2006/958/EC: Council Decision of 19 December 2006 concerning the conclusion of an Agreement between the European Community and the Swiss Confederation on the revision of the Agreement on mutual recognition in relation to conformity assessment between the European Community and the Swiss Confederation
Date: 2006-12-29
Institutions: Council of the European Union
Subjects: Switzerland, agreement (EU), evaluation method, mutual recognition principle, product quality, quality label, ratification of an agreement, revision of an agreement

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COUNCIL DECISION

of 19 December 2006

concerning the conclusion of an Agreement between the European Community and the Swiss
Confederation on the revision of the Agreement on mutual recognition in relation to conformity
assessment between the European Community and the Swiss Confederation

(2006/958/EC)

THE COUNCIL OF THE EUROPEAN UNION,

The text of the Agreement is attached to this Decision.

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 133 in conjunction with the first
sentence of the first subparagraph of Article 300(2) thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

The Commission has negotiated on behalf of the Commu-
nity an Agreement with the Swiss Confederation on the
revision of the Agreement on mutual recognition in rela-
tion to conformity assessment between the European
Community and the Swiss Confederation.

(2)

The Agreement should be approved,

HAS DECIDED AS FOLLOWS:

Article 1

Article 2

The President of the Council is hereby authorised to designate
the person(s) empowered to sign the Agreement in order to bind
the Community.

Article 3

The President of the Council is hereby authorised to designate
the person(s) empowered to transmit on behalf of the European
Community the diplomatic note provided for in Article 2 of the
Agreement.

The Agreement between the European Community and the Swiss
Confederation on the revision of the Agreement on mutual rec-
ognition in relation to conformity assessment between the Euro-
pean Community and the Swiss Confederation is hereby
approved on behalf of the Community.

Done at Brussels, 19 December 2006.

For the Council
The President
J. KORKEAOJA

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revising the Agreement between the European Community and the Swiss Confederation on mutual
recognition in relation to conformity assessment

AGREEMENT

THE EUROPEAN COMMUNITY AND THE SWISS CONFEDERATION,

hereinafter referred to as ‘the Parties’,

Having concluded an Agreement on mutual recognition in relation to conformity assessment

hereinafter referred to as ‘the Agreement’;

WHEREAS the Agreement entered into force on 1 June 2002;

WHEREAS there is a need to simplify the operation of the Agreement;

WHEREAS the Agreement in Articles 1, 5, 6, 7, 8, 9, 10 and 11 refers to conformity assessment bodies listed in Annex 1;

WHEREAS the Agreement in Article 2 refers to definitions laid down in the 1996 edition of ISO/IEC Guide 2 and in the
1993 edition of the European standard EN 45020;

WHEREAS the Agreement in Article 4 restricts the application of the Agreement to products that originate in the Parties
according to non-preferential rules of origin;

WHEREAS the Agreement in Article 6 refers to the procedures set out in Article 11;

WHEREAS the Agreement in Article 8 refers to the Chairman of the Committee;

WHEREAS the Agreement in Article 9 refers to coordination and comparison work between conformity assessment bod-
ies recognised under the Agreement;

WHEREAS the Agreement in Article 10 establishes a Committee that decides on the inclusion of conformity assessment
bodies in Annex 1 and on their removal from Annex 1;

WHEREAS the Agreement in Article 11 sets out a procedure for the inclusion of conformity assessment bodies in Annex 1
and their removal from Annex 1;

WHEREAS the Agreement in Article 12 sets out obligations for information exchange;

CONSIDERING that in order to reflect the changes introduced to Article 11 of the Agreement, the term ‘conformity assess-
ment bodies listed in Annex 1’ should be deleted and replaced by a reference to the ‘recognised conformity assessment
bodies’ in Articles 1, 5, 6, 7, 8, 9, 10 and 11;

CONSIDERING that in order to avoid the need to modify the Agreement when changes are introduced to the definitions
in the relevant ISO/IEC guides, the reference to specific editions of these guides should be deleted from Article 2 and
replaced by a general reference to definitions laid down by ISO and IEC;

CONSIDERING that since the reference to the definitions laid down in European standards 45020 (1993 edition) is no
longer valid, the reference should be deleted from Article 2;

CONSIDERING that in order to facilitate trade between the Parties, and to simplify the operation of the Agreement, the
restriction to apply the Agreement to products that originate in the Parties should be deleted from Article 4;

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CONSIDERING that in order to simplify the Agreement, certain provisions of Article 6 should be deleted in order to avoid
duplication with corresponding provisions set out in Article 11;

CONSIDERING that in order to reflect that the Committee is co-chaired by the Parties, the reference to the Chairman of
the Committee should be deleted from Article 8;

CONSIDERING that in order to facilitate trade between the Parties, and to ensure transparency in the operation of the
Agreement, an obligation to indicate possible suspensions of recognised conformity assessment bodies in the list of rec-
ognised conformity assessment bodies should be included in Article 8;

CONSIDERING that in order to facilitate the functioning of the Agreement, the need for designating authorities to use
their best endeavours to ensure that recognised conformity assessment bodies cooperate in an appropriate way should be
included in Article 9;

CONSIDERING that in order to simplify the operation of the Agreement, the need for the Committee to take decisions on
the recognition or withdrawal of recognition of conformity assessment bodies should be limited to cases that have been
contested by the other Party should be included in Article 10;

CONSIDERING that in order to simplify the operation of the Agreement, a simpler procedure for the recognition, with-
drawal of recognition, modification of the scope, and suspension of conformity assessment bodies should be set up in
Article 11;

CONSIDERING that in order to increase transparency, an obligation to notify in writing changes related to relevant legis-
lative, regulatory and administrative provisions as well as to designating authorities and competent authorities should be
added in Article 12,

HAVE AGREED TO REVISE THE AGREEMENT AS FOLLOWS:

4.

Article 5 is replaced by the following:

Article 1

Revisions to the Agreement

‘Article 5

Recognised conformity assessment bodies

1.

Article 1 is revised as follows:

(i)

In paragraph 1, ‘bodies listed in Annex 1’’ is replaced by
‘bodies recognised in accordance with the procedures of this
Agreement’ (hereinafter recognised conformity assessment
bodies).

(ii)

In paragraph 2, ‘the bodies listed in Annex 1’’ is replaced by
‘recognised conformity assessment bodies.’.

The Parties hereby agree that conformity assessment bodies rec-
ognised in accordance with the procedure provided for in
Article 11 fulfil the conditions of eligibility to assess conformity.’.

5.

Article 6 is replaced by the following:

2.

Article 2(2) is replaced by the following:

‘Article 6

Designating authorities

‘The definitions laid down by ISO and IEC may be used to estab-
lish the meaning of the general terms relating to conformity
assessment contained in this Agreement.’.

3.

Article 4 is replaced by the following:

1.
The Parties hereby undertake to ensure that their designat-
ing authorities have the necessary power and competence to des-
ignate conformity assessment bodies or withdraw designation,
suspend or remove suspension of designated conformity assess-
ment bodies under their respective jurisdiction.

‘Article 4

Origin

The provisions of this Agreement shall apply to products cov-
ered by this Agreement irrespective of their origin.’.

2.
For the designation of conformity assessment bodies, the
designating authorities shall observe the general principles for
designation set out in Annex 2, subject to the provisions of the
respective section IV in Annex 1. These designating authorities
shall observe the same principles when withdrawing designation,
suspending or removing suspension.’.

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6.

Article 7 is revised as follows:

In paragraph 1, ‘the conformity assessment bodies under their
jurisdiction listed in Annex 1’ is replaced by ‘recognised confor-
mity assessment bodies under their jurisdiction’.

(e)

examining any legislative, regulatory and administrative pro-
visions notified by one Party to another pursuant
to
Article 12 in order to assess their repercussions on the
Agreement and to amend the appropriate sections in
Annex 1.’.

7.

Article 8 is revised as follows:

10.

Article 11 is replaced by the following:

(i)

In the first subparagraph of paragraph 1 ‘listed in Annex 1’
is replaced by ‘of recognised conformity assessment bodies.’

(ii)

In the second subparagraph of paragraph 1, the text ‘and to
the Chairman of the Committee’ is deleted.

‘Article 11

Recognition, withdrawal of recognition, modification of the
scope, and suspension of conformity assessment bodies

(iii) In paragraph 4, a new sentence: ‘Such suspension shall be
indicated in the common list of recognised conformity
assessment bodies referred to in Annex 1.’ is added after the
first sentence.

1.
The following procedure shall apply for the recognition of
conformity assessment bodies in relation to the requirements set
out in the relevant Chapters of Annex 1:

8.

Article 9 is revised as follows:

(i)

In paragraph 2, ‘conformity assessment bodies under their
jurisdiction listed in Annex 1’ is replaced by ‘recognised con-
formity assessment bodies under their jurisdiction’.

(a) a Party wishing to have recognised any conformity assess-
ment body shall notify the other Party in writing of its pro-
posal, to that effect, adding the appropriate information to
its request;

(ii)

In paragraph 3, ‘The conformity assessment bodies listed in
Annex 1’ is replaced by ‘The recognised conformity assess-
ment bodies’, and the following sentence is added after the
first sentence: ‘The designating authorities shall use their best
endeavours to ensure that recognised conformity assessment
bodies cooperate in an appropriate way.’.

(b)

if the other Party agrees to the proposal or raises no objec-
tion within 60 days of the notification of the proposal, the
conformity assessment body shall be considered to be a rec-
ognised conformity assessment body under the terms of
Article 5;

9.

Article 10, paragraph 4, is replaced by the following:

(c)

if the other Party raises objections in writing within that
60-day period, Article 8 shall apply.

The Committee may consider any matter related to this

‘4.
Agreement. In particular, it shall be responsible for:

(a) drawing up the procedure for carrying out the verifications

provided for in Article 7;

(b) drawing up the procedure for carrying out the verifications

provided for in Article 8;

(c) deciding on the recognition of conformity assessment bod-

ies contested under Article 8;

(d) deciding on the withdrawal of recognition of recognised con-
formity assessment bodies contested under Article 8;

2.
A Party can withdraw or suspend the recognition or remove
the suspension of recognition of a conformity assessment body
under its jurisdiction. The Party concerned shall immediately
notify the other Party of its decision in writing, together with the
date of such decision. The withdrawal, suspension, or removal
of suspension shall take effect at that date. Such withdrawal or
suspension shall be indicated in the common list of recognised
conformity assessment bodies referred to in Annex 1.

3.
A Party can propose that the scope of activity of a recogn-
ised conformity assessment body under its jurisdiction be
amended. For scope extensions and scope reductions the proce-
dures provided for in Article 11(1) and (2) respectively shall
apply.

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A Party can, in exceptional circumstances, contest the tech-
4.
nical competence of a recognised conformity assessment body
under the jurisdiction of the other Party. In this case Article 8
shall apply.

5.
Reports, certificates, authorisation and conformity marks
issued by a conformity assessment body after the date at which
its recognition has been withdrawn or suspended need not be
recognised by the Parties. Reports, certificates, authorisations and
conformity marks issued by a conformity assessment body before
the date its recognition has been withdrawn shall continue to be
recognised by the Parties unless the responsible designating
authority has limited or cancelled their validity. The Party under
whose jurisdiction the responsible designating authority is oper-
ating shall notify the other Party in writing of any such changes
relating to a limitation or cancellation of validity.’.

11.

Article 12 is revised as follows:

(i)

In paragraph 2, ‘in writing’ shall be added after ‘and shall
notify’.

(ii) A paragraph 2a is inserted after paragraph 2: ‘Each Party
shall notify changes to its designating authorities and com-
petent authorities to the other Party in writing.’.

Article 2

Entry into force

This Agreement shall be ratified or approved by the Parties in
accordance with their own procedures. It shall enter into force
on the first day of the second month following the date on which
the Parties have exchanged diplomatic notes confirming the
completion of their respective procedures for adoption of this
Agreement.

Article 3

Languages

1.
This Agreement is drawn up in two originals in the Dan-
ish, Dutch, English, Finnish, French, German, Greek, Italian, Por-
tuguese, Spanish and Swedish languages, each text being equally
authentic.

2.
This Agreement and the Agreement between the European
Community and the Swiss Confederation on mutual recognition
in relation to conformity assessment will as soon as possible be
translated into the Czech, Estonian, Hungarian, Latvian, Lithua-
nian, Maltese, Polish, Slovak and Slovene languages. The Com-
mittee is empowered to approve these language versions. Once
approved, the versions in these languages shall also be authen-
tic,
in the same way as for the languages referred to in
paragraph 1.

IN WITNESS WHEREOF, the undersigned Plenipotentiaries, duly empowered to this effect, have
signed this Agreement