The Product Safety Zone

The "CE Marking" is the manufacturer's or importer's mark of conformity declaring compliance with all applicable directives (Low Voltage, EMC, etc.). The use of the CE marking and Declaration of Conformity is mandatory for most products sold in the EC (European Community). 

Any person (manufacturer or importer) can affix the "CE Marking", and issue the "Declaration of Conformity".

Introduction to European Conformity

The goal of the EU (European Union) is to implement a system that protects the health of consumers and workers, the condition of the merchandise, and the environment.

To accomplish this, a system of EU Laws (Directives) has been established to insure conformity to safety and quality related regulations.

This system provides the basis for the harmonization of standards for product safety, machinery and quality throughout the EU.

The system unifies the assessment process and acceptance in all EU countries, thereby eliminating redundant testing and submission of products to individual countries.

 Steps to the CE marking process

The following 6 steps are necessary prior to affixing the CE marking to a product. A manufacturer can perform these steps by way of "self-declaration" or select a notified/competent body for "voluntary certification".

1) Identify all applicable EU directives and standards for the product in question.

2) Perform the conformity assessment according to the relevant EU standards and essential requirements of the directives.

3) Manufacturer corrects any deviations found and incorporates the necessary changes into the products and the manufacturing process.

4) Establish a Technical File (test reports, documentation, licenses/certificates, etc.)

5) Prepare and sign the EU Declaration of Conformity (EN 45014).

6) Affix the CE marking to the product.

 The Risk of Non-Compliance in Europe

LVD - Low Voltage Directive - 73/23/EEC: If a Member State prohibits a product to be marketed for safety reasons, such as non-conformance with or faulty application of standards, or failure to comply with good engineering practice, the Member State shall immediately inform the other Member States. If CE Marking has been affixed unduly, the manufacturer or importer shall be obliged to make the product comply. Where non-compliance continues, the Member State shall restrict or prohibit its sale, or ensure that the product is withdrawn from the market.

Related document: Guidelines on the application of council directive 73/23/EEC

EMC Directive - 89/336/EEC: Where a Member State ascertains that a product does not comply with the protection requirements, it shall take all appropriate measures to withdraw the product from the market, prohibit its placing on the market or restrict its free movement and shall immediately inform the Commission for reasons of non-compliance such as failure to satisfy requirements or the incorrect application of the standards, ... The Commission can then inform the Member States and take the appropriate action against the author of the attestation (declaration/CE Marking).

Product Liability Directive - 85/374/EEC: Strict liability on the part of manufacturing and their distributor. There are now only a few defenses: If someone is injured or killed while using a product, the manufacturer/distributor is assumed to be guilty.

General Product Safety Directive - 92/59/EEC: Gives Member States Authority to control the safety of products and take the appropriate measures. Sets up a system of rapid exchange of information on defective products at National and Community levels. Information is passed to all Member States and possible publishing in the Official Journal of the EC (negative PR).

Machinery Directive - 89/392/EEC: When a member state ascertains that machinery, bearing the "CE Marking", is liable to endanger the safety of persons it shall take all appropriate measures to withdraw the machine from the market and prohibit its marketing. If, after consultation with the parties concerned, the commission considers the measure is justified, it shall immediately inform the other member states and the member states shall take appropriate action against whomsoever has affixed the "CE Marking". 

Sample Declaration of Conformity (EN 45014)