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EU Agreements with New Zealand
MUTUAL RECOGNITION AGREEMENT ON CONFORMITY ASSESSMENT (MRA) BETWEEN THE EUROPEAN COMMUNITY AND NEW ZEALAND
Following the completion of the ratification processes, the MRA came into effect on 1 January 1999.
For the MRA to be fully operational Conformity Assessment Bodies (CABs) have to be designated. The first group of CABs were designed in late March 1999. This means the Agreement is now fully operational and is the first such Agreement to be concluded by the European Community to become operational.
WHAT IS AN MRA ?
The MRA will facilitate trade by allowing conformity assessment (testing, inspection and certification) of products traded between Europe and New Zealand to be undertaken in the exporting country rather than have to be carried out at destination.
In the case of New Zealand exporters, this means compliance with the requirements of the relevant EC Directives (or regulations) can be established in New Zealand and the CE marking applied to the product prior to export. In this way the product can be placed on the EU market with no further intervention by EC authorities.
Click here to download a copy of The European Union Standards and Conformance Assessment System - A guide for Australian and New Zealand Manufacturers and Exporters in Word 6.0 format.
Click here to download a copy of CE Marking of Australian and New Zealand Products for Export to the European Union in Word 6.0 format.
Conversely for European Union exporters it means compliance with the relevant New Zealand regulatory requirements. Click here to download a copy of the guide Doing Business in Australia and New Zealand : Conformance Assessment (pdf format).
The MRA is a binding treaty between the Government of New Zealand and the European Community (the Parties). Because they are Government to Government Agreements, their scope is limited to products which are subject to regulation by Government authorities and which involve some form of mandatory third party intervention (conformity assessment) prior to the product being able to be placed on the market.
The MRA covers the following industry sectors:
- pharmaceuticals Good Manufacturing Practice (GMP);
- telecommunications terminal equipment;
- electromagnetic compatibility (EMC);
- low voltage electrical equipment;
- machinery; and
- pressure equipment .
There is scope to extend the coverage of the MRA to new sectors over time (e.g. aircraft airworthiness).
Under the MRA, regulatory agencies in each Party accept the results of conformity assessment procedures carried out by particular designated Conformity Assessment Bodies (CABs) in the other Party. The MRAs do NOT require harmonisation of each Parties’ technical regulations, nor does it involve recognition of the standards that apply in each Party. In this way, each Party maintains its internal standards and regulatory regime against which compliance is assessed by designated CABs located in the other Party.
The MRA takes the form of an over-arching agreement which sets out the broad rights and obligations of the Parties and establishes the administrative mechanisms for implementation of the Agreement. Through annex 1 it also establishes the principles of technical competence and systems under which CABs may be designated for the purpose of the MRA.
The MRA also contains a series of Sectoral Annexes which define the product scope or coverage of the Agreement, list the CABs eligible to provide conformity assessment services to exporters, define more precisely the requirements for designation and set out any additional provisions relating to the operation of the MRA.
Click here to download copy of the EC/New Zealand MRA and Annexes in Word 6.0 format.
The essence of MRAs of this nature is the confidence that each Party is able to maintain in the technical competence of the CABs designated under the Agreements. This confidence is established through the designation systems that are used to appoint CABs under each of the Sectoral Annexes.
The MRAs provide for the Parties regulatory authorities to maintain market surveillance programs to ensure that products continue to meet the health and safety requirements set out in law. There are provisions in the MRA for challenging the competence of particular CABs based on the outcomes of such market surveillance activities and for such bodies to be suspended until their competence is re-established to the satisfaction of both Parties. In this way the integrity of regulatory regimes and the health and safety of people and the environment in New Zealand and the EU is protected.
WHAT ARE THE BENEFITS OF MRAs?
The economic costs of differences in national standards and conformity assessment requirements are becoming more prominent as transactions take place across international borders. The overall impact of such differences on trade is substantial.
For example the OECD (1996) estimates that, depending on the product, the differing standards and technical regulations in different markets, combined with the need for multiple testing and certification, may constitute between 2 and 10% of overall costs of production.
One significant aspect of these differences is the need for certification by a CAB of the importing country before a product can be accepted in an overseas market. The MRA addresses this obstacle by offering manufacturers the ability to have their product assessed for compliance with the regulatory requirements of the importing country by a CAB in his own country.
In this way the Agreement will enable manufacturers to save both time and money and therefore achieve a competitive edge in the importing market without quality or safety being compromised.
The European Union is New Zealand’s second largest trading partner (after Australia) with two-way trade growing from $NZ 5.3 billion in 1985 to over $NZ 10.43 billion in June 2001. Trade in products covered by the MRA accounting for over $NZ 1 billion of this total. By addressing specific conformity assessment related trade barriers, the MRA therefore has the ability to impact significantly on the competitiveness of New Zealand's industry.
Conservative estimates suggest that the MRA could generate significant cost savings for New Zealand exporters through:
- eliminating the need for duplication of testing and certification, saving companies time and money;
- for high technology products where market windows are short, the MRA will bring about an appreciable reduction in "time to market";
- the potential for consumers to benefit from lower prices and be provided with a potentially wider range of choice on domestic markets;
- provision of legal certainty that products will be able to access the importing market without further conformity assessment;
- the importing party is no longer able to apply its domestic conformity assessment regime in a discriminatory or protectionist manner;
- reduces the risks of using conformity assessment as a means of reverse engineering and other illicit forms of technology transfer;
- devolution of conformity assessment from centralised government agencies can stimulate competition, reduce prices and enhance the technological base of the economy;
- regulatory agencies can free resources to other tasks which may enhance public health and safety;
- increased contact with regulatory agencies and conformity assessment bodies in other countries can enhance transparency of regulatory regimes and promote longer term objectives of harmonisation of standards and technical regulations; and
- provides scope to develop a network of MRAs in time, thus opening up access to other key global markets.
CONTACTS IN NEW ZEALAND FOR FURTHER INFORMATION
Electromagnetic compatibility (EMC), low voltage electrical equipment, machinery, Telecommunications terminal equipment, and pressure vessels:
For Testing Laboratories and Inspection Bodies:
International Accreditation New Zealand
Private Bag 28 908,
Remuera, Auckland 1136
Tel: (09) 525 6655
Fax: (09) 525 2266
email: staff@ianz.govt.nz
For Certification Bodies:
Joint-Accreditation System Australia and New Zealand (JAS-ANZ)
Unit 8 , Protech House
6 Phipps Close
DEAKIN ACT 2600, AUSTRALIA
Tel: (612) 6282 5840
Fax: (612) 6282 6818
Internet: http://www.jas-anz.com.au
Medical devices and pharmaceuticals Good Manufacturing Practice (GMP):
For use in humans:
Ministry of Health
Therapeutic Section
PO Box 5013, Wellington
Tel: (04) 496 2000
Fax: (04) 496 2340
For use in animals:
Ministry of Agriculture
Agricultural Compound Unit
PO Box 40063, Upper Hutt
Tel: (04) 528 4794
Fax: (04) 528 6089
General
Competition and Enterprise Branch
Ministry of Commerce
PO Box 1473
WELLINGTON
Ministry of Commerce
Tel: 04 472 0030
Fax: 04 473 4638
CONFORMITY ASSESSMENT BODIES (CABs):
Link for listing for European CABs.
Link for listing for New Zealand CABs.
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