Machine safety in Europe

EU single market directives are the basis for the free movement of goods within the EU. In order to dismantle trade barriers in the EU single market, over 20 EU single market directives have been drawn up for product groups and product aspects. Affected products may only be distributed if they satisfy the basic requirements of the relevant EU directives. 
If a product complies with the relevant harmonized EU standards assigned to a EU directive, it is assumed that the basic safety and health protection requirements are met. This is referred to as the "presumption of conformity" of a harmonized standard: the user of a standard only needs to prove that it has complied with the specified standards – but not that the applied standards adequately reduce the residual risks.
A manufacturer can also use technical solutions other than those described in the standards, provided that an equivalent safety level is proven. In this case, however, the burden of proof lies with the manufacturer. 
Fulfillment of the basic requirements is determined in a formal conformity assessment procedure. Depending on the potential risk of the products, this is largely the responsibility of the manufacturer.

Key EU directives for machine safety:

Safety at Work Framework Directive 89/391/EEC contains minimum requirements and general basic principles for the prevention of work-related hazards, for safety and health protection, for minimizing and eliminating risk and accident factors, and for the appropriate instruction of employees. These are minimum requirements. Each EU Member State may increase the protection level in its national implementation or, for example, set higher test requirements.

Key directives for EU occupational safety:

Machine

A "machine" in terms of the Machinery directive is "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".

Furthermore, various safety-relevant parts such as safety components are regarded as a "machine" in terms of the Machinery directive.

Machines may be put into circulation in Europe only if they have a valid CE marking. This also applies to machines that are manufactured for own use by an operating company as well as to existing machines that have been substantially modified by the operating company or by an integrator.

Partly completed machine

A "partly completed machine" in terms of the Machinery directive is " an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is a partly completed machine. 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".

Quasi machines that are not operational on leaving the factory and only receive their specific functionality through e.g. programming, are partly completed machines. This includes e.g. the drive units already mentioned in the definition, but also industrial robots.

In accordance with the Machinery directive, partly completed machines must be delivered with a declaration of incorporation. The CE marking must be performed by the machine builder or system integrator together with the then "complete" machine.

Assembly of machinery

An "assembly of machinery" exists when multiple individual machines, partly completed machines and other components interact, are arranged and actuated so closely that they can only function usefully as an assembly. This requires both a production-related and a safety-related relationship to exist between all elements. This relationship must be so close that the assembly of the elements must be regarded as a unit. Consequently, this assembly which must be regarded as an autonomous unit requires a separate CE marking irrespective of whether or not individual components of this unit already have a CE marking – the assembly of machinery is a machine in its own right. An essential requirement for the CE marking of an assembly of machinery is a risk assessment of the assembly. In order to do this earnestly, the manufacturer of the assembly of machinery must obtain the necessary information from the manufacturer of each of the elements – a task that is not always straightforward.

A production line consisting of individual machines does not usually require its own CE marking because it is frequently the case here that the production line does not form an assembly of machinery. If an element of a presumed assembly of machinery can be removed relatively easily and replaced by another equivalent element without causing substantial modification of a control system assigned to the assembly of machinery, this is probably not an "assembly of machinery" in terms of the Machinery directive. 
As applicability of the Machinery directive with respect to placing individual machines on the European market is limited, for a "normal" production line consisting of individual machines it unfortunately does not define a document providing an alternative to an EU declaration of conformity. Here, in public law according to the Machinery directive, there is no additional document that applies to the entire line. Due to uncertainty or for convenience, so-called "overall CE declarations" or even "declarations of incorporation" are often issued in practice for entire production lines. According to the Machinery directive, however, a switch-on prohibition is associated with a "declaration of incorporation" – the declaration after all defines the machinery as a partly completed machine.

If required/on request, Leuze recommends issuing a "declaration of integration" based on private law for a normal production line. This declaration of integration indicates that no "assembly of machinery" exists in terms of the Machinery directive.

The Machinery directive not only governs products of a machine manufacturer or system integrator in the European Economic Area, but also:

Machines that an operating company manufactures itself for own use in the European Economic Area.

• Imported used or new machines from a third country outside of the European Economic Area. This also applies e.g. in the case of a used machine that is put into circulation for the first time in the European Economic Area.
• New or used machines that are put into circulation for the first time in the European Economic Area by non-European subsidiaries (e.g. multinational companies). This also applies in the case of exclusively own use.

In addition to machines, the following also fall under the scope of the Machinery directive:

• Replaceable equipment
• Load receptacles
• Chains/ropes/straps for lifting purposes
• Removable joint shafts
• Lifting devices with a travel speed of up to 0.15 m/s of the load carrier, at a travel speed in excess of 0.15 m/s, they are subject to the Lift directive (if they are not covered by its rules of exception)
• Construction site lifts
• Safety components

All affected products must be distributed with the CE marking, declaration of conformity and the necessary user information.

The following do not fall under the Machinery directive, e.g.:

• Safety components that are intended only as spare parts
• Equipment on fairgrounds
• Machinery for nuclear use
• Weapons and machinery for military purposes
• Vehicles
• Mining machinery
• Stage equipment
• Electrical devices for domestic use, audio/video, information technology, office equipment, electric motors, switching and control devices, transformers

What do machine manufacturers and distributors have to comply with?

1. The basic safety requirements of Annex I must be met. This means that early in the design phase the designer must perform a parallel risk assessment so that all required measures for risk reduction are already considered in the machine’s construction phase.
2. The technical documentation for the machine including measurement and test results must be up to date and complete and must be archived for at least 10 years. It must be possible to present the documentation at the request of national authorities.
3. The user information must contain all safety-relevant details regarding intended use, residual dangers and possible misuse of the machine.
4. One of three possible conformity assessment procedures must be performed. For machines that are not listed in Annex IV (List of particularly dangerous machines and safety-relevant components), the manufacturer itself can perform the conformity assessment procedure.
5. The manufacturer compiles a declaration of conformity and thereby certifies observance of the requirements from the Machinery directive and from any other applicable EU directives.
6. Finally, the manufacturer affixes the CE mark.

The user information for partly completed machines differs from that for (complete) machines. While machines have to be delivered with warning notices and a set of operating instructions in the language of the country in which the machine is distributed, a set of assembly instructions as defined in Annex VI (Assembly instructions for partly completed machinery) must be enclosed with a partly completed machine. Partly completed machinery too can be put into circulation as long as it has a CE marking – however, this machinery must then comply with other EU directives such as the low voltage directive or EMC directive. An EU declaration of conformity with reference to the Machinery directive as well as all EU directives referenced by the used partly completed machines must then be issued by the integrator or the manufacturer of the complete machine and enclosed with the machine documentation.

The Machinery directive defines three conformity assessment procedures, at the end of which, provided that all steps are successfully completed, the CE mark is granted.

Procedure in accordance with Machinery Directive 2006/41/EC to obtain the declaration of conformity for
Machines and safety components

The Machinery directive defines extremely precisely the expected content of the EC declaration of conformity for a (completed) machine and for the declaration of incorporation of a partly completed machine.

It is often the case that not only conformity with the Machinery directive has to be declared for machines, but where necessary also conformity with the EMC directive, the RED (Radio equipment directive), the ATEX directive and other directives. All relevant EU directives must be given in exactly one declaration of conformity for the machine, not separately in various declarations of conformity for each directive. The electrical equipment of machines is covered by the harmonized standard EN 60204-1 (Safety of machinery – Electrical equipment of machines – Part 1: General requirements). The Low voltage directive (2014/35/EU) is therefore not named in a EU declaration of conformity for machines.