Proposal for a Council Decision concerning the conclusion of the 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: 2005-05-04
Institutions: European Commission
Subjects: EU policy, Switzerland, agricultural policy, economic policy, multilateral agreement, ratification of an agreement

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 4.5.2005 
COM(2005) 183 final 

2005/0066 (ACC) 
2005/0067 (ACC) 

Proposal for a 

COUNCIL DECISION 

on the signing 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 

Proposal for a 

COUNCIL DECISION 

concerning the conclusion of the 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 

(presented by the Commission) 

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9. 

EXPLANATORY MEMORANDUM 

The  Agreement  between  the  European  Community  and  the  Swiss  Confederation 
(“the  Parties”)  on  mutual  recognition  in  relation  to  conformity  assessment1  entered 
into force on 1 June 2002. 

With a view to further improving and simplifying the functioning of the Agreement, 
the Parties have decided to revise the Agreement in certain parts. 

The  revisions  are  intended  to  reduce  the  administrative  burden  related  to  the 
management of the agreement, to further facilitate trade, and to clarify and simplify 
the operation of the agreement. 

In  order  to  reduce  administrative  burden,  Article  10  will  be  revised  so  that  the 
Committee set up under the Agreement no longer needs to make formal Decisions to 
recognise,  modify  the  scope  of,  or  withdraw  recognition  of  conformity  assessment 
bodies in cases where the recognition, withdrawal or change in the scope of activity 
of  the  conformity  assessment  body  has  not  been  contested  by  the  other  Party.  In 
cases  where  the  recognition,  withdrawal  or  change  in  the  scope  of  activity  of  a 
conformity  assessment  body  has  been  contested,  a  formal  Decision  will  still  be 
required. 

New  procedures  are  clearly  set  out  in  Article  11  for  all  possible  courses  of  action 
related to the recognition, withdrawal of recognition, modification of the scope, and 
suspension of conformity assessment bodies.  

A  new  paragraph  will  be  added  to  Article  11  to  clarify  the  situation  regarding  the 
validity of certificates issued by conformity assessment bodies whose recognition has 
been withdrawn. 

The  wording  of  Articles  1,  5,  6,  7,  8,  9  and  10  has  been  changed  to  reflect  the 
revisions to Articles 10 and 11. 

Certain  provisions  in  Article  6  that  duplicate  provisions  in  Article  11  have  been 
deleted. 

The reference in Article 8(2) to the Chairman of the Committee is erroneous as the 
Committee is co-chaired by the Parties and has therefore been deleted. 

10. 

Article 2 refers to specified editions of the relevant ISO/IEC guides. In order to avoid 
the need to modify the Agreement each time a new edition of the ISO/IEC guide is 
produced,  the  specific  reference  has  been  deleted  from  Article  2  and  replaced  by  a 
general  reference  to  definitions  laid  down  by  ISO  and  IEC.  The  reference  to  the 
definitions laid down in European standards 45020 (1993 edition) is no longer valid 
and has therefore been deleted from Article 2. 

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2002/309/EC, Euratom; OJ L114/1, 30.04.2002 

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11. 

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13. 

14. 

15. 

16. 

An obligation to indicate possible suspensions of recognised conformity assessment 
bodies  in  the  list  of  recognised  conformity  assessment  bodies  has  been  included  in 
Article 8. 

A requirement for designating authorities to use their best endeavours to ensure that 
recognised conformity assessment bodies co-operate in an appropriate way has been 
introduced into Article 9. 

To  facilitate  trade,  and  to  simplify  the  operation  of  the  Agreement  in  cases  where 
there  may  be  doubts  as  to  its  applicability,  the  rule  of  origin  in  Article  4  has  been 
abolished.  The  Agreement  will  apply  to  all  products  covered  by  it,  irrespective  of 
their origin. 

In order to increase transparency in operation, an obligation to notify in writing any 
changes  to  relevant  legislative,  regulatory  and  administrative  provisions  has  been 
added in Article 12. 

There are no financial implications to this proposal, nor implications for SMEs. 

The  revised  Agreement  will  be  published  in  the  Official  Journal  of  the  European 
Union.  

In view of the need for these changes, it is desirable to adopt Decisions of the Council for the 
signature,  and  conclusion,  of  an  Agreement  with  the  Swiss  Confederation  revising  the 
Agreement. 

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2005/0066 (ACC) 

Proposal for a 

COUNCIL DECISION 

on the signing 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 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  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 Commission2, 

Whereas: 

(1) 

The Commission has negotiated on behalf of the Community an Agreement with 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. 

(2) 

Subject  to  its  possible  conclusion  at  a  later  date,  this  Agreement  initialled  on  14 
October 2004 should be signed , 

HAS DECIDED AS FOLLOWS: 

2 

OJ C […], […], p.[…]. 

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Sole Article 

Subject  to  a  possible  conclusion  at  a  later  date,  the  President  of  the  Council  is  hereby 
authorised to designate the person empowered to sign, on behalf of the European Community, 
the  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. 

Done at Brussels, 

For the Council 
The President 

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2005/0067 (ACC) 

Proposal for a 

COUNCIL DECISION 

concerning the conclusion of the 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 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  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 Commission3, 

Whereas: 

(1) 

(2) 

The Commission has negotiated on behalf of the Community an Agreement with 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; 

This  Agreement  has  been  signed,  on  behalf  of  the  European  Community,  on  […] 
subject to its possible conclusion at a later date, in accordance with Decision …/…/EC 
of the Council of […]4; 

(3) 

This Agreement should be approved, 

HAS DECIDED AS FOLLOWS:  

Article 1 

The  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 is hereby approved on behalf 
of the Community. 

The text of the Agreement is attached to this Decision. 

3 
4 

OJ C […], […], p.[…]. 
OJ L […], […], p. […]. 

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Article 2 

The  President  of  the  Council  is  hereby  authorised  to  designate  the  person  empowered  to 
deposit on behalf of the European Community the act of approval provided for in Article 21 
of the Agreement, in order to express the consent of the Community to be bound. 

Done at Brussels,  

For the Council 
The President 

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ANNEX 

AGREEMENT 

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

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 bodies 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 assessment bodies listed in Annex 1” should be deleted and replaced by a 
reference to the “recognised conformity assessment bodies” in the 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; 

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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; 

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 recognised 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 co-operate 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,  withdrawal  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  legislative,  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: 

Article 1 

Revisions to the Agreement 

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”. 

2. 

Article 2 (2) is replaced by the following: 

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“The definitions laid down by ISO and IEC may be used to establish the meaning of 
the general terms relating to conformity assessment contained in this Agreement.” 

3. 

Article 4 is replaced by the following: 

“Article 4 

Origin 

The provisions of this Agreement shall apply to products covered by this Agreement 
irrespective of their origin.” 

4. 

Article 5 is replaced by the following: 

“Article 5 

Recognised conformity assessment bodies 

The  Parties  hereby  agree  that  conformity  assessment  bodies  recognised  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: 

“Article 6 

Designating authorities 

1. 

2. 

The Parties hereby undertake to ensure that their designating  authorities have 
the  necessary  power  and  competence  to  designate  conformity  assessment 
bodies  or  withdraw  designation,  suspend  or  remove  suspension  of  designated 
conformity assessment bodies under their respective jurisdiction.  

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.” 

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  conformity  assessment  bodies  under  their 
jurisdiction”. 

7. 

Article 8 is revised as follows: 

(i) 

In  paragraph  1,  first  subparagraph,  “listed  in  Annex  1”  is  replaced  by  “of 
recognised conformity assessment bodies”. 

(ii) 

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

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(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. 

8. 

Article 9 is revised as follows: 

(i) 

(ii) 

In paragraph 2, “conformity assessment bodies under their jurisdiction listed in 
Annex 1” is replaced by “recognised conformity assessment bodies under their 
jurisdiction”. 

In  paragraph  3,  “The  conformity  assessment  bodies  listed  in  Annex  1”  is 
replaced by “The recognised conformity assessment 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 
co-operate in an appropriate way.” 

9. 

Article 10 paragraph 4 is replaced by the following: 

“4. The Committee may consider any matter related to this 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  bodies  contested  under 
Article 8; 

(d)  deciding on the withdrawal of recognition of recognised conformity assessment 

bodies contested under Article 8; 

(e) 

examining any legislative, regulatory and administrative provisions 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.” 

10. 

Article 11 is replaced by the following:  

“Article 11 

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

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: 

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(a)  A  Party  wishing  to  have  recognised  any  conformity  assessment  body 
shall  notify  the  other  Party  in  writing  of  its  proposal,  to  that  effect, 
adding the appropriate information to its request. 

(b) 

If the other Party agrees to the proposal or raises no objection within 60 
days of the notification of the proposal, the conformity assessment body 
shall be considered to be a recognised conformity assessment body under 
the terms of Article 5. 

(c) 

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

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  recognised  conformity 
assessment  body  under  its  jurisdiction  be  amended.  For  scope  extensions  and 
scope  reductions  the  procedures  provided  for  in  Article  11  (1)  and  11  (2) 
respectively shall apply. 

4.  A Party can, in exceptional circumstances, contest the technical 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  operating  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  competent  authorities  to  the  other  Party  in 
writing.” 

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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. 

2. 

This Agreement is drawn up in two originals in the Danish, Dutch, English, Finnish, 
French,  German,  Greek,  Italian,  Portuguese,  Spanish  and  Swedish  languages,  each 
text being equally authentic. 

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, 
Lithuanian,  Maltese,  Polish,  Slovak  and  Slovene  languages.  The  Committee  is 
empowered to approve these language versions. Once approved, the versions in these 
languages shall also be authentic, in the same way as for the languages referred to in 
paragraph 1. 

On behalf of the Swiss Confederation 

On behalf of the European Community 

Signed in Bern on 

Signed in Brussels on 

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