Enhancing participation in Codex activities

An FAO/WHO training package

Enhancing participation in Codex activities

An FAO/WHO training package

Food and Agriculture Organization of the United Nations World Health Organization 2005

All rights reserved. Reproduction and dissemination of material in this information product for educational and other non-commercial purposes are authorized without any prior written permission from the copyright holders provided the source is fully acknowledged. Reproduction of material in this information product for resale or other commercial purposes is prohibited without written permission from the copyright holders. Applications for such permission should be addressed to the Chief, Publishing Management Service, Information Division, Food and Agriculture Organization of the United Nations, Viale delle Terme di Caracalla, 00100 Rome, Italy or by e-mail to [email protected]; or to World Health Organization Press, 20 Avenue Appia, 1211 Geneva 27, Switzerland, or by e-mail to [email protected]. FAO/WHO 2005

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United Nations nor of the World Health Organization concerning the legal or development status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. All reasonable precautions have been taken by the Food and Agriculture Organization of the United Nations and the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the Organizations be liable for damages arising from its use.

WHO Library Cataloguing-in-Publication Data Food and Agriculture Organization of the United Nations. Enhancing participation in Codex activities An FAO/WHO training package. 1.Food - standards 2.Food industry - standards. 3.National health programmes 4.Guidelines 5.Teaching materials I.World Health Organization II.Title. ISBN 92 4 159349 0 ISBN 92 5 105277 8 (NLM classification: WA 695)

For further information, please contact: Food Quality and Standards Service Food and Nutrition Division Food and Agriculture Organization of the United Nations Viale delle Terme di Caracalla, 00100 Rome, Italy Fax: (+39) 06 57054593 E-mail: [email protected] Web site: www.fao.org/es/esn or Department of Food Safety, Zoonoses and Foodborne Diseases World Health Organization 20, Avenue Appia, CH-1211 Geneva 27, Switzerland Fax: (+41) 22 7914807 E-mail: [email protected] Web site: www.who.int/foodsafety

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Contents
Acknowledgements Foreword Summary Abbreviations

Section 1: Establishing and maintaining national Codex activities

Section 2: Understanding the organization of Codex

Section 3: Basics of national Codex activities

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Section 4: Scientific basis for Codex work

Enhancing participation in Codex activities

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Acknowledgements

FAO and WHO would like to thank the Governments of Canada and Switzerland for their generosity in making available expertise during the development of this training package, and in providing financial support to assist in the field testing and translation of the material into other languages.

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Foreword

FAO, WHO and the Joint Food Standards Programme

The Codex Alimentarius Commission was established by FAO and WHO to develop international food standards, guidelines and recommendations to protect the health of consumers and to ensure fair practices in the food trade. This collection of food standards, entitled the Codex Alimentarius, or the food code, has become the global reference point for consumers, food producers and processors, national food control agencies and the international food trade. This code has had an enormous impact on the thinking of food producers and processors, and has enhanced awareness among end users the consumers. Its influence extends to every continent, and its contribution to the protection of public health and fair practices in the food trade is immeasurable. The responsibility for developing the standards that are adopted into the Codex Alimentarius rests with the Codex Alimentarius Commission and its subsidiary bodies. These standards are science-based and are elaborated taking into consideration the expert advice provided by joint expert committees established by FAO and WHO, such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) and the Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA), or by ad hoc expert consultations such as the Joint FAO/WHO Expert Consultation on Evaluation of Allergenicity of Genetically Modified Foods (2001). FAO and WHO also complement the Commissions activities through their capacitybuilding programmes. In order to be in a position to enact Codex standards, countries need adequate food legislation, as well as a technical and administrative infrastructure with the capacity to implement it and ensure compliance. For many years, FAO and WHO have been providing assistance to developing countries to enable them to take full advantage of the work of the Codex Alimentarius Commission. In order to participate fully, and take advantage of such participation, countries that are Members of the Commission should have solid knowledge of how it is organized and functions and, further, should understand the support provided to it by FAO and WHO through the provision of scientific advice and capacity-building projects and activities. It is also recognized that a strong national Codex framework facilitates not only the national Codex process, but also contributes to a strengthening of national food safety control systems. In this context, FAO and WHO have developed this training package. The reference material drawn on to prepare this training package was available at the time of publication. As the Codex Alimentarius Commission and its subsidiary bodies meet regularly, more up-to-date material may become available before the training package can be updated. Such information may be found on the Codex Web site: www.codexalimentarius.net.

Enhancing participation in Codex activities

Foreword

Structure of the training package

This package serves two purposes. First, it provides a step-by-step guide for use by countries that are becoming involved in Codex work and are developing a national framework to support this involvement. Second, it provides information that can be used by countries to develop training programmes to suit their specific needs and thus enhance their capability to participate in the work of the Codex Alimentarius Commission. The package identifies and provides information in the form of modules with relevant visual aids, grouped around distinct themes. This structure provides the flexibility to develop a training programme to meet the needs of a specific country, by allowing the organizer of the training to select those modules that contribute to the achievement of the training objective.
How to use this package

This package is intended primarily for use by individuals who need to provide information, in a condensed form, to limited audiences composed of ministers and/or senior government officials, and for those who provide training on Codex and the international food standard-setting process. This includes, but is not limited to, consultants, national Codex Contact Points and individuals in observer organizations, including those representing food industry and consumer groups, who have responsibility for coordinating input into Codex work. The material in this package will also be of use to others such as policy-makers and academia involved in developing or strengthening national food safety systems based on Codex standards. The package is composed of four sections, each section having a common theme and containing a number of modules related to that theme. Each module generally consists of: printed material on the subject of the module, including sample documents or case studies; a list of reference material; practical exercises; and suggested text for visual aids. The package includes a CD-ROM containing the visual aids and other relevant reference materials. The package has been designed to permit flexibility in customizing a training programme to meet the needs of a specific country. In developing a customized training programme, trainers should have a clear idea of the desired outcomes. This will enable them to identify which sections and/or modules provide the material relevant to the achievement of the training objective. For example, a Codex Contact Point in a country may need to develop a brief presentation for the purpose of increasing Codex awareness among senior officials or ministers. By selecting information from the appropriate modules, the Codex Contact Point can prepare a presentation outlining the general nature of the Codex Alimentarius, how the countrys Codex process functions, and linkages with the World Trade Organization (WTO) to help highlight the importance of participation in Codex. The package has been compiled as a training tool that can be adapted for use in field training. Each module has been developed so that any or all parts of the module can be reproduced (e.g. photocopied) by the trainer to provide handouts to participants. Furthermore, each module contains proposed text for visual aids that can be used as they are or can be modified by the trainer to suit a specific situation. The related practical exercises may be used to reinforce the training objective.

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Foreword

Getting started

The introductory first section, Establishing and maintaining national Codex activities, is designed to outline the initial steps to be taken to establish a national framework in order to participate in Codex. It outlines the considerations that should be taken into account in establishing a programme, including the importance of identifying which government ministries have a constitutional role in food safety, and how these ministries will communicate. This component of the package is designed primarily for working directly with the national Codex Contact Point and support staff to facilitate the setting up and functionality of the countrys Codex involvement. While the focus is on the initial setting up of the Codex programme, this section also contains general advocacy information that is useful to ensure continued government support, seek additional resources, etc. The remaining sections are intended for the conduct of training in those countries that have identified a Codex Contact Point and wish to enhance the functioning of the Codex Contact Point and national Codex framework. Sections 2 and 3, although designed for a broad audience, should be studied by those involved in the management of the countrys Codex programme, including the Codex Contact Point and any support staff. Section 2 (Understanding the organization of Codex) provides general background information on the Codex Alimentarius and how the Codex Alimentarius Commission is organized to undertake its standard-setting work. The section covers the structure of the Commission and its subsidiary bodies, terms of reference of the subsidiary bodies, the process of standards elaboration, and an outline of procedures at sessions of the subsidiary bodies. Section 3 (Basics of national Codex activities) provides information relating to Codex activities at the national level. It covers the need for the government ministries, departments or agencies with a constitutional mandate to be involved in the national Codex programme. The functions of Codex Contact Points and national Codex structures are elaborated, criteria for building national delegations are suggested, and the responsibilities of delegations are identified. Guidance on developing a national consultative process is also provided, as is guidance on developing national positions. This section emphasizes that participation in Codex is not attendance at a meeting, but involves a number of activities prior to leaving for a meeting such as the review of working documents, appropriate consultation and the preparation of written comments. Section 4 (Scientific basis for Codex work) provides information on the use of scientific and other expert advice in the elaboration of Codex standards. It covers the purpose and functions of the permanent expert bodies (e.g. JECFA and JMPR), the role and functions of JEMRA and ad hoc expert consultations, and the availability of different types of expert advice. The focus of this section is to provide information on the risk analysis terminology used in Codex, and on how the various scientific advisory functions work, but it is not intended to provide guidance on how to conduct a risk analysis. Guidance for member countries on the conduct of a risk analysis at the national level is provided in the FAO/WHO Food safety risk analysis An overview and framework manual.1

Joint FAO/WHO publication, provisional edition. 2005.

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Summary

Section 1: Establishing and maintaining national Codex activities Module 1.1 / Why should my country become involved in Codex?

Outlines the importance for countries of becoming involved in Codex, and the significant role of the FAO/WHO coordinating committees.
Module 1.2 / My country wants to be involved in Codex, what should be done?

Outlines the steps to be taken when deciding whether a country should become involved in Codex, suggests who should be involved in the decision-making process, and provides guidance on how a country becomes a Member.
Module 1.3 / What resources do we need?

Helps countries to determine their minimum resource requirements.

Module 1.4 / What are the first steps my country should take to participate in Codex work?

Designed to help countries identify which ministries should be involved in the implementation of a national Codex programme, addressing issues related to national Codex committees/structures, coordination and networking with other Codex Contact Points, particularly other Codex Contact Points in the same region.

Section 2: Understanding the organization of Codex Module 2.1 / Codex: a historical perspective

Provides a brief history of food standard setting and of the establishment of the Codex Alimentarius Commission.
Module 2.2 / What is Codex?

Reviews the mandate of the Codex Alimentarius Commission and examines key statutes, particularly those related to membership and Rules of Procedure.
Module 2.3 / How is Codex organized?

Looks at the organizational structure of the Codex Alimentarius Commission, the Executive Committee, the role of the Secretariat and the different types of committees within the structure.

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Summary

Module 2.4 / Which committees should my country be involved in?

Reviews the terms of reference of the various subsidiary bodies, with a practical exercise designed to facilitate the identification and prioritization of those Codex committees/task forces of most significance to the country in which the training is being conducted.
Module 2.5 / How do Codex committees function?

Outlines the Rules of Procedure, clarifies the responsibilities of host countries regarding the organization of sessions of subsidiary bodies of the Codex Alimentarius Commission, and provides information on the conduct of meetings including how countries should participate in debates.
Module 2.6 / How does Codex elaborate standards?

Outlines the five- and eight-step elaboration process.

Module 2.7 / Understanding Codex documentation

The purpose is to demystify Codex documentation. ALINORMS, circular letters and the numbering system of Codex documents are explained.
Module 2.8 / Is there a format for Codex standards?

Outlines the format used for Codex standards and the advantages of using this standard format, with a practical exercise for participants to draft a commodity standard for a product relevant to their economy.
Module 2.9 / What is the difference between the Codex Alimentarius Commission and the Codex Alimentarius?

Outlines the scope and nature of the Codex Alimentarius.

Module 2.10 / What is the relationship between Codex standards and WTO?

Outlines the linkages between Codex and the Agreements on the Application of Sanitary and Phytosanitary Measures (SPS) and on Technical Barriers to Trade (TBT) of the World Trade Organization.

Section 3: Basics of national Codex activities Module 3.1 / Functions of a national Codex Contact Point

Outlines the core functions of a national Codex Contact Point.

Module 3.2 / How to develop national positions on Codex issues

Provides guidance on developing national positions on Codex issues, with emphasis on preparation and submission of written comments, also covering issues related to national Codex coordinating structures (e.g. National Codex Committee) and the need for effective consultation. A practical exercise on developing a national position is included.
Module 3.3 / Considerations for selecting national delegations

Provides guidance and criteria to assist in selecting an individual to head a delegation and, if appropriate, and subject to available resources, any other person whose role would be to advise the head of the delegation.

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Summary

Module 3.4 / Organizing Codex documentation

Addresses the receipt and storage of Codex documents, also demonstrating the link between Codex standards and the development of national legislation.
Module 3.5 / What do FAO and/or WHO offer to help implement or make use of Codex standards?

Examines the use of Codex standards as the basis for national food safety legislation or for establishing national food control systems. Appropriate capacity-building activities are identified.

Section 4: Scientific basis for Codex work Module 4.1 / Risk analysis in the framework of Codex

Outlines the scientific principles adopted by the Commission that underpin its sciencebased standard-setting process, and provides the key risk analysis terms found in Codex documents.
Module 4.2 / Requesting, accessing and contributing to expert scientific advice

Provides information on how countries can access the results of risk assessments, and/or how countries can provide input into risk assessments. In addition, guidance will be offered on how countries can request risk assessments on issues relevant to them.
Module 4.3 / Joint FAO/WHO Expert Committee on Food Additives (JECFA)

Outlines the role and functions of JECFA.

Module 4.4 / Joint FAO/WHO Meeting on Pesticide Residues (JMPR)

Outlines the role and functions of JMPR.

Module 4.5 / Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA)

Outlines the role and functions of JEMRA.

Note:

The Codex Alimentarius Commission, through its various subsidiary bodies, elaborates standards, recommended codes of practice and guidelines. Unless stated otherwise, in this training package the term standards is used in its generic sense to include all the types of texts developed by the Codex Alimentarius Commission.

Enhancing participation in Codex activities

Abbreviations

ADI CAC CCEXEC CCAFRICA CCASIA CCCPC CCCPL CCEURO CCFAC CCFFP CCFFV CCFH CCFICS CCFL CCFO CCGP CCLAC CCMAS CCMH CCMMP CCNASWP CCNEA CCNFSDU CCNMW CCPFV CCPR CCRVDF CCS CCVP CL CRD ECE FAO GATT IPCS

Acceptable daily intake Codex Alimentarius Commission Executive Committee of the Codex Alimentarius Commission FAO/WHO Coordinating Committee for Africa FAO/WHO Coordinating Committee for Asia Codex Committee on Cocoa Products and Chocolate Codex Committee on Cereals, Pulses and Legumes FAO/WHO Coordinating Committee for Europe Codex Committee on Food Additives and Contaminants Codex Committee on Fish and Fishery Products Codex Committee on Fresh Fruits and Vegetables Codex Committee on Food Hygiene Codex Committee on Food Import and Export Inspection and Certification Systems Codex Committee on Food Labelling Codex Committee on Fats and Oils Codex Committee on General Principles FAO/WHO Coordinating Committee for Latin America and the Caribbean Codex Committee on Methods of Analysis and Sampling Codex Committee on Meat Hygiene Codex Committee on Milk and Milk Products FAO/WHO Coordinating Committee for North America and the Southwest Pacific FAO/WHO Coordinating Committee for the Near East Codex Committee on Nutrition and Foods for Special Dietary Uses Codex Committee on Natural Mineral Waters Codex Committee on Processed Fruits and Vegetables Codex Committee on Pesticide Residues Codex Committee on Residues of Veterinary Drugs in Foods Codex Committee on Sugars Codex Committee on Vegetable Proteins Circular letter Conference room document Economic Commission for Europe (of the United Nations) Food and Agriculture Organization of the United Nations General Agreement on Tariffs and Trade International Programme on Chemical Safety

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Abbreviations

IPPC International Plant Protection Convention JECFA Joint FAO/WHO Expert Committee on Food Additives JEMRA Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment JMPR Joint FAO/WHO Meeting on Pesticide Residues MRL maximum residue limit NCC National Codex Committee OECD Organisation for Economic Co-operation and Development OIE World Organisation for Animal Health SPS Agreement Agreement on the Application of Sanitary and Phytosanitary Measures TBT Agreement Agreement on Technical Barriers to Trade UN United Nations WHO World Health Organization WTO World Trade Organization

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Section 1

Establishing and maintaining national Codex activities

Contents

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3 4 4 5 6 7 7 7 8 11 9 12 12 12 13 14 14 14 15 15 15 16 16 16 17 19

Introduction Module 1.1 / Why should my country be involved in Codex? Why should countries become involved in Codex? What level of commitment should a country give to Codex? Briefing the decision-makers Module 1.2 / My country wants to be involved in Codex, what should be done? Step 1 Determine if it is appropriate Step 2 Advocacy Step 3 Identify the Codex Contact Point Step 4 Request membership Box 1.2.1 / Notification of membership form Module 1.3 / What resources do we need? The Codex Contact Point Administrative support for the Codex Contact Point Infrastructure Module 1.4 / What are the first steps my country should take to participate in Codex work? Establish contacts with other government ministries Establish contacts with industry Establish contacts with consumers Establish a mechanism to enhance national collaboration Conduct Codex workshops Circulate reports Start submitting written comments Regional liaison/networking Prepare regular briefings for senior officials Visual aids

Enhancing participation in Codex activities

Enhancing participation in Codex activities

Section 1

Introduction

This section is designed to provide guidance to countries that are contemplating or are in the initial processes of becoming involved in the work of the Codex Alimentarius Commission, and addresses the establishment of a Codex Contact Point. It can, however, also be used by countries already involved in Codex as guidance on continuing advocacy for Codex activities in their country. Therefore, general advocacy material is included which may be used from time to time by those responsible for ensuring ongoing support to, and identification of, resources for national Codex activities. Issues that should be taken into account when becoming involved in Codex work are reviewed, including the importance of identifying which government ministries have a constitutional role in food safety and food standard setting, and how these ministries should collaborate to facilitate a countrys effective participation in Codex activities. The need to identify and include all stakeholders in the process is also stressed. This component of the package is designed to assist a country in the process of establishing domestic Codex activities, and to help identify the level of commitment appropriate for its circumstances.

Enhancing participation in Codex activities

Section 1

Module 1.1

Why should my country become involved in Codex?

Often, the first step in obtaining political or senior management support for involvement in the work of the Codex Alimentarius Commission is providing an answer to the basic question Why become involved? In any country, whether it is a developing country, a country with a small economy or a developed country, senior decision-makers will need to be convinced of the benefits that will accrue as a result of utilizing resources, which are often limited, to become involved in the activities of the Codex Alimentarius Commission.
Why should countries become involved in Codex?

It is important for countries to become involved in the Codex process for the following reasons: 1. Growth in world food trade has created potential opportunities for consumers to have greater access to a wider variety of foods. This has subsequently created potential opportunities for countries to expand their economic productivity. The increase in food trade has heightened the need for international food standards to protect the health of consumers and to ensure fair practices in the food trade. 2. As a result of the increase in food trade among nations, there is a greater probability of diseases indigenous in one country to be transmitted to another country in which such diseases had not previously been prevalent. In addition, with the international movement of food products that may carry risks to human health, it is important to develop appropriate standards to protect the health of the consumer. Codex provides a ready-to-use compendium of such standards that can be readily adapted, where appropriate, to the country situation. 3. Codex is an international risk management body and, by using Codex standards and related texts, countries can make substantial savings in time and money incurred in risk assessment and risk management processes. Participation in Codex and use of Codex standards assists policy-makers in building a sound national food control system to provide food of adequate quality and safety, and to protect the consumer. 4. It should be noted that Codex is not just a forum for developing standards, but that the elaboration process also provides opportunities to exchange information and share views on food safety and quality issues. Therefore, member countries can be kept apprised of international developments in food safety and quality including new or pending technological developments, new products entering the marketplace and upto-date measures in the management of food safety and quality issues. 5. The status of Codex standards under World Trade Organization (WTO) agreements has increased the significance of Codex standards. Codex standards are explicitly referenced in the Agreement on the Application of Sanitary and Phytosanitary

Enhancing participation in Codex activities

Section 1 | Module 1.1 / Why should my country become involved in Codex?

Measures (SPS Agreement) as the international benchmark for food safety. According to this agreement, Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, and shall not be applied in a manner that would constitute a disguised restriction on international trade. The Agreement on Technical Barriers to Trade (TBT Agreement) makes reference to international standard-setting bodies. Codex has been designated as the main player in the area of food. In a broad sense, the TBT Agreement establishes that Members shall ensure that technical regulations and conformity assessment procedures are not prepared with a view to, or with the effect of, creating unnecessary obstacles to international trade. 6. These WTO agreements provide member countries that adopt Codex standards as their national standards with a defence in situations where they are challenged by trading partners. National measures based on Codex standards are deemed necessary and thus in compliance with the SPS Agreement. 7. Countries that are Members of WTO and therefore are signatories to the SPS and TBT Agreements are also expected to participate to the extent possible in the standard-setting work of the Codex Alimentarius Commission.
What level of commitment should a country give to Codex?

Consideration should be given at an early stage in the decision-making process to ascertaining the level of commitment to Codex that would provide the greatest benefits for a country. A good starting point in preparing advice for senior decision-makers is to assess the commitment level of other countries within the region and the type of Codex activities they have instigated. As countries in a region often share common problems and have common goals in terms of achieving safe food of adequate quality, countries may find that the work of an FAO/WHO coordinating committee is a good starting point from which to build a long-term Codex programme. Furthermore, the scope of activities addressed by FAO/WHO coordinating committees is much broader than that of other Codex committees. The other committees are primarily standard setters producers of standards, guidelines, codes of practice and other recommendations. However, FAO/WHO coordinating committees are mandated to identify the needs and problems of the region concerning food standards, to define the needs of the region concerning food control and to stimulate the strengthening of food control infrastructures. Hence, many of the outcomes of these committees fall into the realm of technical assistance, which is provided by the parent bodies of Codex (FAO and WHO). The Commission itself is not mandated to provide such assistance. However, through the committees, technical needs can be identified and recommendations brought to the attention of the parent bodies. There are other benefits that may accrue as a result of active participation in FAO/WHO committees. In addition to being able to influence strategic priorities, the committee affords the opportunity to network and develop working relationships with other professionals in the member countries of the region. This facilitates the exchange of information and the promotion of a countrys position on key issues. It opens the door to technical expertise that can be tapped to help develop national food control systems. Furthermore, it is often more realistic with respect to cost to participate in an FAO/WHO committee meeting than a session of the Commission. Most countries have limited budgets for attendance at international Codex meetings, and therefore prioritization and strategic planning are required to ensure a countrys

Enhancing participation in Codex activities

Section 1 | Module 1.1 / Why should my country become involved in Codex?

representation at those committee meetings of most relevance. As stated above, there is strong justification to attend the FAO/WHO coordinating committee, especially when a country has only recently become involved in Codex.
Briefing the decision-makers

In establishing a case to become a Codex member country, or initiating a domestic Codex programme that will require policy commitment and resources, it may be appropriate to present a formal briefing to senior decision-makers. The accompanying set of visual aids is a suggested approach to a briefing session for this purpose. The briefing covers the topics listed below, but can be enhanced or expanded depending on the particular situation and/or needs of the country. For example, it could contain data on national food-borne incidence or internationally available data on food import rejections, analysis of imported/exported food products and projected economic benefits. What is Codex? Why a country should be involved in Codex Value of the FAO/WHO coordinating committees Resources required The accompanying briefing should take no more than 1015 minutes. If possible, several ministers/senior officials should be briefed simultaneously, although this is not a necessity. The remaining modules in this section provide information that will assist in preparing this briefing. In particular, it will assist countries in determining their level of involvement in the Codex process, the resources required to maintain this commitment, and initial steps to be undertaken in establishing the national programme.

Enhancing participation in Codex activities

Section 1

Module 1.2

My country wants to be involved in Codex, what should be done?

The decision to establish a national Codex programme should not be made in isolation by a single individual or government ministry. All the work of Codex is based on the premise of transparency and communication. Accordingly, such a decision should be taken collectively, with the consent of all stakeholders who will be involved in the implementation of the programme. All ministries that have a constitutional responsibility for food safety or food standards should be involved in the decision-making process as each ministry will, at some stage, have a core interest in the issues coming before Codex.
Step 1 Determine if it is appropriate

It is necessary to determine if it is appropriate for a country to become involved in the work of Codex. In this respect, several considerations should be taken into account: a) Is the country a Member of FAO and/or WHO? b) Would the adoption or use of Codex standards in national legislation facilitate protection of the countrys consumers? c) Is it important for the country to introduce a national food control system, improve the existing system, or improve its national capacity to deal with food safety incidence? d) Does the country export agricultural crops, animal products or species of fish in their raw or processed state, and do any of these commodities and products contribute significantly to the countrys economy? e) Are there specific food imports upon which the country relies to ensure an adequate and nutritious food supply? f ) Is the country a Member of WTO? If any of these questions can be answered in the affirmative, then it would be appropriate for the country to become a Member of the Codex Alimentarius Commission.
Step 2 Advocacy

Once it has been determined that membership in the Codex Alimentarius Commission is appropriate, the next step is to identify which government departments/ministries have a legislated responsibility for food standards, and to engage them in the preliminary decision-making process and any briefing sessions. This entails an examination of existing food legislation applicable anywhere along the food chain, from farm to consumer, taking care to identify any government departments/ministries with responsibility for administering and/or enforcing legislation pertaining to food quality and safety. This may entail more than mere identification. It may be necessary to liaise with the various ministries in order to explain what Codex is about, and why it is important for

Enhancing participation in Codex activities

Section 1 | Module 1.2 / My country wants to be involved in Codex, what should be done?

the country to become involved. In this regard, the briefing material provided in Section 1 may be of some value in familiarizing the appropriate senior officials with Codex. Regardless, the need for communication among the relevant government departments/ministries cannot be overemphasized. Transparent decision-making processes and good communication at this early stage will avoid many misunderstandings and duplication of activities in the future. Even at these early stages of Codex involvement, it is important to include or to involve other stakeholders industry, academia and consumer groups. Although they may not be involved in the ultimate decision, they do have an important role to play.
Step 3 Identify the Codex Contact Point

Once there is agreement that the country should become involved in Codex activities, the next step is to identify a Codex Contact Point and the department/ministry that will have responsibility for coordination of the programme. Section 3 provides greater detail regarding the functions of a Codex Contact Point, but it is important to understand that a countrys participation in Codex is a collaborative effort. In order for such participation to be effective, there must be open and constant communication among not only the government ministries, but also industry and consumer groups. It is important to understand that there is a clear difference between the function of a Codex Contact Point and that of the individuals who have the primary responsibility for preparing national positions on issues under consideration by the various Codex committees. Section 3 outlines in greater detail the process for developing national positions and the relationship between the Codex Contact Point and the individuals who are actually developing positions. At this point, it is important to understand that the Codex Contact Point is primarily a coordinator and focal point for Codex activities within the country, and is the link between the country and the Codex Alimentarius Commission (and its Secretariat). The individual identified as the Codex Contact Point must be given the responsibility and authority to coordinate national Codex activities. It is critical that the designated individual has sufficient time and resources (human and financial) to devote to this function. In some countries, a senior official is the designated Codex Contact Point, but the actual coordination and related work is carried out by a professional officer. This is acceptable provided the necessary resources (including time) are devoted to the countrys Codex activities to achieve the desired results. A common question is Where should the Codex Contact Point be? As the Codex Alimentarius Commission is an intergovernmental programme, the designated Codex Contact Point should be a government official. It is important that the individual designated as the Codex Contact Point communicates with all interested stakeholders and has sufficient support and resources to do the work. A key role will be to interact with entities in relevant ministries such as health, agriculture, fisheries and trade. Upon understanding the role and functions of the Codex Contact Point, the decision on where best to locate the Codex Contact Point rests with the respective member country. It is, however, common practice that the government takes up the responsibility to be the Codex Contact Point because: Codex is an intergovernmental body and it is the Member Governments that take decisions at the Codex Alimentarius Commission, with the expectation that they should interpret and implement them accordingly at the national level. Hence, it is more appropriate that the government should coordinate Codex activities.

Enhancing participation in Codex activities

Section 1 | Module 1.2 / My country wants to be involved in Codex, what should be done?

Box 1.2.1 | Notification of membership form

codex alimentarius commission

FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS WORLD HEALTH ORGANIZATION
Joint office: Viale delle Terme di Caracalla 00100 ROME Tel: 39 06 57051 www.codexalimentarius.net E-mail: [email protected] Facsimile: 39 06 5705 4593

CX 2/4-MF-2005 JOINT FAO/WHO FOOD STANDARDS PROGRAMME NOTIFICATION OF MEMBERSHIP OF THE CODEX ALIMENTARIUS COMMISSION
The Government of ________________________________ has the honour to inform the DirectorGeneral of the Food and Agriculture Organization of the United Nations and the Director-General of the World Health Organization that, in accordance with Article 2 of the Statutes of the Codex Alimentarius Commission, it wishes to be considered as a Member. 1. A list of the subsidiary bodies of the Codex Alimentarius Commission is given overleaf. All invitations to sessions of these subsidiary bodies are sent to Member Governments of FAO and WHO. Documentation relating to these sessions is sent to all designated Codex Contact Points. Please advise if a National Codex Committee has/has not been established and give the address: ___________________________________________________________________________________ __________________________________________________________________________________ 3. Please give the name, address, telephone and fax numbers as well as the E-mail address (the use of an institutional rather than personal account is encouraged) of the Contact Point in your country for Codex Alimentarius matters to whom all technical documentation and correspondence should be sent: ___________________________________________________________________________________ _______________________________________________________________________________ ________________________________________________________________________________ 4. Please advise how many copies and in which language Codex documents should be sent to the Contact Point for Codex Alimentarius matters (maximum: a total of five copies).

2.

____________ English ______________ French ______________ Spanish Notification of membership made by: Name: _________________________________________ Official title: _________________________________________ Address: _________________________________________ _________________________________________ _________________________________________

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Section 1 | Module 1.2 / My country wants to be involved in Codex, what should be done?

Box 1.2.1 (cont.) | Notification of membership form

SUBSIDIARY BODIES OF THE CODEX ALIMENTARIUS COMMISSION1
Codex General Subject Committees: Codex Committee on Food Additives and Contaminants Codex Committee on Food Import and Export Inspection and Certification Systems Codex Committee on Food Hygiene Codex Committee on Food Labelling Codex Committee on General Principles Codex Committee on Methods of Analysis and Sampling Codex Committee on Pesticide Residues Codex Committee on Residues of Veterinary Drugs in Food Codex Committee on Nutrition and Foods for Special Dietary Uses Codex Commodity Committees: Codex Committee on Cocoa Products and Chocolate * Codex Committee on Fats and Oils Codex Committee on Fish and Fishery Products Codex Committee on Fresh Fruits and Vegetables Codex Committee on Milk and Milk Products Codex Committee on Processed Fruits and Vegetables Codex Committee on Natural Mineral Waters * Codex Committee on Meat Hygiene * Codex Committee on Cereals, Pulses and Legumes * Codex Committee on Sugars * Codex Committee on Vegetable Proteins * Ad Hoc Intergovernmental Task Forces: Fruit and Vegetable Juices Foods Derived from Biotechnology Codex FAO/WHO Coordinating Committees: Coordinating Committee for Africa Coordinating Committee for Asia Coordinating Committee for Europe Coordinating Committee for Latin America and the Caribbean Coordinating Committee for North America and the South-West Pacific Coordinating Committee for the Near East * Adjourned sine die

1 All references in this manual to Codex subsidiary bodies are based on the status as of March 2005. The Codex Web site should be consulted for more up-to-date information.

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Section 1 | Module 1.2 / My country wants to be involved in Codex, what should be done?

better placed to be effective as the Codex Contact Point. There is a need for perceived neutrality in terms of meeting the basic Codex objectives of protecting the health of consumers and ensuring fair practices in the food trade, and the government is generally considered to be in a position to provide this. Irrespective of the location of the Codex Contact Point, it is desirable that the following criteria are met: neutrality as far as possible with regard to all stakeholders involved in Codex work; capability to perform the functions of the Codex Contact Point; accessibility to all parties interested and/or those involved in the activities of Codex. In general, the Codex Contact Point is located in a ministry. There is no right or wrong location, it is a matter of national choice. The important thing is to have a transparent decision-making process.
Step 4 Request membership

Looking at the functions and requirements, in most cases it is the government that is

The Codex Alimentarius Commission maintains an open invitation to become a Member by virtue of Article 2 of its Statutes that states:
Membership of the Commission is open to all Member Nations and Associate Members of FAO and WHO which are interested in international food standards. Membership shall comprise such of these nations as have notified the Director-General of FAO or of WHO of their desire to be considered as Members.

Therefore, once a decision has been taken by a country that it wishes to become a Member of the Codex Alimentarius Commission, it should communicate this desire by means of a letter addressed to the Director-General of either FAO or WHO. The letter should be signed by a suitably senior official, e.g. a minister or head of agency, and include the name and contact information of the designated Codex Contact Point (including an e-mail address and national Codex Web site where applicable). Any e-mail address for a Codex Contact Point should be generic if at all possible. A copy of the letter should also be referred to the Secretary of the Codex Alimentarius Commission. Box 1.2.1 provides a sample of the form that should be completed and appended to the official letter of request for membership.

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Section 1

Module 1.3

What resources do we need?

The resources a country needs to expend on its Codex activities will depend on the extent to which it is involved. When a country takes a decision to become a Member of the Codex Alimentarius Commission and become involved in its work, it is not necessary for the country to be involved in all of the Commissions subsidiary bodies. Most developing countries, or countries with small economies, tend to focus on the FAO/WHO coordinating committee for their region and one or two other committees/task forces that are developing standards for products of significance to them.
The Codex Contact Point

As indicated in Module 1.2, the Codex Contact Point is designated when a country makes known its desire to become a Member of the Codex Alimentarius Commission. In some countries, the designated Codex Contact Point is a senior official who may have little hands-on dealings with day-to-day Codex activities. This is acceptable provided there is a professional officer with the authority and time to carry out the coordination work and report regularly to the Codex Contact Point. The official responsible for the daily management and coordination of the Codex programme should be a professional officer, preferably with a background in food safety/food standard setting. The individual must be given sufficient authority to coordinate the programme and have sufficient time to devote to it. Ideally, the individual should have no other duties, but this is not always realistic. Regardless, the individual must be able to devote an identified portion of time to dealing with Codex issues. The amount of time will vary, depending on the number of committees a country is involved in, the level of training of the professional officer, etc. It is up to the individual country to determine its needs, but a recommended minimum allocation would be up to approximately 25 percent of the persons time (i.e. the equivalent of approximately 11/4 days per week) to Codex activities, based on minimal Codex activities (e.g. involvement limited to the FAO/WHO coordinating committee). It is important that sufficient administrative and logistical support be available to the Codex Contact Point, e.g. adequate office space, telephone, computer, e-mail, etc. Section 3 provides details on the functions and activities of the Codex Contact Point.
Administrative support for the Codex Contact Point

The level of support needed by the Codex Contact Point will depend on the location of the official. The colocation of the official Codex Contact Point and the Codex office (i.e. the officer and support staff who coordinate the daily work) has benefits in terms of efficiency and leads to greater effectiveness of allocated resources.

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Section 1 | Module 1.3 / What resources do we need?

In terms of resource allocation, there should be an administrative officer/personal assistant or clerk assigned to assist the official responsible for the Codex Contact Point, who should be able to devote at least 25 percent of his/her time in support of the programme. The allocation of other human resources to the Codex programme will be contingent on the level of involvement and coordination required. This issue is addressed more fully in Section 3. However, in determining ongoing commitment as a Codex member country, a preliminary assessment of the projected level of involvement and associated budgetary implications should be made at this stage in the decision-making process.
Infrastructure

In becoming a Codex member country, a nation takes on responsibility for establishing an interface between the Codex Contact Point and the Rome-based Secretariat, and between the Codex Contact Point and the national stakeholders, as well as linkages with other Codex member countries within the region. Certain infrastructure issues will need to be addressed.
Computer facilities

The primary method of contact between the Codex Secretariat in Rome and the Codex Contact Points is via electronic mail. In addition, all the standards, guidelines and recommendations adopted by the Codex Alimentarius are posted on the Codex Web site. Therefore, it is essential that the Codex Contact Point and officers involved in the management of the Codex programme are equipped with a computer capable of accessing e-mail and the Internet, and with up-to-date software capabilities. From a practical viewpoint, it may be desirable to establish a distinct e-mail address for the Codex programme so that communications regarding the programme do not get lost in the general e-mail account of the Codex Contact Point or agency. Many countries have established an e-mail address with a high degree of success along the following lines: (codex.countryname@...). This is also useful to ensure that there is no interruption in the flow of information should there be a change in the individual designated as being responsible for the Codex Contact Point.
Office

The Codex office may be located in an existing office, or provided with a separate facility. Whatever arrangement is implemented, it is important that the Codex programme has a designated area/facility from which the work is conducted.
Essential equipment

Telephone and facsimile access for the Codex office are essential to the overall efficiency of the programme. A photocopy machine and filing cabinet will facilitate the handling and organization of Codex documentation and related correspondence.
Library/reading facility

While most Codex documentation is available electronically, not all interested stakeholders will have access to computers. Therefore, there is still a need to have the capacity to manage printed copies of some Codex documents. The need to ensure transparency and communication of Codex work has led in some countries to the establishment of a reading facility. This ensures ready access for interested parties (industry, consumers) to Codex texts. Another country has set up a specific computer for use by interested parties to access Codex material electronically.

.
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Section 1

Module 1.4

What are the first steps my country should take to participate in Codex work?

Up to this point, the country has made a decision to become involved in the work of the Codex Alimentarius Commission, a decision that was agreed to by all the relevant ministries. A Codex Contact Point has been identified and resources made available in order for the Codex Contact Point to function effectively. Now comes the difficult part making participation in Codex a reality. Taking into consideration the fact that each countrys legal structure and administrative framework are different, the modalities of undertaking national Codex activities, including international linkages, will vary from country to country. Within that context, the following considerations are offered as suggested steps that can be taken to commence actual participation in Codex.
Establish contacts with other government ministries

As explained in the preceding modules, the decision to become involved in the food standard-setting work of the Codex Alimentarius Commission should not be made in isolation. Other relevant ministries need to be consulted and involved in the decisionmaking process. Similarly, in the undertaking of involvement in Codex activities, these other ministries need to remain involved. A good first step would be to identify contacts (i.e. name, position, contact particulars, etc.) in the relevant ministries. This should include a name, telephone number and e-mail address if one exists. The next step is to contact that person, arrange a brief face-to-face meeting to outline what Codex is, and explain the nature of the countrys involvement and the role the contact is expected to fulfil. One important aspect that should be conveyed to such contacts is that they will be the focal point in that ministry to whom the Codex Contact Point can go to obtain input on Codex issues. For example, if a standard on fish is being discussed in Codex, then the Codex Contact Point should ensure that the ministry with responsibility for fisheries is engaged in the process, and takes the lead in developing the national position. The consultative process will be discussed in greater detail in Section 3. The number of contacts in each ministry will vary depending on the organizational structure and the mandate of the ministry concerned. For example, in some cases, it would be desirable to have two contacts, one being a technical expert, the other a policy-maker.
Establish contacts with industry

A key stakeholder in the establishment of food standards is the food industry. Therefore, it is recommended that as early in the process as possible, the Codex Contact Point should make contact with national food industry associations where they exist, or

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commercial establishments involved in the production, processing, exporting or importing of food products. Again, it is important that the Codex Contact Point not only identify the industries the identification should include a name, telephone number and, if possible, an e-mail address. As in the case of the government contacts, a brief face-to-face meeting with the various industry representatives should also be held to familiarize them with the countrys Codex involvement. This contact should facilitate solicitation of input from industry on Codex issues relevant to them. It should be remembered, however, that the final decision as to the content of a national position rests with the government, and it is up to the government to determine to what extent it will incorporate input from industry into the national position.
Establish contacts with consumers

Consumers play an important role in Codex and have a responsibility with respect to food safety. In order to ensure that there is a balance in the expression of opinions on Codex issues, consumers also need to be involved in the process. Therefore, the Codex Contact Point should establish contacts with national consumer organizations in order to facilitate communication on issues relevant to consumers. Again, as in the case of industry, the final decision as to the content of a national position rests with the government, and it is up to the government to determine to what extent it will incorporate input from consumers into the national position.
Establish a mechanism to enhance national collaboration

National Codex activities will not be effective if communication among all interested stakeholders is inadequate.1 A means to achieve this communication should be planned and coordinated by the Codex Contact Point. One mechanism employed in many countries to ensure that this communication occurs is to establish a National Codex Committee (NCC). Should a country wish to establish such a committee, suggested functions and possible membership are discussed in Section 3. As NCCs tend to reflect national requirements, their composition and organization will vary. However, NCCs can provide a forum for discussions and for the formulation of the national position(s) and responses to Codex proposals or policy. Often the Codex Contact Point serves as the secretariat to the NCC although, again, it is up to the country to determine the organizational structure best suited to its needs. Further information on country experiences is included in Module 3.2.
Conduct Codex workshops

Once the Codex Contact Point has met with representatives of the various interested stakeholder groups, it is suggested that Codex workshops be conducted to facilitate the understanding of Codex as an international food standard-setting organization, and of how the national Codex programme interacts with international standard-setting activities.
1

For the purposes of this package, the term interested stakeholders means government officials, consumers, industry, academia and health professionals with an interest in food safety and standard setting related to food.

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Section 1 | Module 1.4 / What are the first steps my country should take to participate in Codex work?

Sections 2 and 3 of this package, including their accompanying visual aids, provide the framework for the conduct of such workshops.
Circulate reports

A first step in engaging stakeholders and making them aware of the issues discussed at Codex meetings is to circulate the latest versions of the reports of the Codex committees relevant to the country. It would be helpful to draw their attention to specific paragraphs in the report that address agenda items of particular interest to the stakeholders. In addition, circulation of reports not only serves to familiarize recipients with the relevant issues, but also to sensitize them to the format and language of Codex documents.
Start submitting written comments

It must be understood that the submission of written comments is the first, and often the most crucial, step in the implementation of a national Codex programme. Written comments are normally submitted prior to a meeting when requested by the Codex Secretariat. These comments are translated into other languages and shared with other countries. However, when countries do not meet the deadline, they may provide written comments on a working document and request them to be circulated at the Codex meeting as a conference room document (CRD) (but only in the original language). Overuse of CRDs should be discouraged as they are not circulated in advance of the meeting and they may overstretch an already full meeting agenda. Where countries have difficulty in attending Codex meetings owing to financial constraints, the submission of written comments is important. Participation in the work of Codex starts with the submission of written comments and, regardless of a countrys ability to travel, it can still make its views known by these submissions. Of course, attending Codex meetings provides the opportunity to draw the attention of the committee to the countrys position through verbal interventions made by the member country, and provides additional opportunities to promote the countrys position. The various circular letters (CLs) and working papers associated with the Codex agenda often request countries to submit comments, and also include a deadline for the submission of those comments. The Codex Contact Point should ensure that the country does submit comments, and does so on time. Section 3 outlines more specific information on the modalities of developing and submitting national positions. Comments can be submitted on a range of issues, including specific standards under preparation and working papers prepared on a given topic, and issues related to Codex procedures.
Regional liaison/networking

The concerns and issues of significance in one country may also be shared by other countries in the region. Therefore, it is recommended that the Codex Contact Point establish contacts with the other Codex Contact Points in other countries in the region. Collaboration among the member countries in a region can enhance the effectiveness of the comments being submitted, i.e. three countries reflecting the same position in their written comments are more effective than one country. Furthermore, since resources are usually limited, it may be more feasible for countries to combine resources to fund one

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countrys attendance at a Codex meeting where it can express the views of the region, rather than several countries trying to obtain funding for individual attendance. Another practical option is to request another country with the same position to raise the concern on behalf of one or more countries, in the event that all the countries concerned cannot attend the meeting. An important venue for regional liaison is the FAO/WHO coordinating committee. For this reason, attendance at sessions of the FAO/WHO coordinating committee could be considered a priority, as it provides an opportunity for the coordination of positions within the region. An important role of a regional coordinator, through the Executive Committee, is to promote issues of relevance to the region, for example drawing the attention of the Commission to aspects of the Commissions work of particular relevance to the region. This enhances opportunities for countries in the region to network with other countries outside their region. More information is provided in Module 2.3.
Prepare regular briefings for senior officials

In order to ensure that politicians and senior-level officials are fully informed of Codex issues of relevance to the country, the Codex Contact Point should prepare regular briefings. These briefings should bring to their attention the status of Codex standards that are of particular interest to the country, or inform them of any policy decisions taken at the international level that may have an impact on the country.

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18

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Section 1

Visual aids
Modules 1.11.4

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Section 1 | Visual aids

Modules 1.11.4 (cont.)

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Section 2

Understanding the organization of Codex

Contents

{
23 24 24 24 25 25 26 27 27 30 30 32 36 37 39 41 42 43 44 44 47 50 54 54 55 57 57

Introduction Module 2.1 / Codex: a historical perspective Food and Agriculture Organization of the United Nations World Health Organization Codex Alimentarius Europaeus Codex Alimentarius Commission Evaluation of Codex Module 2.2 / What is Codex? Statutes of the Codex Alimentarius Commission Module 2.3 / How is Codex organized? Organizational structure of the Codex Alimentarius Commission Box 2.3.1 / Codex organizational chart Module 2.4 / Which committees should my country be involved in? General subject committees Commodity committees FAO/WHO coordinating committees Ad hoc intergovernmental task forces Exercise 2.4.1 / Prioritization of Codex committees Module 2.5 / How do Codex committees function? Codex committees: functions, composition and host country responsibilities Conduct of meetings Box 2.5.1 / Example of a provisional agenda Module 2.6 / How does Codex elaborate standards? Project documentation Procedures for the elaboration of Codex standards Revision of Codex standards Amendments to the Codex Procedural Manual

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Section 2 | Contents

56 56

Box 2.6.1 / The eight-step procedure for elaborating Codex standards, guidelines and related texts Box 2.6.2 / The five-step accelerated procedure for elaborating Codex standards, guidelines and related texts

58 58 59 63 60 61 62 64 64 65 68 69 69 69 70 70 71 71 71 72 72 72 73 73 74 75 74

Module 2.7 / Understanding Codex documentation The Codex Procedural Manual Working documents for Codex sessions Adopted texts Box 2.7.1 / ALINORM numbers for active Codex subsidiary bodies Box 2.7.2 / Document reference system for Codex bodies Box 2.7.3 / Example of a circular letter Module 2.8 / Is there a format for Codex standards? Why should a standard format be used? Format for Codex standards Exercise 2.8.1 / Format for Codex commodity standards Module 2.9 / What is the difference between the Codex Alimentarius Commission and the Codex Alimentarius? Purpose and scope of the Codex Alimentarius Organization of the Codex Alimentarius Where can these standards be found? Box 2.9.1 / Structure of the Codex Alimentarius Module 2.10 / What is the relationship between Codex standards and WTO? Trade agreements of significance in Codex work Rights of Members under the SPS Agreement Obligations of Members under the SPS Agreement Relationship between Codex standards and the SPS Agreement The TBT Agreement Similarities between the SPS and TBT Agreements Differences between the SPS and TBT Agreements Codex since the creation of WTO Why does WTO refer to Codex standards as benchmarks for food safety? Box 2.10.1 / Relationship between a Codex standard and the SPS and TBT Agreements Visual aids

77

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Section 2

Introduction

New Codex member countries, or countries that have not yet become fully involved in Codex work, will need to develop a good appreciation of the functioning of the Codex Alimentarius Commission. Although the Codex programme may appear to be complex, once broken down into its operational components, Codex is like any other committeebased organization. It has a book of rules, or procedures, which set out the way it operates in order to achieve its mandate. This book of rules, the Codex Procedural Manual, is explained in Module 2.7. This section provides general background information on the Codex Alimentarius and how the Codex Alimentarius Commission is organized to undertake its standard-setting work. The section covers the structure of the Commission and its subsidiary bodies, the terms of reference of the subsidiary bodies and the standards elaboration process, and briefly describes how Codex sessions are conducted.

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Section 2

Module 2.1

Codex: a historical perspective

The concept of international food standards is not new, and a desire to manage the quality and safety of food can be traced back to the earliest civilizations. Assyrian tablets described the method to be used in determining the correct weights and measures for food grains. Egyptian scrolls prescribed the labelling to be applied to certain foods. In the year 300 before the Christian era, the Indian statesman Kautilya referred to food quality control measures in his writings. There is other evidence of food control systems to protect consumers from fraud or bad produce in ancient Greece and Rome, and in England in the Middle Ages. The term Codex Alimentarius is Latin and means food code. Thus, the Codex Alimentarius is a collection of written codes of international food standards for use by all nations. The origin of the Codex Alimentarius can be traced back to the AustroHungarian Empire, which developed, between 1897 and 1911, a collection of standards and product descriptions for a wide variety of foods. This was known as the Codex Alimentarius Austriacus. Although lacking legal force, it was used as a reference by the courts to determine standards of identity for specific foods.
Food and Agriculture Organization of the United Nations

The decision to establish an international programme, however, may be traced back to 1943, when 44 nations met for a United Nations Conference on Food and Agriculture in Hot Springs, Virginia, United States of America. That Conference recommended the formation of an international organization to assist governments to extend and improve standards of nutrient content of all important foods and to consider the formulation and adoption of similar international standards to facilitate and protect interchange of such products between countries.
World Health Organization

Another major landmark was the establishment of the World Health Organization (WHO) in 1948, with responsibilities covering human health and, in particular, a mandate to establish food standards. In 1950, Joint FAO/WHO expert meetings commenced on nutrition, food additives and related areas. This was followed in 1953 by a statement by WHOs highest governing body, the World Health Assembly, that the widening use of chemicals in the food industry presented a new public health problem that required attention. A Joint FAO/WHO Conference on Food Additives held in Geneva in 1955 led to a recommendation to the Directors-General of FAO and WHO that one or more expert committees should be convened to address the technical and administrative aspects of chemical additives and their safety in food.

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Section 2 | Module 2.1 / Codex: a historical perspective

This recommendation provided the basis for the first Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1956. While JECFA was initially founded to evaluate the safety of food additives, its work now also includes the evaluation of contaminants, naturally occurring toxicants and residues of veterinary drugs in food. Substances evaluated by JECFA alternate between additives and contaminants on oddnumbered sessions and veterinary drug residues on even-numbered sessions. For example, the Sixty-first Session (June 2003) of JECFA considered a number of additives and contaminants while the Sixty-second Session (February 2004) examined a number of veterinary drugs.
Codex Alimentarius Europaeus

The decision to establish an international programme was accelerated by moves in Europe to develop a European food code. During the period 195458, Austria actively pursued the creation of a regional food code, the Codex Alimentarius Europaeus, or European Codex Alimentarius. In October 1960, the first FAO Regional Conference for Europe endorsed the desirability of international, as distinct from regional, agreement on minimum food standards, and invited the Organizations Director-General to submit proposals for a joint FAO/WHO programme on food standards to the Conference of FAO. This Conference crystallized a widely held view when it recognized:
The desirability of international agreement on minimum food standards and related questions (including labelling requirements, methods of analysis, etc.) ... as an important means of protecting the consumers health, of ensuring quality and of reducing trade barriers, particularly in the rapidly integrating market of Europe.

Within four months of the Regional Conference, FAO entered into discussions with WHO, the Economic Commission for Europe (ECE), the Organisation for Economic Co-operation and Development (OECD) and the Council of the Codex Alimentarius Europeaus with proposals that would lead to the establishment of an international food standards programme.
Codex Alimentarius Commission

A landmark decision was taken at the Eleventh Session of the FAO Conference in November 1961, when a resolution was passed to set up the Codex Alimentarius Commission (CAC), requesting an early endorsement by WHO of a joint FAO/WHO food standards programme. This was followed by approval to establish the Joint FAO/WHO Food Standards Programme at the Sixteenth World Health Assembly in May 1963, including the adoption of the Statutes of the Codex Alimentarius Commission. The Codex Alimentarius Commission, frequently referred to simply as Codex, is an intergovernmental body consisting of 171 member countries and one member organization as of March 2005.1 Membership in the Commission is open to countries who are Members of either FAO or WHO. The mandate of Codex is to establish international food standards to protect the health of consumers and to ensure fair practices in the food trade. The significance of Codex standards has been heightened in recent years as a result of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) of the World Trade
1 It should be noted that the membership of Codex changes as new countries join. The Codex Web site should be consulted from time to time for current membership.

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Section 2 | Module 2.1 / Codex: a historical perspective

Organization (WTO), which specifically refers to Codex standards as the international benchmark for food safety. The First Session of the Codex Alimentarius Commission was held in Rome, Italy, in June 1963. Subsequent venues for Commission sessions have alternated between the headquarters of its two parent organizations, i.e. the meetings alternated between Rome and Geneva. For example, the Twenty-sixth Session of the Commission was held in Rome from 30 June to 7 July 2003, while the Twenty-seventh Session was held in Geneva from 28 June to 3 July 2004. It should be noted here that there is a distinction between the Codex Alimentarius and the Codex Alimentarius Commission (Codex). The Codex Alimentarius Commission is the body that elaborates the food standards that are published in the Codex Alimentarius. This difference is clarified further in Module 2.9. Texts developed by the subsidiary bodies of the Codex Alimentarius Commission consist of standards (e.g. commodity standards, maximum residue limits [MRLs]) for use by Member Governments, as well as recommended codes of practice and guidelines intended as advice to governments. Throughout this package, unless stated otherwise, the term standard is used in its generic sense and includes all these categories of Codex texts.
Evaluation of Codex

A significant landmark in the history of Codex, 40 years after its creation, was the joint FAO/WHO Evaluation of the work of the Codex Alimentarius Commission, which took place in 2002, covering all aspects of the food standards work of FAO and WHO, including capacity building and scientific advice. The Commission considered the report of the Evaluation at an extraordinary session in February 2003, and expressed its commitment to the implementation of the recommendations it contained. The necessary work was then launched to amend the Rules of Procedure, where needed, and to initiate reform.

Reference material

FAO/WHO. 2002. Report of the Evaluation of the Codex Alimentarius and other FAO and WHO food standards work. Geneva, Switzerland/Rome (available at http://www.fao.org/docrep/meeting/005/y7871e/y7871e00.htm). FAO/WHO. 2005. Understanding the Codex Alimentarius. Revised and updated, pp. 19. Rome. Codex Web site: www.codexalimentarius.net

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Section 2

Module 2.2

What is Codex?

The Codex Alimentarius Commission (commonly referred to simply as Codex) is the body established to implement the Joint FAO/WHO Food Standards Programme. In other words, Codex is an intergovernmental body whose purpose is to develop international food standards. The Codex Procedural Manual is one of the most important Codex documents, and all those involved in Codex work should be familiar with its contents. Details are given in Module 2.7.
Statutes of the Codex Alimentarius Commission

The original Statutes were adopted in May 1963. These Statutes provide the legal basis for the Commissions work, and formally reflect the concepts behind and reasons for its establishment. They consist of ten Articles, which are summarized below. The full text can be found in the Codex Procedural Manual. Although it is wise for those involved in the work of Codex, particularly Codex Contact Points, to be familiar with all the Articles, the main ones being Articles 1, 2, 8 and 10.
Article 1 Mandate

(a) Protecting the health of consumers and ensuring fair practices in the food trade. (b) Coordinating all food standards work undertaken by international governmental and non-governmental organizations. (c) Determining priorities and initiating and guiding the preparation of draft standards. (d) Finalizing standards and publishing them in a Codex Alimentarius either as regional or worldwide standards. (e) Amending published standards, after appropriate survey in the light of developments.
Article 2 Membership

Membership of the Commission is open to all Member Nations and Associate Members of FAO and WHO that are interested in international food standards. Membership shall comprise such of these nations as have notified the Director-General of FAO or of WHO of their desire to be considered as Members. In other words, in order to become a Member of the Codex Alimentarius Commission, there are two conditions that must be met. First, the country must be a Member of either FAO or WHO. Second, the country must notify either the DirectorGeneral of FAO or of WHO of its wish to become a Member. The process for this notification is explained in Module 1.2. It should also be noted that membership is limited to countries only the exception being regional economic integration organizations (e.g. the European Community).

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Section 2 | Module 2.2 / What is Codex?

Article 3 Observers (FAO or WHO Member Nations)

Any Member Nation or Associate Member of FAO or WHO which is not a Member of the Commission but has a special interest in the work of the Commission may, upon a request communicated to the Director-General of FAO or WHO, attend sessions of the Commission and of its subsidiary bodies and ad hoc meetings as observers. Members of either FAO or of WHO that do not wish to become full Members of the Commission are permitted to attend Codex sessions as observers. As observers they may address the Commission but cannot vote. Observers identified in Articles 3 and 4 should not be confused with international organizations that have been granted observer status under the Rules of Procedure (see Module 2.5).
Article 4 Observers (other UN Member Nations)

Nations that, while not Member Nations or Associate Members of FAO or WHO, are Members of the United Nations, may be invited on their request to attend meetings of the Commission as observers, in accordance with the provisions of FAO and WHO relating to the granting of observer status to nations. This Article enables countries that are Members of the United Nations but not Members of either FAO or WHO to attend Codex sessions as observers.
Article 5 Reports and recommendations

The Commission shall report and make recommendations to the FAO Conference and the World Health Assembly of WHO through their respective Directors-General. Copies of reports, including any conclusions and recommendations, are circulated to interested Member Nations and international organizations for their information as soon as they become available. Further details on reports from Codex committee sessions can be found in Module 2.5.
Article 6 Executive Committee

The Commission shall establish an Executive Committee whose composition should ensure an adequate representation of the various geographical areas of the world to which the Members of the Commission belong. Between sessions, the Executive Committee shall act as the executive organ of the Commission. This Article provides for ongoing management of the Codex process between sessions of the Commission. The Executive Committee cannot make decisions on behalf of the Commission (e.g. authorize new work, adopt standards), but it has responsibility for strategic planning, budgeting and managing the standards elaboration process.
Article 7 Other subsidiary bodies

The Commission may establish such other subsidiary bodies as it deems necessary for the accomplishment of its task, subject to the availability of the necessary funds. This article provides the Commission with the authority to create the various committees and task forces necessary to elaborate standards.
Article 8 Rules of Procedure

The Commission may adopt and amend its own Rules of Procedure that shall come into force upon approval by the Directors-General of FAO and WHO, subject to such confirmation as may be prescribed by the procedures of these Organizations. This means that the Commission has the authority to amend its Rules of Procedure but cannot amend its Statutes. Only the parent bodies (FAO and WHO) can amend the

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Statutes. Amendments to the Rules of Procedure come into force upon approval of those amendments by the Directors-General of FAO and WHO. The Rules of Procedure prescribe that a special quorum is required to amend the Rules. This special quorum consists of a majority (50 percent + 1) of the Members of the Commission. For example, with 171 member countries and one member organization, the special quorum consists of 87 countries. In all other cases (e.g. to adopt a standard) a quorum consists of 20 percent of the Members, i.e. 34 countries based on the membership as of March 2005.
Article 9 Expenses (Commission and subsidiary bodies)

The operating expenses of the Commission and of its subsidiary bodies, other than those for which a Member has accepted the Chair, shall be borne by the budget of the Joint FAO/WHO Food Standards Programme, which shall be administered by FAO on behalf of the two Organizations in accordance with the financial regulations of FAO. The Directors-General of FAO and WHO shall jointly determine the respective portion of the costs of the Programme to be borne by each Organization and prepare the corresponding annual expenditure estimates for inclusion in the regular budgets of the two Organizations for approval by the appropriate governing bodies. This is the Article that enables the Commission to manage a budget to implement its programme of work. These expenses relate to Secretariat costs (salaries, travel, operational expenses), costs of publication of adopted standards, infrastructure costs, etc.
Article 10 Expenses (preparatory work)

All expenses (including those relating to meetings, documents and interpretation) involved in preparatory work on draft standards undertaken by Members of the Commission, either independently or upon recommendation of the Commission, shall be defrayed by the government concerned. Within the approved budgetary estimates the Commission may recommend, however, that a specified part of the costs of the preparatory work undertaken by the government on behalf of the Commission be recognized as operating expenses of the Commission. This Article makes it clear that costs related to preparatory work of the subsidiary bodies are the responsibility of the host country (e.g. translation of working papers). However, the article does provide for the Commission covering some of these costs when warranted (e.g. the host country is a developing country).

Reference material

FAO/WHO. 2004. Codex Alimentarius Commission Procedural Manual. 14th edition, pp. 35. Joint FAO/WHO Food Standards Programme, Rome. Codex Web site: www.codexalimentarius.net

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Section 2

Module 2.3

How is Codex organized?

It is important to understand how the Codex Alimentarius Commission is structured and to have some knowledge of the roles of the various components of the structure. This will enable those responsible for the coordination of national Codex activities to know where to focus their activities. It will also enhance the effectiveness of national activities, and ensure that international standards reflect the countrys concerns. This module outlines the organizational elements of the Commission, and describes the range of subsidiary bodies (committees and task forces) where Codex standards are drafted and negotiated by member countries. A basic understanding of the structure and functioning of the Commission is essential for building a sound national Codex programme.
Organizational structure of the Codex Alimentarius Commission

The Codex Alimentarius Commission consists of the following main organizational elements (see Organizational chart, page 32): a) the Commission b) the Executive Committee c) the Codex Secretariat d) Codex subsidiary bodies: - general subject committees (also known as horizontal committees) - commodity committees (also known as vertical committees) - FAO/WHO coordinating committees - ad hoc intergovernmental task forces. With the exception of the Codex Secretariat, all these bodies are made up of Codex Member representatives, endeavouring to ensure geographical balance and to reflect stakeholder views as appropriate.
The Codex Alimentarius Commission

The Commission is the decision-making body of the Joint FAO/WHO Food Standards Programme. As of March 2005, the Commission comprises 171 member countries and one member organization. At its Twenty-sixth Session, the Commission decided that each session would decide on the timing of the next session.2 The Commission now meets annually, with meetings alternating between Rome where FAO headquarters is located, and Geneva where WHO headquarters is located.

Report of the Twenty-sixth Session of the Codex Alimentarius Commission (ALINORM 03/41, para. 150).

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The Executive Committee

The Commission elects executive officers for a period commencing at the end of the session in which they were elected until the end of the following regular session. Those elected officials include a chairperson and three vice-chairpersons from among the delegates of the Members of the Commission. These officers can be re-elected for a maximum of one additional term. The Executive Committee of the Commission (CCEXEC) is responsible for making recommendations about the general direction of the Commissions work. The Executive Committee, which meets between Commission sessions, acts as the executive organ of the Commission, and is the body responsible for managing the standards development process. The Executive Committee is geographically balanced, with one member country elected from each of the following seven geographic locations: Africa, Asia, Europe, Latin America and the Caribbean, Near East, North America and the Southwest Pacific. Each Member may be accompanied by not more than two advisers from the region. However, these advisers do not address the sessions of the Executive Committee. Members elected from the regions hold office from the end of the session at which they were elected until the end of the second two regular sessions of the Commission, and may be elected for an additional term of two sessions. Members are ineligible for re-election after having served two consecutive terms. The regional coordinators for the six regions (for coordination purposes, the regions of North America and the Southwest Pacific are combined) are also Members of the Executive Committee. Coordinators may hold office from the end of the session of the Commission at which they are appointed until not later than the end of the third succeeding regular session. After serving two consecutive terms, the coordinators are not eligible to hold office for the next succeeding term. The role of the regional coordinators is to coordinate the views of the region in the preparation of draft standards, guidelines and other recommendations for submission to the Commission. They also assist the Executive Committee and the Commission as required, by advising them of the views of the region on matters under discussion or of interest. The Executive Committee is chaired by the Chairperson of the Codex Alimentarius Commission. The total membership of the Codex Executive Committee is 17.
The Codex Secretariat

The Codex Secretariat is located at FAO headquarters in Rome. The Secretary of the Codex Alimentarius Commission is responsible for the implementation of the Joint FAO/WHO Food Standards Programme, reporting to the Director-General of FAO through the Director, Food and Nutrition Division in Rome and to the Director-General of WHO through the Director, Department of Food Safety, Zoonoses and Foodborne Diseases in Geneva. The Secretary coordinates the work of the Secretariat, which is made up of FAO officials with support from WHO officials. The Secretariat organizes the meetings of the Commission and the Executive Committee, and facilitates the work of the subsidiary bodies in conjunction with the secretariats established by the host countries of Codex committees (see below). This includes the compilation of documents required for the discussion of agenda items, the supervision of preparatory work done by others, and the preparation and finalization of all meeting reports of the Codex Alimentarius Commission and its subsidiary bodies.

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Box 2.3.1 | Codex organizational chart*

Note: The host country rotates among Members within the region.

* Valid as of March 2005. The Codex Web site should be consulted for up-to-date information.

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Codex subsidiary bodies

Under its Rules of Procedure, the Commission is empowered to establish four kinds of subsidiary bodies: general subject committees (sometimes referred to as horizontal), which establish standards and guidelines applicable to all foods; commodity committees (sometimes known as vertical), which prepare standards for specific commodities; FAO/WHO coordinating committees, through which regions or groups of countries coordinate food standards activities in the region, including the development of regional standards; ad hoc intergovernmental task forces, which are time-limited and prepare standards and guidelines on specific issues. A feature of the committee system is that, with few exceptions, each committee is hosted by a member country, which is chiefly responsible for the cost of the committees maintenance and administration, and for providing its chairperson. This places a considerable burden on the budget of the host country, and therefore only countries with sufficient resources are in a position to offer to host a committee. It should be noted however that host countries are encouraged to hold their committee in developing countries from time to time. Examples include the Thirty-fifth Session (March 2003) of CCFAC held in Arusha, United Republic of Tanzania. The FAO/WHO coordinating committees are exceptions, as there are provisions for the cost of these committees to be included in the Commissions estimate of expenditures under certain circumstances (e.g. when the regional coordinator is a developing country).
General subject committees

General subject committees are so called because their work has relevance for all commodity committees and, since this work applies across the board to all commodity standards, general subject committees are sometimes referred to as horizontal committees. There are nine such committees: 1. Committee on Food Additives and Contaminants (CCFAC)3, hosted by the Netherlands 2. Committee on Food Hygiene (CCFH), hosted by the United States of America 3. Committee on Food Import and Export Inspection and Certification Systems (CCFICS), hosted by Australia 4. Committee on Food Labelling (CCFL), hosted by Canada 5. Committee on General Principles (CCGP), hosted by France 6. Committee on Methods of Analysis and Sampling (CCMAS), hosted by Hungary 7. Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), hosted by Germany 8. Committee on Pesticide Residues (CCPR), hosted by the Netherlands 9. Committee on Residues of Veterinary Drugs in Foods (CCRVDF), hosted by the United States of America. Among other issues, the general subject committees develop all-embracing concepts and principles applying to foods in general, specific foods or groups of foods; endorse or review relevant provisions in Codex commodity standards; and, based on the advice of expert scientific bodies, develop major recommendations pertaining to the health and
3

The Twenty-eighth Session of the CAC endorsed the recommendation that CCFAC be split into two separate committees, one for additives and a second for contaminants and toxins.

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Section 2 | Module 2.3 / How is Codex organized?

safety of consumers. The CCGP is responsible for dealing with procedural and general matters of the Commission.
Commodity committees

Commodity committees have responsibility for developing standards for specific foods or classes of food. In order to distinguish them from the horizontal committees and recognize their exclusive responsibilities, they are often referred to as vertical committees. There are eleven such committees, of which five have been adjourned sine die: 1. Committee on Fats and Oils (CCFO), hosted by the United Kingdom of Great Britain and Northern Ireland 2. Committee on Fish and Fishery Products (CCFFP), hosted by Norway 3. Committee on Fresh Fruits and Vegetables (CCFFV), hosted by Mexico 4. Committee on Meat Hygiene (CCMH), hosted by New Zealand 5. Committee on Milk and Milk Products (CCMMP), hosted by New Zealand 6. Committee on Processed Fruits and Vegetables (CCPFV), hosted by the United States of America 7. Committee on Cereals, Pulses and Legumes (CCCPL), hosted by the United States of America (adjourned sine die) 8. Committee on Cocoa Products and Chocolate (CCCPC), hosted by Switzerland (adjourned sine die) 9. Committee on Natural Mineral Waters (CCNMW), hosted by Switzerland (adjourned sine die) 10. Committee on Sugars (CCS), hosted by the United Kingdom of Great Britain and Northern Ireland (adjourned sine die) 11. Committee on Vegetable Proteins (CCVP), hosted by Canada (adjourned sine die). Commodity committees convene as necessary and go into recess or are abolished when the Commission decides their work has been completed. The term sine die is applied to those committees that the Commission adjourns (i.e. places into recess). Host countries call meetings of Codex subsidiary bodies at intervals of between one and two years, according to need.
FAO/WHO coordinating committees

Coordinating committees have no standing host countries. These committees are hosted by one of the member countries in each region that has indicated to the committee their willingness to take on the responsibility. There are six coordinating committees, i.e. one each for the following regions: Africa (CCAFRICA) Asia (CCASIA) Europe (CCEURO) Latin America and the Caribbean (CCLAC) Near East (CCNEA) North America and the Southwest Pacific (CCNASWP).
Ad hoc intergovernmental task forces

Ad hoc intergovernmental task forces are established with a specific mandate and for a limited period of time, not normally exceeding four years. As in the case of the horizontal and vertical committees, Codex task forces are hosted by a member country. As of March 2005, two task forces had been established: the Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology hosted by Japan and

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the Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices hosted by Brazil. As noted above, these task forces are dissolved once their work has been completed.

Reference material

FAO/WHO. 2004. Codex Alimentarius Commission Procedural Manual. 14th edition, pp. 108144. Joint FAO/WHO Food Standards Programme, Rome. FAO/WHO. 2005. Understanding the Codex Alimentarius. Revised and updated, pp. 1619. Rome. Codex Web site: www.codexalimentarius.net

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Section 2

Module 2.4

Which committees should my country be involved in?

Most developing countries and countries with small economies, indeed even some developed countries, cannot afford the resources to participate in the work of all the currently active Codex committees, task forces, the Codex Executive Committee and the Codex Alimentarius Commission itself. Therefore, each country should prioritize and focus its resources to ensure that it is involved in discussing and developing standards of greatest national significance. This module outlines the terms of reference of the various Codex subsidiary bodies (i.e. the committees and task forces). The purpose of this is to assist countries to identify which Codex subsidiary bodies should be of priority to them. The terms of reference, the dates and host countries of past sessions of all the subsidiary bodies are given in the Codex Procedural Manual. This module also contains a practical exercise (Exercise 2.4.1) designed to guide countries through this process. Upon completion of the exercise, participants in Codex workshops are expected to identify the two top priority subsidiary bodies, excluding FAO/WHO coordinating committees. Obviously, this practical exercise is also a useful tool for national policy-makers in determining Codex priorities outside a training environment. Because of their nature, it is strongly recommended that countries actively participate in their FAO/WHO coordinating committee. Although it is the subsidiary bodies that develop the texts of the various standards, guidelines and recommendations, such texts do not become official Codex standards until they are adopted by the Commission (see Module 2.6 for a description of the elaboration process). There might therefore be a tendency by some countries to focus meagre resources towards participating at Commission meetings where texts are adopted. This may not be in the best interest of a country, however, as the drafting and negotiating of the language of the text are undertaken within committees and task forces. Although there are provisions in the Codex Procedural Manual for certain issues (such as implications for economic interests) to be raised at meetings of the Commission, it is highly desirable for a country to ensure that its particular concerns are taken into consideration in the development of a standard, within the relevant committee or task force. Countries need to take a number of factors into consideration when determining where to focus their Codex resources. Some of the considerations include the following: What are the countrys significant food safety/health issues? What are the issues most relevant to the consumer? What are the primary agrifood export industries contributing to the countrys economy? What are the major agrifood imports? What are the agrifood priorities identified by government? Which Codex committees elaborate standards, guidelines or related texts pertaining to the areas identified above?

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programme? In Module 2.3, it is noted that, according to its Rules of Procedure, the Commission can establish four types of subsidiary bodies: General subject or horizontal committees Commodity or vertical committees FAO/WHO coordinating committees Ad hoc intergovernmental task forces A brief outline of the terms of reference of the Codex subsidiary bodies is given below.
General subject committees Codex Committee on Food Additives and Contaminants

What resources (e.g. time, money, etc.) are available to commit to the Codex

The CCFAC is one of the original committees of the Commission, first meeting in 1964. It is mandated to: establish or endorse permitted maximum or guideline levels for food additives, contaminants, naturally occurring toxins and animal feeds; prepare priority lists of food additives and contaminants for evaluation by the Joint FAO/WHO Expert Committee on Food Additives (JECFA); recommend specifications of identity and purity for food additives; consider methods of analysis; consider and elaborate standards or codes for related subjects. It should be noted that only additives endorsed by this committee can be incorporated into Codex standards. The scientific basis for this work is provided by JECFA (see Module 4.3). Texts from this committee are found in Volume 1A General requirements of the Codex Alimentarius (see Module 2.9).
Codex Committee on Food Hygiene

The CCFH first met during 1964 and is mandated to: draft basic provisions on food hygiene; consider, amend if necessary and endorse provisions on hygiene prepared by Codex commodity committees and contained in Codex commodity standards, and Codex codes of practice; consider specific hygiene problems assigned to it by the Commission; suggest and prioritize areas for microbiological risk assessment at the international level and develop questions to be addressed by the risk assessors; consider microbiological risk management matters related to food hygiene and in relation to the risk assessment of FAO and WHO. An example of the type of text developed by this committee is the Recommended international code of practice: general principles of food hygiene including its Annex Hazard Analysis and Critical Control Point (HACCP) system and guidelines for its application. Texts produced by this committee are found in Volume 1B of the Codex Alimentarius and Food Hygiene Basic Texts (Third edition, Codex Alimentarius, 2003). The Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA) were established to provide scientific advice to this committee on microbiological hazards in food (see Module 4.5).
Codex Committee on Food Import and Export Inspection and Certification Systems

Established by the Twenty-second Session of the Commission, the CCFICS first met in

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1992 with terms of reference that require it to: develop principles and guidelines with a view to harmonizing methods and procedures for the application of measures by the competent authorities of exporting and importing countries, and for the utilization, as and when appropriate, of quality assurance systems; develop guidelines and criteria with respect to format, declarations and language of such official certificates as countries may require; make recommendations for information exchange; consult as necessary with other international groups working on matters related to food inspection and certification systems; consider other matters assigned to it by the Commission in relation to food inspection and certification systems. The Principles for food import and export inspection and certification systems is an example of the type of text developed by this committee. Standards developed by this committee are found in Volume 1A of the Codex Alimentarius.
Codex Committee on Food Labelling

The CCFL is mandated to: draft provisions on labelling applicable to foods; consider, amend if necessary and endorse draft specific provisions on labelling prepared by the Codex committees drafting standards, codes of practice and guidelines; study specific labelling problems assigned to it by the Commission; study problems associated with the advertisement of food with particular reference to claims and misleading descriptions. An example of the work of the CCFL is the Codex general standard for the labelling of prepackaged foods. Texts from this committee are found in Food Labelling Complete Texts (Codex Alimentarius, 2001).
Codex Committee on General Principles

The CCGP, established in 1965, is mandated to deal with such procedural and general matters as referred to it by the Codex Alimentarius Commission. It is also responsible for developing guidelines for Codex committees, developing a mechanism for examining any economic impact statements and for establishing a code of ethics for international trade in food. This committee has the general responsibility for maintaining the Codex Procedural Manual, including recommending amendments for adoption by the Commission.
Codex Committee on Methods of Analysis and Sampling

An essential part of Codex work is the determination of methods of analysis and sampling for foods moving in international trade. The CCMAS is mandated to: define the criteria appropriate to Codex methods of analysis and sampling; serve as a coordinating body for Codex with other international groups working on methods of analysis and sampling, and quality assurance systems for laboratories; consider, amend if necessary and endorse, as appropriate, methods of analysis and sampling proposed by Codex commodity committees, except that methods of analysis and sampling for residues of pesticides or veterinary drugs in food, the assessment of microbiological quality and safety in food, and the assessment of specifications for food additives, do not fall within the terms of reference of this committee; elaborate sampling plans and procedures, as may be required; consider specific sampling and analysis problems;

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define procedures, protocols, guidelines or related texts for the assessment of food

laboratory proficiency, as well as quality assurance systems for laboratories. Texts produced by this committee are found in Volume 13 of the Codex Alimentarius.

Codex Committee on Nutrition and Foods for Special Dietary Uses

The CCNFSDU was established at the creation of the Commission. It has been mandated to: study specific nutritional problems assigned to it by the Commission; draft general provisions concerning nutritional aspects of foods; develop standards, guidelines or related texts for foods for special dietary uses in cooperation with other committees where necessary; consider, amend if necessary and endorse provisions on nutritional aspects proposed for inclusion in Codex standards, guidelines and related texts. This committee develops texts intended to ensure the quality and safety of foods for special dietary uses, in particular foods for infants and children, such as General principles for the addition of essential nutrients to foods and the Codex standard for gluten-free foods. Standards developed by this committee are found in Volume 4 of the Codex Alimentarius.
Codex Committee on Pesticide Residues

The CCPR first met in 1966 and is mandated to: establish maximum limits for pesticide residues in foods; establish maximum limits for pesticide residues in certain animal feeding stuffs; prepare priority lists of pesticides in foods for evaluation by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR); consider methods of sampling and analysis for the determination of pesticide residues; consider other matters in relation to the safety of food and feed containing pesticide residues; establish maximum limits for environmental and industrial contaminants showing chemical or other similarity to pesticides in specific food items or groups of foods. Maximum residue limits established by the committee are found in Volume 2B of the Codex Alimentarius. Scientific advice is provided to this committee by the JMPR (see Module 4.4).
Codex Committee on Residues of Veterinary Drugs in Food

The CCRVDF was established in 1985 and first met in 1986. This committee is mandated to: determine priorities for the consideration of residues of veterinary drugs in foods; recommend maximum levels of such substances; develop codes of practice; consider methods of sampling and analysis for the determination of veterinary drug residues in foods. Maximum residue limits for veterinary drugs as well as the Code of practice and guidelines for control of the use of veterinary drugs and of veterinary drug residues in foods are found in Volume 3 of the Codex Alimentarius.
Commodity committees Codex Committee on Fats and Oils

The CCFO is mandated to elaborate worldwide standards for fats and oils of animal,

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vegetable and marine origin, including margarine and olive oil. Standards and codes of practice elaborated by this committee are contained in Volume 8 of the Codex Alimentarius.
Codex Committee on Fish and Fishery Products

The CCFFP has terms of reference to elaborate worldwide standards for fresh, frozen (including quick-frozen) or otherwise processed fish, crustaceans and molluscs. Standards and related texts developed by the CCFFP are found in Volume 9 of the Codex Alimentarius.
Codex Committee on Fresh Fruits and Vegetables

Established by the Seventeenth Session of the Commission in 1987 as the Codex Committee on Tropical Fresh Fruits and Vegetables, its name and terms of reference were amended by the Twenty-third Session in 1995. The CCFFV is required to: elaborate worldwide standards and codes of practice; consult with the UN/ECE Working Party on Standardization of Perishable Produce in the elaboration of worldwide standards and codes of practice, with particular regard to ensuring that there is no duplication of standards or codes of practice and that they follow the same broad format; consult, as necessary, with other international organizations in the area of standardization of fresh fruits and vegetables. Standards developed by this committee are contained in Volume 5B of the Codex Alimentarius.
Codex Committee on Meat Hygiene

The CCMH is mandated to elaborate worldwide standards and/or codes of practice as may seem appropriate for meat hygiene. Texts prepared by this committee are found in Volume 10 of the Codex Alimentarius.
Codex Committee on Milk and Milk Products

The CCMMP, which held its first meeting in 1994, is mandated to elaborate worldwide standards, codes and related texts for milk and milk products. Standards developed by the CCMMP are contained in Volume 12 of the Codex Alimentarius.
Codex Committee on Processed Fruits and Vegetables

The terms of reference of the CCPFV were extended by the Twenty-third Session of the Commission in 1999 to include the work of the abolished Joint ECE/Codex Alimentarius Groups of Experts on Standardization (Quick Frozen Foods). This resulted in a mandate to elaborate worldwide standards for all types of processed fruits and vegetables including dried products, canned dried peas and beans, jams and jellies, for quick-frozen fruits and vegetables, but not dried prunes or fruit and vegetable juices. The Commission has also allocated to this committee the work of revision of standards for quick-frozen fruits and vegetables. Standards elaborated by this committee are contained in Volume 5A of the Codex Alimentarius.
Codex Committee on Cereals, Pulses and Legumes

The CCCPL first met in 1980 to elaborate worldwide standards and/or codes of practice as may be appropriate for cereals, pulses, legumes and their products. It has been adjourned sine die. Standards elaborated by the CCCPL are found in Volume 7 of the Codex Alimentarius.

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Codex Committee on Cocoa Products and Chocolate

The CCCPC has a mandate to elaborate worldwide standards for cocoa products and chocolate. It has been adjourned sine die. Standards elaborated by this committee are contained in Volume 11 of the Codex Alimentarius.
Codex Committee on Natural Mineral Waters

First established as a regional (European) Codex committee, but since allocated the task of elaborating worldwide standards for natural mineral waters and bottled (packaged) water other than natural mineral water. The CCNMW has been adjourned sine die. Standards that have been developed by this committee are found in Volume 11 of the Codex Alimentarius.
Codex Committee on Sugars

The CCS is mandated to elaborate worldwide standards for all types of sugars and sugar products. It has been adjourned sine die. Standards elaborated by this committee are contained in Volume 11 of the Codex Alimentarius.
Codex Committee on Vegetable Proteins

The CCVP is mandated to elaborate definitions and worldwide standards for vegetable protein products deriving from any member of the plant kingdom as they come into use for human consumption, and to elaborate guidelines on utilization of such vegetable protein products in the food supply system, on nutritional requirements and safety, on labelling and on other aspects as may seem appropriate. The Codex standard for vegetable protein products is an example of the work done by this committee, currently adjourned sine die. Standards developed by this committee are found in Volume 7 of the Codex Alimentarius. An example is the General guidelines for the utilization of vegetable protein products in foods.
FAO/WHO coordinating committees

The terms of reference for the six FAO/WHO coordinating committees are identical, as follows: define the problems and needs of the region concerning food standards and food control; promote, within the committee, contacts for the mutual exchange of information on proposed regulatory initiatives and problems arising from food control, and stimulate the strengthening of food control infrastructures; recommend to the Commission the development of worldwide standards for products of interest to the region, including products considered by the committee to have an international market potential in the future; develop regional standards for food products moving exclusively or almost exclusively in intraregional trade; draw the attention of the Commission to any aspects of the Commissions work of particular significance to the region; promote coordination of all regional food standards work undertaken by international governmental and non-governmental organizations within the region; exercise a general coordinating role for the region and such other functions as may be entrusted to it by the Commission; promote the use of Codex standards and maximum residue limits by member countries.

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Ad hoc intergovernmental task forces

The terms of reference of these task forces are given below. It should be noted that these task forces have a limited time frame and specific mandate.
Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology4

Elaborate standards, guidelines or other principles, as appropriate, for foods derived

from modern biotechnology, taking account in particular of the Principles for the risk analysis of foods derived from modern biotechnology. Coordinate and closely collaborate, as necessary, with appropriate Codex committees within their mandate as relates to foods derived from modern biotechnology. Take account of existing work carried out by national authorities, FAO, WHO, other international organizations and other relevant international fora.

Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices

Revise and consolidate the existing Codex standards and guidelines for fruit and

vegetable juices and related products, giving preference to general standards. Revise and update the methods of analysis and sampling. Complete its work prior to the Twenty-eighth Session of the Commission (2005).

Ad Hoc Intergovernmental Task Force on Animal Feeding5

Complete and extend the work already done by relevant Codex committees on the

Draft code of practice for good animal feeding. Address other aspects that are important for food safety such as problems related to toxic substances, pathogens, microbial resistance, new technologies, storage, control measures, traceability, etc. Take full account of and collaborate with, as appropriate, work carried out by relevant Codex committees, and other relevant international bodies, including FAO, WHO, the World Organisation for Animal Health (OIE) and the International Plant Protection Convention (IPPC).

Reference material

FAO/WHO. 2004. Codex Alimentarius Commission Procedural Manual. 14th edition, pp. 112144. Joint FAO/WHO Food Standards Programme, Rome. Codex Web site: www.codexalimentarius.net

This task force completed its work in 2003; however in 2004, the Commission agreed to establish a new Intergovernmental Task Force on Foods Derived from Biotechnology, with the understanding that the final report should be submitted to the Commission in 2009 (ALINORM 04/27/41, para. 89). In 2004, the Task Force had completed its work on the Draft code of practice for good animal feeding, but agreed that further work in the area of animal feed was needed, and that specific project proposals for new work should be prepared and submitted to the Commission for consideration (ALINORM 04/27/10D-Add.1, para. 8).

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Section 2 | Module 2.4 / Which committees should my country be involved in?

Exercise 2.4.1 | Prioritization of Codex committees

Objective The purpose of this exercise is to review the terms of reference of the various Codex committees and identify no more than two committees, in addition to the FAO/WHO coordinating committee, that would be of particular interest to the country or to the region in which the training is being conducted. For developing countries in particular, it is strongly recommended that the FAO/WHO coordinating committee be a committee to which resources are directed. It is in those committees that issues of most significance to the country are discussed and the needs of the region regarding food standards are identified. It also provides an opportunity for communicating to the Commission, and ultimately to FAO and/or WHO, information on areas needing capacity building. Method 1. Depending on the size of the group, groups of five to six trainees should be arranged. 2. Review the subject matter and terms of reference of Codex committees and ad hoc task forces. 3. Identify those Codex committees/ad hoc task forces that should be included in the national Codex programme. Issues to be taken into account include: - What are the significant food safety/health issues?

- What are the issues most relevant to the consumer? - What are the primary agrifood export industries contributing to the countrys economy? - What are the major agrifood imports? - What are the agrifood priorities identified by government? - What resources (e.g. time, money, etc.) are available to commit to the Codex programme? - Which Codex committees elaborate standards, guidelines or related texts pertaining to the areas identified above? The terms of reference for the various committees should be reviewed in the context of the above considerations, which should facilitate the identification and prioritization of those Codex committees of most significance. Time allocation The groups should be allowed 45 minutes to discuss, and then 10 minutes per group to report and discuss in plenary. Outcome The identification of no more than two committees is important as it will be the current issues under consideration in those committees that will be used as practical exercises to develop a consultation plan and positions.

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Section 2

Module 2.5

How do Codex committees function?

The question is discussed here from two perspectives: (1) the function of Codex subsidiary bodies, including their composition, and the role and responsibilities of host countries; and (2) the provision of guidance on how meetings are conducted, including how Members and observers intervene and other procedural issues. As explained in Modules 2.3 and 2.4, there are four types of Codex subsidiary body. Although the nature of the subject matter may be different, all Codex subsidiary bodies follow the same procedures to comply with their respective terms of reference.
Codex committees: functions, composition and host country responsibilities What do Codex committees do?

The main function of Codex subsidiary bodies, as described in the Codex Procedural Manual is to develop standards, guidelines and recommendations (which include codes and principles) relevant to their specific subject area. Specifically, Codex subsidiary bodies are expected to: draw up of a list of priorities among the subjects and products within their terms of reference; consider the safety and quality elements to be covered; consider the types and scope of products to be covered by standards, e.g. whether materials for further processing into food should be covered; prepare draft Codex standards (including guidelines, codes of practice) taking into account the standard-setting methodology adopted by the Commission; report to each session of the Commission on the progress of their work and, where necessary, on any difficulties caused by their terms of reference, together with suggestions for their amendment; review and, as necessary, revise existing standards and related texts on a scheduled, periodic basis to ensure that the standards and related texts within their terms of reference are consistent with current scientific knowledge and other relevant information.
What is the composition of Codex committees?

All Codex committees consist of a chairperson, a body of members (i.e. those Codex Member countries present), observers who have speaking privileges but not voting rights, a secretariat and a host government that facilitates the work of the committee. Chairperson. The Codex Alimentarius Commission designates a member country of the Commission, which has indicated its willingness to accept financial and all other

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Section 2 | Module 2.5 / How do Codex committees function?

responsibility associated with hosting a committee, as having responsibility for appointing a chairperson of the committee. The member country concerned is responsible for appointing the chairperson of the committee from among its own nationals. Although a committee, at any session, may appoint one or more rapporteurs from among the delegates present, most committees have a secretariat provided by the host country. Members. Membership of Codex committees is open to Members of the Commission who have notified the Director-General of FAO or WHO of their desire to be considered as Members. This notification is achieved through the formal registration process. Membership of FAO/WHO coordinating committees is open only to Members of the Commission belonging to the region or group of countries concerned, although other Codex member countries may attend, as observers, meetings of FAO/WHO coordinating committees other than those to which they are geographically allocated. Observers. Procedures for the admittance of observers at a Codex committee are as follows: Notification has been made by the country (for FAO/WHO coordinating committee sessions of which the country is not a Member) or international organization to the Director-General of FAO or WHO. Again this is normally done by responding to the invitation and registering. Observer countries may participate fully in the discussion of the regional committee and shall be provided with the same opportunities as other Members to express their point of view (including the submission of memoranda), but without the right to vote or to move motions either of substance or of procedure. International organizations can also be invited to attend all meetings of Codex subsidiary bodies in an observer capacity. The participation of international organizations in Codex should be in accordance with the Principles concerning the participation of international non-governmental organizations in the work of the Codex Alimentarius Commission (see Codex Procedural Manual, pp. 6266).
What are important preparations for Codex meetings?

Preparations for meetings are mainly in the hands of the secretariat of the host country, working closely with the Codex Secretariat. Secretariat/host government. A member country to which a Codex committee has been assigned is responsible for providing all conference services, including contributing to the secretariat. The host government has a responsibility to ensure that it: has administrative support staff able to work easily in the languages used at the session; has at its disposal adequate word processing and document reproducing equipment; provides for simultaneous interpretation from and into all languages used at the session; makes available the services of a translator if the report of the session is to be adopted in more than one of the working languages of the committee. The members of the secretariat from the host country support the work of the Codex Secretariat, and are not members of the host countrys official delegation. Their primary function is to facilitate the functioning of the session and it is important that they be perceived as being neutral and not influencing the outcome of the discussions. Invitations. Each session of a Codex committee or FAO/WHO coordinating committee is scheduled by the Codex Secretariat in Rome in consultation with the Codex Contact

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Section 2 | Module 2.5 / How do Codex committees function?

Point of the country hosting the respective Codex committee. The biennial schedule of Codex sessions is then tabled for consideration and endorsement by the Commission. The letter of invitation and provisional agenda for each Codex meeting are prepared by the Secretary of the Codex Alimentarius Commission, in consultation with the committee secretariat of the host country or the National Codex Committee, and issued by the respective Director-General to all Members and Associate Members of FAO and WHO or, in the case of coordinating committees, to the countries of the region or group of countries concerned, Codex Contact Points and interested international organizations in accordance with the official mailing lists of FAO and WHO. The invitation and provisional agenda are required by the Rules of Procedure of the CAC to be translated and distributed by FAO/WHO in the working languages of the Commission at least four months before the date of the meeting. However, owing to workloads, this time frame is not always achieved. Invitations should include the following information: title of the Codex committee; time and date of opening and date of closing the session; place of the session; languages to be used and arrangements for interpretation; if appropriate, information on hotel accommodation; request to the Codex Contact Point for information on the country delegation, including the names of the chief delegate and other members of the delegation, and for information on whether the chief delegate of a government will be attending as a representative or in the capacity of an observer. Replies to invitations will normally be requested to be sent to reach the host country secretariat as early as possible, and in any case not less than 30 days before the session. When responding to the invitation, a copy should also be sent to the Secretary of the Codex Alimentarius Commission. A timely response to the invitation letter is very important to facilitate the organization of the committee meeting room by the host country, to ensure correct sequence of countries, sufficient seats for each delegation, coordinated microphone facilities where used, etc. The acceptance by a Codex Member to attend a Codex session should be channelled officially through the national Codex Contact Point. Provisional agenda. A provisional agenda is normally prepared by the Codex Secretariat in consultation with the host country secretariat stating the time, date and place of the meeting. An example of a Codex provisional agenda is given in Box 2.5.1. Provisional agendas comprise three distinct groups of items: fixed items linked to procedure (adoption of the agenda, rapporteurs, matters referred from other committees, etc.); items stemming from previous sessions of the committee (e.g. standards being elaborated); and other business. A provisional agenda would normally include these items in the following order: adoption of the agenda; if considered necessary, election of rapporteurs; items relating to subject matter to be discussed, including, where appropriate, the step in the Commissions Procedure for the elaboration of standards (reference should also be made to the committee papers relevant to the item, standard procedure being that items more advanced in the step process come first on the agenda, i.e. items at step 7 will be considered before items at step 5; items related to public health come before items that are not); other business;

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The work of the committee and the length of the meeting should be arranged so as to leave sufficient time at the end of the session for a report of the committees discussions to be agreed. In most circumstances, there is no plenary session the day prior to the adoption of the report in order to provide sufficient time for the reports preparation, including translation.
Preparation and distribution of working papers

consideration of date and place of next session; adoption of draft report.

Working papers (e.g. draft standards, country comment papers, discussion papers) for a committee session are normally distributed at least two months before the opening of the session. However, owing to workloads of the secretariats, this timeline is often not possible to achieve. Normally, this task of preparing and distributing working papers is carried out by the Rome-based Codex Secretariat, with assistance as necessary from the host country secretariat. These working papers form the basis of discussion at the relevant committee meeting, and distribution in advance enables member countries to consult and develop national positions on issues of importance to their country. Relevant papers should be sent to the following: all Codex Contact Points; international governmental and non-governmental organizations with observer status in the Commission; other participants on the basis of replies received. Codex Contact Points are responsible for ensuring that papers are circulated to those concerned within their own country and for ensuring that all necessary action is taken by the date specified as the deadline for comments. Comments submitted by countries on agenda items or items contained in a circular letter should be circulated to all Members and observers prior to the Codex session. Documents received too late for circulation prior to a session will be circulated at the session itself. These are known as conference room documents (CRDs). The disadvantage of CRDs is that their distribution is limited to those Members and observers present at the session. In addition, Members and observers at the session may not have sufficient time or competence to consider the CRD fully or be able to seek a timely official position on the issues raised therein (see also Module 2.7).
Conduct of meetings Who may attend Codex meetings?

Participation in Codex meetings is open to delegations representing member countries and organizations with official observer status. Meetings of Codex committees and task forces are also held in public unless the committee decides otherwise.
Is there a format for the conduct of meetings?

All Codex sessions follow the same format. First, there may be an official or formal opening of the session. If so, the country responsible for hosting the session decides who will officially open the session. This task is often delegated to a senior official of the host government or a minister of the parliament of the host country. After the session is officially opened, the chairperson proceeds to the adoption of the provisional agenda and invites observations from members of the committee concerning the provisional agenda. Any member country may include specific items in the

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Section 2 | Module 2.5 / How do Codex committees function?

provisional agenda, according to Rules VI.3 and VI.5 of the Rules of Procedure of the Codex Procedural Manual. In the light of such observations, the chairperson requests the committee to adopt the provisional agenda or the amended agenda. Meetings are conducted in accordance with the Rules of Procedure (Guidelines for Codex committees and ad hoc intergovernmental task forces) in the Codex Procedural Manual. Chairpersons of Codex committees are expected to ensure that all questions are fully discussed, including comments on the possible economic implications of the standard being elaborated, when the committee considers submitted comments at Steps 4 and 7. The eight-step elaboration procedure is further explained in Module 2.6. Chairpersons are also expected to ensure that the committee considers the written comments of Members not present at the session and that all issues are put clearly to the committee. It should be noted here that if a country has submitted written comments and is unable to attend the meeting, it would be wise to liaise with a like-minded country that is attending the meeting and can intervene and draw the committees attention to the written comments. However, this can only be done if written comments were duly submitted (see Module 3.2). At appropriate intervals during the discussion of each agenda item, the chairperson summarizes the discussion by stating what appears to be the generally acceptable view, and asking delegates whether they have any objection to it being recorded as the decision of the committee. The chairperson should always try to arrive at a consensus and should not ask the committee to proceed to voting if agreement on the committees decision can be secured by consensus. In fact, voting at the committee level is extremely rare.
How can a country express its views at a meeting?

Members and observers are permitted to speak (intervene) on issues under consideration by the committee. Members and observers indicate their desire to speak by holding up their country or organization nameplate, or placing it on one end. In some committees, delegates can indicate their desire to speak by pushing a button at their seat, which places their country or organizations name on a computer screen in front of the chairperson. Protocol states that Members speak before observers, and delegations speak only when acknowledged by the chairperson. Normally, it is the head delegate who has the right to speak but, with the chairs permission, another member of the delegation may speak on technical matters. At all times comments are directed to the chair, never directly to another delegation. At the beginning of an intervention, the delegate should always acknowledge the chairperson and conclude by thanking the chairperson for the opportunity to speak.
How often and for how long may I speak?

There are no precise rules within Codex regarding the number and duration of interventions. However, by convention the general practice is to intervene only once on any particular issue, although a second intervention may be permitted at the discretion of the chair, to clarify a point or reply to a question raised by another delegation. It is highly desirable for interventions to be as short and clear as possible (two or three minutes are reasonable maximum limits). One should speak slowly to allow for good interpretation. It is difficult to follow lengthy interventions, and other delegations may lose their concentration, with the result that the point that was to be made may be missed, thus diminishing the effectiveness of the intervention. At some committees with a very heavy agenda and time limitations, it is not unusual for the chairperson to ask speakers to make their interventions as short as possible, or to specify an agreed time limit, often two or

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Section 2 | Module 2.5 / How do Codex committees function?

three minutes. It should also be borne in mind that all interventions are interpreted simultaneously into several other languages, with the result that lengthy interventions risk being misunderstood by those who do not comprehend the language of the speaker.
What if my country disagrees with a decision taken by the committee?

Delegations who wish their opposition to a decision of the committee to be recorded may do so, whether the decision has been taken or not, by asking for a statement of their position to be contained in the report of the committee. This statement should not merely use a phrase such as: The delegation of X reserved its position, but should make clear the extent of the delegations opposition to a particular decision of the committee and state whether they were simply opposed to the decision or wished for a further opportunity to consider the question. When an objection has been recorded in the report at the time of adoption, the speaker should ensure the accuracy of the record of the objection, and that the countrys position has not been misinterpreted.
What is in the report of a session?

A draft report of the committees proceedings is prepared by the secretariat for consideration by the committee on the final day of the session. The report is reviewed and adopted by the committee, paragraph by paragraph or section by section. Once adopted, the draft report becomes the official record of the committee session. The review and adoption processes provide countries with an opportunity to ensure that the report is accurate. It is not an opportunity to reopen discussion on agenda items. What has been said and decided cannot be revisited. When requesting an amendment to the draft report, it is important to make a concrete proposal for changes (e.g. deletion or addition of words). The following points should be borne in mind: committee decisions in the report should be clearly stated; action taken in regard to economic impact statements should be fully recorded; all decisions on draft standards should be accompanied by an indication of the step in the procedure that the standards have reached; if action has to be taken before the next meeting of the committee, the nature of the action, who is to take it and when the action must be completed should be clearly stated; where matters require attention by other Codex committees, this should be clearly stated; if the report is of any length, an executive summary of points agreed and the action to be taken should be included at the beginning of the report. All reports contain a section at the end of the report showing clearly in summary form: a) standards considered at the session and the steps they have reached; b) standards at any step of the procedure, the consideration of which has been postponed or which are held in abeyance and the steps which they have reached; c) new standards proposed for consideration, the probable time of their consideration at Step 2 and the responsibility for drawing up the first draft. The following appendixes are normally attached to the report: a list of participants with full postal and e-mail addresses, telephone numbers and fax numbers; the complete text of draft standards with an indication of the step in the procedure that has been reached. The Codex Secretariat makes every effort to ensure that, as soon as possible and in any event not later than one month after the end of the session, copies of the final report are sent to all Codex Contact Points.

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Section 2 | Module 2.5 / How do Codex committees function?

Box 2.5.1 | Example of a provisional agenda

codex alimentarius commission

FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS WORLD HEALTH ORGANIZATION
Joint office: Viale delle Terme di Caracalla 00100 ROME Tel: 39 06 57051 www.codexalimentarius.net E-mail: [email protected] Facsimile: 39 06 5705 4593

CX/FH 05/31/1 January 2005

JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON FOOD HYGIENE Thirty-seventh Session Buenos Aires, Argentina, 1419 March 2005 Sheraton Buenos Aires Hotel and Convention Center, San Martin 1225/1275, Buenos Aires, Argentina, beginning at 10.00 hrs on Monday 14 March through Saturday 19 March 2005

PROVISIONAL AGENDA
Agenda Item Subject Matter Opening of the Session 1. 2. 3. Adoption of the Agenda Matters Referred by the Codex Alimentarius Commission and/or Other Codex Committees to the Food Hygiene Committee Discussion Paper on the Management of the Work of the Committee - Comments 4. Proposed Draft Revision of the Recommended International Code of Hygienic Practice for Foods for Infants and Children at Step 4 - Comments at Step 3 5. Proposed Draft Guidelines on the Application of General Principles of Food Hygiene to the [Management] of Listeria monocytogenes in Foods at Step 4 - Comments at Step 3 6. Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management at Step 4 - Comments at Step 3 7. Proposed Draft Guidelines for the Validation of Food Hygiene Control Measures at Step 4 - Comments at Step 3 CX/FH 05/37/1 CX/FH 05/37/2 CX/FH 05/37/3 CX/FH 05/37/3-Add.1 CX/FH 05/37/4 CX/FH 05/37/4-Add.1 CX/FH 05/37/4-Add.2 CX/FH 05/37/5 Doc. Reference

CX/FH 05/37/5-Add. 1 CX/FH 05/37/6 CX/FH 05/37/6-Add.1 CX/FH 05/37/7 CX/FH 05/37/7-Add.1

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Box 2.5.1 (cont.) | Example of a provisional agenda

8.

Proposed Draft Revision of the Code of Hygienic Practice for Egg Products (CAC/RCP 15-1976) at Step 4 - Comments at Step 3

CX/FH 05/37/8 CX/FH 05/37/8-Add.1 CX/FH 05/37/9 CX/FH 05/37/10

9. 10.

Reports of the ad hoc FAO/WHO Expert Consultations on Risk Assessment of Microbiological Hazards in Food and Related Matters Discussion Paper on the Guidelines for the Application of the General Principles of Food Hygiene to the Risk Based Control of Salmonella spp. in Poultry Discussion Paper on the Guidelines for the Application of the General Principles of Food Hygiene to the Risk Based Control of Enterohemorragic E. coli in Ground Beef and Fermented Sausages Discussion Paper on the Guidelines for Risk Management Options for Campylobacter in Broiler Chickens Other Business and Future Work: (a) Risk Profile of Vibrio spp. in Seafood (b) Discussion Paper on the Viruses in Food (c) Draft Terms of Reference for the FAO/WHO Expert Consultation on the Uses of Active Chlorine

11.

CX/FH 05/37/11

12. 13.

CX/FH 05/37/12

CX/FH 05/37/13 CX/FH 05/37/14 CX/FH 05/37/15

14. 15.

Date and Place of the Next Session Adoption of the Report

N.B.: The hard copies of documents except for Agenda Item 1 will be distributed from the US Codex Secretariat. For enquiry please contact Mr Ali Syed, fax: 1 202 720-3157, e-mail: [email protected] Working documents as prepared will be uploaded onto the Codex Web site. They can be downloaded and printed by accessing the following URL: http://www.codexalimentarius.net Delegates are kindly requested to bring with them to the meeting all documents which have been distributed as the number of additional copies which can be made available at the meeting is limited.

NOTES ON THE PROVISIONAL AGENDA Opening of the Session: The Session will be opened by the Host Government. Agenda Item 1. Adoption of the Agenda (Doc. Ref. CX/FH 05/37/1). In accordance with Rule V.1 of the Rules of Procedure, the first item on the Provisional Agenda shall be the adoption of the Agenda. Agenda Item 2. Matters Referred by the Codex Alimentarius Commission and/or Other Codex Committees to the Food Hygiene Committee (Doc. Ref. CX/FH 05/37/2). The document is based on the information prepared by the Codex Secretariat. The Committee is invited to consider matters referred to it by the Codex Alimentarius Commission and/or other Committees and to take actions, if necessary.

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Box 2.5.1 (cont.) | Example of a provisional agenda

Agenda Item 3. Discussion Paper on the Management of the Work of the Committee (Doc. Ref. CX/FH 05/37/3). The Committee is invited to consider the working procedures in order to identify, prioritize and carry out its work; and interact with other Codex Committees, the ad hoc Expert Consultations and task forces. Comments in response to CX/FH 05/37/3 will be reproduced in CX/FH 05/37/3-Add. 1. Furthermore the Working Group is scheduled to meet prior to the session on Saturday, March 12, 2005 to resolve comments and if necessary, revise the document. The product of the Working Group meeting will be issued as CRD 1. Agenda Item 4. Proposed Draft Revision of the Recommended International Code of Hygienic Practice for Foods for Infants and Children (Doc. Ref. CX/FH 05/37/4). The proposed revised code is prepared by Canada with assistance of their drafting partners. The Committee is also invited to expedite the work of FAO/WHO Meeting on E. sakazaki and other microorganisms in powdered infant formula1. The document CX/FH 05/37/4-Add.1 reproduces comments received in response to the document CX/FH 05/37/4. Agenda Item 5. Proposed Draft Guidelines on the Application of General Principles of Food Hygiene to the [Management] of Listeria monocytogenes in Foods (Doc. Ref.. CX/FH 05/5). At the 36th Session of the Committee several suggested changes to the document were provided t to the drafters of the document. The Committee also asked the drafting group to prepare an Annex to the Guidelines on the establishments of FSOs and related performance objective and performance criteria, including microbiological criteria for Listeria monocytogenes in Ready-to-eat Foods. The Committee is invited to consider the above proposed guidelines as elaborated by Germany with assistance of their drafting partners. Government comments are summarized in CX/FH 05/37/5-Add.1. Agenda Item 6. Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management (Doc. Ref. CX/FH 05/37/6). The current text is the result of improvements made in the light of discussion of the 36th Session of the CCFH and the Drafting Group meeting led by France. CX/FH 05/37/6Add.1 reproduces comments received in response to the document CX/FH 05/6. The Working Group will meet prior to the session on Sunday to resolve comments and revise the document. The product of the Working Group meeting will be issued as CRD 2. Agenda Item 7. Proposed Draft Guidelines for the Validation of Food Hygiene Control Measures (Doc. Ref. CX/FH 05/7). At the 36th Session of the Committee, several suggested changes were provided to the drafting group. The Committee is invited to consider the proposed draft Guidelines as elaborated by the US with their drafting partners at Step 4. Government comments are included in CX/FH 04/37/7-Add.1. Agenda Item 8. Proposed Draft Revision of the Code of Hygienic Practice for Egg Products (CAC/RCP 15-1976) (Doc. Ref. CX/FH 05/37/8). The Committee is invited to consider the proposed draft revision at Step 4 being prepared by Australia. Comments are presented in CX/FH 05/37/8-Add.1. Agenda Item 9. Reports of the ad hoc FAO/WHO Expert Consultations on Risk Assessment of Microbiological Hazards in Food and related Matters (Doc. Ref. CX/FH 05/37/9). This FAO/WHO paper will summarize all of the microbiological risk assessment activities conducted last year in support of the Committee activities. Agenda Item 10. Discussion Paper on the Guidelines for the Application of the General Principles of Food Hygiene to the Risk Based Control of Salmonella spp. in Poultry (Doc. Ref. CX/FH 05/37/10). The current text is the result of improvements made in the light of discussion of the 36th Session of the CCFH and the Drafting Group meeting led by Sweden. Agenda Item 11. Discussion Paper on the Guidelines for the Application of the General Principles of Food Hygiene to the Risk Based Control of Enterohemorragic E. coli in Ground Beef and Fermented Sausages (Doc. Ref. CX/FH 05/37/11). At the direction of the 36th Session the United States and its drafting partners have prepared the discussion paper. The Committee is invited to provide further direction to the drafting group regarding the content and format of the document.

Enterobacter sakazakii and other microorganisms in powdered infant formula. Geneva, FAO/WHO, 2004. (Microbiological Risk Assessment Series, No. 6, ISBN: 92 4 156262 5). http://www.who.int/foodsafety/publications/micro/en/es.pdf

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Box 2.5.1 (cont.) | Example of a provisional agenda

Agenda Item 12. Discussion Paper on the Guidelines for Risk Management Options for Campylobacter in Broilers Chickens (Doc. Ref. CX/FH 05/37/12). At the 36th Session of the Committee, the drafting Group leader Netherlands sought clear directions from the Committee regarding the content and format of this paper. The Committee specified a format for further development of the document and this paper is the product of the Drafting Group lead by Netherlands and its partners. Agenda Item 13. Other Business and Future Work. In accordance with Rule V.5 of the Rules of Procedure, any Member of the Commission may propose the inclusion of specific items of an urgent matter. The Committee may propose to undertake new work which shall be in compliance with the Medium Term Objectives and subject to approval by the Commission or its Executive Committee. (a) Risk Profile of Vibrio spp in Seafood (Doc. Ref.: CX/FH 05/37/13). The Committee is invited to consider how to proceed with further development of the document which had been prepared by the United States and its drafting partners. (b) Discussion Paper on the Viruses in Food. Consideration of this item has been temporary suspended at the 32nd session of the Committee, however the 36th session decided to put it on the list of activities for consideration regarding prioritization (Doc. Ref. CX/FH 05/37/14). (c) Draft Terms of Reference for the FAO/WHO Expert Consultation on the Uses of Active Chlorine (Doc. Ref. CX/FH 05/37/15). The Committee is invited to consider draft Terms of Reference for the FAO/WHO Expert Consultation on the uses of active chlorine, including safety/benefit issues and questions for the above Consultation thath fall within the Committees Terms of Reference. Agenda Item 14. Date and Place of the Next Session. The Committee will be advised of the tentative dates and the venue of the next meeting. Agenda Item 15. Adoption of the Report. In accordance with Rule VIII of the Rules of Procedure, the Committee shall adopt the report of its 37th Session based on a draft provided by the Secretariat.

Reference material

FAO/WHO. 2004. Codex Alimentarius Commission Procedural Manual. 14th edition, pp. 5561 and 6266. Joint FAO/WHO Food Standards Programme, Rome. FAO/WHO. 2005. Understanding the Codex Alimentarius. Revised and upadated, pp. 1516. Rome. Codex Web site: www.codexalimentarius.net

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Section 2

Module 2.6

How does Codex elaborate standards?

When a Codex subsidiary body (i.e. a committee or a task force) proposes to elaborate a standard, code of practice or related text within its terms of reference, it should consider: the priorities that were established by the Commission in the Strategic Plan of Work; any specific relevant strategic project currently being undertaken by the Commission; the feasibility of completing the work within a reasonable period of time. The Codex Alimentarius Commission has established criteria, outlined below but currently under review, to be applied in determining priorities for inclusion of tasks in the programme of work of committees/ad hoc task forces. These criteria are generally addressed when a member country makes a submission to a committee for new work or for the review of an existing, or adopted, Codex text. If the proposal falls outside of the committees terms of reference, the proposal should be referred to another committee or reported to the Commission in writing together with proposals for amendments to the committees terms of reference. Normally, the origin of a standard will come from a country or group of countries that raise the issue at a Codex committee or a FAO/WHO coordinating committee. A committee may only proceed with work on a new standard once it has been approved by the Commission. When a committee or task force starts to elaborate a standard whose development has been approved by the Commission, there is a step procedure to be followed. The normal procedure is eight steps, although an accelerated five-step procedure may be used if agreed to by at least two-thirds of the Members of the Commission. While most Codex documents are elaborated through this step process, it is important to realize that some Codex documents are developed outside of the step process, e.g. internal documents to guide the work of a specific Committee. This module describes the mechanism for initiating work on a standard, the criteria for prioritization, elaboration procedures for standards, codes of practice or related texts and the procedures for revision of standards.
Project documentation

When a committee or other subsidiary body of the Commission is considering elaborating a standard code of practice, or related text, the committee will prepare project documentation for submission to the Executive Committee and the Commission. This documentation will provide the information required by the Commission to determine whether or not the work should be approved, and will be the basis for the Executive Committees monitoring of the progress of the work. This project documentation is not required for individual maximum residue limits for pesticides or veterinary drugs, or the maintenance of standards and texts such as the General standard on food additives or International numbering system.

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Project documentation should consist of the following: purpose of the proposed standard; indication of its relevance to the Codex strategic objectives; scope of the proposed standard; assessment of the proposed standard against the criteria for the establishment of work priorities; proposed time line for completion of the work (including, as a minimum, start date, proposed date for adoption at step 5 and proposed date for final adoption by the Commission); identification of expert advice requirements; identification of any issues related to the needs of developing countries. Preparation of this project documentation is the responsibility of the Member proposing new work. It should be prepared in sufficient time for the committee to reach consensus on whether or not to recommend the work and subsequent consideration by the Executive Committee and the Commission. Specific criteria are used in determining priorities for inclusion of tasks in the programme of work of committees and task forces, as set out below.
Criteria applicable to general subject committees

Contribution to the protection of consumers health and prevention of fraudulent

practices Diversification of national legislation and apparent resultant or potential impediments to international trade Scope of the work undertaken and the establishment of priorities between the various sections of the work Work already undertaken by other international organizations in this field will be considered.

Criteria applicable to commodity committees

Contribution to the protection of consumers health and prevention of fraudulent

practices Volume of production and consumption in individual countries and volume and pattern of trade between countries Diversification of national legislation and apparent resultant or potential impediments to international trade International or regional market potential Amenability of the commodity to standardization Coverage of the main consumer protection and trade issues by existing or proposed general standards Number of commodities that would need separate standards indicating whether raw, semi-processed or processed products are to be included in the standard Work already undertaken by other international organizations in this field

Procedures for the elaboration of Codex standards

The preparation and adoption of food standards and their publication in the Codex Alimentarius is one of the principal purposes of the Codex Alimentarius Commission. Procedures for preparing standards are well defined, open and transparent.

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Box 2.6.1 | The eight-step procedure for elaborating Codex standards, guidelines and related texts
Step 1 The Commission decides to elaborate a standard and assigns the work to a committee. A decision to elaborate a standard may also be taken by a committee, but is subject to endorsement by the Commission. Step 2 The Secretariat arranges preparation of a proposed draft standard. Step 3 The proposed draft standard is sent to governments and international organizations for comment. Step 4 The Secretariat forwards comments to the committee for consideration and possible revision of the draft. Step 5 The proposed draft standard is sent to the Commission through the Secretariat for adoption as a draft standard. Step 6 The draft standard is sent to governments and international organizations for comment. Step 7 The Secretariat forwards comments to the committee. Step 8 The draft standard is submitted to the Commission through the Secretariat for adoption as a Codex standard.

Box 2.6.2 | The five-step accelerated procedure for elaborating Codex standards, guidelines and related texts
Step 1 The Commission decides to elaborate a standard on the basis of a two-thirds majority of votes cast using the accelerated procedure and assigns the work to a committee. Step 2 The Secretariat arranges preparation of a proposed draft standard. Step 3 The proposed draft standard is sent to governments and international organizations for comment. When standards are subject to the accelerated procedure, Members of the Commission and the interested international organizations are notified. Step 4 The Codex Secretariat forwards comments to the committee for consideration and amendments to the proposed draft standard. Step 5 The proposed draft standard subject to the accelerated elaboration procedures is sent to the Commission through the Secretariat, together with any written proposals from Members and interested international organizations, for adoption as a Codex standard.

Codex step process

The submission of a proposal for a standard, code of practice or related text to be developed by a subsidiary body of the Commission is initially brought forward for a decision by the Commission or the Executive Committee. The process involves an assessment of the criteria for the establishment of work priorities and for the establishment of subsidiary bodies to assist the Commission or Executive Committee in their decision-making and in selecting or creating the subsidiary body to be responsible for steering the standard through its development.

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The issue of establishing a subsidiary body may arise where there is a proposal for the elaboration of a standard, code of practice or related text in an area not covered by the terms of reference of an existing subsidiary body. Box 2.6.1 shows the uniform procedure for the elaboration of Codex standards and related texts. Once the decision is made by the Commission to proceed with the elaboration of a Codex text, an eight-step procedure is normally followed in the development and approval of the standard. The Commission may also approve the use of an accelerated procedure for the elaboration of these standards, using a five-step elaboration process. The uniform accelerated procedure for the elaboration of Codex standards and related texts is shown in Box 2.6.2. In some circumstances, steps may be repeated. The Commission or the committee may conclude that a specific issue needs to be discussed in more detail and may suggest that the draft standard be circulated again at the same step or at a previous step. As indicated previously, a committee may recommend following an accelerated procedure and recommend the omission of Steps 6 and 7. Once adopted by the Commission, a Codex standard is included in the Codex Alimentarius (see Module 2.9).
Revision of Codex standards

The Commission and its subsidiary bodies are committed to revision of Codex standards and related texts as necessary to ensure that they are consistent with and reflect current scientific knowledge. Standards may also be revised owing to technological developments or changes in economic considerations. Each Member of the Commission is responsible for identifying and presenting to the appropriate committee any new scientific and other relevant information that may warrant revision of existing Codex standards or related texts. The procedure for revision follows the same step procedure, including the preparation of project documentation. Preparation of project documentation is not required for individual maximum residue limits for pesticides or veterinary drugs, or the maintenance of standards and texts such as the General standard on food additives or International numbering system.
Amendments to the Codex Procedural Manual

It should be noted that amendments to the Codex Procedural Manual do not go through the Codex step procedure, and do not require a project document. Proposed amendments are considered by the CCGP, and recommendations for revision go from that committee to the Commission. Only texts being considered for incorporation into the Codex Alimentarius go through the step procedure.

Reference material

FAO/WHO. 2004. Codex Alimentarius Commission Procedural Manual. 14th edition, pp. 1825, 6768 and 6970. Joint FAO/WHO Food Standards Programme, Rome. Codex Web site: www.codexalimentarius.net

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Module 2.7

Understanding Codex documentation

It is necessary to have an understanding of how Codex documents are organized and referenced. This understanding will make it easier to keep Codex documents in order, and avoid confusion and loss of time when searching for a specific document, in view of the large volume of documents produced by the Codex system. This module includes a description of the Codex Procedural Manual and an outline of its contents. It also clarifies the differences between ALINORMS, Commission working papers, committee working papers, circular letters and conference room documents. The Codex document numbering system is also explained. Codex documentation is divided into six main categories: 1) the Codex Procedural Manual 2) ALINORMS 3) committee working papers (CXs) 4) conference room documents (CRDs) 5) circular letters (CLs) 6) adopted texts All categories of documents follow a specific numbering system that may include a reference to the year of origin and the relevant committee or task force.
The Codex Procedural Manual

The Codex Procedural Manual contains the Statutes of the Commission, the Rules of Procedure and information on how the Commission carries out its work. It also includes a listing of the Commissions subsidiary bodies and their terms of reference, and identifies the Members of the Commission together with the addresses of Codex Contact Points. The Codex Committee on General Principles is responsible for updating the Manual, and such amendments are considered regularly by the Commission. Amendments to the Manual do not follow the Codex step procedure. The Manual outlines the agreed set of rules to ensure uniform running of Codex activities, and is intended to help member countries to participate effectively in the work of the Joint FAO/WHO Food Standards Programme. As of March 2005, the most recent version of the Manual was the Fourteenth edition, published in 2004. Section I of the Manual sets out the Commissions basic Rules of Procedure, and the other internal procedures necessary to achieve the Commissions objectives. These include the procedures for the elaboration of Codex standards and related texts, general principles and guidelines for the acceptance of Codex standards by governments, and some basic definitions. Section II is devoted to guidelines for the efficient operation of Codex committees. These committees are organized and operated by Member Governments designated by

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the Commission. It describes how standards are set out in a uniform manner, describes a uniform reference system for Codex documents and working papers, provides a number of general principles for formulating key sections of Codex standards, and outlines the core functions of national Codex Contact Points. Section III lists the Commissions subsidiary bodies with their terms of reference. It also gives the membership of the Commission (at the time of going to print), together with the addresses of Codex Contact Points. It should be noted that membership numbers are adjusted each time a new Member joins, and therefore the Codex Web site should be consulted for the most up-to-date information.
Working documents for Codex sessions ALINORMS

Reports of the Commission, committees and task forces, recording the outcomes of meetings, and working documents prepared for Commission sessions are called ALINORMS. These documents are identified with the term ALINORM followed by the calendar year in which the meeting is held, followed by the session number. This is then followed by the consecutive number of the document in line with the Commission agenda item. For example, a document on the agenda of the Twenty-sixth Session of the Codex Alimentarius Commission (held in July 2003) would be identified as ALINORM 03/26/xx (xx being a consecutive number, starting at 1). As in the case of the documents related to agendas of subsidiary bodies, the number allocated is not necessarily the same number as the agenda item. Reports of committees and task forces are Commission documents and, as such, are also referenced as ALINORMS. These also follow a standard numbering system, but with a slight variation on the above system. In the case of reports, the number following the word ALINORM indicates the year in which the Commission meeting is being held at which the committee report will be presented.6 For example, ALINORM 04/30 would be the report of a Codex committee that will be presenting its report to the Twenty-seventh Session of the Commission being held in July 2004. In addition, instead of a letter combination indicating the committee, each committee/task force has a number. For example, the Codex Committee on Food Labelling (CCFL) is designated 22. Therefore, a CCFL report from a session held in May 2004 would be identified as ALINORM 04/22 (i.e. report tabled at the Twenty-seventh Session in July 2004). A report from a session of the Codex Committee on Fats and Oils (CCFO) held in November 2004, which would be reported to the Commission meeting in 2005, would be identified as ALINORM 05/17, the 17 being the number assigned to CCFO. Box 2.7.1 gives a list of ALINORM numbers. If there is more than one meeting of a particular committee between Commission sessions, the second session is identified with the letter A after the number.
Working papers for subsidiary bodies

All the working texts of Codex committees and task forces carry the same reference: CX (abbreviation for Codex) followed by the acronym of the committee. These document
6 It should be noted that in 2003 and 2004, a slightly different system was used in order to deal with additional sessions of the Executive Committee and Commission, which were held to discuss the recommendations of the Codex Evaluation (see Module 2.1).

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Box 2.7.1 | ALINORM numbers for active Codex subsidiary bodies

Codex committee/ad hoc task force Food Additives and Contaminants Food Hygiene Food Import and Export Inspection and Certification Systems Food Labelling General Principles Methods of Analysis and Sampling Nutrition and Foods for Special Dietary Uses Pesticide Residues Residues of Veterinary Drugs in Foods Fats and Oils Fish and Fishery Products Fresh Fruits and Vegetables Meat Hygiene Milk and Milk Products Processed Fruits and Vegetables FAO/WHO Coordinating Committee for Africa FAO/WHO Coordinating Committee for Asia FAO/WHO Coordinating Committee for Europe FAO/WHO Coordinating Committee for Latin America and the Caribbean FAO/WHO Coordinating Committee for the Near East FAO/WHO Coordinating Committee for North America and the Southwest Pacific Task Force on Foods Derived from Biotechnology Task Force on Fruit and Vegetable Juices
* xx = year (e.g. 03 stands for 2003)

ALINORM No.* xx/12 xx/13 xx/30 xx/22 xx/33 xx/23 xx/26 xx/24 xx/31 xx/17 xx/18 xx/35 xx/16 xx/11 xx/27 xx/28 xx/15 xx/19 xx/36 xx/40 xx/32 xx/34 xx/39

identities are followed by two digits representing the specific year in which the session will be held, the session number and finally the consecutive number of the document, for example CX/FH 05/37/3. In this case, CX = Codex, FH = Food Hygiene, 05 = 2005 (the year in which the session is being held), 37 = the Thirty-seventh Session of CCFH and 3 = the consecutive number allocated to the document for discussion on the agenda. The consecutive number does not necessarily indicate the agenda item number, since discussion of some agenda items may require more than one document. On some occasions, a committee may have two or more meetings in the same Commission session period. In these cases, the letter A would follow the abbreviated year of the second meeting, to differentiate between the meetings. Box 2.7.2 shows the document reference system used to identify the specific working documents for Codex committees and task forces.

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Box 2.7.2 | Document reference system for Codex bodies

Committee committee/ad hoc task force Executive Committee Food Additives and Contaminants Food Hygiene Food Import and Export Inspection and Certification Systems Food Labelling General Principles Methods of Analysis and Sampling Nutrition and Foods for Special Dietary Uses Pesticide Residues Residues of Veterinary Drugs in Foods Fats and Oils Fish and Fishery Products Fresh Fruits and Vegetables Meat Hygiene Milk and Milk Products Processed Fruits and Vegetables Cereals, Pulses and Legumes Cocoa Products and Chocolate Natural Mineral Waters Sugars Vegetable Proteins FAO/WHO Coordinating Committee for Africa FAO/WHO Coordinating Committee for Asia FAO/WHO Coordinating Committee for Europe FAO/WHO Coordinating Committee for Latin America and the Caribbean FAO/WHO Coordinating Committee for the Near East Reference CX/EXEC CX/FAC CX/FH CX/FICS CX/FL CX/GP CX/MAS CX/NFSDU CX/PR CX/RVDF CX/FO CX/FFP CX/FFV CX/MH CX/MMP CX/PFV CX/CPL CX/CPC CX/NMW CX/S CX/VP CX/AFRICA CX/ASIA CX/EURO CX/LAC CX/NEA

FAO/WHO Coordinating Committee for North America and the Southwest Pacific CX/NASWP Task Force on Foods Derived from Biotechnology Task Force on Fruit and Vegetable Juices CX/FBT CX/FJ

Circular letters

Circular letters (CLs) provide the vehicle for communication from the Codex Secretariat in Rome to Codex member countries and interested international non-governmental organizations. When reports from committees (ALINORMS) are circulated, they always include a CL that invites Members and observers to provide comments on specific elements of the report usually comments on draft text contained in the appendixes to the report. When a committee establishes an ad hoc working group, and the working group wishes to circulate its recommendations, this is normally done through a CL.

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Box 2.7.3 | Example of a circular letter

CX 4/10 CL 2001/24-GP July 2001 TO: Codex Contact Points Interested International Organizations FROM: Secretary, Joint FAO/WHO Food Standards Programme FAO, 00100 Rome, Italy SUBJECT: DEADLINE: PROPOSED DRAFT WORKING PRINCIPLES FOR RISK ANALYSIS 30 October 2001 Copy to: Codex Contact Point for France SGCI/CODEX Carr Austerlitz, 2 Boulevard Diderot 75703 Paris Cedex 12 Fax. 33 (0)1 4487 16 04 E-mail: [email protected]

COMMENTS: To: Secretary Joint FAO/WHO Food Standards Programme FAO Viale delle Terme di Caracalla 00100 Rome, Italy Fax: +39 (06) 5705 4593 E-mail: [email protected] BACKGROUND

The Sixteenth Session of the Committee on General Principles considered the Proposed Draft Working Principles for Risk Analysis and agreed on several amendments to the text. However, it could not come to a consensus on the Scope and the use of precaution in risk analysis, especially in risk management. The Committee therefore agreed to request the Commission for clarification on the Scope of the Working Principles; i.e. whether they were intended exclusively for application in the framework of Codex, or by Member Governments, or by both. The Committee also requested the advice of the Commission on how Codex should react when scientific data were insufficient or incomplete and evidence of a risk to human health existed, in particular whether it should proceed to elaborate a standard or related text. The Twenty-fourth Session of the Codex Alimentarius Commission confirmed the initial mandate of the Committee on General Principles to complete the principles for risk analysis within Codex as a high priority, with a view to their adoption in 2003. It also agreed that the Committee should develop guidance to governments subsequently or in parallel, as appropriate in view of its programme of work. The Commission also decided how it should proceed when scientific data were insufficient or incomplete (ALINORM 01/41, paras. 81-83). Following the decision of the Commission, the Secretariat has redrafted the Principles for Risk Analysis for application within Codex, including the position of the Commission on precaution in risk management. The revised text also includes the amendments made by the last session of the Committee on General Principles and some editorial changes for clarification purposes, in conformity with the decision of the Committee (ALINORM 01/33A, para. 74). The changes made are further explained in the Introduction to the revised text. Governments and international organizations wishing to submit comments should do so in writing, preferably by e-mail, to the above addresses before 30 October 2001.

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Circular letters are numbered consecutively, also indicating the calendar year and committee to which they pertain. For example, CL2001/24 GP identifies the twentyfourth circular letter for the calendar year 2001. This particular CL pertains to the Codex Committee on General Principles. CL2001/25 FFP is the twenty-fifth CL for 2001, and pertains to an issue related to the Codex Committee on Fish and Fishery Products. Box 2.7.3 shows an example of a circular letter.
Conference room documents

Conference room documents (CRDs) are documents that are circulated at a Codex session and are not circulated more broadly to all Codex Members and observers. CRDs are numbered consecutively, but normally have no other identities and may originate from a number of sources. The LIM (limited distribution) document series used in Commission sessions is equivalent to CRD in subsidiary bodies. Where countries submit written comments in response to a CL or CX document, the Secretariat compiles all comments and circulates these prior to the meeting. These documents would have the appropriate CX designation. However, there are times when comments are received too late for translation and circulation to Member Governments. These would be circulated at the meeting itself as a CRD, and are given consecutive numbers by the national Codex secretariat as they are circulated within the committee. Other CRDs may be generated when a committee establishes a working/drafting group that meets during the committee session. The report of the working/drafting group back to the committee is identified as a CRD. CRDs provide information that was late in submission, but they receive only limited distribution. Countries not present at a meeting do not receive copies, as these are neither appended to committee reports nor formally circulated after a committee meeting. Countries relying of CRDs to present their position on a specific issue may find it more difficult to gain support, as there is limited time for members of the delegations of other countries to review the CRD and determine if they can support the position. In addition, where there are technical issues involved, the other delegations may not have the expertise on their respective delegation, necessitating either a call back to their capitals or the deferment of a decision.
Adopted texts

As indicated previously, Codex texts take the form of standards, recommended codes of practice and guidelines. Once a committee has elaborated one of these types of texts, it is forwarded to the Commission for adoption. Upon adoption, the text is incorporated into the Codex Alimentarius. Standards are identified as STAN, recommended codes of practice as RCP and guidelines as GL. For example, a standard would be identified as CODEX STAN or CX STAN, followed by a letter (for selected standards) and number, then the year the standard was adopted and, if applicable, the year it was revised. For example, the Codex international individual standard for cottage cheese, including creamed cottage cheese is identified as CODEX STAN C16 (1968). The Codex standard for named vegetable oils is identified as CX STAN 2101999. Recommended codes of practice and guidelines follow a similar identification system. For example, the Code of hygienic practice for aseptically processed and packaged low-acid foods is identified as CAC/RCP 401993. The Codex general guideline on claims is identified as CAC/GL 11979 (Rev. 11991).

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Section 2

Module 2.8

Is there a format for Codex standards?

This module outlines the standard format for Codex commodity standards. Codex codes of practice, guidelines and recommendations do not have a format prescribed in the Codex Procedural Manual, although they do have similarities. This module will focus on the format of commodity standards. The format is intended for use as a guide by the subsidiary bodies of the Codex Alimentarius Commission in presenting their standards, with the objective of achieving, as far as possible, a uniform presentation of commodity standards. The format also indicates the statements that should be included in standards as appropriate under the relevant headings of the standard. The sections of the format should be completed in a standard only in so far as such provisions are appropriate to an international standard for the food in question. A practical exercise (Exercise 2.8.1) is given at the end of this module. The purpose of the exercise is to permit participants in the training to develop experience with the structured approach of drafting a standard for a commodity that would be relevant to the country in which the training is taking place.
Why should a standard format be used?

There are several advantages in having a format for standards development, namely: a common format guides subsidiary bodies of the Codex Alimentarius Commission in presenting their commodity standards in a uniform manner; it facilitates a structured approach to standards development; the structured approach aids in ensuring that all elements essential to protect the consumer are identified and described; the format can also be used as a model by governments in developing national standards. Although there is no format specified in the Codex Procedural Manual for codes of practice, guidelines or recommendations, there is a format for commodity standards, which is as follows: Name of the standard Scope Description Essential composition and quality factors Food additives Contaminants Hygiene Weights and measures Labelling Methods of analysis and sampling

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Format for Codex standards Name of the standard

The name of the standard should be clear and as concise as possible. It should usually be the common name by which the food covered by the standard is known or, if more than one food is dealt with in the standard, by a generic name covering them all. If a fully informative title is inordinately long, a subtitle may be added.
Scope

This section should contain a clear, concise statement as to the food or foods to which the standard is applicable, unless this is self-explanatory in the name of the standard. In the case of a general standard covering more than one specific product, the specific products to which the standard applies should be made clear.
Description

This section should contain a definition of the product or products with an indication, where appropriate, of the raw materials from which it is derived and any necessary references to processes of manufacture. It may also include references to types and styles of product and to type of pack. There may also be additional definitions when these are required to clarify the meaning of the standard.
Essential composition and quality factors

This section should contain all quantitative and other requirements as to composition including, where necessary, identity characteristics, provisions on packing media and requirements as to compulsory and optional ingredients. It should also include quality factors that are essential for the designation, definition or composition of the product concerned. Such factors could include the quality of the raw material, with the objective of protecting the health of the consumer, provisions on taste, odour, colour and texture that may be apprehended by the senses, and basic quality criteria for the finished products, with the object of preventing fraud. This section may refer to tolerances for defects, such as blemishes or imperfect material but, as these factors may not be essential requirements, this information should be contained in a (non-mandatory) appendix to the standard or in another advisory text.
Food additives

This section should contain the names of the additives permitted and, where appropriate, the maximum amount permitted in the food. It should be prepared in accordance with guidance given in the Codex Procedural Manual (p. 93), and may take the following form:
The following provisions in respect of food additives and their specifications as contained in section ... of the Codex Alimentarius are subject to endorsement [have been endorsed] by the Codex Committee on Food Additives and Contaminants.

This would be followed by a tabulation, viz.:

Name of additive, maximum level (in percentage or mg/kg).

Contaminants

Pesticide residues. Although the Codex Procedural Manual has indicated that this section of a standard should include, by reference, any levels for pesticide residues that have been established by the Codex Alimentarius Commission for the product

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concerned, the Commission has published maximum limits for pesticide residues separately in Volume 2 of the Codex Alimentarius (see Module 2.9). Other contaminants. In addition, this section should contain the names of other contaminants and, where appropriate, the maximum level permitted in the food. The text to appear in the standard may take the following form:
The following provisions in respect of contaminants, other than pesticide residues, are subject to endorsement [have been endorsed] by the Codex Committee on Food Additives and Contaminants.

They should follow a tabulation, viz.:

Name of contaminant, maximum level (in percentage or mg/kg).

Hygiene

Any specific mandatory hygiene provisions not covered by the General standard on food hygiene but considered necessary should be included in this section. They should be prepared in accordance with the guidance given in the Codex Procedural Manual (p. 95). Reference should also be made to applicable codes of hygienic practice. Any parts of such codes, including in particular any end-product specifications, should be set out in the standard, if it is considered necessary that they should be made mandatory. The following statement should also appear:
The following provisions in respect of the food hygiene of this product are subject to endorsement [have been endorsed] by the Codex Committee on Food Hygiene.

Weights and measures

This section should include all provisions, other than labelling provisions, relating to weights and measures, for example, where appropriate, fill of container, weight, measure or count of units determined by an appropriate method of sampling and analysis. Weights and measures should be expressed in SI units. In the case of standards that include provisions for the sale of products in standardized amounts (e.g. multiples of 100 g), SI units should be used, but this would not preclude additional statements in the standards of these standardized amounts in approximately similar amounts in other systems of weights and measures.
Labelling

This section should include all the labelling provisions contained in the standard and should be prepared in accordance with the guidance given in the Codex Procedural Manual (p.92). Provisions should be included by reference to the General standard for the labelling of prepackaged foods. The section may also contain provisions that are exemptions from, additions to, or necessary for the interpretation of the general standard in respect of the product concerned, provided that these can be justified fully. The following statement should also appear:
The following provisions in respect of the labelling of this product are subject to endorsement [have been endorsed] by the Codex Committee on Food Labelling.

Methods of analysis and sampling

This section should include, either specifically or by reference, all methods of analysis and sampling considered necessary and should be prepared in accordance with the guidance given in the Codex Procedural Manual (p. 96). If two or more methods have been proved to be equivalent by the Codex Committee on Methods of Analysis and Sampling, these could be regarded as alternative and included in this section either specifically or by reference. The following statement should also appear:

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The methods of analysis and sampling described hereunder are to be endorsed [have been endorsed] by the Codex Committee on Methods of Analysis and Sampling.

Reference material

FAO/WHO. 2004. Codex Alimentarius Commission Procedural Manual. 14th edition, pp. 8898. Joint FAO/WHO Food Standards Programme. Rome. Codex Web site: www.codexalimentarius.net

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Exercise 2.8.1 | Format for Codex commodity standards

Objective This exercise has two objectives. The first objective is for participants to work through development of a standard, so as to familiarize themselves with the various elements of a standard. This will also facilitate development of a systematic approach to standards development. The second objective is to provide participants with some experience of the manner in which Codex plenary sessions are conducted when reviewing a draft standard. Method Participants should be divided into groups of five to six people. The groups will be asked to develop a standard using the Codex format provided in this module. All groups will work on developing a standard for the same commodity. The trainer should select a commodity relevant to the country where the training is being held, preferably one where no national standard has yet been developed. Each group will provide the trainer with a draft document. Overnight, the trainer will develop a draft standard using elements from the drafts developed by each group. This draft version, which contains elements from each of the groups, will be presented Outcome Trainees will be familiar with both the systematic approach to standards development and with the method used by Codex committees, in either plenary sessions or within working groups, to review a draft text. Time allocation Group work to develop draft standard: 90 minutes. Plenary review of the trainers draft: 45 minutes. (via overhead projection or a slide presentation) to the plenary the next day. As the document is systematically reviewed, each group should be encouraged to intervene and comment on the text either supporting the text or proposing amendments. Each group should only be permitted to intervene once per section, similar to the process for reviewing texts practised by Codex committees. The trainer will act in the role of chairperson, ensuring that each group only intervenes once at the invitation of the chairperson, resolve any dispute on the language of the text, and propose language for the text that will result in consensus.

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Section 2

Module 2.9

What is the difference between the Codex Alimentarius Commission and the Codex Alimentarius?

The purpose of this module is to clarify the difference between the Codex Alimentarius, which is the collection of standards, guidelines and related texts and the Codex Alimentarius Commission, which is the body mandated to develop the texts. This module outlines how the Codex Alimentarius is structured, its scope and purpose, and outlines its organization.
Purpose and scope of the Codex Alimentarius

The Codex Alimentarius is a collection of internationally adopted food standards and other provisions of an advisory nature presented in a uniform manner to assist in protecting consumers health and ensuring fair practices in the food trade. The publication of the Codex Alimentarius is intended to guide countries in the elaboration and revision of their food standards in order to promote the harmonization of these standards, and in so doing to facilitate international trade. The Codex Alimentarius includes standards for all the principal foods, whether processed, semi-processed or raw, for distribution to the consumer. Materials for further processing into foods should be included to the extent necessary to achieve the purposes of the Codex Alimentarius as defined. The Codex Alimentarius includes general provisions in respect of: contaminants food additives food hygiene inspection and certification labelling and presentation methods of analysis and sampling pesticide residues veterinary drug residues It also includes provisions of an advisory nature in the form of: codes of practice guidelines other recommended measures
Organization of the Codex Alimentarius

The Codex Alimentarius is organized in 13 volumes. Each volume contains the standards relevant to the volume, which have been adopted by the Codex Alimentarius Commission. Box 2.9.1 shows the structure of the Codex Alimentarius.

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Box 2.9.1 | Structure of the Codex Alimentarius

Volume 1A 1B 2A 2B 3 4 5A 5B 6 7 8 9 10 11 12 13 Subject General requirements General requirements (food hygiene) Pesticide residues in foods (general texts) Pesticide residues in foods (maximum residue limits) Residues of veterinary drugs in foods Foods for special dietary uses (including foods for infants and children) Processed and quick-frozen fruits and vegetables Fresh fruits and vegetables Fruit juices Cereals, pulses (legumes) and derived products and vegetable proteins Fats and oils and related products Fish and fishery products Meat and meat products; soups and broths Sugars, cocoa products and chocolate and miscellaneous products Milk and milk products Methods of analysis and sampling

Where can these standards be found?

All the adopted Codex standards, guidelines, codes of practice and recommendations can be found on the Codex Web site (http://www.codexalimentarius.net/standard_list.asp). Listings of maximum residue limits for chemical substances used in agricultural production (commonly referred to as pesticides), and residue limits for veterinary drugs in foods, are also available on the Codex Web site (www.codexalimentarius.net). The Codex Contact Points of member countries receive all Codex texts. Printed copies can also be ordered from the Sales and Marketing Group, Publishing Management Service, FAO Information Division, Viale delle Terme di Caracalla, 00100 Rome, Italy, e-mail: [email protected], fax: (+39) 06 57053360.

Reference material

FAO/WHO. 2005. Understanding the Codex Alimentarius. Revised and updated, pp. 1012. Rome. Codex Web site: www.codexalimentarius.net

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Section 2

Module 2.10

What is the relationship between Codex standards and WTO?

It is not the intent of this module to turn all students of Codex into trade experts. Its purpose is to identify the two main trade agreements that are relevant to Codex, highlight some of the key features of each, and outline the relationship between Codex and the World Trade Organization (WTO). It should be noted that not all Members of Codex are Members of WTO. Codex is an organization focused on developing international food standards. WTO is a trade organization mandated to facilitate trade, not a standard-setting organization. WTO came into being as a result of the outcomes of the General Agreement on Tariffs and Trade (GATT) Uruguay Round of Talks that were signed in Marrakesh (Morocco) on 15 April 1994.
Trade agreements of significance in Codex work

The two WTO agreements of most significance for international food trade are the Agreement on the Application of Sanitary and Phytosanitary Measures (commonly referred to as the SPS Agreement) and the Agreement on Technical Barriers to Trade, known as the TBT Agreement. The SPS Agreement is concerned with measures applied to protect human, animal and plant health. The TBT Agreement refers to technical regulations and conformity assessment procedures and applies to all commodities, not just food.
Rights of Members under the SPS Agreement

The SPS Agreement states that Members are entitled to establish their own appropriate level of sanitary and phytosanitary protection provided such measures are not inconsistent with the provisions of the agreement. Sanitary and phytosanitary measures must be science-based, and should not represent an unnecessary or disguised restriction on trade. Members are encouraged to use international standards where they exist, but may impose more stringent measures if required to achieve their appropriate level of protection provided there is scientific justification. Members may be required to justify a stringent measure that results in a barrier to trade. The SPS Agreement covers all relevant laws, decrees, regulations; testing, inspection, certification and approval procedures; and packaging and labelling requirements directly related to food safety. Examples of SPS measures include: (i) inspection of products for microbiological contaminants; (ii) mandating a specific fumigation treatment for products; and (iii) setting maximum allowable levels of pesticide residues in food.

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Obligations of Members under the SPS Agreement

Members are required to base their national measures on international standards and an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health. SPS measures should be applied only to the extent necessary to protect human, animal or plant life or health. The measures should be applied equally to domestic and imported products so as not to discriminate unjustifiably against foreign sources of supply. Members are also required to participate in the relevant international standards organizations to the extent possible. Members are expected to promote the review and development of international standards and to accept the SPS measures of other members as equivalent, even if such measures differ from their own, where it is demonstrated that those measures achieve their appropriate level of protection.
Relationship between Codex standards and the SPS Agreement

The SPS Agreement identifies standards, guidelines and recommendations adopted by the Codex Alimentarius Commission as the international benchmark for food safety. National regulations consistent with Codex standards are deemed to meet the requirements of the SPS Agreement, i.e. they do not have to be justified. Members of WTO should base their food safety standards on the standards of the Codex Alimentarius Commission, keeping in mind the right of WTO Members to establish their appropriate level of protection. In other words, WTO Members may implement standards that are more stringent than those of the Codex Alimentarius Commission, provided there is scientific justification that the more stringent measure is required to achieve their appropriate level of protection. In doing so, WTO Members must have scientific justification for such variations, as well as being able to demonstrate that the action taken was based on an assessment of risk. For the purposes of the SPS Agreement, WTO does not differentiate between standards, guidelines and recommendations elaborated by Codex. They all have the same status under WTO. For food safety, the SPS Agreement refers to standards developed by Codex in the following areas: codes and guidelines of hygienic practices contaminants food additives methods of analysis and sampling veterinary drug and pesticide residues Again, it is important to remember that not all Members of Codex are Members of WTO. Although Codex standards are referred to by WTO, Codex does not establish food standards for WTO. It establishes food standards for the use of its (Codex) Member countries. The direction of the Forty-fifth Session of the Codex Executive Committee should be followed, i.e. the work of Codex should move forward without concern arising from misunderstandings or misinterpretations as to how Codex standards and related texts might be used.
The TBT Agreement

The TBT Agreement covers a large number of technical regulations and standards that are adopted for protecting human safety or health. Numerous examples of these can be provided. For example, national regulations requiring motor vehicles to be equipped with

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seat belts to minimize injury in the event of an accident, or that sockets be manufactured in a manner to prevent the user from electric shocks, fall under the first category. A common example of regulations whose objective is to protect human health is the labelling of cigarettes indicating that they are harmful to health. Most of the regulations falling under the TBT Agreement aim to protect consumers through information, mainly in the form of labelling requirements, and to promote fair trade practices. Other regulations include classification and definition, essential composition and quality factors, packaging requirements and measurements (size, weight, etc.), so as to avoid deceptive practices.
Similarities between the SPS and TBT Agreements

Regulations that address microbiological contamination of food, or set allowable levels of pesticide or veterinary drug residues, or identify permitted food additives, by definition fall under the SPS Agreement. Some packaging and labelling requirements, if directly related to the safety of the food, are also subject to the SPS Agreement. The TBT Agreement seeks to ensure that technical regulations and standards, including packaging, marking and labelling requirements, and analytical procedures for assessing conformity with technical regulations and standards, do not create unnecessary obstacles to trade. An illustrative example of the SPS and TBT measures that can apply to a food item is given in Box 2.10.1. It is noteworthy that the SPS and TBT Agreements both acknowledge the importance of harmonizing standards internationally so as to minimize or eliminate the risk of sanitary, phytosanitary and other technical standards becoming barriers to trade. The TBT Agreement covers all technical regulations, voluntary standards and the procedures to ensure that these are met (conformity assessment procedures), except when these are sanitary or phytosanitary measures as defined by the SPS Agreement. It is thus not only the type of measure that determines whether it is covered by the TBT Agreement, but the purpose of the measure that is relevant in determining whether a measure is subject to the SPS Agreement. For this purpose Annex A of the TBT Agreement defines a technical regulation as follows:
A document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.

Differences between the SPS and TBT Agreements

The two Agreements have some common elements, including basic obligations for nondiscrimination and similar requirements for the advance notification of proposed measures, and the creation of enquiry points. However, many of the substantive rules are different. For example, both Agreements encourage the use of international standards. However, under the SPS Agreement the only justification for not using such standards for food safety and animal/plant health protection is scientific argument resulting from an assessment of the potential health risks. In contrast, under the TBT Agreement governments may decide that international standards are not appropriate for other reasons, including fundamental technological problems or geographical factors. TBT measures could cover any subject, from car safety to energy-saving devices, to the shape of food cartons. To give some examples pertaining to human health, TBT measures

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could include pharmaceutical restrictions, or the labelling of cigarettes. Most measures related to human disease control are under the TBT Agreement, unless they concern diseases that are carried by plants or animals (such as rabies). In terms of food, labelling requirements, quality and packaging regulations are generally not considered to be sanitary or phytosanitary measures and hence are normally subject to the TBT Agreement. Also, sanitary and phytosanitary measures may be imposed only to the extent necessary to protect human, animal or plant health, on the basis of scientific information. Governments may, however, introduce TBT regulations when necessary to meet a number of objectives, such as national security or the prevention of deceptive practices. Because the obligations that governments have accepted are different under the two Agreements, it is important to know whether a measure is a sanitary or phytosanitary measure, or a measure subject to the TBT Agreement.
Codex since the creation of WTO

Considerable interest in the Commissions activities has been stimulated by the specific recognition of Codex standards, guidelines and recommendations within the SPS Agreement, as well as the importance assumed by Codex standards in the Technical regulations and standards provisions contained in Article 2 of the TBT Agreement. Consequently, attendance at Codex meetings, especially by developing countries, has markedly increased. This is a welcome development, particularly since both Agreements direct Members, within the limits of their resources, to play a full part in the work of international standards organizations and their subsidiaries.

Box 2.10.1 | Relationship between a Codex standard and the SPS and TBT Agreements

Bottling method (SPS) *Codex Code of Hygiene Practice

Packaging material in direct contact with food (SPS) Labelling (TBT) *Codex general standard for Labelling of Prepackaged Foods

Product description (TBT) *Codex standard

Contaminants (SPS) *Codex general standard for Contaminants

Additives (SPS) *Codex general standard for Food Additives

Package specifications (TBT)

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The adoption of Codex standards as scientifically justified norms for the purpose of the SPS and TBT Agreements is of immense significance. The standards have become an integral part of the legal framework within which international trade is being facilitated through harmonization. Already, they have been used as the benchmark in international trade disputes, and it is expected that they will be used increasingly in this regard.
Why does WTO refer to Codex standards as benchmarks for food safety?

A fundamental premise of all Codex standards is that they are based on science. The first principle on Codex decision-making states: The food standards, guidelines and other recommendations of Codex Alimentarius shall be based on the principle of sound scientific analysis and evidence, involving a thorough review of all relevant information, in order that the standards assure the quality and safety of the food supply. Codex has also adopted statements of principle relating to the role of food safety risk assessment. The first principle states that health and safety aspects of Codex decisions and recommendations should be based on a risk assessment, as appropriate to the circumstances. The second principle states that food safety risk assessment should be soundly based on science, should incorporate the four steps of the risk assessment process, and should be documented in a transparent manner. As WTO Members are obligated to base their SPS measures on an assessment of the risk taking into account all available scientific information, the usefulness of Codex standards to the WTO/SPS Agreement is evident. It is adherence to this principle of science-based standards that provides the rationale for WTO to make reference to Codex standards.

Reference material

FAO/WHO. 1999. Report of the Forty-fifth Session of the Executive Committee of the Codex Alimentarius Commission. Document ALINORM 99/3. Rome. WHO. 1998. Food safety and globalization of trade in food. Document WHO/FSF/FOS/97.8 Rev. 1. Geneva, Switzerland. WTO. 1998. Sanitary and phytosanitary measures. WTO Agreements Series No.4 (contains the SPS Agreement). Geneva, Switzerland. World Trade Organization Web site: www.wto.org

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Basics of national Codex activities

Contents

{
107 108 108 109 109 110 112 112 112 113 114 117 118 114 116 117 119 120 120 121 125 126 127 127 128

Introduction Module 3.1 / Functions of a national Codex Contact Point Where should the Codex Contact Point be placed? Core functions of the Codex Contact Point Codex Trust Fund Linkages Module 3.2 / How to develop national positions on Codex issues Steps to develop a national position Circulate working documents Solicit input The National Codex Committee National positions Submitting written comments Box 3.2.1 / Types of stakeholders to be consulted on Codex issues Box 3.2.2 / Example of a National Codex Committee Brazil Box 3.2.3 / Codex coordination in the United Republic of Tanzania Box 3.2.4 / Example of a format for preparing the national position Box 3.2.5 / Example of a format for preparing written comments to the Codex Secretariat Box 3.2.6 / Preparation of country positions in Brazil Box 3.2.7 / Checklist for preparing and promoting national positions at Codex sessions Exercise 3.2.1 / Developing a national position Exercise 3.2.2 / Preparing a consultation plan

Module 3.3 / Considerations for selecting national delegations Process for selecting the head delegate Forming delegations to sessions of the Codex Alimentarius Commission, committees and task forces 129 Proposed guidelines for the selection and participation of non-governmental organizations in delegations 130 Responsibilities and obligations of delegations

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130 Responsibilities of the head delegate at Codex committee sessions 128 Box 3.3.1 / Procedure used to form a delegation example from Malaysia 132 Module 3.4 / Organizing Codex documentation 132 How should a country organize its Codex files? 132 Ensuring access to Codex documentation to all interested stakeholders 133 Codex standards and national policies and legislation 133 Box 3.4.1 / Transforming a Codex standard into national legislation

example from Peru Module 3.5 / What do FAO and/or WHO offer to help implement or make use of Codex standards? 137 Food and Agriculture Organization of the United Nations 138 World Health Organization 138 Mechanisms for delivering technical assistance
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Introduction

This section discusses the role and functions of the Codex Contact Point, and provides practical guidance on how countries can meet their obligations as Members of the Codex Alimentarius Commission and interact within the overall Codex process. A primary responsibility of Codex Member countries is to conduct their international food standards activities in a transparent and consultative manner. Guidance is provided here on the steps that should be followed in developing national positions on Codex issues, and some suggestions are made for consideration when selecting a national delegation to a Codex session. The main objective is to highlight key issues and activities that form the basis of national Codex activities. This should ensure that participation in Codex activities is as effective as possible, and that international Codex standards are used optimally as the basis for national standard-setting activities and contribute to strengthening the national food control programme.

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Module 3.1

Functions of a national Codex Contact Point

When a country becomes a Member of the Codex Alimentarius Commission, it is required to designate an official as the Codex Contact Point. The success of a countrys Codex activities depends on the effective functioning of the Codex Contact Point. This module outlines the key functions to be undertaken by the Codex Contact Point when carrying out the responsibilities associated with the position. Additional guidance on the operation of Codex Contact Points can be found in documents produced by the FAO/WHO coordinating committees for Africa and Asia.
Where should the Codex Contact Point be placed?

The location of this official within a governmental entity varies from country to country. Regardless of where the official is located, it must be remembered that coordination and communication are two key functions that the official must ensure are carried out, in order to contribute to a countrys successful Codex programme. The importance of effective coordination, good communication, transparency and inclusiveness cannot be overstated. The Codex Contact Point should be located in a ministry that has responsibility for food safety or food standard setting. As outlined in Section 1 (Module 1.2), the decision where best to locate the Codex Contact Point lies with the government the location of the Codex Contact Point is not as important as the function it carries out. Irrespective of the location of the Codex Contact Point, whether it is in the ministry of health, within the agriculture portfolio or in the bureau of standards, it is important that the designated individual communicates with all interested stakeholders, and has sufficient support and resources to do the work. An inadequately resourced Codex Contact Point will result in an ineffective programme. Examples of where some countries have located their Codex Contact Point include: Australia Department of Agriculture, Fishery and Forestry Barbados National Standards Institution Brazil Ministry of Foreign Affairs Canada Department of Health Guatemala Office of Standards and Regulations, Ministry of Agriculture, Livestock and Food India Directorate General of Health Services Jordan Directorate of Standards, Ministry of Industry and Trade Malaysia Food Quality Control Division, Ministry of Health Nigeria Standards Organization of Nigeria Spain Inter-ministerial Commission for Food Issues, Ministry of Health and Consumer Affairs United States Food Safety and Inspection Service, Department of Agriculture

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Core functions of the Codex Contact Point

The core functions of the Codex Contact Point (included in the Codex Procedural Manual) can be summarized as follows: 1. Acts as the link between the Codex Secretariat and the member country. 2. Coordinates all relevant Codex activities within the country. 3. Receives all Codex final texts (standards, codes of practice, guidelines and other advisory texts) and working documents of Codex sessions and ensures that they are circulated to those concerned within the country. 4. Sends comments on Codex documents or proposals to the Codex Alimentarius Commission or its subsidiary bodies and/or the Codex Secretariat. 5. Works in close cooperation with the National Codex Committee, where such a committee has been established. The Codex Contact Point acts as the liaison with the food industry, consumers, traders and all others concerned to ensure that the government is provided with an appropriate balance of policy and technical advice upon which to base decisions relating to issues raised in the context of the Codex work. 6. Acts as a channel for the exchange of information and coordination of activities with other Codex Members. 7. Receives the invitations to Codex sessions and informs the relevant chairpersons and the Codex Secretariat of the members of the national delegation to attend the meeting. 8. Maintains a library of Codex final texts. 9. Promotes Codex activities throughout the country. 10. Is the focal point for the countrys access to the Codex Trust Fund.
Minimum resources required for effective functioning of the Codex Contact Point

As outlined in Module 1.3, to maintain a minimum level of effective activity in Codex, countries should consider the provision of minimum staffing requirements as follows: one professional officer with a background in food science, veterinary science, food safety or equivalent to spend at least 25 percent of their time on Codex matters; one clerical support person for 25-30 percent of their time to provide administrative support to the programme. In addition, when considering resources for the Codex Contact Point, countries should attempt, where possible, to provide a properly functioning Internet connection. Effective and rapid communication with the Codex Secretariat and other Codex Members is greatly facilitated through the e-mail system. Codex Contact Points should make efforts to register a generic and institutional e-mail address and avoid the use of a personal e-mail address, which may become outdated after job transfer, etc. A functioning e-mail has the added advantage that countries may receive documents up to a few weeks before they receive hard copies. Furthermore, many information documents (other than official documents) are circulated by e-mail, which will not be issued in printed form. However, when it is not possible to communicate by e-mail, provision is made by the Secretariat to use other means.
Codex Trust Fund

FAO and WHO have established a Trust Fund to assist developing countries eligible for funding support to attend sessions of the Codex Alimentarius Commission or its subsidiary committees/task forces.

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The goal of the fund is to further the improvement of global public health and food security by promoting the provision of safer and more nutritious food. This will be achieved by: (a) helping regulators and food experts from all areas of the world to participate in international standard-setting work in the framework of Codex; and (b) enhancing their capacity to help establish effective food safety and quality standards and fair practices in the food trade, both in the framework of the Codex Alimentarius and in their own countries. In order to take advantage of the Codex Trust Fund (its full name is FAO/WHO Project and Fund for Enhanced Participation in Codex), countries seeking funding should establish a national Codex Contact Point. This is because the Codex Contact Point is the only officially recognized channel of communication between a country and the secretariat of the Trust Fund. When applying for funds, in addition to this basic requirement, countries are expected to demonstrate coordination among governmental entities.1
Linkages

One of the key functions identified above is that a Codex Contact Point is a link. Therefore, it is important that once a Codex Contact Point has been established, the linkages identified below are fostered. These linkages, and information obtained through this network, play an essential role in developing country positions and in providing comments on draft standards and other matters under discussion in the Codex system.
Linkages with other government ministries

The work of Codex addresses all aspects of food from farm and fisheries to the table of the consumer. Accordingly, ministries that may be involved in the national Codex programme include: Health Human health/food safety Agriculture Primary production Fisheries Marine production Industry/commerce Product development Science Food safety factors and innovation Trade Negotiations for trade Foreign affairs WTO agreements
Linkages with non-governmental organizations

It is equally important to maintain strong linkages with non-governmental organizations (NGOs) such as consumer organizations and industry associations. Involving industry NGOs is particularly useful for those committees and task forces involved in establishing commodity standards or standards of identity. Frequently these organizations can be a source of technical expertise specific to processing and distribution issues, and may thus enhance the credibility of a countrys national position. Public meetings may also be convened to solicit views or discuss positions in preparation for Codex sessions. Public involvement in the development of a countrys position on Codex issues will provide a greater pool of expertise upon which to draw and, importantly, raise awareness about food safety and quality at the national level.
Information on the Codex Trust Fund is available in six languages at the Web site http://www.who.int/foodsafety/codex/trustfund/en/, or by enquiring at [email protected]. Further assistance can be sought from the representatives of FAO and/or WHO at country and regional level.
1

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Linkage to the Secretariat of the Codex Alimentarius Commission

The Codex Contact Point is the formal link between the Codex Alimentarius Commission and the national Codex programme. However, it is advantageous for a country if the Codex Contact Point can also maintain an informal link. The Codex Secretariat in Rome is a reservoir of knowledge on Codex procedures and historical aspects, and can thus be helpful to Codex Contact Points. The Contact Point should therefore maintain links with all officers of the Codex Secretariat. It is highly recommended that one of the first undertakings of a newly appointed Codex Contact Point is to establish communications with the Codex Secretariat, in order to facilitate information exchange.
Are there other linkages a Codex Contact Point should establish?

In Module 1.4, the concept of regional liaison was identified. As countries in a particular region often share common problems, they can also work together to find common solutions. One of the core functions of a Codex Contact Point is to act as a channel for the exchange of information and coordination of activities with other Codex Members. All countries that are Members of Codex have Codex Contact Points. Therefore, these Codex Contact Points provide entry points into other member countries even on non-Codex issues. The Codex Contact Points provide a channel for initial communication among countries, and can facilitate linking of the appropriate ministries or individuals.

Reference material

FAO/WHO. 2004. Codex Alimentarius Commission Procedural Manual. 14th edition, p. 99. Joint FAO/WHO Food Standards Programme, Rome. Codex Web site: www.codexalimentarius.net

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Module 3.2

How to develop national positions on Codex issues

As stated previously, it is important to understand that participation in Codex means more than getting on an airplane and travelling to a meeting. It means committing time to reviewing the issues under discussion, preparing national positions and, if appropriate, submitting written comments to the Codex Secretariat in Rome. This module outlines some steps and considerations to be taken into account in preparing country positions and ensuring full consultation in the process. The first step towards enhancing participation in Codex is developing national positions on Codex issues and, when appropriate, submitting written comments. This module also explains the National Codex Committee structure as one option for organizing a national Codex programme. Guidelines for preparing and promoting national positions at Codex sessions are included in Box 3.2.7 at the end of this module. This module also includes two practical exercises whereby participants in the training course are able to develop a position on an issue relevant to one of the committees identified as a relevant priority (see Module 2.4). If there is sufficient time, and the Codex Contact Point is involved in the training, the outcome of this practical exercise can be finalized and submitted as written comments to the Codex Secretariat. The second practical exercise facilitates the development of a national consultation plan by participants.
Steps to develop a national position

In order to be effective Members of Codex, countries should establish processes for developing national positions on matters before Codex committees and task forces. These need not be complex, but should follow an administrative process that reflects good management procedures. Where a national delegation is to attend a Codex meeting, a head delegate should be designated. Where this is the case, it should be national policy for the head delegate to coordinate the preparation of national positions relevant to the committee concerned. Regardless of the exact mechanism a country has established, there are five common basic steps in the development of a national position: 1. circulate working documents; 2. solicit input from stakeholders; 3. draft a position; 4. obtain national endorsement of the position; 5. where appropriate, submit the position as written comments.
Circulate working documents

The Codex Contact Point receives Codex working documents from the Codex
Secretariat in Rome.

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The Codex Contact Point determines whether written comments are being requested

and, if so, what time frame needs to be established in order for the country to adhere to the deadline for submission of comments. In other words, the deadline that the Codex Contact Point will establish for completion of the national position will not be the same as the deadline contained in the working papers. The date established by the Codex Contact Point is usually one to two weeks prior to the deadline in the working papers, to allow sufficient time for any formatting, spell checking and government endorsement. The Codex Contact Point circulates working documents for review and comment and refers comments received to the individual responsible for drafting the position (see Solicit input). The mechanism used for this consultation process will vary, depending on national Codex arrangements.

Solicit input

Consultation is a core function of the Codex Contact Point. The Codex Contact Point endeavours to establish communication with other ministries, industry, consumers, academia and public health professionals. It should be understood that not all stakeholders will be interested in all the issues under consideration in Codex. Therefore, to facilitate consultation and avoid overwhelming stakeholders with unwanted documentation, Codex Contact Points should endeavour to identify which groups are interested in what issues. For example, a country may be actively participating in the work of the Codex Committee on Fresh Fruits and Vegetables (CCFFV) and the Codex Committee on Meat Hygiene (CCMH). The types of issues considered by these two committees, however, are quite different. Those industry associations associated with the production, processing, exportation or importation of fresh fruits and vegetables might be very interested in receiving the Codex documents relevant to the CCFFV. However, it is unlikely they would be interested in documents relevant to the CCMH. Therefore, they should not be sent those documents unless they have asked for them. On the other hand, for the FAO/WHO coordinating committee, both the fresh fruit and vegetable industries and the meat industry might be interested in all the documentation. It is the responsibility of the Codex Contact Point to determine the relevant stakeholders for each Codex issue and the mechanism for consultation. Significant effort by the Codex Contact Point is necessary to ensure that appropriate stakeholders are consulted in the development of positions for sessions of the Codex Alimentarius Commission and its subsidiary committees.
Consulting with stakeholders

It is up to national governments to determine the method or process that will enable them to consult with stakeholders on Codex issues. As the Codex Contact Point has a responsibility to circulate Codex working documents, in most countries responsibility for coordinating consultation is done by the Codex Contact Point. However, to facilitate this process and to ease some of the workload of the Codex Contact Point, many countries have established a National Codex Committee. Other countries address this need by ensuring that the Codex Contact Point has a number of professional and administrative officers available to deal with the consultation requirements. Countries are free to choose their own national mechanism to ensure an adequately coordinated and all-inclusive national Codex programme. This may or may not be a National Codex Committee. The important issue is to have a properly functioning coordination mechanism.

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Box 3.2.1 | Types of stakeholders to be consulted on Codex issues

The Codex Contact Point should consider soliciting opinions from the following groups:

all relevant government ministries consumer groups food industry associations (producers and processors, importers, exporters) academia public health professionals.

Regardless of the mechanism established, Box 3.2.1 outlines the various stakeholder groups that should be consulted on Codex issues.
The National Codex Committee

In order to facilitate communication among all interested stakeholders that are interested in Codex, many countries have established a National Codex Committee (NCC). They have discovered that the establishment of an NCC facilitates the functioning of not only the national Codex activities but also the Codex Contact Point itself. Therefore, if a country is considering establishing an NCC it should do so at the same time as it is establishing its Codex Contact Point. There are no international guidelines for NCCs as they are usually established to facilitate the conduct of a countrys Codex activities and hence tend to reflect national requirements. In this respect, the composition and organization of an NCC will vary. NCCs can also provide a forum for discussions and for the formulation of the national position(s) and of responses to Codex proposals or policy. A good reference for NCCs can be found in the Regional Guidelines for National Codex Committees, developed by the FAO/WHO Coordinating Committee for Africa (ALINORM 03/28, Appendix II), adopted by the Commission at its Twenty-sixth Session (July 2003) and those developed by the FAO/WHO Coordinating Committee for Asia (ALINORM 99/11, Appendix II), adopted by the Twenty-third Session of the Commission (1999).
Composition of the National Codex Committee

Ideally, all government departments and organizations concerned with food safety, food production and trade in food should be included in the National Codex Committee. Further, owing to the functions of the NCC, some scientific organizations such as public universities and research institutions and any other notable experts in the relevant field, or with a keen interest and relevant expertise in Codex matters, could be co-opted to the NCC. A typical NCC could include representatives from the following institutions: 1. Relevant ministries/government institutions such as: - ministry of health - ministry of agriculture, fisheries, etc. - ministry of trade, industry, etc. - ministry of consumer protection - national bureau of standards - government laboratories

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2. 3. 4. 5. 6. 7. 8.

Consumer organizations Food industry: manufacturers (representatives from various sectors) Food industry: producers (e.g. representatives of farmers organizations) Traders in food items (e.g. importers and exporters) Universities, professional bodies Leading research institutions Recognized experts The NCC should, however, not be so large as to make it unmanageable. The NCC could elect a chairperson or decide that the countrys Codex Contact Point should be the chairperson.

Appointment to the National Codex Committee

The procedure for nomination/inclusion into the NCC must be known, open and transparent. Whereas different countries could use different methods to select those to participate in the NCC, depending on resources and structures available, it is recommended that the Codex Contact Point identifies and lists all key stakeholders and invites them to the inaugural meeting of the NCC. The participants at this meeting would then identify and invite (through the secretary) other additional members to the NCC. Ideally, the intention to form the NCC should be advertised, and organizations requested to recommend nominees. The government agency responsible for establishing the NCC could form a small subcommittee to sort out the list of applicants and make a selection based on predetermined criteria for representation at the NCC. Possible criteria for selection could include: track record on food issues relevant in Codex Alimentarius; reasonable prospects of continuous participation; expertise; availability to attend meetings and comment on Codex documents. Participation at NCC meetings should be reviewed annually, and new members appointed to replace members who have ceased to participate in national Codex activities.
Secretariat

As circumstances vary from country to country, there is no fixed rule regarding the NCC secretariat. It should be noted, however, that many countries have determined that the NCC functions more efficiently and effectively if the chairperson and the secretariat are from the same institution. The Codex Contact Point normally serves as the secretariat to the National Codex Committee, although this is not an absolute requirement. The duties of the secretariat will vary according to the specific composition and function of the NCC. However, some suggested duties include: taking minutes at NCC meetings; keeping all records relating to the activities of the NCC; drafting agendas and sending invitations to meetings in consultation with the chairperson; keeping an updated file of NCC members; disseminating information on food-related events among NCC members; drafting the annual schedule for the NCC; undertaking such other duties as may be prescribed by the NCC and/or the government.

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Box 3.2.2 | Example of a National Codex Committee Brazil

Every year, by November, the schedule of the National Codex Committee (NCC) meetings is set up based on the schedule of sessions of the Commission and its subsidiary bodies. NCC meetings are planned one month before the session of a Codex subsidiary body, in order to review and approve the national position at that meeting. The NCC has created technical groups to follow up the work of each Codex subsidiary body. These technical groups function as a mirror of the Codex subsidiary body. Before the Brazilian NCC meeting, the technical group responsible for the follow-up of the corresponding Codex subsidiary body organizes its meeting to prepare a draft position to submit to the National Codex Committee. During the NCC meeting, the position is approved. The composition and the head of the delegation are also approved at the NCC meeting. The NCC meets about ten times during the year. At these meetings, national positions are discussed, as well as many other Codex issues such as responses to circular letters and the dissemination of Codex information among stakeholders. It is important to note that the NCC has developed and maintains a Web site, www.inmetro.gov.br/qualidade/comites/ccab. It is another tool to communicate with society and stakeholders, which provides information regarding the Codex programme, the NCC and the circular letters, a summary of the reports of the Codex committees, and relevant items of news.

Functions of the National Codex Committee

As in the case of the composition, the functions of an NCC may also vary, reflecting national priorities or circumstances. As a general guide, the following are some of the functions that can be performed by NCCs: Formulate the country response to the proposals of the Codex Alimentarius Commission i.e. agenda items under consideration by the various Codex committees. This may include coordinating consultation activities, depending on the practice in a particular country. Nominate delegates to represent the country at Codex meetings. Advise the government on the best possible decisions as regards Codex standards and their implementation (e.g. conducting and coordinating activities to harmonize national standards in food safety with international recommendations). Appoint such technical subcommittees to address specific issues as may be needed for the countrys effective participation in Codex. These subcommittees normally focus on specific technical issues or types of standards (e.g. fish and fishery products), and their work may be coordinated by either the national Codex coordinating structure or the Codex Contact Point. Propose and implement an annual programme of work. Present an annual report of its activities. Articulate with the national authorities the strengthening of Codex activities in the country. Undertake such other duties as may be advised by the government. Box 3.2.2 explains how the National Codex Committee of Brazil functions. Box 3.2.3 describes the structure for coordination of Codex activities which has been established in the United Republic of Tanzania.

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Box 3.2.3 | Codex coordination in the United Republic of Tanzania

The United Republic of Tanzania has established a Codex Contact Point and a National Codex Coordinating Committee, both of which are essential for the countrys effective participation in the international food standard-setting process. The Codex Contact Point is located in the Tanzania Bureau of Standards (TBS) and the Head of the Agriculture and Food Section of the TBS is the officer responsible for the national Codex Contact Point. The establishment of the National Codex Committee has ensured that all ministries, non-governmental organizations, consumers and industry have ample opportunities to present their views on various Codex matters, including aspects related to food safety control. The National Codex Committee has representation from public and private institutions including academia, research and consumer organizations. The core functions of Tanzanias National Codex Committee include: to the work undertaken by the Codex Alimentarius Commission;

proposing to the government the acceptance of Codex standards, and suggesting which organizations should take action;

serving as a national forum to assist the government in ensuring a supply of safe food to consumers, while at the same time maximizing the opportunities for industry development, and for the expansion of both domestic and international trade;

appointing the technical (sub)committees to assist in the study or consideration of technical matters;

studying Codex documents, collecting and revising all relevant information related to science, technology, economics, health and control systems, so as to be able to give supporting reasons in the preparation and acceptance of Codex standards;

cooperating with the Codex Alimentarius Commission and nominating delegates to Codex sessions; and

advising the government on the implications of various food standardization and food control issues that may have arisen and that are related

cooperating with other national and foreign organizations whose scope covers food standards.

National positions

National positions are prepared for two main purposes: to enable the country delegation to present the position of their country during the relevant Codex meeting; to form the basis of written comments that will be provided to the Codex Secretariat and/or host country secretariat in response to a request for written comments through a circular letter.
Who should prepare the national position?

Preparing a national position is a collaborative effort. The first step is to prepare a first cut, or initial draft. An individual with technical expertise on the issue under consideration normally prepares this position, and also usually serves as the head of delegation to the Codex session for which the position is being prepared. In preparing the national position, input received as a result of the above consultation process is taken into consideration. However, it must be understood that the final

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decision as to the content of a national position rests with the government, so it would be up to the national government to determine how much and to what extent the input received will be reflected in a national position. When developing a country position on Codex issues, the considerations to be taken into account are as varied as the issues that might be considered by the committee. However, the following are some general criteria that should be borne in mind: Drafting a position is not done in isolation it should be done in consultation with all interested parties. Consideration of an issue is usually not a one-time matter: often the issue may be on the agenda for several sessions. There is a history to the evolution of each issue within the context of any Codex committee or task force. Attempts should be made to understand this history, so that developing a position would be done within context. The committee will generally not revisit comments or interventions on issues that it has already discussed, and on which it has taken a decision. When preparing comments, make sure they are scientifically sound, or supported by risk assessment data (including an economic impact statement). Positions promoted internationally should be consistent with a countrys national policies. Therefore, the countrys domestic policies (including any pertinent legislation) should be considered when developing a position. However, using domestic requirements as a rationale for promoting a particular position at the international level is not appropriate. For example, it is not appropriate to state that My country supports X because that is what is in our national legislation, as national legislation tends to reflect national concerns. National positions that are promoted at the international level should be based on considerations with a global application, e.g. science.
Official endorsement of the national position

This draft may then be shared again with other interested parties (e.g. other members of the countrys delegation if applicable), who provide their final input. The final version should receive a final review at an appropriate level of government, so that it can be endorsed as an official country position. In some countries, the National Codex Committee can perform this function. Due attention should be given to ensuring national agreement and support, as once submitted it is not common practice to withdraw a national position, and countries should avoid changing the national position unless it is absolutely necessary (e.g. new information is received).
Submitting written comments

As a general rule, it is important that a country submit written comments on those issues that have been identified as priority issues for the country. Working on the premise that a developing country, or a country with a small economy, is limiting its active participation to the FAO/WHO coordinating committee and two standard-setting committees, then normally it would submit comments on items being considered by those committees. The advantage of submitting written comments is that the views of the country will be shared with all the other Members of Codex. This is helpful if a country cannot attend a meeting owing to resource limitations. The chairs of committees have a responsibility to ensure that the written comments submitted by countries not present at a session are taken into consideration by the committee. If a country is present at a session and has submitted written comments, the speaker can then draw the attention of the committee to those comments.

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It is the function of the Codex Contact Point to submit any written comments to the Codex Secretariat in Rome and/or the applicable host country secretariat (see Module 3.1 on core functions of the Codex Contact Point). It is not normally the function of the Codex Contact Point to draft the national position.
Format for written comments/national positions

Although there is no officially endorsed format for the provision of written comments, or for preparing national positions for use by delegations (even if they are not submitted as formal written comments), there are some basic components that need to be incorporated into the position: a) name of the committee and identification of the session; b) identification of the agenda item, number and reference documents; c) background information to enable the reader to put the position in context; d) issues and discussion; e) a statement of the national position; f ) a rationale for the national position. Box 3.2.4 suggests a format that might be used when preparing the national position.

Box 3.2.4 | Example of a format for preparing the national position

Agenda item No. (enter agenda item number) C/ (enter reference number)

CODEX COMMITTEE ON (committee name) Date and location of meeting Agenda topic BACKGROUND The purpose of this section is to provide a brief chronology of events leading up to the current consideration. This should include major decisions, previous country support for, or opposition to, those decisions, etc. This section will serve to put into context the elaboration of the issues and subsequent country position/strategy. Keep it as short as possible. ISSUES/DISCUSSION In this section the key issues that will be discussed as part of the agenda item will be identified. The issues should be evaluated from a national perspective; the arguments for and against, the implications, etc. should be identified, as appropriate. Depending upon the circumstances, the issues/discussion section may be separated into two distinct sections if such a separation will enhance the clarity and understanding of the country position. The primary purpose of this section is to provide support clearly to the position promoted below. This is primarily for the use of domestic readers who may not be as involved in the issue as the head delegate. POSITION This section will outline the national position on the issue(s) under consideration. The position must also be supported by a rationale that should flow logically from the discussion/evaluation section.

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The preparation of the national position in this way will assist the delegate presenting it at the Codex session to be more familiar with the issue in the context of Codex. It is important to make a distinction between written positions intended to be submitted to the Codex Secretariat in Rome for consideration of a committee, and national positions that are intended to be used by the head delegate attending a committee session and not intended to be shared. Written positions intended for submission to the Codex Secretariat would not normally include a background section or an issues/discussion section incorporated in the submitted document. They should be clear and concise in presentation, as all written comments submitted to the Codex Secretariat are translated prior to distribution. Countries are strongly encouraged to send the written comments by e-mail from the e-mail account officially registered with the Codex Secretariat, while fax and ordinary mail can be used as backup options.

Box 3.2.5 | Example of a format for preparing written comments to the Codex Secretariat
Country (enter country name) Agenda item No. (enter agenda item number) CL/ (enter reference number)

CODEX COMMITTEE ON (committee name) Date and location of meeting Agenda topic POSITION This section will outline the national position on the issue(s) under consideration. REASON This section will provide the rationale for the position outlined above.

Box 3.2.6 | Preparation of country positions in Brazil

In Brazil, documents received from the Codex Secretariat are sent to the technical group responsible for that issue. Whereas the National Codex Committee is limited to 14 members, the technical groups may have more members, in order to consider all the contributions of the sectors involved in food standards work. They are composed of academia, industry, professionals, experts, etc. The coordinator of the technical group (TG) organizes meetings to study the working documents and prepare a draft position to submit to the National Codex Committee. The coordinator of the TG sends the draft position to the Secretary of the NCC, for distribution to all NCC members, prior to the committee meeting. During the NCC meeting, the draft position is reviewed and approved as a national position. Where appropriate the endorsed position is submitted to the Codex Secretariat and the host country secretariat.

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Box 3.2.5 suggests a format that might be used when preparing the national position to be submitted as written comments to the Codex Secretariat. Some common items of information will be included in the national position as outlined above, which is more intended for internal use, by the Codex Contact Point and by the national delegation. To illustrate the process of developing a national position further, Box 3.2.6 explains the procedure used in Brazil.
Why submit written comments and what happens to them?

Written comments are useful to enable adequate preparation at national level prior to the Codex meeting. This ensures that there is national consensus, and that the best national expertise is included in addressing the relevance of a draft standard or issue to the country. As written positions are circulated prior to the meeting, it also gives time for countries to see which other countries might form an alliance with them, as they have the same concerns/opinion. Forming alliances before or in the initial stages of a meeting may assist in having ones views heard. Written comments are also relevant when resources may not be adequate, or when the meeting is not considered as a priority for sending a delegation. At the meeting, other countries that are present and have the same position can refer to the written comments to promote the position of both countries. If comments have not been submitted, this will not be possible. It is useful to have a checklist for the preparation and promotion of national positions at Codex sessions. With official endorsement, such a checklist would have status as well as ensure consistency in approach at both the administrative and technical levels. Box 3.2.7 is a proposed checklist for preparing and promoting national positions at Codex sessions. Not all items listed are applicable in all cases, but the checklist can serve as a useful aid for all those who work with or present positions as part of a delegation.

Box 3.2.7 | Checklist for preparing and promoting national positions at Codex sessions
The following points provide guidance to assist countries in following a structured approach to developing and promoting national positions at Codex sessions. It should be borne in mind that not all these provisions apply to all issues all the time. However, reviewing these points while developing positions should facilitate the developmental process.

Country positions must be clearly stated and a rationale provided for them. If appropriate, offer alternative text.

Network: establish alliances with other countries. Also, establish a good working relationship with the Codex Secretariat.

Liaise with head delegates of other delegations representing the country at different Codex sessions to ensure consistency among positions in the various Codex committees. Discuss issues early in the development of positions.

Make full use of all available resources in developing positions and strategies: members of the country delegation, Codex Contact Point, National Codex Committee, other ministries, industry/consumer bodies, etc.

If it is the intent to submit written comments, circulate the officially approved position as broadly as possible. The following considerations are offered for use by

Consult broadly and as early as possible. Bring key or controversial issues to the attention of the Codex Contact Point and the National Codex Committee as early as possible.

head delegates and others involved in preparing country positions. The list is not exhaustive, neither
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Box 3.2.7 (cont.) | Checklist for preparing and promoting national positions at Codex sessions
are all points applicable to all delegations all the time. However, they provide a useful checklist to which head delegates and others can refer for guidance on Codex activities. Activities in preparation of committee meetings 1. 2. 3. Review previous reports and positions taken by the country (they may still be fully or partially valid). Identify the issues of significance to the country or the committee that are likely to be on the agenda. Identify expertise/talent in the delegation: are the right people on the delegation to address the issues? Membership of delegations should extend beyond the duration of a Codex session (i.e. delegation members become resource persons). 4. 5. Review the agenda: identify issues with a linkage between a circular letter (CL) and an agenda item. Decide whether a response to a CL would provide a strategic opportunity to advance the countrys position. Responses to CLs are collated by the Codex Secretariat in Rome and/or by the host country secretariat and circulated to all governments by means of the Codex Contact Points. Therefore, it is a good way to get the countrys view circulated. 6. 7. Consider possible SPS and TBT implications. Consult as broadly as possible and do so early. The consultative process is normally coordinated by the Codex Contact Point. Liaise with the Codex Contact Point to ensure that all key stakeholders are included on the consultation list. If you receive comments submitted directly to you, ensure that a copy is provided to the Codex Contact Point. 8. Determine who should prepare the first draft of the response to a CL, or the draft position on an agenda item. 9. Circulate the draft(s) to all delegation members (if applicable), revise as necessary and submit the final draft to the Codex Contact Point and National Codex Committee. 10. Discuss with the National Codex Committee whether the country should be involved in any working/drafting groups that may be established (note resource implications). 3. 2. Activities during the committee session 1. Consider holding pre-session meetings with other countries where there are common views (e.g. other countries in the region, etc.). Conduct meetings with your delegation as necessary to ensure that all members are aware of your strategies and to solicit their opinions on the dynamics of the session. These meetings can also be used to confirm an interpretation of the results of plenary sessions. Make the delegation known to the chair of the committee (i.e. informally introduce yourself and other members of the delegation, if any, during coffee breaks, etc.).
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11. Circulate, through the Codex Contact Point, the officially approved positions as broadly as possible. 12. Identify countries with whom to liaise and find out what their positions are on a particular subject. If necessary, ask others in the delegation to review the comments/previous positions of other countries. This will help to identify potential allies. Identify those countries that have not yet chosen a position: focus on them as potential allies. 13. Make use of the Codex Contact Point and National Codex Committee. 14. State clearly the countrys positions/responses to Codex issues, providing a strong rationale. Avoid references such as this is not permitted in our regulations. The position should be based on scientific evidence that will contribute to consumer health protection, or to ensuring fair practices in the food trade. 15. Are there issues that have an impact on other Codex committees? Liaise with other head delegates from the country who are leading delegations to other Codex committees on issues of mutual interest. 16. Verify logistical/administrative arrangements with members of the delegation (e.g. hotels, embassy contacts, etc.). It is desirable that all members of the delegation stay at the same hotel (or at least in close proximity), to facilitate delegation meetings.

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Box 3.2.7 (cont.) | Checklist for preparing and promoting national positions at Codex sessions
4. Be prepared to make informal suggestions to the chair on strategies to achieve consensus, or to find a way around an impediment to the progress of the meeting. 5. In order to make an intervention, countries need to raise their country nameplate and wait their turn until invited to speak by the chair. Make strategic interventions and observe protocol. Ensure that the delegation is using the most recent copy of the Codex Procedural Manual. Because interventions are being translated into a number of other languages, the delegate should speak slowly, use short sentences and eliminate sentences and thoughts that are unnecessary to make the point. Writing out an intervention before making it can help the delegate craft an effective intervention, but if interventions are written in advance, they must not be read too quickly for the interpreters to follow. Make sure interventions are clear, short and focused. If possible, make reference to written comments previously submitted. Remember that your words are being interpreted as you speak. 6. Be a positive contributor to consensus while ensuring that the countrys position is not compromised. Where possible, try to bridge gaps between opposing/differing views. 7. If the delegation consists of more than one person, there should be one speaker per agenda item only. Determine in advance which member of the delegation will address the various issues. Establish an intervention strategy (i.e. intervene early or later in the discussion). As appropriate, coordinate interventions with other like-minded countries: this creates a cascade effect. Remember, however, that sometimes silence is golden! 8. Liaise as appropriate with other countries by making use of all members of the delegation (while maintaining control). This is also an opportunity to follow up on networks established during pre-meeting activities. 9. Participation in working groups/drafting groups is an excellent way to express the countrys position publicly for consideration by everyone present at 2. Activities after the session 1. Prepare the report of the head delegate. The first draft should be shared with delegation members for their input before finalizing and submission to the National Codex Committee. Debrief the Codex Contact Point and the National Codex Committee at the earliest opportunity, making sure to identify key issues. Review the final report, and identify issues of significance to the country or the committee, as
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the earliest opportunity. However, use discretion when volunteering for participation in working groups, particularly when such participation has not been discussed with the countrys Codex Contact Point or National Codex Committee, owing to potential resource implications. 10. During the adoption of the report of a Codex session, ensure that the draft final report clearly and accurately reflects the outcomes of deliberations during plenary. Make use of all available delegation members to review the draft report. The purpose of the report review/adoption process is to ensure that there are no errors or omissions. Typographical errors and other comments of an editorial nature should not be made. Such revisions will be made by the Codex Secretariat in Rome when the report is finalized for publication. In exceptional circumstances where the country has requested an objection to be noted in the report, ensure that the intervention is accurately recorded. 11. If intervening with a correction or for clarification during the adoption of the report, have alternative text ready, including a written copy to facilitate the work of the Secretariat. 12. Remember that once the report is adopted, it will not be changed. It becomes the historical record of that committee meeting. 13. When abroad, if there is a need for additional guidance from the relevant national government authorities, try to get this guidance as early as possible so that work can progress and is not delayed until the next session.

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Box 3.2.7 (cont.) | Checklist for preparing and promoting national positions at Codex sessions
well as those that have implications for or make use of work done by other committees. 3. 4. Discuss any issues with the Codex Contact Point or National Codex Committee. Identify pertinent circular letters (if any) resulting from the meeting which will be sent out for comment. The final official copy of the committee report normally contains a CL. A response to this CL should be prepared in cases where such a response will advance the countrys position. 5. 6. Make use of all delegation members to start developing strategies for the next session. Is there a need to modify the delegation? Consistency in delegations is important. However, as issues evolve and the agenda changes, it may be necessary to review and change delegation members to ensure that the appropriate expertise is available. 7. The post-session activities are really the start of the pre-session activities for the next meeting. What do I need to bring to a Codex session?

Travel information (visa, airline tickets, hotel address, contact details of embassy, name and address of contact person at Codex Contact Point in host country), weather and currency information.

Official invitation letter to the government to attend the Codex session, and official letter sent from your country notifying the Codex and host country secretariats of the composition of the national delegation.

Report of the last committee session and report of the head of delegation. A copy of the Codex Procedural Manual. Country position on relevant agenda items and related comments. Agenda of the session. All related working documents, as these may not be available in sufficient quantity at the meeting. All other relevant documents such as the report of the last Commission session and the SPS and TBT Agreements.

Reference material

FAO/WHO. 1999. Report of the Eleventh Session of the Codex Coordinating Committee for Asia. Appendix II. (ALINORM 99/15). Rome. FAO/WHO. 1999. The application of risk communication to food standards and safety matters. Report of a Joint FAO/WHO expert consultation, 26 February 1998. Rome. FAO/WHO. 2003. Report of the Fifteenth Session of the FAO/WHO Coordinating Committee for Africa. Appendix II. (ALINORM 03/28). Rome. FAO/WHO. 2005. Understanding the Codex Alimentarius. Revised and updated, pp. 19, 21, 25, 3031. Rome. WHO. 2003. The Codex process A reference manual for Pacific island countries, pp. 3840. Manila, WHO Western Pacific Region. Codex Web site: www.codexalimentarius.net

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Exercise 3.2.1 | Developing a national position

Objective The purpose of this exercise is to develop a national position on issues stemming from the agenda of a committee of interest to participants for submission to the Codex Secretariat in Rome, or to prepare a discussion paper for consideration by the FAO/WHO coordinating committee. Time allocation Method Participants will be divided into groups of five to six people each. The instructor will select an issue from one of the recent ALINORMS of a committee identified by the participants as a priority (see Exercise 2.4.1 in Module 2.4). Each group will develop a position on the selected item in accordance with the components identified in this module. Or If the timing of the workshop is such that it is not Outcome The trainees will gain experience in drafting a position (or discussion paper) that could be circulated to national stakeholders and/or the National Codex Committee for endorsement and submission to the Codex Secretariat, as appropriate. The groups should be allocated 90 minutes to develop the paper, and a further 30 minutes of plenary time should be allocated to finalize the document. possible to submit comments on an item stemming from a committee meeting, the group may develop a discussion paper for consideration by the FAO/WHO coordinating committee using the same process. Draft papers will be reviewed in plenary when the groups recombine, and be finalized as a draft.

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Exercise 3.2.2 | Preparing a consultation plan1

Objective The purpose of this exercise is to give the participants practice in identifying key groups that should be consulted in developing national positions and developing mechanisms to ensure that these groups are included in the process. Method Participants will be divided into groups with five to six members in each group. In Module 2.8, Exercise 2.8.1 is aimed at developing a standard for a commodity of significance to the country in which the training is being conducted. The present exercise requires participants to identify all the government departments and organizations that have a vested interest in that standard. Participants are requested to draft a consultative plan that will solicit the opinions of all stakeholders interested in the content of the standard developed during Exercise 2.8.1. Although there is no format for a consultation plan, participants should consider the following: 1. Who are the contacts? It is not sufficient to identify an organization or government department. An individual or a specific position within the organization or government department should be identified. If an individual/position cannot be identified, trainees should describe how they intend to determine to whom in the organization they should address their request. 2. What information are they looking for? They
1

should prepare a draft letter indicating why the individual is being solicited and on what. 3. How are they going to consult? Personal contact, e-mail, letter, etc.? How will the reference document be circulated? Which document would be the reference or working document? 4. What are the timelines? What is the deadline for comments? Is sufficient time being provided to allow the stakeholder to review and comment? There is also a need to provide time for the individual(s) responsible for drafting the official country position to review the comments provided and incorporate them into the country position to the extent appropriate. Time allocation The groups should be allowed one hour to discuss, and then 10 minutes per group to report and discuss in plenary. Outcome The result of this exercise should be that each group will develop a consultation plan that identifies: (1) with whom they intend to consult; (2) how they intend to carry out the consultation; and (3) a timeline indicating the key dates in the process.
A national consultation plan should include a list of people who need to be consulted when preparing national positions on topics under discussion at Codex. Different sets of lists may be maintained for different topics to ensure that adequate technical expertise and stakeholder opinion are available.

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Module 3.3

Considerations for selecting national delegations

Determining who should be on a national delegation is always a challenge, as there are a number of factors that may affect the selection process. Recognizing that the process of selecting national delegations varies from country to country depending on the situation, this module offers some guidance on the process of putting together a national delegation to attend a Codex session, and outlines its responsibilities before, during and after a Codex meeting. For the purposes of this module, the criteria are broken down to help select a head delegate and other members of the delegation, and to provide some guidance regarding the selection and participation of non-governmental observers on the delegation. Often a country delegation will consist of one person only, owing to a lack of resources, and therefore they will assume the role of head delegate. In such circumstances, participation of non-governmental expert representatives on the delegation is unlikely. This makes the selection process even more critical. In addition, when only one person represents the country at a Codex session, preparation of the national position in advance of the meeting is even more important, to ensure a true reflection of the countrys views or concerns on a given topic. In selecting the right person for the task, there are two important facts to bear in mind. First, Codex is an intergovernmental organization; therefore the official delegate must be a government official or an individual contracted to represent the views of the government. Head delegates represent the views of their governments and not their own. Second, Codex is a food standard-setting organization. Whoever represents the country should have some food safety/food standard-setting experience. The following points are offered for guidance, and it should be remembered that what works in one country may not work in another. Therefore, these should not be considered as fixed rules.
Process for selecting the head delegate

Heads of delegations representing a country at the various committees and task forces of the Codex Alimentarius Commission could be selected using the following process: 1. The Codex Contact Point solicits nominations from senior-level managers of departments or agencies active in the national Codex programme. Nominations are based on: - terms of reference of the Codex committee for which the head delegate is being selected; - position held within a ministry/department with primary responsibility for the Codex committee; - technical expertise of nominee in the subject matter of the relevant Codex committee;

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- degree of experience or involvement in previous Codex activities (e.g. contributions to developing national positions); - other factors, such as level of position if appropriate. 2. The government endorses the nomination submitted by the applicable department/agency, taking into consideration the above criteria. The level at which the nomination is officially endorsed will depend on the management structure of the countrys Codex activities for example it could be the Codex Contact Point if the authority rests there, or it could be the National Codex Committee (or its equivalent). 3. The nominees appointment together with the delegates obligations and funding arrangements may be confirmed in writing if desired. Adequate briefing of the delegate is always important, but even more critical when there is a new representative at Codex meetings. As stated previously, these are only guidelines. They outline the steps that could be followed, and by whom. However, each country will use variations on the above procedure, depending on the circumstances.
Forming delegations to sessions of the Codex Alimentarius Commission, committees and task forces

If a country has adequate resources, it may choose to select people in addition to the head delegate to form a country delegation to attend the Codex session. One method of forming such a delegation is described here. The Codex Contact Point circulates invitations and provisional agendas for upcoming Codex sessions to governmental and non-governmental organizations that have expressed an interest in the relevant Codex committee session. Replies to the invitation are received by the Codex Contact Point, and reviewed by the Codex Contact Point and the head delegate. Delegations usually consist of a head delegate, government advisers and nongovernmental observers. Members of delegations should be selected by the head delegate, in consultation with the Codex Contact Point, based on their expertise and experience relative to the issues being considered by the committee and their ability to contribute to the effectiveness of the delegation in promoting the countrys interests. The following criteria may be applied for selection of members of delegations: expertise relevant to the items on the agenda; regard for an appropriate balance of expertise and skills within the delegation; assistance required by the head delegate for certain items on the agenda;

Box 3.3.1 | Procedure used to form a delegation example from Malaysia

In Malaysia, there is a national Codex fund for government agencies to attend Codex meetings managed by the National Codex Committee (NCC). The NCC is mandated to identify the Codex meetings to be attended. The Ministry of Health, as the secretariat of the NCC, acts on its behalf to identify these meetings. It also selects the delegations, including the head delegate, in consultation with the secretariat of the technical subcommittees and task forces (which may be with various agencies), as well as the facilitators or representatives from the Ministry of Health in those technical subcommittees and task forces.

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the items on the agenda; representativity of the individuals, groups and organizations that might be affected by standards to be considered; extent to which the individual contributed to the development of national positions for the session of the committee. The final composition of all delegations should be reviewed by the National Codex Committee and subject to endorsement by the government. Countries may use a variety of methods. Box 3.3.1 outlines the procedure used by Malaysia.
Proposed guidelines for the selection and participation of non-governmental organizations in delegations

representativity of the individuals, groups and organizations that have an interest in

It is recommended that the government should be encouraged to engage public participation in the activities of Codex to the greatest extent possible. To this end, the Codex Contact Point should maintain a list of people and organizations that have expressed an interest in activities of one or more committees, and regularly disseminate information to those interested parties about Codex activities, including invitations to participate as part of a delegation to Codex meetings. Where feasible and practical, when selecting the national delegation for a Codex meeting, attempts should be made to achieve a balance of non-governmental delegates representing the various non-governmental sectors, e.g. consumer groups, industry associations and professional associations. As Codex committee sessions are normally open to the public, additional non-governmental representatives are free to attend plenary sessions of the committee as observers, provided space in the meeting room permits. These public observers do not sit in the meeting with the delegations and cannot make comments. In all cases, non-governmental representatives, whether considered for official delegate status or not, may provide written comments (when preparing national positions) to the head delegate on the issues to be discussed at the committee session. Comments from stakeholders are solicited prior to the establishment of an official position on an issue, and copies of draft positions should be made available to stakeholders prior to any Codex committee meeting. It is important that the selection process of representatives of non-governmental organizations on delegations is transparent and equitable. Countries are therefore encouraged to establish criteria for this process, and to make such criteria available to all interested parties.
Criteria for selection of non-government members of a delegation

In developing national criteria for the selection of non-government members of delegations to attend a Codex meeting, the NCC should take into account the following: Only those individuals and organizations listed with the Codex Contact Point and/or National Codex Committee (or its equivalent) should be considered as candidates for non-governmental representatives on delegations. It is the responsibility of an organization to submit nominations to the Codex Contact Point for consideration as potential delegates. Preference should be given to organizations that have national status and have indicated an interest in a broad spectrum of issues. Organizations with a more

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localized membership could be given consideration, particularly if such groups have expertise in the subject matter. Nominees for delegation membership should have knowledge of the issues on the committees agenda. Preference should be given to nominees who have recognized credentials in the area of work related to the mandate of the Codex committee in which their participation is being considered. Organizations should act on behalf of their membership, and should be prepared to disclose information concerning their organization (e.g. membership, charter, process used to establish their position, develop comments and select their recommended nominee, etc.). Final composition of all delegations should be subject to endorsement by the National Codex Committee.

Responsibilities and obligations of delegations

Delegations participate in Codex sessions in accordance with the Codex Procedural

Manual, Guidelines for Codex committees and intergovernmental task forces, including Conduct of meetings. It is the responsibility of all delegates to become familiar with the contents of this Procedural Manual. Non-government delegates should advise the head delegate of the concerns of the organization they represent, and make every effort to contribute to enhancing the effectiveness of the delegation at Codex sessions. Delegates are expected to attend all plenary sessions and any meetings convened by the head delegate. With the concurrence of the head delegate, non-government delegates may also attend working group meetings held during the session. Generally, non-governmental observers should not negotiate on behalf of their countrys government, and should only do so with the express permission of the head delegate. If, during informal discussions, non-governmental observers express views that differ from the official country position, they must clearly indicate that these views are their own, or those of the non-governmental organizations they represent, and not those of their countrys government. Non-governmental observers should exercise discretion to ensure that their activities are not prejudicial to the effectiveness of the delegation. A non-governmental observer may be asked to withdraw from the delegation if such activities occur. A delegate may not serve concurrently during a Codex committee session as a member of any other countrys delegation, or on the delegation of an accredited observer organization to the Codex session. Members of the delegation are not immune from any laws or regulations of their country or the host country as a result of participation on a delegation.

Responsibilities of the head delegate at Codex committee sessions

The head delegate to each session of a committee of the Codex Alimentarius Commission, in consultation with the Codex Contact Point and National Codex Committee, is responsible as follows. The checklist for developing and promoting national positions at Codex sessions (Box 3.2.7) provides additional information. Again, it should be noted that the following points are intended as guidelines, and actual practices vary from country to country. The head delegate:

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1.

identifies a list of advisers with an interest in, and expertise relevant to, the terms of reference of the committee, as well as the specific items on the provisional agenda of a particular session. The advisers may be selected from representatives of the various government ministries or departments. Observers may also be identified from nongovernmental organizations; 2. strives to ensure the formation of a delegation of government officials and nongovernmental representatives with an interest in, and expertise relevant to, the items on the provisional agenda;. 3. prepares draft positions for each agenda item, in consultation with the National Codex Committee (or its equivalent); 4. where appropriate, solicits comments by correspondence or electronic means, or at a public meeting, on the draft positions for each item on the provisional agenda. This consultative process may be conducted through the Codex Contact Point, and can be facilitated by the National Codex Committee if one exists; 5. where appropriate, conducts a discussion of the draft positions on each agenda item with officials from other countries that may share common views; 6. presents the draft positions for each agenda item to the National Codex Committee (or its equivalent) for review, amendment as necessary and endorsement. As positions reflect official national government opinion, it is important that the positions be endorsed by the appropriate government authority; 7. provides copies of the final draft positions to: - the Codex Contact Point - each member of the delegation - all interested stakeholder organizations - the designated contacts in other countries as appropriate 8. presents, defends and promotes the positions on each agenda item to the Codex committee, taking into account issues raised by other delegations while ensuring consistency with national policy. Where a particular agenda item falls within the mandate of a ministry represented by another member of the delegation, the head delegate should consider asking this delegate to speak on behalf of the country with respect to this item; 9. on return to the country, prepares a report on the outcome of the session for the Codex Contact Point and the National Codex Committee. Preparation of this report may be delegated to another member of the official delegation. All members of the delegation should, however, endorse the final delegation report. In some countries, it is standard practice to present this report orally to the National Codex Committee, where such a committee exists; 10. continues to coordinate preparation of responses to circular letters issued with respect to the committee, with consultation as per items (4) and (5) above, as appropriate. The reply should be submitted to the Codex Secretariat via the Codex Contact Point, and presented to the National Codex Committee for information.

Reference material

FAO/WHO. 2004. Codex Alimentarius Commission Procedural Manual. 14th edition, pp. 6266. Joint FAO/WHO Food Standards Programme, Rome. Codex Web site: www.codexalimentarius.net

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Module 3.4

Organizing Codex documentation

The Codex system is notorious for the amount of documentation it can produce. It takes a very organized Codex Contact Point to keep all the ALINORMS, circular letters, information documents, discussion papers and numerous other working documents in some kind of order. Whether the documentation is received and maintained in electronic form or as a paper copy, it still amounts to an overwhelming amount of documentation. The question is, of course, what to do with all this documentation? This module offers some suggestions on how to organize and keep track of the flow of documents. In addition, given the extreme importance of consultation in developing national positions on Codex issues, some guidance is provided on how to establish a consultative process. One thing that must not be done is to let documentation accumulate, unattended, on the corner of the desk. This will limit the ability of a country to respond effectively to issues under consideration, as the individual with the necessary expertise may not receive the document. Even if eventually retrieved from the pile, if a document is circulated late there may not be sufficient time for it to be considered by all interested stakeholders, which could result in poorly constructed comments or missed deadlines.
How should a country organize its Codex files?

In principle, whatever works best. It is important that the system used is simple enough to allow managers to find the information without the assistance of busy clerks. As Codex work tends to revolve around committees (and task forces), many countries organize their electronic and paper files based on Codex committees. It should be noted that countries that may only be actively participating in two or three committees should still maintain information files on the activities of all the Codex committees. The only deviation from this general approach is that some countries keep their circular letters (CLs) filed separately. This is because they are issued consecutively, and hence often relate to issues in various committees, so that CL No. 7 may be in one committee file, and No. 8 in another.
Ensuring access to Codex documentation to all interested stakeholders

An important function of the Codex Contact Point is to provide information on Codex activities and the outcome of Codex meetings, and to make available Codex documents to interested stakeholders. This is important for enabling the development of national policy, further described below, and to ensure that those responsible for preparing national positions and selected as members of the national delegation have access to all relevant documentation.

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When organizing Codex documentation, the CCP should consider how best to provide public access to this information. Due consideration should be given to making best use of the Codex Web site where the standards are available. The scope and numbering system of Codex documentation is discussed in Module 2.7.
Codex standards and national policies and legislation

Codex standards are developed to protect the health of consumers and to ensure fair practices in the food trade. It should be noted that there is no obligation for countries that are Members of Codex to adopt any of the standards elaborated by the Commission. Nevertheless, because of their scientific basis, many countries will review the Codex standards as part of their process for developing national policies and legislation. Those countries that are Members of WTO are required to base their national measures on the appropriate international standard (see Module 2.10). When countries are developing national legislation to address food safety or quality issues to protect the health of consumers, the Codex Alimentarius provides a ready-made set of standards that can be adapted to suit a countrys requirements. Countries can review the Codex standard to determine the level of protection the standard would provide to their consumers, and decide whether that level is the level deemed appropriate for their country. Similarly, when developing a national standard for a particular food commodity, the Codex Alimentarius provides a convenient source of ready-made standards of identity. Box 3.4.1 provides an example of how Peru made use of the Codex standard for asparagus in its national legislation, and the subsequent benefits it enjoyed as a result.

Box 3.4.1 | Transforming a Codex standard into a national standard example from Peru1
Since the establishment of the World Trade Organization (WTO) and the implementation of the Sanitary and Phytosanitary (SPS) Agreement, many developing countries continue to view the increasingly strict international agricultural health and food safety standards as non-tariff protectionist trade barriers, rather than legitimate safeguards for the protection of human, plant and animal health. However, there are those who have come to see international standards not as barriers to trade, but as tools to upgrade quality standards and secure market access. The Peruvian asparagus industry is one successful example, in which industry leaders and government specialists realized that it was in the best interest of the industry and the country to adopt international and national standards, and have greatly benefited. Over the past decade, Peru has quickly risen to become one of the worlds largest exporters of asparagus products, together with the United States of America and China. In 2003, earnings from
1

asparagus products (f.o.b2) reached US$206 million, representing nearly 25 percent of Perus total agricultural exports. This has earned valuable export dollars for the Peruvian economy, and generated more than 50 000 jobs, approximately 60 percent of which among women in Perus coastal regions. Owing to high transportation costs, Perus exporters are unable to match prices with less expensive asparagus products from some other countries. Nonetheless, they have continued to increase exports and gain market share by making investments in modern technology and by applying norms to generate consistently higher quality,
Summary of a case study prepared by Tim OBrien of the InterAmerican Institute for Cooperation on Agriculture (IICA) and Alejandra Diez of the Peruvian Commission for Export Promotion (PROMPEX). 2 Stands for free on board. Describes a price that includes goods plus the services of loading those goods onto a vehicle or vessel at a named location (see: http://economics.about.com/cs/ economicsglossary/g/fob.htm). Continued

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Box 3.4.1 (cont.) | Transforming a Codex standard into a national standard example from Peru
internationally certified products, leading to satisfied clients and consumers. By producing products that meet international standards, Peruvian asparagus exporters have increased production and worker efficiency and generated client loyalty, while drastically reducing the industrys risk of trade disruptions owing to quality, food safety or phytosanitary issues. Peru has been able to gain access to developed country markets for its asparagus products because the industry and government officials have worked together to market and maintain quality national products through the adoption and application of national and international standards. The most important efforts that have been made to address problems in and improve the asparagus production chain have been in the establishment of mechanisms of cooperation, governmental incentives and private sector initiative. Good publicprivate sector communication led to the formation of the two most important organizations for the asparagus industry, the Instituto Peruano del Esprrago y Hortalizas (IPEH) and the Fro Areo Sociedad Civil. These two nonprofit organizations represent 80 percent of the industry, and provide the platform for producers, exporters and government officials to organize and join forces to ensure that sanitary and quality norms are enforced, to facilitate technology transfer and to promote the industry internationally. Beginning in 1998, government officials with the Peruvian Commission for Export Promotion (PROMPEX), seeking to benefit the industry through the modernization of food control systems and the setting of minimum national standards for asparagus products based on international norms, facilitated the formation of a technical committee on asparagus standards. The technical committee, working under the national standard-setting body, was able to obtain the participation of all the various sectors. This included not only the producer associations, business representatives and certification laboratories, but also diverse government representatives from the Ministry of Agriculture, the Ministry of Health and the Commission for Export Promotion (PROMPEX). The
3

inclusiveness, transparency and level of familiarity that the technical committee generated among the parties were significant factors in convincing the asparagus industry to implement voluntarily the Codex Recommended international code of practice General principles of food hygiene,3 not because it was the easiest but because it was the most necessary. PROMPEX specialists worked closely with industry leaders and production managers to ensure the proper and successful implementation of these good hygiene standards. As a result of better hygiene practices, the industry saw improved production methods, worker efficiency and product quality. This success created the confidence and expertise necessary for the industry to attempt to certify under the more advanced norms that clients were beginning to demand. Perus technical committee on asparagus also played an important role in establishing the Codex Alimentarius standard for fresh asparagus4 that governs international commerce. Having developed a national position based on input from both private and public sector experts and with political support, Peru sent a person from PROMPEX as the official representative to attend the Ninth Session of the Codex Committee on Fresh Fruits and Vegetables, and proposed changes to the draft standard during the meeting. Two private-sector representatives, one from each of the exporter associations, also attended and provided valuable technical support to the countrys representative during the meeting. At the Twentyfourth Session of the Codex Alimentarius Commission, Peruvian representatives were again able to introduce effectively and gain support for changes that benefited the Peruvian asparagus industry and the industry as a whole. At the same time in Peru, government officials made extra efforts to work with a now organized and committed industry to explain openly the importance of standards, and together they developed the national technical standards for
Codex AlimentariusFood hygiene basic texts. 3rd edition. (Includes

Hazard Analysis and Critical Control Point [HACCP] system and guidelines for its application.) FAO/WHO. 2003. Rome. 4 Codex Standard for Asparagus (Codex Stan 225-2001). Continued

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Box 3.4.1 (cont.) | Transforming a Codex standard into a national standard example from Peru
fresh asparagus based on the international standards established by the Codex Alimentarius Commission. Having included the private sector in the standardsetting process from the beginning, PROMPEX found industry leaders were committed to improving the quality of exports. Thus, when the national fresh asparagus standards were published in early 2001, because industry was already familiar with them and understood their importance for the industry, producers quickly adopted them with few problems and little argument. The national standards established a quality and performance baseline for the industry that allowed many to generate the skills and expertise to certify under other new and increasingly stringent international food safety standards more rapidly. These included Hazard Analysis and Critical Control Points (HACCP), traceability systems, good agricultural practices (GAP) and even GAP certification from the Euro-Retailer Produce Working Group (EUREP). The increasing demand for quality Peruvian asparagus has led to investments to expand cultivation and improve infrastructure, thus increasing local incomes and decreasing unemployment in some of Perus poorest regions. Asparagus production has created more local jobs because it is a more labourintensive crop than other traditional crops, and because processing facilities must be near the production fields. Peru now has the worlds largest asparagus packing and freezing plants and the industry remains almost entirely Peruvian-owned. More jobs have also been created in the new secondary industry of frozen asparagus that developed to make use of the large amount of seconds that do not meet the national standards for fresh export. This secondary industry gives smaller producers an important alternative market when it becomes uneconomical for them to implement the changes needed to comply with the stricter export standards for fresh produce. Even though some small farmers have been excluded from exporting fresh asparagus, there are examples of small producers who have continued to export because they were able to find creative ways to adapt old technologies or create new methods using minimal materials and funds to comply with the new standards. The processing infrastructure built to support asparagus exports has also generated new markets for local farmers by using its extra capacity and certified quality controls to process other products, such as Piquillo red peppers, artichokes and snap peas. This expansion has enabled several production facilities to expand, and they are now able to offer year-round instead of seasonal employment giving these rural agricultural families and communities greater financial and social stability. On the dry coastal plains of Peru, the sun and soil provide the ideal growing conditions, but it has been the cooperation and leadership from both the private and public sectors that has allowed the various actors to develop the trust and common vision needed to identify and resolve the main problems facing the asparagus industry. Through these efforts, the industry is now able to compete and respond better to the changing dynamics in the international market. The Peruvian asparagus industrys growth and success can serve as an example for other industries on how government agencies, associations and producers can successfully work together to develop, adopt and benefit from the establishment of national and international standards, which can lead to both increased economic and social development.

In order for a country to make effective use of Codex standards at the national level, it is necessary for the process used to develop national policies and legislation to include an examination of the existing Codex standards. Some countries have established a formal step-by-step process to develop national legislation, and have incorporated a review of Codex standards as one of the steps. Other countries have a less formal approach. Regardless of the process used, it is important that the Codex Contact Point be linked to the process, so that countries are aware and can take advantage of existing international standards.

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As noted previously, countries that have signed the WTO agreements are encouraged to harmonize their national standards with Codex standards, i.e. Codex standards are used as a basis for developing national standards; however, they do not need to be accepted word for word. Codex standards are not intended to replace national legislation, but rather to assist in establishing national policies and food regulations and/or standards. Countries should enact a national food law to provide the legal framework for administering national policies and regulations.

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Module 3.5

What do FAO and/or WHO offer to help implement or make use of Codex standards?

In order to support countries that wish to harmonize their national standards with those of Codex and thereby comply with international trade regulations, FAO and WHO engage in a variety of capacity-building activities. The Codex Alimentarius Commission, being an independent intergovernmental body for the development of food standards, does not provide technical assistance for participation in the work of Codex or for implementing its outputs at national level. However, in addition to its main role as an international standard-setting body, the Codex Alimentarius Commission provides member countries with an international focal point and forum for informed dialogue on food quality and safety issues. FAO and WHO, as the parent Organizations of Codex, follow closely the discussions and requests of Member States at Codex sessions, and take these into account when planning capacitybuilding programmes at national and regional levels. In turn, regular feedback on FAO/WHO capacity-building activities is provided to member countries through the Codex Alimentarius Commission and its subsidiary bodies. Capacity building has been defined within the United Nations system as follows: Capacity building is the building of organizational and technical abilities, behaviours, relationships and values that enable individuals, groups and organizations to enhance their performance effectively and to achieve their development objectives over time. The purpose of this module is to provide brief information on the ongoing capacitybuilding programmes of FAO and WHO in the field of food safety and food regulation. While Module 1.1 explains why a country should be involved in Codex, this module focuses on other possibilities that may be available to developing countries wishing to enhance not only their involvement in Codex, but also to strengthen their national food safety systems. The technical assistance provided aims to assist countries in strengthening their existing systems. National approaches within the food industry and government agencies are reinforced so that international Codex standards can be introduced and used. FAO and WHO provide tools and organize capacity-building activities for the benefit of developing countries.
Food and Agriculture Organization of the United Nations

The quality and safety of food is at the centre of FAOs mandate. The World Food Summit Declaration (Rome, November 1996) reaffirms the right of everyone to have access to safe and nutritious food, and the fundamental right of everyone to be free from hunger. The Food and Nutrition Division (ESN) hosts the Joint FAO/WHO Secretariat of the Codex Alimentarius Commission, and the Food Quality and Standards Service responsible for the food safety capacity-building programme and the provision of

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scientific advice. Within FAO, the Agriculture and Fisheries Departments also contribute to improving the capacity of food safety and safety-related quality control systems at country level. FAO has a decentralized structure (five regional offices, five subregional offices, five liaison offices and over 120 country offices). These offices are increasingly involved in capacity-building activities through, in particular, the implementation of field projects that are supported by regional or subregional food and nutrition officers (eight in all, stationed in different parts of the world). Further information is available at the FAO homepage www.fao.org. Food safety capacity building within FAO includes all activities undertaken in support of member countries wishing to strengthen their food control programmes and activities. This includes: policy advice on specific issues; institutional development and/or strengthening; review and updating of food legislation; harmonization of food regulations and standards with Codex and other international regulatory instruments; training of technical and managerial staff in a variety of disciplines related to food safety; and studies and applied research on specific food-related subjects. Capacity building also includes the organization of national and regional workshops and seminars on matters related to food safety and enhancing opportunities for international trade, and the development and dissemination of manuals, guidelines, training materials and other tools needed to support these programmes. Activities are undertaken by FAO headquarters in Rome and the FAO regional offices.
World Health Organization

WHO has a specific mandate for the protection of public health, which is the attainment by all people of the highest possible level of health. The WHO Global Strategy for Food Safety1 states WHOs goal in the area of food safety, namely to reduce the health and social burden of food-borne disease. This goal is to be achieved through a number of approaches, notably surveillance of food-borne diseases; improved (tools for) risk assessment, including assessment of safety of new technologies; promotion of increased involvement of the public health sector in the work of the Codex Alimentarius Commission; improved risk communication; increased coordination in international cooperation, and capacity building. The structure of WHO is such that in the area of food safety, as for most technical areas, normative functions are undertaken at the level of its headquarters in Geneva (through its Department of Food Safety, Zoonoses and Foodborne Diseases), mainly in close collaboration with FAO. These activities include the development of tools and guidelines and of a risk analysis framework, the performance of risk assessments and international standard-setting activities related to the Codex Alimentarius. Most of the activities related to technical cooperation, capacity building and country programmes are implemented by WHOs six regional offices through a network of country-based offices (office of the WHO Representative). Further information is available at the WHO homepage www.who.int/foodsafety.
Mechanisms for delivering technical assistance

In keeping with these mandates, FAO and WHO engage in their diverse capacitybuilding activities designed to assist developing countries to improve their food safety
1

WHO. 2002. WHO global strategy for food safety. Geneva.

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and plant and animal health systems. These various initiatives are often undertaken together with other international organizations, national governments, international and regional financial institutions and non-governmental organizations. A variety of mechanisms are used by FAO and WHO to provide technical assistance in response to the needs of member countries. Owing to the different structures and mandates of the two Organizations, technical assistance activities may vary. Joint activities are undertaken wherever possible and appropriate.
Field projects

Projects aimed at building national capacity in developing member countries for the management and control of food quality and safety may be funded through the FAO Technical Cooperation Programme, or by other donors, or even by the country itself. The projects focus on the needs of both public sector institutions with responsibilities for food safety and those in the industry sector. Projects may deal with many aspects of official food control, industry food quality and safety programmes, and broad stakeholder participation in food quality and safety regulation.
Workshops, seminars and training courses

These activities are conducted to meet specific national, and in some cases regional, needs. They may cover a range of topics, including: support in strengthening national Codex programmes, developing tools for food-borne disease surveillance; improving the quality of street foods; food safety risk analysis; developing food safety strategies; ensuring the quality and safety of fresh fruits and vegetables; and enhancement of laboratory facilities and analysis capabilities.
Supporting tools

In support of these capacity-building activities, FAO and WHO are also engaged in the development of manuals, guidelines and training materials. Most of these materials are developed jointly, except for a few which are prepared under specific field projects operated either by FAO or WHO, or which relate to specific organizational mandates. Some examples of such materials are: Assuring food safety and quality Guidelines for strengthening national food control systems. FAO Food and Nutrition Paper No. 76. Rome, FAO/WHO, 2003. Improving the quality and safety of fresh fruits and vegetables A practical approach. Rome, FAO, 2004. Food quality and safety systems: a training manual on food hygiene and the Hazard Analysis and Critical Control Point (HACCP) system. Rome, FAO, 1998. Risk assessment of Salmonella in eggs and broiler chickens. Rome, FAO/WHO, 2002. (Microbiological Risk Assessment Series Nos 1 and 2.) Good hygiene practices for the preparation of street-vended foods: a training manual. (FAO publication in preparation.) Bringing food safety home: how to use the WHO 5 keys to safer food to create effective food safety training for specific target audiences. (WHO publication in preparation.)

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Module 3.4

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Module 3.5

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Module 3.5 (cont.)

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Scientific basis for Codex work

Contents

{
155

Introduction

156 Module 4.1 / Risk analysis in the framework of Codex 156 What is risk analysis? 156 The difference between risk analysis and hazard analysis 157 Risk analysis and Codex 159 Conducting a risk analysis 160 The principles of food safety risk assessment 160 The principles of food safety risk analysis 160 Provision of risk assessment/scientific advice 159 Box 4.1.1 / Risk assessment in the context of the Codex Committee on

Pesticide Residues
162 Module 4.2 / Requesting, accessing and contributing to expert scientific 162 Expert bodies/ad hoc consultations 163 Can a country request a risk assessment? 163 Submission of data to the expert bodies 166 Identification of experts 166 Results of expert consultations 163 Box 4.2.1 / Process for the provision of scientific advice by JECFA 167 167 167 167 168 170 170 170 171 171

advice

Module 4.3 / Joint FAO/WHO Expert Committee on Food Additives Purpose of JECFA Committee membership JECFA evaluations Are the results of JECFA evaluations available to everyone? Module 4.4 / Joint FAO/WHO Meeting on Pesticide Residues Purpose of JMPR Committee membership JMPR evaluations Are the results of JMPR evaluations available to everyone?

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172 172 173 173 174 174 175

Module 4.5 / Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment Purpose of JEMRA Who does the work? International approach to MRA Strengths and limitations of an international approach to MRA Are the results of JEMRA meetings available to everyone? Visual aids

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Section 4

Introduction

This section provides information on the scientific basis for Codex work. It provides an overview of risk analysis within the framework of Codex, and outlines the functions of the three FAO/WHO expert committees: the Joint FAO/WHO Expert Committee on Food Additives (JECFA); the Joint FAO/WHO Meeting on Pesticide Residues (JMPR); and the Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA). It also provides information on other expert consultations and identifies how countries can request, access and contribute data to expert meetings. The process of risk analysis is fundamental to the scientific basis of Codex standards developed to protect the health of consumers. It is also due to this scientific basis that Codex is referenced by WTO as the international benchmark for food safety standards. Codex committees rely on the scientific advice provided by the expert committees and ad hoc expert consultations to develop standards. It must be understood that these expert committees and consultations are not part of the Codex Alimentarius Commission, but are independent bodies established by FAO and WHO to provide expert advice to the Codex Alimentarius Commission and its subsidiary bodies, and to Member Governments.

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Section 4

Module 4.1

Risk analysis in the framework of Codex

The purpose of this module is to introduce the concept of risk analysis as it is understood within Codex. It is not the intent of this module to provide guidance on how to carry out a risk analysis, but rather to explain what it is and define common terms.
What is risk analysis?

Within Codex, risk analysis is defined as a process consisting of three components: risk assessment, risk management and risk communication. Risk analysis is a structured, systematic process that examines the potential adverse health effect consequential to a hazard or condition of a food, and develops options for mitigating that risk. This also includes interactive communication among all interested parties involved in the process.
Is this something new?

Risk analysis is not a new process; it has existed in one form or another for centuries. The expanded globalization in food trade, coupled with the growing mobility of populations, has contributed to an increase in the complexity of food safety issues, so that todays food supply is subject to numerous hazards from different sources. This has led countries to identify methods to address food safety more effectively, and to introduce appropriate food control measures. The use of risk analysis has become the cornerstone in developing food control measures. It provides a framework to manage, assess and communicate risks effectively in cooperation with the diverse stakeholders involved, and enhances the ability of food safety regulators to develop science-based food control programmes. Risk analysis is not only applied by countries, but is also the process used by the Codex Alimentarius Commission and its subsidiary bodies in the elaboration of standards and related texts. In 1991, the FAO/WHO Conference on Food Standards, Chemicals in Food and Food Trade (Rome) recommended that all relevant Codex Committees and their advisory bodies continue to base their evaluations on suitable scientific principles and ensure necessary consistency in their risk assessment determinations. Since that time, Codex has developed principles and guidance on risk analysis for use by Codex subsidiary bodies, and is currently developing guidance on risk analysis for use by governments.
The difference between risk analysis and hazard analysis

To understand the difference between risk analysis and hazard analysis, it is important to understand the difference between risk and hazard. A hazard is the substance

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(biological, chemical or physical agent) in a food that can cause harm, i.e. an adverse health effect, while risk is an estimate of the probability of an adverse health effect occurring owing to a hazard being present, and the severity of that effect. Hazard analysis deals with specific physical, chemical or biological hazards within a narrow context, such as the potential for the hazard to enter a food at a plant/processing level. A hazard analysis is usually conducted at the plant/process level to establish a Hazard Analysis and Critical Control Point (HACCP) plan. Risk analysis. This also deals with physical, chemical or biological hazards, as well as the condition of a food. However, it does so on a broader scale. Risk analysis provides a process to collect, analyse and evaluate, systematically and transparently, relevant scientific and non-scientific information about a chemical, biological or physical hazard possibly associated with food, in order to select the best option to manage that risk based on the various alternatives identified. Risk analysis should be based on all available scientific evidence taking into account, where appropriate, other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in trade.
Risk analysis and Codex

Risk analysis evolved within the Codex Alimentarius Commission during the 1990s. In 1991, an FAO/WHO Conference on Food Standards, Chemicals in Foods and Food Trade, convened in Rome, stressed the importance of scientific committees such as JMPR and JECFA in providing evaluations based on sound science and risk assessment principles. The expert consultation recommended that FAO and WHO take steps to increase awareness of these principles. FAO and WHO subsequently convened a series of three expert consultations to address the three components of risk analysis: risk assessment, risk management and risk communication. Risk analysis is now considered an integral part of the decision-making process of Codex. The Commission has adopted definitions of risk analysis terms related to food safety, and Working principles for risk analysis for application in the framework of the Codex Alimentarius. Furthermore, in 1999, it adopted the Principles and guidelines for the conduct of microbiological risk assessment. These were developed by the Codex Committee on Food Hygiene, which is currently developing Principles and guidelines for the conduct of microbiological risk management. In addition to these developments in risk assessment, the Twenty-second Session of the Codex Alimentarius Commission requested FAO and WHO to convene an international advisory body on the microbiological aspects of food safety in order to address, in particular, microbiological risk assessments. In response to this and to follow up on their previous activities in the area of risk analysis, FAO and WHO convened an expert consultation in March 1999 which outlined a strategy and mechanism for addressing microbiological risk assessment at the international level.
Risk analysis terms used in Codex

Hazard. A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. Risk. A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.

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Risk assessment. The scientific evaluation of known or potential adverse effects resulting from human exposure to food-borne hazards. Risk assessment consists of four steps: 1. Hazard identification 2. Hazard characterization 3. Exposure assessment 4. Risk characterization Hazard identification. The identification of biological, chemical and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods. Hazard characterization. The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. For chemical agents, a doseresponse assessment1 should be performed. For biological or physical agents, a doseresponse assessment should be performed if the data are available. Exposure assessment. The qualitative and/or quantitative evaluation of the likely intake of biological, chemical and physical agents via food, as well as exposures from other sources if relevant. Risk characterization. The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment. Risk management. The process, distinct from risk assessment, of weighing policy alternatives in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers, and for the promotion of fair trade practices and, if needed, selecting appropriate prevention and control options. Risk communication. The interactive exchange of information and opinions throughout the risk analysis process concerning risks, risk-related factors and risk perception among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.
The key components of risk communication

As stated above, risk communication is an integral part of the risk analysis process. In 1998, a Joint FAO/WHO Expert Consultation on Risk Communication identified the following as key components of risk communication: know the audience; involve the scientific experts; establish expertise in communication; be a credible source of information; share responsibility;
1 A doseresponse assessment is the determination of the relationship between the magnitude of the exposure (dose) to the chemical, biological or physical agent and the severity and/or frequency of associated adverse health effects (response).

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All Codex committees, member countries and non-governmental organizations have a role and a responsibility to ensure that effective risk communication is implemented and maintained.
Conducting a risk analysis

differentiate between science and value judgement; assure transparency and put the risk in perspective.

The basic steps in conducting a risk analysis are listed below. Box 4.1.1 gives an example of the process for a specific purpose. 1. A hazard in, or condition of, a food is identified as a possible risk to health. 2. Preliminary risk management activities are carried out. Some call this risk evaluation. However, owing to confusion of the term with risk assessment, a consultation held in Kiel, Germany, in 2002 recommended use of the term preliminary risk management activities. These are activities carried out by risk managers before the evaluation of risk management options. Depending on the issue/nature of the problem to be addressed, some of all of the following actions will be undertaken: - identification of a food safety problem; - initiate immediate interim decisions; - ranking of the hazard for risk assessment if needed and risk management priority; - define purpose and scope of the risk assessment and commission a risk assessment if needed; - presentation of the risk assessment results and consideration of outputs in view of the risk managers needs. 3. A risk assessment is conducted if required (note this is usually considered in parallel with preliminary risk management activities). 4. Risk management options to address the risk are identified.

Box 4.1.1 | Risk analysis process in the context of the Codex Committee on Pesticide Residues
Hazard identification. CCPR determines a priority list of substances for evaluation. Hazard characterization/exposure assessment. JMPR is responsible for evaluating exposure to pesticides. When evaluating the intake of pesticides during its risk assessment, JMPR takes into account the 512 regional diets used to identify consumption patterns on a global scale. The 512 regional diets are used to assess the risk of chronic exposure. The acute exposure calculations are not based on those diets, but on the 97.5th percentile of consumption as provided by a selected number of countries. Risk characterization. Matching maximum residue limits (MRLs) with the acceptable daily intake (ADI) or acute reference dose (acute RfD). Evaluation of options and decision-making: risk management. CCPRs risk management recommendations (MRLs/extraneous MRLs) to the CAC are based on JMPRs quantitative risk assessments and other legitimate factors relevant to the health protection of consumers and for the promotion of fair practices in food trade. CCPRs risk management recommendations to the CAC take into account the relevant uncertainties and safety factors as described by JMPR. When referring substances to JMPR, the CCPR may also refer to a range of risk management options, with a view towards obtaining JMPRs guidance on the attendant risks and the likely risk reductions associated with each option (see Hazard identification above).

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5. The options are evaluated and a decision is made as to which option is the most appropriate, including the option to take no action. 6. The risk management option is implemented. 7. The decision is monitored and reviewed to verify that the selected risk management option is effective. 8. Throughout the process, iterative communication among all interested parties (risk assessors, risk managers, consumers, industry, etc.) is implemented and maintained.
The principles of food safety risk assessment

Recognizing the importance of risk assessment in the elaboration of its standards, Codex adopted four principles for food safety risk assessment, which have been written into the Codex Procedural Manual.
Principle 1. Health and safety aspects of Codex decisions and recommendations should be based on a risk assessment, as appropriate to the circumstances. Principle 2. Food safety risk assessment should be soundly based on science, should incorporate the four steps of the risk assessment process, and should be documented in a transparent manner. Principle 3. There should be a functional separation of risk assessment and risk management, while recognizing that some interactions are essential for a pragmatic approach. Principle 4. Risk assessments should use available quantitative information to the greatest extent possible, and risk characterizations should be presented in a readily understandable and useful form.
The principles of food safety risk analysis

Furthermore, at its Twenty-sixth Session in 2003, the Codex Alimentarius Commission adopted Working principles for risk analysis for application in the framework of the Codex Alimentarius. Their objective is to provide guidance to Codex subsidiary bodies and FAO/WHO expert bodies and consultations, so that food safety and health aspects of Codex standards and related texts are based on risk analysis.
Provision of risk assessment/scientific advice

The scientific basis for risk analysis is essential and, at the international level, scientific advice is provided by FAO and WHO through expert committees or ad hoc expert consultations. Often, this scientific input is provided direct into the Codex decisionmaking process. An example of one of the expert committees is the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Advice from JECFA is considered by CCFAC and CCRVDF in their standard-setting activities. This expert committee is responsible for providing scientific advice on: food additives contaminants residues of veterinary drugs in foods.

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The following modules outline in more detail the provision of scientific advice and the role of the FAO/WHO expert committees.
FAO/WHO risk analysis training package

FAO and WHO are finalizing a training package to provide practical guidance on the application of risk analysis. This package will provide relevant background information and guidance for national regulators and other officials to assist in their capacity-building efforts.

Reference material

FAO/WHO. 1995. Application of risk analysis to food standards issues. Report of a Joint FAO/WHO Expert Consultation, Geneva, Switzerland, 1317 March 1995. Rome. FAO/WHO. 1997. Risk management and food safety. Report of a Joint FAO/WHO Expert Consultation, Rome, Italy, 2731 January 1997. Rome. FAO/WHO. 1998. The application of risk communication in food standards and safety matters. Report of a Joint FAO/WHO Expert Consultation, Rome, Italy, 26 February 1998. Rome. FAO/WHO. 1999. Risk assessment of microbiological hazards in foods. Report of a Joint FAO/WHO Expert Consultation, Geneva, Switzerland, 1519 March 1999. Rome. FAO/WHO. 2002. Principles and guidelines for incorporating microbiological risk assessment in the development of food safety standards, guidelines and related texts. Report of a Joint FAO/WHO Consultation, Kiel, Germany, 1822 March 2002. Rome. FAO/WHO. 2004. Codex Alimentarius Commission Procedural Manual. 14th edition, pp. 4547 and 101107. Joint FAO/WHO Food Standards Programme, Rome. Codex Web site: www.codexalimentarius.net

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Section 4

Module 4.2

Requesting, accessing and contributing to expert scientific advice

The provision of scientific advice is fundamental to the development of Codex standards. The scientific advice that the Commission and its subsidiary bodies utilize to elaborate standards is provided by FAO/WHO expert committees and ad hoc expert consultations. Modules 4.3, 4.4 and 4.5 provide more detailed information on the specific operations of the expert committees, i.e. JECFA (4.3), JMPR (4.4) and JEMRA (4.5). However, there are also ad hoc expert consultations convened by FAO and WHO to address specific issues. Examples include the series of ad hoc expert consultations on foods derived from biotechnology. This module provides information on the process for providing scientific advice, how countries can contribute data to expert committees/consultations, how they can access the results of the consultations, and how they can request expert consultations on issues relevant to them.
Expert bodies/ad hoc consultations

Scientific advice is provided through different mechanisms. These range from formally established expert bodies that have a scheduled programme of work, through a series of ongoing ad hoc meetings on a given topic, to ad hoc expert consultations that are convened once only to address a specific topic. Whether it is an expert committee meeting or an ad hoc consultation, the work is carried out by a group of experts selected to work in their personal capacity and not as representatives of their country, or of the institution by which they may be employed. In appointing experts, FAO and WHO consider the scientific and technical excellence, diversity and complementarity of scientific backgrounds and opinions, and geographical and gender balance. The exact membership of the group will depend on the nature of the expert advice required, but may often include representatives of the natural sciences chemists, biologists, toxicologists, public health specialists, etc. as well as experts from other fields such as the social sciences. The purpose of these ad hoc expert consultations is to provide FAO, WHO and their member countries with scientific advice on the basis of available scientific data, and taking into consideration work done by national authorities, FAO, WHO and other international organizations, and the deliberations of other relevant international fora. Meetings and correspondence are generally carried out in the English language only. A series of joint FAO/WHO expert consultations were held in 2000 and 2001 to address the safety of food derived from biotechnology and to provide a scientific basis for the work of the Codex Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology. The first consultation discussed overall safety aspects of food derived from plants that have been genetically modified using recombinant DNA techniques and

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Box 4.2.1 | Process for the provision of scientific advice by JECFA

Codex Codex Alimentarius Alimentarius Commission msdamdsmasa Codex Statutes Alimentarius and guidelines msdamdsmasa

Codex Issues Alimentarius and priorities msdamdsmasa

Codex Call for data Alimentarius msdamdsmasa

MEETING MEETING OF JECFA OF JECFA

Codex Results and Alimentarius publications msdamdsmasa

FAO, WHO Codex member Alimentarius countries msdamdsmasa

Codex Call for experts Alimentarius msdamdsmasa

Codex Roster Alimentarius of experts msdamdsmasa

recognized that a comparative approach was useful, focusing on the similarities and differences between the genetically modified food and its conventional counterpart. The second consultation addressed the specific issue of allergenicity, and introduced a new approach for the assessment of allergenicity of genetically modified foods based on a decision tree system. The third consultation considered safety assessment of foods derived from genetically modified micro-organisms. Other such ad hoc expert consultations are conducted at the request of FAO and WHO Member Governments or of the Codex Alimentarius Commission, having regard for the FAO/WHO budgets.
Can a country request a risk assessment?

Member countries can request FAO/WHO to conduct a risk assessment of a substance of interest to them, either through an expert committee or an expert consultation. The ability of FAO and WHO to respond to such a request is, of course, dependent on a number of issues such as prioritization criteria and available budget. Although countries can submit their request direct to the appropriate secretariat, they can also work within Codex to have the appropriate Codex committee refer the request to FAO/WHO. This would be a preferred approach for countries to follow, since committees such as CCFAC establish a priority list of substances for JECFA to review. If a substance identified by a country is on the list, its chances of being evaluated are enhanced. When a country makes a request for a substance to be evaluated or for the establishment of an ad hoc expert consultation, it must make a commitment to provide the necessary data in advance of the meeting, usually at least six to seven months before the meeting takes place. Similarly, requests for advice on microbiological hazards in foods, foods derived from biotechnology or other issues can be made in this way.
Submission of data to the expert bodies How can my country contribute data to an expert consultation?

Box 4.2.1 depicts the work of JECFA. Although it illustrates the process for the provision of scientific advice by JECFA, the process is the same for the other FAO/WHO expert bodies and ad hoc consultations.

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Call for data

As can be seen from Box 4.2.1, the first step in the provision of scientific advice is the identification and prioritization of issues. Issues to be examined by an expert body can be raised through the Codex Alimentarius Commission or by member countries of FAO and WHO. It is necessary to put out a call for data to facilitate the evaluation of the identified substances. Frequently, particularly for additives and residues of veterinary drugs and pesticides, it is often industry that provides toxicological data as well as other data related to use. In other cases, national data can be provided by regulatory agencies or scientific institutes as a basis for work on an international risk assessment for example, the FAO/WHO risk assessment work on Campylobacter in poultry was based on national risk assessments provided by Canada, Denmark, the Netherlands and the United Kingdom. A request for data is made through a letter issued through Codex Contact Points, and is also posted on the relevant Web sites. It is important to adhere to the deadlines identified in the calls for data. When a sponsor makes available unpublished proprietary data for evaluation, the joint secretary and experts1 will safeguard the data from unauthorized disclosure. Experts are required to acknowledge that they accept these conditions. When the data are no longer needed, the joint secretary and experts will either return the data files to the submitter at his/her expense or will destroy them, depending upon the data submitters wishes. Those submitting data are requested to inform the joint secretary and experts at the time that they submit them whether or not they wish to have the data returned. In the absence of guidance, the data will be destroyed. Efforts are ongoing to ensure the reliability of data, and that data from different geographical regions are used as a basis for the preparation of FAO/WHO scientific advice. More specific information on data submission for the expert committees is given below.
Joint FAO/WHO Expert Committee on Food Additives

The work of the standing expert bodies is scheduled well in advance. For example, CCFAC and CCRVDF establish priority lists that are submitted to FAO/WHO and the appropriate expert bodies. These bodies prioritize their work, taking the submissions from the Codex committees into consideration. Submissions from member countries are also taken into account. The agendas of JECFA meetings are decided by the FAO and WHO joint secretaries, based on the priority list proposed by CCFAC and CCRVDF, respectively. Consideration is also given to any requests received direct from member countries, or the views of the joint secretaries themselves. Once the issues have been identified and prioritized, there is a call for data. For example for JECFA, the joint secretariat issues a call for data on the food additives and contaminants on the agenda 1012 months before the meeting, which is posted on the FAO and WHO Web sites and sent to Codex and other contact points. The deadline for submission of data is normally six to seven months before the meeting. The late submission of data may result in the postponement of the evaluation to a future meeting. Before inclusion of a substance on an agenda for the first time, the JECFA secretariat will have received a positive indication that there will be one or more submitters of data for the evaluation, or that the data are available from other sources such as a government organization or the published literature. For substances that are being re-evaluated, for example those that have a temporary acceptable daily intake (ADI), the secretariat
1

Experts are referred to as temporary advisers by WHO, while they are known as FAO consultants in the FAO system.

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assumes that the sponsor of the original evaluation will be providing the necessary data unless informed otherwise. The JECFA secretariat sometimes receives requests to include substances on the agenda after the initial call for data has been issued. Such requests are considered in the light of (a) the time schedule of the meeting and (b) whether addition of the item on the agenda is urgent. Such late requests are generally discouraged, as publication of a supplementary call for data is not desirable unless it is an emergency situation. Usually the substance will be placed on the agenda of a later meeting.
Joint FAO/WHO Meeting on Pesticide Residues

For JMPR, the agendas of the meetings are decided by the FAO and WHO joint secretaries, based on the priority list proposed by CCPR and approved by the Commission, and on the information on availability of sufficient data for evaluation. JMPR consists of two panels the FAO Panel of Experts on Residues in Food and the Environment and the WHO Core Assessment Group. Member countries, industry and other data submitters are requested to submit all relevant published and unpublished data that are available on the pesticides on the agenda to the appropriate panel for consideration. The FAO panel reviews all relevant information on identity, metabolism and environmental fate, methods of residue analysis, use patterns (registered and officially authorized uses), supervised residue trials, farm animal feeding studies, fate of residues in storage and processing, residues in food in commerce or at consumption, and national maximum residue limits. The WHO panel reviews all toxicological data and establishes an ADI and acute reference dose (ARfD). JMPR communicates to CCPR the magnitude and source of uncertainties in its risk assessments. When communicating this information, JMPR provides the CCPR with a description of the methodology and procedures by which JMPR estimates any uncertainty in its risk assessment. In both instances, FAO/WHO experts selected for a given session of JMPR prepare working papers in the form of summaries of the data, and an evaluation in time for distribution and review before the meeting. The companies submitting the data will be advised of the name and contact details of the scientist assigned to prepare the evaluation of their data. The joint FAO/WHO secretariat will ensure that the FAO and WHO experts working on the same data sets will work together on cross-cutting issues relating to toxicology and residues.
Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment

In the case of JEMRA, the request for data is to collate as much information as possible from all over the world relevant to the microbiological risk assessment of the particular pathogen-commodity combination. The agendas of meetings are based on requests from relevant Codex committees, including CCFH and CCFFP. Governments, interested organizations, food producers/processors, academia and individuals are invited to submit risk assessments as well as any other relevant information relating to risk assessment of specific pathogen-commodity combinations. The risk assessments or the data may be published or unpublished. Reference should be made to related published studies, where applicable. A risk assessment could be quantitative or qualitative, and not necessarily completed. Receipt of national or regional risk assessments and related data is very important in ensuring the success and the provision of expert advice on risk assessment of microbiological hazards in foods at the international level.

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Identification of experts

The quality of scientific advice provided by the expert bodies relies upon the expertise and experience of the experts who prepare for and participate in the meetings. In establishing scientific groups, FAO/WHO take into account the need for adequate representation of different trends of thought, approaches and practical experience in various parts of the world, as well as appropriate interdisciplinary balance. In the selection process, account is also taken of the desirability of achieving gender balance and geographical distribution. Applications for consideration as an expert are open to all, as the call for experts is normally posted on the FAO and WHO Web sites and can also be circulated through Codex Contact Points. In some cases FAO/WHO will issue targeted calls for experts when they know that a certain country has expertise, especially when the concern is a new emerging issue and expertise may not be globally available. Experts are selected to serve on an expert body on the basis of their expertise. A balance of scientific expertise and other experience is considered essential, and therefore experts in other disciplines may also be included as members of an expert body. It should be remembered that experts are selected to work for the duration of a specific meeting. For the standing expert bodies, a roster of experts is maintained, from which experts are selected. In all cases, the names of the experts selected to serve on an expert body will be made public, including their affiliation. Experts selected to serve on an expert body will be required to declare any potential conflicts of interest.
Results of expert consultations

Results of the expert consultations or evaluations by the expert committees are published in the relevant FAO or WHO publication, and are also posted on the FAO and WHO Web sites. JECFA: http://www.codexalimentarius.net/jecfa.stm JMPR: http://www.codexalimentarius.net/jmpr.stm JEMRA: http://www.codexalimentarius.net/jemra.stm

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Module 4.3

Joint FAO/WHO Expert Committee on Food Additives

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is an international expert scientific committee that is administered jointly by FAO and WHO and has been meeting since 1956. It normally meets twice a year, with individual agendas covering either (i) food additives, contaminants and naturally occurring toxicants in food; or (ii) residues of veterinary drugs in food.
Purpose of JECFA

JECFA serves as a scientific advisory body to FAO, WHO, FAO and WHO Member Governments, and to the Codex Alimentarius Commission. Advice to Codex on food additives, contaminants and naturally occurring toxicants is normally provided via CCFAC, and advice on residues of veterinary drugs via CCRVDF. All countries need to have access to reliable risk assessments of chemicals in food, but relatively few have the expertise and funds available to carry out separate risk assessments on large numbers of chemicals. JECFA performs a vital function in providing a reliable source of expert advice, and some countries use information from JECFA in formulating their own regulatory programmes. In the same way, CCFAC and CCRVDF develop standards for chemicals in food based on JECFA evaluations.
Committee membership

The membership of the meetings varies according to the agenda (i.e. additives or veterinary drugs), with different sets of experts being called on depending on the subject matter. FAO and WHO have complementary functions in selecting members for JECFA. FAO is responsible for selecting members to deal with the development of specifications for the identity and purity of food additives and the assessment of residue levels of veterinary drugs in food. WHO is responsible for selecting members to deal with the toxicological evaluations of the substances under consideration. Both FAO and WHO invite members who are responsible for assessing intake. The selection of members is made only after careful consideration of the scientific credentials of the various candidates, and a balance of scientific expertise and other experience is considered essential. FAO and WHO meet the costs of experts attendance at JECFA meetings.
JECFA evaluations

For food additives, contaminants and naturally occurring toxicants, JECFA: elaborates principles for evaluating their safety;

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tolerable intakes; prepares specifications of purity for food additives; assesses intake. For residues of veterinary drugs in food, JECFA: elaborates principles for evaluating their safety; establishes ADIs and recommends MRLs; determines criteria for the appropriate methods of analysis for detecting and/or quantifying residues in food. For food additives, JECFA normally establishes ADIs on the basis of available toxicological and other relevant information. Specifications of the identity and purity are also developed for food additives, which help to ensure that the product in commerce is of appropriate quality, can be manufactured consistently and is equivalent to the material that was subjected to toxicological testing. For contaminants and naturally occurring toxicants, levels corresponding to tolerable intakes, such as the provisional maximum tolerable daily intake (PMTDI) or provisional tolerable weekly intake (PTWI), are normally established when there is an identifiable noobserved-effect level. When a no-observed-effect level cannot be identified, JECFA may provide other advice depending on the circumstances. In the case of veterinary drugs, data on good practice are evaluated, and corresponding MRLs in animal tissues, milk and/or eggs are recommended. Such MRLs are intended to provide assurance that when the drug has been used properly, the intake of residues of the drug present in food is unlikely to exceed the ADI. In addition to reviewing individual chemicals, JECFA develops general principles for assessing the safety of chemicals in food. The requirement to keep abreast of scientific disciplines requires continuing review and updating of evaluation procedures. JECFA experts are also expected to conduct extensive literature searches on substances they are considering, in addition to reviewing the information submitted by sponsors of the chemicals under review.
Are the results of JECFA evaluations available to everyone?

conducts toxicological evaluations and establishes acceptable daily intakes (ADIs) or

Yes, they are. A summary is published within a few weeks of the meeting, giving the main conclusions including details of the ADIs and MRLs that have been set. This summary is distributed in printed form and is available on the FAO and WHO Web sites. The detailed conclusions of JECFA meetings are also set out in reports published in the WHO Technical Report Series, which reflect the agreed view of the committee as a whole and describe the basis for the conclusions. In the rare event in which some members cannot accept all the conclusions, a minority report may be included as an annex. Two additional reports on toxicological and intake evaluations, and identity and purity of food additives, are published by FAO and WHO. Toxicological and intake monographs are published after the meetings in the WHO Food Additive Series (FAS). These summarize the data used in the committees risk assessments, and provide full references to the relevant literature. Most of the monographs that have been published are available on the INCHEM CD-ROM, information on which is available at the WHO Web site. Specifications for the identity and purity of food additives developed at JECFA meetings are published in the Compendium of food additive specifications (FAO Food and Nutrition Paper (FNP) No. 52 and addenda). Monographs on veterinary drug residues, which summarize the data used for recommending MRLs, are published in FNP No. 41.

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Throughout its existence, JECFA has continued to develop principles for the safety assessment of chemicals in food. To improve the consistency and quality of its decisionmaking process, the International Programme on Chemical Safety (IPCS) sponsored the publication of Environmental Health Criteria No.70, which consolidated and updated the committees principles for the safety assessment of food additives and contaminants to the mid-1980s. Principles developed since that time have been included in more recent reports. Information on JECFA is available at both the FAO and WHO Web sites (http://www.fao.org/es/ESN/jecfa/index_en.stm and http://www.who.int/ipcs/food/jecfa/ en/index.html, respectively).

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Module 4.4

Joint FAO/WHO Meeting on Pesticide Residues

The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) provides independent expert advice to FAO, WHO, member countries of FAO and WHO, and the Codex Alimentarius Commission and its subsidiary bodies. It consists of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group, and has been meeting regularly since 1963. During the meetings, the FAO Panel of Experts is responsible for reviewing residue and analytical aspects of the pesticides under consideration. This includes examining data on their metabolism, fate in the environment and use patterns, and for estimating the maximum residue levels (MRLs) that might occur as a result of the use of the pesticides according to good agricultural practices. The WHO Core Assessment Group is responsible for reviewing toxicological and related data and for estimating, where possible, acceptable daily intakes (ADIs) for humans of the pesticides under consideration and acute reference dose (acute RfD).
Purpose of JMPR

JMPR serves as a scientific advisory body to FAO and WHO, to FAO and WHO Member Governments, and to the Codex Alimentarius Commission. Advice to the Codex Alimentarius Commission on pesticides is provided via CCPR. All countries need to have access to reliable risk assessments of chemicals in food, but relatively few have the expertise and funds available to carry out separate risk assessments on large numbers of chemicals. JMPR performs a vital function in providing a reliable source of advice, and some countries use information from JMPR in formulating their own regulatory programmes. In the same way, CCPR provides advice, based on the evaluations of JMPR, on appropriate standards for pesticide residues in food. A particularly important aspect of the work of Codex committees results from the agreement that scientific, risk-based standards established by the Codex Alimentarius Commission should be employed under the terms of the SPS Agreement to address fair trade practices (see Module 2.10). Governments wishing to argue particular cases at WTO are likely, therefore, to turn increasingly to Codex and through Codex to JMPR and other scientific bodies, for advice on their own legislation.
Committee membership

FAO and WHO have complementary functions in selecting members for JMPR. FAO is responsible for selecting members to deal with residue and analytical aspects, while WHO is responsible for selecting members to deal with the toxicological evaluations of the substances under consideration. The selection of members, who serve in their individual capacities as experts, is made only after careful consideration

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of the scientific credentials of the various candidates. A balance of scientific expertise and other experience is considered essential. FAO and WHO meet the costs of experts attendance at joint meetings.
JMPR evaluations

JMPR establishes ADIs and acute RfDs on the basis of the toxicological data and related information available on the substances that are being evaluated. In addition, JMPR reviews pesticide use patterns, data on the chemistry and composition of pesticides and methods of analysis of pesticide residues, and recommends MRLs for pesticides that occur in food commodities following their use according to good agricultural practice. The potential intake of pesticide residues is compared with the ADI and acute RfD to estimate the potential dietary risks associated with the adoption of the MRLs. In recent years, the scope of the toxicological evaluations has been expanded to include assessment of other routes of exposure that are relevant for public and occupational health. In addition, some environmental hazard assessments have been performed. In addition to reviewing individual chemicals, JMPR develops general principles for assessing the safety of chemicals in food. The requirement to keep abreast of scientific disciplines requires continuing review and updating of evaluation procedures. JMPR participants are also expected to conduct extensive literature searches on substances they are considering, in addition to reviewing the information submitted by sponsors of the chemicals under review.
Are the results of JMPR evaluations available to everyone?

Yes, they are available to all FAO and WHO member countries and the Codex Alimentarius Commission, and are also posted on the FAO and WHO Web sites. The conclusions of joint meetings are summarized in reports published in the FAO Plant Production and Protection Paper series. Reports reflect the agreed view of JMPR as a whole and describe the basis for the conclusions. WHO publishes toxicological monographs after the meetings. These summarize the data used in the meetings evaluations and provide full references to the relevant literature. Most of the monographs that have been published are available on INCHEM. Residues monographs, which contain information on pesticide use patterns, data on the chemistry and composition of pesticides, methods of analysis for pesticide residues, and information on MRLs, are published in the FAO Plant Production and Protection Paper series. Throughout its existence, JMPR has continued to develop principles for the safety assessment of chemicals in food. To improve the consistency and quality of its decision-making process, the International Programme on Chemical Safety (IPCS) sponsored the publication of Environmental Health Criteria No. 104, which consolidated and updated the meetings principles for the safety assessment of pesticide residues to the late 1980s. Principles developed since that time have been included in more recent reports. A project has been initiated to update and consolidate principles for the assessment of food additives, contaminants and residues of veterinary drugs in food (by JECFA), and pesticide residues in food. Information on JMPR is available at the FAO and WHO Web sites (http://www.fao.org/ag/AGP/AGPP/Pesticid/Default.htm and http://www.who.int/ipcs/ food/jmpr/en/index.html, respectively)

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Module 4.5

Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment

In 2000, FAO and WHO expanded their activities in the area of microbiological risk assessment (MRA) to meet the increasing need for risk-based scientific advice and information, and tools to undertake MRA. As microbiological risk assessment requires a multidisciplinary approach, FAO and WHO coordinate their work in this area through JEMRA.
Purpose of JEMRA

JEMRA was established in response to requests from CCFH for scientific advice on microbiological issues. CCFH recognized that there are significant public health problems related to microbiological hazards in foods. It identified 21 pathogen-commodity combinations of concern, and prioritized these according to such criteria as the significance of the public health problem, the extent of the problem in relation to geographical distribution and international trade, and the availability of data and other information with which to conduct a risk assessment. The functions of JEMRA are: to provide sound scientific advice on microbiological issues to FAO, WHO, Codex, and FAO and WHO member countries; to address specific MRA questions from Codex committees (mainly CCFH); to develop adaptable risk assessments and data resources for countries to use in conducting their risk assessments. The activities of JEMRA can be categorized as follows: 1. Generation of scientific information risk assessments 2. Elaboration of guideline documents 3. Data collection and generation 4. Use of risk assessment within a risk management framework 5. Information and technology transfer One of the main aims of JEMRA is to provide a transparent review of scientific opinion on the state of the art of MRA, and to develop the means of achieving sound quantitative risk assessments of specific pathogen-commodity combinations. The work includes an evaluation of existing risk assessments; a review of the available data and current risk assessment methodologies, highlighting their strengths and weaknesses and how they may be applied; provision of examples; and identification of ongoing data and information needs. The following pathogen-commodity combinations are examples of the work done or ongoing up to March 2005: Salmonella spp. in broilers Salmonella enteritidis in eggs

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Listeria monocytogenes in ready-to-eat foods Campylobacter spp. in broiler chickens Vibrio spp. in seafood Enterobacter sakazakii and other micro-organisms in powdered infant formula A further aim of JEMRA is to provide guidance on how risk assessment can be effectively used by risk managers as a decision support tool. It is the risk manager who will first decide whether a risk assessment would facilitate his/her task. It is also the risk manager who will be one of the ultimate users of the outputs from the risk assessment. Therefore, assisting risk managers in understanding the risk assessment process and its scientific basis is critical to ensure optimal use of this tool.

Who does the work?

As microbiological risk assessment requires a multidisciplinary approach, implementing the programme of work of JEMRA requires the input of experts in a number of fields. FAO and WHO continually strengthen procedures for designating experts that assure the transparency, excellence and independence of the opinions delivered. Both organizations want to ensure that the pool of selected experts includes a diversity of viewpoints and includes representatives from all geographical regions of the world, including both developing and developed countries. Periodically, FAO and WHO will issue a call for experts aimed at identifying specialists in microbiology, epidemiology, mathematical modelling, public health, food technology, veterinary medicine, risk assessment and other relevant areas to participate in a variety of activities required for the provision of this scientific advice. The specialists may be involved in drafting risk assessment reports, reviewing the work of drafting groups, and/or participating in expert consultations. JEMRA usually meets twice a year with working groups being established to carry out work between meetings. Final reports are peer-reviewed before publication. Progress reports are made available while the risk assessment is ongoing.
International approach to MRA

The Commission defines risk assessment as a scientifically based process consisting of the following four steps (see Module 4.1): 1. Hazard identification 2. Hazard characterization 3. Exposure assessment 4. Risk characterization The risk assessment process is a means of providing an estimate of the probability and severity of illness attributable to a particular pathogen-commodity combination. The four-step process enables this to be carried out in a systematic manner, but the extent to which the steps are carried out will depend on the scope of the risk assessment. This can be clearly defined by the risk manager through ongoing dialogue with the risk assessor. Carrying out an MRA, particularly a quantitative MRA, is recognized as a resourceintensive task requiring a multidisciplinary approach. While MRA is becoming an important tool for assessing the risks to human health from food-borne pathogens, it is not within the capacity of many, perhaps even most, countries to carry out a complete quantitative MRA. Yet food-borne illness is one of the most widespread public health problems, creating social and economic burdens that countries need to address. Risk

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assessment is a tool that can be used in the management of the risks posed by food-borne pathogens. On the other hand, risk assessment can also be used to justify the introduction of more stringent standards for imported foods. Knowledge of MRA is therefore also important for trade purposes, and there is a need to provide countries with the tools for understanding and, if possible, carrying out MRA. This need, combined with the requests for scientific advice of the Commission and CCFH on MRA, has led FAO and WHO to undertake a programme of activities to address the issue of MRA at the international level.
Strengths and limitations of an international approach to MRA

Undertaking MRA at the international level enables the identification of areas that are similar or common to a particular region or even to all countries. It enables the identification of available data on a global scale and equally important, of the areas where knowledge and data are lacking. Undertaking this work at the international level results in the provision of valuable information on particular pathogen-commodity combinations for use by risk managers at both the national and international levels. At the national level in particular this should help facilitate optimal use of limited resources. It is important to recognize that risk assessment at the international level is substantially different from risk assessment at the national level it tends to be more generic in nature, and cannot capture local scenarios and variations between countries. Therefore, it cannot produce a globally applicable risk estimate, i.e. one risk estimate valid for all countries.
Are the results of JEMRA meetings available to everyone?

Yes, they are available to all FAO and WHO member countries and the Codex Alimentarius Commission, and are also posted on the FAO and WHO Web sites. Once finalized, an interpretive summary and technical report of each pathogencommodity combination are published in the FAO/WHO Microbiological Risk Assessment Series. To date the following titles have been published: 1. Risk assessment of Salmonella in eggs and broiler chickens. Interpretive summary. 2002. ISBN 92-5-104873-8. 2. Risk assessment of Salmonella in eggs and broiler chickens. Technical report. 2002. ISBN 92-5-104873-8. 3. Hazard characterization for pathogens in food and water guidelines. 2003. ISBN 92-5-104940-8. 4. Risk assessment of Listeria monocytogenes in ready-to-eat foods. Interpretive summary. 2004. ISBN 92-5-105126-7. 5. Risk assessment of Listeria monocytogenes in ready-to-eat foods. Technical report. 2004. ISBN 92-5-105127-6. 6. Enterobacter sakazakii and other microorganisms in powdered infant formula. Meeting report. 2004. ISBN 92-5-105164-X Further information on JEMRA is available at the FAO and WHO Web sites (http://www.fao.org/es/ESN/food/risk_mra_en.stm and http://www.who.int/foodsafety/ micro/jemra/en/, respectively).

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Publications of the World Health Organization can be obtained from: WHO Press World Health Organization, 20 Avenue Appia CH-1211 Geneva 27, Switzerland Tel.: (+41) 22 791 2476 Fax: (+41) 22 791 4857 E-mail: [email protected] or on the Internet from www.who.int/publications

Publications of the Food and Agriculture Organization of the United Nations can be ordered from: Sales and Marketing Group, Information Division Food and Agriculture Organization of the United Nations Viale delle Terme di Caracalla 00100 Rome, Italy Fax: (+39) 06 57053360 E-mail: [email protected] or on the Internet from www.fao.org/icatalog/inter-e.htm

The Codex Alimentarius Commission was established by FAO and WHO to develop international food standards, guidelines and recommendations to protect the health of consumers and to ensure fair practices in the food trade. This collection of food standards, entitled the "Codex Alimentarius", or food code, contains provisions concerning the hygienic and nutritional quality of food, including microbiological norms, food additives, pesticide and veterinary drug residues, contaminants, labelling and presentation, methods of sampling and analysis and risk analysis methodologies in food safety. They are an important reference point for consumers, food producers and processors, national food control agencies and the international food trade. The Codex Alimentarius Commission is an intergovernmental body, with member governments participating directly in standard setting, throughout the eight-step process. To ensure the relevance of Codex standards on a global scale and to enhance harmonization of standards, there is a need for broad participation from all geographical regions. This training package has been developed to enhance countries participation in the Codex process. It explains the organization and operation of Codex and the scientic basis for its work, and provides guidance on developing national Codex structures and activities. The information is presented in modules, with visual aids and practical exercises. A CD-ROM provides the visual aids in electronic format and other relevant reference materials. The training package is equally useful as a practical reference guide for those involved in Codex, but not directly involved in training.

ISBN 92-5-105277-8

789241 593496

789251 052778 TC/M/Y5884E/1/08.05/2400