Product label: CE mark
Find out more about the European CE mark here.
Product certification: CE mark
The CE mark (Conformité Européenne) is a mark on products that confirms that they comply with the basic EU requirements regarding safety, health protection, environmental protection and consumer protection. It enables the free movement of goods within the European Economic Area (EEA). By affixing the CE mark, the manufacturer declares that the product complies with the relevant EU directives. The CE mark is a prerequisite for all products manufactured worldwide that are to be marketed in the EU.
Award criteria for the CE mark: EU product requirements
European law lays down basic requirements to ensure that products traded in the EU meet high health, safety and environmental standards. The CE mark confirms that these requirements have been met. Unlike other product labels, manufacturers cannot choose which criteria they fulfill and to what extent, but are subject to strict requirements. These requirements relate to various product properties, such as flammability, the manufacturing process and product performance, for example energy efficiency.
The majority of product requirements are harmonized across the EU, which means that there are uniform EU-wide rules for product groups or features that manufacturers must comply with. All product requirements are collected in the European Commission’s Access2Markets database. If there is no EU-wide regulation on product requirements, the national regulations apply.
To ensure successful CE marking, there are a few important steps that manufacturers must follow:
- Intended use: Specify what the product does and who uses it.
- Directives and harmonized standards: Identify the applicable EU directives and regulations that are relevant to the product. For many directives, there are EU-wide harmonized standards that contain detailed technical specifications.
- Risk assessment: Manufacturers are obliged to carry out a risk assessment and to include documentation of the safety-relevant features of the product in the technical documentation.
- Technical documentation: Preparation and compilation of the technical documentation, which includes a detailed description of the product, the declaration of conformity, circuit diagrams, construction plans, user information and, if applicable, maintenance instructions. The technical documentation is mandatory.
- EU Declaration of Conformity: Issuing of a Declaration of Conformity by the manufacturer or an authorized person of the company, which confirms conformity with all applicable EU directives. The declaration of conformity is mandatory. It contains, among other things, the name and address of the manufacturer, the serial number and model of the product, a declaration of liability, details of the notified body if applicable, details of the product origin, the relevant legal regulations and standards and the date and signature.
- CE marking: affixing the CE mark to the product, together with other necessary information such as the name and address of the manufacturer or importer. The CE marking must be visible, legible and indelible.
- User information and translations: Where applicable, user information must be provided in the language of the target market within the EU.
CE mark: Certification body
There is no certification in the true sense of the word for marking a product with the CE mark. The manufacturer can mark his product with the CE mark himself if:
- conformity with all EU-wide requirements is ensured,
- the test has been carried out by the manufacturer himself or by a notified body,
- the conformity of the product is proven on the basis of the technical documentation,
- an EU Declaration of Conformity has been drawn up and signed.
For some products, testing by a notified conformity assessment body is mandatory, but manufacturers can also make use of this service voluntarily or carry out the conformity assessment themselves.
A notified body is an independent organization that has been designated by an EU Member State and recognized by the European Commission to assess the conformity of products with the EU directives and to issue a certificate of conformity. A comprehensive list of these bodies is available on the European Commission’s website.
Costs for the CE mark
The costs for CE marking can vary greatly and depend, among other things, on whether an independent assessment is mandatory or voluntary for the manufacturer and how complex the assessment procedure is (depending on the product type and characteristics). If the manufacturer carries out the conformity assessment himself, there are generally no fees.
The CE mark is suitable for the following product groups:
The CE mark is mandatory for a large number of product groups that are placed on the market in the European Union. Here is a selection of applicable EU directives on CE marking:
- Elevators (2014/34/EU)
- Construction products (Regulation EU 305/2011)
- Electromagnetic compatibility (EMC: 2014/30/EU)
- Machinery (2006/42/EEC)
- Environmentally friendly design
- Low Voltage Directive for electrical equipment (2014/35/EU)
- Ecodesign of energy-using products (2005/32/EC)
Is the CE mark mandatory?
CE marking is mandatory for many products. It is an indication that the product complies with EU legal requirements to ensure health, safety and environmental protection before it is placed on the market. A labeling obligation exists if the product is subject to corresponding EU regulations that prescribe CE labeling. Without applicable regulations or a labeling requirement, products may not be labeled.
Recognition of the CE mark for certification systems
Sources:
European Commission – CE marking (2024)
Your Europe – CE marking (2024)
Your Europe – Technical documentation (2024)
TÜV Rheinland (2024)