CE marking - Basics and FAQs
The CE marking indicates a product’s compliance with EU legislation and so enables the free movement of products within the European market. By affixing the CE marking to a product, a manufacturer declares, on his sole responsibility, that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (EEA, the 28 Member States of the EU and European Free Trade Association (EFTA) countries Iceland, Norway, Liechtenstein). This also applies to products made in other countries which are sold in the EEA.
However, not all products must bear the CE marking, only product categories mentioned in specific EU directives on the CE marking.
CE marking does not indicate that a product was made in the EEA, but merely states that the product has been assessed before being placed on the market and thus satisfies the applicable legislative requirements (e.g. a harmonised level of safety) enabling it to be sold there. It means that the manufacturer has:
verified that the product complies with all relevant essential requirements (e.g. health and safety or environmental requirements) laid down in the applicable directive(s) and
if stipulated in the directive(s), had it examined by an independent conformity assessment body.
It is the manufacturer’s responsibility to carry out the conformity assessment, to set up the technical file, to issue the declaration of conformity and to affix the CE marking to a product. Distributors must check that the product bears the CE marking and that the requisite supporting documentation is in order. If the product is being imported from outside the EEA, the importer has to verify that the manufacturer has undertaken the necessary steps and that the documentation is available upon request.
Can we be sure that a product affixed with the CE marking is safe?
Unfortunately due to counterfeiting or misuse of the marking, there is never a 100% guarantee that a product bearing the CE marking is safe. However, with the adoption of Regulation 765/2008 and Decision 768/2008 , the obligations of the manufacturer are spelled out and it is clear that by affixing the CE marking to a product, the manufacturer assumes full responsibility for its compliance with all applicable requirements in EU legislation.
It is the system behind the CE marking that ensures its proper functioning. The entire system, consisting of manufacturers, importers, distributors, notified bodies and market surveillance authorities, has been strengthened through the New Legislative Framework, which aims to further reduce burdens on trade while, at the same time ensuring a high level of safety and protection of other public interests.
Can I, as a manufacturer, affix the CE marking to my products?
Yes, the CE marking is always affixed by the manufacturer himself/herself or by his/her authorised representative after the necessary conformity assessment procedure has been performed. This means that, before the CE marking is affixed and the product is put on the market, the product must undergo the conformity assessment procedure provided for in one or more of the applicable directives. The directives specify whether the conformity assessment may be performed by the manufacturer or whether a third party (the notified body) has to be involved.
Where should the CE marking be affixed?
The marking shall be affixed either to the product or to the product's data plate. When that is not possible due to the nature of the product, the CE marking must be affixed to the packaging and/or to any accompanying documents.
What is a manufacturer's Declaration of Conformity?
The EU Declaration of Conformity (DoC) is a document in which the manufacturer, or his authorised representative within the European Economic Area (EEA), indicates that the product meets all the necessary requirements laid down in the applicable directives. The DoC must also contain the name and address of the manufacturer along with information about the product, such as the brand and serial number. The DoC must be signed by an individual working for the manufacturer or his/her authorised representative, and the employee's function must also be indicated. Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EC Declaration of Conformity.
What is the difference between the CE marking and other markings, and can other markings be affixed to the product if it bears the CE marking?
The CE marking is the only marking that indicates compliance with the essential requirements of the Directives that provide for its affixing. A product may bear additional markings provided that they do not have the same significance as the CE marking, they are not liable to cause confusion with the CE marking and they do not impair the legibility and visibility of the CE marking.
Who supervises the correct use of the CE marking?
Supervision of CE marking is the responsibility of public authorities in EU Member States in cooperation with the European Commission.
What are the penalties for counterfeiting the CE marking?
The procedures, measures and sanctions that apply to counterfeiting of the CE marking vary according to Member States' national administrative, civil and criminal laws. Depending on the seriousness of the crime, economic operators may be liable to a fine and, in some circumstances, imprisonment. Products may be withdrawn or recalled from the market. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given the opportunity to bring the product into compliance with the applicable legislation rather than being obliged to take the product off the market.
Where can I find more information?
On the European Commission website, you can download the Guide to the Implementation of Directives based on the New Approach and the Global Approach, (often referred to as "The Blue Guide").
Businesses can also contact the Enterprise Europe Network.