Economic and Social Council

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1 UNITED NATIONS Document available on the website only Economic and Social Council Distr. GENERAL TRADE/WP.6/2005/7 3 October 2005 E ENGLISH AND FRENCH ONLY ECONOMIC COMMISSION FOR EUROPE COMMITTEE FOR TRADE, INDUSTRY AND ENTERPRISE DEVELOPMENT Working Party on Regulatory Cooperation and Standardization Policies Fifteenth session, October 2005 Item 8 (b) of the provisional agenda Conformity Assessment Mutual Recognition Agreements (MRAs) It is recalled that the Working Party at its fourteenth session decided to initiate an information exchange on the state of play regarding government mutual recognition agreements (MRAs) where UNECE member countries are parties. Delegations were invited to provide the secretariat with information on government MRAs where their countries were engaged - according to the template agreed at the session (document TRADE/WP.6/2004/8). This document has been prepared by Ms. Marie-Christine PONCIN, Rapporteur on MRAs, and contains information on MRAs in the UNECE region and proposals for possible future work in this area. The document is submitted for discussion and it is reproduced in the form and language as received by the secretariat.

2 page 2 1. In accordance with the conclusions of 14th plenary session of the UNECE Working Party on Regulatory Cooperation and Standardization Policies (WP.6) in November 2004, an inventory of the Mutual Recognition Agreements (MRAs) where UNECE member Sates are parties, was established. The scope of this inventory aims at facilitating discussions regarding negotiating and implementing these MRAs. 2. The data collected show various experiences: such as intensive negotiating policy of some member States, recourse to formal agreements or Memorandums of Understanding (MoUs), unilateral, bilateral and multilateral approaches, involvement of governments, administrations or governmental bodies. In addition, the data collected display a large scope of diversity such as procedures for the conformity assessment of technical norms and standards; and also diversity of the economic areas involved. Furthermore, in accordance with the negotiated agreements, the targeted goal (in some cases prior to the negotiation) ends up in mutual recognition agreements, uniformity or harmonization. 3. The inventory was mainly established on the basis of notifications by way of: a WTO Agreement on Technical Barriers to Trade; and, European agencies Europa website; Canadian Ministry of Foreign Affairs Website; American NIST Website; and, the APEC website. 4. At its next plenary session in October 2005, the WP.6 members are invited to: (a) (b) (c) Share their experiences or viewpoints on the mutual recognition agreements at bilateral and regional levels. It would be interesting to have an illustration of : (1) the European Community enlargement experience with its new members, such as Poland, which developed in the past through the Polish Centre for Testing and Certification (PCBC), an active negotiation policy of mutual recognition agreement; (2) Switzerland, (3) the Russian Federation s experience with the CIS countries and also (4) APEC members, (5) USA and (6) Canada; Complete and update the inventory at. To that effect the agreement expiry dates should also be indicated; Make, in addition to the current inventory to be updated, their comments on the proposal to prepare a document covering some areas. The telecommunications sector could be an example for implementation. In that case, should the WP.6 members endorse this proposal, the type of information and the level of accuracy should be clearly indicated.

3 page 3 ANNEX PROVISIONAL LIST OF THE MUTUAL RECOGNITION AGREEMENTS NEGOTIATED BY UN/ECE MEMBERS IN THE FIELD OF TECHNICAL STANDARDS AND REGULATIONS, CONFORMITY ASSESSMENT PROCEDURES AND ACCREDITATION Rapporteur: Marie-Christine PONCIN 3 October 2005 ACRONYMS MoU MRA PECA ACAA EMC GLP GMP n.a. E S T Memorandum of understanding Mutual recognition agreement Protocol to the Europe Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Czech Republic, of the other part, on Conformity assessment and acceptance of industrial products. Agreement on conformity assessment and acceptance of industrial products Electromagnetic compatibility Good laboratory practice in the field of chemical products Good manufacturing practices in the field of pharmaceutical products Non available Entry into force Signature of the agreement or of the arrangement Termination

4 PROVISIONAL LIST OF THE MUTUAL RECOGNITION AGREEMENTS NEGOTIATED BY UN/ECE MEMBERS IN THE FIELD OF TECHNICAL STANDARDS AND REGULATIONS, CONFORMITY ASSESSMENT PROCEDURES AND ACCREDITATION, 3 October 2005 Albania ANDORRA ARMENIA AZERBAIDJAN BELARUS BOSNIA-HERZEGOVINA BULGARIA Ongoing negotiation of a PECA See EU CANADA Sectoral MRA Conformity assessment (GMP audits and inspection) AUSTRALIA S: 16 March 2005 E: n.a CANADA MRA Conformity assessment ISLAND, LIECHTENSTEIN AND NORWAY S: n.a E: 1 January 2001 CANADA MRA Conformity assessment SWITZERLAND S: October 1998 E: 1 May 1999 Pharmaceutical products 6 sectors: telecom equipment, EMC, electrical safety, recreational craft, pharmaceutical products (GMP), medical devices. 6 sectors: telecom equipment, EMC, electrical safety, recreational craft, GMP, medical devices The Department of Industry and Standards Council of Canada (SCC, governmental body) MRA Conformity assessment EUROPEAN COMMUNITY S: 14 May 1998 E: 1 November 1998 APEC telecom mutual recognition arrangement of 8 May 1998 APEC electrical and electronic MRA Sectoral MRA Inter American mutual recognition agreement (CITEL MRA) 6 sectors: telecom equipment, EMC, electrical safety, recreational craft, GMP, medical devices Conformity assessment Phase I (tests) and phase II (approval) APEC E: n.a. Telecom equipment Conformity assessment APEC S: n.a Electrical and electronic equipment Conformity Assessment Organization of American states (OAS): 34 members S: 29 October 1999 In phases I and II Telecommunication Equipment

5 page 5 The Department of Industry of Canada Sectoral mutual recognition arrangement Conformity assessment Republic of KOREA-The ministry of information and communication S: 10 January 1997 E: n.a Sector of telecommunications, radio and information technology equipment CANADA Standards Council of Canada (SCC ) CANADA (SCC) CROATIA EFTA (ICELAND, LIECHTENSTEIN NORWAY) MRA Cooperation agreement Testing and calibration results, Under national accreditation program, recognition of equivalency of certificates according to ISO 9000 and ISO Participation to evaluation and harmonization of conformity assessment procedures USA ANSI S: August 1997 E: n.a USA- occupational Health and safety administration (OHSA) S: May 1997 E: n.a MRA Conformity assessment AUSTRALIA S: n.a E: 1 January sectors: automotive products, EMC, medical devices, pharmaceuticals/gmp, telecommunications terminal equipment, low voltage electrical equipment, machinery and pressure equipment EUROPEAN UNION LATVIA, LITUANIA AND ESTONIA Agreement on the abolition of non tariff barriers to trade Mutual recognition of conformity assessment procedures Ministry of Economy of the Republic of Latvia; Ministry of Foreign Affairs of the Republic of Estonia; Ministry of Foreign Affairs of the Republic of Lithuania. E: 1 July 1998 T: SLOVENIA The Standards and Metrology Institute of the Republic of Slovenia (SMIS) MRA Test results CZECH REPUBLIC- The Czech Office for Standards, Metrology and Testing (COSMT) E : 29 April 1997 T : Electrotechnical and construction products

6 page 6 POLAND CENTER FOR TESTING AND CERTIFICATION (PCBC, governmental body before 2004) MOU Recognition of testing reports and certificates of conformity, and of registration of quality systems. POLAND ( PCBC) MOU To perform an evaluation of manufacturer(s), service organization(s) or distributor(s) system and as a result a registration of their quality system according to the international standards ISO 9001, ISO 9002 and ISO 9003 and other comparable standards. CHINESE TAIPEI- Bureau of Commodity Inspection and Quarantine in Taipei ITALY-Federazione Certificazione Italiana Sistemi Qualita Aziendali (CISQ) S: E: 2 July 1996 S : E : 29 February 1996 POLAND (PCBC) MOU To perform an evaluation of manufacturer(s), service organization(s) or distributor(s) system and as a result a registration of their quality system according to the international standards ISO 9001, ISO 9002 and ISO 9003 and other comparable standards ITALY- Instituto Italiano del Marchio di Qualità S: E: 6 July 1995

7 page 7 POLAND (PCBC) MOU To provide a mechanism whereby the parties would perform an evaluation of manufacturer(s), service organization(s) or distributor(s) system and as a result a registration of their quality system according to the international standards ISO 9001, ISO 9002 and ISO 9003 and other comparable standards. POLAND (PCBC) Cooperation Agreement Mutual recognition of the results of certification. Cooperation based on mutual recognition of the Polish national certification system and Ukrainian national product certification system (UkrSEPRO) aiming at harmonization of national product certification systems with international and European standards and recommendations POLAND (PCBC) Cooperation Agreement on mutual recognition Conformity assessment. The agreement shall establish principles of the mutual audit of accreditation bodies, testing laboratories, SWITZERLAND- Swiss Association for Testing and Certification UKRAINE- the State Committee of Ukraine for Standardization, Metrology and Certification PEOPLE'S REPUBLIC OF CHINA - State Administration of Import and Export Commodity Inspection E: 27 September 1995 S: 25 June 1996 S: 15 December 1995

8 page 8 POLAND (PCBC) Cooperation Agreement on mutual recognition product certification bodies Conformity assessment BYELORUSSIAN REPUBLIC- Committee for Standardization, Metrology and Certification S: 27 November 1995 POLAND (PCBC) POLAND (PCBC) Cooperation Agreement on mutual recognition Cooperation Agreement on mutual recognition Certificates, product test results; Testing laboratories and certification bodies accredited Test results; Final objective of harmonising their product certification on the basis of international and European recommendations POLAND (PCBC) Cooperation Agreement Granting of the Polish safety mark under certain conditions CZECH REPUBLIC - Office for Technical Standardization, Metrology and State Tests Russia- Committee of Russian Federation for Standardization, Metrology and Certification (Gosstandart of Russia) Germany-VDE Testing and Certification Institute S: 11 March 1996 Fuels, fuel products, iron metallurgic products, noniron metallurgic products, metal industry products, machines and appliances, precision industry products, vehicles, electrotechnical and electronical industry products, chemical industry products, construction materials, glass and fine pottery products, wood and paper industry products, other clothing industry products and other industrial products S: 18 July 1994 E: 18 July 1994 requirements concerning environmental protection, human safety and property protection. S: 26 April 1996 Electrotechnical products

9 page 9 POLAND (PCBC) MOU Conformity assessment Germany-Deutsche To provide a mechanism whereby the parties would Gessellschaft zur Zertifizierung von Qualitätsmanagement systemen mbh perform an evaluation of manufacturer(s), service organization(s) or distributor(s) system and as a result a registration of their quality system according to the international standards ISO 9001, ISO 9002 and ISO 9003 and other comparable standards POLAND (PCBC) MOU Idem Austria- Österreichische Vereinigung zur Zertifizierung von Qualitäts management systemen S: E: 2 March 1994 S: E: 19 August 1994 CZECH OFFICE FOR STANDARDS, METROLOGY AND TESTING MRA Conformity Assessment UKRAINE-The State Committee of the Ukraine for Standardization, Metrology and Certification. S: E: 4 December 1996 T: 1 May 2004 List of products

10 page 10 EU 25 (25 members- Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg Malta, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom MRA Conformity assessment, certificates and marking AUSTRALIA S: 24 June 1998 E: 1 January 1999 EU NEW ZEALAND S: 26 June 1999 E: 1 January1999 EU UNITED STATES S: 18 May 1998 E: 1 November 1998 (confidence building period not achieved for the annexes of medical devices and GMP; implementation suspended for the electrical security annex since 28 January 2003) EU CANADA S: 14 May 1998 E: 1 November 8 sectors : pharmaceuticals/ GMP, medical devices, telecom, electrical security, EMC, machine tools, pressure vessels, motor vehicles 7 sectors : automotive products, EMC medical devices; GMP, telecommunications terminal equipment, low voltage electrical equipment, machinery and pressure equipment 6 sectors : telecom, EMC, electrical safety, recreational craft, medical devices, GMP 6 sectors (telecom, EMC, electrical safety, recreational

11 page (confidence building period not achieved for the sector of medical devices) JAPAN S: 4 April 2001 E : 1 January 2002 craft, medical devices, GMP) Good laboratory practises ( GLP) SWITZERLAND S: 21 June sectors: machinery, personal protective equipment, toys, medical devices, gas appliances and boilers, pressure vessels, telecom, APEX equipment, electrical safety, construction plant and equipment, measuring instrument and prepackages, motor vehicles, agricultural and forestry tractors, GLP, GMP ISRAEL S: 17 July 1999 E: 1 May 2000 e.g. medicinal products, cosmetics and chemical products PECA and ACAA agreements Conformity Assessment and Acceptance of Industrial Products CZECH REPUBLIC, ESTONIA, HUNGARY, LATVIA, LITUANIA, MALTA, SLOVAK REPUBLIC, SLOVENIA Entry into force between Termination date: 1 May 2004 Acquis communautaire Equivalency agreement UNITED STATES S : 17 February 2004 E : 1 July 2004 Maritime equipment EC COMMISSION Exchange of letters Unilateral arrangement Conformity assessment CHINESE TAIPEI S : 2000 Medical devices ISRAEL GLP agreement See EU 25 KAZAKHSTAN KYRGYSTAN REPUBLIC OF MOLDOVA

12 page 12 ROMANIA Ongoing negotiation of a PECA agreement in the framework of joining EU RUSSIAN FEDERATION Telecommunication APEC MRA Tests ( phase I) And Approval (phase II) EU APEC Data on signature not available Electrical and electronic MRA Conformity assessment APEC Part I, II, III n.a RUSSIAN FEDERATION State Committee for Standardization, Quality Certification and Metrology Agreement on Cooperation Conformity assessment procedures, quality certification and laboratory accreditation system MONGOLIA- Ministry of Trade and Industry of Mongolia and the Mongolian National Center for Standardization and Metrology E: 7 February 1996 SAN MARINO SERBIA-MONTENEGRO SWITZERLAND MRA Conformity assessment See EU MRA Conformity assessment See Canada TADJIKISTAN THE FORMER YUGOSLAV REPUBLIC OF MACEDONIA TURKEY TURKMENISTAN UKRAINE The state committee of the Ukraine for standardization, metrology and certification Agreement on the results of conformity assessment Mandatory testing and certification CZECH REPUBLICthe Czech office for standards, metrology and testing E: 4 December 1996 Products originating in the two countries UNITED STATES MRA Conformity assessment see EU

13 page 13 USA Federal communication commission (FCC) And ANSI Telecommunication APEC MRA Tests ( phase I) And Approval (phase II) APEC ( 21 Economies) APEC electrical and electronic Conformity assessment MRA ( part I, II, III) Sectoral MRA (CITEL MRA Conformity assessment OAS Inter American mutual recognition) E: 1999 (phase I), 2002 (phase II) Telecom equipment APEC S: n.a Electrical and electronic equipment E: n.a in phases I Telecom equipment and II UNITED STATES Unilateral recognition, equivalency Technical regulations, standards and conformity assessment procedures related to the United States National Organic Program JAPAN- Japanese Ministry of Agriculture, Forestry and Fisheries Raw or processed plantbased agricultural products labelled as organic. UZBEKISTAN