CE Consultancy and Certification Services

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Since 1985, any product sold in the European Union must bear the CE mark certification. CE is an acronym for Conformité Européenne, which means, “Conforms to European legislation.” In other words, the product meets the requirements of EU directives or EU regulations, which qualifies the product for sale throughout the European Union. Each of the member states within the European Union has its laws and regulations pertaining to commerce. These jurisdictional differences make it a challenge for manufacturers to market their products in each of the countries.

A directive describes a legal act issued by the EU that requires member states to obtain a specific result. Directives do not dictate to the member states the manner in which to achieve that result. In comparison, regulations are self-executing, which does not require implementation measures. Typically, directives provide latitude as to the regulation to adopt. Depending on the subject matter, lawmakers adopt directives using an array of legislative procedures and maneuvers to achieve the desired result.

The process for issuing a new directive starts with the formulation of a proposed directive by the business marshal, the European Commission, and the Advisory Commission. The European Council of Ministers decides whether to adopt the directive. If the ministry decides to make the amendment final, member states have the responsibility to append the new requirements in the directive in their national legislation within two years.

The period between the proposed-directive and adoption is called the transitional phase. During this period, member states may change or enact national laws to avoid duplicate and contradictory legislation, and national laws cannot be more stringent. The directive becomes binding after the expiration of the transitional period.

The directives provide the guidance for the basic criteria relating to the health, safety, and environment and consumer protection for products trade within the European Economic Area (EEA). The directives provide a starting point. When manufacturers apply the harmonized standards to their product, even when it is not mandatory, they realize a number of advantages:

• Application of the best practices for safety as it relates to the product
• Makes the directives tangible
• Achieves a presumption of conformity by implementation of the directives requirements

Assimilation of the directive requirements into the product also allows companies to have the maximum accumulation of legal burden of proof.

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