Machinery Directive 2006/42/EC (6th Ed)
The new Machinery Directive 2006/42/EC became applicable on 29 December 2009, superseding the Machinery Directive 98/37/EC. While the two are broadly similar, there are significant differences that affect machine builders, those performing final assembly and CE marking of machinery, and those placing imported machinery on the market in the European Economic Area (EEA)
The directive covers a wide range of machinery defined as: "an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control, and power circuits, etc. joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material."
The Machinery Directive applies both to machinery for use by workers at work and to machinery for use by consumers or providing a service to consumers, i.e. where the consumer either uses the item or would be directly affected by any defect. In general, the design and construction of machinery must take account of the intended use.
The Machinery Directive applies to the following products:
• Interchangeable equipment
• Safety components
• Lifting accessories
• Chains, ropes, and webbing
• Removable mechanical transmission devices
• Partly completed machinery
The following are excluded from the scope of this Directive:
(a) safety components intended to be used as spare parts to replace identical components
and supplied by the manufacturer of the original machinery;
(b) specific equipment for use in fairgrounds and/or amusement parks;
(c) machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;
(d) weapons, including firearms;
(e) the following means of transport:
• agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles,
• motor vehicles and their trailers covered by Council Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), with the exclusion of machinery mounted on these vehicles,
• vehicles covered by Directive 2002/24/EC relating to the type-approval of two or three-wheel motor vehicles, with the exclusion of machinery mounted on these vehicles,
• motor vehicles exclusively intended for competition, and
• means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these vehicles,
(f) seagoing vessels and mobile offshore units and machinery installed on board such
vessels and/or units;
(g) machinery specially designed and constructed for military or police purposes;
(h) machinery specially designed and constructed for research purposes for temporary use in laboratories
(i) mine winding gear;
(j) machinery intended to move performers during artistic performances;
(k) electrical and electronic products falling within the following areas, insofar as they
are covered by Low Voltage Directive on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits:
• household appliances intended for domestic use,
• audio and video equipment,
• information technology equipment,
• ordinary office machinery,
• low-voltage switchgear and control gear,
• electric motors;
(l) the following types of high-voltage electrical equipment:
• switch gear and control gear,
It should be noted that section 1.5.1 of Annex I to the machinery directive requires the electrical aspects of machinery to meet the safety objectives of the Low Voltage Directive. Thus, whilst machinery with an electrical supply, which is not in any of the categories listed in Article 1(2) (k) of machinery directive, shall fulfil the safety objectives of the Low Voltage Directive, the manufacturer’s EC Declaration of conformity shall not refer to the Low Voltage Directive but to the machinery directive
Article 2 – Definitions
The definition of ‘machinery’ refers to a ‘drive system other than directly applied human or animal effort.’ Machinery may, therefore, be powered by natural sources of energy such as wind or water power.
Furthermore, machinery can be powered by manual effort that is not directly applied but stored (e.g by means of a spring, raised weight, or hydraulic or pneumatic accumulator) so that the machinery can function after the manual effort has ceased. The fourth indent of 2(a) makes it clear that assemblies of machinery may include partly completed machinery.
The definition of assemblies of machinery does not extend to a complete industrial plant consisting of a number of production lines each made up of a number of machines, assemblies of machinery and other equipment, even if they are controlled together by a single production control system. Only if the plant (which may be any combination of machinery, partly completed machinery and other equipment resulting in machinery subject to the Machinery Directive) forms a single integrated line is it subject to the Machinery Directive as an assembly.
Assemblies of machinery are subject to the Machinery Directive because their safety depends not just on the safe design and construction of their constituent units but also on the suitability of the units linked together and the safety of the interfaces between them.
Note; that there is now a harmonised standard for assemblies of machinery (EN ISO 11161:2007+A1:2010, Safety of machinery. Integrated manufacturing systems (Basic requirements) whereas no such standard was harmonised to the old Directive.
Interchangeable equipment means 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, in so far as this equipment is not a tool
Lifting accessory means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories;
Partly Completed Machinery
Whereas the old Directive referred to ‘machinery which cannot function independently’, the new Directive introduces – and more clearly explains – the concept of ‘partly completed machinery.’ Under the new Directive, a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation, assembly instructions, and declaration of incorporation.
For machine groups listed in Annex IV of the directive, self-declaration of conformance is not possible unless the product complies with a C-type standard in its entirety. For products that do not comply with a C-type standard, an EC type-examination carried out by a Notified Body must be made to assure conformance
Some products which are machinery (in both the strict and general sense as explained above) may also be covered by other product legislation in addition to the Machinery Directive, including:
• electrically powered/controlled machinery where the Electromagnetic Compatibility Directive (EMC) also applies
• machinery incorporating radio equipment where the Radio Equipment Directive also applies
• machinery incorporating pressure vessels where the Pressure Equipment and/or Simple Pressure Vessels Directives may also apply
• construction products subject to the Construction Products Regulation which are machinery for permanent incorporation in construction works (buildings), such as powered gates, doors, windows, shutters and blinds, ventilation and air conditioning systems
• non-road mobile machinery with combustion engines, where the gaseous and particulate emissions are covered by the Non-road Mobile Machinery Directive
• Noise emissions by equipment for use outdoors where the Outdoor Noise Directive also applies
Machinery modified before it is first put into service
In some cases, machinery is sold to an importer or a distributor who then modifies the machinery at the request of a customer before the machinery is put into service for the first time. If the modifications were foreseen or agreed by the manufacturer and covered by the manufacturer’s risk assessment, technical documentation and EC Declaration of Conformity, the original manufacturer’s CE marking remains valid. On the other hand, if the modification is substantial (for example, a change of function and/or performance of the machinery) and not foreseen or agreed by the manufacturer, the original manufacturer’s CE-marking becomes invalid and has to be renewed.
Placing on the market and putting into service
Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall:
(a) ensure that it satisfies the relevant essential health and safety requirements set out in Annex I
(b) ensure that the technical file referred to in Annex VII, part A is available;
(c) provide, in particular, the necessary information, such as instructions;
(d) carry out the appropriate procedures for assessing conformity in accordance with Article 12;
(e) draw up the EC declaration of conformity and ensure that it accompanies the machinery;
(f) affix the CE marking in accordance with Article 16.
Technical Construction File
The technical file provides the relevant technical documentation which enables a manufacturer to explain the measures he has taken to deal with the risks associated with the machinery in order to comply with the applicable essential health and safety requirements.
Therefore, the manufacturer’s technical construction file is both a means to enable the market surveillance authorities to check the conformity of machinery after it has been placed on the market and a means for the manufacturer to demonstrate the conformity of his product
The technical file shall comprise the following:
(a) a technical construction file including:
• a design risk assessment to ISO 12100:2010 the risk assessment demonstrating the procedure followed, including:
o a list of the essential health and safety requirements which apply to the machinery,
o the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery,
• a general description of the machinery,
• the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery,
• full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements,
• the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards if not using a 'C' Type standard,
• any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,
• a copy of the instructions for the machinery,
• where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery,
• where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery,
• a copy of the EC declaration of conformity;
(b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive.
The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.
A technical file is required for each model or type of machinery. The terms 'model' or 'type' designate machinery with a given design, technical characteristics and application. A type of machinery may be produced in series or as a single unit. One type of machinery may have variants; however, to be considered as belonging to the same type, variants must have the same basic design, present similar hazards and require similar protective measures. The description of the machinery in the technical file must specify any variants of the model or type concerned.
Standards have been defined as "an agreed, repeatable way of doing something". Normally they are published documents containing technical information to guide or define practice in a consistent way, and are used by designers and manufacturers of products to establish conformity.
Standards are valuable tools that can help your business to:
• ensure the quality and safety of products and/or services
• achieve compatibility between products and/or components
• access markets and sell to customers in other countries
• satisfy your customers’ expectations and requirements
• reduce costs, eliminate waste and improve efficiency
• comply with relevant legislation including EU regulations
• gain knowledge about new technologies and innovations
Knowing which standards to use, and how to apply them in the correct way, is vital for the
success of your business. It is also important to understand how standards contribute to the regulatory process.
At present harmonised standards to the machinery, directive are listed in the official journal listed below. Note the difference between Type A, B, and C standards?
Type A standards are basic safety standards covering basic concepts, design principles, and general aspects that can be applied to all machinery.
Example of a Type A standard:
• EN ISO 12100 - General principles for design
Type B standards are generic safety standards covering safety aspects or one type of safeguard that can be used across a wide range of machinery. However, there are two types of B standards,
Type B standards are divided into two groups B1 standards for particular safety aspects and Type B2 standards for safeguards.
Examples of Type B1 standards:
• EN ISO 13849-1/-2 - Safety-related parts of control systems
• EN ISO 13855 - Positioning of safeguards
Examples of Type B2 standards:
• EN 574 - Two-hand control devices and
• EN 14120 - Fixed and movable guards
Type C standards are machine safety standards dealing with detailed safety requirements for a particular machine or group of machines.
Examples of Type C standards:
• EN 693 - Hydraulic presses
• EN 13736 - Pneumatic presses
If a Type C safety standard does exist, and there are discrepancies between the related Type B and Type C safety standards, the Type C safety standard takes precedence over the Type B standard
The products as a minimum have the following markings:
• Product type,
• Batch or serial number
• Manufactures, registered trade name
• A contact address
• The year of construction,
• A CE mark
The EC Declaration of Conformity of machinery
Annex II 1 A concerns the EC Declaration of Conformity that must be drawn up by the
manufacturer of machinery or his authorised representative in the EU and that must accompany the machinery until it reaches the user. The EC Declaration of Conformity is a legal statement by the manufacturer or his authorised representative attesting that the machinery concerned complies with all of the relevant provisions of the Machinery Directive.
The EC declaration of conformity must contain the following particulars:
1. business name and full address of the manufacturer and, where appropriate, his authorised representative;
2. name and address of the person authorised to compile the technical file, who must be established in the Community;
3. description and identification of the machinery, including generic denomination, function, model, type, serial number and commercial name;
4. a sentence expressly declaring that the machinery fulfils all the relevant provisions of this Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies. These references must be those of the texts published in the Official Journal of the European Union;
5. where appropriate, the name, address and identification number of the notified body which carried out the EC type-examination referred to in Annex IX and the number of the EC type-examination certificate;
6. where appropriate, the name, address and identification number of the notified body which approved the full quality assurance system referred to in Annex X;
7. where appropriate, a reference to the harmonised standards used, as referred to in Article 7(2);
8. where appropriate, the reference to other technical standards and specifications used;
9. the place and date of the declaration;
10. the identity and signature of the person empowered to draw up the declaration on
behalf of the manufacturer or his authorised representative.
The declaration of incorporation must contain the following particulars:
1. business name and full address of the manufacturer of the partly completed machinery and, where appropriate, his authorised representative;
2. name and address of the person authorised to compile the relevant technical documentation, who must be established in the Community;
3. description and identification of the partly completed machinery including generic denomination, function, model, type, serial number and commercial name;
4. a sentence declaring which essential requirements of this Directive are applied and fulfilled and that the relevant technical documentation is compiled in accordance with part B of Annex VII, and, where appropriate, a sentence declaring the conformity of the partly completed machinery with other relevant Directives. These references must be those of the texts published in the Official Journal of the European Union;
5. an undertaking to transmit, in response to a reasoned request by the national authorities, relevant information on the partly completed machinery. This shall include the method of transmission and shall be without prejudice to the intellectual property rights of the manufacturer of the partly completed machinery;
6. a statement that the partly completed machinery must not be put into service until the final machinery into which it is to be incorporated has been declared in conformity with the provisions of this Directive, where appropriate;
7. the place and date of the declaration;
8. the identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or his authorised representative.
HOW WE CAN HELP:
Our customers contact us because they need help and advice on how to apply the UKCA or CE Mark to their products.
The CE Marking Authority have a positive attitude and approach regulatory compliance by looking at the opportunities rather than seeing them as an inconvenience and meddling with your practices. We specialise in staying ahead of the game by using our technical knowledge (skills) conducting the necessary assessments to help our clients demonstrate their technical files meet the requirements of the regulations
Our expert team is here to help you meet the UKCA and CE Marking the requirements
• Free initial consultation to assess your requirements and plan the CE marking of your product.
• Identify the statutory instruments, the essential safety requirements, and harmonised standards, which apply to the product.
• Perform design risk assessments and clause by clause assessments against the designated standards
• Conduct a product compliance report to the applicable requirements outlining areas of non-compliance and advice on how to close out any gaps found.
• Assist in the compilation of the technical construction file, which contains the information required by the EU safety regulations.
• Provide a draft EU Declaration of Conformity and help you complete it.
• Offer follow up advice on changes in requirements for the life cycle of the product
• Act as your Authorised Representative in the UK or EU via or European office if required.
The many benefits of compliance range from brand and reputation, revenue enhancement, asset protection, higher profitability and lower costs, improved workforce performance, the provision of better data for better-made business decisions, and allows for a total harmonisation of your systems