Integrated Risk Management going beyond Corporate Governance

by Dr. Edmond Jurczek, Vice-President of the European Organization for Conformity Assessment (EOTC) based in Brussels, and founder of the World Organization for a new understanding of Technology and Culture (WOTC) based in Switzerland

No culture can be achieved directly, no culture simply can be made; culture shows up as an art of behaviour; cultural behaviour is depending on continuous education and processing. Consequently, no risk management culture can be achieved directly, no risk management culture can simply be made; risk management culture shows up as an art of behaviour; risk management cultural behaviour again is depending on continuous education and processing, and such an education and processing includes corporate governance measures.

The most advanced risk management model which I ever met has been developed and introduced to the market-place in Switzerland. It is the TSM Total Security Management model. TSM can be considered as the innovative evolution of TQM Total Quality Management. Of course, there is an intrinsic relationship in between the management of quality and the management of risks. But, and as is well known at the level of day-to-day practice, the impact of a management system model such as e.g. the EFQM model on the quality of the final products is not guaranteed just through application of such a management system only. Further measures have to be taken, such as explicit process management and explicit product management, and this not only regarding quality but regarding safety, environmental and social accountability htmlects as well.

As a conclusion risk management has to cover on one side quality, safety, environmental and social accountability htmlects, and on the other side products, procedures, management of cultural behaviour and management of corporate uniqueness. This is asking for specific activities in 4 x 4 = 16 fields. And this is just the systematic risk management approach of the TSM model, which has been published by the way as part of the book "Security for Healthy Growth" in 2002.

One might question whether the financial htmlects of corporate governance are covered with the TSM model or not; of course, they are. This can be seen by identifying the four layers of the so called BSC Balanced Score Cards method, namely Finance, Innovation, Market and Learning with the four layers Products, Procedures, Management of Cultural Behaviour and Management of Corporate Uniqueness, which fully correspond to each other.

In this context it is worthwhile to mention that there is an ISO Technical Management Board working group on Risk Management Terminology. On June 2002 there happened the publication of the ISO/IEC Guide 73, Risk Management Vocabulary Guidelines for use in standards. One should also take notice of the development of the Australian/ New Zealand standard on risk management, AS/NZS 4360:1999, which currently is going through the final stages of its five-year review process. A great deal of alignment of definitions in-between these two works has been achieved. However there is still an area of non-consensus. The most notable being "Risk Management" where the Australian/New Zealand committee has decided to remain with the existing definition used in AS/NZS 4360 which recognizes the fact that effective risk management involves a multi-layer scheme including cultural htmlects, as well as process/procedure and structure/product, if its benefits are to be fully realized. Interestingly this corresponds highly with the TSM Total Security Management risk management approach.

Please submit all reactions to this article to:

Further information on either the ISO/IEC Guide 73 or on the AS/NZS 4360:1999 can be gained e.g. from the recent article on "Risk Management: an integral component of corporate governance and good management", ISO Bulletin October 2003

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Commission seeks to boost new Member States' participation in EU research

Commissioner Busquin on 28 November met with representatives of the 13 accession and candidate countries to boost their participation in the EU's Sixth Framework Program.

Brief news:
Ministers and high-level representatives of the 13 acceding and candidate countries held talks on 28 November with Research Commissioner Philippe Busquin in order to increase their participation in the EU's Sixth Framework Program for Research 2002-2006 (FP6). In early 2003, the Commission launched "specific support actions" worth a total of 13 million euro to encourage these countries' participation.

Accession and candidate countries were involved in 40 per cent of all FP6 proposals, and their participation was most marked in the fields of nanotechnologies (21.8 per cent), information society (16.8 per cent) and sustainable development, global change and ecosystems (9.4 per cent).

Bucharest will host a conference on the participation of accession and candidate countries in FP6 on 12-13 February 2004.

Official documents:
CORDIS: Commission clarifies FP6 funding for future Member States prior to accession
CORDIS: Specific Support Actions for Associated Candidate Countries
CORDIS: Sixth Framework Programme Calls
Commission: Sixth Framework Programme 2002-2006

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Industry disappointed with Council conclusions on the state of the internal market

While ministers agreed to renew efforts to implement internal market directives, the industry calls for a much stronger commitment.

The Council agreed conclusions on the Commission's Internal Market Strategy designed to tackle obstacles hindering the trading in goods and services, which the Commission had presented to the Competitiveness Council on 19 May 2003.
Internal Market Commissioner Bolkestein expressed concerns over areas in which the internal market seems to have slowed down considerably. This includes intra-Community trade, foreign direct investment and price convergence, all of which indicate a structural rigidity in the functioning of the EU's product and capital markets. He emphasized that it is essential to implement the Commission's strategy to stimulate economic integration.
As expected, Mr. Bolkestein also rebuked the Member States for their failure to fully transpose EU legislation into national law, as latest figures have shown a substantial "transportation deficit" in many Member States (see e.g.; web-site of EurActiv on 22 September 2003).
The Competitiveness Council in its conclusions committed to tackle remaining obstacles and to speedily implement all internal market directives. However, Philippe de Buck, Secretary General of UNICE, was not satisfied with this outcome. "This is not enough", he said. "The full potential of the internal market can only be realised if Member States show full support and a much stronger commitment."

Links/Official Documents:
Council: Competitiveness Council 22 September (Provisional version)

EU Actors' positions:
UNICE: Internal Market Strategy: Now it's time to deliver!

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A Guide to the Mutual Recognition Agreement between the European Community and Japan

Doing Business in Japan

The European Union (EU) and Japan concluded an agreement on mutual recognition (MRA) which
entered into force on 1 st January 2002. The MRA has the overriding objective of promoting trade in
goods between the EU and Japan by facilitating market access. The EU-Japan MRA covers the
following sectors: Telecommunication Terminal Equipment and Radio Equipment, Electrical
Products, Good Laboratory Practice (GLP) for Chemical Products and Good Manufacturing Practice
(GMP) for Medicinal Products.
MTA Japan Co., Ltd. and Mitsubishi Research Institute, Inc. prepared this Guide to EU-Japan
MRA with financial assistance from the Commission of the European Communities. The views
expressed herein are those of the author, and do not represent any official view of the Commission.
The EU-Japan MRA is based on the relevant legislation, regulations and administrative provisions of
these parties. Those legal acts evolve over time and the MRA is also modified to reflect such
changes. It is always the current legal acts in force that apply. This guide reflects the status on such
its date of publication. Uses of this guide should therefore ensure that they have available the current
legislative, regulatory and administrative documents. Information on where this is available is
provided herein.
The MRA lays down the conditions under which the EU and Japan will accept certificates of
conformity issued by the conformity assessment bodies (CABs) of the other party according to the
requirements of the importing party. This means that a manufacturer wherever located can have its
product tested and certified according to a Japanese requirement by a CAB located in the EU.
This will permit manufacturers to turn to European CABs they are familiar with and thus avoid the
burden, cost and time associated with having to seek out the service of a body in Japan. European
CABs will in their turn to be given the possibility of offering more comprehensive services.
The MRA does not call for a harmonization of product or conformity assessment requirements
between the EU and Japan. Each party maintains its own legislation and regulatory requirements.
The smooth functioning of the agreement therefore requires that both sides have full knowledge and
understanding of the other party™s legislative, regulatory and administrative requirements.
From the European point of view, the objective of the EU-Japan MRA is to give benefits to
European manufacturing industry in terms of more direct market access for their products in Japan.
To achieve this objective, key players in Europe must become aware of the possibilities the MRA
offers and have correct and timely information in order to take advantage of the agreement. Key
players in this regard are designating authorities at the Member State level, the CABs and the
European manufacturing industry itself, including but not limited to SMEs.
Late in 1999, the Commission services concluded that it would be useful for Member States,
European CABs and industry to have the benefits of a guide with clear and practical information on
the MRA. Such a guide, the Commission believed, would advance the two goals of the smooth
functioning of the agreement and the more direct access for European industry to the Japanese
marketplace.

The Guide begins with a background and context for the EU-Japan MRA and follows as; Chapter 2
Structure and Content of MRA, Chapter 3 Structure and Understanding the MRA Law Established in
Japan Chapter 4 Japan™s Standards and Conformity Assessment Infrastructure. Each chapter
contains a comprehensive list of European and Japanese organizational contacts for further
information. Each chapter includes reference text of applicable sectoral Annexes to the MRA
including amendments current through June 2003. The chapters look as follows:

Chapter 1 Background and Context for the EU-Japan Mutual Recognition Agreement (MRA) 1
1.1. Introduction 1
1.2. Objective of The Guide 1
1.3. Background to the Development of the MRA 2
1.3.1. MRAs in Force 2
1.3.2. Referring Information 3

Chapter 2 Structure and Content of the MRA 5
2.1. Explanation of EU-Japan MRA 5
2.2. Structure and Product Sectors Covered by the MRA 5
2.3. Content of the EU-Japan MRA 6
2.3.1. Overall Framework 6
2.3.2. Functions of Joint Committee and Joint Sectoral Committees 8

Chapter 3 Structure and Understanding the MRA Law Established in Japan 9
3.1. What is the MRA Law_ 9
3.1.1. Purpose 9
3.1.2. Definitions of Terminology 9
3.2. The Content of the Law for Implementation of the Mutual Recognition
between Japan and the European Community and the Republic of Singapore
in relation to Conformity Assessment of Specified Equipment 10
3.2.1. Contents of the Law 10
3.2.2. Evaluations by Designated Accreditation Bodies 12
3.2.3. Structure of the MRA Law 13
3.3. Exceptions of Related Laws Stated in the MRA Law 14
3.3.1. Exceptions under the Telecommunications Business Law 14
3.3.2. Exceptions under the Radio Law 14
3.3.3. Exceptions under the Electrical Appliance and Material Safety Law 15

Chapter 4 Japan™s Standards and Conformity Assessment Infrastructure 17
4.1. Overview 17
4.1.1. Telecommunications Terminal Equipment and Radio Equipment
& Electrical Products 19
4.1.2. Conformity Assessment Infrastructure of EMC in Japan 21
4.2. GLP Monitoring Infrastructure in Japan 22
4.2.1. Overview of GLP Monitoring Infrastructure in Japan 22
4.2.2. GLP in Japan 23
4.3. Good Manufacturing Practice (GMP) for Medicinal Products 23
4.3.1. Designating Authority and the Related Laws for GMP in Japan 23
4.3.2. Flow of Medicinal Approval, Manufacturing Control, Distribution
and Post-Marketing System under the Pharmaceutical Affairs Law in Japan 24

Annex I Telecommunications Terminal Equipment and Radio Equipment 28
1.1. The Applicable Laws, Regulations and Administrative Provision
Stipulating Telecommunications Terminal Equipment and Radio
Equipment in Japan 28
1.2. The Applicable Laws, Regulations and Administrative Provisions
Stipulating the Requirements and the Conformity Assessment Procedures 28
1.3. Designating Authorities 30
1.3.1. Implications for European Designating Authorities 30
1.3.2. Designating Authorities in Japan 35
1.4. The Applicable Laws, Regulations and Administrative Provisions
Stipulating the Criteria for Designation of Conformity Assessment Bodies 36
1.5. Japan™s Conformity Assessment Infrastructure for Telecommunications
Terminal Equipment and Radio Equipment 36
1.6. Technical Regulation Conformity Certification System Stipulated
in the Radio Law 38
1.6.1. What is the Technical Regulations Conformity Certification System_ 38
1.6.2. Designated Certification Agencies 40
1.6.3. Attested Private Inspectors, etc.: Simplification of Procedures 41
1.6.4. Specified Radio Equipment 45
1.6.5. Three Ways to Proceed the Technical Regulations Conformity
Certification System 48
1.7. Technical Conditions Compliance Approval System Stipulated
in the Telecommunications Business Law 49
1.7.1. What is the Technical Conditions Compliance Approval System_ 49
1.7.2. Designated Approval Agencies 51
1.7.3. Recognized Approval Body 52
1.7.4. Attested Examiners 52
1.8. Amendment of MRA related Laws 55
1.8.1. Contents of Amendment of MRA Related Laws Regarding Conformity
Assessment System 55
1.8.2. Effects on MRA 56

Annex II Electrical Products 58
2.1. Overview 58
2.1.1. Electrical Appliance and Material Safety Law and other related
Regulations for the MRA 58
2.1.2. Classification of Electrical Appliances and Materials (Article No.2 of the Law) 58
2.1.3. Outline from Pre-Market Measures, Marking Requirements to
Post-Market Measures 67
2.1.4. Concrete Procedure of Pre-Marketing and Marking Requirement 68
2.2. Implication for European Designating Authority 70
2.3. Implication for European Conformity Assessment Bodies 75
2.3.1. Outline of Actual Approved CAB and Authorized CAB in Japan
based on the Law 75
2.3.2. Conformity Assessment Issues in Electrical Application and
Material Safety Law and its Relationship with the MRA
(Article 35 of the MRA Implementation Law and the Article 35 of Ordinance) 77
2.4. Implication for European Manufacturers
(Emphasizing Small and Medium Sized Companies) 79
Annex III Good Laboratory Practice (GLP) for Chemical Products 82
3.1. Overview: GLP Related Laws and Regulations 82
3.2. Implication for European GLP Monitoring Authorities 84
3.2.1. Contact Points of European GLP Monitoring Authorities 84
3.2.2. Contact Points with Japanese GLP Monitoring Authorities
and Related Organizations 93
3.3. Japanese GLP Inspection Authorities 95
3.4. Implication for European manufacturers
(Emphasizing Small and Medium Sized Companies) 97
Annex IV Good Manufacturing Practice (GMP) for Medicinal Products 100
4.1 Overview 100
4.1.1. Historical Background of GMP in Japan 100
4.1.2. Outline of GMP in Japan 100
4.1.3. Regulations for Manufacturing Control and Quality Control of
Drugs and Quasi-drugs 101
4.1.4. Provisions on Buildings and Facilities in Manufacturing Facilities 102
4.1.5. Standards for the Quality Control of Imported Drugs and
Medical Devices (so called iaGMPIld) 103
4.2. Implication for European Designating Authorities 103
4.2.1. Organizational Structure in Japan 103
4.2.2. Pharmaceutical Affairs Law and Related Laws 104
4.2.3. Scope of GMP in Japan 106
4.3. Implication for European Conformity Assessment Bodies 106
4.4 Implication for European Manufacturers
(Emphasizing Small and Medium Sized Companies) 108
4.5 Contacts for Further Information 109
4.5.1. List of European GMP Authorities 109
4.5.2. Contacts for Further Information in Japan 109

The Guide contains the available information at the moment of final drafting. Readers can obtain updated information by visiting the
relevant web-pages.

This guide was prepared with financial assistance from the Commission of the European Communities. The views expressed herein are those of the Contractor and do not represent any official view of the Commission.

Note about the acronyms that might have been used in the text above:

Acronyms
ASNITE Accreditation System of National Institute of Technology and Evaluation
CAB Conformity Assessment Body
CSCL Chemical Substances Control Law
EMC Electromagnetic Compatibility
GCP Good Clinical Practice
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
IA Japan International Accreditation Japan
JAB the Japan Accreditation Board for Conformity Assessment
JATE Japan Approval Institute for Telecommunication Equipment
JCLA Japan Chemical Laboratory Accreditation
JCSS Japan Calibration Service System
JECTEC Japan Electric Cable Technology Center, Inc.
JET Japan Electrical Safety and Environment
JIS Japan Industrial Standards
JNLA Japan National Laboratory Accreditation
JQA Japan Quality Assurance Organization
METI Ministry of Economy, Trade and Industry
MPHPT Ministry of Public Management, Home Affairs, Posts and Telecommunications
MRA Mutual Recognition Agreement
NITE National Institute of Technology and Evaluation
OPSR Organization for Pharmaceutical Safety and Research Center
PAFSC Pharmaceutical Affairs and Food Sanitation Council
PMDEC Pharmaceutical and Medical Devices Evaluation Center
TELEC Telecom Engineering Center
VLAC Voluntary EMC Laboratory Accreditation Center, Inc.

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Trade body criticises trade liberalization agenda

A new UNCTAD report, published on 2 October, warns against placing trade and the financial liberalization agenda first at a time of sluggish global growth and unemployment:

The United Nations Conference on Trade and Development (UNCTAD) released its annual world economic forecast on 2 October 2003. The Trade and Development Report 2003 concludes that a number of urgent tasks need to be performed, including the stabilization of financial and currency markets, advancement of global recovery and reversal of the rapid rise in unemployment. The UNCTAD report warns that if decisive action is not taken in these areas, trade imbalances, differences in the rate of growth, as well as resulting job losses could lead to a further increase in dissatisfaction with globalization in many parts of the world.
According to UNCTAD Secretary-General Rubens Ricupero, "the current economic landscape in the developing world has an uncanny resemblance to conditions prevailing in the early 1980s", when many countries slipped into deep crisis.
The Report does not believe that a "second generation" of neoliberal reforms will lead to economic growth in developing countries. Rather, it is in favour of re-thinking options on the basis of the economic record of the past two decades and re-considering the experience of the more successful cases of development. Generalised approaches will not work, instead, the diversity of conditions should be taken into consideration, concludes the report.

Links/Dossier:
The Doha Round of WTO Negotiations

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Study: Commission officials predict 'rough ride' for enlargement

Enlargement will likely be a bumpy ride, but support for the process is running high among the Commission's officials, a new study concludes.

Drawing on interviews with over 30 senior Commission officials who have been closely involved in the enlargement process, the PR-firm Burson Marsteller has compiled a sequence of studies on the enlargement's projected effects on the EU's key policy areas.
Issues:
Describing enlargement as a "rough ride", the study rests on the interviewed Commission officials' premise that some accession countries are "not ready" and thus will struggle to come up to the EU's standards. And yet, the study senses explicit support for the process.
The officials cited in the study shared the belief that enlargement could retard the Union's pace of progress, and many pointed to the language issue as posing a real threat to the decision-making process.
On the positive side, the officials expect the new Member States to boost policy areas such as IT and telecoms, trade and economic modernization. On the flip side, setbacks are foreseen in the fields of environmental protection and social and employment legislation.
In general terms, the officials quoted in the study expect enlargement to promote the EU's Lisbon Competitiveness Agenda, while on the social front the ambitions are perceptibly lower. The biggest of big intra-EU fights are predicted over the EU's 2007-2011 budget, starting next year.
The study says the officials' major concerns included Poland, which many labeled as "another Spain"; the level of preparedness of the EU's institutions; the quality of people sent by the new Members to Brussels; the enforcement of food safety measures; and when - if at all - the EU should resort to the safeguard clauses designed to protect the internal market.

Links/Official documents:
Burson-Marsteller: Enlargement 2004 - Big Bang and Aftershocks

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Promoting innovation in the future Member States

Developing and applying innovative techniques and products is essential for business if they are to improve their industrial competitiveness and meet the growing demands of sustainable development . Two European Commission networks - the Innovating Regions in Europe (IRE) and Innovation Relay Centers (IRC) - are helping enterprises in both existing and future Member States to meet these challenges.

IQNet Qweb: more and more ...

Qweb, the IQNet certification system for e-business and e-commerce activities is now operating in Argentina, Brazil, Czech Republic, Finland, Germany, Hungary, Israel, Italy, Portugal, Slovenia and Switzerland.

In terms of research and development a group of IQNet Qweb partners has set-up a project for a high level post-graduate training course with the purpose of enhancing the knowledge of e-business management. The project partners include three Universities in Europe. The project named “DIGI-Q - Quality and on-line confidence in SMEs e-business processes” has been funded (IST-2001-38157) by the European Commission – Information Society Directorate within the “e-Europe” action plan.

The main aim of DIGI-Q is to increase the SMEs capabilities by being more competitive in the digital economy age. Candidate trainees, currently under selection, are not only graduate student wishing to enhance their knowledge, but also professionals and company personnel desiring to get the right training in order to become “process managers” for a transition towards the e-economy. The first training course is ready to start in the Czech Republic, Greece, Italy, Portugal and Slovenia. It will last one year until July 2004. The course includes practical project works carried out by the trainees under the tutorship of the University teachers. The analysis and development will consist of an e-business process in a real company. We also expect these companies to access the Qweb certification in a privileged way.

IQNet is now enhancing the Qweb system by including a new character: the Qweb Enabler. In the other certification schemes the applicant company needs, in most cases, help from a consultant in order to set-up a certifiable system. After many years of experience consultants are well defined professionals which are partners of both the IQNet certification bodies and the certified companies: they are generally specialized in one or more management systems and their services on the market can be easily found and accessed.

The case of Qweb is different. The setup of a company website for e-business or e-commerce activities is not in the hand of a defined professional or organization. We noticed that websites are designed and implemented by a variety of companies and professionals: advertiser, marketing and public relation persons, software companies, just to mention a few. Potential Qweb customers are sometimes in trouble when they decide to enter the world of e-business. For this reason IQNet has implemented a qualification system for providers of Qweb conforming websites: the Qweb Enablers. In fact it is not an actual “certification” in compliance with a defined standard, but just a method to qualify them and give them visibility in the Qweb system. The qualification defined by the IQNet partners is described in the document “Qweb Enablers qualification - edition 1” which may be obtained from the IQNet Secretariat. After the qualification the Qweb Enablers shall be registered in the www.qwebmark.net website. The registration includes the Enabler identification data and a short presentation page. The Enablers shall expose the Qweb Enabler logo on their websites and the validity of the qualification is checked with a mouse click (the same happens for the Qweb certified websites).

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First immediate feedback from the EOTC Critical Issue Conference on the New Approach Review, Brussels 03-04 December 2003

The Critical Issue Conference on the New Approach Review (NAR) turned out to be a success. First of all there were participants and speakers present from almost all around the globe, such as from Asia, Canada, CIS, Europe and the US. Second the conference covered the domains of the EA (European Accreditation), the EC (European Commission), Eurolab, Eurachem, EOTC of course as well as UNECE (United Nations Economic Commission for Europe) and WOTC (World Organization for a new understanding of Technology and Culture).

Mr. Carlos Ganopa, President of EOTC, was chairing the conference, and it turned out to become a real critical issue conference, since participants and speakers were contributing with clear messages in an open minded manner. There have been so many important points being made that it was decided along the conference to produce a conference position paper from the Conference to the European Commission with EOTC to manage that act. Just to give some examples upfront, lets address the future role of accreditation as a major issue, or the roles of legislation and standards as well as their linking, or the issue regarding traceability, the CE-marking as well as a world-wide approach to enlarge it (using the so called O-T-C mark scheme) to a wider Europe, the concerns from ISO/CASCO or some deficiency of legislation in Europe.

EOTC will be pleased to inform about the further steps and outcomes as soon as available.

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EU preparing sustainability rules for tourism sector

On 21 November the Commission published a Communication establishing a Tourism Sustainability Group which will prepare guidelines for the tourist sector.

Tourism is of major economic importance for growth and employment in the EU.

The EU has had an active role in tourism since the 1980s. In 1986, a Tourism Advisory Committee was set up to facilitate exchange of information and co-operation. In 1995, the Commission issued a Green Paper on the role of the Union in the field of tourism. The priority in those years was on the employment htmlects of tourism. A High Level Group on Tourism and Employment was set up and held a conference in November 1997 and a Communication "Enhancing tourism's potential for employment" identified measures to implement this strategy.

In November 2001, the Commission published a new Communication "Working together for the future of European Tourism", highlighting the need to enhance co-operation and involvement of all stakeholders.

Issues:
With its Communication "Basic orientations for the sustainability of European tourism", published on 21 November 2003, the Commission aims to enhance the economic, social and environmental sustainability of European tourism. It calls for closer co-operation between all stakeholders in the sector, including regional and local authorities. It wants to establish a Tourism Sustainability Group, which will set out guidelines for the sector and prepare a detailed framework for action. This group will use the open method of co-ordination.

Next Step:
The Commission intends to present some measures to be taken in 2004. It will report back to the institutions on the progress of implementation of these measures in the autumn of 2005.

Official documents:
DG Enterprise: Communication "Basic orientations for the sustainability of European tourism", COM(2003) 716 final (21 Nov. 2003)
Commission: Press release "Tourism: Commission proposes joint efforts to increase sustainability" (21 Nov. 2003)
DG Enterprise: Tourism and the European Union

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The role of standards in consumer confidence

On 09 September 2003 the ISO/COPOLCO (ISO Committee on consumer policy) workshop took place at Bangkok, Thailand.

More information can be taken from ISO Bulletin No 11 November 2003

EOTC especially refers to the subject "standards and the law - a couple that need each other" being treated by Mrs. Benedicte Federspiel, President of ANEC (European Association for the Coordination of Consumer Representation in Standardization). Legislation is a contributing factor to balance the market and give confidence to the consumer - in relevant instances underpinned by standards, said Mrs. B. Federspiel, talking on "standards as an extension of the law - how standards and law interact". Furthermore, they were sometimes co-opted by national laws and "taken on board" to become part of national legislation. In some parts of the world there is legislation - but not in all - and while standards cannot replace legislation, they can often be a highly useful adjunct to it.

EOTC also refers to the very recent speech about "Conformity-Consonance-Consensus - a WOTC concept" which was held along EOTC's conference on "a critical review of the New Approach" on 03/04 December in Brussels, a speech which dealed precisely with the topic raised by Mrs. B. Federspiel, President of ANEC.

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Sustainability and EMAS among Retailers and Wholesalers

EuroCommerce has compiled a survey on EMAS validated commercial sites and sustainability. As all wholesalers are striving for an environmental friendly image, encouragement for suppliers is a priority to take over an EMS. Three out of four attribute the improvement of their image as the main goal to go for, with more than half of the interviewees admitting an increase in their capacity to compete.

Contact: Christine Marlet

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Key Strategic Issues for ILAC in 2003 and 2004

Over the past two years ILAC has been progressing towards incorporation and this goal was finally achieved on 20 January 2003. In support of this, a comprehensive revision of ILAC's Articles and Bylaws was undertaken. From a strategic perspective, another crucial document being developed is the ILAC Strategic and Business Plan, which is now nearing completion, this happening after an extensive process of consultation and review. The latest draft of the plan was presented to the membership at an ILAC open forum in Bratislava on September 2003.

Read more about this and also about joint ILAC/IAF Activities in the ilac news, Issue 24, October 2003

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Key Statistics on the 10 future members

There is a marvelous presentation of the future 10 member states to find in the EU ENLARGEMENT SPECIAL of Enterprise Europe 13, October-December 2003

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The Environmental liability: debate on mandatory financial security is not closed

On 26 September 2003, the Commission published its stance on the Council's common position starting the process for the second reading in the Parliament on the draft directive on environmental liability.

On 18 September 2003, the Council formally adopted its common position on the draft directive on environmental liability based on the political agreement reached in June 2003. (See EurActiv, 16 June 2003).
The Commission, in a Communication dated 26 September, considers that the Council's common position aims to simplify the procedures and clarify the concepts necessary to the good functioning of an environmental liability regime and will ease the implementation of the directive.
The point on which the Common Position differs the most from the Commission proposal concerns the issue of "orphan damage", that is those cases in which no operator will remedy environmental damage. The Commission proposal required Member States to find alternative sources of financing; the Common Position now leaves full discretion to Member States to decide to act or not.
As regards the hotly debated issue of financial security, the Council agreed that the Commission may submit proposals for mandatory financial security based on its assessment of the implementation of the directive. The Commission is requested to produce a report on the effectiveness of the Directive in terms of actual remediation of environmental damages, on the availability at reasonable costs and on conditions of insurance.

Official document:
EU Business associations (UNICE, UEAPME, Eurochambres...): Common Statement on the proposal for a Directive on Environmental Liability (February 2003)

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Nanoparticle safety concerns will be focus of UK nanotechnology study

In a first progress report, the UK's Royal Society has laid down the priorities for its study on nanotechnology.
Nanotechnology is high up on the EU's research agenda, granting this area a specific budget of over 700 million euro in its 6th Framework Program for Research. However, there is no debate yet at EU level on the opportunities and dangers of this new technology, nor on the societal and environmental implications.
In the UK, the Royal Society and the Royal Academy of Engineering were commissioned to conduct a study into the benefits and problems of nanotechnology and nanoscience by the UK government in July 2003 (see EurActiv 31 July 2003).

Issues:
An first progress report on the study was published on 30 September. It laid out the form that the study will take, following a stakeholder consultation process with over 80 parties from academia, NGOs and industry to identify areas on which the study should focus.
A majority of respondents addressing health and safety issues highlighted nanoparticles as a major area of concern. Many stakeholders also emphasized the importance of establishing a set of scientific facts on nanotechnology as a basis for a public debate in order to prevent potentially far-fetched "science fiction" scenarios.
Next Steps:
The first workshop with scientists and engineers working in nanotechnology will take place on 30 September to establish the status quo and future perspectives of research in this area. Other elements of the study will include a workshop with NGOs in October, as well as a public consultation and further meetings with health, safety and environmental experts and regulators.

Links/Official Documents:
Commission: Nanotechnologies and Nanosciences
Cordis: Nanotechnology
NanoForum: European Nanotechnology Gateway
EuroNanoForum 2003 (Trieste Conference 9-12 December 2003)

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Commission to draft Ukraine 'action plan'

The Commission said on 1 October it would soon publish an "action plan" aimed at strengthening economic ties between the EU and Ukraine.

The "action plan", planned to be released in the first half of 2004, will identify areas for improved cooperation in order to promote Ukraine's full integration in the EU's economic structures, Enlargement Commissioner Günter Verheugen said. He said this "very ambitious" project would send "a very clear signal that Ukraine and the EU want to share not only values and policy objectives but also an economic potential."
Meanwhile, Ukrainian President Leonid Kuchma was quoted as saying on 30 September that, "How much longer can we be kept on the doorstep [of the EU]_ Ukraine is tired of this waiting." Mr. Kuchma added: "None of the [EU] officials have said Ukraine is wanted in the EU." At the same time, Mr. Kuchma said Ukraine was not ready to enter the EU. "If I was asked to enter the EU, I would refuse. Who in Europe needs Ukrainian planes, who in Europe needs Ukrainian machinery, who in Europe needs the Ukrainian coal industry_ We would not be able to fight the competition for even a month", Mr. Kuchma said. He added, however, that Ukraine should "keep face".

Links:
Commission: The EU's relations with Ukraine
Press articles: Interfax, Russia Journal, MSNBC.

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26th ISO General Assembly in Buenos Aires

ISO - the International Organization for Standardization - celebrated this year its 26th General Assembly. For the first time in history, this event took place in Latin America, precisely in Buenos Aires, Argentina, from September 15 to September 20.

IRAM, the Argentinean Standardization Institute, the only ISO representative in Argentina, was responsible for the organization of this Assembly in coordination with the ISO General Secretariat in Geneva.

At present, ISO has 148 country members and a great number of International liaison organizations. A total of about 350 delegates was realized, many of them bringing accompanying people.

On Tuesday night, 16 September the Open Ceremony was held at the Opera Theatre of Buenos Aires City, the renowned Teatro Colón, with the presence of all the delegations and high-range authorities.

Wednesday, 17 and Friday, 19 September was dedicated to the Assembly itself, in which the results achieved by ISO in the past, the new undertakings and the advanced degree of the International Survey for the preparation of the ISO 2005-2020 Strategy Plan were submitted..

On Thursday, 18 September the Seminar (Open Session) about Global Trade Facilitation - Ensuring effective links among International Standards, Technical Rules and Conformity Assessment, was hold.

The Seminar was scheduled to begin with a dissertation by a WTO's representative, followed by presentations on experiences in different regions of the world: Mercosur, Asia-Pacific, European Union.

The morning session was finished with a round table attended by top company managers from Argentina, the United Stated and Europe.

In the evening, the attendees had the opportunity to know the vision and the contributions of ISO, IEC - International Electrotechnical Commission - and ITU - International Communication Union - in a debate hold by their respective General Secretaries.

The ISO Council and its TMB (Technical Management Board) were meeting in parallel with the Assembly.

For IRAM and for Argentina, this was representing a unique occasion for bringing together the standardization bodies from all over the world, the top managers of the international organizations, as well as the representatives of regional trade blocks related to standardization and conformity assessment.

More information can be taken from ISO Bulletin No 11 November 2003

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Conformityassessment.org: New "Equipment suppliers" and "Training & consulting" categories launched.

Conformityassessment.org, the web-portal on conformity assessment , has just launched 2 new categories dedicated
to the topics of "Equipment suppliers" and "Training & consulting".

The new category "Equipment suppliers" features 35 websites dealing specifically with suppliers of Scientific Instruments,
software, materials, ...

The new category "Training & consulting" feathers 114 websites dealing specifically with providers of training services,
consultants, programs, education, ...

If your organization is involved in any of these activities, we invite you to submit your website to our portal via the following link:
http://www.conformityassessment.org#. Please allow several days before checking if your website is online due
to the fact that all of the websites submitted must be evaluated and approved by the EOTC portal editorial team.

The launch of these 2 new categories is a unique opportunity for you to promote your organizations services via the
ConformityAssessment.org's numerous sponsorship options which are designed to boost your organizations image and business
opportunities.

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Technical assistance to near neighbours

Since 1989 (and 1990 considering EOTC), the European Commission has financed technical assistance to help future EU members set up the administrative machinery that ensures goods traded across the Union are up to standard. As with conformity assessment agreements (PECA's, Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products), this can also be provided to near neighbours who do not plan to join the EU.

To receive more information on this item please contact
at EOTC
at EC

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>> Call for expert in the field of Internal Market aquis /Turkey<<

EOTC is looking for experts that would be called for a mission of 5-10 days in Turkey.

The overall objective:
The general objective of the assignment is to contribute to the enforcement of the EU acquis communautaire in the area of internal market, specifically focusing on conformity assessment and market surveillance by means of upgrading the required laboratory infrastructure.

The specific objectives:
The specific objective will be to identify and elaborate the needs for laboratory infrastructure (equipment and human resources) for the enforcement of technical legislation related to conformity assessment and market surveillance New Approach and Old Approach directives).

We are currently looking for the following experts:

• 1 short-term expert in Civil explosives (5-10 MDs)
• 1 short-term expert in New hot boilers (5-10 MDs)
• 1 short-term expert in Pharmaceuticals (for human use) (5-10 MDs)
• 1 short-term expert in Pharmaceuticals (for veterinary use) (5-10 MDs)
• 1 short-term expert in Textiles (5-10 MDs)
• 1 short-term expert in Fertilizers (5-10 MDs)
• 1 short-term expert in Protective equipment used in explosive environment (5-10 MDs)
• 1 short-term expert in Non-automatic weighing instruments (5-10 MDs)
• 1 short-term expert in Agricultural and forestry tractors (5-10 MDs)

Expert profile:

• Broad experience in conformity assessment and market surveillance structures in Europe;
• Good general knowledge of EU legislation regarding the Directive you apply for;
• Substantial knowledge on laboratory techniques and latest laboratory technology and equipment in their sector you apply for;
• Proven knowledge of the tests necessary for the delivery of technical approvals;
• Knowledge of /experience in practical training of laboratory personnel;
• Good drafting and communication skills;
• Fluent level of written and spoken English.

Project period:
The project is expected to start at early January 2004 and finish by the end of May 2004.
Should you be interested in co-operating with EOTC for this project, please send your CV in EC-format at: or contact us by phone +32-2-505.30.66. Do not forget to mention the code "EoI003 assessment of sector xxx" in the title of your email.

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Call for Speaker - Workshop on WEEE

EOTC is looking for a European expert with experience in compliance with the Waste from Electrical and Electronic Equipment (WEEE Directive) in order to speak at a joint workshop on WEEE Directive being organized in Bangkok by the EC Delegation in Bangkok and the Thailand Industrial Standards Institute (TISI).

Due to the very limited budget, only travel expenses and per diem (max. 1500 Euro) will be reimbursed. It will be a 1-day or 1.5-day workshop. However, this upcoming workshop will be a not-to-be-missed event for all relevant stakeholders. For the European expert, it will be an invaluable occasion to network with these institutions that will submit technical assistance proposals to EC in 2004. They will need European experts. So the expert who would come will be almost ensured to get projects in 2004 and after on the WEEE Directive in Thailand.

Should you be interested in co-operating with EOTC for this project, please send your CV in EC-format at: or contact us by phone +32-2-505.30.65. Do not forget to mention 'Thailand WEEE Directive' in the title of your email.

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Experts for EOTC Training Seminars

EOTC, the European Organization for Conformity Assessment, is seeking experts for EOTC's Training seminars (2 to 4 training days):

• Should you want to apply for one of the available positions or should you need more information on trainings, please feel free to send and email to Ms. Estelle Desmit at:

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