The CE mark is mandatory in countries that require compliance with the EU consumer safety standards.
The European Economic Area (EEA) agreement was designed to facilitate commerce and movement between its member countries. Products that are sold in an EEA country must bear the Conformite Europeene (CE) mark. The CE mark certifies that the product was manufactured according to European Union (EU) consumer safety standards. Certification requires the applicant to identify the directive, verify requirements, complete conformity assessment, test conformity, compile technical documentation and sign the declaration of conformity.
CE Marking Countries
The CE mark is mandatory in countries that require compliance with the EU consumer safety standards. The EEA includes all 27 European Union countries (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, La, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom), the four European Free Trade Area (EFTA) countries (Iceland, Liechtenstein, Norway, and Switzerland) and Turkey. The EFTA is a free-trade organization that was established in 1960.
Directives
Identifying the proper directive is the first step to acquiring the right to affix the CE mark to a product. Directives contain the provisions that are required to meet EU consumers safety standards. Manufacturers are required to review and adhere to all directives that apply to the product that are sold on the EU market. In some cases, multiple directives may apply to a single product.
Conformity Requirements
There are two approaches to determining if a product conforms to directive standards. Self-certification is valid for some products, and a formal laboratory assessment is required for others. The Safety of Machinery Directive is an example of products for which self-certification is acceptable. Self-certification would not be acceptable for an Appliances Burning Gaseous Fuels Directive.
When a product is not a candidate for self-certification, the formal assessment must be conducted by a facility that is itself or is affiliated with a Notified Body. Notified Bodies are sanctioned and authorized to determine that the product conforms to the standards of the directive.
Testing
The manufacturer bears responsibility for quality control testing. Including a risk assessment test as part of the methodology for certification is a good practice. This is a testing step that should take place after the conformity testing. The risk assessment test is independent of the self-certification or third party testing.
Technical Documentation
The conformity assessment results must be documented. This establishes a record of how the directive guidelines were met. The documentation must include testing results. This includes self-certification testing, third-party testing and risk assessment testing. The identify risk and a prevention or recovery plan should also be included in the technical documentation. The manufacture is required to present the documentation upon request.
Declaration of Conformity
After the technical documentation has been completed, a Declaration of Conformity (DoC) must be prepared and signed by an official of the company. The DoC states that the product does conform to the EU consumer safety standards. The DoC is a legal declaration of responsibility.
CE Mark
The manufacturer or the representative third party is required to affix the CE mark to the product according to the designated guidelines. The mark indicates that the product was manufactured in a manner that adheres to EU requirements.
Tags: safety standards, consumer safety, consumer safety standards, that product, assessment test, risk assessment
