Recently, in order to eliminate consumer confusion regarding the nature of certificates and to ensure the authority and clarity of the CE marking as the mandatory conformity declaration within the EU, the European Commission has reiterated the rules governing the use of the CE marking. It is prohibited for voluntary certificates to include the term "certification" or to display the CE marking.

 

As early as June 29, 2022, the EU issued the COMMISSION NOTICE – The ‘Blue Guide’ on the implementation of EU product rules 2022, which outlined the requirements for the use of the CE marking. Access to the EU market depends on a precise understanding of regulatory details, and particular attention should be paid to the restrictive provisions concerning voluntary certificates.

 

The European Commission has emphasized specific requirements regarding product conformity assessment on its official website, explicitly stating that voluntary certificates must not use terms such as "certification" or "independent third party," and are strictly prohibited from displaying the CE marking.

 

The official website of the European Union has announced as follows:
https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/conformity-assessment_en

 

 

1. Nature and Importance of the CE Marking

The CE marking is a "passport" for products to enter the EU market. Many products must bear the CE marking before they can be sold in the EU—regardless of their origin.

It indicates that a product complies with EU requirements related to safety, health, and environmental protection. It is the manufacturer's declaration that the product conforms to all applicable European legislation. The CE marking is not a quality mark nor an indication of origin; it is a declaration of conformity with EU law.

EU legislation explicitly stipulates that the CE marking applies only to specific product categories. Unless explicitly required by EU law, the CE marking must not be affixed to a product.

 

2. The Correct Conformity Assessment Process

Obtaining the CE marking requires adherence to a strict procedure. Manufacturers must first identify the EU legislation (Directives or Regulations) applicable to their product, which specifies the essential requirements the product must meet.

Subsequently, the product must undergo testing to verify compliance with safety and performance standards. For simple products, manufacturers may conduct testing themselves (known as CE SDoC); for complex or high-risk products, testing must be performed by a Notified Body designated by the EU.

Manufacturers must compile all technical documentation demonstrating product conformity (the "Technical File"), including test reports, product specifications, safety information, and instructions for use, and must sign a Declaration of Conformity (DoC).

 

3. Common Issues with Voluntary Certificates

Unregulated certificates, which are often called ‘voluntary certificates’ besides other names, are often issued for some products covered by EU harmonisation legislation by certification bodies not acting in their capacity as notified bodies under EU law. These practices are misleading, since only notified bodies may issue certificates of compliance for harmonised products and only in the area for which they are notified. For example, if a body is notified for issuing certificates for machinery, it should not issue certificates (voluntary or other) for non-machinery products (such as personal protective equipment – masks).

Please note that, under EU law, voluntary or other additional certificates are not a recognised means to prove compliance. Consequently, they have no value in case of checks by market surveillance authorities or customs. However, an exception arises in instances where voluntary certification is outlined in specific legislation. In such cases, while the certificate is not obligatory, it must adhere to explicit requirements if chosen to be acquired.

Voluntary certificates can create the impression that the product conforms with applicable EU harmonisation legislation, although such certificates are not issued by an authorised body.

Voluntary certificates must not be confused with third party conformity assessment certification by notified bodies within the area for of competence for which they are notified, due to the use of terms such as ‘certification’ or ‘independent third party’ or the presence of the CE marking on the certificate.

CE marking can only be affixed after testing the product and performing the conformity assessment procedure prescribed by the applicable EU harmonisation legislation. It is not acceptable for voluntary certificates to bear a CE marking.

 

4. Correct Use of the CE Marking

• The CE marking must be legible, visible, and indelible. It must not be applied using easily removable stickers. The marking must consist of the initials "CE," with both letters being the same vertical dimension and at least 5 mm in height (unless specifically stated otherwise in the relevant legislation).

• The size of the CE marking may be reduced or enlarged, but its proportions must be maintained. It may be presented in color, black and white, solid, or outlined—provided it remains clearly visible.

• If it is not possible to affix the marking directly on the product (e.g., due to size), the CE marking must be attached to the packaging or accompanying documents.

• If a product falls under multiple CE marking legislations, the accompanying documentation must clearly state that the product conforms to all applicable requirements.

 

5. EU Compliance Warnings and Recommendations

The EU strongly recommends that manufacturers, importers, and distributors rely solely on Notified Bodies designated by the EU for any necessary conformity assessments.

Information on these bodies can be found in the EU's NANDO (New Approach Notified and Designated organisations) database.

For products not requiring the involvement of a Notified Body, manufacturers may conduct the assessment themselves (i.e., CE self-declaration), but must still identify risks and properly document compliance.

 

6. Frequently Asked Questions on CE marking

Q1：What does the CE marking on a product indicate?

A1：By affixing the CE marking to a product, the manufacturer declares on his sole responsibility that the product is in conformity with the essential requirements of the applicable Union harmonisation legislation providing for its affixing and that the relevant conformity assessment procedures have been fulfilled. Products bearing the CE marking are presumed to be in compliance with the applicable Union harmonisation legislation and hence benefit from free circulation in the European Market.

Q2：Is a product affixed with the CE marking always produced in the EU?

A2：No. The CE marking only signals that all essential requirements have been fulfilled when the product was manufactured. The CE marking is not a mark of origin, as it does not indicate that the product was manufactured in the European Union. Consequently, a product affixed with the CE marking may have been produced anywhere in the world.

Q3：Are all CE marked products tested and approved by authorities?

A3：No. In fact, the assessment of the conformity of the products with the legislative requirements applying to them is the sole responsibility of the manufacturer. The manufacturer affixes the CE marking and drafts the EU Declaration of Conformity. Only products which are regarded as presenting a high risk to the public interest, e.g. pressure vessels, lifts and certain machine tools, require conformity assessment by a third party, i.e. a notified body.

Q4：Can I, as a manufacturer, affix my products with the CE marking myself?

A4：Yes, the CE marking is always affixed by the manufacturer himself or his authorised representative after the necessary conformity assessment procedure has been performed. This means that, before being affixed with the CE marking and being placed on the market, the product must be subject to the conformity assessment procedure provided for in one or more of the applicable Union harmonisation acts. The latter establish whether the conformity assessment may be performed by the manufacturer him- self or if the intervention of a third party (the notified body) is required.

Q5：Where should the CE marking be affixed?

A5：The marking shall be affixed either to the product or to the product’s data plate. When that is not possible due to the nature of the product, the CE marking shall be affixed to the packaging and/or to any accompanying documents.

Q6：What is a manufacturer’s Declaration of Conformity?

A6：The EU Declaration of Conformity (EU DoC) is a document in which the manufacturer, or his authorised representative within the European Economic Area (EEA), indicates that the product meets all the necessary requirements of the Union harmonisation legislation applicable to the specific product. The EU DoC shall also contain the name and address of the manufacturer along with information about the product, such as the brand and serial number. The EU DoC must be signed by an individual working for the manufacturer or his authorised representative, and the employee’s function shall also be indicated. Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EE Declaration of Conformity.

Q7：Is CE marking mandatory, and if so; for what products?

A7：Yes, CE marking is mandatory. However, only the products that are covered by the scope of one or more of the Union harmonisation acts providing for CE marking shall be affixed with it in order to be placed on the Union market. Examples of products that fall under Union harmonisation acts providing for CE marking are toys, electrical products, machinery, personal protective equipment and lifts. Products that are not covered by CE marking legislation shall not bear the CE marking. C 247/150 EN Official Journal of the European Union 29.6.2022 Information the products that are CE marked and the Union harmonisation legislation providing for CE Marking under

https://ec.europa.eu/growth/single-market/ce-marking_en

Q8：What is the difference between the CE marking and other markings, and can other markings be affixed on the product if there is a CE marking?

A8：The CE marking is the only marking that indicates conformity to all the essential requirements of the Union harmonisation legislation that provide for its affixing. A product may bear additional markings provided that they do not have the same meaning as the CE marking, that they are not liable to cause confusion with the CE marking and that they do not impair the legibility and visibility of the CE marking. In this respect, other markings may be used only if they contribute to the improvement of consumer protection and are not covered by harmonisation legislation of the European Union.

Q9：Who supervises the correct use of the CE marking?

A9：In order to guarantee the impartiality of market surveillance operations, the supervision of the CE marking is the responsibility of public authorities in the Member States in cooperation with the European Commission.

Q10：What are the sanctions for counterfeiting the CE marking?

A10：The procedures, measures and sanctions that apply to counterfeiting of the CE marking are laid down in Member State’s national administrative and penal law. Depending on the seriousness of the crime, economic operators may be liable to a fine and, in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given a second opportunity to ensure that the product is in conformity with the applicable legislation before being obliged to take the product off the market.

Q11：Where can I find more information?

A11：Information about CE marking, the products that are CE marked, the Union harmonisation legislation providing for CE Marking and the steps to follow under:

1. https://ec.europa.eu/growth/single-market/ce-marking_en

2. https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/conformity-assessment_en

3. https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/free-search

 

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