Abbreviations: CIOMS, Council for International Organizations of Medical Sciences; NBAC, National Bioethics Advisory Commission; UNAIDS, United Nations Programme on HIV/AIDS; WMA, World Medical Association
NEW STANDARDS GUIDELINES FOR EUROPE
Nice, France – 28 March 2003
European standardization policy has been brought up to date today as the result of the
adoption of new guidelines between the European Commission (EC), the European Free Trade
Association (EFTA), and the three official European Standards Organizations (ESOs).
These new guidelines were signed today in Nice, France, by Erkki Liikanen, the EC
Commissioner responsible for Enterprise & Information Society, EFTA Secretary-General
William Rossier, and senior representatives of the three standards organizations. The signing
ceremony took place during a conference on "Accessibility for all", organized by the ESOs - a
conference that was set in the context of 2003 being designated the European Year of People
with Disabilities, and which reflected the key role that standards play in the life of all people,
regardless of their age and ability.
The guidelines replace the previous version established in November 1984, which laid down for
the first time a common political understanding of the conditions under which the EC and the
then two ESOs, the European Committee for Standardization (CEN) and the European
Committee for Electrotechnical Standardization (CENELEC), would co-operate. Equivalent
guidelines were signed between these ESOs and EFTA in 1985. Since then, many changes
have taken place in Europe and beyond, economically, technologically, at a regulatory level
and in standardization itself.
As an example, the creation of the European Telecommunications Standards Institute (ETSI) in
1988 contributed significantly to the restructuring of the European standardization process that
was already under way (ETSI subsequently received official recognition as an ESO alongside
CEN and CENELEC in the EC Directive 98/34/EEC). This process has become increasingly
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open to all interested parties and considerably more responsive to the very tight timescales of
today's technological developments, and the demands for technical quality. As a result,
European standardization is now extremely dynamic; for instance, over the last ten years the
number of European Standards available has risen from 2000 to more than 14 000 – and the
number continues to grow by more than 1000 annually.
These figures illustrate the huge demand from industry in all sectors for standards that help
ensure products and services are safe, fit for their purpose and compatible. European
standards provide a powerful means of enhancing the competitiveness of companies in Europe
and creating the single European market. This success also ensures Europe a very powerful
position in world-wide standardization.
The progressive widening of European policy since the original guidelines were first drawn up
has created a role for standards in support of issues such as safety in the workplace, and
protection of consumers and the environment. The new guidelines also recognize the EC/EFTA
"New Approach", under which standards provide technical solutions for presumption of
conformity with legal requirements; the guidelines thus include a mutual commitment to use
standardization to support legislation.
These developments in policy have, in turn, encouraged wider participation in European
standards-making by non-governmental economic and social interest groups, and has
generated greater openness of the European standard-setting process. As a result, all sectors
of society now benefit greatly from this efficient and well-structured European standardization
framework, based upon the three independent ESOs.
The signatories welcomed the new guidelines as a further strengthening of the co-operation
between the political and technical communities in Europe. They declared their conviction that
the new agreement constitutes a solid basis for future collaboration and a reinforcement of the
role of European standardization in support of European policy. Commissioner Liikanen
emphasized in addition the great importance given by the signatories in the guidelines to the
participation of non-governmental economic and social interest groups in the standards-setting
process.
The new Guidelines will appear shortly in the Official Journal of the European Communities and
thus be available in all the official Community languages.