CE marking

CE marking
Name	CE marking
Caption	The CE marking as it appears on products
Type	Conformity mark
Country	EU and EEA
Introduced	1993
Managing authority	European Commission
Purpose	Indicates conformity with EU law

CE marking. The CE marking is a mandatory conformity mark for many products sold within the European Economic Area and Turkey. It signifies that a product has been assessed by the manufacturer and deemed to meet the essential requirements of the relevant European Union health, safety, and environmental protection legislation. The mark is a key indicator of a product's compliance with EU law and allows for the free movement of goods within the European Single Market.

Overview and purpose

The primary purpose of the CE marking is to function as a visible declaration by the manufacturer that the product complies with all applicable Community harmonization legislation. This system facilitates the free movement of products across the European Single Market, eliminating the need for multiple, differing national regulations from countries like France, Germany, and Italy. It provides a uniform standard that authorities, such as national market surveillance bodies, and economic operators can recognize. Ultimately, the mark aims to ensure a high level of protection for public interests such as health and safety and consumer protection while guaranteeing fair competition for manufacturers.

Legal basis and requirements

The legal foundation for the CE marking is established by Regulation (EC) No 765/2008, which sets out the requirements for accreditation and market surveillance, and Decision No 768/2008/EC, which provides a common framework for product legislation. Key requirements mandate that the manufacturer, whether based in the European Union or a third country like China or the United States, bears sole responsibility for declaring conformity. The product must meet all essential requirements detailed in the applicable EU directives or regulations, which cover aspects from electromagnetic compatibility to gas appliances safety. Non-compliance can lead to severe penalties enforced by entities like DG GROW and national courts.

Conformity assessment procedures

The specific conformity assessment procedure required depends on the product's classification and the risk level as defined by the relevant directive, such as the Machinery Directive or the Medical Devices Regulation. For low-risk products, the manufacturer may perform a self-assessment, often involving internal production control. For higher-risk products, the involvement of a Notified Body—an independent organization designated by an EU member state like the Netherlands or Poland—is mandatory. These bodies, which might include companies like TÜV SÜD or Bureau Veritas, conduct tasks such as quality assurance system audits or type examinations to verify compliance before the mark can be affixed.

Product scope and directives

A vast range of products fall under the scope of CE marking requirements, governed by over twenty specific pieces of legislation known as New Approach Directives and Regulations. Key examples include the Low Voltage Directive, the Radio Equipment Directive, the Construction Products Regulation, and the Personal Protective Equipment Regulation. Products like toys, pressure equipment, recreational craft, and explosives for civil uses are all covered. It is crucial for manufacturers to correctly identify which directives apply to their product, as enforced by surveillance authorities in countries like Sweden and Spain.

Affixing the mark and obligations

The manufacturer or its authorized representative in the European Union, such as one established in Belgium or Austria, must affix the CE marking visibly, legibly, and indelibly to the product or its data plate. This action must be accompanied by the creation of an EU declaration of conformity and, for many products, comprehensive technical documentation. The documentation must be made available to national surveillance authorities, such as those in the United Kingdom (for products placed on the market before Brexit) or Greece, for a period of up to ten years. Importers and distributors, under regulations like the Market Surveillance Regulation, also have obligations to verify the presence of the mark and documentation.

International recognition and comparisons

While the CE marking is a requirement for market access in the European Economic Area, it is also recognized in other jurisdictions through mutual recognition agreements, such as those with Switzerland and Turkey. It is often compared to other mandatory conformity marks like the UKCA marking in the United Kingdom or the EAC marking used in the Eurasian Economic Union comprising Russia and Belarus. Unlike voluntary quality marks like the GS mark or UL certification, the CE marking is a legal administrative requirement, not a quality mark or indicator of origin, a distinction emphasized by the European Commission and organizations like ANEC.

Category:European Union law Category:Technical standards Category:Trade