MEMO/05/168
Brussels, 24 May 2005
20 years on – Standards and single market made easy
20 years ago, European product legislation was revolutionised by what was then called the “New Approach” method. This consisted of making harmonisation possible based on the simple condition that the producer can guarantee that its products, (e.g. toasters, TVs, washing machines et)c. are safe. The ‘essential requirements’ set by the New Approach Directives created the basis on which European Standards are developed by standardisation bodies (CEN, CENELEC and ETSI[1]) This is done by consensus between all industrial and societal stakeholders in an open and transparent procedure. In most cases they take the form of harmonized European standards and their application is voluntary. Most products covered by this legislation have to show the CE marking by doing this the manufacturer declares that the product is safe and in conformity with the requirements of the relevant Directives.
The New Approach has been instrumental in opening up the single market and continues to be its engine allowing the swift, but safe, introduction of new products. The strength of this lean and flexible regulatory technique lies in its simplicity and flexibility. Mutually agreed voluntary standards throughout the EU contribute to better regulation, stimulate business competitiveness and remove barriers to trade.”
The new approach restricts product legislation to the sole essential requirements necessary to make products safe. They cover entire product sectors from household appliances, other electrical equipment, machinery, pressure equipment, toys, construction materials, medical devices, measuring instruments, lifts, and recreational craft, to personal protective equipment. Together, the trading volume of the products covered only by the major sectors is estimated to exceed €1500 billion per year.
Standards can be updated much faster than legislation. In particular technological developments can be more easily incorporated into regulatory requirements. This reduces the negative impacts of outdated legislation on competitiveness, thereby encouraging innovation and enabling interoperability.
In addition to standards, reliable conformity assessment is also part of the New Approach. It is based on manufacturers’ internal design and production control activities and third-party examinations by conformity assessment bodies, which are “notified” on the basis of harmonised criteria.
Experience of implementation and identification of shortcomings have incited the Council to call for a revision of the New Approach in order to enhance its effectiveness, e.g. in the fields of market surveillance (enforcement of legislation at national level) and to ensure coherence of rules for the operation of Notified Bodies for conformity assessment. A draft proposal by the Commission is expected for the first half of 2006.
More information
http://ec.europa.eu/enterprise/newapproach/index.htm
[1] CEN (for general standards), CENELEC (for electrotechnical standards) and ETSI (telecommunications standards)
