The aim of the EC Directives is to harmonize the national legislation of the Member States so as to have common regulations concerning technical,
economic, social aspects, etc. and to facilitate the free circulation of goods, service and people within the European Union.
In particular, where the safety of workers is concerned, the harmonization of legal provisions has resulted in the formulation and approval of Directives
and Standards of great importance.
Define the objectives to be achieved.
Define the means and methods by which to achieve the objectives established by the Directives.
A product/service that complies with the harmonized Standards is presumed to conform to the Directives.
Stages for the realization of a Standard:
• Creation of a Working Group (WG) made by experts of the subject to be treated, which represent the Member States
• Preparation of a draft version of the Standard (prEN) to be examined by the various national Committees involved,
for comments, proposals and the subsequent final approval.
• Drafting of the definitive formulation of the text of the Standard (EN), official publication, and acceptance into the legislationof the
individual Member States.
The Directives concerning the protection of workers are:
• 89/391/EC “Health and safety at work - Framework directive”
• 89/655/EC “Use of work equipment” and amendments / additions
The Directives governing safety components are:
• 98/37/EC (2006/42/EC starting from 29/12/2009) “Machinery directive”
• 2006/95/EC “Low Voltage Directive”
• 2004/108/EC “Electromagnetic Compatibility Directive”
“Social Directives” 89/655/EC and 89/391/EC, are aimed at the improvement of safety in working environment.
• Determine the preventive measures to be adopted in the working environment.
• Supply information on:
- risk analysis
- program of prevention and achievement of compliance of the machines
- procedures concerning the compliance of machines
- responsibilities of the employer
- education and training of the people in charge of system operation.
• Imposes the adaptation of existing machinery in compliance with the provisions of the Machinery Directive.
THE MACHINERY DIRECTIVE
The “Machinery Directive” 98/37/EC and, starting from 29/12/2009 2006/42/EC, is meant for the manufacturers of machines and safety components,
and has the following objectives:
• The definition of safety and health protection requirements for the improvement of the degree of protection offered to the operators of hazardous
• The design, construction and marketing in the European Union of safety machines and components complying with the minimum safety requirements
laid down by the Directive itself.
• The free circulation in the Member States of machines and safety components complying with the Directive.
The Machinery Directive:
• It applies to all new machines and safety components that are sold, lent or hired, and to used machinery in the event of sale, rental or loan
• It sets forth the essential safety requirements relating to the design and construction of machines and safety components and it defines the respective
• It is mandatory for machines and for safety components. Only products conforming to the Directive can be marketed or commissioned in the European
• Lays down stringent procedures for safety components and highly hazardous machines which are listed in annex 4
• Lays down simplified procedures for low and medium risk machines not included in annex 4
• Requires that manufacturers prepare a technical dossier for each product stating the safety principles adopted in the design, manufacture,
transport, use and maintenance of the machine or the safety component.
Declaration of conformity
In order to certify the conformity of a product to the Directive, the manufacturer must:
• Affix the CE mark to the product
• Attach the CE declaration of conformity attesting compliance to the Directive
The new Machinery Directive (2006/42/EC) published in 2006 will replace the current version as from
MAIN OBJECTIVES OF THE REVISION
• The list of products covered by the Directive is more explicit
• New product classes have been added
• Borderline relative to other Directives have been clarified
• Definitions have been improved.
• The fourth Proviso states: “In order to ensure legal certainty for users, the scope of this Directive and the concepts relating to its application should
be defined as precisely as possible”.
• The criteria used for the nomination of Notified Bodies are more rigorous
• Market surveillance. The obligations of the Member States are defined more accurately
• Rules have been added for the withdrawal of dangerous products.
The conformity evaluation procedures have been revised
• It will no longer be possible to submit a technical file to a notified body without undergoing any verification of the content by the latter
• Internal inspection of manufacturing process (Annex VIII) is required for all conformity evaluation procedures. Responsibility for inspection lies with
MANAGING THE TRANSITION FROM MD 98/37/EC TO MD 2006/42/EC
|Note on the annexes listing dangerous machinery and safety-related components
Contrary to MD 98/37/EC, MD 2006/42/EC Annex 4 - which lists dangerous machinery and safety-related components – now includes
logic blocks ( e.g. programmable control units, PLCs, etc.).
Moreover, Annex 5 was added to include a non-exhaustive list of safety-related components.
Declaration of conformity
• Looking at practical and technical aspects, manufacturers may already begin to produce and market machinery in line with the new MD
• For legal purposes Directive 2006/42/EC may only be referred to as from 29/12/2009
• For products manufactured prior to 29/12/2009, if unaware of, or uncertain about the date of the first placement on the market, manufacturers may
issue a declaration of conformity referring to both Directives. Reference to Directive 98/37/EC should subsequently be deleted after 29/12/2009.
• Modifications to mandatory health and safety requirements in the new Annex I might invalidate previous declarations. In any case the declarations of conformity will have to be re-written as they must refer to the new Directive
• CE type examination certificates issued by notified bodies must be updated
• The new CE type certificates shall be valid for 5 years (Annex IX para. 9.3), the five-year period starting from the revision date of the old certificate.
Validity of self-certifications
• Procedures specified in art. 8 paragraph 2 sub-paragraph C of Directive 98/37/CE will cease to be valid as from 29/12/2009
• Accordingly, manufacturers who have certified their products in compliance with these procedures must repeat the entire certification process using
the procedures listed in art. 12 paragraphs 3 and 4 and the associated Annexes of the new Directive.
LOW VOLTAGE DIRECTIVE
2006/95/EC is aimed at:
ensuring that electrical materials are designed and manufactured so as to guarantee the protection of people against any risk of injury arising from
the use of such materials.
This Directive applies to all electrical materials meant for use at a nominal voltage of between:
• 50V and 1000V for alternating current
• 75V and 1500V for direct current.
The last revision of the directive is in force starting from 16/01/2007.
ELECTROMAGNETIC COMPATIBILITY DIRECTIVE
The aim of “Electromagnetic Compatibility Directive” 2004/108/EC is to ensure that electrical devices are designed and manufactured so that:
• Electromagnetic emissions are limited and low enough to permit other electrical devices to operate according to their intended purpose
• The level of built-in immunity to external disturbances enables them to operate according to their intended purpose.
This Directive applies to all electrical and electronic devices able to cause electromagnetic disturbances and whose operation can be affected by
The last revision of the directive is in force starting from 20/01/2005
Atex DIRECTIVE 94/9/EC
applies to all products for use in explosive atmosphere.
The Directive specifies minimum safety requirements for electrical devices used in environments classified as dangerous regarding the aspect of
risk of explosion from gas or dust.
The risk of explosion consists of three levels:
• Category 1 : maximum risk level (areas 0 and 20)
• Category 2 : high risk level (areas 1 and 21)
• Category 3 : risk level defined as “normal” (areas 2 and 22).
The ATEX Directive is in force since 1/07/2003.
In each Member State, the role of the accredited Bodies is to assess and verify the compliance and the application of the Directives concerning machines
and safety components.
Each State is responsible for the appointment and control of its own Bodies.
The Accredited Bodies must have the expertise and the resources which are necessary to perform their activities of inspection, analysis, technical
support, measuring, etc.
Notified Bodies are authorized to examine and certify machines and safety components in compliance with the applicable Directives.
Each Member State of the European Union is required to:
• Appoint the Notified Bodies by specifying their tasks
• Submit a list of the Notified Bodies to the European Commission and to the other Member States.
The European Commission publishes a Directory of all the Notified Bodies on the Official Journal of the European Commission (GUCE), together with a
list of the services, the machines and/or the safety components on which they are authorised to intervene.
The Member States of the European Union must make sure that these Bodies respect specified ethical and technical criteria.