MACHINERY DIRECTIVE 2006/42/EC

The Machinery Directive 2006/42/EC stands as the cornerstone for the design and production of machinery and partly completed machinery that adhere to European health and safety protection standards.

ATTENTION

The Machinery Directive will be applicable until 20/01/2027, when it will be repealed

and replaced by EU Regulation 2023/1230 Machinery.

LET'S START FROM PRINCIPLE

One of the objectives of the European Union is to guarantee the safety and protection of persons (whether consumers or workers), throughout the entire EU territory, by means of the regular and continuous monitoring of the market carried out by the control authorities designated by each Member State.

The industrial sectors such as mechanics, for instance, are particularly susceptible to encountering potentially severe situations, largely due to the frequent exposure to high levels of danger arising from the operation of machinery.

This is where the founding element of the Machinery Directive 2006/42/ECcomes from:

The machinery sector forms a significant component of the mechanical engineering industry and stands as one of the cornerstone sectors within the EU economy. The societal burden resulting from the high number of accidents directly attributed to machine usage can be mitigated through the integration of safety measures into the design and construction of machines, coupled with diligent installation and maintenance procedures.

Due to this reason, it was deemed necessary to establish a harmonised legal framework among the various states. This primarily delineates the essential health and safety requirements to be adhered to in the design and manufacturing processes of machinery intended for commercial use. Additionally, it affords states the pivotal function of market surveillance, ensuring consistent and accurate implementation of shared provisions aimed at enhancing machinery safety within the European market.

The forerunner in this matter was Directive 89/392/EEC, which gave way to Directive 98/37CE, which was later repealed by the Machinery Directive 2006/42/EC that is still under review (started in January 2019).

RECIPIENTS OF THE MACHINERY DIRECTIVE

The Machinery Directive is aimed at:

• each Member State of the European Union who are designated as a party accountable for ensuring the directive's effective implementation within their territory. They are also tasked with ensuring robust market surveillance by adopting all requisite measures to ensure that machinery circulates solely within the Community territory (EEA) when compliant with directive provisions, safeguarding the health and safety of individuals, as well as, where applicable, domestic animals, and general property.
• manufacturers of machinery or their authorised representatives, defining them as being responsible for the actions necessary to prove conformity with the essential health and safety requirements defined by the directive, for carrying out a risk assessment, but also for compiling a technical file regarding the construction of the machinery intended to be placed on the market (in the absence of a manufacturer, the natural or legal person who puts the machinery into service or places it on the market falls within the definition of a manufacturer).

SCOPE OF APPLICATION OF THE MACHINERY DIRECTIVE AND DEFINITIONS

The provisions of the Machinery Directive 2006/42/EC apply to the following:

1. machinery
   a machine is
   - an assembly, fitted with or intended to be installed with a drive system other than directly applied human or animal effort, consisting of parts or components, at least one of which moves, and which are joined together for a specific application
   - an assembly referred to in the first indent, missing only elements for connecting it to its place of use or for connecting it to sources of energy and motion
   - an assembly referred to in the first and second indents ready to be installed and able to function only after being mounted on a means of transport or installed in a building or a structure,
   - an assembly of machinery referred to in the first, second and third indents, or partly completed machinery referred to in point (g), which, in order to achieve the same end, is arranged and controlled so as to function as an integral whole
   - an assembly of parts or components, at least one of which moves, which are joined together and are intended for lifting weights and whose only power source is directly applied human effort
2. interchangeable equipment
   interchangeable equipment is
   a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function insofar as this equipment is not a tool
3. safety components
   a component is
   - intended to perform a safety function
   - placed on the market separately
   - the failure and/or malfunction of which endangers the safety of persons and
   - which is not essential for the purpose for which the machinery was designed or which can be replaced by other components for this function.
   (Annex V of the Machinery Directive contains an indicative list of safety components)
4. lifting accessories
   components or equipment, not connected to the lifting machinery, which allow the load to be lifted, and which are arranged between the machinery and the load or on the load itself, or which are intended to become an integral part of the load and be placed on the market separately. Slings and their constituent parts are also categorised as lifting accessories
5. chains, ropes, and straps
   chains, ropes, and straps are items specifically designed and constructed for lifting purposes, forming an integral component of lifting machinery or lifting accessories.

removable mechanical transmission devices

refer to components intended for power transmission between self-propelled machinery or a tractor and driven machinery, achieved by connecting to the latter's first fixed bearing. Upon their introduction to the market alongside guards, they are deemed a singular entity
1. partly completed machinery
   denote assemblies that bear a close resemblance to a complete machine; however, in isolation, they lack the capacity to ensure a defined application. A drive system is a partly completed machinery. Partly completed machinery is exclusively designated for integration into or assembly with other machinery, partly completed machinery, or equipment, thereby forming machinery subject to the provisions outlined in the directive.

PLACING ON THE MARKET AND PUTTING INTO SERVICE

The regulations stipulated within the Machinery Directive are applicable to both machinery and partly completed machinery intended for placement on the market or putting into service. We see the difference:

• The term “placement on the market”, denotes the initial act of making machinery or partly completed machinery available within the Community, whether through commercial transactions or without charge, for distribution or utilisation.
• “Putting into service”, refers to the first use, conforming to its designated purpose, within the Community, of machinery subject to the provisions delineated within the directive.

Regarding this matter, the Machinery Directive delves into greater detail, elucidating comprehensively the requisite actions that the manufacturer (or their authorised representative) must undertake prior to the placement of a machine on the market and/or its commencement of service:

1. ensure that it meets the relevant essential health and safety requirements as per Annex I
2. ensure that the technical file is available
3. provide the necessary information, such as instructions
4. carry out the appropriate conformity assessment procedures
5. draw up the EC declaration of conformity and ensure that it accompanies the machine
6. affix the CE marking

Each of these points is further detailed, defining principles and objectives.

PRESUMPTION OF CONFORMITY

The Machinery Directive, like other directives, falls into the group of “new approach” directives. In fact, akin to the “old approach” directives, it no longer delineates specific safety objectives and methodologies for their attainment. Rather, it solely stipulates the objectives, allowing manufacturers absolute autonomy regarding the approaches to be adopted in achieving them.

As a matter of fact, the Machinery Directive provides indications of presumption of conformity:

• Machinery bearing the CE marking and accompanied by the pertinent EC declaration of conformity is presumed to adhere to the stipulations outlined within the Machinery Directive.
• Machinery crafted in accordance with a harmonised standard is presumed to align with the essential health and safety requirements outlined by said standard.

MACHINERY AND PARTLY COMPLETED MACHINERY

Machinery and partly completed machinery require different conformity assessment procedures.
For machinery, it is necessary to check whether it is

1. machinery not covered by Annex IV (i.e. not potentially hazardous)
2. machinery covered by Annex IV (i.e. potentially hazardous) and manufactured in accordance with harmonised standards
3. machinery covered by Annex IV (i.e. potentially hazardous) but manufactured without complying (or only partly complying) with the harmonised standards

depending on the situation, a different conformity assessment procedure will be used (either in-house or with the assistance of a verification body). For partly completed machinery, no conformity assessment procedure is necessary:

• prepare the relevant technical documentation, as per Annex VII, part B
• prepare the assembly instructions, as per Annex VI

prepare the declaration of incorporation, as per Annex II.

CE MARKING

The CE marking symbolizes the culmination of the CE certification procedure for a machine. It entails the visible, legible, and permanent application of a plate containing the CE symbol, adhering strictly to the model prescribed in Annex III.

All markings, signs, and inscriptions that could potentially mislead third parties regarding the interpretation or graphical representation (or both) of the CE marking are strictly prohibited. Any additional marking may be applied to the machinery, under the condition that it does not compromise the visibility, legibility, or significance of the CE marking.

A CE marking is deemed non-compliant under the following circumstances:

1. the application of the CE marking under the Machinery Directive on products not encompassed by its scope.
2. the absence of the CE marking and/or EC declaration of conformity for a machine
3. The application of a marking other than the CE marking on a machine, which is expressly prohibited under the directive.

In the event that a Member State determines the non-conformity of the marking with the provisions outlined in the Directive, the manufacturer or their authorised representative is obligated to rectify the product's non-conformity and cease the infringement in accordance with the conditions specified by the Member State.

If non-conformity persists, the Member State shall undertake all necessary measures to limit or prohibit the product's placement on the market, or to ensure its withdrawal from the market, in accordance with the procedure stipulated in the Directive.

MACHINERY DIRECTIVE ANNEXES

It is imperative to become familiar with the annexes of a directive. Those pertinent to the Machinery Directive are as follows:

1. Annex I – it contains the Essential health and safety requirements relating to the design and construction of machinery with specific regard to
   ◼ Additional requirements for
   – food machines as well as cosmetics and pharmaceutical machines
   – Portable hand–held and/or hand–guided machines
   – Machines for working wood and materials with similar physical characteristics
   ◼ Additional requirements to offset hazards due to the mobility of machinery
   ◼ Additional requirements to prevent hazards due to lifting operations
   ◼ Additional requirements for machinery intended for use in underground operations
   ◼ Additional requirements for machinery presenting particular hazards due to lifting persons
   
   
2. Annex II – features a more detailed description of
   ◼ the EC Declaration of Conformity of a machine
   ◼ the Declaration of incorporation of partly completed machinery
   ◼ the storing of the Declarations
   
   
3. Annex III – features an in–depth examination of the CE conformity marking
   
   
4. Annex IV – features the categories of machines that require verification by a Notified Body and specific conformity procedures, given the high risk of danger they involve
   
   
5. Annex V – an indicative list of safety components can be found here
   
   
6. Annex VI – instructions on how to package partly completed machinery can be found here
   
   
7. Annex VII – features the specifications for the technical file for machinery and the relevant technical documentation for partly completed machinery can be found here
   
   
8. Annex VIII – features Conformity Assessment, which includes internal checks on the manufacturing process
   
   
9. Annex IX – features the EC Type Examination (representative model of a machine)
   
   
10. Annex X – features Full Quality Assurance i.e. describes the conformity assessment of a machine referred to in Annex IV and manufactured using a total quality system
    
    
11. Annex XI – contains the Minimum criteria to be observed by Member States for the notification of bodies

You can download the document Machinery Directive 2006/42/EC

here