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

❝ External aspects ❞
clause, consultations between <strong>the</strong> Commission and <strong>the</strong> Surveillance
Authority are envisaged. The Commission communicates
its decision <strong>to</strong> <strong>the</strong> EFTA Surveillance Authority,
which sends it <strong>to</strong> <strong>the</strong> EEA EFTA States for fur<strong>the</strong>r actions. If
an EEA EFTA State does not follow <strong>the</strong> decision, <strong>the</strong> Surveillance
Authority can initiate an infringement procedure.
9.1.4. Mutual recognition agreements and European
conformity assessment pro<strong>to</strong>cols
The mandate from <strong>the</strong> Council <strong>to</strong> <strong>the</strong> Commission <strong>to</strong> negotiate
mutual recognition agreements and European conformity
assessment pro<strong>to</strong>cols indicated <strong>the</strong> objective that
<strong>the</strong> third countries concerned will conclude with <strong>the</strong> EEA
EFTA States parallel agreements and pro<strong>to</strong>cols equivalent
<strong>to</strong> those <strong>to</strong> be concluded with <strong>the</strong> Community, and which
will, possibly, have <strong>the</strong> same date for entry in<strong>to</strong> force ( 189 ).
The system <strong>of</strong> parallel agreements and pro<strong>to</strong>cols formally
grants <strong>the</strong> third country concerned <strong>the</strong> same market
access throughout <strong>the</strong> European Economic Area for products
covered by <strong>the</strong> mutual recognition agreements or European
conformity assessment pro<strong>to</strong>cols. As <strong>to</strong> <strong>the</strong> practical
<strong>implementation</strong> <strong>of</strong> <strong>the</strong>se agreements and pro<strong>to</strong>cols, common
sessions <strong>of</strong> <strong>the</strong> Joint Committee meetings with <strong>the</strong>
third country concerned will be arranged.
The Community in its relations with third
countries endeavours <strong>to</strong> promote international
trade in regulated products, in particular
by concluding mutual recognition
agreements (MRAs) on <strong>the</strong> basis <strong>of</strong> Article
133 <strong>of</strong> <strong>the</strong> EC Treaty.
MRAs are designed so that each party
shall accept <strong>the</strong> reports, certificates and
marks that are in accordance with its own
legislation. These are drawn up and issued
by bodies that <strong>the</strong> o<strong>the</strong>r party has designated
under <strong>the</strong> MRA for assessing conformity
in <strong>the</strong> field(s) covered by <strong>the</strong> MRA. This can
be achieved, because MRAs include all <strong>the</strong> conformity
assessment requirements <strong>of</strong> <strong>the</strong> parties necessary <strong>to</strong>
obtain full market access ( 190 ), and <strong>the</strong> products are evaluated
in <strong>the</strong> country <strong>of</strong> production against <strong>the</strong> regula<strong>to</strong>ry
requirements <strong>of</strong> <strong>the</strong> o<strong>the</strong>r party.
MRAs cover <strong>the</strong> entire terri<strong>to</strong>ry <strong>of</strong> <strong>the</strong> parties in order <strong>to</strong>
guarantee, in particular in States with a federal structure,
<strong>the</strong> full free movement <strong>of</strong> products certified <strong>to</strong> be in conformity.
As a general rule, MRAs are limited <strong>to</strong> products that
have <strong>the</strong>ir origin on <strong>the</strong> terri<strong>to</strong>ry <strong>of</strong> ei<strong>the</strong>r party ( 191 ).
MRAs apply <strong>to</strong> one or more categories <strong>of</strong> products or
sec<strong>to</strong>rs falling within <strong>the</strong> regulated field (<strong>the</strong>y are covered
by New Approach or o<strong>the</strong>r Community technical harmonisation
<strong>directives</strong> in force) and, in certain cases, by nonharmonised
national law. In principle MRAs should cover all
<strong>the</strong> industrial products for which <strong>the</strong> regulations <strong>of</strong> at least
one <strong>of</strong> <strong>the</strong> parties require third party conformity assessment.
MRAs comprise a framework agreement and sec<strong>to</strong>rial
annexes. The framework agreement lays down <strong>the</strong> essential
principles <strong>of</strong> a traditional agreement. Sec<strong>to</strong>rial annexes
specify, in particular, <strong>the</strong> scope and coverage, regula<strong>to</strong>ry requirements,
<strong>the</strong> list <strong>of</strong> designated conformity assessment
bodies, <strong>the</strong> procedures and authorities responsible for
9.2. Mutual recognition agreements
● Mutual recognition agreements are established between
<strong>the</strong> Community and <strong>the</strong> government <strong>of</strong> third countries, which
are on a comparable level <strong>of</strong> technical development and have
a compatible approach concerning conformity assessment.
● These agreements are <strong>based</strong> on <strong>the</strong> mutual acceptance <strong>of</strong>
certificates, marks <strong>of</strong> conformity and test reports issued by <strong>the</strong>
conformity assessment bodies <strong>of</strong> ei<strong>the</strong>r party in conformity
with <strong>the</strong> legislation <strong>of</strong> <strong>the</strong> o<strong>the</strong>r party.
designating <strong>the</strong>se bodies and, if applicable, transitional
periods. More sec<strong>to</strong>rial annexes can be added successively.
MRAs are not <strong>based</strong> on <strong>the</strong> necessity <strong>to</strong> mutually accept
o<strong>the</strong>r party’s standards or technical regulations, or <strong>to</strong> consider
<strong>the</strong> legislation <strong>of</strong> <strong>the</strong> two parties as equivalent. However,
MRAs can pave <strong>the</strong> way <strong>to</strong>wards a harmonised system
<strong>of</strong> standardisation and certifications <strong>of</strong> <strong>the</strong> parties. Never<strong>the</strong>less,
<strong>the</strong> two legislations are, as a rule, deemed <strong>to</strong>
ensure a comparable level regarding <strong>the</strong> protection <strong>of</strong>
health, safety, environment or o<strong>the</strong>r public interests. Moreover,
MRAs increase <strong>the</strong> transparency <strong>of</strong> <strong>the</strong> regula<strong>to</strong>ry systems,
since <strong>the</strong> different systems are shown <strong>to</strong> o<strong>the</strong>r countries
and <strong>the</strong>y have <strong>to</strong> demonstrate coherence.
As a result <strong>of</strong> <strong>the</strong> different conditions established and
<strong>the</strong> interest <strong>of</strong> third countries and <strong>the</strong> Community, <strong>the</strong> Commission
was authorised in 1992 <strong>to</strong> negotiate with <strong>the</strong> following
countries: United States, Japan, Canada, Australia,
New Zealand, Hong Kong, Israel, Singapore, Philippines,
South Korea and Switzerland.
At <strong>the</strong> time <strong>of</strong> writing (May 1999), <strong>the</strong> Commission has
finalised negotiations with Australia, New Zealand, <strong>the</strong>
United States, Canada, Switzerland and Israel ( 192 ), and is
negotiating with Japan. The concluded MRAs all contain
commitments <strong>to</strong> fur<strong>the</strong>r negotiations.
( 189 ) See Section 9.2 for
mutual recognition
agreements and
Section 9.3 for
European conformity
assessment pro<strong>to</strong>cols.
( 190 ) This is <strong>the</strong>
principal difference
with subcontracting
that provides only for
some <strong>of</strong> <strong>the</strong>
procedures, such as
tests.
( 191 ) According <strong>to</strong> some
MRAs <strong>the</strong> rule <strong>of</strong> origin
may not be applicable
(such as MRAs with
<strong>the</strong> USA and Canada).
( 192 ) The MRA with
Israel covers only good
labora<strong>to</strong>ry practice.
63