Many products placed on the EU market have CE marking affixed to them. This marking is the visible symbol showing that the manufacturer has taken all necessary measures to ensure that the product complies with the applicable safety legislation. It plays a crucial part in the New Legislative Framework for the EU internal market for goods which entered into force at the beginning of 2010. The New Legislative Framework provides for the appropriate control of testing laboratories and certification bodies, and more importantly sets out a Union policy on surveillance of products on the market and of effective controls of products from third countries.

European product legislation was revolutionized by the “New Approach” introduced in 1985. This New Approach has become a role model for Better Regulation. The Legislation sets out the levels of protection that must be achieved and does not pre-judge the choice of technical solutions to achieve the levels. Today, the so called New Approach directives cover a large proportion of products marketed in the EU in more than 20 industrial sectors, including electro-technical products, machinery, radio/telecoms equipment, toys, medical devices, construction products and high-speed rail systems. It is estimated that the trade in products covered by the major New Approach sectors is in excess of €1500 billion per year. Most products covered by this legislation have CE marking affixed to them, which is the visible symbol that indicates that a product complies with all the applicable safety legislation.

1. Improving the understanding of CE marking
The CE marking is required for specific product categories and indicates that such products meet EU safety, health or environmental requirements. It guarantees the free movement of safe products within the European market and is a key indicator of a product’s compliance with EU legislation.

The CE marking is affixed by the manufacturer to its products. By placing CE marking on a product, he declares the product’s conformity with the applicable legal requirements valid in Europe. The manufacturer on his sole responsibility has to verify that the goods he is selling comply with all relevant legislations or – if necessary – has to have it examined by a notified conformity assessment body for that purpose.

Not all products sold in the EU need to bear CE marking. CE marking applies to 24 different product categories, ranging from electrical equipment to toys and from explosives to medical devices. Each product falls under one or more Directives, which determine the specific requirements that the product must meet in order to be CE-marked. Only the product categories subject to specific directives are required to be CE marked.

In order to avoid non-conformity abuses, legal measures and economic sanctions have been established to deter the vast majority from doing so.

Six steps to obtain the CE marking

• Identify the directive(s) and harmonized standards applicable to the product. The essential requirements products have to fulfill (e.g. safety) are harmonized at EU level and are set out in general terms in the Directives. Harmonized European standards are issued with reference to the applied directives and express in detailed technical terms the essential requirements.

• Identify whether an independent conformity assessment is required from a Notified body. Each directive covering a particular product specifies whether an authorized third party (Notified Body) must be involved in the conformity assessment procedure necessary for CE marking.

• Test the product and check its conformity to the EU legislation. One part of the procedure is a risk assessment. By applying the relevant harmonized European standards, the manufacturer will be able to fulfill the essential legislative requirements of the directives.

Accreditation bodies are organized at European level into the European co-operation for Accreditation (EA). EA ensures that National accreditation bodies all work to the same requirements, so that accreditation granted from one body is directly comparable to that granted from another. However, not all European accreditation bodies are members of EA and not all Notified Bodies undergo accreditation.

The New Legislative Framework for the free movement of goods therefore provides for:

This will provide the EA with public recognition and provide it with the authority it currently lacks to provide accreditation services to all Notified Bodies. It will also ensure that all Member States use accreditation as a basis of notification.

3. Common legal framework to ensure an equivalent level of market surveillance throughout the EU

The enforcement of product safety legislation is an important task; not only to protect consumers and other users from unsafe products but also to ensure a level playing field for reputable businesses. In the EU market surveillance is the responsibility of the Member States.