A summary of the CE Marking process which is required for certain products to be lawfully sold within the Single Market.
The CE Mark is a self certified mark that is put on certain products to certify that they conform to European consumer safety/health/environmental standards (usually called essential requirements).
These standards are usually established through laws passed by the EU and when the mark is put on a product it indicates the compliance with all the relevant legislation meaning it is allowed to be sold legally within the European Economic Area (The Single Market).
What is its purpose?
The overall aim is to improve standards across Europe to help facilitate the free movement of safe goods.
What is the CE Mark not?
- a quality mark
- a certification mark (therefore it cannot be licensed or withdrawn)
- an indicator that a product is made in the EU
What kind of products does it cover?
Relevant products are defined under various EU Directives, but generally speaking it mainly covers toys, machinery and electrical equipment.
Is it mandatory?
If the product falls under the scope of one of the ‘New Approach’ Directives, then yes the CE mark is mandatory. If you wish to legally place your product in the EU market then the CE mark must be affixed.
What are the New Approach Directives?
Each New Approach Directive contains:
- A definition of the products covered and excluded by the Directive
- A set of essential requirements that the product must meet
- The procedures needed to establish compliance
The new approach, rather than over regulating and causing conflicting rules, aims to leave the detailed technical specifications (product standards) to be developed by specialised organisations such as:
Although the standards issued by these organisations are not legally required, they do however create a ‘presumption of conformity’ and are a way of proving that the ‘essential requirements’ have been met.
What are ‘essential requirements’?
The Essential Requirements are rules laid out in the New Approach Directives which create the minimum standards for which a product must meet before it can be put on the EU market legally. These requirement can usually be satisfied by completing various forms of product testing to prove the product is market worthy. Each Directive has its own individual set of requirements and these requirements usually cover the protection of people, animals, property and/or the environment.
What does ‘presumption of conformity’ mean?
When European Standards (or EN marks) are achieved for a product, then they create a presumption that the product conforms with the CE marking standards. So essentially they are a way of proving you comply with the requisite legal standard, as usually to obtain these standards you will have to pass various forms of product testing which in turn will satisfy the CE marking regulations.
You obtain these standards through the specialised organisations mentioned above.
What is a ‘Declaration of Conformity’?
This is the official legal declaration that the product has met all the requisite legal standards for health and safety. This is usually shown by a special form detailing all the assessments completed on the product, how it meets the legal requirements and identifying the person placing the product on the market.
How do I achieve the CE Mark?
- Identify the Directives(s) that are applicable to your product.
- Identify the conformity assessment procedure.
- Determine the dates by which you must take action.
- Identify if there are any Harmonised European Standards applicable to your product.
- Ensure the product complies with all the essential requirements of the Directive(s).
- Identify whether independent conformity assessment is required by a Notified Body
- Maintain Technical Documentation required by the Directive(s).
- Prepare the Declaration of Conformity and the required supporting evidence.
- Check that no other purely national requirements exist in the country where the product is to be sold. (This part can be tricky but Enterprise Europe can help with this)
- Affix CE marking on your product and/or packaging.
Whats the main legislation?
The legislation most often applicable is:
Electromagnetic Compatibility Directive
More InformationEuropa websiteFind your national notified body here
