CE & Pi Marking

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Details Related to CE / Pi [π] Marking

Factors like globalization, increasing liabilities and more intense competition are considerations for each company in its every day business.

The European Union implements and has implemented requirements for the harmonization of this unique single market. The task is to break down national certification requirements and to encourage the acceptance of products that fulfill European Directives (EU Legislative Requirements), and free movement of goods is a cornerstone of the single market. The mechanisms in place to achieve this aim are based on prevention of new barriers to trade, mutual recognition, and technical harmonization.

National technical regulations are subject to the provisions of Articles 28 and 30 of the Treaty establishing the European Community (the EC Treaty), which prohibit quantitative restrictions or measures having equivalent effect. Case law of the European Court of Justice, especially Case 120/78 (the 'Cassis de Dijon'case), provides the key elements for mutual recognition. The effect of this case law is as follows:

• Products legally manufactured or marketed in one country should in principle move freely throughout the Community, where such products meet equivalent levels of protection to those imposed by the Member State of exportation, and where they are marketed in the territory of the exporting country.
• In the absence of Community measures, Member States are free to legislate in their territory.
• Barriers to trade, which result from differences between national legislation, may only be accepted, if national measures:
  • are necessary to satisfy mandatory requirements (such as health, safety, consumer protection, and environmental protection);
  • serve a legitimate purpose justifying the breach of the principle of free movement of goods; and
  • can be justified with regard to the legitimate purpose and are proportionate with the aims. Restrictions to free movement of products, which may be acceptable under Articles 28 and 30 of the EC Treaty, can only be avoided or eliminated through technical harmonization on a Community level. This harmonization was, at first, rather slow to implement for two reasons. First, the legislation became highly technical, as it had the objective of meeting the individual requirements of each product category. Second, the adoption of technical harmonization directives was based on unanimity in the Council.

The creation of a single market by December 31, 1992 could not have been achieved without a new regulatory technique that set down only the general essential requirements, reduced the control of public authorities prior to a product being placed on the market, and integrated quality assurance and other modern conformity assessment techniques.

Moreover, the decision-making procedure needed to be adapted in order to facilitate the adoption of technical harmonization directives by a qualified majority in the Council. A new regulatory technique and strategy was laid down by the Council Resolution of 1985 on the New Approach to technical harmonization and standardization, which established the following principles:

• Legislative harmonization is limited to essential requirements that products placed on the Community market must meet, if they are to benefit from free movement within the Community.
• The technical specifications of products meeting the essential requirements set out in the directives are laid down in harmonized standards.
• Application of harmonized or other standards remains voluntary, and the manufacturer may always apply other technical specifications to meet the requirements.
• Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the corresponding essential requirements.

The operation of the New Approach requires that the standards offer a guaranteed level of protection with regard to the essential requirements established by the directives, and that the national authorities carry out their responsibilities for the protection of safety or other interests covered by the directive. Further, a safeguard clause procedure is necessary to allow the possibility of contesting the conformity of a product, or failures or shortcomings of harmonized standards.

The New Approach entailed refining conformity assessment in such a way as to allow the Community legislator to evaluate the consequences of the utilization of different conformity assessment mechanisms. The objective was to provide flexibility of conformity assessment over the entire manufacturing process in order for it to be adapted to the needs of each individual operation.

The Global Approach introduced a modular approach, which subdivided conformity assessment into a number of operations (modules). These modules differ according to the stage of development of the product (for example design, prototype, full production), the type of assessment involved (for example documentary checks, type approval, quality assurance), and the person carrying out the assessment (the manufacturer or a third party).

The Global Approach was completed by Council Decision 90/683/EEC, which was replaced and brought up to date by Decision 93/465/EEC. These decisions lay down general guidelines and detailed procedures for conformity assessment that are to be used in New Approach directives.

Thus, conformity assessment is based on:

• Manufacturers' internal design and production control activities;
• Third party type examination combined with manufacturers' internal production control activities;
• Third party type or design examination combined with third party approval of product or production quality assurance systems, or third party product verification;
• Third party unit verification of design and production; or
• Third party approval of full quality assurance systems.

In addition to laying down guidelines for the use of conformity assessment procedures in technical harmonization directives, Decision 93/465/EEC harmonizes the rules for the affixing and use of the CE marking.

The legal basis for adopting or modifying New Approach directives is Article 95 of the EC Treaty.

According to Article 251 of the EC Treaty, the Commission initiates the legislative procedure by making a proposal to the Council and to the European Parliament. Such Commission proposals concerning health, safety, environmental protection, and consumer protection should, according to Article 95 take as a basis a high level of protection.

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