What you need to know
The CE mark appear on most of the products one can find on the EU market. The CE marking means that products made available on the market have been assessed to meet all the applicable EU requirements namely, the safety, health, and environmental protection requirements. This also applies for products made in third countries, but which are sold on the EU market.
When you buy a new appliance, a toy or a TV unit within the European economic area, you will find the CE mark on them. It is good to note that the CE marking also supports fair competition by holding all companies accountable to the same rules.
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.
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Product groups for which CE marking is compulsory can be found on this link. It is forbidden to affix CE marking to other products.
The general principles of CE marking are laid down by Regulation (EC) 765/2008. This Regulation is implemented by Subsidiary Legislation 427.73 under the Product Safety Act, Chapter 427.
‘CE marking’ as defined by Regulation (EC) 765/2008 mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing.
Obligations of manufacturers and their role in CE marking
Manufacturers are obliged to ensure that products they place on market are safe. They are responsible for checking that their products meet all the applicable EU requirements. The manufacturer is responsible for all aspects of the product, to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product.
Manufacturers must follow these 6 steps to affix a CE marking to their product:
- Identify the applicable directive(s) and harmonised standards;
- Verify product specific requirements;
- Identify whether an independent conformity assessment(by a notified body) is necessary;
- Test the product and check its conformity;
- Draw up and keep available the required technical documentation;
- Affix the CE marking and draw up the EU Declaration of Conformity.
These 6 steps may differ by product as the conformity assessment procedure varies.
For products that present higher safety risks such as gas boilers, safety cannot be checked by the manufacturer alone. In these cases, an independent organisation, specifically a notified body appointed by national authorities, has to perform the safety check. The manufacturer may affix the CE marking to the product only once this has been done.
To purchase European standards or obtain free abstracts of the standards you may click the following link to the Standardisation Directorate, contact the Librarian or call +356 23952000.
Harmonised Standards
Under the New legal Framework, manufacturers can use harmonised standards to demonstrate that products comply with relevant EU legislation. A standard becomes a ‘harmonised standard’ once it is published in the Official Journal of the European Union.
The use of harmonized standards is voluntary. Manufacturers and conformity assessment bodies are free to choose another technical solution to demonstrate compliance with the mandatory EU legal requirements. However, when a harmonized standard is used, it provides ‘presumption of conformity’ with the applicable EU harmonised requirements.
The list of harmonised Standards can be accessed through this link.
Other useful information
The list of Notified Bodies can be found here. You can search for notified bodies by selecting either a country or the relevant legislation.
This website provides information for manufacturers, importers and distributors on their responsibilities when placing a product on the EEA market. It also informs consumers about the rights and benefits that CE marking brings them.
Comprehensive guidance on the implementation of EU product rules can be found in the so-called Blue Guide.
Important Note
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 has been approved as safe by the EU or by another authority. It does not indicate the origin of a product either. 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.
As a **manufacturer** , that is, any natural or legal person who manufactures a product or has a product designed or manufactured and markets it under their name or trademark, you must have a comprehensive understanding of your legal obligations and ensure that products placed on the EU market are fully compliant with EU legislation. This includes ensuring that products bear the appropriate CE marking, are accompanied by the required technical documentation and EU declaration of conformity, and meet all applicable safety, health, and environmental protection requirements.
As an **importer**, that is, a person or entity that places products on the EU market from outside the European Union, you must have a comprehensive understanding of your legal obligations and ensure that only products fully compliant with EU legislation are placed on the EU market. This includes verifying that products bear the appropriate CE marking, are accompanied by the required documentation, and meet all applicable safety, health, and environmental protection requirements.
It is the responsibility of the economic operator, who has detailed knowledge of the product, to determine which EU legislation is applicable. Where an importer does not possess sufficient knowledge to make this determination, they may wish to consider obtaining independent legal advice from an external consultant prior to importing the product into the EU.
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