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

❝ Market surveillance ❞
8.6.1. Outline for administrative
cooperation
8.6. Administrative cooperation
The proper application <strong>of</strong> Community law
depends upon smooth administrative cooperation
<strong>to</strong> ensure uniform and efficient
enforcement <strong>of</strong> Community legislation in all
Member States. The obligation <strong>to</strong> cooperate
is in accordance with Article 10 <strong>of</strong> <strong>the</strong>
EC Treaty, which states that Member States
must take all appropriate measures <strong>to</strong> fulfil
<strong>the</strong>ir obligations ( 174 ).
Although technical harmonisation has
created a single market, where products
move over national borders, market surveillance
is carried out on a national basis.
Administrative cooperation mechanisms
between national surveillance authorities,
<strong>the</strong>refore, need <strong>to</strong> be developed <strong>to</strong> increase
<strong>the</strong> efficiency <strong>of</strong> surveillance, <strong>to</strong> minimise
<strong>the</strong> effect <strong>of</strong> different surveillance practices
and <strong>to</strong> reduce <strong>the</strong> overlapping <strong>of</strong> national
surveillance operations. Cooperation
between market surveillance authorities can
also spread good surveillance practice and
techniques across <strong>the</strong> Community, as
national authorities can compare <strong>the</strong>ir methods
with those <strong>of</strong> o<strong>the</strong>r authorities, for
example in <strong>the</strong> framework <strong>of</strong> comparisons
and joint surveys or study visits. In addition,
cooperation can be useful for exchanging views and solving
practical problems.
Administrative cooperation calls for mutual trust and
transparency between national surveillance authorities.
Member States and <strong>the</strong> Commission need <strong>to</strong> be informed
about <strong>the</strong> way enforcement <strong>of</strong> New Approach <strong>directives</strong>, in
particular market surveillance <strong>of</strong> products covered by <strong>the</strong>
New Approach, is organised throughout <strong>the</strong> single market.
This includes information about national authorities in charge
<strong>of</strong> market surveillance for <strong>the</strong> different product sec<strong>to</strong>rs, and
about national market surveillance mechanisms <strong>to</strong> clarify
how moni<strong>to</strong>ring <strong>of</strong> products placed on <strong>the</strong> market takes
place and what corrective actions and o<strong>the</strong>r activities <strong>the</strong>
surveillance authority is entitled <strong>to</strong> use. Transparency is also
necessary regarding <strong>the</strong> national rules on confidentiality.
For <strong>the</strong> achievement <strong>of</strong> effective market surveillance in
<strong>the</strong> Community, it is important that national surveillance
authorities assist each o<strong>the</strong>r. On request, a national authority
should make information available and provide o<strong>the</strong>r
assistance. Without prior request, a national authority may
consider sending <strong>to</strong> <strong>the</strong> o<strong>the</strong>r national authorities all relevant
information concerning operations that constitute, or
are likely <strong>to</strong> constitute, breaches <strong>of</strong> New Approach <strong>directives</strong>,
which may have an impact on <strong>the</strong> terri<strong>to</strong>ry <strong>of</strong> o<strong>the</strong>r
Member States. In addition, <strong>the</strong> national authorities should
● Administrative cooperation is an obligation <strong>of</strong> Member
States. National surveillance authorities and <strong>the</strong> Commission
must provide mutual assistance <strong>to</strong> ensure proper and uniform
application <strong>of</strong> New Approach <strong>directives</strong>.
● Member States need <strong>to</strong> communicate <strong>to</strong> <strong>the</strong> Commission and
<strong>the</strong> o<strong>the</strong>r Member States a list <strong>of</strong> surveillance authorities,
which <strong>the</strong>y have designated as contact points <strong>to</strong> coordinate
administrative cooperation.
● National surveillance authorities should make information
available spontaneously or on request, according <strong>to</strong> mutually
agreed principles and mechanisms.
● National surveillance authorities should consider if coordination
<strong>of</strong> national operations provides a means <strong>to</strong> increase <strong>the</strong>
efficiency <strong>of</strong> market surveillance at Community level.
● The information exchanged in <strong>the</strong> framework <strong>of</strong> administrative
cooperation has <strong>to</strong> be covered by <strong>the</strong> requirements <strong>of</strong>
pr<strong>of</strong>essional secrecy.
● Administrative cooperation regarding <strong>the</strong> enforcement <strong>of</strong>
New Approach <strong>directives</strong> is organised in <strong>the</strong> standing committees
established under <strong>the</strong> <strong>directives</strong>, and in <strong>the</strong> horizontal
group <strong>of</strong> Senior Officials for Standardisation and Conformity
Assessment Policy.
communicate <strong>to</strong> <strong>the</strong> Commission any information <strong>the</strong>y consider
relevant, spontaneously or in response <strong>to</strong> a reasoned
request from <strong>the</strong> Commission. The Commission may <strong>the</strong>n
communicate this information <strong>to</strong> <strong>the</strong> o<strong>the</strong>r national authorities
when considered necessary.
Information exchange has been set up in Community legislation
<strong>to</strong> a limited extent, mainly where a risk <strong>of</strong> a serious
danger is present ( 175 ). For instance, <strong>the</strong> safeguard clause <strong>of</strong>
<strong>the</strong> New Approach <strong>directives</strong> is, basically, only applicable <strong>to</strong>
CE marked products, and all non-consumer products as well
as minor non-compliance are excluded from <strong>the</strong> application
<strong>of</strong> <strong>the</strong> rapid information exchange system according <strong>to</strong> <strong>the</strong>
Directive on general product safety. In some circumstances,
<strong>the</strong> existing information exchange systems are not quick
enough as regards <strong>the</strong> potential or actual risk. For example,
<strong>the</strong> safeguard clause requires consultation and an opinion
taken by <strong>the</strong> Commission that justifies <strong>the</strong> national measure
before <strong>the</strong> information is forwarded <strong>to</strong> o<strong>the</strong>r Member States.
In cases where <strong>the</strong> mechanisms provided for are insufficient,
<strong>the</strong> need <strong>to</strong> exchange information should be considered,
with a view <strong>to</strong> assuring confidentiality. To keep exchange <strong>of</strong>
information manageable, it should be limited <strong>to</strong> findings
where <strong>the</strong> non-compliance is considered as substantial or
where it is o<strong>the</strong>rwise considered as essential <strong>to</strong> keep surveillance
authorities in different Member States informed.
( 174 ) An explicit
obligation for
administrative
cooperation is laid
down in <strong>the</strong> Directives
relating <strong>to</strong> pressure
equipment and in vitro
diagnostic medical
devices: Member
States are required <strong>to</strong>
take appropriate
measures in order <strong>to</strong>
encourage/ensure that
<strong>the</strong> authorities
responsible for
implementing <strong>the</strong>
Directive cooperate
with each o<strong>the</strong>r, and
provide each o<strong>the</strong>r
(and <strong>the</strong> Commission)
with information in
order <strong>to</strong> assist <strong>the</strong>
functioning <strong>of</strong> <strong>the</strong>
Directive.
( 175 ) See Sections
8.3 — 8.5.
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