I. Definition & Purpose
The Directive 2006/42/EC is a revised version of the Machinery Directive, the first version of which was adopted in 1989. The new Machinery Directive was published on the 9th of June 2006, but it wasn’t applicable until the 29th of December 2009.
The Directive promotes harmonisation through a combination of mandatory health and safety requirements and voluntary harmonised standards. It further stimulates the free movement of machinery within the EU and ensures a high level of safety for EU workers and citizens. The Machinery Directive is only applicable to products that are to be placed on the EU market for the first time. There aren’t any radical changes introduced in the new Directive in comparison with its former versions. As overall, the purpose of the newly revised version is to clarify better and consolidate all provisions of the previous version of the Machinery Directive and improve its practical application.
Currently, the Machinery Directive 2006/42/EC includes the following types of products:
- Machinery and interchangeable equipment
- Safety components and lifting accessories
- Removable mechanical transmission devices
- Ropes, webbing and chains
- And, machinery that is partially completed.
The scope of the former Machinery Directive didn’t include an extensive list of equipment. However, significant changes were made in regards to the scope of the new Directive 2006/42/EC and several of the excluded-before product types were included in the directive’s scope and others only better clarified. Now, outside of the scope of the Directive is the following 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.
III. General mandatory health and safety requirements for placing machinery on the EU market
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. Afterwards, the design and construction of the machine must be following 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 recognised hazards and reduce all risks associated with them.
However, sometimes, when taking into account the state of the art, it may not be possible to be met all safety and health requirements. In such cases, the design and construction of the machine must be, as close as possible, in accordance with what is set as requirements in the Machinery Directive 2006/42/EC.
IV. Affected parties
In most of the cases, the Machinery Directive is part of the CE compliance process of products of:
- Manufacturers or machine builders
- Manufacturers that perform final assembly and CE Marking of machinery
- Or, manufacturers of special purpose tools, skids and rigs.
The Directive also affects agents and representatives that what to place imported machinery on the EU market.
V. Conformity of machinery under the Machinery Directive 2006/42/EC
The CE compliance process of any machinery should include the following steps, performed by the manufacturer:
- Ensuring that the product satisfies all essential health and safety requirements applicable to it.
- Carrying out all appropriate procedures necessary for assessing the conformity of the product
- Having a technical file with all the documentation related to the product’s compliance
- Drawing up a Declaration of Conformity and ensuring that it accompanies the product
- Affixing the CE marking on the product.
However, the process described above can be a bit different when it comes to partly completed machinery. In such case, the manufacturer needs to:
- Prepare all technical documentation described in Annex VII, Part B of the Directive
- 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.
VI. Safeguard procedure in case of non-compliant machinery
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 the essential requirements of the Machinery Directive 2006/42/EC
- Improper application of the harmonised standards
- Shortcomings in the harmonised standards themselves.
Then, after it is notified about the problem, the European Commission will consult with the parties concerned and take appropriate measures according to what is stated in the Directive 2006/42/EC.