Why CE Marking?
We live in an increasingly litigious world where manufacturers are required to justify and prove the capability of their products, and ever more aware consumers want to know what they’re buying. To respond to these commercial needs the ability to meet, prove and then advertise adherence to widely recognized standards is paramount. This is especially true when selling into the huge but savvy consumer world that is Europe, where CE marking is a pre-requisite, where applicable. If you are considering selling into any countries in the European Economic Area (EEA), this could apply to you.
What does having a CE Mark actually mean?
It’s a declaration made by the supplier that all applicable conformity assessment procedures have been completed and that the product conforms to EU Directives. There are numerous product categories presently covered including:
• Equipment with electromagnetic emission (EMC)
• Low voltage electrical equipment (LV)
Is CE Marking Obligatory?
Yes, under European Law, as well as the national laws of each EU Member State.
European Union directives, known as the “New Approach Directives”, define “essential requirements” related to health, safety and environmental issues. All products covered by these New Approach Directives must be CE marked unless a specific Directive says otherwise. Note too that the same product may be subject to several CE Marking Directives.
Use of a CE mark is a declaration of conformity; it follows that a product should not be CE marked if there is no Directive in place for that product. Note that, when applicable the CE Mark should be attached to
• All new products, whether manufactured in the Member States or in third countries
• Used and second-hand products imported from third countries; and
• To products that have been substantially modified, unless the applicable Directives specifically excludes this requirement.
How should I apply the CE Mark?
Only the manufacturer, or his authorised representative within the EEA may apply CE Marking, which must take the form described in Directive 93/68/EEC. The manufacturer assumes ultimate responsibility for applying the mark or the manufacturer may appoint an authorised representative who should be based within the Community to act on their behalf. This person or organisation then assumes the responsibilities of the manufacturer.
When is the CE Mark applied?
Only once all assessment procedures covering conformity have been completed and the product is completely compliant.
Can we be sure that a product affixed with the CE marking is safe?
There is never a 100% guarantee that a product bearing the CE marking is safe. However, with the adoption of Regulation 765/2008pdf and Decision 768/2008pdf, 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 or by their authorised representative after the necessary conformity assessment procedure has been performed.
What is a manufacturer’s Declaration of Conformity (DoC)?
This document indicates that the product in question meets all the necessary requirements stipulated in the applicable directive. It can only be issued by the manufacturer or his representative, as detailed above.
Who supervises the correct use of the CE marking?
Public authorities in EU Member States in cooperation with the European Commission.
What are the penalties for counterfeiting the CE marking?
It varies by Member State but Economic operators may be liable to a fine and, in some circumstances, imprisonment and products may be withdrawn or recalled from 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“). You can also contact the Enterprise Europe Network.
For the full version of this article or any other questions please contact IES.