The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA).
They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements.
When you buy a new phone, a teddy bear, or a TV within the EEA, you can find the CE mark on them. CE marking also supports fair competition by holding all companies accountable to the same rules. By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA.
There are two main benefits CE marking brings to businesses and consumers within the EEA:
Businesses know that products bearing the CE marking can be traded in the EEA without restrictions. Consumers enjoy the same level of health, safety, and environmental protection throughout the entire EEA.
Not all products must have CE marking. It is compulsory only for most of the products covered by the New Approach Directives. It is forbidden to affix CE marking to other products. Please note that a CE marking does not indicate that a product have been approved as safe by the EU or by another authority. It does not indicate the origin of a product either.
EU consumers may have different preferences when it comes to the colour or brand of products such as a new laptop or a toy for their children. At the same time, they expect all products on the market to be safe. By affixing the CE marking to a product, the manufacturer assumes full responsibility for its compliance with all safety requirements. Unfortunately, due to counterfeiting or the misuse of CE marking, there is never a 100% guarantee that a product bearing the mark is safe. The EU has strengthened the entire system, consisting of manufacturers, importers, distributors, notified bodies, and market surveillance authorities, through the New Legislative Framework. The new legislation aims to reduce burdens on trade while ensuring a high level of safety.
Manufacturers play a crucial role in ensuring that products placed on the extended Single Market of the EEA are safe. They are responsible for checking that their products meet EU safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, to set up the technical file, to issue the EU declaration of conformity, and to affix the CE marking to a product. Only then can this product be traded on the EEA market.
If you are a manufacturer, you have to follow these six steps to affix a CE marking to your product:
- 1. Identify the applicable directive(s) and harmonised standards;
- 2. Verify product specific requirements;
- 3. Identify whether an independent conformity assessment (by a notified body) is necessary;
- 4. Test the product and check its conformity;
- 5. Draw up and keep available the required technical documentation;
- 6. Affix the CE marking and draw up the EU Declaration of Conformity
Importers and distributors
Importers and distributors help ensure that only products compliant with EU legislation and bearing the CE marking are placed on the extended Single Market of the EEA. As they are the intermediaries between manufacturers and traders, they must have overall knowledge of the legal requirements and make sure that the products they distribute or import meet them.
When importing from non-EU countries, importers must check that products fulfil all EU safety, health and environmental protection requirements before placing them on the market.
- The importer has to verify that: the manufacturer outside the EU has taken the necessary steps to allow the product to be placed on the EU market;
- the necessary documentation such as the EU Declaration of Conformity and the technical documentation is available upon request;
- contact with the manufacturer is possible at any time.
Distributors must handle the product carefully and they mustn’t affect its compliance with EU legislation. The distributor has to know which products must bear the CE marking and the accompanying documentation. They should be able to identify products that are not in compliance. Distributors must be able to demonstrate to national authorities that they:
- have confirmation from the manufacturer or the importer that the necessary measures have been taken;
- Are able to assist national authorities in their efforts to receive the required documentation.