New requirement for U.S. Exporters of Machines
As of December 29, 2009 when the new Machine Safety Directive (2006/42/EC) becomes mandatory, U.S. exporters of machines will need to identify a person established in the European Union who is authorized to keep the manufacturer’s technical file or have quick access to it. This person’s name must appear on the declaration of conformity along with the name and address of the manufacturer.
Point 2 of Annex II of the new Machine Directive outlines this new requirement: “name and address of the person authorized to compile the technical file, who must be established in the Community.”
The person could be no more than a letterbox, a point of contact for the authorities in case there are questions about conformity of the machine or about accidents. The person based in Europe could be the importer/distributor, a lawyer, an authorized representative, or any other person. The manufacturer remains responsible for compiling the technical file. The technical file does not have to be physically in the EU but should be rapidly accessible in case of need.
This requirement is an example of the beefed up surveillance and enforcement the EU is putting into effect to back up the CE mark program.
The following are names of people who can serve as a European representative or who can provide a European representative to fulfill this requirement:
Obelis, Belgium (http://www.obelis.net/)
QNet, the Netherlands (www.ce-mark.com)
Laidler Associates, United Kingdom (http://www.laidler.co.uk/)
SDA Technical Services, United Kingdom (www.sda-ltd.co.uk)
Consultants Europe, the Netherlands (www.ce-marking.nl)
(Note -- This list is just a small sample of consulting firms that can provide this service. The list does not represent an endorsement by the U.S. Department of Commerce but is just to provide companies with some immediate contacts to meet this European Union rule).
For more information, contact Bob Straetz (Office of Europe, Main Commerce Building, Washington, D.C.) at 202-482-4496.