Concurrently with the TBT Agreement, the European Union adopted a “New Approach to technical harmonization and standardization” in 1985, was aiming at simplifying the movement of goods throughout the European Union (EU) and the European Free Trade Area (EFTA). New Approach Directives are confined to outlining “essential requirements” or regulatory objectives associated with the manufacturing of products, mainly related to safety. The regulatory framework applies either directly to final electronic goods or indirectly to electronic components used in other goods. Table 1 lists the Directive areas for which CENELEC has issued harmonized standards.

# Table 1  here

Compliance with the New Approach Directives’ is compulsory for the free movement of certain or covered products within the EU. The system in place does not, however, specify how specific objectives, such as consumer protection through product safety, should be achieved. This role is fulfilled by European standards published by supranational standardization bodies, such as the European Committee for Standardization (CEN) or the European Committee for Electrotechnical Standardization (CENELEC). The latter institution prepares and publishes standards relevant to the electronic sector. These standards are “harmonized” EU standards and member countries are obliged to adopt them and withdraw any national standard that might conflict with them.

If a manufacturer chooses to produce a product according to these harmonized standards, the product carries the “CE” marking, which implies compliance with the “essential requirements” mandated by law in Europe. On the other hand, manufacturers may use other technical specifications when manufacturing a product provided there is documentation certifying that the product meets the “essential requirements” formulated in the European Directives. By 2006, the number of harmonized standards linked to compliance with New Approach Directives account for 27.3 percent of the total stock of standard published by CENELEC<sup>6</sup> . The remaining standards are market driven and are not referenced in relation to compliance with the New Approach Directives.

The decision making process to create a standard in CENELEC consists of three stages elapsed in general over a three year period. The first stage involves producing a draft standard prepared by a CENELEC technical committee. This step requires a project proposal emanating from one of four possible bodies: CENELEC’s own technical bodies, CENELEC’s Cooperating partners<sup>7</sup> , the International Electrotechnical Commision (IEC), or the national committees themselves. The second stage involves an enquiry procedure

> 6 CENELEC facts & figures as of January 2008. <u>http://www.cenelec.eu/Cenelec/CENELEC+in+action/News+Centre/CENELEC+in+figures/Default.htm</u> 7 A cooperating partner is an independent European or international organization representing, with a sufficient degree of representativity within its defined area of competence, a sector or subsector of the electrotechnical field. Examples of such bodies are: The European Committee for Cooperation of the Machine Tool Industries (CECIMO); The European Coordination Committee of the Radiological, Electromedical and Medical IT Industries (COCIR); and The European Electronic Component Manufacturers Association (EECA), among others.

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