Guide to the implementation of directives based on the New ...

❝ Conformity assessment procedure ❞
established within <strong>the</strong> Community. In some cases <strong>the</strong>
importer or <strong>the</strong> person responsible for placing on <strong>the</strong>
market must take on this responsibility ( 99 ).
The contents <strong>of</strong> <strong>the</strong> EC declaration <strong>of</strong> conformity are
laid down, directive by directive, in accordance with <strong>the</strong>
products concerned. The standard EN 45014 has been
drawn up with <strong>the</strong> objective <strong>of</strong> providing <strong>the</strong> general criteria
for <strong>the</strong> declaration <strong>of</strong> conformity, and it can also be used as
a guidance document in view <strong>of</strong> New Approach <strong>directives</strong>.
According <strong>to</strong> <strong>the</strong> standard <strong>the</strong> declaration may take <strong>the</strong>
form <strong>of</strong> a document, a label or equivalent, and should contain
sufficient information <strong>to</strong> enable all products covered by
it <strong>to</strong> be traced back <strong>to</strong> it.
As a minimum <strong>the</strong> following information should be provided:
● <strong>the</strong> name and address <strong>of</strong> <strong>the</strong> manufacturer or <strong>the</strong> authorised
representative issuing <strong>the</strong> declaration;
● <strong>the</strong> identification <strong>of</strong> <strong>the</strong> product (name, type or model
number, and any relevant supplementary information, such
as lot, batch or serial number, sources and numbers <strong>of</strong>
items);
● all relevant provisions complied with;
<strong>the</strong> referenced standards or o<strong>the</strong>r normative documents
(such as national technical standards and specifications) in
a precise, complete and clearly defined way;
● all supplementary information that may be required (for
example grade, category), if applicable;
● <strong>the</strong> date <strong>of</strong> issue <strong>of</strong> <strong>the</strong> declaration;
signature and title or an equivalent marking <strong>of</strong> authorised
person ( 103 ); and
● <strong>the</strong> statement that <strong>the</strong> declaration is issued under <strong>the</strong>
sole responsibility <strong>of</strong> <strong>the</strong> manufacturer and, if applicable,
<strong>the</strong> authorised representative.
O<strong>the</strong>r useful information <strong>to</strong> be included in <strong>the</strong> EC declaration
<strong>of</strong> conformity is <strong>the</strong> name, address and identification
number <strong>of</strong> <strong>the</strong> notified body when it has been involved in <strong>the</strong>
conformity assessment procedure, as well as <strong>the</strong> name and
address <strong>of</strong> <strong>the</strong> person who keeps <strong>the</strong> technical documentation.
Where several New Approach <strong>directives</strong> apply <strong>to</strong> a product,
<strong>the</strong> manufacturer or <strong>the</strong> authorised representative can,
basically, merge all <strong>the</strong> declarations in<strong>to</strong> a single document.
However, this is not possible if <strong>the</strong> directive provides for a
specific form <strong>of</strong> <strong>the</strong> EC declaration <strong>of</strong> conformity (such as
<strong>the</strong> Directive relating <strong>to</strong> personal protective equipment).
Consequently, <strong>the</strong> EC declaration should also provide information
on whe<strong>the</strong>r or not it covers only one directive. In
such a case <strong>the</strong> declaration should include a reference <strong>to</strong>
o<strong>the</strong>r <strong>directives</strong> in order <strong>to</strong> verify whe<strong>the</strong>r <strong>the</strong> manufacturer
has followed all <strong>the</strong> Community legislation, or which legislation
has been chosen during <strong>the</strong> transitional period.
The EC declaration <strong>of</strong> conformity must be made available
<strong>to</strong> <strong>the</strong> surveillance authority immediately upon request.
Moreover, Directives relating <strong>to</strong> machinery, gas appliances,
potentially explosive atmospheres, recreational craft, lifts
and high-speed rail systems require that products are
accompanied by <strong>the</strong> EC declaration <strong>of</strong> conformity.
The EC declaration <strong>of</strong> conformity must be drawn up in
one <strong>of</strong> <strong>the</strong> <strong>of</strong>ficial languages <strong>of</strong> <strong>the</strong> Community. If <strong>the</strong> Community
<strong>directives</strong> contain no fur<strong>the</strong>r provisions concerning
<strong>the</strong> language <strong>of</strong> <strong>the</strong> declaration, <strong>the</strong> requirements <strong>of</strong> <strong>the</strong>
Member States <strong>to</strong> use a specific language must be
assessed according <strong>to</strong> Articles 28 and 30 <strong>of</strong> <strong>the</strong> EC Treaty
on a case by case basis. However, for products, which are
required <strong>to</strong> be accompanied by <strong>the</strong> declaration <strong>of</strong> conformity,
it has <strong>to</strong> be in <strong>the</strong> <strong>of</strong>ficial language <strong>of</strong> <strong>the</strong> country <strong>of</strong> use.
In <strong>the</strong>se situations a translation should be provided by <strong>the</strong>
manufacturer, <strong>the</strong> authorised representative or <strong>the</strong> distribu<strong>to</strong>r.
Additionally, a copy <strong>of</strong> <strong>the</strong> declaration in <strong>the</strong> original
language should be supplied.
telecommunications
terminal equipment.
( 101 ) As an exception,
<strong>the</strong> Directive relating <strong>to</strong>
<strong>to</strong>ys does not require
an EC declaration <strong>of</strong>
conformity.
( 102 ) According <strong>to</strong> <strong>the</strong>
Directives relating <strong>to</strong>
active implantable
medical devices,
medical devices and
in vitro diagnostic
medical devices <strong>the</strong> EC
declaration must be
kept for five years.
According <strong>to</strong> <strong>the</strong>
Directive relating <strong>to</strong>
refrigeration appliances
<strong>the</strong> time period is three
years. The Directives
relating <strong>to</strong> simple
pressure vessels,
machinery, nonau<strong>to</strong>matic
weighing
instruments, gas
appliances and
construction products
do not define a time
period, but <strong>the</strong> general
rule should be applied
also <strong>to</strong> <strong>the</strong> EC
declaration required
according <strong>to</strong> <strong>the</strong>se
Directives.
( 103 ) It is not necessary
for <strong>the</strong> signa<strong>to</strong>ry <strong>to</strong> be
domiciled in <strong>the</strong>
Community. A
manufacturer
established outside <strong>the</strong>
Community is entitled
<strong>to</strong> carry out all <strong>the</strong>
certification
procedures at his
premises and,
<strong>the</strong>refore, <strong>to</strong> sign <strong>the</strong>
declaration <strong>of</strong>
conformity, unless
o<strong>the</strong>rwise provided for
in <strong>the</strong> directive(s).
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