Selling technology in Europe: new rules, new opportunities
March 01, 1998
by Teresa Acklin
A European expert explains “CE labeling” for grain handling and milling equipment.
By Ralf Noack
Manufacturers of electric devices, machines and plants who have exported their products to Europe know the dilemma of the past: import requirements differed from country to country. For example, a machine that could be exported to France might not be admitted into the German market, while Italian admission requirements might differ still.
Since 1997, the differing trade restrictions are no longer applicable, and the market is united. Once a product is admitted for export to Europe, it may be exported within all of the European Union.
To gain this unlimited access, all technical products (as well as other products such as toys, safety devices and medical products) must be affixed with a “CE” label before being sold to Europe. “CE” is an abbreviation of the French word for European Community and it is written in special letters.
A Product “Passport.”
The CE label on a technical product (or even on a complete plant) can be considered as its “passport” and allows the seller of that product to export it to any European country except Switzerland and Norway. The manufacturer is responsible for putting the CE label on most types of technical products, machines and plants. By doing so, the manufacturer promises the product has gone through the CE certification procedure and fulfills all requirements of European safety standards relevant to that product.
In this context, the manufacturer must sign the “Declaration of Conformity,” meaning the product is made in conformance with European safety standards. Exceptions exist for special “dangerous products,” such as woodworking machinery, plastics-spraying machinery and some others. The complete list of “dangerous machines” can be found in Appendix IV of the “Machinery Directive,” which is one of the most important directives for selling technical products to Europe.
Compliance with the CE label requirements relies on the marketplace. In our experience, a manufacturer's competitors in the European market keep a very close eye on all competing products. If competitors perceive there is nothing to support the affixation of the CE label, they will report the circumstance to local authorities.
Failure to comply with the CE label requirements can result in the assessment of a fine and a general sales prohibition for that manufacturer throughout the European market. Fines and the sales prohibition also mean a severe loss of reputation.
Today, three European Community directives concerning the safety of the technical product itself are relevant for manufacturers of technical products, machinery and plants to be exported. Also, several other E.C. directives on workplace safety are relevant for employers who have a factory or a plant where workers use machinery.
In this context, it is important to consider each directive as a type of general law outlining broad safety requirements. All technical details concerning the safety requirements can be found in the European standards (E.N.), which were implemented to carry out the directives. The E.N. standards can be changed according to technical developments.
The first directive guiding CE labeling of products is E.C. Directive 89/392/EWG, or the “Machinery Directive.” This safety regulation covers the mechanical safety and proper technical documentation of technical products.
The procedures leading to CE certification of technical products under this directive consist of the following:
the manufacturer must find out which E.N. standards are relevant to his product;
machines and plants must be designed and constructed according to those specific E.N. safety standards;
all relevant standards must be listed and documented;
a hazard-analysis must be done for the product;
all documents in regards to the relevant product (such as all drawings, plans, calculations and so on) must be maintained;
all labels on the machines inside the plant must be in the language of the operator;
noise emission must be measured; and
a User's Manual in the language of the operator must be delivered with the machine/plant.
This last point is very important. The manual must contain special chapters and certain statements and information according to C.E. requirements. The manual is considered “as a part of the machine/plant.”
The second law pertaining to machinery/plants is E.C. directive 89/336/EWG, or the E.M.C. directive for machines. This regulation concerns electromagnetic compatibility (E.M.C.); machinery or plants and all electrical equipment must not exceed a certain limit of electromagnetic emission and must have a certain electromagnetic immunity.
Certification procedures are outlined as follows:
measurements must be taken to make sure the machine's electromagnetic emission (such as electric fields, magnetic fields or high-voltage-peaks) does not exceed a certain limit as provided in the relevant E.N. standard; and
measurements must be taken to demonstrate that a machine can withstand a certain amount of electromagnetic disturbance (electric or magnetic fields, surge, burst, high voltage peaks), a level known as the electromagnetic immunity.
One exception to this law exists for complete plants. According to section 5, paragraph 5, Satz 1 E.M.V.G., the manufacturer of complete plants has to measure neither the electromagnetic emission nor the electromagnetic immunity when every machine and every electric component inside the plant is marked with the CE sign or when the manufacturer is in possession of the CE Declaration of Conformity for all those components.
The third law relating to machinery is E.C. directive 73/23/EWG, or the low voltage directive, a safety regulation specifically for the electric safety of machinery/plants as well as all electrical equipment.
Under this regulation, measures must be taken to make sure the entire machine or plant is safe from electrical hazards. This directive covers electrical systems such as wiring, all electrical equipment, all control components and all emergency stop devices. Further details can be found in E.N. standards such as the DIN E.N. 60204, which is very similar to the international standard I.E.C. 204-1.
After following these procedures, the manufacturer or the importer of the machine or plant signs the Declaration of Conformity and assures that the CE label is affixed on a centrally visible place.
It is recommended that manufacturers or engineers use only those parts (or machines to be integrated in the machine/system) that are marked with the CE sign. Also, the manufacturer should tell all his suppliers to provide either the Declaration of Conformity (in case of electrical components or in case of complete machines that could run independently of the whole system) or the Declaration of the Manufacturer (in cases where a manufacturer is buying complete machines that are to be integrated in the system and cannot run independently).
Two other E.C. directives are relevant for employers who have a factory or plant where machinery is used. The first is E.C. directive 89/391/EWG, which covers the safety of all workplaces. Under this directive, the employer is directly responsible for worker safety, and effective in August 1997, the employer must make written hazard analyses for every single place of work in the factory.
The second regulation is E.C. directive 89/655/EWG, which covers the safety of machines older than five years. Effective this July, all machines built before 1993 must be upgraded to a higher safety standard according to Appendix I of this directive. One of the major points of this directive is that the employer is not allowed to have machines on a site where free access is possible to moving parts (no transmissions without covers).
Finally, another safety regulation is E.C. directive 93/44/EWG, governing hygiene in all technical processes producing food, including flour. In the near but as yet indefinite future, food manufacturers will be responsible for product purity. With the help of the written “Hazard Analysis and Critical Control Point” method, the manufacturer must describe all efforts to prevent impurities in his products.
Although these regulations seem to make exportation of technical products to the European Union rather complicated, compliance will facilitate entry into the European market. The regulations provide equal safety requirements for new products, free trade to and within Europe and increased safety for European workers at every single workplace.
Ralf Noack is a specialist on European law regarding the export of technical and medical products to Europe. His engineering company, ARANO GmbH, Wetzlar, Germany, provides consulting services for CE certification, European technical standards, documentation and hazard analysis.