GLOSSARY OF
TERMS FOR THE OPERATION OF CE MARKING
Accreditation of conformity
assessment bodies
Third party attestation that a conformity assessment body
fulfils
specified requirements and is competent to carry out specific
conformity assessment tasks.
Cassis de
( ECJ Case C-120/78)
Mutual acceptance of EU products manufactured according
to national
technical regulations where no European harmonised
legislation is
applicable.
CE-marking
The CE marking indicates that the product complies with
the essential
requirements of the relevant directive(s) and that the product has
been
subject to a conformity assessment procedure.
Competent bodies
An expression used in some directives, for example the
EMC directive
(89/336/EEC). A Competent Body has the necessary equipment and
competences to carry out tests and verify actions taken by the
manufacturer.
Conformity assessment
Under the New Approach directives, manufacturers must
subject their
products to a conformity assessment procedure to prove that their
products fulfil the essential health and
safety requirements stated in the
directive. There are several conformity assessment procedures. The
procedures are divided into “modules” covering the design phase,
the
production phase or both.
Declaration of Conformity
A declaration where the manufacturer, or the authorised representative
established within the European Community, states that he applied
the
conformity assessment procedure(s) required by the relevant
directives. From the declaration you should be able to identify the
directives, the manufacturer or the representative, the product,
the
notified body if applicable and, where appropriate, the standards
referred to.
Essential health and safety
requirements
The New Approach directives contain mandatory “essential
health and
safety requirements” for product design and usage. Essential
requirements are binding. Manufacturers must choose a technical
solution that will meet the essential requirements.
Harmonised standards
The Commission harmonises a standard by publishing the title of the
standard and the reference of the applicable directive in the
Official
Journal. Once adopted, European Harmonised
standards must be
published by national members of CEN, CENELEC and ETSI and
national standards must be withdrawn.
Market Surveillance
Market surveillance is an essential tool for the
enforcement of New
Approach directives. It needs to function effectively in order to
provide the following guarantees:
• Uniform application of
Community law
• Equal protection for
all citizens
• Maintenance of a level
playing field for enterprises
It involves two main stages:
- national surveillance
authorities verify that products placed on the
market comply with the provisions of the applicable national
legislation which transpose the New Approach Directives;
- when necessary, they take
action to establish conformity.
Modules
The different conformity assessment procedures are linked
to linked to
modules from A to H. Module A implies the use of self-certification
by the manufacturer, while anything above A leads to the involvement
of a Notified Body.
Different directives stipulate different modules,
depending on the
category of products.
MRA: Mutual Recognition Agreements
Mutual Recognition Agreements are established between the
European
Community and the governments of third countries which
are at a
comparable level of technical development and have a compatible
approach concerning conformity assessment.
These agreements are based on the mutual acceptance of
test reports,
certificates and marks of conformity issued by the conformity
assessment bodies of one of the Parties to the Agreement if
acceptable
under the legislation of the other Party.
New Approach Directives
Total harmonisation directives
that provide for CE marking. Member
States have an obligation to transpose them into their
national
legislation.
Notified bodies
Notified bodies carry out conformity assessment
procedures when a
third party is required. Notified bodies must be accredited by a
national accreditation body.
PECA:European Conformity Assessment Protocols
Mutual recognition agreements with Central and Eastern
European
countries which have signed association agreements with the EU.
These agreements are called European Conformity Assessment
Protocols (ECAP or PECA). Under PECAs, candidate
countries are
obliged to bring their regulatory requirements in line with
those
existing in the EU. If a product is covered by a PECA agreement,
it
can be tested and certified in a candidate country and then placed on
the EU market without any additional procedures.
Placing on the market
Placing on the market is the initial action of making a
product
available for the first time on the Community market. Making
available can be either for payment or free of charge.
Presumption of conformity
Products in conformity with harmonised
standards are considered to
fulfil the essential requirements of the directive.
Product Liability
Manufacturers are liable for damages or injuries caused
by their
products even if they have met the requirements of national or
European legislation. The principle of liability without fault covers
industrial and agricultural products.
Standards
Technical specifications adopted by national, European or
international standards organisations for
repeated or continuous
application. The use of standards is not compulsory.
Technical File
New Approach directives require the manufacturer to draw
up
technical documentation containing information demonstrating the
conformity of the product with the applicable requirements. The
content of the technical documentation is stipulated for each
directive
according to the products concerned.