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 8 MRA newsletter Edition 8 1

2 Foreword 2012 This is the eight 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. 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 between the EU and the US 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. Agreements on Conformity Assessment and Acceptance of Industrial Products (s) are a specific type of mutual recognition agreement based on the full alignment of the legislative system, including standards, and implementing infrastructure of the country concerned with those of the European Union. The conclusion of an is the end result of extensive dialogue and assistance in the fields of technical regulations and standards for industrial products. The adoption of the EU system by other third countries will contribute to the elimination of technical barriers to trade, thereby increasing the accessibility of third countries markets to products from the EU and vice versa. 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, for Environment 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. If you have suggestions or want to make a contribution, please contact EU Trade. 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 8 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 View the text of the Agreement. Sectoral Annexes Operational since Number of CABs Telecommunications equipment 14 December EU CABs and 18 US CABs Electromagnetic compatibility 14 December EU CABs and 24 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) See a complete list of the designated CABs under the MRA with the United States. 2. Joint Committee meetings The last Joint Committee meeting was held by videoconference on 24 February However, the Joint Sectoral Group on EMC & Telecom was held by video conference on 26 September 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. Telecomms: The US is requesting regular reassessments of CABs. In general this Annex is working satisfactorily. MRA newsletter Edition 8 3

4 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 8 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). 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. The directive underlying the MRA is being proposed for revision. MRA newsletter Edition 8 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, 12 EU for certification Electrical safety Not in operation Not in operation Rec craft 31 September EU Medical devices Not in operation Not in operation See a complete list of the designated CABs under the MRA with Canada. 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. 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. MRA newsletter Edition 8 6

7 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. Note: This MRA will be affected by the outcome of the current negotiations on a Comprehensive Economic and Trade Agreement (CETA) with Canada. MRA newsletter Edition 8 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 2005 See a complete list of the designated CABs under the MRA with Japan. 2. Joint Committee meetings Last meeting on 7 June 2010 by video-conference. Next meeting not yet planned. 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). MRA newsletter Edition 8 8

9 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 taking the necessary steps towards the expansion of the coverage of the GMP annex to the GMP inspection authorities of the new EU Member States, and are also considering making the MRA operational for additional categories of medicinal products. A meeting of the GMP subcommittee to take these issues forward is envisaged for spring Note: This MRA will be affected by the outcome of the current negotiations on a Free Trade Agreement with Japan. MRA newsletter Edition 8 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 21 November 2013 in Brussels. The next one is tentatively scheduled for fall Sectoral Annexes Operational since Machinery 1 June 2002 Personal Protective Equipment (PPE) 1 June 2002 Toys 1 June 2002 Medical Devices 1 June 2002 Gas Appliances and Boilers 1 June 2002 Pressure Vessels 1 June 2002 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 June June 2002 Construction Plant and Equipment 1 June 2002 Measuring Instruments and Prepackages 1 June 2002 Motor Vehicles 1 June 2002 Agricultural and Forestry tractors 1 June 2002 MRA newsletter Edition 8 10

11 Good Laboratory Practice (GLP) 1 June 2002 Medicinal products GMP inspection and batch certification 1 June 2002 Construction Products 12 March 2008 Lifts 21 December 2009 Biocidal Products 18 October 2010 Cableway Installations 20 December 2011 Explosives for civil use 17 December 2012 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: 3. 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 Pre-packages is equivalent for certain products only. The most recent Joint Committee Decision dates from spring 2014, and concerns the revision of Chapter 16 (Construction Products) and Chapter 6 (Pressure Vessels) to take account of significant changes in both Parties' legislation. MRA newsletter Edition 8 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) and Council Decision 2012/837/EU of 18 July (OJ L 359/1 of , p.1). 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 19 EU. See note below on applicability of this Annex. Low voltage equipment 1 January AUS and 12 EU Machinery 1 January AUS and 11 EU Medical devices 1 January AUS and 7 EU Pressure equipment 1 January AUS and 7 EU Telecomms terminal equipment 1 January 1999 Automotive products 1 January AUS and 3 EU GMP 1 January 1999 for human medicinal products 1 June 2001 for veterinary medicinal products See a complete list of the designated CABs under the MRA with Australia. 2. Joint Committee meeting Last meeting in Canberra, Australia, March Next meeting not yet planned. 3. State of play Traditional type MRA: Mutual recognition of conformity assessment certificates without alignment of the relevant requirements. Amendment: The Amendment to the main text of the MRA to empower the Joint Committee to amend the Sectoral Annexes and otherwise to simplify the operation of the MRA has been ratified (see section 1 above); a proposal to amend the Annexes to take account of legislative and other developments by means of a Joint Committee Decision is under consideration. 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 8 12

13 GMP: At the time of implementing the Sectoral Annex, only Australia had legal requirements for GMP for Active Pharmaceutical Ingredients (API) in place, however with the adoption of Directives 2004/27/EC and 2011/62/EU amending Directive 2001/83/EC as regards GMP for API the EU explicitly includes API in the scope of Directive 2001/83/EC. Regarding the Australian legislation, the 'equivalence assessment' which was conducted by the European Commission in the context of Article 111b of Directive 2001/83/EC has confirmed that the Australian Therapeutic Goods Act has equivalent legal requirements for GMP for API in place. It is therefore understood that API for medicinal products for human use are within the operational scope of the MRA. MRA newsletter Edition 8 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) and Council Decision 2012/828/EU of (OJ L356, p.1). 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 18 EU. See note below on applicability of this Annex. Low voltage equipment 1 January NZ and 16 EU Machinery 1 January NZ and 10 EU Medical devices 1 January NZ and 6 EU Pressure equipment 1 January NZ and 7 EU Telecoms terminal equipment 1 January NZ and 4 EU GMP 1 January 1999 See a complete list of the designated CABs under the MRA with New Zealand. 2. Joint Committee meeting The last Joint Committee meeting was held in Wellington, NZ in October Next one has not been set yet. 3. State of play Traditional type MRA: Mutual recognition of conformity assessment certificates without alignment of the relevant requirements. Amendment: The Amendment to the main text of the MRA to empower the Joint Committee to amend the Sectoral Annexes and otherwise to simplify the operation of the MRA has been ratified (see section 1 above). A proposal to amend the Annexes to take account of legislative and other developments by means of a Joint Committee Decision is currently negotiated. 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 8 14

15 ISRAEL A. Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) 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. B. Protocol to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, on Conformity Assessment and Acceptance of Industrial Products (CAA) 1. Signature Council Decision 2013/1/EU of 20 November 2012 (OJ L1 of , p.1) 2. Sectoral Annexes Sectoral Annexes Operational since Good manufacturing practice (GMP) for medicinal products 21 January 2013 There are no CABs since GMP does not rely on them. 3. Joint Committee meeting There is no Joint Committee under this. 4. State of play The has entered into force. The Parties have exchanged information on contact points, responsible authorities and scope of recognition as provided for in the text. MRA newsletter Edition 8 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 Former Yugoslav Republic of Macedonia Turkey Legal Basis A commitment to an agreement is included in the Stabilisation and Association Agreement with the former Yugoslav Republic of Macedonia. Status 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 8 16

17 3. Agreements with other European countries Legal Basis Status Albania Bosnia & Herzegovina Montenegro Serbia A commitment to an agreement of this Albania has not yet requested the start of type is included in the Stabilisation negotiations. and Association Agreement with Albania. A commitment to an agreement of this Bosnia and Herzegovina has not yet type is included in the Stabilisation requested the start of negotiations. and Association Agreement with Bosnia & Herzegovina. A commitment to an agreement of this type is included in the Stabilisation and Association Agreement with Montenegro. Preliminary discussions were held with Montenegro in March 2010, but Montenegro has not yet requested the start of negotiations. A commitment to an agreement of this Serbia has not yet requested the start of type is included in the Stabilisation negotiations. and Association Agreement with Montenegro. MRA newsletter Edition 8 17

18 4. Agreements with Euromed countries or economies Legal Basis Status Algeria 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 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 on-going. Egypt An action plan to facilitate the free Under consideration movement of industrial products Priority sectors identified by Egypt: between the EU and the Euro-Med partners was outlined in the Palermo Action Plan, agreed by Euro-Med Ministers on 7 July 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. Progress stalled due to the political situation. MRA newsletter Edition 8 18

19 Legal Basis Status Israel 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 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 Entered into force: An on pharmaceutical products has entered into force on (see Israel). Under consideration: Other sectors for which the preparations are advanced are pressure equipment and medical devices. Machinery and cosmetics are also under consideration. Under consideration. Priority sectors identified by Jordan: electrical products, toys, gas appliances. Alignment of horizontal and sectoral legislation is progressing well. Adoption of framework legislation still pending. The upgrading of quality infrastructure is on-going with the help of technical assistance. preparations are advanced. MRA newsletter Edition 8 19

20 Legal Basis Status Lebanon Morocco An action plan to facilitate the free Under consideration movement of industrial products Priority sectors identified by between the EU and the Euro-Med Lebanon: electrical products, partners was outlined in the Palermo pressure equipment, Action Plan, agreed by Euro-Med construction products. Ministers on 7 July The Action programme prepared by the National Committee has been adopted. Some horizontal legislation has been sent for screening. The upgrading of the quality infrastructure is on-going. An action plan to facilitate the free Under consideration. movement of industrial products Priority sectors identified by between the EU and the Euro-Med Morocco: electrical products, partners was outlined in the Palermo toys, machinery, construction Action Plan, agreed by Euro-Med products, gas appliances, energy Ministers on 7 July efficiency and labeling of refrigerators, measuring and weighing instruments, personal protective equipment, equipment to be used in potentially explosive atmosphere. A Joint Declaration has been signed in November 2012 by VP Tajani and Minister Amara to speed up the preparatory work. preparations are advanced. Screening of horizontal and sectoral legislation is on-going. preparations are advanced. Screening of horizontal and sectoral legislation is ongoing as well as upgrading of the infrastructure with the help of technical assistance. MRA newsletter Edition 8 20

21 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 has not yet started. MRA newsletter Edition 8 21

22 Syria Legal Basis Status An action plan to facilitate the free An is not presently movement of industrial products considered as the Association between the EU and the Euro-Med partners was outlined in the Palermo Agreement has not yet entered into force. Action Plan, agreed by Euro-Med Priority sectors: electrical Ministers on 7 July products. A technical assistance project aimed at the re-organisation and upgrading of the quality has been finalised in Activities in the area have been stalled due to the political situation. Tunisia An action plan to facilitate the free Under consideration movement of industrial products Priority sectors: electrical between the EU and the Euro-Med products, machinery, partners was outlined in the Palermo construction products, pressure Action Plan, agreed by Euro-Med equipment, measuring Ministers on 7 July instruments. Tunisia is 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 in the course of Progress stalled due to the political situation. MRA newsletter Edition 8 22