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 ❞
must be safe when
used as intended or in
a foreseeable way,
bearing in mind <strong>the</strong>
normal behaviour <strong>of</strong>
children.
( 160 ) The manufacturer
is explicitly required <strong>to</strong>
supply data according
<strong>to</strong> <strong>the</strong> Directives
relating <strong>to</strong> low voltage
equipment, simple
pressure vessels, <strong>to</strong>ys
(only for certain <strong>to</strong>ys),
machinery, personal
protective equipment,
active implantable
medical devices, gas
appliances, medical
devices, potentially
explosive atmospheres,
recreational craft, lifts,
pressure equipment, in
vitro diagnostic
medical devices, and
radio and
telecommunications
terminal equipment.
( 161 ) The <strong>of</strong>ficial
notification usually
takes place via <strong>the</strong>
Permanent
Representation with a
copy sent <strong>to</strong> <strong>the</strong>
Commission
department responsible
for managing <strong>the</strong>
directive in question.
( 162 ) As an exemption,
Member States have <strong>to</strong>
inform <strong>the</strong> o<strong>the</strong>r
Member States as well
as <strong>the</strong> Commission
when invoking <strong>the</strong>
safeguard clause
according <strong>to</strong> <strong>the</strong>
Directive relating <strong>to</strong>
low voltage equipment.
( 163 ) The copy is
usually sent via <strong>the</strong>
Permanent
Representation.
( 164 ) A safeguard clause
that is notified
according <strong>to</strong> <strong>the</strong>
Directive relating <strong>to</strong>
low voltage equipment
is examined only if
o<strong>the</strong>r Member States
raise objection as
regards <strong>the</strong> measures
taken.
( 165 ) In addition, <strong>the</strong>
Directives on medical
devices and in vitro
medical devices
foresee a possibility <strong>to</strong>
take measures at
Community level.
( 166 ) For withdrawal <strong>of</strong>
<strong>the</strong> presumption <strong>of</strong>
conformity, see
Section 4.4.
in such a way that it complies with <strong>the</strong> applicable provisions, will consider initiating <strong>the</strong> procedure provided for by Article
<strong>the</strong> Member State should withdraw <strong>the</strong> safeguard clause 226 <strong>of</strong> <strong>the</strong> EC Treaty ( 165 ).
notification.
Conversely, should <strong>the</strong> Commission see no justification
for <strong>the</strong> national action that invoked <strong>the</strong> safeguard clause, it
8.3.3. Administering <strong>the</strong> safeguard clause
will ask <strong>the</strong> Member State <strong>to</strong> withdraw its action and take
The Commission is responsible for administering <strong>the</strong> safeguard
clause at Community level, and for ensuring that it ment <strong>of</strong> <strong>the</strong> products in question on its terri<strong>to</strong>ry. This opin-
immediate appropriate steps <strong>to</strong> re-establish <strong>the</strong> free move-
applies <strong>to</strong> <strong>the</strong> whole <strong>of</strong> <strong>the</strong> Community. To this end, <strong>the</strong> ion is addressed <strong>to</strong> <strong>the</strong> Member State that invoked <strong>the</strong> safeguard
clause, <strong>to</strong> <strong>the</strong> manufacturer and, if appropriate, <strong>to</strong> <strong>the</strong>
Commission consults <strong>the</strong> interested parties <strong>to</strong> verify
whe<strong>the</strong>r or not <strong>the</strong> action that invoked <strong>the</strong> safeguard clause authorised representative or o<strong>the</strong>r person who is responsible
for placing <strong>the</strong> product on <strong>the</strong> Community market. Also,
can be justified. Precautions are necessary during <strong>the</strong> consultations
<strong>to</strong> protect <strong>the</strong> confidentiality <strong>of</strong> <strong>the</strong> information
( 164 ).
infringement procedure provided for by Article 226 <strong>of</strong> <strong>the</strong>
in this case, <strong>the</strong> Commission will consider initiating <strong>the</strong>
The action <strong>to</strong> be taken is decided case by case. After EC Treaty, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> Member State not complying
<strong>the</strong> Commission departments responsible for managing <strong>the</strong> with <strong>the</strong> principle <strong>of</strong> free movement <strong>of</strong> goods. This procedure
may cause <strong>the</strong> Commission <strong>to</strong> take <strong>the</strong> matter <strong>to</strong> <strong>the</strong>
directive have been informed, <strong>the</strong>y will, as a general rule,
first contact <strong>the</strong> Member State and <strong>the</strong> national surveillance Court <strong>of</strong> Justice. In such cases, legal proceedings may be
authority which invoked <strong>the</strong> procedure, and <strong>the</strong> manufacturers
concerned or <strong>the</strong>ir authorised representative. The Com-
who considers himself <strong>to</strong> have suffered damage, in order <strong>to</strong>
taken at national level by <strong>the</strong> manufacturer, or o<strong>the</strong>r person
mission may also contact <strong>the</strong> o<strong>the</strong>r Member States most obtain compensation for <strong>the</strong> damage that resulted from a
directly concerned by <strong>the</strong> case in question (usually <strong>the</strong> national measure not in compliance with Community law.
Member States where <strong>the</strong> manufacturer or notified body is If <strong>the</strong> safeguard clause is invoked because <strong>of</strong> a shortcoming
in a harmonised standard that gives a presumption
established), and <strong>the</strong> notified bodies (or o<strong>the</strong>r third parties)
involved in <strong>the</strong> conformity assessment procedure.
<strong>of</strong> conformity, <strong>the</strong> Commission, after consulting <strong>the</strong> interested
parties, will submit <strong>the</strong> case <strong>to</strong> <strong>the</strong> Committee set up
If <strong>the</strong> Commission considers it necessary, it may — in
collaboration with <strong>the</strong> Member State(s) concerned — seek by Directive 98/34/EC and, if provided for, <strong>the</strong> sec<strong>to</strong>ral
<strong>the</strong> opinion <strong>of</strong> o<strong>the</strong>r adequately qualified, impartial bodies or committees ( 166 ).
experts capable <strong>of</strong> providing fur<strong>the</strong>r information directly relevant
<strong>to</strong> <strong>the</strong> subject (such as o<strong>the</strong>r surveillance authorities, sidered justified or not, in ei<strong>the</strong>r case, <strong>the</strong> Commission
Whe<strong>the</strong>r <strong>the</strong> action taken by <strong>the</strong> Member State is con-
o<strong>the</strong>r notified bodies, scientific committees <strong>of</strong> <strong>the</strong> Commission,
standards organisations, conformity assessment bod-
results <strong>of</strong> <strong>the</strong> procedure.
keeps <strong>the</strong> Member States informed <strong>of</strong> <strong>the</strong> progress and <strong>the</strong>
ies, organisations representing industry,
distribu<strong>to</strong>rs or consumers, trade unions, 8.4. Protection <strong>of</strong> CE marking
research institutes or scientific experts).
Although <strong>the</strong>se consultations can be relatively
wide, <strong>the</strong> urgency <strong>of</strong> <strong>the</strong> problem is
● Market surveillance authorities must check that <strong>the</strong> affixing
and use <strong>of</strong> <strong>the</strong> CE marking is correct, and that <strong>the</strong> principles
taken in<strong>to</strong> account and <strong>the</strong> procedure is
kept as short as possible.
regarding additional markings and marks are respected.
At <strong>the</strong> end <strong>of</strong> <strong>the</strong> consultation procedure,
<strong>the</strong> Commission takes an opinion on corrective action <strong>to</strong> protect <strong>the</strong> CE marking.
● Where necessary, <strong>the</strong> authority has <strong>to</strong> take appropriate
<strong>the</strong> justification <strong>of</strong> <strong>the</strong> national measure that ● A Member State must notify <strong>to</strong> <strong>the</strong> Commission and <strong>to</strong> <strong>the</strong>
restricted or prohibited <strong>the</strong> free movement o<strong>the</strong>r Member States when it decides <strong>to</strong> restrict free movement
due <strong>to</strong> incorrect affixing <strong>of</strong> <strong>the</strong> CE marking, or when it
<strong>of</strong> products.
Where <strong>the</strong> Commission considers in its
takes action against those who are responsible for a noncompliant
product bearing <strong>the</strong> CE marking.
opinion that <strong>the</strong> action is justified, it informs
<strong>the</strong> Member State concerned and <strong>the</strong> o<strong>the</strong>r
Member States immediately. The Commission
may also decide <strong>to</strong> publish this opinion. Consequently, Member States must provide in <strong>the</strong>ir national legislation for
Member States have an obligation <strong>to</strong> take appropriate appropriate measures both <strong>to</strong> prevent <strong>the</strong> abuse and misuse
<strong>of</strong> CE marking, and <strong>to</strong> redress <strong>the</strong> situation if such
action, with a view <strong>to</strong> <strong>the</strong> opinion <strong>of</strong> <strong>the</strong> Commission, <strong>to</strong>
ensure a similar level <strong>of</strong> protection throughout <strong>the</strong> Community.
This requirement is <strong>based</strong> on <strong>the</strong> general obligation <strong>of</strong> The affixing <strong>of</strong> <strong>the</strong> CE marking <strong>to</strong> a product that is not
abuse or misuse takes place.
Member States for market surveillance and for enforcement covered by any <strong>of</strong> <strong>the</strong> <strong>directives</strong> providing for its affixing is
<strong>of</strong> Community legislation. If a Member State refuses <strong>to</strong> follow
<strong>the</strong> position taken by <strong>the</strong> Commission, <strong>the</strong> Commission for instance, are likely <strong>to</strong> get <strong>the</strong> impression that
considered <strong>to</strong> be deceiving because consumers or users,
<strong>the</strong>
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