The CE marking is also called a “product’s passport” for the markets within the European Economic Area (EU Member States plus Liechtenstein, Iceland and Norway) and in Turkey.1 This is due to the fact the CE marking enables the free movement of a product within this area in the sense of the free movement of goods (Art. 28 Treaty on the Functioning of the European Union, TFEU). It is the first indication that a product complies with the requirements under European Product Law.
There are, however, many uncertainties about if and how to affix the CE marking to a specific product. This article will provide some guidance and address some common misunderstandings with regard to the CE marking.
Meaning of the CE Marking
The CE marking is a declaration of the manufacturer that its product complies with the relevant legal European product requirements. It is neither a quality marking nor any confirmation of conformity given by a third party. Even if the manufacturer involves third parties – such as notified bodies – in its conformity assessment procedure, the third party must not affix the CE marking to the product. This is the sole responsibility of the manufacturer. Likewise, the manufacturer cannot shift the responsibility for compliance of its products to a third party. The manufacturer is always the responsible person (cases in which the responsibility can be transferred to authorised representative, importer or distributor will be assessed later in this article).
It is also to be taken into account that there are a variety of additional legal provisions on product requirements which do not follow the system of CE marking but have their own compliance markings, for example, the EU’s REACH Regulation (EC) No. 1907/2006 on the restriction of certain chemicals. As this article focusses on European product legislation requiring a CE marking, it will be referred to “CE Directives” as a description of the legal rules in question in the following.
Even if the CE marking was originally implemented to indicate conformity with European Product Safety Law, it goes way beyond product safety today. There are, for example, the EU Electromagnetic Compatibility Directive 2014/30/EU, the RoHS Directive 2011/65/EU and the EU Ecodesign Directive 2009/125/EC that also oblige the manufacturer to confirm compliance of its products with the CE marking. The conformity assessment is quite complicated specifically within the EU Ecodesign Directive as it legally works together with product-specific implementing measures adopted by the European Commission.
Legal Effect of the CE Marking – Presumption of Conformity?
There is no general presumption of conformity linked to the CE marking. The CE marking only triggers a presumption of conformity together with an appropriate EU Declaration of Conformity if the relevant CE Directive explicitly implements such legal effect. Such a provision exists for example in Art. 7(1) of the EU’s Machinery Directive 2006/42/EC.
Even if such a special provision exists, the market surveillance authority is free to take samples of the products and test them (e.g., electro technical tests from the applicable European harmonised standards). If the product does not pass these tests, the market surveillance authority has a starting point for proving that the product does not comply with the relevant product requirements under EU law. A reason for different test results achieved by the manufacturer and the market surveillance authority might be slight differences in the setting of the testing environment or the like. Those cases need very careful legal-technical assessment and argumentation to refute a possible complaint of the market surveillance authority. The market surveillance authority may then – inter alia – ban a product from the European market even though it carries the CE marking. The CE marking does not, therefore, render a product inviolable but gives a product the right of free movement as long as there is no indication of non-conformity.
A legally binding presumption of conformity is only triggered by compliance with a harmonised European standard which is published in the Official Journal of the European Union. Every CE Directive orders such presumption of conformity, for example Art. 14 of the Low Voltage Directive 2014/35/EU, Art. 13 of the EMC Directive 2014/30/EU, Art. 16 of the RoHS Directive 2011/65/EU, and Art. 7 of the Machinery Directive 2006/42/EC. This presumption of conformity is a core principle of European product compliance law under the so-called New Approach. The manufacturer is free to choose whether or not it designs its products in accordance with harmonised standards as standards are not legally binding. If the manufacturer decides to comply with the standards, the specific product is privileged by being covered by the presumption of conformity. It is important to keep in mind, though, that the presumption of conformity only applies to product characteristics that are covered by such a harmonised standard.
Responsibility for Affixing the CE Marking
The manufacturer is ultimately responsible for affixing the CE marking appropriately – no matter whether it is based inside or outside the European Economic Area. The manufacturer may, however, appoint an authorised representative by written mandate to affix the CE marking on its behalf.
If the manufacturer is based outside the European Economic Area, the importer is obliged to ensure that: 1) the appropriate conformity assessment procedure has been carried out; 2) the necessary technical documentation is drawn up; 3) the CE marking is affixed appropriately; and 4) the required documents are accompanying the product.
If the importer or distributor or any other economic operator place their own name or trademark on the product, the responsibility for appropriate CE marking shifts to the specific operator. The person indicated on the product is considered the manufacturer by definition of European Product Law (see for example Art. 10 of the Low Voltage Directive 2014/35/EU).
Evaluation of Applicable Product Legislation
Evaluation of the applicable product legislation is in many cases a real challenge. The scope of the CE Directives is often worded in a broad way and definitions are sometimes quite unclear. It is possible that several CE Directives (plus additional legal requirements from other than CE Directives) are applicable to a product. In these cases, the conformity assessment procedures provided in all applicable CE Directives have to be carried out before affixing the CE marking. One single CE marking is the statement of the manufacturer that its product complies with all applicable CE Directives.
An example: a laser printer – as electrical equipment –
falls under the scope of the EU’s Low Voltage Directive 2014/35/EU. According to Art. 8 of the Low Voltage Directive, the manufacturer must, therefore, make sure that the conformity assessment procedure under the Low Voltage Directive is carried out. The manufacturer also has to issue the EU Declaration of Conformity and affix the CE marking before the product is placed on the EU market. A laser printer would generally also fall under the Machinery Directive 2006/42/EC. “Ordinary office machinery” is, however, explicitly excluded if it is regulated by the EU Low Voltage Directive.
With regard to larger laser printers, it is more complicated to find out whether or not these are covered by the term “ordinary office machinery.” The European Commission’s Guidelines on the application of the Machinery Directive state in § 67 that the exclusion “does not concern machinery with similar functions intended for use in industries such as, for example, the printing paper industries.”2
Evaluation of Appropriate Conformity Assessment Procedure
If the applicable CE Directives are found, there is in many cases still uncertainty about the question of which conformity assessment procedure would be the right one. Some CE Directives provide a single method of conformity assessment, such as the Low Voltage Directive 2014/35/EU in its Annex III. But there are CE Directives which provide a sophisticated combination of the different modules of conformity assessment. Some CE Directives differentiate between product groups and set up different conformity assessment procedure with and without obligatory involvement of notified bodies as third parties (such as the ATEX Directive 2014/34/EU and the Regulation on Medical Products (EU) 2017/745). Some CE Directives allow the manufacturer to choose between different methods of conformity assessment (such as the EMC Directive 2014/30/EU in its Art. 14, and the Radio Equipment Directive 2014/53/EU in its Art. 17).
CE Marking and the EU Declaration of Conformity
If the CE marking has to be affixed to a product, the manufacturer must also issue an EU Declaration of Conformity. Every CE Directive has a model EU Declaration of Conformity in its Annexes. The manufacturer should follow the model EU Declaration of Conformity as closely as possible, specifically with regard to the order of information provided, wording and requirements with regard to date and place of issue as well as with regard to the persons to be indicated. Market surveillance authorities tend to base further complaints and investigations on non-compliance of the EU Declaration of Conformity – even with regard to merely formal aspects.
If several CE Directives apply to a product, the manufacturer must still issue a single EU Declaration of Conformity. It has to cover a statement referring to conformity with all applicable CE Directives. As the CE Directives contain quite different requirements with regard to the wording of the EU Declaration of Conformity, the European Commission states that the “single EU Declaration of Conformity” may be a dossier of EU Declarations of Conformity.
Affixing the CE Marking Appropriately
The design and size of the CE marking is specified in European Product Law. Art. 30 of Regulation EU (No) 765/2008 together with its Annex II contain precise rules on the appearance of the CE marking and restrictions on indicating other markings on the product, e.g. markings that could be mistaken for the CE marking. This provision is referred to in the CE Directives issued under the New Legislative Framework, such as the Low Voltage Directive 2014/35/EU (Art. 16), the EMC Directive (Art. 16), the RoHS Directive 2011/65/EU (Art. 14). These Directives provide for additional rules on legibility and the place of indication. Accordingly, even though there are common general principles in place, it is still necessary to carry out a product specific assessment on the details of appropriately affixing the CE marking. According to the general principles in
Art. 30 Regulation EU (No) 765/2008 together with its Annex II, the CE marking must be at least 5mm high and conform to the proportions of the pictogram referred to in Figure 1.
Figure 1: The CE marking, Regulation EU (No) 765/2008, Annex II
If an older CE Directive not yet issued under the New Legislative Framework – such as, for example, the Machinery Directive 2006/42/EC – applies to a product, the rules on appropriately affixing the CE marking are only to be taken from the applicable Directive. Annex II of the Machinery Directive 2006/42/EC requires for example the CE marking to be affixed in the immediate vicinity of the name of the manufacturer.
The CE marking has to correspond with the EU Declaration of Conformity which the manufacturer issues after it carried out the obligatory conformity assessment procedure.
Consequences of “Wrong” CE Marking
The CE marking has to be placed on products that fall under a CE Directive. On the other hand, the CE marking must not be placed on products that do not fall under a CE Directive.
“Wrong” CE marking can have several consequences for the manufacturer. Even though CE Directives are European legislation, the specific consequence must be assessed under the national law of every country of distribution as it is codified in national administrative or civil law.
Coming back to our laser printer example: the Low Voltage Directive 2014/35/EU obliges Member States merely to take appropriate measures if the CE marking is affixed to a product without legal justification. It does not prescribe the specific consequences in case the laser printer does not carry the CE marking. It is the EU Member States which take the appropriate measures by means of national legislation. And there might be different opinions amongst the EU Member States legislators on what would be an appropriate measure as well as on the scale of actions to be sanctioned.
For example, according to the German implementing law (Produktsicherheitsgesetz, abbr. ProdSG), affixing the CE mark without a legal basis is an offence liable to the same penalty as not affixing the CE marking even though a CE Directive prescribes it. In both cases of “wrong” CE marking, the market surveillance authority may impose a fine of up to EUR 10,000. Additionally, a product with a wrong CE marking does not comply with the provisions of the ProdSG and may, therefore, be subject to measures ordered by a market surveillance authority. Those measures include, for example, the banning of the products until they comply with the provisions on the CE marking.
CE Marking and Competition Law
Every manufacturer placing its products onto the European market should also have in mind that CE marking might also be relevant under competition law, especially the law against unfair competition which is, again, national law of every EU Member State.
For example, under German law against unfair competition, advertising with a CE marked product as “CE tested” was held not to be permitted by the Higher Regional Court Frankfurt (Oberlandesgericht , abbr. OLG). The OLG Frankfurt decided that the advertising was misleading in the meaning of Sec. 5 of the Act against Unfair Competition (UWG). By the addition “tested,” the manufacturer gave rise vis-à-vis a consumer not familiar with the principles of product law the (false) impression that an independent body had tested the product. This is precisely not expressed by the attachment of a CE marking.
Additionally, the “wrong” CE marking as mentioned above also provides competitors with the possibility of objecting to that conduct under competition law.
The CE Directives themselves also contain provisions that prohibit the use of a sign similar to the CE marking as it might confuse consumers.
Summary and Conclusion
To sum up, the CE marking is, indeed, a product’s “passport” to the European Economic Area as it is seen as first indication of product compliance. It does not, however, generally trigger a legally binding presumption of conformity and does not mean that the manufacturer does not have to be prepared for legal defence of his products, since market surveillance authorities might still start investigations and complain about non-compliance.
In these cases, it is of utmost importance to be prepared with comprehensive technical documentation as required by the applicable CE Directive and further demonstrate that the assessment of applicable product regulations and conformity assessment procedure has been carried out with due care. Such technical backup provides the basis for reliable and effective legal defence in order to prevent a sales ban or even the ordering of a product recall.
Endnotes
- European Commission, Blue Guide on the implementation of EU products rules 2016, Official Journal 2016/C272/01, p. 59.
- European Commission, Guide to application of the Machinery Directive 2006/42/EC, Edition 2.1 – July 2017, § 67, available at http://ec.europa.eu/docsroom/documents/24722.
Dr. Susanne Wende, LL.M., is an attorney at Noerr LLP, and specializes in European Product Law. She advises and represents clients vis à vis market surveillance authorities across Europe as well as with regard to product liability issues. She lectures on product liability law at the Technical University Berlin and regularly speaks on different aspects of European product compliance at conferences and in webinars and in-house trainings. Wende can be reached at Susanne.Wende@noerr.com.
