New requirements on Machinery in Europe

On December 29th 2009 a new Machinery Directive, 2006/42/EC, came into force in the EEA (EU + Iceland, Liechtenstein and Norway) and Switzerland. Exporters of machinery to the states in this area should analyse the provisions as there are important changes in the new directive. Some of these are explained in this article.

Person authorised to compile the technical file

One of the changes is directed towards manufacturers outside the EEA. A person, that is authorised to compile a technical file, has to be appointed. The name and address must be presented in the Declaration of Conformity or in the Declaration for Incorporation. The agreement between this person and the manufacturer must be in a written form.

Relation to LVD (low voltage directive), 2006/95/EC

The old Machinery Directive gave the manufacturer of machinery the authority to choose to comply with the machinery directive or with the low voltage directive, if the risk assessment indicated that the electrical risks were the predominant. The new directive does not provide  this entitlement. Instead, the new directive contains a list of machinery that are excluded as they are covered by LVD.

The essential health and safety requirements of the LVD are included in the new machinery directive.

Manuals

Each state in Europe requires the manuals to be written in its official language(s). The requirements of the old directive were often understood that it was only the safety instructions that had to be written in the member state’s official language(s).  The new directive is clear; Product manuals have to be written in the member state’s official language(s), otherwise the product must not be sold or taken into service.

Harmonised standards

Machinery that is manufactured in conformity with a harmonised standard is presumed to comply with the essential health and safety requirements covered by such a harmonised standard. It must be observed that all standards that were harmonised with the old directive are not automatically harmonised with the new directive.

Partly completed machinery

The scope of the new directive has been expanded. It comprises not only completed machinery but also partly completed, defined as “an assembly which is almost machinery but which cannot in itself perform a specific application”. The only requirement in the old Machinery Directive on partly completed machinery was that the manufacturer had to draw up a Manufacturer’s Declaration (annex IIb). In the new directive, article 13 explains what has to be done before partly completed machinery is placed on the market in the EEA:

  1. 1.       The manufacturer of partly completed machinery or his authorised representative shall, before placing it on the market, ensure that:

(a)  the relevant technical documentation described in Annex VII, part B is prepared;

(b)  assembly instructions described in Annex VI are prepared;

(c)   a declaration of incorporation described in Annex II, part 1, section B has been drawn up.

  1. 2.       The assembly instructions and the declaration of incorporation shall accompany the partly completed machinery until it is incorporated into the final machinery and shall then form part of the technical file for that machinery.

Summary

The new Machinery is explaining the responsibilities of the manufacturers and of the representatives in more plain terms. Furthermore, it requires additional liability and accountability for partially completed machinery so that even though it might form part of the complete machinery the manufacturer is still held accountable for their product ensuring liability in case if non-compliance with the essential occupational health and safety requirements.

As the new directive requires a representative having the authority to compile a technical file, a manufacturer in Australia should consider expanding this mandate. The authorities in the EEA will never address a manufacturer outside the EEA with questions if they doubt that a product doesn’t comply with the provisions of the machinery directive. Instead the importer will be considered manufacturer and eventually held responsible for non-compliance. This could potentially result in importers in the EEA all requiring copies of the technical file. Instead of sending copies to several importers, an authorised representative established in the can receive a written authorisation from the manufacturer to perform on behalf all or part of the obligations and formalities relating to the machinery directive.

Contact Approval Specialists for assistance in placing your product on the European Market.