Technical Barriers to Trade

Transcription

1 Trade issues Technical Barriers to Trade Mutual Recognition Agreements and Agreements on Conformity Assessment and Acceptance of Industrial Products MRA Newsletter N 6 MRA newsletter Edition 6 1

2 Foreword 2012 This is the sixth edition of a newsletter 1 on Mutual Recognition Agreements (MRA) concluded between the European Union and third countries. MRAs are instruments that facilitate market access by reducing costs and time associated with obtaining product approvals. The newsletter provides information on the current status of MRAs with the United States, Canada, Japan, Switzerland, Australia and New Zealand, and the Agreement on chemical Good Laboratory Practice with Israel. It also covers the agreement with the US on marine equipment. It has been compiled from a trade perspective, on the basis of information provided by the Directorates General for External Trade, for Enterprise and Industry, for Health and Consumer Protection, and for Mobility and Transport. An overview of the Agreements on Conformity Assessment and Acceptance of Industrial Products (s) currently agreed and under consideration with countries in the European neighbourhood is also included. Traditional MRAs enable Conformity Assessment Bodies (CABs) nominated by one Party to certify products for access to the other Party s market, according to the other Party s technical legislation. They provide for the mutual recognition between trading partners of mandatory test results and certificates for certain industrial products. No regulatory convergence is implied by a traditional MRA. In other words, there is no implication that the regulations imposed on products by the Parties are to be brought into alignment at any stage, though there are exceptions to this: for example, the MRA with Switzerland deals for the most part with mutual recognition of certificates in areas where Swiss and EU regulations are deemed "equivalent"; and the MRA on marine equipment, for which the underlying regulations are International Maritime Organisation Conventions (IMO) agreed by both the US and the EU s Member States. MRAs only confer benefits on importing parties for products subject to mandatory certification. No further traditional MRAs are foreseen, but there is a certain amount of evolution in their operation, for example, as amendments to their scope are considered and as mandatory certification gives way to reliance on supplier s declarations of conformity. Accordingly, it is intended that this newsletter will be issued from time to time to reflect the evolution of the current position. The Newsletter will be available on If you have suggestions or want to make a contribution, please contact External Trade, Unit F3, Tariff and Non-Tariff Negotiations, Rules of Origin (contact: TRADE-F3-REQUEST-BOX@ec.europa.eu). 1 This newsletter is provided to enhance public access to information with the goal to keep this information timely and accurate. However, the Commission accepts no responsibility or liability whatsoever with regard to the information in this newsletter. MRA newsletter Edition 6 2

3 UNITED STATES 1. Signature Council Decision 1999/78/EC of 22 June 1998 on the conclusion of an Agreement on Mutual Recognition between the European Community and the United States of America (OJ L 31, , p.1), as amended by Council Decision 2002/803/EC of (OJ L 278, , p.22). Entered into force in December To view the text of the Agreement: Sectoral Annexes Operational since Number of CABs Telecommunications equipment 14 December EU CABs and 19 US CABs Electromagnetic compatibility 14 December EU CABs and 25 US CABs Electrical safety Not in operation Nil Recreational craft 1 June 2000 Nil Pharmaceutical Good Manufacturing Practices (GMPs) Nominally in operation 1 December 2001 (see below) Not applicable (the legislation does not refer to CABs) Medical devices Not in operation Not in operation (see below) For a complete list of the designated CABs under the MRA with the United States, see the Commission s Web sites: 2. Joint Committee meetings The last Joint Committee meeting was held by videoconference on 24 February State of play Traditional type MRA: Mutual recognition of conformity assessment certificates without alignment of the relevant requirements. Electrical Safety: Not in operation. The Annex (and the EC s obligations under it) remains suspended because of the position of the Occupational Safety and Health Administration (OSHA). In any case the EC makes no mandatory requirements for third party certification in the area of electrical safety. GMP: Regulatory cooperation and information exchange in the context of pharmaceutical GMP exists; however the Annex is not now expected to come into operation. MRA newsletter Edition 6 3

4 Telecomms: The US is requesting regular reassessments of CABs. In general this Annex is working satisfactorily. Medical devices: Regulatory cooperation between the US and the EU on medical devices is taking place. The Annex is regarded as superseded by this co-operation. EMC: The Community has eliminated mandatory requirements for third party testing in EMC (although the US maintains them): the EMC Directive 2004/108/EC of 15 December 2004, (OJ L390, ), amending Directive 89/336/EEC of 3 May 1989 (OJ L 139/19, ) imposes no third party certification obligation on manufacturers - and thus there is no need for an MRA on the part of the EU (though voluntary third party involvement is still envisaged in the Directive). This Annex is however still needed for EU access to the US market. Recreational Craft: Directive 2003/44/EC of 16 June 2003 (OJ L 214/18, ) amending Directive 94/25/EC of 16 June 1994 (OJ L 164/15, ), relates to emissions and a new scope. This Annex is not in use; there are no operational CABs; in any case, the US has stated that it does not impose third party certification requirements. MRA newsletter Edition 6 4

5 UNITED STATES: MARINE EQUIPMENT 1. Signature Council Decision 2004/425/EC of 21 April 2004 on the conclusion of an Agreement between the European Community and the United States of America on the Mutual Recognition of Certificates of Conformity for Marine Equipment (OJ L 150, , p.42). To view the text of the Agreement: 2. Joint Committee meetings The latest meeting of the US-EC Marine Equipment MRA Joint Committee was held by video conference on 24 February State of play The EU-US MRA is intended to facilitate transatlantic trade in marine equipment. Under its terms, designated products which comply with EU requirements will be accepted for sale in the US without any additional testing or certification and vice versa. Both parties have based their respective legislations on the Conventions of the International Maritime Organisation (IMO) and the relevant international standards. The European Maritime Safety Agency (EMSA) carries out the technical work for the European Union relating to the maintenance of this Agreement. The Agreement covers 49 types of marine equipment ranging from life-saving equipment (distress signals, rigid life rafts), to fire protection equipment (flame-retardant materials) and navigational equipment (GPS equipment, echo-sounding equipment). Notified bodies under the MED are all entitled to certify according to this MRA, together with the US Coast Guard. MRA newsletter Edition 6 5

6 CANADA 1. Signature Implemented by Council Decision 98/556/EEC of (OJ L 280, , p.1), as amended by Council Decision 2002/800/EC of (OJ L 278, , p.19), on 14 May Entered into force on 1 November Sectoral Annexes Operational since Number of CABs EMC TTE 31 September 2001 Not relevant. Both sides have abandoned third party certification for EMC. 31 September Canadian, 11 EU for certification Electrical safety Not in operation Not in operation Rec craft 31 September EU Medical devices Not in operation Not in operation For a complete list of the designated CABs under the MRA with Canada, see the DG Enterprise Website: 2. Joint Committee meetings Last meeting in March 2003, by videoconference. Next one not yet set. 3. State of play Traditional type MRA: Mutual recognition of conformity assessment certificates without alignment of the relevant requirements. Electrical safety: Implementation was intended to rely on a mutual auditing process. The EC side audited the potential Canadian certifiers in 2000 but it is clear that there remains no interest on either side in completing the process. Note that the MRA has no effect the other way (i.e., for imports of Canadian goods into the EU), since the European legislation - Directive 2006/95/EC of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits does not require third party certification. Pharma GMP: It is now in operation. Ongoing assessment by Canada of the new Member States inspection systems is almost complete. Medical devices: It is not operational because (in 2002) Canadian regulators - citing primacy of their domestic responsibilities - required control over approval of CABs, which in the EC s opinion is not compatible with the principle of the MRA. MRA newsletter Edition 6 6

7 Recreational craft: Directive 2003/44/EC of 16 June 2003 (OJ L 214/18, ); amending Directive 94/25/EC of 16 June 1994 (OJ L 164/15, ), and the corresponding Canadian legislation has been amended. In practice the Sectoral Annex is not in operation, although certain EU CABs have been designated. EMC: Canada has abolished mandatory third party testing in the area of EMC, and EMC Directive 2004/108/EC of 15 December 2004 (OJ L 390, ), amending Directive 89/336/EEC of 3 May 1989 (OJ L 139/19, ) do the same, meaning that this Annex has been unnecessary since that time. MRA newsletter Edition 6 7

8 JAPAN 1. Signature Council Decision 2001/747/EC of 27 September 2001 on the conclusion of an Agreement on Mutual Recognition between the European Community and Japan (OJ L 284, , p.1). Entered into force on 1 January 2002, was the first bilateral agreement on mutual recognition for Japan. Sectoral Annexes Operational since Number of CABs Telecommunications and radio equipment 1 January EU CABs and 2 JP CAB Electrical products 1 January 2002 Good manufacturing practice (GMP) for medicinal products Good laboratory practice (GLP) for chemicals 1 January 2002 Exchange of lists of confirmed facilities in July Joint Committee meetings For a complete list of the designated CABs under the MRA with Japan, see the DG Enterprise Website: Last meeting on 7 June 2010 by video-conference. MRA newsletter Edition 6 8

9 3. State of play R&TTE: The telecommunications and radio equipment annex of the MRA is functioning reasonably well with 9 CABs currently operating under it. The range of products which need third party certification has been narrowed as Japan introduced a system of Supplier's Verification of Conformity (SVC) some time ago for a broad range of products. The SVC system can be used in the case of "special specified radio equipment", defined in Article 2-2 of the "Ordinance concerning Technical Regulations Conformity Certification etc. of Specified Radio Equipment." Electrical products: No new developments since the last newsletter. The EU has amended the EMC directive, introducing SDoC for all products as from 20 July 2007 (date of application of the new provisions). GMP: A subcommittee was created by JC Decision 2/2002 of 20 June Mutual visits to exchange information and discuss key elements of the preparatory work under this Annex took place in June and July Further rounds of mutual visits took place in 2003 and early The third subcommittee meeting on February 2004 confirmed equivalence except for biological pharmaceuticals, including immunological and stable medicinal products derived from human blood or plasma and sterile medicinal products. The last subcommittee meeting took place in Japan in October At the moment, the EU and Japan are discussing the expansion of the coverage of the GMP annex to the GMP inspection authorities of the new EU Member States. MRA newsletter Edition 6 9

10 SWITZERLAND 1. Signature: Council and Commission Decision 2002/309/EC of 4 April 2002 on the conclusion of an Agreement on Mutual Recognition between the European Community and Switzerland (OJ L 114, , p.1), signed on 21 June Entered into force on 1 June Joint Committee meetings Last meeting on 23 November 2011 in Bern. The next one is tentatively scheduled for fall 2012 in Brussels. Sectoral Annexes Operational since Number of CABs Machinery 1 June EU and 3 Swiss CABs Personal Protective Equipment (PPE) 1 June EU and 3 Swiss CABs Toys 1 June EU Medical Devices 1 June EU and 5 Swiss CABs under Directive 93/42/EEC; 24 EU CABs and 1 Swiss CAB under Directive 98/79/EC; 19 EU CABs under Directive 90/385/EEC Gas Appliances and Boilers 1 June EU CABs and 1 Swiss CAB; Pressure Vessels 1 June EU CABs and 1 Swiss CAB under Directive 87/404/EEC; 251 EC and 8 Swiss CABs under Directive 97/23/EC; 174 EC CABs and 1 Swiss CAB under Directive 99/36/EC Radio and Telecommunications Terminal Equipment (R&TTE) Equipment and Protective Systems intended for use in potentially explosive atmospheres (ATEX) Electrical Safety and Electromagnetic Compatibility 1 June EU CABs 1 June EU CABs and 1 Swiss CAB 1 June EU and 10 Swiss CABs under Directive 2006/95/EC; 133 EU and 7 Swiss CABs under Directive 2004/108/EC Construction Plant and Equipment 1 June EU and 2 Swiss CABs Measuring Instruments and Prepackages 1 June EU and 2 Swiss CABs under Directive 90/384/EEC; 141 EU CABs and 1 Swiss CAB under Directive 2004/22/EC MRA newsletter Edition 6 10

11 Motor Vehicles 1 June Swiss CABs; for a list of EU CABs, please visit DG Enterprise website. Agricultural and Forestry tractors 1 June Swiss CABs; for a list of EU CABs, please visit DG Enterprise website. Good Laboratory Practice (GLP) 1 June EU and 37 Swiss CABs Medicinal products GMP inspection and batch certification 1 June EU and 0 Swiss CABs Construction Products 12 March EU and 11 Swiss CABs Lifts 21 December EU CABs Biocidal Products 18 October 2010 Cableway Installations 20 December 2011 Up to date information on Swiss CABs and EU Notified Bodies operating under each respective sector of the MRA can be found on the DG Enterprise website, as well as in the NANDO database: State of play Enhanced type MRA: Mutual recognition of certificates based on equivalent or common requirements. Gas Appliances and Efficiency Hot Water Boilers are nonequivalent sectors. Pressure Equipment, Construction Plant and Equipment, Non- Automatic Measuring Instruments are non-equivalent but Switzerland accepts compliance with EC Directives. Measuring Instruments and Prepackages is equivalent for certain products only. New chapter on Cableway Installations: A new chapter on cableways has been added to Annex I of the Agreement following Joint Committee Decision 1/2011 of 20 December MRA newsletter Edition 6 11

12 AUSTRALIA 1. Signature Council Decision 98/508/EC of (OJ L 229, , p.1), as amended by Council Decision 2002/800/EC of (OJ L 278, , p.19). Signed on 24 June 1998 (OJ L 229 of , p.3). Entered into force on 1 January Sectoral Annexes Operational since Number of CABs EMC 1 January AUS and 33 EU. See note below on applicability of this Annex. Low voltage equipment 1 January AUS and 25 EU Machinery 1 January AUS and 20 EU Medical devices 1 January AUS and 15 EU Pressure equipment 1 January AUS and 18 EU Telecomms terminal equipment 1 January AUS and 5 EU Automotive products 1 January AUS and 10 EU For a complete list of the designated CABs under the MRA with Australia, see the DG Enterprise Websites: 2. Joint Committee meeting Last meeting in Wellington, NZ, October Next meeting in Canberra, Aus, March State of play Traditional type MRA: Mutual recognition of conformity assessment certificates without alignment of the relevant requirements. Amendment: The powers of the Joint Committees are more limited than with other MRAs. It cannot amend Sectoral Annexes except to add or delete CABs. The EC has proposed amending the main text of the MRA to empower the Joint Committee to amend the Sectoral Annexes, and then to amend the Annexes by means of a Joint Committee Decision. The draft Amendment -which is the same for Australian and New Zealand - has been discussed with the Australian and New Zealand Governments. The text has now been agreed, and a Council Decision for its signature has been approved by the Council. It has been signed in February 2012 and will then go for ratification. MRA newsletter Edition 6 12

13 EMC: The EMC Directive (2004/108/EC) of 15 December 2004 (OJ L 390, ), amending Directive 89/336/EEC of 3 May 1989 (OJ L 139/19, ), removed the need for all third party certification in the EU. Electrical products: The EU has amended the EMC directive, introducing SDoC for all products as from 20 July 2007 and removing the need for third party certification in the EU. MRA newsletter Edition 6 13

14 NEW ZEALAND 1. Signature Council Decision 98/509/EC of (OJ L 229 of ), as amended by Council Decision 2002/801/EC of (OJ L 278, , p.20). Signed on 26 June 1998 (OJ L 229, , p.62). Entered into force on 1 January Sectoral Annexes Operational since Number of CABs EMC 1 January NZ and 32 EU. See note below on applicability of this Annex. Low voltage equipment 1 January NZ and 26 EU Machinery 1 January NZ and 18 EU Medical devices 1 January NZ and 11 EU Pressure equipment 1 January NZ and 18 EU Telecoms terminal equipment 1 January NZ and 6 EU For a complete list of the designated CABs under the MRA with New Zealand, see the DG Enterprise Website: 2. Joint Committee meeting The last Joint Committee meeting was held in Wellington, NZ in October Next one has not been set yet. There have been informal discussions in the intervening period which are expected to continue. 3. State of play Traditional type MRA: Mutual recognition of conformity assessment certificates without alignment of the relevant requirements. Amendment: The powers of the Joint Committee are more limited than with other MRAs: it cannot amend Sectoral Annexes except to add or delete CABs. The EC has proposed amending the main text of the MRA to empower the Joint Committee to amend the Sectoral Annexes, and then to amend the Annexes by means of a Joint Committee Decision. The draft Amendment -which is the same for Australia and New Zealand - has been discussed with the Australian and New Zealand Governments. The text has been approved by the Council and was signed in February It will be presented for ratification in accordance with Article 218 of the Treaty on the Functioning of the European Union. EMC: Revision of the EMC Directive (2004/108/EC) of 15 December 2004 (OJ L 390, ) removed the need for all third party certification in the EU. Electrical products: The EU has amended the EMC directive, introducing SDoC for all products as from 20 July 2007 (date of application of the new provisions). MRA newsletter Edition 6 14

15 ISRAEL 1. Signature Council Decision 99/662/EC of 19 July 1999 (OJ L 263, , p.7). The Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of Israel allows Israel to use the OECD guidelines for Good Laboratory Practice. MRA newsletter Edition 6 15

16 Overview of PECAs and s currently under consideration 1. Introduction This text provides an overview of all the s (Agreements on Conformity Assessment and Acceptance of Industrial Products) currently under negotiation between non-ec countries and the Community. 2. Agreements with acceding countries and candidate countries Croatia Legal Basis A commitment to an agreement is included in the Stabilisation and Association Agreement with Croatia. Status Negotiations are in progress. Former Yugoslav Republic of Macedonia Turkey A commitment to an agreement is included in the Stabilisation and Association Agreement with the former Yugoslav Republic of Macedonia. Negotiations are in progress; No agreement of this type is necessary, as there is a customs union which goes further. Relevant provisions are included in the Agreement establishing the definite phase of the Customs Union (OJ L 35, ). MRA newsletter Edition 6 16

17 3. Agreements with other European countries Ukraine Albania Bosnia & Herzegovina Montenegro Serbia Legal Basis A commitment to an is included in the ENP Action Plan with Ukraine and covered in principle by the Partnership and cooperation Agreement between the EU and Ukraine. In December 2005, an Action Plan was agreed between the Commission and Ukrainian authorities, which foresees an being signed by A commitment to an agreement of this type is included in the Stabilisation and Association Agreement with Albania. A commitment to an agreement of this type is included in the Stabilisation and Association Agreement with Bosnia & Herzegovina. A commitment to an agreement of this type is included in the Stabilisation and Association Agreement with Montenegro. A commitment to an agreement of this type is included in the Stabilisation and Association Agreement with Montenegro. Status Under negotiation. It has been agreed in principle that an will be attached to the FTA with Ukraine for which negotiations have recently been concluded. Albania has not yet requested the start of negotiations. Bosnia and Herzegovina has not yet requested the start of negotiations. Preliminary discussions were held with Montenegro in March 2010, but Montenegro has not yet requested the start of negotiations. Serbia has not yet requested the start of negotiations. MRA newsletter Edition 6 17

18 4. Agreements with Euromed countries or economies Algeria Legal Basis An action plan to facilitate the free movement of industrial products between the EU and the Euro-Med partners was outlined in the Palermo Action Plan, agreed by Euro-Med Ministers on 7 July Status Under consideration Priority sectors identified by Algeria: Construction products, low voltage equipment, simple pressure vessels, toys and energy efficiency of refrigeration products. Algeria has started its preparatory work for an with the support of technical assistance. Some legislation has been received for screening. Technical assistance is ongoing. Egypt An action plan to facilitate the free movement of industrial products between the EU and the Euro-Med partners was outlined in the Palermo Action Plan, agreed by Euro-Med Ministers on 7 July Under consideration Priority sectors identified by Egypt: construction products, electrical products, pressure equipment, gas appliances, medical devices, machinery, toys, vehicles and their parts. Egypt is advanced in the preparatory work for an. Horizontal and sectoral legislation has been received for screening; the adoption of EN standards in the priority sectors is well advanced; the upgrading of quality infrastructure is on-going with the support of technical assistance. MRA newsletter Edition 6 18

19 Legal Basis Status Israel An action plan to facilitate the free movement of industrial products between the EU and the Euro-Med partners was outlined in the Palermo Action Plan, agreed by Euro-Med Ministers on 7 July Signed: An on pharmaceutical products has been signed with Israel and has been submitted to the European Parliament consent procedure where it remains in discussion. Under consideration: Other sectors for which the preparations are advanced are pressure equipment and medical devices. Machinery is also under consideration. Jordan An action plan to facilitate the free movement of industrial products between the EU and the Euro-Med partners was outlined in the Palermo Action Plan, agreed by Euro-Med Ministers on 7 July Under consideration. Priority sectors identified by Jordan: electrical products, pressure equipment, toys, measuring instruments, construction products, gas appliances. Some legislation has been received for screening. Adoption of horizontal legislation still pending. The upgrading of quality infrastructure is on-going with the help of technical assistance. MRA newsletter Edition 6 19

20 Legal Basis Status Lebanon An action plan to facilitate the free movement of industrial products between the EU and the Euro-Med partners was outlined in the Palermo Action Plan, agreed by Euro-Med Ministers on 7 July Under consideration Priority sectors identified by Lebanon: electrical products, pressure equipment, construction products. The National Committee has prepared an Action programme that has not been adopted yet. Some horizontal legislation has been sent for screening. The upgrading of the quality infrastructure has started. Morocco An action plan to facilitate the free movement of industrial products between the EU and the Euro-Med partners was outlined in the Palermo Action Plan, agreed by Euro-Med Ministers on 7 July Under consideration. Priority sectors identified by Morocco: electrical products, machinery, construction products, gas appliances, toys. preparations have been speeded up following the adoption of the horizontal legislation. Technical assistance will allow progress with the view to open negotiations as soon as ready. Palestinian Authority An action plan to facilitate the free movement of industrial products between the EU and the Euro-Med partners was outlined in the Palermo Action Plan, agreed by Euro-Med Ministers on 7 July Under consideration. Priority sectors: Construction products, pharmaceuticals. Some legislation has been received for screening. The technical assistance project aimed at the re-organisation and upgrading of the quality infrastructure has been delayed and will hopefully start this year. MRA newsletter Edition 6 20

21 Syria Tunisia Legal Basis An action plan to facilitate the free movement of industrial products between the EU and the Euro-Med partners was outlined in the Palermo Action Plan, agreed by Euro-Med Ministers on 7 July An action plan to facilitate the free movement of industrial products between the EU and the Euro-Med partners was outlined in the Palermo Action Plan, agreed by Euro-Med Ministers on 7 July Status Under consideration. Priority sectors: electrical products. A technical assistance project aimed at the re-organisation and upgrading of the quality. Under consideration Priority sectors: electrical products, machinery, construction products, pressure equipment, measuring instruments Tunisia is very advanced in the preparations. A Joint Declaration has been signed in March 2012 by VP Tajani and Minister Chakhari to speed up the finalisation of the preparations and launch the negotiations as soon as possible. MRA newsletter Edition 6 21