Scope of CE marking is regulating the free movement of the goods in the European market, removing any possible undue barrier that can be created by national regulations. In order to achieve this goal it needed to provide the Member States with a legislative body consistent and, at the same time, able to limit to the minimum necessary the intervention of the public authority, providing the industry with a variety of applicable procedures to fulfill the obligations to the general public.
For this scope the concepts of New Approach and Global Approach were devised. They apply to the Directives that since 1987 the European Community issue (they are 30, currently) in order to regulate the production of those goods that have a serious impact on safety and health of persons and environment (http://www.newapproach.org/Directives/DirectiveList.asp).
The first step aimed at reducing the risk of new national barriers to the free movement of goods made concrete with the publication of the Directive 98/34/EC (http://ec.europa.eu/enterprise/tris/about/index_it.htm).
In order to achieve the creation of the common market started on December 31st 1992, it was taken the decision to adopt a new approach for the technical harmonization and standardization. This approach is ruled by the 1985 Council resolution that stated the following principles.
- The harmonized legislation is limited to the essential requirements that the goods circulating in the European Community must fulfill;
- Technical specifications applicable to products in order to fulfill the essential requirements are provided by harmonized standards;
- Using the harmonized standard is not mandatory, but remains voluntary; the manufacturers are free to choose any technical solution that provides compliance with the essential requirements;
- Products manufactured in compliance with an harmonized standard are presumed to conform to the related essential requirements.
The concept of Global Approach to conformity assessment is sourced by the observation that the principle of the New Approach are not sufficient for the conformity assessment of a product, if they are not coupled with a methodology to conduct in a reliable way the conformity assessment.
The key elements to perform a reliable conformity assessment are:
- Increasing the confidence on the assessment adequacy through competence and transparency;
- Setting up a comprehensive policy and a general framework to perform this assessment.
The Decision 93/465/EEC lays down a set of procedures for the assessment of industrial products conformity to the essential requirements specified by the Directives for technical harmonization.
Scope of the CE marking is the protection of the safety and health of individuals and other public interests.
The CE marking is a concise way that allows the manufacturer to inform the market that the product put on the market complies with all Community Directives regarding its use.
The Member States cannot restrict the placing on the market and putting it into service in their territory of products bearing the CE marking, unless it is proved that the provisions relating to CE marking is improperly applied.
The CE marking shall be affixed before the product is placed on the marked or put into service.