Machinery Directive 2006/42/EG and CE marking
Machinery Directive 2006/42/EG
Each machinery that is traded or put into service within the European Union must comply with the essential health and safety requirements provided by the Machinery Directive 2006/42/EG. This directive ensures the highest possible safety level for consumers and employers and protection of the environment. In this article you will read what a manufacturer or importer needs to know and do in order to obtain a CE marking.
Which products fall within the scope of the Machinery Directive?
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 exact definition of these product groups can be found in article 2 of the directive.
Machinery specially manufactured or imported for domestic use also falls within the scope of this directive.
Which products do not fall within the scope of the Machinery Directive?
There are also a large number of products that are excluded from the scope of the Machinery Directive. These are:
- Safety components that replace identical components and are supplied by the manufacturer of the original machinery;
- Material specially intended for use in fairgrounds and/or amusement parks;
- Machinery specially designed or in operation for nuclear purposes, which in the event of any defect, may result in an emission of radioactivity;
- Weapons, including firearms;
- Agricultural and forestry tractors, motor vehicles and their trailers covered by Directive 2003/37/EC and 70/156/EEC, as well as vehicles covered by Directive 2002/24/EC;
- Motor vehicles exclusively intended for competition;
- Means of transport by air, on water and on rail networks, with the exclusion of machinery mounted on these means of transport;
- Seagoing vessels and mobile offshore units;
- Machinery specially designed and built for military, police or temporary use in laboratories;
- Mine winding gear;
- Machinery intended to move performers during artistic performances;
- Specific electrical and electronical devices covered by the Low voltage directive, among which, household appliances for domestic use, audio and video equipment, information technology (IT) equipment, ordinary office machinery, low voltage switch gear and control gear, and electric motors;
- Switch gear, control gear and transformers for high voltage installations.
When is CE marking on machinery mandatory?
CE Marking on machinery is always mandatory in case it was manufactured to be traded or put into service after 1 January 1995.
It is not mandatory to affix a CE marking on machinery that was traded before 1 January 1995. This machinery must, however, comply with the Work Equipment Directive 2009/104/EC.
In case such machinery was adjusted functionally, however, after 1 January 1995, then CE marking becomes mandatory again.
When must the CE marking be affixed to the machinery?
The CE marking must be affixed to the machinery, before the machine is placed on the market or put into service. This also applies to:
An assembly consisting of different machinery. In that case the assembly is regarded as a “new” machinery or installation which requires a new CE marking;
An existing machinery or installation that is functionally adjusted. In that case this machinery will also be regarded as a “new” machinery or installation and require a CE marking as well;
Machinery from outside the EC that is placed on the EC market. The importer shall then be considered a manufacturer.
Which procedure must be followed for CE marking?
Before you place a machinery on the European market or put it into service, it must comply with the essential requirements of the Machinery Directive and be affixed with the CE marking. In order to reach this goal, the following steps must be followed:
- Product classification: define whether your machinery falls within the scope of the Machinery Directive and/or other CE requirements. It is also possible that your machinery falls within the scope of other regulations, such as the Pressure Equipment Directive, the Low Voltage Directive or the EMC Directive. In that case more requirements are applicable;
- Risk analysis: carry out an analysis in order to determine what potential risks this machinery entails and which essential health and safety requirements of the Machine Directive will be applicable in that case. The possibly identified risks must be restricted to the lowest possible risk level;
- Conformity procedure: determine whether the machinery complies with the requirements mentioned in step 2;
- Technical documentation: draft a technical file, or, in case you are an importer, verify the technical documentation that has been supplied with the machinery. The technical documentation proves that the machinery is in accordance with the Directive and includes, among others, construction drawings, a User Manual and a description of the performed risk assessments. After the last manufacturing date of the machinery, the technical documentation must be kept for at least 10 years;
- CE Declaration of Conformity: draw up a CE Declaration of Conformity. This declaration is also referred to as a CE Certificate or EU Declaration of Conformity. This declaration is a document stating that your machinery complies with the Machinery Directive. With this declaration you take full responsibility for the conformity of your machinery. The declaration must comply with the requirements referred to in Annex II (section 1.A) of the directive. This declaration must contain your signature and be maintained for at least 10 years. At the request of regulators the declaration must be provided.
Are you the manufacturer of partly completed machinery? In that case you must draw up a declaration of incorporation, stating 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 Machine Directive. This declaration must comply with the requirements referred to in Annex II (section 1. B) of this directive.
- CE marking: if you have successfully completed all previous steps, you will be authorized to affix the CE marking on the machinery. The CE marking must be affixed visibly, legibly and indelibly to the machinery, and in the immediate vicinity of the name of the manufacturer. In case a Notified Body was involved in the conformity assessment procedure of a hazardous machinery (see below), then in that case its identification number must also be included. Further instructions on affixing the CE marking can be found in Annex III of the Directive.
Who is responsible for the CE marking procedure?
As a manufacturer or importer you yourself are responsible for this procedure. This means then that you are allowed to apply this procedure yourself, except when hazardous machinery that is not manufactured according to the EN-standards, is involved.
Annex IV of the directive contains a limitative list of hazardous machinery, such as sawing machinery, planing machinery, presses and (high) hoisting and lifting equipment. In case these machineries are not entirely manufactured according to the EN-standards, these must be assessed by a so called Notified Body. The Notified Body will then carry out a conformity assessment and will see to it that the Technical Documentation will sufficiently support the compliance with the product requirements. After the Notified Body has given its approval of the product conformity, they will present to you a CE Declaration of Conformity for confirmation.
Who is responsible for supervising the compliance with the Machinery Directive?
In the Netherlands the Social Affairs and Employment Inspectorate (SZW) (machinery for professional service) and the Dutch Food and Drug Administration (Nederlandse Voedsel- en Warenautoriteit) (machinery for domestic use) are responsible for supervising the compliance with the Machinery Directive.
Sanctions in case of a machinery without the CE marking may vary from a warning to a penalty for infringement of the Commodities Law (to a maximum of € 810.000,-).
Should we carry out the entire CE marking procedure ourselves?
No, you do not have to carry out the procedure yourself. Certification-Company can perform the entire CE marking procedure on your behalf. Feel free to contact one of the experts of Certification Company.