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ISO F ocus
The Magazine of the International Organization for Standardization

Volume 1, No. 8, September 2004, ISSN 1729-8709
Food and beverage

The flavour of Nestl Efficacy in dental practice
Contents
1 2 3 4
ISO Focus is published 11 times
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Comment Prof. Andras Salg, Chair ISO/TC 34, Food products The fruit of cooperation : better, safer food World Scene
Highlights of events from around the world
ISO Scene
Highlights of news and developments from ISO members
Guest View
Dr. Werner Bauer, Executive Vice President, Technical, Production, Environment, Research and Development, Nestl
Main Focus
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Food and beverage

Ensuring integrity of the food supply chain Tracking food paths Detection of genetically modified organisms and derived foods Microbiological analysis of foods and animal feeding stuffs Cooperation works: uniting strengths for better standards Steamed or boiled ? Promoting the production and trade of rice Tracking fruit and vegetable products quality and safety Fresh, dry and dried fruits and vegetables Fats and oils for healthy living Comparing coffees Brewing the best tea standards
34 Developments and Initiatives

Standards of practice in dentistry A world of applications for gas calibration
ISSN 1729-8709 Printed in Switzerland Cover photo : PRISMA-Dia Agentur. Oil on canvas by Erik Slutsky, 2000
ISO Focus September 2004
39 New this month 41 Coming up
Comment
n recent years, multiple alimentary problems concerning human health (mad cow disease, Salmonella poisoning), the threat of starvation in certain areas, the worries connected with junk food and obesity, and the moral challenges involved in Genetically Modified Organisms, have contributed to bringing the issue of food safety into the limelight.
The fruit of cooperation : better, safer food I

Codex Alimentarius Commission is an intergovernmental body comprised of members that have the power to regulate the implementation of food standards and guides in their country. ISO, as a producer of voluntary International Standards, does not have such regulatory powers. However
ISO/TC 34, Food products, with its 13 subcommittees, has been working towards the goal of improving food quality and safety for several decades, and its portfolio of standards, adopted by many industries worldwide, has proved most useful in setting test methods, defining product specifications and providing the technical standards to ensure that food products conform to acceptable levels for human and animal health. Furthermore, in addition to the interest generated in the new horizontal standard now under development, ISO 22000, Food safety management systems, the work of the committee is expanding to tackle issues such traceability and detecting the use of GMOs. In todays global market, to obtain optimal efficiency, it has become imperative to work not in isolation but in cooperation with the international agencies involved in this area. There is nothing new in this : ISO has had a long and harmonious relationship with Codex Alimentarius, a joint Food Standards Programme of the FAO (UN Food and Agriculture Organization) and WHO, aimed at protecting the health of consumers, ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and nongovernmental organizations.
To obtain optimal efficiency, it has become imperative to work not in isolation but in cooperation with the international agencies involved
in the framework of good regulatory practice, as promoted at international and regional levels, International Standards and Guides are often considered most useful by regulators as effective and efficient tools to achieve important regulatory mandates, manage risk and address market failure. Using International Standards may help a regulator to achieve aims in public health and safety at less cost to manufacturers, consumers and the taxpayer. Using International Standards also assists countries to meet their WTO, TBT and SPS Agreement obligations. It had became clear that it would be useful to reinforce not only the harmonization of work between ISO and Codex Alimentarius and to deepen the collaboration but, more specifically, to inform Codex Alimentarius members about ISO activities and to spread the word of what ISO had done, was doing and was planning to do in the food product area. Thus it was particularly appreciated that, at the recent Codex Alimentarius meeting in Geneva in June
2004, ISO was invited to address the delegates and give an overview of ISO/ TC 34 work, of ISOs activities and functions, including conformity assessment, that were of direct relevance to Codex members, and to look at where there could be synergies between the work of the two organizations. The questions afterwards suggested that this exchange had been a most fruitful and useful exercise, and laid the ground for yet deeper cooperation. We are at present examining in detail areas of cooperation that could be submitted to the Codex Alimentarius Commission to enhance the mutual coordination of work and elimination of any duplication of efforts. We are convinced that to reduce the number of food-borne illnesses and to avoid food scares, Codex Alimentarius and ISO need to cooperate yet more closely in support of each others work.
Prof. Andrs Salg Chair ISO/TC 34, Food products
World Scene
WSIS agrees on roadmap to Tunis Summit
Some 425 representatives from government, international organizations, members of civil society and the private sector attended the first preparatory meeting of the World Summit on Information Society (WSIS) in Hammamet, Tunisia, to discuss the roadmap for the Summits second phase in Tunis.
WTO examines conformity assessment

The World Trade Organizations Technical Barriers to Trade (WTO TBT) Committee held a special meeting on conformity assessment on June 29, in Geneva, Switzerland. The meeting, which was intended to give Members an opportunity to have a more focused discussion on issues of conformity assessment, highlighting suppliers declaration of conformity (SDoC), accreditation and various other aspects concerning Members approach to conformity assessment. ISO attended the meeting and, in the course of the discussions, highlighted the relevance of the CASCO toolbox for conformity assessment practices and recognition as well as the usefulness of ISO/IEC 17011:2004, Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies, and ISO/IEC FDIS 17050, Conformity assessment Suppliers declaration of conformity Part 1: General requirements and Part 2: Supporting documentation. The WTO TBT Committee, at the end of the Third Triennial Review in November 2003, agreed on a work programme on conformity assessment. As part of this work programme, the Committee will organize in the future two workshops; the first on SDoC and the second on different approaches to conformity assessment. ISO has been asked to attend the events and give presentations on achievements and current developments in ISO on these issues. For more information: www.wto.org
Global Compact Summit fights corruption

More than 400 corporate executives, government officials and civil society leaders assembled at the UN headquarters on 24 June 2004 to take stock of the Global Compact and chart its future course. Introduced by the SecretaryGeneral Kofi Annan in 1999 as an international initiative to advance responsible corporate citizenship, and launched operationally the following year, the Global Compact challenges world business leaders to embrace and enact the benefits of global economic development through voluntary corporate policies and actions. Currently, the Compact includes nearly 1 500 firms in some 70 countries. The one-day Summit saw a range of specific pledges being made, including defending human rights in conflict zones, ensuring decent working conditions and implementing no-bribe policies. SecretaryGeneral Kofi Annan, who chaired the meeting, announced the adoption of a tenth Global Compact principle against corruption in all its forms. Twenty major investment companies endorsed a Global Compact report and initiative on connecting financial markets to environmental, social and governance criteria, and agreed on steps to bring other actors in the financial world into agreement on how these factors would become standard components in the analysis of corporate performance and investment decision-making. The UN Global Compact was an important contributor to the ISO Strategic Advisory Group on Social Responsibility (SR) and to ISOs international conference on the subject held in June 2004. For more information: www.globalcompact.org
Focus on Russias oil and gas sector

Some 100 experts from the oil and gas industry gathered in Moscow, Russia to discuss standardization and certification for the sector in Russia and the Commonwealth of Independent States. International Association of Oil and Gas Producers (OGP) Standards Committee Chair, Alf Reidar Johansen, and Technical Manager Don Smith spoke on the theme of Moving towards global standards for the oil and gas industry and encouraged the sector to make use of the new set of International Standards that is emerging from ISO and IEC (International Electrotechnical Commission). According to Messrs. Johansen and Smith, the OGP supports the development and use of ISO and IEC standards, which should be promoted and used without modification, wherever possible. International Standards developed by ISO and IEC reduce the need for company specifications and national regulations and facilitate trade across national borders, while achieving higher levels of safety through better design. OGP encompasses most of the worlds leading publicly-traded, private and state-owned oil and gas companies, associations and major upstream service companies. The ISO/OGP collaboration serves to help identify the standardization needs of the oil and gas industry and to help ISO gauge current and future market sector trends and conditions. For more information: www.ogp.org.uk
The focus of the preparatory process to the Tunis phase will be two-pronged : 1) provide solutions on how to implement and follow up the Geneva decisions (Declaration of Principles and Plan of Action) by stakeholders at national, regional and international levels with particular attention to challenges facing the least developed countries, and 2) complete the unfinished business in Geneva on Internet Governance and Financing. The role of International Standards in contributing to the development of a global Information Society was acknowledged at the first phase of the World Summit on the Information Society held in Geneva, Switzerland, in December 2003. The second phase of the Summit, which takes place in Tunis, Tunisia, from 16 to 18 November 2005, will measure progress to the ambitious goals set in Geneva. Hard work now lies ahead before the meeting to show that development of the Information Society is on the right path. For more information: www.itu.int/wsis/
ISO Scene
ISOs high-level advisory group on security invites stakeholder input
ISOs high-level advisory group on security held its first meeting on 1 and 2 June 2004 in New York, USA, when it reviewed a draft inventory of relevant ISO activities and established a framework for classifying existing standards and ongoing work. The group agreed to conduct a stakeholder outreach programme to invite suggestions for additional standards that may be needed, as well as to carry out in-depth studies in the areas of the built environment, mass transportation, the oil and gas industry, and freight containers. Concerned ISO committees are being solicited over the next few months to assist with the classification of their standards and current projects. The group is expected to submit its final report in time for ISOs Technical Management Board (TMB) meeting in February 2005. Global Economy , and highlighted the growing use of ISO standards by public authorities to express requirements related to the assessment of compliance of products and equipment to regulations. He underlined the relevance of the CASCO toolbox , particularly its role in helping to ensure that conformity is assessed with methods and competence which may be appraised and accepted internationally. The seminar was organized by the Institute of Standards and Industrial Research of Iran (ISIRI) and Iranian Society for Quality (ISQ). Mr. Bryden also held meetings with Dr. Jahangiri, Irans Minister of Industries and Mines and Dr. Tofigh, Deputy Minister of Industries and Mines and President of ISIRI. He encouraged the public authorities and all other economic actors to increase their participation in international standardization which supported of their countrys economic competitiveness and social development. President of Ukraine Leonid Kuchna (2nd from right) and other Ukrainian officials met with ISO Secretary-General Alan Bryden. Ukrainian products on the way to the WTO and the EU . He met the President of Ukraine, Leonid Kuchma, and addressed the strategic importance of International Standards as a tool for accelerating Ukraines social and economic development. President Kuchma highlighted the steady development of the Ukrainian economy as a result of the economic reforms, which have been implemented in the country recently, and stressed the importance of enhancing Ukraines cooperation with ISO that could contribute to expanding international trade and transferring advanced technologies and good management practices. Alan Bryden also met Nicolai Azarov, Vice Prime Minister of Ukraine, and Borys Paton, President of the National Academy of Sciences of Ukraine. Mr. Bryden also held meetings with Leonid Shkolnyk, Head of DSSU (State Committee of Ukraine on Technical Regulation and Consumer Policy), ISO member for the country. Regarding plans to help developing countries, the ISO President said that ISO was carrying out specific actions and formulating further plans for assisting developing countries to increase awareness of International Standards and conformity assessment systems and to develop their standardization capacity, including by increased use of information and communication technologies.
Quality management for the automotive industry
Director-General of INORPI Saloua Ghedamsi (far right) with INORPIs Training Officer Ben Farhart (far left) and seminar instructors Frdric Paris and Raji Zouari. The benefits of implementing a quality management system in the automotive sector was the subject of a seminar organized by the ISO Programme for Development and Training in Tunis, Tunisia on 28-29 June 2004. Some 30 quality practitioners representing Tunisian suppliers of automotive components to the major car manufacturers in Europe, USA and Japan attended the two-day seminar on ISO/TS 16949:2002, which specifies quality system requirements for suppliers in this sector. The seminar was designed to train quality practitioners on the implementation of ISO/TS 16949:2002 which defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products. The seminar was hosted by INORPI, Institut national de la normalisation et de la proprit industrielle, ISO member for Tunisia. For more information contact : Virginia Gomez at gomez@iso.org
Seminar in Iran on conformity assessment and product certification
ISO President underlines diversity of ISO standards

ISO President Oliver Smoot underlined the scope and breadth of ISOs standards on the occasion of visits to ISO members in Turkey, Costa Rica and Mexico. Alan Bryden with Dr. Jahangiri, Iranian Minister of Industries and Mines (centre) and Dr. Ali A. Tofigh, ISIRI President and Deputy Minister of Industries and Mines (far right). Some 650 participants from various sectors of industry attended a recently concluded seminar on Conformity Assessment and Product Certification held in May 2004 in Tehran, Iran. ISO Secretary-General Alan Bryden made a speech on the theme of Certification and Conformity Assessment in the He highlighted ISOs broad portfolio of standards for products, services, materials, processes, information technology, conformity assessment, quality and the environment. ISOs work is increasing in scope to address new service sectors including financial services security, food safety and quality, intelligent transport systems, new technologies and good management practice to constitute a complete offering in support of sustainable development.
ISO Secretary-General meets with President of Ukraine

ISO Secretary-General Alan Bryden visited Ukraine from 14 to 16 June and had a series of meetings and presentations to Public Authorities and stakeholders. He addressed an International Conference on Provision of competitiveness of
Guest View
Werner Bauer
r. Werner Bauer is Executive Vice President, Technical, Production, Environment, Research and Development at Nestl. After completing his education in Chemical Engineering with a PhD from the University of ErlangenNrnberg, Mr. Werner Bauer began his career as a Professor at the Universities of Hamburg and Munich. Between 1986 and 1990 he was Head of the Frauenhofer-Institute for Food Technology. His interest in nutrition led him to accept the position of Head of the Nestl Research Centre in 1990, a position he held for 7 years. Mr. Bauer was then promoted to Head of Research and Development at Nestl Headquarters in Vevey. He moved to take over Technical Management of Nestl South Africa and subsequently the management of Nestl Southern and Eastern region. Since May 1, 2002 he has been in charge of Corporate Technical, Production, Environment and R&D. In this position and amongst his other responsibilities, he oversees the numerous factories and product development centres of the Nestl Group.
suggest and we make it easy for them by providing them with an address, a telephone number or a Web site on each of our products. ISO Focus : A number of Nestl employees provide expert advice to the work of ISO technical committees. How important is it for Nestl to contribute to the development of International Standards ? Werner Bauer : International Standards are important for a good and efficient business environment. When applied to entire fields of activity, they contribute very effectively to enhance fair competition and in many cases to raise the overall level of quality. On the other hand, such International Standards, if developed only by people outside the industry, might either impose too many restrictions on the companys ability to develop and expand and could, in some cases, impose excessive costs. We therefore believe that by providing expert advice to ISO technical committees and participating in the establishment of rules, the major companies, knowing best the prevailing conditions in their industry, render an important service both to ISO and to themselves. ISO Focus : To what extent does Nestl use an environmental management system based on ISO 14001 ? How do you think acting sustainably positively affects the bottom line of companies ? Werner Bauer : Nestl, having actively contributed to the establishment of ISO 14001, has been one of the first companies to implement a Group-wide environmental management system, based on the principles of ISO 14001, even before its official publication. Today, all our factories worldwide use the
There is not one Nescaf but 200 and this explains why very many consumers perceive Nestl as a trusted local supplier of high quality food and beverage products.
cultural and ethnic context, which a global marketer has to understand and respect. Nestl was founded by a German (Henri Nestl) in Switzerland, a small country, and expanding meant going abroad. This could only be done by relying on the experience and knowledge of local staff and by adapting the products to local tastes, traditions and ways of doing business. This is why there is not one Nescaf but 200 and this explains why very many consumers perceive Nestl as a trusted local supplier of high quality food and beverage products. Maintaining that trust also means listening to consumers : today we have some 80 consumer services worldwide, dealing with about 7 million spontaneous contacts per year. We encourage our consumers to comment, criticize and
ISO Focus : As todays largest food and beverage company in the world, Nestl produces a wide range of products from meals to chocolate, and from mineral water to coffee. How does Nestl manage to maintain a worldwide consumer base when traditions and tastes vary from one country to the next? What is the key ingredient to its success? Werner Bauer : There is no single ingredient to our success but many! The key is certainly our conviction that there is no such thing as a global consumer, but that consumers everywhere make their decisions in a given
Photo : A. Diglas
tally responsible company. This is and undoubtedly will be an asset for our company, our brands, our staff and our customers. ISO Focus : ISO is currently in the process of developing a Food safety management systems standard (ISO 22000) for all organizations, which produce, manufacture, handle or supply food. What benefit do you see here in terms of safety, communication and trade? Werner Bauer : We believe that ISO 22000 could contribute to reducing the number of individual, non-official food safety standards currently appearing on the market. Their variety and ever-increasing number is creating complexity and confusion in the food chain, thus raising costs without bringing consistent reliability. Certificates delivered on the basis of an internationally agreed standard would improve the relationship between suppliers and customers throughout the food chain. Customers could concentrate their efforts on their specific requirements which may not be covered by the standard, and suppliers would have better harmonized requirements to follow, which should limit and rationalize the number and
Nestl Environmental Management System (internally known as NEMS) to improve constantly on their environmental performance. External bodies have certified some 30 of our sites worldwide according to ISO 14001, but we also verify compliance with our NEMS through internal procedures. As all have been able to see the effect on our eco efficiency, this system has been embraced by employees at all levels. But we have gone further and have invested significantly way over what is legally required into environmental technologies. We are fully aware that such investments increase our costs compared to our competitors and we know that we might, therefore, lose some market share in the short term, especially in developing countries. But Nestl, a company almost 140 years old, has never been too keen on short term views and we are convinced that in the long run, our policy will enhance our reputation as a socially and environmen-
The Nestl Research Center near Lausanne, Switzerland, provides the basic knowledge in food science which is applied in the whole Nestl Group. The Nestl plant science unit in Tours, France, studies plant species such as coffee, cocoa and chicory.
Photo : Nesstl Research Center
Photo : A. Diglas
Guest View
scope of the assessments requested by their customers. If ISO 22000 fulfils our expectations, Nestl would integrate such a standard in its Supplier Management System. As part of our supplier and co-manufacturer requirements, it should simplify our relationship with them and it should allow us to reallocate some of the assessment and monitoring resources from the scope covered by ISO 22000 to more Nestl-specific expectations. All partners in the food chain could derive benefit from the implementation of ISO 22000, no matter the size or activity of the certified operation or which kind of product is considered. Therefore, we are actively collaborating with our partners to ensure that this standard is reliable and takes into account all common food safety requirements. We are especially keen to obtain an action-oriented tool without useless administrative or paperwork requirements. Moreover, it will be essential
Photo : A. Diglas
to prevent misleading communication about the certificates ; it is the food safety management system that will be certified by a third party and not the safety of the product.
Nestl, a company almost 140 years old, has never been too keen on short term views
ISO Focus : At a recently concluded ISO conference on social responsibility, Mr. Khaled Abu Osbeh, representative of the United Nations Global Compact, said that ISO can be a key force in helping to realize the Global Compact Offices hope that CSR initiatives will ultimately converge. What are your thoughts on the issue?
Werner Bauer : A clearer definition of some of the terms used in the Global Compact might well benefit the application of these principles and secure a broader following. But one should keep in mind that the Global Compact covers a very broad range of situations and that its practical application needs to take into account diverse starting points as well as social and economic differences and priorities. It is therefore vital to avoid simply designing rigid checklists that might well be irrelevant to some industries or regions, but that would allow self-appointed critics of corporations to launch their campaigns based on their own interpretation of some specific point. The Global Compact is a means for corporations to freely and publicly express their commitment to social responsibility. Turning it into an enforceable body of law, over and beyond national legislation and international conventions, raises entirely different issues.
Nestl International Headquarters in Vevey, Switzerland.
ISO Focus July-August 2004
Photo : Nestl
Ensuring integrity of the food supply chain

by Jacob Frgemand, convenor and project leader of ISO/TC 34, Food products, WG 8, Food safety management systems, and Dorte Jespersen, secretary of the WG, Danish Standards Association (DS)
ailures in food supply can be dangerous and cost plenty. ISO 22000 for food safety management systems is intended to provide security by ensuring that there are no weak links in the food supply chain. ISO/22000, Food safety management systems Requirements throughout the food chain, is currently at the stage of Draft International Standard (DIS). It is expected to be available as an International Standard in 2005. The standard can be applied on its own, or in combination with other management system standards
Photo : ISO
such as ISO 9001:2000, with or without independent (third party) certification of conformity.
What is the standard about ?

ISO 22000 specifies requirements for a food safety management system in the food chain where an organization needs to demonstrate its ability to control food safety hazards in order to consistently provide safe end products that meet both the
Main Focus
requirements agreed with the customer and those of applicable food safety regulations, and aims to enhance customer satisfaction through the effective control of food safety hazards, including processes for updating the system.
Who are the intended users?

ISO 22000 may apply to all types of organizations within the food chain ranging from feed producers, primary producers through food manufacturers, transport and storage operators and subcontractors to retail and food service outlets together with inter-related organizations such as producers of equipment, packaging material, cleaning agents, additives and ingredients. Food safety is related to the presence of and levels of food-borne hazards in food at the point of consumption (intake by the consumer). As food safety hazards may be introduced at any stage of the food chain, adequate control throughout the food chain is essential. Thus, food safety is a joint responsibility that is principally assured through the combined efforts of all the parties participating in the food chain.
Photos : ISO
ISO 22000 specifies requirements for a food safety management system.

The number of national standards has led to confusion. Consequently, there is a need to harmonize the national standards on an international level. This was the reason why the Danish Standards Association (DS www.ds.dk) submitted a new work item proposal for a food safety management systems standard to the secretariat of ISO/TC 34, Food products, in 2001.
Figure 1 : Example for communication along the food chain.
What does it cover ?

The standard will combine generally recognized key elements to ensure food safety along the food chain, as follows : Interactive communication Communication along the food chain (see Figure 1) is essential to ensure that all relevant food safety hazards are identified and adequately controlled at each step within the food chain. This implies communication of the needs of the organization to both organizations upstream in the food chain and organizations downstream in the food chain.
Producers of pesticides, fertilizers, and veterinary drugs Food chain for the production of ingredients and additives Transport and storage operators Producers of equipment Producers of cleaning agents Producers of packaging materials
Crop producers
Feed producers
Why is it important now ?

Organizations that produce, manufacture, handle or supply food recognize the increasing requirement of customers for them to demonstrate and provide adequate evidence of their ability to identify and control food safety hazards and the many conditions impacting food safety. ISO 9001:2000 on quality management does not deal specifically with food safety. As a result, many countries, such as Denmark, the Netherlands, Ireland and Australia, amongst others, developed voluntary national standards and other documents specifying auditable requirements for food safety management systems.
Primary food producers Regulatory authorities
Food processors
2 nd food processors
Wholesalers Service providers Retailers

Arrows indicate interactive communication.
Other supplying food chains
Consumer
Communication with customers and suppliers, based on the information generated through systematic hazard analysis, will also assist in substantiating customer and supplier requirements with regard to their feasibility, need, and impact on the end product. The standard will require that such communication is planned and maintained. System management The most effective food safety systems are designed, operated and updated within the framework of a structured management system and incorporated into the overall management activities of the organization. This provides maximum benefit for the organization and interested parties. ISO 22000 will take due consideration of the requirements of ISO 9001:2000 in order to enhance compatibility of the two standards and to allow their joint or integrated implementation. Hazard control Effective systems that are capable of controlling food safety hazards to acceptable levels in end products that are delivered to the next link in the food chain require the balanced integration of prerequisite programmes 1) and a detailed HACCP (Hazard Analysis and Critical Control Point) plan. ISO 22000 will dynamically combine the HACCP principles and application steps with prerequisite programmes, using the hazard analysis to determine the strategy to be used to ensure hazard control by combining the prerequisite programmes and the HACCP plan.
ISO 22000 may apply to all types of organizations within the food chain.
The standard will further clarify the concept of prerequisite programmes. These are divided into two subcategories: infrastructure and maintenance programmes and operational prerequisite programmes. Infrastructure and maintenance programmes are used to address basic requirements of food hygiene and accepted good practice of a more permanent nature, whereas operational prerequisite programmes are used to
control or reduce the impact of identified food safety hazards in the product or the processing environment. The HACCP plan is used to manage the critical control points determined to eliminate, prevent or reduce specified food safety hazards from the product, as determined during hazard analysis.
What are the benefits for users ?

The benefits for organizations implementing the standard include among others the following : organized and targeted communication among trade partners ; resource optimization (internally and along the food chain) ; improved documentation ;
1) A prerequiste programme is a specified procedure(s) or instruction(s), specific to the nature and size of the operation, that enhances and/or maintains operational conditions to enable more effective control of food safety hazards and/or that controls the likelihood of introducing food safety hazards and their contamination of or proliferation in the product(s) and product processing environment.
About the authors

Jacob Frgemand, an food engineer, graduated from Aalborg Technical University, Denmark. Since 1994, he has worked with Bureau Veritas BVQI Denmark as lead auditor ISO 9000 and HACCP (DS 3027) and hygiene inspector on BRC. In 1996, he became Food sector manager, and in 2002 sales director BVQI Denmark. He is responsible for Bureau Veritas BVQi activities worldwide on BRC inspection and HACCP certification on DS 3027. He chairs the Danish food safety standardization group and, in 2001, initiated the launch of ISO/TC 34, Working Group 8, Food safety management systems to develop ISO 22000, the working group he chairs. Dorte Jespersen, a chemical engineer, graduated from the Technical University of Denmark in 1992. Since 1994, she has worked with the Danish Standards Association (DS) as project manager. She is secretary of a number of national standardization committees in the areas of food, laboratory equipment and medical devices. Furthermore, she is the secretary of ISO/TC 34, Working Group 8, Food safety management systems.
Main Focus
better planning, less post-process verification ; more efficient and dynamic food safety hazard control ; all control measures subjected to hazard analysis ; systematic management of prerequisite programmes ; widely applicable because it is focused on end results ; valid basis for taking decisions ; increased due diligence ; control focused on what is necessary ; and saves resources by reducing overlapping system audits. fills a gap between ISO 9001:2000 and HACCP ; contributes to a better understanding and further development of Codex HACCP ; auditable standard requirements ; with clear
system approach, rather than product approach ; and suitable for regulators.
Status of the work

The Draft International Standard ISO/DIS 22000 was issued on 3 June 2004. The deadline for comments is 3 November 2004. ISO 22000 is expected to be available as an International Standard in 2005. The standard is being developed by working group WG 8, Food safety management systems, of ISO technical committee ISO/TC 34, Food products. The 6th meeting of the working group took place on 21-22 June 2004 in Copenhagen, Denmark. Experts from the following countries are currently participating in the working group : Argentina, Australia, Belgium, Canada, Denmark, France, Germany, Greece, Hungary, Indonesia, Ireland, Italy, Japan, Netherlands, Poland, Republic of Korea, Sweden, Switzerland, Tanzania, Thailand, United Kingdom, USA and Venezuela. The following organizations have liaison status : Confederation of the Food and Drink Industries of the European Union (CIAA), Codex Alimentarius Commission, CIES/Global Food Safety Initiative, and World Food Safety Organization (WFSO).
What are the benefits for other stakeholders ?

The benefits for other stakeholders may include : confidence that the organizations which are implementing the standard have the ability to identify and control food safety hazards.
The most effective food safety systems are designed, operated and updated within the framework of a structured management system.
Furthermore, the standard adds value because of the following features : international ; provides potential for harmonization of national standards ; food processors are waiting for this standard ; provides a reference for the whole food chain ; provides a framework for third party certification;
By Andrs Salg, Chair ISO/TC 34, Food products
he significant increase in the attention being paid to the concept of traceability and its introduction into the real world of chemical, microbiological or of any other measurements has been one of the most remarkable features of recent years. The concept of traceability, starting in physical measurements, has been found useful for many years, but its exact meaning has been open to varying interpretations. In chemical, microbiological and related measurements, however, the concept has only been partially applied. The usual thinking is that
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Photo : ISO
Tracking food paths
One other meaning and aim of traceability (or, to put it in other words), product tracing, is to define, to put in a system, to increase, and to document food safety. Traceability is a useful tool but insufficient in itself to achieve food safety and other defined objectives in a management system. It is the ability to trace the history, application or location of whatever is under consideration.
Governments and consumers demand traceability

Governments and consumer groups are increasingly pressurizing the food and feed supply chains to adopt traceability measurements. Major scandals in the last decade in different food and feed chains (BSE, Dioxin, E-coli, Salmonella
problems) have highlighted and confirmed that a lack of traceability measures and/or traceability systems can have very negative effects on food/ feed safety. Traceability systems would be able to recreate the history of a product and to trace the destination in a food/feed chain, and would help in the search in identifying the causes of nonconformities, in the withdrawal or recall of products, and in achieving greater reliability of information and thereby contributing to a higher level of business efficiency.
Where can traceability systems help ?

Let us look at some important areas of food and feed production where sensory perception, quality or health problems can be avoided by using effective traceability systems. These can be the effects of and/or the follow-up of Genetically Modified materials or ingredients, the appearance of new microbes, detection of the falsification of food products, and investigation into the authenticity of food, among others. In January 2005, new legislation for traceability will be introduced in the European Union (EU). As part of the EU General Food Law regulation, Article 18 contains specific requirements for traceability of food, feed and food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food product or feed. The USA has also recently been considering the traceability issue. The intention of House of Representatives (2003) is : to improve the safety of meat and poultry products by enhancing the ability of Secretary of Agriculture to retrieve the history, use and location of a meat or poultry product through a record-keeping and audit system, or registered identification, and for other purposes.
Traceability is the ability to trace the history, application or location of whatever is under consideration.
quantitative chemical, microbiological, and suchlike measurements (in analogy with physical measurements) should be made traceable to the SI (Systme international dunits) unit of the amount of substance, whereas the entity measured can be identified, for instance, by chemical formulae, which automatically means measurements of the amount of substance, the relevant basic quantity in our international measurement system. Clearly, the idea of traceability is not sufficiently widespread in the field of chemical, microbiological, biological and suchlike measurements. To support the current need for global measurement comparability, a clear and generally accepted concept of traceability and the infrastructure to support such a concept are still missing.
About the author

Andrs Salg, Chair of ISO/TC 34 and TC 34/ SC4, Cereals and pulses, is a chemical engineer who studied at the Budapest University of Technology and Economics (BUTE). He has a Ph.D. in cereal chemistry from the Hungarian Academy of Sciences, and has a post-doctorate in cereal chemistry and physiology from the University of Berne, Switzerland. He has been Head of the Department Biochemistry and Food Technology, BUTE Budapest, since 1994, and is a member of Executive Committee of the International Association of Cereal Science and Technology.
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Main Focus
A clear ISO role
These trends and new regulations encouraged ISO/TC 34 to establish the WG 9 (under Italian leadership) in June 2001 with a view to elaborating a new work item proposal entitled Traceability in feed and food chain General principles and guidance for system design and development. The elements of a system concept in food and feed chain traceability are the following : Identification the specific objectives to be achieved (safety, quality, history, origin, recall, parties, communication) ; Definition of product(s) ingredient(s) to be traced ; Relevant steps in food chain ; Procedures ; Documentation.
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and
has reached the Committee Draft stage (ISO/CD 22519) and it is being circulated for voting. This standard provides principles and guidance to establish a traceability system ; it is generic and therefore not related to specific needs. ISO/CD 22519 is intended to be flexible enough to allow organizations to use it to achieve the specific identified objectives. In the course of the development of the Committee Draft, working group 9 has been taking into consideration the progress of the Traceability/ Product tracing project underway in the Codex Alimentarius Commission (under Swiss leadership), and the ISO standard now being developed is harmonized with the Codex documents. It is expected that the ISO standard will be finished by the end of 2005 and will be published in spring 2006.
Detection of genetically modified organisms and derived foods

By Marianna Schauzu, Head of Center of Novel Foods and Genetic Engineering at the Federal Institute for Risk Assessment, Berlin, and scientific secretary of the German Advisory Committee for Novel Foods.
Traceability as a two-way exchange
Traceability can become a two-way exchange, enabling the feedback of information from retailers and consumers that could help the food trade and farmers gain commercial advantage.
The proposal, the future ISO 22519, that has ISO 9001:2000 and ISO/DIS 22000:2004 as its normative references, and is adopting the definitions used in ISO/DIS 22000,
The experience is interesting because it points to the possibility of viewing the traceability system not merely as a means to facilitate recalls nor purely as a system imposed by legislation. Rather, traceability can become a two-way exchange, enabling the feedback of information from retailers and consumers that could help the food trade and farmers gain commercial advantage. We hope that the introduction and application of the new traceability standard will enhance the transparency of processes in the food/feed chain, and will improve food safety as well as fair cooperation and communication between the different stakeholders in the food chain.
n 25 % of the global crop areas, GM (genetically modified) varieties of soybeans, cotton, corn, and rapeseed (canola) are grown today. The genes that have been introduced into these crops confer resistance to certain herbicides or produce toxins against specific insect pests. The United States accounts for almost two-thirds of bio-engineered crops produced globally. Other major countries where GM crops are grown include Argentina, Canada, Brazil, China, and South Africa 1). The future ISO standards being developed are of global relevance since they can contribute to facilitate international trade and services by providing an internationally consistent approach to the detection and analysis of GMO
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new legislation with extended labelling provisions came into effect 3). Other governments around the world followed the European Union example and have also developed labelling provisions for GM foods. However, the approaches taken in different countries towards GM food labelling differ greatly, as shown in Table 1. With labelling requirements in place, there was a demand for suitable means to control compliance. Following a suggestion mainly from European Codex Alimentarius members, the Codex Ad Hoc Intergovernmental Task Force on Foods Derived
1) James C. (2003) Preview : Global Status of Commercialized Transgenic Crops : 2003. ISAAA Briefs No 30. ISAA, Ithaca, NY (www.isaaa.org)
derived foods. This will enable affected stakeholders such as seed industries, crop growers, food producers and analytical laboratories to respond to labelling provisions that numerous countries around the world have developed, or are now developing and will provide food control authorities with a tool to control compliance with legal requirements.
Labelling provisions
When the USA first exported GM soybeans to Europe in 1996, the European Union (EU), partly in response to the public debate, introduced mandatory labelling for foods derived from genetically modified organisms (GMO) 2). In April 2004,
2) Regulation (EC) No 258/97. Official Journal of the European Communities L 43 : 1-7. 14.2.1997 3) Regulation (EC) No 1829/2003 and Regulation (EC) Nr. 1830/2003. Official Journal of the European Communities L 268: 1-28. 18.10.2003.
About the author

Marianna Schauzu is Head of Center of Novel Foods and Genetic Engineering at the Federal Institute for Risk Assessment, Berlin, and scientific secretary of the German Advisory Committee for Novel Foods. She has been a German delegate to the European Commissions Working Group of Competent Authorities and Food Assessment Bodies, the OECD Task Force for the Safety of Novel Foods and Feeds, the CODEX Task Force on Foods Derived from Biotechnology and the COST Technical Committee on Agriculture, Food Sciences and Biotechnology. Dr. Schauzu is Convener of CEN Technical Committee 275, Working Group 11, Genetically Modified Foodstuffs.
Table 1. Samples of international labelling provisions for GM foods
Countries Argentina Canada United States Brazil China European Union Japan South Korea Taiwan
Labelling Scheme Voluntary Voluntary Voluntary Mandatory Mandatory Mandatory Mandatory Mandatory Mandatory
% Threshold for Unintended GM Material Not applicable 5% Not applicable 1% 1% 0% 0,9 % 5 % (in top 3 ingredients) 3 % (in top 5 ingredients) 5 % (of GM soya or corn products)
Australia & New Zealand Mandatory
Sources : compiled from Agricultural Issues Center, UC Davis, March 2003 ; Canadian Food Inspection Agency and International Trade Canada, April 2004 ; USDA Foreign Agricultural Service, June 2004 ; Reuters, March 30, 2004
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Main Focus
from Biotechnology established at its first session in March 2000 4) a Working Group on analytical methods. The working group under the chairmanship of Germany compiled a list of analytical methods together with their performance characteristics and validation status through information reported by member countries. A selection of validated methods was submitted for consideration to the Codex Committee on Methods of Analysis and Sampling (CCMAS) in 2002. The methods are accessible via the Methods Database of the Joint Research Center of the European Commission (http://139.191.1.19/ GMOmethods.htm).
Figure 1 : Strategy of the detection of genetically modified material in foods
Food sampling
DNA extraction
Protein extraction and immunoassay
Qualitative PCR
Quantitative PCR
Detection of genetic modifications in foods

The extensive knowledge of DNA technology that led to the construction of GMOs also allowed the development of very specific and sensitive detection methods. In order to determine whether a food has been produced from a GMO, searching for modified DNA sequences and/or new proteins resulting from the genetic modification is the preferred method of choice. Figure 1 illustrates schematically the detection of GMO derived materials in foods. Starting point is a sampling strategy suitable to obtain a representa-
tive sample of the goods under investigation. A next step is the extraction of either protein or DNA from the sample under study. The extracted proteins are taken to an immunoassay. The extracted DNA is subject to either a qualitative or quantitative PCR (Polymerase Chain Reaction). Protein Analysis Immunoassays are based on the specific binding of a protein to an antibody. They offer a high degree of automation and a high throughput of samples. A major drawback of immunoassays is that detection and measurement may be limited due to low levels of protein expression and degradation associated with food processing. Moreover, the content of new proteins is not evenly distributed in all plant tissues. Immunoassays can,
however, offer a test of considerable practical value for rapid field monitoring and testing of raw materials, e.g. grains and meal. PCR Analysis Because of its sensitivity and specificity, the polymerase chain reaction (PCR) which allows the exponential multiplication of a specific DNA fragment is currently the leading analytical technology employed in the qualitative and quantitative analysis of GMOs. The specificity of the PCR analysis relies on the binding of short oligonucleotides (primers) to the flanking regions of a DNA segment associ4) Report of the first session of the Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology, Chiba 14 -17 March 2000. Codex Alimentarius Commission ALINORM ; 01/34
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Promotion
Transgene
Terminator
Marker gene
5
Screening Event-specific Construct-specific
3
oped under CEN lead and commented by the members of ISO and CEN and afterwards pre-assessed by ISO/TC 34/WG 7. After a comments resolution meeting held by CEN/TC 275/WG 11, the resulting final drafts are put up to a parallel vote and, if agreed upon, they are eventually published as EN ISO standards. The work programme decided by CEN/TC 275/WG 11 is based on the strategy of detection of genetic modified materials in Foods as given in figure 1. It comprises the development of standards for sampling strategies ( ISO 21568) protein-based methods (ISO 21572: 2004: E 5)) nucleic acid extraction methods (ISO 21571) qualitative nucleic acid based methods (ISO 2169) quantitative nucleic acid based methods (ISO 21570) general requirements and definitions (ISO 24276).
Figure 2: PCR-based GMO detection methods
ated with the specific genetic modification. Since DNA is present in every cell of a GMO and the detection of only a short DNA fragment (50 100 bp) is sufficient to identify a genetic modification, PCR-based detection methods are suitable to detect traces of specific DNA sequences even in highly processed foods. Qualitative DNA detection methods provide either a yes or no response to the question whether GMO-derived DNA is present in the food sample under study. In order to control quantitatively, i.e. to check if a given labelling threshold is exceeded in a foodstuff, the ratio of genetically modified versus non-modified DNA is determined using a real-time PCR (polymerase chain reaction) system. PCR-based detection methods can be categorized into different levels of specificity (see figure 2) : Screening methods may be applied as a first check for the presence of certain genetic elements that are common to many of the currently commercialized genetically modified plants, such as promoters, terminators and marker genes. Construct-specific methods target the artificial junction between two DNA elements, such as a promoter and the transgene, that is not present in nature. Event-specific methods are used to discriminate GMOs that share the same DNA construct by targeting the unique junction found at the integration locus between the inserted DNA and the plant genome.
Standardization of Methods of GMO Detection

Following a proposal from Germany, where official GMO detection method development began in 1997, the CEN Technical Committee on Food Analysis Horizontal Methods (CEN/TC 275) decided in June 1998 to establish a Working Group to elaborate standards for the detection of genetically modified organisms and derived foodstuffs (WG 11). The CEN/ TC 275/WG 11 held its first meeting under German leadership in February 1999. Its members represent science, food industry, analytical laboratories, and food control authorities. In order to bring together international efforts, an ISO Working Group (ISO/TC 34/ WG 7) was set up in July 2000 within the frame of the Vienna Agreement of 1991. Draft standards are being devel-
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The future standards will help allow food control authorities to control compliance with legal requirements.
Since the work of CEN/TC 275 is restricted to foodstuffs, ISO/TC 34/ WG 7 decided to take up future work on genetically modified seeds. A first draft standard on Oilseeds and oilseed flours Detection of genetically modified organisms by real-time quantitative PCR Soybean (ISO/CD 24274) has been developed.
5) published by CEN in March 2004
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Main Focus
Microbiological analysis of foods and animal feeding stuffs

By Bertrand Lombard, Chair, ISO/TC 34/SC 9, Microbiological methods
Micro-organisms are present in many foods, and some of them are very useful for producing foods (such as wine, yogurt, cheese) by fermentation. Others represent a significant danger for human health : pathogens as Salmonella and Listeria monocytogenes are responsible for human illnesses (such as gastroenteritis, meningitis) when they are ingested by consumers with food. Some can cause even death of immuno-compromised persons, such as neonates, AIDS patients and elderly people. It is thus obvious why food safety, in particular in terms of microbiological hygiene, is an essential requirement of consumers. This is particularly important nowadays, where the extended shelf life of foods, new processes with milder treatment to help safeguard taste, and longdistance transport of products represent more risks in terms of food safety, the micro-organisms having greater opportunities to develop in foods prior to their consumption. All these aspects make it essential to develop reliable methods for checking the microbiological contamination of foods. Not only are reliable methods in this field needed, but harmonization of these methods is also required. From a scientific point of view, the microbiological methods which can be used worldwide are still based on classical Pasteur microbiology, that is, on the ability of micro-organisms to grow in culture media : this being the case, the result of an analysis is completely dependent on the method used (especially in cases of enumeration of micro-organisms).
Potential trade barriers

In the absence of any unique reference method for a given target micro-organism, a diversity of methods represents a potential trade barrier, and the blocking of imported products (by importers that do not recognize the method used by the exporter, for example), even for a few days, can lead to considerable loss in market share. In addition, a multiplicity of methods often results in a duplication of the analyses (by the producer and the customer), and therefore in an overall increase in costs. In these cases, standardization by ISO represents the ideal tool for harmonization, where all parties can gather and agree. It is thus not surprising that the standardization of microbiological methods is an important area of activity within ISO/TC 34, and that a subcommittee has been set up entirely devoted to this field since the mid1970s subcommittee SC 9, Microbiology.
Methods of functioning
SC 9 has been managed by France (an AFNOR secretariat with a French chair) since its creation. It has 27 P- (Participating) members, 20 O-
About the author

Bertrand Lombard graduated from the College of Agricultural and Agro-food Sciences of Paris-Grignon, obtaining a postgraduate diploma in spectrochemistry, and prepared a PhD on interlaboratory studies in food microbiology. Between 1990 and1998, he was at AFNOR, in charge of standardization in food sector, especially microbiology, and secretary of ISO/TC 34/SC 9. From1998, he has been a scientist at the French Food Safety Agency (AFSSA), coordinator of the European Community Reference Laboratory on Milk , and chair of ISO/TC 34/SC 9.
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(Observer) members and 14 international organizations in liaison. The objective is to standardize horizontal methods, broadly applicable not only to all foods, but also to animal feed, as well as to environmental samples in the area of food production and food handling. General standards are also prepared, such as ISO 7218 defining general requirements and recommendations for microbiological examinations. This standard is a basis for accreditation of laboratories in food microbiology. SC 9 currently comprises two working groups : WG 1 dedicated to meat and meat products (for the few standards specific to this food type), and the newly created WG 2 on statistics, which is to bring statistical expertise to SC 9 whenever needed. An adhoc group is also currently reflecting on how to rationalize the preparation of standardized methods within SC 9, as well as on the minimum requirements for standardizing a method (in terms of validation).
alternative methods, was published in 2003, after a long preparation process, where harmonization with AOAC in the USA was realized. ISO 6579, Microbiology of food and animal feeding stuffs Horizontal method for the detection of Salmonella spp., a standard dealing with the most common analysis of pathogen in food microbiology, the detection of Salmonella, was revised in 2002. It includes performance data derived from an inter-laboratory trial organized at inter-continental scale, involving US and European laboratories, and the first on this scale on a pathogen. Further to this, in 2003, AOAC recognized this ISO International Standard as an Official Method. SC 9 is currently developing Guidelines on measurement uncertainty in quantitative microbiology.
Use of ISO standards in food microbiology

The public authorities in charge of protecting consumers health and ensuring that foods on the market are not harmful, both at national and regional level, need reliable methods, which have been validated, established and agreed by experts. These methods will be used in official controls. Here again, public authorities need reference methods which have been agreed at international level, enabling the recognition of these controls within interPhoto ISO Photo : ISO
A multiplicity of methods often results in a duplication of the analyses.

SC 9 has a close relationship with its mirror European standardization working group (CEN/TC 275/ WG 6), and the Vienna Agreement is implemented in a very satisfactory way : most ISO reference methods are taken over as CEN standards (for pathogens, given the scope of WG 6), and CEN standards related to specific topics (such as quality assurance and performance testing of culture media, validation of alternative methods, use of PCR in food microbiology, viruses) are taken over as ISO International Standards. Here are just a few examples, to illustrate recent and current work : a standard establishing a protocol for the validation of alternative methods, ISO 16140, Microbiology of food and animal feeding stuffs Protocol for the validation of
national trade. More precisely, national or regional authorities define, based on the works of the Codex Committee on Food Hygiene (CCFH), microbiological criteria (absence of a given micro-organism, or a maximum tolerated number of micro-organisms per quantity of product) permitting the commercialization of foods without endangering consumer health. Given the strong relationship between the result and the method previously mentioned, a criterion is not fully defined unless a reference method is attached to it. ISO standards are indeed cited in several national regulations, as well as in a draft European Regulation on microbiological criteria. These microbiological criteria, and other risk management measures, should be based, according to the principles laid down by CCFH, on risk analysis. Here again, the generation of epidemiological data, required for risk analysis, needs reliable methods recognized at international level for the recognition of the validity of the risk analysis studies themselves.
ISO standards are cited in several national regulations.

The whole portfolio of standards prepared by SC 9 is used by accreditation bodies as a sound basis for accreditation of laboratories in the food microbiology sector. Finally, the food industry benefits also from standard reference methods, that they can use for their own checks that will therefore be more easily accepted by the public authorities. Moreover, if certain laboratories prefer to use alternative methods available on the market, a reference method is still needed as an anchor method against which these alternative methods can be validated according to the protocol given in ISO 16140.
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Main Focus
Cooperation works : uniting strengths for better standards

by Edward Hopkin, Director General of the International Dairy Federation 1)
ooperation works and, in working, saves work, but it also takes work to achieve this aim. The cooperation goes back to 1961 when the FAO/WHO Joint Committee of Government Experts on the Code of Principles concerning Milk and Milk Products requested IDF (International Dairy Federation) and ISO and the US-based Association of Official Analytical Chemists (AOAC) to get together to propose methods for adoption by the committee. In the intervening period cooperation has become steadily closer so that now the stages in development are aligned between IDF and ISO/TC 34/SC 5 2), and identical texts are used for consultation of the respective membership and voting for approval for publication. Joint publication, the last logical step, was achieved in 2001 and the two organizations are attacking the mountain of 162 standard methods of analysis and sampling. At the time of writing, 43 jointly published International Standards have appeared. Each of them bears the logo of ISO and the logo of IDF, bears also the publication references of both ISO and IDF and has two Forewords, one addressed to ISO members and one to IDF members.
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Cooperation in practice
The interesting question for standardizers and those interested in understanding how cooperation can work will be How was this achieved ? Naturally there have had to be adjustments in the organizations procedures to achieve alignment but, given the number of years that has passed, and the steady evolution and improvement that is normal in bodies like ours it has been a relatively painless process. IDF has, step by step, accepted the more formal, but also more transparent, approval system of ISO and ISOs system of handling
ment methods and results, between meetings. Each body has striven to benefit from the others strengths. An important factor has been the mutual respect that the individuals involved have enjoyed for the major part of the 40+ years of cooperation. In that time there have, of course, been changes of personnel, but harmony has been a key factor in the success.
IDF has, step by step, accepted the more formal, but also more transparent, approval system of ISO.
comments and controlling the process of developing a standard. ISO/TC 34/SC 5 has taken over the pragmatic IDF procedure on developing methods, bringing all the experts named by the two organizations to participate in the work together in a large Analytical Week comprising up to 25 Joint Action Team meetings and involving over 150 participants every year. Besides the technical input, the Joint Action Teams (JAT) organize the interlaboratory studies to determine the precision of the methods demanded by the IDF and fulfilling the requirements of the ISO 5725 series, Accuracy (trueness and precision) of measure-
The alignment of technical content is achieved by the experts named by the member bodies of the two organizations all meeting in joint meetings.
ISO/TC 34/SC 5 and IDF have also each been able to see their work on methods of analysis and sampling of milk and milk products as part of a wider effort. The work covers a major group of foods within the scope of ISO/TC 34, Food products, whose work is largely, if not exclusively, orientated towards analysis and sampling of food commodities. For IDF it serves as support for the dairy sectors effort towards the FAO/WHO Codex Alimentarius Commission, the body recognized by the WTO as the source of standards of identity for human foodstuffs in international trade, but also as an unbiased and independent point of reference for the analysis of milk to determine its quality, and hence the price paid to the milk producer.
1 The International Dairy Federation is a body established in 1903 and funded by the dairy sector. In 2004 IDF has 41 member countries. 2 ISO/TC 34/SC 5, Milk and milk products, was set up in 1959 and has at present 19 P (Participating) member countries and 31 O (Observer) member countries.
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Rationalizing the work

Cooperation saves effort number of ways. Quite obviousl production of only one public per standard is less work than previous arrangement in which ISO and IDF produced a public separately and sold them around world. However, effort is also sav the earlier stages of development. experts responsible for drafting, te in interlaboratory studies and cor ing texts in the light of comments have to do these things once. In bad old days , when even the of consulting the respective bo members were not aligned, it happened twice. Time is also s when citing and checking the relev of texts to a specific purpose.
mes a year to ensure advance in parallel in s. This level of effort ntinue until the entire ternational Standards k items has appeared n.
dy has striven om the others ngths.

t standards
lectronic means of provide the opporible arrangement for nd sale of the jointlyds. The arrangement or the physical proocuments at the ISO at and sale of standes to their respective customers. Pricing follows the ISO system but each body follows its own conventions with respect to its own members and each body promotes the standards to its own constituency .
The original programme e aged completing joint publicatio all existing equivalent IDF and TC 34/ SC 5 International Stand within a relatively short time, bearing in mind that production capacity is finite. It must not be forgotten that, at the same time, the normal (joint) ISO and IDF process of a five-yearly review and, if necessary, revision of existing standards has to proceed, and new work items are being added in the usual way. A systematic approach from the start identified the items that would progress rapidly because they were already close to completion or required only minor adjustment, those that would need more work to complete, and a third category of those which, up to 2001, had only just appeared and would not require review until 2005. Cooperation has resulted in recognizing that a special effort is required to keep the procedures of development and consultation in step in the two bodies. A refined work alignment procedure between the secretariats of IDF and ISO/TC 34/SC 5 has been established and, naturally, this joint effort takes work. In the first place, the alignment of technical content is
Photo : ISO
The end-user benefits from our cooperation
y p y member bodies of the two organizations all meeting in joint meetings. An alignment effort has also been undertaken by both secretariats with respect to other ISO work, notably on methods for food microbiology (ISO/TC 34/SC 9). On the administrative side the two secretariats (IDF and ISO/TC 34/SC
More ?
Any reader interested to know more about IDF-ISO cooperation is welcome to contact the author, EHopkin@fil-idf.org, ISO/TC 34/ SC 5 Secretariat, SCHAIK@COKZ.nl or Pauline Jones, Technical Programme Manager, at jones@iso.org
About the author

Edward Hopkin as been Head f IDF Secretariat ince 1989, aving been at DF since 1979. rior to joining DF, Edward Hopkin worked t the British tandards Institution (BSI) for 13 years, involved to a large extent in United Kingdom participation in ISO/TC 34 and its subcommittees and working groups. He has thus known IDF-ISO cooperation from both sides.
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Main Focus
Steamed or boiled ? Promoting the production and trade of rice
Rice production of the world

There are over 7000 varieties of rice grown around the world on a wide range of ecological environments (from dry land to flooded land) varying climates (from tropical to temperate) and different soil types and associations (from saline soils along seacoasts to aluminium toxic uplands). Rice is cultivated in more than 100 countries from Nepal, which has the highest rice lands, to Australia, which has the most productive. According to the database of the Food and Agricultural Organization of the United Nations (FAO), between 1974 and 1999 the rice production of the world continuously increased (by 77 % overall) from 332 to 611 million metric tons, and since 2000 it has decreased slowly. The distribution of the rice (paddy) production of the world in 1999 and 2003 is shown in Table 1. Asia is not only the greatest producer but also the greatest consumer of rice. China, India and Indonesia account for three-fourths of world consumption. The marketable surplus of these countries is thus small: for example, the rice exports of China were barely higher than 1 % of its total production for both the years shown. With growing economic prosperity and urbanization, per capita consumption has started declining in the middle- and the high-income Asian countries. People prefer highcost quality food with more protein and vitamins, such as fish, meat and vegetables. However, at low level of income, rice is considered a luxury commodity. Thailand is the greatest exporter of rice. The total exported quantity (paddy, husked, milled and broken rice) of Thailand was 6,8 million tons in 1999 and 7,3 million tons in 2002. It has a reputation for high quality, long-grain, white rice, which usually commands a substantial price advantage over lower grades.
n China, tradition holds it that the precious things are not pearls and jade but the five grains ; the first of these is, of course, rice. This unique grain helps sustain two-thirds of the worlds population as rice is the staple food in Asia, Africa, and Latin America, but its consumption has also increased in Europe and also in North America in the last years.
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By Martha Petro-Turza, Secretary ISO/TC 34/SC 4, Cereals and pulses
The biological value of rice

On average, 100 g paddy (rough) rice contains : about 12 g water, 8 g protein 2 g fat, 70-75 g carbohydrate (starch and fibre) ; from the group of B vitamins: about 0,3 mg B1, trace amount B2 and 4,7 mg niacin ; from the minerals : about 150 mg potassium, 30 mg calcium, 120 mg magnesium, 220 mg phosphorus and 120 mg sulphur. The fuel from which the human body derives most of its energy is the carbohydrates, and rice contains a great amount of it. Approximately 10 % of the carbohydrate content of rice is dietary fibre, but during processing (husking, milling, etc.), its content drastically decreases. At the same time, the proportion of starch content can reach 80 % in milled rice.
The composition of rice protein is the best among cereals, as the essential amino acids (that cannot be manufactured by the body) are present in it in the highest proportion and in the right ratios. In addition, rice is non-allergenic food as it does not contain gluten (in contrast with wheat, barley, rye and oats), and therefore people who suffer from celiac sprue disease (faulty absorption of food) can consume it without any difficulty. Processed rice contains fat only in trace amounts, and it is practically free of sodium also requirements for some types of diet. The vitamins and minerals are mainly present in the bran and embryo of rice ; therefore during the milling or polishing process, the quantity of these nutrients is also drastically reduced. However, parboiling of the rough crop (the original purpose of this process was to loosen the husk) increases the nutritive value of the milled rice as, during this treatment, water dissolves the vitamins and minerals present in the husk and bran coat and carries them into the endosperm (inside part of the grain). To bring the nutritional value of the processed grain to the whole, in the USA and some other countries rice is enriched with the above-mentioned nutrients and also with folic acid (among others, this latter has a role in the production of blood).
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Rice standards and requirements
International Standards for rice are developed by ISO/TC 34, Food products, subcommittee SC 4, Cereals and pulses. Among the current 52 International Standards developed by this subcommittee, three deal with rice solely, but 31 others are applicable to this crop as well as to all other cereals. The majority of the latter standards specify methods for the determination of various impurities, physical or chemical characteristics of cereals. However, there are standards containing recommendations for the storage of cereals, methods for samRice producers pling, etc. There are 11 items in the work programme of the Asia subcommittee for the develChina opment of new standards for cereals, including two for rice South America and four for all cereals. Brazil
Table 1 : Distribution of the rice (paddy) production of the world in the years 1999 and 2003.
those relating to the maximum level of impurities) are defined more stringently. ISO 6646:2000, Determination of the potential milling yield from paddy and from husked rice, details a method to standardize the determination of milling yield, to ensure that results obtained by different operators using abrasive test mills are comparable. Naturally, the milling yield is an important factor of the price. This standard helps to avoid litigation between seller and buyer originating in different results reached by different methods.
ISO 14864:1998, Evaluation of gelatinization time of kernels during cooking, specifies a method for the evaluation of gelatinization time of rice kernel during cooking which is also an important parameter of rice quality. The revised version of the former ISO 6647, Determination of amylose content, is under development. This is a very important standard as it deals with the determination of amylose, a constituent of starch.
1999 amount (ton) 554 627 820 200 403 308 22 078 704 11 709 700 17 726 090 5 816 960 9 343 954 9 343 954 % 90,79 36,13* 3,61 53,04* 2,90 32,82* 1,53 100,00*
2003 amount (ton) 534 262 715 166 417 000 20 133 181 10 198 900 19 076 017 5 800 000 9 033 610 9 033 610 3 217 311 1 359 826 2 428 209 715 800 412 890 391 000 588 563 933
Source: FAO
% 90,77 31,15 * 3,42 50,66 * 3,24 30,40 * 1,53 100,00 * 0,55 42,27 * 0,41 29,48 * 0,07 94,70 * 100,00
Africa Egypt North America USA
The most important rice standard is ISO 7301, Europe 3 238 858 0,53 Rice Specification, conItaly 1 427 100 44,06* taining the general, orgaCentral America 2 451 134 0,40 noleptic, physical and chemand Caribbean ical specifications of rice. It Dominican Republic (1999) 566 501 23,11* was developed to lay down Cuba (2003) the minimum requirements which rice has to meet in Oceania 1 412 341 0,23 the world market. The standAustralia 1 389 800 98,40* ard gives the definition of 21 terms relating to the processWorld total 610 878 901 100,00 ing and the defects of rice to avoid misinterpretations. ISO 7301 summariz* : expressed in the total production of the continent or the region. es the defect tolerances of the different rice categories and describes methods for checking how commercial products fulfil these requirements. To promote rice trade, the standard also specifies what should be included in all commercial contracts. The second edition of ISO 7301 was published in 2002, and compared to the first (published in 1988), the requirements (mainly
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Main Focus
Starch is the main carbohydrate of rice consisting of two different parts, amylose and amylopectin. The ratio of these two constituents differs between the different rice varieties and determines the textural properties of rice when it is processed or cooked. Amylose is present in a higher proportion in long grain rice that when cooked becomes fluffy and stand-alone , with a low tendency to stick. In medium, short, jasmine and waxy rice, on the other hand, amylopectin is the dominant element that makes these rice varieties more tender with a greater tendency to stick. Uncooked grains with high amylose content look translucent while those with low amylose content look opaque. The digestibility of the two starch constituents is different. Amylose is much harder to digest than amylopectin. Therefore, consumption of rice containing higher proportion of amylose raises the blood sugar level less than those containing higher proportion of amylopectin. As can be deduced from the above, the amylose content of rice is a key factor in the selection of new rice varieties in breeding programmes.
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Tracking fruit and vegetable products quality and safety

Unquestionably, standardization of method(s) for the determination of amylose content of rice has great importance. The new standard will consist of two parts, the first containing the reference method, the second, the routine method. A comprehensive interlaboratory study for the determination of repeatability and reproducibility of these methods is going on under Swedish project leadership. It is hoped that the new standard will be published in the first half of 2005.
About the author

Martha Petr-Turza, a hemical engieer, graduated nd received her octors degree rom the Budaest Technical University, Hunary. Between 966 and 1990, she worked as a researcher for the Central Food Research Institute, Budapest. Over the last 13 years of this period, she was the head of the Analytical Chemistry Division of the Institute. Between 1990 and 1995 she was the director of quality assurance of the Canning Research Institute, in Budapest. Since 1996 she has worked for the Hungarian Standards Institution as secretary of ISO Technical Committee TC 34, Food products, and its subcommittee SC 4, Cereals and pulses.
By Renata Jedrzejczak, Chair ISO/TC 34/SC 3, and Sylwia Skapska, Secretary of ISO/TC 34/SC 3, Fruit and vegetable products Production and trade
ruits and vegetables and the products derived from them are widely consumed all over the world, and are very important commodities in the trade of most countries. The world production of fruit and vegetables demonstrates a systematic growth which exceeded 480 and 840 million tones in 2003, respectively, while total export and import values exceeded 150 billion USD. China, India, Brazil and the USA are the biggest fruit producers, while China, India, USA and Turkey lead in the vegetables production. Among different species of fruits that
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are cultivated all over the word, citrus fruits, bananas and apples have shown the largest annual output, while for vegetables potatoes, tomatoes, cabbages, onions, cucumbers and carrots. The short shelf life, especially of most fruits, and the frequent need to store and spread out the surplus of a harvest over a prolonged period of time has brought about a number of processes which provide more durable and stable fruit and vegetable products. They included canning, drying, freezing, and preparation of juices, nectars, jams, marmalades, jellies and purees. Unique vegetable products can be obtained by lactic acid fermentation. Except for preserving the perishable crops, processing can improve the nutritional value and increase the bioavailability of nutrients and the organoleptic qualities of some fruits and vegetables.
circumstances, like conditions of cultivation of plant raw materials, processing, packaging, transportation and storage. Despite all differences, every product needs to keep to the quality stated in the appropriate international or national standards and regulations. Over many years, analyses performed in different countries have allowed tables of chemical composition of fruit and vegetables and their by-products to be drawn up which enables us to compare them and find out their alteration and the authenticity of the same products from different origins. On the other hand, the risk of contamination of environmental or processing origins as well as the multiplicity of authorized food additives has resulted in developing sophisticated analytical methods for controlling these factors.
determination of natural compounds, physical and biochemical properties; determination of additives; determination of contaminants and impurities. The first group of standards concerns the analytical methods designed for checking the basic features of the products, such as composition (sugars, acids, vitamins, flavours) and quality indicators (pH, content of ethanol, etc.). These standards allow a control of product authenticity and overall nutritious and commercial quality. The second group of standards includes methods of determination of substances deliberately added to the product during the processing, such as preservatives (e.g. benzoic, sorbic, formic acids,
Consumption and nutritional value

Fruits, vegetables and their products are one of the most important components of human diets. Their composition can be strongly influenced by the cultivar, climate and origin. Fruits major constituents are sugars, polysaccharides and organic acids; vegetables contain mainly carbohydrates, nitrogen compounds and minor amounts of lipids. Fruits and vegetables provide an abundant and cheap source of many vitamins (e.g. A, B1, B2, B6, C, D, E, K), minerals (e.g. calcium, magnesium, potassium), and dietary fiber that are essential for human health. Vitamin A, C, E, carotenoids and phenolic compounds exhibit an antioxidant activity. Some vegetables, like garlic, onion, horseradish, contain substances of strong antimicrobial activity. Those, and many other fruit and vegetable phytochemicals, play the crucial role in maintaining health and preventing some widespread diseases, like cancer and coronary heart diseases. That is why dietitians recommend eating at least 700 g of fruits, vegetables and their products a day. Quality and safety of fruit and vegetable products depend on many
Controlling the quality and safety of fruit and vegetable products

ISO standards for fruit and vegetable products are in the responsibility of ISO Technical Committee TC 34, Food products, subcommittee SC 3, Fruit and vegetables products. They include 41 standards that cover the three main areas:
Photo : ISO
About the authors

Renata Jedrzejczak, a chemical engineer, graduated from Gdansk Technical University, Poland. She received her doctors degree and at Lodz Technical University, Poland and in 2001 obtained the position of associate professor. From 1979 she has worked as a researcher for the Institute of Agricultural and Food Biotechnology, Warsaw. Over the last 15 years, she has been head of the Spectrophotometry Laboratory in the Department of Food Analysis of the Institute. Since 1992, she has been Chair of ISO/TC 34/ SC 3, Fruit and vegetable products. Sylwia Skapska, a food technologist, graduated and received her doctors degree from the Warsaw Agricultural University, Poland. From1982, she has been working as a researcher for the Institute of Agricultural and Food Biotechnology, Warsaw. Over the last three years, she has been the head of the Fruit and Vegetable Product Technology Department of the Institute. Since 2001, she has been secretary of ISO/TC 34/SC 3, Fruit and vegetable products.
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Main Focus
sulphur dioxide). The third group of standards is aimed at the detection and determination of different kinds of undesirable and harmful substances, such as mineral and organic impurities, heavy metals (e.g. lead, cadmium) and micotoxins (e.g. patulin in apple products). Because of the fast scientific progress, analytical standards need to be constantly reviewed and, if necessary, new, more up-to-date techniques have to be introduced. Thus, there are four projects underway in the SC 3 work programme concerning determination of heavy metals : cadmium, arsenic and tin, with the advanced atomic absorption spectrometry methods. SC 3 standards are mostly used by fruit and vegetable producers, processing and trading companies, food controlling institutions, as well as by scientific laboratories. The field of activity of ISO/TC 34/SC 14, Fresh, dry and dried fruits and vegetables (see opposite) looks on the surface somewhat similar to that of SC 3, but in fact its standards almost exclusively concern product specifications and storage and refrigeration requirements. Only three SC 14 standards include test methods for dried apples, pears and peaches. Currently 16 member countries actively participate in the work of subcommittee SC 3, 41 countries have the status of observer members. Eight international organizations : AOAC (AOAC International), CAC (Codex Alimentarius Commission), IFRA - fragrance (International Fragrance Association), IFU (International Federation of Fruit Juice Producers), OECD (Organisation for Economic Co-operation and Development), OIV (International Vine and Wine Office), UN/ECE (United Nations Economic Commission for Europe), and WCO (World Customs Organization) are in liaison with SC 3.
Photo : ISO
Fresh, dry and dried fruits and vegetables

By Nevzat Artik, Chair, ISO/ TC 34/SC 14 and Servet Atayeter, Secretary of ISO/TC 34/SC 14, Fresh, dry and dried fruits and vegetables
here is a growing interest in Turkey in the use of International Standards and in being involved in the development process of the standards on fresh, dry and dried fruits and vegetables. All interested parties in the country such as public and private scientific laboratories, exporters unions and associations are involved in the
standards development process. Turkey ranks third in the world as an exporter of fresh fruits and vegetables, with the European Union its most important market for exports. Turkish exporters, that have now reached the figure of 40, are paying special attention to International Standards to ensure their trade is as smooth as possible. Exporters enjoy a close relationship with growers, the warehouse, packaging and processing firms. Participation in ISOs standardization work is therefore important to the country. The scope of the subcommittee is : Standardization in the field of fresh, dry and dried fruits and vegetables, in particular, terminology, sampling, product specifications, requirements for packaging, storage, transportation, methods of tests and analysis. The number of published ISO standards under the responsibility of the TC 34/SC 14 Secretariat stands at 69.
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Our objective is : to provide validated methods of analysis ; to facilitate international trade of fresh, dry and dried fruits and vegetables ; to satisfy consumers requirements from the point of view of human nutrition ; to provide guidance and common terminology for the product specifications, storage and transportation of fruits and vegetables.
to offer a greater volume of products designed to meet the requirements laid down in the standards.
The influence of standardization on producer market organization

The scale and nature of packaging operations based on the requirements of standardization have made it essential to locate packaging stations, whether cooperative or private, in the production areas. These stations have two functions : The technical function of sorting, sizing and packaging the goods, leading to quality grading for the market, and of cold-storing them (pre-refrigeration and conservation for varying periods in a normal or controlled atmosphere). An economic function which is a natural extension of the producers activity at the marketing stage take, for instance, the transport and sale of the products in line with the qualitative requirements fixed by the purchaser ; or the possible holding of crops for short or longterm warehousing in order to even out the flow of consignments by eliminating excessive peaks which would bring down prices ; or the grouping of small consignments to/ from bigger and more homogeneous
units which can meet a correspondingly big demand over a period of time. Centralized marketing was only made possible by adopting uniform standards in line with the regulations in force in foreign markets.
The influence of standardization on the organization of trade

On their way from centres of production to points of consumption, products normally move along through marketing channels whose operation has changed over the years. These changes are partly due to the application of standardization rules, the spread of which has generally had several effects, namely :
The influence of standardization on production and marketing

The safety of fresh food produce is becoming increasingly important in comparison to other processed food products by the fact of its very nature. Many standards exist for processed food as such foods do not deteriorate easily during storage and transport ; fresh produce, on the other hand, is inspected more carefully by importer countries. The producer must constantly endeavour to adapt to market conditions, and this triggers off the immediate result that any varieties of low market value will be eliminated. The producer has also to realize that, today, the standardization of products begins when they are still on the tree or in the field, and that the result of his efforts depends on the extent to which his production is adapted to market requirements. The tonnage withdrawn from the market as a result of the application of standardization would not at present seem to exceed 10 % of the tonnage harvested, but this percentage varies, of course, with the product. The best sorting, sizing and presentation practices were therefore codified for common reference. For obvious reasons, production techniques and marketing methods together with improved transport conditions and a more efficient use of cold storage were only developed subsequently, in order
About the authors

Nevzat Artk is Chair of ISO/TC 34, Dried and fresh fruit and vegetables. After graduating from the Food Engineering Dept, Ankara University, Turkey, Nevzat Artk is at present Professor and Lecturer in the Food Engineering Department at Ankara University, where he has worked for 25 years. He has worked as a Project Management of Food Quality Control, ISO 9000 Food Quality Control and a System Inspector, ISO 9000 Food Quality System Education, and HACCP System Management, Food Process Design. Servet Atayeter (PhD), Secretary of ISO/TC 34/SC 14, graduated from Ankara University, Faculty of Agriculture in 1988. He has worked in the Turkish Standards Institution (TSE) as a Technical Chief of International Affairs Department-Ankara, ISO 9000/ISO 14001 Lead Auditor-Istanbul and Director of Quality-Konya between 1988 and 2002, and has been Regional Director of TSE Antalya Branch since July 2002. At the same time, he has been Secretary of ISO/ TC 34/SC 14 since 1988.
Photo : ISO
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Main Focus
A geographical expansion of trade following the adoption of transport techniques whereby products can be protected over considerable distances and for periods which are sometimes very long ; A speeding-up of trade transactions partly due to the more extensive and rapid information now available to traders that enable them, by using modern means of communication, to place orders in accordance with their requirements and with the stipulations laid out in the standards ; The development of the marketing of large quantities, because homogeneous consignments can be delivered by complete lorry or wagon loads, by palletized load units or by containers, so that business can be transacted at a distance from the goods or on the basis of samples ; A change in the relations between traders, whereby personal confidence in their business relations is partly replaced by the use of guarantees of a public or professional nature that the standards will be observed. simultaneously, since prices tend to follow the values of these goods to the detriment of better quality products. Furthermore, standardization can be a means for effectively regulating trade. In most countries, the internal regulations of producers cooperatives fix prices for deliveries in the light of what the standards require, and this principle is an incentive to produce goods of superior quality.
Fats and oils for healthy living

By John Hancock, Secretary, and Hans-Jochen Fiebig, Chair, ISO/ TC 34/SC 11, Animal and vegetable fats and oils
The influence of standardization on inspection of quality

As the organization of the fruit and vegetable market is based on standardization, it is necessary to ensure that the standards are taken into consideration. Consequently the arrangements adopted in most countries have led to the establishment of inspection bodies, whose function may also be educative.
and on cost and prices

If products of a commercially unsaleable quality are removed from the market at the start, the cost of preparation, packaging, storage, transport, handling and marketing will be charged only on those products which can be sold in normal commercial conditions, but the depreciation of the plant required by the different operations involved in standardization is a factor in the cost price of the product which must be taken into account. Standardization enables producers to charge different prices, depending on the qualities they offer, on a given market and at a particular time.
The standardization of products begins when they are still on the tree or in the field.
It is thanks to standardization that collective information an important factor in the functioning of a market can be provided in a useful form and exert its full weight. Standardization also plays a part in the economics of the market as a factor associated with all the forces which help to adjust supply to demand. By imposing a selection, standardization tends to eliminate low-quality surpluses which devalue production and push down prices by their quantities. Consequently, the selling of standardized fruit and vegetables can lessen, and even halt, the falls in prices which occur when quantities of inferior goods arrive
ats and oils are an important part of the human diet, providing 9 kcal/g compared with 4 kcal/g for protein and carbohydrates. They also provide the essential fatty acids which are required for the maintenance of a healthy human body. They are used for direct consumption as edible fats and oils, fully refined seed oils or as cold pressed fruit oils. Subcommittee 11 of ISO/TC 34, Food products, is responsible for the standardization of methods of sampling and analysis for animal, marine and vegetable fats and oils. But fats and oils are also important raw materials for the food industry, and this is reflected in a total worldwide annual production of 124 million tons. Consequently, fats and oils are major commodities of world trade with almost 40 million tonnes being shipped annually, and thus, they are an important sector for the application of international standardization. The surface area of the world being used to produce oils and fats is increasing with increased consumer demand, and there is now a greater regional diversity of the production of all oilbearing crops. Thus, it is essential that the quality control tests performed on a shipment of palm oil being loaded in Papua New Guinea are the same as those carried out when it is received in Europe, and the case for standardization is obvious.
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Complex analysis methods pose new challenges

As oils and fats have been traded since long before Roman times, one would expect that the methods of analysis are well developed and cast in stone . But as we all know, ISO rules require the stone to be turned over every five years. A common feature across all areas of analysis is the increasing use of technology and instrumentation, and it would appear that analytical chemistry is now merely a branch of physics. These new techniques do have many advantages, one being the speed of analysis. Methods, which used to take up to a whole day, can now be performed within minutes, but there are also some disadvantages of these developments. The new rule of thumb is that the time it takes to get a result is inversely proportional to the cost of the equipment . The increasing cost and complexity of analytical equipment is restricting the availability of laboratories able to carry out the tests, and also restricting the use of these methods within the developing world. The complexity of the methods, for example, Gas Chromatography followed by tandem Mass Spectroscopy, is also providing a challenge to the developers of new standards. It is becoming more and more difficult to write down the exact details of the procedures, which must be followed, particularly when this may vary with instrument manufacturer. This will lead to greater emphasis on the extraction and preparation phases of the analysis. At the opposite end of the scale is low technology such as the automatic measurement of the colour of oils, and There is still much to be done in the area of contaminants such as pesticides and dioxins, and there is no doubt that we will have plenty of work to keep us busy in the future.
it is proving very difficult to replace the simple human eyeball.
The reduction in the parameters of detection limits

The use of high technology also means that detection limits for most parameters are reducing. The analysis of dioxins is a case in point. If we convert the detection limit in this type of analysis into more practical terms, it is equivalent to finding one blue soyabean in two shiploads of yellow soyabeans ; in other words, finding 1 bean in 85 000 tonnes. The ability to determine smaller and smaller amounts of chemicals is giving problems to traders and regulators alike. It used to be that if any amount of foreign chemical was found in a consignment of oil, then it was assumed to be contaminated and was rejected : if you could detect it, you could reject it . This is no longer the case, and the regulators are having to decide what levels of potentially harmful contaminants are acceptable.
The development of functional foods

Another interesting area for fats and oils is the development of functional foods. One of the latest work items of SC 11 concerns the measurement of phytosterols. Phytosterols are the components not only in the new range of margarines but also milk and yoghurt that reduce the level of cholesterol in the blood. As more companies are producing this type of product, it is necessary to be able to measure the content of the effective ingredient within the product. SC 11 is also developing a better method of measuring tocopherols and tocotrienols, which are the natural antioxidants in many vegetable oils. These are being marketed as food supplements which can mop up the free radicals in the human body, and thus stop us going rancid. It seems that most people want to eat more healthily but not change what they eat. SC 11 also
About the authors

Hans-Jochen Fiebig, Chair of ISO/TC 34/SC 11, is a food chemist in the Institute for Lipid Research, which is part of the German Federal Research Centre for Nutrition and Food, where he is involved in issues related to methods of analysis for fats and oils. He is also the chairman of the German Fats and Oils Committee (GA Fett) of DIN and DGF (German Society for Fat Research). John Hancock, Secretary of ISO/TC 34/SC 11, is the Technical Manager of FOSFA International, a contract issuing and arbitral trade association for companies involved in the trading, broking and supply chain services of oilseeds and oils and fats commodities. Within this role, he manages schemes which certify member laboratories and superintending companies to carry out contractual analysis and cargo surveying. After graduating and carrying out research in physics, he has spent over 25 years in the chocolate, confectionery and edible oils industries.
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Main Focus
includes animal fats such as tallow and lard, and also fish oils such as cod liver oil. With greater disposable incomes in the more developed countries, the analysis of minor components which may be of benefit to the human body will again provide an interesting area for the future development of analytical methods.
More collaborative trials are required

SC 11 would like to increase the number of P-members (currently 17), as more countries are increasing their production of fats and oils and oilseeds above the level demanded by domestic consumption. However, some of these new growing countries are not even Observer members of the Committee. It may be timely to try to contact these countries and ask if they wish to join or change their status. However, with the current worldwide economic climate and the associated rationalization and downsizing of many companies, we are finding that analysts no longer have the time to participate in ISO activities, particularly in collaborative trials. This means that the workload is falling on fewer active members. SC11 is a very active subcommittee and meets about every 18 months. At the last two meetings, in Bordeaux (France) in October 2002 and in Cincinnati (USA) in May 2004, there were about 25 attendees from 12 members bodies as well as liaison members. Last but not least it should be mentioned that SC 11 has a good cooperation with the Codex Alimentarius Committee on Fats and Oils, where commodity standards for international trade for both fats and oils and margarines and fat spreads are developed. For this purpose standard methods are required and SC 11 is happy to support this work by offering current and new ISO standards for adoption by Codex.
Photo : ISO
Comparing coffees
Which standards for whom ? By Maurice Blanc, Coffee Scientific Advisor and International Regulatory Affairs, Nestec, Chair of ISO/TC 34/SC 15, Coffee
Several ISO standards on coffee have recently been fully revised. An important standard on vocabulary (ISO 3509), is the reference standard to define products and operations throughout the coffee production chain. Referring to this standard avoids confusion when producers debate, for instance, the description of a defect or the exact description of a technical term. However, the core standard is ISO 10470, Green coffee Defect reference chart. This standard lists the different defects that can be identified in a coffee lot. The previous version was too complicated, describing in detail the impact of every defect on the quality of the product. It did not, however, address the impact in quantitative terms. Such a kind of quantitative impact only exists in classification systems developed by trading organizations. The ultimate objective of an ISO standard, by inserting qualitative and quantitative impact of the defects, is a first step towards better harmonization between the different systems. Every actor throughout the supply chain would benefit from such harmonization, from the farmer, the cooperative
offee export is a vital source of income for many countries. The recent revision of different ISO standards dealing with the quality of green coffee was driven by the importance of ensuring a sound trading system for this major commodity. Green coffee is traded according to its quality. This is determined by the presence of foreign matter or defective beans in a more or less large quantity. Two major green coffee varieties are traded and different classification systems exist depending on the variety. The level of quality is only assessed by counting the defects. The parallel existence of many different national and international classification systems makes comparison between the different coffee origins more complicated.
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or the mill cleaning the green coffee at origin to the trader, the buyer and the user at the end of the chain.
What is new ?
Legibility has been dramatically improved by introducing a simple and straightforward classification of defects in a limited number of categories according to their origin. In addition, the consequences of the presence of each defect can be now assessed in a real quantitative way. The classification systems applied by trade organizations is based on counting the number of defects. But because a stone is a stone whatever the size and the same for every foreign matter, the revised ISO standard suggests a weight approach i.e. once the defects have been sorted they are no longer counted but weighed and the percentage of each defect is calculated. Impact on quality from the presence of foreign matter and defective beans is calculated for both loss of mass and sensorial concern after multiplying each percentage by specific coefficients. These coefficients have been determined to take into account the level of influence of every defect. It is expected that the standard can be used to negotiate any contract of purchase between a provider and a client. For some particular defects, a non-normative annex presenting pictures of these
Coffee vocabulary avoids confusion when producers debate the description of a defect or the exact description of a technical term.
defects has been developed. This kind of visual tool can facilitate identification in case of doubt.
Close cooperation between producers and buyers

Coffee trading is a multidimensional system. Partners from the relevant sectors participated in the revision of these different standards. However, differing views proved a challenge in reaching agreement on the impact on quality of many defects. Certain defects considered important in one producing country are not so frequent in another. There are also countries with a significant proportion of high-quality coffees, mainly marketed in coffee specialty distribution channels, and others producing more for the mainstream channel. In order to develop a worldwide manageable system, compromises were found. As a result, the system now designed is flexible enough to be applied in many situations. Several international organizations were consulted during the revision and experts from a few major producing countries regularly participated in working committees. The International Coffee Organisation (ICO) also supports the approach taken into account for this revision. The coffee world is experiencing a difficult period characterized by overproduction and depressed prices. Efforts are made to avoid that sub-standard coffee enters the supply chain. This should decrease the excessive volume of coffee on the market and contribute to reaching a higher price level. In this context, ISO plays a key role by proposing a manageable standard to the various national and international bodies responsible for coffee classification and commercialization. The role of an ISO committee or sub-
committee should continue, even after the adoption of the standard. As regards coffee, members of TC 34/SC15 should take the lead in promoting ISO 10470. Ideally this standard should be used to reconsider all existing green coffee classification systems. As already mentioned, direct comparison between the various classification systems is almost impossible. Flexibility in the supply chain is of increasing importance. But flexibility means that a very transparent system exists and allows the coffee companies buyers more choice in obtaining the best possible quality and cup profile. This revised ISO standard would be seen as a radical solution by part of the coffee world traditionally installed in familiar procedures. The actual low prices of coffee will trigger important modifications in the profession. These modifications should be associated with a greater importance given to cup quality of the products. The revision of the ISO standard has been done in this spirit.
About the author

Maurice Blanc is a chemical engineer. He joined Nestl in 1968, becoming head of a laboratory active in research in the non-volatile components area of coffee, chicory and tea. He was made head of a technological group active in the areas of coffee decaffeination and soluble coffee manufacturing. He participates in the main scientific and professional coffee associations such as Association of Soluble Coffee Manufacturers of the European Union and the Physiological Effects of Coffee, an organization that studies the physiological effects that coffee has on the body. He is administrative secretary of the Association Scientifique International du Caf, Paris, and chair of ISO/TC 34/SC 15, Coffee.
Photos : Nestl
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Photo ISO
Tea three leaves and a bud
Main Focus
Brewing the best tea standards

By Andrew Scott, Chair TC 34/ SC 8, Tea
hances are, that someone, somewhere is drinking a cup of tea every minute of the day. If tea is so common and traded as a commodity why do we need standards ? This is a short outline of the historical back drop for tea today, how the tea trade came to work with ISO and independent researchers to develop International Standards so that everyone can be assured that they can enjoy a good cup of tea.
The history of tea

The story of tea is veiled in myths and history providing a romantic aura; lore and legend intertwine to create a karma that resonates in every sip we take. Chinese and Japanese mythology offer a number of accounts of the discovery of tea. Chinese folklore relates how the Emperor Shen Nung first tasted the delights of tea in 2737 BC. Japanese legend tells of a Buddhist saint, Bodhidharma, who fell asleep during his devotions to awake in distress and cut off his eyelids, throwing them to the ground where they took root and grew into a tea bush. Early Chinese literature refers to tea in Shennongs herbalist book where he describes how he found tea infusions to be a beneficial antidote to the noxious herbal concoctions he tasted in his search for medicinal plants (Han Dynasty c. 206 BC - 220 AD) and in Lu Yus scholarly tea handbook Cha Ching or Tea Classic written circa 780 AD. Tea established itself very early on as part of the fabric of Chinese life as is recognized by the ancient saying, there are seven matters to the starting of a familys life : fire wood, rice, oil, soy sauce, vinegar and tea . The early plants, or more correctly trees, were found in south-west
China speading through Sechuan, Yunnan and the Yun-Gui plateau. There are two varieties of Camellia sinesis, the China plant, or jat, (var. sinesis) and the India plant, or jat, (var. assamica). The China jat is a bush which grows up to 2,75 m tall with many stems and is very hardy. The Assam jat is a single stemmed tree which grows up to 18 m in height and less hardy. Modern cultivars are hybrids of these two varieties, this improves the yield and quality of the Assam jat whilst losing some of the hardiness of the China jat. Tea cultivation quickly spread from China to Japan and was introduced to Java in 1648 by a German naturalist, Andreas Cleyer. Subsequently tea was discovered in Assam in 1823 but its cultivation had to await another decade. The delights of Sri Lankan tea have their roots in disaster, coffee was destroyed by rust in the late 1870s and tea was planted to replace it. Later on in the century, Russia began cultivation of tea in 1847 and cultivation was established in Africa (Kenya, Uganda and Malawi) in the early 1900s.
Tea consumption and the global economy

The importance of tea both to the global economy and to the social order can be seen by the historical record. Countries and Empires, China, Japan, India, Britain and Holland all involve international tea trade and its consumption. Its economic history is illustrated by the earliest tax on tea being imposed in 780 AD by Emperor Tih Tsung in the Tang Dynasty and was very unpopular. Later on, the fortunes of the English East India company were involved with the tea trade from the 1700s for two centuries. In the USA, The Tea Act of 1773 made law in Britain and its colonies included a tax that they refused to pay which resulted in the infamous Boston Tea Party and the making of a nation of coffee drinkers. From these early beginnings in China, tea is now enjoyed by consumers all over the world. Over 3 million tonnes of tea is now produced in over 30 countries around the world to pro-
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ALL PHOTOS COURTESY TETLEY
vide over 1000 billion cups of tea a year. Hot drinks represent about a third of all drinks consumed in the world and tea consumption is a quarter of all hot drinks. Over one and a half million tonnes of tea is consumed outside the producing countries and this valued at over USD 16 billion in domestic consumption alone. Drinking tea is enjoyed in over 100 countries around the globe with different styles of infusion, by young and old alike, signifying the fundamental nature of teas universal popularity. The billion dollar trade of tea between producing countries and consuming countries is therefore of major commercial importance and is also of key concern to many consumers. The degree of industrialization in producing countries, in the main, is much less than that in the majority of the consuming countries and tea is plays an import part in their economy. Consumption
Tea and International Standards

Black tea growing at the Tata Tea estates in Munnar, South India.
International standards are vital to facilitate international trade in tea, to ensure consumers expectations are met.
varies from country to country and can be below 1 kg per capita per annum or over 8 kg per capita per annum.
Tea manufacture
Green tea is predominantly made by hybrid plants from the China jat with a smaller more delicate leaf than those which produce black tea which are hybrid plants from the Assam jat, but this is not a hard and fast rule. The manufacture of tea differs in that for green tea, the leaves are plucked and processed without letting the leaf constituents combine and pursue chemical and biochemical reactions. This is made possible by treating the leaf with a heat process as soon after plucking as is practical. In contrast, for black tea the leaves are plucked and then the leaves are macerated to allow the leaf constituents to mix and pursue chemical and biochemical reactions to create a range of liquors with a characteristic reddish-brown hue and taste which can be enjoyed both with, or without, milk. It is not surprising therefore that this major international trade in tea required some basic guidelines to ensure the producers and the consumers cultivated, sold and purchased tea of a quality which is expected from day to day and from year to year. Being from a plant, tea leaves have natural variations due to climatic and agronomic changes ; however, in the main there are basic characteristics which can be measured to maintain the qualities we all expect.
International standards are vital to facilitate international trade in tea, to ensure consumers expectations are met, to support the development of Good Manufacturing Practice for both black and green tea through minimum compositional specifications and to provide validated methods of analysis. Tea can be grown in some of the worlds remote locations, although this is not always the case as can be seen in China and Japan, across a number of continents including Asia, Africa and South America. One of the many challenges in developing standards for tea, particularly in developing methods of analysis, is to ensure those who cultivate and manufacture tea can use the methods equally well to the sophisticated scientific laboratories
About the author

Andrew Scott is a biochemist with research experience in drug metabolism (doctoral studies at the University of Surrey supported by Glaxo) and food biochemistry (at the Chorleywood and Campden Food Research Association). He joined The Tetley Group, now a subsidiary of Tata Tea Limited, in 1991. He has been head of the companys worldwide Research and Development department and now works with the Group Marketing Development team, bringing innovative new tea products to Tetley markets across the globe. He has been a member of the BSI AW8 Tea Committee since 1991 working on the new standards to measure substances characteristic of tea (total flavonoids and catechins) to be published next year. He has recently been appointed Chair of the ISO/TC 34/SC 8 tea subcommittee to continue this work.
Above Black tea (left) and green tea (right) bushes. Below Green tea growing near Hangzhou, China the area famous for the, Longjing (Dragon Well) tea.
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Main Focus
used by the regulatory authorities in the highly consumer oriented countries. Standards developed in this way enable the tea producers to demonstrate that tea is of the quality to be enjoyed by consumers the world over. In addition, the trade expectations are to promote good manufacturing practice, quality conservation during economic transport and suitability of tea for high speed packing for attractive presentation in the supermarkets around the world. The next phase of work involved developing a standard for instant tea (ISO 6079) which is not only used for a more convenient way of preparing tea but is also a key ingredient in iced tea whether in the ready-to-drink form, which is increasingly becoming available, or in the dry mixes form which is available in countries where iced tea is very popular. The analytical methods to support this specification have also been developed and validated by international ring trials with laboratories representing producing and consuming countries. The advent of bulk packaging and containerization meant that the traditional tea chests became less economically viable, and they were also not ideal for protecting tea from moisture and taint. This stimulated the need for a packaging solution to transporting tea around the world. A major work programme was undertaken to develop a reference sack specification (ISO 9884-1) to provide standard dimensions for efficient use of container space, constructed with materials which ensure adequate strength, protection from moisture and taint together with the methods of test. The second part of the standard (ISO 9884-2) defines the performance specification for the sack. This does not envisage that one sack should be used for the transport of tea, but defines the material characteristics and performance characteristics by which alternatives can be evaluated and found acceptable.
Tasting tea in the sales room at Tetley using ISO 7516 every day.
It is important to develop methods of analysis validated internationally for the measurement of flavonoid and flavanol levels in tea.
The importance of world trade in tea lead to the recognition in the late 1960s and early 1970s that standards for tea quality should be established to smooth the progress of trade and to ensure consumers expectations are met. So, the tea committee was established and became part of ISO as Working Group 8 in the early 1970s and was fully established as a subcommittee (SC 8) of TC 34 in 1976. The good work of the committee started to made early progress by publishing the black tea standard (ISO 3720) in 1977. This established the basic parameters for good manufacturing practice for guidance with leaf plucking and tea sorting standards, prevent the sale of spent leaf and prevent the use of traditional adulterants. The definition of black tea was developed and provided the basic specifications of extractable solids, fibre and ash. The supporting work developing analytical methods for preparing samples and measuring moisture content, extractable solids, fibre and ash content were developed and validated in ring trials with laboratories representing both producing and consuming countries provided the 7 analytical methods which established the means of measuring the basic tea parameters. These methods form the basis of the international
trade of tea and are used for auditing purposes and for resolving of differences of opinion. In parallel with this work, methods for sampling tea (ISO 1839), for the preparation of liquor for use in sensory tests (ISO 7516), and for a glossary of terms relating to black tea were established to aid a common language to be developed in the tea sales rooms. Black tea is manufactured on a daily basis in season and a large volume of this production is sold at auction. This means that samples are distributed to agents and purchasers around the world to evaluate the organoleptic qualities of the tea to determine if it is suitable either for direct sale or for use in the familiar blends of tea we find on the supermarket shelves around the world. These methods are used everyday in the tea sales rooms for tea selection, valuation and purchase. An ISO tea grading nomenclature system (ISO 11286) has also been established to define different sizes and grades of tea leaf which can be used as part of this evaluation process.
The statue of Lu Yu, the early tea scholar, at the tea museum near Hangzhou, China.
New international analytical methods

The recent work programme has focussed on the development of compositional analytical methods for tea. A method for measuring caffeine in tea and instant tea (ISO 10727) was originally published in 1995 and has been updated to improve the sensitivity for determinations in decaffeinated tea. The two most recently developed methods to determine substances characteristic of tea, part 1 to determine total polyphenol content and part 2 to determine catechins in green tea,
32
are to be published in 2005. The need for these methods was envisaged in the first edition of the black tea specification but it is becoming even more important because in recent years there has been an increasing interest in the health benefits of tea consumption. Scientific research and epidemiology studies are proposing that consuming tea may maintain a healthy disposition to reduce the likelihood of succumbing to the excesses of cardiovascular disease and some cancers ; if it helps
The famous Longjing (Dragon Well) green tea.
Tea everyday at work
with hydration, it could assist weight maintenance programmes and bone maintenance amongst other benefits. It is therefore very important to develop methods of analysis which are validated internationally for the measurement of flavonoid and flavanol levels in tea. This is not only for compositional analysis to support the black tea standard but also to ensure that the quoted flavonoid contents of teas is meaningful and can be used for comparative purposes by consumers, the trade and legislators alike. The working group including participants in the UK, Germany, China and initially Malawi who looked at a number of different methods of analysis to form the basis for measuring total polyphenols (flavonoids) in tea before basing its work on the method of Singleton & Rossis 1965 paper in the American Journal of Enology and Viticulture. The challenges were
greater when developing a method to measure catechins (flavanols) in green tea because pure, verified chemical standards for accurate quantitation of the catechins are not commercially available. These standards were purified and circulated to the participants of the international ring trial together with HPLC columns filled with chromatographic material from the same batch so that quantitation could be verified and validated. This work has enabled the calculation of relative response factors which means that any analyst can now quantify the levels of catechins in green and black tea without the need to purchase very expensive chemical standards which may vary in their purity. This valuable work means that the methods can now be used equally well by analysts in the producing and consuming countries without placing either at a commercial disadvantage. The results of measurements with these methods can now also be used by the leading researchers in the
Dr. Scott (centre), recently appointed ISO/TC 34/SC 8 chair, with Professor Luo (right), leader of the Chinese delegation, and her colleague Ms Guo (left) at the recent ISO conference at Hangzhou, China in October 2003.
field who establishing the health benefits for consumers of tea. It has taken over 10 years to develop these methods, introduce refinements to improve their application and internationally validate their use with the collaboration of over 20 laboratories representing both producer and consumer countries. So it was fitting, and with great pleasure, that Dr Peter Collier, SC 8 Chair 1988-2003, presided over the ISO TC 34/SC 8 meeting which confirmed the proposal to publish these two methods as ISO standards in Hangzhou, China in October 2003.
Achievements of TC 34/ SC 8 and the future

The ISO Tea Committee, SC 8 which forms part of TC 34, has diligently worked for nearly 40 years to provide 19 international standards and provide technical expertise and support to ISO to ensure consumer expectations are met, to facilitate the international trade in tea, estimated to be worth over USD 25 billion, and to provide the guidance and common understanding of good manufacturing practices for black and green tea. The work is not complete, the two new compositional methods of analysis are ready for publication early next year and we are now ready to embark on the work to develop a green tea standard, long awaited by our Chinese colleagues. In addition, we are planning to develop a method for the analysis of theanine in tea and evaluate its use, because it is thought to be useful as an additional constituent in tea which might benefit health and because it is also a potential authenticity marker for tea. So when you raise your cup or glass of tea to your lips, you can rest assured that many experts in the trade are working with the officers at ISO to ensure you enjoy a good cuppa !
33
Developments and Initiatives

Standards of practice in dentistry
Prof. Dennis C. Smith, Chair, ISO /TC 106, Dentistry
t has been said that no one on their deathbed said that they wished they had spent more time at the dentist. For most of us a visit to the dentist comes to the top of the agenda only when it is absolutely necessary. A visit to the dentist is associated with the image of toothache and painful drilling and filling. Yet the reality is that todays dentistry provides pain-free restoration and preventive treatment. If preventive oral care was initiated in childhood and continued by the adult, most of us would have excellent teeth and would need only preventive care. Most of us did not inherit that situation so there is still a high demand as well as an unfulfilled need in many countries for clinical dentistry. In the last half-century, dental practice has been transformed by dental research and evidence-based clinical practice and by the development of standards for dental materials, instruments, appliances and equipment. Modern dentistry is much greater in scope, more complex and has a vastly greater scientific base. Todays general practice encompasses minimal tooth drilling, adhesive aesthetic fillings, periodontal care, root canal therapy and minor surgery and implants. This breadth of care stimulates an increasing need for standards of practice.
A systematic and collaborative approach

The development of dental materials technology and instrumentation for the fabrication of tooth restorations and dentures using ceramics, metals and polymers began two centuries ago. By the middle of the 19 th century, measurement of physical and mechanical properties to improve and standardize dental cements and filling materials was underway, most notably for dental silver-tin amalgam which provided a durable filling material for the masses. In 1920 a research group was set up at the US National Bureau of Standards in collaboration (in 1928) with the American Dental Association, to study and establish specifications for materials used in dentistry. The first specification for dental amalgam was published in 1927. This systematic and collaborative approach had a dramatic influence on manufacturers and the profession which was to extend world wide in the susequent decades. Several other countries set up similar programmes involving testing and certification which came to fruition after the Second World War. About the same time the FDI recognized the need for internationally applicable dental standards and by 1958 had created nine FDI Standards that were based on American National Standards. In that year the FDI entered into a collaborative arrangement with ISO to foster the worldwide acceptance of standards for dental materials and devices. This led to the establishment of an ISO technical committee for dentistry (ISO/TC 106) in 1963. After 1977 ISO/TC 106 assumed responsibility for dental materials, instruments, devices and equipment with the FDI being responsible for clinical and biological evaluations.
(appearance, bruxism prevention) and functional (chewing, temporomandibular joint) health. In recent studies, effects have been noted as diverse as increased blood flow to the brain as a result of chewing and the findings of epidemiologists that expectant mothers with gum disease are more likely to deliver too early or to have babies that are too small.
At present there are more than 100 dental bonding products on the market.
The inexorable aging of the population which is occurring in many Western and some other countries means that many people will maintain good health to the age of 85, but the majority will require at least some assistance for physical and mental impairment including dental rehabilitation. The implications of these changes for dental practice and the utilization of dental biomaterials are clear. Further, without consensual agreement on standards for practice the complex system of dental health care technology required to treat dental diseases in this population would be unable to function. The players in the dental standards area, in addition to the millions of patients, are the more than 700 000 dentists represented by the FDI (Fdration Dentaire Internationale) and its more than 150 constituent National Dental Organizations and the more than 4000 dental manufacturers represented by the International Dental Manufacturers and their constituent regional member associations.
Good oral health for general, psychological and functional health

It is now recognized that the mouth is an integral part of the body, and that good oral health is essential not only to general health (mastication, digestion) but also to psychological
34
The early work on ISO standards for dentistry was primarily concerned with physico-chemical characterizations of materials and their use as a basis for evaluation of fitness for practice. However, the rapid development of new materials and techniques, beginning in the 1960s, led to recognition of the importance of biological evaluations also to assure safety and efficacy in dental practice. This was accentuated by the introduction of legislative requirements for mandatory testing of dental and medical biomaterials in several countries. This necessity for biologic as well as physicochemical assessment has led to a much wider scope and area of responsibility for ISO/TC 106.
Fostering a youthful and aesthetic appearance

Over the last two decades, ISO/TC 106 has grown substantially as a result of the flood of new products and clinical techniques. There are three main trends that have prompted new work. Firstly, there is the public acceptance and appreciation of the importance of good teeth to a youthful and aesthetic appearance. Thus, the interest in oral hygiene and preventive materials such as toothpaste and other fluoride products, tooth whiteners and orthodontics.
1.
About the author

Professor Dennis C. mith was born n England, where he graduted in Chemistry from he University of London. He btained his PhD from the University of Manchester, and began his career in dental biomaterials there. In 1969, he moved to Canada to become Professor of Biomaterials and founding Director of the Centre for Biomaterials. He has been involved in standards work for 40 years, and is Chair of TC 106, Dentistry.
2.
Innovations demand both new standards and the revision of existing specifications.
Secondly, the increasing desire for cosmetic or aesthetic dentistry, which involves minimal size fillings and tooth-coloured filling materials such as polymer-ceramic composites and ceramics. This includes also the incorporation of bonding systems that show adhesion to the tooth and so improve retention and reduce marginal leakage and staining. This is the most rapidly growing area: for example, at present there are more than 100 dental bonding products on the market. Thirdly, the exponential increase in the use of titanium implants embedded in the jaws as a foundation for the replacement of a missing tooth or teeth
3.
1. The upper jaw of a patient with 7 titanium implant posts embedded in the bone. 2. The denture framework held in place by screws into the implant posts. 3. Front view of denture structure in the mouth.
Photos courtesy Dr. Philip Watson
35
Photo : ISO

so improving the retention of conventional dentures or avoiding such dentures altogether. Implants may also be used as anchors for orthodontic appliances. As a result of these trends, there are many new work items and many innovations which demand both new standards and the revision of existing specifications. Some estimate of the rapid growth can be gained from the fact that 20 years ago the average attendance at the annual ISO/TC 106 meeting was about 40 persons whereas now it is about 300. ties of current materials known to be acceptable in practice. Narrower limits and upgraded values would be possible if there were more data from the clinical setting or from realistic clinical simulations. A major problem of course is the rapid turnover of commercial products. We need to identify test methods that detect early deterioration of materials under clinical conditions. alie Martel has been appointed as the Secretary for the technical committee. Ms. Martel has a background in business administration and previously had experience with the Federation of Canadian Municipalities and the National Research Council of Canada. Nathalie Martel can be reached at nmartel@cda-adc.ca
Twenty years ago the average attendance at the annual ISO/TC 106 meeting was about 40 persons ; now it is about 300.
In addition to TC 106, about 20 other TCs are concerned directly or indirectly with healthcare technology. Those relevant to dentistry include : sterilization and disinfection, anaesthetic equipment, surgical instruments and materials, and surgical implants. A liaison is maintained with most of these committees. ISO/TC 106 has seven active subcommittees and 47 working groups. The total membership of the group is about 300. There are 150 published ISO standards relating to dentistry. This brief account of ISO/ TC106 is not able to detail the technical complexity of modern dental standards but it is hoped that it does indicate the dedication, effort and contribution of the members of the technical committee towards the endeavours to maintain dependable standards of practice in a rapidly changing world. In April 2004, BSI (United Kingdom) relinquished the secretariat of ISO/TC106, Dentistry after 30 years. The responsibility was assumed by Canada, which has been a member of the committee for many years. The secretariat is located at the Canadian Dental Association in Ottawa with the support of the Standards Council of Canada. Nath-
1.
2.
1 shows two corroded and broken silver tin amalgam fillings. 2 shows the same teeth after the metal fillings have been replaced by tooth-coloured resin-ceramic composite materials. (Illustrations courtesy of Dr. D. McComb).
Lack of clinical performance data

A considerable limitation to the existing standards is the lack of clinical performance data. This is improving, and there is an ISO standard on clinical trials (ISO 14155 Parts 1 and 2). Nevertheless, the standards reflect physico-chemical, mechanical and biological proper-
36
Photo : ISO
A world of applications for gas calibration

By Theo Hafkenscheid, Chair, ISO/TC 158, Analysis of gases, and Ortwin Costenoble, Secretary ISO/TC 158
ppearances can be deceptive. Although at first glance, the scope of our work appears restricted (preparation and use of calibration gas mixtures), on closer inspection, the standards it develops have a big impact on a wide range of applications where accurate knowledge of gas mixture composition is required : for demonstration of compliance with regulations, e.g., measurement of car emissions, alcohol tests, stack emissions, occupational exposure ; for trade purposes, e.g., measurement of compositions of natural gases, refinery gases, coke oven gases, measurements of air pollutant emission levels for the purpose of emission trading ; for industrial purposes, e.g., purity analysis of industrial gases, verification and certification of gas mixture compositions ; for environmental purposes, e.g., monitoring of greenhouse gases, stratospheric ozone scavengers, tropospheric ozone precursors. Our work is mainly concerned with the calibration of gases and gas mixtures; our market is limited specifically to the calibration of gas market, although the direct influence of what we do affects the whole gas market. All gas analysing equipment needs calibration: the use of calibration of gas mixtures is of extreme importance in situations in which even the smallest deviations in measurements
can have major consequences. In the international natural gas market, the caloric value needs to be known to the permillage, as it concerns major quantities in which a small deviation may involve millions of dollars.
Our incentive for implementation

Ten years ago, ISO/TC 158 set out upon its work programme under new Dutch chairmanship. For all the applications highlighted above, ISO/TC 158 has produced guidance standards to describe generic methods for preparation of calibration gas mixtures and ways of calculating gas composition and the determination of uncertainty when measuring.
Photo : TNO-NMI, Dutch Metrology Institute
Calibration of gas mixtures is of extreme importance in situations in which even the smallest deviations in measurements can have major consequences.
Over the years, four standards dealing with dated preparation methods were withdrawn, and some others transposed to ISO/TC 193, Natural gas. Moreover, the gas analysis vocabulary (ISO 7504) has been updated. Additional standards focus on quality control of gas analysis and handling of gas cylinders, aimed at supporting the production of reliable gas composition data and, thereby, at promoting a smooth and reliable worldwide transaction of industrial and other gases.
Photo : Scott Specialty Gases
37

Our library currently consists of 19 standards and technical reports. ISO/TC 158 members have been, and still are, active in other standardization committees, such as in ISO/TC 193, Natural gas, and ISO/TC 146, Air quality, providing input aimed at the accurate measurement of specific gas mixture compositions. As a consequence, TC 158 standards have now become normative references in many standards devoted to the applications mentioned above. Additional standards enhance quality control and the handling of products, avoid the risks of producing quality data that are not sound, and ensure smooth and reliable worldwide transactions in industrial and other gases. starting a process of consultation with CEN, the European Committee for Standardization, to have its standards adopted as European standards.
All players meet in Amsterdam

In Kiev, we solved the ultimate problems and made the final touchups on a work programme that started in 1994 and consisted of a revision of all the TCs standards and the addition of four guidance documents. This explains the interest of the subject and why we have organized an international symposium, the International Gas Analysis Symposium and Exhibition, to be held between 6 and 8 October 2004 in the RAI congress centre in Amsterdam that is to be addressed by Mr. Rein Willems, President Director of Shell Netherlands, to highlight and show off our rejuvenated standards. This has become a regular event, unique in the gas and calibration world, where researchers, industrials, laboratory workers and calibration gas users meet each other with a focus on international standardization. The event is also used to test new standardization
ideas in and to extract new directions for standardization from the work field. At the symposium, experts from all over the world will assemble to exchange knowledge on the latest developments. A variety of subjects will be addressed in parallel sessions, such as trace elements, on- and off-line analyses, sampling guidance and new applications of gases, gaseous fuels and calibration gases. With the Kiev update of our programme, ISO/TC 158 is ready for new challenges, and cooperation with other ISO technical committees working on gases. We will discuss all existing and upcoming ideas and requests from standard users. ISO/TC 158 work in the future is likely to be mainly in producing technical specifications and informative standards, to act as a generic starting point for the development of more specific, compound-oriented methods for gas analysis. Obviously, ISO/TC 158 offers its support to other TCs dealing with analyses of gases and gas mixtures.
Photos : TNO-NMI, Dutch Metrology Institute
About the authors

Theo Hafkenscheid, chair of ISO/TC 158, Analysis of gases, has a background in analytical chemistry and a PhD in physics and mathematics. He is a senior scientist at the Mass and Chemistry department of NMi van Swinden Laboratory, the Netherlands. Mr. Hafkenscheid is an expert in quality assurance/quality control of measurements of gases, with a focus on air quality monitoring, and has 20 years of experience in various standardization committees and working groups. Ortwin Costenoble, secretary of ISO/TC 158, Analysis of gases, has a background as a materials engineer. He joined The Netherlands Standardization Institute (NEN) in 2000 as a standardization consultant, immediately taking care of the Secretariat of ISO/TC 158. He is also involved in (mainly European) projects in petroleum, LPG, alternative fuels and natural gas.
When ISO/TC 158 met in a plenary session in April 2004 in Kiev, Ukraine, we finalized the work of four of our six working groups. Only a few amendments and a technical report were added to our work programme. To bolster the incentive to users to implement its standards in particular, to the new European Union member states the TC is currently
38
New this month

Circumscribing a scourge : corrosion
The corrosion process is the starting point or the catalyst for a number of industrial failures, accidents and catastrophes (Bhopal, for instance), as well as day-to-day problems. Corrosion is the physicochemical interaction between a metal and its environment that results in changes in the properties of the metal. Under modern industrial conditions, corrosion as a process is no longer just a build-up of layers of rust on the surface of metal as a result of water vapour and salt action. Like a virus, it adapts itself insidiously to environmental conditions, and causes great damage and considerable loss of income, estimated at 3 % of GNP in developed countries. ISO standards have a very considerable and significant role to play in preventing it arising and halting its progress.
The ISO Standards Handbook : Corrosion will prove a useful tool for designers, engineers, technologists.
Year of transition for ISO 9000 and confirmed growth for ISO 14001
The ISO Survey of ISO 9001: 2000 and ISO 14001 Certificates, which each year provides a panorama of certification to ISOs well-known quality and environmental management system standards, has just been published revealing the worldwide situation at the end of 2003, which was a year of transition for ISO 9000 and confirmed growth of ISO 14001. ISO itself does not perform certification to its ISO 9000 and ISO 14001 management system standards and does not issue ISO 9000 and ISO 14001 certificates. It carries out The ISO Survey, which is now in its 11th year, as a public information service. ISO collects the survey data from disparate sources and cannot guarantee their quality and accuracy. However, the survey is eagerly awaited each year since it provides a unique indicator to the worldwide implementation of ISOs management system standards although organizations may also implement and benefit from the standards without seeking certification. The survey provides the following principal results for 2003 : ISO 9001:2000 Up to the end of December 2003, at least 500 125 certificates to the ISO 9001:2000 quality management system standard had been issued in 149 countries and economies. The 2003 total represents an increase of 332 915 (+ 200 %) over 2002, when the total was 167 210 in 134 countries and economies. The 2003 total represents an increase of 455 737 (more than ten times higher) over 2001, the first year for which the survey recorded ISO 9001:2000 certifications, when the total was 44 388 in 98 countries and economies.
The ISO Standards Handbook Corrosion 1) gathers together into one volume 56 International Standards for corrosion and corrosion protection mostly prepared by ISO/TC 156, Corrosion of metals and alloys (38 standards), that takes the lions share. But, showing just how prevalent this scourge is, many other ISO technical committees have developed specific standards related to the phenomenon: ISO/TC 17, Steel, ISO/TC 28, Petroleum products and lubricants, ISO/TC 67, Materials, equipment and offshore structures for petroleum, petrochemical and natural gas industries, ISO/TC 79, Light metals and their alloys, ISO/TC 44, Welding and allied processes, ISO/TC 22, Road vehicles, ISO/TC 26, Copper and copper alloys, ISO/TC 114, Horology, and ISO/ TC 123, Plain bearings. So important are the preparation and protection of steel substrates that the whole of Volume 4 of the ISO Standards Handbook, Paints and varnishes, is devoted to this subject. Failures due to corrosion impact on health and safety, and on the environment so that the avoidance and control of corrosion are of the utmost importance. The ISO Standards Handbook : Corrosion will prove a useful tool for designers, engineers, technologists, and for all those dealing with corrosion protection in different branches of industry.
1) ISO Standards Handbook, Corrosion. In English, ISBN 92-67-10395-4, 1st ed. 2004, 930 p.
39
New this month

ISO 14001 The increase in the number of certificates in 2003 to the ISO 14001 environmental management system standard is the largest so far recorded in the nine surveys in which ISO 14001 has been included. Up to the end of December 2003, at least 66 070 certificates to ISO 14001 had been issued in 113 countries and economies. The 2003 total represents an increase of 16 621 (+ 34 %) over 2002, when the total was 49 449 in 117 countries and economies. Following the 15 December 2003 deadline for transition from the 1994 versions of the ISO 9001, ISO 9002 and ISO 9003 standards, ISO 9001:2000 became the only ISO 9000 standard for accredited certification recognized by ISO and the International Accreditation Forum (IAF). At the end of 2003, two weeks after the transition deadline, the 500 125 total of ISO 9001:2000 certificates was equivalent to 89 % of the 2002 world total of 561 747 of ISO 9000 (old and new versions) certificates. However, ISO qualifies this, stating : The 11 % of non-ISO 9001: 2000 certificates identified by the survey at the end of 2003 cannot be taken as a final measure of the transition. This 11 % includes organizations that have made the transition since the deadline, or are still to do so during the course of 2004. These include late starters in the transition process who were unable to complete it by the deadline, and also includes organizations that, due for a re-certification audit in 2004, decided to make the transition by this date. The number of ISO 9001: 2000 certificates shows an increase of 332 915 over 2002, and the worldwide total of ISO 9000 certificates (old and new versions), shows an apparent increase of 6 238 from 561 747 to 567 985. ISO states that this increase has to be qualified apparent because not all survey sources were able to supply 1994 version figures, having deleted these from their databases. certificate covering multiple sites. This evolution affects multinational companies in particular. Its complete extent is unknown, although the partial figures obtained indicate that the phenomenon is growing. A second evolution is that several major global industries are implementing quality management system requirements that incorporate ISO 9001:2000 with additional ones specific to their sector. This reduces the number of pure ISO 9001:2000 certificates, replacing them by sectorspecific certification. However, the survey adds : Paradoxically, this evolution may actually be increasing the number of ISO 9001:2000 certified organizations because ISO 9001:2000 is incorporated within sector-specific documents that are being cascaded down the global supply chains of important sectors comprising many thousands of supplier companies. Examples are ISO/TS 16949:2000 (automotive), TL 9000 (telecommunications) and ISO/TS 29001 (oil and gas). It has not been possible to analyze precisely the impact of the above factors. Consequently, ISO intends to improve and refine the modalities for the collection of data for the 2004 edition, in particular to obtain a clearer picture of single multiple-site certificates as well as of certification to other ISO management system standards. The principal survey findings are provided free of charge on ISOs Web site, including world, regional and country breakdowns. Previous survey editions are also posted on the site allowing comparison of data from the first survey in January 1993. The ISO Survey of ISO 9001: 2000 and ISO 14001 Certificates 2003 (ISBN 92-67-10393-7) is also available as a combined report and CD-ROM. In addition to the categories of data listed above, the report includes world totals by industrial sector, while the CDROM also provides country-by-country breakdowns by industrial sector. A considerable amount of free information on ISO 9000 and ISO 14000 is available on ISO Online.
In addition, the survey identifies two developments in particular as being responsible for reducing the worldwide total of certificates. One is the evolution from multiple, single-site certificates to single, multiple-site certificates. This is the case of organizations operating multiple sites, each of which previously held a separate certificate, that have now rationalized their certification programme as they made the transition and obtained a single ISO 9001:2000
40
Coming up
on the part of its stakeholders were condensed into a global vision for the coming five years that is being considered at the General Assembly. The broad lines and thinking behind the Plan are highlighted in this issue of ISO Focus. The role that standards can play in assuring global security and ISOs current and potential involvement is to be the theme of a talk at the General Assembly, followed by a case study in maritime and multi-modal transport ; the potential for ISO standards to develop tools to assist in attaining greater global security is also the subject of a report from ISOs highlevel advisory group on security, that is conducting a stakeholder outreach programme. The global relevance of standards has been a topic of discussion for some time ensuring that the standards ISO produces are good for use through the world. To emphasize the importance of this aspect of International Standards to standardizers, members and stakeholders, ISOs Technical Management Board has developed a Policy Statement giving the theory and practice behind the term of global relevance ; ISO explains why these represent important notions for members and standardizers to keep constantly in mind. vide a basis for international trade in system products and services . From a summary of a vast body of systems thinking about products and services, best practice has been progressively refined and formalized, and has culminated for the first time in a single, commonly accepted, international viewpoint set in the business context.
Corrosion protection of steel structures. ISOs

Standards Handbook on Corrosion is now available. Corrosion has a voracious appetite, and the damage it causes is very considerable. Corrosion of steel can be prevented by various procedures most effectively, by coating systems. ISO 12944, Paints and varnishes Corrosion protection of steel structures by protective paint systems (in eight parts) contains all the important information on the protection of steel structures against corrosion by coating systems. Through the wide variety of options of design of steel structures, their range of application is vast. ISO Focus takes a look at the standards potential.
Main Focus
Global relevance and global strategies
Global is not only a very concrete concept in the business context of today, but a vital component in social and technical fields as well, where it is difficult to operate effectively without taking the global factor into account. In the standards area, it is a key element to ensure the effectiveness of the use of standards and to help avoid raising technical barriers to trade . Though the phenomenon has been growing exponentially over last decades, the notion of global will be especially present at the ISO General Assembly this month. The 2004 event in Geneva, debating about both what has happened over the year since the General Assembly in Argentina in 2003 and what is in the pipeline today, global has been an issue affecting many or most of the major issues currently on the table. Between May and October 2003, ISO organized a consultation of ISO members and stakeholders and of ISOs major international partners to collect suggestions and expectations regarding ISOs strategy, ISO Strategic Plan 2005-2010 Standards for a Sustainable World. The fruits of the thought, reflection and consultation

Business excellence. Global, too are todays patterns of trade, leading to products and services that can be more complex, have wider scopes of operation and draw on suppliers offering a greater diversity of technology than ever before. ISO/IEC 15288, Systems engineering System life cycle processes is an ambitious standard from ISO/IEC JTC 1/SC 7, Software and system engineering, to pro-
Measurement of water cycle components. Water in a stream

knows no jurisdictional boundaries, neither local nor national, and that same water may eventually move to any other part of the earth through the water cycle. Measurement of the components of the water cycle therefore require to be measured to universally acceptable methods and the function of ISO/TC 113, Hydrometry, is to prepare the necessary standards.
Whether its Autumn or Spring in your region...

...the environment is global.
1 1400 ISO
ISO 1 4004
Coming this Winter (or Summer), the revised ISO 14001* and ISO 14004*. The global EMS standards. www. .org
* Already available as FDIS (Final Draft International Standards)

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ISO F ocus

The Magazine of the International Organization for Standardization

Food and beverage

Food and beverage

34 Developments and Initiatives

39 New this month 41 Coming up

The fruit of cooperation : better, safer food I

Prof. Andrs Salg Chair ISO/TC 34, Food products

ISO Focus September 2004

WTO examines conformity assessment

Global Compact Summit fights corruption

Focus on Russias oil and gas sector

ISO Focus September 2004

Quality management for the automotive industry

Seminar in Iran on conformity assessment and product certification

ISO President underlines diversity of ISO standards

ISO Secretary-General meets with President of Ukraine

ISO Focus September 2004

Photo : Nesstl Research Center

ISO Focus September 2004

Nestl International Headquarters in Vevey, Switzerland.

ISO Focus July-August 2004

Ensuring integrity of the food supply chain

What is the standard about ?

Who are the intended users?

ISO 22000 specifies requirements for a food safety management system.

What does it cover ?

Why is it important now ?

Wholesalers Service providers Retailers

Other supplying food chains

ISO Focus September 2004

What are the benefits for users ?

About the authors

ISO Focus September 2004

Status of the work

What are the benefits for other stakeholders ?

By Andrs Salg, Chair ISO/TC 34, Food products

ISO Focus September 2004

Tracking food paths

Governments and consumers demand traceability

Where can traceability systems help ?

About the author

Detection of genetically modified organisms and derived foods

Traceability as a two-way exchange

ISO Focus September 2004

About the author

Table 1. Samples of international labelling provisions for GM foods

Australia & New Zealand Mandatory

Figure 1 : Strategy of the detection of genetically modified material in foods

Protein extraction and immunoassay

Detection of genetic modifications in foods

ISO Focus September 2004

Figure 2: PCR-based GMO detection methods

Standardization of Methods of GMO Detection

ISO Focus September 2004

Microbiological analysis of foods and animal feeding stuffs

Potential trade barriers

About the author

ISO Focus September 2004

Use of ISO standards in food microbiology

A multiplicity of methods often results in a duplication of the analyses.

ISO standards are cited in several national regulations.