CE Mark Requirements for Machinery

Updated March 4th, 2000

© copyright Heinrich Birck, BICON GmbH, Frankfurt, Germany, 1996-2000. All rights reserved. You may copy and distribute this report provided that a) the report is distributed in its entirety including all pages b) the report is provided free of charge.

EC directive 89/37/EEC (former directive 89/392/EEC together with its amendments 93/44/EEC and 93/68/EEC) makes the CE Mark mandatory effective January 1st, 1995 for all machinery which falls under the definitions of that directive. The compliance with the EC directives doesn't depend on a voluntary decision. If somebody likes to sell his products (which are subjected to a EC directive) in or into the European Market, then his products have to comply with. In a short form: No CE Mark - No sales! So if you want to sell a machine into the European Community, your machine must carry the CE Mark, and it has to be accompanied by a document called EC declaration of conformity (CE = Communauté Européenne, EC = European Community).

In this document the manufacturer or authorized representative declares that the machinery is designed and built according to all applicable European safety standards.

It has to be pointed out that all requirements mainly apply to the safety of the machine and not to the entire technical system and technology. Safety means safety of persons, of the environment, of goods, and in several countries including Germany safety of pets as well.

This may look like another hurdle if you want to sell to the European Community. However, the basic idea behind it is simple: once you have taken the hurdle you can sell to any country of the European Community without further technical changes necessary. The member states of the EC shall not prohibit, restrict or impede the placing on the market and putting into service in their territory of machinery which complies with the provisions of the EC directive.

Definition of Machinery

For the purpose of the directive, 'machinery' means 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 material.

The directive does even apply to machinery that are not stand alone systems. The term 'machinery' also covers an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integrated whole.

The individual components of the machinery do not have to carry the CE Mark. However, some separately sold components ("safety components, placed on the market separately") will need to bear the CE Mark.
Exception: where, for machinery, the risks are mainly of electrical origin, such machinery is covered exclusively by the Low Voltage Directive 73/23/EEC, which is not covered by this report.

Additionally the EMC (electromagnetic compatibility) Directive 89/336/EEC has come into effect since January 1st, 1996. Manufacturers must ensure their products conform to this strict directive. Not only must they not emit electromagnetic disturbances, they must also be immune to them. Any electrical product that could be construed as having an intrinsic purpose (i.e. is not simply a component), will have the CE marking to indicate conformity.

What CE standards are applicable for machinery?

What standards your machine has to comply with depends on the machine itself and its use. The standards are so numerous that usually a database search is required.

The most important harmonized standards which most likely apply to your machinery are

EN 60204: Safety of machinery - Electrical equipment of machines; Part 1: General Requirements; (Identical to the German standard VDE 0113, Teil 1)
EN 292: Safety of machinery. Basic terminology. General principles; Part 1 and 2

A harmonized standard is a standard which is harmonized for use in all member states of the European Community.

The manufacturer retains the responsibility for certifying the conformity of their machinery to the relevant essential requirements. Conformity to harmonized standards creates a presumption of conformity to the relevant essential requirements. It is left to the sole discretion of the manufacturer, where he feels the need, to have his products examined and certified by a third party.

Hazard Assessment

The manufacturer is under an obligation to assess the hazards in order to identify all those which apply to his machine; he must then design and construct it taking his assessment into account. The assessment is to be recorded and included in the construction file.

Documentation

Before issuing an EC declaration of conformity it is essential that the manufacturer or his authorized representative established in the European Community provides a technical construction file. It is not, however, essential that all documentation be permanently available in a material manner but it must be made available on demand. If a competent national authority asks that full documentation be presented, it will suffice that this documentation is compiled and made available in a reasonable time frame.

The documentation need not include detailed plans of the subassemblies used in manufacturing the machines, unless knowledge of these is indispensable in order to ascertain conformity with essential safety requirements.

The technical construction file comprises

an overall drawing of the machinery together with drawings of the control circuits
full detailed drawings, accompanied by any calculation notes, test results, etc required to check the conformity of the machinery with the essential safety and health requirements.
a list of
- the essential requirements of the EC directive
- standards, and
- other technical specifications, which were used when the machine was designed
if he so desires, any technical report or certificate obtained from a competent body or laboratory
if he declares conformity with a harmonized standard which provides therefor, any technical report giving the results of tests carried out at his choice either by himself or by a competent body or laboratory
a description of methods adopted to eliminate hazards presented by the machinery
a copy of the instructions for the machinery.

The above construction file has to be in any one official language of the EC and will be accepted in other EC countries as well, even if a different language is spoken there. The maintenance manual may be required in local language; this differs from case to case, see below. The operating manual is always needed in local language.

You will find this info in the EC directive 89/392/EEC amended by directive 93/44/EEC Annex 1, 1.7.4: "... On being put into service, all machinery must be accompanied by a translation of the instructions in the language of the country in which the machinery is to be used and by the instructions in the original language. .... By way of derogation of this requirement, the maintenance instructions for use by specialized personnel employed by the manufacturer or his authorized representative established in the Community may be drawn up in only one of the Community languages understood by that personnel."

You can't write your operating manual as you like any more. The EC directive lists very specifically what an operating manual must contain. All machinery must be accompanied by instructions including at least the following:

repeat of the information with which the machinery is marked, together with any appropriate additional information to facilitate maintenance (e.g. address of the importer, repairers etc.)
foreseen use of the machinery
workstations likely to be occupied by operators
instructions for safe
- putting into service
- use
- handling, giving the mass of the machinery and its various parts where they are regularly to be transported separately
- assembly, dismantling
- adjustment
- maintenance (servicing and repair)
- where necessary, training instructions.

Where necessary, the instructions should draw attention to ways in which the machinery should not be used.

Authorized representative

If the manufacturer does not reside in the European Community, directive 89/392/EEC requires that he must name an authorized representative established in the EC. This representative noted in the EC declaration of conformity must be capable of making the construction file available to competent authorities on demand.

Checking of conformity

How does the CE marking become enforced? The member states of the European Community are free to choose the way how and when to check whether a machinery is bearing the CE Mark. Thus each state does it differently through "competent authorities". Generally no standard procedure exists to check on the machinery and it may never be checked at all.

The rule for the latest moment to affix the CE Mark and for issuing the EC declaration of conformity is: The machinery has to bear the CE Mark at the moment it is given to the user. For standard machinery this may be the time of purchase or delivery. For special designed equipment or equipment which is assembled at the customers site, this may be the moment after having set up the machinery and having put it into operation by the manufacturer and handing it over to the user.

In Germany the authorities to look for the CE Mark are the authorities that control businesses. Depending on the type of business this can vary considerably. In Germany it can be the "Gewerbeaufsichtsamt" or the "Berufsgenossenschaft". In other countries checking by customs authorities is more likely when entering the European Community.

To sum it up: you never know, when you will be checked. It may be possible to use/sell machinery without CE marking unnoticed for quite a while. But the user/seller will be in bad shape, if an accident happens or if he is subject to a routine check.

If the machinery bears the CE Mark, local authorities may ask for the construction file, which is required before issuing the EC declaration of conformity. The file has to remain available for at least 10 years following the date of manufacture of the machinery. The documentation has to be delivered in a reasonable time frame, e.g. 7 to 14 days, depending on the type of documentation. Failure to present the documentation in response of a duly substantiated request by the competent national authorities may constitute sufficient grounds for doubting the presumption of conformity with the requirements of the EC directive.

The authorities may check, whether the documentation and machinery fulfill the requirements of the EC directive. A competent national autority in Germany is for instance the "Bundesanstalt für Arbeitsschutz".

What if you don't comply?

If a machine does not carry a CE Mark it will perhaps not be stopped at the border. It is even legal to display a machine which does not conform to the EC directive at a trade fair, an exhibition or similar event. However, interested parties should be properly informed that the machinery does not conform and cannot be purchased in that condition. Local authorities will prevent it from being put into operation or order it out of operation when they find out.

Where a member State of the EC ascertains that a machinery bearing the CE Mark and used in accordance with its intended purpose is liable to endanger the safety of persons, and where appropriate, domestic animals and property, it will take all appropriate measures to withdraw such machinery from the market, to prohibit placing on the market, putting service or use thereof or restrict free movement of thereof.

How to reach EC conformity

Reaching conformity may seem to be more complicated than it actually is. The first step is to check, whether your equipment falls under the scope of the EC directive. If in doubt, you may ask an expert for a report on it. If the CE Mark requirements apply to your equipment, you may for instance proceed with these practical steps:

Make a database search for all European standards which are applicable to your machinery.
Check your equipment against these standards, make a safety analysis (hazard assessment) and keep a written record of this procedure.
Make changes to your equipment if required by the above analysis.
Compile the construction file.
Localize the operating manual and if necessary any maintenance manual. State herein the safety rules with which the equipment complies. Give notice in the manuals for which purpose the equipment is built. Give notice which safety hazards may arise and how to avoid them.

A fast, safe, and economical way to ensure you are fulfilling the CE Mark requirements is to employ local expertise in this field, to guide you through the necessary actions to be taken. BICON provides all services needed. Please refer to our list of those services designed to help you to get started fast and smooth in the European Community.

Contact the author

For all services needed to obtain the CE Mark, please contact the author of this report:

Dr. Heinrich Birck

BICON Engineering & Datentechnik GmbH
Wilhelm-Beer-Weg 181
D-60599 Frankfurt
Germany
Phone +49 (69) 96 860 360
Fax +49 (69) 96 860 362
E-mail: BICON@ compuserve.com
WWW http://ourworld.compuserve.com/homepages/BICON

Back to Home Page.