Rs 0.946.526.81 Agreement Of 21 June 1999 Between The Swiss Confederation And The European Community On Mutual Recognition Of Conformity Assessment (With Annexes And Final Act)

Original Language Title: RS 0.946.526.81 Accord du 21 juin 1999 entre la Confédération suisse et la Communauté européenne relatif à la reconnaissance mutuelle en matière d’évaluation de la conformité (avec annexes et acte final)

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0.946.526.81 original text agreement between the Swiss Confederation and the Community European relative to the MRA on conformity assessment concluded on 21 June 1999 and approved by the Federal Assembly on 8 October 1999 of Swiss ratification deposited on 16 October 2000, entered into force on 1 June 2002 (State April 14, 2015) the Swiss Confederation, hereinafter referred to as the Switzerland etla European Community, hereinafter referred to as the community, both hereinafter referred to as the Parties, considering the close relations which exist between the community and Switzerland, whereas the free trade agreement of 22 July 1972 between the Switzerland and the European economic community, willing to enter into an agreement allowing mutual recognition of the results of mandatory procedures for assessment of conformity for the access to the respective markets of the Parties , whereas the recognition of conformity assessment to facilitate trade between the Parties, in respect of the protection of health, safety, the environment or consumers, considering that an approximation of laws facilitates mutual recognition, considering their obligations as Contracting Parties to the agreement establishing the WTO of the trade, and in particular the agreement on technical barriers to the trade which encourages the negotiation of mutual recognition agreements, considering that mutual recognition agreements contribute to harmonization at the international level of technical regulations, standards and principles governing the implementation of conformity assessment procedures, whereas the close relationship between the community and the Switzerland on the one hand, and the Iceland, the Liechtenstein and Norway on the other , make it appropriate to the conclusion of parallel agreements between those countries and the Switzerland, have agreed to conclude the following agreement: art. 1 object 1. The community and the Switzerland mutually accept reports, certificates, authorisations and marks of conformity issued by bodies recognised in accordance with the procedures laid down by this agreement (hereinafter referred to as "recognised conformity assessment bodies") and the declarations of conformity of the manufacturer, certifying compliance with the requirements of the other party in the fields covered by art. 3 2. So as to avoid the duplication of procedures, when the Swiss requirements are considered to be equivalent to Community requirements, the community and the Switzerland mutually accept reports, certificates and authorizations issued by assessment bodies of recognized conformity and declarations of conformity of the manufacturer, certifying compliance with their respective requirements in the areas covered by art. 3. the reports, certificates, authorizations and statements of conformity of the manufacturer includes the compliance with Community legislation. Conformity marks required by the legislation of a party must be affixed to products put on the market in this part.
3. the Committee referred to in art. 10 sets the application cases of the by. 2. new term according to art. 1 c. 1 i of the Ac. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).
New term according to art. 1 c. 1 ii of the Ac. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).

Art. 2 definitions 1. For the purposes of this agreement, means: 'conformity assessment', systematic review of the extent to which a product, process or service meet the requirements specified.
"conformity assessment body", entity of public law or private whose activities are intended execution of all or part of the conformity assessment process.
"appointing authority", appointing authority the power to appoint or to revoke, suspend or restore conformity assessment bodies under its jurisdiction.
2. the definitions established by the ISO and IEC can be used to determine the meaning of general terms relating to the conformity assessment used in this agreement.

New content according to art. 1 No. 2 of the Ac. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).

Art. 3 scope of application 1. This agreement concerns the mandatory procedures of conformity assessment as a result of the legislative, regulatory and administrative provisions listed in annex 1.
2. Annex 1 defines the sectors of products covered by this agreement. This appendix is divided into sectoral chapters, themselves generally subdivided as follows: Section I: provisions legislative, regulatory and administrative; Section II: conformity assessment bodies; Section III: the authorities of designation; Section IV: specific principles for the designation of conformity assessment bodies; Section V: possibly additional provisions.

3. Annex 2 defines the General principles for the designation of bodies.

Art. 4Origine the provisions of this agreement apply to the products covered by this agreement, regardless of their origin.

New content according to art. 1 c. 3 HQ. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).

Art. The Parties recognized conformity assessment 5Organismes recognize that the conformity assessment bodies recognized in accordance with the procedure provided for by art. 11. meet the requirements for the assessment of conformity.

New content according to art. 1 c. 4 HQ. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).

Art. Designation 6autorites 1. The Parties agree that their designation authorities have the power and the skills necessary to proceed with the designation of bodies for conformity assessment to the revocation, suspension or recovery of bodies appointed under their jurisdiction.
2. for the designation of conformity assessment bodies, designation authorities follow the General principles of designation in annex 2, subject to the provisions of section IV of Schedule 1. These authorities follow the same principles for revocation, suspension and restoration.

New content according to art. 1 c. 5 HQ. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).

Art. 7 verification of designation procedures 1. Each Party shall provide to the other party information about the procedures used to ensure respect for the General principles of designation in annex 2, subject to the provisions of section IV of Schedule 1, recognized conformity assessment bodies under its jurisdiction.
2. the Parties compare their methods of verification of the conformity of organizations to the General principles of designation in annex 2, subject to the provisions of section IV of Schedule 1. Accreditation systems of the organizations existing in parts conformity assessment can be used in these comparisons.
3. the audit is carried out according to the procedure that will be implemented by the Committee in accordance with art. 10 below.

New term according to art. 1 c. 6 HQ. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).

Art. 8 verification of 1 conformity assessment bodies. Each party has the right, in exceptional circumstances, to contest the technical competence of the conformity assessment bodies proposed by the other party or recognized and placed under the jurisdiction of the other party.
Such a challenge should be the subject of one written justification objective and well-argued, addressed to the other party...
2. in case of disagreement between the Parties, confirmed to the breast of an Audit Committee, according to the requirements of the technical competence of the contested conformity assessment body is carried out jointly by the Parties, with the participation of the competent authorities concerned.
The result of this verification is discussed in the Committee to arrive at a solution as soon as.
3. each party ensures the availability of assessment bodies of compliance under its jurisdiction for conducting audits of their technical competence according to the requirements.
4. unless otherwise decided by the Committee, the disputed body is suspended by the appointing authority competent from the observation of the disagreement until an agreement is reached in the Committee. This suspension is reported in the common list of conformity assessment bodies recognized in annex 1.

New term according to art. 1 ch. 7 HQ i. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).
Terms abrogated by art. 1 ch. 7 ii of HQ. Dec 22. 2006, with effect from Feb. 1. 2007 (2007 713 RO).
Sentence introduced by art. 1 ch. 7 HQ iii. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).

Art. 9 implementation of the agreement 1. The Parties work together to ensure the satisfactory application of the legislative, regulatory and administrative provisions listed in annex 1.

2. the designation authorities ensure by appropriate means of respect for the General principles of designation set out in annex 2, subject to the provisions of section IV of annex 1, of the conformity assessment bodies recognized, placed under their jurisdiction.
3. the conformity assessment bodies recognized cooperate in an appropriate way in the work of coordination and comparison conducted by each of the Parties for the sectors covered by Annex 1, with a view to uniform application of procedures of conformity assessment provided for in the legislation of the Parties subject to this agreement. The designation authorities are trying to ensure that the conformity assessment bodies recognized cooperate appropriately.

New term according to art. 1 ch. 8 HQ i. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).
New term according to art. 1 ch. 8 ii of the Ac. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).
Sentence introduced by art. 1 ch. 8 ii of the Ac. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).

Art. 10 Committee 1. There is established a Committee for the mutual recognition of conformity assessment (referred to as the Committee) consisting of representatives of the Parties who is responsible for the management of the agreement and ensures its functioning. For this purpose it recommendations and take decisions in the cases provided for by this agreement. It shall act by mutual agreement.
2. the Committee shall establish its rules of procedure, which contains, among other provisions, procedures for convening meetings, designation of the President and the definition of its mandate.
3. the Committee meets as needed and at least once a year. Each party may request the convening of a meeting.
4. the Committee shall decide on any question relating to this agreement. It is in particular responsible: has) the establishment of the procedure for the realization of the audits provided for in art. 7; b) of the establishment of the procedure for the realization of the audits provided for in art. 8; c) recognition or non conformity assessment organizations challenged under art. 8; d) the withdrawal or not recognized conformity assessment organizations challenged under art. 8; e) review of the legislative, regulatory and administrative provisions that the parties will be provided in accordance with art. 12, to assess the implications for the agreement and to modify the appropriate schedule 1 sections.

5. the Committee may, upon proposal of either party, amend the annexes to this agreement.

New content according to art. 1 c. 9 HQ. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).

Art. 11Reconnaissance, withdrawal of recognition, changes in the scope of activity and suspension of 1 conformity assessment bodies. The following procedure applies to the recognition of conformity assessment on the basis of the requirements laid down in the corresponding chapters of annex 1: has) a party that wishes to make known a conformity assessment body shall notify its proposal in writing to the other party, by joining its application necessaires.b information) if the other party accepts the proposal or raises no objection within a period of sixty days from the notification the conformity assessment body is deemed recognized under art. 5.c) if the other party raises objections in writing within the period of sixty days, art. 8 applies.

2. a party may withdraw, suspend or reinstate the recognition of a conformity assessment body under its jurisdiction. It shall immediately notify its decision in writing to the other party, indicating the date of its decision. The withdrawal, suspension or recovery takes effect at this date. The withdrawal or suspension is reported in the common list of annex 1 conformity assessment bodies.
3. a party may propose that the scope of an assessment agency of conformity recognised, placed under its jurisdiction, be amended. For extensions or reductions in field of activity, the procedures provided for in art. 11, paragraphs 1 and 2, shall apply respectively.
4. a party may, under these circumstances, challenge the technical competence of a conformity assessment body recognized, under the jurisdiction of the other party. In this case, art. 8 applies.
5. the reports, certificates, authorisations and marks of conformity issued by a body in the conformity assessment after the date of withdrawal or suspension of the recognition should not be recognized by the parties. Reports, certificates, authorisations and marks of conformity issued by a body in the conformity assessment prior to withdrawal of its recognition continue to be recognized by the parties, unless the competent appointing authority has restricted or cancelled their validity. The part in the jurisdiction of which operates the appointing authority shall notify the other party in writing of this type, which changes on a restriction or cancellation of validity.

New content according to art. 1 c. 10 kt. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).

Art. 12 exchange of information 1. The Parties exchange any useful information on the 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 plans to make to the legislative, regulatory, and administrative for the purpose of the agreement and shall provide in writing, no later than 60 days before their entry into force, the new provisions.
2. each Party shall inform the other party in writing of the changes have occurred regarding its designation authorities and competent authorities.
3 where the legislation of a party provides that certain information must be kept available to the competent authority by a person established in its territory, the competent authority may also apply to the authority of the other party or directly to the manufacturer or, where appropriate, its agent established within the territory of the other party for this information.
4. each Party shall immediately inform the other party of the measures taken on its territory.

Terms introduced by art. 1 c. 11 HQ i. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).
Introduced by art. 1 c. 11 ii of the Ac. Dec 22. 2006, in force since Feb. 1. 2007 (2007 713 RO).

Art. 13 privacy representatives, experts and other agents of the Parties shall, even after the termination of their functions, not to disclose information obtained under this agreement, which is covered by professional secrecy. These can be used for different purposes from those provided for by this agreement.

Art. 14 settlement of disputes each party may submit to the Committee a dispute relating to the interpretation or application of this agreement. It endeavours to settle the dispute. All relevant information to allow for a thorough review of the situation to find an acceptable solution are provided to the Committee. For this purpose, the Committee considered the possibilities to maintain the good functioning of this agreement.

Art. 15 agreements with States the third, Parties agree that agreements of mutual recognition established by each party with all countries to this agreement, in any case, cannot create obligations for the other party in terms of acceptance of the declarations of conformity of the manufacturer, as well as reports, certificates, authorisations and marks issued by that third country compliance assessment bodies formal unless agreed between the Parties.

Art. 16 annexes the annexes to this agreement are an integral part.

Art. 17 territorial application this agreement applies, on the one hand, to the territories where the Treaty establishing the European Community applies under the conditions laid down in that Treaty, and to the territory of the Switzerland.

Art. 18 revision 1. If a party wishes to a revision of the agreement, she informs the Committee. The modification of this agreement will be implemented after the completion of the respective internal procedures parts.
2. the Committee may, on proposal of a party, amend Schedules 1 and 2 of this agreement.

Art. 19 suspension if a party finds that the other party does not respect the conditions of this agreement, it may, after consultation within the Committee, suspend partially or totally the application of annex 1.

Art. 20. the Parties acquired rights continue to recognize the reports, certificates, authorisations, marks of conformity and declarations of conformity of the manufacturer issued before the expiry of this agreement in accordance with this, insofar as demand for the work of conformity assessment were made before the notification of renewal or denunciation of this agreement.

Art. 21 entry into force and duration


1. this agreement will be ratified or approved by the Parties according to specific procedures. It comes into force on the first day of the second month following the last notification of deposit of the instruments of ratification or approval of all the following seven agreements: - agreement on mutual recognition of conformity assessment, - agreement on the free movement of persons, - the agreement on air transport, - agreement on the transport of goods and passengers by rail and road , - agreement on trade in agricultural products, - agreement on certain aspects of government procurement -, agreement on scientific and technological cooperation.

2. this agreement is concluded for an initial period of seven years. It is renewed for an indefinite period unless the community or the Switzerland does notify the opposite party, before the expiry of the initial period. In the event of notification, the provisions of the by. 4 apply.
3. the community or the Switzerland may denounce this agreement by notifying its decision to the other party. In the event of notification, the provisions of the by. 4 apply.
4. the seven agreements referred in the by. 1 cease to be applicable six months after receipt of the notification to the affected renewal to the by. 2 or the denunciation referred to the by. 3. made in Luxembourg, the twenty and a June year millet nine hundred and ninety-nine, in duplicate, in the languages German, English, Danish, Spanish, Finnish, French, Greek, Italian, Dutch, Portuguese and Swedish, each of these texts being equally authentic.

For the Confederation Switzerland Pascal Couchepin SCRS Deiss for the Community European Joschka Fischer Hans van der Broek RS 0.142.112.681 RS 0.748.127.192.68 RS 0.740.72 RS 0.916.026.81 RS 0.172.052.68 RS 0.420.513.1 Annex I this annex product areas is divided into chapters corresponding to the different sectors following: Chapter 1 MachinesChapitre 2 individuelleChapitre 3 JouetsChapitre 4 devices Medicauxchapitre protection equipment 5 appliances to gas and Chaudiereschapitre 6 devices to pressionChapitre 7 radio equipment and Terminal Telecommunicationschapitre equipment 8 devices and protection systems for use in atmosphere 9 electrical explosibleChapitre and compatibility Electromagnetiquechapitre 10 gear and equipment chantierChapitre 11 Measuring Instruments and Preemballageschapitre 12 moteurChapitre 13 tractors or forestiersChapitre 14 good vehicles practices laboratory (BPL) Chapter 15 GMP Inspection of medicines and certification of the lotsChapitre 16 products constructionChapitre 17 AscenseursChapitre 18 products biocidesChapitre 19 facilities to Cableschapitre 20 explosives for civil use Chapter 1 machinery Section I legislative provisions regulatory and administrative provisions covered by art. 1, by. 2 European union 1. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 relating to the machinery and amending directive 95/16/EC (recast) (OJ L 157 of the 9.6.2006, p. 24), amended last 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 machines for the application of pesticides (JO L 310 of the 25.11.2009 (, p. 29) Switzerland 100. Federal law of June 12, 2009 on the safety of products (RO 2010 2573) 101. Order of 19 May 2010 on the safety of products (RO 2010 2583) 102. Order of 2 April 2008 on the safety of machines (RO 2008 1785), amended last April 20, 2011 (RO 2011 1755) assessment of compliance the Committee Section II bodies established by art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV special principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect general principles of annex 2 to this agreement as well as the evaluation criteria set out in annex XI to directive 2006/42/EC.

Section V supplementary provisions 1. Second-hand machines the legislative, regulatory and administrative provisions referred to in section I shall not apply to second-hand machines.
The principle stated in art. 1, by. 2, of the present agreement is applicable to machines that were legally placed on the market and/or put into service in the territory of one of the Parties and which are exported as second-hand machines on the market of the other party.
The other provisions relating to second-hand machines, such as those relating to safety in the workplace, in force in the importing State still apply.

2. Exchange of information in accordance with art. 9 of this agreement, the parties exchange the information necessary for the correct application of this chapter.
The parties undertake to provide, at the request of the authorities of the other party, all of the relevant technical documentation.

3. person authorized in the technical dossier, mentioned in the declaration of conformity for machinery the declaration of conformity for machines must include the name and address of the person authorized to the technical dossier, it has to be established on the territory of the party concerned.
The parties mutually recognize this person. The manufacturer, his agent or, in the absence of these, the person responsible for placing on the market of the products in the territory of one of the parties does not have the obligation to designate a person responsible for the technical file on the territory of the other party.

Chapter 2 protection equipment individual Section I legislative, regulatory and administrative provisions referred to in art. 1, by. 2 European union 1. Directive 89/686/EEC of the Council of 21 December 1989 on the approximation of the laws of the Member States relating to the individual protection equipment (OJ L 399 of the 30.12.1989, p. 18), amended lastly by Regulation (EU) No. 1025/2012 of the European Parliament and of the Council of 25 October 2012 (OJ L 316 of the 14.11.2012, p. 12) Switzerland 100. Federal law of June 12, 2009 on the safety of products (RO 2010 2573) 101. Order of 19 May 2010 on the safety of products (RO 2010 2583) Section II the Committee conformity assessment bodies established by art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV specific principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect the General principles set out in Appendix 2 of this agreement, as well as the evaluation criteria set out in annex V to the directive 89/686/EEC.

Chapter 3 toys Section I provisions, legislative, regulatory and administrative provisions covered by art. 1, by. 2 European union 1. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 relating to the safety of toys (OJ L 170 of the 30.6.2009, p. 1), as amended in the last place by the Regulation (EU) n 681/2013 the Commission (JO L 195 of the 18.7.2013, p. 16) (hereinafter referred to as 'directive 2009/48/EC') Switzerland 100. Federal law of 9 October 1992 on foodstuffs and customary objects (RO 1995 1469), amended last November 9, 2011 (RO 2011 5227) 101. Order of 23 November 2005 on foodstuffs and customary objects (RO 2005 5451), amended last October 23, 2013 (RO 2013 3669) 102. Ordinance of the federal Department of the Interior (DFI) of August 15, 2012 on the safety of toys (RO 2012 4717), as last amended on 25 November 2013 (RO 2013 5297) 103. Order the DFI of 23 November 2005 on the implementation of legislation on foodstuffs (RO 2005 6555), last modified August 15, 2012 (RO 2012 4855) 104. Order of June 17, 1996, on the Swiss of accreditation system and the designation of laboratories testing and assessment bodies in compliance, record and approval (RO 1996 1904), last amended June 1, 2012 (2012 2887 RO) Section II the Committee set up by the art compliance assessment bodies. 10 of this agreement establishes and maintains, according to the procedure referred to in art. 11 of the agreement, a list of the conformity assessment bodies.

Section III designation authorities the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV special principles for the designation of conformity assessment bodies


For the designation of conformity assessment bodies, designation authorities respect the General principles set out in Appendix 2 of this agreement, as well as art. 24 of directive 2009/48/EC.

Section V supplementary provisions 1. Exchange of information on the certificate of conformity and the technical documentation of the Switzerland or the Member States market surveillance authorities, on reasoned request, invite a manufacturer established on the territory of the Switzerland or of a Member State to provide the technical documentation or a translation of parts of it. Surveillance of the market of the Member States and the Switzerland authorities can ask a manufacturer established in the EU or in Switzerland to provide the relevant parts of the technical documentation, written in an official language of the requesting authority or in English.
When a supervisory authority of the market demand to a manufacturer to provide the technical documentation or a translation of parts of it may require to do within a period of 30 days, unless a shorter deadline is justified because of a serious and immediate risk.
If the manufacturer established on the territory of the Switzerland or of a Member State does not respect this provision, the market surveillance authority may require him to perform a test by a body notified, at its own expense and within a specific time frame, in order to verify the respect of the harmonised standards and essential requirements.

2 requests for information to designated organizations surveillance of the market of the Member States with the Switzerland authorities may ask an organization designated in Switzerland or in a Member State to provide information concerning any type examination certificate that it has issued or withdrawn, or any refusal to issue such a certificate, including the test reports and technical documentation.

3. obligations of the agencies designated pursuant to art information. 36, by. 2, of the directive 2009/48/EC, designated agencies provide other agencies designated under this Agreement who perform similar activities of conformity assessment covering the same toys relevant information on issues relating to negative and, on request, to the positive results of the conformity assessment.

4. sharing of experience Swiss authorities may participate in the exchange of experience between national authorities of Member States responsible for the policy of notification referred to in art. 37 of directive 2009/48/EC.

5. coordination of the designated bodies Swiss conformity assessment bodies may participate in the mechanisms of coordination and cooperation and to the group or groups of notified bodies provided for in art. 38 of directive 2009/48/EC, directly or through agents.

6. market access importers established in the territory of the European Union or of the Switzerland show on the toy their name, their name or their trademark and the address at which they can be contacted or, when this is not possible, on its packaging or in a document accompanying the toy.
The Parties acknowledge each other this indication of the address of the manufacturer and the importer, their name or their trademark and the address at which they can be contacted, that should be mentioned as stated above. For the purposes of this specific obligation, importer means any natural or legal person established on the territory of the European Union or the Switzerland that puts a toy from a third country on the market of the European Union or of the Switzerland.

7. harmonised standards the Switzerland recognizes the harmonised standards giving a presumption of conformity to the legislation referred to in section 1 of this chapter. When the Switzerland considers that conformity with a harmonised standard does not entirely satisfy the requirements set out in the legislation referred to in section I, it must seize the Committee setting out the reasons.
The Committee examines the issue and may ask the European Union to act in accordance with the procedure laid down in art. 14 of directive 2009/48/EC. The Committee was informed of the outcome of the procedure.

8. procedure applicable to toys presenting a nonconformance that is not limited to the national territory in accordance with art. 12, by. 4, of the present agreement, in cases where the market of a Member State supervisory authorities the Switzerland took measures or have sufficient reason to believe that a toy covered by section I of this chapter presents a risk to the health or safety of persons, and if they consider that non-compliance is not limited to their national territory , they inform each other and the Commission as soon as possible: - of the results of the assessment they have and what they have required the economic operator concerned; - measures interim taken to prohibit or restrict the making available of the toy on the national market, to withdraw it from the market or to recall it when the economic operator concerned does not take appropriate corrective measures. The information provided for in art. 42, by. notably, 5, of directive 2009/48/EC should be provided.

The supervisory authorities of the market of the Member States or the Switzerland other than those that have committed this procedure shall immediately inform the European Commission and the other national authorities of any measures adopted and of any additional information available to them in what concerns the non-compliance of the toy concerned.
The Parties shall ensure that appropriate restrictive measures, such as the withdrawal of the toy concerned of their market, are taken as soon as possible.

9. procedure of backup in case of objections against national measures so the Switzerland or a Member State disputed the notified national measure, it must inform the European Commission of its objections.
When, at the end of the procedure set in point 8 above, objections are issued by a Member State or Switzerland against a measure taken by a Member State, or by the Switzerland respectively, or when the European Commission considers that a national measure is not in conformity with the legislation referred to in this chapter, the latter committed without delay consultations with the Member States , the Switzerland and the economic operators concerned and proceeds to the evaluation of the national measure in order to determine whether it is justified or not.
In the event of agreement between the Parties on the results of their investigations, the Member States and the Switzerland take the necessary measures to ensure the immediate implementation of the appropriate restrictive measures, such as the withdrawal of the toy from their market.
In case of disagreement between the Parties on the results of their investigations, the matter is referred to the Committee, which may decide to carry out a study by experts.
When the Committee considers that the measure is: a) unjustified, the national authority of the Member State or the Switzerland who took her place to remove; b) justified, the Parties take the necessary measures to ensure the withdrawal of the non-compliant toy from their market.

Statement of the European Commission in order to ensure the effective application of the chapter 3 'toys' and in accordance with the statement by the Council on the participation of the Switzerland to the committees, the European Commission will consult Swiss experts in the preparatory phases of the proposals for measures to be submitted later to the Committee set up by art. 47, per. 1, directive 2009/48/EC.

Chapter 4 devices medical Section I legislative, regulatory and administrative provisions referred to in art. 1, by. 2 European union 1. 90/385/EEC Council directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, modified by Regulation (EC) n. 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284 of the 31.10.2003, p. 1) 2. Directive 93/42/EEC of the Council of 14 June 1993 on medical devices, modified by Regulation (EC) n. 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284 of the 31.10.2003, p. 1) 3. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on medical devices for diagnosis in vitro (OJ L 331 of the 7.12.1998, p. 1), amended by Regulation (EC) n. 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284 of the 31.10.2003, p. 1) 4. 2002/364/EC Commission decision of 7 May 2002 on common technical specifications of the medical devices in-vitro (JO L 131 of the 16.5.2002, p. 17) 5. 2003/12/EC of the Commission of 3 February 2003 on the reclassification of breast implants in the context of directive 93/42/EEC medical devices (OJ L 28 of the 4.2.2003, p. 43)


6 Regulation (EU) No. 722/2012 the Commission of 8 August 2012 on the special requirements in which the requirements laid down in directives 90/385/EEC and 93/42/EEC of the Council for active implantable medical devices and medical devices manufactured from tissues of animal origin (OJ L 22 of the 9.8.2012, p. 3) 7. Directive 2005/50/EC of the Commission of 11 August 2005 on the reclassification of joint replacements of the hip, knee and shoulder under directive 93/42/EEC on medical devices (OJ L 210 of the 12.8.2005, p. 41) 8. Regulation (EC) n 2006/2007 of the Commission of 22 December 2006 establishing the application of Regulation (EC) n 1774/2002 of the European Parliament and the Council regards the importation and transit of certain intermediate products derived from category 3 material intended for technical uses in medical devices, products for diagnosis in vitro and laboratory reagents and amending that Regulation (OJ L 379 of the 28.12.2006 (, p. 98) 9. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending directive 90/385/EEC of the Council concerning the approximation of the laws of the Member States relating to active implantable medical devices directive 93/42/EEC of the Council on medical devices and directive 98/8/EC on the placing on the market (OJ L 247 of 21.9.2007 the biocidal products (, p. 21) 10. 2011-869-EU Commission decision of December 20, 2011, amending decision 2002/364/EC of common technical specifications of the medical devices in-vitro (OJ L 341 of the 22.12.2011, p. 63) 11. 2011/100/EU Commission directive of December 20, 2011, amending the directive 98/79/EC of the European Parliament and the Council on medical devices for diagnosis in vitro (OJ L 341 of the 22.12.2011, p. 50) 12. Directive 65/2011/EU of the European Parliament and of the Council of 8 June 2011 on limiting the use of certain hazardous substances in electrical and electronic equipment (OJ L 174 of the 1.7.2011, p. 88) 13. 2010/227/EU Commission decision of 19 April 2010 on the European database on medical devices (decision) (OJ L 102 of the 23.4.2010, p. 45) 14. Regulation (EU) No. 207/2012 Commission March 9, 2012 the electronic instructions for use of medical devices (OJ L 72 of the 10.3.2012, p. 28) 15. Implementing Regulation (EU) n 920/2013 the Commission of September 24, 2013 on the designation and the control of notified bodies on the basis of directive 90/385/EEC of the Council concerning active implantable medical devices and the directive 93/42/EEC of the Council on medical devices (OJ L 253 of the 25.9.2013, p. 8) Switzerland 100. Federal law of 15 December 2000 on drugs and medical devices (RO 2001 2790), amended last December 14, 2012 (RO 2013 1493) 101. Federal law of June 24, 1902, concerning electrical installations in low and high current (RO 19 252 and RS 4 798), modified in last place March 20, 2008 (RO 2008 3437) 102. Federal law of June 9, 1977 on Metrology (RO 1977 2394), as last amended on June 17, 2011 (OR 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. Order of 17 October 2001 on medical devices (RO 2001 3487), last modified on 11 June 2010 (RO 2010 2749) 105. Order of 18 April 2007 concerning the import, transit and export of animals and animal products (RIGHT) (RO 2007 1847), last modified September 4, 2013 (RO 2013 3041) 106. Order of 17 June 1996 on accreditation and designation (RO 1996 1904), amended last June 15, 2012 (RO 2012 3631) 107. Federal law of June 19, 1992, on the protection of data (LPD) (RO 1992 1945), as last amended on 30 September 2011 (RO 2013 3215) Section II the Committee compliance assessment bodies established by art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV specific principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect the General principles set out in Appendix 2 of this agreement, as well as the evaluation criteria set out in annex XI to directive 93/42/EEC, in annex VIII of directive 90/385/EEC and in annex IX of directive 98/79/EC , regarding the agencies designated under these directives.

Section V supplementary provisions 1. Record of the person responsible for the placing of devices on the market any manufacturer or his agent who puts on the market of one of the Parties the medical devices referred to in art. 14 of the directive 93/42/EEC or art. 10 of directive 98/79/EC shall notify the competent authorities of the party in which it has its head office planned information those articles. The Parties mutually acknowledge this record. The manufacturer is not required to designate a person responsible for the placing on the market established in the territory of the other party.

2. labeling of medical devices for the labelling of medical devices referred to in annex I, point 13.3) and directive 93/42/EEC for medical devices for diagnosis in vitro provided for in annex I, point 8.4 has), the directive 98/79/EC, the manufacturers of the two Parties indicate their name or their company name as well as their address. They are not required to indicate, on labelling, the outer packaging or instructions for use, the name and address of the person responsible for the placing on the market, of the agent or the importer established in the territory of the other party.
Regarding devices imported from third countries to be distributed in the community and in Switzerland, labelling, the outer packaging or instructions for use contains name and address of the unique representative of the established manufacturer, as the case may be, in the community or in Switzerland.

3. Exchange of information in accordance with art. 9 of the agreement, the Parties exchange including the information provided for in art. 8 of the directive 90/385/EEC, art. 10 of directive 93/42/EEC and art. 11 of directive 98/79/EC.

4 European database the competent Swiss authorities access to European databases established by art. 12 of directive 98/79/EC and art. 14 of directive 93/42/EEC. They pass on to the Commission or to the body responsible for the management of the data bank the information referred such art. and collected by the Switzerland to be integrated in the European database.

Chapter 5 devices in gas and boilers Section I provisions legislative, regulatory and administrative provisions covered by art. 1, by. 1 European union 1. Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 on gas (OJ L 330 of the 16.12.2009, p. 10) Switzerland 100 appliances. Order of 16 December 1985 on the protection of air (appendices 3 and 4) (RS 814.318.142.1) and subsequent amendments provisions covered by art. 1, by. 2 European union 2. 90/396/EEC Council directive of 29 June 1990 on the approximation of the laws of the Member States regarding gas appliances, amended last place by directive 93/68/EEC of the Council of 22 July 1993 (OJ L 220 of the 30.8.1993, p. 1) Switzerland 101. Federal law of June 12, 2009 on the safety of products (RO 2010 2573) 102. Order of 19 May 2010 on the safety of products (RO 2010 2583) Section II the Committee conformity assessment bodies established by art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV specific principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect the General principles set out in Appendix 2 of this agreement, as well as the evaluation criteria set out in annex V to directive 90/396/EEC.

Chapter 6 devices to pressure Section I provisions legislative, regulatory and administrative provisions covered by art. 1, by. 2 European union 1. Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009 (OJ L 264 of the 8.10.2009, p. 12) simple pressure vessels, as last amended by the Regulation (EU) No. 1025/2012 to the European Parliament and of the Council of 25 October 2012 (OJ L 316 of the 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 regarding the equipment under pressure (OJ L 181 of the 9.7.1997, p. 1), last amended place by Regulation (EC) n. 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284 of 31.10.2003 the (, p. 1) 3. Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on the transportable pressure equipment and repealing the directives of the Council 76/767 / EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165 of the 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 of the 30.9.2008, p. 13) Switzerland 100. Federal law of June 12, 2009 on the safety of products (RO 2010 2573) 101. Order of 19 May 2010 on the safety of products (RO 2010 2583), amended last June 15, 2012 (RO 2012 3631) 102. Order of 20 November 2002 on the safety of pressure vessels simple (RO 2003 107), last modified may 19, 2010 (RO 2010 2583) 103. Order of 20 November 2002 on the safety of pressure equipment (RO 2003 38), last modified may 19, 2010 (RO 2010 2583) 104. Ordinance of 31 October 2012 to the placing on the market and the market surveillance of containers of dangerous goods (RO 2012 6607) 105. Order of 29 November 2002 relating to the transport of dangerous goods by road (RO 2002 4212), amended last held October 31, 2012 (2012 6535 and 6537 RO) 106. Order of October 31, 2012, on the transport of dangerous goods by rail and installation cables (RO 2012 6541) assessment of compliance the Committee Section II bodies established by art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV specific principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect the General principles set out in Appendix 2 of this agreement as well as the evaluation criteria defined in annex III of the directive 2009/105/EC, annex IV or V of the directive 97/23/EC or Chapter 4 of directive 2010/35/EU.

Section V supplementary provisions 1. Containers to simple pressure and pressure equipment with regard to technical documentation to the national authorities for inspection purposes, just as manufacturers, their agents or, in the absence of these, those responsible for the placing on the market hold this documentation available on the territory of one of the Parties for a period of at least ten years from the last date of manufacture of the product. The Parties undertake to provide all relevant documentation at the request of the authorities of the other party.

2. 1 transportable pressure equipment. 1 market access. Directive 2010/35/EU or to the relevant Swiss legislation, the agent shows his name and address on the certificate of conformity. For the purposes of this obligation, "representative" means an individual person established in the EU or in Switzerland who received a mandate written from a manufacturer to act on its behalf for the purposes of tasks determinees.2. Directive 2010/35/EU or Swiss legislation relevant, the importer indicates the name and the address at which it can be reached either on the certificate of conformity or on a document attached to the certificate. For the purposes of this obligation, means "importer" any physical or legal person established in the EU or in Switzerland that puts a transportable pressure or elements of such equipment equipment from a third country on the market of the European Union or on the suisse.3 market. For the purposes of by. 1 and 2, it is sufficient to mention the importer or the agent.

2 Exchange of information regarding the technical documentation and cooperation together measures correctivesLes economic operators of Switzerland or of a Member State, at the request substantiated of a competent national authority of the Switzerland or a Member State, he shall communicate all information and documents necessary to demonstrate the conformity of the equipment with the 2010/35/EU directive or with the relevant Swiss legislation in a language easily understandable by that authority or in English. At the request of this authority, they cooperate on any measure to eliminate the risks posed by transportable pressure equipment which they have made available on the market.

((3 identification of economic operators at the request of the supervisory authority of the market of a Member State of the European Union or of the Switzerland, economic operators identify the authority, for a period of at least ten 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 by the authorities of market surveillance to ensure effective cooperation regarding measures related to economic operators based in a Member State or in Switzerland, surveillance of the market of a Member State with the Switzerland authorities to provide mutual assistance, a suitable range, by providing information or documentation by searching or by taking any other appropriate measure and by participating in investigations initiated by the other party.

5. procedure for transportable pressure equipment that pose a risk at national level 1. In accordance with art. 12, by. 4, of this agreement, when surveillance of the market of a Member State or of the Switzerland authorities have taken measures or have sufficient reason to believe that transportable pressure equipment covered by the present chapter presents a risk to the health or safety of persons or to other aspects of public interest protection covered by the directive 2010/35/EU or Swiss legislation , and if they consider that the non-compliance is not limited to the national territory, they shall inform without delay the Commission, other Member States and the Switzerland: - results of the assessment that they have done and what they have required the economic operator to take, - when the economic operator concerned does not take corrective measures that are necessary, all appropriate provisional measures to prohibit or restrict the making available of their market transportable pressure equipment national, to withdraw it from the market or to remind.

2. the information contains all the available information, including the data necessary to identify the non-compliant transportable pressure equipment, its origin, the nature of the alleged non-compliance and the risk involved, as well as nature and the duration of the national measures taken and the arguments put forward by the economic operator concerned. In addition, it is indicated if the non-compliance of the transportable pressure equipment is linked:-to comply with requirements relating to the health or safety of persons or to other aspects relating to the protection of the public interest defined in the law of section I, or-shortcomings in the standards or technical codes referred in law of section I.

3. the Switzerland or the Member States other than the Member State which initiated the procedure shall immediately inform the European Commission and the other national authorities of any measures adopted and of any additional information available to them in what concerns the conformity of the pressure equipment portable so.4. Member States and the Switzerland shall ensure that appropriate restrictive measures, such as the withdrawal of their market, are taken without delay against the pressure equipment portable concerne.5. The Switzerland shall notify the European Union details of its supervisory authority of the market, as well as any subsequent changes to these coordinates, through the Committee established under art. 10 of this agreement.

6. procedure of backup if the Switzerland or a Member State disputed the notified national measure, it must inform the European Commission of its objections.


1 objections to measures nationalesLorsque, at the end of the procedure set out in point 5, by. 3 above, objections are issued by a Member State or Switzerland against a measure taken by the Switzerland or a Member State, respectively, or when the Commission European considers that a national measure is not in conformity with the legislation referred to in section I, the latter committed without delay consultations with the Member States, the Switzerland and the economic operators concerned and to the assessment of the national to determine measure if It is justified or not. If the national measure is: - justified, all Member States and the Switzerland take the necessary measures to ensure the withdrawal of their market non-compliant transportable pressure equipment and shall inform the Commission, - unjustified, the Member State concerned or the Switzerland removes it.

2 disagreement between the PartiesEn case of disagreement between the Parties, the matter will be submitted to the Joint Committee, which will decide on a line of conduct, including the opportunity to carry out a study by experts.
When the Committee considers that the measure is: - justified, the Parties take the necessary measures to ensure the withdrawal of non-compliant for their market transportable pressure equipment, - unjustified, the Member State concerned or the Switzerland removes it.

7. free movement of transportable pressure equipment without prejudice to the procedures laid down in the by. 3 and 4, neither the Member States nor the Switzerland don't prohibit, don't restrict or hamper the free movement, making available on the market or use in their territory of transportable pressure equipment in accordance with the legal provisions of section I.

Chapter 7 equipment radio and terminal equipment of telecommunications Section I provisions legislative, regulatory and administrative provisions covered by art. 1, by. 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) n. 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284 of the 31.10.2003, p. 1) 2. 2000/299/EC Commission decision of 6 April 2000 establishing the initial classification of radio equipment and Terminal telecommunications equipment and associated identifiers (OJ L 97 of the 19.4.2000, p. 13) 3. 2000/637/EC Commission decision of 22 September 2000 on the application of art. 3, by. 3, point e), of the directive 1999/5/EC to radio equipment subject to the regional agreement on the radiotelephony services in inland navigation (JO L 269 of the 21.10.2000, p. 50) 4. 2001/148/EC Commission decision of 21 February 2001 on the application of art. 3, by. 3, point e), of the directive 1999/5/EC on the tags of avalanche (OJ L 55 of the 24.2.2001, p. 65) 5. Decision 2005/53/EC of the Commission of 25 January 2005 on the application of art. 3, by. 3, point e), of the directive 1999/5/EC of the European Parliament and of the Council to radio equipment intended to participate in the automatic identification system (Automatic Identification System (AIS) (OJ L 22 of the 26.1.2005, p. 14) 6. 2005/631/EC Commission decision of 29 August 2005 concerning essential requirements covered by the directive 1999/5/EC of the European Parliament and of the Council ensuring access of emergency services to the locator beacons Cospas-Sarsat (JO L 225 of the 31.8.2005, p. 28) 7. Decision 2013/638 / EU Commission on August 12, 2013, for the essential requirements relating to marine radio equipment intended to be used on ships not subject to the SOLAS convention to participate in the global system distress and safety at sea (GMDSS) (OJ L 296, the 7.11.2013, p. 22) Switzerland 100. Federal law of 30 April 1997 on telecommunications (LTC); (RO 1997 2187,) which amended last June 12, 2009 (RO 2010 2617) 101. Order of 14 June 2002 on telecommunications facilities (ILO); (RO 2002 2086,) which amended last October 31, 2012 (RO 2012 6561) 102. Order of 14 June 2002 of the federal Office of communications (OFCOM) on telecommunications facilities; (RO 2002 2111,) which changed last August 12, 2013 (RO 2013 2649) 103. Annex 1 of the Ordinance of OFCOM on the facilities of telecommunication (RO 2002 2115), as last amended on 21 November 2005 (RO 2005 5139) 104. List of technical standards published in the Federal Gazette, with the titles and references, last modified December 28, 2012 (FF 2012 9084) 105. Order of March 9, 2007 on telecommunications (RO 2007 945), as last amended December 9, 2011 (OR 2012 367) Section II the Committee compliance assessment bodies established by art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV specific principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect the General principles set out in Appendix 2 of this agreement, as well as the evaluation criteria defined in annex VI of directive 1999/5/EC.

Section V supplementary provisions 1. AAGR the Switzerland participates in the work of the AAGR and its subgroups as an observer.

2 market surveillance the Parties to notify the names of the authorities established on their territory which are charged the surveillance tasks related to the execution of their legislation referred to in section I.
The Parties learn about the activities in the field of monitoring the market as part of the bodies provided for this purpose.

3 interfaces regulated Parties learn about the interfaces which they have regulated their territory. When establishing the equivalence between notified interfaces and the determination of the category identifiers, the European Community considers the interfaces regulated in Switzerland.

4 interfaces offered by operators of public networks of telecommunications the Parties learn about the interfaces offered their territory by operators of public telecommunications networks.

5. application of the essential when the Commission plans to adopt a decision to apply an requirement in art. 3, by. 3, of directive 1999/5/EC, consult the Switzerland on the issue before it is formally submitted to the Committee.
When the Switzerland plans to adopt a technical and administrative requirement to apply an requirement in art. 7, by. 4, of the Ordinance on telecommunications facilities, it shall consult the Committee on the issue before it is formally submitted to the Committee.

6. authorization to disconnect when one of the Parties considers as a unit, declared in accordance with its legislation, causes serious damage to a network or radio disturbances, or prejudice to the network or its functioning, and that she allowed the operator to refuse connection, to disconnect or to cease providing the service for this installation, it communicates this authorization to the other party.

7 harmonized standards where the Switzerland considers that conformity with a harmonised standard does not ensure compliance with the essential requirements of the legislation referred to in section I, she informed the Committee by stating the reasons.
The Committee examines the issue and may request the European Community to act in accordance with the procedure laid down in art. 5 of directive 1999/5/EC. The Committee was informed of the outcome of the procedure.

8. mutual information about radiocommunication facilities meet the requirements that are not intended to be used in the spectrum of one of the Parties when one of the Parties stop any appropriate measure intended to prohibit or restrict the placing on its market, and/or to demand the withdrawal from its market, of radio equipment, including types of radio equipment that caused or which it reasonably considers that they will cause harmful interference, including interference with existing services or planned on the bands of frequencies allocated at national level, it shall inform the other party in him giving the reasons and specifying the countries concerned.

9 safeguard clause concerning industrial products


9.1. when a party takes a measure to ban on its market of a declared in line with directive 1999/5/EC telecommunication facility, it shall immediately inform the other party indicating the reasons for its decision and stating how the non-compliance has been constatee.9.2. The Parties examine the extent and the evidence brought to their attention and to inform each other of the results of their investigations.9.3. If agreement on the results of their investigations, the Parties shall take appropriate measures to ensure that the products in question are not put on the marche.9.4. In the event of disagreement as to the results of their investigations, the case is submitted to the Committee, who may decide to perform an expertise.9.5. When only the Committee considers that the measure is: a) unjustified, the national authority of the party who took her place to remove; b) justified, the Parties shall take appropriate measures to ensure that the products in question are not placed on the market.

Chapter 8 devices and protection systems for use in atmosphere explosive Section I legislative, regulatory and administrative provisions referred to in art. 1, by. 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 for devices and protection systems for use in explosive atmospheres, amended last by the European regulation (EU) No. 1025/2012 of the Parliament and of the Council of 25 October 2012 (OJ L 316 of the 14.11.2012 (, p. 12) Switzerland 100. Federal law of June 24, 1902, concerning electrical installations in low and high current (RO 19 252 and RS 4 798), modified in last place March 20, 2008 (RO 2008 3437) 101. Order of 2 March 1998 on devices and protection systems for use in explosive atmospheres (RO 1998 963), last modified on 11 June 2010 (RO 2010 2749) 102. Federal law of June 12, 2009 on the safety of products (RO 2010 2573) 103. Order of 19 May 2010 on the safety of products (RO 2010 2583), last amended 15 June 2012 (2012 3631 RO) Section II the Committee compliance assessment bodies established by art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV specific principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect the General principles set out in Appendix 2 of this agreement, as well as the evaluation criteria set out in annex XI to directive 94/9/EC.

Section V supplementary provisions 1. Exchange of information conformity assessment bodies recognised under this Agreement shall communicate to other agencies of the conformity assessment certificates of review information type "CE" and add-ins that they have issued or withdrawn, and information concerning approvals of quality system they have issued or withdrawn, in accordance with the provisions, respectively, of annex III point 7, of annex IV, point 6, and annex VII, point 6, of directive 94/9/EC. They are also at the disposal of other agencies of the conformity assessment certificates of examination schedules 'EC' type that they have issued, in accordance with annex III, point 8, of the 94/9/EC directive.

2. technical documentation regarding the technical documentation necessary to the national authorities for inspection purposes, just as manufacturers, their agents or, in the absence of these, those responsible for the placing on the market hold this documentation available on the territory of one of the Parties for a period of at least ten years from the last date of manufacture of the product.
The Parties undertake to transmit all the relevant technical documentation at the request of the authorities of the other party.

Chapter 9 electrical equipment and compatibility electromagnetic Section I legislative, regulatory and administrative provisions referred to in art. 1, by. 2 European union 1. Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the approximation of the laws of Member States relating to electrical equipment designed to be used within certain limits of voltage (JO L 374 of the 27.12.2006, p. 10) 2. Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States regarding electromagnetic compatibility and repealing directive 89/336/EEC (OJ L 390 of 31.12.2004, p. 24) Switzerland 100. Federal law of June 24, 1902, concerning electrical installations in low and high current (RO 19 252 and RS 4 798), modified in last place March 20, 2008 (RO 2008 3437) 101. Order of 30 March 1994 on the electric current installations low (RO 1994 1185), amended last November 16, 2011 (RO 2011 6243) 102. Order of 30 March 1994 on the electric current installations fort (RO 1994 1199), amended last November 16, 2011 (RO 2011 6233) 103. Order of 9 April 1997 on the hardware electric low voltage (RO 1997 1016), changed last June 11, 2010 (RO 2010 2749) 104. Order of 18 November 2009 on the electromagnetic compatibility (RO 2009 6243), last modified August 24, 2010 (RO 2010 3619) 105. Order of 14 June 2002 on telecommunications facilities (ILO); (RO 2002 2086,) which amended last October 31, 2012 (RO 2012 6561) 106. List of technical standards published in the Federal Gazette, with the titles and references, as last amended November 6, 2012 (2012 7968 FF) assessment of compliance the Committee Section II bodies established by art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV specific principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect the General principles set out in Appendix 2 of this agreement, as well as the evaluation criteria defined in annex VI of directive 2004/108/EC.

Section V supplementary provisions 1. Technical documentation regarding the technical documentation necessary to the national authorities for inspection purposes, simply that manufacturers, their agents or individuals responsible for the placing on the market, keep this documentation available on the territory of one of the Parties for a period of at least ten years from the last date of manufacture of the product.
The Parties undertake to provide all relevant documentation at the request of the authorities of the other party.

2. indication of the name and address of the manufacturer just for manufacturers, their agents or, in the absence of these, those responsible for the market established in the territory of one of the Parties to indicate their name or company name as well as their address, in accordance with art. 9, by. 2 of the directive 2004/108/EC. They are not required to be established or to appoint a representative on the territory of the party where the products are placed on the market to meet this requirement.

3. organizations of standardization in accordance with art. 11 of the directive 2006/95/EC, the Parties themselves shall notify the names of law enforcement agencies to establish the standards referred to in art. 5 of the directive.

4. notified bodies the Parties will notify and recognize each other law enforcement agencies to establish technical reports and/or certificates in accordance with art. 8, by. 2, and art. 9, by. 3, of the directive 2006/95/EC, as well as agencies of the duties provided for in annex III to directive 2004/108/EC.

5. safeguard clause when a party takes a measure to ban on its market of a product in accordance with directive 2004/108/EC, it shall immediately inform the other party indicating the reasons for its decision and stating how the non-compliance has occurred.
The Parties examine the extent and the evidence brought to their attention and to inform each other of the results of their investigations.
In case of agreement on the results of their investigations, the Parties shall take appropriate measures to ensure that the products in question are not placed on the market.
In the event of disagreement as to the results of their investigations, the case is submitted to the Committee, who may decide to carry out an expertise.
When only the Committee considers that the measure is:

((a) unjustified, the national authority of the party who took it is required to remove it; b) justified, the Parties shall take appropriate measures to ensure that the products in question are not placed on the market.

Chapter 10 equipment and materials of construction Section I provisions legislative, regulatory and administrative provisions covered by art. 1, by. 2 European union 1. 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 of the materials to be used outside buildings (JO L 162 of the 3.7.2000, p. 1), amended by directive 2005/88/EC of the European Parliament and of the Council of 14 December 2005 (OJ L 344 of the 27.12.2005 (, p. 44) and its corrigendum (OJ L 165 of the 17.6.2006, p. 35) Switzerland 100. Order of May 22, 2007 on noise emissions of materials intended to be used outdoors (RO 2007 2827) assessment of compliance the Committee Section II bodies established by art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV specific principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect the General principles set out in Appendix 2 of this agreement, as well as the evaluation criteria defined in annex IX to directive 2000/14/EC of the European Parliament and of the Council.

Section V supplementary provisions 1. Location of the manufacturer by derogation from the provisions of art. 4 of directive 2000/14/EC, it is sufficient that the manufacturer, his agent or, in the absence of these, the person responsible for the placing on the market or the commissioning of the equipment is established on the territory of one of the Parties.

2. Exchange of information in accordance with art. 9 of the agreement, the Parties exchange including the information referred to in art. 9 and art. 14, by. 3, of the directive 2000/14/EC.
Furthermore, conformity assessment bodies recognised under this Agreement shall communicate to other agencies of the conformity assessment information on approvals of insurance system of the quality that they have issued or withdrawn, in accordance with the provisions of annex VIII, point 6, of directive 2000/14/EC.

3. collection of data on noise the Swiss competent authorities have access to the data bank established by art. 16 of directive 2000/14/EC. They pass on to the Commission or to the body responsible for the management of this database the information referred to in art. and collected by the Switzerland to be included in the data bank.

Chapter 11 Instruments of measurement and prepackages Section I provisions legislative, regulatory and administrative provisions covered by art. 1, by. 1 European union 1. 71/347/EEC Council directive of 12 October 1971 on the approximation of the laws of the Member States relating to the measuring of the mass to the hectolitre of cereals (OJ L 239 of the 25.10.1971, p. 1) and subsequent amendments 2. 76/765/EEC Council directive of 27 July 1976 on the approximation of the laws of the Member States relating to alcoholmeters and hydrometers for alcohol (JO L 262 of the 27.9.1976, p. 143) and subsequent changes 3. 86/217/EEC Council directive of 26 May 1986 on the approximation of laws of the Member States relating to the pressure gauges for tyres of motor vehicles (OJ L 152 of the 6.6.1986, p. 48) and subsequent amendments 4. 75/107/EEC Council directive of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as containers-measures (OJ L 42 of the 15.2.1975, p. 14) and subsequent amendments 5. 76/211/EEC Council directive of 20 January 1976 on the approximation of the laws of Member States concerning pre-adaptation mass or volume of certain products in prepackages (OJ L 46 of the 21.2.1976, p. 1) and subsequent amendments 6. Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 laying down rules on the nominal quantities of prepackages products, repealing directives 75/106/EEC and 80/232/EEC of the Council and amending the directive 76/211/EEC of the Council (OJ L 247 of the 21.9.2007, p. 17), effective as of April 11, 2009, Switzerland, 100. Order of 5 September 2012 on the statements of quantity in the sale in bulk and on the pre-packages (RS 941.204) and subsequent amendments 101. Ordinance of the federal Department of justice and police (FDJP) of 10 September 2012 on the statements of quantity in the sale in bulk and on the pre-packages (RS 941.204.1) and subsequent amendments provisions covered by art. 1, by. 2 European union 1. Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 on the common provisions to measuring instruments and methods of metrological control (recast) (OJ L 106 of the 28.4.2009, p. 7) 2. 71/317/EEC Council directive of 26 July 1971 on the approximation of the laws of Member States relating to rectangular weights of accuracy of 5 to 50 kilograms and cylindrical weights of average precision of 1 gram to 10 kilogram (JO L 202 of the 6.9.1971, p. 14) 3. 74/148/EEC Council directive of 4 March 1974 on the approximation of the laws of the Member States relating to weights from 1 mg to 50 kg with a precision greater than the average precision (OJ L 84 of the 28.3.1974, p. 3) 4. Directive 80/181/EEC of the Council of 20 December 1979 on the approximation of the legislation of States relating to units of measurement and repealing directive 71/354/EEC (OJ L 39 of the 15.2.1980, p. 40), amended last by directive 2009/3/EC of the European Parliament and of the Council of March 11, 2009 (OJ L 114 of 7.5.2009 the (, p. 10) 5. 76/766/EEC Council directive of 27 July 1976 on the approximation of the laws of the Member States relating to alcoholimetric tables (JO L 262 of the 27.9.1976, p. 149) 6. Directive 2009/23/EC of the European Parliament and of the Council of 23 April 2009 on the instruments of weighing in non-automatic operation (JO L 122 of the 16.5.2009, p. 6), as last amended by the Regulation (EU) No. 1025/2012 to the European Parliament and of the Council of 25 October 2012 (OJ L 316 of the 14.11.2012, p. 12) 7. Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring (OJ L 135 of the 30.4.2004, p. 1) Switzerland 102 instruments. Federal law of June 17, 2011 on Metrology (RO 2012 6235) 103. Order of 23 November 1994 (RO 1994 3109) units, amended last December 7, 2012 (RO 2012 7193) 104. Order of 15 February 2006 on the measuring instruments (RO 2006 1453), amended last December 7, 2012 (RO 2012 7207) 105. Ordinance of the federal Department of justice and police (FDJP) of 16 April 2004 on instruments weighing in non automatic operation (RO 2004 2093), lastly amended on 7 December 2012 (RO 2012 7183) 106. Ordinance of the federal Department of justice and police (FDJP) on March 19, 2006, on instruments of measure of length (RO 2006 1433), lastly amended on 7 December 2012 (RO 2012 7183) 107. Ordinance of the federal Department of justice and police (FDJP) on March 19, 2006, on volume measures (RO 2006 1525), as last amended on 7 December 2012 (RO 2012 7183) 108. Ordinance of the federal Department of justice and police (FDJP) on March 19, 2006, on the sets of measurement and measuring instruments of liquids other than water (RO 2006 1533), as last amended on 7 December 2012 (RO 2012 7183) 109. Ordinance of the federal Department of justice and police (FDJP) on March 19, 2006, on instruments weighing to automatic operation (RO 2006 1545), lastly amended on 7 December 2012 (RO 2012 7183) 110. Ordinance of the federal Department of justice and police (FDJP) on March 19, 2006 on measuring instruments of thermal energy (RO 2006 1569), lastly amended on 7 December 2012 (RO 2012 7183) 111. Ordinance of the federal Department of justice and police (FDJP) on March 19, 2006 on measures of quantities of gas (RO 2006 1591), as last amended on 7 December 2012 (RO 2012 7183) 112. Ordinance of the federal Department of justice and police (FDJP) on March 19, 2006, on devices measurers of exhaust gas of combustion engines (RO 2006 1599), lastly amended on 7 December 2012 (RO 2012 7183) 113. Ordinance of the federal Department of justice and police (FDJP) on March 19, 2006, on the measuring instruments of energy and electric power (RO 2006 1613), lastly amended on 7 December 2012 (RO 2012 7183) 114. The order of August 15, 1986 on the weight (RO 1986 2022), last modified 7 December 2012 (RO 2012 7183) Section II the Committee compliance assessment bodies set up by the art. 10 of this agreement establishes and maintains, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.


Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV specific principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect the General principles set out in Appendix 2 of this agreement as well as the evaluation criteria defined in annex V of the directive 2009/23/EC and art. 12 of the directive 2004/22/EC, which concerns the products of these guidelines.

Section V supplementary provisions 1. Exchange of information the conformity assessment bodies recognized under this agreement periodically make available to the Member States and the competent Swiss authorities the information referred to in annex II, point 1.5, of the directive 2009/23/EC.
Conformity assessment bodies recognised under this agreement may request the information referred to in annex II, point 1.6, to directive 2009/23/EC.

2. prepackages the Switzerland recognises the controls carried out in accordance with the legislation of the European Union referred to in section I by a body of the European Union recognized under this agreement for the placing on the market, in Switzerland, of prepackages of the Union European.
Regarding statistical control quantities declared on prepackages, the European Union recognizes the Swiss method defined in annex 3, point 7, of the order of 5 September 2012 on the statements of quantity in the sale in bulk and on the pre-packages (RS 941.204) as equivalent to the method of the European Union defined in annex II to directive 75/106/EEC and annex II to directive 76/211/EEC such as modified by directive 78/891/EEC. Swiss producers whose prepackages conform to the legislation of the European Union and which were controlled on the basis of the Swiss method put the 'e' marking on their products exported to the European Union.

3 marking 3.1. For the purposes of this agreement, the directive 2009/34/EC of 23 April 2009 is adapted as follows: a) to annex I, point 3.1, first indent, and annex II, point 3.1.1.1 has), first indent, the text in brackets is supplemented by the following text: "CH for the Switzerland"; b) referred to in annex II, point 3.2.1 drawings are complemented by the drawing below : 3.2. By derogation from art. 1 of this agreement, the rules on the marking for measuring instruments placed on the Swiss market are the following: the marking to be affixed is the marking "THIS" and the supplementary metrology marking or the national sign of the Member State of the European Union concerned, in accordance with Annex I, point 3.1, first indent, and annex II, point 3.1.1.1, first indent «, the directive 2009/34/EC of 23 April 2009.»

4 measuring instruments covered by the directive 2004/22/EC 4.1 Exchange of information, market surveillance and cooperation Administrativeconformement to art. 18 of the directive 2004/22/EC, the competent authorities of the Member States and the Switzerland lend each other assistance in the fulfilment of their obligations of market surveillance.
In particular, the competent authorities Exchange: - information about the level of compliance with the provisions of the directive 2004/22/EC of the instruments that they have reviewed, as well as the results of these reviews, - certificates of review 'EC' type and the test certificate "CE" of design issued by notified bodies, as well as their annexes and addenda, amendments and withdrawals relating to certificates already issued - the quality system approvals issued by notified, bodies as well as information concerning quality systems for which approval has been refused or withdrawn, - evaluation reports established by notified bodies, when they are required by other authorities.

Member States and the Switzerland shall ensure that all the necessary information concerning the certificates and approvals of quality systems are made available to bodies they have notified.
Each Party shall provide to the other party the names of the competent authorities it has designated for such exchange of information.
4.2 technical documentation and declaration of Conformiteen regard to technical documentation and statements of compliance necessary to the national authorities for inspection purposes, it is enough that manufacturers, their agents or individuals responsible for the placing on the market are available to these documents on the territory of one of the Parties for a period of at least ten years from the last date of manufacture of the product.
The Parties undertake to provide all relevant documentation at the request of the authorities of the other party.

Chapter 12 automotive Section I provisions legislative, regulatory and administrative provisions covered by art. 1, by. 2 European union 1. Directive 2007/46 / EC of the Parliament European and of the Council of 5 September 2007 establishing a framework for the reception of vehicles to engine, their trailers and systems, components and technical units intended for such vehicles (framework directive) (OJ L 263 of the 9.10.2007, p. 1), amended lastly by Regulation (EU) No 195/2013 March 7, 2013 (OJ L 65 of the 8.3.2013 Commission (, p. 1) and taking into account the acts listed in annex IV of directive 2007/46/EC, such as amended until December 1, 2013 (hereinafter designated together "framework directive 2007/46/EC") Switzerland 100. Order of 19 June 1995 concerning technical requirements for motor vehicles of transport and their trailers (RO 1995 4145), such as modified until November 30, 2012 (RO 2012 7137) 101. Ordinance of 19 June 1995 on the type-approval of road vehicles (RO 1995 3997), as amended up to December 7, 2012 (RO 2012 7065) and taking into account the changes accepted in accordance with the procedure described in section V, by. 1 section II assessment bodies of compliance the Committee set up by art. 10 of this agreement establishes and maintains, according to the procedure described in art. 11 of the agreement, a list of the conformity assessment bodies.

Section III designation authorities the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the parties.

Section IV special principles for the designation of the bodies of the conformity assessment for the designation of conformity assessment bodies, designation authorities refer to their legislative, regulatory and administrative provisions listed in section I, respective.

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

1. changes to schedule IV or the acts listed in annex IV of directive 2007/46/EC without prejudice to art. 12, by. 2, the European Union shall notify without delay to the Switzerland, after their publication in the Official Journal of the European Union, changes made after December 1, 2013, to annex IV to directive 2007/46/EC or the acts listed there.
The Switzerland shall notify without delay to the European Union relevant changes to Swiss law, no later than the date of application of these changes in the European Union."

2 Exchange of information the authorities responsible for the Switzerland and Member States type approval exchange, in particular, the information referred to in art. 8, by. 5 to 8, framework directive 2007/46/EC.
In case of refusal, the Switzerland or a Member State, to receipt by type in accordance with art. 8, by. 3, of the framework directive 2007/46/EC, the State concerned immediately send to the other Member States, to the Switzerland and the Commission, a detailed file explaining the reasons for its decision and establishing proof of its findings.

3. recognition of receipt by type of vehicles the Switzerland recognizes also the type-approval of vehicles granted before the entry into force of this agreement in accordance with directive 70/156/EEC of the Council of 6 February 1970 (OJ L 42 of 23.2.1970, p. 1), as amended last by directive 2007/37/EC of the Commission on June 21, 2007 (JO L 161 of the 22.6.2007 (, p. 60), by the authorities responsible for type-approval when this approval is still valid in the European Union.
The European Union acknowledges the Switzerland type approval when the prescriptions of the Switzerland are deemed equivalent to those of the framework directive 2007/46/EC.
The recognition of type-approval issued by the Switzerland is suspended if the Switzerland fails to adapt its legislation to all the legislation of European Union rules on type-approval.

4 clauses of backup vehicles, systems, components or separate technical units in accordance with the applicable legislation

1. If a Member State or the Switzerland finds that new vehicles, systems, components or separate technical units, although in line with the regulations applicable or properly marked, present a serious risk to road safety, or affect severely the environment or public health, the State concerned may, for a maximum period of six months, refuse to register such vehicles or to permit the sale or putting into service on its territory of such vehicles components or separate technical units.
In such cases, the Member State concerned or the Switzerland shall immediately notify its decision to the manufacturer, to the other Member States, to the Switzerland and the Commission, stating the reasons on which its decision is based.
2. the Commission and the Switzerland consult the parties concerned as soon as possible and, in particular, their own authorities which granted the type-approval. The Committee shall be kept informed and, where necessary, engages appropriate consultations to achieve a settlement.
Vehicles, systems, components or separate technical units not conform to the approved type 1. If, having granted type-approval, a Member State or the Switzerland finds that of new vehicles, systems, components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the approved type, he or she takes the necessary measures, including, if necessary, the withdrawal of type-approval, to ensure that such vehicles systems, components or separate technical units of production are made in conformity with the approved type. The authority of that Member State or the responsible for Switzerland of the reception shall notify the responsible authorities of the receiving Member States and/or Switzerland of the measures it has taken.
2. for the purposes of the by. 1, deviations from the data contained in the type-approval certificate or the information package shall constitute a case of non-conformity to the approved type.
A vehicle may be regarded as not in line with the approved type when a margin of tolerance is permitted by the applicable regulatory acts and that this margin of tolerance is respected.
3. If a Member State or the Switzerland demonstrates that new vehicles, components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the approved type, it may request the Member State or the Switzerland which has granted the approval by type to check that vehicles systems, components or separate technical units in production continue to meet the approved type. Receipt of such a request, the Member State concerned or the Switzerland committed the required action as soon as possible and, in any case, within six months of the date of the request.
4. the authority responsible for receiving application to the Member State or the Switzerland which granted type-approval of the system, component, separate technical unit or the incomplete vehicle to take the necessary measures to ensure that vehicles in production are made in conformity with the type approved in the following cases: has) as part of a vehicle type-approval (when the non-conformity of a vehicle is attributable exclusively to the non-conformity of a system, a component or a separate technical unit; b) as part of a multi-stage type-approval, where the non-compliance of a complete vehicle is attributable exclusively to the non-compliance of a system, a component or a separate technical unit being part of the incomplete vehicle, or of the incomplete vehicle itself.

Upon receiving such a request, the Member State concerned or the Switzerland takes the necessary measures, as appropriate in consultation with the Member State making the request or Switzerland, as soon as possible and, in any case, within six months of the date of the application. If non-compliance is established, the responsible authority of the receipt of the Member State or the Switzerland which granted the system, of the component or the separate technical unit type-approval or the approval of the incomplete vehicle shall take the measures indicated in the by. 1 5. Receiving authorities inform each other, within 20 working days of any withdrawal of type-approval and of the reasons for this withdrawal.
6. If the Member State or the Switzerland which granted type-approval disputes non-compliance which it is notified, the Member States concerned and the Switzerland are working to settle the dispute. The Committee shall be kept informed and, where necessary, engages appropriate consultations to achieve a settlement.

Chapter 13 tractors or forest Section I provisions legislative, regulatory and administrative provisions covered by art. 1, by. 2 European union 1. 76/432/EEC Council directive of 6 April 1976 on the approximation of the laws of Member States relating to the braking of agricultural tractors or foresters wheeled, amended last by directive 97/54/EC of the European Parliament and of the Council of 23 September 1997 (OJ L 277 of the 10.10.1997, p. 24) 2. Directive 76/763/EEC of the Council, July 27, 1976, on the approximation of the laws of the Member States relating to the seats of farm tractors or foresters wheeled conveyor, amended lastly by directive 52/2010/EU of the Commission on August 11, 2010 (JO L 213 of the 13.8.2010, p. 37), 3. Directive 77/537/EEC of the Council of 28 June 1977 on the approximation of the laws of the Member States relating to measures to be taken against the emission of pollutants from Diesel engines intended for the propulsion of agricultural or forestry wheeled tractors, as last amended by directive 97/54/EC of the European Parliament and of the Council of 23 September 1997 (OJ L 277 of 10.10.1997 the (, p. 24) 4. 78/764/EEC Council directive of 25 July 1978 on the approximation of the laws of Member States relating to the driver's seat of the farm tractors or foresters wheeled, amended last by directive 2006/96/EC of the Council of 20 November 2006 (OJ L 363 of the 20.12.2006, p. 81) 5. Directive 80/720/EEC of the Council, of 24 June 1980, concerning the approximation of the laws of the Member States relating to manoeuvring space, to the ease of access to the driving position as well as the doors and windows of tractors or foresters to wheels, amended lastly by directive 2010/62/EU Commission on September 8, 2010 (OJ L 238 of the 9.9.2010 (, p. 7) 6. 86/297/EEC Council directive of 26 May 1986 on the approximation of the laws of Member States relating to the power take of tractors and their protection, as last amended by the 2012/24/EU Commission directive of October 8, 2012 (JO L 274 of the 9.10.2012, p. 24) 7. Directive 86/298/EEC of the Council of 26 May 1986 on devices of protection, mounted at the rear, in the event of reversal of agricultural and forestry tractors, wheeled, narrow gauge, amended last by the 2010/22/EU Commission directive of March 15, 2010 (OJ L 91 of the 10.4.2010, p. 1), 8. Directive 86/415/EEC of the Council of 24 July 1986 on the installation, location, operation and identification of controls of tractors or foresters to wheels, as last amended by directive 2010/22/EU Commission on March 15, 2010 (OJ L 91 of the 10.4.2010, p. 1), 9. Directive 87/402/EEC of the Council of 25 June 1987 on protective devices in case of reversal, mounted at the front of agricultural and forestry tractors, wheeled, narrow gauge, amended last by the 2010/22/EU Commission directive of March 15, 2010 (OJ L 91 of the 10.4.2010, p. 1), 10. Directive 2000/25 / EC of the European Parliament and of the Council of 22 May 2000 on measures to be taken against the emissions of gaseous pollutants and polluting particles from engines intended for the propulsion of agricultural or forestry tractors and amending directive 74/150/EEC of the Council, amended lastly by directive 2011/87/EU of the European Parliament and of the Council of 16 November 2011 (OJ L 301 of the 18.11.2011 (, p. 1) 11. Directive 2003/37 / EC of the European Parliament and of the Council of 26 May 2003, concerning the type-approval of agricultural or forestry tractors, their trailers and interchangeable gear towed, as well as systems, components and technical vehicle units, and repealing directive 74/150/EEC, amended last by directive 2010/62/EU Commission on September 8, 2010 (OJ L 238 of the 9.9.2010 (, p. 7) 12. Directive 2008/2/EC of the European Parliament and of the Council of 15 January 2008 on the field of vision and the wipers of the forest or agricultural wheel tractors (JO L 24 of the 29.1.2008, p. 30) 13. Directive 2009/57/EC of the European Parliament and of the Council of 13 July 2009 on the protection devices in the event of reversal of the forest or agricultural wheel tractors (JO L 261 of the 3.10.2009, p. 1) 14. Directive 2009/58/EC of the European Parliament and of the Council of 13 July 2009 on towing and devices back off of tractors or foresters wheeled (JO L 198 of the 30.7.2009, p. 4) 15. Directive 2009/59/EC of the European Parliament and of the Council of 13 July 2009 on the mirrors of tractors or foresters wheeled (JO L 198 of the 30.7.2009, p. 9)


16 directive 2009/60 / CE of the European Parliament and of the Council of 13 July 2009 relative to maximum speed by construction and platforms for loading tractors or foresters to wheels, modified last place by directive 2010/62/EU Commission on September 8, 2010 (OJ L 238 of the 9.9.2010, p. 7) 17. Directive 2009/61/EC of the European Parliament and of the Council of 13 July 2009 relating to the installation of devices of lighting and light-signalling of the forest or agricultural wheel tractors (OJ L 203 of the 5.8.2009, p. 19) 18. Directive 2009/63/EC of the European Parliament and of the Council of 13 July 2009 relating to certain parts and characteristics of tractors agricultural or forest (OJ L 214 of the 19.8.2009, p. 23)-wheeled 19 Directive 2009/64 / EC of the European Parliament and of the Council of 13 July 2009 relating to the suppression of radio noise (electromagnetic compatibility) produced by the farm tractors or foresters (OJ L 216 of the 20.8.2009 (, p. 1) 20. Directive 2009/66/EC of the European Parliament and of the Council of 13 July 2009 relating to the system of management of the forest or agricultural wheel tractors (OJ L 201 of the 1.8.2009, p. 11) 21. Directive 2009/68/EC of the European Parliament and of the Council of 13 July 2009 concerning type approval of component devices of lighting and light-signalling of the forest or agricultural wheel tractors (OJ L 203 of the 5.8.2009, p. 52) 22. Directive 2009/75/EC of the European Parliament and of the Council of 13 July 2009 on the protection devices in the event of reversal of forest or agricultural wheel tractors (static testing) (OJ L 261 of the 3.10.2009, p. 40) 23. Directive 2009/76/EC of the European Parliament and of the Council of 13 July 2009 relating to the noise level at the ears of the drivers of forest or agricultural wheel tractors (OJ L 201 of the 1.8.2009, p. 18) 24. Directive 2009/144/EC of the European Parliament and of the Council of 30 November 2009 on certain elements and characteristics of wheeled agricultural or forestry tractors, amended last by the 2013-8-EU Commission directive of 26 February 2013 (OJ L 56 of the 28.2.2013, p. 8) 25. Regulation (EU) n 167/2013 of the European Parliament and of the Council of 5 February 2013 on the reception and monitoring of the market of agricultural and forestry vehicles (OJ L 60 of the 2.3.2013, p. 1) Switzerland 100. Order of 19 June 1995 concerning technical requirements for farm tractors and their trailers (RO 1995 4171), amended last March 2, 2012 (RO 2012 1915) 101. Order of 19 June 1995 on the type-approval of road vehicles (RO 1995 3997), last modified 7 December 2012 (2012 7065 RO) assessment of compliance the Committee Section II bodies established by art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV special principles for the designation of the bodies of the conformity assessment for the designation of conformity assessment bodies, the authorities of designation refer to their legislative, regulatory and administrative provisions referred to in section I.

Section V supplementary provisions the provisions of this section shall apply exclusively to relations between the Switzerland, on the one hand, and the European Community, on the other hand.

1 Exchange of information the competent authorities of the Member States and of the Switzerland to inform each other of vehicles, systems, components and separate technical units conform (arts. 4, 6, 8 and 9 of directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and their interchangeable towed machinery (, and the systems, components and separate technical units of such vehicles and repealing directive 74/150/EEC, such as amended last) or non-conforming (art. 14 and 16 of directive 2003/37/EC, as last amended place) placed on the market.
When the Switzerland or the Member States refuse to give a reception in accordance with art. 4 of directive 2003/37/EC, as amended in the last place, their competent authorities to inform each other indicating the reasons for their decision.

2. recognition of receipts by type of vehicle the Switzerland recognizes also receipts by type of tractors or technical units granted before the entry into force of this agreement by the competent authorities on receipt of the Member States of the Union European in accordance with the provisions of directives 74/150/EEC and 2003/37/EC, as last amended place , and which are still in force in the European Community.
The European community recognizes receipts by type established by the Switzerland when the Swiss requirements deemed equivalent to those of the directive 2003/37/EC, as amended in the last place.
The recognition of receipts by type of vehicle, issued by the Switzerland is suspended if the Switzerland does not fit its legislation all the relevant Community legislation in force.

3 safeguard clauses on receipts by type of vehicle registration and setting up 1. Each Member State and the Switzerland allow registration, the sale or the commissioning of tractors brand new on grounds relating to their construction or operation, only if these tractors are accompanied by a certificate of conformity valid.
2. each Member State and the Switzerland allow the sale or commissioning of technical units, only if they meet the requirements of the corresponding specific directive or the requirements of Swiss legislation equivalent to the specific directive corresponding.
3 If the Switzerland or a Member State finds that tractors of a particular type are a serious risk to road safety or the safety of the work, although they are accompanied by a certificate of conformity valid, during six months at the most, that country may refuse to register these tractors, or prohibit the sale, commissioning or use in its territory. It shall immediately inform other Member States, the Commission and the Switzerland, motivating its decision. Within a period of six weeks, the Commission shall in consultation with the States concerned in the dispute (Member States or Switzerland). The Commission decides whether the measure is justified or not, and the procedure laid down in art. 16 of directive 2003/37/EC is applicable.
Measures relating to the conformity of production 1. A Member State or the Switzerland making a type-approval shall take the measures provided for in annex IV to directive 2003/37/EC to verify, where appropriate in cooperation with the competent authorities in receipt of other Member States or Switzerland, if adequate measures have been taken to ensure that vehicles systems, components or separate technical units produced conform to the approved type. This review is limited to the procedures set out in annex IV, section 2, of directive 2003/37/EC.
2. the Member State or the Switzerland which has conducted type-approval takes the necessary measures to be informed of the possible stop of production and of any change in the information given in the information sheet. If the country finds that an amendment to the information sheet justifies new checks or new tests and results, that's a change in the form of existing reception or the establishment of a new care reception, the authorities concerned of such country shall inform the manufacturer and pass these new documents to the competent authorities of the other Member States or the Switzerland within a period of one month from the date of their establishment.
Non-compliance with the approved type 1. There is non-compliance with the type received when we see over the form of receipt and/or the receive folder, differences that have not been authorized under art. 5, by. 3, of the directive 2003/37/EC, as amended in the last place, by the Member State or the Switzerland who made the reception. A vehicle is not considered as not in conformity with the approved type where tolerances laid down by specific directives are met.
2. If the Member State or the Switzerland which has conducted type-approval finds that vehicles, systems, components or separate technical units accompanied by a certificate of conformity or bearing an approval mark THAT do not conform to the approved type, the country takes steps to ensure that the models produced become in line with the approved type. The authorities of the competent Member State or of the Switzerland shall notify those Member States and/or Switzerland of the measures taken, which can go up to the withdrawal of reception. The said authorities shall take the same provisions if they are informed by the competent authorities of another Member State or Switzerland of the existence of such lack of conformity.

3. the receipt of the Member States and the Switzerland authorities inform each other, within a period of one month, of the withdrawal of type-approval and of the reasons for this measure.
4 If the Member State or the Switzerland which has conducted type-approval challenges the lack of conformity that it has been notified, the Member States concerned and the Switzerland shall attempt to resolve the dispute. The Commission and the Committee are kept informed and proceed, if necessary, to the consultations necessary to achieve a solution.

Chapter 14 good laboratory practices (GLP) purpose and scope the provisions of this chapter apply to the testing of products made in accordance with GLP, whether substances or preparations, covered by the legislative, regulatory and administrative provisions referred to in section I. For the purposes of this chapter, the provisions of art. originally 4 of the related agreement are not applicable.
Unless specific definitions, the definitions of the terms contained in the "principles of OECD good laboratory practice', such as revised in 1997 [ENV/MC/CHEM (98) 17], based on the decision of the Council of the OECD of 12 May 1981 [C (81) 30 (final)] amended on 26 November 1997 [C (97) 186 (final)], as well as on the decision-recommendation of the Council of October 2, 1989 [C (89) 87 (final)] amended on March 9, 1995 [C (95) 8 (final)] and documents consensus BPL, OECD series on principles of good laboratory practice and the verification of the respect of these principles, as well as any changes are related, are applicable.
The Parties recognize the equivalence of the respective audit programs compliance with good laboratory practices in line with decisions and recommendations above the OECD, as well as to the procedures and principles legislative, regulatory and administrative referred to in section IV.
The Parties mutually accept studies and data arising from that are produced by the testing of the other facilities, provided that they participate in the program of verification of compliance with good laboratory practices of this part, in accordance with the above-mentioned principles and provisions.
The Parties mutually accept the conclusions of study audits and inspections carried out by the authorities of audit for GLP.

Section I legislative, regulatory and administrative provisions regarding the tests on chemicals carried out according to GLP, the relevant components of the legislative, regulatory and administrative provisions referred to below are applicable.
Provisions covered by art. 1, by. 2: Union European food and feedingstuffs 1. Regulation (EC) n 429/2008 of the Commission on April 25, 2008, modalities of application of the Regulation (EC) n 1831/2003 of the European Parliament and of the Council regarding the establishment and the presentation of applications and assessment and authorization of additives for animal feed (OJ L 133 of the 22.5.2008, p. 1) 2. Regulation (EU) n 234/2011 Commission March 10, 2011 for application of Regulation (EC) n 1331/2008 of the European Parliament and of the Council establishing an authorisation procedure for additives, enzymes and food flavourings (OJ L 64 of the 11.3.2011, p. 15), amended lastly by the implementing Regulation (EU) No. 562/2012 of the Commission (JO L 168 of the 28.6.2012 uniform (, p. 21) 3. Implementing Regulation (EU) n 503/2013 the Commission of April 3, 2013 relative to applications for authorisation of genetically modified feed and food introduced under the Regulation (EC) n. 1829/2003 of the European Parliament and of the Council and amending the regulations of the Commission (EC) No. 641/2004 and (EC) n 1981/2006 (OJ L 157 of the 8.6.2013 (, p. 1) new and existing chemical products 4. 67/548/EEC Council directive of 27 June 1967 concerning the approximation of legislative, regulatory, and administrative provisions on classification, packaging and labelling of dangerous substances, amended last by directive 92/32/EEC of 30 April 1992 (OJ L 154 of the 5.6.1992, p. 1) 5. Regulation (EC) n 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, evaluation and authorization of chemical substances, as well as the restrictions applicable to these substances (REACH), establishing a European Chemicals Agency, amending directive 1999/45/EC and repealing Regulation (EEC) 793/93 of the Council n and the Regulation (EC) n. 1488/94 the Commission directives 91/155/EEC and directive 76/769/EEC of the Council 93/67/EEC, 93/105/EC and 2000/21/EC of the Commission (JO L 396 of the 30.12.2006, p. 1), amended lastly by Regulation (EU) n 895/2014 the Commission of 14 August 2014 (JO L 244 of the 19.8.2014, p. 6) 6. Regulation (EC) n 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67/548/EEC and 1999/45/EC and amending regulations (EC) n 1907/2006 (OJ L 353 of 31.12.2008, p. 1), amended lastly by Regulation (EU) n 605/2014 the Commission of June 5, 2014 (JO L 167 of the 6.6.2014 (, p. 36) 7. Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the provisions of legislative, regulatory and administrative of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 200 of the 30.7.1999, p. 1), amended last by directive 2006/08/EC of the Commission of 23 January 2006 (OJ L 19 of the 24.1.2006 (, p. 12) 8. Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 regarding the approximation of legislative, regulatory, and administrative pertaining to the application of the principles of good laboratory practice and the control of their application for tests on chemical substances (OJ L 50 of the 20.2.2004, p. 44) drugs 9. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community code for medicines for human use (OJ L 311 of the 28.11.2001, p. 67), amended last by directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 (JO L 299 of the 27.10.2012, p. 1). NB: directive 2001/83/EC has been amended and good laboratory practices are now contained in the chapter "Introduction and general principles" of the directive 2003/63/EC of the Commission of 25 June 2003 amending directive 2001/83/EC of the European Parliament and of the Council establishing a Community code for medicines for human use (OJ L 159 of 27.6.2003 the (, p. 46) 10. Regulation (EU) n 536/2014 European Parliament and Council of 16 April 2014 relating to clinical trials of medicines for use in human and repealing the directive 2001/20/EC (OJ L 158 of the 27.5.2014, p. 1) veterinary drugs 11. Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community code for veterinary medicines (JO L 311 of the 28.11.2001, p. 1), amended last by directive 2009/9/EC of the Commission on February 10, 2009 (OJ L 44 of the 14.2.2009, p. 10) 12 plant protection products. Regulation (EC) n. 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing on the market of plant protection products and repealing directives 79/117/EEC and 91/414/EEC of the Council (OJ L 309 of the 24.11.2009, p. 1) 13. Regulation (EU) n 283/2013 the Commission of 1 March 2013 establishing requirements for data applicable to active substances, in accordance with the Regulation (EC) n. 1107/2009 of the European Parliament and of the Council concerning the placing on the market of products (OJ L 93 of the 3.4.2013, p. 1) 14. Regulation (EU) n 284/2013 the Commission of 1 March 2013 establishing plant protection product data requirements, in accordance with the Regulation (EC) n. 1107/2009 of the European Parliament and of the Council on the placing on the market of plant protection (OJ L 93 of the 3.4.2013, p. 85) 15 biocidal products products. Regulation (EU) No. 528/2012 of the European Parliament and of the Council of May 22, 2012 on the implementation available on the market and use of biocidal (JO L 167 of the 27.6.2012, p. 1) cosmetic products 16 products. Regulation (EC) n 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342 of the 22.12.2009, p. 59) Detergents 17. Regulation (EC) no 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104 of the 8.4.2004, p. 1) Switzerland 100. Federal law of 7 October 1983 on the protection of the environment (RO 1984 1122), amended Lastly on 22 March 2013 (FF 2012 8671) 101. Federal law of 15 December 2000 on the protection against substances and dangerous preparations (RO 2004 4763), last modified 17 June 2005 (RO 2006 2197) 102. Order of 18 May 2005 on protection against substances and dangerous preparations (RO 2005 2721), lastly amended on 20 June 2014 (RO 2014 2073) 103. Order of 18 May 2005 on the placing on the market and use of the biocides (RO 2005 2821), amended last July 15, 2014 (RO 2014 2073)


104. order of 18 May 2005 on the release of plant protection products (RO 2005 3035), amended last December 11, 2012 (RO 2013 249) 105. Federal law of 15 December 2000 on drugs and medical devices (RO 2001 2790), last modified June 21, 2013 (RO 2013 4137) 106. Order of 17 October 2001 on drugs (RO 2001 3420), amended September 8, 2010 (RO 2010 4039) Section II organizations of conformity assessment for the purpose of this sectoral chapter in last place, there is to be understood by "conformity assessment bodies", test facilities under the program of audit of the BPL of each party.
The Committee set up by art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities designation for the purpose of this sectoral annex, there is to be understood by 'authorities designation', authorities of the Parties responsible for checking the BPL. The coordinates of the authorities of audit for GLP of States members of the European Union and Switzerland are available on the websites mentioned below.
For the European Community: http://ec.europa.eu/growth/sectors/chemicals/good-laboratory-practice/index_en.htm for the Switzerland: www.glp.admin.ch Section IV specific principles for the designation of the bodies of the conformity assessment for the purpose of this sectoral chapter, there is to be understood by "designation of conformity assessment bodies", the procedure by which the audit for GLP authorities acknowledge that the test facilities meet the principles of GLP. To this end, they apply the principles and procedures set out in the following provisions, recognized equivalent and consistent with the acts C (81) 30 (final) and C (89) 87 (final) adopted by the OECD Council: European Union 1. Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 regarding the approximation of legislative, regulatory, and administrative pertaining to the application of the principles of good laboratory practices and the monitoring of their application for tests on chemical substances (OJ L 50 of the 20.2.2004, p. 44) 2. Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good practices of laboratory (GLP) (OJ L 50 of the 20.2.2004, p. 28) Switzerland 100. Federal law of 7 October 1983 on the protection of the environment (RO 1984 1122), changed last March 22, 2013 (RO 2012 8671) 101. Federal law of 15 December 2000 on the protection against substances and dangerous preparations (RO 2004 4763), last modified 17 June 2005 (RO 2006 2197) 102. Federal law of 15 December 2000 on drugs and medical devices (RO 2001 2790), last modified June 21, 2013 (RO 2013 4137) 103. Order of 18 May 2005 on good practices of laboratory (RO 2005 2795), amended Lastly November 11, 2012 (RO 2012 6103) Section V supplementary provisions 1. Exchange of information in accordance with art. 12 of this agreement, the Parties are transmitted, at least once a year, a list of the test facilities which, on the basis of the results of inspections and audits of studies meet the principles of GLP, as well as the dates that were held inspections or audits, and compliance to GLP testing facilities.
In accordance with art. 6 of this agreement, the Parties shall inform in good time when a test installation meets the conditions set out in section II of this sectoral chapter, which says respect good laboratory practices, departs in a measure such as the integrity or authenticity of the studies she realizes may be compromised.
Parties are transmitted additional information relating to the inspection of a facility, test or verification of studies as soon as the other party address him such a reasonable request.

2. test facility inspection each party may request a test facility inspection or additional study checks if it has doubts based as to the compliance of a test with good laboratory practices.
When, in exceptional cases, doubts persist and the requesting party can justify a special interest, it may, in accordance with art. 8 of the agreement, appoint one or more experts of its authorities to participate in a test facility inspection or verification of study carried out by the authorities of the other party.

3 confidentiality in accordance with art. 13 of the agreement, the Parties undertake to not disclose information that is conveyed in the context of this sectoral chapter or they obtain through participation in an inspection or audit of study and which meet the definition of a trade secret or information confidential financial or commercial. They treat such information with a confidentiality at least equal to that guarantees the party providing them and ensure that the authorities to which the information is transmitted give identical treatment.

4. cooperation by virtue of art. 9 of the agreement, each Contracting Party may, at his request, participate as an observer in a test facility inspection by the authorities of the other party with the consent of the test facility concerned, in order to keep informed of the other party's inspection procedures.

Chapter 15 GMP Inspection of medicines and object batch certification and scope the provisions of this chapter cover all medications industrially manufactured in Switzerland and in the European Community, and to which apply the requirements of the good manufacturing practices (GMP).
In respect of drugs covered by this chapter, each party acknowledges the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other party and the manufacturing authorizations granted by the competent authorities of the other party.
The certification by the manufacturer of the conformity of each batch to its specifications is recognised by the other party who fails to perform an import control again.
In addition, the official batch releases carried out by an authority of the exporting Party is acknowledged by the other party.
'Drugs', means all products regulated by the pharmaceutical legislation in the European Community and Switzerland referred to in section I of this chapter. The definition of drugs includes all products for human use and for veterinary use, including the pharmaceutical, immunological and radiopharmaceuticals chemical and biological medicines derived from blood and human plasma, premixes for the manufacture of medicated feedingstuffs for animals and, where appropriate, vitamins, minerals, herbs, and homeopathic medicines.
"GMP" are the part of the quality assurance that ensures that drugs are manufactured and controlled in a consistent manner according to the quality standards appropriate to their job and according to the requirements of the authorisation for placing on the market and the product specifications. For the purposes of this chapter, this includes the system whereby the manufacturer receives the specification of the product and the process of the holder or of the applicant for authorisation for placing on the market and guarantees that the drug is manufactured in accordance with this specification.
Regarding drugs covered by the legislation of a party, but not by the other, the manufacturer may request, for the purposes of this agreement, an inspection by the locally competent inspection service. This applies, among other things, in the manufacture of active pharmaceutical ingredients, intermediate products and products intended for clinical trials, as well as inspections to the placing on the market. Operational provisions on this subject can be found in section III, by. 3. certification of manufacturers A request of an exporter, importer or the competent authority of the other party, the authorities responsible for the licensing of manufacturing and control of the production of medicines certify that the manufacturer:-is duly authorized to manufacture the drug in question or to perform the operation of manufacturing specified in question; - is regularly inspected by the authorities; - meets the national requirements of GMP equivalent recognized by both sides and referred to the section I of this chapter. When referring to different GMP requirements, this must be mentioned in the certificate.

Certificates also need to identify the place or places of production (and, if applicable, contract quality control laboratories).
Certificates are made quickly within a period which may not exceed 30 calendar days. Exceptionally, especially when a new inspection has to be carried out, this period may be extended to 60 days.
Batch certification

Each lot exported must be accompanied by a batch certificate prepared by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active ingredients and after having carried out all tests or checks necessary to ensure the quality of the product in accordance with the requirements of the authorisation for placing on the market. The certificate must attest that the batch meets the specifications and must be kept by the importer of the batch. It is presented at the request of the competent authority.
When a certificate is established, the manufacturer should take account of the provisions of the current system of certification of WHO regarding the quality of pharmaceutical products subject to international trade. The certificate must detail the agreed product specifications and indicate the methods and the analytical results. It must include a statement that documents related to the treatment and conditioning of the lot have been examined and found to comply with the GMP. The batch certificate shall be signed by the person empowered to authorize the sale or delivery of the lot, that is, in the European Community the 'qualified person' referred to in art. 48 of directive 2001/83/EC and art. 52 of directive 2001/82/EC, and in Switzerland, the "technical authority" referred to in art. 5 and 10 of the Ordinance on the authorizations in the field of drugs.
Official release of lots when an official batch release procedure applies, the official batch releases carried out by an authority of the exporting Party referred to in section II are recognized by the other party. The manufacturer shall provide the certificate of official release.
With regard to the community, the official batch release procedure is specified in document 'Control Authority Batch Release of Vaccination and Blood Products, 2001' or its versions later, as well as in different specific batch release procedures. For Switzerland, the official batch release procedure is defined in art. 17 of the Act on drugs and medical devices and the art. 18 to 21 of the Ordinance of the Swiss Institute for therapeutic products on the requirements for the authorisation of medicines market.

Section I legislative, regulatory and administrative provisions referred to in art. 1, by. 2: European union 1. Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 establishing the Community procedures for the authorization and oversight regarding drugs for human use and for veterinary use and establishing a European Agency of medicines (OJ L 136 of the 30.4.2004, p. 1), amended lastly by Regulation (EU) n 1027/2012 European Parliament and of the Council of 25 October 2012, amending the (EC) No. 726/2004 on regards pharmacovigilance (JO L 316 of the 14.11.2012, p. 38) 2. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community code for medicines for human use (OJ L 311 of the 28.11.2001, p. 67), amended last by directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending directive 2001/83/EC with regard to the pharmacovigilance (JO L 299 of the 27.10.2012 (, p. 1) 3. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, control, processing, preservation and distribution of human blood and blood components and amending directive 2001/83/EC (OJ L 33 of the 8.2.2003, p. 30) 4. Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community code for veterinary medicines (JO L 311 of the 28.11.2001, p. 1), amended last by directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending directive 2001/82/EC instituting a Community code for veterinary medicines (OJ L 136 of 30.4.2004 the (, p. 58) 5. Directive 2003/94/EC of the Commission of October 8, 2003, establishing the principles and guidelines of good manufacturing practice for drugs for human use and investigational medicinal products for human use (OJ L 262 of the 14.10.2003, p. 22) 6. Directive 91/412/EEC of the Commission of 23 July 1991 establishing the principles and guidelines of good manufacturing practice for veterinary drugs (JO L 228 of the 17.8.1991, p. 70) 7. Guidelines on good practice of distribution of medicines for human use (OJ C 343 of the 23.11.2013, p. 1) 8. Volume 4 of EudraLex - drugs for human use and for veterinary use: guidelines of the EU establishing good manufacturing practices (available in English on the website of the European Commission) 9. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of provisions legislative, regulatory and administrative provisions of the Member States relating to the application of good clinical practice in the conduct of clinical trials of medicinal products for human use (OJ L 121 of the 1.5.2001, p. 34) 10. 2005/28/EC Commission directive of 8 April 2005 laying down principles and detailed guidelines for good clinical practices with regard to investigational medicinal products for human use, as well as the requirements for the grant of the authorization to manufacture or import these drugs (OJ L 91 of the 9.4.2005, p. 13) 11. Delegated Regulation (EU) n 1252/2014 the Commission of 28 may 2014, supplementing directive 2001/83/EC of the European Parliament and of the Council regarding the principles and guidelines of good manufacturing practice for active substances of medicines for human use (OJ L 337 of the 25.11.2014, p. 1) Switzerland 100. Federal law of 15 December 2000 on drugs and medical devices (RO 2001 2790), last modified July 1, 2013 (RO 2013 1493) 101. Order of 17 October 2001 on authorizations in the field of drugs (RO 2001 3399), last changed January 1, 2013 (RO 2012 3631) 102. Order of the Institute Swiss therapeutic products of 9 November 2001 on requirements for the authorisation of placing on the market of drugs (RO 2001 3437), as last amended January 1, 2013 (RO 2012 5651) 103. Order of September 20, 2013, on clinical trials as part of research on the human being (RO 2013 3407) Section II assessment agencies compliance with the purposes of this chapter, there is to be understood by "conformity assessment bodies", the official inspection services of GMP of each party.
Details of official inspection services of the GMPS of Member States of the European Union and Switzerland are available on the following websites: www.hma.eu/index.php?id=148 for assessment of the conformity of Switzerland bodies: for all drugs for human use and for veterinary use (except veterinary immunological products): www.swissmedic.ch/index.html?lang=fr&lang_old=2&lang_old=2 for veterinary immunobiologiques products : www.bvet.admin.ch/ivi/index.html?lang=fr for assessment of the conformity of the European Community bodies: http://ec.europa.eu/enterprise/pharmaceuticals/mra/index_a.htm Section III additional provisions 1. Transmission reports inspection on a reasoned request, the relevant inspection services are a copy of the last inspection of the manufacturing report or, if the analyses are carried out under contract, the place of control. The request may concern a 'full inspection report' or a 'detailed report' (see point 2 below). Each party uses inspection reports with the discretion that is desired by the party that supplied.
The Parties shall ensure that inspection reports are transmitted within 30 calendar days at the latest, this period being extended to 60 days when a new inspection has to be carried out.

2. inspection reports a "full inspection report" has one main folder (Site Master File), established by the manufacturer or by the inspection service, and a descriptive report established by the latter. A "detailed report" responds to specific questions about society posed by the other party.

3. reference GMP has) manufacturers are subject to inspections based on the GMP in force in the exporting Party (see section I) .b) regarding drugs that are only covered by the pharmaceutical legislation of the importing party and not by that of the exporting Party, the locally competent inspection who wishes to carry out an inspection of the manufacturing operations is taking into account of its own GMP or , in the absence of specific GMP requirements, based on the GMP of the importing part. For the products or categories of specific products (medicines within research, raw not limited to active pharmaceutical ingredients), the equivalence of the requirements GMP is established by applying the procedure established by the Committee.

4. nature of inspections


(a) inspections are usually intended to determine adherence to GMP by the manufacturer. We're talking about general inspections GMP (or regular, periodic, or routine inspections) .b) inspections of "product or process" (which can also be inspections "prior to the placing on the market") are essentially one or a series of products or processes and include an assessment of the validation and respect the specific process or aspects of control described in the authorization for placing on the market. If necessary, information about the product (the quality of an application or the authorization folder) are given in confidence to the inspection service.

5. fees the regime of inspection fees / settlement is determined by the place of manufacture. No fee is required of manufacturers established in the territory of the other party.

6 safeguard clause for inspections each party reserves the right to conduct its own inspection for reasons identified to the other party. These inspections should be notified in advance to the other party and are conducted jointly by the competent authorities of the Parties, in accordance with the provisions of art. 8 of this agreement. The recourse to this safeguard clause must be exceptional.

7. Exchange of information between authorities and approximation of quality requirements in accordance with the General provisions of this agreement, the Parties exchange information necessary for the mutual recognition of inspections.
In addition, authorities in Switzerland and the European Community are informed of any new technical training and new inspection procedure. Each party consults with the other before adopting such a procedure and strives to promote their reconciliation.

8. training of inspectors in accordance with art. 9 of the agreement, inspectors training sessions organized by the authorities are accessible to inspectors of the other party. The Parties to the agreement to inform each other of these sessions.

9. Joint art inspections. 12 of this agreement, joint inspections can be arranged if the Parties decide by mutual agreement. These inspections are intended to develop an understanding and interpretation of common practices and requirements. The Organization of these inspections and their form are decided according to procedures approved by the Committee set up by art. 10 of this agreement.

10. warning system the parties agree on correspondents in order to allow the authorities and manufacturers to inform the authorities of the other party with all the diligence required in case of default, reminder batch, infringement or any other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch. A detailed alert procedure must be agreed.
The Parties shall inform themselves, with due care, any suspension or withdrawal (total or partial) of a manufacturing authorization based on non-compliance of GMPS, which could affect the protection of public health.

11. corresponding to the purposes of this agreement, the corresponding to technical questions such as exchanges of inspection reports, training of inspectors, technical requirements, are: for the European Community: the Director of the European Medicines Agency.
For the Switzerland: the official GMP inspection services referred to in section II.

12 differences the two Parties implement all in order to overcome their differences regarding, among other things, the compliance by manufacturers and conclusions of inspection reports. If the disagreement persists, the case is brought before the Committee set up by art. 10 of this agreement.

Chapter 16 products of construction Section I provisions legislative, regulatory and administrative provisions covered by art. 1, by. 2: European union 1. Regulation (EU) n 305/2011 of the European Parliament and of the Council of 9 March 2011 establishing harmonised conditions for marketing of construction products and repealing the directive 89/106/EEC of the Council (OJ L 88 of the 4.4.2011, p. 5), amended lastly by Regulation (EU) No 574/2014 February 21, 2014 (OJ L 159 of the 28.5.2014 (, p. 41), as well as delegated acts and implementing acts of the Commission adopted in accordance with regulation until December 15, 2014 (hereinafter referred to as overall "rules (EU) n 305/2011") 2. 94/23/EC Commission decision of 17 January 1994 on the common rules of procedure for the European technical approvals (OJ L 17 of the 20.1.1994, p. 34) 2 a. 94/611/EC Commission Decision of 9 September 1994 in application of art. 20 of the directive 89/106/EEC on construction products (OJ L 241 of the 16.9.1994, p. 25) 2 b. 95/204/EC Commission Decision of 31 May 1995 implementing art. 20, by. 2, of the directive 89/106/EEC of the Council (OJ L 129 of the 14.6.1995, p. 23) building products 3. 95/467/EC Commission decision of 24 October 1995 implementing art. 20, by. 2, of the directive 89/106/EEC of the Council (OJ L 268 of the 10.11.1995, p. 29) building products 4. Decision 96/577/EC of the Commission of 24 June 1996 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to fixed systems of firefighting (OJ L 254 of the 8.10.1996, p. 44) 5. Decision 96/578/EC of the Commission of 24 June 1996 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the sanitary appliances (OJ L 254 of the 8.10.1996, p. 49) 6. Decision 96/579/EC of the Commission of 24 June 1996 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the stationary traffic (OJ L 254 of the 8.10.1996, p. 52) 7. Decision 96/580/EC of the Commission of 24 June 1996 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the curtain walls (OJ L 254 of the 8.10.1996, p. 56) 8. Decision 96/581/EC of the Commission of 24 June 1996 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the geotextiles (OJ L 254 of the 8.10.1996, p. 59) 9. Decision 96/582/EC of the Commission of 24 June 1996 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, regarding the glued outer glazing and metal anchors for concrete (OJ L 254 of the 8.10.1996, p. 62) 10. 96/603/EC Commission decision of 4 October 1996 establishing the list of products belonging to classes A 'No contribution to fire' provided for in decision 94/611/EC in application of art. 20 of the directive 89/106/EEC of the Council (OJ L 267 of the 19.10.1996, p. 23) building products 11. Decision 97/161/EC of the Commission of 17 February 1997 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council concerning the metal anchor for fixing lightweight systems in concrete (OJ L 62 of the 4.3.1997, p. 41) 12. Decision 97/176/EC of the Commission of 17 February 1997 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council with regard to the products of lumber and related products (JO L 73 of the 14.3.1997, p. 19) 13. Decision 97/177/EC of the Commission of 17 February 1997 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council concerning the metal pegs to injection for masonry (JO L 73 of the 14.3.1997, p. 24) 14. Decision 97/462/EC of the Commission of 27 June 1997 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council with regard to the signs made from wood (JO L 198 of the 25.7.1997, p. 27) 15. Decision 97/463/EC of the Commission of 27 June 1997 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council with regard to the ankles in plastic to concrete and masonry (JO L 198 of the 25.7.1997, p. 31) 16. Decision 97/464/EC of the Commission of 27 June 1997 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of directive 89/106/EEC of the Council with regard to the products of sanitation (JO L 198 of the 25.7.1997, p. 33)


17. decision 97/555 / EC of the Commission of 14 July 1997 relating to the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the cement, lime for construction and other hydraulic binders (OJ L 229 of the 20.8.1997, p. 9) 18. Decision 97/556/EC of the Commission of 14 July 1997 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to mixed systems/kits for external thermal insulation with plaster (ETICS) (OJ L 229 of the 20.8.1997, p. 14) 19. Decision 97/571/EC of the Commission of 22 July 1997 on the general model of European technical approval for construction (JO L 236 of the 27.08.1997, p. 7) 20 products. Decision 97/597/EC of the Commission of 14 July 1997 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council with regard to the steel reinforcement and prestressing for concrete (OJ L 240 of the 2.9.1997, p. 4) 21. 97/638/EC Commission decision of 19 September 1997 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council with regard to products for joining pieces of wood (OJ L 268 of the 1.10.1997, p. 36) 22. Decision 97/740/EC of the Commission of 14 October 1997 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council concerning the masonry and related products (JO L 299 of the 4.11.1997, p. 42) 23. Decision 98/143/EC of the Commission of 3 February 1998 on the attestation of conformity procedure of construction in accordance with art products. 20, by. 2, of the directive 89/106/EEC of the Council with regard to the systems of flexible membranes attached mechanically for the waterproofing of roofs (OJ L 42 of the 14.2.1998, p. 58) 24. Decision 97/808/EC of the Commission of 20 November 1997 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, regarding the flooring (OJ L 331 of the 3.12.1997, p. 18) 25. Decision 98/213/EC of the Commission of 9 March 1998 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the kits of partitions (JO L 80 of the 18.3.1998, p. 41) 26. Decision 98/214/EC of the Commission of 9 March 1998 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC, with regard to metal construction products and related products (JO L 80 of the 18.3.1998, p. 46) 27. Decision 98/279/EC of the Commission of 5 December 1997 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the systems or not carry permanent formwork sets consisting of hollow blocks or insulation, and eventually concrete (JO L 127 of the 29.4.1998, p. 26) 28. Decision 98/436/EC of the Commission of 22 June 1998 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, regarding the roofs, skylights, Dormer Windows and related products [notified under number C (1998) 1598] (OJ L 194 of the 10.7.1998, p. 30) 29. Decision 98/437/EC of the Commission of 30 June 1998 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the internal and external finishes of walls and ceilings (OJ L 194 of the 10.7.1998, p. 39) 30. Decision 98/456/EC of the Commission of 3 July 1998 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the kits for the powering of prestressed structures (OJ L 201 of the 17.7.1998, p. 112) 31. 98/457/EC Commission decision of 3 July 1998 concerning the test according to the method of the object isolated in fire (OIF) referred to in decision 94/611/EC in application of art. 20 of the directive 89/106/EEC of the Council (OJ L 201 of the 17.7.1998, p. 114) building products 32. Decision 98/598/EC of the Commission of 9 October 1998 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the aggregates (JO L 287 of the 24.10.1998, p. 25) 33. Decision 98/599/EC of the Commission of 12 October 1998 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the kits of sealing liquid for roofs (JO L 287 of the 24.10.1998, p. 30) 34. Decision 98/600/EC of the Commission of 12 October 1998 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to roofing kits, translucent efficience (except those based on glass products) (JO L 287 of the 24.10.1998, p. 35) 35. Decision 98/601/EC of the Commission of 13 October 1998 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to products for the construction of roads (JO L 287 of the 24.10.1998, p. 41) 36. Decision 99/89/EC of the Commission of 25 January 1999 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the kits of prefabricated stairs (JO L 29 of the 3.2.1999, p. 34) 37. Decision 1999/90/EC of the Commission of 25 January 1999 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council with regard to the membranes [notified under number C (1999) 114] (OJ L 29 of the 3.2.1999, p. 38) 38. Decision 1999/91/EC of the Commission of 25 January 1999 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council with regard to the products of thermal insulation (JO L 29 of the 3.2.1999, p. 44) 39. Decision 1999/92/EC of the Commission of 25 January 1999 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council regarding the beams and light composite poles made from wood [notified under number C (1999) 116] (OJ L 29 of the 3.2.1999, p. 49) 40. Decision 1999/93/EC of the Commission of 25 January 1999 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council with regard to the doors, windows, shutters, blinds, gates and associated hardware (JO L 29 of the 3.2.1999, p. 51) 41. Decision 1999/94/EC of the Commission of 25 January 1999 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of directive 89/106/EEC of the Council regarding the prefabricated concrete products of common aggregates in concrete of light aggregates or aerated autoclaved cellular concrete (JO L 29 of the 3.2.1999, p. 55) 41. Decision 1999/453 / THE Commission of 18 June 1999 amending decisions 96/579/EC and 97/808/EC on the procedure for attestation of conformity of construction products , pursuant to art. 20, by. 2, of the directive 89/106/EEC of the Council, concerning respectively the fixed traffic equipment and floor coverings. (OJ L 178 of the 14.7.1999, p. 50) 42. Decision 1999/454/EC of the Commission of 22 June 1999 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of directive 89/106/EEC of the Council in what concerns the structures against fire protection products, calfeutrements and seals resistant to fire (OJ L 178 of the 14.7.1999, p. 52) 43. Decision 1999/455/EC of the Commission of 22 June 1999 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2 of the directive 89/106/EEC of the Council concerning the kits prefab structures and logs of wood (OJ L 178 of the 14.7.1999, p. 56) 44. Decision 1999/469/EC of the Commission of 25 June 1999 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to products for concrete, mortar and grout (JO L 184 of the 17.7.1999, p. 27) 45. Decision 1999/470/EC of the Commission of 29 June 1999 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of directive 89/106/EEC of the Council, with regard to the adhesives used in the construction (JO L 184 of the 17.7.1999, p. 32)


46. decision 1999/471 / EC of the Commission of 29 June 1999 relating to the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the devices of heating (JO L 184 of the 17.7.1999, p. 37) 47. Decision 1999/472/EC of the Commission of 1 July 1999 on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the pipes, tanks and accessories of piping not entering in contact with water intended for human consumption (OJ L 184 of the 17.7.1999, p. 42) 48. 2000/147/EC Commission decision of 8 February 2000 on application of directive 89/106/EEC of the Council with regard to the classification of the characteristics of reaction to fire of building (OJ L 50 of the 23.2.2000, p. 14) 49 products. Decision 2000/245/EC of the Commission of 2 February 2000 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 4 of directive 89/106/EEC of the Council, regarding the flat glass, profiled glass and products of cast glass (OJ L 77 of the 28.3.2000, p. 13) 50. Decision 2000/273/EC of the Commission of 27 March 2000 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to seven products for European technical approval without a guide (OJ L 86 of the 7.4.2000, p. 15) 51. 2000/367/EC Commission decision of 3 May 2000 implementing the directive 89/106/EEC of the Council, with regard to the classification of the characteristics of fire resistance of building products, works of construction or parts thereof (OJ L 133 of the 6.6.2000, p. 26) 52. Decision 2000/447/EC of the Commission of 13 June 2000 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, regarding the carrying prefabricated wood frame and the panels light composite trays (OJ L 180 of the 19.7.2000, p. 40) 53. Decision 2000/553/EC of the Commission of 6 September 2000 on the implementation of directive 89/106/EEC of the Council with regard to the performance of the covers of the roof exposed to an external fire (JO L 235 of the 19.9.2000, p. 19) 53. Decision 2000/605/EC of the Commission of 26 September 2000 amending decision 96/603/EC establishing the list of products belonging to the classes has ' no contribution to fire "provided for in decision 94/611/EC in application of art. 20 of the directive 89/106/EEC of the Council (OJ L 258 of the 12.10.2000, p. 36) building products 54. Decision 2000/606/EC of the Commission of 26 September 2000 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to six products subject to European technical approval without a guide (OJ L 258 of the 12.10.2000, p. 38) 55. Decision 2001/19/EC of the Commission of 20 December 2000 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the expansion joints for road bridges (OJ L 5 of the 10.1.2001, p. 6) 56. 2001/308/EC Commission decision of 31 January 2001 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, in which case the investitures (JO L 107 of the 18.4.2001, p. 25) 56. 2001/596/EC Commission Decision of 8 January 2001 amending decisions 95/467/EC, 96/578/EC, 96/580/EC, 97/176/EC, 97/462/EC, 97/556/EC, 97/740/EC, 97/808/EC 98/213/EC, 98/214/EC, 98/279/EC, 98/436/EC, 98/437/EC, 98/599/EC, 98/600/EC, 98/601/EC, 1999/89/EC, 1999/90/EC, 1999/91/EC, 1999/454/EC, 1999/469/EC, 1999/470/EC, 1999/471/EC, 1999/472/EC, 2000/245/EC, 2000/273/EC and 2000/447/EC relating to the procedure for attestation of conformity of certain construction products , pursuant to art. 20 of the directive 89/106/EEC of the Council (OJ L 209 of the 2.8.2001, p. 33) 57. 2001/671/EC Commission decision of 21 August 2001 with application of the directive 89/106/EEC of the Council with regard to the classification of the performance of roofs and roof covers exposed to an external fire (JO L 235 of the 4.9.2001, p. 20) 58. Decision 2002/359/EC of the Commission of 13 May 2002 on the procedure for attestation of conformity of construction products in contact with water intended for human consumption, pursuant to art. 20, by. 2, of the directive 89/106/EEC of the Council (OJ L 127 of the 14.5.2002, p. 16) 59. 2002/592/EC Commission decision of 15 July 2002 amending decisions 95/467/EC, 96/577/EC, 96/578/EC and 98/598/EC relating to the procedure for attestation of the conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council concerning the gypsum products, fixed fire, sanitary systems and aggregates (JO L 192 of the 20.7.2002, p. 57) 60. Decision 2003/43/EC of the Commission of 17 January 2003 establishing performance classes of reaction to fire of some 61 (OJ L 13 of the 18.1.2003, p. 35) building products. Decision 2003/312/EC of the Commission of 9 April 2003 on the publication of the reference of standards for thermal insulation products, geotextiles, fixed fire-fighting installations and tiles plaster according to the directive 89/106/EEC of the Council (OJ L 114 of the 8.5.2003, p. 50) 62. 2003/424/EC Commission decision of 6 June 2003 amending decision 96/603/EC establishing the list of products belonging to classes A 'No contribution to fire' provided for in decision 94/611/EC in application of art. 20 of the directive 89/106/EEC of the Council on the 63 building (JO L 144 of the 12.6.2003, p. 9) products. 2003/593/EC Commission decision of 7 August 2003 amending decision 2003/43/EC establishing the performance classes of reaction to fire for some products of construction (OJ L 201 of the 8.8.2003, p. 25) 64. 2003/629/EC Commission decision of 27 August 2003 amending decision 2000/367/EC establishing a classification system of the fire resistance of the building products, with regard to the addition of products used in control systems of smoke and heat (JO L 218 of the 30.8.2003, p. 51) 65. 2003/632/EC Commission decision of 26 August 2003 amending decision 2000/147/EC with application of the directive 89/106/EEC of the Council with regard to the classification of the characteristics of reaction to fire of building (OJ L 220 of the 3.9.2003, p. 5) 66 products. 2003/639/EC Commission decision of 4 September 2003 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the pins for structural joints (OJ L 226 of the 10.9.2003, p. 18) 67. 2003/640/EC Commission decision of 4 September 2003 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the kits of cladding (OJ L 226 of the 10.9.2003, p. 21) 68. Decision 2003/655/EC of the Commission of 12 September 2003 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, regarding the watertight floor coating kits and walls of wet rooms (JO L 231 of the 17.9.2003, p. 12) 69. Decision 2003/656/EC of the Commission of 12 September 2003 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to seven products for European technical approval without a guide (JO L 231 of the 17.9.2003, p. 15) 70. 2003/722/EC Commission decision of 6 October 2003 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the water-repellent kits for aprons of bridge in the form of liquid applied (OJ L 260 of the 11.10.2003, p. 32) 71. Decision 2003/728/EC of the Commission of 3 October 2003 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC with regard to the buildings to metal chassis in kit, the constructions to chassis of concrete in kit, prefabricated construction units, rooms cold storage in kit, protections against landslides in kit (JO L 262 of the 14.10.2003, p. 34) 72. 2004/663/EC Commission decision of 20 September 2004 amending decision 97/464/EC of the Commission on the procedure of attestation of conformity of products in accordance with art. 20, by. 2, of directive 89/106/EEC of the Council with regard to the products of sanitation (OJ L 302 of the 29.9.2004, p. 6)


73 decision 2005/403 / EC of the Commission of 25 May 2005 establishing the classes of performance of roofs and roof covers exposed to an outdoor fire for some construction products Directive 89/106/EEC of the Council (OJ L 135 of the 28.5.2005, p. 37) 74. 2005/484/EC Commission decision of 4 July 2005 on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, regarding the cold rooms in kit and the envelopes of cold rooms in kit (JO L 173 of the 6.7.2005, p. 15) 75. 2005/610/EC Commission decision of 9 August 2005 establishing the classification of the characteristics of reaction to fire of some products of construction (JO L 208 of the 11.8.2005, p. 21) 76. 2005/823/EC Commission decision of 22 November 2005 amending decision 2001/671/EC on application of directive 89/106/EEC of the Council with regard to the classification of the performance of roofs and roof covers exposed to an external fire (JO L 307 of the 25.11.2005, p. 53) 77. 2006/190/EC Commission decision of 1 March 2006 amending decision 97/808/EC on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, regarding the flooring (OJ L 66 of the 8.3.2006, p. 47) 78. 2006/213/EC Commission decision of 6 March 2006 establishing the classification of the characteristics of the fire reaction of certain construction products as regards soil in wood and paneling and exterior wall coverings in solid wood (OJ L 79 of the 16.3.2006, p. 27) 79. 2006/600/EC Commission decision of 4 September 2006 establishing the classification of the characteristics of the fire reaction of certain construction products as regards signs sandwiches double skin to metal facings for blankets (JO L 244 of the 7.9.2006, p. 24) 80. 2006/673/EC Commission decision of 5 October 2006 amending decision 2003/43/EC establishing the performance classes of reactions to fire for the plates of plasterboard (JO L 276 of the 7.10.2006, p. 77) 81 wall. 2006/751/EC Commission decision of 27 October 2006 amending decision 2000/147/EC with application of the directive 89/106/EEC of the Council with regard to the classification of the characteristics of reaction to fire of building (OJ L 305 of the 4.11.2006, p. 8) 82 products. Decision 2006/893/EC of the Commission of 5 December 2006 on the withdrawal of the reference of en 10080:2005 "Steel for the reinforcement of concrete - weldable steels for concrete - General" according to the directive 89/106/EEC of the Council (OJ L 343 of the 8.12.2006, p. 102) 83. 2007/348/EC Commission decision of 15 May 2007 amending decision 2003/43/EC establishing the performance classes of reaction to fire for some construction products with regard to the signs made from wood (JO L 131 of the 23.5.2007, p. 21) 84. 2010/81/EU Commission decision of 9 February 2010 establishing the classes of features of reaction to fire for some construction products with regard to adhesives for tiles ceramic (OJ L 38 of the 11.2.2010, p. 9) 85. 82/2010/EU Commission decision of 9 February 2010 establishing the classes of features of reaction to fire for some construction products regarding decorative wall coverings in roll form and panels (OJ L 38 of the 11.2.2010, p. 11) 86. 2010/83/EU Commission decision of 9 February 2010 establishing the classes of reaction to fire for some features products of construction in what concerns mastics of Grouting air-drying (OJ L 38 of the 11.2.2010, p. 13) 87. 2010/85/EU Commission decision of 9 February 2010 establishing the classes of features of reaction to fire for some construction products regarding the clevises cementitious, at base of calcium sulphate screeds and screeds of soils in synthetic resin (OJ L 38 of the 11.2.2010, p. 17) 88. 2010-679-EU Commission decision of November 8, 2010 amending decision 95/467/EC with application of art. 20, by. 2, of the directive 89/106/EEC of the Council (OJ L 292 of the 10.11.2010, p. 55) construction products 89. 2010/683/EC Commission decision of 9 November 2010 amending decision 97/555/EC on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the cement, lime for construction and other hydraulic binders (JO L 293 of the 11.11.2010, p. 60) 90. 2010-737-EU Commission decision of December 2, 2010, establishing the classification of the characteristics of reaction to fire of some construction products with respect to steel plate coated polyester or plastisol (JO L 317 of the 3.12.2010, p. 39) 91. 2010-738-EU Commission decision of December 2, 2010 establishing the classes of features of reaction to fire for some construction products regarding the castings in staff (JO L 317 of the 3.12.2010, p. 42) 92. 2011-14-EU Commission decision of January 13, 2011, amending decision 97/556/EC on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to mixed systems/kits for external thermal insulation with plaster (ETICS) (JO L 10 of the 14.1.2011, p. 5) 93. 2011/19/EU Commission decision of 14 January 2011 procedure of attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, regarding the sealants for joints for nonstructural uses in real estate construction and footpaths (OJ L 11, the 15.1.2011, p. 49) 94. 2011-232-EU Commission decision of April 11, 2011, amending decision 2000/367/EC establishing a classification system of the characteristics of fire resistance of building products, works of construction or parts thereof (OJ L 97 of the 12.4.2011, p. 49) 95. 2011-246-EU Commission decision of April 18, 2011, amending decision 1999/93/EC on the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council with regard to the doors, windows, shutters, blinds, gates and associated hardware (JO L 103 of the 19.4.2011, p. 114) 96. 2011-284-EU Commission decision of 12 May 2011 relating to the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the power cables, control and communication (JO L 131 of the 18.5.2011, p. 22) 97. Implementing decision 2012/201/EC of the Commission of March 26, 2012, amending decision 98/213/EC on the procedure for attestation of conformity of construction products, in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council, with regard to the kits of partitions (OJ L 109 of the 21.4.2012, p. 20) 98. Implementing decision 2012/202/EU Commission on March 29, 2012, amending decision 1999/94/EC relating to the procedure for attestation of conformity of products in accordance with art. 20, by. 2, of the directive 89/106/EEC of the Council regarding the prefabricated concrete products of common aggregates in concrete of light aggregate concrete or cellular autoclaved ventilated (OJ L 109 of the 21.4.2012, p. 22) Switzerland 100. Federal law of March 21, 2014, on the products of construction (RO 2014 2867) 101. Order of 27 August 2014 on 102 construction (RO 2014 2887) products. Order FBL on September 10, 2014, on the designation of acts of execution and delegated European related products of construction, as last amended February 2, 2015 (RO 2015 515) 103. Order of June 17, 1996, on the Swiss accreditation system and the designation of laboratories testing and assessment bodies in compliance, record and approval (RO 1996 1904), last modified July 1, 2014 (RO 2014 1411) 104. Intercantonal agreement on the removal of technical barriers to trade of October 23, 1998 (RO 2003 270) Section II 1 conformity assessment bodies. For the purposes of this chapter, and according to the legislation of the Parties, as referred to in section I of this chapter, "conformity assessment bodies" means the bodies appointed to carry out the tasks under the procedure assessment and verification of constancy of performance (EVCP) as well as the technical assessment bodies (TAB) that are members of the Organization European technical assessment (EOTA).
2. the Committee set up by art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of naming authorities and competent authorities notified by the Parties.

Section IV special principles for the designation of conformity assessment bodies


For the designation of conformity assessment bodies, designation authorities respect the General principles set out in this agreement.

Section V supplementary provisions 1. Changes to the legislative, regulatory and administrative provisions referred to in section I without prejudice to art. 12, by. 2 of this agreement, the European Union shall notify without delay to the Switzerland, after their publication in the Official Journal of the European Union, implementing acts and delegated acts adopted on the basis of Regulation (EU) n 305/2011 after December 15, 2014.
The Switzerland shall immediately notify the European Union relevant changes in Swiss legislation.

2 implementation the competent authorities of Parties and organizations to determine, in accordance with the Regulation (EU) n 305/2011: - the essential characteristics for which the manufacturer says the product performance - performance classes and threshold levels for the essential characteristics of construction products, - the conditions in which a construction product is deemed to satisfy a certain level or a certain class of performance or-the systems of assessment and verification of constancy of performance (EVCP) applicable to a construction product, guarantee mutual respect for the regulatory needs of the Member States and the Switzerland.

3. European harmonised standards for construction products has) for the purposes of this agreement, after their publication in the Official Journal of the European Union in accordance with art. 17, by. 5, to Regulation (EU) n 305/2011, the Switzerland will publish the references of European harmonised standards for construction products, which provide methods and evaluation criteria for the performance of construction products, including: - performance classes and threshold levels for the essential characteristics of construction products, - the conditions under which products of construction are deemed satisfy a certain level or a certain class of performance without testing.

(b) where the Switzerland considers that a harmonised standard does not entirely satisfy the requirements set out in the legislation referred to in section I, the Swiss competent authority may ask the European Commission to consider the issue in accordance with the procedure laid down in art. 18 of the Regulation (EU) n 305/2011.La Switzerland may submit the question to the Committee, setting out its reasons. The Committee examines the issue and may ask the European Union to act in accordance with the procedure laid down in art. 18 of the Regulation (EU) n 305/2011.

4. European technical assessments (SUMMER) a) the Switzerland is entitled to designate the OET to deliver the SUMMER. It ensures that designated TABS become members of EOTA and participate in its work, including the preparation and adoption of European assessment documents according to the provisions of art. 19 of the Regulation (EU) n 305/2011.Les procedures and decisions of EOTA shall apply also for the purposes of this agreement.
(b) the European assessment documents issued by the EOTA and SUMMER issued by TABS are recognized by both Parties for the purposes of the present Accord.c) when an OET receives a request for the SUMMER for a product that is not fully covered by a harmonised standard as referred to in art. 21, by. 1, of Regulation (EU) n 305/2011, it informs the EOTA and the Commission of the content of the request and the reference of the legal act relevant to the Commission's assessment and verification of constancy of performance that he intends to apply to the product in question, or the absence of such an act juridique.d) if TABS do not reach an agreement on the European within the prescribed assessment document EOTA shall submit the question to the Commission. In case of disagreement concerning a Swiss OET, the Commission may visit the Swiss designation authority when it settles a question in accordance with art. 23 of the Regulation (EU) n 305/2011.e) where the Switzerland considers that a European assessment document does not fully meet the requirements regarding the fundamental requirements for the construction works set out in the legislation referred to in section I of this chapter, the Swiss competent authority may ask the Commission to act in accordance with the procedure laid down in art. 25 of the regulations (EU) n 305/2011.La Switzerland may submit the question to the Committee, setting out its reasons. The Committee examines the issue and may ask the European Union to act in accordance with the procedure laid down in art. Article 25 of Regulation (EU) n 305/2011.

5. Exchange of information has) according to art. 9 of this agreement, the Parties exchange the information necessary for the correct application of the present chapitre.b) pursuant to art. 12, by. 3, of this agreement, the Member States and the Switzerland refer to "product contact points" for construction, exchanging relevant information on demande.c) if the Switzerland's regulatory needs, it can propose the adoption of provisions, in particular in order to determine the essential characteristics for which the performance should be reported or to define performance classes of threshold levels in relation to the essential characteristics of construction products, or conditions in which products of construction are deemed satisfy a certain level or a certain class of performance without testing, as provided for in art. 3 and art. 27 of the Regulation (EU) n 305/2011.

6. market access and technical documentation) for the purposes of this chapter, the following definitions apply:-"importer": any physical or legal person established on the territory of the European Union or the Switzerland who places a product from a third country on the market of the European Union or of the Switzerland, - "agent": any person person established in the EU or in Switzerland who received a mandate written from a manufacturer to act on its behalf for the purposes the fulfilment of tasks,-"distributor": any physical or legal person forming part of the supply chain, other than the manufacturer or the importer, who makes a construction product available on the market of the European Union or of the Switzerland.

(b) according to the legislation referred to in section I of this chapter, the manufacturers and importers indicate on the construction product or, where that is not possible, on its packaging or in a document accompanying the product, their name, their trade name or trademark and their coordonnees.c) simply for manufacturers, their agents or importers to hold the declaration of performance and the technical documentation at the disposal of the national authorities for the period required by the legislation referred to in section I on the date of the product on the market of one or the other Partie.d) at query motivated a competent national authority, the manufacturers, their authorised agent or importers shall communicate all information and documents necessary to demonstrate the conformity of the construction with the declaration of performance product and with other requirements of the present chapter, in a language easily understood by that authority. They cooperate with that authority, at its request, any measure adopted to eliminate the risks of construction products which they have placed on the market.

7. sharing of experience Swiss authorities may participate in the sharing of experience between the national authorities of the States referred to in art. 54 of Regulation (EU) n 305/2011.

8. coordination of notified bodies designated notified bodies Swiss can participate in the coordination and cooperation mechanisms provided for in art. 55 of Regulation (EU) n 305/2011, directly or through representatives designated.

9. procedure for construction products presenting a risk due to a nonconformance that is not limited to the national territory in accordance with art. 12, by. 4, of this agreement, when surveillance of the market of a Member State or of the Switzerland authorities have taken measures or have sufficient reason to believe that, due to a non-compliance with the provisions of the legislation referred to in section I of this chapter, a construction product is a risk due to this non-compliance and that they consider that it is not restricted to their national territory , they will inform each other and the Commission European, at the earliest, of the following: - the results of the assessment that they have done and what they have required the economic operator concerned, - when the economic operator concerned does not the corrective measures that are necessary, all appropriate provisional measures to prohibit or restrict the making available of the construction product on their national market to remove it from the market or to remind. The information provided for in art. 56, per. 5, to Regulation (EU) n 305/2011 must be provided.


Member States, or Switzerland, inform as soon as the European Commission and other national authorities of any measures adopted and of any additional information available to them in what concerns the non-compliance of the construction product concerned.
The Member States and the Switzerland shall ensure that appropriate restrictive measures are taken promptly against the construction product concerned, for example the removal of the product from their market.

10 backup procedure in case of objections against national measures if the Switzerland or a Member State challenges the national measure referred to the by. 9 above, he or she shall inform the European Commission of its objections within a period of 15 working days from the receipt of the information.
When, at the end of the procedure set in the by. 9 above, objections are issued by a Member State or Switzerland against a measure taken by the Switzerland or a Member State, respectively, or where the Commission considers that a national measure is not in conformity with the legislation referred to in section I, the latter engages in timely consultations with Member States, the Switzerland and the economic operators concerned and to the assessment of the national to determine measure whether it is justified or not. If the national measure is considered: - justified, all Member States and the Switzerland take the necessary measures to ensure the withdrawal of the illegal construction of their market product and communicate this to the Commission - unjustified, the Member State concerned or the Switzerland removes it.

In both cases, a party may submit the question to the Committee, in accordance with the by. 12 11. Products of consistent construction which nevertheless present a risk to health and safety when a Member State or the Switzerland finds that, although a construction product has been made available on the market in the Union and Switzerland in accordance with the legislation referred to in section I of this chapter, this construction product poses a risk to the respect of the fundamental requirements for construction works to the health or safety of persons or to other aspects related to the protection of public interest, he or she takes all appropriate measures and shall immediately inform the Commission, the other Member States and the Switzerland. This information includes all available information, including the data necessary to identify the construction product concerned, its origin and its supply chain, the nature of the risk involved, and the nature and duration of national measures taken.
The Commission starting in the Switzerland, timely consultations with the Member States and the economic operators concerned and makes the assessment of the national measures taken to determine if the national measure is justified or not.
A party may submit the question to the Committee, in accordance with the by. 12 12. Safeguard clause in case of disagreement remaining between the Parties in the event of disagreement between the Parties on the measures referred to in the by. 10 and 11, the question will be submitted to the Committee, which will decide on a line of conduct, including the opportunity to carry out a study by experts.
When the Committee considers that the measure is: a) justified, the Parties take the necessary measures to ensure the withdrawal of the product from their market; b) unjustified, the national authority of the Member State or the Switzerland withdraws.

The Commission statement European in order to ensure the application and implementing effective chapter on building products of annex 1 of the agreement and to the extent where the Switzerland adopted the acquis relevant EU or equivalent measures to the title of the chapter on products of construction, the Commission, in accordance with the declaration of the Council on the participation of Switzerland to committees and to the art. 100 of the agreement on the European economic area, will consult Swiss experts in the preparatory phases of the proposals for measures to be submitted later to the Committee set up by art. 64 of the Regulation (EU) n 305/2011 in order to assist the Commission in the exercise of its executive powers.
The Commission also notes that the Chairman of the Committee set up pursuant to art. 64 of Regulation (EU) n 305/2011 may decide to invite experts to speak on specific issues at the request of a member or on its own initiative, particularly in the areas of direct interest to the Switzerland Swiss.

Chapter 17 elevators Section I provisions, legislative, regulatory and administrative provisions covered by art. 1, by. 2 European union 1. 95/16/EC of the European Parliament and the Council, of 29 June 1995 on the approximation of the laws of the Member States relating to lifts (OJ L 213 of the 7.9.1995, p. 1), amended last by directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending directive 95/16/EC (recast) (OJ L 157 of 9.6.2006 the (, p. 24) Switzerland 100. Federal law of June 12, 2009 on the safety of products (RO 2010 2573) 101. Order of 19 May 2010 on the safety of products (RO 2010 2583) 102. Order of 23 June 1999 on the safety of elevators (RO 1999 1875), last modified may 19, 2010 (RO 2010 2583) assessment of compliance the Committee Section II bodies set up by the art. 10 of this agreement establishes and updates, according to the procedure laid down in art. 11 of this agreement, a list of the conformity assessment bodies.

Section III authorities of designation the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.

Section IV special principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect general principles of annex 2 to this agreement as well as the evaluation criteria defined in annex VII of directive 95/16/EC.

Section V supplementary provisions 1. Exchange of information in accordance with art. 8, by. 3, of directive 95/16/EC, the Commission European, the authorities referred to in section III and recognized under this agreement compliance assessment bodies may, on request, obtain from the installer a copy of the declaration of conformity and reports of the trials related to the final control.
In accordance with annex V, points A 5 and B 5, of directive 95/16/EC, they can get agency conformity assessment which the type test certificate issued a copy of the certificate and, on reasoned request, a copy of the technical dossier and reports of examinations, calculations, or tests.
In accordance with annex V, points A 7 and B 7 of directive 95/16/EC, conformity assessment organizations that have issued certificates of type review must communicate to the Member States, the Switzerland and other conformity assessment bodies information concerning certificates of type examination they have issued or withdrawn.
According to the point 6 of annexes VIII, IX, XII, XIII and XIV of directive 95/16/EC, organizations recognized under this agreement conformity assessment must communicate to other conformity assessment bodies the relevant information concerning approvals issued or withdrawn quality assurance systems.
In the cases referred to in art. 8, by. 2, points i), (ii) and (iii) of directive 95/16/EC, the person responsible for the design of the elevator must provide to the person responsible for the construction, installation and testing of it all the documentation and information necessary so that these operations can be carried out safely.

2 technical documentation regarding the necessary documents for inspection authorities, it is sufficient that the manufacturer of a component security, his authorized representative established in the EU or in Switzerland or, in the absence of these, the person responsible for the placing on the market of the safety component held technical documentation along with a copy of the declaration of conformity and its supplements (if applicable) at the disposal of these authorities on the territory of one of the parties for a period of at least ten years from the last date of manufacture of the safety component.
Simply that the installer of the lift shall keep a copy of the declaration of conformity of its add-ins and the certificate of final control (if necessary) for ten years from the placing on the market of the lift with technical documentation.
When the installer is not established in the EU or in Switzerland, this obligation on the competent notified body.
The parties undertake to provide, at the request of the authorities of the other party, all of the relevant technical documentation.

3. monitoring of the market parties shall notify on the names of the authorities established on their territory which are charged the surveillance tasks related to the execution of their legislation referred to in section I.

The parties learn about the activities in the field of monitoring the market as part of the bodies provided for this purpose.

Chapter 18 biocidal products scope and coverage 1. The provisions of this sectoral chapter apply to active substances, produced biocides, product families biocides and items treated as defined in art. 3 of the Regulation (EU) No. 528/2012 on the implementation available on the market and use of biocidal products (hereinafter referred to as "regulation on biocides" or "OPR"), subject to the procedures provided by the OPR and equivalent Swiss provisions, with the exception:-biocidal products that are or contain genetically modified organisms, and - biocides to combat other vertebrates, piscicides and avicides.

2. the acts of the Commission adopted pursuant to art. 9, art. 14, by. 4, and art. 15, by. 1, the OPR for the approval of active substances, and delegated acts adopted in application of art. 28, by. 1 and 3, of the OPR regarding the entry of active substances in annex I of the OPR, are part of this chapter.
3. the Switzerland is free to limit access to its market in accordance with the requirements of its existing legislation on the date of entry into force of this chapter regarding:-biocidal products containing the octylphenol or their ethoxylates, and - spray cans containing substances stable in air Section I provisions legislative, regulatory and administrative provisions covered by art. 1, by. 2: European union 1. Regulation (EU) No. 528/2012 of the European Parliament and the Council of May 22, 2012, about the availability on the market and use of biocidal products (OPR), (OJ L 167 of the 27.6.2012, p. 1), amended lastly by Regulation (EU) n 334/2014 of the European Parliament and of the Council of March 11, 2014 (JO L 103 of the 5.4.2014 (, p. 22), as well as implementing acts and delegated acts of the Commission adopted on the basis of this regulation until October 10, 2014.

Switzerland 100. Federal law of 15 December 2000 on the protection against substances and dangerous preparations (RO 2004 4763), last modified June 13, 2006 (RO 2006 2197) 101. Federal law of 7 October 1983 on the protection of the environment (RO 1984 1122), amended last held August 1, 2010 (RO 2010 3233) 102. Order of 18 May 2005 concerning the placing on the market and the use of the biocides (Ordinance on biocides, RO 2005 2821), amended last July 15, 2014 (RO 2014 2073) (hereinafter "OBP") 103. Order of the DFI on August 15, 2014, on the implementing rules relating to the Ordinance on biocidal products (RO 2014 2755) Section II organizations of conformity assessment for the purposes of this chapter, means "conformity assessment bodies", EU authorities and the competent authorities of Member States of the EU and the Switzerland responsible enforcement of the legislation referred to in section I.
The contact details of the competent authorities of the Parties are available on the following websites.
EU Biocides: - competent authorities and other points of contactHYPERLINK "http://ec.europa.eu/environment/chemicals/biocides/regulation/comp_authorities_en.htm" \h - HYPERLINK "http://www.echa.europa.eu/regulations/biocidal-products-regulation" \h federal Switzerland Office of public health, notification body of chemical www.bag.admin.ch/biocide Section III additional provisions 1. Changes to the legislative, regulatory and administrative provisions referred to in section I without prejudice to art. 12, by. 2, of the present agreement, the European Union shall notify without delay to the Switzerland, after their publication in the Official Journal of the European Union, implementing acts and the delegated Commission acts adopted under the Regulation (EU) n 528/2012 after October 10, 2014.
The Switzerland shall immediately notify the European Union relevant changes in Swiss legislation.

2. procedures of the OPR and its implementing acts that apply between the parties) for the purposes of this chapter, specified below, which are planned by the OPR as well as by his delegated acts and acts of execution as referred to in section I, procedures as common procedures to complete as equivalent provisions.
In this section, references to a 'Member States' or their competent authorities in articles of the OPR which "apply between the Parties" agree to include, in addition to their significance in the regulation, the Switzerland. For the purposes of this chapter:-the 'licence holders' and the persons referred to in art. 95 of the OPR can be established in the EU or in Switzerland, applicants use the registry of biocidal products (hereinafter referred to as 'register') to submit applications and data for all procedures, as provided for in art. 71, by. 3, of the OPR. Applicants are not required to be established in the EU or in Switzerland.

The procedures of the OPR and its implementing acts and delegated acts, listed below, apply between the Parties:-chapters II and III and the (EU) n 1062/2014 the Commission delegated regulation, regarding the approval of active substances. Applicants may propose the Swiss competent authority as competent authority for evaluation, - art. 27 regarding the biocides permitted in accordance with the simplified procedure, - the art. 32 to 34 and delegated the regulations (EU) n 492/2014 the Commission with respect to mutual recognition of authorizations and their renewal, - the art. 35 to 37 on the objections and exceptions, - the art. 43 to 46 of the authorizations of the Union, with the following adjustments: when the Commission grants, renews, cancels or changes a Union for a biocidal product authorisation, or when she decides not to grant it or refuse to renew, the Switzerland, without prejudice to legal recourse, takes a decision within a period of 30 days in accordance with art. 14A OPBbio regarding the granting, renewal, cancellation or editing a permission for this product,-the art. 47 to 50 and the implementing Regulation (EU) n 354/2013 the Commission regarding the notification of adverse reactions and the cancellation or modification of an authorisation, provisions-art. 53 on parallel trade-art. 54 regarding the establishment of the technical equivalence of active substances, - the art. 62 and 63 on the sharing of data. Where an application has been made to the Swiss competent authority, the applicant is redirected to the Agency and made his request in the register-art. 69, per. 2, regarding the name and address of the holder of the authorization and the number of the authorisation to be included on the labels,-art. 88 concerning the measures taken on the basis of new evidence, art. 95 [according to Regulation (EU) n 334/2014], with the transitional, scheduled period in art. 95, by. 2, until September 1, 2016, for the provision of the product on the market of the Suisse.b) if the Switzerland intends to derogate from a decision under art. 36, by. 3 or art. 37, by. 2, a decision, in the case of authorizations of the Union, in accordance with art. 44, by. 5, art. 46, by. 4 and 5, or in art. 47 to 50, or decisions adopted in accordance with the art. 88 of the OPR, or plans to adapt certain conditions specific to its territory in accordance with art. 12, by. 2, OBP, it may take appropriate measures and shall immediately inform the Commission, setting out its reasons. If necessary, the matter is referred to the Joint Committee, which will decide on a course of appropriate action.

3. Exchange of information in accordance with art. 9 of this agreement, the Parties exchange including the information necessary for the coordination of the procedures referred to in this chapter, as that provided for in art. 71 of the OPR.
In accordance with art. 29, by. 4, of the OPR, except in cases where the regulations (EU) n 414/2013 the Commission applies, the Switzerland refuses the demand if another competent authority examines an application for the same biocidal product or already authorized this product.
The Parties agree that the permissions and other decisions relating to the application of this chapter may be notified by the competent authorities directly to the applicant in the territory of the other party.
The information is protected and processed by the competent authorities of the Parties in accordance with the art. 59, 64, 66 and 67 of the OPR.

4. financial contribution for the services provided by the Agency (ECHA) chemicals


(a) the Switzerland participates in the expenditure of the Agency for the activities referred to in this chapter by an annual financial contribution to be added to the grant of the EU referred to in art. 78, by. 1, of the OPR. This annual financial contribution is calculated based on its gross domestic product (GDP), as a percentage of the GDP of all participating States, according to the formula described in Appendix 1. The annual contribution will be paid to the Agency on the basis of a debit note issued by ECHA.
(b) the financial contribution referred to in point (a) shall apply from the day following that of the entry into force of this decision. The first financial contribution is reduced in proportion to the time remaining between the date of entry into force and the end of the year.

Appendix 1 Financial Contribution of Switzerland to the services provided by the European Agency for chemical products (ECHA) 1. The annual financial contribution of Switzerland to the grant referred to in art. 78 of the OPR is calculated in the following way: the gross domestic product (GDP) of the Switzerland, established according to the latest definitive figures available at March 31 of each year, is divided by the sum of the GDPS of all States involved in these activities, according to the figures for the same year. The resulting percentage is applied to the grant of the Union referred to in art. 78, by. 1, point (a) of the OPR for the amount of the financial contribution from the Switzerland.
2. the financial contribution is paid in euros.
3. the Switzerland pays its financial contribution no later than 45 days after receiving the debit note. Any delay in payment gives rise to payment by Switzerland of interest on the amount outstanding on the due date. The interest rate corresponds to the rate applied by the European Central Bank to its main refinancing operations the first calendar day of the month of the due date, as that published in the Official Journal of the European Union, C series, plus 1.5 percentage points.
4. the financial contribution of the Switzerland is suitable when the Union grant entered in the general budget of the European Union, as it is defined in art. 78, by. 1, point (a) of the OPR is increased by application of art. 26, 27 or 41 of Regulation (EU, Euratom) no 966/2012 to the European Parliament and Council of October 25, 2012 on the financial rules applicable to the general budget of the Union and repealing Regulation (EC, Euratom) 1605/2002 of the Council n. In this case, the difference is due 45 days after the receipt of the debit note.
5. when the subsidy received by ECHA in accordance with art. 78, by. 1, point (a) of the OPR for a year N is not spent by 31 December of year N or ECHA for year N budget decreased in accordance with the art. 26, 27 or 41 of Regulation (EU, Euratom) no 966/2012, the part of these spent or reduced payment appropriations corresponding to the percentage of the contribution of the Switzerland is deferred to the budget of the Agency for the year N + 1. The contribution of Switzerland to the grant from the Agency for the year N + 1 will be reduced accordingly.

The Commission statement European in order to ensure the application and implementing effective chapter on biocides of annex 1 of the agreement and to the extent where the Switzerland has adopted the EU acquis relevant or measures equivalent to the title of the chapter on biocides, the Commission, in accordance with the Declaration of the Council on the participation of Switzerland to committees and to the art. 100 of the agreement on the European economic area, will consult Swiss experts in the preparatory phases of the proposals for measures to be submitted later to the Committee set up by art. 82 of the Regulation (EU) No. 528/2012 in order to assist the Commission in the exercise of its executive powers.
The Commission also notes that the Chairman of the Committee set up pursuant to art. 82 of Regulation (EU) No. 528/2012 may decide to invite experts to speak on specific issues at the request of a member or on its own initiative, particularly in the areas of direct interest to the Switzerland Swiss.
In addition, the Commission notes that the Swiss experts are invited to participate in the Group of competent authorities responsible for enforcement of the OPR, which assists the Commission with a view to a harmonised Regulation (EU) n 528/2012 implementation and, if necessary, to the Committee referred to in art. 75 of Regulation (EU) No. 528/2012 and the coordination group referred to in art. 35 Regulation (EU) No. 528/2012, with regard to matters of the chapter on biocidal products.

Chapter 19 facilities to cables Section I legislative, regulatory and administrative provisions referred to in art. 1, by. 2 European union Directive 2000/9/EC of the European Parliament and of the Council of 20 March 2000 on Cableways carrying people (OJ L 106 of the 3.5.2000, p. 21; hereinafter the 'directive 2000/9/EC').

Switzerland Federal law of 23 June 2006 on Cableways carrying people (RO 2006 5753), as last amended on March 20, 2009 (RO 2009 5597).
Order of 21 December 2006 on Cableways carrying people (RO 2007 39), as last amended on June 11, 2010 (RO 2010 2749).

Section II assessment bodies of compliance the Committee set up by art. 10 of this agreement establishes and updates, according to the procedure referred to in art. 11 of the agreement, a list of the conformity assessment bodies.

Section III designation authorities the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the parties.

Section IV special principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect general principles of annex 2 to this agreement as well as the evaluation criteria set out in annex VIII of directive 2000/9/EC.

Section V supplementary provisions 1. Exchange of information in accordance with the art. 9 and 12 of this agreement, the parties exchange the information necessary for the correct application of this chapter.
In particular, the competent authorities of the Switzerland and the Member States, and the European Commission, exchange the information referred to in art. 11 and 14 of directive 2000/9/EC.
The conformity assessment bodies designated in accordance with the provisions of section IV of this annex exchange the information referred to in annex V to the directive 2000/9/EC, which covers the module B, items 7 and 8, module D, point 6, and module H, point 6 and 7.5.

2. technical documentation just for manufacturers, their agents or individuals responsible for the marketing of products, to keep available the technical documentation required by the directive 2000/9/EC on the territory of one of the parties.
The parties undertake to provide, at the request of the authorities of the other party, all of the relevant technical documentation.

3. monitoring of the market parties shall notify on the names of the authorities established on their territory which are charged the surveillance tasks related to the execution of their legislation referred to in section I.
The parties inform activities they conduct in the field of monitoring the market as part of the bodies provided for this purpose."

Chapter 20 explosives for civil use Section I legislative, regulatory and administrative provisions referred to in art. 1, by. 2 European union 1. Directive 93/15/EEC of the Council, of 5 April 1993, relating to the harmonization of the provisions on the placing on the market and the control of explosives for civilian use [in the version of the OJ L 121 of 15.5.1993, p. 20, corrected in OJ L 79 of 7.4.1995, p. 34 (ARE, DA, EL, EN, FR, IT, NL, PT, FI, SV) and the OJ L 59 of the 1.3.2006] [, p. 43 (DE)], hereinafter referred to as 'directive 93/15/EEC' 2. Directive 2008/43/EC of the Commission of 4 April 2008 on implementation, in accordance with directive 93/15/EEC of the Council, of a system of identification and traceability of explosives for civil use (OJ L 94 of the 5.4.2008, p. 8), amended by the 2012-4-EU directive (OJ L 50 of the 23.2.2012, p. 18), hereinafter referred to as 'directive 2008/43/EC' 3. Decision 2004/388/EC of the Commission of 15 April 2004 on a document on the intra-Community transfer of explosives (OJ L 120 of the 24.4.2004, p. 43), amended by decision 347/2010/EU of the Commission (OJ L 155 of the 22.6.2010, p. 54), hereinafter referred to as 'decision 2004/388/EC' Switzerland 100. Federal law of 25 March 1977 on explosive substances (Explosives Act), amended last June 12, 2009 (RO 2010 2617) 101. Order of 27 November 2000 on hazardous substances (explosives Ordinance), last modified September 21, 2012 (RO 2012 5315) Section II the Committee set up by the art compliance assessment bodies. 10 of this agreement establishes and maintains, according to the procedure referred to in art. 11 of the agreement, a list of the conformity assessment bodies.

Section III designation authorities the Committee set up by art. 10 of this agreement establishes and maintains a list of the designation authorities notified by the Parties.


Section IV specific principles for the designation of for designating conformity assessment bodies of the conformity assessment bodies, designation authorities respect the General principles set out in Appendix 2 of this agreement, as well as the evaluation criteria defined in art. 6, by. 2, of directive 93/15/EEC and annex III.

Section V supplementary provisions 1. Identification of products both Parties ensure that companies specializing in explosives, who manufacture or import explosives or assemble detonators, affix a unique identification on explosives and each basic packaging unit. When an explosive is the object of other manufacturing process, manufacturers are not required to affix a new unique identification on the explosive, unless the original unique identification no longer appears in accordance with directive 2008/43/EC and/or explosives Ordinance.
The unique identification includes the elements described in the annex to the directive 2008/43/EC and in annex 14 of the Ordinance on explosives, and is mutually recognized by both Parties.
Each company that specializes in explosives and/or manufacturer is assigned a code three-digit by the national authority of the Member State in which he is established or the Swiss national authority, as the case may be. Both Parties mutually acknowledge this three digit code as soon as the production site or the manufacturer is established in the territory of one of them.

2. provisions on the control of transfers between the European Union and Switzerland 1. Explosives covered by this chapter may be transferred between the European Union and the Switzerland according to the procedure laid down in the following paragraphs.
2. the checks carried out pursuant to the law of the European Union or national law in the event of transfers of explosives that are governed by section V.2 are only under the normal procedures of control applied in a non-discriminatory manner throughout the territory of the Union European or the Switzerland.
3. in order to achieve the transfer of explosives, the recipient must obtain authorisation from the competent authority of the place of destination transfer. The competent authority verifies that the recipient is legally entitled to acquire explosives and that he holds the licenses or permissions. The transit of explosives through the territory of one or more Member States or the Switzerland must be notified by the person responsible for the transfer to the competent authorities of this (these) State (s) member (s) or Switzerland, whose approval is required.
4. If a Member State or the Switzerland considers that there is a problem regarding the verification of the clearance to the acquisition of explosives, referred to the by. 3, that Member State or the Switzerland, according to the case, transmits the information available on this subject to the European Commission, which, without delay, shall present to the Committee referred to in art. 13 of directive 93/15/EEC. The European Commission informs the Switzerland through the Committee set up by art. 10 of this agreement.
5. If the competent authority of the place of destination authorizes the transfer, it delivers to the consignee a document embodying the transfer authorization with all of the information set out in the by. 7. This document must accompany the explosives until the intended point of their destination. It must be presented on request to the competent authorities. A copy of this document is retained by the recipient, who presents it to the competent authority of the place of destination at the request thereof.
6. when the competent authority of a Member State or of the Switzerland considers that special requirements of security, such as those mentioned in the by. 5, are not required, the transfer of explosives on the territory or part of the territory of that Member State or the Switzerland, as the case may be, can be performed without the prior provision of this information to the by. 7. the competent authority of the place of destination then issues a transfer authorization valid for a period determined but likely to be at any time suspended or withdrawn on reasoned decision. The document referred to the by. 5, accompanying the explosives to their destination, then mention only the aforementioned transfer authorization.
7. when explosives transfers require specific controls to determine whether these transfers meet specific requirements of safety on the territory or part of the territory of a Member State or of the Switzerland, the following information is provided prior to the transfer, by the consignee to the competent authority of the place of destination:-the name and address of the operators concerned. These data must be sufficiently detailed to allow, on the one hand, to contact these operators and, on the other hand, to establish that the people involved are officially authorized to receive send, - the number and the quantity of transferred explosives, - a full description of the explosive in question and of the means of identification, including the United Nations identification number, - information on compliance with conditions for placing on the market When he was placed on the market, - transfer mode and the itinerary, - the dates of departure and arrival -, to the need, specific crossings at the entrance and exit of the Member States or of the Switzerland.

The competent authorities of the place of destination examine the conditions in which the transfer must take place, particularly in terms of the specific security requirements. Where the special security requirements are met, the transfer is authorized. In the case of transit through the territory of other Member States or of Switzerland, the concerned States or Switzerland, depending on the case, review and approve the information related to the transfer under the same conditions.
8. without prejudice to the normal controls the country of departure has on its territory, the recipients or the explosives sector operators transmit to the competent authorities of the country of departure as well as to those of the country of transit, on their request, any useful information they have about transfers of explosives.
9. no supplier may transfer explosives if the recipient does not have permissions for this purpose according to the provisions of by. 3, 5, 6 and 7.
10. for the purposes of the application of the per. 4, when a measure referred to in art. 13 of directive 93/15/EEC was adopted about products from companies specialized in explosives and Swiss manufacturers, it is immediately communicated to the Committee set up by art. 10 of this agreement.
If the Switzerland disagrees with this measure, the application of it is delayed for a period of three months from the date of the communication. The Committee set up by art. 10 this agreement engages consultations to resolve the dispute. If no agreement is reached within the time limit referred to in this paragraph, each party may suspend the chapter in whole or in part.
11. for the purposes of the application of by. 5 and 6, the provisions of decision 2004/388/EC shall apply.

3 exchanging information in accordance with the General provisions of this agreement, the Member States and the Switzerland hold each other at their disposal all the information necessary for the implementation of directive 2008/43/EC.

4. location of the manufacturer for the purposes of this chapter, simply that the company specialized in explosives, the manufacturer, agent or, in the absence thereof, the responsible person of the placing on the market of the product, be established in the territory of one of the Parties.

New content according to section 1 of D n 2/2008 of May 16, 2008 (RO 2009 4621) Committee. Update according to the of the Committee 1/2009 of 21 dec. 2009 (RO 2010 4003), n 1/2010 of 18 oct. 2010 (RO 2011 1355), no. 1/2011 dec 20. 2011 (OR 2012 2379), no. 1/2012 of Dec. 17. 2012 (RO 2013 2039), n 1/Apr 1, 2014. 2014 (RO 2014 3065) and n 1/2015 to Apr. 14. 2015, in force for Switzerland since Apr. 14. 2015 (2015 2645 RO).
This procedure does not impose on the European Union to grant to the Switzerland access to the Community system of rapid exchange of information (RAPEX) under art. 12, by. 4, of the directive 2001/95/EC of the European Parliament and the Council on Dec. 3. 2001 relative to the General safety of products (OJ L 11 of the 15.1.2002, p. 4).
OJ L 114 of 30.4.2002, p. 429.
The Switzerland shall notify promptly the EU change corresponding to the guidelines of EU good practices of distribution of medicines for human use (OJ C 343 of the 23.11.2013, p. 1) Declaration on the participation of Switzerland in the committees (OJ L 114 of the 30.4.2002, p. 429).
Declaration on the participation of Switzerland in the committees (OJ L 114 of the 30.4.2002, p. 429).
This chapter does not apply to explosives intended to be used, in accordance with national law, by the armed forces or the police, ammunition and pyrotechnic articles.

State on April 14, 2015 annex 2 General principles of designation of the compliance A. requirements and conditions assessment bodies


1. in the context of this agreement, designation authorities remain solely responsible for the skills and capacity of the bodies they have designated as do that designate entities with a legal identity under their jurisdiction.
2. designation authorities refer to conformity assessment bodies able to demonstrate through objective evidence that they understand the requirements and the certification procedures of the legislative, regulatory and administrative provisions listed in annex 1 and applicable to the particular product, in the class of products or sector for which the agencies are designated, and they have the experience and the skills to apply these requirements and procedures.
3. evidence of the technical competence must cover: - the technical knowledge of the categories of products, processes or services that conformity assessment body is willing to control; - understanding technical standards and/or legislative, regulatory and administrative provisions covered by the designation; - the material ability to complete a given task in the conformity assessment; - the adequate management of this task; and - any other element to ensure that the task of conformity assessment will be carried out in all circumstances.

4. the criteria of technical competence are based, wherever possible, on recognized documents at the international level, including the series of standards IN 45 000 or its equivalent, as well as appropriate interpretative documents. However, it is clear that these documents should be interpreted to incorporate different types of requirements provided by the laws, regulations and administrative provisions applicable.
5. the Parties encourage harmonisation of designation procedures and the coordination of the procedures for assessment of conformity by the cooperation between authorities of designation and assessment agencies compliance with the means of coordination meetings, participation in arrangements for mutual recognition and by ad hoc working groups sessions. The Parties also encourage accreditation bodies to participate in mutual recognition arrangements.

B. system of verification of the competence of the 6 conformity assessment bodies. To verify the technical competence of conformity assessment bodies, authorities may appeal to different mechanisms to ensure a level of trust between the Parties. If necessary, a specific part to the appointing authority how technical expertise can be established.
(a) accreditation accreditation constitutes a presumption of technical competence of organizations of conformity assessment for the purposes of the requirements set by the other party, when the competent accreditation body:-respects the relevant provisions in force at the international level (EN 45000 standards or guides ISO / IEC); and -is signatory to multilateral arrangements under which it is subject to assessments by peers or-participle, working under the authority of a naming authority, and in accordance with modalities to be decided, comparison and exchange of technical experience, programs to ensure the continued confidence in the technical capacity of agencies of accreditation and conformity assessment bodies. Such programs may include joint assessments, special programmes of cooperation or the conformity assessments.

When the criteria for conformity assessment bodies provide that they assess the conformity of the product, process or service directly to standards or technical specifications, designation authorities may use accreditation as a presumption of technical competence of the conformity assessment body, provided that it allows to evaluate the ability of agencies to enforce these standards or those technical specifications. The designation is limited to those tasks of the conformity assessment body.
When the criteria for conformity assessment bodies provide that they assess the conformity of the product, process or service not not directly to standards or technical specifications but to General requirements (essential requirements), the designation authorities may use accreditation as a presumption of technical competence of the conformity assessment body, provided that it contains so elements to assess the conformity assessment body's ability (technical knowledge of the product) (, knowledge of its use, etc.) to assess the conformity of the product with these essential requirements. The designation is limited to those tasks of the conformity assessment body.
(b) other means in the absence of system for certification or for other reasons, the responsible authorities are asking compliance assessment bodies to demonstrate their competence through other means such as: - participation in regional or international mutual recognition or certification systems; - the regular peer review, on the basis of transparent and conducted with the appropriate expertise criteria; - aptitude tests; or-comparisons between conformity assessment bodies.

C. assessment of the audit system 7. After a verification system to evaluate the competence of conformity assessment bodies have been defined, the other party will be invited to check that the system guarantees the conformity of the designation process to its own legal requirements. This review will focus on the relevance and effectiveness of the verification system rather than on conformity assessment bodies themselves.

D. Designation formal 8. When the Parties present their proposals to the Committee to include in the annexes compliance assessment bodies, they transmit the following information to each agency: a) name; b) mailing address; c) number of fax; d) sectoral chapter, categories of products or products, processes and services covered by the designation e) procedures of conformity assessment under the designation; f) means used to determine the jurisdiction of the Agency.

State on April 14, 2015 final act the Plenipotentiaries of the Swiss Confederation and the European Community, together the twenty and a June of year one thousand nine hundred ninety nine in Luxembourg for the signature of the agreement between the Swiss Confederation and the European Community on recognition of conformity assessment have adopted the joint declarations mentioned below and attached to the present final act : Joint declaration on the revision of art. 4, joint declaration on the mutual recognition of good clinical practice and inspections PCBS, Joint Declarations of the contracting parties on the update of the annexes, Joint Declaration on future additional negotiations.
They also took note of the following declaration annexed to this final act Declaration on the participation of Switzerland in the committees, to Luxembourg, twenty-one June of the year one thousand nine hundred and ninety-nine.

For the Confederation Switzerland Pascal Couchepin SCRS Deiss for the Community European Joschka Fischer Hans van der Broek. Joint Declaration by the Contracting Parties on the revision of art. 4. the Contracting Parties undertake to review art. 4 of the agreement on mutual recognition of conformity assessment, notably to include products from other countries, once the parties have concluded with these countries for the mutual recognition agreements on conformity assessment.
At that time, the provisions of section V of Chapter 12 of this agreement will be revised.

Joint Declaration on the mutual recognition of good clinical practice and inspections PCBS for medical products, the inclusion of the results of clinical trials carried out on the territory of the contracting parties in applications for marketing authorisation on the market or any Variant or extension of it is currently accepted. In principle, the contracting parties undertake to continue to accept these clinical trials for market authorisation applications. They agree to work to reconcile their clinical practices, including through the implementation of current statements Helsinki and Tokyo as well as all clinical recommendations adopted at the International Conference on harmonization. However, due to changes in the legislation applicable to the verification and approval of clinical trials in the Community European, mutual recognition of official control of these tests will have to be studied in detail in the near future and the practical arrangements should be laid down in a separate chapter.

Joint Declaration by the Contracting Parties on the update of the annexes


The Contracting Parties undertake to update the annexes to the agreement on mutual recognition of conformity assessment no later than one month after the entry into force.

Joint Declaration on future negotiations additional. the European Community and the Swiss Confederation declare their intention to enter into negotiations to conclude agreements in areas of common interest such as the updating of Protocol 2 to the free trade agreement of 1972, Swiss participation in certain Community programmes for training, youth, media statistics and the environment. These negotiations should be prepared soon after the conclusion of the current bilateral negotiations.

Declaration on the participation of Switzerland in the committees the Commission agrees that the representatives of the Switzerland participate as observers and for the points which concern them in meetings of the committees and following expert group:-committees of research programmes; including Committee on scientific and technical research (CREST) - administrative Commission on social security for migrant workers - coordinating group on mutual recognition of higher education diplomas - advisory committees on air routes and the application of the competition rules in the field of air transport.

These committees shall meet without the presence of representatives of the Switzerland in the votes.

RO 2002-1803; FF 1999 5440 art. 1 al. let 1. c of the Federal Decree of 8 October. 1999 (RO 2002-1527).
Currently European Union.
RS 0.632.401 RS 0.632.401.2 State on April 14, 2015

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