To sell products legally on the EU market, you must comply with the EU:s comprehensive product compliance legislation. This article provides an overview of the process of CE marking products and the wider system for product compliance in the EU. Hopefully, it can provide an ideal starting point for understanding how the CE legislation applies to products and what is required for products to be considered compliant.
The article aims to answer such questions as:
When discussing the system for product compliance in the EU market, it is almost always done through the perspective of CE marking. This shows a general misconception about what the CE mark means. Still, it also shows how effective this iconic marking that adorns most products within the EU is at introducing the citizens of Europe to the concept of product compliance.
The CE mark or Conformité Européenne mark (European Conformity in French) is a product label that has been established by the European Commission (EC). The CE mark is often interpreted as an assurance of the product’s safety and quality, but in reality, it has a more nuanced meaning.
1.1 When is the CE mark required?
The CE mark is required for product types that fall within the scope of a CE marking legislation that requires products to be CE marked.
To put the CE mark in its correct perspective, it is essential to understand the legislative framework that defines the requirements for products, both products described within and outside the scope of the CE mark.
The product requirements are defined within EU directives and regulations. Each legislation (legislation will be used as the collective term for directives and regulations) defines a scope for which products it covers. For each product that falls within the scope, different requirements are defined. Within a number of these legislation, the requirement for CE marking is stated, for instance, the Personal Protective Equipment regulation (PPER – 2016/425) and the Toys Safety Directive (TSD – 2009/48/EC). These are collectively referenced as CE legislation or CE directives by various actors, but not in the legislation itself..
The legislations are designed in a manner that every product which is intended for consumers is covered by at least one legislation. In essence, this means that all products must take the legislation into account, and no goods destined for use by consumers in the EU market can be deemed outside the scope of the EU legislation. Note that not all legislation requires the CE mark.
1.2 Application of the CE mark
The CE mark means that the manufacturer is taking responsibility that the product has been assessed to be legal.
In the previously mentioned CE legislation, the CE mark is defined as a marking by which the manufacturer indicates that the product conforms with the applicable requirements in the “Union harmonisation legislation, providing for its affixing” with minor differences in the specific wording, depending on the legislation. The interpretation of this should focus on the facts that:
This shows that the CE mark is not proof that a product is safe for consumers and other end-users. Instead, it is only indicative that the manufacturer takes responsibility for certain aspects of the product safety. This responsibility is formalised in certain declarations; these will be further explained with the CE marking process.
1.3 Who is responsible for CE marking a product?
The person or company placing their name or trademark on the product is responsible for CE marking it.
As stated above, it is the sole responsibility of the manufacturer to correctly apply the CE mark to their product. But who is the manufacturer?
Sometimes the answer is easy. When a company designs, produces and sells a product themselves there is generally no confusion about who the responsible party is.
But private labelling is very common, and there is some general confusion about who holds which responsibilities. Private labelling is when a company buys a completed product from a manufacturer (often referenced as a Original Equipment Manufacturer or OEM), and then rebrands the product with their own trademark, company name or similar. In this case it is the company doing the private labelling that is considered the manufacturer.
The definition of manufacturer is defined official documents as:
The manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and places it on the market under his own name or trademark.
1.4 Free movement in the EU for CE marked products
One of the main aspects of the CE mark and other parts of the “Union harmonised legislation” is the concept of “presumption of conformity” (via the New Legislative Framework); this concept is applied to a variety of things. Regarding the CE mark, authorities and customs must assume that products labelled with the CE mark are compliant until proven otherwise. This grants CE marked products free movement across the entire EU market, the so-called European Economic Area (EEA).
However, this does not mean that a CE-marked product is compliant with national requirements that might be in place. For instance, the first and foremost thing that customs look for is so-called formal incompliance, such as, faults in the visible marking of the product. This could be that the CE mark has the wrong proportions, the CE mark is too small, the product is not marked with the manufacturer’s contact details, etc.
From the point of view of manufacturers and sometimes other economic actors, the whole system is approached from the lens of “How do we CE mark our product?” or similar sentiments. While this is a great place to start looking at how the EU legislation must be applied to a product, it is somewhat misleading. First of all, not all products are eligible for the CE mark, and secondly, the CE mark is only one part of a more extensive product compliance system.
A more holistic question would be, “How do we achieve product compliance in the EU market?”!
Let’s show some examples of legislation that apply to CE marked products, non-CE marked products, or either.
2.1 Which products require CE marking?
As previously mentioned, CE marking applies to products within the scope of specific legislations. The EC keeps a list of these legislations on their website; they call them product groups which is somewhat misleading as many products fall within the scope of several of these. Nevertheless, it is a good resource for manufacturers to understand which legislations requiring CE marking could apply to their products. For most, they also include a summary of what parts of the legislation the manufacturer has to be most aware of.
Let’s show some examples of products that are easily identified within the legislation, and others that are more deceptive.
Looking through the list, sunglasses are easily identified as falling within the scope of Personal Protective Equipment as they fall within the definition “equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety” and must therefore be CE marked.
Toilets and other similar fixtures fall within the scope of Construction Products. Toilets must be CE marked.
It falls within the scope of Construction Products. But these do not have to be CE marked due to some intricacies of the Construction Product Regulation. Construction Products is the only product group that sometimes has the option of CE marking; read more in our article about the CPR.
Height adjustable desks (with electrical motors)
Electrical products have a handful of legislations that could apply; this product falls within the scope of:
But it also falls within the scope of Machinery since it has motors. When the Machinery Directive is applied to a product, it supersedes the Low Voltage Directive. Thus the Low Voltage Directive is not applicable even though the product is within its scope. The product must be CE marked.
This is in no way a comprehensive list of examples, but it shows that the question if a product should be CE marked is sometimes easy and sometimes more complicated. It also shows that the question of which legislations a product should be CE marked under is not always easy to answer, even when it is obvious that it has to be CE marked.
If you want to know which legislation applies to your product, try our Legislation finder Tool, which can assist with the process.
2.2 Products that do not require the CE mark
So what if your product does not fall within the scope of any legislations requiring CE marking? Maybe your business has designed a completely novel product, which falls outside the scope of all specific product safety legislations.
The EC has introduced a simple solution for these cases, the General Product Safety Directive (GPSD) 2001/95/EC. The GPSD governs the product safety of all products, but is mainly relevant when the product is not within the scope of any specific product safety legislation. It is very vague regarding specific requirements to be as widely applicable as possible.
The GPSD in its purest form requires that manufacturers (called “producers” in the current version of the GPSD) mainly “shall be obliged to place only safe products on the market.”. Outside some requirements for labelling and user instructions, the GPSD does not specify how a product should be deemed safe. Although this has generally been interpreted as that a technical documentation must exist that proves that the manufacturer has taken safety into account when designing the product. This, in effect, places similar requirements for general products as for CE-marked products; the technical documentation will be further explained below.
Here are some examples of products that fall upon the GPSD for their product safety requirements and are not eligible for CE marking:
Scaffolding could be misinterpreted as being defined as a Construction Product, but it is not considered as such.
Some legislations apply to clothing, but none that allow CE marking or covers the product’s safety.
Furniture that does not have any components that require CE marking, such as electrical components, falls under the GPSD.
2.3 Legislation that applies to all products
So GPSD and CE legislation cover the product safety aspects of product compliance in the EU, but this is far from the only part of the system. There is a wide range of legislation that places restrictions on substances, requirements on labelling, responsibility for waste, and much more.
These affect products regardless of whether they are CE marked or not, so a correctly placed CE mark does not indicate that the product is compliant with all requirements within the EU market.
We approach these legislation by sorting them into rough categories; here are two examples that are almost always applicable:
Restrictions on substances and chemicals
For products on the EU market, there are two regulations that set restrictions for substances and chemicals for all products.
Together these two regulations define over 300 substances that are either not allowed or only allowed in specific concentrations. Failure to comply with these regulations can be considered a serious offence, and all manufacturers should be aware of and take all these substances into account. Unfortunately, the presence of these substances is often unknown, especially for materials and components manufactured outside the EU.
Extended Producer Responsibility
As a measure to counteract the amount of waste produced within the EU, “Extended Producer Responsibility” have been put into force among the various waste laws. These require that the manufacturer/producer of certain products and materials be responsible for complying with the national waste collection systems. Common examples of these are:
When these directives describe responsibilities for producers, they do not mean the manufacturer; they either mean the party that introduces the product onto the national market or anyone who uses the material as part of a business. The PPWD is likely applicable to more than 99% of consumer products on the market.
The question “How do we CE mark our product?” might not be entirely correctly formulated, but it is a common question that we would like to answer in a general sense.
One will find the “6 steps to affix a CE marking to your product” on official webpages about CE marking, such as this one. These are:
But as the EC states, “These 6 steps may differ by product […]”, they should not be interpreted as a complete guide for all products. In reality, the process is rarely so linear as this, but all these steps must be included. (For instance, we do this in three simplified steps instead. Read all about our three-step process to compliance here.)
Below will be described a general outline of what is needed before CE marking a product, not necessarily the process itself.
3.1 Identifying all product requirements
Before a manufacturer starts proving the compliance of their product, they must know what it is required to comply with. The 6 steps identify the EU directives (and regulations), harmonised standards, product-specific requirements and eventual requirements for a notified body. These 3 steps can be summarised as the product requirements.
The hardest part here is to correctly identify all EU-legislation and harmonised standards. All legislation are found on the commission’s website. This is quite time consuming the first few times doing it. Summaries and guides for some of the legislation can be found on our website.
3.2 Technical documentation and declarations
With the requirements identified, the manufacturer has to assess and document that the product conforms to the requirements. This can include testing, documentation of product design and much more. The goal is to end up with documentation that shows that the product is compliant (and also why it is compliant).
This is called a technical documentation or a technical file, and is included in one format or another in every CE legislation.
The documentation should be compiled during the design process. By continuously working with the documentation the manufacturer is always able to check which requirements remain to be complied with or documented.
3.2.1 Content of a technical documentation
When the technical documentation is deemed sufficient by the manufacturer to prove compliance with all applicable CE legislation, they must draw up a Declaration of Conformity (DoC). This DoC is a legally binding document where the manufacturer takes full responsibility that the product conforms with all applicable CE legislations.
This document is effectively a summary of the product’s technical documentation. Which authorities can read to get an overview of products stated compliance, so it is important to get it right!
Construction products are the only CE marked products that do not use a DoC, instead they have a DoP. Read more about the deviations of construction products from the usual CE process here.
3.3 Placing the CE mark on the product
When the DoC (and/or DoP) is drawn up and signed, the product can legally be CE marked and placed on the market. In this sense, the CE mark is an indication to consumers and authorities that the previous steps have been taken.
The CE marking must consist of the initials “CE,” in a defined format and be no smaller than 5mm (unless specified differently in the relevant product requirements). CE image files are available on the EC website; these must be used without modification or distortion to ensure that the mark has the correct dimensions.
3.4 Obligations after the product is sold
Once the product is placed on the market, the manufacturer’s obligations are not yet over.
The manufacturer must ensure that the technical documentation and the DoC (and/or DoP) are kept for the duration stated in the CE legislation, typically 10 years after the last unit is placed on the market. During this period, the manufacturer must supply these documents to market surveillance authorities in response to a reasoned request.
Also, if the manufacturer believes that a product that they have placed on the market is not in conformity with relevant legislations, they are obligated to take corrective actions.