COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 13.11.1996 
COM(96) 564 final 
COMMUNICATION FROM THE COMMISSION 
COMMUNITY EXTERNAL TRADE POLICY 
IN THE FIELD OF 
STANDARDS AND CONFORMITY ASSESSMENT 

COMMUNITY EXTERNAL TRADE POLICY IN THE FIELD OF STANDARDS AND CONFORMITY 
ASSESSMENT 
EXECUTIVE SUMMARY 
This Communication sets out the European Community's trade policy objectives in the field of standards and 
conformity assessment, and the strategy to achieve these objectives. Its aim is twofold. First, to establish better 
understanding of the Community's policy and strategy in this area, so that it may be promoted coherently. 
Secondly, to review and where necessary modify the strategy. 
The Communication rests on two assumptions. First, that trade barriers related to product standards and 
conformance - technical barriers to trade - appear to be increasing, demanding greater attention and action than in 
the past. Secondly, that the completion of the single market regulatory regime now places the Community in a 
position to pursue a more outward looking trade policy in this field. 
The Community's trade objectives can be summarised simply. First, to reduce technical barriers in overseas 
markets and prevent the emergence of new ones. Secondly, to encourage our trading partners to adopt standards 
and regulatory approaches based on, or compatible with international and European practice. Achievement of 
both objectives will facilitate our trade and market access for regulated products. 
These trade objectives are being pursued through a four-fold strategy comprising: reliance on under the WTO, 
notably the Agreement on Technical Barriers To Trade, in the multilateral framework, and on agreements in the 
bilateral framework to reduce barriers and open markets; negotiation of mutual recognition agreements to reduce 
the costs of testing and certification in other markets; technical assistance to a large number of countries to ensure 
that regulatory regimes are transparent and trade friendly, and regulatory cooperation aimed at harmonising 
standards and regulations with other trading partners. 
Concerning the WTO, we need to carry out a comprehensive review of the operation and implementation of the 
Agreement on Technical Barriers To Trade, as a means to ensure full adherence by all WTO members, and 
where necessary improve its operation. This implies also more systematic use of the WTO Trade Policy Review 
mechanism, and greater attention to technical trade barriers in the context of WTO accessions. Bilateral 
negotiations can also secure adherence to WTO rules, as part of the Community's Market Access Strategy. 
On Mutual Recognition Agreements a clear line needs to be drawn between the benefits of mutual recognition 
on the one hand and harmonisation of standards and regulations, since each can be pursued on its own merits. We 
should however place greater emphasis on using mutual recognition as a vehicle for greater harmonisation. In the 
longer term, we should be open to plurilateralising MRAs and consider the case for MRAs on a regional basis. 
Technical Assistance programmes to developing countries already promote the adoption by partner countries of 
international and European standards and practices. But there are ways in which technical assistance can better 
serve external trade objectives in future, and provide a basis for future mutual recognition agreements. We can 
also improve coordination of programmes and achieve better coherence between Community and Member States' 
programmes, so as to maximise economies of scale. 
As concerns Regulatory Cooperation, the principal Community initiatives in this field, whether multilateral, 
plurilateral, or bilateral, cover key industrial sectors such as vehicles, pharmaceuticals, medical equipment, 
foodstuffs and chemicals. These different forms of cooperation promote international harmonisation or 
acceptance of the Community's regulatory approach, and in many cases provide a basis for mutual recognition. 
In all these areas, cooperation and coordination between the Commission, Member States, European industry, 
and the European standards and certification community, is essential. We consider it possible to improve this 
cooperation. 
The Communication ends with a summary of conclusions, and asks the Council to endorse both the broad 
strategy set out in this document, and the specific proposals made. 
/- * 
COMMUNITY EXTERNAL TRADE POLICY IN THE FIELD OF 
STANDARDS AND CONFORMITY ASSESSMENT 
INTRODUCTION 
1. In recent years, standards and certification issues have become a significant factor in the 
Community's external trade relations. With industrial tariffs at historically low levels, the relative 
importance of non-tariff, technical barriers, has increased. In parallel, more and more countries, 
responding to a legitimate demand for increased health, safety and environmental protection, have 
progressively introduced new product standards and regulatory requirements. Despite the efforts of 
international bodies to develop globally applicable standards and requirements, different countries 
and regions have frequently, without justification, adopted differing standards for the same product, 
unnecessarily increasing costs, and preventing manufacturers from enjoying the economies of scale 
that flow from being able to produce against one common standard. 
2. This proliferation of different standards and requirements has been accompanied by the growing 
demand that compliance be demonstrated through independent inspection, testing or certification, by 
the country of import. Today, an ever-growing range of industrial products, from electrical 
equipment, toys and machinery to chemicals, drugs and medical devices must to be tested and 
certified to differing national requirements before sale. These conformity assessment procedures, 
while often unavoidable, imply additional costs to companies seeking to sell in multiple markets. 
Even in cases where countries rely on harmonised rules or accept as equivalent other countries' 
regulations, reliance on the exporting country's tests and certificates of conformity is the exception. 
3. This creates a number of potential barriers to trade. It necessitates the costly and largely redundant 
repetition of testing and certification for different national markets, raising costs for manufacturers in 
a global market place, without commensurate public welfare benefits. The need to submit products for 
approval in often distant markets means delays which, particularly for innovative technologies or 
products with a short life-cycle can hamper their marketability. Difficulties in understanding the 
regulatory regime in a foreign market, whether because of distance, language, or cultural differences, 
can also operate as a de facto discriminatory barrier against imports. Last but not least, the imposition 
of burdensome standards, testing and certification requirements can be used effectively to frustrate 
imports and shelter domestic companies from competition. 
4. Discussions with Member States and European industry reveal growing concern over the propensity 
of standards and conformity requirements to present trade obstacles, and one that shows no sign of 
receding. A number of solutions have been proposed, whose appropriateness may vary with 
circumstances, but which include: encouraging third countries to reduce obligatory technical 
requirements and conformance procedures to what is necessary to meet legitimate policy objectives; 
promoting, where feasible, greater harmonisation of standards and regulatory approaches in other 
markets; encouraging our trading partners to adopt or accept the equivalence of the standards and 
technical requirements applicable in the Community; and establishing mutual recognition of 
conformity assessment results, as a means to reduce conformity barriers. 
5. If standards and conformity obstacles demand greater attention than in the past, recent 
developments within the Community now enable us to address these obstacles more coherently. The 
introduction of harmonised European product directives through the Single Market exercise is now all 
but complete and the implementation of the directives is well underway, allowing more attention to be 
channelled to seeking improvements in the regulatory regimes of our trading partners. At the same 
time, the regulatory solutions developed by Europe, particularly under the Single Market programme 
offer, by virtue of their flexibility, trade-friendliness and consistency with international practice, an 
appropriate reference point for other countries or regions as they establish or reform their own 
regulatory systems. 
6. Against this background, the Community has set itself two basic objectives. First, to reduce or 
prevent the emergence of new standards and conformity assessment barriers for industrial products in 
other markets. Secondly, to promote where possible, the adoption overseas of standards and 
regulatory approaches based on, or compatible with, international and European practices, in order to 
improve the market access and competitiveness of European products. 
7. These trade objectives are being pursued through a four fold strategy comprising: reliance on the 
WTO, notably the Agreement on Technical Barriers To Trade, in the multilateral framework, and on 
agreements in the bilateral framework to reduce barriers and open markets; negotiation of mutual 
recognition agreements to reduce the costs of testing and certifying products in other markets; 
technical assistance to developing countries to ensure that nascent regulatory regimes are transparent, 
and trade friendly ; and regulatory cooperation aimed at harmonising standards and regulations with 
our trading partners. 
8. Section I below describes the role of the WTO - in particular the Agreement on Technical 
Barriers To Trade - in containing and reducing technical barriers, and suggests ways to use 
multilateral instruments more effectively in future. The role of bilateral initiatives in securing 
adherence to WTO rules is also highlighted. 
9. Section II of the document describes the key objectives of Mutual Recognition Agreements 
(MRAs), and the relationship between mutual recognition, technical assistance and regulatory 
cooperation. It suggests some adjustments to the current MRA strategy. 
lO.Section HI describes the objectives of the various Technical Assistance programmes offered by 
the Community to developing country partners, and suggests a number of improvements to enable 
them better to meet our external trade objectives. 
11. Section IV identifies the principal Community initiatives in the field of regulatory cooperation. 
The term is interpreted broadly to include both bilateral and plurilateral exercises, and describes 
initiatives to internationally harmonise standards and regulations, to simplify conformity 
requirements, and to promote regulatory reform. 
SECTION I: STANDARDS AND CONFORMITY ASSESSMENT ISSUES IN THE WORLD 
TRADE ORGANISATION. 
12. Since the late 1970's the multilateral trading system has attempted to limit the impact of standards 
and conformance barriers. The GATT Tokyo Round led to the conclusion in 1979 of a TBT code, 
adherence to which was voluntary, and which established basic disciplines such as transparency and 
non-discrimination in the use of product standards and regulations. This code was strengthened and 
made binding on all members of the now World Trade Organisation (WTO) following the Uruguay 
Round in 1994. 
13. The 1994 Agreement on Technical Barriers To Trade carries several innovations. It draws a clear 
distinction between standards, which are voluntary, and technical regulations, which are mandatory. It 
brings regulations and standards on product - related process and production methods within its scope. 
It strengthens the test of proportionality in the adoption of technical regulations, requiring members to 
regulate products in the least-trade-restrictive way possible. It makes members responsible for 
standards and rules applied at sub-federal level, and establishes a Code of Good Practice for non­
governmental standards bodies. It imposes disciplines on the way in conformity assessment of 
products may be carried out, and encourages WTO members to recognise tests and certificates of 
other members where they can be relied upon, noting that this may be secured through mutual 
recognition negotiations. Finally, as part of the Uruguay Round package, the Agreement is subject to 
the integrated WTO Dispute Settlement system. 
Operation and Implementation of the TBT Agreement 
14. At this stage it is too early to draw firm conclusions as to whether the new TBT Agreement has 
fully met its objectives. On one hand, there is arguably a limited awareness of the Agreement 
amongst those WTO members adhering to it for the first time, and of the domestic reforms they may 
have to make to bring their regimes into compliance. An educational effort is therefore needed. It may 
be questioned whether some of our trading partners are making sufficient effort to accept and use 
international standards, to comply with notification procedures, to encourage adherence to the Code 
of Good Practice, or ensure that technical regulations are proportionate. 
15. On the other hand, the introduction of several new disciplines in the 1994 Agreement, their 
binding nature, and the availability of dispute settlement procedures in the event of non-compliance, 
should over time lead to improvements. Already, the number of WTO dispute settlement consultations 
related to the new Agreement shows the determination of some WTO members to ensure proper 
implementation and to take action where its provisions are not respected. 
16. A major review of the operation and implementation of the Agreement will take place not later 
than the end of 1997 (Article 15.4 of the Agreement), and this will be the appropriate time to review 
the Agreement's success, to identify if it has been adequately implemented, and to consider whether 
its operation is adequate. 
17. The WTO Ministerial meeting in Singapore in December this year will be an opportunity for 
Members to reaffirm the importance of full implementation of the TBT Agreement, and to obtain a 
commitment to make the 1997 review a comprehensive one. Further to that we should then consider 
elements appropriate for this review. One such element is to consider how to reinforce the role of 
international standards, concern having been expressed that international standardisation fails to 
reflect the real needs of international trade. To achieve this objective, the coordination between 
national, regional and international standards bodies is an area for improvement. A procedure to 
measure the extent of members' adoption and use of international standards should be developed. 
Other issues which have been raised include the possibility of developing guidelines to assist WTO 
members in complying with the agreement, for example concerning the "least trade restrictive" test in 
the use of technical regulations and conformity assessment procedures. It could also include clarifying 
the scope of existing rules relating in particular to non-product related process and production 
methods (PPMs), and, if need be, whether a more structured relationship between the WTO and 
international standards-making bodies may be useful 
18. The Commission therefore concludes that if both the implementation and the operation of the 
Agreement are to be properly examined, the WTO Ministerial must both underline the importance of 
proper implementation of the TBT Agreement, and commit to a thorough 1997 review. The 
Community should therefore seek, at the Singapore Ministerial meeting : 
a) reaffirmation by all WTO Members of their commitment to thorough implementation of the TBT 
Agreement; and 
b) commitments to undertake a comprehensive and in-depth review of the implementation and 
operation of that Agreement in 1997. 
19. A closely related issue is the relationship between the Community and international rule-
making/standards setting bodies. The TBT Agreement and other WTO Agreements have given great 
weight to the activities of international bodies and in several fields it has become difficult to deviate 
from internationally developed rules and standards even where there may be technical reasons for 
doing so. Because of this it would be desirable to consider whether, and in which circumstances, the 
Community should be involved more closely in the work of such international bodies, so as to ensure 
continued consistency between internationally established rules and standards, Community rule­
making and our WTO obligations. These questions will also need to be considered. 
Complementary Actions in the WTO 
20. The WTO offers several additional avenues to secure full implementation of the Agreement, and 
which can in future be used more fully. 
a) The Trade Policy Review Mechanism (TPRM). 
21. The TPRM was established in 1988 as a mechanism to study at fixed intervals the trade policies of 
each WTO member, and to enable other WTO members to evaluate their WTO-compatibility. So far 
TPRM treatment of standards, conformity assessment and technical barriers to trade has been cursory. 
It is clear however that the growing importance of these issues merits closer TPRM scrutiny. 
22. A benefit of the TPRM is obviously to focus attention on the regimes of our trading partners. 
Problems in other members regimes can be identified and solutions proposed. Transparency is 
required, and the country under review has to justify the maintenance of particular rules or standards, 
which in many cases could be a challenge. The process itself can be used by the reform-minded as an 
external pressure to encourage regulatory reform. 
23. In addition, the Community should be open to detailed review of its standards and regulatory 
policy under the TPRM. Our regime offers a good model of compliance with the TBT Agreement. 
Harmonised Directives satisfy its key requirements. Standards - largely based on international ones -
are mostly voluntary, and regulatory requirements set only where necessary on health, safety or other 
legitimate grounds. Producers thus have flexibility in how to meet requirements, in line with the 
obligation to make technical regulations the least restrictive possible. Conformity assessment 
procedures are transparent, while the modular system under the New Approach, which provides 
different approval procedures related to degree of risk, offers an example of how to meet the least-
trade restrictive test. Acceptance of third country test data is possible through sub-contracting by 
European certification bodies, while the Community can also point to its efforts to secure mutual 
recognition agreements with other partners. 
24. The Commission therefore recommends that standards and certification issues be more thoroughly 
addressed in future TPRM reviews, notably those of our major trading partners and those countries 
where barriers are particularly acute. We would also be open to similar study of the Community's 
standards and conformance system at its next review. To do this will require improved coordination 
within the Commission and with Member States in the run-up to TPRM reviews, while we will need 
also to request the WTO Secretariat, to focus on the issue more fully when compiling future TPRM 
reports. 
b) WTO Accessions 
25. In the past technical barriers to trade were rarely an issue for GATT accessions due to the 
voluntary nature of the Tokyo Round TBT Code. And in those cases where a GATT member 
voluntarily subscribed to the Code, this was quasi-automatic. With the integration of the Uruguay 
Round TBT Agreement into the body of WTO obligations, compliance has naturally become an issue 
for new accessions, and one to which European industry attaches priority. Considerable attention has 
been given to standards and certification issues in the accessions of Russia and Saudi Arabia, and 
similar attention should be given to these issues in other Working Parties, so as to secure concrete 
commitments to align systems to TBT Agreement rules. 
26. The Commission will therefore ensure, in coordination with Member States, that these issues are 
given high priority in current and forthcoming accession negotiations. 
Bilateral Initiatives to Secure Compliance with WTO Rules and Reduce TBTs 
27. The Council recently approved a new Community Market Access Strategy by which the 
Commission will address trade barriers in third countries both through the multilateral framework and 
where appropriate bilaterally. Trade barriers relating to standards and certification clearly figure 
among the non-tariff barriers the market access strategy must overcome. In conformity with the 
approach underlined there, the Community will continue to use WTO dispute settlement proceedings 
to address the most egregious and clear breaches of the TBT Agreement. 
28. For those barriers which will continue to be more amenable to bilateral resolution without 
recourse to the full WTO machinery, the Community has a range of resources at its disposal, 
including its trade and cooperation agreements with many trading partners, formal consultative 
mechanisms such as Ministerial and high level meetings, and the possibility to address problems in a 
sector specific or ad hoc way as they arise. The Trade Barriers Regulation, while primarily 
multilateral in purpose, can also be a useful instrument to resolve bilateral disputes. 
29. In view of the apparently growing number and importance of technical barriers to trade, more 
systematic use of these mechanisms may be necessary in future. It follows from this that the 
Community's limited resources will need to be used effectively, and priorities set rigorously. 
Decisions will need to be made, for example, on whether in a particular case to use the WTO route or 
bilateral means; whether to seek solutions through market access negotiations or via longer term 
regulatory dialogue; whether to concentrate efforts on resolving problems in one or two major 
markets or cast the net more widely; and whether to seek to address all TBTs in a particular market or 
focus only on the most serious ones. 
30. It is not easy to give a categorical answer on how such priorities should be fixed. But experience 
to date suggests that the Community has emphasised problems in the USA at the expense of other 
countries where problems clearly exist and are growing. At the same time the relative priority to be 
accorded to different problems has not always been established. A refocussing to encompass other 
trading partners, as well as to assess the relative importance of different barriers - and hence the 
resources to devote to them - is warranted. 
31.This refocussing will be carried out in the following ways. First, within the framework of the 
Market Access Strategy a data base of third country barriers is being established and will be 
operational next year. This will carry information on technical trade barriers of our trading partners, 
and be verified, updated and published regularly. This information will provide a basis for 
consultations with Member States and industry so that collectively our priorities, both geographical 
and sectoral, can be firmly established, regularly updated, and agreement reached on the appropriate 
actions to take. 
32. Secondly, and separately, we can improve coordination by pooling the resources of all interested 
parties in Europe: the Commission and the Member States (with their respective overseas 
delegations), European industry including European Business Councils in third countries, and 
European standards, certification and accreditation bodies, to understand more fully regulatory issues 
and barriers in key markets - for example the USA, Japan, Korea, China and Russia, and to follow and 
influence the course of regulatory change. Information (for example translations of regulations made 
by different parties) needs to be shared, a continuous dialogue established with regulatory agencies in 
the third countries in question, an ongoing assessment of problems made, and systematic pressure 
applied to reduce technical barriers on the basis of the priorities identified. 
33. This is an exercise which demands time and expertise, and involves not only thorough 
coordination within the Community, but also in the third countries concerned. In respect of the key 
markets noted above, and potentially others, the Commission will ensure that its delegations are 
charged with making standards and regulatory issues a priority. In this way, coordination between the 
Commission and the Member States (and their respective overseas delegations), European business 
and the third country authorities can be enhanced, developments in the third country regimes followed 
systematically, and more coherent action taken. Such coordination will of course be of benefit not 
only in cases involving technical barriers to trade, but also to support the Community's activities in 
the fields of mutual recognition, technical assistance and regulatory cooperation, each of which is 
considered below. 
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SECTION II: MUTUAL RECOGNITION AGREEMENTS 
34. Two years ago, on the basis of negotiating directives from the Council, the Commission opened 
negotiations for mutual recognition agreements (MRAs) with a number of third countries. 
Negotiations are currently underway with the USA, Canada, Australia, New Zealand, Japan and 
Switzerland, some of which should be concluded this year. Further negotiations with additional 
priority countries will subsequently be opened'1. 
Nature of MRAs 
35. Mutual Recognition Agreements are agreements on the mutual recognition of conformity 
assessment of regulated products. Through an MRA, each party is given the authority to test and 
certify products against the regulatory requirements of the other party, in its own territory and prior to 
export. Each party recognises the tests, certificates and approvals issued by agreed conformity 
assessment bodies of the other party, and the products can be exported and placed on the other party's 
market without undergoing additional procedures. Such delegation of procedures can be envisaged, 
for obvious reasons, only in those cases where countries require mandatory third-party certification of 
products. This is normally required for products which present risks and which governments must 
submit to stringent controls. 
MRAs seek to facilitate trade while safeguarding the health, safety and environmental objectives of 
each party. They do not require or presuppose harmonisation of each Party's substantive 
requirements or recognition of their equivalence (as is the case in the EC internal market). Each party 
to an MRA is free to set its health, consumer protection, environmental standards or other regulations 
at whatever level it deems necessary as long as they comply with international obligations. MRAs do 
not interfere iwith that freedom at all. However, they do require that each side has full confidence that 
the certification process of the other side can wholly satisfy its requirements. Such confidence is most 
easily established at a bilateral level and between partners with broadly comparable concepts of 
product testing and approval, and once established requires mechanisms for its maintenance. 
Benefits of MRAs 
36. MRAs can bring several benefits : some immediate and others long term, some tangible in terms 
of savings to industry, some less quantifiable but nonetheless useful in promoting efficient, 
transparent, and increasingly compatible regulatory systems in different countries. All of these factors 
should be borne in mind when considering the benefits of mutual recognition in the future. 
a) the expense, time and above all the unpredictability incurred in obtaining approvals can be reduced 
by having the product evaluated in the country of production, or a quality system evaluated by local 
inspectors. These savings can be particularly important: where the market is distant, and where 
rejection of products by agencies in the country of destination can create delays and necessitate 
additional shipping or other costs; where the sector is very heavily regulated; where testing is carried 
out both prior and post export, or where early marketing may be crucial to competitiveness of a 
product. 
b) for small and medium sized enterprises, who may lack the resources to understand and access the 
regulatory systems of a distant third country market. MRAs can bring benefits by enabling all testing 
and certification steps to be carried out locally. 
1 The Council indicated the following priorities : USA, Canada, Japan, Australia, New Zealand, Hong Kong, 
Israel, Korea, Singapore, Philippines and, upon membership of the GATT (now WTO) TBT Agreement : China, 
South Africa, Malaysia, Indonesia, Thailand and Turkey. Among the latter six countries, all but China are now 
members of the WTO TBT Agreement. Mutual recognition arrangements with Turkey form part of the EC-
Turkey Customs Union. A separate negotiating mandate for Switzerland was obtained in 1995 following 
Switzerland's decision not to accede to the Agreement Establishing the European Economic Area (EEA). 
11 
37. In addition, MRAs can create longer term regulatory benefits, including the following: 
c) delegation of the right to certify products to bodies in the other party to the MRA represents a type 
of regulatory reform, particularly where regulation of a sector had previously been the preserve of a 
single regulatory agency. This can reduce the risk of conformity assessment being used to protect 
domestic manufacturers, or in a way which could lead to unauthorised technology transfer, problems 
over intellectual property rights, or other uncompetitive practices (a risk where testing and 
certification is carried out in conjunction with research for domestic industrial interests). 
d) long term regulatory cooperation, and indeed regulatory convergence, may be stimulated by 
MRAs, since each party must understand and apply correctly the regulatory requirements of the other 
party. This implies regular contact between regulatory agencies and conformity assessment bodies in 
order to ensure continued and uniform application of each other's rules. This in turn creates an 
incentive to seek compatible solutions when developing new regulations, or conformity assessment 
procedures. 
e) finally, mutual recognition can assist regulatory efficiency. Through being able to rely on 
assessments carried out by another competent party, the limited resources of the regulator can be 
reallocated. 
MRAs and Harmonisation of Standards and Regulations 
38. It was noted in paragraph 35 that mutual recognition of conformity assessment can operate 
irrespective of whether the parties' underlying product standards and requirements are the same or 
equivalent. In the case of the EEA, the EC-Turkey customs union, and future arrangements with 
Central European Countries, the goal of economic integration dictates that mutual recognition be 
based on common regulations. In most other cases however - such as negotiations with the USA or 
Canada - MRAs will also operate where the parties' underlying rules remain different. 
39. It follows from this that mutual recognition and harmonisation are in no way mutually exclusive. 
Harmonisation brings economies of scale to the producer, enabling him to sell on multiple markets a 
product produced against a single or equivalent standard. However, harmonisation does not of itself 
guarantee market access in terms of product approvals: only mutual recognition will enable the 
product to be certified in the country of export, and then placed on the market of destination. 
Conversely, mutual recognition on its own does not allow one-stop approval for multiple markets, 
unless accompanied by harmonisation or equivalence of the regulations of each party. In general, the 
greatest gains are to be made where mutual recognition is achieved against a background of 
harmonised or equivalent rules, so that a single test and approval is sufficient for both domestic and 
foreign markets. 
40. This distinction has not always been understood. Increasingly however, European industry and 
other interested groups have begun to recognise the separate though clearly complementary roles of 
MRAs and harmonisation initiatives, and have demanded that both be pursued in order to facilitate 
trade. The real question is not then whether to pursue MRAs or harmonisation, since their objectives 
and benefits are different, but rather if there are any circumstances in which one should receive 
priority over the other. 
41. On this question we cannot be categorical. In some sectors the benefits of harmonisation, by 
removing the costs to industry of national differences in standards or technical regulations, may be 
judged more important than MRAs. In these cases mutual recognition may be perceived mainly as an 
important first step towards regulatory convergence, which remains the priority and should be pursued 
in parallel. Clearly, mutual recognition should not operate to hinder this objective, for example by 
diverting resources away from harmonisation work, or from inhibiting regulatory change. In cases 
where harmonisation is imminent, there may be an economic argument for basing mutual recognition 
arrangements up-on such harmonisation, as in the field of pharmaceutical Good Clinical Practice 
(GCP) (paragraph 74 below), or vehicle approvals (paragraph 76). 
12 
42. In other cases, however, mutual recognition may be the priority or sole interest of industry. This 
may be the case where conformity assessment costs are particularly burdensome, where regulatory 
differences do not represent major additional costs in terms of product modification, - where 
harmonisation is considered achievable only in the very long term or, in particular, where 
harmonisation is not feasible because conditions and parameters are different in each country. The 
non-quantifiable benefits of mutual recognition, such as their regulatory benefits, need also to be built 
into any such assessment. 
43. The Commission draws from this assessment two general conclusions. First, the difference 
between harmonisation initiatives and mutual recognition needs to be well understood, and each be 
pursued on its own merits. In particular, in situations where mutual recognition has been identified as 
beneficial for the Community, harmonisation initiatives applicable to the same sector should not be 
allowed to interfere or delay mutual recognition unless the harmonisation is imminent. 
44. Secondly, in view of the importance industry places on achieving greater international 
harmonisation of standards and regulations, and the frequent complementarity between harmonisation 
and mutual recognition, we should ensure that MRAs support this goal wherever possible. 
45. In the light of these two conclusions, we must, first, ensure in future consultation of European 
industry groups that the relationship if any between mutual recognition and harmonisation initiatives 
can be established in each case , their technical feasibility understood, the appropriate timescale for 
each determined, and resources appropriately allocated. Such consultation should obviously take 
account of the separate but complementary nature of mutual recognition. 
46. Secondly, MRAs should be used explicitly to enhance regulatory cooperation and promote 
harmonisation or convergence. While MRAs do not imply or require convergence, clearly their 
benefits may be greater, compliance easier to monitor, and regulatory efficiency maximised, to the 
extent that the regulatory systems of the parties to MRAs are similar. We should therefore seek within 
each MRA a commitment by the parties to increase regulatory cooperation and, as appropriate, greater 
convergence of technical requirements, which the agreement itself can support, and to identify within 
agreements those sectors where harmonisation or equivalence exists. 
47. Thirdly, in determining future negotiating partners, and future sectors to negotiate, we should take 
account of the partner's commitment to harmonising rules in a given sector with international or 
European practice, as we are doing, for example, in the case of Central and Eastern European 
Countries. Where possible, mutual recognition should be a means to encourage greater convergence 
by partners who have developed divergent national rules. For those countries where technical 
assistance is being given, as a prelude to future mutual recognition, this assistance should continue to 
be used to facilitate convergence with European and international approaches. This will make future 
mutual recognition between the Community and these countries easier to establish, and maximise its 
value. 
Current and Future Priorities 
48. The Community's negotiating priorities and strategy for mutual recognition were last considered 
by the Council in March 1995, when the Commission's proposals to open additional negotiations or 
exploratory discussions with Korea, Singapore, Israel and Hungary were endorsed. The rationale for 
these proposals still holds, and on the basis that current negotiations with a number of countries 
should soon be successfully concluded, further negotiations can be progressively opened. Since that 
time however, a number of developments have taken place which necessitate further adjustments to 
this strategy. 
49. First, requests have been made by some additional associated Central European countries to open 
MRA negotiations with the Community. This issue has been discussed several times by the Council, 
which has endorsed the principle of opening negotiations with associated countries which can fulfil 
the necessary technical conditions. It has also been stressed that any MRAs should both benefit 
13 
bilateral trade in the pre-accession phase, and be based on these countries' legislative alignment with 
Community rules. Against this background the Commission is now preparing for negotiations as 
provided for under the respective Europe agreements, once the countries concerned meet the relevant 
conditions. 
50. Secondly, the prospect in the near future of the Community having a series of bilateral MRAs 
raises questions as to whether they could be made plurilateral. Discussions in the QUAD framework 
and elsewhere have shown interest in networking future bilateral agreements to create a plurilateral 
framework. We should support this idea, provided that we first secure a number of bilateral 
agreements, that any future plurilateralisation preserves our trade benefits, and that such a 
"networking" is consistent with ensuring that health and safety objectives are in no way compromised. 
51. Thirdly, mutual recognition arrangements are now being developed within the APEC region. To 
ensure that the Community's interests in this field are safeguarded, we should seek the greatest 
possible consistency between these arrangements and our own approach and objectives in mutual 
recognition. This can in practice be achieved by progressively negotiating MRA's with those 
members of APEC, which fulfil the technical and other conditions for MRAs. In practice, the 
geographical priorities identified by the Council in 1992 also include a number of APEC member 
economies. 
52. Fourthly, the growth of regional trading agreements may become over time relevant to our MRA 
policy. Currently a number of regional groupings, including Australia and New Zealand via its Closer 
Economic Relations Agreement, NAFTA, ASEAN, the Gulf Cooperation Council, Mercosur and the 
Central European Free Trade Agreement (CEFTA), all plan to introduce forms of mutual recognition, 
once a common regulatory framework has been introduced. With some exceptions (eg the Australia -
New Zealand Trans-Tasman MRA), these arrangements are at a nascent stage. While in the medium 
term the Commission will continue to negotiate bilateral MRAs, we should be sensitive to any future 
regional arrangements, and seek to benefit from them. If, in the future, such arrangements constitute a 
regulatory union like that of the European single market, and provide the necessary technical 
guarantees, there may be economies of scale in concluding MRAs at regional level. In discussing 
technical assistance programmes in Section III below, we suggest giving greater emphasis on 
encouraging regional arrangements through our programmes. In doing so, the scope for such 
arrangements to lead to regionally-based mutual recognition in the long term should be kept in view. 
53. Fifth, the Community must remain sensitive to the importance attached to mutual recognition by 
other countries and regions, in for example the Mediterranean and Latin America, with whom we 
have important bilateral economic relations, for whom the Community is the principal market or 
whose domestic regimes approximate to or may be guided by European standards and regulatory 
approaches. For many such countries and regions, mutual recognition is seen as a specific long term 
aim, and an objective of technical assistance, or can create an incentive for approximation to 
Community standards and rules. The Community also has an interest in MRAs which can facilitate its 
exports to these regions and stimulate compatible standards and regulations. While our policy should 
continue to be guided by the geographical priorities set out in Council negotiating mandates, and must 
take account of resource constraints, we should nonetheless be open to consider negotiations in future 
with additional countries, once they are able to meet the technical conditions for mutual recognition. 
54. Finally, we note that the implementation of a number of MRAs in the future will have resource 
implications, for both Member States and the Commission services. They will need to coordinate 
relations between authorities and conformity assessment bodies of each party, track legislative 
changes, and ensure the continued good operation of agreements, ensuring in particular the good 
functioning of their testing and certification bodies. As far as the Commission is concerned, priority 
should be given to ensuring that resources are identified among the existing ones, both at headquarters 
and in delegations to ensure the proper functioning of future MRAs. 
14 
SECTION III: TECHNICAL ASSISTANCE PROGRAMMES IN THE FIELDS OF 
STANDARDISATION. CERTIFICATION. METROLOGY AND QUALITY 
55. Since 1990 the Community has provided a growing number of countries with technical assistance 
programmes in standards, certification, metrology and quality. Some of these have been executed on 
the Community's behalf by the Comité Européen de Normalisation (CEN). Programmes are currently 
being provided to numerous trading partners, including those of Central and Eastern Europe, Russia 
and the CIS, several countries in the Mediterranean and Middle East, Latin America, Asia, and ACP 
countries. Some of these programmes are delivered within the framework of trade or cooperation 
agreements with our partners. A list of current and planned programmes is at Appendix 1. 
56. When a technical assistance policy was first established, it was for the following purposes: 
- to respond to developing countries' requests for information on European standardisation and 
regulations, particularly those developed for the Single Market. In this way the transparency of the 
Community system could be demonstrated, and developing countries would find it easier to export 
to the Community; 
- to assist developing countries to develop a standards and conformity infrastructure that would 
facilitate international trade; 
- and to encourage the adoption by developing countries of International and European standards, as 
a form of technology transfer. 
57. Over time, the scope of programmes has often gone beyond these original elements. Programmes 
are now typically multi-annual undertakings, and may include : providing information on Community 
standards and regulations; training and advice on the establishment or improvement of 
standardisation bodies; assistance in upgrading physical infrastructure; assistance in setting up 
accreditation systems; training of personnel in standards writing, conformity assessment and 
accreditation; assistance in developing technical regulations; and training and awareness programmes 
in the field of quality, from developing quality systems certification capabilities to improving the 
capacity of industry to meet European quality requirements at both the regulatory and private levels. 
58. In setting priorities for such programmes, the Commission takes into account a number of factors, 
in particular: the importance of such cooperation in the context of overall relations with the third 
country; its economic or technological level; the capacity of programmes to reduce technical barriers; 
and their capacity to facilitate trade and investment through promoting the acceptance of international 
and European standards and regulatory approaches, including where these compete with other 
countries' standards and rules. In terms of programme design, the Commission has also taken in 
account the specific priorities established by the Community and the partner country; sectoral needs; 
budgetary limitations; and whether the programme should be purely bilateral or could benefit from a 
regional focus. 
59. Technical assistance programmes have certainly helped to demonstrate the openness of the 
Community's regulatory regime, and in doing so have helped third countries' understanding of that 
regime and the exports of their products. This continues to be the main goal of programmes for lesser-
developed countries. It has also been in the interest of both the Community and the third country in 
question to be assisted in producing better quality or safer products, while the Community has an 
obvious interest in promoting in third countries a consumer demand for quality which Community 
products are often best able to supply. It is less clear however, whether all programmes have 
effectively reduced barriers to trade, or have propagated international or European standards and 
practices to the maximum extent. 
60. The Commission has identified some areas which need more attention if the value of technical 
assistance is to be maximised. First, Community trade interests have not always been explicitly 
determined, or fully integrated into programme implementation. Companies and individuals chosen to 
15 
carry out programmes have not always been adequately aware of their trade, as opposed to technical 
and industrial objectives. Programmes can be designed and executed so as to take more account of the 
specific needs or characteristics of the partner country and priorities of European industry. 
61. Secondly, programme coordination can be further improved so as to better fix priorities and 
ensure a consistent approach between programmes. We can be more active in ensuring exchange of 
information with Member States, to avoid duplication of resources, and ensure common objectives 
between Community and Member States' programmes. Similarly, synergy with programmes in related 
fields such as consumer protection policy, customs procedures, pre-shipment inspection and market 
surveillance could be beneficial. Programmes could also in some cases benefit from a more resources, 
and more systematic follow up or evaluation of their success. Improved coordination and management 
are thus possible. 
Programme Objectives and Content 
62. In terms of the content of technical assistance in this field, we believe that while the original 
objectives listed above remain relevant, they need to be complemented in at least four areas. 
63. First, we must integrate into future programmes a clearer concept of their trade and economic 
objectives. Mutual economic and trade interest should be a more explicit factor in programme design, 
the means to accomplish these objectives specified, and programmes evaluated in terms of whether 
these goals have been achieved. Training and assistance in applying and complying with multilateral 
trade disciplines, notably the WTO TBT Agreement, can also be incorporated into more programmes 
as a specific component. Programmes can also provide more systematically for the identification of 
priority industrial sectors, to be carried out in consultation with partner countries and European 
industry, and on the basis of mutual economic interest. 
64. Secondly, some partner countries have now reached a stage of economic and industrial 
development where basic infrastructures - such as a functional standards body, a range of basic 
industrial standards, and testing laboratories - are in place. Assistance may therefore be better targeted 
towards areas such as improving the regulatory regime for specific sectors, or refining the 
infrastructure necessary for mutual recognition agreements to be concluded. The potential to promote 
the absorption of European and international regulatory approaches, as opposed to solely standards, 
should receive more attention, since an increasing number of trade barriers are related not to 
standardisation but to regulatory activity, including conformity assessment. 
65. Thirdly, we should ensure that, where appropriate, and where technical conditions are met, 
mutual recognition can be one of the objectives pursued by technical assistance. 
66. Fourthly, the rapid growth of regional arrangements and groupings in the last five years can in 
future be better reflected in the aims of technical assistance, which is still mostly delivered bilaterally 
or geared to national, rather than regional solutions. Today a number of regional groupings, including 
ASEAN, Mercosur, the Gulf Cooperation Council and the CIS, are developing common standards and 
regulatory systems. To the extent these and other regions develop, over the next decades, regulatory 
unions like that of the Community, these should where possible be reflected in and supported through 
our programmes. We have an interest in encouraging standardisation, and the development of 
technical regulations and conformity assessment on a regional basis, in view of the economies of scale 
it brings to producers, the potential to access multiple markets on the strength of a single product 
assessment and the likelihood of regional structures using international standards and practices. At the 
same time the Community's own single market experience may be a relevant model for many areas of 
the world considering regional systems. The solutions we have found can be shared. We therefore 
consider that we should encourage other countries seeking to establish regional regulatory systems, 
and that our programmes should to a greater extent than heretofore be designed to facilitate such 
developments. 
16 
Programme Coordination and Management 
67. In order to improve programme coordination and management in future, we need : 
a) to ensure that European industry is aware of, and able to indicate its priorities in the provision of 
technical assistance programmes. We propose to inform industry federations on a regular basis about 
both current and forthcoming programmes, and to seek the involvement of European industry and 
other interested parties in programme implementation where this can be beneficial. 
b) to ensure the best possible synergy, and to avoid duplication between Community programmes and 
those provided by Member States or other international organisations (eg ISO, World Bank, UN, 
WTO), through regular exchange of information about the broad lines of current and planned 
programmes. Programmes can then be designed or modified to dovetail with other programmes. 
Basic information can be shared between the Commission and Member States through the mechanism 
of the 113 Committee Technical Group on Mutual Recognition. The Commission will aim to secure 
similar information exchange with the international organisations, and inform Member States of these 
through the same channel. The Commission will also seek closer coordination with programmes in 
related fields, as consumer protection, customs procedures, pre-shipment inspection and market 
surveillance practices. It is not intended that this exchange of information would in any way replace 
the established mechanisms for consultation on technical assistance and cooperation with developing 
countries 2; instead it will offer a forum which is broader in scope. 
c) to provide a new means to administer programmes in future through a new framework contract 
envisaged with the CEN, which will allow programmes to be administered by CEN on the 
Community's behalf. Use of this mechanism while optional, and not replacing existing tendering 
procedures, can nonetheless bring advantages. First, CEN can maximise resource efficiency by having 
a reliable medium term forecast of programming needs and budget. Secondly through CEN we can 
better promote the European nature of programmes. Today many partner countries are virtually 
unaware that the programmes are Community ones. Thirdly, CEN will be charged with building up a 
repository of information on third country systems, agencies and consultants used, and a library of 
programme information and training materials, which can be drawn on in designing and carrying out 
programmes. In this way a focal point for the different European organisations competent in this field 
can be provided. 
d) to improve choice of programme executors, first by ensuring in the framework contract with CEN 
access to the best possible sources, and by giving the Commission a clearer say in the choice of 
programme sub-contractors. To a greater extent than in the past, we should give public sector 
organisations (European and Member State standards bodies and accreditation organisations, Member 
States regulatory authorities) the opportunity to participate in programmes. These have a long-term 
public interest in the success of programmes and can establish permanent links with partner 
organisations and officials. Greater involvement of regulators is also desirable to the extent that 
future programmes place greater emphasis on improving the regulatory framework in third countries 
(paragraph 64 above). 
e) finally, to incorporate in programmes the possibility of their independent review in order to 
evaluate whether they are achieving their objectives. 
2 In particular the Committee established under Article 15 of Council Regulation (EEC) N) 443/92 of 
25 February 1992 on financial and technical assistance to, and economic cooperation with with, the developing 
countries in Asia and Latin America (OJ L 52 of 27.2.1992); and the Committee established under article 21 of 
the Internal Agreement on the financing and administration of Community aid under the Fourth ACP-EEC 
Convention (91/401/EEC; OJ L 229 of 17.8.1991) 
17 
SECTION IV: REGULATORY COOPERATION 
68. The term regulatory cooperation is used broadly, encompassing both : 
a) multilateral and plurilateral initiatives for the harmonisation or equivalence of standards, 
regulatory requirements and conformity procedures, or promoting best practices; and 
b) bilateral cooperation with our trading partners in developing technical regulations, standards 
harmonisation, and regulatory reform. 
69. An overview of multilateral and plurilateral initiatives is presented first, followed by a review of 
principal bilateral activities. Technical assistance programmes, while an important form of regulatory 
cooperation, and indeed the major form of cooperation with developing countries - are not discussed 
here in detail, having been presented in Section III above. Bilateral mutual recognition agreements, 
which may be a vehicle for regulatory cooperation, have been dealt with separately in Section II 
above. 
Mutilateral and Plurilateral Initiatives 
70. Below is a description of the key multilateral and plurilateral activities of the Community in the 
field of regulatory cooperation, together with the objectives of each. 
The following is not comprehensive, but identifies the priority initiatives underway. 
a) OECD 
71. The Community and Member States have been active in developing within OECD a multi-
disciplinary study on Regulatory Reform. This aims at an agreed statement of the principles, 
arguments for, and trade benefits of regulatory reform, and encompasses deregulation, harmonisation, 
and mutual recognition. The process has let the Community share its experience of the single market, 
and promote Europe's regulatory approach as an example of good practice. By extending the OECD 
process to non-OECD countries via the organisation's "outreach" policy, this will spread 
internationally the argument for regulatory reform. 
72. A parallel exercise in the OECD Consumer Policy Committee aims to clarify the relationship 
between consumer policy, certification, and international trade. This has led to a study and 
recommendations for consideration by Ministers. The study underlines the consumer and trade 
importance of standards and conformity assessment, and how to align consumer, regulatory and trade 
objectives. The work draws on the Community's regulatory approach as an example of how to 
achieve alignment, and again will be shared with non-OECD countries. 
73. Finally, since the 1980's the OECD Chemicals Committee has promoted harmonisation of testing 
practices used when approving chemical products, and the mutual recognition of data from 
laboratories complying with Good Laboratory Practice (GLP). OECD principles of GLP have 
progressively become the international standard, and the Community and others have integrated them 
in their own regulations. The common OECD standards, and the cooperation between members 
organised through OECD, have provided a technical basis to negotiate MRAs between the 
Community and third countries. The OECD's work in this area is expected soon to be opened to non-
OECD countries, which will further internationalise the OECD standards. 
b) Pharmaceuticals : the International Conference on Harmonisation 
74. The International Conference on Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals (ICH) brings together the regulatory authorities of the European Union, Japan and 
the United States and pharmaceutical industry experts to discuss scientific and technical aspects of 
pharmaceutical registration. The purpose is to reduce or obviate the need to duplicate the testing 
carried out during the research and development of new medicines, so as to achieve a more rational 
use of human, animal and material resources. Harmonised guidelines are adopted by the regulators of 
18 
the three regions under a stepwise process. It is anticipated that all the current ICH guidelines could 
be finalised in the next ICH to take place in July 1997, with follow-up work continuing thereafter. 
ICH work is likely to facilitate conclusions of MRAs, notably in the area of GCP (Good Clinical 
Practice). 
The International Co-operation on Harmonisation of Technical Requirements for Registration of 
Veterinary Medicinal Products (VICH) was launched in April 96 with a similar purpose and 
participation. 
Separately, the Community acceded in 1994 to the Convention on the Elaboration of a European 
Pharmacopeia drawn up by the Council of Europe. This aims to harmonise specifications for the 
manufacturing and quality control of pharmaceuticals in order to enable them to circulate within 
Europe. The monographs of the European Pharmacopeia become official technical rules applicable 
within the territories of parties to the Convention 
c) Food and Agriculture Organisation (FAO) 
75. The Codex Alimentarius Commission, a joint programme of the FAO and the World Health 
Organisation (WHO), adopts standards, guidelines and recommendations covering certain aspects of 
food safety and hygiene. The WTO Agreement on the Application of Sanitary and Phytosanitary 
Measures presumes that Members are in conformity with their WTO obligations if their measures are 
based on Codex standards, guidelines and recommendations. WTO Members who adopt other 
measures may be called upon to justify them on the basis of scientific evidence or as a consequence of 
the need to achieve a higher level of protection. The Community has based much of its legislation in 
the fields of food safety and hygiene on Codex standards and will continue to so where they are 
appropriate to our needs. Furthermore, the Commission will continue to monitor the sanitary and 
phytosanitary measures of our trading partners to ensure that they conform to their international 
obligations. The Commission has received a mandate to start negotiations with the Codex secretariat 
in order to become a full member of Codex in order to ensure that the Community can play its proper 
role in international harmonisation in this field. 
d) United Nations Economic Commission for Europe (ECE) 
76. Under the UN-ECE an agreement has existed since 1958 on the harmonisation of standards and 
technical regulations for motor vehicle equipment and parts, and mutual recognition of approvals. The 
Community, fourteen of whose Member States are contracting Parties to the Agreement, has 
introduced a large number of UN-ECE rules into domestic legislation. With the anticipated accession 
of the Community itself to the UN-ECE Agreement, which is currently under discussion in the 
Council and the European Parliament, the Community will be better placed to integrate more ECE 
rules into the EC type approval system in the future. 
77. The Community has spearheaded efforts to turn the ECE agreement into a global regime, in order 
to encourage adoption internationally of ECE-based vehicle regulations, and approvals. This goal was 
recently brought nearer through a renegotiation of the 1958 Agreement which opens it to non-
European countries. Japan has committed itself to joining the Agreement, while the EU and the US 
have designated the establishment of a revised agreement to develop international standards for 
automotive products in the UN-ECE on a worldwide basis as a priority under the New Transatlantic 
Agenda for the second half of 1996. The Community will continue to seek participation of other 
important car producing and importing countries, so as to ensure the widest possible adoption of ECE-
based rules, and mutual recognition of approvals. Any bilateral MRA's in this sector should be 
designed in such a way that they serve as a stepping stone for the partner countries' accession. 
e) Global Harmonisation Task Force for Medical Devices 
78. Established in 1992 as a forum for exchanging experience on medical devices regulation, the 
Global Harmonisation Task Force has become a focal point for efforts to introduce harmonised 
quality system requirements among the major economies. Supported by both European and US 
19 
industry, the Task Force has allowed the Community's regulatory approach in the field of quality 
systems certification to gain acceptance as the international model. Canada, Australia and Japan have 
been influenced through this to adopt rules close to those of the Community, while evidence is 
appearing that the USA is starting to do the same. The Task Force is an example of how the 
Community single market experience - resulting in a flexible regulatory approach - offers a model 
which may be referred to elsewhere. The Commission will continue to give priority to the Task 
Force's work, in particular as a basis for promoting the quality systems approach in other countries, 
notably in East Asia, which are overhauling their medical device rales. 
f) Civil Aviation 
79. Extensive regulatory cooperation in civil aviation matters is carried out at the international level 
by the International Civil Aviation Authority (ICAO), and at European level through the Joint 
Aviation Authorities (JAA). The latter, which groups the EC Member States and 12 other European 
Countries, cooperates to harmonise aviation regulations and promote the mutual recognition of 
aircraft certification throughout Europe. 
The Community's role in these activities has in the past been limited, but is expected to grow in 
future. First, the further development of the Community's regulatory regime for civil aviation will in 
both international fora and bilaterally strengthen its capacity to cooperate with third countries. 
Secondly, as part of a future aviation safety strategy, the Commission envisages launching technical 
cooperation programmes aimed at improving safety standards in these countries and promote adoption 
of the European regulatory approach. These programmes are likely, in the first instance, to be carried 
out in collaboration with ICAO or the JAA. 
g) The Organisation for Asia Pacific Economic Cooperation (APEC) 
80. In 1995 the APEC members launched a long term programme of cooperation in the field of 
standards and conformance. This encompasses harmonisation of standards and regulations, based on 
international ones, cooperation to improve certification and accreditation systems, and mutual 
recognition agreements. The Community's trade can potentially benefit from these APEC initiatives. 
We have an interest in seeing maximum possible compatibility between the standards, regulations, 
and conformity assessment infrastructure developed by APEC economies - especially their newly 
industrialising members - and Community ones. In view of the technical cooperation being offered to 
some APEC Members by both the Community and the more developed APEC members, there should 
also be an interest in seeking coherence between these programmes, so as to maximise their value. 
81 The Commission considers that our interest in the APEC process can be served first, by continuing 
to monitor developments, and secondly to seek a dialogue with the APEC Working Group on 
Standards and Conformance, which would be used to exchange information and experience on our 
respective activities. 
Bilateral Initiatives 
82. At the bilateral level the objectives of regulatory cooperation with the Community's principal 
trading partners can be summarised as follows: 
a) to improve transparency through exchanging information on current and planned initiatives, such as 
forthcoming laws and technical regulations affecting industrial products; 
b) to minimise divergences in regulatory approaches, and the risk of ensuing trade friction with our 
trading partners, through pre-legislative consultation; 
c) to facilitate harmonisation, or recognition of equivalence of standards, technical regulations and 
conformity assessment procedures between the Community and third countries, in those sectors where 
these have been judged achievable and of economic benefit to Community exporters. 
20 
In some cases bilateral cooperation can lay the foundations for the development of standards or 
regulations in the multilateral framework. 
a) USA 
83. Regulatory cooperation between the world's two largest trading entities has always been a priority, 
and in recent years has been extended and formalised. In 1995 the Community and the USA adopted, 
at sub-cabinet level, a document setting out "Principles of Regulatory Cooperation". This statement of 
principles encompasses the objectives listed above, and is meant to guide officials and regulatory 
agencies in their work. EC-US regulatory cooperation is currently being pursued, taking these 
principles into account, in many areas including: industrial standards (DGHI-CEN/ANSI-Dept of 
Commerce); Environment (DGXI/EPA); civil aviation (DG VTJ/FAA); telecommunications 
(DGXIII/FCC); foodstuffs and pharmaceuticals (DGIII/FDA); energy (DGXVII/EPA-Dept of 
Energy); pesticides (DGVI/EPA); and biotechnology (DG m/VI/XI/FDA/USTR). At the sub-cabinet 
meeting in May 1996, five pilot projects on regulatory cooperation (covering smoke measurement, 
dioxins, biotechnology, diesel engines and port state control) were proposed for future work. 
84. Regulatory cooperation has been significantly boosted through the announcement, at the 
Ministerial summit of December 1995, of the EC-US Transatlantic Agenda and Action Plan, which 
instituted a comprehensive and forward-looking agenda for further cooperation in the field of 
standards, technical regulations and conformity assessment in several industrial sectors. Industry on 
both sides of the Atlantic has contributed to setting priorities through a Transatlantic Business 
Dialogue (TABD), in which different sectors have identified the short, medium and long term actions 
to reduce technical barriers, and enhance convergence of EC and US regulatory systems. 
b)Japan 
85. Although regulatory cooperation with Japan has not been as comprehensive as with the USA, 
dialogue between the two sides has increased in recent years. The main bilateral activities linked to 
standards and regulatory issues are : 
- Japan's autonomous deregulation initiative, in which changes to Japan's standards and 
conformance regime figures prominently, and where the Community has indicated priorities for 
improving access to Japan's regulatory regime in several sectors. 
- the annual Industrial Policy and Industrial Cooperation dialogue, through which the EC and Japan 
facilitate cooperation programmes between key industrial sectors, and which includes 
consideration of regulatory issues; 
- the EC-Japan Standards and Quality dialogue, which aim to improve understanding of each party's 
standardisation and quality certification approaches. 
- annual high level consultations on telecommunications policy. 
- the annual high level consultations on environmental issues aimed at cooperating in the 
development of environmental regulations; 
86. Regulatory cooperation with Japan also occurs in several of the plurilateral fora, described above. 
There is nonetheless scope for intensifying bilateral cooperation with Japan, as was recognised in the 
1995 Communication to the Council "Europe and Japan: The Next Steps". There, we indicated that 
the dialogue on regulatory cooperation should be perceived as a continuous one, in which the EC's 
experience in regulatory reform, acquired particularly through the Single Market exercise, could be 
put to use. This remains a priority for the Community, and we intend to seek from Japan a 
commitment to such an ongoing exercise which could over time become comparable to that with the 
USA. 
21 
c) Canada 
87. The regulatory dialogue with Canada has in the past been pursued mainly through plurilateral 
fora. Recently however Canada has sought to strengthen the framework for bilateral cooperation with 
the Community through concluding an accord comparable to the EU-USA Transatlantic agenda. 
Although an agreement with Canada may be not as comprehensive in its scope, it will nonetheless 
provide an important vehicle to increase convergence in the future in sectors of common trade 
interest, while enhancing the scope for future NAFTA cooperation, which can bring obvious 
economies of scale.. 
d) The Associated Countries of Central and Eastern Europe 
88. A special case is that of the Central and Eastern European countries with whom the Community 
has concluded Europe Agreements. To prepare these countries for eventual EU accession, major 
programmes have been launched to assist institutional reform enabling alignment of their standards 
and regulatory systems with those of the Community. Implementation of the Europe Agreements, in 
particular through the Committees of the Association Councils dealing with legislative alignment, and 
industrial cooperation; PHARE programmes of technical cooperation; the development of 
progressively closer relations with European-level standardisation, certification and accreditation 
bodies; and possible mutual recognition agreements, are the main means to promote regulatory 
alignment in the pre-accession period. 
e) Other Countries 
89. With the exception of Switzerland, with whom there is a sustained regulatory cooperation in 
several fields, most regulatory cooperation with other trading partners is pursued through plurilateral 
or multilateral means, which were described above. As further needs arise in a particular sector or 
field of cooperation, these will be pursued. 
22 
SECTION V: CONCLUSIONS AND SUMMARY OF RECOMMENDATIONS 
Conclusions 
90. In the preceding pages the Commission has underlined the need for a more active and outward-
looking strategy to reduce technical barriers to trade, to facilitate the wider use of European and 
international standards and regulations, and to bring nearer the goal of one-stop testing and 
certification. We consider such a strategy to be both necessary and timely. It is necessary if we are to 
stem the proliferation of unjustifiably divergent standards and rules in a growing number of countries, 
and encourage approaches which are compatible with multilateral obligations, transparent, 
proportionate and advantageous to European exporters on world markets. It is timely because the 
regulatory system underpinning the Community's own internal market has now matured to the stage 
where we can afford both to focus more on our partners' regimes, and draw on our own experience to 
propose solutions to some of the problems faced. 
91. In reviewing the elements of this strategy - the instruments of the WTO, and bilateral agreements, 
technical assistance, regulatory cooperation and mutual recognition - we have recommended ways to 
make them more effective or respond better to a rapidly changing trading environment. The 
recommendations made are summarised in paragraph 96 below. 
92. At the same time we have stressed the importance of coherence between different components of 
this strategy. We have noted the importance of WTO instruments in reducing technical barriers to 
trade and in promoting use of international standards and regulations, and have suggested how these 
instruments can be used more fully. Technical assistance programmes can also however support the 
goals of the WTO: we have argued that such programmes, given a suitable trade orientation, provide a 
major means to assist compatibility with WTO rules. They also constitute a major vehicle for 
promotion in other countries of European standards and regulatory practices - themselves 
substantially based on international rules - in sectors of mutual commercial interest. Technical 
assistance programmes can also help prepare more advanced partners to meet the necessary conditions 
for future mutual recognition agreements, which may provide an important incentive for good 
programme implementation. 
93. We have presented mutual recognition as a response to the legitimate - but increasing - use of 
third party conformity assessment in international trade. MRAs can facilitate trade in sectors which 
will continue to require government regulation, and whether or not underlying product requirements 
are or can be harmonised. We have argued however that mutual recognition may often bring the 
greatest trade benefits in sectors which have been harmonised, and that the necessary confidence 
between MRA partners may be more rapidly gained and maintained in these circumstances. 
Membership of the WTO TBT Agreement, while a precondition to conclude MRAs, is of itself not 
enough to provide this confidence. 
94. Finally, we have noted that harmonisation of standards and regulatory requirements is achieved 
through regulatory cooperation taking place both at the multilateral level and bilaterally. These 
initiatives, like technical assistance, help to prevent trade barriers and may establish a good technical 
basis for mutual recognition. Regulatory cooperation in particular at the multilateral level ensures that 
the Community's interests in the development of international standards and regulations - vital for our 
international trade, besides being the basis on which our WTO obligations largely rest - are 
safeguarded. 
95. The policy goals set out in this paper can only succeed however with good coordination and the 
right institutional framework. Some specific recommendations have been made: to consult industry 
more widely when setting priorities; to improve exchange of information on technical assistance 
programmes, to strengthen external delegations' coverage of standards issues. But the full benefit of 
the strategy set out in this Communication can only be reaped through proper coordination and 
monitoring. Within the Commission, we will consider the case for strengthening the resources of the 
services responsible for oversight and interservice coordination of policies set out in this document. 
23 
At the level of the Council however, we see merit in broadening the current mandate of the 113 
Committee Technical Group on Mutual Recognition to encompass technical barriers to trade, 
technical assistance and regulatory cooperation in the field of standards and conformity assessment. 
This Council committee comprises both trade and regulatory expertise and is well placed to give 
guidance on this issues while remaining subject to the strategic guidance and oversight of the 113 
Committee. The Commission therefore recommends such an extension of the MRA Group's mandate. 
Summary of Recommendations 
96. Below is a summary of the recommendations made : 
a. To ensure improved implementation and operation of the WTO Agreement on Technical Barriers 
To Trade (TBT), the Community should seek, at the WTO Singapore Ministerial meeting in 
December 1996: 
1) reaffirmation by all WTO Member of their commitment to fully implement the TBT 
Agreement; 
2) commitment to ensure a comprehensive and in-depth review of the TBT Agreement as 
foreseen in 1997 (paragraph 18). 
b. Furthermore, to consider whether, and in which circumstances, the Community should be 
involved more closely in the work of the international rule-making/standards bodies, so as to 
ensure continued consistency between international rules and standards, Community rule­
making, an our WTO obligations (paragraph 19). 
c. To seek thorough coverage of standards and conformity issues in future TPRM reviews, notably 
those of our major trading partners or in countries where barriers have been identified as 
particularly acute. In addition, to be open to thorough TPRM review of the Community's 
regulatory system (paragraph 24). 
d. In the context of current and forthcoming negotiations on accession of new WTO Members, to 
ensure that standards and conformity assessment issues are given prominence (paragraph 26). 
e. Within the framework of the Market Access Strategy, to ensure that market access problems 
relating to technical barriers to trade are comprehensively documented, and that adequate 
consultation and exchange information on these issues takes place between the Commission, 
Member States and European industry (paragraph 31). 
f. To ensure that key external delegations make coordination on standards and conformity issues a 
priority (paragraphs 32-33). 
g. As concerns Mutual Recognition Agreements (MRAs), to ensure that the differences between 
harmonisation on the one hand and mutual recognition on the other be better understood, and 
each continue to be pursued on its own merits. Consistent with this, the objective of regulatory 
harmonisation should be taken into account in future MRA negotiations, in particular through 
using such agreements to enhance cooperation and promote harmonisation. At the same time, in 
determining future negotiating priorities, commitment to harmonising its regulatory regime in a 
given sector with international or European practice should be taken into account (paragraphs 43-
47). 
h. To open negotiations on mutual recognition with associated countries of Central and Eastern 
Europe to the extent they can fulfil the technical and other conditions for such agreements 
(paragraph 49). 
i. To be open to the principle of plurilateralising bilateral MRAs, once concluded, and where 
consistent with both our trade interests and regulatory objectives. In addition, to be open to the 
possibility in the long term, of establishing agreements on a regional basis (paragraph 50). 
24 
j. To continue to attach priority to MRAs with individual members of APEC in order to maximise 
consistency between these arrangements and APECs work in this field (paragraphs 51) 
k. Taking account of existing guidelines and mandates, to continue to be open 10 negotiating mutual 
recognition with other countries which meet the necessary technical requirements (paragraph 53). 
1. To ensure the means are available to allow the proper implementations of MRAs, both at he 
national level and within the Commission (paragraph 54). 
m. In respect of technical assistance programmes, to integrate trade objectives fully into current and 
future programmes including, where appropriate, assistance in complying with WTO obligations 
and disciplines (paragraph 63). The specific trade/market access needs of lesser-developed 
countries should continue however to be served by programmes. 
n. To ensure that technical assistance programmes concentrate adequately on regulatory issues, 
where necessary in a more sector-specific way (paragraph 64). 
o. To continue to utilise technical assistance to establish a basis for mutual recognition agreements 
and other forms of regulatory cooperation (paragraph 65); 
p. To take full account of the regional dimension in providing programmes, including the 
encouragement of regional systems of product regulation and conformity assessment, and to 
promote where appropriate the Community's regulatory approach in such programmes (paragraph 
66). 
q. To consult with and seek involvement of European industry groups on a regular basis about 
current and forthcoming technical assistance programmes (paragraph 67a). 
r. To establish through the 113 Committee of the Council a mechanism for systematic exchange of 
information between the Commission, Member States, European and international organisations 
on programmes in this field, so as to enhance transparency, reduce duplication of effort and 
create synergies between programmes (paragraph 67b). Noting however that this is without 
prejudice to existing provisions for information exchange and consultation. 
s. To offer as an option a new mechanism for programme administration through a framework 
contract with the Comité Européen de Normalisation. This will assist programme planning, 
enable the creation of an information base for use by programme planners, the Commission, 
Member States, industry and other interested parties, and promote the European profile of 
programmes (paragraph 67c). 
t. To improve the means of choosing programme consultants and contractors, and in particular to 
use to a greater extent than in the past European level or national organisations and Member 
States regulatory authorities (paragraph 67d). 
u. In the field of regulatory cooperation, to continue to give priority to the work being carried out in 
the OECD in the area of regulatory reform, in order to improve international understanding and 
consensus on its benefits, to share experience with the single market exercise, and to promote the 
use of Europe's regulatory approach. In addition, to continue to support ongoing OECD activities 
in the field of harmonisation and mutual recognition of data in the chemicals field (paragraphs 
71-73). 
v. To ensure that the current work under the International Conference on Harmonisation in the 
pharmaceutical sector is completed by July 97, in order to allow a reallocation of resources 
towards harmonisation of the registration dossier and inclusion of GCP in MRAs with the USA, 
Canada, Japan, Australia and others, (paragraph 74). 
25 
w. To promote actively the adoption by our trading partners of the standards set by the Codex 
Alimentarius in order to reduce technical barriers and facilitate trade in foodstuffs (paragraph 
75). 
x. In respect of the UN-ECE Agreement on harmonisation of regulations and mutual recognition of 
approvals for vehicles and parts, to seek participation in the Agreement of other important 
trading partners, so as to ensure the widest possible adoption of UN-ECE-based rules, and mutual 
recognition of approvals. Any bilateral agreements on mutual recognition of vehicle approvals in 
this sector should serve as a stepping stone for the accession of partner countries to the UN-ECE 
system (paragraph 77). 
y. To continue to support the work of the Global Task Force on Harmonisation in the medical 
device sector, as a means to promote the quality systems approach in other countries (paragraph 
78). 
z. To strengthen the Community's regulatory cooperation in the field of civil aviation, in particular 
through developing technical cooperation programmes which promote safety and the wider use 
of European regulations (paragraph 79). 
aa. In respect of APEC, to monitor the work of the APEC Working Group on Standards and 
Conformance, and to establish a dialogue with APEC on this matter (paragraphs 80-81). 
bb. As regards bilateral regulatory cooperation, to continue to attach priority to such cooperation 
with the USA, in particular through implementation of the Transatlantic Action Plan decisions in 
this respect; and with the associated countries of Central and Eastern Europe; and to strengthen 
cooperation with other major trading partners such as Japan and Canada (paragraphs 82-89). 
cc. To ensure that standards and conformity assessment issues receive appropriate attention and to 
improve coordination of the various policy instruments described in the document, to consider 
resource and needs within the Commission services (paragraph 95). 
dd. At the level of the Council, to broaden the current mandate of the 113 Committee Technical 
Group on Mutual Recognition to encompass technical barriers to trade, technical assistance in 
the field of standards and conformance, and regulatory cooperation (paragraph 95). 
97. The Council is invited to note the contents of this Communication, and to endorse both its broad 
conclusions and the specific proposals made. 
26 
SX 1 : SUMMARY OF CURRENT MRA NEGOTIATIONS 
BY COUNTRY / SECTOR 
Sectors under 
discussion 
MEDICAL DEVICES 
PHARMACEUTI­
CALS GMP 
GLP 
TELECOMS 
EQUIPMENT 
ELECTRICAL 
EQUIPMENT & EMC 
PRESSURE VESSELS 
MACHINERY 
PPE 
AIRCRAFT 
AUTOMOTIVE 
PRODUCTS 
RECREATIONAL 
CRAFT 
LAWN MOWERS 
MEASURING 
INSTRUMENT 
TOYS 
PHYTOPHARMACE 
UTICALS 
DANGEROUS 
SUBSTANCES AND 
PREPARATIONS 
CONSTRUCTION 
SITE EQUIPMENT 
ELECTRICAL 
EQUIPMENT FOR 
EXPLOSIVE 
ATHMOSPHERS 
(ATEX) 
GAS APPLIANCE 
TRACTORS USA 
X 
X 
X 
X 
X 
X 
X 
X 
X CANADA 
X 
X 
X 
X 
X 
X 
X 
X AUSTRALIA 
X 
X 
X 
X 
X 
X 
X 
X 1 NZ 
X 
X 
X 
X 
X 
X 
X JAPAN 
X 
X 
X 
X 
X 
X 
X 
X SWITZERLAND] 
X 
X 
X j 
X | 
x l 
X 1 
X Î 
X 
x 
x ! 
X x 1 
x X j 
x 
X 
X 
X 
X 
27 
ANNEXE2A 
ACTIONS IN PREPARATION 
THIRD 
COUNTRIES 
India 
Sri Lanka 
Vietnam 
Malta 
Mexique 
Marocco 
Algeria 
Tunisia 
Israel 
Egypt 
Argentina 
Bulgaria NATURE OF 
PROGRAMME 
Metrology, standardisation, 
certification, quality 
assurance, testing 
Normes, quality assurance 
Normes, quality, assurance 
Standardisation, certification 
metrology, quality assurance, 
testing 
Certification, accreditation, 
standardisation 
Certification, accreditation, 
metrology, quality promotion 
Certification, 
standardisation, intellectual 
property, quality assurance 
Certification, 
standardisation, quality 
assurance 
Identification mission to 
design a comprehensive 
programme 
Certification and assistance 
to laboratories 
Certification, 
standardisation, 
methodology, quality 
assurance, testing SECTORS 
Vehicle, 
foodstuffs, 
domestic 
electrical 
appliances and 
ITT 
Horizontal 
Horizontal 
Horizontal 
Not specific 
Horizontal 
Plumbing 
Cement 
Horizontal 
electrical and 
electronic 
products 
Not specific DURATION 
Parti 
1988/1992 
Part 2 : 
1992-1997 
2 years 
3years 
4 years 
1992/1996 
3 years 
1993/1996 
6 years 
1992-1997 
1995/1997 
3 years 
1996 
2 phases 
91-95 ; 96-98 
3 years 
1996/1998 AMOUNT(ECU) 
2000000 
2.528.000 
450.000 
3.500.000 
2200000 
1650000 
1575000 
400.000 
5.000.000 
200000 
35000 
1089000 
2.000.000 
18 
ANNEXE 2 A (follow) 
PROGRAMMES IN PREPARATION 
THIRD 
COUNTRIES 
Romania 
(Phare) 
Hungary 
(Phare) 
Hungary 
(Phare) 
Czech Republic 
(Phare) 
Czech Republic 
(Phare) 
Czech Republic 
(Phare) 
Czech Republic 
(Phare) 
Slovak Republic 
Lithuania 
(Phare) 
Latvia 
(Phare) 
Estonia 
(Phare) 
Romania 
(Phare) 
Bulgaria 
Multicountry 
Programmes 
PRAQ 91, 
PRAQ 93 
PRAQ in NATURE OF 
PROGRAMME 
Quality assurance, 
Standardisation, 
Certification, Accreditation, 
testing 
Metrology, Certification, 
Accreditation and Quality 
assurance 
Certification, type approval 
Metrology, Standardisation, 
Testing 
Standardisation and 
Metrology 
Testing, Standardisation, 
Accreditation 
Testing & Certification 
Standardisation, Science et 
Technologie 
Standardisation, 
Approximation of legislation 
Standardisation 
Approximation of legislation 
Standardisation, 
Accreditation, Metrology, 
conformity assessment 
Standardisation,Consumer 
protection 
Certification Methodology 
quality assurance, 
Standardisation 
Metrology, Certification, 
Standardisation, 
Accreditation, Testing, 
Legislation SECTORS 
various sectors 
not specific 
Telecoms 
Quality 
infrastructure 
Quality 
infrastructure 
Quality 
infrastructure 
Telecoms 
Not specific 
Foodstuffs 
industry 
Pressure 
equipment. 
Electrical 
équipement 
Not specific 
Quality 
Infrastructure 
Not specific 
Not specific 
Various sectors DURATION 
5 years 
1993/1997 
5 years 
1991/1995 
3 years 
1995/1997 
5 ans 
1991/1995 
4 years 
1992/1995 
4 years 
1995/1998 
4 years 
1991/1994 
3 years 
1995/1997 
3 years 
1996/1998 
3 years 
1996/1998 
4 years 
1995/1998 
3 years 
1996/1998 
1996/1998 
3 years AMOUNT (ECU) 
500000 
500000 
690.000 
1580000 
4000000 
700000 
5000000 
3800000 
2055000 
1800000 
600000 
2000000 
35500000 
& 
ANNEXE2B 
PROGRAMMES IN PREPARATION 
THIRD COUNTRIES 
Pakistan 
Chili 
Mongolia 
China 
Cyprus 
ASEAN 
Jordan 
Lebanon 
Marocco 
Paraguay 
Brazil 
MERCOSUR 
AIDMO 
GCC 
ANDEAN PACT 
(5 countries) NATURE OF PROGRAMME 
Certification, standardisation 
and quality assurance 
Certification standardisation, 
quality assurance, metrology 
Standardisation, certification 
Certification standardisation, 
quality assurance, metrology 
Standardisation, certification, 
metrology, quality assurance 
Standards, quality assurance 
of conformity 
Identification mission 
certification, standardisation, 
quality assurance 
Industrial and Commercial 
standards 
alignment of rules, 
legislation, mission to 
identify needs 
Certification, standardisation, 
quality assurance, metrology 
Metrology, certification 
Certification, standardisation, 
procedures of notification, 
metrology and quality 
assurance and management 
Certification, standardisation 
Certification, quality, 
standardisation 
Regulations, notification, 
standardisation, testing, 
certification, quality 
assurance, metrology SECTORS 
Certification, 
quality, 
Awareness 
Training 
not specific 
not specific 
horizontal 
horizontal 
horizontal 
industrial 
products 
industrial 
products 
industrial 
products 
not specific 
to be 
determined 
to be 
determined DURATION 
2 years 
4 years 
1997-2000 
5 years 
1997-2002 
1996-
3 years 
1997-1999 
1996 
2 months 
2 - 3 years 
(to be 
determined) 
8 months 
3 years' 
1993/1996 
3 years 
1997/2000 
3 years 
1996/1999 
3 years 
1997-2000 AMOUNT 
500000 
5210000 
not yet 
determinded 
30.000 
6.000.000 
30.000 
+/- 900.000 
+/- 400.000 
3950000 
750000 
700000 
2.300.000 
h:public:jc:diveis:auexpoll .doc 
^SSr 3o 
ISSN 0254-1475 
COM(96) 564 final 
DOCUMENTS 
EN 11 10 02 15 
Catalogue number : CB-GO-96-587-EN-C 
ISBN 92-78-11605-X 
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