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

❝ Compliance with <strong>directives</strong> ❞
Harmonised standards provide a presumption
<strong>of</strong> conformity with <strong>the</strong> essential requirements
( 84 ), if <strong>the</strong>ir reference has been published
in <strong>the</strong> Official Journal and if <strong>the</strong>y have
been transposed at national level. However,
it is not necessary that transposition takes
place in all Member States before <strong>the</strong> presumption
<strong>of</strong> conformity becomes effective.
Since European standards have <strong>to</strong> be transposed
in a uniform way, a manufacturer may
choose any <strong>of</strong> <strong>the</strong> corresponding national
standards.
The objective <strong>of</strong> publishing <strong>the</strong> reference
in <strong>the</strong> Official Journal is <strong>to</strong> set <strong>the</strong> earliest
date for <strong>the</strong> presumption <strong>of</strong> conformity
<strong>to</strong> take effect. Before <strong>the</strong> Commission publishes
<strong>the</strong> reference, it may verify that <strong>the</strong>
terms <strong>of</strong> <strong>the</strong> mandate are fulfilled. When it
considers that a standard does not meet
<strong>the</strong> terms <strong>of</strong> <strong>the</strong> mandate, it will ei<strong>the</strong>r not
publish <strong>the</strong> reference <strong>of</strong> this standard, or it
will limit publication <strong>of</strong> <strong>the</strong> reference <strong>to</strong> parts
<strong>of</strong> this standard. In such cases, <strong>the</strong> condition
for a harmonised standard <strong>to</strong> produce a
presumption <strong>of</strong> conformity is not met, or it
is only met for <strong>the</strong> part that <strong>the</strong> published references cover.
The application <strong>of</strong> harmonised standards that give a presumption
<strong>of</strong> conformity remains voluntary ( 83 ).The manufacturer
can choose whe<strong>the</strong>r or not <strong>to</strong> refer <strong>to</strong> harmonised
standards. However, if <strong>the</strong> manufacturer chooses not <strong>to</strong> follow
a harmonised standard, he has <strong>the</strong> obligation <strong>to</strong> prove
that his products are in conformity with essential requirements
by <strong>the</strong> use <strong>of</strong> o<strong>the</strong>r means <strong>of</strong> his own choice (for
example by means <strong>of</strong> any existing technical specifications).
If <strong>the</strong> manufacturer applies only a part <strong>of</strong> a harmonised standard
or <strong>the</strong> applicable harmonised standard does not cover
all <strong>the</strong> essential requirements, <strong>the</strong> presumption <strong>of</strong> conformity
exists only <strong>to</strong> <strong>the</strong> extent <strong>the</strong> standard corresponds <strong>to</strong> <strong>the</strong>
essential requirements.
Compliance with harmonised standards will, according
<strong>to</strong> certain <strong>directives</strong>, determine <strong>the</strong> applicable conformity
assessment procedure, which sometimes opens <strong>the</strong> possi-
New Approach <strong>directives</strong> contain a clause
according <strong>to</strong> which a harmonised standard
can be challenged ( 87 ).
* Where a Member State or <strong>the</strong> Commission
considers that a harmonised standard
does not fully meet <strong>the</strong> essential requirements,
<strong>the</strong> matter shall be brought before
<strong>the</strong> committee established under Directive
98/34/EC, and, if provided for, <strong>the</strong> sec<strong>to</strong>ral committee,
giving reasons for doing so.
* The committee shall deliver an opinion without delay.
4.3. Presumption <strong>of</strong> conformity
● Conformity with a national standard that transposes a
harmonised standard, whose reference has been published,
confers a presumption <strong>of</strong> conformity with <strong>the</strong> essential
requirements <strong>of</strong> <strong>the</strong> applicable New Approach directive that
is covered by such a standard ( 81 ).
● References (such as titles, identification numbers) <strong>of</strong> harmonised
standards are published in <strong>the</strong> Official Journal for <strong>the</strong>
directive in question. An updated list <strong>of</strong> references for each
directive can be found at <strong>the</strong> following Internet address:
http://europa.eu.int/comm/dg03/directs/dg3b/newapproa/
eurstd/harmstds/index.html ( 82 ).
● Member States must publish <strong>the</strong> reference <strong>of</strong> <strong>the</strong> national
standard that transposes a harmonised standard. It is useful <strong>to</strong>
indicate in <strong>the</strong> publication <strong>the</strong> link with <strong>the</strong> legislation in
question.
● The application <strong>of</strong> harmonised standards, which give a presumption
<strong>of</strong> conformity, remains voluntary in <strong>the</strong> field <strong>of</strong> New
Approach <strong>directives</strong>. Thus, <strong>the</strong> product may be manufactured
directly on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> essential requirements ( 83 ).
bility for conformity assessment without <strong>the</strong> intervention <strong>of</strong>
a third party or for a larger choice <strong>of</strong> procedures ( 85 ).
According <strong>to</strong> certain <strong>directives</strong>, national standards may
give a presumption <strong>of</strong> conformity – as a transitional measure
– ins<strong>of</strong>ar as <strong>the</strong>re is no harmonised standard covering
<strong>the</strong> same area ( 86 ). Member States may communicate <strong>to</strong>
<strong>the</strong> Commission <strong>the</strong> text <strong>of</strong> those national standards, which
<strong>the</strong>y consider <strong>to</strong> meet <strong>the</strong> essential requirements. After consulting
<strong>the</strong> Committee under Directive 98/34/EC and, if provided
for, <strong>the</strong> sec<strong>to</strong>ral Committee, <strong>the</strong> Commission notifies
<strong>the</strong> Member States whe<strong>the</strong>r or not <strong>the</strong> national standard
should enjoy presumption <strong>of</strong> conformity. If <strong>the</strong> opinion is
positive, Member States are required <strong>to</strong> publish references
<strong>of</strong> such standards. The reference is also published in <strong>the</strong>
Official Journal. This procedure has not been used so far in
order <strong>to</strong> give full priority <strong>to</strong> <strong>the</strong> development <strong>of</strong> European
standards.
4.4. Withdrawal <strong>of</strong> <strong>the</strong> presumption <strong>of</strong> conformity
● The Commission withdraws <strong>the</strong> presumption <strong>of</strong> conformity,
if it has been established that <strong>the</strong> harmonised standard does
not fully meet <strong>the</strong> essential requirements.
* In <strong>the</strong> light <strong>of</strong> <strong>the</strong> committee’s opinion, <strong>the</strong> Commission
shall inform <strong>the</strong> Member States who shall take necessary
measures.
<strong>the</strong> document, and by
<strong>the</strong> withdrawal <strong>of</strong>
conflicting national
standards. However, it
is acceptable <strong>to</strong> retain
or publish a national
standard dealing with a
subject covered by <strong>the</strong>
harmonisation
document, provided
that it has technically
equivalent contents. In
addition, harmonisation
documents allow for
national divergences
under special
conditions, which
could create some
application problems if
<strong>the</strong>y were accepted as
harmonised standards.
Publicly available
specifications, which
are adopted by private
consortia <strong>of</strong> companies,
or o<strong>the</strong>r documents
from European
standards
organisations, are not
harmonised standards
in <strong>the</strong> meaning <strong>of</strong> <strong>the</strong>
New Approach.
( 77 ) The term ‘mandate’,
although common, is
not <strong>the</strong> only term used
in this context. Ra<strong>the</strong>r
than focusing on <strong>the</strong>
terminology, it is
important <strong>to</strong> consider
that standardisation
activities must be
<strong>based</strong> on a formal
invitation <strong>of</strong> <strong>the</strong>
Commission, on which
Member States were
consulted.
( 78 ) The revision <strong>of</strong>
<strong>the</strong>se <strong>Guide</strong>lines is
underway. The basic
principles laid down in
<strong>the</strong> <strong>Guide</strong>lines have
been reinforced by <strong>the</strong>
Council conclusions on
efficiency and
accountability in
European
standardisation that
were adopted on 18
May 1998.
( 79 ) Still, <strong>the</strong>
Commission may verify
that <strong>the</strong> terms <strong>of</strong> <strong>the</strong>
mandate are fulfilled
(see Section 4.3).
( 80 ) This is without
prejudice <strong>to</strong> <strong>the</strong>ir right
<strong>to</strong> refuse a mandate.
( 81 ) As regards <strong>the</strong>
Directive relating <strong>to</strong>
ow-voltage equipment,
a harmonised standard
provides a presumption
<strong>of</strong> conformity after
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