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Horizontal organisations representing SMEs in EU policies:

The Voice of Crafts and SMEs in Europe:

The European association of young entrepreneurs:




    


Legal framework

 

European standardisation policy is based on some legal documents:

  • Directive 98/34 of the European Parliament and of the Council of 22nd June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations ( it is expected to be revised in 2008).
  • Directive 98/48/EC amending Directive 98/34
  • Council Resolution of 7th May 1985 on the new approach to technical harmonization and standards.

Standardisation is an integral part of the EU to achieve the Lisbon goals by carrying out better regulation and by simplifying legislation, by increasing competitiveness between enterprises and by removing barriers of trade at international level.

On 18th October 2004, the Commission adopted a Communication on “the Role of European Standardisation in the Framework of European Policies and Legislation” accompanied by a staff working paper dealing with “the challenges for European Standardisation”. Both documents analyse the current situation of European standardisation and identify the key areas where the European standardisation system and the instruments available to European standardisation policy can and should be further improved. Both documents are a response to the Council Conclusions of March 2002 and the Council Resolution of October 1999 on ”the Role of Standardisation in Europe” in which the Council had acknowledged the important role of standards and invited the Commission to analyse the current situation of European standardisation and to respond to the challenges the European standards system is faced with. The final output of this process is the European Standardisation Action Plan in October 2005 that was revised in 2007. Alongside, the European Commission has released a report on the Operation of Directive 98/34/EC from 2002 to 2005.

In its Conclusions of December 2004 on “European Standardisation”, the Council has acknowledged the Commission’s findings and invited the Commission to pursue the activities proposed in the Communication and in the staff working paper.

General guidelines for the co-operation between CEN, CENELEC and ETSI and the European Commission and the European Free Trade Association were adopted and signed on 28th March 2003 which give more details on the European standardisation framework.

On 24th October 2006 a decision of the European Parliament and the Council on the financing of European standardisation was adopted.

More information can be found on this European Commission web page and on the one which lists reference documents. Besides, many European Institution's documents include the framework of the New Approach.

Below you can also find a table, which is also available on the website of the Commission, presenting all the New Approach directives.

New Approach directives (directives providing for CE marking)
Text of 
directive and
amendments
Consolidated version of
directive
Subject (short title of directive)
Lists of references of harmonised standards and general information

2006/95/EC

 

Low Voltage

87/404/EEC 
90/488/EEC 
93/68/EEC

87/404/EEC

Simple Pressure Vessels

88/378/EEC
93/68/EEC

88/378/EEC

Safety of toys

89/106/EEC 
93/68/EEC

89/106/EEC

Construction products

89/336/EEC
92/31/EC 
93/68/EEC
2004/108/EC

89/336/EEC

Electromagnetic compatibility (EMC)

98/37/EC  
98/79/EC
2006/42/EC

98/37/EC

Machinery

89/686/EEC 
93/68/EEC
93/95/EEC 
96/58/EC 

89/686/EEC 

Personal protective equipment (PPE)

90/384/EEC 
93/68/EEC

90/384/EEC

Non-automatic weighing instruments 

90/385/EEC 
93/42/EEC  
93/68/EEC
2007/47/EC

90/385/EEC 

Active implantable medical devices

90/396/EEC 
93/68/EEC

90/396/EEC 

Appliances burning gaseous fuels

92/42/EEC 
93/68/EEC
2004/8/EC
2005/32/EC

92/42/EEC 

Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels

93/15/EEC 

 

Explosives for civil uses

93/42/EEC  
98/79/EC  
2000/70/EC
2001/104/EC
2007/47/EC

93/42/EEC

Medical devices

94/9/EC 

 

Equipment explosive atmospheres (ATEX)

94/25/EC
2003/44/EC

94/25/EC

Recreational craft

95/16/EC 

 

Lifts

97/23/EC 

 

Pressure equipment

98/79/EC 

 

In vitro diagnostic medical devices

1999/5/EC 

 

Radio Equipment and Telecommunications Terminal Equipment and the Mutual Recognition of their Conformity

2000/9/EC 

 

Cableway installations designed to carry persons

2004/22/EC

 

Measuring instruments

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