This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents  
►B AGREEMENT  
between the European Community and the Swiss Confederation on mutual recognition in relation 
to conformity assessment  
(OJ L 114, 30.4.2002, p. 369)  
Amended by:  
Official Journal  
No page  date  
►M1 Decision No 2/2002 of 8 January 2003  L 68  1  12.3.2003  
►M2 Decision No 1/2004 of 16 January 2004  L 34  72  6.2.2004  
►M3 Decision No 1/2005 of the Committee of 7 March 2005  L 93  40  12.4.2005  
►M4 Decision No 2/2005 of 30 March 2005  L 110  78  30.4.2005  
►M5 Decision No 3/2005 of 25 October 2005  L 322  29  9.12.2005  
►M6 Decision No 4/2005 of 25 October 2005  L 322  31  9.12.2005  
►M7 Decision No 1/2006 of 29 September 2006  L 325  22  24.11.2006  
►M8 Agreement revising the Agreement between the European Community 
and the Swiss Confederation on mutual recognition in relation to conformity assessment
 L 386  51  29.12.2006  
►M9 Decision No 2/2006 of 13 December 2006  L 32  135  6.2.2007  
►M10  Decision No 1/2008 of 12 March 2008  L 282  22  25.10.2008  
►M11  Decision No 1/2009 of 21 December 2009  L 147  11  12.6.2010  
►M12  Decision No 1/2010 of the Committee established under the Agreement 
between the European Community and the Swiss Confederation on 
mutual recognition in relation to conformity assessment of 18 
October 2010  L 46  51  19.2.2011  
►M13  Decision No 1/2011 of the Committee established under the Agreement 
between the European Community and the Swiss Confederation on 
mutual recognition in relation to conformity assessment of 20 December 2011
 L 80  31  20.3.2012  2002A5430 — EN — 20.12.2011 — 001.001 — 1
AGREEMENT  
between the European Community and the Swiss Confederation on 
mutual recognition in relation to conformity assessment  
THE EUROPEAN COMMUNITY, hereinafter referred to as ‘the Community’, 
and 
THE SWISS CONFEDERATION, hereinafter referred to as ‘Switzerland’,  
together hereinafter referred to as ‘the Parties’,  
Considering the close ties that exist between the Community and Switzerland;  
Considering the Free Trade Agreement of 22 July 1972 between Switzerland and 
the European Economic Community;  
Desiring to conclude an Agreement providing for the mutual recognition of the 
results of conformity assessment procedures required for access to the respective markets of the Parties;
 
Considering that mutual recognition in relation to conformity assessment will 
facilitate trade between the Parties and ensure protection for health, safety, the environment and consumers;
 
Considering the alignment of legislation will facilitate mutual recognition;  
Considering their obligations as Contracting Parties to the Agreement estab ­
lishing the World Trade Organisation and, in particular, to the Agreement on Technical Barriers to Trade, which encourages the negotiation of mutual recog ­
nition agreements;
 
Considering that mutual recognition agreements contribute to harmonisation at 
international level of the technical regulations, standards and principles governing 
implementation of conformity assessment procedures;  
Considering that the close ties between the Community and Switzerland, of the 
one part, and Iceland, Liechtenstein and Norway, of the other, makes the 
conclusion of parallel agreements between those countries and Switzerland 
appropriate,  
Have agreed to conclude the following Agreement:  
Article 1  
Purpose  
1. The Community and Switzerland hereby grant mutual acceptance 
of reports, certificates, authorisations and conformity marks issued by the ►
M8 bodies recognised in accordance with the procedures of this 
Agreement (hereinafter recognised conformity assessment bodies) ◄ 
and of the manufacturer's declarations of conformity certifying conformity to the requirements of the other Party in the areas covered by Article 3.
 
2. In order to avoid duplication of procedures when Swiss and 
Community requirements are deemed equivalent, the Community and 
Switzerland shall mutually accept reports, certificates and authorisations issued by  ►
M8 recognised conformity assessment bodies ◄ and 
manufacturer's declarations of conformity certifying conformity to their respective requirements in the areas covered by Article 3. Reports, certificates, authorisations and manufacturer's declarations of conformity shall in particular indicate conformity with the Community legislation. Conformity marks required by the legislation of one of the Parties must be affixed to products placed on the market of that Party.  ▼
B 2002A5430 — EN — 20.12.2011 — 001.001 — 2
 
3. The Committee provided for in Article 10 shall specify the cases 
in which paragraph 2 shall apply.  
Article 2  
Definitions  
1. For the purposes of this Agreement:  
‘Conformity assessment’ shall mean systematic examination to 
determine the extent to which a product, process or service fulfils specified requirements;
 
‘Conformity assessment body’ shall mean a public or private law body 
whose activities include performance of all or any stage of the conformity assessment process;
 
‘Designating authority’ shall mean an authority with the legal power to 
designate, suspend, withdraw designation or remove suspension of conformity assessment bodies under its jurisdiction.
 
2. ►M8 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. ◄
 
Article 3  
Scope  
1. This Agreement covers the obligatory conformity assessment 
procedures ensuing from the legislative, regulatory and administrative provisions listed in Annex 1.
 
2. Annex 1 defines the product sectors covered by this Agreement. 
The Annex is divided up into sectoral chapters and these are subdivided in principle as follows:
 
section I: legislative, regulatory and administrative provisions;  
section II: conformity assessment bodies;  
section III: designating authorities;  
section IV: special rules relating to the designation of conformity 
assessment bodies;  
section V: any additional provisions.  
3. Annex 2 sets out general rules applicable to the designation of 
conformity assessment bodies.  
▼M8 
Article 4  
Origin  
The provisions of this Agreement shall apply to products covered by 
this Agreement irrespective of their origin.  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 3
 
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.
 
Article 6  
Designating authorities  
1. The Parties hereby undertake to ensure that their designating auth ­
orities 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.
 
2. For the designation of conformity assessment bodies, the desig ­
nating 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.  
▼
B 
Article 7  
Verification of designation procedures  
1. The Parties shall exchange information concerning the procedures 
used to ensure  ►M8 recognised conformity assessment bodies under 
their jurisdiction ◄ comply with the general principles of designation 
outlined in Annex 2 subject to the provisions of the respective section IV in Annex 1.
 
2. The Parties shall compare methods used to verify conformity of 
the bodies with the general principles of designation outlined in Annex 2, subject to the provisions of the respective section IV in Annex 1. Existing systems for the accreditation of conformity assessment bodies in the Parties may be used for the purpose of such comparisons.
 
3. Verification shall be carried out in accordance with the procedure 
implemented by the Committee under Article 10 below.  
Article 8  
Verification of compliance of conformity assessment bodies  
1. Each Party shall, in exceptional circumstances, have the right to 
contest the technical competence of the conformity assessment bodies proposed by the other Party or  ►
M8 of recognised conformity 
assessment bodies ◄ under the jurisdiction of the other Party.  
For this purpose, it shall submit in writing an objective and reasoned 
argument to the other Party  ►M8 __________  ◄. ▼M8 2002A5430 — EN — 20.12.2011 — 001.001 — 4
 
2. In the event of a disagreement between the Parties, confirmed in 
the Committee, a verification of the technical competence of the conformity assessment body in question shall be undertaken in accordance with requirements jointly by the Parties, with the partici ­
pation of the competent authorities concerned.
 
The result of that verification shall be discussed in the Committee with 
a view to resolving the issue as soon as possible.  
3. Each Party shall ensure that the conformity assessment bodies 
under its jurisdiction are available for verification of their technical competence as required.
 
4. Unless otherwise decided by the Committee, the disputed body shall 
be suspended by the competent designating authority from the time disagreement has been established until agreement has been reached in the Committee.  ►
M8 Such suspension shall be indicated in the common 
list of recognised conformity assessment bodies referred to in Annex 1. ◄ 
Article 9  
Implementation of the Agreement  
1. The Parties shall cooperate with a view to ensuring the satisfactory 
application of the legislative, regulatory and administrative provisions listed in Annex 1.
 
2. The designating authorities shall ascertain by appropriate means 
whether the  ►M8 recognised conformity assessment bodies under their 
jurisdiction ◄ are observing the general principles of designation listed 
in Annex 2, subject to the provisions listed in the respective section IV in Annex 1.
 
3. ►M8 The recognised conformity assessment bodies ◄ shall 
cooperate in an appropriate way in the framework of the coordination and comparison work conducted by each of the Parties in respect of the sectors covered by Annex 1 in order to ensure that the conformity assessment procedures provided for in the laws and regulations of the Parties covered by this Agreement are applied in a consistent manner.  
►
M8 The designating authorities shall use their best endeavours to 
ensure that recognised conformity assessment bodies cooperate in an appropriate way. ◄
 
Article 10  
Committee  
1. A Committee on mutual recognition in relation to conformity 
assessment (hereinafter referred to as the ‘Committee’), is hereby estab ­
lished. It shall be composed of representatives of the Parties, and shall be responsible for the management and monitoring of the smooth func ­
tioning of this Agreement. To that end, it shall issue recommendations 
and take decisions in the circumstances provided for in this Agreement. It shall act by mutual agreement.
 
2. The Committee shall establish its own rules of procedure, which 
shall contain,  inter alia , provisions on the convening of meetings, the 
appointment of the chairman and the chairman's term of office.  
3. The Committee shall meet as and when necessary and at least 
once a year. Either Party may request the convening of a meeting.  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 5
 
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.  
▼
B 
5. The Committee may, on a proposal from one of the Parties, 
modify the Annexes to this Agreement.  
▼M8 
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:
 
(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 (2) respectively shall apply.  ▼
M8 2002A5430 — EN — 20.12.2011 — 001.001 — 6
 
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.  
▼
B 
Article 12  
Information exchange  
1. The Parties shall exchange all relevant information regarding 
implementation and application of the legislative, regulatory and admin ­
istrative provisions listed in Annex 1.  
2. Each Party shall inform the other Party of the changes it intends to 
make to the legislative, regulatory and administrative provisions relating to the subject matter of this Agreement and shall notify  ►
M8 in 
writing ◄ the other Party of the new provisions at least 60 days 
before their entry into force.  
▼M8 
2a. Each Party shall notify changes to its designating authorities and 
competent authorities to the other Party in writing.  
▼B 
3. Where the legislation of one of the Parties stipulates that a specific 
item of information must be made available to the competent authority by a person established in its territory, that authority may also approach the competent authority of the other Party or enter into direct contact with the manufacturer or, if appropriate, the latter's agent in the territory of the other Party, in order to obtain that information.
 
4. Each Party shall immediately notify the other Party of safeguard 
measures taken in its territory.  
Article 13  
Confidentiality  
Representatives, experts and other agents of the Parties shall be 
required, even after their duties have ceased, not to disclose information acquired under this Agreement which is of the kind covered by the obligation of professional secrecy. This information may not be used for purposes other than those envisaged by this Agreement.  ▼
M8 2002A5430 — EN — 20.12.2011 — 001.001 — 7
 
Article 14  
Dispute settlement  
Each Party may refer any dispute relating to the interpretation or appli ­
cation of this Agreement to the Committee. The Committee shall endeavour to settle the dispute, and must be supplied with any information which may facilitate a thorough examination of the situation with a view to finding an acceptable solution. For that purpose, the Committee shall consider every possible means of main ­
taining the smooth functioning of this Agreement.
 
Article 15  
Agreements with third countries  
The Parties hereby agree that mutual recognition agreements concluded 
by either Party with a country that is not party to this Agreement shall in no circumstances entail an obligation upon the other Party in terms of the acceptance of manufacturer's declarations of conformity as well as of reports, certificates, authorisations and marks issued by conformity assessment bodies in that third country, unless there is an explicit agreement between the Parties.
 
Article 16  
Annexes  
The Annexes to this Agreement shall form an integral part thereof.  
Article 17  
Territorial application  
This Agreement shall apply, as regards the Community, to the territories 
in which the Treaty establishing the European Community is applied under the conditions laid down in that Treaty, on the one hand, and to the territory of Switzerland, on the other.
 
Article 18  
Revision  
1. If a Party wishes to have this Agreement revised, it shall inform 
the Committee. Modifications to this Agreement shall enter into force after the respective internal procedures have been completed.
 
2. The Committee may modify Annexes 1 and 2 to this Agreement 
on a proposal from one of the Parties.  
Article 19  
Suspension  
Where a Party establishes that the other Party is failing to comply with 
the conditions of this Agreement, it may, after consulting the Committee, suspend application of Annex 1 in full or in part.  ▼
B 2002A5430 — EN — 20.12.2011 — 001.001 — 8
 
Article 20  
Acquired rights  
The Parties shall continue to recognise reports, certificates, authori ­
sations and conformity marks and manufacturers' declarations of conformity issued in accordance with, and prior to the expiry of, this Agreement, provided that the request for conformity evaluation to be started was made before the notice of non-renewal or denunciation was given.
 
Article 21  
Entry into force and duration  
1. 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 last notification of deposit of the instruments for ratification or approval of all the following seven agreements:
 
Agreement on the mutual recognition in relation to conformity 
assessment  
Agreement on the free movement of persons  
Agreement on air transport  
Agreement on the carriage of goods and passengers by rail and road  
Agreement on trade in agricultural products  
Agreement on certain aspects of public procurement  
Agreement on scientific and technical cooperation.  
2. This Agreement shall be concluded for an initial period of seven 
years. It shall be tacitly extended, unless the Community or Switzerland notifies the other Party to the contrary before the expiry of that period. Where such notification is given, the provisions of paragraph 4 shall apply.
 
3. The Community or Switzerland may denounce this Agreement by 
notifying the other Party. Where such notification is given, the 
provisions of paragraph 4 shall apply.  
4. The seven agreements referred to in paragraph 1 shall cease to 
apply six months after receipt of the non-renewal notice described in paragraph 2 or the denunciation notice described in paragraph 3.
 
Hecho en Luxemburgo, el veintiuno de junio de mil novecientos noventa y 
nueve. El presente Acuerdo se establecerá por duplicado en lenguas alemana, danesa, española, finesa, francesa, griega, inglesa, italiana, neerlandesa, portu ­
guesa y sueca y cada uno de estos textos será auténtico.
 
Udfærdiget i Luxembourg, den enogtyvende juni nitten hundrede og nioghalv ­
fems i to eksemplarer på dansk, engelsk, finsk, fransk, græsk, italiensk, neder ­
landsk, portugisisk, spansk, svensk og tysk, idet hver af disse tekster har samme 
gyldighed.  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 9
 
Geschehen zu Luxemburg am einundzwanzigsten Juni neunzehnhundertneunund ­
neunzig in zwei Urschriften in dänischer, deutscher, englischer, finnischer, fran ­
zösischer, griechischer, italienischer, niederländischer, portugiesischer, schwe ­
discher und spanischer Sprache, wobei jeder Wortlaut gleichermaßen verbindlich ist.
 
Έγινε  στο Λουξεμβούργο , στις είκοσι  μία Ιουνίου  χίλια  εννιακόσια  ενενήντα  
εννέα . Η παρούδα  συμφωνία  καταρτίζεται  εις διπλούν  στα αγγλικά , τα γαλλικά , 
τα γερμανικά , τα δανικά , τα ελληνικά , τα ισπανικά , τα ιταλικά , τα ολλανδικά , τα 
πορτογαλικά , τα σουηδικά  και τα φινλανδικά , καθένα  από τα κείμενα  αυτά  είναι  
αυθεντικό . 
Done at Luxembourg on the twenty-first day of June in the year one thousand 
and ninety-nine. This Agreement is drawn up in duplicate in the Danish, Dutch, 
English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic.
 
Fait à Luxembourg, le vingt-et-un juin mil neuf cent quatre-vingt dix-neuf, en 
double exemplaire, en langues allemande, anglaise, danoise, espagnole, finnoise, 
française, grecque, italienne, néerlandaise, portugaise et suédoise, chacun de ces textes faisant également foi.
 
Fatto a Lussemburgo, addì ventuno giugno millenovecentonovantanove, in due 
copie nelle lingue danese, finlandese, francese, greco, inglese, italiano, olandese, 
portoghese, spagnolo, svedese e tedesco; tutte facenti ugualmente fede.  
Gedaan te Luxemburg, de eenentwintigste juni negentienhonderd negenennegen ­
tig, in tweevoud in de Deense, de Duitse, de Engelse, de Finse, de Franse, de Griekse, de Italiaanse, de Nederlandse, de Portugese, de Spaanse en de Zweedse 
taal, zijnde alle teksten gelijkelijk authentiek.
 
Feito em Luxemburgo, em vinte e um de Junho de mil novecentos e noventa e 
nove, em dois exemplares em língua alemã, inglesa, dinamarquesa, espanhola, finlandesa, francesa, grega, italiana, neerlandesa, portuguesa e sueca, todas as versões fazendo igualmente fé.
 
Tehty Luxemburgissa kahdentenakymmenentenäensimmäisenä päivänä kesäkuuta 
vuonna tuhatyhdeksänsataayhdeksänkymmentäyhdeksän kahtena kappaleena eng ­
lannin, espanjan, hollannin, italian, kreikan, portugalin, ranskan, ruotsin, saksan, suomen ja tanskan kielellä, ja jokainen teksti on yhtä todistusvoimainen.
 
Utfärdat i Luxemburg den tjugoförsta juni nittonhundranittionio i två exemplar på 
det danska, engelska, finska, franska, grekiska, italienska, nederländska, portugi ­
siska, spanska, svenska och tyska språket, vilka samtliga texter är lika giltiga.  
Por la Comunidad Europea  
For Det Europæiske Fællesskab  
Für die Europäische Gemeinschaft  
Για την Ευρωπαϊκή  Κοινότητα  
For the European Community  
Pour la Communauté européenne  
Per la Comunità europea  
Voor de Europese Gemeenschap  
Pela Comunidade Europeia  
Euroopan yhteisön puolesta  
På Europeiska gemenskapens vägnar
  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 10
 
Por la Confederación Suiza  
For Det Schweiziske Edsforbund  
Für die Schweizerische Eidgenossenschaft  
Για την Ελβετική  Συνομοσπονδία  
For the Swiss Confederation  
Pour la Confédération suisse  
Per la Confederazione svizzera  
Voor de Zwitserse Bondsstaat  
Pela Confederação Suíça  
Sveitsin valaliiton puolesta  
På Schweiziska edsförbundets vägnar
  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 11
 
ANNEX 1  
PRODUCT SECTORS  
This Annex is divided up into the following Chapters by sector:  
Chapter 1 Machinery  
Chapter 2 Personal protective equipment  
Chapter 3 Toys  
Chapter 4 Medical devices  
Chapter 5 Gas appliances and boilers  
Chapter 6 Pressure vessels  
Chapter 7 Radio equipment and telecommunications terminal equipment  
Chapter 8 Equipment and protective systems intended for use in poten ­
tially explosive atmospheres  
Chapter 9 Electrical equipment and electromagnetic compatibility  
Chapter 10 Construction plant and equipment  
Chapter 11 Measuring instruments and prepackages  
Chapter 12 Motor vehicles  
Chapter 13 Agricultural and forestry tractors  
Chapter 14 Good laboratory practice (GLP)  
Chapter 15 Medicinal products GMP Inspection and Batch Certification  
Chapter 16 Construction products  
Chapter 17 Lifts  
Chapter 18 Biocidal products  
Chapter 19 Cableway installations  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 12
 
CHAPTER 1  
MACHINERY  
S e c t i o n I  
Legislative, regulatory and administrative provisions  
Provisions covered by Article 1(2)  
▼M13  
European Union  1. Directive 2006/42/EC of the European 
Parliament and of the Council of 17 May 
2006 on machinery, and amending Directive 
95/16/EC (OJ L 157, 9.6.2006, p. 24) as last amended by Directive 2009/127/EC of the European Parliament and of the Council of 
21 October 2009 amending Directive 2006/42/ 
EC with regard to machinery for pesticide application (OJ L 310, 25.11.2009, p. 29)
 
Switzerland  100. Federal Law of 12 June 2009 on product safety 
(RO 2010 2573)  
101. Ordinance of 19 May 2010 on product safety 
(RO 2010 2583)  
102. Ordinance of 2 April 2008 on the safety of 
machinery (RO 2008 1785), as last amended on 19 May 2010 (RO 2010 2583)
 
▼M11  
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the 
Agreement, a list of the conformity assessment bodies.  
S e c t i o n I I I  
Designating authorities  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date a list of the designating authorities notified by the Parties.  
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, the designating authorities 
shall comply with the general principles contained in Annex 2 to this Agreement 
and the assessment criteria set out in Annex XI to Directive 2006/42/EC.  
S e c t i o n V  
Supplementary provisions  
1. Second-hand machinery  
The legislative, regulatory and administrative provisions listed in section I 
shall not apply to second-hand machinery.  ▼M11  2002A5430 — EN — 20.12.2011 — 001.001 — 13
 
The principle contained in Article 1(2) of this Agreement shall apply, 
however, to machinery legally placed on the market and/or put into 
service in one of the Parties and exported as second-hand machinery to the market of the other Party.
 
The other provisions relating to second-hand machinery, e.g. those relating 
to safety in the place of work in force in the importing state, shall remain applicable.
 
2. Information exchange  
In accordance with Article 9 of this Agreement, the Parties shall exchange 
information needed to ensure a proper implementation of this chapter.  
The Parties hereby undertake to forward all relevant technical documents at 
the request of the authorities of the other Party.  
3. Person named in the declaration of conformity of machines, authorised to 
compile the technical file  
The declaration of conformity of the machinery must contain the name and 
address of the person authorised to compile the technical file, who must be established in the respective Parties’ territory.
 
The Parties shall mutually recognise this person. The manufacturer, his 
authorised representatives or, where neither of these is present, the person 
responsible for placing products on the market of one Party, shall not be 
obliged to designate a person, who is responsible for compiling the technical file, in the territory of the other Party.
 
▼B 
CHAPTER 2  
PERSONAL PROTECTIVE EQUIPMENT  
▼M1 
S e c t i o n I  
Legislation, regulations and administrative provisions  
Provisions covered by Article 1(2)  
European Community  Council Directive 89/686/EEC of 21 December 1989 
on the approximation of the laws of the Member States relating to personal protective equipment, as 
last amended by Directive 96/58/EC of the 
European Parliament and of the Council of 3 September 1996 (OJ L 236, 18.9.1996, p. 44)
 
▼M13  
Switzerland  100. Federal Law of 12 June 2009 on product safety 
(RO 2010 2573)  
101. Ordinance of 19 May 2010 on product safety 
(RO 2010 2583)  
▼B 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the 
Agreement, a list of the conformity assessment bodies.  ▼M11  2002A5430 — EN — 20.12.2011 — 001.001 — 14
 
TESTEX  
Gotthardstrasse 61  
8027 Zürich  
Switzerland  
Mr. Adrian Meili  
Tel.: + 41 (0) 44 206 42 42  
Fax: + 41 (0) 44 206 42 30  
E-mail: zuerich@testex.ch  
▼M1 
S e c t i o n I I I  
Designating authorities  
European Community:  
— Belgium:  Ministère de l'Emploi et du Travail/Ministerie voor 
Arbeid en Tewerkstelling  
— Denmark:  Arbejdsministeriet, Arbejdstilsynet  
— Finland:  Sosiaali- ja terveysministeriö/Social- och hälsovårds ­
ministeriet  
— France:  Ministère de l'emploi et de la solidarité, Direction des 
relations du travail, Bureau CT 5 Ministère de l'Economie, des Finances et de l' 
Industrie, Direction générale de l'industrie, des tech ­
nologies de l'information et des postes (DIGITIP) — SQUALPI
 
— Germany:  Bundesministerium für Arbeit und Sozialordnung  
— Greece:  Ministry of Development. General Secretariat of 
Industry  
— Spain:  Ministerio de Ciencia y Tecnología  
— Ireland:  Department of Enterprise and Employment  
— Italy:  Ministero dell'Industria, del Commercio e dell'Arti ­
giniato  
— Luxembourg:  Ministère du Travail (Inspection du Travail et des 
Mines)  
— Netherlands:  Minister van Volksgezondheid, Welzijn en Sport  
— Austria:  Bundesministerium für Wirtschaft und Arbeit  
— Portugal:  Under the authority of the Government of Portugal: 
Instituto Português da Qualidade  
— Sweden:  Under the authority of the Government of Sweden: 
Styrelsen för ackreditering och teknisk kontroll 
(SWEDAC)  
— United Kingdom:  Department of Trade and Industry  
Switzerland:  State Secretariat for Economic Affairs  
▼B 
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, the designating authorities 
shall comply with the general principles contained in Annex 2 and those in 
Annex V to Directive 89/686/EEC.  ▼M9 2002A5430 — EN — 20.12.2011 — 001.001 — 15
 
CHAPTER 3  
TOYS  
S e c t i o n I  
Legislative, regulatory and administrative provisions  
▼M4 
Provisions covered by Article 1(2)  
▼B 
European Community  Council Directive of 3 May 1988 on the approxi ­
mation of the laws of the Member States concerning the safety of toys (88/378/EEC) (OJ L 187, 16.7.1988, p. 1), as subsequently amended
 
Switzerland  ►M4 Federal Law of 9 October 1992 on foodstuffs 
and commodities (RO 1995 1469) as last amended on 
21 March 2003 (RO 2003 4803) ◄ 
►M4 Ordinance of 1 March 1995 on commodities 
(RO 1995 1643) as last amended on 15 December 2003 (RO 2004 1111) ◄
 
►M4 Ordinance of EDI of 27 March 2002 on the 
safety of toys (RO 2002 1082) as last amended on 
2 October 2003 (RO 2003 3733) ◄ 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the 
Agreement, a list of the conformity assessment bodies.  
▼M2 
Chapter  Body  Contact/Tel./Fax/E-mail  Directive  
3 — Toys  Kantonales Labora ­
torium Basel-Land ­
schaft Hammerstrasse 25 
CH-4410 Liestal
 Dr Peter Wenk 
Tel.: (41-61) 906 64 64 Fax: (41-61) 906 64 65 kl@vsd.bl.ch
 88/378/EEC  
▼B 
S e c t i o n I I I  
Designating authorities  
European Community:  
Switzerland:  Swiss Federal Office of Public Health  
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, the designating authorities 
shall comply with the general principles contained in Annex 2 and those in 
Annex III to Directive 88/378/EEC.  
S e c t i o n V  
Supplementary provisions  
1. Information concerning the certificate and the technical file  
In accordance with Article 10(4) of Directive 88/378/EEC, the authorities listed 
in section III may obtain on request a copy of the certificate and, on reasoned 
request, a copy of the technical file and the reports on the examinations and tests 
carried out.  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 16
 
2. Notification of grounds for refusal by approved bodies  
In accordance with Article 10(5) of Directive 88/378/EEC, the Swiss bodies shall 
inform the Swiss Federal Office of Public Health when refusing to issue an EC 
type-examination certificate. The Federal Office shall likewise notify the Commission of the European Communities thereof.
 
CHAPTER 4  
MEDICAL DEVICES  
▼M1 
S e c t i o n I  
Legislation, regulations and administrative provisions  
Provisions covered by Article 1(2)  
European Community  Council Directive 90/385/EEC of 20 June 1990 on the 
approximation of the laws of the Member States relating to active implantable medical devices, as last amended by Council Directive 93/68/EEC of 
22 July 1993 (OJ L 220, 30.8.1993, p. 1) 
Council Directive 93/42/EEC of 14 June 1993 
concerning medical devices, as last amended by 
Directive 2001/104/EC of the European Parliament 
and of the Council of 7 December 2001 (OJ L 6, 10.1.2002, p. 50) 
Directive 98/79/EC of the European Parliament and of 
the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1)
 
Switzerland  Federal Law of 15 December 2000 on medicinal 
products and medical devices (RO 2001 2790) 
Federal Law of 24 June 1902 concerning the electrical 
weak and heavy current installations (RO 19 252 et RS 4 798), as last amended on 18 June 1999 (RO 
1999 3071) 
Federal Law of 9 June 1977 on metrology (RO 1977 
2394), as last amended on 18 June 1993 (RO 1993 
3149) 
Federal law of 22 March 1991 on radiation protection 
(RO 1994 1993) 
Ordinance of 17 October 2001 on medical devices (RO 
2001 3487)
 
▼B 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the 
Agreement, a list of the conformity assessment bodies.  
▼M1 
S e c t i o n I I I  
Designating authorities  
European Community:  
— Belgium:  Ministère de la Santé Publique, de l'Environment et 
de l'Intégration Sociale. Inspection Pharmaceutique/ 
Ministerie van Volksgenzondheid, Leefmilieu en 
Sociale Integratie. Farmaceutische Inspectie 
Ministère des Affaires Economiques/Ministerie van 
Economische Zaken  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 17
 
— Denmark:  Sundhedsministeriet, Sundhedsstyrelsen  
— Germany:  Bundesministerium für Gesundheit  
— Greece:  Ministry of Health  
— Spain:  Ministerio Sanidad y Consumo  
— France:  Agence francaise de securité sanitaire des produits de 
santé (AFSSAPS) 
Ministère de l'Economie, des Finances et de l'In ­
dustrie. Direction générale de l'industrie, des tech ­
nologies de l'information et des postes (DIGITIP) — 
SIM 
— Ireland:  Department of Health  
— Italy:  Ministero della Sanità  
— Luxembourg:  Ministère de la Santé  
— Netherlands:  Ministerie van Volksgezondheid, Welzijn en Sport; 
inspectie Volksgezondheid  
— Austria:  Bundesministerium für soziale Sicherheit und Gener ­
ationen  
— Portugal:  Ministerio da Saude  
— Finland:  Sosiaali- ja terveysministeriö/Social- och hälsovårds ­
ministeriet  
— Sweden:  Under the authority of the Government of Sweden: 
Styrelsen för ackreditering och teknisk kontroll 
(SWEDAC)  
— United Kingdom:  Department of Health, Medical Devices Agency  
Switzerland:  Swissmedic, Swiss Agency for Therapeutic Products  
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies 
listed in Section II  
For the designation of conformity assessment bodies, the designating authorities 
shall comply with the general principles contained in Annex 2 to this Agreement 
and those in Annex XI to Directive 93/42/EEC, in Annex VIII to Directive 
90/385/EEC and in Annex IX to Directive 98/79/EC, in respect of the bodies designated under those Directives.
 
S e c t i o n V  
Additional provisions  
1. Registration of the person responsible for placing devices on the market  
Any manufacturer who places on the market of one of the Parties the medical 
devices referred to in Article 14 of Directive 93/42/EEC or Article 10 of 
Directive 98/79/EC shall inform the competent authorities of the Party in which he has his registered place of business of the particulars referred to in those Articles. The Parties shall reciprocally recognise that registration. The 
manufacturer shall not be obliged to designate a person responsible for placing 
devices on the market established in the territory of the other Party.
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 18
 
2. Labelling of medical devices  
Manufacturers of both Parties shall indicate their name or trade name and address 
on the label of medical devices specified in Annex 1, point 13.3(a) to Directive 
93/42/EEC and  in vitro  diagnostic medical devices specified in Annex 1, point 
8.4(a), to Directive 98/79/EC. They shall not be obliged to indicate the name and address of the person responsible for placing the device on the market, of the 
representative or of the importer established within the territory of the other Party 
on the label, outer packaging or instructions for use.
 
3. Information exchange  
In accordance with Article 9 of the Agreement, the Parties shall in particular 
exchange the information referred to in Article 8 of Directive 90/385/EEC, 
Article 10 of Directive 93/42/EEC and Article 11 of Directive 98/79/EC.  
4. European databank  
The competent Swiss authorities shall have access to the European databanks 
established under Article 12 of Directive 98/79/EC and Article 14a of Directive 
93/42/EEC. They shall transmit to the Commission and/or body responsible for managing the databank the data provided for in those Articles collected in Swit ­
zerland for entry into the European databank.
 
▼B 
CHAPTER 5  
GAS APPLIANCES AND BOILERS  
▼M1 
S e c t i o n I  
Legislation, regulations and administrative provisions  
Provisions covered by Article 1(1)  
European Community  Council Directive 92/42/EEC of 21 May 1992 on 
efficiency requirements for new hot-water boilers 
fired with liquid or gaseous fuels (OJ L 167, 
22.6.1992, p. 17), as subsequently amended  
Switzerland  Ordinance of 16 December 1985 on Air Pollution 
Control (OAPC) (Annexes 3 and 4) (RS 
814.318.142.1), as subsequently amended  
Provisions covered by Article 1(2)  
European Community  Council Directive 90/396/EEC of 29 June 1990 on the 
approximation of the laws of the Member States 
relating to appliances burning gaseous fuels, as last amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 1993, p. 1)
 
▼M13  
Switzerland  101. Federal Law of 12 June 2009 on product safety 
(RO 2010 2573)  
102. Ordinance of 19 May 2010 on product safety 
(RO 2010 2583)  
▼B 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the 
Agreement, a list of the conformity assessment bodies.  ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 19
 
S e c t i o n I I I  
Designating authorities  
European Community:  
— Belgium:  Ministère des Affaires Economiques/Ministerie van 
Economische Zaken  
— Denmark:  Økonomi- og Erhvervsministeriet; Danmarks 
Gasmateriel Prøvning  
— Germany:  Bundesministerium für Arbeit und Sozialordung  
— Greece:  Υπουργείο  Ανάπτυξης . Γενική  Γραμματεία  
Βιομηχανίας  (Ministry of Development. General 
Secretariat of Industry)  
— Spain:  Ministerio de Ciencia y Tecnología  
— France:  Ministère de l'Economie, des Finances et de l'In ­
dustrie, Direction de l'Action Régionale et de la 
Petite et Moyenne Industrie (DARPMI). Sous- direction de la sécurité industrielle
 
— Ireland:  Department of Enterprise and Employment  
— Italy:  Ministero delle Attività Produttive  
— Luxembourg:  Ministère du Travail (Inspection du Travail et des 
Mines)  
— Netherlands:  Ministerie van Economische Zaken  
— Austria:  Bundesministerium für Wirtschaft und Arbeit  
— Portugal:  Under the authority of the Government of Portugal: 
Instituto Português da Qualidade  
— Finland:  Kauppa- ja teollisuusministeriö/Handels- och industri ­
ministeriet  
— Sweden:  Under the authority of the Government of Sweden: 
Styrelsen för ackreditering och teknisk kontrol 
(SWEDAC)  
— United Kingdom:  Department of Trade and Industry. Department for 
Environment, Food & Rural Affairs  
Switzerland:  Provisions covered by Article 1(1) 
Swiss Agency for the Environment, Forests and 
Landscape 
Provisions covered by Article 1(2) 
State Secretariat for Economic Affairs  
▼B 
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, the designating authorities 
shall comply with the general principles contained in Annex 2 to this Agreement and those in Annex V to Directive 92/42/EEC, in respect of the bodies 
designated under that Directive, and in Annex V to Directive 90/396/EEC, in 
respect of the bodies designated thereunder.
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 20
 
CHAPTER 6  
PRESSURE VESSELS  
▼M1 
S e c t i o n I  
Legislation, regulations and administrative provisions  
Provisions covered by Article 1(1)  
▼M13  
European Union  1. Directive 2010/35/EU of the European 
Parliament and of the Council of 16 June 2010 on transportable pressure equipment and 
repealing Council Directives 76/767/EEC, 84/ 
525/EEC, 84/526/EEC, 84/527/EEC and 1999/ 36/EC (OJ L 165, 30.6.2010, p. 1).
 
Switzerland  102. Federal Law of 12 June 2009 on product safety 
(RO 2010 2573)  
103. Ordinance of 19 May 2010 on product safety 
(RO 2010 2583)  
104. Ordinance of 20 November 2002 on the safety 
of simple pressure vessels (RO 2003 38), as last amended on 19 May 2010 (RO 2010 2583)
 
105. Ordinance of 20 November 2002 on the safety 
of pressure equipment (RO 2003 38), as last amended on 19 May 2010 (RO 2010 2583)
 
▼B 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the 
Agreement, a list of the conformity assessment bodies.  
▼M5 
Atest  
Contrôles et essais métallurgiques SA  
Route de Vevey 55A  
CH-1618 Châtel-St-Denis  
Tel. (41) (0) 21 948 24 40  
Fax (41) (0) 21 948 24 48  
E-mail: admin@atest.ch  
Schweizerische Gesellschaft für Zerstörungsfreie Prüfung (SGZP)  
c/o EMPA  
Überlandstrasse 129  
CH-8600 Dübendorf  
Tel. (41) (0) 61 317 84 21  
Fax (41) (0) 61 317 84 80  
E-mail: blumhofer.pw@svsxass.ch  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 21
 
S e c t i o n I I I  
Designating authorities  
European Community:  
— Belgium:  Ministère de l'Emploi et du Travail/Ministerie voor 
Arbeid en Tewerkstelling  
— Denmark:  Arbejdsministeriet, Arbejdstilsynet  
— Germany:  Bundesministerium für Arbeit und Sozialordnung  
— Greece:  Ministry of Development. General Secretariat of 
Industry  
— Spain:  Ministerio de Ciencia y Tecnología  
— France:  Ministère de l'Economie, des Finances et de l'In ­
dustrie, Direction de l'action régionale et de la petite 
et moyenne industrie (DARPMI). Sous-direction de la sécurité industrielle
 
— Ireland:  Department of Enterprise and Employment  
— Italy:  Ministero dell'Industria, del Commercio e dell'Arti ­
gianato  
— Luxembourg:  Ministère du Travail et de l'Emploi  
— Netherlands:  Minister van Sociale Zaken en Werkelegenheid  
— Austria:  Bundesministerium für Wirtschaft und Arbeit  
— Portugal:  Under the authority of the Government of Portugal: 
Instituto Português da Qualidade  
— Finland:  Kauppa- ja teollisuusministeriö/Handels- och industri ­
ministeriet  
— Sweden:  Under the authority of the Government of Sweden: 
Styrelsen för ackreditering och teknisk kontroll 
(SWEDAC)  
— United Kingdom:  Department of Trade and Industry  
Switzerland:  State Secretariat for Economic Affairs  
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, the designating authorities 
shall comply with the general principles contained in Annex 2 and those in 
Annex III to Directive 87/404/EEC or Annexes IV or V to Directive 97/23/EC.  
S e c t i o n V  
Additional provisions  
1. Recognition of certificates by Switzerland  
Where the provisions of Swiss legislation listed in Section I lay down a 
conformity assessment procedure, Switzerland shall recognise certificates issued by a designated Community body listed in Section II which certifies that the product conforms to either Directive 87/404/EEC or Directive 97/23/EC.
 
2. Technical documentation  
It shall be sufficient for manufacturers, their authorised representatives or the 
person responsible for placing products on the market to hold the technical documents required by the national authorities for inspection purposes at their 
disposal in the territory of one of the Parties for a period of at least ten years 
after the last date of manufacture of the product.
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 22
 
The Parties hereby undertake to forward all relevant documents at the request of 
the authorities of the other Party.  
CHAPTER 7  
RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL 
EQUIPMENT  
S e c t i o n I  
Legislation, regulations and administrative provisions  
Provisions covered by Article 1(2)  
European Community  Directive 1999/5/EC of the European Parliament and of 
the Council of 9 March 1999 on radio equipment and 
telecommunications terminal equipment and the mutual recognition of their conformity (OJ L 91, 7.4.1999, p. 10). 
Commission Decision of 6 April 2000 establishing the 
initial classification of radio equipment and telecom ­
munications terminal equipment and associated identifiers (OJ L 97, 19.4.2000, p. 13) 
Commission Decision of 22 September 2000 on the 
application of Article 3(3)(e) of Directive 1999/5/EC 
to radio equipment covered by the regional arrangement concerning radiotelephone service on inland waterways (OJ L 269, 21.10.2000, p. 50) 
Commission Decision of 22 September 2000 on the 
application of Article 3(3)(e) of Directive 1999/5/EC 
to marine radio communication equipment intended to be fitted to seagoing non-SOLAS vessels and which is intended to participate in the global maritime distress 
and safety system (GMDSS) and not covered by 
Council Directive 96/98/EC on marine equipment (OJ L 269, 21.10.2000, p. 52) 
Commission Decision of 21 February 2001 on the 
application of Article 3(3)(e) of Directive 1999/5/EC 
to avalanche beacons (OJ L 55, 24.2.2001, p. 65)
 
▼M13  
Switzerland  100. Federal Law of 30 April 1997 on telecommuni ­
cations (LTC); (RO 1997 2187), as last amended on 12 June 2009 (RO 2010 2617)
 
101. Ordinance of 14 June 2002 on telecommuni ­
cations equipment (OIT); (RO 2002 2086), as last amended on 18 November 2009 (RO 2009 
6243)
 
102. Ordinance of 14 June 2002 of the Federal Office 
of Communications (OFCOM) on telecommuni ­
cations equipment; (RO 2002 2111), as last amended on 7 April 2011 (RO 2011 1391)
 
103. Annex 1 to the OFCOM Ordinance on telecom ­
munications equipment (RO 2002 2115), as last 
amended on 21 November 2005 (RO 2005 5139)  
104. List of technical standards published in the 
Feuille Fédérale with titles and references, as last amended on 3 May 2011 (FF 2011 0799)
 
105. Ordinance of 9 March 2007 on telecommuni ­
cation services (RO 2007 945), as last amended on 4 November 2009 (RO 2009 5821)
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 23
 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the 
Agreement, a list of the conformity assessment bodies.  
▼M1 
S e c t i o n I I I  
Designating authorities  
European Community:  
— Belgium:  Institut belge des services postaux et des télécom ­
munications 
Belgisch Instituut voor Postdiensten en Telecommuni ­
catie  
— Denmark:  Ministeriet for Videnskab, Teknologi og Udvikling, 
IT- og Telestyrelsen  
— Germany:  Bundesministerium für Wirtschaft und Technologie  
— Greece:  Ministry of Transport  
— Spain:  Ministerio de Ciencia y Tecnología  
— France:  Ministère de l'Economie, des Finances et de l'Industrie 
Direction Générale de l'Industrie, des Technologies de 
l'Information et des Postes (DIGITIP), STSI  
— Ireland:  Department of Transport, Energy and Communica ­
tions  
— Italy:  Ministero delle Comunicazione (aspects CEM) 
Ministero dell'Industria, del Commercia e dell'Arti ­
gianato  
— Luxembourg:  Ministère des Transports (aspects CEM) Adminis ­
tration des Postes et Télécommunications  
— Netherlands:  Ministerie van Economische Zaken  
— Austria:  Bundesministerium für Verkehr, Innovation und Tech ­
nologie  
— Portugal:  Instituto das Communicações de Portugal  
— Finland:  Liikenne- ja viestintäministeriö/Kommunikationsmin ­
isteriet  
— Sweden:  Under the authority of the Government of Sweden: 
Styrelsen för ackreditering och teknisk kontrol 
(SWEDAC)  
— United Kingdom:  Department of Trade and Industry  
Switzerland:  Federal Office for communications  
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, designating authorities shall 
comply with the general principles contained in Annex 2 to this Agreement and 
those in Annex VI to Directive 1999/5/EC.  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 24
 
S e c t i o n V  
Additional provisions  
1. TCAM  
Switzerland shall participate as observer in TCAM work and that of its 
subgroups.  
2. Market surveillance  
The Parties shall notify each other of the authorities established on their territory 
responsible for carrying out the surveillance tasks involved in the implementation 
of their legislation as set out in Section I.  
The Parties shall notify each other of their market surveillance activities within 
the bodies designated for this purpose.  
3. Regulated interfaces  
The Parties shall inform each other of the interfaces they have regulated on their 
territory. When establishing the equivalence of notified interfaces and deter ­
mining equipment class identifiers, the European Community shall take 
account of the interfaces regulated in Switzerland.  
4. Interfaces offered by public telecommunications network operators  
The Parties shall inform each other of interfaces offered on their territory by 
public telecommunications network operators.  
5. Application of essential requirements  
When the Commission intends to adopt a decision to apply a requirement set in 
Article 3(3) of Directive 1999/5/EC, it shall consult Switzerland on the issue before submitting it formally to the Committee.
 
When Switzerland intends to adopt a technical and administrative regulation to 
apply a requirement set in Article 7.4 of the Ordinance on Telecommunications 
Equipment, it shall consult the Commission on the issue before submitting it formally to the Committee.
 
6. Authorisation to disconnect  
Where one of the Parties considers that apparatus declared to comply with its 
legislation causes serious damage to a network or radioelectric interference, or 
degradation of a network or its operation, and that Party has authorised the operator to refuse connection of the apparatus, disconnect it or withdraw it from service, it shall inform the other Party of this authorisation.
 
7. Harmonised standards  
Where Switzerland considers that compliance with a harmonised standard does 
not guarantee that the essential requirements of its legislation as listed in Section I will be fulfilled, it shall inform the Committee and give its reasons.
 
The Committee shall consider the case and may ask the European Community to 
act in accordance with the procedure provided for in Article 5 of Directive 
1999/5/EC. The Committee shall be informed of the result of the procedure.  
8. Mutual notification concerning radiocommunication equipment which 
conforms to requirements but is not intended for use in the spectrum of one of the parties
 
When either of the Parties adopts any appropriate measure to prohibit or restrict 
the placing on its market and/or require the withdrawal from its market of radio ­
communications equipment, including types of radio equipment which has caused or which it reasonably considers will cause harmful interference, including interference with existing or planned services on nationally allocated 
frequency bands, it shall notify the other party thereof giving its reasons and 
naming the countries concerned.
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 25
 
9. Safeguard clause relating to industrial products  
9.1. Where either of the Parties takes a measure to prohibit the placing of its 
market of a telecommunications installation declared to be in compliance 
with Directive 1999/5/EC, it shall immediately inform the other party, giving the reasons for its decision and stating how non compliance was established.
 
9.2. The Parties shall consider the measure and the evidence presented to them 
and shall notify each other of the results of their investigations.  
9.3. If the parties agree regarding the results of their investigations they shall 
take the appropriate measures to ensure that such products are not placed on the market.
 
9.4. If the Parties disagree regarding the results of their investigations, the case 
shall be forwarded to the Committee, which may decide to have an expert 
study carried out.  
9.5. Where the Committee considers that the measure is  
(a) unjustified, the national authority of the Party which took the measure 
shall withdraw it;  
(b) justified, they shall take the appropriate measures to ensure that 
products are not placed on the market  
▼B 
CHAPTER 8  
EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN 
POTENTIALLY EXPLOSIVE ATMOSPHERES  
▼M1 
S e c t i o n I  
Legislation, regulations and administrative provisions  
Provisions covered by Article 1(2)  
European Community  Directive of the European Parliament and the Council 
of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and 
protective systems intended for use in potentially 
explosive atmospheres (94/9/EC) (OJ L 100, 19.4.1994, p. 1) 
Council Directive 76/117/EEC of 18 December 1975 
on the approximation of the laws of the Member 
States concerning electrical equipment for use in 
potentially explosive atmospheres (OJ L 24, 30.1.1976, p. 45) 
Council Directive 79/196/EEC of 6 February 1979 on 
the approximation of the laws of the Member States 
concerning electrical equipment for use in potentially explosive atmospheres employing certain types of protection, as last amended by Commission 
Directive 97/53/EC of 11 September 1997 (OJ 
L 257, 20.9.1997, p. 27) 
Council Directive 82/130/EEC of 15 February 1982 
on the approximation of the laws of the Member States concerning electrical equipment for use in 
potentially explosive atmospheres in mines 
susceptible to firedamp, as last amended by Commission Directive 98/65/EC of 3 September 1998 (OJ L 257, 19.9.1998, p. 29)
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 26
 
Switzerland  100. Federal Law of 24 June 1902 concerning the 
electrical weak and heavy current installations 
(RO 19 252 and RS 4 798), as last amended on 
20 March 2008 (RO 2008 3437)  
101. Ordinance of 2 March 1998 on the safety of 
equipment and protective systems intended for use in potentially explosive atmospheres (RO 1998 963), as last amended on 11 June 2010 
(RO 2010 2749)
 
102. Federal Law of 12 June 2009 on product safety 
(RO 2010 2573)  
103. Ordinance of 19 May 2010 on product safety 
(RO 2010 2583)  
▼B 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the 
Agreement, a list of the conformity assessment bodies.  
▼M3 
QS SCHAFFHAUSEN AG  
Wiesengasse, 20  
8222 Beringen  
Switzerland  
Tel. (41) 52 687 20 10  
Fax (41) 52 682 18 02  
▼M1 
S e c t i o n I I I  
Designating authorities  
European Community:  
— Belgium:  Ministère des Affaires Economiques/Ministerie van 
Economische Zaken  
— Denmark:  For electrical aspects: 
Økonomi- og Erhvervsministeriet, Elektricitetsrådet For mechanical aspects: Arbejdsministeriet, Arbejdstilsynet
 
— Germany:  Bundesministerium für Arbeit und Sozialordnung  
— Greece:  Υπουργείο  Ανάπτυξης . Γενική  Γραμματεία  Βιομηχανίας  
(Ministry of Development. General Secretariat of Industry)
 
— Spain:  Ministerio de Ciencia y Tecnología  
— France:  Ministère de l'Economie, des Finances et de l'Industrie, 
Direction de l'Action Régionale et de la Petite et Moyenne Industrie (DARPMI), Sous-direction de la sécurité industrielle
 
— Ireland:  Department of Enterprise and Employment  
— Italy:  Ministero dell'Industria, del Commercio e dell'Artigianato  
— Luxembourg:  Ministère de l'Economie — Service de l'Energie de l'Etat  ▼M13  2002A5430 — EN — 20.12.2011 — 001.001 — 27
 
— Netherlands:  Ministerie van Sociale Zaken en Werkgelegenheid  
— Austria:  Bundesministerium für Wirtschaft und Arbeit  
— Portugal:  Under the authority of the Government of Portugal: 
Instituto Português da Qualidade  
— Finland:  Kauppa- ja teollisuusministeriö/Handels- och industri ­
ministeriet  
— Sweden:  Under the authority of the Government of Sweden: 
Styrelsen för ackreditering och teknisk kontroll 
(SWEDAC)  
— United Kingdom:  Department of Trade and Industry  
Switzerland:  Federal Office of Energy  
▼B 
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, designating authorities shall 
comply with the general principles contained in Annex 2 and those in Annex XI to Directive 94/9/EC.
 
S e c t i o n V  
Supplementary provisions  
1. Information exchange  
The conformity assessment bodies listed in section II shall provide the Member 
States, the competent Swiss authorities and/or the other conformity assessment 
bodies with the information provided for in Article 9(2) of Directive 
76/117/EEC.  
2. Technical documentation  
It shall be sufficient for manufacturers, their authorised representatives or the 
person responsible for placing products on the market to hold the technical documents required by the national authorities for inspection purposes at their disposal in the territory of one of the Parties for a period of at least ten years 
after the last date of manufacture of the product.
 
The Parties hereby undertake to forward all relevant technical documents at the 
request of the authorities of the other Party.  
CHAPTER 9  
ELECTRICAL EQUIPMENT AND ELECTROMAGNETIC COMPATI ­
BILITY  
▼M1 
S e c t i o n I  
Legislation, regulations and administrative provisions  
Provisions covered by Article 1(2)  
European Community  Council Directive 73/23/EEC of 19 February 1973 on 
the approximation of the laws of the Member States 
relating to electrical equipment designed for use within 
certain voltage limits (OJ L 77, 26.3.1973, p. 29), as last amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1) 
Council Directive 89/336/EEC of 3 May 1989 on the 
approximation of the laws of the Member States 
relating to electromagnetic compatibility, as last amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1)
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 28
 
Switzerland  100. Federal Law of 24 June 1902 concerning the 
electrical weak and heavy current installations (RO 19 252 and RS 4 798), as last amended 
on 20 March 2008 (RO 2008 3437)
 
101. Ordinance of 30 March 1994 on electrical weak 
current installations (RO 1994 1185), as last amended on 18 November 2009 (RO 2009 6243)
 
102. Ordinance of 30 March 1994 on electrical heavy 
current installations (RO 1994 1199), as last 
amended on 8 December 1997 (RO 1998 54)  
103. Ordinance of 9 April 1997 on electrical low 
voltage equipment (RO 1997 1016), as last amended on 11 June 2010 (RO 2010 2749)
 
104. Ordinance of 18 November 2009 on electrom ­
agnetic compatibility (RO 2009 6243), as last 
amended on 24 August 2010 (RO 2010 3619)  
105. Ordinance of 14 June 2002 on telecommuni ­
cations equipment (OIT); (RO 2002 2086), as last amended on 18 November 2009 (RO 2009 6243)
 
▼B 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.
 
▼M1 
S e c t i o n I I I  
Designating authorities  
European Community:  
— Belgium:  Ministère des Affaires Economiques/Ministerie van 
Economische Zaken  
— Denmark:  For electrical aspects: 
Økonomi- og Erhvervsministeriet, Elektricitetsrådet For EMC aspects: 
Ministeriet for Videnskab, Teknologi og Udvikling, 
IT- og Telestyrelsen
 
— Germany:  For electrical aspects: 
Bundesministerium für Arbeit und Sozialordung For EMC aspects: Bundesministerium für Wirtschaft und Technologie
 
— Greece:  Υπουργείο  Ανάπτυξης . Γενική  Γραμματεία  
Βιομηχανίας  (Ministry of Development. General 
Secretariat of Industry)  
— Spain:  Ministerio de Ciencia y Tecnología  
— France:  Ministère de l'Economie, des Finances et de l'In ­
dustrie. Direction Générale de l'Industrie, des Tech ­
nologies de l'Information et des Postes (DIGITIP) — SQUALPI
 ▼M13  2002A5430 — EN — 20.12.2011 — 001.001 — 29
 
— Ireland:  Department of Enterprise and Employment  
— Italy:  Ministero delle Attività Produttive  
— Luxembourg:  Ministère de l'Economie — Service de l'Energie de 
l'Etat 
Ministère du Travail (Inspection du Travail et des 
Mines)  
— Netherlands:  For electrical aspects: 
Minister van Volksgezondheid, Welzijn en Sport 
(consumer goods). Minister van Sociale Zanken en Werkgelegenheid (others) 
For EMC aspects: Ministerie van Verkeer en Waterstaat
 
— Austria:  Bundesministerium für Wirtschaft und Arbeit  
— Portugal:  Under the authority of the Government of Portugal: 
Instituto Português da Qualidade  
— Finland:  Kauppa- ja teollisuusministeriö/Handels- och industri ­
ministeriet 
For EMC aspects of telecommunications and radio 
equipment: 
Liikenne-javiestintäministeriö/Kommunikatiosminis ­
teriet  
— Sweden:  Under the authority of the Government of Sweden: 
Styrelsen för ackreditering och teknisk kontrol 
(SWEDAC)  
— United Kingdom:  Department of Trade and Industry  
Switzerland:  Federal Office of Energy 
Federal Office for Communications (for EMC aspects 
of radio- and telecommunications terminal equipment)  
▼B 
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, designating authorities shall 
comply with the general principles contained in Annex 2 and those in Annex II 
to Directive 89/336/EEC.  
S e c t i o n V  
Supplementary provisions  
1. Technical documentation  
It shall be sufficient for manufacturers, their authorised representatives or the 
person responsible for placing products on the market to hold the technical documents required by the national authorities for inspection purposes at their 
disposal in the territory of one of the Parties for a period of at least ten years 
after the last date of manufacture of the product.
 
The Parties hereby undertake to forward all relevant documents at the request of 
the authorities of the other Party.  ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 30
 
2. Standardisation bodies  
In accordance with Article 11 of Directive 73/23/EEC, the Parties shall notify 
each other of the bodies responsible for drawing up the standards referred to in 
Article 5 of this Directive.  
3. Competent bodies  
The Parties shall inform each other of and mutually recognise the bodies made 
responsible for drawing up technical reports and/or certificates pursuant to 
Article 8(2) of Directive 73/23/EEC and Article 10(2) of Directive 89/336/EEC.  
4. Special measures  
In accordance with Article 6(2) of Directive 89/336/EEC, each Party shall inform 
the other of the special measures taken pursuant to paragraph 1 of that Article.  
5. Competent authorities  
In accordance with Article 10(6) of Directive 89/336/EEC, each Party shall notify 
the other of the competent authorities referred to in that Article.  
CHAPTER 10  
CONSTRUCTION PLANT AND EQUIPMENT  
▼M1 
S e c t i o n I  
Legislation, regulations and administrative provisions  
Provisions covered by Article 1(1)  
European Community  Directive 2000/14/EC of the European Parliament and 
of the Council of 8 May 2000 on the approximation 
of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L No 162, 3.7.2000, p. 1)
 
Switzerland  No legislation  
▼B 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the 
Agreement, a list of the conformity assessment bodies.  
▼M1 
S e c t i o n I I I  
Designating authorities  
European Community:  
— Belgium:  Ministère de l'Emploi et du Travail/Ministerie voor 
Arbeid en Tewerkstelling  
— Denmark:  National Agency for Enterprise and Housing  
— Germany:  
— Greece:  Ministry of Environment and Public Works  
— Spain:  Ministerio de Ciencia y Tecnología 
Ministerio de Fomento  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 31
 
— France:  
— Ireland:  
— Italy:  
— Luxembourg:  
— Netherlands:  Minister van Volkshuisvesting, Ruimtelijke Ordening 
en Milieu  
— Austria:  Bundesministerium für Wirtschaft und Arbeit  
— Portugal:  
— Finland:  Ympäristöministeriö/Miljöministeriet  
— Sweden:  For Directive 2000/14/EC, under the Government of 
Sweden: 
Styrelsen för ackreditering och teknisk kontroll  
— United Kingdom:  Department of Trade and Industry  
Switzerland:  Swiss Agency for the Environment, Forests and Land ­
scape  
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, designating authorities shall 
comply with the general principles contained in Annex 2 and those in Annex IX to Directive 2000/14/EC of the European Parliament and the Council.
 
▼B 
CHAPTER 11  
MEASURING INSTRUMENTS AND PREPACKAGES  
▼M7 
S e c t i o n I  
Legislative, regulatory and administrative provisions  
Provisions covered by Article 1 paragraph 1  
European Community  Council Directive of 12 October 1971 on the approxi ­
mation of the laws of the Member States relating to the measuring of the standard mass per storage volume of grain (71/347/EEC) (OJ L 239, 25.10.1971, p. 1), as 
subsequently amended 
Council Directive of 12 October 1971 on the approxi ­
mation of the laws of the Member States relating to the calibration of the tanks of vessels (71/349/EEC) (OJ L 239, 25.10.1971, p. 15), as subsequently amended 
Council Directive of 27 July 1976 on the approximation 
of the laws of the Member States relating to alcoholo ­
meters and alcohol hydrometers (76/765/EEC) (OJ L 262, 27.9.1976, p. 143), as subsequently amended 
Council Directive of 26 May 1986 on the approxi ­
mation of the laws of the Member States relating to 
tyre pressure gauges for motor vehicles (86/217/EEC) (OJ L 152, 6.6.1986, p. 48), as subsequently amended 
Council Directive of 19 December 1974 on the approxi ­
mation of the laws of the Member States relating to the 
making-up by volume of certain pre-packaged liquids 
(75/106/EEC) (OJ L 42, 15.2.1975, p. 1), as subsequently amended
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 32
 
Council Directive of 19 December 1974 on the approxi ­
mation of the laws of the Member States relating to bottles used as measuring containers (75/107/EEC) (OJ L 42, 15.2.1975, p. 14), as subsequently amended 
Council Directive of 20 January 1976 on the approxi ­
mation of the laws of the Member States relating to the making-up by weight or by volume of certain pre- packaged products (76/211/EEC) (OJ L 46, 21.2.1976, 
p. 1), as subsequently amended 
Council Directive of 15 January 1980 on the approxi ­
mation of the laws of the Member States relating to the ranges of nominal quantities and nominal capacities permitted for certain pre-packaged products (80/232/ 
EEC) (OJ L 51, 25.2.1980, p. 1), as subsequently 
amended
 
Switzerland  Ordinance of 8 June 1998 concerning the measurement 
and declaration of quantities of goods in trade (RS 
941.281), as subsequently amended 
Ordinance of 12 June 1998 on technical provisions 
concerning the declaration of quantities on industrial 
pre-packages (RS 941.281.1), as subsequently amended  
Provisions covered by Article 1 paragraph 2  
European Community  Council Directive of 31 March 2004 on measuring 
instruments (2004/22/EC) (OJ L 135, 30.4.2004) as subsequently amended 
Directive 1999/103/EC of the European Parliament and 
of the Council of 24 January 2000 amending Council 
Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement (OJ L 34, 9.2.2000, 
p. 17) 
Council Directive of 26 July 1971 on the approximation 
of the laws of the Member States relating to common provisions for both measuring instruments and methods of metrological control (71/316/EEC), as last amended 
by Council Directive 88/665/EEC of 21 December 1988 
(OJ L 382, 31.12.1988, p. 42) 
Council Directive of 26 July 1971 on the approximation 
of the laws of the Member States relating to 5 to 50 
kilo medium accuracy rectangular bar weights and 1 to 
10 kilo medium accuracy cylindrical weights (71/317/ EEC) (OJ L 202, 6.9.1971, p. 14) 
Council Directive of 4 March 1974 on the approxi ­
mation of the laws of the Member States relating to 
weights from 1 mg to 50 kg of above medium- 
accuracy (74/148/EEC) (OJ L 84, 28.3.1974, p. 3) 
Council Directive of 27 July 1976 on the approximation 
of the laws of the Member States relating to alcohol 
tables (76/766/EEC) (OJ L 262, 27.9.1976, p. 149)
 
▼M13  
Switzerland  102. Federal Law of 9 June 1977 on metrology (RO 
1977 2394), as last amended on 18 June 2010 (RO 2010 5003)
 
103. Ordinance of 23 November 1994 on units 
measurement (RO 1994 3109)  
104. Ordinance of 15 February 2006 concerning 
measuring instruments (RO 2006 1453), as last amended on 8 September 2010 (RO 2010 4489)
 ▼M7 2002A5430 — EN — 20.12.2011 — 001.001 — 33
 
105. Ordinance of the Federal Ministry of Justice and 
Police of 16 April 2004 on non-automatic weighing instruments (RO 2004 2093), as last amended on 2 October 2006 (RO 2006 4189)
 
106. Ordinance of the Federal Ministry of Justice and 
Police of 19 March 2006 on measuring instruments of length (RO 2006 1433)
 
107. Ordinance of the Federal Ministry of Justice and 
Police of 19 March 2006 on measure of volume (RO 2006 1525)
 
108. Ordinance of the Federal Ministry of Justice and 
Police of 19 March 2006 on measuring systems for liquids other than water (RO 2006 1533), as last amended on 5 October 2010 (RO 2010 4595)
 
109. Ordinance of the federal Ministry of Justice and 
Police of 19 March 2006 on automatic weighing instruments (RO 2006 1545)
 
110. Ordinance of the Federal Ministry of Justice and 
Police of 19 March 2006 on instruments for thermal energy (RO 2006 1569)
 
111. Ordinance of the Federal Ministry of Justice and 
Police of 19 March 2006 on measuring instruments for gas quantities (RO 2006 1591)
 
112. Ordinance of the Federal Ministry of Justice and 
Police of 19 March 2006 on measuring instruments for exhaust gases of combustion 
engines (RO 2006 1599)
 
113. Ordinance of the Federal Ministry of Justice and 
Police of 19 March 2006 on measuring 
instruments for the electrical energy and power 
(RO 2006 1613)  
114. Ordinance of 15 August 1986 on weights (RO 
1986 2022), as last amended on 2 October 2006 
(RO 2006 4193)  
▼M7 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the 
Agreement, a list of the conformity assessment bodies.  
S e c t i o n I I I  
Designating authorities  
Provisions covered by Article 1 paragraph 1  
European Community:  
— Belgium:  Ministère des affaires économiques/Ministerie van 
Economische Zaken  ▼M13  2002A5430 — EN — 20.12.2011 — 001.001 — 34
 
— Denmark:  National Agency for Enterprise and Housing  
— Germany:  
— Greece:  Ministry of Development, General Secretariat of 
Consumer  
— Spain:  Ministerio de Fomento  
— France:  Measuring Instruments: 
Ministère de l'économie, des finances et de l'industrie 
— Direction de l'action régionale et de la petite et moyenne industrie — Sous-direction de la métrologie 
Pre-packages: Ministère de l'économie, des finances et de l'industrie 
— Direction générale de la consommation, de la 
concurrence et de la répression des fraudes
 
— Ireland:  
— Italy:  
— Luxembourg:  
— Netherlands:  Minister van Economische Zaken  
— Austria:  Bundesministerium für Wirtschaft und Arbeit  
— Portugal:  
— Finland:  Kauppa- ja teollisuusministeriö/Handels- och industri ­
ministeriet  
— Sweden:  Under the Government of Sweden: 
Styrelsen för ackreditering och teknisk kontroll For Directive 75/33/CEE and Directive 79/830/CEE: 
Boverket 
For Directive 77/95/CEE: Vägverket
 
— United Kingdom:  Department of Trade and Industry  
Switzerland:  Swiss Federal Office of Metrology (METAS)  
Provisions covered by Article 1 paragraph 2  
European Community:  
— Belgium:  Ministère des affaires économiques/Ministerie van 
Economische Zaken  
— Denmark:  National Agency for Enterprise and Housing  
— Germany:  
— Greece:  Ministry of Development, General Secretariat of 
Consumer  
— Spain:  Ministerio de Fomento  
— France:  
— Ireland:  
— Italy:  
— Luxembourg:  
— Netherlands:  Minister van Economische Zaken  
— Austria:  Bundesministerium für Wirtschaft und Arbeit  ▼M7 2002A5430 — EN — 20.12.2011 — 001.001 — 35
 
— Portugal:  
— Finland:  Kauppa- ja teollisuusministeriö/Handels- och industri ­
ministeriet  
— Sweden:  Under the Government of Sweden: 
Styrelsen för ackreditering och teknisk kontroll 
For Directive 75/33/CEE and Directive 79/830/CEE: 
Boverket 
For Directive 77/95/CEE: Vägverket  
— United Kingdom:  Department of Trade and Industry  
Switzerland:  Swiss Federal Office of Metrology (METAS)  
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, designating authorities shall 
comply with the general principles contained in Annex 2 and those in Annex V to Directive 90/384/EEC and in Article 12 to Directive 2004/22/EC, as regards the products covered by those Directives.
 
S e c t i o n V  
Supplementary provisions  
1. Information exchange  
The conformity assessment bodies listed in section II shall periodically 
provide the Member States and the competent Swiss authorities with the 
information provided for in point 1.5 of Annex II to Directive 90/384/EEC.  
The conformity assessment bodies listed in section II may request the 
information provided for in point 1.6 of Annex II to Directive 90/384/EEC.  
2. Pre-packages  
Switzerland shall recognise checks carried out in accordance with the 
provisions of Community legislation listed in section I by a Community body listed in section II in the case of Community pre-packages placed on the market in Switzerland.
 
As regards statistical checking of the quantities declared on pre-packages, 
the European Community shall recognise the Swiss method laid down in Articles 24 to 40 of the Ordinance on technical provisions concerning the 
declaration of quantities on industrial pre-packages (RS 941.281.1) as 
equivalent to the Community method laid down in Annex II of Directives 75/106/EEC and 76/211/EEC, as amended by Directive 78/891/EEC. Swiss producers whose pre-packages conform to Community legislation and have 
been checked according to the Swiss method shall affix the ‘e’ mark on 
their products exported to the EC.
 
3. Marking  
3.1. For the purposes of this Agreement, the provisions of Directive 71/316/EEC 
shall be read with the following adaptations:  
(a) To the first indent of point 3.1 of Annex 1 and to the first indent of 
point 3.1.1.1 (a) of Annex II, the following shall be added to the text in brackets: ‘CH for Switzerland’.
 
(b) The drawings to which Annex II point 3.2.1 refers, shall be supple ­
mented by the letters necessary for the sign ‘CH’.  
3.2. By the way of derogation from Article 1 of this Agreement, the rules on 
marking for measuring instruments placed on the Swiss market are as 
follows:  
The marking that must be affixed is the CE marking and supplementary 
metrology marking or the national sign of the EC Member State concerned 
as provided in the first indent of point 3.1 of Annex I and the first indent of 
point 3.1.1.1 of Annex II to Directive 71/316/EEC.  ▼M7 2002A5430 — EN — 20.12.2011 — 001.001 — 36
 
4. Measuring instruments covered by Directive 2004/22/EC  
4.1. Information exchange, market surveillance and administrative cooperation  
In accordance with Article 18 of Directive 2004/22/EC, the competent 
authorities of the Member States and Switzerland shall assist each other 
in the fulfilment of their obligations to carry out market surveillance.  
In particular, the competent authorities shall exchange:  
— information concerning the extent to which instruments they examine 
comply with the provisions of Directive 2004/22/EC, and the results of such examinations,
 
— EC-type examination and design examination certificates and their 
annexes issued by notified bodies as well as additions, amendments and withdrawals relating to certificates already issued,
 
— quality system approvals issued by notified bodies, as well as 
information on quality systems refused or withdrawn,  
— evaluation reports established by notified bodies, when demanded by 
other authorities.  
The Member States and Switzerland shall ensure that all necessary 
information relating to the certificates and quality system approvals is 
made available to bodies they have notified.  
Each Party shall inform the other Party which competent authorities it has 
designated for such an exchange of information.  
4.2. Technical documentation and declaration of conformity  
It shall be sufficient for manufacturers, their authorised representatives or 
the person responsible for placing products on the market to hold the 
technical documentation and declarations of conformity required by the 
national authorities for inspection purposes at their disposal in the territory of one of the Parties for a period of at least 10 years after the last date of manufacture of the product.
 
The Parties hereby undertake to forward all relevant documents at the 
request of the authorities of the other Party.  
▼M12  
CHAPTER 12  
MOTOR VEHICLES  
S e c t i o n I  
Legislative, regulatory and administrative provisions  
Provisions covered by Article 1(2)  
European Union  1. Directive 2007/46/EC of the European 
Parliament and of the Council of 5 September 
2007 establishing a framework for the approval 
of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework 
Directive) (OJ L 263, 9.10.2007, p. 1), as last 
amended by Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 (OJ L 200, 31.7.2009, p. 1), and 
taking into account the acts listed in Annex IV 
to Directive 2007/46/EC, as amended until 14 October 2009 and amendments to the afore ­
mentioned Annex respectively to acts listed 
therein, accepted according to the procedure 
described in Section V, paragraph 1 (hereinafter together referred to as ‘Framework Directive 2007/46/EC’)
 ▼M7 2002A5430 — EN — 20.12.2011 — 001.001 — 37
 
Switzerland  100. Ordinance of 19 June 1995 relating to the 
technical requirements for power-driven trans ­
portation vehicles and their trailers (RO 1995 
4145), as amended until 14 October 2009 (RO 2009 5705) and taking into account amendments accepted according to the 
procedure described in Section V, paragraph 1
 
101. Ordinance of 19 June 1995 relating to the type 
approval of road vehicles (RO 1995 3997), as 
amended until 14 October 2009 (RO 2009 5805) and taking into account amendments accepted according to the procedure described 
in Section V, paragraph 1
 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established pursuant to Article 10 of this Agreement shall draw 
up and keep up-to-date, according to the procedure described in Article 11 of the 
Agreement, a list of the conformity assessment bodies.  
S e c t i o n I I I  
Designating authorities  
The Committee established pursuant to Article 10 of this Agreement shall draw 
up and keep up-to-date a list of the designating authorities notified by the Parties.  
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, the designating authorities 
shall refer to their respective legislative, regulatory and administrative provisions 
as listed in Section I.  
S e c t i o n V  
Supplementary provisions  
The provisions of this Section shall apply exclusively to relations between Swit ­
zerland and the European Union.  
1. Amendments to Annex IV respectively to acts listed in Annex IV to Directive 
2007/46/EC  
The legislation adopted in the European Union and listed in Annex IV to 
Directive 2007/46/EC after 14 October 2009 shall be considered to be part of the provisions covered by Article 1(2) of this Agreement after the accomplishment of the following procedure:
 
(a) without prejudice to Article 12(2) of this Agreement, the European 
Union shall notify Switzerland of the changes to Annex IV to Directive 2007/46/EC respectively to acts listed therein without delay 
after their publication in the  Official Journal of the European Union ;
 
(b) Switzerland shall notify the European Union of the acceptance of the 
new provisions and of the adoption of the corresponding Swiss legis ­
lation before those changes apply in the European Union;  
(c) the changes in the legislative provisions shall be deemed to be included 
in Section I on the date of the notification by Switzerland.  
The Joint Committee will take regular note of the abovementioned changes. 
The introduction of these changes will be made publicly available.  ▼M12  2002A5430 — EN — 20.12.2011 — 001.001 — 38
 
2. Information exchange  
The competent type-approval authorities in Switzerland and the Member 
States shall in particular exchange the information referred to in Article 8(5) 
to (8) of the Framework Directive 2007/46/EC.  
In the event of refusal by Switzerland or a Member State to grant type- 
approval in accordance with Article 8(3) of the Framework Directive 
2007/46/EC, it shall immediately send the other Member States, Switzerland and the Commission a detailed file explaining the reasons for its decision and setting out the evidence for its findings.
 
3. Recognition of vehicle type-approval  
Switzerland shall also recognise vehicle type-approval granted before the 
entry into force of this Agreement in accordance with Council Directive 
70/156/EEC of 6 February 1970 (OJ L 42, 23.2.1970, p. 1), as last amended 
by Commission Directive 2007/37/EC of 21 June 2007 (OJ L 161, 22.6.2007, p. 60), by the authorities responsible for type-approval where that approval is still valid in the European Union.
 
The European Union shall recognise Swiss type-approval where Switzer ­
land’s requirements are deemed to be equivalent to those of the Framework Directive 2007/46/EC.
 
Recognition of Swiss-issued type-approval shall be suspended should Swit ­
zerland fail to adapt its legislation to all the European Union type-approval legislation in force.
 
4. Safeguard clauses  
1. V e h i c l e s , s y s t e m s , c o m p o n e n t s o r s e p a r a t e t e c h n i c a l 
u n i t s i n c o m p l i a n c e w i t h t h e a p p l i c a b l e l e g i s l a t i o n  
1. If a Member State or Switzerland finds that new vehicles, systems, 
components or separate technical units, albeit in compliance with the 
applicable requirements or properly marked, present a serious risk to road safety, or seriously harm the environment or public health, that State may, for a maximum period of 6 months, refuse to register such 
vehicles or to permit the sale or entry into service in its territory of such 
vehicles, components or separate technical units.
 
In such cases, the Member State concerned or Switzerland shall 
immediately notify the manufacturer, the other Member States, Swit ­
zerland and the Commission accordingly, stating the reasons on which its decision is based.
 
2. The Commission and Switzerland shall consult the Parties concerned as 
soon as possible and, in particular, their respective approval authorities that granted the type-approval. The Committee shall be kept informed 
and, where necessary, shall hold appropriate consultations with the view 
to reaching a settlement.
 
2. V e h i c l e s , s y s t e m s , c o m p o n e n t s o r s e p a r a t e t e c h n i c a l 
u n i t s n o t i n c o n f o r m i t y w i t h t h e a p p r o v e d t y p e  
1. If a Member State or Switzerland which has granted a type-approval 
finds that new vehicles, systems, components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the type it has approved, it shall take the necessary 
measures, including, where necessary, the withdrawal of type-approval, 
to ensure that production vehicles, systems, components or separate
 ▼M12  2002A5430 — EN — 20.12.2011 — 001.001 — 39
 
technical units, as the case may be, are brought into conformity with the 
approved type. The approval authority of that Member State or Swit ­
zerland shall advise the approval authorities of the other Member States and/or Switzerland of the measures taken.
 
2. For the purposes of paragraph 1, deviations from the particulars in the 
type-approval certificate or the information package shall be deemed to 
constitute failure to conform to the approved type.  
A vehicle shall not be deemed to deviate from the approved type where 
tolerances are permitted by the relevant regulatory acts and those tolerances are respected.
 
3. If a Member State or Switzerland demonstrates that new vehicles, 
components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the approved type, it may ask the Member State or Switzerland which granted the 
type-approval to verify that vehicles, systems, components or separate 
technical units in production continue to conform to the approved type. On receipt of such a request, the Member State concerned or Swit ­
zerland shall take the requisite action as soon as possible and in any 
case within 6 months of the date of the request.
 
4. The approval authority shall request the Member State or Switzerland 
which granted the system, component, separate technical unit or incomplete vehicle type-approval to take the necessary action to 
ensure that vehicles in production are brought back into conformity 
with the approved type in the following cases:
 
(a) in relation to a vehicle type-approval, where the non-conformity of a 
vehicle is attributable exclusively to the non-conformity of a system, component or separate technical unit;
 
(b) in relation to a multi-stage type-approval, where the non-conformity 
of a completed vehicle is attributable exclusively to the non- conformity of a system, component or separate technical unit being part of the incomplete vehicle, or of the incomplete vehicle 
itself.
 
On receipt of such a request, the Member State concerned or Swit ­
zerland shall take the requisite action, if necessary in conjunction with the Member State making the request or Switzerland, as soon as possible 
and in any case within 6 months of the date of the request. Where a 
failure to conform is established, the approval authority of the Member State or Switzerland which granted the system, component or separate technical unit type-approval or the approval of the incomplete vehicle 
shall take the measures set out in paragraph 1.
 
5. The approval authorities shall inform each other within 20 working days 
of any withdrawal of type-approval and of the reasons therefor.  ▼M12  2002A5430 — EN — 20.12.2011 — 001.001 — 40
 
6. If the Member State or Switzerland that granted type-approval disputes 
the failure to conform notified to it, the Member States concerned and 
Switzerland shall endeavour to settle the dispute. The Committee shall be kept informed and, where necessary, shall hold appropriate consul ­
tations with a view to reaching a settlement.
 
▼B 
CHAPTER 13  
AGRICULTURAL OR FORESTRY TRACTORS  
▼M1 
S e c t i o n I  
Legislation, regulations and administrative provisions  
Provisions covered by Article 1(2)  
European Community  Council Directive 74/150/EEC of 4 March 1974 on the 
approximation of the laws of the Member States 
relating to the type-approval of wheeled agricultural 
or forestry tractors, as last amended by Commission Directive 2001/3/EC of 8 January 2001 (OJ L 28, 30.1.2001, p. 1) 
Council Directive 74/151/EEC of 4 March 1974 on the 
approximation of the laws of the Member States relating to certain parts and characteristics of wheeled 
agricultural or forestry tractors, as last amended by 
Commission Directive 98/38/EC of 3 June 1998, (OJ L 170, 16.6.1998, p. 13) 
Council Directive 74/152/EEC of 4 March 1974 on the 
approximation of the laws of the Member States 
relating to the maximum design speed of and load platforms for wheeled agricultural or forestry tractors, as last amended by Directive 98/89/EC of the European 
Parliament and the Council of 20 November 1998 (OJ 
L 322, 1.12.1998, p. 40) 
Council Directive 74/346/EEC of 25 June 1974 on the 
approximation of the laws of the Member States 
relating to rear-view mirrors for wheeled agricultural or forestry tractors, as last amended by Commission Directive 98/40/EC of 8 June 1998, (OJ L 171, 
17.6.1998, p. 28) and corrigendum (OJ L 351, 
29.12.1998, p. 42) 
Council Directive 74/347/EEC of 25 June 1974 on the 
approximation of the laws of the Member States 
relating to the field of vision and windscreen wipers 
for wheeled agricultural or forestry tractors, as last amended by Directive 97/54/EC of the European 
Parliament and the Council of 23 September 1997 
(OJ L 277, 10.10.1997, p. 24) 
Council Directive 75/321/EEC of 20 May 1975 on the 
approximation of the laws of the Member States 
relating to the steering equipment of wheeled agri ­
cultural or forestry tractors, as last amended by Commission Directive 98/39/EC of 5 June 1998 (OJ L 170, 16.6.1998, p. 15) 
Council Directive 75/322/EEC of 20 May 1975 on the 
approximation of the laws of the Member States relating to the suppression of radio interference produced by spark-ignition engines fitted to wheeled 
agricultural or forestry tractors, as last amended by 
Commission Directive 2001/3/EC of 8 January 2001 (OJ L 28, 30.1.2001, p. 1)
 ▼M12  2002A5430 — EN — 20.12.2011 — 001.001 — 41
 
Council Directive 76/432/EEC of 6 April 1976 on the 
approximation of the laws of the Member States relating to the braking devices of wheeled agricultural or forestry tractors, as last amended by Directive 97/54/ 
EC of the European Parliament and the Council of 23 
September 1997 (OJ L 277, 10.10.1997, p. 24) 
Council Directive 76/763/EEC of 27 July 1976 on the 
approximation of the laws of the Member States 
relating to passenger seats for wheeled agricultural or forestry tractors, as last amended by Directive 99/86/ EC of the European Parliament and the Council of 11 
November 1999 (OJ L 297, 18.11.1999, p. 22) and 
corrigendum (OJ L 87, 8.4.2000, p. 34) 
Council Directive 77/311/EEC of 29 March 1977 on the 
approximation of the laws of the Member States relating to the driver-perceived noise level of wheeled agri ­
cultural or forestry tractors, as last amended by 
Decision 2000/63/EC of the Commission of 18 January 
2000 (OJ L 22, 27.1.2000, p. 66) 
Council Directive 77/536/EEC of 28 June 1977 on the 
approximation of the laws of the Member States relating 
to the roll-over protection structures of wheeled agri ­
cultural or forestry tractors, as last amended by Commission Directive 99/55/EC of 1 June 1999 (OJ 
L 146, 11.6.1999, p. 28) 
Council Directive 77/537/EEC of 28 June 1977 on the 
approximation of the laws of the Member States relating 
to the measures to be taken against the emission of 
pollutants from diesel engines for use in wheeled agri ­
cultural or forestry tractors, as last amended by Directive 97/54/EC of the European Parliament and the Council of 
23 September 1997 (OJ L 277, 10.10.1997, p. 24) 
Council Directive 78/764/EEC of 25 July 1978 on the 
approximation of the laws of the Member States relating 
to the driver's seat on wheeled agricultural or forestry tractors, as last amended by Directive 99/57/EC of the Commission of 7 June 1999 (OJ L 148, 15.6.1999, p. 35) 
Council Directive 78/933/EEC of 17 October 1978 on 
the approximation of the laws of the Member States relating to the installation of lighting and light-signalling 
devices on wheeled agricultural and forestry tractors, as 
last amended by Directive 99/56/EC of the Commission 3 June 1999 (OJ L 146, 11.6.1999, p. 31) 
Council Directive 79/532/EEC of 17 May 1979 on the 
approximation of the laws of the Member States relating to the component type-approval of lighting and light- signalling devices on wheeled agricultural or forestry 
tractors, as last amended by Directive 97/54/EC of the 
European Parliament and the Council of 23 September 1997 (OJ L 277, 10.10.1997, p. 24) 
Council Directive 79/533/EEC of 17 May 1979 on the 
approximation of the laws of the Member States relating to the coupling device and the reverse of wheeled agri ­
cultural or forestry tractors, as last amended by Directive 
99/58/EC of the Commission of 7 June 1999 (OJ L 148, 15.6.1999, p. 37)
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 42
 
Council Directive 79/622/EEC of 25 June 1979 on the 
approximation of the laws of the Member States relating to the roll-over protection structures of wheeled agri ­
cultural or forestry tractors (static testing), as last 
amended by Commission Directive 99/40/EC of 6 May 
1999 (OJ L 124, 18.5.1999, p. 11) 
Council Directive 80/720/EEC of 24 June 1980 on the 
approximation of the laws of the Member States relating 
to the operating space, access to the driving position and 
the doors and windows of wheeled agricultural or forestry tractors, as last amended by Directive 97/54/ EC of the European Parliament and the Council of 23 
September 1997 (OJ L 277, 10.10.1997, p. 24) 
Council Directive 86/297/EEC of 26 May 1986 on the 
approximation of the laws of the Member States relating 
to the power take-offs of wheeled agricultural and 
forestry tractors and their protection, as last amended by Directive 97/54/EC of the European Parliament and the Council of 23 September 1997 (OJ L 277, 
10.10.1997, p. 24) 
Council Directive 86/298/EEC of 26 May 1986 on rear- 
mounted roll-over protection structures of narrow-track 
wheeled agricultural and forestry tractors, as last 
amended by Commission Directive 2000/19/EC of 13 April 2000 (OJ L 94, 14.4.2000, p. 31) 
Council Directive 86/415/EEC of 24 July 1986 on the 
installation, location, operation and identification of the 
controls of wheeled agricultural or forestry tractors, as last amended by Directive 97/54/EC of the European Parliament and the Council of 23 September 1997 (OJ 
L 277, 10.10.1997, p. 24) 
Council Directive 87/402/EEC of 25 June 1987 on roll- 
over protection structures mounted in front of the driver's 
seat on narrow-track wheeled agricultural and forestry 
tractors, as last amended by Commission Directive 2000/22/EC of 28 April 2000 (OJ L 107, 4.5.2000, p. 26) 
Council Directive 89/173/EEC of 21 December 1988 on 
the approximation of the laws of the Member States 
relating to certain components and characteristics of wheeled agricultural or forestry tractors, as last 
amended by Commission Directive 2000/1/EC of 14 
January 2000 (OJ L 21, 26.1.2000, p. 16) 
Directive 2000/25/EC of the European Parliament and of 
the Council of 22 May 2000 on action to be taken against 
the emission of gaseous and particulate pollutants by 
engines intended to power agricultural or forestry tractors and amending Council Directive 74/150/EEC (OJ L 173, 12.7.2000, p. 1)
 
Switzerland  Ordinance of 19 June 1995 relating to the technical 
requirements for agricultural tractors (RO 1995 4171), 
as last amended on 21 August 2002 (RO 2002 3182) 
Ordinance of 19 June 1995 relating to the type approval 
of road vehicles (RO 1995 3997), as last amended on 
6 September 2000 (RO 2000 2291)  ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 43
 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the 
Agreement, a list of the authorities responsible for type-approval, technical services and testing bodies.
 
European Community  
Switzerland  
Authority responsible for type-approval  
Swiss Federal Roads Office  
CH-3003 Berne  
▼M1 
S e c t i o n I I I  
Designating authorities  
European Community:  
— Belgium:  Ministère des Communications et de l'Infrastructure 
Ministerie van Verkeer en Infrastructuur  
— Denmark:  Road safety and Transport Agency  
— Germany:  Kraftfahrt-Bundesamt  
— Greece:  Ministry of Transport  
— Spain:  Ministerio de Ciencia y Tecnología  
— France:  Ministère des Transports  
— Ireland:  Department of Enterprise and Employment  
— Italy:  Ministero dei Trasporti  
— Luxembourg:  Ministère des Transports  
— Netherlands:  Rijksdienst voor het Wegverkeer  
— Austria:  Bundesministerium für Verkehr, Innovation und Tech ­
nologie  
— Portugal:  Direcção-Geral de Viação  
— Finland:  Liikenneministeriö/Trafikministeriet  
— Sweden:  Under the authority of the Government of Sweden: 
Styrelsen för ackreditering och teknisk kontroll 
(SWEDAC) Vãgverket Statens Naturvardsverk (for emissions aspects: Directives 70/220/EEC, 72/306/ EEC, 88/77/EEC, 77/537/EEC and 2000/25/EC)
 
— United Kingdom:  Vehicle Certification Agency  
Switzerland:  Federal Roads Authority Worblentalstrasse 68, Ittigen 
CH-3003 Berne, Switzerland  
▼B 
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, the designating authorities 
shall refer to their respective legislative, regulatory and administrative provisions 
as listed in section I.  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 44
 
S e c t i o n V  
Supplementary provisions  
The provisions of this section shall apply exclusively to relations between Swit ­
zerland and the Community.  
1. Information exchange  
The competent Member State's and Swiss authorities shall notify each other of 
conforming (Article 5 and 6, Directive 74/150/EEC, as last amended) or non- 
conforming (Article 8, Directive 74/150/EEC, as last amended by Commission Directive 2001/3/EC) vehicles, devices and systems placed on the market.
 
In the event of refusal by Switzerland or the Member States to grant type- 
approval in accordance with Article 4 of Directive 74/150/EEC, as last 
amended by Directive 2001/3/EC, their competent authorities shall notify each 
other of their decision and give the reasons for it.  
2. Recognition of vehicle type-approval  
Switzerland shall also recognise tractor or separate technical unit type-approvals 
granted before the entry into force of this Agreement in accordance with Directive 74/150/EEC, as last amended by Commission Directive 2001/3/EC, 
by the authorities responsible for type-approval in the EU Member States 
where that approval is still valid in the EC.
 
The European Community shall recognise Swiss type-approval where Switzer ­
land's requirements are deemed to be equivalent to those of Directive 74/150/EEC, as last amended by Commission Directive 2001/3/EC.
 
Recognition of Swiss-issued type-approval shall be suspended should Swit ­
zerland fail to adapt its legislation to all the Community type-approval legislation 
in force.  
3. Vehicle type-approval safeguard clauses  
Registration and entry into service  
1. Each Member State and Switzerland shall permit the registration, the sale or 
entry into service of new tractors on grounds relating to their construction and operation if, and only if, they are accompanied by a valid certificate of conformity.
 
2. Each Member State and Switzerland shall permit the sale or entry into service 
of separate technical units if, and only if, they comply with the requirements of 
the relevant separate Directive or the requirements of the Swiss legislation equivalent to the relevant separate Directive.
 
3. If a Member State or Switzerland finds that tractors of a particular type maybe 
a hazard to safety on the road or at work, although they are accompanied by a 
valid certificate of conformity, it may, for a maximum period of six months, 
refuse to register new tractors of that type or may prohibit their sale, entry into service or use in its territory. It shall forthwith notify the other Member States, Switzerland and the Commission thereof, stating the reasons on which its 
decision is based. The Commission shall within six weeks consult the States 
concerned by the dispute (Member States or Switzerland). The Commission shall deliver an opinion without delay and take appropriate steps.
 
Measures related to the conformity of production  
1. When a Member State or Switzerland grants type-approval, it shall take the 
necessary measures to verify, if need be in cooperation with the approval auth ­
orities of the other Member States or Switzerland, that production models 
conform to the approved prototype. Such verification shall be limited to spot checks.
 
2. When a Member State or Switzerland has granted a type approval, it shall 
take the necessary measures to ensure that it is informed of any cessation of production and of any change in particulars appearing in the information 
document. If the State in question finds that an amendment to an information 
document warrants fresh checks or fresh tests and that it is accordingly necessary
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 45
 
to 
amend the existing type-approval certificate or complete a new type-approval 
certificate, the competent authorities of that state shall inform the manufacturer thereof and shall, within one month of such new documents being completed, send them to the competent authorities of the other Member States or Swit ­
zerland.
 
Nonconformity with the approved type  
1. There shall be failure to conform to the approved type where deviations from 
the particulars in the information document are found to exist and where these 
deviations have not been authorised under Article 6(2) or (3) of the Directive 
74/150/EEC, as last amended by Directive 2001/3/EC, by the Member State or Switzerland which granted the type-approval. A tractor shall not be considered to deviate from the approved type where tolerances are permitted by separate 
Directives and these tolerances are respected.
 
2. Where a Member State or Switzerland has granted type-approval and finds 
that a number of tractors accompanied by a certificate of conformity do not 
conform to the type it has approved, it shall take the necessary measures to ensure that production models conform to the approved type. The approval auth ­
orities of that Member State or Switzerland shall notify those of the other 
Member States and/or Switzerland of the measures taken which may extend to 
withdrawal of the type-approval. The said authorities shall take like measures if they are informed by the type-approval authorities of another Member State or Switzerland of such failure to conform.
 
3. The approval authorities of the Member States or Switzerland shall inform 
each other within one month of any withdrawal of EC type-approval and of the reasons for such a measure.
 
4. If the Member State or Switzerland which granted type-approval disputes the 
failure to conform notified to it, the States (Member States or Switzerland) 
concerned shall endeavour to settle the dispute. The Commission and the 
Committee shall be kept informed and shall, where necessary, hold appropriate consultations for the purpose of reaching a settlement.
 
▼B 
CHAPTER 14  
GOOD LABORATORY PRACTICE (GLP)  
▼M1 
Scope and coverage  
The provisions of this Chapter shall apply to the testing of chemicals according 
to GLP, being either substances or preparations, covered by the legislative, 
regulatory and administrative provisions listed in section I. For the purposes of 
this Chapter the provisions of Article 4 of this Agreement concerning origin do not apply.
 
Unless specific definitions are given, the definition of terms in the ‘OECD 
Principles of Good Laboratory Practice’ as revised in 1997 [ENV/MC/ CHEM(98)17] based on OECD Council Decision of 12 May 1981 C(81)30(Final)] amended on 26 November 1997 [C(97) 186 FINAL], as well 
as Council Decision-Recommendation of 2 October 1989 [C(89)87(Final)] and 
GLP Consensus documents, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, and all amendments made thereto, shall apply.
 
The Parties recognise the equivalence of each other's compliance monitoring 
programmes on Good Laboratory Practice that are in accordance with the 
OECD decisions and recommendations mentioned above and the legislative, 
regulatory and administrative procedures and principles listed in Section IV.  
The Parties mutually accept studies and data generated therefrom, produced by 
the test facilities of the other Party listed in Section II provided they participate in 
the Good Laboratory Practice compliance monitoring programme of that Party in accordance with the principles and provisions stated above.
 
The Parties mutually accept the conclusions of study audits and test facility 
inspections performed by the monitoring authorities referred to in Section III.  ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 46
 
S e c t i o n I  
Legislation, regulations and administrative provisions  
With regard to the testing of chemicals according to GLP, the relevant parts of 
the legislative, regulatory and administrative provisions listed below shall apply.  
Provisions covered by Article 1(1)  
European Community  Feed additives 
Council Directive 83/228/EEC of 18.4.1983 on the 
fixing of guidelines for the assessment of certain 
products used in animal nutrition (OJ L 126, 13.5.1983, p. 23), as subsequently amended 
Council Directive 87/153/EEC of 16.2.1987 fixing 
guidelines for the assessment of additives in animal 
nutrition (OJ L 64, 7.2.1987, p. 19), as subsequently amended
 
Foodstuffs: 
Council Directive 89/397/EEC of 14.6.1989 on the 
official control of foodstuffs (OJ L 186 of 30.6.1989, p. 23), as subsequently amended 
Council Directive 93/99/EEC of 29.10.1993 on the 
subject of additional measures concerning the official control of foodstuffs (OJ L 290 of 24.11.1993, p. 14) as subsequently amended
 
Cosmetics: 
Council Directive 93/35/EEC of 14.6.1993 amending 
for the sixth time Directive 76/768/EEC on the approxi ­
mation of the laws of the Member States relating to 
cosmetic products (OJ L 151, 23.6.1993, p. 32) as 
subsequently amended  
Switzerland  No GLP-relevant legislation  
Provisions covered by Article 1(2)  
European Community  New and existing chemicals: 
Council Directive 87/18/EEC of 18.12.1986 on the 
harmonisation of laws, regulations and administrative provisions relating to the application of the principles 
of good laboratory practice and the verification of their 
applications for tests on chemical substances (OJ L 15, 17.1.1987, p. 29) as last amended by Commission Directive 99/11/EC of 8 March 1999 (OJ L 77, 
23.3.1999, p. 8) 
Council Directive 92/32/EEC of 30.4.1992 amending 
for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and adminis ­
trative provisions relating to the classification, 
packaging and labelling of dangerous substances (OJ L 154, 5.6.1992, p. 1) 
Council Regulation 793/93/EEC of 23.3.93 on the 
evaluation and control of the risks of existing substances (OJ L 84, 5.4.1993, p. 1) 
Directive 1999/45/EC of the European Parliament and of 
the Council of 31 May 1999 concerning the approxi ­
mation of the laws, regulations and administrative provisions of the Member States relating to the classifi ­
cation, packaging and labelling of dangerous preparations 
(OJ L 200, 30.7.1999 p. 1)
 
Medicinal products: Directive 2001/83/EC of the European Parliament and of 
the Council of 6 November 2001 on the Community code 
relating to medicinal products for human use (OJ L 311, 
28.11.2001, p. 67)
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 47
 
Veterinary Drugs: 
Directive 2001/82/EC of the European Parliament and of 
the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1)
 
Plant Protection Products: 
Council Directive 91/414/EEC of 15.7.1991 concerning 
the placing of plant protection products on the market (OJ 
L 230 of 19.8.1991, p. 1 
Commission Directive 93/71/EEC of 27.7.1993 
amending Council Directive 91/414 concerning the placing of plant protection products on the market (OJ 
L 221 of 31.8.1993, p. 27) 
Commission Directive 95/35/EC of 14.7.95 amending 
Council Directive 91/414/EEC concerning the placing on the market of plant protection products (OJ L 172 of 
22.7.1995, p. 6)
 
Biocides: Directive 98/8/EC of the European Parliament and of the 
Council of 16 February 1998 concerning the placing of 
biocidal products on the market (OJ L 123, 24.4.1998, 
p. 1)
 
▼M13  
Switzerland  100. Federal law of 7 October 1983 on the protection 
of the environment (RO 1984 1122), as last amended on 19 March 2010 (RO 2010 3233)
 
101. Federal law of 15 December 2000 on protection 
against dangerous substances and preparations 
(RO 2004 4763), as last amended on 17 June 2005 (RO 2006 2197)
 
102. Ordinance of 18 May 2005 on protection against 
dangerous substances and preparations (RO 2005 
2721), as last amended on 10 November 2010 
(RO 2010 5223)  
103. Ordinance of 18 May 2005 on the authorisation of 
plant protection products (RO 2005 3035), as last amended on 17 June 2011 (RO 2011 2927)
 
104. Federal law of 15 December 2000 on medicinal 
products and medical devices (RO 2001 2790), as 
last amended on 8 September 2010 (RO 2010 
4027)  
105. Ordinance of 17 October 2001 on medicinal 
products (RO 2001 3420), as last amended on 8 September 2010 (RO 2010 3863)
 
▼B 
S e c t i o n I I  
Conformity assessment bodies  
For the purpose of this Sectoral Chapter, ‘Conformity Assessment Bodies’ means 
the test facilities recognised under each Party's GLP monitoring programme.  ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 48
 
On the basis of information provided by the Parties according to Section V of 
this Chapter, the Committee referred to in Article 10 of this Agreement shall 
establish and keep up to date, according to the procedure described in Article 11 of this Agreement, a list of the test facilities that have been found to be in conformity with the GLP principles.
 
▼M1 
S e c t i o n I I I  
Designating authorities  
For the purpose of this sectoral Annex, the term ‘Designating authorities’ means 
the GLP monitoring authorities of the parties.  
European Community: 
— Belgium:  Ministère de la Santé Publique. Institut Scientifique pour la 
Santé Publique — Louis Pasteur. Ministerie van Volks ­
gezondheid. Wetenschappelijk Instituut voor Volks ­
gezondheid — Louis Pasteur  
— Denmark:  For Pharmaceuticals: 
Lægemiddelstyrelsen (Danish Medicines Agency) 
For Industrial chemicals and pesticides: 
National Agency for Enterprise and Housing  
— Germany:  Bundesministerium für Umwelt, Naturschutz und Reaktorsi ­
cherheit  
— Greece:  General Chemical State Laboratory  
— Spain:  Agencia Española del Medicamento 
Ministerio de Ciencia y Tecnología Ministerio Sanidad y Consumo Ministerio de Agricultura, Pesca y Alimentación
 
— France:  Pour les produits chimiques autres que les médicaments et 
les cosmétiques: GIPC 
Pour les médicaments à usage humain et les cosmetiques: 
Agence française de sécurité sanitaire des produits de santé (AFSSAPS) 
Pour les médicaments à usage vétérinaire: Agence national 
du médicament vétérinaire
 
— Ireland:  Irish Laboratory Accreditation Board (ILAB)  
— Italy:  Ministry of Health Department of Prevention GLP 
Compliance Monitoring Unit  
— Netherlands:  Ministerie van Volksgezondheid, Welzijn en Sport 
Inspectie Volksgezondheid  
— Austria:  Bundesministerium für soziale Sicherheit und Generationen 
(Pharmaceuticals, cosmetic products) Bundesministerium für Land- und Forstwirtschaft, Umwelt 
und Wasserwirtschaft (all others)
 
— Portugal:  For Pharmaceuticals and veterinary drugs: 
Instituto National de Farmacia e do Medicamento 
(INFARMED) 
For Industrial chemicals and pesticides: Instituto Português da Qualidade
 ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 49
 
— Finland:  Sosiaali- ja terveysministeriö/Social- och hälsovårdsminis ­
teriet  
— Sweden:  For Pharmaceuticals and hygiene and cosmetic products: 
Läkemedelsverket (Medical Products Agency) 
For all other products: Styrelsen för ackreditering och teknisk kontroll (SWEDAC)
 
— United 
Kingdom:  Department of Health GLP Monitoring Authority  
Switzerland:  For environmental studies on all products: 
Swiss Agency for the Environment, Forests and Landscape 
CH-3003 Berne For health studies on pharmaceutical products: 
Swissmedic, Swiss Agency for Therapeutic Products 
CH-3003 Bern 9 For health studies on all products except pharmaceuticals: Federal Office of Public Health 
Chemicals Division 
CH-3003 Berne
 
S e c t i o n I V  
Special principles for designating conformity assessment bodies  
For the purpose of this sectoral chapter, ‘designation of conformity assessment 
bodies’ means the procedure by which the GLP Monitoring Authorities recognise that test facilities comply with the GLP principles. To this end they shall apply 
the principles and procedures of their provisions listed below, that are recognised 
to be equivalent and in conformity with the aforementioned OECD Council Acts C(81)30 Final and C(89)87 (Final): 
European Community
 Council Directive 87/18/EEC of 18.12.1986 on the 
harmonisation of laws, regulations and administrative 
provisions relating to the application of the principles 
of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 15, 17.1.1987, p. 29) as last amended by Commission 
Directive 99/11/EC of 8 March 1999 (OJ L 77, 
23.3.1999, p. 8) 
Council Directive 88/320/EEC of 9.6.1988 on the 
inspection and verification of Good Laboratory 
Practice (GLP) (OJ L 145, 11.6.1988, p. 35) as last 
amended by Commission Directive 99/12/EC of 8 March 1999 (OJ L 77, 23.3.1999, p. 22) 
Commission Directive 90/18/EEC of 18.12.1989 
adapting to technical progress the Appendix of Council Directive 88/320/EEC on the inspection and verification of good laboratory practice (GLP) (OJ 
L 11, 13.1.1990, p. 37)
 
Switzerland  Federal law of 7 October 1983 on the protection of the 
environment (RO 1984 1122) as last amended on 
15 December 2000 (RO 2001 2827) 
Ordinance of 9 June 1986 relating to dangerous 
substances for the environment (RO 1986 1254) as last 
amended on 17 October 2001 (RO 2001 3296) 
Federal law of 21 March 1969 on trade in toxic substances 
(RO 1972 435) as last amended on 29 April 1998 (RO 1998 3087)
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 50
 
Ordinance of 19 September 1983 relating to toxic 
substances (RO 1983 1387) as last amended on 1 May 
2002 (RO 2002 1406) 
Federal law of 15 December 2000 on medicinal products 
and medical devices (RO 2001 2790) 
Ordinance of 17 October 2001 on medicinal products 
(RO 2001 3420) 
Ordinance of 2 February 2000 on Good Laboratory 
Practice (RO 2000 548) as last amended on 16 November 
2001 (RO 2001 3165)  
▼B 
S e c t i o n V  
Additional provisions  
1. Information exchange  
In accordance with Article 12 of this Agreement, the Parties in particular provide 
each other at least annually with a list of the test facilities which, in the light of 
the results of the inspections and study audits, conform to Good Laboratory 
Practice, as well as of the dates of inspection or audit and their compliance status.
 
In accordance with Article 6 of the Agreement, the Parties shall inform each 
other in a timely manner when a test facility coming under the terms of section II 
of this sectoral Chapter which states that it applies Good Laboratory Practice fails 
to conform to such practice to an extent which may jeopardise the integrity or authenticity of any such studies it conducts.
 
The Parties shall supply each other with any additional information on a test 
facility inspection or study audit in response to a reasonable request from the 
other Party.  
2. Test Facility Inspections  
Each Party may request further test facility inspection or study audits if there is a 
documented doubt as to whether a test was conducted in accordance with Good Laboratory Practice.
 
If, in exceptional cases, doubts persist and the requesting Party can justify special 
concern, it may, in accordance with Article 8 of the Agreement, designate one or 
more experts of its authorities listed in section III to participate in a laboratory inspection or the audit of a study conducted by the authorities of the other Party.
 
3. Confidentiality  
In conformity with Article 13 of the Agreement, the Parties shall keep 
confidential any information brought to their knowledge pursuant to this 
Sectoral Chapter or that came to their knowledge in the framework of partici ­
pation in an inspection or study audit and which falls within the definition of a trade secret or confidential commercial or financial information. They shall treat 
such information with at least the same confidentiality as that accorded to it by 
the providing Party and ensure that any authority to whom the information is transmitted treats it in the same way.
 
4. Cooperation  
Based on Article 9 of the Agreement, each Party may, on request, participate as 
an observer in an inspection of a test facility conducted by the authorities of the 
other Party with the consent of the test facility concerned in order to maintain a 
continuing understanding of the other Party's inspection procedures.  ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 51
 
CHAPTER 15  
MEDICINAL PRODUCTS GMP INSPECTION AND BATCH 
CERTIFICATION  
▼M1 
Scope and coverage  
The provisions of this Sectoral Chapter cover all medicinal products which are 
industrially manufactured in Switzerland or the European Community, and to which Good Manufacturing Practice (GMP) requirements apply.
 
For medicinal products covered by this Chapter, each party shall recognise the 
conclusions of inspections of manufacturers carried out by the relevant inspection 
services of the other Party and the relevant manufacturing authorisations granted by the competent authorities of the other Party.
 
The manufacturer's certification of the conformity of each batch to its specifi ­
cations shall be recognised by the other Party without re-control at import.  
In addition, official batch releases carried out by an authority of the exporting 
Party will be recognised by the other Party.  
‘Medicinal products’ means all products regulated by pharmaceutical legislation 
in the European Community and Switzerland as listed in Section I of this Chapter. The definition of medicinal products includes all human and veterinary 
products, such as chemical and biological pharmaceuticals, immunologicals, 
radio-pharmaceuticals, stable medicinal products derived from human blood or human plasma, pre-mixes for the preparation of veterinary medicated feeding ­
stuffs and, where appropriate, vitamins, minerals, herbal remedies and homeo ­
pathic medicinal products.
 
‘GMP’ is that part of quality assurance which ensures that products are 
consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation and products 
specifications. For the purpose of this Chapter it includes the system whereby the 
manufacturer receives the specification of the product and the process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification.
 
With respect to medicinal products covered by the legislation of one Party but 
not the other, the manufacturing company can request, for the purpose of this Agreement, an inspection be made by the locally competent inspection service. 
This provision shall apply,  inter alia , to the manufacture of active pharmaceutical 
ingredients, intermediate products and investigational medicinal products, as well as to pre-marketing inspections. Operational arrangements are detailed under section III, paragraph 3.
 
Certification of manufacturers  
At the request of an exporter, importer or the competent authority of the other 
Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products shall certify that the 
manufacturer:
 
— is appropriately authorised to manufacture the relevant medicinal product, or 
to carry out the relevant specified manufacturing operation,  
— is regularly inspected by the authorities,  
— complies with the national GMP requirements recognised as equivalent by the 
two parties, and which are listed in Section I of this Chapter. Should different GMP requirements be used as reference, this is to be mentioned in the 
certificate.
 
The certificates shall also identify the site(s) of manufacture (and contract quality 
control laboratories, if any).  
Certificates shall be issued expeditiously, and the time taken should not exceed 
thirty calendar days. In exceptional cases,  inter alia , when a new inspection has 
to be carried out, this period may be extended to sixty days.  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 52
 
Batch certification  
Each batch exported shall be accompanied by a batch certificate established by 
the manufacturer (self-certification) after a full qualitative analysis, a quantitative 
analysis of all the active ingredients and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation. This certificate shall attest that the batch meets its spec ­
ifications and shall be kept by the importer of the batch. It will be made available 
upon request of the competent authority.
 
When issuing a certificate, the manufacturer shall take account of the provisions 
of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce. The certificate shall detail the agreed specifications of the product, the reference of the analytical methods 
and the analytical results. It shall contain a statement that the batch processing 
and packaging records were reviewed and found in conformity with GMP. The batch certificate shall be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Community the ‘qualified person’ referred 
to in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC, 
and in Switzerland the ‘responsible person’ referred to in Articles 5 and 10 of the Ordinance on establishment licences.
 
Official batch release  
When an official batch release procedure applies, official batch releases carried 
out by an authority of the exporting Party (listed in section II) will be recognised by the other Party. The manufacturer shall provide the certificate of the official batch release.
 
For the Community, the official batch release procedure is specified in document 
‘Control Authority Batch Release of Vaccination and Blood Products, 2001’ or 
subsequent versions and in different specific batch release procedures. For Swit ­
zerland, the official batch release procedure is specified in Article 17 of the Federal Law on medicinal products and medical devices and in Articles 18 to 21 of the Ordinance of the Swiss Agency for Therapeutic Products on the 
requirements for the marketing authorisation of medicinal products.
 
S e c t i o n I  
With regard to GMP, the relevant parts of the legislative, regulatory and adminis ­
trative provisions listed below apply. However, the reference quality 
requirements of products to be exported, including their manufacturing method and product specifications, shall be those of the relevant marketing authorisation granted by the competent authority of the importing Party.
 
Provisions covered by Article 1(2)  
European Community  Directive 2001/83/EC of the European Parliament and 
of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 
L 311, 28.11.2001, p. 67) 
Directive 2001/82/EC of the European Parliament and 
of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1) 
Commission Directive 91/356/EEC of 13 June 1991 
laying down the principles and guidelines of good 
manufacturing practice for medicinal products for human use (OJ L 193, 17.7.1991, p. 30) 
Commission Directive 91/412/EEC of 23 July 1991 
laying down the principles and guidelines of good manufacturing practice for veterinary medicinal 
products (OJ L 228, 17.8.1991, p. 70) 
Council Regulation (EEC) No 2309/93 of 22 July 1993 
laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for 
the evaluation of medicinal products, as last amended by 
Commission Regulation (EC) No 649/98 of 23 March 1998 (OJ L 88, 24.3.1998, p. 7)
 ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 53
 
Guidelines on Good Distribution Practice of medicinal 
products for human use (94/C 63/03) 
Guide to Good Manufacturing Practice Volume IV of 
Rules Governing Medicinal Products in the European Community.
 
▼M13  
Switzerland  100. Federal law of 15 December 2000 on medicinal 
products and medical devices (RO 2001 2790), as 
last amended on 8 September 2010 (RO 2010 4027)
 
101. Ordinance of 17 October 2001 on the estab ­
lishment of licences (RO 2001 3399), as last amended on 25 May 2011 (RO 2011 2561)
 
102. Ordinance of the Swiss Agency for Therapeutic 
Products of 9 November 2001 on the 
requirements for the marketing authorisation of medicinal products (RO 2001 3437), as last amended on 22 June 2006 (RO 2006 3587)
 
103. Ordinance of 17 October 2001 on clinical trials of 
pharmaceutical products (RO 2001 3511), as last 
amended on 8 September 2010 (RO 2010 4043)  
▼M1 
S e c t i o n I I  
Conformity assessment bodies  
For the purpose of this Chapter ‘Conformity Assessment Bodies’ means the 
official GMP inspection services of each Party.  
European Community  ( 1 ) 
— Germany:  
Bundesministerium für Gesundheit  
Am Propsthof 78a  
D-53108 Bonn;Tel. (49-228) 941 23 40  
Fax. (49-228) 941 49 23  
for immunologicals:  
Paul-Ehrlich-Institut, Federal Agency for Sera & Vaccines  
Paul-Ehrlichstr. 51-59  
D-63225 Langen;Tel. (49-6103) 77 10 10  
Fax. (49-6103) 77 12 34  
— Austria:  
Bundesministerium für soziale Sicherheit und Generationen  
Radetzkystraße 2  
A-1030 Wien  
Tel. (43-1) 711 72 46 42  
Fax. (43-1) 714 92 22  ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 54  
( 1 ) Up-to-date contact points should be confirmed with the EMEA
 — Belgium:  
Inspection générale de la Pharmacie/Algemene Farmaceutische Inspectie 
Vesaliusgebouw V309  
Pachecolaan 19 bus 5  
B-1010 Bruxelles  
Tel. (32-2) 210 49 24  
Fax. (32-2) 210 48 80  
— Denmark:  
Lægemiddelstyrelsen:  
Frederikssundsvej 378  
DK-2700 Bronshoj  
Tel. (45-44) 88 91 11  
Fax. (45-44) 88 91 95  
— Spain:  
Agencia Española del Medicamento  
c/Paseo del Prado, 18-20  
E-28014 Madrid  
Tel. (34-91) 596 14 64 65 66  
Fax. (34-91) 596 14 55  
— Finland:  
Lääkelaitos  
Feld 55  
FIN-00301 Helsinki  
Tel. (358-9) 47 33 41  
Fax. (358-9) 71 44 69  
— France:  
for medicinal products for human use:  
Agence Française de Sécurité Sanitaire des Produits de Santé  
143-147 Boulevard Anatole France  
F-93285 Saint-Denis Cedex  
Tel. (33-1) 55 87 30 00  
Fax. (33-1) 55 87 37 20  
for veterinary medicinal products:  
Agence Française de Sécurité Sanitaire des Aliments/Agence Nationale 
du Médicament Vétérinaire (AFSSA — ANMV)  
BP 90203  
F-35302 Fougeres  
Tel. (33-2) 99 94 78 78  
Fax. (33-2) 99 94 78 99  
— Greece:  
National Organisation for Medicines (EOF)  
284 Mesogion Avenue Holargos  
GR-15562 Athinai  
Tel. (30-210) 650 72 00  
Fax. (30-210) 654 95 91  
— Ireland:  
Irish Medicines Board (Bord Leigheasra na hÉireann)  
Earlsfort Centre  
Earlsfort Terrace  
Dublin 2  
Ireland  
Tel. (353-1) 676 49 71  
Fax. (353-1) 676 78 36  ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 55
 
— Italy:  
For medicinal products for human use:  
Ministero della Salute  
Viale della Civiltà Romana 7  
I-00144 Roma  
Tel. (39-06) 59 94 36 76  
Fax. (39-06) 59 94 33 65  
For medicinal products for veterinary use:  
Ministero della Salute Direzione Generale Sanità Pubblica Veterinaria, 
Alimenti e Nutrizione Ufficio XI  
Piazzale G Marconi 25  
I-00144 Roma  
Tel. (39-06) 59 94 39 46  
Fax. (39-06) 59 94 33 17  
— Luxembourg:  
Direction de la Santé  
Villa Louvigny  
Allée Marconi  
L-2120 Luxembourg  
Tel. (352) 478-55 90-93  
Fax.: (352) 22 44 58  
— Netherlands:  
Staatstoezicht op de volksgezondheid — Inspectie voor de Gezond ­
heidszorg  
Postbus 16119  
2500 BC Den Haag  
Netherlands  
Tel. (31 70) 340 79 11  
Fax. (31 70) 340 51 77  
— Portugal:  
Instituto Nacional da Farmácia e do Medicamento — Infarmed  
Parque de Saúde de Lisboa Av. do Brasil, 53  
P-1749-004 Lisboa  
Tel. (351-21) 217 98 52 74  
Fax. (351-21) 217 98 72 57  
— United Kingdom:  
for human and veterinary (non immunologicals):  
Medicines Control Agency  
Market Towers  
1 Nine Elms Lane  
London SW8 5NQ  
United Kingdom  
Tel. (44-20) 72 73 05 00  
Fax. (44-20) 72 73 06 76/06 38  
for veterinary immunologicals:  
Veterinary Medicines Directorate  
Woodham Lane  
New Haw  
Addlestone  
Surrey KT15 3LS  
United Kingdom  
Tel. (44-193)-233 69 11  
Fax. (44-193)-233 66 18  ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 56
 
— Sweden:  
Läkemedelsverket (Medical Products Agency)  
Husargatan 8  
PO Box 26  
S-751 03 Uppsala  
Tel. (46-18) 17 46 00  
Fax. (46-18) 54 85 66  
Switzerland  
Swiss Agency for Therapeutic Products, Swissmedic  
Erlachstraße 8  
CH-3000 Bern  
(for all products for human and veterinary use — except immunological 
products for veterinary use)  
Tel. (41-31) 3 22 02 11  
Fax. (41-31) 3 22 02 12  
Institute for Virology and Immunoprophylaxis Research Station of the 
Swiss Federal Veterinary Office  
Sensemattstr. 293  
CH-3147 Mittelhäusern  
(for immunobiological products for veterinary use)  
Tel. (41-31) 848 92 11  
Fax. (41-31) 848 92 22  
▼B 
S e c t i o n I I I  
Additional provisions  
1. Transmission of inspection reports  
Upon reasoned request, the relevant inspection services shall forward a 
copy of the last inspection report of the manufacturing site or, in case analytical operations are contracted out, of the control site. The request 
may concern a ‘full inspection report’ or a ‘detailed report’ (see item 2 
below). Each party shall deal with these inspection reports with the degree of confidentiality requested by the providing Party.
 
Parties will ensure that inspection reports are forwarded in no more than 
30 calendar days, this period being extended to 60 days should a new inspection be carried out.
 
2. Inspection reports  
A ‘full inspection report’ comprises a Site Master File (compiled by the 
manufacturer or by the inspectorate) and a narrative report by the 
inspectorate. A ‘detailed report’ responds to specific queries about a firm by the other Party.
 
3. GMP Reference  
(a) Manufacturers shall be inspected against the applicable GMP of the 
exporting party (see section I).  
(b) With respect to medicinal products covered by the pharmaceutical 
legislation of the importing Party but not the exporting one, the 
locally competent inspection service willing to carry out an 
inspection of the relevant manufacturing operations shall inspect against its own GMP or, in the absence of specific GMP require ­
ments, against the applicable GMP of the importing Party.
 
For specific products or classes of products (e.g. investigational 
medicinal products, starting materials not limited to active phar ­
maceutical ingredients), equivalence of GMP requirements shall be 
determined according to a procedure established by the Committee.  ▼M1 2002A5430 — EN — 20.12.2011 — 001.001 — 57
 
4. Nature of inspections  
(a) Inspections shall routinely assess the compliance of the manu ­
facturer with GMP. These are called general GMP inspections 
(also regular, periodic, or routine inspections).  
(b) ‘Product- or process-oriented’ inspections (which may be ‘pre- 
marketing’ inspections as relevant) focus on the manufacture of one or a series of product(s) or process(es) and include an 
assessment of the validation of and compliance with specific 
process or control aspects as described in the marketing authori ­
sation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) shall be provided in 
confidence to the inspectorate.
 
5. Fees  
The regime of inspection/establishment fees is determined by the manu ­
facturer's location. Inspection/establishment fees shall not be charged to manufacturers located on the territory of the other Party.
 
6. Safeguard clause for inspections  
Each Party reserves the right to have its own inspection conducted for 
reasons identified to the other Party. Such inspections are to be notified 
in advance to the other Party and shall, in accordance with Article 8 of the Agreement, be carried out jointly by the competent authorities of the two Parties. Recourse to this safeguard clause should be an exception.
 
7. Exchange of information between authorities and approximation of 
quality requirements  
In accordance with the general provisions of the Agreement, the parties 
shall exchange any information necessary for the mutual recognition of inspections.
 
The relevant authorities in Switzerland and in the Community shall also 
keep each other informed of any new technical guidance or inspection 
procedure. Each party shall consult the other before their adoption and shall endeavour to proceed towards their approximation.
 
8. Inspectors training  
In accordance with Article 9 of the Agreement, training sessions for 
inspectors, organised by the authorities, shall be accessible to inspectors 
of the other Party. The Parties to the Agreement shall keep each other informed on these sessions.
 
9. Joint Inspections  
In accordance with Article 12 of the Agreement, and by mutual 
agreement between the Parties, joint inspections may be organised. 
These inspections are intended to develop common understanding and 
interpretation of practice and requirements. The setting up of these inspections and their form shall be agreed through procedures 
approved by the Committee established under Article 10 of the 
Agreement.
 
10. Alert system  
Contact points shall be agreed between both Parties to permit authorities 
and manufacturers to inform the authorities of the other Party with the appropriate speed in case of quality defect, batch recalls, counterfeiting 
and other problems concerning quality, which could necessitate 
additional controls or suspension of the distribution of the batch. A detailed alert procedure shall be agreed.
 
The Parties shall ensure that any suspension or withdrawal (total or 
partial) of a manufacturing authorisation, based on non-compliance 
with GMP and which could have public health implications, are 
communicated to each other with the appropriate degree of urgency.  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 58
 
11. Contact points  
For the purpose of this Agreement, the contact points for any technical 
question, such as exchanges of inspection reports, inspectors training 
sessions, technical requirements, are:  
for the EC  
the Director of the European Agency for the Evaluation of Medicinal 
Products and  
for Switzerland  
the official GMP inspection services listed in Section II above.  
12. Divergence of views  
Both Parties shall use their best endeavours to resolve any divergence of 
views concerning  inter alia  compliance of manufacturers and 
conclusions of inspection reports. Unresolved divergences of view will 
be referred to the Committee as established under Article 10 of the 
Agreement.  
▼M10  
CHAPTER 16  
CONSTRUCTION PRODUCTS  
S e c t i o n I  
Legislative, regulatory and administrative provisions  
Provisions covered by Article 1 paragraph 2  
European Community  1. Council Directive 89/106/EEC of 21 December 
1988 on the approximation of the laws, regu ­
lations and administrative provisions of the Member States relating to construction 
products (OJ L 40, 11.2.1989, p. 12) 
I m p l e m e n t i n g m e a s u r e s 2. Commission Decision 94/23/EC of 17 January 
1994 on common procedural rules for European technical approval (OJ L 17, 20.1.1994, p. 34) 
2(a). Commission Decision 94/611/EC of 
9 September 1994 implementing Article 20 of 
Directive 89/106/EEC on construction products 
(OJ L 241, 16.9.1994, p. 25) 
2(b). Commission Decision 95/204/EC of 31 May 
1995 implementing Article 20(2) of Council Directive 89/106/EEC on construction products 
(OJ L 129, 14.6.1995, p. 23) 
3. Commission Decision 95/467/EC of 24 October 
1995 implementing Article 20(2) of Council Directive 89/106/EEC on construction products (OJ L 268, 10.11.1995, p. 29) 
4. Commission Decision 96/577/EC of 24 June 
1996 on the procedure for attesting the 
conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ EEC as regards fixed fire-fighting systems (OJ 
L 254, 8.10.1996, p. 44)
 ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 59
 
5. Commission Decision 96/578/EC of 24 June 
1996 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards sanitary appliances (OJ L 254, 8.10.1996, p. 49) 
6. Commission Decision 96/579/EC of 24 June 
1996 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards circulation fixtures (OJ L 254, 8.10.1996, p. 52) 
7. Commission Decision 96/580/EC of 24 June 
1996 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards curtain walling (OJ L 254, 8.10.1996, p. 56) 
8. Commission Decision 96/581/EC of 24 June 
1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ 
EEC as regards geotextiles (OJ L 254, 
8.10.1996, p. 59) 
9. Commission Decision 96/582/EC of 24 June 
1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ 
EEC as regards structural sealant glazing 
systems and metal anchors for concrete (OJ L 254, 8.10.1996, p. 62) 
10. Commission Decision 96/603/EC of 4 October 
1996 establishing the list of products belonging to classes A ‘No contribution to fire’ provided 
for in Decision 94/611/EC implementing 
Article 20 of Council Directive 89/106/EEC on construction products (OJ L 267, 19.10.1996, p. 23) 
11. Commission Decision 97/161/EC of 17 February 
1997 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards metal anchors for use in concrete for fixing lightweight systems (OJ L 62, 4.3.1997, p. 41) 
12. Commission Decision 97/176/EC of 17 February 
1997 on the procedure for attesting the 
conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ EEC as regards structural timber products and ancillaries (OJ L 73, 14.3.1997, p. 19)
 ▼M10  2002A5430 — EN — 20.12.2011 — 001.001 — 60
 
13. Commission Decision 97/177/EC of 17 February 
1997 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards metal injection anchors for use in masonry (OJ L 73, 14.3.1997, p. 24) 
14. Commission Decision 97/462/EC of 27 June 
1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ 
EEC as regards wood-based panels (OJ 
L 198, 25.7.1997, p. 27) 
15. Commission Decision 97/463/EC of 27 June 
1997 on the procedure for attesting the 
conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ EEC as regards plastic anchors for use in 
concrete and masonry (OJ L 198, 25.7.1997, 
p. 31) 
16. Commission Decision 97/464/EC of 27 June 
1997 on the procedure for attesting the 
conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ EEC as regards waste water engineering 
products (OJ L 198, 25.7.1997, p. 33) 
17. Commission Decision 97/555/EC of 14 July 
1997 on the procedure for attesting the 
conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ EEC as regards cements, building limes and other hydraulic binders (OJ L 229, 20.8.1997, 
p. 9) 
18. Commission Decision 97/556/EC of 14 July 
1997 on the procedure for attesting the 
conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ EEC as regards external thermal insulation composite systems/kits with rendering (ETICS) 
(OJ L 229, 20.8.1997, p. 14) 
19. Commission Decision 97/571/EC of 22 July 
1997 on the general format of European 
Technical Approval for construction products 
(OJ L 236, 27.8.1997, p. 7) 
20. Commission Decision 97/597/EC of 14 July 
1997 on the procedure for attesting the 
conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ EEC as regards reinforcing and prestressing steel for concrete (OJ L 240, 2.9.1997, p. 4)
 ▼M10  2002A5430 — EN — 20.12.2011 — 001.001 — 61
 
21. Commission Decision 97/638/EC of 
19 September 1997 on the procedure for attesting the conformity of construction 
products pursuant to Article 20(2) of Council 
Directive 89/106/EEC as regards fasteners for structural timber (OJ L 268, 1.10.1997, p. 36) 
22. Commission Decision 97/740/EC of 14 October 
1997 on the procedure for attesting the 
conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ EEC as regards masonry and related products 
(OJ L 299, 4.11.1997, p. 42) 
23. Commission Decision 97/808/EC of 
20 November 1997 on the procedure for attesting the conformity of construction 
products pursuant to Article 20(2) of Council 
Directive 89/106/EEC as regards floorings (OJ L 331, 3.12.1997, p. 18) 
24. Commission Decision 98/143/EC of 3 February 
1998 on the procedure for attesting the 
conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ EEC as regards systems of mechanically 
fastened flexible roof waterproofing 
membranes (OJ L 42, 14.2.1998, p. 58) 
25. Commission Decision 98/213/EC of 9 March 
1998 on the procedure for attesting the 
conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ EEC as regards internal partition kits (OJ L 80, 18.3.1998, p. 41) 
26. Commission Decision 98/214/EC of 9 March 
1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ 
EEC as regards structural metallic products 
and ancillaries (OJ L 80, 18.3.1998, p. 46) 
27. Commission Decision 98/279/EC of 
5 December 1997 on the procedure for 
attesting the conformity of construction 
products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards non-load- bearing permanent shuttering kits/systems 
based on hollow blocks or panels of insulating 
materials and, sometimes, concrete (OJ L 127, 29.4.1998, p. 26) 
28. Commission Decision 98/436/EC of 22 June 
1998 on the procedure for attesting the 
conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ EEC as regards roof coverings, roof lights, 
roof windows and ancillary products (OJ 
L 194, 10.7.1998, p. 30)
 ▼M10  2002A5430 — EN — 20.12.2011 — 001.001 — 62
 
29. Commission Decision 98/437/EC of 30 June 
1998 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards internal and external wall and ceiling finishes (OJ L 194, 10.7.1998, p. 39) 
30. Commission Decision 98/456/EC of 3 July 
1998 on the procedure for attesting the 
conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ EEC as regards post-tensioning kits for the prestressing of structures (OJ L 201, 17.7.1998, 
p. 112) 
31. Commission Decision 98/457/EC of 3 July 
1998 concerning the test of the Single 
Burning Item (SBI) referred to in Council Decision 94/611/EC implementing Article 20 of Council Directive 89/106/EEC on 
construction products (OJ L 201, 17.7.1998, 
p. 114) 
32. Commission Decision 98/598/EC of 9 October 
1998 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards aggregates (OJ L 287, 24.10.1998, p. 25) 
33. Commission Decision 98/599/EC of 12 October 
1998 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards liquid applied roof water ­
proofing kits (OJ L 287, 24.10.1998, p. 30) 
34. Commission Decision 98/600/EC of 12 October 
1998 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards self-supporting translucent roof kits (except glass-based kits) (OJ L 287, 
24.10.1998, p. 35) 
35. Commission Decision 98/601/EC of 13 October 
1998 on the procedure for attesting the 
conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ EEC as regards road construction products (OJ 
L 287, 24.10.1998, p. 41) 
36. Commission Decision 1999/89/EC of 25 January 
1999 on the procedure for attesting the 
conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ EEC as regards prefabricated stair kits (OJ 
L 29, 3.2.1999, p. 34)
 ▼M10  2002A5430 — EN — 20.12.2011 — 001.001 — 63
 
37. Commission Decision 1999/90/EC of 25 January 
1999 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards membranes (OJ L 29, 3.2.1999, p. 38) 
38. Commission Decision 1999/91/EC of 25 January 
1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ 
EEC as regards thermal insulating products 
(OJ L 29, 3.2.1999, p. 44) 
39. Commission Decision 1999/92/EC of 25 January 
1999 on the procedure for attesting the 
conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ EEC as regards light composite wood-based 
beams and columns (OJ L 29, 3.2.1999, p. 49) 
40. Commission Decision 1999/93/EC of 25 January 
1999 on the procedure for attesting the 
conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ EEC as regards doors, windows, shutters, blinds, gates and related building hardware 
(OJ L 29, 3.2.1999, p. 51) 
41. Commission Decision 1999/94/EC of 25 January 
1999 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards precast normal/light-weight autoclaved aerated concrete products (OJ L 29, 3.2.1999, p. 55) 
41(a). Commission Decision 1999/453/EC of 18 June 
1999 amending Decision 96/579/EC and 97/ 808/EC on the procedure for attesting the 
conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ EEC as regards circulation fixtures and floorings respectively (OJ L 178, 14.7.1999, 
p. 50) 
42. Commission Decision 1999/454/EC of 22 June 
1999 on the procedure for attesting the 
conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ EEC as regards fire stopping, fire sealing and fire protective products (OJ L 178, 14.7.1999, 
p. 52) 
43. Commission Decision 1999/455/EC of 22 June 
1999 on the procedure for attesting the 
conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ EEC as regards timber frame and log prefab ­
ricated building kits (OJ L 178, 14.7.1999, 
p. 56)
 ▼M10  2002A5430 — EN — 20.12.2011 — 001.001 — 64
 
44. Commission Decision 1999/469/EC of 25 June 
1999 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards products related to concrete, mortar and grout (OJ L 184, 17.7.1999, p. 27) 
45. Commission Decision 1999/470/EC of 29 June 
1999 on the procedure for attesting the 
conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ EEC as regards construction adhesives (OJ L 184, 17.7.1999, p. 32) 
46. Commission Decision 1999/471/EC of 29 June 
1999 on the procedure for attesting the 
conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ EEC as regards space heating appliances (OJ L 184, 17.7.1999, p. 37) 
47. Commission Decision 1999/472/EC of 1 July 
1999 on the procedure for attesting the 
conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/ EEC as regards pipes, tanks and ancillaries 
not in contact with water intended for human 
consumption (OJ L 184, 17.7.1999, p. 42) 
48. Commission Decision 2000/147/EC of 
8 February 2000 implementing Council Directive 89/106/EEC as regards the classifi ­
cation of the reaction to fire performance of 
construction products (OJ L 50, 23.2.2000, 
p. 14) 
49. Commission Decision 2000/245/EC of 
2 February 2000 on the procedure for attesting the conformity of construction products pursuant to Article 20(4) of Council 
Directive 89/106/EEC as regards flat glass, 
profiled glass and glass block products (OJ L 77, 28.3.2000, p. 13) 
50. Commission Decision 2000/273/EC of 
27 March 2000 on the procedure for attesting 
the conformity of construction products 
pursuant to Article 20(2) of Council Directive 89/106/EEC as regards seven products for European Technical Approvals without 
Guideline (OJ L 86, 7.4.2000, p. 15) 
51. Commission Decision 2000/367/EC of 3 May 
2000 implementing Council Directive 89/106/ 
EEC as regards the classification of the resistance to fire performance of construction products, construction works and parts thereof 
(OJ L 133, 6.6.2000, p. 26)
 ▼M10  2002A5430 — EN — 20.12.2011 — 001.001 — 65
 
52. Commission Decision 2000/447/EC of 13 June 
2000 on the procedure for attesting the conformity of construction products pursuant 
to Article 20(2) of Council Directive 89/106/ 
EEC as regards prefabricated wood-based load-bearing stressed skin panels and self- supporting composite lightweight panels (OJ 
L 180, 19.7.2000, p. 40) 
53. Commission Decision 2000/553/EC of 
6 September 2000 implementing Council Directive 89/106/EEC as regards the external 
fire performance of roof coverings (OJ L 235, 
19.9.2000, p. 19) 
53(a). Commission Decision 2000/605/EC of 
26 September 2000 amending Decision 96/ 
603/EC establishing the list of products 
belonging to class A ‘No contribution to fire’ provided for in Decision 94/611/EC imple ­
menting Article 20 of Council Directive 89/ 
106/EEC on construction products (OJ L 258, 
12.10.2000, p. 36) 
54. Commission Decision 2000/606/EC of 
26 September 2000 on the procedure for 
attesting the conformity of construction 
products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards six products for European Technical Approvals without 
Guideline (OJ L 258, 12.10.2000, p. 38) 
55. Commission Decision 2001/19/EC of 
20 December 2000 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council 
Directive 89/106/EEC as regards expansion 
joints for road bridges (OJ L 5, 10.1.2001, p. 6) 
56. Commission Decision 2001/308/EC of 
31 January 2001 on the procedure for 
attesting the conformity of construction 
products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards ventures (OJ L 107, 18.4.2001, p. 25) 
56(a). Commission Decision 2001/596/EC of 
8 January 2001 amending Decisions 95/467/ EC, 96/578/EC, 96/580/EC, 97/176/EC, 97/ 462/EC, 97/556/EC, 97/740/EC, 97/808/EC, 
98/213/EC, 98/214/EC, 98/279/EC, 98/436/EC, 
98/437/EC, 98/599/EC, 98/600/EC, 98/601/EC, 1999/89/EC, 1999/90/EC, 1999/91/EC, 1999/ 454/EC, 1999/469/EC, 1999/470/EC, 1999/ 
471/EC, 1999/472/EC, 2000/245/EC, 2000/ 
273/EC, 2000/447/EC on the procedure for attesting the conformity of certain construction products pursuant to Article 20 of Council 
Directive 89/106/EEC (OJ L 209, 2.8.2001, 
p. 33) 
57. Commission Decision 2001/671/EC of 
21 August 2001 implementing Council 
Directive 89/106/EEC as regards the classifi ­
cation of the external fire performance of roofs and roof coverings (OJ L 235, 4.9.2001, p. 20)
 ▼M10  2002A5430 — EN — 20.12.2011 — 001.001 — 66
 
58. Commission Decision 2002/359/EC of 13 May 
2002 on the procedure for attesting the conformity of construction products in contact 
with water intended for human consumption, 
pursuant to Article 20(2) of Council Directive 89/106/EEC (OJ L 127, 14.5.2002, p. 16) 
59. Commission Decision 2002/592/EC of 15 July 
2002 amending Decisions 95/467/EC, 96/577/ 
EC, 96/578/EC and 98/598/EC on the 
procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards 
gypsum products, fixed fire-fighting systems, 
sanitary appliances and aggregates respectively (OJ L 192, 20.7.2002, p. 57) 
60. Commission Decision 2003/43/EC of 17 January 
2003 establishing the classes of reaction-to-fire 
performance for certain construction products 
(OJ L 13, 18.1.2003, p. 35) 
61. Commission Decision 2003/312/EC of 9 April 
2003 on the publication of the reference of standards relating to thermal insulation 
products, geotextiles, fixed fire-fighting 
equipment and gypsum blocks in accordance with Council Directive 89/106/EEC (OJ L 114, 8.5.2003, p. 50) 
62. Commission Decision 2003/424/EC of 6 June 
2003 amending Decision 96/603/EC estab ­
lishing the list of products belonging to Classes A ‘No contribution to fire’ provided for in Decision 94/611/EC implementing 
Article 20 of Council Directive 89/106/EEC 
on construction products (OJ L 144, 12.6.2003, p. 9) 
63. Commission Decision 2003/593/EC of 
7 August 2003 amending Decision 2003/43/ 
EC establishing the classes of reaction-to-fire 
performance of certain construction products (OJ L 201, 8.8.2003, p. 25) 
64. Commission Decision 2003/629/EC of 
27 August 2003 amending Decision 2000/367/ 
EC establishing a classification system for resis ­
tance-to-fire performance for construction products, as regards the inclusion of smoke and heat control products (OJ L 218, 30.8.2003, 
p. 51) 
65. Commission Decision 2003/632/EC of 
26 August 2003 amending Decision 2000/147/ EC implementing Council Directive 89/106/ EEC as regards the classification of the 
reaction-to-fire performance of construction 
products (OJ L 220, 3.9.2003, p. 5) 
66. Commission Decision 2003/639/EC of 
4 September 2003 on the procedure for attesting the conformity of construction 
products pursuant to Article 20(2) of Council 
Directive 89/106/EEC as regards pins for structural joints (OJ L 226, 10.9.2003, p. 18)
 ▼M10  2002A5430 — EN — 20.12.2011 — 001.001 — 67
 
67. Commission Decision 2003/640/EC of 
4 September 2003 on the procedure for attesting the conformity of construction 
products pursuant to Article 20(2) of Council 
Directive 89/106/EEC as regards kits for exterior wall claddings (OJ L 226, 10.9.2003, p. 21) 
68. Commission Decision 2003/655/EC of 
12 September 2003 on the procedure for attesting the conformity of construction 
products pursuant to Article 20(2) of Council 
Directive 89/106/EEC as regards watertight covering kits for wetroom floors and walls (OJ L 231, 17.9.2003, p. 12) 
69. Commission Decision 2003/656/EC of 
12 September 2003 on the procedure for attesting the conformity of construction 
products pursuant to Article 20(2) of Council 
Directive 89/106/EEC as regards seven products for European technical approvals without Guideline (OJ L 231, 17.9.2003, p. 15) 
70. Commission Decision 2003/722/EC of 
6 October 2003 on the procedure for attesting the conformity of construction products 
pursuant to Article 20(2) of Council Directive 
89/106/EEC as regards liquid-applied bridge deck waterproofing kits (OJ L 260, 11.10.2003, p. 32) 
71. Commission Decision 2003/728/EC of 
3 October 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 
89/106/EEC as regards metal frame building 
kits, concrete frame building kits, prefabricated building units, cold storage room kits and rockfall protection kits (OJ L 262, 14.10.2003, 
p. 34) 
72. Commission Decision 2004/663/EC of 
20 September 2004 amending Commission 
Decision 97/464/EC on the procedure for 
attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards waste water 
engineering products (OJ L 302, 29.9.2004, 
p. 6) 
73. Commission Decision 2005/403/EC of 25 May 
2005 establishing the classes of external fire 
performance of roofs and roof coverings for certain construction products as provided for by Council Directive 89/106/EEC (OJ L 135, 
28.5.2005, p. 37) 
74. Commission Decision 2005/484/EC of 4 July 
2005 on the procedure for attesting the 
conformity of construction products pursuant
 ▼M10  2002A5430 — EN — 20.12.2011 — 001.001 — 68
 
to Article 20(2) of Council Directive 89/106/EEC 
as regards cold storage building kits and cold storage building envelope kits (OJ L 173, 
6.7.2005, p. 15) 
75. Commission Decision 2005/610/EC of 
9 August 2005 establishing the classes of 
reaction-to-fire performance for certain 
construction products (OJ L 208, 11.8.2005, p. 21) 
76. Commission Decision 2005/823/EC of 
22 November 2005 amending Decision 2001/ 
671/EC implementing Council Directive 89/ 106/EEC as regards the classification of the external fire performance of roofs and roof 
coverings (OJ L 307, 25.11.2005, p. 53) 
77. Commission Decision 2006/190/EC of 1 March 
2006 amending Decision 97/808/EC on the 
procedure for attesting the conformity of 
construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards floorings (OJ L 66, 8.3.2006, p. 47) 
78. Commission Decision 2006/213/EC of 6 March 
2006 establishing the classes of reaction-to-fire performance for certain construction products as regards wood flooring and solid wood panelling 
and cladding (OJ L 79, 16.3.2006, p. 27) 
79. Commission Decision 2006/600/EC of 
4 September 2006 establishing the classes of 
reaction-to-fire performance for certain 
construction products as regards double skin metal faced sandwich panels for roofs (OJ L 244, 7.9.2006, p. 24) 
80. Commission Decision 2006/673/EC of 
5 October 2006 amending Decision 2003/43/ EC establishing the classes of reaction-to-fire performance for certain construction products 
as regards gypsum plasterboards (OJ L 276, 
7.10.2006, p. 77) 
81. Commission Decision 2006/751/EC of 
27 October 2006 amending Decision 2000/ 
147/EC implementing Council Directive 89/ 106/EEC as regards the classification of the reaction-to-fire performance of construction 
products (OJ L 305, 4.11.2006, p. 8) 
82. Commission Decision 2006/893/EC of 
5 December 2006 on the withdrawal of the reference of standard EN 10080:2005 ‘Steel 
for the reinforcement of concrete — Weldable 
reinforcing steel — General’ in accordance with Council Directive 89/106/EEC (OJ L 343, 8.12.2006, p. 102) 
83. Commission Decision 2007/348/EC of 15 May 
2007 amending Decision 2003/43/EC estab ­
lishing the classes of reaction-to-fire 
performance for certain construction products 
as regards wood-based panels (OJ L 131, 23.5.2007, p. 21)
 ▼M10  2002A5430 — EN — 20.12.2011 — 001.001 — 69
 
Switzerland  100. Loi fédérale du 8 octobre 1999 sur les produits 
de construction (RO 2000 3104) 
101. Ordonnance du 27 novembre 2000 sur les 
produits de construction (RO 2001 100) 
102. Accord intercantonal sur l’élimination des 
entraves techniques au commerce du 23 octobre 1998 (RO 2003 270)
 
S e c t i o n I I  
Conformity assessment bodies  
1. The Committee established under Article 10 of this Agreement shall draw up 
and keep up to date, according to the procedure described in Article 11 of 
this Agreement, a list of the conformity assessment bodies.  
2. Conformity assessment bodies can be differentiated in three different bodies 
involved in the attestation of conformity: Certification body, inspection body 
and testing laboratory. For the purpose of this Agreement the definitions of 
Annex III Section 3 to Directive 89/106/EEC shall apply.  
S e c t i o n I I I  
Designating authorities  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date a list of the designating authorities and the competent authorities 
notified by the Parties.  
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, the designating authorities 
shall comply with the general principles contained in Annex 2 to this Agreement 
and the assessment criteria set out in Annex IV to Directive 89/106/EEC.  
S e c t i o n V  
Supplementary provisions  
1. European harmonised standards for construction products  
For the purpose of this Agreement, Switzerland will publish the reference of 
the European harmonised standards for construction products after their 
publishing in the  Official Journal of the European Union  according to 
Article 7 of the Directive 89/106/EEC.  
To state the equivalence of the Swiss systems of conformity attestation, 
Switzerland will add to every harmonised standard a conversion table. This 
conversion table shall ensure the comparability of the Swiss and the European 
systems of conformity attestation describing the relevant procedures to assess conformity.
 
2. Interpretative documents and guidance papers  
The six Interpretative Documents referred to in Article 3 of the Directive 
89/106/EEC and in the Communication 94/C 62/01 of the Commission (OJ C 
62, 28.2.1994, p. 1) established according to Article 20 of the Directive 89/106/EEC shall also apply for the purpose of this Agreement.
 
3. European technical approvals  
(a) Switzerland shall be entitled to designate Swiss bodies to issue 
European technical approvals. It shall make sure that designated 
bodies become members of the European Organisation for Technical Approvals (EOTA) and participate in its work, in particular for estab ­
lishing guidelines for European technical approvals according to 
Article 11 of the Directive 89/106/EEC and issuing European 
technical approvals (ETAs).
 ▼M10  2002A5430 — EN — 20.12.2011 — 001.001 — 70
 
Switzerland shall notify the Committee established under Article 10 of 
this Agreement of the names and addresses of such bodies.  
Decisions of EOTA shall also apply for the purpose of this Agreement.  
European Technical Approvals are issued by the EOTA Approval 
Bodies and are recognised by both Parties for the purpose of this 
Agreement.  
(b) ‘Approval Body’ shall mean a public or private law body which is 
authorised to issue European technical approvals.  
Approval bodies are designated by the Parties according to their relevant 
procedures.  
The Committee established under Article 10 of this Agreement shall 
draw up and keep up to date a list of the approval bodies. To this end, 
the notification procedure described in Section II paragraph 1 in 
accordance with Article 11 of this Agreement shall also apply to approval bodies analogously.
 
The Parties hereby recognise that the bodies thus listed for the purpose 
of this Agreement fulfil the conditions to issue European technical approvals.
 
4. Information exchanges  
In accordance with Article 9 of this Agreement, the Parties shall exchange 
information needed to ensure a proper implementation of this chapter.  
5. Technical documentation  
It shall be sufficient for manufacturers, their authorised representatives or the 
person responsible for placing products on the market to hold the technical documents required by the national authorities for inspection purposes at their 
disposal in the territory of one of the Parties for a period of at least ten years 
after the last date of manufacture of the product.
 
The Parties hereby undertake to forward all relevant technical documents at 
the request of the authorities of the other Party.  
6. Person responsible for placing the products on the market and labelling  
The manufacturer shall not be obliged to designate an authorised represen ­
tative or a person responsible for placing products on the market established in the territory of the other Party, nor to indicate the name and address of an 
authorised representative, responsible person or importer on the label, outer 
packaging or instructions for use.
 
▼M11  
CHAPTER 17  
LIFTS  
S e c t i o n I  
Legislative, regulatory and administrative provisions  
Provisions covered by Article 1(2)  
▼M13  
European Union  1. European Parliament and Council Directive 95/16/EC 
of 29 June 1995 on the approximation of the laws of the Member States relating to lifts (OJ L 213, 
7.9.1995, p. 1), as last amended by Directive 2006/ 
42/EC of the European Parliament and of the Council of 17 May 2006 on machinery and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24)
 ▼M10  2002A5430 — EN — 20.12.2011 — 001.001 — 71
 
Switzerland  100. Federal Law of 12 June 2009 on product safety (RO 
2010 2573)  
101. Ordinance of 19 May 2010 on product safety (RO 
2010 2583)  
102. Ordinance of 23 June 1999 on the safety of lifts (RO 
1999 1875), as last amended on 19 May 2010 (RO 
2010 2583)  
▼M11  
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the 
Agreement, a list of the conformity assessment bodies.  
S e c t i o n I I I  
Designating authorities  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date a list of the designating authorities notified by the Parties.  
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, the designating authorities 
shall comply with the general principles contained in Annex 2 to this Agreement 
and the assessment criteria set out in Annex VII to Directive 95/16/EC.  
S e c t i o n V  
Supplementary provisions  
1. Information exchange  
In accordance with Article 8(3) of Directive 95/16/EC, the European 
Commission, the authorities listed in section III and the conformity assessment bodies recognised under this Agreement may, on request, obtain from the installer a copy of the declaration of conformity and reports of the 
tests carried out in the final inspection.
 
In accordance with Annex V, points A 5 and B 5 of Directive 95/16/EC, they 
may obtain from the conformity assessment body which has issued the type- 
examination certificate, a copy of the certificate and, on a reasoned request, a copy of the technical dossier and reports of examinations, calculations and tests carried out.
 
In accordance with Annex V, points A 7 and B 7 of Directive 95/16/EC, the 
conformity assessment bodies which have issued type-examination certificates must communicate to the Member States, Switzerland and the other 
conformity assessment bodies the relevant information concerning the type- 
examination certificates they have issued or withdrawn.
 
In accordance with point 6 of Annexes VIII, IX, XII, XIII and XIV of 
Directive 95/16/EC, the conformity assessment bodies recognised under this 
Agreement must forward to the other conformity assessment bodies the relevant information concerning the quality assurance system approvals issued or withdrawn.
 
In the cases referred to in Article 8(2) (i), (ii) and (iii) of Directive 95/16/EC, 
the person responsible for the design of the lift must supply to the person responsible for the construction, installation and testing of the lift all 
necessary documents and information for the latter to be able to operate in 
absolute security.
 ▼M13  2002A5430 — EN — 20.12.2011 — 001.001 — 72
 
2. Technical documentation  
It shall be sufficient for manufacturer of a safety component, his authorised 
representative established in the Union or in Switzerland or, where neither of 
these is present, the person responsible for placing its safety components on the market to keep with the technical documentation a copy of the declaration of conformity and their additions (as the case may be) required by the 
national authorities for inspection purposes at their disposal in the territory 
of one of the Parties) for at least ten years from the date on which the safety component was last manufactured.
 
It shall be sufficient for the installer of the lift to keep with the technical 
documentation a copy of the declaration of conformity and their additions 
and the final inspection certificate (if needed) for 10 years from the date on 
which the lift was placed on the market.  
Where the installer is not established in the Union or in Switzerland, this 
obligation falls to the relevant notified body.  
The Parties hereby undertake to forward all relevant technical documents at 
the request of the authorities of the other Party.  
3. Market surveillance  
The Parties shall notify each other of the authorities established on their 
territory responsible for carrying out the surveillance tasks involved in the 
implementation of their legislation as set out in Section I.  
The Parties shall notify each other of their market surveillance activities 
within the bodies designated for this purpose.  
▼M12  
CHAPTER 18  
BIOCIDAL PRODUCTS  
SCOPE AND COVERAGE  
The provisions of this Sectoral Chapter apply to biocidal products as defined in 
Directive 98/8/EC, with the exemption of:  
— biocidal products which are or which contain genetically modified or 
pathogenic micro-organisms, and  
— avicides, piscicides and biocides for control of other vertebrates.  
Commission Directives to include active substances to the Annex I, IA or IB are 
part of this Chapter.  
Switzerland will be free to limit access to its market according to the 
requirements of its legislation existing at the date of entry into force of this Chapter concerning:
 
— biocidal products containing octylphenol or its ethoxylates, and  
— aerosol dispensers containing substances stable in the air.  
The Parties shall jointly review the situation in 2013.  ▼M11  2002A5430 — EN — 20.12.2011 — 001.001 — 73
 
S e c t i o n I  
Legislative, regulatory and administrative provisions  
Provisions covered by Article 1(2)  
European Union  1. Directive 98/8/EC of the European Parliament and of 
the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ 
L 123, 24.4.1998, p. 1), as last amended by 
Directive 2009/107/EC of the European Parliament and of the Council of 16 September 2009 (OJ L 262, 6.10.2009, p. 40), hereinafter referred to as 
‘Directive 98/8/EC’
 
2. Commission Regulation (EC) No 1896/2000 of 
7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the 
Council on biocidal products (OJ L 228, 8.9.2000, 
p. 6)
 
3. Commission Regulation (EC) No 1687/2002 of 
25 September 2002 on an additional period for notifi ­
cation of certain active substances already on the 
market for biocidal use as established in Article 4(1) 
of Regulation (EC) No 1896/2000 (OJ L 258, 26.9.2002, p. 15)
 
4. Commission Regulation (EC) No 1451/2007 of 
4 December 2007 on the second phase of the 10- 
year work programme referred to in Article 16(2) of 
Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3)
 
▼M13  
Switzerland  100. Federal Law of 15 December 2000 for the protection 
against dangerous substances and preparations (RO 
2004 4763), as last amended on 17 June 2005 (RO 2006 2197)
 
101. Federal Law of 7 October 1983 relating to the 
protection of the environment (RO 1984 1122), as 
last amended on 19 March 2010 (RO 2010 3233)  
102. Ordinance of 18 May 2005 concerning the placing on 
the market and the use of biocidal products (RO 2005 2821), as last amended on 4 April 2011 (RO 2011 
1403)
 
▼M12  
S e c t i o n I I  
Conformity assessment bodies  
For the purposes of this Chapter, ‘Conformity Assessment Bodies’ means the 
competent authorities of the Member States of the European Union and Swit ­
zerland for placing biocidal products on the market.  
The contact details of the competent authorities of the Member States and of 
Switzerland can be found on the websites indicated below.  
Member States  
Biocides: ‘Competent Authorities and other Contact Points’ http://ec.europa.eu/ 
environment/biocides/pdf/ca_contact.pdf  ▼M12  2002A5430 — EN — 20.12.2011 — 001.001 — 74
 
Switzerland  
Federal Office of Public Health, Notification Authority for Chemicals 
www.bag.admin.ch/biocide  
S e c t i o n I I I  
Supplementary provisions  
For the purpose of paragraphs 2-5 of this Section, any reference to Directive 
98/8/EC shall, as far as Switzerland is concerned, be understood to equally refer 
to the equivalent Swiss provisions.  
1. Inclusion of active substances in Annex I, IA or IB  
Article 11 of Directive 98/8/EC shall apply between the Parties with the 
following adaptations:  
inclusion or subsequent changes to the inclusion, of an active substance in 
Annex I, IA or IB shall also be considered where an applicant has forwarded 
the required dossier to the competent authority of Switzerland, and where the receiving competent authority has sent the required evaluation to the Commission.
 
2. Mutual recognition of authorisations between Member States and Switzerland  
1. Without prejudice to Article 12 of Directive 98/8/EC, a biocidal product 
that has already been authorised or registered in one Member State or in Switzerland shall be authorised or registered in another Member State or in Switzerland within 120 days, or 60 days respectively, of an application 
being received by the other Member State or by Switzerland, provided 
that the active substance of the biocidal product is included in Annex I or IA to Directive 98/8/EC and conforms to the requirements thereof. For the mutual recognition of authorisations, the application shall include a 
summary of the dossier as required in Article 8(2)(a) and Annex IIB, 
Section X of Directive 98/8/EC and a certified copy of the first auth ­
orisation granted. For mutual recognition of registration of low-risk biocidal products, the application shall include the data requirements of 
Article 8(3) of Directive 98/8/EC, except for the efficacy data for which a 
summary shall suffice.
 
The authorisation may be subject to provisions resulting from the imple ­
mentation of other measures in accordance with the Parties’ law, relating 
to the conditions for distribution and use of biocidal products intended to 
protect the health of the distributors, users and workers concerned.  
This mutual recognition procedure shall be without prejudice to measures 
taken by Member States and by Switzerland pursuant to the Parties’ law 
intended to protect the health of workers.  
2. If, in accordance with Article 5 of Directive 98/8/EC, a Member State or 
Switzerland establishes that:  
(a) the target species is not present in harmful quantities;  
(b) unacceptable tolerance or resistance of the target organism to the 
biocidal product is demonstrated; or  
(c) the relevant circumstances of use, such as climate or breeding period 
of the target species, differ significantly from those in the Member 
State where the biocidal product was first authorised or in Swit ­
zerland, and an unchanged authorisation may therefore present unacceptable risks to humans or the environment,
 
the Member State or Switzerland may request that certain conditions 
referred to in Article 20(3)(e), (f), (h), (j) and (l) of Directive 98/8/EC 
be adjusted to the different circumstances, so that conditions for issue of 
an authorisation laid down in Article 5 of Directive 98/8/EC are satisfied.  ▼M12  2002A5430 — EN — 20.12.2011 — 001.001 — 75
 
3. Where a Member State or Switzerland believes that a low-risk biocidal 
product which has been registered by another Member State or by Swit ­
zerland does not comply with the definition provided for in Article 2(1)(b) of Directive 98/8/EC, it may provisionally refuse registration thereof and shall immediately communicate its concerns to the competent authority 
responsible for the verification of the dossier.
 
If, within a maximum period of 90 days, an agreement is not reached 
between the authorities concerned, the matter will be forwarded to the 
Commission for a decision in accordance with the procedure laid down in paragraph 4.
 
4. Notwithstanding paragraphs 2 and 3, where a Member State or Swit ­
zerland believes a biocidal product authorised by another Member State or Switzerland cannot meet the conditions set out pursuant to Article 5(1) 
of Directive 98/8/EC and consequently proposes to refuse the authori ­
sation or the registration or to restrict the authorisation under certain conditions, it shall notify the Commission, other Member States, Swit ­
zerland and the applicant and shall provide them with an explanatory 
document containing the name of the product and its specification and 
setting out the grounds on which it proposes to refuse or to restrict the authorisation.
 
The Commission shall prepare a proposal on these matters in accordance 
with Article 27 of Directive 98/8/EC for a decision in accordance with the 
procedure laid down in Article 28(2) of Directive 98/8/EC.  
5. If the procedure laid down in paragraph 4 leads to the confirmation of a 
refusal of a second or subsequent registration by a Member State or by 
Switzerland, the Member State that had previously registered the low-risk biocidal product or Switzerland shall, where deemed appropriate by the Standing Committee, take this refusal into consideration and review its 
registration according to Article 6 of Directive 98/8/EC.
 
If this procedure confirms the initial registration, the Member State or 
Switzerland having introduced the procedure shall register the low-risk 
biocidal product concerned.  
6. By way of derogation from paragraph 1, Member States or Switzerland 
may refuse mutual recognition of authorisations granted for product types 15, 17 and 23 of Annex V to Directive 98/8/EC provided that such a limitation can be justified and does not jeopardise the purpose of this 
Chapter.
 
Member States and Switzerland shall inform each other and the 
Commission of any decision taken in this respect and indicate the reasons therefor.
 
3. Market access  
The applicant shall indicate his name or trade name and address on the label 
of biocidal products. It will be sufficient, for the purposes of Article 8 of Directive 98/8/EC, if the applicant for an authorisation has a permanent office 
either within the European Union or Switzerland. The Parties agree that 
authorisations and other decisions relating to the application of this Chapter may be notified by the competent authorities directly to the applicant in the territory of the other Party.
 
4. Information exchange  
In accordance with Article 9 of this Agreement, the Parties shall in particular 
exchange information referred to in Article 18 of Directive 98/8/EC. 
Confidential information shall be defined and treated in accordance with Article 19 of Directive 98/8/EC.
 
5. Safeguard clause  
Where a Member State or Switzerland has valid reasons to consider that a 
biocidal product which it has authorised, registered or is bound to authorise or register pursuant to Article 3 or 4 of Directive 98/8/EC constitutes an 
unacceptable risk to human or animal health or the environment, it may 
provisionally restrict or prohibit the use or sale of that product on its territory.
 ▼M12  2002A5430 — EN — 20.12.2011 — 001.001 — 76
 
It shall immediately inform the Commission, the other Member States and 
Switzerland of such action and give reasons for its decisions. A decision shall 
be taken on the matter within 90 days in accordance with the procedure laid down in Article 28(3). If Switzerland disagrees with the Commission Decision, the case will be forwarded to the Joint Committee, which will 
decide on an appropriate course of action, including the possibility to call 
an expert meeting. If a settlement is not reached within 90 days, either party may suspend the Biocidal products Chapter in part or in full.
 
Recourse to this safeguard clause should be an exception.  
6. Transitional period  
Article 16(1) of Directive 98/8/EC shall apply between the Parties, with the 
transitional period up to 14 May 2014 for Switzerland.  
▼M13  
CHAPTER 19  
CABLEWAY INSTALLATIONS  
S e c t i o n I  
Legislative, regulatory and administrative provisions  
Provisions covered by Article 1(2)  
European Union  Directive 2000/9/EC of the European Parliament and 
of the Council of 20 March 2000 relating to cableway installations designed to carry persons (OJ L 106, 3.5.2000, p. 21; hereinafter referred to as Directive 
2000/9/EC)
 
Switzerland  Federal Law of 23 June 2006 on cableway instal ­
lations designed to carry persons (RO 2006 5753), 
as last amended on 20 March 2009 (RO 2009 5597)  
Ordinance of 21 December 2006 on cableway instal ­
lations designed to carry persons (RO 2007 39), as last amended on 11 June 2010 (RO 2010 2749)
 
S e c t i o n I I  
Conformity assessment bodies  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.
 
S e c t i o n I I I  
Designating authorities  
The Committee established under Article 10 of this Agreement shall draw up and 
keep up to date a list of the designating authorities notified by the Parties.  
S e c t i o n I V  
Special rules relating to the designation of conformity assessment bodies  
For the designation of conformity assessment bodies, the designating authorities 
shall comply with the general principles contained in Annex 2 to this Agreement 
and the assessment criteria set out in Annex VIII to Directive 2000/9/EC.  
S e c t i o n V  
Supplementary provisions  
1. Information exchange  
In accordance with Articles 9 and 12 of this Agreement, the Parties shall 
exchange information needed to ensure a proper implementation of this 
Chapter.  ▼M12  2002A5430 — EN — 20.12.2011 — 001.001 — 77
 
The competent authorities in Switzerland and in the Member States as well as 
the European Commission shall in particular exchange the information 
referred to in Article 11 and Article 14 of Directive 2000/9/EC.  
The conformity assessment bodies designated according to Section IV of this 
Annex shall exchange the information referred to in Annex V to Directive 2000/9/EC, as regards Module B points 7 and 8, Module D point 6, and 
Module H points 6 and 7.5.
 
2. Technical documentation  
It shall be sufficient for manufacturers, their authorised representatives or the 
person responsible for placing products on the market to hold the technical documentation as required by Directive 2000/9/EC in the territory of one of 
the Parties.
 
The Parties hereby undertake to forward all relevant technical documents at 
the request of the authorities of the other Party.  
3. Market surveillance  
The Parties shall notify each other of the authorities established on their 
territory responsible for carrying out the surveillance tasks involved in the 
implementation of their legislation as set out in Section I.  
The Parties shall notify each other of their market surveillance activities 
within the bodies designated for this purpose.  ▼M13  2002A5430 — EN — 20.12.2011 — 001.001 — 78
 
ANNEX 2  
GENERAL RULES REGARDING THE DESIGNATION OF 
CONFORMITY ASSESSMENT BODIES  
A. General terms and conditions  
1. Under this Agreement, the designating authorities shall remain solely 
responsible for the competence and the capacity of the bodies they have 
designated and shall designate only legally identifiable bodies under their jurisdiction.
 
2. Designating authorities shall designate conformity assessment bodies able to 
demonstrate by objective means that they understand and have the requisite experience and competence to apply the requirements and certification procedures laid down in the legislative, regulatory and administrative 
provisions referred to in Annex I, that are applicable to the specific 
product, product category or sector for which they are designated.
 
3. Demonstration of technical competence shall cover:  
— the conformity assessment body's technical knowledge of the relevant 
products, processes or services which it is willing to treat;  
— the understanding of the technical standards and/or legislative, regulatory 
and administrative provisions for which designation is sought;  
— the physical capability to perform a given conformity assessment activity;  
— the adequate management of the activity concerned; and  
— any other circumstance necessary to give assurance that the conformity 
assessment activity will be adequately performed at all times.  
4. The technical competence criteria shall be based as far as possible on inter ­
nationally accepted documents, such as the EN 45000 series of standards or equivalents as well as on supplemented interpretative documents as appro ­
priate. However these documents clearly need to be interpreted in such a way 
as to take account of the different types of requirements laid down in the 
applicable legislative, regulatory and administrative provisions.
 
5. The Parties shall encourage harmonisation of designation procedures and 
coordination of conformity assessment procedures through cooperation 
between designating authorities and conformity assessment bodies based on 
coordination meetings, participation in mutual recognition arrangements, and ad hoc working party meetings. The Parties shall also encourage accreditation bodies to participate in mutual recognition arrangements.
 
B. System for verification of conformity assessment bodies' competence  
6. In order to verify the technical competence of conformity assessment bodies, 
the authorities concerned may use various procedures ensuring an appropriate level of trust between the Parties. If necessary, a Party shall indicate to the 
designating authority possible ways of demonstrating competence.
 
(a) Accreditation  
Accreditation shall constitute a presumption of the technical competence 
of conformity assessment bodies in relation to the application of the 
requirements of the other Party provided that the competent accreditation 
body:  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 79
 
— complies with the relevant international provisions in force 
(EN 45000 standards or ISO/IEC guides); and  
— is signatory to multilateral arrangements under which it is subject to 
peer evaluation, or  
— takes part, under the authority of a Designating Authority, and in 
accordance with whatever conditions are decided on, in programmes 
to conduct comparisons and exchange technical experience, in the interests of ensuring continued trust in the technical competence of the accreditation and conformity-assessment bodies. Such programmes 
could include joint evaluations, special cooperation exercises or 
conformity assessment.
 
Where the criteria applicable to conformity assessment bodies require the 
latter to assess the conformity of products, processes or services directly to standards or technical specifications, the designating authorities may use accreditation as a presumption of the conformity assessment body's 
technical competence provided that it enables assessment of those bodies' 
ability to apply such standards or technical specifications. Designation shall be limited to those activities of the conformity assessment body.
 
Where the criteria applicable to conformity assessment bodies require the 
latter to assess the conformity of products, processes or services not directly to standards or technical specifications, but to general (essential) 
requirements, the designating authorities may use accreditation as a 
presumption of the conformity assessment body's technical competence provided that it incorporates elements which will enable assessment of the capacity of the conformity assessment body (technical knowledge of the 
product, of its use, etc.) to assess the conformity of the product to those 
essential requirements. Designation shall be limited to those activities of the conformity assessment body.
 
(b) Other means  
If there is no accreditation scheme, or on other grounds, the authorities 
concerned shall require the conformity assessment bodies to demonstrate their competence by other means, e.g.:
 
— participation in regional or international mutual recognition 
arrangements or certification systems;  
— regular peer evaluation, based on clear criteria and conducted with the 
appropriate expertise;  
— aptitude tests; or  
— comparison of conformity assessment bodies.  
C. Evaluation of the verification system  
7. Once a verification system to evaluate the competence of conformity 
assessment bodies has been defined, the other Party will be invited to check that the system guarantees the conformity of the designation process 
to its own legal requirements. Such checks shall focus on the appropriateness 
and effectiveness of the verification system rather than on the conformity assessment bodies themselves.
 
D. Formal designation  
8. When the Parties submit their proposals to the Committee on the inclusion of 
conformity assessment bodies in the Annexes, they shall provide the following details in respect of each body:
 
(a) its name;  
(b) its postal address;  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 80
 
(c) its fax number;  
(d) the Sectoral Chapter, product categories or products, processes and 
services covered by the designation;  
(e) the conformity assessment procedures covered by the designation;  
(f) the methods used to establish the body's competence.  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 81
 
FINAL ACT  
The plenipotentiaries  
of the  ‘EUROPEAN COMMUNITY’,  
and 
of the  SWISS CONFEDERATION,  
meeting on the twenty-first day of June in the year one thousand nine 
hundred and ninety-nine in Luxembourg for the signature of the Agreement between the European Community and the Swiss Confed ­
eration on mutual recognition in relation to conformity assessment have 
adopted the Joint Declarations mentioned below and attached to this 
Final Act:
 
Joint Declaration by the Contracting Parties on the revision of Article 4,  
Joint Declaration on the mutual recognition of good clinical practice and 
inspections relating thereto,  
Joint Declaration by the Contracting Parties on updating the Annexes,  
Joint Declaration on further negotiations.  
They also took note of the following Declaration annexed to this Final 
Act: 
Declaration on Swiss attendance of Committees,  
Hecho en Luxemburgo, el día ventiuno de junio del año mil novecientos noventa 
y nueve.  
Udfærdiget i Luxembourg, den enogtyvende juni nitten hundrede og nioghalv ­
fems.  
Geschehen zu Luxemburg am einundzwanzigsten Juni neunzehnhundertneunund ­
neunzig.  
Έγινε  στο Λουξεμβούργο , στις είκοσι  μία Ιουνίου  χίλια  εννιακόσια  ενενήντα  
εννέα . 
Done at Luxembourg on the twenty-first day of June in the year one thousand 
nine hundred and ninety-nine.  
Fait à Luxembourg, le vingt-et-un juin mil neuf cent quatre-vingt dix-neuf.  
Fatto a Lussemburgo, addì ventuno giugno millenovecentonovantanove.  
Gedaan te Luxemburg, de eenentwintigste juni negentienhonderd negenennegen ­
tig. 
Feito no Luxemburgo, em vinte e um de Junho de mil novecentos e noventa e 
nove  
Tehty Luxemburgissa kahdentenakymmenentenäensimmäisenä päivänä kesäkuuta 
vuonna tuhatyhdeksänsataayhdeksänkymmentäyhdeksän.  
Som gjordes i Luxemburg den tjugoförsta juni nittonhundranittionio.  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 82
 
Por la Comunidad Europea  
For Det Europæiske Fællesskab  
Für die Europäische Gemeinschaft  
Για την Ευρωπαϊκή  Κοινότητα  
For the European Community  
Pour la Communauté européenne  
Per la Comunità europea  
Voor de Europese Gemeenschap  
Pela Comunidade Europeia  
Euroopan yhteisön puolesta  
På Europeiska gemenskapens vägnar
  
Por la Confederación Suiza  
For Det Schweiziske Edsforbund  
Für die Schweizerische Eidgenossenschaft  
Για την Ελβετική  Συνομοσπονδία  
For the Swiss Confederation  
Pour la Confédération suisse  
Per la Confederazione svizzera  
Voor de Zwitserse Bondsstaat  
Pela Confederação Suíça  
Sveitsin valaliiton puolesta  
På Schweiziska edsförbundets vägnar
  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 83
 
JOINT DECLARATION BY THE CONTRACTING PARTIES  
on the Revision of Article 4  
The Contracting Parties undertake to revise Article 4 of the Agreement on mutual 
recognition in relation to conformity assessment to include in particular products 
originating in other countries with which the Parties conclude agreements on mutual recognition in relation to conformity assessment, once such agreements have been concluded.
 
At that point the provisions of Chapter 12 in Section V of this Agreement will be 
revised.  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 84
 
JOINT DECLARATION  
on the Mutual Recognition of Good Clinical Practice and Inspections 
Relating thereto  
For medicinal products, the results of clinical trials carried out on the territory of 
the Parties to this Agreement are currently accepted for inclusion in applications for marketing authorisations and their variations or extensions. In principle, the Parties agree to continue to accept these clinical trials for the purpose of 
marketing authorisations applications. They agree to work towards an approxi ­
mation of Good Clinical Practice, namely by implementing the current Declar ­
ations of Helsinki and Tokyo and all guidance relevant to clinical trials adopted in the framework of the International Conference on Harmonisation. However, 
due to legislative developments concerning inspections and authorisations of 
clinical trials in the European Community, detailed arrangements for the mutual recognition of the official supervision of these trials will have to be considered in the near future and laid down in a specific Chapter.
 ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 85
 
JOINT DECLARATION  
by the Contracting Parties on Updating the Annexes  
The Contracting Parties undertake to update the Annexes to the Agreement on 
mutual recognition in relation to conformity assessment not later than one month 
after its entry into force.  ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 86
 
JOINT DECLARATION  
on Further Negotiations  
The European Community and the Swiss Confederation declare their intention of 
undertaking negotiations to conclude agreements in areas of common interest 
such as the updating of Protocol 2 to the 1972 Free Trade Agreement and Swiss participation in certain Community training, youth, media, statistical and environmental programmes. Preparatory work for these negotiations should 
proceed rapidly once the current bilateral negotiations have been concluded.
 ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 87
 
DECLARATION  
on Swiss attendance of committees  
The Council agrees that Switzerland's representatives may, in so far as the items 
concern them, attend meetings of the following committees and expert working 
parties as observers:  
— Committees of research programmes, including the Scientific and Technical 
Research Committee (CREST)  
— Administrative Commission on Social Security for Migrant Workers  
— Coordinating Group on the mutual recognition of higher-education diplomas  
— Advisory committees on air routes and the application of competition rules in 
the field of air transport.  
Switzerland's representatives shall not be present when these committees vote.  
In the case of other committees dealing with areas covered by these agreements 
in which Switzerland has adopted either the  acquis communautaire  or equivalent 
measures, the Commission will consult Swiss experts by the method specified in Article 100 of the EEA Agreement.
 ▼B 2002A5430 — EN — 20.12.2011 — 001.001 — 88