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EU Agreements with Australia  
MUTUAL
RECOGNITION AGREEMENT ON CONFORMITY ASSESSMENT (MRA) BETWEEN
THE EUROPEAN COMMUNITY AND AUSTRALIA
Following the completion
of the ratification processes, the EC/Australia MRA and EC/New
Zealand MRA both came into effect on 1 January 1999.
For the MRAs to be fully
operational Conformity Assessment Bodies (CABs) have to be
designated. The first group of CABs were designed in late
March 1999 and a second group agreed upon in late May for
the MRA with Australia. This means the two Agreements are
now fully operational and are the first such Agreements to
be concluded by the European Community to become operational.
To faciliate understanding
and uptake of the EC/Australia MRA, the Department of Industry,
Science and Resources, in conjunction with the Delegation of the European Union to Australia and New Zealand, held
information seminars on the MRA in Sydney on 8 June 1999 and
Melbourne on 10 June 1999. Similar events may be subsequently
held in other major commercial centres on the basis of demand
and local assistance.
WHAT IS AN MRA ?
These MRAs will facilitate
trade by allowing conformity assessment (testing, inspection
and certification) of products traded between Europe and Australia
and 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 Australian
and New Zealand exporters, this means compliance with the
requirements of the relevant EC Directives (or regulations)
can be established in Australia / 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 Australian
and New Zealand regulatory requirements. Click
here to download a copy of the guide Doing Business
in Australia and New Zealand : Conformity Assessment (pdf
format).
These MRAs are binding
treaties between the Governments of Australia and the European
Community and between the Governments 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 MRAs covers the
following industry sectors:
-
medical devices;
-
pharmaceuticals Good Manufacturing
Practice (GMP);
-
telecommunications terminal equipment;
-
electromagnetic compatibility (EMC);
-
low voltage electrical equipment;
-
machinery; and
-
pressure equipment .
The EC/Australia MRA
also covers:
There is scope to extend
the coverage of the MRA to new sectors over time (e.g. aircraft
airworthiness).
Under the MRAs, 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 MRAs 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 MRAs 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/Australia MRA and
Annexes in Word 6.0 format.
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 Australia, 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
Australia’s largest trading partner. Total two-way trade
has grown from $A15.7 billion to $A32.3 billion in the decade
to 1997-98. Trade in products covered by the MRA accounts
for around $A8 billion of this total. Regarding New Zealand,
the European Union is the second largest trading partner (after
Australia) with two-way trade growing from $NZ 5.3 billion
in 1985 to over $NZ 7.5 billion in 1997. 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 Australian industry.
Conservative estimates
suggest that the MRAs could generate cost savings for Australian
exporters of as much as $A10 million per annum with a significant
saving also expected 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 MRAs 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 AUSTRALIA
FOR FURTHER INFORMATION
Electromagnetic compatibility
(EMC), low voltage electrical equipment, machinery, Telecommunications
terminal equipment, and pressure vessels:
For Testing Laboratories and Inspection
Bodies:
National Association of Testing Authorities
(NATA)
71-73 Flemington Rd,
North Melbourne, VIC 3051
Tel: (03) 9329 1633
Fax: (03) 9326 5148
email: Rob.Oke@nata.asn.au
Internet: http://www.nata.asn.au
For Certification Bodies:
Joint-Accreditation System Australia
and New Zealand (JAS-ANZ)
Unit 8 , Protech House
6 Phipps Close
DEAKIN ACT 2600
Tel: (02) 6282 5840
Fax: (02) 6282 6818
Internet: http://www.jas-anz.com.au
Medical devices and
pharmaceuticals Good Manufacturing Practice (GMP):
Therapeutic Goods Administration (TGA)
Symonston
NARRABUNDAH ACT 2604
Medical devices: GMP:
Tel: (02) 6232 8444 Tel: (02) 6232
8632
Fax: (02) 6232 8605 Fax: (02) 6232 8659
Internet: http://www.health.gov.au/tga
Automotive products:
Federal Office of Road Safety
15 Mort St
CANBERRA CITY ACT 2600
Tel: (02) 6274 7111
Fax: (02) 6274 7708
Internet: http://safety.fhwa.dot.gov/
Telecommunications
terminal equipment:
Australian Communications Authority
PO Box 78
BELCONNEN Act 2616
Tel: (02) 6256 5555
Fax: (02) 6256 5393
Internet: http://www.aca.gov.au
General:
Brian Phillips
Standards and International Liaison Section
Department of Industry, Tourism and Resources
Tel: (02) 6213 6156
MRAs
on Department of Industry website
Standards and Conformance
Policy Section
Department of Industry, Science and Tourism
GPO Box 9839, CANBERRA ACT 2601
Tel: (02) 6213 7909
Fax: (02) 6213 6617
Internet: http://www.industry.gov.au/content/controlfiles/display_details.cfm?objectid=EDC69097-7073-4EA8-9B33682DB7A70C2E
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
NZ: http://www.delaus.ec.europa.eu/newzealand/EU_NZ_relations/agreements_mra.htm
CONFORMITY ASSESSMENT BODIES (CABs):
Link for listing for European CABs. http://ec.europa.eu/enterprise/international/nz_en.htm#EU%20CABs
Link for listing for New Zealand CABs. http://ec.europa.eu/enterprise/international/nz_en.htm#NZ%20CABs
CONFORMITY ASSESSMENT BODIES (CABs):
Link for listing of European CABs.
http://ec.europa.eu/enterprise/international/aus_en.htm#List%20of%20approved%20conformity%20assessment%20bodies%20(CABs)%20designated%20by%20the%20EU%20member%20states
Link for listing of Australian CABs.
http://ec.europa.eu/enterprise/international/aus_en.htm#List%20of%20approved%20conformity%20assessment%20bodies%20designated%20by%20Australia
This page updated
September 22, 2009
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