The CE Mark - A Passport For Your Products

1999-10-01

The mark is everywhere – a rounded, stylized "CE" affixed inconspicuously to products like lamps, computers and children’s toys.

Chances are, unless you export to the European Union, you have no idea what this "CE mark" means. And if you’ve just started thinking about exporting to the European Union, you may wish you’d never heard of it.

Qualifying for the mark is a complicated process, but a little knowledge and a little help can make it a lot easier.

What is the CE Mark?

"CE" stands for Conformité Européenne. Unlike the product certification marks Canadians are most familiar with, the CE mark doesn’t belong to a particular product certification organization – it’s a logo that shows that products have met the requirements of the European Union (EU).

It’s part of the EU’s drive to create a single market, allowing companies to access all 15 countries in the European economic area without having to meet separate safety, inspection or customs requirements for each.

To work toward this single market, the EU created a set of directives outlining common European requirements. The directives are based on safety objectives known as the Essential Health and Safety Requirements and cover such areas as the safety of children’s toys, machinery, personal protective equipment and medical devices. They also cover customs and excise related matters and transportation of goods between European countries.

European Norm (EN) standards have been developed to support each directive. It’s important to note that while the goal may be to have a single set of requirements for all EU nations, that hasn’t yet been achieved. Although it is essential to have the CE Mark to access any European market, there may still be other requirements for individual nations. What those requirements are will depend on the product and where it is being sent.

How do I get a CE Mark?

There are three major steps in acquiring a CE mark. To begin with, you need to find out what requirements you need to meet. That means determining which CE directive applies to your product – for example, there are directives for low voltage products, machinery or personal protective equipment – and then acquiring the appropriate directive and the standards you need to meet it.

Second, you have to make sure your products are manufactured in accordance with the specified European standard. It is possible to use other standards so long as they meet the safety requirements of the directive. The Standards Council of Canada can help you identify comparable standards.

Third, you need to show that you have met the standard, in a process called attestation. The way that this is done is outlined in the directive, and depends on the type of product being certified and the standards being met. It can be a fairly simple process – many products exported to Europe can be tested inhouse to see if they meet the standards in the directive. If they do, you can then simply declare that your product complies. Just remember, you must keep records of technical documents relating to compliance even if you declare conformity yourself.

On the other hand, attestation can be more involved if there is potential risk to health and safety. For instance, companies that manufacture implantable medical devices like pacemakers face the most stringent requirements.

If your company manufactures such devices, you will be required to manufacture your products using a quality management system registered to ISO 13485, the medical devices specific version of ISO 9000. And you’ll have to have test results from a "notified body," an independent testing and certification body recognized by the EU.

The reason is simple: the more potential risk to health and safety, the more important it is to have independent confirmation that a product meets the requirements. The delegation of the EU in Canada can provide lists of European notified bodies if they are required, and can also provide names of Canadian certification bodies that can perform tests on behalf of the notified bodies.

Once you have demonstrated conformity to the requirements, you can affix the CE logo to your products, allowing them to gain entry to the EU.

What will the CE Mark do for me?

The most obvious benefit of the CE Mark is that it is like a passport for products, allowing them entry to the entire European market. If a product is covered by a directive, it can’t be sold in the EU unless it has the mark.

Once the single market system is in place, companies will be able to take dvantage of the common directives and produce only one product model for the entire EU, instead of needing different models to meet varying national requirements. And because the single market eliminates tariffs between EU nations, companies will need only one European base from which they can export to all the EU countries.

Finally, getting the mark and keeping the technical documentation that relates to compliance protects companies from fines or legal problems that may result from non-compliance, not keeping documents, or falsifying documents.

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This article first appeared in Volume 26 of CONSENSUS Magazine, 1999.  The information it contains was accurate at the time of publication but has not been updated or revised since, and may not reflect the latest updates on the topic.  If you have specific questions or concerns about the content, please contact the Standards Council of Canada.

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