machinery, which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole
- an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort.
4. What is meant by partly completed machinery?
Article 2 of the Directive also contains the following definition of partly completed machinery:
“An assembly which is almost machinery but which cannot in itself perform a specific application. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies.”
Since many manufacturers specialize in the production of single devices, with multiple final applications, it follows that much of the equipment on the market cannot be classed as “machinery” but more specifically as “partly completed machinery”.
For more about the CE marking of partly completed machinery, see point 7 of this article.
The complete text of the Machinery Directive is available in PDF at the following link.
5. Are any categories excluded from the scope of the Directive?
Some types of equipment are covered by different regulations, and so are excluded from the terms of the Directive. They include:
- seagoing vessels and mobile offshore units as well as machinery installed on board such vessels and/or units
- mine winding gear
- means of transport by air, on water and on rail networks, with the exclusion of machinery mounted on these means of transport
- electrical and electronic products covered by the Low Voltage Directive (2014/35/EU)
- all weapons (not just firearms)
- agricultural and forestry tractors for the risks covered by Directive 2003/37/EC.
6. Contents of the Machinery Directive
The Directive lays down the essential health and safety requirements that products must meet at every stage of their design, manufacture and operation before being placed on the European market.
The Directive divides machinery into two large groups:
- machines that must be certified by accredited third parties
- machines that can be self-certified by the manufacturer.
The machinery included in Annex IV of the Directive must undergo a process of assessment by specific agencies (notified certification bodies) to confirm its compliance with the set health and safety requirements.
For all other types of machinery, the manufacturer is only required to draw up and keep the relevant technical file, in accordance with the instructions set out in Annex VII of the Directive itself.
Products placed on the market or subject to substantial changes after the Directive came into force must carry the appropriate marking and must be accompanied by a Declaration of Conformity (or a Declaration of Incorporation in the case of partly completed machinery).
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All machinery must be marked visibly, legibly and indelibly with the following minimum particulars in relation to CE certification:
- the business name and full address of the manufacturer and, where applicable, his authorized representative
- designation of the machinery
- the “CE” marking (logo)
- designation of series or type
- serial number, if any
- year of construction, that is the year in which the manufacturing process is completed
It is prohibited to pre-date or post-date the machinery when affixing the CE marking.
An important point needs to be made regarding partly completed machinery: these products must NOT carry the CE marking or logo as they are intended to be incorporated into more complex equipment, which will then be affixed with the appropriate CE marking at a later stage.
8. CE declaration of conformity for machinery
Every product placed on the market and subject to the Machinery Directive must be accompanied, for its entire useful life, by a CE Declaration of Conformity for machinery, issued by the manufacturer.
Annex II of the Directive outlines the minimum contents that must be included in this document, both for machinery and for partly completed machinery.
Once again, it is important to point out that the Directive makes a distinction between the two types of products; for in the case of partly completed machinery, the declaration not only serves the main function of identifying the product, but also provides the constructor incorporating the part with evidence that the essential safety requirements (ERS) have been subject to a risk analysis. The constructor will then have to assess all the ERS that the manufacturer of the product has been unable to meet, as the supplier of incomplete machinery.
Finally, to make a clear distinction between the two types of the document, the Directive identifies them in the following way:
- Declaration of conformity, for machinery (Annex II-A)
- Declaration of incorporation, for partly completed machinery (Annex II-B).
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