The 'CE' conformity marking is made of the "CE" acronym and the identification number of the notified body involved in the production control phase. The 'CE' marking is placed on most non-food products that wish to be shipped within the European market. It is affixed to the product itself, if not, on the packaging or accompanying document.
This marking allows for the compliance of the product's manufacturer, as defined by EU regulations. Those purchasing a product with a 'CE' mark can have peace of mind that their product is compliant.
Why the 'CE' marking?
The 'CE' marking is compulsory for all products covered by one or more European Regulations of the type "New Legal Framework" (previously called "New Approach" legislation). These products have the right to move throughout the European Union freely.
To affix the 'CE' marking to a product, the manufacturer must have inspections and tests carried out. This guarantees the conformity of the product to the essential requirements defined in the applicable European texts.
The 'CE' marking is not a certification. Regulation (EC) 765-2008 of July 9, 2008, lays down the general principles of the 'CE' marking (see, in particular, its Article 30 and Annex II).
Which products are concerned?
It's necessary to refer to the European texts/nation measures regarding whether the manufactured or imported product requires a 'CE' marking.
These texts provide a scope of application relating to the families of products concerned by other specific European directives or regulations. They never contain a detailed and exhaustive list of products concerned.
For context, there are around twenty "New Legal Framework" directives or regulations, providing for the 'CE' marking. They cover broad categories of products.
Knowing whether the product is concerned by the 'CE' marking may be technical and difficult. In case of doubt, you should contact the SQUALPI (Sub-Directorate) for the standardization, regulation of products, and metrology – Directorate-General for companies (DGE).
Procedure to assess conformity
Procedure to assess conformity
The assessment of conformity generally follows a two-step procedure. This is made of the design phase of the product and its manufacturing phase.
This includes eight assessment procedures or modules that apply to these two phases in different ways:
Internal production control
Conformity to type
Quality assurance of the production process
Product quality assurance
Full quality assurance
Note: If an industrial product is concerned by other European texts relating to other issues, it means that the product is compliant with all applicable directives or regulations. Any other marking, particularly conformity markings to national or European standards, may be affixed to industrial products.
The 'CE' declaration of conformity
The 'CE' declaration of conformity is drafted by the manufacturer or its agent established in one of the countries of the European Economic Area (EEA). This stands in cases where it used a third-party inspection body.
This document aims at certifying that the product is compliant with the '"essential health and safety requirements" of the applicable regulation. This is on the basis of which the product may be held liable.
Declarations of conformity usually contain the following information:
- Name and address of the manufacturer or agent
- Description of the equipment
- Reference to the harmonized standards or other specifications used
- Identification of the signatory
This document should be accompanied by the certificate issued by a notified body. Proof modules generally require the preparation of a technical dossier by the manufacturer to assess the conformity of the product.
It must contain administrative information on the company and various documents enabling to check the conformity of the product to technical rules (test reports, description of the product and manufacturing process, drawings, etc.).
Subject to exceptions, this dossier doesn't need inclusion with the product as it doesn't have to be submitted spontaneously.
The customer should not ask for it and only the inspection authorities, pursuant to a justified request, may obtain it.
Consequences of the 'CE' marking
No product subjected to a "New Legal Framework" regulation or directive can be placed on the market without a "CE" marking.
Once the "CE" marking is affixed, the product can freely move on the European market. This is without any procedure, national safety standard or new test being required.
Affixing the "CE" marking to a product that is not concerned by a European regulation requiring such is prohibited and may constitute a misleading commercial practice.
The national surveillance authorities in charge of guaranteeing the safety and conformity of products (Customs or DGCCRF) can request the submission of the declaration of conformity and technical dossier from the responsible party.
In the absence of any other responsible person in Europe and for some categories of products, from economic operators acting as " providers of order fulfillment services", to verify the validity of the marking.
These documents must be submitted within a reasonable period of time. During such an inspection, the national authorities are competent to punish the absence of or the fake 'CE' marking using administrative and/or criminal penalties (conformity works, fine, etc.).