Many products sold on the EU market must be identified with a CE label. The products for which CE labels are required are currently defined in 25 different EU directives on CE marking. These directives and associated regulations not only define which requirements a product must meet in order to be sold in the EU, but also the specific obligations of each member of the supply chain.
Is your product affected by a CE directive?
The responsibility you bear in connection with CE regulations ultimately depends on your role in the overall process chain. We have compiled below some of the essential obligations concerning the manufacture, marketing, sales and distribution of electrical and electronic products:
As a manufacturer of electrical/electronic products: Before you can start selling in the EU, you must
- carry out a conformity assessment for the product to determine which directives, standards, norms are applicable to the product and must be complied with
- declare the CE conformity of the respective product with the applicable CE directives (CE Declaration)
- be able to prove compliance with the legal requirements (technical documentation)
- label the products accordingly (CE label) and provide the company name, trade name or brand and address
- and later on ensure conformity throughout the sales period of each product, i.e. in terms of changes to regulatory requirements as well as product design
- save all conformity documents for 10 years.
As an importer of electrical/electronic products: Before bringing a product from a third country into the EU market, you must, among other things:
- ensure that a conformity assessment has been carried out by the manufacturer, that the manufacturer has drawn up the technical documentation and affixed the CE marking
- put your company name, trade name or brand and address on the product
- save the EU Declaration of Conformity for ten years (after the product has been brought into the market)
- ensure that, if requested, the technical documentation is available to the responsible national authority.
As a retailer: Before making electrical/electronic products available on the market, you must check, among other things:
- that the product bears the required conformity marking
- that the necessary documentation (e.g. the EU Declaration of Conformity), instructions for use and safety information are all enclosed in the packaged product
- that the manufacturer and importer have provided their names, registered trade names or brands and contact information
So-called fulfilment service providers may also be partially subject to the above obligations, depending on the extent to which their services extend beyond those of a typical parcel service.
Legal background of the CE label
CE labelling has been newly regulated in the so-called "New Legislative Framework"
in Regulation (EC) No 765/2008 and Decision No 768/2008/EC. In EU Regulation 765/2008/EC, Article 30 includes e.g. the following principles for CE labelling:
General principles of the CE marking
1. The CE marking shall be affixed only by the manufacturer or his authorised representative.
2. The CE marking as presented in Annex II shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed
to any other product.
3. By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.
CE labelling: legal framework
The illustration "Overview of the legal framework for CE labelling" provides an overview of the entire legal framework applicable to the CE labelling. As we cannot list all of the harmonisation regulations here due to their large number, the illustration only indicates the directives that currently affect the majority of our customers.
GPSD: General Product Safety Directive, Directive 2001/95/EC of the European Parliament and Council of 3 December 2001 – on general product safety
New: EU Regulation EU 2019/1020 on market surveillance and the conformity of products of 20 June 2019, comes into force on 16 July 2021, replaces/deletes § 15-29 of EU Regulation 765/2008. According to this regulation, almost all products covered by a CE directive may only be offered for sale from 16 July 2021 if there is a responsible 'economic operator' in the Union for these products (Article 4 (1)).
Economic operator within the meaning of the Market Surveillance Regulation are according to Article 4 (2):
- a manufacturer established in the Union;
- an importer, where the manufacturer is not established in the Union;
- an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform tasks on the manufacturer's behalf; or
- a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator is established in the Union.
NLF: New legislative framework,
- Regulation 765/2008/EC, Regulation (EC) No 765/2008 of the European Parliament and Council of 9 July 2008 – on the requirements for accreditation and market surveillance relating to the marketing of products
- Decision 768/2008/EC, Decision No 768/2008/EC of the European Parliament and Council of 9 July 2008 – on a common legal framework for the marketing of products
LVD: Low Voltage Directive, Directive 2014/35/EU of the European Parliament and Council of 26 February 2014 – on the harmonisation of the laws of Member States relating to the sales and marketing of electrical equipment designed for use within certain voltage limits
EMCD: Electromagnetic Compatibility Directive, Directive 2014/30/EU of the European Parliament and Council of 26 February 2014 – on the harmonisation of the laws of the Member States relating to electromagnetic compatibility
RED: Radio Equipment Directive, Directive 2014/53/EU of the European Parliament and Council of 16 April 2014 – on the harmonisation of the laws of the Member States relating to bringing radio equipment onto the market
RoHS-D: RoHS-Directive, Directive 2011/65/EU of the European Parliament and Council of 8 June 2011 – on restrictions regarding the use of certain hazardous substances in electrical and electronic equipment
ErP-D: ErP-Directive, Directive 2009/125/EC of the European Parliament and Council of 21 October 2009 – on establishing a framework for determining requirements for environmentally-sound design of energy-related products
Each applicable directive specifies:
- which essential requirements the product must fulfil,
- whether a notified body is to be involved,
- which modules for conformity assessment can be applied.
Multiple directives may apply to one product. All directives must be transposed into national law by the EU Member States. More detailed specifications for the different products covered by a specific directive can be found in the corresponding EU harmonised standards.