The Machinery Directive, what is it and how does it impact your business? How is it related to CE marking and European Union’s product certification rules? In this Definitive Guide to the Machinery Directive 2006/42/EC, you will find the answers to these questions and more. You will learn why there is a Machinery Directive, to whom it concerns, what it is all about, and how to achieve CE compliance for machinery.
Table of Contents
What is the Machinery Directive 2006/42/EC?
The Machinery Directive is a European Union directive concerning machinery and certain parts of machinery: mandatory specifications in health and safety are combined with voluntary harmonized standards. The Machinery Directive applies to machinery as well as interchangeable equipment, safety components, lifting accessories, chains/ropes/webbing, removable mechanical transmission devices, and partly completed machinery.
Directive 2006/42/EC is all about safety. Safety of machinery, but also the safety of related products are regulated. It provides the requirements that products must comply with. The potential for the machinery to create hazardous situations must be minimized, or -even better- eliminated. It also lays out the procedures how to assess conformity.
Why did the European Union adopt a regulation for machinery?
The aim of the Machinery Directive is to harmonize essential health and safety requirements for machinery between all member states of the European Union. Common rules allow for the removal of trade restrictions, and the free movement of machinery within the EU market. At the same time, the requirements guarantee a high level of protection for European workers and European citizens. Safe machinery and fair competition, that’s the purpose.
Which products are covered by the Machinery Directive?
The directive applies to the following types of products:
- Interchangeable equipment
- Safety components
- Lifting accessories
- Removable mechanical transmission devices
- Ropes, webbing and chains and
- Partly completed machinery.
Let’s look into each of these in more detail:
- ‘Machinery’ is defined as an assembly of linked parts or components of which at least one moves and joined together for a specific application, fitted with a drive system other than directly applied human or animal effort. A conveyor belt, for example, is a machine in its own right. Applications with only directly applied human power may be machinery if intended for lifting and lowering loads, for example, a pulley is a machinery.
- ‘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.
- A ‘safety component’ means a component: which serves to fulfill a safety function, which is independently placed on the market, the failure and/or malfunction of which endangers the safety of persons, and which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function. An indicative list of safety components is set out in Annex V link to an external website, which may be updated in accordance with Article 8(1)(a)
- A ‘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.
- ‘Chains, ropes and webbing’ means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories.
- ‘Removable mechanical transmission device’ means a removable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing. When it is placed on the market with the guard it shall be regarded as one product.
- ‘Partly completed machinery’ means it is an assembly that is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. 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 the Directive applies.
Which products are exempted from the Machinery Directive?
Some types of machinery and equipment are exempted from Directive 2006/42/EC. Typically, this is because these are covered by other, specific EU regulations. Currently outside of the scope of the directive are the following types of equipment:
- Equipment used explicitly in fairgrounds and/or amusement parks.
- Weapons, with the inclusion of firearms.
- Means of transport, such as forestry and agricultural tractors; motor vehicles and trailers covered by Council Directive 70/156/EEC; vehicles covered by Directive 2002/24/EC; vehicles meant for competing; air/water/rail means of transport, excluding any machinery mounted on them.
- Any military and police machinery.
- Any research machinery for temporary use in labs.
- Mind winding gear.
- Machinery equipment intended to move performers during artistic performances.
- High-voltage equipment, such as switch and control gears, and transformers.
- Safety components used as spare parts for replacing identical components in the original machinery.
- Machinery equipment for nuclear purposes that, in the event of failure, can emit radioactivity.
- Mobile offshore units and seagoing vessels, and any machinery mounted on them.
- Electrical and electronic equipment, such as ordinary office machinery, electric motors, audio, and video equipment, domestic household appliances, information technology equipment, and, low-voltage switch and control gears.
Who is responsible for compliance with the Machinery Directive?
The following persons or companies are responsible for compliance of machinery with the Machinery Directive:
- Machine builders.
- Assemblers of machine parts or installations.
- Manufacturers of special-purpose tools, skids and rigs.
- Machinery importers located in the EU.
- Machinery distributors or dealers that buy from the EU-based manufacturer or importer have the obligation to verify that the conformity assessment was performed and that the necessary documentation and information is available.
How to comply with the Machinery Directive (2006/42/EC)?
The compliance process of any machinery should include the following steps, performed by the manufacturer:
- Determine the applicable essential health and safety requirements from the directive and from related harmonised standards.
- Conformity assessment: ensure that the product satisfies all essential health and safety requirements applicable to it.
- Compile the set of technical documentation proving the machinery’s compliance with the requirements into a Technical File.
- Draw up an EU Declaration of Conformity and ensure that it accompanies the product.
- Affix the CE marking to the product.
- Take steps to ensure the machinery remains in compliance, even after modifications and after amendments of the regulations and standards.
However, the process described above can be a bit different when it comes to partly completed machinery. In such a case, the manufacturer needs to:
- Prepare all technical documentation described in Annex VII, Part B of the Directive and ensure compliance by doing the conformity assessment
- Prepare assembly instructions as defined in Annex VI of the Directive.
- Draw up a Declaration of Incorporation as stated in Annex II, part 1, section B.
- Ensure that the assembly instructions and the Declaration of Incorporation accompany the partly completed machinery. The CE marking may not be affixed to partly complted machinery.
There are basically two ways for manufacturers to perform the conformity assessment.
The Machinery Directive (2006/42/EC) offers two ways to perform conformity assessment: ‘self-certification’ or ‘self-declaration’ versus third party certification. Read this linked article to learn more about how for most products CE marking self-certification is allowed.
1. Internal Production Control or CE marking self-certification: the manufacturer performs the conformity assessment and documents the assessment in his own right.
When putting machinery on the EU market, manufacturers must guarantee that a risk assessment is carried out. The purpose of the risk assessment is to determine all the necessary health and safety requirements applicable to the machinery. Afterward, the design and construction of the machine must follow the results of the risk assessment.
Usually, what the manufacturers need to do in regards to the risk assessment is:
- To determine the limits of the machinery when used.
- To make sure all hazards, which the machinery can generate, are identified and considered, along with all associated hazardous situations.
- To estimate all possible health risks and their probability of occurrence.
- To evaluate all the identified risks and determine if risk reduction is needed.
- To eliminate all recognized hazards and reduce all risks associated with them.
2. Involvement of a Notified Body: For higher risk machinery (listed in Annex IV to the Machinery Directive, as seen in the paragraph above), for which no European harmonized standards are available, or for which the manufacturer did not apply these standards, the manufacturer is required to involve a third-party certification body, or so-called ‘Notified Body’. This is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation when a third party is required.
The following machines are listed in Annex IV of the Machinery Directive, and this means that for these machines it is mandatory to involve a Notified Body in the conformity assessment if the manufacturer has not used (all) European harmonised standards:
- Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
- 1.1. sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the workpiece or with a demountable power feed;
- 1.2. sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage;
- 1.3 sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading;
- 1.4. sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading.
- Hand-fed surface planing machinery for woodworking.
- Thickeners for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking.
- Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
- 4.1. sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece;
- 4.2. sawing machinery with blade(s) assembled on a carriage with reciprocating motion.
- Combined machinery of the types referred to in points 1 to 4 and in point 7 for working with wood and material with similar physical characteristics.
- Hand-fed tenoning machinery with several tool holders for woodworking.
- Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics.
- Portable chainsaws for woodworking.
- Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.
- Injection or compression plastics-moulding machinery with manual loading or unloading.
- Injection or compression rubber-moulding machinery with manual loading or unloading.
- Machinery for underground working of the following types:
- 12.1. locomotives and brake-vans;
- 12.2. hydraulic-powered roof supports.
- Manually loaded trucks for the collection of household refuse incorporating a compression mechanism.
- Removable mechanical transmission devices including their guards.
- Guards for removable mechanical transmission devices.
- Vehicle servicing lifts.
- Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than three meters.
- Portable cartridge-operated fixing and other impact machinery.
- Protective devices designed to detect the presence of persons.
- Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11.
- Logic units to ensure safety functions.
- Roll-over protective structures (ROPS).
- Falling-object protective structures (FOPS).
What if the machinery does not comply?
If machinery does not comply with the requirements of the Machinery Directive (2006/42/EC), or any other EU directive or regulation that applies to it, it may not be made available in the market. Compliance is checked and enforced by market surveillance authorities of the EU Member States. (In other words, there is not a European Union agency or organisation that checks CE conformity.)
In the event of discovering non-compliant machinery placed on the EU market, the Member State can take immediate actions to:
- Withdraw such products from the market.
- Prohibit the placing on the EU market and/or putting into service of such machinery.
- Restrict the free movement of such equipment.
Consequently, the Member State will inform the European Commission and the other Member States of its actions, stating the motives for its decision, which could be related to:
- Failure to comply with the essential requirements of the Machinery Directive 2006/42/EC.
- Improper application of the harmonized standards.
- Shortcomings in the harmonized standards themselves.
- Significant safety risks, despite compliance with the requirements and standards.
Then, after it is notified about the problem, the European Commission will consult with the parties concerned, inform all other member States and take appropriate measures according to what is stated in the Directive 2006/42/EC.
Do you need CE marking for machinery?
Are you making available machinery, safety components, interchangeable equipment or any other products covered by Directive 2006/42/EC in the EU market? In that case, your product may need to comply with the CE rules. Hopefully, this article has provided you with the guidance to get started.
We understand that the requirements can be complex. The process is daunting and rather intimidating, considering that all your efforts may be in vain if you don’t get it right. We will be happy to help. We offer consulting and coaching solutions and can tailor our services to your specific needs.
Reach out to us by phone, or simply fill out the form below to ensure we have the information we need to provide you with a fitting offer. Our team looks forward to assisting you.
Other articles that may interest you:
- What is CE marking?
- What does the CE mark mean? What do the initials CE stand for?
- Do your products need CE marking?
- How do you benefit from CE marking??
- In which countries is the CE marking required?
- What does CE certification cost?
- Do our products automatically qualify for the CE mark when they are UL/CSA approved?
- Who should undertake CE marking?
- Notified Bodies: What Are They? What Is Their Role
- What is the CE marking process?
- What files / documentation must I keep?
- How and where must the CE mark appear?
- Other Posts About CE Marking
- The Machinery Directive (2006/42/EC) is amended by the new Machinery Regulation (EU) 2023/1230.
Other CE Directives and Regulations
- Machinery Directive
- Low Voltage Directive
- EMC Directive
- Medical Devices Regulation
- Personal Protective Equipment Regulation
- Construction Products Regulation 305/2011
- Pressure Equipment Directive
- REACH Regulation
- Restriction of Hazardous Substances Directive (RoHS)
- ATEX Directive
- Toys Safety Directive (2009/48/EC)
- Radio Equipment Directive
- Recreational Craft and Personal Watercraft Directive
- Active Implantable Medical Devices Directive
- Explosive for Civil Use (CIVEX) Directive
- Noise Emission Directive
- Gas Appliances Directive 2009/142/EEC
- Lifts Directive 1995/16/EC
- Pyrotechnic Directive 2013/29/EU
- Measuring Instruments Directive