European regulation for machines - standardization for machines - harmonized standards


European regulation for machines

At top level regulation for safety of of machines and certification, there is at regulatory level, one official source: the Machinery Directive 2006/42/EC.

Certification of conformity of machiner is done only regardless with respect to the essential requirements of health and safety of Annex I of the Machinery Directive.

Always at the regulatory level, there are tree main sources for putting into practice the essential safety and health of the Machinery Directive: :

  • the harmonized standards     
  • The application guide of the Machinery Directive 2006/42/EC.
  • The « recommendations for use » which are clarification sheets  that give some answers for some essential requirements of health and safety or for the application of some requirements of the Directive or harmonized standards.

Standardization and machines.

In order to facilitate the work of machines manufacturers, safety components manufacturers and notified bodies, an important standardization work has been done ate european level in safety of machinery. This standardization work for machines had started in the early 1990 after the publication of the first edition of machinery directive 1989/392/EEC and under the pressure of  « new approach ».

The use of these standards allows to demonstrate the conformity of machines or a safety component to the requirement of essential requirement of health  and safety. However, the only standard status is not enough. This standard should be an harmonized standard. Machine Directive 2006/42/EC provides a definition of a harmonized standard in Article 2, paragraph l.

"harmonised standard" means a non-binding technical specification adopted by a standardisation body, namely the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI), on the basis of a remit issued by the Commission in accordance with the procedures laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services

  •       The list of harmonized standards is published by the European Commission and is updated twice a year in average.
  •       Standards are elaborated, depending of their scope both by CEN sor by CENELEC

Standardization and presumption of conformity for the period from 2006 to the republication of harmonized standards under the Directive 2006/42/EC

During the transition from Directive 98/37/EC to Directive 2006/42/EC, harmonized standards giving presumption of conformity with the essential requirements  of health and safety were reviewed.

In most cases, the normative work was to amend Annexes ZA of the standards that have integrated the new Directive 2006/42/EC instead of Directive 1998/37/CE, the technical contents of the standard n 'have not changed meanwhile.

During the period that lasted between 2006 and 2011 - 2012 where all standards had not been reviewed, There were not officially existing harmonized standards giving presumption of conformity with the essential requirements of the new Machinery Directive 2006 / 42/EC requirements for all machines or safety components.

Therefore, certified machines or certified components according the requirements of an harmonized standards refering to Machine Directive 98/37/EC cannot automatically satisfy the essential requirements of the new Directive 2006/42/EC.

In addition, some harmonized standards which gave presumption of conformity with the essential requirements of the Machinery Directive have disappeared from publication of transition period between 1998/37/EC directive and 2006/42/EC directive.


Status of harmonzed standards for machines in 2013

The current situation is now stabilized, and most of the harmonized standards are harmonized under the new Machinery Directive 2006/42/EC. Normative work and the number of standards is significant in the field of machinery.

For example, the list of harmonized standards published on 15.11.2012 OJ C 350 of 15/11/2012, lists 689 harmonized standards representing :

  •       633 issued by CEN and
  •       56 issued by CENELEC

These harmonsized standards are issued by CEN and CENELEC on the following juridic basis :

Mandate to CEN and CENELEC for standardization in the field of machines - Mandate of 13 December 1994 M/079 that list other manadtes in order to insure coherence with other directives, especially low voltage directive and lift directive.

Harmonized standards and classification according type A, Type B and Type C of CEN classification

As explained in the page related to standardization, CEN classify standards according 3 levels Type A, type B and Type C standards.

Since Publication OJ C 348 of 28/11/2013, harmonized standards are classified according this classification. However, if you look in details, you will find a list of  Standards developed by Cenelec with a sentense "Standards developed by Cenelec are not classified as A, B or C-type standards in this list."

The standards issued by CENELEC are listed after the C-type standards of CEN, but they are not  to be considered asC standards