Amendment 2006/42/EC

Future

The Machinery Directive has recently been modified - Directive 2006/42/EC of the European Parliament and of the Council of May 17, 2006 on machinery, and amending Directive 95/16/EC (recast)

Date of application

Directive 2006/42/EC was published on June 9, 2006. It came into force twenty days later on June 29, 2006. The Member States have until June 29, 2008 to adopt and publish the national laws and regulations transposing the provisions of the new directive into national law. The provisions of the new directive become applicable on December 29, 2009. Until that date, the provisions of the current Machinery Directive 98/37/EC continue to apply.

Aim

The aim of the Machinery Directive is extended, since construction-site hoists and cartridge-operated fixing and other impact machinery will no longer be excluded. The borderline between the machinery and the Low Voltage Directives are clarified. The distinction will no longer be made on the basis of the “main risk”. Instead, the new Machinery Directive lists six categories of electrical machinery that are subject to the Low Voltage Directive – for other electrical machinery, the safety objectives of the Low Voltage Directive apply for the electrical risks, but the obligations concerning conformity assessment and the placing on the market are governed by the Machinery Directive. The borderline with the Lifts Directive has also been clarified. The new text modifies the scope of the Lifts Directive so that lifts with
a travel speed no greater than 0.15 m/s will be excluded from the Lifts Directive and will thus be subject to the Machinery Directive. The range of safety components subject to the Machinery Directive has been clarified. An indicative list of safety components is given in a new Annex. This list can be updated by the Machinery Committee to cover new machinery.

Changes

Extensive changes are especially prevalent with the conformity assessment procedure
of Annex IV Machines.

As under the current Machinery Directive, the conformity of most machinery will continue
to be certified by the manufacturer himself. Manufacturers of Annex IV machinery will have a wider choice of procedure:

• for Annex IV machinery designed according to harmonized standards covering all the relevant essential requirements, the manufacturer will be able to certify the conformity of the machinery himself;
• for other Annex IV machinery, the manufacturer will be able to choose between EC type-examination by a Notified Body or approval by a Notified Body of his full quality assurance system.

The new Machinery Directive includes an obligation for the Member States to monitor the performance of Notified Bodies and to withdraw or suspend the notification if a Body fails to carry out its duties properly.

In the event that there are no harmonized EU standards or the product was not constructed under compliance of these standards, an EC Type Examination by a recognized test center is currently required. The new directive now opens up the option of self-certification for the manufacturer without the participation of a test center, if they have a quality assurance procedure in accordance with Annex X.

• The basic safety and health requirements (Annex I) will in the future require a risk assessment by the manufacturer.
• In the Machinery Directive 98/37/EC there are different procedures for proving the safety of machinery, exchangeable equipment, safety components, chains/ropes/belts for lifting purposes, card an shafts and load-carrying equipment. In the future the same machine regulations will also apply for these products. They will have to be distributed in the future with CE conformity assessment, Declaration of Conformity and the required user information.
• The requirements for “part-machines” (also referred to as “incomplete machines”) have been re-formulated in the new version of the Machinery Directive. Until now a manufacturer declaration was sufficient, but in the future the manufacturer will also have to supply a declaration of incorporation, which must specify which requirements of the directive apply to the part-machine and have been complied with. Installation instructions must be provided with the machine’s documentation.
• Lifting machinery with a speed of up to 0.15 m/s of the load carrier are subject to the Machinery Directive; with a speed of more than 0.15 m/s they are subject to the Lift Directive (if they are not covered by its rules of exception).
• The delimitation of the Low Voltage Directive is no longer regulated as risk-related, but rather machinery-related.
• Construction site lifts are subject to the Machinery Directive.
• Instead of a “hazard analysis”, a risk assessment and “risk evaluation” are required.
• Clearer delimitation of the Machinery Directive for the Low Voltage Directive.
• Internal production controls for series machines (Annex VIII).
• The validity of EC Type Examination certifications must be checked by the test center every 5 years. Manufacturers and test centers are obligated to retain the relevant technical documents for 15 years.