The CE mark applies to many products which are sold within the EU; it is recognisable throughout the world as a sign of safety. The European Union has put together a number of Directives for different products which outline the requirements that must be met in order to be deemed safe to go on sale.
There is a rigorous and mandatory process that all applicable products need to go through in order to earn the right to display that mark, and a failure to undergo this will restrict how and where your products can be sold.
What is CE marking?
The Conformité Européene (CE) mark is a mark which most of us will be familiar with, as we are likely to have homes and businesses full of items which have this mark. It is the mandatory conformity mark for most goods which are sold in the European Economic Area (EEA) and represents a declaration on the part of the manufacturer that the product in question meets all of the safety requirements set out in various pieces of legislation called ‘Directives’.
It is a small symbol which is primarily affixed to a product to show that it meets all of the stipulated safety criteria and that the item will not cause harm.
As we all know, the landscape of the EU is changing, and so the list of countries in which it is required can also change.
The current list of countries includes:
- Austria (Member since 1 January 1995)
- Belgium (Member since 1 January 1958)
- Bulgaria (Member since 1 January 2007)
- Croatia (Member since 1 July 2013)
- Cyprus (Member since 1 May 2004)
- Czech Republic (Member since 1 May 2004)
- Denmark (Member since 1 January 1973)
- Estonia (Member since 1 May 2004)
- Finland (Member since 1 January 1995)
- France (Member since 1 January 1958)
- Germany (Member since 1 January 1958)
- Greece (Member since 1 January 1981)
- Hungary (Member since 1 May 2004)
- Ireland (Member since 1 January 1973)
- Italy (Member since 1 January 1958)
- Latvia (Member since 1 May 2004)
- Lithuania (Member since 1 May 2004)
- Luxembourg (Member since 1 January 1958)
- Malta (Member since 1 May 2004)
- Netherlands (Member since 1 January 1958)
- Poland (Member since 1 May 2004)
- Portugal (Member since 1 January 1986)
- Romania (Member since 1 January 2007)
- Slovakia (Member since 1 May 2004)
- Slovenia (Member since 1 May 2004)
- Spain (Member since 1 January 1986)
- Sweden (Member since 1 January 1995)
As the UK has now left the European Union it has created its own UKCA mark to replace the CE mark for goods being sold in Great Britain. The CE mark has been permitted to be used in the UK for a period of transition, which, as of August 2023, is currently indefinite.
Switzerland is not an EU member but permits CE marking and Turkey has also fully implemented the European CE marking Directives.
The history of CE marking
The CE mark began in the mid-1980’s within the European community’s efforts to create a single European market. The CE mark was fully implemented by the mid 1990’s across the European Economic Area.
The harmonised product safety standard is designed to facilitate free trade as compliant products can be freely sold across member states. The CE mark signifies conformity to essential European safety standards and must be applied to the relevant products.
What is the CE marking process?
To have the right to put a CE mark on a product, you will first need to identify which of the EU Directives are applicable to it and make yourself familiar with the requirements. This will help you to see whether your product is already compliant or whether any amendments are needed. In some cases, you may need to have the product assessed by a Notified Body (a government appointed institution) to show its compliance.
If your product does not require this, you can test the product yourself and put together the proof and results of your tests, including any possible risks that customers might face. You will then be able to compile the necessary proof that your product complies with the EU Directives and show that it is fit to go on sale.
This can all be put together into a technical file, and you can complete a Declaration of Conformity to state that your product meets all of the legal requirements. Once this is done, you can affix the CE mark to your product.
All of this shall be put together by the manufacturer. If the manufacturer is outside of – and the goods are imported into – the EU (or the UK), then this becomes the responsibility of the importer. Often, an Authorised Representative may be used as a more convenient alternative when importing / exporting. In addition to covering the mandatory requirement of having a region-based representation, an Authorised Representative will also verify the technical file before the product goes on sale.
To summarise, here is a simple 6 step process on how to CE mark a product:
- Identify the applicable directives and harmonised standards that your product needs to comply with
- Verify product-specific requirements that must be adhered to
- Determine if conformity assessment by a notified body is necessary
- Test the product and check its conformity
- Prepare and provide the technical documentation
- Affix the CE mark to the product and draft an EU Declaration of Conformity
Is CE marking mandatory?
CE marking is mandatory but only for products that fall under the relevant Directives. The CE mark shows that the product meets all of the required levels of safety for that product. This is normally achieved by satisfying the ‘standards’ that are also applicable to the products. A failure to comply means that the product cannot go on sale. If the product is found to not have the correct marking and documentation it can be removed from sale and there can be significant penalties.
Who is responsible for CE marking?
CE marking and the process required beforehand must always be completed by the person or company that places their name or brand on the product.
How to achieve a CE Mark
To achieve a CE mark, it is vital that your product meets all of the harmonised standards which have been set out by the European Directives. These can be complicated to understand, and so you may need the assistance of an expert to help you work your way through them. If you are not based in the EU, then you will need to appoint an Economic Operator that is based within the EU in order to place your products on the EU market. An Authorised Representative can represent you in the EU and so perform this function on your behalf. This is also applicable for exporting into the UK, for which a UK Authorised Representative is needed.
How to affix the CE mark
When affixing the CE mark to a product, you need to be sure that it is clearly visible, indelible and that it is legible. Both of the CE letters should be displayed at the same size and must be at least 5mm. Only when it is not possible to fix it to the product itself, then can it be placed on the packaging or accompanying documentation instead.
Does the CE mark have a period of validity?
There is no period of validity for the CE mark. However, the DoC that is required for the CE mark to be applied must be kept up to date. Should any elements of the DoC change, the declaration must be updated otherwise this will void the CE mark.
Changes can include a modification of the legislation and updated contact details of either the manufacturer or authorised representative.
For imported products, the importer must retain a copy of the DoC for a minimum of 10 years after the product was first placed on the market.
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CE marking is a very important process, so it is important that you get it right in order to ensure that your product is not only safe, but also that it complies with EU regulations that will allow it to go on sale within EU member states.
We are able to advise you on the information we expect to see and, if necessary, put you in touch with our sister company who are experts in assisting companies with compliance.