2002A5430 — EN — 01.04.2014 — 002.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

Amended by:









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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 establishing the World Trade Organisation and, in particular, to the Agreement on Technical Barriers to Trade, which encourages the negotiation of mutual recognition 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.

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.

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Article 4

Origin

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

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 authorities have the necessary power and competence to designate conformity assessment bodies or withdraw designation, suspend or remove suspension of designated conformity assessment bodies under their respective jurisdiction.

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

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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 ————— ◄ .

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 participation 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 established. It shall be composed of representatives of the Parties, and shall be responsible for the management and monitoring of the smooth functioning 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.

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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.

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5. The Committee may, on a proposal from one of the Parties, modify the Annexes to this Agreement.

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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.

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.

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Article 12

Information exchange

1. The Parties shall exchange all relevant information regarding implementation and application of the legislative, regulatory and administrative 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.

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2a. Each Party shall notify changes to its designating authorities and competent authorities to the other Party in writing.

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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.

Article 14

Dispute settlement

Each Party may refer any dispute relating to the interpretation or application 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 maintaining 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.

Article 20

Acquired rights

The Parties shall continue to recognise reports, certificates, authorisations 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, portuguesa y sueca y cada uno de estos textos será auténtico.

Udfærdiget i Luxembourg, den enogtyvende juni nitten hundrede og nioghalvfems i to eksemplarer på dansk, engelsk, finsk, fransk, græsk, italiensk, nederlandsk, portugisisk, spansk, svensk og tysk, idet hver af disse tekster har samme gyldighed.

Geschehen zu Luxemburg am einundzwanzigsten Juni neunzehnhundertneunundneunzig in zwei Urschriften in dänischer, deutscher, englischer, finnischer, französischer, griechischer, italienischer, niederländischer, portugiesischer, schwedischer 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 negenennegentig, 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 englannin, 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, portugisiska, 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

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

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 potentially 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 Chapter 20 Explosives for civil use

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CHAPTER 1

MACHINERY

Section I

Legislative, regulatory and administrative provisions







Provisions covered by Article 1(2) ▼M15 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 (recast) (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) ▼M14 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 20 April 2011 (RO 2011 1755) ▼M11

Section II

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.

Section III

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.

Section IV

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.

Section V

Supplementary provisions

1. Second-hand machinery

The legislative, regulatory and administrative provisions listed in section I shall not apply to second-hand machinery.

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.

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CHAPTER 2

PERSONAL PROTECTIVE EQUIPMENT

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Section I

Legislation, regulations and administrative provisions







Provisions covered by Article 1(2) ▼M15 European Union 1. Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 399, 30.12.1989, p. 18), as last amended by Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 (OJ L 316, 14.11.2012, p. 12) ▼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)

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Section II

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.

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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

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Section III

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 hälsovårdsministeriet — 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 technologies 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'Artiginiato — 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

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Section IV

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.

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CHAPTER 3

TOYS

Section I

Legislative, regulatory and administrative provisions







Provisions covered by Article 1(2) European Union 1. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1), as last amended by Commission Regulation (EU) No 681/2013 (OJ L 195, 18.7.2013, p. 16) (hereinafter referred to as ‘Directive 2009/48/EC’) Switzerland 100. Federal Law of 9 October 1992 on foodstuffs and commodities (RO 1995 1469) as last amended on 9 November 2011 (RO 2011 5227) 101. Ordinance of 23 November 2005 on foodstuffs and commodities (RO 2005 5451) as last amended on 23 October 2013 (RO 2013 3669) 102. Ordinance of the Federal Department of Home Affairs (FDHA) of 15 August 2012 on the safety of toys (RO 2012 4717) as last amended on 25 November 2013 (RO 2013 5297) 103. Ordinance of the FDHA of 23 of November 2005 on the enforcement of foodstuff legislation (RO 2005 6555) as last amended on 15 August 2012 (RO 2012 4855) 104. Ordinance of 17 June 1996 on the Swiss accreditation system and on the designation of test laboratories and conformity assessment bodies (RO 1996 1904), as last amended on 1 June 2012 (RO 2012 2887)

Section II

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.

Section III

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.

Section IV

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 with Article 24 of Directive 2009/48/EC.

Section V

Supplementary provisions

1. Exchange of information concerning the certificate of conformity and the technical documentation

The market surveillance authorities of the Member States or Switzerland may, on reasoned request, ask for the technical documentation, or a translation of parts thereof from a manufacturer based in the territory of either Switzerland or a Member State. The market surveillance authorities of the Member states and Switzerland may request from a Swiss or a European Union-based manufacturer the relevant part of the technical documentation into an official language of the requesting authority or in English.

When a market surveillance authority requests the technical documentation or a translation of parts thereof from a manufacturer, it may set a deadline for receipt of 30 days, unless a shorter deadline is justified in the case of serious and immediate risk.

If the manufacturer based on the territory of either Switzerland or a Member State does not comply with this provision, the market surveillance authority may require it to have a test performed by a designated body at its own expense within a specified period in order to verify compliance with the harmonised standards and essential requirements.

2. Information requests to designated bodies

The market surveillance authorities of the Member States and of Switzerland may request a designated body in Switzerland or in a Member State to provide information relating to any type examination certificate which that body has issued or withdrawn, or which relates to any refusal to issue such a certificate, including the test reports and technical documentation.

3. Information obligations of designated bodies

In accordance with Article 36(2) of Directive 2009/48/EC, designated bodies shall provide the other bodies designated under this Agreement which carry out similar conformity assessment activities covering the same toys with relevant information on issues relating to negative and, on request, positive conformity assessment results.

4. Exchange of experience

Swiss national authorities may take part in the exchange of experience between the Member States’ national authorities responsible for the notification procedure referred to in Article 37 of Directive 2009/48/EC.

5. Coordination of designated bodies

Designated Swiss conformity assessment bodies may take part in the coordination and cooperation mechanisms and sectoral groups or groups of notified bodies provided for in Article 38 of Directive 2009/48/EC, directly or by means of designated representatives.

6. Market access

Importers based in the European union or Switzerland shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the toy or, when that is not possible, on its packaging or in a document accompanying the toy.

The Parties mutually recognise this indication of the coordinates of the manufacturer and importer, registered trade name or registered trade mark and the address at which they can be contacted, which must be mentioned as above. For the purpose of this specific obligation, “importer” shall mean any natural or legal person established within the territory of either the European Union or Switzerland who places a toy from a third country on the European Union or on the Swiss market.

7. Harmonised standards

Switzerland recognises harmonised standards conferring a presumption of conformity with the legislation referred to in Section 1 of this Chapter. Where Switzerland considers that compliance with a harmonised standard does not entirely satisfy the requirements which are set out in the legislation listed in Section I, it shall bring the matter before the Committee and give its reasons.

The Committee shall consider the case and may ask the European Union to act in accordance with the procedure provided for in Article 14 of Directive 2009/48/EC. The Committee shall be informed of the result of the procedure.

8. Procedure for dealing with toys presenting a non-compliance that is not restricted to their national territory ( 1 )

Pursuant to Article 12(4) of this Agreement, in cases where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reasons to believe that a toy covered by Section I of the present Chapter presents a risk to the health or safety of persons, and if they consider that the non-compliance is not restricted to their national territory, they shall inform each other and the European Commission immediately of:

— the results of the evaluation they have carried out and of the actions which they have required the relevant economic operator to take;

— provisional measures taken to prohibit or restrict the toy being made available on their national market, to withdraw the toy from that market or to recall it when the relevant economic operator does not take adequate corrective action. This includes the details set out in Article 42(5) of Directive 2009/48/EC.

The market surveillance authorities of the Member States or Switzerland other than the one initiating this procedure shall inform without delay the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the toy concerned.

The Parties shall ensure that appropriate restrictive measures in respect of the toy concerned, such as withdrawal of the toy from their market, are taken without delay.

9. Safeguard procedure in case of objections against national measures

Should it disagree with the notified national measure, Switzerland or a Member State shall inform the European Commission of its objections.

Where, on completion of the procedure set out in paragraph 8 above, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State respectively, or where the European Commission considers a national measure to be non-compliant with the legislation referred to in this Chapter, the European Commission shall without delay enter into consultation with the Member States, Switzerland and the relevant economic operator or operators and shall evaluate the national measure in order to determine if it is justified or not.

In case of an agreement between the Parties on the results of their investigations, the Member States and Switzerland shall take the measures necessary to ensure that appropriate restrictive measures are taken in respect of the toy concerned, such as the withdrawal of the toy from their market, without delay.

In case of a disagreement between the Parties on the results of their investigations, the issue will be forwarded to the Committee, which may decide to have an expert study carried out.

Where the Committee considers that the measure is:

(a) unjustified, the national authority of the Member State or Switzerland which took the measure shall withdraw it;

(b) justified, the Parties shall take the measures necessary to ensure that the non-compliant toy is withdrawn from their market.

▼B

CHAPTER 4

MEDICAL DEVICES

▼M1

Section I

Legislation, regulations and administrative provisions







Provisions covered by Article 1(2) European Union 1. 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 amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1) 2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Regulation (EC) No 1882/2003 of the European Parliament and the Council of 29 September 2003 (OJ L 284, 31.10.2003. p. 1) 3. 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), as amended by Regulation (EC) No 1882/2003 of the European Parliament and the Council of 29 September 2003 (OJ L 284, 31.10.2003. p. 1) 4. Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L 131, 16.5.2002, p. 17) 5. Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, p. 43) 6. Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 22, 9.8.2012, p. 3) 7. Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, p. 41) 8. Commission Regulation (EC) No 2007/2006 of 22 December 2006 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents and amending that Regulation (OJ L 379, 28.12.2006, p. 98) 9. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (OJ L 247, 21.9.2007, p. 21) 10. Commission Decision 2011/869/EU of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (OJ L 341, 22.12.2011, p. 63) 11. Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and the Council on in-vitro diagnostic medical devices (OJ L 341, 22.12.2011, p. 50) 12. Directive 2011/65/EU of the European Parliament and the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88) 13. Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, p. 45) 14. Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, p. 28) 15. Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (OJ L 253, 25.9.2013, p. 8) Switzerland 100. Federal Law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended on 14 December 2012 (RO 2013 1493) 101. 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 20 March 2008 (RO 2008 3437) 102. Federal Law of 9 June 1977 on metrology (RO 1977 2394), as last amended on 17 June 2011 (RO 2012 6235) 103. Federal law of 22 March 1991 on radiation protection (RO 1994 1933), as last amended on 10 December 2004 (RO 2004 5391) 104. Ordinance of 17 October 2001 on medical devices (RO 2001 3487), as last amended on 11 June 2010 (RO 2010 2749) 105. Ordinance of 18 April 2007 on import, transit and export of animals and animal products (RO 2007 1847), as last amended on 4 September 2013 (RO 2013 3041) 106. Ordinance of 17 June 1996 on Accreditation and Designation of Conformity Assessment Bodies (RO 1996 1904), as last amended on 15 June 2012 (RO 2012 3631) 107. Federal Act on Data Protection of 19 June 1992 (RO 1992 1945), as last amended on 30 September 2011 (RO 2013 3215)

▼B

Section II

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

Section III

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 — 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'Industrie. Direction générale de l'industrie, des technologies 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 Generationen — Portugal: Ministerio da Saude — Finland: Sosiaali- ja terveysministeriö/Social- och hälsovårdsministeriet — 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

Section IV

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.

Section 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.

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 Switzerland for entry into the European databank.

▼B

CHAPTER 5

GAS APPLIANCES AND BOILERS

▼M1

Section 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) ▼M15 European Union 1. Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous fuels (OJ L 330, 16.12.2009, p. 10) ▼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

Section II

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

Section III

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'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 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 industriministeriet — 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

Section IV

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.

▼M15

CHAPTER 6

PRESSURE VESSELS

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)







European Union 1. Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009 relating to simple pressure vessels (OJ L 264, 8.10.2009, p. 12), as last amended by Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 (OJ L 316, 14.11.2012, p. 12) 2. Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment (OJ L 181, 9.7.1997, p. 1), as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1) 3. 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), hereinafter referred to as ‘Directive 2010/35/EU’ 4. Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13) 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), as last amended on 15 June 2012 (RO 2012 3631) 102. Ordinance of 20 November 2002 on the safety of simple pressure vessels (RO 2003 107), as last amended on 19 May 2010 (RO 2010 2583) 103. Ordinance of 20 November 2002 on the safety of pressure equipment (RO 2003 38), as last amended on 19 May 2010 (RO 2010 2583) 104. Ordinance of 31 October 2012 relating to the placing on the market of dangerous goods receptacles and the market surveillance (RO 2012 6607) 105. Ordinance of 29 November 2002 on the transport of dangerous goods by road (RO 2002 4212), as last amended on 31 October 2012 (RO 2012 6535 and 6537) 106. Ordinance of 31 October 2012 on the transport of dangerous goods by rail and cableway (RO 2012 6541)

Section II

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.

Section III

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.

Section IV

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 III to Directive 2009/105/EC, Annexes IV or V to Directive 97/23/EC or Chapter 4 of Directive 2010/35/EU.

Section V

Additional provisions

1. Simple pressure vessels and pressure equipment

It shall be sufficient for manufacturers, their authorised representatives or, where neither of these is present, 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 10 years after the last date of manufacture of the product. The Parties undertake to forward all relevant documents to the authorities of the other Party upon request.

2. Transportable pressure equipment

1. Market access

1. Pursuant to Directive 2010/35/EU or, respectively, the relevant Swiss legislation, the authorised representative shall indicate its name and address on the certificate of conformity. For the purpose of this obligation; ‘authorised representative’ shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from the manufacturer to act on his behalf in relation to specified tasks.

2. Pursuant to Directive 2010/35/EU or, respectively, the relevant Swiss legislation, the importer shall indicate its name and the address at which it can be contacted either on, or attached to the certificate of conformity. For the purpose of this obligation, ‘importer’ shall mean any natural or legal person established within the European Union or Switzerland who places transportable pressure equipment or parts thereof from a third country on the European Union or on the Swiss market.

3. For the purposes of paragraphs 1 and 2, it shall be sufficient to mention either the importer or the authorised representative.

2. Information exchange regarding technical documentation and cooperation regarding corrective action

Economic operators of Switzerland or a Member State shall, further to a reasoned request from the competent national authority of Switzerland or a Member State, provide it with all the information and documentation necessary to demonstrate the conformity of the transportable pressure equipment with Directive 2010/35/EU or the relevant Swiss legislation in a language easily understood by that authority or in English. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by transportable pressure equipment which they have placed on the market.

3. Identification of economic operators

Economic operators shall, on request from the market surveillance authority of either an EU Member State or Switzerland, identify the following to it for a period of at least 10 years:

(a) any economic operator who has supplied them with transportable pressure equipment;

(b) any economic operator to whom they have supplied transportable pressure equipment.

4. Mutual assistance of market surveillance authorities

To ensure efficient cooperation for actions concerning economic operators based in a Member State or in Switzerland, the market surveillance authorities of a Member State and Switzerland shall give each other assistance on an adequate scale by supplying information or documentation, by carrying out appropriate investigation or any other appropriate measure, by participating in investigations initiated by the other Party.

5. Procedure for dealing with transportable pressure equipment presenting a risk at national level

1. Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that a transportable pressure equipment covered by this chapter presents a risk to the health or safety of persons or to other aspects of public interest protection covered by Directive 2010/35/EU respectively the relevant Swiss legislation, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of: — the results of the evaluation and of the actions which they have required the economic operator to take. — where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the transportable pressure equipment being made available on their national market, to withdraw the equipment from that market or to recall it.

2. This information shall include all available details, in particular the data necessary for the identification of the non-compliant transportable pressure equipment, the origin of the equipment, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. Further, it shall be indicated whether the non-compliance is due to either: — failure of the transportable pressure equipment to meet requirements relating to the health or safety of persons or to other aspects of public interest protection in the legislation in section I, or — shortcomings in the standards or technical codes referred to in the legislation in section I.

3. Switzerland, or Member States other than the Member State initiating the procedure shall without delay inform the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the transportable pressure equipment concerned.

4. Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the transportable pressure equipment concerned, such as withdrawal of the transportable pressure equipment from their market, without delay.

5. Switzerland shall notify the contact details of its market surveillance authority, as well as any changes thereof, to the European Union via the Committee established under Article 10 of this Agreement.

6. Safeguard procedure

Should it disagree with the notified national measure, Switzerland or a Member State shall inform the European Commission of its objections.

1. Objections against national measures

Where, on completion of the procedure set out in paragraph 3 of section 5 above, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State or where the Commission considers a national measure to be non-compliant with the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland and the relevant economic operator or operators and shall evaluate the national measure, in order to determine whether the national measure is justified or not. If the national measure is considered:

— justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant transportable pressure equipment is withdrawn from their markets, and shall inform the Commission accordingly.

— unjustified, the Member State concerned or Switzerland shall withdraw it.

2. Disagreement between the Parties

In case of a disagreement between the Parties the issue will be forwarded to the Joint Committee, which will decide on an appropriate course of action, including the possibility to have an expert study carried out.

Where the Committee considers that the measure is:

— justified, the Parties shall take the measures necessary to ensure that the non-compliant transportable pressure equipment is withdrawn from their market.

— unjustified, the Member State or Switzerland shall withdraw it;

7. Free movement of transportable pressure equipment

Without prejudice to the procedures in paragraph 3 and 4 above, no Member State or Switzerland shall prohibit, restrict or impede on its territory the free movement, the making available on the market and the use of transportable pressure equipment, which complies with the legal provisions in Section I.

▼M1

CHAPTER 7

RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT

Section I

Legislation, regulations and administrative provisions







Provisions covered by Article 1(2) European Union 1. 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, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1) 2. Commission Decision 2000/299/EC of 6 April 2000 establishing the initial classification of radio equipment and telecommunications terminal equipment and associated identifiers (OJ L 97, 19.4.2000, p. 13) 3. Commission Decision 2000/637/EC 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) 4. Commission Decision 2001/148/EC 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) 5. Commission Decision 2005/53/EC of 25 January 2005 on the application of Article 3(3)(e) of Directive 1999/5/EC of the European Parliament and of the Council to radio equipment intended to participate in the Automatic Identification System (AIS) (OJ L 22, 26.1.2005, p. 14) 6. Commission Decision 2005/631/EC of 29 August 2005 concerning essential requirements as referred to in Directive 1999/5/EC of the European Parliament and of the Council ensuring access of Cospas-Sarsat locator beacons to emergency services (OJ L 225, 31.8.2005, p. 28) 7. Commission Decision 2013/638/EU of 12 August 2013 on essential requirements relating to marine radio communication equipment which is intended to be used on non-SOLAS vessels and to participate in the Global Maritime Distress and Safety System (GMDSS) (OJ L 296, 7.11.2013, p. 22) Switzerland 100. Federal Law of 30 April 1997 on Telecommunications (LTC); (RO 1997 2187), as last amended on 12 June 2009 (RO 2010 2617) 101. Ordinance of 14 June 2002 on Telecommunications Equipment (OIT); (RO 2002 2086), as last amended on 31 October 2012 (RO 2012 6561) 102. Ordinance of 14 June 2002 of the Federal Office of Communications (OFCOM) on Telecommunications Equipment; (RO 2002 2111), as last amended on 12 August 2013 (RO 2013 2649) 103. Annex 1 to the OFCOM Ordinance on Telecommunications 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 28 December 2012 (FF 2012 9084) 105. Ordinance of 9 March 2007 on Telecommunication Services (RO 2007 945), as last amended on 9 December 2011 (RO 2012 367)

▼B

Section II

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

Section III

Designating authorities







European Community: — Belgium: Institut belge des services postaux et des télécommunications Belgisch Instituut voor Postdiensten en Telecommunicatie — 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 Communications — Italy: Ministero delle Comunicazione (aspects CEM) Ministero dell'Industria, del Commercia e dell'Artigianato — Luxembourg: Ministère des Transports (aspects CEM) Administration des Postes et Télécommunications — Netherlands: Ministerie van Economische Zaken — Austria: Bundesministerium für Verkehr, Innovation und Technologie — Portugal: Instituto das Communicações de Portugal — Finland: Liikenne- ja viestintäministeriö/Kommunikationsministeriet — 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

Section IV

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.

Section 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 determining 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 radiocommunications 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.

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

Section I

Legislation, regulations and administrative provisions







Provisions covered by Article 1(2) European Union 1. Directive 94/9/EC of the European Parliament and of 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, as last amended by Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 (OJ L 316, 14.11.2012, p. 12) 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), as last amended on 15 June 2012 (RO 2012 3631)

▼B

Section II

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

Section III

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 — 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 industriministeriet — 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

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Section IV

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.

Section 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 COMPATIBILITY

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Section 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) ▼M15 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 16 November 2011 (RO 2011 6243) 102. Ordinance of 30 March 1994 on electrical heavy current installations (RO 1994 1199), as last amended on 16 November 2011 (RO 2011 6233) 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 electromagnetic compatibility (RO 2009 6243), as last amended on 24 August 2010 (RO 2010 3619) 105. Ordinance of 14 June 2002 on Telecommunications Equipment (OIT); (RO 2002 2086), as last amended on 31 October 2012 (RO 2012 6561) 106. List of the technical standards published in the Feuille Fédérale with titles and references, as last amended on 6 November 2012 (FF 2012 7968)

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Section II

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.

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Section III

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'Industrie. Direction Générale de l'Industrie, des Technologies de l'Information et des Postes (DIGITIP) — SQUALPI — 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 industriministeriet For EMC aspects of telecommunications and radio equipment: Liikenne-javiestintäministeriö/Kommunikatiosministeriet — 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)

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Section IV

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.

Section 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.

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

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Section 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

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Section II

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.

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Section III

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 — 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 Landscape

Section IV

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.

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CHAPTER 11

MEASURING INSTRUMENTS AND PREPACKAGES

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Section I

Legislative, regulatory and administrative provisions







Provisions covered by Article 1 paragraph 1 ▼M15 European Union 1. Council Directive 71/347/EEC of 12 October 1971 on the approximation of the laws of the Member States relating to the measuring of the standard mass per storage volume of grain (OJ L 239, 25.10.1971, p. 1), as subsequently amended 2. Council Directive 76/765/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to alcoholmeters and alcohol hydrometers (OJ L 262, 27.9.1976, p. 143), as subsequently amended 3. Council Directive 86/217/EEC of 26 May 1986 on the approximation of the laws of the Member States relating to tyre pressure gauges for motor vehicles (OJ L 152, 6.6.1986, p. 48), as subsequently amended 4. Council Directive 75/107/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as measuring containers (OJ L 42, 15.2.1975, p. 14), as subsequently amended 5. Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making up by weight or by volume of certain pre-packaged products (OJ L 46, 21.2.1976, p. 1), as subsequently amended 6. Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC (OJ L 247, 21.9.2007, p. 17) applicable as from 11 April 2009 Switzerland 100. Ordinance of 5 September 2012 on the declaration of quantities for unpackaged and prepackaged products (RS 941.204), as subsequently amended 101. Ordinance of the Federal Ministry of Justice and Police of 10 September 2012 on the declaration of quantities for unpackaged and pre-packaged products (RS 941.204.1), as subsequently amended ▼M7 Provisions covered by Article 1 paragraph 2 ▼M15 European Union 1. Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control (Recast) (OJ L 106, 28.4.2009, p. 7) 2. Council Directive 71/317/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to 5 to 50 kilogramme medium accuracy rectangular bar weights and 1 to 10 kilogramme medium accuracy cylindrical weights (OJ L 202, 6.9.1971, p. 14) 3. Council Directive 74/148/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to weights of from 1 mg to 50 kg of above-medium accuracy (OJ L 84, 28.3.1974, p. 3) 4. Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40) as last amended by Directive 2009/3/EC of the European Parliament and of the Council of 11 March 2009 (OJ L 114, 7.5.2009, p. 10) 5. Council Directive 76/766/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to alcohol tables (OJ L 262, 27.9.1976, p. 149) 6. Directive 2009/23/EC of the European Parliament and of the Council of 23 April 2009 on non-automatic weighing instruments (OJ L 122, 16.5.2009, p. 6), as last amended by Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 (OJ L 316, 14.11.2012, p. 12) 7. European Parliament and Council Directive 2004/22/EC of 31 March 2004 on measuring instruments (2004/22/EC) (OJ L 135, 30.4.2004, p. 1) Switzerland 102. Federal Law of 17 June 2011 on metrology (RO 2012 6235) 103. Ordinance of 23 November 1994 on units measurement (RO 1994 3109), as last amended on 7 December 2012 (RO 2012 7193) 104. Ordinance of 15 February 2006 concerning measuring instruments (RO 2006 1453), as last amended on 7 December 2012 (RO 2012 7207) 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 7 December 2012 (RO 2012 7183) 106. Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measuring instruments of length (RO 2006 1433), as last amended on 7 December 2012 (RO 2012 7183) 107. Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measure of volume (RO 2006 1525), as last amended on 7 December 2012 (RO 2012 7183) 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 7 December 2012 (RO 2012 7183) 109. Ordinance of the federal Ministry of Justice and Police of 19 March 2006 on automatic weighing instruments (RO 2006 1545), as last amended on 7 December 2012 (RO 2012 7183) 110. Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on instruments for thermal energy (RO 2006 1569), as last amended on 7 December 2012 (RO 2012 7183) 111. Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measuring instruments for gas quantities (RO 2006 1591), as last amended on 7 December 2012 (RO 2012 7183) 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), as last amended on 7 December 2012 (RO 2012 7183) 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), as last amended on 7 December 2012 (RO 2012 7183) 114. Ordinance of 15 August 1986 on weights (RO 1986 2022), as last amended on 7 December 2012 (RO 2012 7183) ▼M7

Section II

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.

Section III

Designating authorities







Provisions covered by Article 1 paragraph 1 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: 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 industriministeriet — 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 — Portugal: — Finland: Kauppa- ja teollisuusministeriö/Handels- och industriministeriet — 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)

Section IV

Special rules relating to the designation of conformity assessment bodies

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For the designation of conformity assessment bodies, designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Annex V to Directive 2009/23/EC and in Article 12 to Directive 2004/22/EC, as regards the products covered by those Directives.

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Section V

Supplementary provisions

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1. Information exchange

The conformity assessment bodies recognised under this Agreement 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 2009/23/EC.

The conformity assessment bodies recognised under this Agreement may request the information provided for in point 1.6 of Annex II to Directive 2009/23/EC.

2. Prepackages

Switzerland shall recognise checks carried out in accordance with the provisions of European Union legislation listed in section I by a European Union body recognised under this Agreement in the case of European Union prepackages placed on the market in Switzerland.

As regards statistical checking of the quantities declared on prepackages, the European Union shall recognise the Swiss method laid down in Annex 3 Point 7 of the Ordinance of 5 September 2012 on the declaration of quantities for unpackaged and prepackaged products (RS 941.204) as equivalent to the European Union 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 prepackages conform to European Union legislation and have been checked according to the Swiss method shall affix the ‘e’ mark on their products exported to the EU.

3. Marking

3.1. For the purposes of this Agreement, the provisions of Directive 2009/34/EC of 23 April 2009 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 point 3.2.1 of Annex II refers, are supplemented by the following drawing:

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 EC 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 2009/34/EC of 23 April 2009.

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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.

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CHAPTER 12

MOTOR VEHICLES

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Section 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 (EU) No 195/2013 of the Commission of 7 March 2013 (OJ L 65, 8.3.2013, p. 1), and taking into account the acts listed in Annex IV of Directive 2007/46/EC, as amended until 1 December 2013 (hereinafter together referred to as ‘Framework Directive 2007/46/EC’) Switzerland 100. Ordinance of 19 June 1995 relating to the technical requirements for power-driven transportation vehicles and their trailers (RO 1995 4145), as amended until 30 November 2012 (RO 2012 7137) 101. Ordinance of 19 June 1995 relating to the type approval of road vehicles (RO 1995 3997), as amended until 7 December 2012 (RO 2012 7065) and taking into account amendments accepted according to the procedure described in Section V, paragraph 1

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Section II

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.

Section III

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.

Section IV

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.

Section V

Supplementary provisions

The provisions of this Section shall apply exclusively to relations between Switzerland and the European Union.

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1. Amendments to Annex IV respectively to acts listed in Annex IV of Directive 2007/46/EC

Without prejudice to article 12(2), the European Union shall notify Switzerland of amendments to Annex IV and to acts listed in Annex IV of Directive 2007/46/EC after 1 December 2013 without delay after their publication in the Official Journal of the European Union.

Switzerland shall notify the European Union without delay of the relevant amendments of the Swiss legislation, at the latest by the date of application of these amendments in the European Union.

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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 Switzerland’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 Switzerland fail to adapt its legislation to all the European Union type-approval legislation in force.

4. Safeguard clauses

1. Vehicles, systems, components or separate technical units in compliance with the applicable legislation

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, Switzerland 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. Vehicles, systems, components or separate technical units not in conformity with the approved type

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 technical units, as the case may be, are brought into conformity with the approved type. The approval authority of that Member State or Switzerland 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 respecte