EU Market Compliance

1. The complete guide to selling products legally on the EU market

To sell products legally in the EU, EEA, Turkish and (until 2023) the UK market (we simplify things by saying EU market from now on), you must comply with the comprehensive product compliance legislation in the EU. 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 EU legislations apply to products and what is required for products to be considered compliant.

The article aims to answer such questions as:

  • What is the meaning of the CE mark?
  • Do I need to CE mark my product?
  • What is required before I CE mark my product?
  • If it is not supposed to be CE-marked, what other legislation applies?

2. The CE mark

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.

2.1 Product safety in the European Union

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 (PPE – 2016/425) and the Toys Safety Directive (TSD – 2009/48/EC).

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 these legislations into account, and no goods destined for use by consumers in the EU market can be deemed outside the EU legislation’s scope.

2.2 Application of the CE mark

In the previously mentioned legislations, 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:

  • The CE mark is placed on the product by the manufacturer, not by any authority or third party. This also means that no certificate grants the right to use the CE mark. Hence, the manufacturer is solely responsible for the correct application of the mark.
  • The CE mark only represents conformity with the legislation that is declared. This means that a product can have completed all requirements for CE marking a product, but the product could still lack conformity to other legislations.

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.

2.3 Free movement on the EU market

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.

3. Product compliance

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.

3.1 CE marking

As previously mentioned, CE marking applies to products within the scope of specific legislations (these legislations are commonly denoted as CE legislations, CE directives, or similar). 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.

Here is a list of the legislations which require CE marking that we have written summaries for:

3.1.1 Examples of products
Let’s show some examples of products that are easily identified within the legislation, and others that are more deceptive.

Sunglasses Looking through the list, sunglasses are easily identified as falling within the scope of Personal Protective Equipment. These must therefore be CE marked. Toilets Toilets and other similar fixtures fall within the scope of Construction Products. Toilets must be CE marked. Tapware 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 (electrical motors) Electrical products have a handful of legislations that could apply; this product falls within the scope of:
  • Electromagnetic Compatibility
  • Low Voltage
  • Restriction of Hazardous Substances in Electrical and Electronic Equipment
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 evident that it has to be CE marked. If you want to know which legislation applies to your product, try our
 

3.2 General product safety

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. 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 it requires that 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.

3.2.1 Examples of products
Here are some examples of products that fall upon the GPSD for their product safety requirements and are not eligible for CE marking:

Scaffolding
Scaffolding could be misinterpreted as being defined as a Construction Product, but it is not considered as such.

Clothing
Some legislations apply to clothing, but none that allow CE marking or covers the product’s safety.

Furniture
Furniture that does not have any components that require CE marking, such as electrical components, falls under the GPSD.

3.3 Overarching legislations

So GPSD and CE legislations 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 is not indicate that the product is compliant with all requirements within the EU market.

3.3.1 Examples
We approach these legislations 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.

Regulation 2019/1021 Persistent Organic Pollutants (POP)
Regulation 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACh)

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.

Take-back directives

As a measure to counteract the amount of waste produced within the EU, “take-back directives” 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:

  • Directive 94/62/EC Packaging and Packaging Waste (PPWD)
  • Directive 2012/19/EU Waste Electrical and Electronic Equipment (WEEE)
  • Directive 91/157/EC batteries and accumulators and waste batteries and accumulators

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.

4. The CE marking process

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. These are:

  1. Identifying applicable directives and harmonised standards
  2. Verifying product-specific requirements
  3. Identifying if conformity assessments by a notified body are necessary
  4. Testing the product and checking its conformity
  5. Drawing up, and keeping available, the required technical documentation
  6. Affixing the CE mark and drawing up an EU Declaration of Conformity


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 simple 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.

4.1 Identifying all product requirements

Before a manufacturer starts proving the compliance of their product, they must know what it is supposed to comply with. The 6 steps identify the EU directives and harmonised standards, and together with EU regulations, all the relevant requirements will be identified. But again, in reality, requirements will also come from:

  • Official guidance documents for directives and regulations
  • Associated websites (such as ECHA)
  • Non-harmonised standards

Even though these sources are not explicitly legally binding, they are sometimes used as requirements where the earlier sources lack specifications.

4.2 Technical documentation and declarations

The most essential part of the CE marking process is the technical documentation. Every CE-marked product (and non-CE marked product) requires that the manufacturer drawn up technical documentation. In general, the technical documentation must be sufficient enough to prove;

  • the identity and traceability of the product,
  • the safety of the product, and
  • the compliance with all applicable directives and regulations.

The EC does not define these 3; they are how we conceptualise the technical documentation requirements.

4.2.1 Content of a technical documentation
The actual documentation required for technical documentation is not defined within the legislation for the most part. In those legislations where specific requirements for technical documentation are defined (which is most), it is always in a way that indicates that additional documentation could be required.

“The technical documentation shall, wherever applicable, contain at least the following elements:”

“The technical documentation shall include at least the following elements:”

“The technical documentation referred to in Article 21 shall contain, in particular, so far as relevant for assessment:”

Our interpretation is that it is up to the manufacturer to determine what level of documentation is required to prove the 3 points described earlier.

The technical documentation will likely require testing the product against one or several standards, depending on the applicable legislation. The reports from these tests are essential in documenting the compliance of most products on the market. When possible, so-called “harmonised standards” are used as they come with additional “presumptions of conformity” read more about harmonised standards here. But these test reports alone do not sufficiently cover the technical documentation requirements.

See this blog post for technical documentation where we explain some documents commonly included in technical documentation.

4.2.2 Declaration of Conformity
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.

Even though this is the legally binding document, a person placing a product on the market is responsible even if such a declaration has not been drawn up.

4.2.3 Declaration of Performance
The Construction Product Regulation (CPR) is the only CE legislation that deviates from using the DoC for CE marking. Instead, construction products require a Declaration of Performance (DoP), which includes additional technical information about the product.

The main difference is that a DoP declares that the product meets specific performance; therefore, it can resonably be that a product that is CE marked vs. CPR is illegal or inappropriate to use in certain member states or under certain conditions.

Products that fall under the CPR and any other CE legislation require both a DoP and a DoC.

Read more about the deviations of construction products from the usual CE process here.

4.2.4 Declaration of Incorporation
The Machinery Directive (MD) includes another declaration, the Declaration of Incorporation (DoI). This declaration is used for machinery that is within the scope of the MD but will only be used after it has been incorporated into a complete machine. The “partly completed machinery” is not eligible for CE marking; instead, the completed machine must be CE marked. The DoI shows that the partly completed machinery complies with the MD, reducing the burden of CE marking the completed machinery.

4.3 Affixing the CE mark to 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 customs that the previous steps have been taken.

The CE marking must consist of the initials “CE,” both letters should have the same vertical dimension and be no smaller than 5mm (unless specified differently in the relevant product requirements). CE image files are available on the EC website; these should be used without modification or distortion to ensure that the mark has the correct dimensions.

4.4 Obligations after the product is placed on the market

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. Most legislations do not have a set time that the information must be provided, which means it is up to the authority to decide. This could vary from a couple of days to several months, so it is essential to have the documentation in order.

Also, if the manufacturer believes that a product that they have placed on the market is not in conformity with relevant legislations, they must take corrective actions.

Relevant Legislation

Take-back directives

1. Take-back directives – A guide for economic operators to their responsibilities for the most commonly applicable EU Waste Laws This article is meant to

Read More »

Rohs

1. Scope of article This article is meant to explain Directive 2011/65/EU on the Restriction of the use of certain Hazardous Substances in electrical and

Read More »

ERP Ecodesign

1. Ecodesign for Energy-related Products Directive 2009/125/EC – A guide for economic operators in regard to Ecodesign and Energy Labelling of Energy related products This

Read More »

Want to know more?

If you want to know better how Zatisfy can help with complying with EU market legislation, please read more here or contact us below.

You can also schedule a free 30 min appointment with one of our experts here.