MRA newsletter – Edition 91
October 2015
MRA newsletter – Edition 91
October 2015
Trade issues…
Technical Barriers to Trade
Mutual Recognition Agreements and Agreements on Conformity Assessment and Acceptance of Industrial Products
MRA Newsletter N°9
2012
Foreword
This is the ninth edition of a Newsletter[1] on Mutual Recognition Agreements (MRAs) concluded between the European Union (EU) 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 EU-US 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.
Agreements on Conformity Assessment and Acceptance of Industrial Products (ACAAs) are a specific type of MRA based on the full alignment of the legislative system, including standards, and implementing infrastructure of the country concerned with those of the EU. The conclusion of an ACAA 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, as it concerns Israel, the Annex to the ACAA on Good Manufacturing Practices (GMP), as well as the Agreement on chemical Good Laboratory Practice. 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 Trade, for Internal Market, Industry, Entrepreneurship and SMEs, for Health and Food Safety, for Environment and for Mobility and Transport.
An overview of theACAAs 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 contactTrade, Unit F3, Tariff and Non-Tariff Negotiations, Rules of Origin.
MRA newsletter – Edition 91
October 2015
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, 4.02.1999, p.1), as amended by Council Decision 2002/803/EC of 8.10.2002 (OJ L 278, 16.10.2002, p.22). Entered into force in December 1998.
View the text of the Agreement.
Sectoral Annexes / Operational since / Number of CABsTelecommunications equipment / 14 December 2000 / 12 EU CABs and 18 US CABs
Electromagnetic compatibility (EMC) / 14 December 2000 / 46 EU CABs and 23US CABs
Electrical safety / Not in operation / Nil
Recreational craft / Not in operation / 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 European Commission’s Web site
2.Joint Committee meetings
The last Joint Committee meeting was held by videoconference on 24 February 2009. However,
the Joint Sectoral Group on EMC & Telecom was held by video conference on 26 September 2013.
3.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 EU’s obligations under it) remains suspended because of the position of the Occupational Safety and Health Administration (OSHA). In any case, the EU makes no mandatory requirements for third-party certification in the area of electrical safety.
PharmaceuticalGMPs: Regulatory cooperation and information exchange in the context of pharmaceutical GMP exists; however, the Annex is not expected to come into operation.
Telecommunications: The US is requesting regular reassessments of CABs. In general, this Annex is working satisfactorily.The EU has adopted new legislation - Directive 2014/53/EU of the European Parliament and of the Council of 16 April2014 on the harmonisation of the laws of the Member States relating to themaking available on the market of radio equipment and repealing Directive1999/5/EC (OJ L 153,22.5.2014, p.62),which shall apply from 13 June 2016. On this date,the old Directive 1999/5/EC will be repealed and replaced by Directive 2014/53/EU.As the new legislation provides new requirements for CABs, the currently designated US conformity assessment bodies will have to be re-designated in accordance with the requirements of the new EU legislation.From 13 June 2016, CABs that havebeen notified following the procedures set out in the new Directive will be entitled tocarry out conformity assessment under the new Directive. The bodies notified underDirective 1999/5/EC will be automatically withdrawn from the NANDO database as of 13June 2017 (end of the transitional period specified in Article 48 of Directive2014/53/EU) and thus, as of that date, will be automatically de-notified.
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 EU 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, 31.12.2004, p. 24), amending Directive 89/336/EEC of 3 May 1989 (OJ L 139/19, 23.05.1989, p. 19) imposes no third-party certification obligation on manufacturers - and thus there is no need for a MRA on the part of the EU (though voluntary third-party involvement is still envisaged in the Directive). Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast) (OJ L 96,29.3.2014, p.79),which also imposes no third-party certification obligation on manufacturers,shall apply from 20 April 2016. On this date, the old Directive 2004/108/EC will berepealed and replaced by Directive 2014/30/EU. As the new legislation provides new requirements for CABs, the currently designated US CABs will have to be re-designated in accordance with the requirements of the new EU legislation.
This Annex is still needed for EU access to the US market.
Recreational Craft:This Annex is not operational; in any case, the US has stated that it does notimpose third-party certification requirements.
MRA newsletter – Edition 91
October 2015
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, 30.04.2004, 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 2009.
3.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 on board of US flagged ships without any additional testing or certification and vice versa. Notified bodies under the Marine Equipment Directive are all entitled to certify according to this MRA, together with the US Coast Guard.Marine equipment falling under the MRA can thereforedisplayan appropriate USCoast Guard ApprovalNumber (allocated bythe Coast Guard or an EU Notified Body), as well as the EU's Wheelmark.
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 EU 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).
The EU Directive underlying the MRA has been revised.Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC(OJ L 257, 28.8.2014, p. 146) will need to be applied by the Member States from 18 September 2016. References to the repealed Directive shall be construed as references to the new Directive.
MRA newsletter – Edition 91
October 2015
CANADA
1. Signature
Implemented by Council Decision 98/556/EEC of 20.7.1998 (OJ L 280, 16.10.1998, p.1), as amended by Council Decision 2002/800/EC of 8.10.2002 (OJ L 278, 16.10.2002, p.19). Entered into force on 1 November 1998.
View the text of the Agreement.
Sectoral Annexes / Operational since / Number of CABsEMC / 31 September 2001 / Not relevant. Both sides have abandoned third-party certification for EMC.
TTE / 31 September 2001 / 1 Canadian, 13EU for certification
Electrical safety / Not in operation / Not in operation
Recreational craft / Not in operation / Not in operation
Medical devices / Not in operation / Not in operation
Pharmaceutical GMP / 1 February 2003 / Not applicable (the legislation does not refer to CABs)
For a complete list of the designated CABs under the MRA with Canada, see the Commission's Website.
2.Joint Committee meetings
The last meeting was held in March 2003, by videoconference. Next one is 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 EU 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 EU 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 (OJ L 374, 27.12.2006, p. 10), does not require third-party certification.Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96,29.3.2014, p. 357) - shall apply from 20 April 2016. Under the new Low Voltage Equipment Directive 2014/35/EU, conformity assessment is solely the obligation of the manufacturer, and therefore there is no conformity assessment procedure which requires the intervention of a CAB.
Pharmaceutical GMP: It is in operation as of February 2003. It is applicable between Canada and EU Member States assessed and recognised as equivalent. The agreement is based on the acceptance of the results of the GMP inspections (recognition of the GMP compliance certificates) carried out on the territory of the Party concerned.The assessment by Health Canada of the equivalency of the GMP compliance programs of the new Member States is still ongoing.The stable medicinal products derived from human blood or human plasma, as well as the veterinary biologics, do not fall within the operational scope of the Annex.
This Annex on GMP will be replaced, after the entry into force of the Comprehensive Economic and Trade Agreement (CETA) with Canada, by its protocol on mutual recognition of GMP.
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 EU’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, 26.08.2003, p. 18); amending Directive 94/25/EC of 16 June 1994 (OJ L 164/15, 30.06.1994, p. 15), and the corresponding Canadian legislation has been amended in scope and thus the sectoral annex is not operational.
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, 31.12.2004, p. 24), amending Directive 89/336/EEC of 3 May 1989 (OJ L 139/19, 23.05.1989, p. 19) does the same, meaning that this Annex has been unnecessary since that time.Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast) (OJ L 96,29.3.2014, p.79) which also imposes no third-party certification obligation on manufacturers shall apply from 20 April 2016.
Note: This MRA will be affected by the recently finalised negotiations on the CETA with Canada.
MRA newsletter – Edition 91
October 2015
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, 29.10.2001, p.1). Entered into force on 1 January 2002 and was the first bilateral agreement on mutual recognition for Japan.
View the text of the Agreement.
Sectoral Annexes / Operational since / Number of CABsTelecommunications terminal equipment and radio equipment / 1 January 2002 / 7 EU CABs and 2 JP CABs
Electrical products / 1 January 2002 / 0 EU CABs and 0 JP CABs
Good manufacturing practice (GMP) for medicinal products / 29 May 2004 / Not applicable (the legislation does not refer to CABs)
Good laboratory practice (GLP) for chemicals / 1 January 2002 / Not applicable (the legislation does not refer to CABs)
See the Commission's websitefor a complete list of the designatedCABs
2.Joint Committee meetings
The last meeting was held 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 EU has adopted new legislation - Directive 2014/53/EU of the European Parliament and of the Council of 16 April2014 on the harmonisation of the laws of the Member States relating to themaking available on the market of radio equipment and repealing Directive1999/5/EC (OJ L 153,22.5.2014, p.62),which shall apply from 13 June 2016. On this date,the old Directive 1999/5/EC will be repealed and replaced by Directive 2014/53/EU.As the new legislation provides new requirements for CABs, the currently designated CABs will have to be re-designated in accordance with the requirements of the new EU legislation.From 13 June 2016, CABs that havebeen notified following the procedures set out in the new Directive will be entitled tocarry out conformity assessment under the new Directive. The bodies notified underDirective 1999/5/EC will be automatically withdrawn from the NANDO data base as of 13June 2017 (end of the transitional period specified in Article 48 of Directive2014/53/EU) and thus, as of that date, will be automatically de-notified.
Electrical products: Under the new Low Voltage Equipment Directive 2014/35/EU(OJ L 96,29.3.2014, p. 357), which shall apply from 20 April 2016,conformity assessment is solely the obligation of the manufacturer, and therefore there is no conformity assessment procedure which requires the intervention of a CAB. The new Directive 2014/30/EU on electromagnetic compatibility (recast) (OJ L 96,29.3.2014, p.79),which shall apply from 20 April 2016,imposes no third-party certification obligation on manufacturers, though voluntary third-party involvement is still envisaged.
GMP Medicinal products: A subcommittee was created by JC Decision 2/2002 of 20 June 2002. Mutual visits to exchange information and discuss key elements of the preparatory work under this Annex took place in June and July 2002. Further rounds of mutual visits took place in 2003 and early 2004. The third subcommittee meeting on 18-19 February 2004 confirmed equivalence, except for biological pharmaceuticals, including immunological and stable medicinal products derived from human blood or plasma and sterile medicinal products. 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. The fifth meeting of the sub-committee set up under the Joint Committee of the Agreement on Mutual Recognition between the EU and Japan took place through videoconference on 8 April 2014. It acknowledged that the expansion of the coverage of the Agreement had been identified as a priority and both sides decided to continue their ongoing efforts in this perspective. The sub-committee reviewed the work that had been carried out and confirmed steps to be taken to add Competent Authorities. The sub-committee also identified different categories of products for possible inclusion in the scope of the Sectoral Annex on GMP.
This MRA will be affected by the outcome of the current negotiations on a Free Trade Agreement with Japan.
MRA newsletter – Edition 91
October 2015
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, 30.04.2002, p.1), signed on 21 June 1999. Entered into force on 1 June 2002.
View theCommission's website for the text of the Agreement.
2.Joint Committee meetings
Last meeting was held on 23October2014 in Brussels. The next one is tentatively scheduled for fall 2015.
Sectoral Annexes / Operational sinceMachinery / 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) / 1 June 2002
Equipment and Protective Systems intended for use in potentially explosive atmospheres (ATEX) / 1 June 2002
Electrical Safety and Electromagnetic Compatibility / 1 June 2002
Construction Plant and Equipment / 1 June 2002
Measuring Instruments and Pre-packages / 1 June 2002
Motor Vehicles / 1 June 2002
Agricultural and Forestry tractors / 1 June 2002
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 theCommission's website, as well as in the NANDO database.