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

❝ <strong>Guide</strong> <strong>to</strong> <strong>the</strong> <strong>implementation</strong> <strong>of</strong> <strong>directives</strong> <strong>based</strong> on <strong>the</strong> New Approach and <strong>the</strong> Global Approach ❞
account <strong>the</strong> need <strong>to</strong> ensure <strong>the</strong> health and safety <strong>of</strong> persons
or o<strong>the</strong>r public interests foreseen in <strong>the</strong> <strong>directives</strong>, as well
as <strong>to</strong> protect <strong>the</strong> economic opera<strong>to</strong>rs from unnecessary
burden. Fur<strong>the</strong>r, failure <strong>to</strong> present <strong>the</strong> documentation in
response <strong>to</strong> a duly substantiated request by a national surveillance
authority, within an acceptable delay, may constitute
sufficient grounds for doubting <strong>the</strong> presumption <strong>of</strong> conformity
with <strong>the</strong> requirements <strong>of</strong> <strong>the</strong> directive ( 147 ).
A national authority may request a translation <strong>of</strong> <strong>the</strong>
technical documentation and <strong>the</strong> EC declaration <strong>of</strong> conformity
in<strong>to</strong> its <strong>of</strong>ficial language. However, it should avoid
doing so if <strong>the</strong>y, especially <strong>the</strong> detailed technical information
<strong>of</strong> <strong>the</strong> documentation, are available in a language that
can be unders<strong>to</strong>od by <strong>the</strong> national authority in question. If
<strong>the</strong> authority considers a translation necessary, it must
clearly define <strong>the</strong> part <strong>of</strong> <strong>the</strong> documentation <strong>to</strong> be translated
and allow reasonable time for this <strong>to</strong> take place. No fur<strong>the</strong>r
conditions may be imposed on <strong>the</strong> translation, such as
a requirement <strong>of</strong> a transla<strong>to</strong>r accredited or recognised by
<strong>the</strong> public authorities. The request for a translation must be
assessed on <strong>the</strong> basis <strong>of</strong> Article 28 <strong>of</strong> <strong>the</strong> EC Treaty on a
case by case basis, taking in<strong>to</strong> consideration <strong>the</strong> proportionality
<strong>of</strong> <strong>the</strong> demands.
It must be possible <strong>to</strong> make <strong>the</strong> technical documentation
available in <strong>the</strong> Community. However, it need not be
kept inside <strong>the</strong> Community, unless o<strong>the</strong>rwise provided for in
<strong>the</strong> applicable <strong>directives</strong> ( 148 ). The requirement for making
it available does not mean that <strong>the</strong> person who bears this
responsibility must be in possession <strong>of</strong> it, as long as he is
capable <strong>of</strong> stating where it can be found and <strong>of</strong> presenting
it on request from <strong>the</strong> national authority. The name and
address <strong>of</strong> <strong>the</strong> person in possession <strong>of</strong> <strong>the</strong> documentation
need not be expressly mentioned on <strong>the</strong> product or on its
packaging, unless o<strong>the</strong>rwise specified. Fur<strong>the</strong>r, <strong>the</strong> technical
documentation can be kept in any format (for example
as a hard copy or CD-ROM), which allows it <strong>to</strong> be made
available within a period <strong>of</strong> time commensurate with its
importance and <strong>the</strong> risk in question.
Member States must ensure that everyone receiving
information about <strong>the</strong> contents <strong>of</strong> <strong>the</strong> technical documentation
during market surveillance is bound <strong>to</strong> secrecy according
<strong>to</strong> principles laid down in <strong>the</strong> national legislation.
( 147 ) As essential
technical data is <strong>to</strong> be
considered, in
particular: <strong>the</strong> name
and address <strong>of</strong> <strong>the</strong>
manufacturer; <strong>the</strong> list
<strong>of</strong> harmonised
standards followed or
o<strong>the</strong>r solutions adopted
<strong>to</strong> satisfy <strong>the</strong> essential
requirements; a
description <strong>of</strong> <strong>the</strong>
product; <strong>the</strong> operating
instructions, if any; and
<strong>the</strong> overall plan <strong>of</strong> <strong>the</strong>
product, if any.
Examples <strong>of</strong> detailed
technical information
are test reports, quality
manual information,
quality control plans
and o<strong>the</strong>r plans,
descriptions <strong>of</strong> <strong>the</strong>
products and
processes and
standards applied.
( 148 ) According <strong>to</strong>
Annex IV <strong>of</strong> <strong>the</strong>
Directive relating <strong>to</strong>
low voltage equipment
<strong>the</strong> technical
documentation must be
kept on Community
terri<strong>to</strong>ry.
8.2.2. Corrective actions
could also be <strong>the</strong> situations where o<strong>the</strong>r
conformity markings provided for in <strong>the</strong>
● Before any action is taken, <strong>the</strong> party concerned must be notified
and — unless <strong>the</strong> matter is urgent — given <strong>the</strong> possibility
directive are incorrectly affixed, or where
<strong>the</strong> EC declaration <strong>of</strong> conformity cannot be
<strong>of</strong> being consulted.
provided for immediately or it does not
● The corrective action depends on <strong>the</strong> level <strong>of</strong> noncompliance,
which has <strong>to</strong> be established on a case by case <strong>to</strong>ry, or <strong>the</strong> requirement <strong>to</strong> accompany
accompany <strong>the</strong> product when this is manda-
basis, and it has <strong>to</strong> be in accordance with <strong>the</strong> principle <strong>of</strong> o<strong>the</strong>r information provided for in <strong>the</strong> directive(s)
is complied with insufficiently, or,
proportionality:
where applicable, <strong>the</strong> identification number
* first, <strong>the</strong> manufacturer, or <strong>the</strong> authorised representative,
<strong>of</strong> <strong>the</strong> notified body has not been affixed <strong>to</strong>
should be obliged <strong>to</strong> make <strong>the</strong> product comply with <strong>the</strong> provisions
and <strong>to</strong> remedy <strong>the</strong> infringement;
<strong>the</strong> CE marking.
Non-conformity <strong>to</strong> essential requirements
must usually be considered as a sub-
* ultimately, where o<strong>the</strong>r measures have failed or <strong>the</strong>y are not
considered as sufficient, all appropriate measures shall be stantial non-compliance, because this may,
taken <strong>to</strong> restrict or prohibit <strong>the</strong> placing on <strong>the</strong> market and putting
in<strong>to</strong> service <strong>of</strong> <strong>the</strong> product in question, and <strong>to</strong> ensure that risk <strong>to</strong> <strong>the</strong> health and safety <strong>of</strong> citizens.
for instance, present a potential or actual
it is withdrawn from <strong>the</strong> market.
However, non-conformity <strong>to</strong> a harmonised
standard is not, as such, sufficient evidence
<strong>of</strong> non-conformity <strong>to</strong> essential requirements,
but indicates that fur<strong>the</strong>r investigations may be nec-
Competent national authorities must take action <strong>to</strong> enforce
conformity, when <strong>the</strong>y discover that a product is not in compliance
with <strong>the</strong> provisions <strong>of</strong> <strong>the</strong> applicable <strong>directives</strong>.
Depending on <strong>the</strong> circumstances, it may be considered
essary.
The corrective action depends on <strong>the</strong> degree <strong>of</strong> noncompliance
and, thus, must be in accordance with <strong>the</strong> prin-
a product is not CE marked when it should be according <strong>to</strong>
ei<strong>the</strong>r as a non-substantial or substantial non-compliance, if
ciple <strong>of</strong> proportionality. However, <strong>the</strong> difference between <strong>the</strong> applicable <strong>directives</strong>, or a product is CE marked when it
non-substantial and substantial non-compliance is not should not be. It needs <strong>to</strong> be taken in<strong>to</strong> account that <strong>the</strong>
always clear, and must be decided on a case by case basis. application <strong>of</strong> a directive, and accordingly <strong>the</strong> requirement
The incorrect affixing <strong>of</strong> <strong>the</strong> CE marking as regards, for <strong>to</strong> affix <strong>the</strong> CE marking, can sometimes prove <strong>to</strong> be difficult.
instance, <strong>the</strong> design, size, visibility, indelibility or legibility, On <strong>the</strong> o<strong>the</strong>r hand, if a product covered by a New Approach
can usually be considered as a non-substantial non-compliance.
Examples <strong>of</strong> typically non-substantial non-compliance uct does not comply with <strong>the</strong> essential requirements or
directive is not CE marked, it is an indication that <strong>the</strong> prod-
<strong>the</strong>
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