On December 29th 2009 the new Machine Directive 2006/42/CE was enforced to substitute the directive 98/37/CE. All member states must comply with such directive in order to grant safety and health on their territories, particularly as far as people, workers, domestic animals and goods are concerned, specifically as far as risks deriving from the use of machines. As for Directive 98/37/CE the European Commission has issued a guide to grant a Unitarian interpretation and to clarify concepts and requisites described in it. In the version that is available today, the guide regards only the Directive’s Annex II.
In May 2008 a publication was issued on the New Machine Directive, by ETUI-REHS (European Trade Union Institute for Research, Education, Health and Safety) and by KAN (Commission for Occupational Health and Standardization). It compares the new Directive’s text in English with the corresponding text of Directive 9837/CE. It is an easy instrument of reference, very useful also when the need arises to reviews harmonized regulations to comply with new requisites. In the same way, ISPELS has issued a “Guide to Compare the new Machine Directive (2006/42/CE) with the Directive 98/37/CE”, in order to compare the Italian versions of the two directives, where all the news are highlighted and commented, that were introduced by the new directive and then the Annexes I of both directives are compared.
The changes from Directive 98/37/CE are many and not all so clear. We will try hereafter to summarize some of the news introduced. Application Field The main modifications of Directive 2006/42/CE in comparison with the Directive 98/37/CE, now expired, are already clear in the Application Field that clarifies some points already present in the old directive and shows others, such as the concept of “quasi machine” and “Ergonomics”. The Concept of Quasi Machine Based on the definition on the Directive 2006/42/CE, Quasi Machines are: “The sets that constitute a quasi machine but which alone cannot grant a well-determined application. An auctioning system is a quasi-machine. Quasi-machines are used nearly only to be incorporated or assembled within other quasi-machines or devices to build a machine disciplined by this directive”. The key point of such definition is that quasi-machines alone are not capable of carrying out any kind of application.
The directive establishes that the builder of a quasi-machine must accompany them with a specific declaration of incorporation (AnnexII, letter B) and by their assemblyinstructions to the other parts based on the indications of annex IV. Moreover for such sub-sets a pertinent technical documentation must be prepared, in compliance with the requisites of letter B annex VII. CE Declarations The new Directive foresees only 2 types of declataions (Annex II): 1. IIA – the declaration CE of conformity to the directive and to the oter directive on whwhich possibly the machine is included 2. IIB – the incorporation declaration for quasi-machinmes. Such declaration contains compulsorily a precise list of RES OTTEMPERATI (BIG NEWS) Both declarations contain another very important piece of news: the explicit indication of authorized peson (name and addres within the European Union) to carry the Pertaining Technical Documentation or theBuilding Technical File Ergonomics One of the concepts that are clarified and extended by the new directive is the concept of “Ergonomics”.
The term “Ergonomics” comes from the two greek words “érgon” (work) and “nòmos” (regulation,law). Based on IEA (International Ergonomics Association) Ergonomics is the scientific discipline that is aimed at understanding the interaction between human beings and other elements of a system. It is moreover the prefession that applies theories principles and methods finalized to the design of man’s interactions with prodicts services and organizations with the target to increase the well-being of human beings and the general performance of the system. Requisites 1.1.2d) and 1.2.B have been cancelled and requisite 1.1.6 has bbeen introduced, i.e. “Ergonomics”, in order to clarify it as a speiici objective to be reached. Such requisite clarifies the orientamento of the new machine directive to the real will to improve working conditions and well-being ofpeople giving the concept of safety a wider accezione, and finally speaking of ergonomics.