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The mechanical equipment sector, including many EPTDA members, should pay careful attentions to the recent revision of the Machinery Directive 98/37/EC - which provides the regulatory basis for the harmonisation of the essential health and safety requirements for machinery at European Union level.
A revised Machinery Directive will be applicable from 29 December, 2009. It will promote the free movement of machinery within the Single Market, and it will guarantee a high level of protection to EU workers and citizens. Being a ‘New Approach’directive, it promotes harmonisation through a combination of mandatory health and safety requirements and voluntary harmonised standards. Such directives apply only to products that are intended to be placed (or put into service) on the EU market for the first time.
Machinery is described in the directive as "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 a material". The manufacturer is responsible for verifying whether a particular product falls within the scope of the directive.
Key points of the revised directive:
- The scope of the directive has been extended: construction-site hoists and cartridge-operated fixing and other impact machinery will no longer be excluded.
- The distinction between the Machinery and the Low Voltage Directives has been clarified and 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 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 products.
The essential health and safety requirements have not been subject to major changes, although several have been redrafted. The requirement relating to risk assessment has been made more explicit, and there are new requirements for risks associated with machinery serving fixed landings to take account of the extension of the scope of the directive to construction site hoists and
slow-moving lifts. In addition, certain requirements currently applicable to mobile machinery or machinery for lifting have been made applicable to all machinery presenting the risk concerned. Requirements concerning noise and vibration emissions have been made more precise.
The duty of Member States to organise market surveillance is also addressed in the revision. These obligations include co-operation between the market surveillance authorities and respect for confidentiality and transparency. The revised directive enables the European Commission to adopt a decision, after consultation of the Machinery Committee, to prohibit or restrict the placing on the market of a category of machines presenting the same risk by virtue of its technical characteristics. This measure is inspired by a similar provision in the General Product Safety Directive.
Member States have primary responsibility for implementing the directive. Manufacturers have to notify the intention to place certain products on the market and market surveillance authorities communicate with manufacturers when it suspects that products do not comply with the directive.
EPTDA members that are manufactures should anticipate application of the revised directive (2006/42/EC) though from a legal point of view, the directive cannot be applied before 29 December, 2009. However, the Commission is encouraging manufacturers to review their products without delay and adapt them as necessary to take account of the requirements of the new directive.
The legislation also obliges manufacturers to establish an EC Declaration of conformity according to the revised directive for products first placed on the market as from 29 December, 2009. In cases where the manufacturer cannot be certain on what date individual products will be first placed on the market, providing the products concerned
comply with both the current and the new directives, an EC Declaration of conformity referring to both directive can be established. The reference to Directive 98/37/EC should be removed from the EC Declaration of conformity after the new directive comes into force.
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