| Background of the CE Marking In
the past, each Member State was permitted to set its own safety requirements for products.
Since this contradicts one of the European Union’s intended free-trade objectives
(free movement of goods), the European Union has decided to harmonize different national
legislation of the Member States. Therefore, technical trade barriers were being abolished
and the European Union has been drawing up directives for various product groups and
-aspects. These contain essential requirements concerning safety, health, environment and
consumer protection.
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1. |
What is the CE Marking?
The CE Marking indicates that a product complies with the requirements of the applicable
directive. These directives for products, which are called “New Approach”
directives, set out essential requirements which must be met before products may be
marketed or traded within the European Economic Area. Thus, to indicate that a product
complies with the applicable directive, it must bear the CE Marking.
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2. |
What does CE stand for?
CE stands for Conformitée Européenne, which, translated literally, means “European
Conformity”. A product bearing the CE Marking accompanied with the right formalities
can be traded in every country of the European Economic Area.
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3. |
Which countries form the European Economic Area?
The European Economic Area (EEA) is formed by the fifteen Member States of the European
Union (EU), viz: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland,
Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom as well
as Iceland, Norway and Liechtenstein (members of the European Free Trade Association
(EFTA)).
The treaty of the EEA came into force in July 1993. This means that the free movement of
goods, persons, services and capital according to the European Economic Community treaty
is also safeguarded in Iceland, Norway and Liechtenstein. The European directives and CE
Marking will therefore also apply to these countries.
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4. |
How to affix the CE Marking?
For a large number of products with a relatively low risk, the producer himself may
declare that the product meets the essential requirements of the corresponding directive.
This process is called the internal manufacturing inspection. This situation
involves a process of self-certification and the importer meets his responsibility by
drawing up the EC declaration of conformity and affixing the CE Marking to the
product.
Products with a higher risk have to be audited by an external inspection body (Notified
Body). The European Commission has developed several standard modules for these procedures
to audit these products for oneself or to have them audited. These procedures are
officially known as conformity assessment procedures.
The gravity of the various types of inspection modules varies depending on the product.
Eight modules have been drafted that producers and/or importers can utilize in order
eventually to affix the CE Marking on their products.
For products with an increased risk or which have not been produced according to the
standards, a Notified Body must be called in. This applies both to the design phase and
the production phase.
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5. |
How does the CE Marking affect trade and industry?
For some products the requirements of the new directives are very strict. Sometimes they
are even stricter than the present national laws and regulations. This means that many
producers will have to change their way of producing because their products have to comply
with the essential requirements of the directives. Once a product complies with the
essential requirements of the directive, producers have unrestricted trade throughout the
European Economic Area. The CE Marking on a product is a recognised “trade
passport” for the whole EEA.
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What is a directive?
Directives are the best means of harmonizing the legislation between Member States. A
European directive is legally binding for every Member State of the European Union and is
superior to the legislation of the individual Member States. The Member State is free to
decide how the directive must be implemented into national legislation. However, authority
is given to national bodies to select the form and means for realising the aim of the
directive.
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7. |
What is the importance of standards?
A EU harmonized standard is a standard that has been accepted by all the national
standardisation institutes involved. European harmonized standards are of great
importance. The essential requirements which are set by a directive have been elaborated
in the harmonised European standards. The advantage of manufacturing products meeting
these harmonised European standards is that this will automatically result in a Presumption
of Conformity with the European directive. A EU harmonized standard is a standard that
has been accepted by all the national standardization institutes involved. Each country
within the EEA can use its influence when European standards are being established.
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8. |
What is the relation between CE Marking and Product Liability?
Safety is the keyword for the relation between CE Marking and Product Liability. The
difference between the old and the new European Product Liability directive is the fact
that the consumer does not have to prove that a product has caused damage. Since the
producer is liable for damage caused by a defect in his product, he has to prove that his
product has not been the cause. Therefore, it is important that products are produced
according to the essential requirements which are set by the European product directives
so that the CE Marking can be affixed. This ensures that a product complies with the
minimum safety requirements and damage claims can be limited.
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9. |
What are the advantages of the CE Marking?
The advantages of CE Marking are that with a CE Marking on your product you have
unrestricted trade within the European Economic Area because there are no more different
national trade barriers for products.
Besides with the CE Marking, claims for damages will also be limited, because a safe
product must be put on the market with good instructions for the user and with safety
regulations. This also means that the product is safer for the consumer.
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