EU legislation: FAQ on CE marking
If you want to export to the EU, you have to take into account that the EU set requirements regarding
CE marking for specific products. This document provides general information on CE marking to
understand the most important issues you have to know and consider to be able to affix CE marking
on your product. Once you have read this document, you can find specific information on your
product and the steps you have to follow to comply with CE requirements in the related documents
available in the CBI database (also mentioned at the end of this document).
Frequently Asked Questions on CE marking




















What is CE marking?
What is the purpose of CE marking?
Do all products require CE marking?
How to know if my product requires CE marking?
If my product requires CE marking, is only one EU Directive applicable?
Where can I find the requirements?
CE- marking is often associated to EU standards, do I have to comply with EU standards to
demonstrate compliance with EU legislation?
Are standards available for all products requiring CE-marking?
What is a Notified Body?
Do I always need a Notified Body?
How do I know which Notified Body I have to contact?
What is a Conformity Assessment Procedure?
The Directive mentions a Technical Documentation, what does this mean?
How long do I need to keep the Technical Documentation?
What is an EC Declaration of Conformity and why do I need it?
What does the EC Declaration of Conformity look like?
What is an authorised representative?
How to affix CE marking?
Do I have to affix the CE marking?
Once I have affixed the CE marking in my product, can I export my product?
What is CE marking?
CE marking, an acronym for the French
"Conformité Européenne", is since 1993 a
key indicator of a product’s compliance with
EU legislation regarding safety, health and
environmental protection. The CE logo ensures
the free movement for products within the
European Economic Area (EEA)1. The New
Approach Directives are the legal basis of CE
marking and aim to harmonise requirements
and remove barriers for free circulation of
products in the European Union.
What is the purpose of CE marking?
CE marking does not indicate that a product was made in the EU. It states that the product is
assessed before being placed on the market and thus satisfies the legal requirements to be sold in
the EU. It means also that the manufacturer has verified that the product complies with all relevant
essential requirements of applicable Directives.
1 The EEA consists of the 27 EU Member States and EFTA countries Iceland, Norway, Liechtenstein.
Source: CBI Market Information Database • URL: http://www.cbi.eu • Contact: marketaccess@cbi.eu • www.cbi.eu/disclaimer
EU legislation: FAQ on CE marking
Do all products require CE marking?
Not all products are required to be CE marked, only the products that fall within the scope of at least
one of the Directives in Table 1.There are Directives for 24 product groups.
How to know if my product requires CE marking?
Each New Approach Directive specifies the product groups covered by the Directive. Usually in the
first articles, you can find the definition of the specific products covers by the Directive.
If my product requires CE marking, is only one EU Directive applicable?
A product may be subject to more than one Directive which determines the specific requirements
that your product must meet in order to be CE marked. CE marking requirements vary from Directive
to Directive and thus for each product can be different. In case more than one Directive is
applicable, your product has to comply with the requirements of all Directives.
Where can I find the requirements?
The Directive specifies in detail the essential requirements the product must meet in order to affix
the CE marking. Normally the essential requirements are available in the Annexes of the Directive.
CE marking is often associated to EU standards, do I have to comply with EU standards to
demonstrate compliance with EU legislation?
Although complying with the standards is not obligatory according to the EU legislation, it is a
common practice that importers and buyers require certification as a way to confirm compliance.
Although costs are associated to get and implement the standards, they improve the safety and
quality of your product and in some cases a market requirement of your potential EU buyers.
Are standards available for all products requiring CE marking?
It is possible that you cannot find applicable EU standards for your product. Maybe it is because you
have a rather new or innovative product and standards have not been developed yet. In that case,
you still have to comply with the legal requirements stated in the applicable Directive(s).
What is a Notified Body?
Notified Bodies are laboratories or organisations, authorised by the EU to serve as independent
testing bodies and perform conformity assessments. Notified Bodies are located in Europe.
However, some Notified Bodies have subsidiaries outside the EU that perform tests and submit
results back to Europe for final approval.
Do I always need a Notified Body?
No. There is a common misunderstanding that your product always has to be inspected and
approved by some kind of authority. Only for some products third party certification done by Notified
Bodies is required. The applicable Directive states whether a Notified Body is required. Often
notified bodies are required whenever products represent significant risks to consumers. In other
cases, self-assessment is possible.
Source: CBI Market Information Database • URL: http://www.cbi.eu • Contact: marketaccess@cbi.eu • www.cbi.eu/disclaimer
EU Standards
EU standards are being drafted
by three European Standards
Organisations: CEN, CENELEC
and ETSI. Besides, all EU
Member States have their own
national standardisation
bodies which adopt European
standards. You can buy the
standards from these national
bodies. Look for more
information on the websites of
CEN, CENELEC and/or ETSI.
EU legislation: FAQ on CE marking
How do I know which Notified Body I have to contact?
You may choose a Notified Body in any Member State of the EU. If you know the country you want to
export to, you should prefer to contact a Notified Body in that country. In the NANDO (New Approach
Notified and Designated Organisations) database you can find a list of Notified Bodies.
What is a Conformity Assessment Procedure?
Many products can be assessed by the manufacturer itself. In that
case it is your responsibility to test the product and checking its
conformity to the EU legislation. You must go through a series of
checks to assess and ensure that your products conform to the
relevant EU Directive(s). This is called the Conformity Assessment
Procedure.
One important part of the procedure is a risk assessment. In the
Directive applicable to your product you can find specific
information about carrying out the Conformity Assessment.
The Directive mentions a Technical Documentation, what
does this mean?
You, or your authorised representative in the Europe Union, have to establish the technical
documentation (sometimes referred to as the technical file) required by the Directive(s).
The documentation includes details of the design, development and manufacture of the product.
Technical Documentation can be made available in any format (i.e. paper or electronic) and varies
by each Directive.
How long do I need to keep the Technical Documentation?
You need to keep the technical documentation for a period of at least 10 years after the last product
is placed on the market. The exact number of years is stated in the Directive.
What is an EC Declaration of Conformity and why do I need it?
Before affixing the CE marking, you need to draw up an EC Declaration of Conformity. The
Declaration of Conformity is a document in which you as the manufacturer indicate that the product
meets all the necessary requirements of the EU Directive(s) applicable to the specific product.
What does the EC Declaration of Conformity look like?
Each Directive has slightly different requirements for the content of its Declaration of Conformity.
But some features are common to all, such as:
Name and address of the producer
Essential characteristics of the product, such as the brand and serial number
The identification number of the Notified Body (if applicable).
Whether a Notified Body has been involved or not, you as the manufacturer must draw up and sign
the EC Declaration of Conformity. Some Directives contain a standard declaration in the annexes. In
case there is none, you can search on internet for examples.
What is an authorised representative?
An authorised representative is any natural or legal person established within the EU who has
received a written mandate from a manufacturer to act on his behalf in relation to specific tasks.
This can be an importer or distributor.
Source: CBI Market Information Database • URL: http://www.cbi.eu • Contact: marketaccess@cbi.eu • www.cbi.eu/disclaimer
EU legislation: FAQ on CE marking
How to affix CE marking?
Once the necessary steps have been successfully completed, you must affix the logo to the product
as described in the relevant Directive. The CE marking must be affixed to the product according to its
legal format. It must be visible, legible and indelible. When this is not possible, it must be affixed to
the packaging and to the accompanying documents. If a Notified Body was involved in the
assessment, its identification number also must be displayed.
Do I have to affix the CE marking?
You as the manufacturer have to affix the CE marking. If your authorised representative in the EU put
your products under his/her own name, then she/he takes over your responsibilities. In this case
he/she must have sufficient information on the design and production of the product, as he/she will
be assuming the legal responsibility when affixing the CE marking.
Once I have affixed the CE marking in my product, can I export my product?
After affixing the CE marking, you may export your product to the EU. However, you have to make
sure that the conformity is maintained. EU legislation and standards can change and CE marked
products are subject to inspection by EU authorities. In order to keep complying with the legislation,
you may need to make changes to your product. If this happens you need to add these changes in
the technical documentation and inform the Notified Body, if applicable. Together with the EC
Declaration of Conformity, the technical documentation must be presented on request to the
appropriate national authorities of the EU.
EU New Legislative Framework
The New Legislative Framework is the modernisation of several of the EU New Approach Directives
and was adopted in 2008. This broad package of measures is established to:
1) Remove the remaining obstacles to the free circulation of products.
2) Improve market surveillance rules.
3) Better protect both consumers and professionals from unsafe products.
4) Clarify the meaning of CE marking and enhance its credibility.
At this moment the European Commission is in the process of revising the current Directives.
Please keep informed about the New Legislative Framework to assess whether this revision may
have implication for your business. More information can be found on the website of the European
Commission.
Non-compliance
When a product does not comply with the EU Directive(s) the EU will withdraw the product from the market. This
will have financial consequences for you as a manufacturer. The withdrawn product will be put on RAPEX, the
EU rapid alert system. The system facilitates the exchange of information between Member States and the
Commission on measures taken to prevent or restrict the marketing or use of products posing a serious risk to
the health and safety of consumers. More information about the risks of non-compliance can be found here.
Example
In 2012 a protective roller skater helmet from a Chinese producer was withdrawn
from the French market. The helmet did not provide sufficient shock absorption and
thus did not effectively protect the user’s head. Therefore the product was withdrawn
because non compliance with the Personal Protective Equipment Directive
89/686/EEC and the relevant European standard EN 1078. The helmet was put on
RAPEX.
What will your importer/buyer require from you?
When your company is not represented in the EEA, the importer/buyer must make sure that the
products they place on the market comply with the applicable requirements and do not present a
risk to the European consumers. As importers/buyers are the final responsible of the products set in
the EU market, they will ask you for a written assurance to guarantee that:
Source: CBI Market Information Database • URL: http://www.cbi.eu • Contact: marketaccess@cbi.eu • www.cbi.eu/disclaimer
EU legislation: FAQ on CE marking
1)
2)
They will have access to the necessary documentation, such as the EC Declaration of
Conformity and the technical documentation. This is needed in case EU authorities will ask for
the documentation.
The product complies with all relevant EU legislation.
In case you are an exporter and no manufacturer, EU importers/buyers may require permanent
communication to make sure that contact with the manufacturer can always be established.
Related documents
Please find below an overview of other legislative and non-legislative requirements that are of relevance. Some
of the requirements are shortly highlighted in this document. More details however, can be found in the CBI
database under the following document titles:
Legislation:




EU legislation: Chemical REACH
EU legislation: Liability for defective products
EU legislation: Product safety (consumer products)
EU legislation: Non-compliance with product safety legislation (consumer products cases)
Non legislation:



European buyer requirements: Personal protective equipment
Quality management system ISO 9001
Third party certification
Last updated: October 2012
This document was compiled for CBI by CREM B.V.
Disclaimer CBI market information tools: http://www.cbi.eu/disclaimer
Source: CBI Market Information Database • URL: http://www.cbi.eu • Contact: marketaccess@cbi.eu • www.cbi.eu/disclaimer
EU legislation: FAQ on CE marking
Annex I - EU Directives on CE marking
Below you see a list of product groups that fall under one or more Directives which determine the
specific requirements that the product must meet in order to be CE marked.
Table 1: Product groups and related Directives with CE marking
Product groups by European Commission:
EU Directive/Regulation: CBI document:
1.
Active implantable medical devices
90/385/EEC
2.
Appliances burning gaseous fuels
2009/142/EC
3.
Cableway installations designed to carry
persons
2000/9/EC
4.
Construction products
Regulation 305/2011
Yes
5.
Eco-design of energy related products
2009/125/EC
Yes
6.
Electromagnetic compatibility
2004/108/EC
Yes
7.
Equipment and protective systems intended for
use potentially explosive atmospheres (ATEX)
94/9/EC
Yes
8.
Explosives for civil uses
93/15/EEC
9.
Hot-water boilers
92/42/EEC
10.
In vitro diagnostic medical devices
98/79/EC
11.
Lifts
95/16/EC
12.
Low Voltage Devices
2006/95/EC
Yes
13.
Machinery
2006/42/EC
Yes
14.
Measuring Instruments
2004/22/EC
Yes
15.
Medical devices
93/42/EEC
Yes
16.
Noise emission in the environment
2000/14/EC
17.
Non-automatic weighing instruments
2009/23/EC
Yes
18.
Personal protective equipment
89/686/EEC
Yes
19.
Pressure equipment
97/23/EC
Yes
20.
Pyrotechnic articles
2007/23/EC
21.
Radio and telecommunications terminal
equipment
1999/5/EC
22.
Recreational craft
94/25/EC
23.
Safety of toys
2009/48/EC
Yes
24.
Simple pressure vessels
2009/105/EC
Yes
Yes
Yes
Source: CBI Market Information Database • URL: http://www.cbi.eu • Contact: marketaccess@cbi.eu • www.cbi.eu/disclaimer
For CMS
Active
Revision date
(standard 1 year, unless changes are
expected at earlier date)
Summary
(IMPORTANT: the first lines must highlight the
application and for which CBI sector is
important. Not mention specific Directives’
numbers)
NEW document? (yes / no)
If Yes, `new´ icon is presented
Changes in document’s title?
Old title:
Type of document
(leave only the correct option)
Information type
(leave only the correct option)
Number of pages
(number of pages of the text that will be
uploaded)
Ranking
EU legislation: 30
Transpositions: 40
National leg (aanvullend): 35
Related markets
(list all export markets for which relevant). EU
and/or national, and/or Norway
Sources and comments
(NEW: Give a short description of the work
done)
Agriculture, fishery and
forestry
Cut flowers and foliage
Always Yes
(unless document should not be shown from the moment it is uploaded in the database)
September 2013
If you want to export to the EU, you have to take into account that the EU set requirements regarding
CE marking for specific products. This document provides general information on CE marking to
understand the most important issues you have to know and consider to be able to affix CE marking
on your product. Once you have read this document, you can find specific information on your
product and the steps you have to follow in the related documents of the CBI database (also
mentioned at the end of this document).
Yes
Yes
EU legislation on CE-marking: Instruction on implementing CE-marking
New
6
30
EU
Executer: Flip
Rosa, Dianthus, Orchids, Dendranthema, Gladiolus, flowers grown from bulbs and other fresh cut flowers
Summer flowers
Tropical flowers
Prepared cut flowers
Foliage
Fishery products
Fresh, chilled or frozen fish and fish fillets
Fresh, chilled or frozen crustaceans and cephalopods
Fresh, chilled or frozen molluscs
Prepared or preserved fish and fish fillets
Prepared or preserved crustaceans and cephalopods
Prepared or preserved molluscs
Food ingredients
Coffee
Tea
Cocoa (inc. Cocoa butter, oil and fat)
Edible nuts
Source: CBI Market Information Database • URL: http://www.cbi.eu • Contact: marketaccess@cbi.eu • www.cbi.eu/disclaimer
EU legislation: FAQ on CE marking
Dried fruit and dried vegetables
Fruit juices and concentrates
Canned fruit and vegetables
Frozen fruit and vegetables
Jams, jellies, purees and marmalades
Honey and other bee products
Natural colours
Natural thickeners
Thickeners
Rice
Pulses
Spices
Herbs (dried)
Raw cane sugar
Refined sugar, fructose and molasses
Conventional oils - niche markets (palm, sunflower, cocos - focus on virgin, organic, fair trade)
Specialty oils (peanut, mais, sesame, sheabutter, mango butter, rich omega 3 oils)
Olive oil (focus on organic etc)
Oil seeds
Fresh fruit and vegetables
Tropical fruit
Off-season fruit
Exotic fruit
Tropical vegetables
Off-season vegetables
Natural ingredients for
cosmetics
Vegetable derived oils, fats and waxes
Essential oils and oleoresins
Vegetable saps and extracts
Raw plant material
Colouring matter
Natural ingredients for
pharmaceuticals
Medicinal and aromatic plants
Vegetable saps and extracts
Vegetable alkaloids
Timber
Timber (planks, boards, veneer)
Timber building materials (doors, flooring)
Timber Garden products (incl. garden furniture)
Wine
Wine
Domestic furniture
Upholstered seating
Non-upholstered seating
Dining and living room furniture
Source: CBI Market Information Database • URL: http://www.cbi.eu • Contact: marketaccess@cbi.eu • www.cbi.eu/disclaimer
EU legislation: FAQ on CE marking
Kitchen furniture
Bedroom furniture
Home office furniture
Other furniture
Furniture parts
Apparel
Bodywear
Knitted and woven clothing
Sports clothing
Leather clothing
Babies clothing
Home decoration
Candles
Woodware
Wickerwork
Artificial flowers & fruits
Ceramics
Glassware
Metalware
Plasticware
Paperware
Cutlery
Home and furnishing textiles
Household textiles
Furnishing textiles
Office and school supplies
Paper-based items
Filing and storage products
Writing and drawing instruments
Presentation and planning materials
Office and desk accessories
Cases and satchels
Office furniture
Industrial
Automotive parts and
components
Parts, components and accessories for all kinds of common automotive vehicles
All kinds of machinery that is used in agriculture and horticulture
Parts for construction equipment
Parts for lifting and materials handling equipment
Pipes and process equipment
Process instruments
Process equipment
Metal pipes and fittings
Plastic pipes and fittings
Pumps
Source: CBI Market Information Database • URL: http://www.cbi.eu • Contact: marketaccess@cbi.eu • www.cbi.eu/disclaimer
EU legislation: FAQ on CE marking
Valves
Electronic components
Semiconductors
Embedded Systems
Sensors and Microsystems
Passive components
Electromechanical components and connector technology
Electronic Manufacturing Services (EMS)
Displays
Power supplies
Assemblies and subsystems (including modules)
ED/EDA, testing and measurement
Energy Efficient Lighting (EEL) Products
Engineering products
Electric Drives
Moulds, magnets and elevators
(Parts) of Transmission
Hydraulics
Pneumatics
Tooling and workpiece holders
Medical & Laboratory Devices
Medical disposables
Medical devices
Dental devices
Laboratory devices
Medical furniture
Medical apparel
Personal protective equipment
Full body protection
Hand and arm protection
Foot and leg protection
Air purification
Descender devices
Head protection
Hearing protection
Eye protection
Paints & other coatings
Formulations dissolved in water
Formulations not dissolved in water
Pigments
Additives
Resins
Sanitary ware and ceramic tiles
Sanitary ware
Ceramic tiles
Source: CBI Market Information Database • URL: http://www.cbi.eu • Contact: marketaccess@cbi.eu • www.cbi.eu/disclaimer
EU legislation: FAQ on CE marking
Services
KPO
Call centres
Digitisation
Web services
Human Resources
Finance and accounting services
Research and Development
Procurement
Engineering services
Animation services
Architectural services
ITO services
Finance & banking
Healthcare
Wholesale & Retail
Government & Public sector
Telecom
Manufacturing
Tourism
Adventure travel
Wildlife travel
MICE
CBT
Cruises
Sun and beach holidays
Touring holidays
Cultural tourism
Spa and health tourism
Source: CBI Market Information Database • URL: http://www.cbi.eu • Contact: marketaccess@cbi.eu • www.cbi.eu/disclaimer