Metrologimetrologi.com/Egenkontrol(Food)/The Risk Analysis Process.pdf · Final Version, January...

Final Version, January 2002

A practical Approach to the Application of The Risk Analysis Process

- Illustrated with two Examples

Caffeine and Campylobacter

Risk Management

A.Risk

• Risk perception• Value judgement• Precautionary

i i l• Benefits/costs• Other technical factors

RiskCommunication

C. Implementatiof management

1. Assessment of effectiveness fmeasures taken

2. Review risk management and / or assessment as necessary

D. Monitori and revie

B. Ris managemeoptio assessme

A brief description of the situation Product or commodity The values expected to be placed at risk , (e.g. human health , economic ) Potential consequences Consumer perception of the risks The distribution of risks and benefits

Value judgements and policychoices for the risk assessment proces

• Hazard id ifi i• Hazard h i i• Exposure

• Risk h i i

1. Identification of a food safety problem2. Establishment of a risk profile3. Ranking of the hazard for risk

assessmentand risk management priority4. Establishment of risk assessment policy

for conduct of risk 5. Commitment of ressources6. Commissioning of risk 7. Consideration of risk assessment

l

1. Identification of available management options2. Selection of preferred management option, including

consideration of an appropriate safety standard3. Final management decision Regulatory or other control

Risk Assessment

A practical Approach to the Application of The Risk Analysis Process

- Illustrated with two Examples

Caffeine and Campylobacter

By Bente Fabech, Denmark

Kari Bryhni, Norway Lars Plym Forshell, Sweden Franklin Georgsson, Iceland

Jørn Gry, Denmark Bodil Thiim Hansen, Denmark

Helena Hallström, Sweden Maija Hatakka, Finland Edel Holene, Norway

Georg Kapperud, Norway Jakob Kristinsson, Iceland

Riitta Maijala, Finland Niels L. Nielsen, Denmark Ulla Nordström, Sweden

Anna Charlotte Schultz, Denmark Cornelia Solheim, Norway

Àsmundur E. Thorkelsson, Iceland

Kolofon

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Contents

Contents .............................................................................................................................5 Preface .............................................................................................................................7 Introduction .............................................................................................................................9 Summary ...........................................................................................................................11 Samantekt ...........................................................................................................................13 Yhteenveto ...........................................................................................................................15 Resumé ...........................................................................................................................17 Risk analysis - Codex definitions .............................................................................................19 Risk analysis Terminology used in English and the Nordic languages ................................22 Abbreviations ...........................................................................................................................24 1 Risk analysis as a tool for the quality assurance of the decision-making process.....26

1.1 Risk analysis of two examples, a chemical and a microorganism................................26 1.2 The risk analysis process ..............................................................................................27

by Ib Knudsen, Danish Veterinary and Food Administration ......................................27 1.3 The need for quality management in food law administration .....................................35 1.4 Quality assurance in public food law administration. ..................................................36

by Göran Engström, National Food Administration, Sweden ......................................36 1.4.1 Quality management ..................................................................................................... 37

1.5 Other views on the need for quality control in public administration. .........................37 1.5.1 Is quality assurance needed in Public Administration?................................................. 38 1.5.2 Roles and responsibilities in the risk analysis process. ................................................. 39

2 A risk analysis model for a stepwise procedure ...........................................................42 2.1 Workshop decisions on the risk analysis procedure. ....................................................42 2.2 Proposal for a Nordic Risk Analysis model using a stepwise procedure. ....................43 2.3 Risk communication and transparency.........................................................................46

3 The risk analysis model – illustrated with caffeine and Campylobacter as examples50 3.1 Risk management – first step .......................................................................................50

3.1.1 Risk evaluation.............................................................................................................. 50 3.1.2 Identification of a food safety problem. ........................................................................ 51 3.1.3 Establishment of a risk profile. ..................................................................................... 51 3.1.4 Ranking of the hazard for risk assessment and risk management priority. ................... 52 3.1.5 Establishment of a risk assessment policy .................................................................... 52 3.1.6 Commitment of resources ............................................................................................. 52 3.1.7 Commissioning of a risk assessment............................................................................. 53 3.1.8 Risk evaluation of caffeine and Campylobacter using the model ................................. 54

3.2 Risk assessment ............................................................................................................62 3.2.1 Hazard identification..................................................................................................... 63 3.2.2 Hazard characterization................................................................................................. 69 3.2.3 Exposure assessment..................................................................................................... 74 3.2.4 Risk characterization..................................................................................................... 80 3.2.5 Consideration of the risk assessment result................................................................... 83

3.3 Risk management – further steps .................................................................................84 3.3.1 Risk management option assessment ............................................................................ 84 3.3.2 Identification of available management options ........................................................... 85 3.3.3 Selection of preferred management option. .................................................................. 87 3.3.4 Final management decision........................................................................................... 88

3.4 Implementation of the management decision...............................................................89 3.5 Monitoring and review .................................................................................................90

3.5.1 Assessment of the effectiveness of measures taken ...................................................... 90 3.5.2 Review of the risk management and/or assessment as necessary ................................. 91

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3.6 Risk communication .................................................................................................... 91 4 Conclusions and recommendations .............................................................................. 93

4.1 Conclusions.................................................................................................................. 93 4.2 Recommendations........................................................................................................ 93

5 References ....................................................................................................................... 95 Annex A - Background information for the risk analysis of caffeine ................................ 101 by Christer Andersson, National Food Administration, Sweden

Introduction ........................................................................................................................ 101 a Problems related to the risk assessment of caffeine.................................................................101 b Caffeine-containing foods and beverages ................................................................................102 c Medicinal drugs with caffeine .................................................................................................106 d Total caffeine intake ................................................................................................................107 e Absorption, distribution and degradation of methylxanthines in man .....................................107 f Pharmacological and toxicological effects of caffeine ............................................................108

Annex B – Background information for the Risk Analysis of Campylobacter. ................. 111 by Niels L. Nielsen and Hanne Rosenqvist, Danish Veterinary and Food Administration, Denmark Annex C - Risk analysis - glycyrrhizic acid in liquorice; a case story ............................... 119 by Helena Hallström, National Food Administration, Uppsala, Sweden 1. Risk assessment. ..................................................................................................................................119 2. Risk management.................................................................................................................................122 3. Risk communication ............................................................................................................................123 Conclusions .....................................................................................................................................123 Annex D-1 - D-5: Proposals for a stepwise procedure......................................................... 125 Annex E - Working methods of the workshop..................................................................... 131 Annex F - Posters from the workshop and the different Nordic countries ....................... 135 Annex F-1 - Risk assessment of zoonoses ............................................................................. 137 Annex F-2 - Risk assessment of zoonoses ............................................................................. 138 Annex F-3 - Surveillance program on thermophilic Campylobacter spp. (C. jejuni, C. coli and C. lari) in raw meat products from Danish retail outlets............................................. 139 Annex F-4 - Human Campylobacteriosis in Iceland ........................................................... 141 Annex F-5 - Campylobacter in animals and food in Iceland .............................................. 144 Annex F-6 - Campylobacter Risk Assessment....................................................................... 146 Annex F-7 - Campylobacter isolated from food and water in Norway ............................... 147 Annex F-8 - Campylobacter isolated from food and water in Norway ............................... 148 Annex F-9 - Prevalence, incidence and quantitative data related to Campylobacter in Sweden ........................................................................................................................ 149 Prevalence, incidence and quantitative data related to Campylobacter in Sweden .......... 149 Annex F-10 - Campylobacters in Finland.............................................................................. 151 Annex G - Information on caffeine ....................................................................................... 152 Annex H - Hazard Identification of zoonoses ...................................................................... 155 Annex I - List of Participants ................................................................................................ 157

Preface 7

Preface

The Nordic countries – Denmark, Finland, Iceland, Norway and Sweden – have trade agree-ments and co-operation in many areas in common. The food area is to a large extent subject to the same legal requirements in the Food Acts and in the political, democratic decision-making process. Official opinions in one country within an area will, in many cases, raise questions in the other countries. Frequently, the call for uniform interpretations or decisions is brought forward, especially when the decisions and opinions within a certain area deviate from one another.

The Nordic countries have a long tradition of co-operation in the area of food safety as well as in many other areas. Furthermore, these countries have similarities in the Food Laws and in many of the administrative traditions. With Denmark, Finland and Sweden being members of the European Union (EU), and Iceland and Norway being associated through the European Economic Agreement (EEA) the corporation is still of importance, and the subject of risk analysis was dealt with in a project group under the Nordic Council of Ministers.

These years, a request for transparency and openness is often made by the politicians, consu-mers, media etc., both nationally and in international fora. On food safety issues, the request for transparency has become of high priority both due to the growth in international trade and the WTO agreement (world Trade Organisation). This has put pressure on national authorities for uniform legislation or interpretation of international legislation or guidelines in order to achieve fair competition, as well as appropriate levels of consumer protection. Consumers are highly aware of food safety issues, they are well educated and do require a solid basis for choices. Also the responsible politicians have the interest in a proper, science-based decision-making process.

Quality assurance in public administration has always been a demand. However, as the amount of information and knowledge seems to be growing exponentially and the demands for transparency and participation in the public debate require more and more resources from public administrations, quality assurance becomes even more important.

WHO/FAO initiated the development of the risk analysis process some years ago, and they have arranged many expert consultations etc. on the subject. Many definitions have been adopted on the individual terms used for the steps in the process. The risk analysis process has come on the agenda in the national and international administrations and many other places as principles. However, the uses in practice of the risk analysis process, as a stepwise quality assurance pro-cess has not been examined in details. Under the Nordic Council of Ministers, a decision was made in an attempt to work in practice with the process on two examples, caffeine and Campylobacter. The two examples were chosen because of their nature, caffeine being a chemical component both used as an additive and found as a natural component of traditionally used food items and Campylobacter being a micro-organism which is found widespread in nature and in food. These two subjects should not only provide the basis for the practical testing of the risk analysis process, but also the basis for testing the process on different types of food safety risks. Comparisons can be made between the guidelines on test requirements, regulations, traditions etc. in the areas of chemical components and microorganisms.

Preface 8

This report has been worked out by the following working group:

Denmark Bente Fabech (project leader), Jørn Gry, Bodil Thiim Hansen, Niels L. Nielsen, and Anna Charlotte Schultz, the Danish Veterinary and Food Administration

Finland Riitta Maijala, National Veterinary and Research Institute and Maija Hatakka, National Food Administration.

Iceland Franklin Georgsson, Àsmundur E. Thorkelsson, Environmental & Food Agency of Iceland, and Jakob Kristinsson, University of Iceland, Institute of Pharmacy, Pharmacology and Toxicology

Norway Kari Bryhni and Cornelia Solheim, Norwegian Food Control Authority, Georg Kapperud and Edel Holene, Norwegian Veterinary University

Sweden Lars Plym Forshell, Helena Hallström and Ulla Nordström, National Food Admi-nistration

Bente Fabech has directed the project. Layout, text processing and correction of the English language was carried out by Anne Tilling, and the figures and posters for the workshop and the report are made by Asger Johansen, both the Danish Veterinary and Food Administration, and by participants from the individual Nordic countries. Furthermore, the project group would like to thank Helga Odden Reksnes, Norwegian Food Research Institute, Norway for comments given on the Nordic Seminar on Risk Acceptance and Risk Communication, June 2001, on parts of the Nordic Risk Analysis project seen through risk communication glasses.

This report has been discussed and approved in the Joint Nordic Working Group on Food Toxi-cology (NNT) and sponsored by the Nordic Committee of Senior Officials for Food Issues under the Nordic Council of Ministers.

Introduction 9

Introduction

Risk analysis has been made whenever humans (and animals) have selected food. Fruits, vegeta-bles etc. have been gathered in the nature, evaluated and decided on as suitable or not for human nutrition. Experience on what could or could not be eaten, or which items could be eaten after special treatment has been passed on from parents to children in the daily life selection and preparation of food in the homes.

In the modern society, many people live in big cities, and the knowledge of food and handling of potential risks in food is getting poorer for the individual consumers, while on the other hand, knowledge on food and safety issues is increasing tremendously. As to the risk that people meet in their everyday life, a difference can be shown between the levels of risk that they can accept. For instance they may accept the risk by lifestyle factors like alcohol and tobacco, and certain nutrients like fat – but they do not accept the risks that they find themselves exposed to and which they do not have direct influence on, like nuclear power plants. These days, when the food production mainly takes place in the industry, many consumers feel insecure and may think that the food is not safe. Many processes are unfamiliar or unknown to them, the food may not be like “grandma made it”, and food safety certainly has become a subject for debate in the Nordic countries. A published risk analysis process might provide a more transparent evaluation and make the decision-making on food safety better understood by more people, so that the risk seems comparatively minor.

At the same time, the international trade increases and thereby also the demand for a harmo-nised, transparent global approach to risk analysis. This is described in connection with the WTO and SPS agreements, e.g.:

“Hence, each Member of the WTO has the independent right to determine the level of environ-mental or health protection they consider appropriate. Consequently, a member may apply mea-sures, ... although the general rule is that all sanitary and phytosanitary measures must be based on scientific principles and that they should not be maintained without adequate scientific evidence, a derogation from these principles is provided for in Article 5 (7) which stipulates that: “in cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time.

Hence, according to the SPS Agreement, measures adopted in the application of a precautionary principle when the scientific data are inadequate, are provisional and imply that efforts be undertaken to elicit or generate the necessary scientific data. It is important to stress that the provisional nature is not bound up with a time limit but with the development of scientific knowledge.”

The SPS Agreement includes the risk assessment

“The concept of risk assessment in the SPS leaves leeway for interpretation of what could be used as a basis for a precautionary approach. The risk assessment on which a measure is based may include non-quantifiable data of a factual or qualitative nature and is not uniquely confined to purely quantitative scientific data. This interpretation has been confirmed by the WTO’s Appellate body in the case of growth hormones, which rejected the panel’s initial interpretation that the risk assessment had to be quantitative and had to establish a minimum degree of risk.”

Introduction 10

The above quotations includes a discussion on who should evaluate or assess safety, how should other legitimate factors than safety be included – or should this be an individual responsibility based on available knowledge? Furthermore, the question about who should and who can take responsibility in these questions does come up.

The risk analysis process has been discussed in principle. Furthermore, definitions on several of the individual steps has been elaborated in Codex Alimentarius, and in the present report the risk analysis process is being used in practice, as a stepwise procedure and a structured approach for the analysis of two safety risks in food. These two examples have been chosen in order to try to exchange knowledge in two different areas of risk: chemicals and microorganisms. Available guidelines or international Codes of Practice are different, normally the available amount and nature of scientific data are different and the management options would normally also be diffe-rent. Caffeine and Campylobacter have been chosen for this exercise. Caffeine being a food additive but also a naturally occurring toxicant found in normally accepted and used foods like coffee and tea, Campylobacter a widespread microorganism in the nature and a common cause of food-borne infections in humans. The examples given are also chosen because of a certain degree of similarity in the natural occurrence. Furthermore, the examples have been chosen due to differences in the risk assessment procedure for chemicals and for microorganisms and in the available options in the risk management.

Summary 11

Summary

Humans have made risk analysis for thousands of years. During the last decades, discussions of a formalized risk analysis process have been going on in international and national fora.

The principles on which steps there should be in the risk analysis process of food safety issues have been discussed and definitions on the individual steps have been elaborated in Codex Alimentarius. The functionality of the formalized risk analysis in practice - as a stepwise proce-dure - has, however, not been discussed in details internationally. The Nordic countries, Den-mark, Finland, Iceland, Norway and Sweden decided to work together with actual food safety issues, caffeine and Campylobacter on this topic with the experience from the National administrations. As part of the project, risk analysis was discussed in a workshop with participants from the five Nordic countries. The participants included administrators, toxicologists, microbiologists, epidemiologists, communication experts and consumer represen-tatives. Knowledge of the different steps in the risk analysis of chemicals and microorganisms was represented in order to obtain the benefits from the exchange of knowledge between the two different areas. The workshop approached the risk analysis process as a process for quality assurance in the decision-making process and how the process should run as a stepwise procedure in reality. Participants from each country elaborated a proposal for risk analysis as a stepwise procedure, discussed the proposed solutions and concluded that in principle they were similar. Based upon the discussions, they chose one model as appropriate to be used on the selected examples, caffeine and Campylobacter.

In this process and in this report, the risk analysis process is being used in practice as a stepwise procedure and a structured approach for the analysis of two safety risks in food. The two examples that are chosen as examples, caffeine and Campylobacter, were chosen in order to try to exchange knowledge between two different areas of risk: chemicals and microorganisms. Caffeine being a food additive but also a naturally occurring toxicant found in foods like coffee and tea, and Campylobacter being a widespread microorganism in the nature. There is though a certain degree of similarity in the natural occurrence.

Available guidelines or international Codes of Practice for chemicals and for microorganisms differ, normally the amount and nature of available scientific data is different and the manage-ment options are normally different, too.

The risk analysis of these two substances is supposed to provide a model for a quality assured process to be used in public food administration.

Based on the results from the workshop, the Nordic project group concluded that a stepwise risk analysis procedure must start in the risk management part of the process with a risk evaluation. The risk evaluation should include the identification of safety problems, the establishment of a risk profile, commitment of resources, formulation of a risk assessment policy etc.

The next step in the procedure needs to be the risk assessment, including all four steps. The conclusions of the risk assessment are supposed to form the basis for decisions at the next step, risk management, including the identification of management options, selection of the preferred option and final decision.

The Nordic group discussed the responsibility of the evaluations and decision-making on the individual steps, and the conclusion was that many of the steps will involve decisions made not only by scientists but by administrators and the responsible politicians as well. The Nordic project group concluded that even in the risk assessment part of the process, there are decisions that are more of a political nature than scientific evaluations, even though the scientist should be

Summary 12

responsible for the elaboration of the scientific basis for the decisions. Risk managers should be responsible for the inclusion of issues like safety factors, protection levels etc. in the risk assessment policy under the risk evaluation step.

In the discussion of the background documentation for the evaluation and decision-making, it is obvious that work needs to be done to standardize the requirements, test models etc. in some of the steps. The two examples chosen clearly demonstrate that in some areas, the test models, demand for documentation etc. are standardized through internationally accepted guidelines, while other areas would benefit from having established internationally standardized requirements, test models etc.

Concerning the risk communication part of the risk analysis procedure, the Nordic project group agreed that communication should be part of all the steps. Preferably, the information should be available to the public on all steps, e.g. on the Internet, in order to have an open and transparent risk analysis process. The risk analysis should furthermore include more proactive communication through the media.

The goals for the project were to evaluate the risk analysis process as a quality assurance pro-cess to be used by decision-makers on food safety issues in practice. This should include an evaluation of who could be responsible for the decisions made in each step. The responsible may be any stakeholder like a politician, a scientist, an administrator, the industry or the consu-mers. The project group found that the risk analysis process would be an excellent tool for this purpose. A more systematic approach to risk analysis would improve the transparency and openness of the process and would be likely to improve the confidence in the final decision.

In conclusion, the Nordic project group recommend that the risk analysis process is used as a quality assurance procedure (or in-house control) in public administration and elsewhere, when conducting the evaluation of risks.

The risk analysis process needs to be discussed and developed further in the national admi-nistrations in order to create a functional procedure for the individual administrations or others using the risk analysis.

Samantekt 13

Samantekt

Menn hafa stundað áhættugreiningu í þúsundir ára. Á síðustu áratugum hafa umræður um fastmótaða áhættugreiningarferla átt sér stað á landsvísu og á alþjóðlegum vettvangi.

Umræður hafa átt sé stað um hvaða grundvallareglur eigi við um áhættugreiningarferla er varða öryggi matvæla og skilgreiningar fyrir einstaka þrep hafa verið ákvarðaðar af Alþjóða Staðlaskrárráðinu. Notkun fastmótaðrar áhættugreiningar í áföngum hefur aftur á móti ekki verið rædd í smáatriðum á alþjóðlegum vettvangi. Norðurlöndin, þ.e. Danmörk, Finnland, Ísland, Noregur og Svíþjóð ákváðu að eiga samstarf á þessu sviði um raunveruleg málefni er snerta öryggi matvæla, þ.e. koffín og Campylobacter, þar sem stuðst er við þá reynslu sem til staðar er hjá stjórnsýslu- og eftirlitsstofnunum landanna. Hluti af verkefninu var að ræða á vinnufundi áhættugreiningu með þátttaken-dum frá öllum fimm Norðurlöndunum. Meðal þátttakenda voru stjórnendur, eiturefna-fræðingar, örverufræðingar, faraldsfræðingar, sérfræðingar í fjölmiðlun og fulltrúar neytenda. Upplýsingar voru kynntar um mismunandi áfanga áhættugreiningar á efnum og örverum með það að markmiði að hafa gagn af upplýsingaskiptum milli þessara mismunandi sviða. Á vinnufundinum var rætt um áhættugreiningaferlið sem aðferð við gæðatryggingu í tengslum við ákvörðunartöku og hvernig áhættugreiningin þyrfti í raun að ganga fyrir sig í áföngum. Þátttakendur frá hverju landi settu saman tillögu um áhættugreiningu í áföngum, ræddu tillögurnar og ályktuðu að þær væru í megin atriðum svipaðar. Í framhaldi af umræðunum valdi vinnufundurinn eina tillögu sem þótti viðeigandi til að nota við áhættugreiningu á koffíni og Campylobacter.

Við þessa vinnu og í þessari skýrslu er áhættugreiningaferlið í raun notað sem áfangabundin aðferð og skipulögð nálgun til að greina tvo áhættuþætti í matvælum. Dæmin sem hér eru valin eru koffín og Campylobacter, valin með það að markmiði að prófa að skiptast á upplýsingum milli ólíkra áhættusviða, þ.e. efna og örvera. Koffín er efnasamband en einnig náttúrulegt eiturefni sem finnst í matvælum eins og kaffi og te, og Campylobacter er örvera sem finnst víða í náttúrunni. Það er þó ákveðinn sameinkenni í náttúrulegri tilvist þessara áhættuþátta.

Aðgengilegar leiðbeiningar eða alþjóðlegar lagareglur fyrir efni og örverur eru mismu-nandi. Yfirleitt er magn og eðli aðgengilegra vísindagagna mismunandi og einnig eru valkostir stjórnenda mismunandi hvað varðar íhlutandi aðgerðir.

Áhættugreiningu fyrir þessa tvo þætti er ætlað að útvega fyrirmynd að gæðatryggðum ferli sem hægt verður að nota í almennu matvælaeftirliti.

Með útgangspunkti í niðurstöðum vinnunefndarinnar, ályktaði norræni verkefnastýri-hópurinn að áfangabundinn áhættugreiningarferill verði að hefjast í áhættustjór-nunarhluta ferilsins með áhættuskoðun. Áhættuskoðunin ætti að felast í greiningu öryggisvandamála, gerð áhættulýsingar, fjármögnun, framsetningu gæðamatsstefnu o.s.fr.

Næsti áfangi í ferlinum þarf að vera áhættumatið með sínum fjórum undiráföngum. Gert er ráð fyrir að niðurstöður úr áhættumatinu skapi grundvöll til ákvörðunartöku í næsta áfanga, þ.e. við áhættustjórnun og þá m.a. við greiningu á mögulegum valköstum stjórnenda, vali á bestu úrlausn og lokaákvörðun.

Samantekt 14

Norræni verkefnastýrihópurinn ræddi ábyrgð á áhættuskoðun og ákvarðanatöku í hverjum áfanga og komst að þeirri niðurstöðu að í mörgum áfanganna þyrftu bæði vísindamenn, stjórnsýslan og stjórnmálamenn að koma að málum. Í niðurstöðu hópsins kom fram að jafnvel á áhættumatsstigi væri um að ræða ákvarðanir sem væru pólitískar fremur en vísindalegar enda þótt vísindamenn ættu að bera ábyrgð á hinum vísindalega grunni ákvarðanatöku. Á áhættuskoðunarstigi eiga stjórnendur að bera ábyrgð á því að sé tekið tillit til þátta sem eru hluti af áhættumati, svo sem öryggismála, neytendaverndar o.s.frv..

Í umræðum um þau grunngögn sem safna þarf fyrir áhættuskoðun og ákvarðanatöku kom fram að í sumum áfanganna þarf augljóslega að leggja vinnu í að samræma kröfur og útbúa vinnulíkön o.s. frv. Til eru alþjóðlega viðurkenndar leiðbeiningar fyrir sum svið innan þeirra tveggja fyrirmynda sem valdar voru og fyrir önnur svið væru slíkar samræmdar alþjóðlegar kröfur til bóta.

Norræni verkefnastýrihópurinn var sammála um að áhættukynning eigi að fara fram í öllum áföngum áhættugreiningar. Æskilegast væri að upplýsingar væru aðgengilegar fyrir almenning í öllum áföngum, t.d. á netinu, þannig að áhættugreiningin væri opin og gagnsæ. Einnig ætti að fara fram virk upplýsingagjöf í fjölmiðlum.

Markmið norræna verkefnisins var að meta hvort áhættugreiningarferlið gæti nýst sem gæðatryggingakerfi fyrir þá sem taka ákvarðanir varðandi öryggi matvæla. Í ferlinu ætti m.a. að felast mat á því hver á að vera ábyrgur fyrir ákvarðanatöku í hverjum áfanga. Ábyrgur aðili gæti verið hvaða hagsmunaaðili sem er, t.d. stjórnmálamaður, vísindamaður, embættismaður, iðnaðurinn eða neytendur. Niðurstaða norræna verkefnastýrihópsins var sú að áhættugreiningarferlið væri ágætlega til þess fallið að þjóna þessum tilgangi. Því skipulegri nálgun sem beitt væri í áhættugreiningu þeim mun gagnsærri yrði hún og þeim mun meiri líkur væru á að lokaákvörðun nyti trausts.

Lokaniðurstaða norræna verkefnastýrihópsins var að mæla með áhættugreiningu sem gæðatryggingatæki (eða innra eftirliti) við áhættuskoðun, bæði í stjórnsýslu og annars staðar.

Þörf er á að ræða og þróa áhættugreiningu frekar í innlendri stjórnsýslu með það að markmiði að koma á virku ferli fyrir einstakar stjórnsýslueiningar eða aðra sem þurfa að beita áhættugreiningu.

Yhteenveto 15

Yhteenveto

Ihminen on käyttänyt hyväkseen riskianalyysiä jo tuhansia vuosia. Viimeisten vuosikymmenten aikana on keskusteltu järjestelmällisestä riskianalyysistä sekä kansainvälisesti että kansallisesti.

Periaatekeskustelua on käyty siitä, mitä eri vaiheita elintarviketurvallisuuskysymyksissä sovellettavaan riskianalyysiin tulisi sisältyä. Codex Alimentarius on laatinut tarkat määritelmät riskianalyysin eri vaiheille. Kansainvälisellä tasolla ei kuitenkaan ole pohdittu yksityiskohtaisesti sitä, kuinka järjestelmällinen riskianalyysi vaiheittaisena prosessina toimii käytännössä. Siksi Pohjoismaat (Tanska, Suomi, Islanti, Norja ja Ruotsi) päättivät kansallisten hallintovirkamiesten kokemusten pohjalta selvittää tätä kahden elintarvikekysymyksen, kofeiinin ja kampylobakteerin, avulla. Osana tätä projektia järjestettiin riskianalyysiseminaari, jossa oli osanottajia kaikista viidestä Pohjoismaasta; virkamiehiä, toksikologeja, mikrobiologeja, epidemiologeja, tiedottajia ja kuluttajien edustajia. Seminaarissa esiteltiin kemiallisten aineiden ja mikro-organismien riskianalyysin eri vaiheista saatua tietoa, jotta näiden kahden eri alueen kokemuksia voitiin verrata keskenään. Seminaarissa korostettiin riskianalyysiprosessin merkitystä päätöksenteon laadunvarmistuksessa ja sitä, miten prosessivaiheiden pitäisi edetä käytännössä. Eri maiden osanottajat laativat ehdotuksensa vaiheittain tapahtuvaksi riskianalyysiprosessiksi ja keskustelivat ehdotetuista ratkaisumalleista. Johtopäätöksenä todettiin, että ehdotukset olivat periaatteessa samankaltaisia. Käytyjen keskustelujen perusteella seminaari valitsi yhden esitetyistä malleista kofeiinin ja kampylobakteerin jatkokäsittelyä varten.

Projektissa ja tässä raportissa riskianalyysiä käytetään käytännönläheisesti järjestelmällisenä ja vaiheittaisena lähestymistapana kahden elintarvikevaaran analysoinnissa. Malliksi valittiin sekä kemiallinen vaara (kofeiini) että mikrobiologinen vaara (kampylobakteeri), koska haluttiin verrata näiden kahden eri alueen kokemuksia. Kofeiini on kemiallinen yhdiste ja myrkyllinen aine, jota esiintyy luonnollisena ainesosana myös eräissä elintarvikkeissa, kuten kahvissa ja teessä. Kampylobakteeri on laajalle levinnyt mikro-organismi luonnossa. Näiden kahden tekijän esiintymisellä on kuitenkin tiettyä samankaltaisuutta.

Kansainväliset toimintaohjeet ja suuntaviivat kemiallisille aineille ja mikro-organismeille ovat erilaisia. Saatavilla oleva tieteellisen tiedon määrä ja luonne kuten myös hallintavaihtoehdot eroavat myös yleensä toisistaan.

Näiden kahden vaaran riskianalyysin kuvaamisen tarkoituksena on antaa esimerkki siitä, miten valvontaviranomaiset voisivat varmistaa päätöksenteon laatua.

Seminaarin tulosten perusteella pohjoismainen työryhmä totesi, että vaiheittainen riskianalyysi on aloitettava riskinhallinnan yhteydessä riskin kokonaisarvioinnilla. Riskin kokonaisarviointiin tulisi sisältyä elintarviketurvallisuuteen liittyvien ongelmien tunnistaminen, riskin yleiskuvan määrittely, resurssien järjestäminen, riskinarvioinnin toimintaperiaatteiden määrittäminen jne.

Yhteenveto 16

Prosessin seuraava vaihe on riskinarviointi käsittäen neljä eri vaihetta. Sen johtopäätösten tulisi muodostaa pohja riskinhallinnan päätöksenteolle mukaan lukien myös toimenpidevaihtoehtojen tunnistaminen, halutun vaihtoehdon valinta sekä lopullinen päätös.

Pohjoismaisessa työryhmässä keskusteltiin myös arvioiden ja päätöksenteon vastuista prosessin eri vaiheissa. Johtopäätöksenä todettiin, että päätöksiä tehdään monissa eri vaiheissa tutkijoiden lisäksi myös viranomaisten ja vastuullisten poliitikkojen toimesta. Jopa riskinarviointiosassa tehdään päätöksiä, jotka ovat luonteeltaan enemmän poliittisia kuin tieteellisiä, vaikka tutkijoiden pitäisi tehdä arviointi tieteellisin perustein. Riskinhallinnasta vastaavien tahojen tulisi vastata riskin kokonaisarvioinnissa turvallisuuskertoimista, tarvittavasta suojatasosta jne.

On ilmeistä, että taustamateriaalin dokumentaatiossa kokonaisarviointia ja päätöksentekoa varten standardisointityötä pitäisi tehdä vaatimuksille, testimalleille jne. Projektissa käytetyt kaksi mallia osoittavat selvästi, että eräillä alueilla tutkimusmallit, dokumentaatiot jne. ovat jo standardoituja kansainvälisesti hyväksyttyjen ohjeiden muodossa. Yhdenmukaisten kansainvälisten vaatimusten asettamisesta olisi hyötyä myös muilla alueilla.

Pohjoismainen työryhmä totesi, että riskiviestintäosuuden tulisi olla mukana riskianalyysin kaikissa vaiheissa. Jotta riskianalyysi olisi avointa ja läpinäkyvää, yleisön tulisi saada tietoa kaikissa vaiheissa, esim. Internetin välityksellä. Edelleen riskianalyysiin tulisi sisällyttää enemmän proaktiivista viestintää tiedotusvälineiden kautta.

Projektin tarkoituksena oli arvioida riskianalyysiä laadunvarmistusprosessissa ja sen soveltuvuutta käytännön päätöksentekoon elintarvikkeiden turvallisuuteen liittyvissä kysymyksissä. Riskianalyysiin tulisi sisällyttää arviointi siitä, kuka on vastuussa päätöksistä missäkin vaiheessa. Vastuu voi olla kenellä tahansa asianosaisella, kuten poliitikolla, tutkijalla, viranomaisella, teollisuudella tai kuluttajilla. Projektiryhmä totesi riskianalyysiprosessin soveltuvan erinomaisesti tähän tarkoitukseen. Järjestelmällisempi lähestymistapa parantaisi kuitenkin riskianalyysin läpinäkyvyyttä ja avoimuutta sekä parantaisi luottamusta lopullisiin päätöksiin.

Yhteenvetona pohjoismainen työryhmä suosittelee riskianalyysin käyttöä laadunvarmistusprosessissa (tai omavalvonnassa) sekä julkishallinnolle että muilla tahoille, joiden tehtävänä on arvioida riskejä.

Kansallisten viranomaisten tulisi keskustella riskianalyysiprosessista ja kehittää toimivia menettelytapoja yksittäisille hallintoviranomaisille tai muille, jotka käyttävät riskianalyysiä.

Resumé 17

Resumé

Mennesker har foretaget risikoanalyser i tusinder af år. Gennem de sidste årtier har en drøftelse af en formaliseret risikoanalyseproces foregået i internationale og nationale fora. Principperne for, hvilke trin, der bør være i risikoanalysen for fødevaresikkerheds-mæssige emner, er blevet diskuteret, og der er blevet udarbejdet definitioner af de for-skellige trin i Codex Alimentarius. Imidlertid har man ikke i detaljer diskuteret, hvordan en formel risikoanalyse skulle foregå i praksis som en trinvis procedure internationalt. De nordiske lande, Danmark, Finland, Island, Norge og Sverige besluttede derfor at samarbejde om konkrete fødevaresikkerhedsmæssige emner, nemlig koffein og Campy-lobacter ud fra de erfaringer, som man har i de nationale administrationer. Som en del af projektet blev risikoanalyseprocessen diskuteret på en workshop med deltagere fra de fem nordiske lande. Deltagerne var administratorer, toksikologer, mikrobiologer, epi-demiologer, kommunikationseksperter og forbrugerrepræsentanter. Der var repræsenteret viden om de forskellige trin i risikoanalysen af kemiske og mikrobiologiske emner, for at drage fordel af muligheden for at udveksle viden mellem de to områder. Workshoppen behandlede risikoanalyseprocessen som en proces til kvalitetssikring af beslutningsprocessen og drøftede, hvorledes processen skulle foregå i praksis som en trinvis procedure. Deltagerne fra hvert nordisk land udarbejdede et forslag til risikoanalyse som en trinvis procedure, diskuterede de forslag, der forelå, og konkluderede, at i princippet var forslagene ens. På baggrund af diskussionerne valgte man en model som den foretrukne til brug for risikoanalysen af de valgte emner, koffein og Campylobacter. I denne proces og i denne rapport anvendes risikoanalysen i praksis som en trinvis og formaliseret måde at analysere to fødevaresikkerhedsmæssige problemer. De to eksemp-ler, der blev valgt, var koffein og Campylobacter, som også skulle bidrage til viden-ud-veksling mellem de to områder: kemiske stoffer og mikroorganismer. Koffein er et ke-misk stof, som også forekommer naturligt i fødevarer som kaffe og te, og Campylobac-ter er en mikroorganisme, der forekommer overalt i naturen. Der er derfor en vis grad af lighed i naturlig forekomst af koffein og Campylobacter.

De vejledninger og internationale retningslinier, man har for kemiske stoffer og for mikroorganismer, er forskellige. Normalt er mængden og arten af de foreliggende vi-denskabelige data forskellige, og risikohåndteringsmulighederne er normalt også for-skellige.

Risikoanalysen af disse to emner er tænkt at skulle give en model for kvalitetssikring af den proces, som anvendes i den offentlige fødevareadministration.

På baggrund af resultaterne fra workshoppen konkluderede den nordiske projektgruppe, at risikoanalysen må starte i risikohåndteringsdelen af processen med en risikoevalue-ring. Risikoevalueringen bør omfatte identifikation af fødevaresikkerhedsmæssige pro-blemer, udarbejdelse af en risikoprofil, tildeling af resurser, formulering af en risiko-vurderingspolitik osv.

Det næste trin i proceduren bør være risikovurderingen og omfatte alle fire trin i risikovurderingen. Konklusionerne for risikovurderingen danner basis for

Resumé 18

beslutningerne på det næste trin, risikohåndtering, herunder identifikation af håndteringsmuligheder, valg af den foretrukne mulighed og endelig beslutning.

Den nordiske gruppe diskuterede, hvem der har ansvaret for evaluering og beslutninger på de forskellige trin, og konklusionen var, at mange af disse trin vil omfatte beslut-ninger ikke kun fra videnskabsfolk, men også fra administratorer og ansvarlige politike-re. Men den nordiske projektgruppe vurderede, at selv i risikovurderingsdelen af processen er der beslutninger, som har mere politisk end videnskabelig karakter, selvom videnskabsfolk bør være ansvarlige for udarbejdelse af den videnskabelige baggrund for beslutninger. Risikohåndtører bør være ansvarlige for beslutninger omkring sikker-hedsfaktorer, beskyttelsesniveau etc. i risikovurderingspolitikken under risikoeva-lueringstrinnet.

I diskussionen om baggrundsdokumentation for evaluering og beslutningstagen er det klart, at arbejdet bør ske på basis af standardiserede krav, testmodeller osv. på nogle trin. De to emner, som var valgt, demonstrerer klart, at på nogle områder er de testmo-deller, krav til dokumentation etc. standardiserede gennem internationalt accepterede guidelines, mens der på andre områder med fordel kunne udarbejdes internationale, standardiserede krav, testmodeller etc.

Risikokommunikation er en del af risikoanalyseprocessen, og den nordiske projekt-gruppe var enig om, at kommunikation skulle være en del af alle trinnene i proceduren. Idealet burde være, at information skulle være offentligt tilgængelig på alle trin, f.eks. over internettet, således at man får en åben og gennemskuelig risikoanalyseproces. Risi-koanalysen skulle herudover omfatte en mere dialogpræget kommunikation gennem medierne.

I projektet har det været hensigten at vurdere risikoanalyseprocessen som en kvalitetssikringsproces for beslutninger på fødevaresikkerhedsområdet. Det bør omfatte en vurdering af, hvem der kunne være ansvarlig for beslutninger på de enkelte trin. Den ansvarlige kan i princippet være enhver interessent som en politiker, en videnskabsmand, en administrator, industrien eller forbrugerne. Projektgruppen fandt, at risikoanalyseprocessen vil være et udmærket værktøj til dette formål. En mere systematisk anvendelse af risikoanalyseprocessen ville forbedre gennemskueligheden og åbenheden i processen og ville forventes at give større tillid til den endelige beslutning. Som konklusion anbefaler den nordiske projektgruppe, at risikoanalyseprocessen bruges som en kvalitetssikringsprocedure (eller egenkontrol) i den offentlige administration og andre steder, hvor man gennemfører vurderinger af risici.

Risikoanalyseprocessen bør diskuteres og udvikles nærmere i de nationale administra-tioner, således at man opbygger en funktionel procedure efter individuelle forhold.

Risk analysis - Codex definitions 19

Risk analysis - Codex definitions


The definitions listed below are definitions adopted by the Codex Commission.

Risk analysis A process consisting of three components: risk as-sessment, risk management and risk communication.

Risk A function of the probability of an adverse health ef-fect and the severity of that effect, consequential to a hazard(s) in food.

Hazard A biological, chemical or physical agent in, or con-dition of, food with the potential to cause an health effect.

Risk assessment A scientifically based process consisting of the fol-lowing steps: (i) hazard identification, (ii) hazard characterisation, (iii) exposure assessment, and (iv) risk characterisation.

Risk assessment policy Guidelines for value judgement and policy choices, which may need to be applied at specific decision points in the risk assessment process.

Risk assessment policy setting is a risk management responsibility, which should be carried out in full collaboration with risk assessors, and which serves to protect the scientific integrity of the risk assessment. The guidelines should be docu-mented so as to ensure consistency and transparen-cy. Examples of risk assessment policy setting are establishing the population(s) at risk, establishing criteria for ranking of hazards, and guidelines for ap-plication of safety factors.

Hazard identification The identification of biological, chemical, and phy-sical agents capable of causing adverse health effects and which may be present in a particular food or group of food.

Hazard characterisation The qualitative and/or quantitative evaluation of the nature of the adverse health effect associated with biological, chemical and physical agents, which may be present in food. For chemical agents, a dose re-sponse assessment should be performed. For biologi-cal or physical agents, a doseresponse assessment should be performed if data are obtainable

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 characterisation The qualitative and/or quantitative estimation, inclu-ding attendant uncertainties, of the probability of oc-currence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterisation and exposure assessment

Risk management The process, distinct from risk assessment, of weigh-ing, policy alternatives, in consultation with all inte-rested parties, considering risk assessment and other factors relevant for the health protection of consu-mers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.

Risk evaluation The definition has not yet been adopted, but the term i l i d l t i th t

Risk analysis Terminology used in English and the Nordic languages 22

Risk analysis Terminology used in Eng-lish and the Nordic languages

English Dansk Suomi Islandsk Norsk

Svensk

Hazard Fare Vaara Hætta Fare Fara

Risk Risiko Riski Áhætta Risiko Risk

Risk analysis Risiko- analyse

Riski-

analyysi Áhættu-greining Risiko analyse Riskanalys

Risk assessment

Risiko- vurdering

Riskinar-viointi Áhættumat Risiko vurdering Riskvärdering

Hazard identification

Identifi-cering af sundheds-fare

Vaaran tun-nistaminen Hættukennsl Identificering af

sundhedsfare Faroidenti-fiering

Hazard characte-rization

Karak-teristik af sund-hedsfare

Vaaran ku-vaaminen Hættulýsing Karakteristik af

sundhedsfare Farokarak-tärisering

Risk assessment policy

Risiko- vurde-rings-politik

Riskinar-vioinnin toiminta-

periaatteet

Áhættu-matsstefna

Risiko vurde-ringspolitik/-retningslinjer

Riskvärde-ringspolicy

Risk characte-rization

Risiko- karakte-ristik

Riskin

kuvaaminen Áhættu-lýsing

Risiko karakteri-sering

Riskkarak-tärisering

Risk communi-cation

Risiko- kommu-nikation

Riski-viestintä

Áhættu-kynning

Risiko kommuni-kation

Riskkom-munikation

Risk evaluation

Risiko-evaluering

Riskin kokonais-

arviointi

Áhættu-skoðun Risiko evaluering Risk-

evaluering

Risk ma-nagement

Risiko-håndtering

Riskin-hallinta

Áhættu-stjórnun

Risiko håndtering Riskhantering

Risk analysis Terminology used in English and the Nordic languages 23

Abbreviations 24

Abbreviations

ADI Acceptable daily intake; the amount of a certain substance that can be consumed daily during the entire lifetime without risk for negative health effects. ADI is expressed in mg/kg body weight.

Codex Abbreviation for Codex Alimentarius covering the cooperation about foodstuffs under the UN, FAO and the WHO.

DBM Danish budget method.

DNA Desoxyribonucleinic acid.

EEA European Economic Agreement

EU European Union

FAO Food and Agriculture Organization.

GBS Guillain Barré-Syndrome.

HPLC High-Pressure Liquid Chromatography.

JECFA Joint Expert Committee on Food Additives and Contaminants.

LOEL Lowest observed effect level (expressed in mg/kg body weight)

NNT Joint Nordic Working Group on Food Toxicology.

NNL Joint Nordic Working Group on Food Legislation.

NNM Joint Nordic Working Group on Food Microbiology.

NOEL No observed effect level (expressed in mg/kg body weight)

OECD Organisation for Economic Co-operation and Development.

OIE Organisation Internationale Epizootique.

QRA Quantitative Risk Assessment.

RNA Ribonucleinic acid.

SCF Scientific Committee on Food.

SPS Sanitary and Phytosanitary Measures, as defined by the WTO.

TDI Tolerable daily intake.

WHO World Health Organization.

WTO World Trade Organisation.

Abbreviations 25

Risk analysis as a tool for the quality assurance of the decision-making process 26

1 Risk analysis as a tool for the quality assurance of the deci-sion-making process

The risk analysis process1 is being developed in international co-operation in the food area as a result of different requirements like the need for transparency in the decision-making and the discussion of risks in connection with international trade and dispute thereof. In public administration, in private enterprises etc. risks are being analysed now and have been so in the past. However, as the amount of information available in the world seems to be exploding and so does the public interest in food safety issues, there seems to be a growing demand for the possibility of following the whole decision-ma-king process in this area too.

Even though the public administrations in the Nordic countries have a tradition of open-ness and have followed steps similar to the steps in the risk analysis process, a struc-tured approach and a discussion about which type of documentation to use is needed for each decision in the process. It would be beneficial to have a validated contribution to the quality assurance in decision-making and to traceability in risk analysis. The risk analysis should include validated communication, ensure independent scientific advice as well as co-ordination and co-operation between authorities.

1.1 Risk analysis of two examples, a chemical and a micro-organism.

For the examinations of the risk analysis in practice, two different subjects were chosen: a chemical component, caffeine, and a microorganism, Campylobacter. In order to provide the same basic knowledge to the participants in the workshop, speeches were given on the general principles of quality assurance and on caffeine and Campylobacter. For the important background information on caffeine and Campylobacter, please see Annex A and B.

The risk analyses of caffeine and Campylobacter are discussed in the following, and as an example used in the project group, the risk analysis of glycyrrhizic acid is included in Annex C.

1 Definitions are given in the beginning of this report together with the translation into the Nordic languages.


1.2 The risk analysis process by Ib Knudsen, Danish Veterinary and Food Administration, Denmark2

International risk assessment takes place in several fora: Joint FAO/WHO Expert Com-mittee on Food Additives, Joint FAO/WHO Meeting on Pesticide Residues, Joint FAO/WHO Consultations on Biotechnology, Allergy, Food Irradiation, Food Microbio-logy, Risk Management. International Agency for Research on Cancer evaluates any possible carcinogenicity of chemicals. OECD deals with test guidelines and biotechno-logy. The Council of Europe assesses packaging materials and flavourings. The Nordic Working Groups on Food Toxicology and Risk Assessment and the Nordic Working Group on Food Microbiology and Safety make Nordic safety assessments. The Euro-pean Commission has established eight specific committees for risk assessment headed by a Steering Committee (see figure 1).

Below this level, regional and national risk assessments are performed and dealt with in local management processes.

2 Speech given at the Nordic workshop, June 2000.

Figure 1

THE 8 SCIENTIFIC COMMITTEES established by Commission Decision 97/579

and the Steering Committee

Scientific Steering Committee

Toxicity, Ecotoxicity and the Environment Food

Plants

Cosmetics and Non-Food Consumer Products

Animal Nutrition

Animal Health and Welfare

Medicinal Products and Medical Devices

Veterinary measures relating to Public Health


In order to obtain a certain harmonization of the whole risk analysis process to foods FAO/ WHO hosted a Joint Expert Consultation in 1995, and later issued a report on the application of risk analysis to food standards issues (FAO/WHO 1995). In this report, an overall structure of the risk analysis process is suggested (figure 2).

This structure recommends interaction between the risk assessment process and the risk management process assisted by a thorough risk communication both between mana-gers and assessors and to third parties, including users of the technologies as well as consumers of the products.

Risk Assessment Risk Management

Risk Communication

• Hazard assessment • Hazard characterization • Exposure assessment • Risk characterization

• Risk evaluation • Assessment of options • Implementation • Monitoring and evaluation

STRUCTURE OF RISK ANALYSIS

Figure 2


Later, the definitions for the terms used in the risk assessment and risk management process are harmonized through the work of the Codex Alimentarius Commission in 1996 (see figure 3).

In 1997 a new Joint FAO/WHO Consultation looked into the elements of risk manage-ment.

3 Codex Alimentarius commission, CL 1996/21-GEN, June 1996.

DEFINITIONS3

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.

RISK ANALYSIS: A process consisting of three components: risk assessment, risk management and risk communication.

RISK ASSESSMENT: A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) 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 dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable.

DOSE-RESPONSE ASSESSMENT: The determination of the relationship between the magnitude of exposure (dose) to a chemical, biological or physical agent and the severity and/or frequency of associated adverse health effects (response).

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 CHARCTERIZATION: 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 of weighing policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures.

RISK COMMUNICATION: The interactive exchange of information and opinions concerning risk among risk assessors, risk managers, consumers and other interested parties.

Figure 3


This Consultation on risk management and food safety lists eight basic principles, which are considered crucial to the reliance and trust in the process (figure 4).

The report from this Consultation thoroughly discusses and explains the individual elements of the risk management: Risk evaluation, risk management option assessment,

4 from Risk Management and Food Safety Report of a Joint FAO/WHO Consultation, Rome, Italy, 27 to 31 January 1997. 5 (from Risk Management and Food Safety Report of a Joint FAO/WHO Consultation, Rome, Italy, 27 to 31 January 1997)

GENERAL PRINCIPLES OF FOOD SAFETY RISK MANAGEMENT4

Principle 1 Risk management should follow a structured approach Principle 2 Protection of human health should be the primary consideration in risk management

decisions Principle 3 Risk management decisions and practices should be transparent Principle 4 Determination of risk assessment policy should be included as a specific component

of risk management Principle 5 Risk management should ensure the scientific integrity of the risk assessment process

by maintaining the functional separation of risk management and risk assessment Principle 6 Risk management decisions should take into account the uncertainty in the output of

the risk assessment Principle 7 Risk management should include clear, interactive communication with consumers

and other interested parties in all aspects of the process Principle 8 Risk management should be a continuing process that takes into account all newly

generated data in the evaluation and review of risk management decisions

Figure 4

ELEMENTS OF RISK MANAGEMENT5

A. RISK EVALUATION • Identification of a food safety problem • Establishment of a risk profile • Ranking of the hazard for risk assessment and risk management priority • Establishment of risk assessment policy for conduct of risk assessment • Commissioning of risk assessment • Consideration of risk assessment result

B. RISK MANAGEMENT OPTION ASSESSMENT • Identification of available management options • Selection of preferred management option, including consideration of an appropriate safety standard • Final management decision

C. IMPLEMENTATION OF MANAGEMENT DECISION

D. MONITORING AND REVIEW • Assessment of effectiveness of measures taken • Review risk management and / or assessment as necessary

Figure 5


implementation of management decision and monitoring and review.

A crucial starting point for the whole process is the establishment of a risk profile (figure 6). This profile is supposed to be put together based on consultations with all stakeholders. The risk profile is the basis for ranking the hazard for risk assessment and risk management.

If the hazard in question is given priority for risk assessment, the risk assessment policy

is established through a management procedure (Figure 7). Basically, a risk assessment policy determines the magnitude of economic resources available for the creation, col-lection and evaluation of scientific data for the risk assessment. The risk assessment po-licy also establishes the societal trust in the different scientific instruments and data for the risk assessment (Figure 8).

6 from Risk Management and Food Safety Report of a Joint FAO/WHO Consultation, Rome, Italy, 27 to 31 January 1997.

RISK ASSESSMENT POLICY6

Risk assessment policy setting is: • a risk management responsibility • to be carried out in full collaboration with risk assessors • serve to protect the scientific integrity of the risk assessment • to be documented so as to ensure consistency and transparency

Examples are: • establishing the population(s) at risk • establishing criteria for ranking of hazards • establishing guidelines for applications of safety factors Figure 7

RISK PROFILE

A typical risk profile might include the following: • a brief description of the situation • product or commodity involved • the values expected to be placed at risk, (e.g. human health,

economic concerns) • potential consequences • consumer perception of the risks • the distribution of risks and benefits Figure 6


After the establishment on the risk assessment policy, the risk assessment is commis-sioned to the experts who do the hazard identification, hazard characterization, exposure assessment and finally the risk characterization. The outcome of the risk assessment is delivered to the risk managers for consideration. Depending on the scientific data available for the risk assessment, the risk assessors may be more or less convinced about the scientific validity and predictability of their risk assessment for human health. It is important that their certainty/uncertainty in this regard is precisely reflected in the opinion given.

If the uncertainty expressed by the risk assessors regarding the actual risk is too large, if the potential for great harm is too alarming, or if the potential for great consequences by not acting immediately is too large, the risk managers may choose to apply the so-called Precautionary Principle (Figure 9).

The following step of the risk management process includes the implementation of the management decision and the monitoring and review of effectiveness of measures taken.

The conclusion from the review may be that the risk management procedures should be repeated in a process where the weak elements of the risk management process (inclu-ding the risk assessment) are improved by better data and more knowledge.

In figure 10 is given an overview of the risk management procedure based on the principles outlined in the report from the FAO/WHO Consultation on Risk Management and Food Safety, 1997. The figure describes the risk management circular process moving from north to east, south, west and north again. The beauty of the stepwise pro-cess as described in the figure is its potential for being logical, clear, transparent and scientifically based allowing communication with all stakeholders at all relevant deci-sion points during the process.

One run through the circle may take from a few hours to several years depending on the complexity of the problem, prior knowledge and experience regarding the assessed problem as well as the degree of consensus obtained and compliance with the decided measures.

RISK ASSESSMENT POLICY in JECFA and JMPR

• Reliance on animal models to establish potential human effects • Using body weight scaling for interspecies comparison • Assuming that absorption in animals and humans is approximately the same • Using a 100-fold safety factor to account for likely inter- and intra-species differences in

susceptibility, with guidelines for deviations that are permitted in specified situations • The decision not to assign ADIs to food additives, veterinary drugs and pesticides which are

found to be genotoxic carcinogens. Quantitative risk assessment has not been employed for these substances. In effect, there is no recognised acceptable risk level for genotoxic food additives, residues of veterinary drugs or pesticides

• Permitting contaminants at levels “as low as reasonably achievable” (ALARA) • Establishing temporary ADIs for additives and residues of veterinary drugs pending submission

of requested data. It should be noted, however, that this policy is not used by JMPR in the establishment of ADIs for pesticide residues.

Figure 8


Each time the circle is passed on the same food safety problem, the experience and confidence regarding the effectiveness of the measures to be taken will improve and the chances for societal success of the management process will increase.

COMMUNICATION FROM THE COMMISSION ON THE PRECAUTIONARY PRINCIPLE, 2 FEBRUARY, 2000

• The precautionary principle should be considered within a structured approach to the analysis of risk, which comprises three elements: risk assessment, risk management, risk communication. The precautionary principle is particularly relevant to the management of risk.

• The precautionary principle, which is essentially used by decision-makers in the manage-ment of risk, should not be confused with the element of caution that scientists apply in their assessment of scientific data.

• Recourse to the precautionary principle presupposes that potentially dangerous effects deriving from a phenomenon, product or process has been identified, and that scientific evaluation does not allow the risk to be determined with sufficient certainty.

• Decision-makers need to be aware of the degree of uncertainty attached to the results of the evaluation of the available scientific information. Judging what is an “acceptable” level of risk for society is an eminently political responsibility. Decision-makers faced with an unacceptable risk, scientific uncertainty and public concerns have a duty to find answers. Therefore, all these factors have to be taken into consideration.

• The decision-making procedure should be transparent and should involve as early as possible and to the extent reasonably possible all interested parties

• Where action is deemed necessary, measures based on the precautionary principle should be, inter alia: proportional to the chosen level of protection non-discriminatory in their application, consistent with similar measures already taken, based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis), subject to review, in the light of new scientific data, and capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.

Figure 9

Risk Management

A. Risk Evaluation

• Risk perception• Value judgement• Precautionary principle• Benefits/costs• Other technical factors

Risk Communication

C. Implementation of management decision

1. Assessment of effectiveness of measures taken

2. Review risk management and /or assessment as necessary

D. Monitoring and review

B. Risk management option assessment

A brief description of the situationProduct or commodity involvedThe values expected to be placed at risk,(e.g. human health, economic concerns)Potential consequencesConsumer perception of the risksThe distribution of risks and benefits

Value judgements and policychoices for the risk assessment proces

• Hazard identification• Hazard characterisation• Exposure assessment• Risk characterisation

1. Identification of a food safety problem2. Establishment of a risk profile3. Ranking of the hazard for risk

assessment and risk management priority4. Establishment of risk assessment policy

for conduct of risk assessment5. Commitment of ressources6. Commissioning of risk assessment7. Consideration of risk assessment result

1. Identification of available management options2. Selection of preferred management option, including

consideration of an appropriate safety standard3. Final management decision

Regulatory or other control measures

Risk Assessment

Figure 10

35 The need for quality management in food law administration

Figure 11

1.3 The need for quality management in food law administra-tion

In the quality assurance of the risk analysis process, the starting point should be to define the need, see figure 11.

The basic elements in quality assurance should be based on the good practice for risk analysis.

The quality assurance should comprise: organisation integrity, qualification in science and the necessary resources. In the process control, it is of importance to have a scienti-fically, based identification of critical control points, prevention of failures by check-lists, process documentation, control of final products, reviews etc. The product control should include standardization, reports and minimum demands.

This should comprise a quality philosophy (objectives and policy) about the quality assurance covering all parameters related to quality and product control and is described in the following section.

The Covering-of-needs-model: The ideal versus the supplied total quality

Not realized needs

Not expressed realized needs

Not perceived expressed

needs

Lack of quality

Decided deviation

The ideal total quality

Manage-ment uncer-tainty

Need Realized needs

Expressed needs

Perceived needs

Decision of realization

Actually realized

Supplied quality

36 Quality assurance in public food law administration.

1.4 Quality assurance in public food law administration. by Göran Engström, National Food Administration, Sweden7

During the past years we have experienced an increasing public interest in how govern-mental authorities perform and interact with citizens. This is not only a trend in the Nor-dic countries, but also a more or less international trend.

There are quite a few reasons for this interest that one could put forward. One reason is less economical resources for the governmental sector in many countries. Another rea-son is that we are living in a more international world with easy access to information. Some special events during the last years like the Estonia and Chernobyl accidents have certainly increased citizen’s interest in governmental authorithies. It is probably also correct to mention the BSE-crisis in this context.

It is of great importance for the citizens to have confidence in society such as food au-thorities, and quality management is a way to meet this demand or interest.

In a proposal to the Swedish parliament, the Swedish government lays down a number of statements.

The quality in Swedish governmental administrations is described as follows:

The Swedish administration shall, with high demands for legal rights, efficiency and democracy, be available and obliging. It shall have the citizen’s full confidence, give good working and expansion conditions for the industry and be successful and respected in international co-operation.

The authorities shall carry out their duties with

In early 1999 a new governmental authority was established to work within the field of

quality management. The working field for the authority is

7 Speech given at the Nordic Workshop, June 2000.

- high quality

- openness

- motivated and competent staff

- good leaders

- developing abilities

- to be a meetingplace for competence enhancement and the exchange of experience, as a support for the work with continuous improvements

- to develop a wide spectrum of seminars, conferences etc. for persons in leading po-sitions at the authorities

- to develop educational and discussion material for different staff categories

- establish a close contact with scientists and teachers at universities.

37 Other views on the need for quality control in public administration.

1.4.1 Quality management The development of quality management is driven by two forces, commitment and structure. Structure is represented by quality systems such as the ISO-system and the accreditation of laboratories. Commitment comprises then all activities making people

more devoted to their work. In any given situation, the problem is then to find the right proportion between the two forces.

Often it is argued that the corner stones in quality management are:

Finally, in connection with the points mentioned above, a text from the Commission’s white paper on food safety giving the foundation and principles guiding the activities at food administrations could be enlightening. ”Risk analysis must form the foundation on which food safety policy is based. The EU must base its food policy on the application of the three components of risk analysis: risk assessment (scientific advice and infor-mation analysis), risk management (regulation and control) and risk communication”.

1.5 Other views on the need for quality control in public ad-ministration.

In preparing the workshop, the Nordic Food Administrations were asked for some viewpoints on the need for quality control in public administration. This question may be seen as either an obviously easy question to answer, or as superfluous, because the answer is obvious. However, it can be complicated to answer in details.

The question was discussed during the workshop, but each of the Nordic countries have given some remarks on it as follows:

• A well-considered and well-described risk analysis process is a prerequisite for a proper decision-making process.

• Quality assurance in the public administration is a necessity and a tool the admini-stration will have to define in order to ensure legal decisions and to fulfill the requirements set up for it.

• A clearly described risk analysis process might not seem to give a flexible administration; however, the main task of the public administration is to base its flexibility on its legal obligations and the political decisions.

- decisions based on facts

- continuous improvements

- everyone’s involvement

- process orientation

Commitment Naive Total success 0 Bureaucratic structure


The National food administration is primarily based on legal acts such as the general Food Act etc. and legal principles. Additionally, the administration is often based on po-litical decisions made by either the Parliament or the Minister in charge.

• The administration must comply with the legal acts and principles, the basic require-ments and the political decisions in order to make proper and legal decisions.

• “Equality before the law” is one of the basic principles the administration has to respect in the exercising of its authority. The principle states the fact that cases with a similar content are subject to a uniform treatment and interpretation.

Furthermore, the administration needs to have sufficient scientific information (inclu-ding the consequences of each option) described in a scientific manual and avoid a mix-up of science and politics. The scientists and administrators must make sure that it is evident which part of the evaluation that is based on science and which part of the deci-sion that is based on risk management.

In the food administration, as well as in other parts of the public administration, the

quality assurance in the decision-making process should ensure that:

The ideal situation is when the steps in the decision-making and in the risk analysis process are well described and well known - to the administrators, the scientists and the public in general.

In the Nordic countries, steps in the risk analysis process are in general well known to both the public and the administration (e.g. the requirements for the risk assessment of food additives and pesticides are based on international guidelines). Political decisions can be filed in a socalled “Books of wisdom”.

However, a systematic risk analysis process known to all employees is not described in one place. The internal groups of managers will in some cases go though the major sub-items in an area, e.g. the use of veterinary drugs and food contact materials, while in other cases, the individual administrator will solve the problems.

1.5.1 Is quality assurance needed in Public Administration? Quality assurance is important on every stage of the risk analysis process, risk assess-ment, risk management and risk communication. This is especially the case when the national food authorities evaluate a risk through a risk analysis. Essential elements of the quality assurance will be to ensure that risk assessment is independent of risk man-

- The steps in the decision-making process are well known to the administrators.

- The decisions are not arbitrary.

- The person in charge is making the decisions.

- The decisions are based on consultations with the relevant experts.

- The decisions are based on sound science.

- Only validated methods are used in the control system.

- The scientific and administrative documentation must be available as background information for the decisions.


agement. Furthermore, the retraceability and transparency of the whole process, the effi-ciency of case handling and the impartiality and objectivity of the treatment of custo-mers must be ensured as well.

The Codex Alimentarius guidelines on the conduct of risk analysis state that the risk analysis process must be kept transparent and stresses the necessity of involving all stakeholders. Risk managers have responsibilities in a draft document on the conduct of risk management being developed in the Codex Alimentarius Committee on Food Hy-giene. Quality assurance of the process can be considered as a part of its transparency. The quality assurance in laboratories used for official food control purposes is now well established. This guarantees comparable results between laboratories. In the public food law administration, quality assurance would promote further the compatibility and harmony of food law requirements between nations in a similar manner.

An assessment of the need says that quality assurance is highly important and that the administration, in future, should elaborate a “quality assurance guideline” for the em-ployees.

1.5.2 Roles and responsibilities in the risk analysis process. Risk Analysis is defined by Codex Alimentarius as follows:

A process consisting of three components: risk assessment, risk management

and risk communication.

Some of the decisions on the individual steps are based on pure science, others are pure-ly political while several of the decisions made are combinations of decisions where se-veral responsabilities have been taken into account in the decision-making process.

It is highly important to evaluate which type of decisions are required on each step in the process, and for each step in the risk analysis, to identify who would be the respon-sible person(s)/function(s). Furthermore, guidelines on the type and quality of informa-tion needed should be specified.

In the Codex risk analysis process, the Codex Commission would be regarded as re-sponsible for the politics. The Codex Commission has decided that:

• “Health and safety aspects of Codex decisions and recommendations should be based on a risk assessment, as appropriate to the circumstances.

• 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 trans-parent manner.

• There should be a functional separation of risk assessment and risk management, while recognizing that some interactions are essential for a pragmatic approach.

• 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.

• Relevant Codex committees should consider developing quality criteria for data used for risk assessment. As far as possible, such criteria should be consistent with one another, taking into account the technical differences in the disciplines covered.


• Recognizing that, in developing countries, the primary production takes place in small and medium-sized enterprises, the risk assessment should be based on global data, including that from developing countries. These data should particularly in-clude epidemiological surveillance data and exposure studies.

• Risk management should take into account the economic consequences and the fea-sibility of risk management options in developing countries. Risk management should also recognize the need for flexibility in the establishment of standards, guidelines and other recommendations, consistent with the protection of the consumer's health.”

In the public administrations and in this project, the “responsible” persons could be

• Politicians

• Administrators

• Scientists (toxicologists, microbiologists, chemists, nutritionists)

• Other interested parties (consumers, industry or retailers).

Clearer definitions of the roles and responsibilities could be in line with the requirement for transparency in public decision-making, and they could be useful for the quality assurance in the risk analysis. It would be evident and important that the decisions were made by the persons in charge. In this connection, it should be realised and included in the discussion that risk analysis is not only the responsibility of the ministers and the public food administration, but also the responsibility of the other interested parties, like the industry and the consumers.

In the following chapters, all the steps in the risk analysis process are listed, and during the project, the participants have made proposals about who should be responsible in decision-making on each step in the process.’

42 Workshop decisions on the risk analysis procedure.

2 A risk analysis model for a step-wise procedure

The risk analysis process as a stepwise procedure can be seen as a tool for the quality assurance in the process dealing with food safety issues.

It should be kept in mind, that the process can be stopped at any step if a decision has been made not to carry out a full risk analysis of a potential problem. A decision to stop the process may be made for several reasons, e.g., due to resources.

2.1 Workshop decisions on the risk analysis procedure. During the workshop, the pros and cons of having a formalized risk analysis process described as a process to be used in the daily life handling of risks in the Nordic food administration were discussed.

The general agreement was that the concept of risk analysis should form a basis for quality assurance in the administrative process. It was furthermore agreed that quality assurance is a must in public administration. The use of a formally described process would increase transparency in decision-making, enhance the uniformity of control measures, facilitate the adoption of decisions through a better understanding among stakeholders who are hence more likely to commit themselves to implementing the decisions and to enhance the validation of decisions. As to the element of quality assu-rance, the point was raised that a quality assurance of the risk analysis process is more applicable to the risk assessment part of the process than to the risk management part.

The advantages mentioned were that all stakeholders would benefit from a more formal process due to the improved transparency, and that a transparent process would improve the confidence in authorities. A separation between risk assessment and risk manage-ment was seen as a very important quality factor, since different competence is needed in the two parts of the process – also since the risk analysis may be improved by consi-derations of the specialists.

Other general disadvantages would be that such a formalised risk analysis process would require more resources both in the administration and elsewhere. This might lead to a demand for more careful priority setting.

It was discussed whether a formalized process could function in all types of situations, e.g., also in an acute situation. The proposal was to be pro-active and as a kind of precautionary principle limit the requirements to the risk assessment, and improve com-munication at all steps, also before the final decision.

Based on the workshop discussion on the advantages and disadvantages of having a formally described risk analysis process in the national administrations and e.g. in the industry, the participants from the five countries worked out a model of a process for the use in practise. Several proposals were discussed in the workshop, and the conclusion was that the process described below for further work on the national level

43 Proposal for a Nordic Risk Analysis model using a stepwise procedure.

should be used. See Annex D about proposals elaborated during the Nordic workshop on how a stepwise risk analysis could be made. These examples were in general in line with each other, and they were discussed in plenary. The workshop decided to continue the work based on the proposal from the Icelandic group. This model is describedin a slightly modified form in chapter 2.2 and will be named the Nordic Model for a Stepwise procedure for a Risk analysis.

2.2 Proposal for a Nordic Risk Analysis model using a stepwise procedure.

The risk analysis process has been discussed as a process to be used in the daily life handling of risks. The Nordic project group found that the process should be elaborated in more details for the practical use in the national food administration and elsewhere.

The prerequisites for the procedure are the following:

• Risk communication: The process will be based on a dialogue between the stakeholders involved in either the whole process or the individual steps. After each step in the process, the documents developed should be placed on a special Internet site describing the risk analysis process as risk communication is crucial. An evaluation on the further communication of results to stakeholders, the public or governmental agencies will be made after each step and actions will be taken accordingly.

• Responsibilities: The governmental agency responsible for the risk management of food hazards will have the overall responsibilities for the work. One single person will be assigned to take responsibility for the initiation, the management and the finalizing of each step of the process, including the risk assessment

• Teamwork: The risk analysis will as far as possible be carried out in teams assigned to the work.

Step Comments Risk communication

Proper risk communication to all interested parties be ensured during the entire process and when communicating the results/conclusions

A. Risk Management - first step

Risk evaluation

Identification of food safety problems

Background data: Outbreaks/acute situations. Human incidence data. Prevalence in foods. Surveillance. Exposure data. Research/Scientific publications. Consumer concerns.


Other relevant information (i.e. production figures for foods). A central database with epidemiological data from the environment, animals, food and humans should be established to facilitate a constant overview of the situation.

The establishment of a risk profile

• A brief description of the situation.

• Product or commodity involved.

• The values expected to be at risk.

• Economic concern.

• Potential consequences.

• Consumer perception of the risks.

• The distribution of risks and benefits.

Ranking of the hazard for risk assessment and risk management priori-ty

The work to be done is to be ranked in order of priority.

Establishment of a risk assessment policy for the conduct of a risk as-sessment

Guidelines for the application of safety factors. Establishment of a percentage of the population accepted to be at risk. Criteria for the ranking of hazards. Accepted documentation or models to be used, including accepted uncertainty in the calculation of the result.

The commitment of resources

In an acute situation, the responsible person for the risk man-agement of food hazards should assign resources to the work.

In other situations, support should be a decision of the minister responsible. The request will include the identification of haz-ards, a risk profile, the ranking of priorities and the risk assess-ment policy.

Commissioning of a risk assessment

In this step, a procedure will be followed where valid criteria pertaining to the selection of assessors and the resources (financial, time, data, ad hoc expertise etc.) will be followed. The assessor(s) selected must be scientifically competent, independent from identified stakeholders, have an established quality control for his activities etc.

B. Scientific Risk Assessment

References to background documentation should be included in a scientific way on all steps.

Hazard identification • Methods of analysis. • Effective agent. • Environmental factor. • Source of hazard. • Growth pattern of micro-organisms.

Hazard characterization • Virulence.


• Dose-response. • Information on host and micro-organism. • Chemical substance (specification of identity, physical

properties, structure etc. • Toxicity. • Infectiousness. • Health effects, including symptoms. • Economic impact (cost of illness).

Exposure assessment • Level of food consumed. • Consumption pattern. • Prevalence and quantity of the agent in the foodstuffs. • Survival. • Age and sex. • Risk behaviour (hygiene in home cooking, travelling, etc.). • Effect of processing on the content in final food.

Risk characterization • Likelihood. • Severity effects (adverse effect included). • Uncertainties. • Tolerable daily intake. • Reported side effects. • Reproductive toxicity. • Toxicological studies. • Epidemiological studies.

Consideration of risk assessment result

• Establishment of ADI, TDI, PWTI etc. • Comparison with reports of human incidences of illness

and of food borne outbreaks. • Identification of possible risk management options and

calculation of consequences for public health.

C. Risk management – further steps

Risk management option assessment

Identification of avail-able management op-tions

• Legislation. • Guidelines. • Information to producers/consumers. • Prevention.

Selection of the pre-ferred management op-tion, including the con-sideration of an appro-priate safety standard

Regulatory or other control measures.

46 Risk communication and transparency

Final management decision

• Risk perception. • Value judgement. • Precautionary principle. • Benefits/costs. • Other technical factors.

Implementation of management decision

• Legislation. • Guidelines. • Information for producers/consumers.

Monitoring and review

• Market surveys. • Intake studies. • Case control studies.

Assessment of the effectiveness of measures taken

A central database with epidemiological data from the environment, animals, food and humans will be used for monitoring purposes.

Review risk manage-ment and/or assessment as necessary

2.3 Risk communication and transparency The project did not specifically cover communication since this topic is dealt with in an-other Nordic project. (Risk acceptance and risk communication, workshop. June 2001, report under preparation).

However, risk communication is very important in the risk analysis process, both during the process between the different interested parties, and afterward when communicating the result. In each step of the risk analysis process, the need for risk communication should be addressed. The project group and the workshop were of the opinion that communication should, preferably, take place on each step of the process.

In many cases, the public trust in authorities will depend on knowledge and on the transparency of the risk analysis. In the Nordic countries, the public has a high level of education and knowledge about many items. Furthermore, there has been a growing in-terest in food safety for many years, and risks related to foods concern consumers. The recommendations from the workshop are therefore to communicate as much informa-tion as possible during the process to the public and to have an open debate with all in-terested parties. Even though the two examples described in this report consider risk that is found difficult to communicate, such as caffeine found in a normally consumed food item like coffee or tea and being of risk.

Information could be made available on the Internet, as this is an inexpensive and fast way to communicate. However, this channel should not be the only tool for communica-tion. Certain consumer groups with whom the official authorities might want to commu-nicate might never seek information on the Internet. In this report, there are summarised some of the available options as examples. More options should be carefully discussed on national level. An evaluation of the effect of different risk communication options should be made.


Options in risk communication.

Risk assessment and risk management are based on sound science and performed by scientists and experts in the fields. In most cases, the competence in the field of risk communication has not been developed within the official food authorities in the same manner. People specialized in public relations and people who develop and apply the relevant scientific principles must communicate food risks to the consumers and other stakeholders.

Examples of risk communication in the cases of caffeine and Campylobacter in the Nor-dic countries are: Special labelling on energy drinks in Sweden where pregnant women are warned against the excessive consumption of caffeine during the pregnancy; and special labelling on poultry products in Iceland where the consumer is instructed to avoid cross contamination and assure that all poultry meat is properly cooked. Similar labelling is also known from tobacco and products containing alcohol in many coun-tries.

There is a long tradition for using advertising campaigns to influence the day-to-day be-haviour of the general public. Examples of such campaigns that can be considered as risk communication are anti-smoking campaigns. A campaign on the importance of kit-chen hygiene in reducing Campylobacter infections in Iceland received considerable at-tention and fuelled an extensive public discussion on food hygiene. Special care has to be taken not to damage the industry by delivering unclear or mixed messages.

Press releases are generally used among the official food authorities in the Nordic coun-tries. The outcome of such communications is difficult to predict. In some cases, very important messages get limited coverage in the media. Therefore, press releases have to be carefully designed and, if possible, the timing of publication should also be consi-dered. Experts in public relations should be consulted or recruited for these purposes

The Internet is still in its infancy and it is possible that only professionals and enthusi-asts read the homepages of the official authorities. The homepage of the Environmental & Food Agency of Iceland has about 2000 visits each month on average. It is obvious that information published only on the homepage would not reach a large audience. On the other hand, placing data on the homepage with relation to the ongoing risk analysis activities can be considered as a feasible option to bring transparency to the process.

Distributing brochures, wallpapers and stickers, writing newspaper articles and giving interviews to the media are other means of risk communication commonly used by the public authorities.

When selecting from the various options available (see table below) to bring messages to the consumers and other interested parties, the authorities have to develop a measurement for each option. Factors like target groups, likelihood of getting the attention of the target group and likelihood of influencing the behaviour of the target group must be known. When considering the risk of Campylobacter, for example, a certain age and geographical distribution of cases is known. In that case, messages on good kitchen practices would have to be targeted to the age group at most risk and to food services catering to the needs of this group. Furthermore, the outcome of the risk communications efforts should be monitored, and the data acquired should be analysed with exposure assessment models.


An example list of some of the available options for risk communication is given below. Option Cost for

authorities Other consideration

Special labelling of foods

Low Legal problems.

Advertising campaigns

High

Press releases

Low

The Internet

Low Limited audience.

Brochures, wallpapers and stickers

Moderate to high

Newspaper articles

Low

Scientific journals Moderate Time consuming Very limited audience

Interviews Low People need training and experience to deliver the desired message.

50 Risk management – first step

3 The risk analysis model – illu-strated with caffeine and Campy-lobacter as examples

In this chapter, the risk analysis process is being used in practice, following the model8 with the stepwise procedure chosen by the Nordic workshop to be the most logical one to be used in the risk analysis of food safety issues in the national food administrations, private enterprises and other places where food safety risks have to be analysed. In the text below, information is summarised on exact background for the decision on each step in the process. The text is not meant to be exhaustive, but it is meant to summarise the type of background information considered in each step.

Even though the model is described with steps separating risk management and risk assessment, the process will be based on a dialogue between the different sectors of knowledge: A clear separation of e.g. risk management and risk assessment will clarify which part of the analysis is based on science and which part is based on other considerations such as politics. This separation would be regarded as beneficial for the transparency of the risk analysis and the validity of the results. The analysis using the schematic model is illustrated by the examples chosen, namely caffeine and Campy-lobacter. See also Annex A and Annex B for background information.

3.1 Risk management – first step

3.1.1 Risk evaluation The Nordic project group recommended that the risk analysis process should start in the risk management section and that the risk evaluation should be the first step. The process should be described from the point when a problem arises to the point when the managers get the result from the scientific assessment of the health risk. The risk evaluation step does not have a formal definition in Codex Alimentarius yet, but is described by a set of steps. These include

• The identification of a food safety problem • The establishment of a risk profile • The ranking of the hazard for risk assessment and risk management priority • The establishment of a risk assessment policy for the conduct of risk assessment • The commitment of resources • The commissioning of a risk assessment • The consideration of a risk assessment result 8 described in chapter 2.


From this description it is clear that risk evaluation should be the starting point of the process and that it is a risk management responsibility to initiate. Still, many people think of the risk assessment as the first step. However, the work on the stage of risk evaluation will normally be done in close cooperation with risk assessors. Hence, there is confusion as to who should carry out the various risk evaluation steps. For example scientists often identify and describe a problem without consulting the risk managers, and managers may leave decisions on risk assessment policy to scientists, only without realizing the political and economical decisions taken in the risk assessment part of the process.

The risk evaluation should be based on published documentation on the risk and references should be part of the documentation in the risk evaluation.

3.1.2 Identification of a food safety problem. In theory, the identification of a food safety problem could be made by all interested parties such as consumers, toxicologists, microbiologists, managers, politicians, medical doctors and journalists. The consumers can recognize that certain types of food make them feel uncomfortable or make them get ill. Analysts can identify components in food known to cause safety problems in humans, like e.g. cadmium in sunflower kernels or “edible” mushrooms etc. Such a finding would start the risk analysis. Even though risk communication is not dealt with in detail in the present report, the decisions taken on the risk evaluation step, should be communicated to the interested stakeholders.

3.1.3 Establishment of a risk profile. A risk profile is defined as “A description of the food safety problem and its context”. A risk profile can in short terms be described as a “risk assessment light”.

Risk profiling is the process of describing a food safety problem and its context, in or-der to identify those elements of the hazard or risk relevant to various risk management decisions. The risk profile would include identifying aspects of hazards relevant to making an order of priority and setting the risk assessment policy and aspects of the risk relevant to the choice of safety standards and management options.

The risk profile would be based on available knowledge and would not be a complete risk assessment at the first step. The establishment of a risk profile will in most cases be made in corporation between risk managers, risk assessors and others as the risk profile should include a lot of different information.

A typical risk profile might include the following:

• a brief description of the situation

• products or commodities involved

• values expected to be placed at risk, e.g. human health

• economic concerns

• potential consequences

• consumer perception of risks, and

• the distribution of risks and benefits


The risk profile would describe the extent, including background information for expo-sure assessment and potential economical consequences of the possible management options.

3.1.4 Ranking of the hazard for risk assessment and risk management priority.

One of the decisions to be made is whether or not thorough risk analysis should be made. A decision on not to start could be based on the evaluation of available resources, the predicted possibilities to do something about the potential problem, or an evaluation on the political support for a solution. In some cases, a safety problem cannot be solved nationally, so the analysis should be conducted in an international forum. In the national administrations, an evaluation should always include the question of which part of the legislation that should cover the safety problem.

In Denmark, for example, the Government published ”Denmark: Top priority on Food Safety”, 1998, in which a total priority of the allocation of resources to the different areas responsible for food safety is found. This order of priority is based on the size of the problems and an ideal situation. For instance, with respect to Campylobacter, the Government stated in this publication that more resources should be allocated to work on the subject.

3.1.5 Establishment of a risk assessment policy A risk assessment policy has to be set wherever a value judgement relating to quality or the lack of data has to be made. Risk assessment policy has been defined by Codex as follows “Guidelines for value judgement and policy choices which may need to be applied at specific decision points in the risk assessment process”.

According to the FAO/WHO consultation report on risk management (FAO/WHO, 1997), examples of risk assessment policy setting are establishing the population(s) at risk, establishing criteria for the ranking of hazards, and guidelines for the application of safety factors. The risk assessment policy should approach questions on the safety levels required, requirement on the data used, e.g. only use data published in international peer-reviewed journals, calculation of the uncertainty/certainty or assumptions in the assessment, basis test requirements etc.

Risk assessment policy setting is a risk management responsibility, which should be carried out in full collaboration with risk assessors, and which serves to protect the scientific integrity of the risk assessment part. The guidelines should be documented so as to ensure consistency and transparency. Risk assessment policy setting can be exemplified by the establishment of population(s) at risk, by the establishment of criteria for the ranking of hazards, and by guidelines for the application of safety factors.

3.1.6 Commitment of resources The commitment of resources is an important part of the risk evaluation. A proper risk analysis will require resources for scientists, managers, analysts, communicators etc. An estimation of resources needed should form part of the risk evaluation and decision whether a risk analysis should be started or not.


3.1.7 Commissioning of a risk assessment The final conclusion of the risk evaluation should end up with either

• A decision not to carry on with the risk analysis, or

• Setting the frame for the risk assessment of the safety problem. The frame should specify which subject should be assessed, if there are special limits in the task, e.g. only qualitative data for the occurrence of a chemical component being an inherent toxicant in foods, deadlines, committed resources.

This should commission an assessment including information on which calculated un-certainties there would be in the results and highlights of which parts of the decision should be discussed with e.g. risk managers before the final conclusion is made. The un-certainties in the risk assessment could be due to use of data based on average exposure, model calculation, limited tests available etc. This would be important information for the risk managers.


3.1.8 Risk evaluation of caffeine and Campylobacter using the model

Identification of the food safety problem.

Caffeine Campylobacter

Caffeine is present in food either because it has been used as an additive or as a naturally occurring component in some types of food like coffee and tea. When caffeine is added to a product, it may be regarded as either a technological food additive or a flavouring substance. Since the intake of caffeine at certain dose levels is known to result in adverse effects, both situations require that producers who want to add caffeine must prove that it is safe before it may be used. That is, a reversed safety problem situation. Caffeine found as a naturally occurring toxicant could be identified as a food safe-ty problem due to the acute toxicity symptoms such as headaches etc. or long term effects like reproduction toxicity.

During the 1990s, many countries have ex-perienced an increase in the number of re-gistered cases of human enteric infections caused mainly by Salmonella and Campylo-bacter spp. Due to this development, the Nordic countries decided to initiate a strate-gy for the control of pathogenic microorga-nisms in foods.

Establishment of a risk profile

- The establishment of a risk profile for caffeine and Campylobacter will include se-veral elements, as mentioned above. This is described below:

Risk profile for caffeine Risk profile for pathogenic species of Campylo-bacter

A brief description of the situation Traditionally, the caffeine intake in the Nordic countries originates to a great ex-tent from the consumption of coffee. Fin-land, Sweden, Denmark and Norway, in that order, are the countries in the world with the largest per capita consumption of coffee. In addition, more food products containing caffeine are likely to be found on the market in the future because caffe-ine-containing beverages are now adver-tised on the Internet. It has been called in

A brief description of the situation Human infections caused by Campylobac-ter jejuni are an increasing problem in Nordic countries as well as the rest of Europe. The incidence of human campylo-bacteriosis in the Nordic countries is illustrated in Annex F. It is estimated that the actual number of ca-ses is approximately twenty times higher, as many patients do not consider them-selves ill enough to consult a doctor, but al-


question whether this high intake of caffe-ine could pose any health risks in the general populations or in certain subgroups of the populations in the Nordic countries. If health risks due to a high consumption of caffeine are probable (or cannot be excluded), actions of risk management should be considered.

so due to the fact that faecal specimens from patients are not always sent to bacte-riological examination in cases with a milder degree of diarrhoea. The sensitivity of the cultivation test is also lower the lon-ger the course of an illness due to a higher isolation of bacteria in the first days of illness. Men and women are affected to the same extent. Most infections occur as sporadic cases, possibly as outbreaks in households or smaller general ones, which can presu-mably be ascribed to the extraintestinal vul-nerability of the bacterium as well as the non-existing ability to reproduce in foods.


Products or commodities involved Caffeine-containing beverages like coffee, tea, soft drinks, energy drinks and medi-cines containing caffeine are commodities that may be involved. In addition, certain new food products like bread, energy bars, pizza, salmon etc. with added caffeine have occasionally been found on the mar-ket. Pharmaceutical preparations and food supplements may contribute to the total intake of caffeine with 90 - 600 mg per person per day. It is, however, complica-ted to make an estimate of the caffeine in-take from these sources because the amount of caffeine is not indicated on the labelling of many supplements.

Products or commodities involved Several investigations carried out in Europe and the USA have pointed out poultry, other meat types, unpasteurized milk, con-taminated drinking water and pets as the main sources of human campylobacteriosis. Data regarding the presence of Campy-lobacter in the primary production and in foods from the Nordic countries is presented in Annex F.

Case-control investigations concerning Campylobacter carried out during the last 15-20 years have focussed on outbreaks as well as sporadic cases of human Campylo-bacteriosis.

Outbreaks are very often associated to the ingestion of contaminated water, unpasteu-rized milk and poultry.

Since 1979, at least 15 case-control investi-gations have been carried out in e.g. Nor-way, Sweden, the Netherlands, the USA and New Zealand with a view to explain the causes of sporadic cases of human cam-pylobacteriosis. The most important risk factors in these investigations have been the following: The consumption of chicken or poultry products (10 investigations), con-tact with dogs or cats (8 investigations), the consumption of unpasteurized milk or dairy products (3 investigations), the consump-


tion of unprocessed water (3 investigations) and journeys abroad (3 investigations). The latest published European investigation co-ming from Norway includes 52 cases and 103 controls. This investigation shows that next to daily contact with dogs and the con-sumption of poultry brought home in a raw condition, the consumption of sausages pre-pared by grill posed a risk factor.

A case-control investigation of foodborne risk factors for sporadic campylobacteriosis in Denmark was carried out from May 1996 to September 1997. 227 cases and 250 control persons were matched on gender, date of birth and municipality of residence. A journey abroad posed a significant risk factor for being affected by a Cam-pylobacter infection. The following va-riables were furthermore independently as-sociated with the risk for infection: insufficiently heat treated poultry (especial-ly chicken), meat prepared by grill or fire, or bad smell or taste of drinking water in the household combined with the water supply being a private well.


Values expected to be placed at risk It is believed that the no effect level (NOEL) in healthy humans, based on the occurrence of "caffeinism", could approxi-mately be in the range of 500-600 mg/day [SCF 300 mg/kg] equivalent to 7-8 mg/kg body weight and day. The lowest observed effect level (LOEL) in humans is not well defined. It is, however, likely that for acute effects it could be found at dose levels between 10 and 15 mg/kg body weight, since it has been reported that intakes of more than 1 gram/day could result in untoward effects (based on acute toxicity). In conclusion, the margins between the desired and untoward effects seem to be small.

Values expected to be placed at risk The dose response relationship related to Campylobacter and human disease is not fully established. The infectious dose is assumed to be as low as 500 bacteria. Due to the now known and recognized obvious association between Campylobacter jejuni and the Guillain Barré Syndrome - a form of nervous condition that can cause a state of temporary paralysis - new human tests are rendered impossible.


Potential consequences Symptoms of acute toxicity include head-ache, nausea and stomach cramps, insom-nia, agitation and restlessness, tachycardia and extrasystoles. Severe intoxication may result in tremor, delirium, hypertonicity, hyperthermia, hyperventilation, tachyar-rythmias, seizures, coma and death. The lethal dose in adults is approx. 10 g, while 2-3 g has given rise to serious intoxication in a 1-year-old child. Mild intoxication has been noted in a child after an intake of 20 mg/kg body weight. There are no data concerning the lowest observed dose level resulting in acute toxicity in healthy adults, but it seems likely that early symptoms may occur at a dose level of approximately 10-15 mg/kg or possibly even at lower dose levels in sensitive individuals. On 21 January 1999, the SCF of the EU expressed the following opinion on caffe-ine and other constituents of so-called ”energy” drinks: ”For children who do not normally consume much tea or coffee, and who might substitute cola or other soft drinks with ”energy” drinks, the consump-tion of ”energy” drinks might represent an increase in daily caffeine exposure com-pared with their previous intake. For ex-ample, the consumption of 160 mg caffe-ine/day from 0.5 l of ”energy” drink would be equivalent to 5.3 mg/kg bw/day for a 10-years-old, 30-kg child. This might result in transient behavioural changes such as increased arousal, irritability, ner-vousness or anxiety”. As for chronic toxicity, 'caffeinism' or 'syndrome of coffee' are used by authors as broadly descriptive terms that lack a clear definition. The condition may appear after only a short or a prolonged intake of caffeine and may include symptoms like tinnitus, arrhythmia, nausea, vomiting, abasia (difficulty in walking) and anginoid pain. The effect level for caffeinism is >7-8 mg/kg bodyweight and day which is

Potential consequences The following thermophilic species of Campylobacter constitute the most impor-tant pathogenic species and their human pathogenic importance has undergone tho-rough documentation: C. jejuni, C. coli, C. lari. Scientific information and documenta-tion concerning gastrointestinal illness are more limited in the cases of most other spe-cies. The incubation period for the Campylobac-ter infection may vary from 24 hours to 1 week, typically 1-3 days. The typical clini-cal course is a gastroenteritis that lasts for 4-5 days. In 20% of the cases symptoms may last from 1 to 3 weeks. Reactive arthritis may occur after a Campy-lobacter infection, typically after the cea-sing of gastrointestinal symptoms, but may also occur while the patient still suffers from diarrhoea. Reactive arthritis cannot be separated from the affectation of the joints that may follow from a Yersinia, Sal-monella or Shigella infection and like these are associated with the characteristics of the tissue type HLA-B27. For years, it has been commonly known that the Campylobacter jejuni infections are associated with the Guillain Barré-Syn-drome (GBS). It is estimated that 1 ‰ of the cases of Campylobacter develop into GBS. Today, it is estimated that approxi-mately half of the GBS-cases can be associ-ated with a Campylobacter infection, typi-cally beginning with gastrointestinal symp-toms 1-3 weeks before the neurological symptoms appear.


equivalent to intakes above 500-600 mg/day for adults (70 kg). The effect of caffeine intake on serum cholesterol and lipids has been discussed in the context of coronary heart disease. Other conditions where the association with caffeine intake has been discussed are osteoporosis and different forms of cancer. The effect of caffeine on reproduction has been subject to investigation and discus-sions during the last twenty years, since teratogenic effects were observed in rodent studies. In the opinion on “energy” drinks, the SCF has also expressed that: “Risk assessment in relation to pregnancy is more difficult. Most of the available epidemiological data suggest there is no problem if the total intake is below 300 mg caffeine/day. The question of possible effects on pregnancy and the offspring at regular intakes above this level remains open. This suggests that moderation of caffeine intake, from whatever source, is advisable during pregnancy”. A report of a Nordic project assessing published studies of major interest regar-ding potential effects on human reproduc-tion will be finished in 2002. When studying chronic exposure, it is dif-ficult to assess the impact of concomitant exposures. Common confounders are to-bacco and alcohol consumption. Caffeine Campylobacter

Consumer perception of the risks According to the experience of authorities, consumers often consider new products such as energy drinks to be the most questionable and potentially dangerous type of food containing caffeine. Traditio-nally consumed beverages containing caf-feine, like coffee and tea, are seldom of

Consumer perception of the risks For many years, consumers have been in-formed about the risks associated with the presence of Salmonella in raw meat and eggs. Since Campylobacter must be recog-nized as relatively new bacteria with human health impact, consumer awareness has not been established to the same extent. Within


concern to the consumers, probably except for parents of small children and preg-nant/lactating women.

the last few years, more focus has been placed on this subject due to a more intense covering by different media.

Distribution of risks and benefits People are generally not likely to consume extremely high amounts of caffeine, because acute adverse effects like arrhyth-mia, nausea, dizziness, insomnia, headache etc. will occur, but variations in dose-response among individuals are likely to be great. Despite certain health concerns, caffeine seems generally to be a rather safe substance. However, subgroups like pregnant and lactating women and possibly (?) children and persons suffering from heart diseases may need advice regarding “maximum” daily consumption. Furthermore, products in which caffeine is concentrated constitute a danger to small children, due to the risk of accidental poi-soning.

Many people are every day benefiting from the taste of coffee and tea and the stimulating properties of caffeine. In the Nordic countries, coffee drinking is also an important social activity.

Distribution of risks and benefits As Campylobacter may be present in a wide range of basic foods like poultry, meat and vegetables without any visible signs, many of these “everyday foods” may pose a risk to the consumers if not handled safely. Related to the increasing number of human infections, it is obvious that effort has to be placed in further research in different management options including reduction programmes and information of consumers.

Ranking of the hazard for risk assessment and risk management priority.


The legislation on additives has a require-ment on risk assessment before approved use. If caffeine is classified as an additive, a risk assessment will thus have to be prio-ritized. A political decision on the regula-tion of caffeine as a food additive would have to be in line with the harmonized legislation in this field. Another decision might be in conflict with international obligations. Caffeine is found as a naturally occurring toxicant in foodstuffs that have a long tra-dition of use.

The Nordic countries have not, in general, established a procedure for the ranking of hazard for risk assessment and risk man-agement priority. In the case of Campylo-bacter, the decision was made based on the magnitude of the problem.


Establishment of a risk assessment policy for the conduct of risk assessment


For caffeine as an additive, one of the basic criteria for the approval of food additives is that the use of food additives should not endanger human health. The policy for the risk assessment is then to evaluate which levels of use will be in compliance with this. For food additives, the test requirements are formulated by the SCF (EU) and by JECFA (WHO/FAO). They include in vivo and in vitro testing after international guidelines (OECD). Test results can be both published and unpublished data. Exposure can be based either on screening methods, e.g. the Danish Budget Method (DBM) or con-sumer surveys. Allocation of an ADI is the basis for the risk management decisions. For caffeine as a natural, inherent toxicant in edible parts of food plants, the policy would be that the risk assessment should evaluate which levels could be acceptable if a minimum risk is the goal. In most cases, the acceptable risk from the intake of natural toxicants is not specified by politicians.

Examples of risk assessment policies for Campylobacter: - The use of non-validated methods for

the quantification of Campylobacter in foods might be justified, whereas vali-dated methods do not exist. Various other policies might have to be set per-taining to sampling and analysis. For example analyzing faecal samples from broilers might be considered to have acceptable sensitivity, although some experts claim that sampling appendices might give better sensitivity.

- Dose-response models have to be gene-

rated from various sources in the ab-sence of a good animal model and the fact that human challenge studies can-not be justified because of the risk of Guillain Barré syndrome and other seri-ous complications.

- Determination of a baseline for Campy-

lobacter incidence. This might be fea-sible as case control studies indicate that only a portion of registered cases can be traced back to known sources such as eating or handling of poultry meat, attending to young pets, drinking unpasteurized milk etc.

- The risk of Guillain Barré syndrome

and other serious complications might or might not be taken into account when ranking the hazard of Campylobacter.

- Assuming that the infectiousness of all

viable Campylobacter is the same, re-gardless of food matrix or previous handling.

In Denmark, it was recommended on the basis of the existing results including the case-control investigation from the Danish


Zoonosis Centre that an actual risk assess-ment should be carried out concerning the existence of Campylobacter jejuni in foods and water. An actual strategy for the assessment in question would be prepared as the initial step. However, recommending the implementa-tion of a risk assessment for Campylobacter jejuni happens with reservations that insuf-ficient data concerning other possible sour-ces of infection, other risk factors and ty-ping methods etc. may be generated simul-taneously with or connected to the work process with the actual risk assessment. These reservations are being put forward here since otherwise there would not be the necessary scientific basis for the risk as-sessment itself and the concurrent use for e.g. the determination of microbiological criteria.

Commitment of resources Caffeine Campylobacter

Resources have been allocated though the international scientific cooperation with Codex and the EU and the substance has been evaluated in JECFA and in EU’s Scientific Committee on Food. The Nordic Council of Ministers has allocated resour-ces for the assessment of caffeine (a natu-rally occurring toxicant) in relation to adverse effects in pregnant women and their foetuses.

Before a final decision is made, an estimate of the need for resources should be calcula-ted and decided on as part of the decision. In all the Nordic countries, it was decided to allocate resources to work in this area. Furthermore, it was decided that significant pathogenic microorganisms in foods should be handled by the principles for food safety risk analyses currently being established in different international fora e.g. the World Health Organization, the Food and Agricul-ture Organization, the Codex Alimentarius Commission and the European Commis-sion. However, resources are furthermore needed for the development of methods of e.g. analysis and typing. A discussion and deci-sion is needed whether private enterprises shall provide the authorities with documen-tation for occurrence, analysis etc.

62 Risk assessment


The final conclusion of the risk evaluation should end up with either

• A decision not to carry on with the risk analysis, or

• Setting the frame for the risk assessment of the safety problem. The frame should specify which subject should be assessed, if there are special limits in the task, e.g. only the occurrence of a chemical component found as inherent toxicant in foods, deadlines, committed resources.


As caffeine as food additive can be accepted only after a risk assessment, the risk assessment has to be performed, either in the national food administration or in the SCF. The frame is set in the basic criteria in the EU directive 89/107/EEC. Caffeine is found in traditionally used food items, and risk assessment will have to include all new, scientific results in order to have sufficient background information in the food inspection to evaluate and decide whether these food items can still be accepted on the market in accordance with the general requirements in the Food Acts or whether guidance to consumers is sufficient.

Campylobacter is found in traditionally used food items, and a risk assessment will have to include all new, scientific results in order to make decisions in the food inspec-tion as to whether these food items can still be accepted on the market in accordance with the general requirements in the Food Acts.

3.2 Risk assessment Risk assessment consists of 4 steps (both for chemical components and for zoonoses):

- Hazard identification

- Hazard characterization

- Exposure assessment

- Risk characterization

The risk assessment is finalized by the consideration of the assessment result. These steps will be discussed in the following, including considerations on the risk assessment of caffeine and Campylobacter.

63 Risk assessment

Risk assessment should be based on science and should be transparent and conducted according to structured approach. Furthermore, risk assessment should comprise a presentation of uncertainties, assumptions and variability of inputs. It should be reas-sessed and re-evaluated over time, include the presentation of costs, resources and time (CAC) and finally it should be flexible and related to real life situations (OIE), see below9.

3.2.1 Hazard identification

Hazard is defined as: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

Hazard identification is defined as “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 food”.

In most cases, a hazard will be identified by scientists like food toxicologists, microbio-logists, medical doctors or other professionals.

The “ideal model” for the decision procedure and for finding the decision-makers in the hazard identification step would comprise the initiation of a risk evaluation of the pro-blem, once the food safety problem was identified. As a result of the risk evaluation, a risk assessment could be started. Then the starting point would be the solid documenta-tion included in the risk profile.


The intention of this chapter is to give a brief review of sources of caffeine, ob-served adverse effects in humans, some in-formation about effects on reproduction in experimental animals and effects in in vitro systems. It is, however, by no means intended to in-clude a complete risk assessment of caffe-

Hazard identification of zoonoses can, in general, be described as in Annex H. Concerning Campylobacter, hazard identi-fication started in the 1970s (with the deve-lopment of suitable selective media and cultivation methods). It was then estab-lished that Campylobacter jejuni and to a lesser extent Campylobacter coli were

9 Codex Alimentarius Commission (CAC), Principles and guidelines for the conduct of microbiological risk assessment (Step 8, Rome 1999, FH), Scientific Committee for Food (EU), Principles for the development of risk assessment of microbiological hazards under Dir. 93/43 EEC concerning the hygiene of foodstuffs (1998), and International Office of Epizootics (OIE), Import risk analysis (International animal health code 1999).

Risk assessment – OIE definition

The evaluation of

• likelihood and

• the biological and

• economic consequences of: entry, establishment or spread of a pathogenic agent within the territory of an importing country

64 Risk assessment

ine. It should be noted that the conclusions regarding caffeine presented in this report are entirely based on review documents (see reference list).

Short historical background In 1980, the American Food and Drug Ad-ministration (FDA) issued warnings to wo-men to avoid caffeine-containing bevera-ges during pregnancy. This recommenda-tion was based on results from studies on experimental animals, which had shown te-ratogenic effects of caffeine in very high doses. In the last two decades, many epide-miological studies have been conducted in order to investigate whether the intake of caffeine could affect pregnancy outcome. These studies have predominantly been performed in the US and Canada, but there are also some European studies.

Sources of caffeine in the Nordic countries The caffeine intake in the Nordic countries originates traditionally to a great extent from the consumption of coffee. As a mat-ter of fact, the Nordic countries are known to have the highest per capita consumption of coffee in the world. Another source of caffeine in the Nordic countries is caffeina-ted soft drinks, which probably is the main source of caffeine for children. It should also be mentioned that caffeine is found in several medical preparations, used in the Nordic countries. In addition, more food products containing caffeine are likely to be found on the market in the future.

Human data

Pharmacology Caffeine is known to affect many tissues in the body. Effects on the central nervous system include the increase of spontaneous electrical activity, enhancement of neuro-transmitter release, induction of convulsant activity, stimulation of locomotor activity, and increase of operant response rates. A positive inotropic/chronotropic effect on the heart, increased diuresis in the renal system, dilation in peripheral vasculature

major causes of human diarrhoeal illness. Campylobacter is now rivalling and even surpassing Salmonella in importance in many countries. In 1997, the incidence rate of Campylobacter had exceeded that of Salmonella in Spain, Sweden, The Nether-lands, Scotland, Northern Ireland, and England and Wales. In 1999, Campylobac-ter became the most frequent recorded cause of human foodborne infections in all the Nordic countries, with the following incidence pr. 100,000 citizens: 81 (S), 78 (DK), 46 (N), 56 (FIN) and 159 (Icel.) (see Annex H, Fig.1). In general, the incidence only reflects labo-ratory-confirmed cases of human Campy-lobacter infections, i.e. only the cases where the patients have consulted the health care system and where Campylobac-ter has been detected afterwards in a stool sample, i.e. only a fraction of the true num-ber of infections. The true rate of infection is considered to be 10-100 times as high as the number of reported cases. Characteristics of the organism

Campylobacters are non-sporeforming, oxidase-positive, Gram-negative rods. Cells are pleomorphic. Log-phase cells have a characteristic slender, curved or spi-ral shape and have flagella, usually single, at one or both poles (monotrichate or am-phitricate) and are highly motile, spinning around their long axes and frequently re-versing direction. As cultures age, spiral or curved forms may be replaced by coccoid forms. In general, Campylobacters do not grow in conventional aerobic or anaerobic culture systems. Campylobacters do not ferment or oxidize sugars and are oxygen-sensitive microaerophiles, growing best in an atmosphere containing 5-10% oxygen. Most strains grow in sloppy media (0.16% agar) incubated aerobically and suitably supplemented with oxygen scavenging compounds (e.g. blood, haemin, inorganic iron salts, pyruvate and charcoal).

65 Risk assessment

and constriction in central vasculature are effects that have been observed. Further-more, caffeine stimulates an increase in gastric secretion in the gastrointestinal sys-tem and relaxes bronchial smooth muscle in the respiratory system. Tolerance has been shown to develop to some effects of caffeine. A withdrawal syndrome has been described, which see-mingly does not relate to the quantity of the daily intake. The reinforcement func-tion of caffeine is very limited. When the dose is increased, there is a rapid transition from positive to negative effects, which makes the augmentation of caffeine intake self-limited. This phenomenon should therefore be considered in the context of acute toxic effects (see below). Caffeine might be considered to fulfil some of the WHO criteria for dependence, but is not comparable to psychoactive drugs classi-fied and regulated as addictive drugs.

Adverse effects in humans Data on humans consist of clinical, epide-miological studies and case reports. The following adverse effects have been repor-ted:

Acute toxicity Symptoms include headache, nausea and stomach cramps, insomnia, agitation and restlessness, tachycardia and extrasystoles. Further intoxication may produce frequent vomiting and pronounced diuresis. Severe intoxication may result in tremor, delirium, hypertonicity, hyperthermia, hyperventila-tion, tachyarrythmias, seizures, coma and death.

Subchronic and chronic toxicity Caffeinism or “syndrome of coffee” is used by authors as a broadly descriptive term that lacks a clear definition. The condition may appear after only a short or a pro-longed intake of caffeine and may include symptoms like tinnitus, arrhythmia, nau-sea, vomiting, abasia and anginoid pain.

C. jejuni and to a lesser extent C. coli are the species most often encountered in me-dical laboratories as causes of acute entero-colitis in man. They are distinguished from most other Campylobacters by their high optimum growth temperature (42°C). C. jejuni has two subspecies; subsp. jejuni – the familiar cause of enterocolitis in man and subsp. doylei – a more fastidious and slower growing organism which does not grow at 43°C. C. upsaliensis also appear to be enteropathogenic for man. This species is related to the “thermophilic” Campylo-bacters though not all strains grow at 43°C. As primary isolation of this species usually requires the use of selective filtra-tion and non-selective media incubated at 37°C, this species is seldom detected by conventional methods used for C. jejuni and C. coli. C. lari is “thermophilic like C. jejuni and C. coli but is of low virulence and encountered only occasionally in man. Reservoir

The principal reservoir of pathogenic Cam-pylobacter spp. is the alimentary tract of wild and domesticated animals and birds. It is evident that Campylobacter is common-ly found in broilers, fowls, cattle, pigs, wild animals and birds, and in dogs. Other investigations have shown that healthy puppies and kittens, rodents, beetles and houseflies may also carry Campylobacter. Water is also an important part of the eco-logy of Campylobacter. Campylobacter has been isolated from surface water, ri-vers, and lakes at prevalence up to about 50%. Additionally, Campylobacter has been found in sand from bathing beaches at a prevalence of 45%. This means that Campylobacter may be present in untrea-ted drinking water and bathing water. Campylobacter is introduced into the water by sewage and faeces from wild animals and birds. The isolation frequency of Cam-pylobacter from water is highest in cold winter months. This is explained by a high-er survival rate at low temperatures. It has been shown that in water C. jejuni survived

66 Risk assessment

The effect of caffeine intake on serum cho-lesterol and lipids has been discussed in the context of coronary heart disease. The re-sults of published investigations on this theme seem to vary considerably, which makes it difficult to draw any firm conclu-sions concerning the relation between caf-feine intake and heart diseases. Other con-ditions that have been subject to discussion in association with caffeine intake are oste-oporosis and different forms of cancer. It seems, however, highly unlikely that nor-mal exposure to caffeine via foods and beverages will induce mutations in man. The conclusion of the International Agency for Research on Cancer, which evaluated caffeine, theophylline and theobromine in 1991 (IARC, 1991), is that there is inade-quate evidence for the carcinogenicity of caffeine in humans and experimental ani-mals. The reproductive effects of caffeine have been subject to investigation and discus-sion during the last twenty years, since te-ratogenic effects had been observed in rodent studies. According to the opinion of the Scientific Committee for Food, (21 January 1999) ”contradictory results have been noted in human studies on the effects of prenatal caffeine intake on birth weight and on the incidence of spontaneous abortions. Some reviews attribute apparent effects of caf-feine on birth weight to the confounding effect of smoking. No clear association has been established between caffeine intake in early pregnancy and spontaneous abortion or delayed conception. Similarly, there are no consistent associations between prenatal caffeine exposure and pre-term delivery or congenital malformation. In many of the human studies reviewed, caffeine consu-mers have been subdivided into low, mo-derate and high consumers for the analysis of data. In those studies, indicating effects on pregnancy outcome, the association

for one to over four weeks at 4°C, whereas at 25°C the bacterium persisted for only 4 days. Another study has shown that C. je-juni remained recoverable for up to four months when suspended in aged, filter-sterilized stream water held at 4°C. At 25°C and 37°C, the bacteria became non-culturable within 28 and 10 days, respec-tively. In water and other environments with sub-optimal growth conditions, Campylobacter may convert into a “viable but noncultu-rable state”. The importance of this “state” in the transmission of Campylobacter to animals and man is not agreed upon. The question is if the viable nonculturable or-ganisms are still virulent or if they can reverse into a culturable, virulent state after passage through a host. In some studies “viable but nonculturable” organisms have shown to regain culturability after passage through for example chicks, mice and rats. In other studies, it has not been possible to demonstrate that “viable but noncultu-rable” Campylobacter can change into a culturable state. C. jejuni and C. coli seem to have a fa-voured reservoir. C. jejuni is predominant-ly associated with poultry, but has also been isolated from cattle, sheep, goats, dogs and cats. C. coli is predominantly found in pigs, but has also been isolated from poultry, cattle, and sheep. In a Nor-wegian survey, 100 percent of the pigs examined were infected with C. coli.

67 Risk assessment

with caffeine was confined to large-scale consumers. Studies on prenatal caffeine exposure have shown no consistent behavioural or cogni-tive effects on children either at pre-school or school age. A long-term follow-up study in children whose mothers were exposed to 150-200 mg caffeine/day during pregnancy found no clear effects on mental develop-ment, psychomotor functions or behaviour up to 7 years of age. Caffeine appears in breast milk but has not been detected in the urine of breast-fed in-fants even when maternal caffeine con-sumption was high.” In children directly exposed to caffeine, hyperactivity, transient behavioural chan-ges such as increased arousal, irritability, nervousness or anxiety have been observed in some studies but not in others. Thus it still seems controversial whether these effects could be ascribed to caffeine intake or not. In conclusion, possible susceptible sub-groups may be pregnant and lactating wo-men, foetuses, babies born prematurely and possibly older children, directly exposed to caffeine. In addition, patients suffering from heart diseases may possibly also con-stitute a risk group, although data regar-ding this relation seem to be conflicting. When studying chronic exposure, it is dif-ficult to assess the impact of concomitant exposures. Common confounders are to-bacco and alcohol consumption.

Data from studies in experimental animals A great amount of toxicological investiga-tions of caffeine in many animal species has been published.

The pharmacokinetics of caffeine varies by species, which implies great caution when assessing data from experimental animals in order to predict what will occur in man.

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According to the opinion of the Scientific Committee on Food, (21 January 1999): ”caffeine exposure during pregnancy in rodents is associated with intrauterine growth retardation, increases in resorptions and malformations, particularly facial clefts and ectrodactyly. A 2-generation stu-dy in rats showed reduced pup weights. Low dose exposure during pregnancy in rats caused only inconsistent post-weaning behavioural effects in the offspring. Higher doses were associated with lower birth weights and delayed physical development. One study in primates has shown caffeine exposure to be associated with increased still births, miscarriages, reduced birth weight and impaired postnatal performance in a behavioural task. Some studies suggest caffeine is a competitive inhibitor of ben-zodiazepine receptors at very high doses and at low doses to have a selective affini-ty for adenosine receptors, thus acting as an inhibitory neuro-modulator.“

Caffeine has been known to be mutagenic in various experimental systems since 1949. The doses used to induce mutations in various short-term tests were much higher than the doses man is exposed to via the consumption of caffeine-containing foods and beverages.

In conclusion, very high doses of caffeine give rise to congenital malformations in experimental animals. These doses are much higher than humans will ever be ex-posed to. This is also the case for the muta-genic effects of caffeine. Thus, the rele-vance of data from studies of caffeine on experimental animals for risk assessment is very limited.

Mechanisms The most likely mechanism for many of the observed pharmacological effects is a competitive antagonism for adenosine re-ceptors, and possibly also a competitive in-hibition of dopamine activity.

The mechanisms involved in the reproduc-ti ff t t t k

69 Risk assessment

tive effects are not yet known.

Uncertainties The effects on human reproduction and the significance of effects that have been ob-served in children directly consuming caf-feine is still controversial. In addition, data concerning the relation between caffeine intake and heart diseases are conflicting.

Lacking information Information about probable mechanisms that could explain the reproductive effects observed is lacking.

3.2.2 Hazard characterization

Hazard characterization should be the next step in the risk assessment. In Codex, the de-finition of hazard characterization is the following: “The qualitative and/or quantitative evaluation of the nature of the adverse health effect associated with biological hazards, chemical and physical agents, which may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if data are obtainable”.

In the “ideal model situation”, the data used for the hazard characterization step would be in accordance with international guidelines and code of practices for the testing of dose-response etc.


Pharmacokinetics The information in this section is entirely based on James JJ., (1991) and Debry G. (1994).

The absorption of caffeine is rapid and al-most complete after oral ingestion. The caffeine dose and food in the intestine may affect absorption. The maximal plasma concentration is reached within about 30 minutes to one hour after ingestion. The rate of absorption of caffeine is the same from coffee and tea. The rate of absorption is slower for caffeine in soft drinks than for coffee and tea, depending on lower pH in soft drinks.

Virulence / pathogenicity In general, the mechanisms involved in the pathogenesis of Campylobacter are rather poorly understood. Motility, chemotaxis and the flagella are known to be important factors in the virulence as they are required for the attachment and colonization of the intestinal epithelium. Once colonization has occurred, Campylobacter bacteria may perturb the normal absorptive capacity of the intestine by damaging epithelial cell function either directly, by cell invasion and/or production of toxin(s), or indirectly, following the initiation of an inflammatory response. Several virulence determinants have been described to be involved in the

10 Andersson C.; Hallström H., and Kihlman B.A., in press

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Caffeine is readily distributed throughout the entire body and crosses the placenta into the foetus and passes into breast milk. There is no accumulation of caffeine in any tissue or organ.

The biotransformation of caffeine is per-formed primarily in the liver. CYP1A2 is the most important enzyme in caffeine metabolism. Caffeine metabolism is com-plex. Three major types of metabolites are the products of a) demethylations, b) oxi-dation of uric acid and c) ring opening to diamonouracils. Principle metabolites found in plasma are paraxanthine, theobromine and theophylline.

Elimination half-life (t1/2) in humans varies between 3 and 7 hours. Genetics (pheno-types of acetylations) results in inter- and intra-individual variations in caffeine eli-mination. Young age, pregnancy, using oral contraceptives and the intake of alcohol increase the time for elimination. It should be noted that in the foetus and new-born elimination half-life (t1/2) of caffeine is much longer than in adults; (4 days).

Furthermore, it is known that smoking de-creases the time for elimination. Other fac-tors known to affect caffeine elimination in various ways are sex, medication and dis-ease.

Dose effect relationships Plasma levels of caffeine in coffee consu-mers are commonly 0.2-2 microgram/ml. Shortly after the consumption of 3 cups of coffee, the level increases to around 10 microgram/ml. The ingestion of 800 mg caffeine in tablet form during 30 days equi-librates the caffeine level in plasma to around 30 microgram/ml. Pharmacological (and toxicological) effects of caffeine start to appear when the plasma concentration reaches 10-30 microgram/ml.10

induction of diarrhoea; adhesion and inva-sion molecules, outer membrane proteins, lipopolysaccharides, stress proteins, flagel-la and motility, M cells, iron-acquiring mechanisms, and cytotonic and cytotoxic factors. However, their relative role and importance for the development of diar-rhoea is not quite clear. Not all strains involved in human enteritis produce toxins, and no correlation has been found between serotype and toxin production.

Susceptibility Populations at risk often include the elderly, children and individuals suffering from illnesses that compromise their im-mune systems (e.g. aids and cancer pa-tients). As regards campylobacteriosis, young adults (around 15-25 years old) ap-pear to be more susceptible or more fre-quently exposed than other age groups.

Vehicle The vehicle with which Campylobacter bacteria are ingested is important for the development of illness. In a volunteer fee-ding experiment, the illness rate was higher in volunteers given the organisms in bicar-bonate as compared to milk. This can be explained by the barrier effect of the gas-tric acid, which is reduced when Campy-lobacter bacteria are ingested with a buffe-ring vehicle.

Dose-response The infectious dose depends upon a num-ber of factors including the virulence of the strain, the vehicle by which it is ingested and the susceptibility of the individual.

Dose-response investigations The infectious dose of C. jejuni has been investigated in a few experiments invol-ving volunteers. In one experiment, a dose of 500 organisms ingested with milk caused illness in one volunteer. In another experiment involving 111 healthy young adults from Baltimore, doses ranging from 800 to 20,000,000 organisms caused diar-

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rhoeal illness. The rates of infection in-creased with dose, but the development of illness did not show a clear dose relation. In an outbreak at a restaurant, the number of C. jejuni in the causative chicken meal was estimated to 53 to 750 Campylobacter per g.

These few investigations indicate that the infectious dose of C. jejuni may be rela-tively low.

The mathematical relationship between the ingested dose and the probability of infec-tion (or illness) can be applied to quantify the risk of acquiring an infection by expo-sure to known numbers of Campylobacter via a certain vehicle.

Immunity Patients suffering from campylobacteriosis may develop immunity for the causative Campylobacter strain (for a period of time). Acquired immunity may explain why employees in broiler slaughterhouse get campylobacteriosis in the beginning of an employment, but not after a while. In addition, a higher rate of poultry and meat process workers than the normal popula-tion has been found to have complement-fixing antibody against Campylobacter.

Acute toxicity The LOEL for symptoms of acute toxicity is not known. This may be explained by the fact that untoward effects may appear even at low dose levels, but their severity is influenced by the wide individual variation and development of tolerance. However, it appears likely that the margins between the NOEL and the LOEL could be small. Mild intoxication was noted in a child after an intake of 20 mg caffeine/kg body weight. The lethal dose for human beings is 150-200 mg caffeine/kg body weight. Intakes of 6-12 g have given rise to lethal intoxications in adults. Chronic toxicity (adults and children) The effect level for caffeinism is >7-8

Disease Enteropathogenic Campylobacter can cause an acute enterocolitis, which is not easily distinguished from illness caused by other pathogens. The incubation period may vary from 1 to 11 days, typically 1-3 days. The main symptoms are malaise, fe-ver, severe abdominal pain and diarrhoea. Vomiting is not common. The diarrhoea may produce stools that can vary from pro-fuse and watery to bloody and dysenteric. In most cases the diarrhoea is self-limiting and may persist for up to a week, although mild relapses often occur. In 20% of the cases, symptoms may last from one to three weeks. Excretion of the organism

11 Andersson C., Hallström H., and Kihlman B.A., in press.

72 Risk assessment

mg/kg body weight and day which is equi-valent to intakes above 500-600 mg/day for adults. The effect levels for other conditions that have been discussed in the context of serum cholesterol and lipids coronary heart disease are not known. According to the opinion of the Scientific Committee on Food: ”studies on the effects of direct caffeine consumption by pre-school and school children have given variable results. In experimental studies in which single doses up to 10 mg/kg bw have been given to children, either no effect or small, inconsistent effects have been noted on mood, behavioural, cogni-tive and motor functions, some of which could be interpreted as beneficial. Some of these studies indicated that a dose of 5 mg/kg bw increased arousal, irritability, nervousness or anxiety in some subjects, particularly if they were normally low con-sumers of caffeine.” (Scientific Committee on Food, 1999) Caffeine and potential effects on reproduction In high doses (more than 50 mg/kg body weight in mice and 80 mg/kg body weight in rats) congenital malformations (orofa-cial clefts and ectrodactyly) have been ob-served in the offspring of rodents. A dose of 50 mg/kg body weight in rodents corre-sponds to a human daily intake of 3,500 mg of caffeine (approx. 35 cups of strong coffee). In addition, at doses below 100 mg/kg body weight, teratogenic effects in rodents have been observed only when the total dose has been administered by gavage at a single occasion. When the same total dose was administered at several occasions during the day, i.e. in a way that resembles the human intake via foods, the teratogenic effects of caffeine was greatly reduced11. No increase of malformations has been ob-served in human studies. The Scientific Committee on Food has sta-ted that: “In general, maternal caffeine

may continue for up to 2-3 weeks.

Late complications Late complications may follow gastrointes-tinal infections caused by various food-borne pathogens including infections with Campylobacter. The late complications as-sociated with Campylobacter infections are reactive arthritis, the Guillain Barré syn-drome and the Miller Fisher Syndrome. These complications show different pic-tures of symptoms or disorders. In rare cases, Campylobacter has shown to cause the serious disease, Guillain Barré syndrome (GBS), a demyelating disorder of the peripheral nervous system. GBS has been estimated to occur about once in eve-ry 1000 cases of campylobacteriosis. Campylobacteriosis has also been associa-ted with the Miller Fisher Syndrome, which is considered to be a variant of the Guillain Barré syndrome. In general, very few deaths are related to Campylobacter infections and these deaths do usually occur among infants, elderly and immuno-suppressed individuals. Antimicrobial resistance

Development of antimicrobial resistance may compromise the treatment of patients with bacteremia. In the beginning of the 1990ies, fluoroquinolone-resistant C. jejuni emerged in human populations in Europe as reported in the UK, Austria, Finland and the Netherlands. This resistance has been linked to the approval of enrofloxacin for the treatment of diseases of broiler chic-kens as investigations have shown that flu-oroquinolone-sensitive C. jejuni strains were able to convert to resistant forms when fluoroquinolone was added to broiler chicken feed.

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consumption during pregnancy does not appear to have any measurable adverse consequences for the human foetus at in-takes up to 300 mg/day.”

Conclusions including uncertainties The effect level for caffeinism is >7-8 mg/kg body weight and day which is equi-valent to intakes above 500-600 mg/day for healthy (non-pregnant) adults. ”Risk assessment in relation to pregnancy is more difficult. Most of the available epi-demiological data suggest there is no pro-blem if total intake is below 300 mg caffe-ine/day. The question of possible effects on pregnancy and the offspring at regular intakes above this level remains open.” (Scientific Committee on Food, 1999). A Nordic report on risk assessment of caffeine is in press, 2002. A caffeine intake equivalent to approxi-mately 5 mg/kg bw daily for a child of 10 years could result in transient behavioural changes, such as increased arousal, irritabi-lity, nervousness or anxiety. However, this opinion has been discussed and in conclusion it still seems controver-sial whether these effects could be ascribed to caffeine intake or not.

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3.2.3 Exposure assessment

Exposure assessment is defined in Codex as “The qualitative and/or quantitative evalua-tion of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant”.

Exposure assessment is a subject dealt with in many international guidelines on e.g. food additives, pesticides, flavourings etc. Exposure assessment is based on scientific knowledge on intake pattern, consumption surveys etc. As consumption surveys are ve-ry expensive and as the consumption pattern changes over time, the assessments are in many cases based on models simulating the real intake of food. These models are often developed in international cooperation and accepted in the guidelines for risk assess-ment. The exposure assessment should include an evaluation of the problems of cross contamination and possible differences in hygienic behaviour, both in the industrial pro-duction and in production made by the consumer at home. Some parts of the fundamen-tal assumptions are, however, management decisions and should be incorporated in the risk assessment results as uncertainties. Furthermore, the exposure assessment will often include decisions on how big a percentile of the population should be secured. This is also a risk management decision.

The “ideal model” for the decision procedure and for decision-makers in the exposure assessment step would be that risk assessors include the uncertainties and assumptions in their assessment report and enable the risk managers to make the final decision of the uncertainties.


In the assessment of caffeine exposure to humans, the sources, the content of caffe-ine in the sources and human intake is ta-ken into account. Exposure assessment can be conducted in different ways, either mean consumption, market basket, inter-view studies on consumer or model calcu-lations. The figures given in Annex G are mean figures, and in order to estimate the uncertainties in these figures, the distribution has to be known or estimated. Furthermore, the content of natural inherent toxicants is not stable, but can differ from year to year, depending on the conditions for growth of the plants. Data in this section are based on a lecture held by Christer Andersson, National Food Administration, Uppsala Sweden (see Annex A), which was based on a coming Nordic report: Intake of methylated oxypu-rines during pregnancy and risk for adverse effects in pregnant women and their fe-tuses, by Andersson C., Hallström H., and

Behaviour during processing As Campylobacter is a common inhabitant of the gastrointestinal tract of warm-bloo-ded animals, faeces content will inevitably contaminate the meat during slaughter and evisceration. As regards cattle and pigs, the number of Campylobacter has shown to decline during the slaughter processes. This decline is primarily a consequence of the dehydration that takes place during cooling with forced ventilation procedures. In 1995, a Danish investigation of 600 pig carcasses showed that the chilling proce-dure reduced the prevalence of Campylo-bacter on the carcass surfaces from 43-85% to 11-18%.

Contrary to the processing of cattle and pig, broiler processing does not tend to re-duce the Campylobacter prevalence signi-ficantly. Scalding, plugging, cooling, free-zing and subsequent storage do not elimi-nate the organism, they only reduce the

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Kihlman B.A., (in press). This exposure assessment is intended to be a brief review of relevant exposure data derived from the mentioned references. For more details, see references. Caffeine occurrence Caffeine has been found in at least 60 different plants, but only some of these are used in the production of foods. In Annex F, table 1 below, some well-known sources of caffeine are presented. Levels in food including the effects of proces-sing (See also Annex A). Caffeine is a naturally occurring ingredient in the beverages cocoa, guarana, maté (pa-raguayan tea), tea, yaupon (cassina tea) and yoco, as well as in chocolate and the chewed cola nut. Caffeine is also found in cola drinks and other soft drinks like ener-gy drinks and smart drinks and medicinal drugs. In these cases, however, purified or synthesized caffeine has been added to the product during production. A brief summary of caffeine contents of the most important beverages and foods containing caffeine is given below. See Annex G, table 2. Cocoa The seeds contain 1.8-3.8% theobromine and 0.1-0.8% caffeine. Cacao liquor or ca-cao mass contain on average around 1.2% theobromine and 0.2% caffeine. Common-ly reported average amounts of theobro-mine and caffeine in chocolate products are: Dark chocolate Theobromine (mg/kg) Caffeine (mg/kg) 4 600 700 Milk chocolate Theobromine (mg/kg) Caffeine (mg/kg) 1 530 220 Since cacao and chocolate are used in the production of many types of baked pro-ducts (cakes, cookies) and deserts, a ser-i f th d t t i 25 250

concentration. Investigations of broiler processing plants have shown that C. jejuni is present at all stages of production when a Campylobacter positive flock has passed the equipment. This means that cross-con-tamination between broilers takes place du-ring processing.

General growth and survival characteristics The general growth characteristics of Cam-pylobacter are seen in Annex H, table 1. From this, it appears that Campylobacter grows at 37°C, but not below 32°C, i.e. in general, Campylobacter does not multiply during slaughtering, post processing, trans-port and storage. However, the organisms may survive these steps, especially when the temperature is low. In various food items, survival has been recorded after se-veral weeks of storage at 4°C and in frozen poultry after several months. Though Cam-pylobacter may persist for prolonged peri-ods in chilled and frozen products, a reduc-tion in the concentration and a decline in the viability are observed during storage. Campylobacter is particularly sensitive to drying and reduced pH. For example Cam-pylobacter is inhibited at pH values below 5.1. In addition, Campylobacter is sensi-tive to salt concentrations above 1.5%. C. jejuni and C. coli are rather sensitive to heat and do not survive cooking or pasteu-rization temperatures (D-values are 0.21-2.25 minutes at 55-60°C).

Prevalence in food The incidence of Campylobacter in food has been registered in the EU. These data show that especially poultry meat is infec-ted with Campylobacter (prevalence up to 85.7%). At low frequencies, Campylobac-ter has also been found in beef, pork, other meat products, raw milk and milk pro-ducts, and in fish and fish products. In 1996, also oysters and mussels were found to contain Campylobacter at the prevalence of 11% and 58%, respectively. Other food items, from which C. jejuni has been detec-ted, are mushrooms, fresh vegetables such

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ving of these products may contain 25-250 mg theobromine and 5-30 mg caffeine. Coffee The caffeine content of coffee beans is on average 1.7%; ranging from 1.2 to 2.2 % depending on the type of bean (C. arabica, C. canephora and C. liberica), type of grounds and roasting. The method of pre-paring the coffee (boiling coffee, filter cof-fee (also called brewed coffee) percolated coffee, infusions, espresso, mocha coffee, Greek coffee/Turkish coffee, instant (so-luble) coffee) greatly influence the amount of caffeine in the consumed product. The average caffeine content of instant coffee, percolated coffee and filter coffee from 13 studies (5 from the US, 2 from Australia, 3 from the UK, 2 from Canada and 1 from South Africa) were 53, 84 and 103 mg/cup (150 ml), respectively. Guarana The seeds are extremely rich in caffeine, 2-6% on a dry weight basis, and also contain small quantities of theophylline (0-0.25%) and theobromine (0.01-0.06%). In the Nor-dic countries, exposure to methylxanthines from guarana mainly occurs via energy drinks and smart drinks. Maté The leaves of maté (Ilex paraguariensis) have been found to contain between 0.8-2.0% caffeine. The consumption of maté is negligible in the Nordic countries. Tea The average caffeine content of young leaves of first flush shoots of Assam tea (var. assamica) is 4.1%, (range: 2.7-5.5%), and that of China tea (var. sinensis) and Ja-pan tea (var. sinensis) to be 3.1% (range: 1.6-4.6%) and 2.9% (range: 1.9-3.9), respectively. Measurements of the methylxantine con-tent in the tea beverage shows that fairly similar amounts are found in bag tea and

as spinach, lettuce, radish, green onions, parsley and potatoes.

Prevalence in retail products In Denmark, the prevalence of thermophi-lic Campylobacter in retail poultry pro-ducts has been surveyed since 1995 (Annex H, figure 3). From 1995 to 1999, the prevalence of thermophilic Campylo-bacter has decreased in both Danish and imported products. In Danish and imported turkey products, the prevalence is similar. The influence by season on the prevalence of Campylobacter, which is seen in broiler flocks, is reflected in chilled retail chicken products, the prevalence being higher in summer than in winter. The prevalence of thermophilic Campylobacter tends to be higher in chilled chicken products than in frozen products, and this is the case for both Danish and imported products except from Danish products sampled in the low prevalent winter period.

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leaf tea, but the quantity depends on brew-ing time. A 150-ml cup of tea, prepared ac-cording to the suggestion of the tea produ-cer, contains 31 mg caffeine and 2-3 mg theobromine on average and very low le-vels of theophylline. Cola The plant tissues contain approximately 5% caffeine. Kola furnishes the base for many types of cola soft drinks. However, the amount used for flavouring would pro-vide only a few milligrams of caffeine per Cola bottle. Therefore, in order to make the beverages popular, synthetic (or purified) caffeine is added. A can (360 ml) of a typi-cal Cola drink usually contains between 30 and 45 mg caffeine. The maximum content of caffeine allowed in Cola drinks and caf-feinated soft drinks is 135 mg/litre. Other types of caffeinated beverages Beverages belonging to this group are energy drinks and smart drinks. Energy drinks may contain higher quantities of caffeine than soft drinks. The Ministry of Agriculture Fisheries and Foods in the United Kingdom measured the caffeine content in 26 energy drinks and found a mean content of 60 mg per 250-ml can. Smart drinks contain caffeine and are often also stuffed with vitamins, ginseng, and other ingredients. The level of caffeine in smart drinks is not known.

Medicinal drugs containing caffeine Within the Nordic countries at least 50 dif-ferent drugs containing caffeine are marke-ted. The amount of caffeine usually present in these pharmaceuticals is 50 or 100 mg/tab-let or about 2-3 mg/ml mixture. Pharma-ceuticals intended to give strength, called tonics, have lower caffeine contents, and give intake values ranging from 90 to 112.5 mg/day. A daily dose of pharmaceu-tical preparations and food supplements

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etc. may contain 90-600 mg caffeine. The caffeine content is not always declared. Estimated intake and consumption pattern

General considerations It is very difficult to estimate the total daily individual intake of caffeine. Most esti-mates are on the population level, general-ly based on per capita calculations. In the Nordic countries, people are general-ly considered to have higher coffee con-sumption than people elsewhere, and cof-fee consumption gives the predominant contribution to caffeine intake. Gilbert (1984) estimated the per capita intake of caffeine from all food sources in Sweden to be 425 mg/day in 1982/1983. The ave-rage intake of caffeine in Denmark has been estimated to 490 mg/day. High consumers of caffeinated beverages in Denmark ingested 1,043 mg caffeine per day. The estimated average caffeine exposure in different countries is presented in the table below.

Subgroups

Pregnant women The average pregnant woman reduces caf-feine intake. Intake estimates have been re-ported from the United States, the United Kingdom and Denmark. In these countries the average daily caffeine intakes for preg-nant woman are 144-168 mg, 220 mg and 375 mg, respectively.

Children In comparison with adults, children have a relatively low consumption of coffee. Since coffee is the beverage with the high-est relative amount of caffeine, it may therefore be easy to underestimate the caf-feine intake in children. Children may, however, consume large amounts of tea, chocolate candies, and caffeinated soft drinks, which can contain significant

Consumption data Consumption data are needed when esti-mates for the exposure of Campylobacter in a given food item are to be calculated.

In 1995, the Danish consumption habits were estimated. A total of 3098 persons from 1 to 80 years old registered their daily intake for one week. The estimated average consumption per day of different food items in Denmark in 1995 appears from Annex G, table 2. This table may be used to compare daily intake between sex and age groups. In risk assessment, however, the frequency of consumption of a given product is preferred to the average con-sumption per day. On basis of the con-sumption survey from 1995, the frequen-cies for the consumption of chicken may be estimated.

The consumption of different food items can also be calculated on basis of the regis-tered retail sale. As an example, the sales of Danish and imported poultry products are listed in Annex H, table 3. From this table, it is evident that chicken products dominate the sale of poultry and that the Danish products account for a large per-centage of this sale.

Risk factors

The risk factors that have usually been as-sociated with outbreaks of campylobacte-riosis are the consumption of unpasteurized milk, untreated surface water - or food, particularly poultry.

The risk factors of sporadic Campylobacter infections have been studied in several case-control studies. The most frequently identified risk factors in these studies have been

Eating undercooked poultry, Handling raw poultry, (Daily) contact with (diarrheic) dogs or

cats, particularly young pets such as kitt d i

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amounts of caffeine.

Available intake estimates for children are summarised in Annex G, table 4.

Conclusions Caffeine is a naturally occurring ingredient in the beverages cocoa, guarana, maté (Pa-raguayan tea), tea, yaupon (cassina tea) and yoco, as well as in chocolate and the chewed cola nut. Caffeine is also found in cola drinks and other soft drinks like ener-gy drinks and smart drinks and medicinal drugs. Traditionally, the caffeine intake in the Nordic countries originates to a great ex-tent from the consumption of coffee. Fin-land, Sweden, Denmark and Norway, in that order, are the countries in the world with the largest per capita consumption of coffee. Available data from Sweden and Denmark indicate an estimated average daily intake of approximately 400 to 500 mg. Pregnant women and children seem to have lower intakes of caffeine in compari-son with non-pregnant adults according to data from the United States, UK, Finland and Denmark.

Uncertainties It is very difficult to estimate the total daily individual intake of caffeine. Most esti-mates are on the population level, general-ly based on per capita calculations. The most important reasons for this are problems with self-report reliability, vary-ing concentrations of caffeine in the same type of beverage, no standardization of used cups/glasses, which may result in a considerable volume variation of con-sumed cups and variation of intake during life-time.

Lacking information See Uncertainties.

kittens and puppies, Drinking unprocessed (raw) water, Drinking unpasteurized milk or dairy

products, Drinking doorstep-delivered milk with

caps damaged by birds, Eating barbequed poultry, pork or

sausages, Eating poultry liver, and Journeys abroad.

Other risk factors that have been related to campylobacteriosis are the consumption of contaminated shellfish, consumption of contaminated cucumbers, diabetes melitus, and medication with omeprazole and H2 and H2 antagonists (=anti-secretory drugs). Travel abroad seems to be a common cause of campylobacteriosis. In Denmark and UK, travelling abroad has been estimated to account for 10-15% of the reported cases. In Sweden and Norway, the esti-mated percentage is 40-60%. Campylobac-teriosis has mainly been associated with travel to the Mediterranean countries and Asia. Overlap is reported between serotypes of C. jejuni found in humans, poultry and cattle, humans, water and chicken and hu-mans, offal, beef, sewage and poultry indi-cating that foods of animal origin may play a major role in transmitting C. jejuni to humans. Although a number of risk factors have been described, these do not explain all the Campylobacter infections. Therefore, more work has to be directed into elucidating the epidemiology of Campylobacter in order to get an overview over the actual causes of Campylobacter infections and thereby pro-vide a basis for a more specific control strategy.

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3.2.4 Risk characterization

The last step in the risk assessment process is the risk characterization. Risk characteri-zation is defined as ”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 characterization is made by scientists like food toxicologists and microbiologists and is often based on animal testing. The result of risk characterization should include uncertainties like the safety factors used.


General considerations Could a tolerable daily intake (TDI) for caffeine be estimated? It is believed that the no effect level (NOEL) in humans, based on the occurrence on "caffeinism", could approximately be in the range of 500-600 mg/day equivalent to 7-8 mg/kg body weight and day, while ”normal” ex-posures in the Nordic countries range be-tween 0 and 700 mg/day. Is there a need for a TDI for caffeine? Should special re-commendations be worked out for e.g. pregnant women and children? The lowest observed effect level (LOEL) based on acute effects in healthy humans is not known, but it is likely that the margins between NOEL and LOEL could be small. Could it be considered appropriate to use the NOEL based on occurrence for "caffeinism" in the estimation of a TDI? And if so, which safety factor should be applied?

Establishing ADIs/TDIs in general Usually, a tolerable daily intake (TDI) or an acceptable daily intake (ADI) is derived by dividing the no effect level (NOEL) with a safety factor. The safety factor is usually 100. For the extrapolation from ex-perimental animals to humans, a factor 10 is used, and for the difference between in-dividuals, an additional factor 10 is used. Higher safety factors are used when seri-ous adverse effects have been observed.

Incidence in human medicine Most human Campylobacter infections oc-cur as sporadic single cases or as part of small family-related outbreaks, but larger outbreaks have been described. Outbreaks and sporadic cases seem to have different epidemiological characteristics. For ex-ample, the sporadic cases seem to peak in summer, whereas the outbreaks (based on 57 outbreaks in the United States) seem to culminate in May and October.

Age and sex distribution All age groups may become infected with Campylobacter. However, the reporting rate of campylobacteriosis is higher for young adults (around 15 - 25 years) and young children (Annex I, table 1). The high incidence rate in children may be a result of a higher notification rate in this age group as compared to adults, reflecting that parents more likely seek medical care for their children. The high incidence rate in young adults has been suggested to be due to a higher travel activity in this age group compared to other age groups, a higher recreational activity including parti-cipation in water sports, and an increased exposure to high risk food items. The high-er incidence may also be a result of unsafe food handling practices in a population that has left the parents and still has to learn how to prepare food.

81 Risk assessment

The lowest observed effect level (LOEL) can also be used, but usually with a higher safety factor.

Which safety factor should/could be used? In case of caffeine this is a difficult question to answer. As there are human data, no extrapolation from experimental animals is needed. As stated above, 10 is the general factor often used to compensate for the variation between individuals. The use of safety factors lower than 10 in order to allow compensation for individual variation has sometimes been proposed when the data base indicates that the variation between individuals may not be great and the observed effects are not considered to be severe. Considering these conditions for caffeine, the following options could be proposed: Alternative 1: NOEL/Safety factor of 10 results in a TDI of 0.7 mg/kg bw = 0.6 cup of coffee daily for a person with a body weight of 70 kg. This approach clearly turns out to be the most conservative. Alternative 2: NOEL/Safety factor of 5 re-sults in a TDI of 1.4 mg/kg bw = 1.2 cup of coffee daily for a person with a body weight of 70 kg. (1 cup of coffee is in this case assumed to contain 85 mg caffeine) In conclusion, applying the safety factors suggested above results in an estimate of a “safe” daily intake ranging between 42 and 102 mg.

What is the need for a TDI? People are not likely to consume extreme doses, because acute adverse effects like arrhythmia, nausea, dizziness, insomnia, headache etc. will occur. Pharmacologically this has been described as "the margin for dose increases may be limited by the biphasic effects of the drug." In addition, variations in dose-response

Area distribution The campylobacteriosis incidence seems to be area-dependent i.e. some areas in for ex-ample Denmark, Norway, UK, and New Zealand have a much higher incidence than the rest of the country.

Seasonal variation in the number of human cases A seasonal variation in the number of hu-man cases has been noticed in Denmark and in several countries including Sweden, Norway, UK and New Zealand with a more than doubling of the incidences in late summer.

82 Risk assessment

(including differences in tolerance) among individuals are likely to be great. The examples above also illustrate that the traditional way of estimating a “safe” dose does not seem to be useful for caffeine. In the light of this, advice and/or restric-tions regarding overall caffeine intake does not appear to be a matter of concern for non-pregnant healthy adults. However, subgroups like pregnant and lac-tating women and possibly children and persons suffering from heart disease may need advice regarding “maximum” daily consumption. Quantitative risk estimation

Non-pregnant healthy adults As most coffee-drinking individuals – at least in the Nordic countries – usually in-gest much higher daily amounts of caffeine without any apparent discomfort, there is probably no need for establishing a TDI (see above).

Pregnant and lactating women Most of the available epidemiological data suggest there is no problem if total intake is below 300 mg caffeine/day. The quest-ion of possible effects on pregnancy and the offspring at regular intakes above this level remains open. This suggests that mo-deration of caffeine intake, from whatever source, is advisable during pregnancy.

New-born children (0-3 months) Total intake, see Pregnant and lactating women.

Children (3 months-18 years) In pre-school and school children directly exposed to caffeine in single doses up to 10 mg/kg body weight, either no effect or small inconsistent effects on mood, behavi-our, and cognitive and motor functions have been observed. Some of these studies indicate that for a child of 10 years, a daily caffeine intake equivalent to approximately

83 Risk assessment

5 mg/kg bw could result in transient beha-vioural changes, such as increased arousal, irritability, nervousness or anxiety, particu-larly if they were normally low consumers of caffeine.

Thus, it still seems controversial whether the observed effects in children directly ex-posed to caffeine (at the mentioned dose levels) could be ascribed to caffeine intake or not.

Patients suffering from heart diseases The results of published investigations on this theme seem to vary considerably, which makes it difficult to draw any firm conclusions concerning the relation be-tween caffeine intake and possible effects on patients suffering from heart diseases.

Uncertainties See below.

Lacking information An officially established TDI/ADI for caf-feine is lacking. Specific information con-cerning the significance of effects on preg-nant women, foetuses, babies born prema-turely, children (3 months and older) and patients suffering from heart diseases.

3.2.5 Consideration of the risk assessment result

The conclusion of the risk assessment results is that both caffeine, added or natural, and Campylobacter are risks and that risk managers should make the decision on how to handle these risks.

The risk assessment results will be reported by the scientists involved in the assessment, pointing out the uncertainties and assumptions made during the assessment. The discussion and consideration should involve the risk managers, including politicians.


Caffeine as a food additive should be re-stricted as adverse effects are likely to ap-pear at high dose levels and as certain sub-groups of the population like for example pregnant women and children may be more susceptible and thus at risk.

Campylobacter is a potential risk for hu-mans, and the exposure should be avoided or be as low as possible.

Campylobacter in foodstuffs is either due to contamination in the primary production and/or insufficient hygiene. The result of

84 Risk management – further steps

The intake of caffeine as a natural constitu-ent should of course also be limited in the mentioned subgroups. Advice and informa-tion should be given in order to prevent the risk.

When there is caffeine in foodstuffs, it is either an inherent content or has been ad-ded as a chemical, that is, used as an addi-tive. The result of the risk assessment is that exposure to caffeine in larger extent may be a risk. The exposure should there-fore be limited.

the risk assessment is that exposure to Campylobacter may be a risk. The expo-sure should therefore be limited.

3.3 Risk management – further steps

3.3.1 Risk management option assessment When the risk evaluation has been fulfilled as the first step of risk management and risk assessment, the risk management process is continued. Risk management is defined as “The process, distinct from risk assessment, of weighing policy alternatives in consul-tation 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” (WHO/FAO 1997).

Risk management is divided into the following steps:

- Risk evaluation (carried out prior to the risk assessment) when following the stepwise procedure.

- The identification of available management options.

- The selection of preferred management option.

- Final management decision.

- Implementation of the management decision.

- Monitoring and review (WHO/FAO 1997).

The steps included in risk management are under discussion in the different committees in Codex Alimentarius. The present project, however, has chosen to follow the above-mentioned steps of risk management.

According to the general principles of food safety risk management listed in the WHO Risk Management and Food Safety report, food safety risk management should follow the principles lists below:

a. Risk management should follow a structured approach.

b. The protection of human health should be the primary consideration in risk manage-ment decisions.

c. Risk management decisions and practices should be transparent.


d. The determination of risk assessment policy should be included as a specific compo-nent of risk management.

e. Risk management should ensure the scientific integrity of the risk assessment pro-cess by maintaining the functional separation of risk management and risk assess-ment.

f. Risk management should include clear, interactive communication with consumers and other interested parties in all aspects of the process.

g. Risk management should be a continuing process that takes into account all newly generated data in the evaluation and review of management decisions.

h. If, and when other legitimate factors than safety are taken into account in the decisions made, this should be clearly stated in the final management decision. The legitimate factors could be e.g. a demand for documented technological need for the use of food additives, economy etc. Further discussions on the possibility of an international acceptance of this take place in Codex Alimentarius.

The model chosen by the Nordic project group includes these principles.

3.3.2 Identification of available management options

The available management options for a safety risk could be to

- issue specific legislation which either band the use, or setting maximum levels for content in food, and/or

- give guideline and information to producers, consumers etc.

The identification of the available management options should be based on the results of the risk assessment and be identified in cooperation between scientists such as analysts and food toxicologists, and risk managers, including politicians. Other interested parties such as consumers, producers and retailers should have information on the options and possibilities for commenting in this phase.

The decision-makers in this step will be risk managers in the administration in a dia-logue with the political level. Final decision would be taken by the responsible politi-cians based on an evaluation of the available options.


The options for management of the safety risk of caffeine could be some of the above-mentioned:

- issue specific legislation setting maxi-mum levels for the content in food

- give guideline to producers, consumers etc.

- information

As a conclusion of the risk assessment, the options would not include a ban. Since caf-f i i b h dd d h i l b

Campylobacter are found in different habi-tats and at present, general legislation establishing tolerable quantitative limits would not be meaningful. However, establishing food safety objectives could be effective. An example could be to set the objective to reduce the prevalence of Campylobacter-positive broiler flocks by 50% within 5 years. Furthermore, quantita-tive limits could be introduced for food types that have been treated in such a way that the Campylobacter content is reduced


feine is both an added chemical substance and a naturally occurring substance in food, the options will have to include both cases. To establish limits for naturally oc-curring substances in food will require all solid documentation on the natural level, including the variations and guidelines to specific consumer groups is normally the preferred option.

Specific considerations Topics to take into consideration when dis-cussing the risk management of caffeine:

- Products in which caffeine is concen-trated, as in food supplements, consti-tute a danger to small children, due to the risk of serious accidental poisoning.

- Caffeine is considered a doping sub-stance by the International Olympic Committee, as well as by other athletic federations. Caffeine has an upper limit in urine that may not be exceeded.

- Caffeine may aggravate (adverse) ef-fects of other stimulants.

- The declaration of a caffeine content as e.g. ”guarana”, ”natural flavouring”, ”cola”, ”natural stimulant” etc. is mis-leading, and it is potentially dangerous if the caffeine concentration in the pro-duct is high.

- The addition of caffeine to other food-stuffs than those naturally containing caffeine renders it difficult to self-regu-late the caffeine intake. Caffeine is ad-ded to soft drinks, bread, energy bars, pizza, salmon etc., often without any declaration of the amount of caffeine added.

- Subgroups may be susceptible to ad-verse effects of caffeine.

or eliminated.

Management options for Campylobacter in food would thus be

- food safety objectives like the order of slaughter and heat/freezing treatment.

- specific legislation, setting maximum, acceptable, quantitative limits for cer-tain categories of food

- give guideline to producers, consumers etc.

- information.

In relation to information/guidelines, medical doctors should be considered as an essential target group in all cases as com-municators of guidance and information to the public.


3.3.3 Selection of preferred management option.

The selection of preferred management options should be based on the results of the risk assessment and it should be discussed in cooperation between the scientist such as analysts and food toxicologists, and the risk managers, including politicians. Other inte-rested parties like consumers, producers and retailers should have information and pos-sibilities for commenting in this phase.

Risk managers, mainly politicians, should make the final decision, as this would be a political decision on how to handle the risk.


For caffeine as an additive - either a tech-nological food additive or flavouring, deci-sions in the Nordic countries were based on the lack of specific regulation and con-trol of the intake of caffeine from food.

When the regulation of food additives was harmonized in the European Union, caffeine was not included in the list of additives and was not covered by the defi-nition of food additives. Caffeine has a bitter taste and could be covered by the de-finition on flavourings. A positive list for flavourings has not been established, but this specific substance should have special provisions. This option was chosen as the preferred management option for caffeine as a chemical component added to foodstuffs in some of the Nordic countries like Denmark and Norway.

As flavourings in general were removed from the food additive positive list, Nor-way has chosen to maintain a regulation for flavourings similar to that for food ad-ditives. Thus, Norway regulates the use of caffeine in Annex G (the flavouring posi-tive list) of regulation 12 December 1993 no. 1379 with relation to flavourings etc. in foodstuffs.

For caffeine as inherent toxicant, the pre-ferred management option would be to give information to the consumer groups at risk. This would especially be pregnant women. In the absence of data, pregnant women in Sweden are advised to moderate their caffeine consumption so that their daily intake does not exceed 300 mg caffe-ine.

When selecting the preferred risk manage-ment options for Campylobacter, commo-dity combinations of the appropriate safety standards have to be considered. It is nor-mally assumed in the case of poultry and other foods that the multiplication of Cam-pylobacter does not occur. When more ac-curate knowledge on the dose-response relationship for Campylobacter becomes available, it might be necessary to consider if a zero tolerance limit is to be set for poultry. It is an example of a non-zero tole-rance safety standard to accept the pre-sence of Campylobacter in frozen poultry because freezing lowers the number of vi-able Campylobacters and therefore reduces human exposure. When considering safety standards, other legitimate factors will have to be taken into account. These might be economic costs, benefits, technical fea-sibility, risk perceptions, etc.


In Denmark, no advice has been given to pregnant women regarding caffeine con-sumption, but as for producers and impor-ters, a recommended limit has been estab-lished for caffeine-containing plants in health food.

In Norway, the official authorities have not given advice to pregnant women regarding caffeine consumption. This decision is based on the lack of resources and lack of satisfactory data on caffeine and the poten-tial effects for pregnant women. The autho-rities have decided to await the report from the Nordic project mentioned above, and use these conclusions as a basis for the de-cision on whether to give an advice or not.

3.3.4 Final management decision

The final management decision should address the safety concern and the result of the risk assessment. Furthermore, it should be made by the politically responsible minister based on the previous step in the risk analysis process including the background information. This step should be communicated to all interested parties, including the food inspection.


The use of caffeine as an added chemical component is regulated with maximum use levels and guidance is given to consumers on caffeine as a naturally occurring toxi-cant.

Caffeine as an added chemical component. The Nordic countries have regulation on caffeine as an added chemical component. However, the same option has not been chosen in all the countries.

Caffeine as a naturally occurring toxicant In general, the Nordic countries have no specific regulation on caffeine as a natural-ly occurring toxicant.

In Norway, caffeine as a naturally occur-ring toxicant is regulated under the same li-mitations as for the use as a flavouring agent.

No final decision has been made in the Nordic countries, since background infor-mation is still being developed. However, a general safety cause in the Food Act does also relate to the occurrence of Campylo-bacter in food.

89 Implementation of the management decision

In Denmark and in Iceland, general food safety issues, e.g. naturally occurring caf-feine is regulated in accordance with the requirements in the general Food Act. Den-mark has furthermore given guidance for the use of caffeine-containing plants in health food.

In Sweden, caffeine as a naturally occur-ring toxicant is not regulated specifically. Current consumer guidance has been given in books edited by the National Food Ad-ministration: Pregnant women are advised to limit their intake of caffeine to 300 mg daily (corresponding to approximately 3 cups of coffee daily). In addition, the Swe-dish Sports Confederation has been in-formed about the doping limit for the in-take of caffeine (= 600 mg) before/during competitions.

Guidance to companies: Products contai-ning guarana and caffeine must be labelled with recommendations to store these pro-ducts in a secure place (not available for children). The company producing or dis-tributing the products will be responsible (according to the law regarding responsibi-lity for products) if labelling is found to be inadequate in this respect.

This information has been distributed in the periodicals edited by the National Food Administration (Vår Föda and Livsteck-net), to the trade organisation and to sepa-rate companies asking for guidance.

3.4 Implementation of the management decision The implementation is made by issuing orders on the subject or by elaborating the com-munication strategy on the issue. The implementation would be followed by surveil-lance and the in-house control of the producers and at the public food inspection.

Politicians are the responsible persons for issuing of orders.


Denmark, Finland and Norway have regu-lated caffeine under the flavour regulation with a permitted maximum level of 150 mg/kg. Sweden has also chosen to regulate caffeine under the flavour regulation with a limit of 135 mg/kg For energ drinks

Information pamphlets are sent to the con-sumers especially concentrating on good hygiene during food preparation and stor-age.

Following the Campylobacter epidemic in

90 Monitoring and review

limit of 135 mg/kg. For energy drinks, Sweden accepts a level of 320 mg/kg with special labelling requirements. Iceland has chosen to include caffeine in the regulation of technological food additive when the substance is used in amounts below 135 mg/kg, and as medicine if used in amounts above 135 mg/kg.

Iceland in 1999, the food control authori-ties decided that all poultry flocks must be tested four weeks and at slaughter for Campylobacter. Products from positive flocks must be either frozen or cooked be-fore retail sale.

3.5 Monitoring and review

3.5.1 Assessment of the effectiveness of measures taken

The effectiveness of measures taken should be measured through a consumer survey conducted by the authorities. The survey could include interviews of consumers about their consumption of e.g. specific food items or of foodstuffs in general, including the food items of special concern. Since pathogenic microorganisms in food may cause ill-ness, a systematic diagnosis reported from the medical doctor could create the basis for an evaluation of the effectiveness of the measures taken.

The responsible for allocating resources to such a survey would be the responsible politicians.

The “ideal model” would let the management decisions be followed by a measurement of the effect.


To be able to assess the effectiveness of measures taken, the consumption of caffe-ine in the population must be known. This can be done with a large-scale consump-tion study that takes into account the vari-able amounts of caffeine coming from dif-ferent dietary sources. Smaller scale con-sumption studies or questionnaires done at a later time would detect all major devia-tions from the original study and could be used to assess the effectiveness of all measures taken in order to control the intake of the substance. In Iceland, a survey has been conducted on the intake of caffeine.

The methods for assessing the effective-ness of the measures taken will vary accor-ding to the character of the respective mea-sures. In cases where guidelines and/or in-formation to producers, consumers or spe-cial professional groups were chosen, op-tion surveys in the form of interviews would be a good measurement. In cases in-volving pathogenic microorganisms, the prevalence of an organism in foodstuffs in general or specifically together with the in-cidence of the corresponding disease in hu-mans would be appropriate data to use.

In the Nordic countries, data has been col-lected on the status for Campylobacter in food. When a final management decision is made, these data will provide the basis for an assessment of the effectiveness of the measures taken.

In Iceland, the number of domestic Campy-

91 Risk communication

lobacter cases in 2000 was reduced to only 92 cases from record high 320 cases in 1999, most probably due to the measures taken in the poultry industry and by infor-mation campaigns directed towards consu-mers and other stakeholders.

3.5.2 Review of the risk management and/or assessment as necessary

A review of the risk management and/or assessment will in most cases take place if new knowledge is provided as part of the risk assessment documentation or if human dis-eases are reported. The public administrations in the Nordic countries have an obli-gation to follow the scientific literature in general.

The “ideal model” would include reviews on a regular basis like every 5th year and at the same time, the responsible scientists should have currently updated literature on the subject.


Caffeine is for the time being subject to a Nordic risk assessment project. When the assessment is finalised, a review on the risk management of caffeine should be made.

As final risk management decisions are pending, review will have to wait. How-ever, reviews should include information on case-control studies.

3.6 Risk communication The project did not specifically cover communication since this topic is dealt with in an-other Nordic project.

However, risk communication is very important in the risk analysis process, both during the process between the different interested parties, and afterward when communicating the result. The two examples described in this report consider risk that is difficult to communicate, caffeine because it is found in normally consumed food item like coffee or tea, and Campylobacter because guidelines will have to adjust cooking behaviour which the consumer regard as normal handling of food.


Caffeine is found in food either as a food additive, including the use as flavouring, or as a natural component in e.g. coffee and tea.

Caffeine and the use as a food additive or as flavouring.

One of the basis criteria for the approval of food additives is that the use should not

A case-control investigation of foodborne risk factors for campylobacteriosis in Den-mark has identified a number of risk fac-tors for infection: Insufficiently heat trea-ted poultry, meat cooked on a barbecue or over an open fire, any contact with pets, drinking water in the household combined with the water supply being a private well.

92 Risk communication

harm the consumer. This criterion has the implication that, in principle, no risk has to be communicated. However, in many countries, consumers are worried about the use of food additives in general, and in the Nordic countries information has been given to consumers about the safe use of food additives. In some of the Nordic countries, caffeine is regulated under the regulation on flavourings. For flavourings, the general concept of safety is a require-ment, too. However, flavourings are not re-gulated in positive lists and are not neces-sarily evaluated to be safe by the authori-ties. One exception being caffeine that is accepted in a specific maximum concentra-tion after a toxicological evaluation.

Caffeine and the natural occurrence. In general, very little has been communica-ted to the public about the risk of naturally occurring caffeine in foodstuffs.

In Denmark, a maximum limit has been communicated on the use of caffeine-con-taining plants in e.g. health food products. This communication includes remarks about which precautions should be taken to protect pregnant women. In the absence of data, pregnant women in Sweden are ad-vised to moderate their caffeine consump-tion so that their daily intake does not ex-ceed 300 mg caffeine.

The risks concerning barbecued meat have been communicated to the public in pam-phlets on cooking on a barbecue or over an open fire (in the summers of 1998, 1999 and 2000). The pamphlet was distributed via the retail sector. Since 1993, a series of general information activities has been made to prevent foodborne illness and also to make people who work with foods on an occupational basis aware of hygiene as well as improve their knowledge on the subject. Thus, more general advice on food hygiene is given to the public concerning heat treatment, cooling, and prevention of cross contamination etc. These information activities have included campaigns with newspaper advertisements, television spots, posters, the distribution of pam-phlets, the distribution of temperature re-corders, and the publishing of various kinds of written material such as "Com-mon Sense is the Best Raw Material", “Critical Points in the Kitchen - of Bacteria and Hygiene”, "Facts on Food Hygiene", “Facts on Bacteria”, “It takes two to make a successful Barbecue”, and “Poultry with-out any risks – wishful thinking?”.

In 1999, a “Risk Profile for Pathogenic Species of Campylobacter in Denmark” was published on the internet and a special page on the internet is being prepared with information on Campylobacter. A pam-phlet with focus on the importance of washing hands after contact with pets is under preparation.

93 Conclusions

4 Conclusions and recommenda-tions

4.1 Conclusions In conclusion of this project, the Nordic project group finds that the risk analysis pro-cess is a valid process to be used in practice as a quality assurance of the decision-making process. A structured risk analysis process is required as part of the decision-making process in the modern society, including the demand for transparent information and documentation on the decisions made in the public administration. The use of a systematic risk analysis process would improve the basis for making decisions and the transparency in the process.

In the Nordic countries, there is a tradition for openness and communication with the interested parties, thereby facilitating the introduction of the structured approach of the risk analysis process. However, all types of routines should be evaluated regularly, and the structured risk analysis approach as a stepwise procedure would serve as the basis for an improvement of the process.

4.2 Recommendations The Nordic project group recommends the risk analysis process as a quality assurance procedure or in-house control in public administration and elsewhere, when conducting analysis of risks. The group evaluates the above-mentioned stepwise procedure as a valid and logic process to base future work on.

The following recommendations can be given to those who consider the use of the risk analysis process:

a. The risk analysis process should be discussed and developed further in the national administrations in order to create a functional procedure for each individual admi-nistration or others using the risk analysis. A more systematic use of the risk analy-sis process would require more resources than allocated to this work today. The question of resources would need to be decided on a political level.

b. The national administrations should develop and introduce the risk analysis proce-dure in their quality assurance.

c. Proposals for projects/work that could be initiated would include

exposure assessment models

systematic identification of uncertainty factors in the standardized toxicological test models for chemicals.

d. Exchange of experience should be continued in the Nordic co-operation, e.g. in the permanent Joint Nordic Working Groups NNT, NNL, NNK and NNM on the

94 Recommendations

development of and the experience with the practical use of the risk analysis process.

e. Proposals for other international initiatives would include

work on the standardization of the data requirements for the risk assessment of microorganisms

support to the continuous introduction and use in practice of the risk analysis in the decision-making process in e.g. the EU and Codex Alimentarius.

f. As to communication, the recommendations from the workshop were to communi-cate as much information as possible during the process to the public and to have an open debate with all interested parties. This could be made available either on the internet alone or on information publications from the administrations.

95 References

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101 Annex A - Background information for the risk analysis of caffeine

Annex A - Background information for the risk analysis of caffeine

by Christer Andersson, National Food Administration, Sweden12

Introduction The Nordic project has the objective to illustrate the use of the risk analysis with two examples in order to try the functionality of the risk analysis process in practice. Under the Nordic Council of Ministers, a decision was made in an attempt to work with the process on two examples, caffeine and Campylobacter. The two examples chosen should not only provide the basis for the practical testing of the risk analysis process, but also the basis for testing the process on different types of food safety risks, and make comparisons between the guidelines on test requirements, regulations, traditions etc. in the areas.

The examples should illustrate the risk analysis of a chemical substance and a microor-ganism. As background information to the participants in the workshop, a speech was given on each subject. See also Annex B.

a. Problems related to the risk assessment of caffeine Caffeine was discovered independently of German and French scientists in coffee beans in the early 1820’s but was then called Kaffebase or Kaffeestoff. Who first gave the new compound the name caffeine is difficult to tell. The term first appears in a French Medical dictionary in 1823. Later under the 19th century thein was found in tea, and guaranine in guarana. These substances were later shown to be identical with caffeine. The elucidation and verification of the chemical structure of caffeine was done much later and were the excellent work of the German chemist Emil Fischer. He worked with this project over twenty-four years and published his findings in a book 1907. Caffeine was identified as a methylated oxypurine (a methylxanthine). The basic structure of the molecule is 2,6-dioxypurine, commonly known as xanthine. In caffeine the xanthine molecule is methylated in positions 1,3, and 7. Thus, caffeine is also known as 1,3,7-trimethylxanthine. The modern technique to separate, identify and quantify methylxanthines from various natural sources and from foods is HPLC.

Methylxanthines are produced by a large number of plant species belonging to many genera, families and orders. Plant parts of many of these species are used to prepare beverages that have a natural place in the social life of man. The most important beverages and foods containing caffeine are coffee, tea, guarana, maté, cola nuts, cola drinks, cocoa, chocolate, yaupon and yoko. The part of the plants most commonly used in the production of caffeine containing drinks is the seeds. In tea, maté and yaupon it is 12 Speech given at the Nordic workshop on Risk Analysis, June 2000


the leaf that is used, and in yoco the bark. The beans from the cacao tree contain substantially higher amounts of the dimethylxanthine theobromine than of caffeine.

A long-going discussion in the scientific society has been whether methylxanthines are produced in the plant by a separate metabolic pathway or as by-products of nucleic acid metabolism. For a long time it was thought that caffeine and the other methylxanthines were produced when nucleic acids, particularly RNA, was degraded. It is now generally agreed that the compounds are produced by a specific metabolic route using inosine monophosphate (IMP) as a precursor. IMP has a central position in the metabolic pathway for the nucleic acid precursors adenine and guanine. The biosynthetic route for caffeine goes from inosine monophosphate over xanthine monophosphate, xanthosine, 7-methylxanthosine, 7-methylxanthine, 3,7-dimethylxanthine to caffeine (1,3,7-trime-thylxanthine). Several genes encoding enzymes catalysing these reactions have been cloned. Many are located in the chloroplast DNA.

The amount of caffeine found in methylxanthine-containing beverages and foods mentioned above varies, but is generally very high. On a dry weight basis the highest amounts are found in guarana (4-7%). Tealeaves contain around 3.5% caffeine, coffee beans 1.1-2.2%, cola nuts 1.5%, and cacao beans 0.03%. In cacao beans the theobromine content is around 1.8-2.5%. The reason why the food plants mentioned contain such high quantities of caffeine seems to be a very slow endogenous catabolism of the compounds. The sequence of catabolism is different from the methylation steps of biosynthesis and can be described by the sequence caffeine, theophylline (1,3-dimethylxanthine), 3-methylxanthine and xanthine, which later is converted to carbon dioxide and ammonia via allantoin, allantoate and uric acid. It is the first step, the degradation of 1,3,7-methylxanthine (caffeine) to 1,3-dimethylxanthine that is rate-limiting and keeps the caffeine content in the plant high. Since high concentrations of caffeine inhibits mitosis and cell plate formation in plant cells, coffee embryos and other tissues producing caffeine have specific means of avoiding caffeine autotoxicity. In root tips this is achieved by separation in space (elongation of cells) and in cotyledons in separation in time. Many investigators believe that methylxanthine-producing plants accumulate these substances as part of a chemical defence system against pests and herbivores.

From what have been stated above it is clear that caffeine is a natural ingredient in the beverages cocoa, guarana, maté (paraguayan tea), tea, yaupon (cassina tea) and yoco, as well as in chocolate and the chewed cola nut. Caffeine also occurs in cola drinks and other soft drinks, in energy drinks, smart drinks and medicinal drugs. In these cases, however, purified or synthesised caffeine has been added to the product during production.

b. Caffeine-containing foods and beverages The most important beverages and foods containing methylxanthines are summarised below:

Cocoa is produced from beans of the cacao tree (Theobroma cacao). It was Carl von Linné that gave the tree its name – Theobroma meaning “food of the gods”. The plant originates from the Amazon and Orinoco areas of South America but is mainly cultiva-ted in Africa. The Ivory Coast, standing for 41-42% of the world production, has the highest production in the world. Each tree produces 50-60 cacao pods that contain 20-40 seeds each. The seeds are harvested by hand, fermented for 4-6 days and sun dried


for nearly a week. At this stage the seeds contain 1.8-3.8% theobromine and 0.1-0.8% caffeine. Cacao seeds from Africa contain higher theobromine and lower caffeine contents than beans from South America.

Dried beans are usually sold for cacao production. After cleaning of the beans and roasting (40 minutes at 100-220oC), seeds are broken up into nibs by machines and ground to cacao liquor or cacao mass. This is a product containing 55% vegetable fat and less than 2% water with an average around 1.2% theobromine and 0.2% caffeine. The cacao liquor is put under pressure to remove the fat, the cacao butter. The remai-ning product contains 10-20% fat and is milled to cacao powder. The cacao powder contains between 2 and 4% theobromine, whereas the cacao butter contains negligible amounts of methylxanthines. The products obtained are used to produce chocolate. Dark chocolate is a mixture of sugar, cacao mass (in the Nordic countries 40%) and cacao butter. Milk chocolate is made up of sugar, dried milk, cacao butter, and cacao mass (around 10%). Since white chocolate is a mixture of sugar, dried milk and cacao butter, it does not contain any significant levels of methylxanthines. Commonly reported aver-age amounts of theobromine and caffeine in chocolate products are: Product Theobromine (mg/kg) Caffeine (mg/kg) Dark chocolate 4,600 700 Milk chocolate 1,530 220 Since cacao and chocolate is used in the production of many types of baked products (cakes, cookies) and desserts, a serving of these products may contain 25-250 mg theo-bromine and 5-30 mg caffeine. The intake of caffeine from chocolate foods and beverages is highest in children and teenagers 1-17 years old, the average intake in the United States being less than 0.2 mg/kg body weight.

Coffee is produced from the beans of Coffea arabica, Coffea canephora and to a limited extent Coffea liberica. Almost 75% of the coffee produced in the world comes from C. arabica. C. canephora is more tolerant and can be cultivated under a wider range of conditions than C. arabica, but it produces a more bitter coffee, partly due to its higher caffeine content, on average 1.7% versus 1.0-1.1%. C. canephora is often used in in-stant coffees. Countries with a long tradition of coffee drinking usually prefer the milder C. arabica. Nearly all coffee sold on the Finnish, Norwegian and Swedish market is Arabica coffee. The coffee plant, Coffea arabica, originates from the forests of Ethiopia and Zaire, but is nowadays mainly cultivated in South and Latin America. Brazil and Columbia stand for over 40% of the world production.

Coffee production is not very complicated. The pulp and seed coat from the coffee bean is removed by dry or wet methods, the latter including a short fermentation. The dried beans are subsequently roasted (for 5-10 min at 200oC) to bring out taste and aroma. Roasted beans are rapidly cooled, ground and vacuum-packed for the market.

Many factors influence the caffeine content of coffee drinks. The type of coffee used by various individuals when preparing the beverage differs – various mixes of Coffea species, different grounds and different roasting. The preference in taste will determine the amount of ground coffee used when preparing the hot beverage. The methods of preparing the coffee (boiling coffee, filter coffee (also called brewed coffee) percolated coffee, infusions, espresso, mocha coffee, Greek coffee/Turkish coffee, instant (soluble) coffee) greatly influence the amount of caffeine in the consumed product. The average caffeine content of instant coffee, percolated coffee and filter coffee from 13 studies (5


from the US, 2 from Australia, 3 from the UK, 2 from Canada and 1 from South Africa) were 53, 84 and 103 mg/cup (150 ml), respectively. A Finnish study from 1998 shows that men and women seem to have similar preference: 80-87% prefer filter coffee, 1-8% boiled coffee, 1-5% instant coffee and 0-2% other types of coffee, depending on the geographical region. Between 5 and 10% of the population did not drink coffee.

Another factor determining the exposure to caffeine from coffee is the amount of coffee consumed. The quantity consumed differs a lot from one individual and culture to an-other, and some people prefer milk and sugar together with the coffee. How much a cup of coffee is, is far from easy to answer. Coffee consumption seems to be highest in the age group 25-49 years, and men consume a little more than women do. This could pos-sibly be explained by a higher percentage of men having permanent work. Coffee breaks during work give rise to important social interaction in the Nordic countries. In accordance with this theory, coffee consumption is slightly higher during weekdays than during the weekend.

From what has been stated above, it can come as no surprise that the daily per capita in-take of caffeine from coffee varies between countries. In the early 1980’s, it was repor-ted to be 84 mg in the United Kingdom, 125 mg in the United States and 340 mg in Sweden. When the information on coffee consumption was obtained from the consu-mers, the daily caffeine intake was calculated to 198 mg in the United Kingdom, 229 mg in the United States and 330/360 mg in Norway. The lower Norwegian figure was for women, the higher for men.

Guarana is produced from seeds of the sprawling shrubs Paullinia cupana and Paullinia sorbilis growing in the central Amazon Basin. The seeds are extremely rich in caffeine, 2-6% on a dry weight basis, and also contain small quantities of theophylline (0-0.25%) and theobromine (0.01-0.06%). The seeds are picked from the shrub, cleaned manually, and roasted to remove the seed coat. The roasted kernels are ground and crushed, and mixed with water to dough. The dried dough can be used as it is or powdered and prepared with hot or cold water to a beverage. Owing to the high caffeine and tannin content, the beverage is slightly bitter, astringent and acid. In the Nordic countries, exposure to methylxanthines from guarana mainly occurs via energy drinks and smart drinks.

Whereas guarana seeds contain high amounts of caffeine and small quantities of theo-bromine and theophylline, the quantity of these methylxanthines in commercial pro-ducts varies from sample to sample. Many of the products contain caffeine as the major alkaloid, with traces of theophylline and theobromine. Numerous sodas and syrups contain up to ten times more theobromine than caffeine, indicating that these products were adulterated with cacao, the major source of theobromine.

Maté, also called Paraguayan tea, is produced from leaves of Ilex paraguariensis that accumulate 0.8-2.0% caffeine. Young leaves also contain small quantities of theobro-mine (0.08-0.1%) and theophylline (less than 0.02%). Maté, which can be produced in various ways, is consumed daily by 20 million people in South America, the highest per capita consumption being in Paraguay and Uruguay. The consumption is high also in Argentina. The beverage contains slightly less caffeine than normal tea, and in addition, small quantities of theobromine and theophylline. An average daily caffeine intake from maté has been calculated to 85 mg in Paraguay and Uruguay. The consumption of maté is negligible in the Nordic countries.


Tea is produced from leaves of the perennial shrub Camellia sinensis and is the most widely consumed non-alcoholic beverage in the world. Camellia sinensis occurs in two variants, C. sinensis variant assamica and C. sinensis variant sinensis, with the latter divided into Chinese and Japanese subgroups. The average caffeine content of young leaves of first flush shoots of Assam tea (var. assamica) is 4.1%, and that of Chinese tea (var. sinensis) and Japanese tea (var. sinensis) 3.1% and 2.9%, respectively.

There are three main groups of tea; green, black and oolong tea. The flavonols of green tea are reduced. When black tea is manufactured, plucked tea is withered under ambient conditions, macerated and fermented for 1½ hour. During the fermentation process, tea flavonols are oxidized. Fermentation is terminated by drying, producing the black tea. Black tea is the most commonly used tea in the Nordic countries. Oolong tea contains a mixture of reduced and oxidized flavonols.

China and India produce more than 50% of the tea on the world market in 1996. Black tea accounts for over 75% of the world production, green tea for approximately 22%, and oolong tea for the remaining part of the world production.

The consumption of tea varies much more from one country to another than the con-sumption of coffee. The annual per capita consumption in a typical Nordic country such as Sweden was 0.3 kg in 1997. The corresponding consumption in Ireland was 3.21 kg (1993) and in the United Kingdom 2.6 kg (1990). In the United States, the tea consump-tion is only slightly higher than in Sweden, 0.35 kg per capita.

Measurements of the methylxanthine content in the tea beverage show that fairly similar amounts are found in bag tea and leaf tea, but the quantity depends on the brewing time. A 150-ml cup of tea prepared according to the suggestion of the tea producer contains on average 31 mg caffeine and 2-3 mg theobromine and very low levels of theophylline. The daily per capita intake of caffeine from tea has been calculated to be 34 mg in Swe-den, 35 mg in the United States, 79 mg in Canada and 320 mg in the United Kingdom. These calculated figures could be compared with the information available from food frequency questionnaires that shows that on average, a Swedish person consumes 12 mg caffeine from tea, and a person in the United Kingdom consumes 159 mg per day. The data from the United States show that the caffeine intake from tea is lower in persons that also drink coffee. Present coffee drinkers daily consume 36 mg caffeine from tea, people who have never drunk coffee 44 mg and earlier coffee drinkers that have stopped 58 mg.

Cassina tea, or yaupon, is a beverage produced from the leaves and berries of Ilex cassine and Ilex vomitoria, particularly in some regions of North America. The beve-rage is rarely consumed today. This beverage is not consumed in the Nordic countries.

Yoco is a beverage prepared from the bark of Paullina yoko. The bark is rich in caffeine, on average containing 2.7% on a dry weight basis. The beverage is very important for a small group of Indians living in the northwestern parts of South America (Columbia, Ecuador and Peru), but is of no importance in the Nordic countries.

Cola is the dried cotyledons of seeds of Cola nitida, Cola acuminata, Cola verticillata and Cola anomala, all evergreen trees. The plant tissues contain around 1.5% caffeine and are chewed by the local inhabitants. The tree is cultivated in West Africa (particu-larly in Nigeria), the West Indies and South America.

However, the kola nut is not only chewed. Dried nuts are produced and exported to North America and Europe where their flavour merits them to be used for beverages and


pharmaceutical purposes. Kola furnishes the base for many types of cola soft drinks. However, the amount used for flavouring would provide only a few milligrams of caffeine per cola bottle. Therefore, in order to make the beverages popular, synthetic (or purified) caffeine is added. A can (360 ml) of a typical cola drink usually contains between 30 and 45 mg caffeine. Cola drinks do not have to be labelled with information saying that they contain caffeine, while soft drinks not counted as cola drinks do have to be labelled. The maximum content of caffeine allowed in Cola drinks and caffeinated soft drinks is 135 mg/litre.

In 1984, the daily per capita intake of caffeine from soft drinks was estimated to 35 mg in the United States and 16 mg in Canada. In Denmark, the caffeine intake from caffeinated soft drink was 14 mg/day in 1996.

Other types of caffeinated beverages. A new type of caffeinated beverage, called energy drinks, entered the market a few years ago. These beverages may contain higher quantities of caffeine than the better-known soft drinks. In Sweden, however, energy drinks with higher amounts of caffeine than 135 mg/litre cannot be sold without permission. The maximum amount of caffeine being allowed in permitted drinks is 320 mg/litre. Most of these drinks are sold in smaller cans (250 ml). The Ministry of Agriculture Fisheries and Foods in the United Kingdom measured the caffeine content in 26 energy drinks and found a mean content of 60 mg per 250 ml can.

Another even more modern caffeinated drink is the smart drink. This beverage is consumed to increase the capacity of memory and cognitive performance, or as a health drink stuffed with vitamins, ginseng, and other ingredients. Plant extracts, such as guarana, is common and introduces caffeine into the drink. The level of caffeine in these new drinks is not known.

Lastly, it is possible to buy caffeinated water over the Internet. Analysed samples con-tained between 120 and 290 mg/litre.

c. Medicinal drugs with caffeine Caffeine has been used therapeutically as a cardiac and bronchial stimulant and in the treatment of infant apnoea and a variety of skin disorders. The substance is also used in the treatment of migraine headaches and overweight. Its wide use in analgesics, diure-tics, allergy relief preparations, and alertness compounds make the exposures to caffeine much greater than most people are aware of. Within the Nordic countries, at least 50 different drugs containing caffeine are marketed. Also theobromine and theophylline are used for therapeutical purposes. Theobromine is used in the treatment of diuresis and theophylline for coronary dilation.

The amount of caffeine usually present in these pharmaceuticals is 50 or 100 mg/tablet or about 2-3 mg/ml mixture. The caffeine intake, after a maximum dose used for therapy, has been calculated. Values from 200 to 600 mg/day are registered for different migraine preparations, and analgesics can give caffeine contributions of 150-400 mg/day. Pharmaceuticals taken in the purpose to give strength, called tonics, have lower caffeine contents, and give intake values ranging from 90 to 112.5 mg/day.

Many people use caffeine-containing pharmaceuticals during limited periods of their lives. But not all are aware of the increased caffeine intake the consumption of these drugs can give. If more caffeine-containing drugs than one are used at the same time, the caffeine intake from pharmaceuticals alone can be substantial.


Since people use pharmaceuticals individually and sporadically, it is possible to quest-ion the point in calculating an average caffeine intake from drugs. Nonetheless, this exercise has been done in Iceland. The per capita intake of caffeine from pharmaceuti-cals was found to be 35.53 mg/day in Iceland in 1998. This amount was lower than the amounts consumed 1989-1997 that were between 35.60 and 41.21 mg/day.

d. Total caffeine intake The presentation given above should make it clear that it is very difficult to estimate the total daily individual intake of caffeine. Most estimates are on the population level, generally based on per capita calculations. In the United States, the average daily caffe-ine intake has been estimated to be between 186 and 227 mg. Corresponding intakes in Canada, Australia, Brazil, Sweden and Denmark are 238 mg, 240 mg, 171 mg, 425 mg and 490 mg, respectively. It is obvious that the intake is higher in the Nordic countries than elsewhere, mainly because of the high contribution to caffeine intake given by coffee in the Nordic countries. A fraction of the population of course has much higher caffeine intakes.

The average pregnant woman reduces the caffeine intake during pregnancy. Intake estimates are available from the United States, the United Kingdom and Denmark. The average daily caffeine intakes for the pregnant woman in these countries are 144-168 mg, 220 mg and 375 mg, respectively.

e. Absorption, distribution and degradation of methylxanthines in man Methylxanthines are easily absorbed. Peak plasma levels are reached 0.5-1.0 hours after ingestion of synthesized or purified methylxanthines, a little later when the compounds occur naturally in foods and beverages. The compounds are distributed to nearly all tis-sues. They cross the placenta, enter the gonadal tissue and is excreted into milk. The tis-sue levels are nearly as high as the plasma levels, but no accumulation of methylxan-thines occur in any tissue. Caffeine has also been shown to diffuse the blood/brain bar-rier.

The metabolism of methylxanthines primarily occurs in the liver. In adults, nearly 98% of an oral dose is found metabolised in the urine. Faeces only contain 1-3% of the dose ingested. The four primary biotransformation products of caffeine being formed in man are paraxanthine (1,7-dimethylxanthine), theobromine (3,7-dimethylxanthine), theo-phylline (1,3-dimethylxanthine) and 1,3,7-dimethyluric acid. Thus, demethylations, and oxidation at the 8-position of the purine ring predominates. The primary metabolites mentioned are further degraded by demethylation, oxidation and ring opening. The most important metabolic route without questioning is the demethylation of caffeine by cytochrome P450 1A2 to paraxanthine (11%), which then is further degraded to 1,7-dimethyl uric acid (14%), 1-methylxanthine (24%), 1-methyluric acid (28%) and 8-acethylamino-6-formylamino-3-methyluracil (10%). The figures given in parenthesis are the amounts found in human urine.

Plasma levels of caffeine in coffee consumers are commonly 0.2-2 µg/ml. Shortly after the consumption of 3 cups of coffee, the level increases to around 10 µg/ml. Ingestion of 800 mg caffeine in tablet form during 30 days equilibrate the caffeine level in plasma to around 30 µg/ml. The pharmacological (and toxicological) effects of caffeine start to appear when the plasma concentration reaches 10-30 µg/ml.


The half-life of caffeine in adults is around 4-6 hours, but it is influenced by many fac-tors. For example, the half-life is prolonged by a modest consumption of alcohol (to 7-10.5 hours), use of oral contraceptives (to 10 h), or during pregnancy (to 18 h). Other factors that increase the half-life of caffeine are liver damage (cirrhosis, viral hepatitis, alcohol-induced fatty liver), use of cytochrome P450 1A2-inhibiting drugs, and some genetic constitutions. However, the half-life can also be shortened. This has been described for cytochrome P450 1A2-inducing drugs, cigarette smoking and polychlori-nated biphenyls. The increased metabolism of caffeine in smokers could explain the observation of a correlation between cigarette smoking and high consumption of caffeine. The smoker has to consume more caffeinated beverages in order to reach a plasma level that produces the pharmacological effects the consumer is striving for.

Of particular concern is the fact that the half-life of caffeine is very, very long in the foetus. There is nearly no metabolism at all. In the newborn the half-life is 82 hours, in 3-4.5 months old infants 14 hours. The metabolic profile characteristic of adults has not been reached until the child is around 7 to 9 months old.

Measurements of caffeine content in umbilical cord blood at delivery of full-term infants to mothers who consume coffee have revealed average plasma levels around 1.2 µg/ml. However, in 25% of the studied infants the level was above 15.4 µg/ml.

At the neonatal stage infants are exposed to caffeine through breast milk. The peak level of caffeine in breast milk is reached around 1 hour after caffeine intake. The amount of caffeine found in milk is around 1% of the amount consumed by the mother. The half-life of caffeine in breast milk is around 6 h, slightly shorter than the half-life of paraxanthine and theophylline and half as short as that of theobromine.

f. Pharmacological and toxicological effects of caffeine Caffeine has pharmacological effects on many tissues. These actions have been summa-rized in a poster (see the following presentation), and are therefore only mentioned briefly here. Effects registered in the central nervous system include increased sponta-neous, electrical activity, enhanced neurotransmitter release, induced convulsant activi-ty, stimulated locomotor activity, and increased operant response rates. A positive ino-tropic/chronotropic effect has been observed on the heart, diuresis in the renal system, and dilation in the peripheral vasculature and constriction in the central vasculature. Caffeine stimulates an increase in gastric secretion in the gastrointestinal system and re-laxes bronchial smooth muscle in the respiratory system. Some of these effects are recognized as adverse by the consumers. The most likely mechanism for many of these effects is a competitive antagonism for adenosine receptors, and possibly also a compe-titive inhibition of dopamine activity.

Early symptoms of acute toxicity may occur at doses above 20-50 mg/kg and are characterized by headache, nausea and stomach cramps, insomnia, agitation and restlessness, tachycardia and extrasystoles. Many people have experienced at least one of these symptoms. At higher doses, 150-200 mg/kg, acute symptoms of severe toxicity may occur. Among these symptoms are tremor, delirium, hypertonicity, hyperthermia, hyperventilation, tachyarrythmias, seizure, coma and death. Very few people are ex-posed to doses giving rise to severe toxicity. The lethal dose of caffeine is around 6-12 g in adults.


Chronic toxicity characterized as the poorly defined condition caffeinism can occur at 7-8 mg/kg body weight. Other conditions of chronic exposure are effects on the heart via alterations in the serum cholesterol and lipids, osteoporosis, and influence on various types of cancer. A chronic consumption of caffeine may stimulate the tolerance deve-lopment, but could also result in withdrawal symptoms when caffeine no longer is sup-plied. Caffeine might actually be considered to fulfil some of the WHO criteria for dependence, but not comparable to psychoactive drugs classified and regulated as addic-tive drugs.

Very high doses of caffeine give rise to congenital malformations in experimental ani-mals. These doses are much higher than the ones that humans will ever be exposed to. Since 1949, caffeine has been known to be mutagenic in various experimental systems. The doses that were used to induce mutations in various short-term tests were much higher than the doses that man is exposed to via the consumption of caffeine-containing foods and beverages. It seems highly unlikely that a normal exposure to caffeine via foods and beverages will induce mutations in man. The International Agency for Re-search on Cancer evaluated caffeine, theophylline and theobromine in 1991 and conclu-ded that there is an inadequate evidence for the carcinogenicity of these methyl-xanthines in humans and experimental animals. The Scientific Committee on Foods within the European Commission evaluated caffeine in 1983 and 1999. They expressed the view that there is no reason for concern about carcinogenic and mutagenic effects of caffeine in man at normal levels of intake. Neither is there any concern for teratogenic effects in humans. According to the Scientific Committee for Foods, risk assessment in relation to pregnancy is more difficult. Most data suggest that there is no problem if the total intake of caffeine is below 300 mg/day. The question of possible effects on preg-nancy and the offspring above this level remains open. This suggests that moderation of caffeine intake, from whatever source, is advisable during pregnancy. There is an expert group within the Nordic Council of Ministers that is evaluating available epidemiologi-cal data connecting caffeine exposure to effects on pregnant women and their offspring. This expert group will present their findings in 2001.

111 Annex B – Background information for the Risk Analysis of Campylobacter.

Annex B – Background information for the Risk Analysis of Campylobacter.

by Niels L. Nielsen and Hanne Rosenqvist, Danish Veterinary and Food Administration, Denmark13

At the workshop, June 2000 a speech was given on each of the risks used as model, see also Annex A.

a Implementing the food safety risk analysis in Denmark – a case story on Campylobacter

During the 1990s, many countries, including Denmark, have experienced an increase in the number of registered cases of human enteric infections caused mainly by Salmonella and Campylobacter spp.. In addition, several countries in Europe have experienced an increase in the number of cases caused by E. coli O157. Due to this development, the Danish Veterinary and Food Administration decided to initiate a strategy for the control of pathogenic microorganisms in foods in 1997. In this paper, it is established that signi-ficant pathogenic microorganisms in foods in Denmark should be handled by the principles for food safety risk analysis currently being established in different interna-tional fora e.g. the World Health Organization, the Food and Agriculture Organization, the Codex Alimentarius Commission and the European Commission.

b Ranking Hazards As stated by the Codex Alimentarius Commission, the risk management part includes - at a regional or national level - a ranking of the most important hazards. The ranking procedure carried out by the Danish Veterinary and Food Administration states that spe-cial attention should be given to Campylobacter species, E. coli O157 and Salmonella as a consequence of the actual number of registered cases of Campylobacter and Salmo-nella infections and the potential threat by E. coli O157 to human health.

c Risk Profile In 1998, it was decided to initiate the risk management procedure on Campylobacter and E. coli O157 by elaborating risk profiles describing the food safety problems related to these organisms. The Risk Profile on Campylobacter was prepared by the Danish Ve-terinary and Food Administration in cooperation with the Danish Zoonosis Centre, the Danish Veterinary Laboratory, Statens Serum Institut, the Danish Meat Research Insti-tute, Danpo A/S, the Danish Environment Protection Agency, and the Danish Consumer Council in order to ensure transparency and communication between stakeholders. The Risk Profile on Campylobacter was finished in September 1998 and published on the Internet (www.fdir.dk/publikationer).

13 Speech given at the Nordic workshop on Risk Analysis, June 2000.


d Risk Assessment The risk profile for Campylobacter recommends the risk management procedure to be continued by ordering a formal risk assessment carried out according to the principles stated by the Codex Alimentarius Commission. In commissioning the risk assessment, risk managers and risk assessors agreed that the initial phase of the risk assessment should focus on Campylobacter jejuni in chicken products as this is the most intensively described area through data from literature and ongoing surveillance programs. Further, it was decided to include other food and environmental items when sufficient data rela-ted to these areas have been generated. The responsibility for the Risk Assessment pro-cedure regarding Campylobacter in Denmark has been placed in The Division of Micro-biological Safety at the Institute of Food Safety and Toxicology, the Danish Veterinary and Food Administration.

The aim of the present risk assessment work in Denmark is to describe a quantitative risk assessment model for Campylobacter jejuni in chicken products based on the prin-ciples stated by the Codex Alimentarius Commission. In addition, the work will provide the risk managers with information on the spread of Campylobacter from “stable to table” and the relative importance of the different critical control points at the produc-tion, retail and consumer level. Further on, the work on the quantitative risk assessment model reveal areas where, in the future, it will be necessary to improve and optimize sampling plans and analytical methods. The data included are based on surveillance pro-grams established in Denmark as well as information from the international literature in areas where no Danish data are available.

In the speech, the steps in the risk analysis process of Campylobacter were described in detail. In this report, parts of the description of the risk analysis are found in chapter 3.3 in order to avoid the duplication of texts.

Characteristics of the organism

Bacteria belonging to the genus Campylobacter are non-sporeforming, oxidase-positive, Gram-negative rods. Cells are pleomorphic. Log-phase cells have a characteristic slen-der, curved or spiral shape and have flagella, usually single, at one or both poles (mono-trichate or amphitricate) and are highly mobile, spinning around their long axes and fre-quently reversing direction. As cultures age, spiral or curved forms may be replaced by coccoid forms.

In general, Campylobacter species do not grow in conventional aerobic or anaerobic culture systems. Campylobacter does not ferment or oxidize sugars and are oxygen-sensitive microaerophilic bacteria, growing best in an atmosphere containing 5-10% oxygen. Since Campylobacter is sensitive to hydrogen peroxide and superoxide anions produced in media, lysed blood and FBP (0.025% each of ferrous sulphate, sodium metabisulphite, sodium pyruvate) are added to enrichment broths and selective agars to neutralize these toxic products of oxygen and to increase the aerotolerance of the organisms.

C. jejuni and to a lesser extent C. coli are the species most often encountered in medical laboratories as causes of acute enterocolitis in man. They are distinguished from most other Campylobacter species by their high optimum growth temperature (42°C). C. jejuni has two subspecies; subsp. jejuni – the familiar cause of enterocolitis in man and subsp. doylei – a more fastidious and slower growing organism which does not grow at 43°C. C. upsaliensis also appears to be enteropathogenic for man. This species is related


to the “thermophilic” Campylobacter, even though not all strains grow at 43°C. C. upsaliensis is seldom detected by conventional methods used for C. jejuni and C. coli. Primary isolation of this organism usually requires the use of selective filtration, non-selective media and incubation at 37°C. Additionally, C. upsaliensis requires H2 or formate for microaerophilic growth. C. lari is “thermophilic” like C. jejuni and C. coli but is considered to be of low virulence and is only occasionally encountered in man.

Reservoir

The principal reservoir of pathogenic Campylobacter spp. is the alimentary tract of wild and domesticated animals and birds.

Figure 1. The prevalence of Campylobacter in Danish broilers and ducks. The data are generated on the basis of one pooled sample comprising 10 cloacal swabs taken from each flock at the entrance to the slaughterhouse. The data represent all slaughtered flocks in Denmark in 1998 and 1999 (Danish Veterinary Laboratory, unpublished data).

The prevalence of Campylobacter in these animals and birds is reported for 1997 by the EU Member States. From these data it is evident that Campylobacter is commonly found in broilers, cattle, pigs, sheep, wild animals and birds, and in dogs. Other investi-gations have shown that healthy puppies and kittens, rodents, beetles and houseflies may also harbour Campylobacter.

The prevalence of Campylobacter in Danish broilers and ducks is seen in Fig. 1. The data represent all slaughtered flocks in Denmark in 1998 and 1999. A distinct seasonal variation is seen for broilers, with around 30% positive flocks in winter and around 70% positive flocks in summer. Turkey flocks have not been examined until September 1999. In this month, the prevalence was 70%. In December, the prevalence had de-creased to 50% (Danish Veterinary Laboratory, unpublished data). These data may indi-cate that the prevalence in turkey flocks is dependent on the season like the prevalence in broiler flocks.

In 1998, the prevalence of Campylobacter in Danish cattle and pigs were 51% and 59%, respectively (Annex G). Preliminary results indicate that in 1999, the prevalence was 49% in cattle and 53% in pigs (Danish Veterinary Laboratory, unpublished data). The prevalence in cattle and pigs is estimated on the basis of one faecal sample (from one animal) per herd at slaughtering.

C. jejuni and C. coli seem to have a favoured reservoir. C. jejuni is predominantly associated with poultry but has also been isolated from cattle, sheep, goats, dogs and

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cats. C. coli is predominantly found in pigs but has also been isolated from poultry, cattle, and sheep. In a Norwegian survey, 100 per cent of the pigs examined were infec-ted with C. coli. In a Danish investigation of faeces from 600 pigs, 94.7% of the animals were infected with C. coli and 0.3% with C. jejuni.

Water is also an important part of the ecology of Campylobacter. Campylobacter has been isolated from surface water, rivers, and lakes at prevalence up to about 50%. Addi-tionally, Campylobacter has been found in sand from bathing beaches at a prevalence of 45%. This means that Campylobacter may be present in untreated drinking water and bathing water. Unfortunately, the occurrence of Campylobacter in water in Denmark has not yet been surveyed. In water and other environments with sub-optimal growth conditions, Campylobacter may convert into a “viable but nonculturable state”. The im-portance of this “state” in the transmission of Campylobacter to animals and man is not agreed upon. The question is if the viable nonculturable organisms are still virulent or if they can reverse into a culturable, virulent state after passage through a host.

Risk factors and risk behaviour

The impact of different risk factors and patterns of behaviour on human cases of campylobacteriosis are not fully described. The information available on these topics is mainly based on epidemiological investigations of outbreaks, case control investigations and general studies on food handling procedures in private households.

The term “risk factor” is related to the specific sources of infection (like different food items and water) or specific host factors (like underlying disease or medication) re-vealed by epidemiological investigations. The term “risk behaviour” is used to describe different patterns of behaviour assumed to increase the risk of acquiring an infection by Campylobacter spp. Typically, the term risk behaviour is related to areas like travelling, contact with animals, profession, recreational activities and food handling procedures.

Risk factors

The major risk factors that have usually been associated with outbreaks of campylobac-teriosis are the consumption of unpasteurized milk, foods – in particular poultry, untrea-ted surface water and contaminated public and private water supplies.

The possible risk factors related to sporadic cases of human campylobacteriosis have been investigated in several case-control studies. The major risk factors described in these studies have been

- handling raw poultry,

- eating undercooked poultry,

- eating barbecued poultry, pork or sausages,

- eating poultry liver,

- drinking untreated surface water,

- drinking unpasteurized milk or dairy products,

- drinking doorstep-delivered milk with caps damaged by birds.

Other food items that have been related to sporadic cases of human campylobacteriosis are contaminated shellfish and cucumbers.


The relative importance of the potential sources of C. jejuni for human cases of campy-lobacteriosis has been investigated by applying different subtyping methods to isolates of C. jejuni obtained from patients and the possible sources described. Similarities in the distribution of serotypes of C. jejuni isolated from humans and different reservoirs are reported.

In Denmark, similarities between C. jejuni serotypes have been demonstrated among isolates from humans, broilers, poultry products and - to a lesser extent – cattle, with serotype O:2 being the most dominant type.

Similarities between serotypes of C. coli isolated from humans, broilers, pigs and retail poultry products have been described. However, the frequency by which C. coli is isolated from humans and from retail poultry products in Denmark is low compared to C. jejuni.

Underlying diseases like liver cirrhosis, neoplasia, immunosuppressive therapy and human immunodeficiency virus infection and diabetes mellitus have been described as predisposing factors for acquiring intestinal infections. In addition, an underlying dis-ease seems to enhance the severity of such infections.

Medication with antisecretory drugs like omeprazole and H2 and H2 antagonists has been shown to increase the risk for acquiring campylobacteriosis, presumably due to a raise in pH of the stomach contents. Further, some studies suggest that the use of antibi-otics and hormones will increase the risk of acquiring infection by Campylobacter spp..

Risk behaviour

Travelling

Travel abroad seems to be a common cause of human campylobacteriosis in the Northern European countries. In Denmark and UK, travelling abroad has been estimated to account for 10-25% of the reported cases. In Sweden and Norway, the estimated percentage is 40-60%. Campylobacteriosis has mainly been associated with travel to the Mediterranean countries and Asia.

Contact with pets

Several investigations have pointed out contact with pets, particularly young pets like kittens and puppies, as a behaviour increasing the risk of acquiring infection by Campylobacter spp.. In Denmark, it has been shown that 29% of the healthy puppies examined carried Campylobacter spp. with a species distribution of 76% C. jejuni, 5% C. coli and 19% C. upsaliensis. Only 2 (5%) of 42 healthy kittens examined excreted Campylobacter – both C. upsaliensis.

Professional occupation and residential area

The information about the risk associated with professional handling of production ani-mals at farm level is contradictory. Some studies indicate that rural residence associated with live animals increases the risk of human campylobacteriosis. Other investigations have revealed a higher incidence among the urban population than in the population living in rural areas. Danish results do not indicate an increased risk of acquiring campylobacteriosis for people handling production animals at farm level. In addition, the incidence of campylobacteriosis in the rural areas of Denmark seems to be equal to


or lower than the incidence in the Copenhagen area (Statens Serum Institut, unpublished data).

Several investigations have revealed that workers at slaughterhouses – and especially poultry slaughterhouses - are a part of the population with an increased risk of getting infected by Campylobacter spp.. This is presumably due to the heavily contaminated environment at the slaughterhouse. Further, contamination of the hands of processing line workers by C. jejuni has been demonstrated. The contamination by the hands of the processing line workers poses a risk to the health of the exposed person but also the possibilities of cross contamination of the products should be considered.

Recreational activities

As a consequence of the presence of Campylobacter spp. in the environment and in par-ticular in untreated water, recreational activities taking place in the nature like camping, trekking and bathing could pose a risk of acquiring a Campylobacter spp. infection.

Unsafe food handling procedures in private households.

Unsafe food handling procedures in private kitchens are assumed to be responsible for a significant number of cases of foodborne diseases in most countries. In the USA, it was estimated that 21% of 7219 cases of foodborne diseases were related to private house-holds in the period from 1973 to 1987, and in England it was estimated that 35% and 28%, respectively, of 101 outbreaks of foodborne diseases were related to insufficient heat treatment and to the cross contamination of foods during the preparation of meals in private households. In Sweden, the authorities estimate that half of the number of foodborne disease cases was acquired in private households.

Cross contamination

Cross contamination either by hands or by utensils is estimated to happen with a frequency between 20% and 50% based on several telephone and observation studies.

Insufficient heat treatment

Insufficient heat treatment of meals is estimated to happen with a frequency between 10% and 40% also based on several telephone and observation studies.

Age and Sex

Several investigations have shown that demographic factors like age and sex do have an impact on risk behaviour related to food safety in the private kitchen as the high-risk food handling procedures seems to be more prevalent among younger people than among middle-aged and elderly people. Several investigations on the distribution of C. jejuni infections among different age groups and between the sexes have shown that the incidence is relatively high in children between 0 – 4 years old and in young people be-tween 15 – 30 years old. Further, the incidence is generally higher in males than in fe-males. The higher incidence of campylobacteriosis in the group of people between 15 and 30 years of age could be explained by less attention to the safe ways of handling food in this population group.


Barbecue

Preparing meals at barbecue has in several investigations been shown to increase the risk of acquiring a Campylobacter spp. infection. The increased risk associated with barbecue may be explained by the increased risk of cross contamination and insufficient heat treatment related to this way of handling food.

Selected parts of a quantitative risk assessment model for C. jejuni on chicken are available on: www.who.int/fsf/mbriskassess/studycourse/annac/index.

At present, another risk assessment on broilers is being carried out in the UK. Finally, a risk assessment dealing with the human health impact of fluoroquinolone-resistant Campylobacter associated with the consumption of chicken is available on: www.fda.gov/cvm/fda/mappgs/ra/risk.

119 Annex C - Risk analysis - glycyrrhizic acid in liquorice; a case story

Annex C - Risk analysis - glycyrrhizic acid in liquorice; a case story

by Helena Hallström, National Food Administration, Uppsala, Sweden14

Introduction Liquorice is one of the oldest flavours in the world. Liquorice is used as a sweetener and aromatizer in for example beverages, confectionery, chewing gum, toothpaste, drugs and tobacco.

Liquorice is extracted from the dried roots of the plant, Glycrrhizia glabra. There are three main varieties, which originate from Southwestern Asia and Southeastern Europe. In addition there is a separate variety in China. All these varieties are used in the production of liquorice.

Liquorice has been used in medical treatments for more that 4000 years. In Europe, the indications have been coughing, indigestion and peptic ulcer.

Adverse effects have been observed in approx. 20% of the patients. The most frequently observed adverse effects were gain of body weight and oedema depending on electro-lyte irregularities and a number of other biochemical and hormonal activities (often re-ferred to as the hypermineralocorticosteroid syndrome).

The active component in liquorice: glycyrrhizic acid is characterised by its strong and long lasting taste, which is 50-200 times sweeter than sucrose.

Risk analysis The risk analysis process involves three major steps:

A. Risk assessment

B. Risk management

C. Risk communication

In the following, the risk analysis process will be described using glycyrrhizic acid as an example.

A. Risk assessment. Risk assessments of glycyrrhizic acid have been performed by the EU Scientific Committee on Food 1991 (“Recommendation on glycyrrhizin in liquorice products; Opinion expressed on 11 October, 1991”) and by the Nordic Working Group on Food 14 The text is derived from a lecture at the Danish Veterinary and Food Administration in November 1999. For more details the report “Adverse effects of glycchizic acid in liquorice – a risk assessment” Nordiske Seminar- og Arbejdsrapporter 1993: 526, is recommended.


on Toxicology and Risk Evaluation, (NNT) 1993; reference see above. A summary is given in the following.

a. Hazard identification

Human data

Data on humans mainly consists of case reports. In addition a few clinical and epidemi-ological studies are available.

The following adverse effects have been reported:

• Changes in levels of hormones, which regulate the salt balance (renin-angiotensin-aldosteron)

• Disturbance in the electrolyte balance

• Oedema

• Hypertension

• Reduction of testosterone levels (recently reported)

Depending on dose and time, these effects may result in:

gain of body weight, heart diseases, weakness, diseases of the kidneys, infertility in man? (not confirmed) etc.

It should, however, be noted, that all reported adverse effect may not be attributed to intake of glycyrrhizic acid, only.

Data from studies in experimental animals

Genotoxicity: Only a few studies are available. Though the quality varies, it seems likely, that liquo-rice is not genotoxic.

Glycyrrhetic acid has not been investigated in this respect, but is known to be anticarci-nogenic in animal studies.

Reproduction/teratogenicity studies:

Reproduction study in rats during pregnancy days 7-17; dose levels 21-680 mg glycyrrhizic acid/kg body weight. Results: mothers receiving the highest dose (equivalent to an intake of 7 kg liquorice by an adult human) exhibited an abnormal thirst; in the foetuses: a small dose-related increase in thirst, some defects in the skeleton, soft tissue anomalies and bleedings were observed.

For comparison, results from a human study:

An epidemiological study of 6,408 deliveries in Australia (1982) showed no relation between intake of cough medicine (containing liquorice) during pregnancy and any of the studied pregnancy outcome parameters.


Mechanism Reversible inhibition of the enzyme β-hydroxysteroid dehydrogenase, which is respon-sible for the transformation of cortisone → cortisol in the corticosteroid metabolism. The result is a hypermineralocorticosteroid effect of cortisol (disturbance in the salt balance).

b. Hazard characterisation

Farmacokinetics

• Complete absorption in the gastrointestinal tract.

• Glycyrrhetic acid can be detected in serum and urine after consumption of liquorice.

• The bacteria in the intestines split glycyrrhizic acid into glycyrrhetic acid and glucu-ronic acid.

• How fast and effective is the splitting in the intestines?

• Great interindividual variation.

• Farmacokinetic is incompletely studied: 14- compartment model has been suggested.

Dose effect relationship

What is the amount of liquorice that can be consumed without risk? – This question cannot be answered at present, as available data have been obtained from investigations on selected groups.

Regular daily consumption of 100-mg glycyrrhizic acid may result in biochemical chan-ges and symptoms in the most sensitive persons.

Great individual variations are known to exist. However, most humans are affected by a daily intake of 400 mg.

A tolerable daily intake (TDI): 10 mg glycyrrhizic may derived from the lowest ob-served adverse effect level (LOAEL): 100mg and a safety factor of 10.

c. Exposure assessment The content of glycyrrhizic acid in liquorice has been found to be in the range: 0.29-7.9 mg/g. In most products the concentration is actually lower than 3.5 mg/g. However, in some products the content is higher. Analyses of glycyrrhizic acid were carried out using HPLC (high performance liquid chromatography) and GC (gas chromatography). Furthermore, a lot of other components have been identified in liquorice.

Average consumption in the Nordic countries per person per year has been estimated as follows:

Country Liquorice consumption (kg/person/gear) Denmark 2.5 Finland ? Island 2.0 Norway 1.0-1.5 Sweden 1.5


The consumption varies significantly in the population, but the figures correspond to approx. 2–5 g glycyrrhizic acid/person/year = 6–15 mg/person/day (assuming that the products contain 0.2 % glycyrrhizic acid)

d. Risk characterisation

Acute exposure

Occasional large intakes are not likely to result in harmful effects; however, intakes of more than 1 gram glycyrrhizic acid may cause acute effects.

Chronic exposure

Regular intake of liquorice will inhibit the enzyme β-hydroxysteroid- dehydrogenase, which may give rise to clinical symptoms.

Estimated tolerable intake is 10 mg glycyrrhizic acid per day. A concentration in liquo-rice of 0.2% will result in a tolerable consumption of 5 gram liquorice per day.

B. Risk management

a. Risk evaluation Exposure data on liquorice and information on content of glycyrrhizic acid in liquorice are needed.

An estimate of “safe” daily intake would be approximately 10 mg glycyrrhizic acid/5 gram liquorice.

More data are, however, needed as the available data are based on selected persons (in some cases especially sensitive persons) in case studies. In addition, pharmacokinetics should be clarified and exposure data on glycyrrhizic acid are needed (se above).

SCF 1991 recommended that daily intake should not exceed 100 mg.

Average consumption is estimated to approx. 10 % of the LOAEL.

In order to prevent the public from harmful effects it is appropriate to not only to consi-der the clinical symptoms as not acceptable, but also to include the inhibition effcts of the enzyme in the overall evaluation.

The sensitivity towards glycyrrhizic acid varies in the population. Groups at risk are patients with hypertension or diseases in heart/kidney.

Guidance to consumers: consumption of liquorice is not advisable in combination with a diet rich in sodium chloride.

Regular intake of liquorice is not advisable.

b. Evaluation of options for risk management Possible options may be:

• Reduction of the concentration of glycyrrhizic acid in liquorice

• Allocation of a maximum limit of glycyrrhizic acid in liquorice

• Guidance to consumers regarding the intake of products containing glycyrrhizic acid

• Guidance to special groups at risk


• Labelling

c. Implementation European Council Directive on Flavouring? (SCF 1991)

d. Monitoring Analytical studies or surveys on concentration

Studies on liquorice intake

Documentation of cases showing clinical symptoms

C. Risk communication Based upon the recommendation of the SCF, 1991 and the risk assessment by NNT (Stormer, Reistad and Alexander), 1993, the National Food Administration in Sweden has informed the public in its publication: “Matverket”(1995) and in the periodical “Vår Föda” (No1, 1995). Information on this subject is currently also given by the NFA on Internet. Furthermore, advice has been communicated in personal contacts via tele-phone, letters and Internet.

In addition, information (from doctors) has been communicated in case stories, which have been published in medical periodicals.

Newspapers have also communicated information about possible risks, which may be associated with intake of liquorice. An example: In the Swedish newspaper “Aftonbla-det” an article about liquorice consumption and male infertility appeared in October 1999.

Conclusions The case story may be briefly summarised by the main facts presented and some impor-tant questions to be answered in the future:

• The suggested LOAEL has been found to be approximately 100 mg glycyrrhizic acid per day, which corresponds to an intake of 50 g liquorice per day.

• The safety margin between the NOAEL and the LOAEL is small.

• A regular intake of liquorice can thus not be recommended.

• Which management option(s) should be chosen?

• What has been done in the field of risk management?

• How could/should this risk be communicated?

125 Annex D-1

1. Risk evaluation

2. Risk assessmentincluding identification of uncertainties

3. Risk evaluation

4. Options

5a. No action 5b. Implementation

6. Monitoring

• Hazard characterization• Exposure• Risk characterization• Hazard identification

• Assessors

• Managers

• Politicians

• Assessors

• Managers

• Politicians

• Producers

• Consumers

Risk Analysis

• Standard basic model - “Cook book”• Specific model(s) for

- Chemicals added- Pathogens- Contamination- Naturally occurring agents- etc.

• Stand by basis info• Involve/commit consumers

industry etc. inprioritization/resourcemanagement

STRATEGY

Who is involved?

Who is involved?

• Communication at all steps

Risk profile

Risk

No activity

ANNEX D-1 THE DANISH PROPOSAL

126 Annex D-2

Annex D-2 THE FINNISH PROPOSAL

Ris

k A

sses

smen

tR

isk

Man

agem

ent

Com

mun

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ion

for

stak

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ders

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term

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t

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onom

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r. re

view

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view

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ng-te

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anag

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t dec

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tical

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men

t

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el fo

r act

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+ EX

IT

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hang

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rmat

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for s

take

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side

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ult

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asis

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ion

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ad h

oc

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is a

s a st

epw

ise

proc

ess,

- a F

inni

sh p

ropo

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127 Annex D-3

Annex D-3 THE SWEDISH PROPOSAL

The

Ris

k A

naly

sis P

roce

ss a

sst

epw

ise

proc

edur

e

Ris

k E

valu

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ion

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men

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isk

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acte

rizat

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t you

do

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you

do

it•V

alue

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t•W

hat y

ou d

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izat

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tern

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rans

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Doc

umen

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128 Annex D-4

Annex D-4 THE NORWEGIAN PROPOSAL

con

tinue

Ris

k E

valu

atio

n

Iden

tific

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n

Ris

k pr

ofile

Ran

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isk

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ass

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esul

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with

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/aut

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fluen

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entif

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ISK

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a st

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129 Annex D-5

CommentsStep

Communication

Internet Internet/Media

Risk Evaluation

Identification of food safety problemsA. Risk evaluation

II. Scientific riskassessment

Establishment of a risk profile

Ranking of the hazard for risk assessment andrisk management priority

Establishment of risk assessment policy for theconduct of risk assessment

The commitment of resources


Background data:• Outbreaks/acute situations.• Human incidence data• Surveillance• Exposure data• Research/Scientific literature• Consumer concerns

• Other relevant data (i.e. production figuresfor foods)

• A central database with epidemiologicaldata from environment, animals, food andhumans will be established to facilitateconstant overview of the situation.

• A brief description of the situation• Product or commodity involved• The values expected to be place at risk

• Potential consequences• Consumer perception of the risks• The distribution of risks and benefits

In acute situation (were actions cannot wait for more than a week) the directorgeneral of the agency responsible for risk management of food hazards will beasked to assign resources to the work, in other situations a request for support,with the identification of hazards, risk profile, ranking of priorities and riskassessment policy, will be sent to the minister responsible.

In this step a procedure will be followed where valid criteria pertaining to theselection of assessors and the resources (financial, time, data, Ad hoc expertiseetc.) will be followed. The assessor(s) selected must be scientificallycompetent, independent from identified stakeholders, have established qualitycontrol for his activities, …


Hazard characterization

Exposure assessment

Risk characterization

Consideration of risk assessment result

I. Risk management

Annex D

-5 TH

E ICELA

ND

IC PR

OPO

SAL

130 Annex D-5

CommentsStep

Communication

Internet Internet/Media

Risk Evaluation

B. Risk managementoption assessment Identification of available management options

D. Monitoring and review

Selection of preferred management option,including consideration of an appropriate safetystandard

Final management decision

Regulatory or other control measures

A central database with epidemiological data from environment, animals,food and humans will be used for monitoring purposes.Assessment of effectiveness of measures taken

Review risk management and/or assessment asnecessary

• Risk perception• Value judgement• Precautionary principle• Benefit/cost• Other technical factors

C. Implementation ofmanagement decision

Annex D

-5 TH

E ICELA

ND

IC PR

OPO

SAL

131 Annex E - Working methods of the workshop

Annex E - Working methods of the workshop

The project group worked with the question using different types of activities. One of the activities being a workshop with the following programme: Nordic Workshop on Risk Analysis, June 14th – 16th 2000, Helsingør 13.00 – 13.15 Welcome to the workshop, 13.15 – 14.30 Risk analysis process, - a ”farm to fork” quality assurance process in the food administration 13.15 – 13.45 Risk analysis process, step by step By Ib Knudsen, Danish Veterinary and Food Administration 13.45 – 14.30 The need for quality assurance in public food law administration By Göran Engström, Swedish Food Administration

15.00 – 15.45 Caffeine – health aspects, - state of the art? By Christer Andersson, Swedish Food Administration 15.45 – 16.15 Campylobacter – health aspects, - state of the art? By Niels L. Nielsen, Danish Veterinary and Food Administration 16.15 – 17.45 Café discussion on quality assurance of the risk analysis process including discussion on the following items in the groups

The discussions shall be summarised Thursday after lunch under the item: Report from each of the items in the café discussion.

Thursday 15th June 2000 09.00 – 10.00 Introduction and preparation of a dialog shop on the risk analysis process. Which documentation is required? – Who should be responsible for decisions on each step? 10.00 – 12.00 Dialog shop Invited experts (resource persons)

• Consumer representative: Yvonne Andersen, Herbert Lundström, Martin Frid • Administrator Kristina Bockhahn, Jon Gislason • Microbiologist Georg Kapperud • Toxicologist Leif Busk, Jens Jørgen Larsen • Industry Eva Berntsson


13.00 – 14.00 Report from each of the items in the café discussion 14.00 – 17.00 How should the risk analysis process be conducted - based on which type of documentation? Who would be the responsible for the decision on each step? Participants from each country should present a model for the ideal risk analysis process. The group will have to choice a way of presentation in the plenary group e.g. on overheads.

Friday 16th June 2000 09.00 – 12.00 Presentation in the plenary of proposals from the groups of the “ideal risk analysis model” to be used in public administration and risk analysis. 13.30 – 15.00 Discussion on the risk analysis model – for caffeine and Campylobacter 15.15 – 16.30 Discussion of a model for a risk analysis process as a stepwise process (plenary) 16.30 – 17.00 Closure of the meeting The following models for discussion or collection of knowledge were used: a. Café What is a café 2-3 project group members are joining as permanent members of one of five discussion groups and are responsible for chairing and summarising the discussion. The project group members have knowledge in chemistry and/or microbiology (information will follow). The participants in the workshop have a free choice on which discussion group they will join. The participants can and should preferably change groups and join the discussion in several of the five groups Café groups discussed the following questions: Risk analysis as part of the administrative process • quality assurance and the decision making process on Campylobacter • quality assurance and the decision making process on caffeine • quality assurance – importance in the decision-making process, now and in the

future • who would benefit from having the risk analysis process formalised? b. DIALOG - SHOP What is a dialog shop? A dialog shop is a method for development of ideas and or information. A group of persons in the dialog shop can get information from invited experts (resource persons) through prepared questions, and where they should try to disclose positions and values behind statements of importance for the subjects under discussion from these persons.


The dialog should be based on the expectations to the resource persons that they are willing and prepared to answer the questions put to them. However, the group has to respect that in certain cases, the experts might not have sufficient knowledge or the expert might not want to or is not allowed to answer. The dialog shop is not meant to lead to confrontations. In the dialog shop, the participants are responsible for the initiation of the dialog, the process and the timing. Preparation of questions shall ensure that questions of importance for the discussions of the subject, risk analysis are gathered in order to facilitate an interesting and lively discussion.

135 Annex F - Posters from the workshop and the different Nordic countries

Annex F - Posters from the workshop and the different Nordic countries

137 Annex F-1

Annex F-1Risk assessment of zoonoses

* 1997 and 1998

RISK COMMUNICATION1. nature of the risk2. nature of the benefits3. uncertainties in risk assessment4. risk management options

RISK MANAGEMENT1. r isk e va lu at io n2. o p t io n a sse ssm e n t3. o p t io n im p le m e n t a t io n4. m o n ito r in g a n d r e vie w

RISK ASSESSMENT1. hazard identification2. hazard characterization3. exposure assessment4. risk characterization

Structure of risk analysis FAO/WHO*

Codex alimentarius commission (CAC)– Principles and guidelines for the conduct of

microbiological risk assessment (Step 8, Rome 1999, FH)

Scientific committee for food (EU)– Principles for the development of risk assessment of

microbiological hazards under Dir. 93/43 EEC concerningthe hygiene of foodstuffs (1998)

International Office of Epizootics (OIE)– Import risk analysis (International animal health code 1999)

Some of the main papersconcerning risk assessment of zoonoses

Risk assessment - CAC definitionThe scientifically based process consistingof the following steps:– hazard identification– hazard characterisation– exposure assessment– risk characterisation

Hazard identification of zoonoses

Risks, which are not detected

In-house control programmes

Monitoring, surveillanceand control

Reported cases in humans and animals

Reportedoutbreaks

Zoonosesdirective

Risk assessment - OIE definitionThe evaluation of– likelihood and– the biololgical and– economic consequences

of– entry– establishment– or spread

of a pathogenic agent within the territory of animporting country

Maijala, R.Risk assessment of zoonoses inWorkshop on Analytical methods in the epidemiology of zoonoses in the EU.11-13 October 1999, Berlin

FAO/WHO expert consultations– 1995 Risk analysis– 1997 Risk management– 1998 Risk communication– 1999 Risk assessment of microbiological hazards

» FAO/WHO Application o f risk analysis to food standards issues. Report of theJoint FAO/WHO Expert Consultation,1995, Geneva.

» FAO/WHO Application o f risk management to food safety matters, Repor t of theJoint FAO/WHO Expert Consultation 1997, Rome.

» FAO/WHO Application o f risk communication to food standards and safetymatters. Repor t of the Joint FAO/WHO Expert Consultation. 1998, Rome

» FAO/WHO Risk assessment of microbiological hazards in foods. Report of a jointFAO/WHO expert consul tation, 1999, Geneva

138 Annex F-2

Annex F-2Risk assessment of zoonoses

Risk assessment should beBased on scienceTransparentQualitative and/or quantitativeConducted according to structured approachPresentation of uncertainties, assumptions andvariability of inputsReassessed and re-evaluated over timePresentation of costs, resources and time (CAC)Flexible - real life situations (OIE)

Questions for risk assessmentGeneral

What can cause risk?How can it cause risk?What is the probability?What are the consequences?What are the necessary events for occurance?

OIEWhat are the costs?

Risk assessment documentEstimated number of herds, flocks, animals or peoplelikely to experience heath impacts over timeprobability dis tributions, confidence intervals and otherexpressions of uncertaintiesConstraints, uncertaint ies and assumptions should bepresentedExpress the varianceSensitivity analys isAnalysis of dependance and correlation between the modelinputs

Risk assessment and data collection

Data collection

Risk assessment- preliminary- reassessment

Collection of lacking data

Risk assessment

Report

Maijala, R.Risk assessment of zoonoses inWorkshop on Analytical methods in the epidemiology of zoonoses in the EU.11-13 October 1999, Berlin


FAO/WHO and CAC

The identification ofknown or potentialhealth effectsassociated with aparticular agent

part of risk assessment

OIE

The identification thepathogenic agentswhich couldpotentially beintroduced in thecommodity consideredfor importation

Risk assessment

Scientific risk assessment– for approval of food additives etc.– for international trade– for legislation

Practical risk assessment– for quick answers– for HACCP (RACCP)

139 Annex F-3

Annex F-3 Surveillance program on thermophilic Campylobacter spp. (C. jejuni, C. coli and C. lari) in raw meat products from Danish retail outlets.

By Hanne Rosenquist and Niels Ladefoged Nielsen, The Danish Veterinary and Food Administration The results of a Danish surveillance program (1995-1999) indicate that the prevalences of thermophilic Campylobacter spp. in broilers and turkeys at retail level in Denmark are in the range of 20 – 30% and 10 – 20%, respectively. In raw beef and pork products from Danish retail outlets, the prevalences of thermophilic Campylobacter spp are approx. 1%. The results indicate that poultry products should be considered as one of the risk factors regarding human Campylobacteriosis. The relative importance of beef and pork products in relation to cases of sporadic human Campylobacteriosis is to be investigated.

Aim The aim of the surveillance program was to estimate the prevalence of thermophilic Campylobacter species (C. jejuni, C. coli and C. lari) in raw poultry, beef and pork products sold from Danish retail outlets. Data obtained will be used in the exposure assessment part of a risk assessment procedure regarding the role of Campylobacter spp. in foods. Material and methods During 1995 - 1999, 1166 samples of raw beef, 1080 samples of raw pork and 4202 samples of raw poultry products were examined for the presence of thermophilic Campylobacter spp.. The examination was carried out according to a standard procedure involving a sample preenrichment in Preston broth followed by isolation on modified Cefaperazone Charcoal Desoxycholate Agar (mCCDA) [1]. The Municipal Food Control Laboratories in Denmark carried out the sampling and analysis.

Figure 1. The prevalence of Campylobacter species in Danish and imported poultry products 1995-1998. The numbers above the bars are the numbers of samples examined. Results and discussion The development in prevalences of thermophilic Campylobacter spp. in broiler and turkey products of foreign and Danish origin in the period 1995 - 1999 is shown in Figure 1. During this period, the prevalences of thermophilic Campylobacter spp. seem to have decreased in Danish and imported poultry products, the decrease being most significant in turkey products of Danish origin. Mean prevalences during the sampling period were 29% (N=1478) in broiler products of Danish origin,

24191

34

133

43103

88186

140

238320637

160251

297522

0

10

20

30

40

50

60

70

80

BroilersDanish

BroilersImported

TurkeysDanish

TurkeysImported

Prevalence (%)

1995 1996

1997 1998

140 Annex F-3

33% (N=739) in imported broiler products, 23% (N=783) in turkey products of Danish origin and 17% (N=367) in imported turkey products.

The indication of certain seasonal fluctuations in the prevalence of thermophilic Campylobacter spp. in poultry of Danish origin that cannot be seen in imported poultry is illustrated in Figure 2.

Figure 2. The influence of seasonal fluctuations on the prevalence of Campylobacter species in Danish and imported

poultry products 1995-1999. The numbers above the bars are the numbers of samples examined.

The prevalence of thermophilic Campylobacter spp. was approximately 6% higher in fresh poultry products (26%, N=443) as compared to frozen poultry products (20%, N=707).

In raw beef and pork products 1% (N=1166) and 1.2% (N=1080) of the samples respectively were found to be contaminated with thermophilic Campylobacter spp.

The results of this surveillance program indicate that poultry products may be one of the important risk factors regarding human Campylobacteriosis as also suggested in several case-control studies [2,3].

References [1] Circular on Microbiological Investigations of Foods (1997). Danish Veterinary and Food Administration.

[2] Neimann J., Engberg J., Moelbak K. and Wegener H.C. (1998). Foodborne risk factors associated with sporadic Campylobacteriosis in Denmark. Dansk Veterinaertidsskrift. 81 (19), 702-705.

[3] Kapperud G. (1994). Campylobacter infection. Epidemiology, risk factors and preventive measures (in Norwegian language). Tidsskrift for Den Norske Laegeforening, 114 (7), 795-799.

117102

41

31

43

57

108 2655

39129

73

164

162

129

169

0

10

20

30

40

50

60

Danish poultry Impo rted poultry

P revalence (%)

141 Annex F-4

Annex F-4

Human Campylobacteriosis in Iceland by Ásmundur E. Þorkelsson[1], Franklín Georgsson[2], Hjördís Harðardóttir[3] and Haraldur Briem[4].

Introduction Since 1980 stool samples have been analyzed systematically for Campylobacter at the Department of Microbiology, University Hospital, Reykjavik. The average incidence rate during ‘90-’95 was 14,6. Since then the annual incidence rate has been climbing steadily. Most recent data on human cases indicate that the incidence rate is rapidly decreasing. Methods Case definition: An individual with culture confirmed presence of Campylobacter spp. in stools. Epidemiological data collection: The reporting microbiologist and physician obtain data on sex, age, residence and foreign travelling activities. Recently a questionnaire on food consumption prior to illness was added to the data collection. Culture methods: Samples are recieved in modified Carry-Blair medium and plated directly on Skirrows and CCDA culture media. Incubated at 42°C (Skirrows) and 37°C (CCDA) for 48-72 hrs in microaeorophilic atmosphere. Identification:. Suspiciuous looking colonies are idendified to the genus level by direct microscopy (cell morphology and motility), Gram reaction and oxidase and catalase activity. Further identification to the species level is done by determination of hippurate hydrolysis and evt. API Campy (Bio Mérieux), indoxyl acetate hydrolysis and sensitivity for cephalothin and nalidixin. All Campylobacter isolate are finally tested for erythromyacin and cyprofloxacin sensitivity (E-test, AB Biodisc).

[1] Environmental & Food Agency of Iceland, tel: + 354 585 1000, email: [email protected], [2] Environmental & Food Agency of Iceland, tel: + 354 585 1000, email: [email protected], [3] University Hospital, tel: +354 5601900, email: [email protected] and [4] Directorate of Health, tel: +354 510 1900, email: [email protected]

Culture confirmed cases of Campylobacteriosis in Iceland 1983-2000.Data from State Epidemiologist and University

0

50

100

150

200

250

300

350

400

450

500

1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000

Year

Cases Cases

Incidence rate

Predictied

Cases for Januarythrough May 2000.

Fig. 1. Human cases during 1990-1999. The average incidence rate during ‘90-’95 was 14,6. Since then the annual incidence rate has been climbing steadily to 31, 34, 80 and 159 cases in ’96, ’97, ’98 and ’99, respectively. The first signs of increase appear in 1996 and already in 1998 the increase is very pronounced. Most recent data on human cases indicate that the incidence rate is rapidly decreasing

142 Annex F-4

Rel

ativ

e po

rtio

n (%

)

0 5

10 15 20 25 30 35 40 45

0-4 5-9 10-14 15-19 20-29 30-39 40-49 50-59 60-69 >70 Age group (years)

199719981999

Fig. 2. Age distribution: The rapid increase in human cases in 1998-1999 is mainly in the age group 20-29 years. Similar age distribution has been reported for many developed countries.

0

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100

150

200

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Reykjavík area

Vesturland

Suðurnes

VestfirðirNorðurland Vestra

Norðurland Eystra

Austurland

Suðurland

Vestmannaeyjar

Fig. 3. Geographical distribution. The increase in human cases is apparent in most geographical areas. The highest incidence was observed in the Reykjavik area and Suðurland area, which are adjacent areas.

143 Annex F-4

1 13

9 8

14

8

16

9 8 9 8

2 2

17

8

2

24

52

40

2824

14

75

20

15

4139

62

101

66

35

2320

10

5

1114 15

20

0

20

40

60

80

100

120

1 2 3 4 5 6 7 8 9 10 11 12

Mo nth

Num

ber

of c

ases 1997

199819992000

Fig. 4. Seasonal distribution. Before the rapid increase in human cases in 1998 and 1999, the distribution of cases through season was rather even. In 1998 and 1999 a peak in human incidence during the summer months is observed. Similar peak during the summer months has been reported for several countries in Northern Europe.

0

20

40

60

80

100

120

jan.99 feb.99 mar.99 apr.99 maí.99 jún.99 júl.99 ágú.99 sep.99 okt.99 nóv.99 des.99 jan.00 feb.00 mar.00 apr.00 maí.00

Month

Num

ber o

f cas

es

Not registered/unknownForeignDomestic

Fig. 5. Sources of Campylobacter infections in January 1999 through May 2000. About 70% of the infections in this period are aquired domestically.

144 Annex F-5 - Campylobacter in animals and food in Iceland

Annex F-5 - Campylobacter in animals and food in Iceland by Àsmundur E. Þorkelsson[1], Franklín Georgsson[2], Eggert Gunnarsson[3] and Jarle Reiersen[4]. Introduction. A survey on the prevalence of Campylobacter in the environment, in animals and in foods was performed in Iceland in August through November 1999. In samples from the environment the organism was found in surface water and wild animals. In samples from live animals the organism was demonstrated in broilers, other poultry, pork and lamb. No samples from horse and cattle were taken. The organism was also found in two private waterworks. Methods. Sampling from animals: Cloacal swabs taken from 10 four weeks old birds in a single flock were pooled into 2 samples. Feacal samples from 10 lambs or 10 pigs from a single herd at slaughter were pooled into two samles. Feacal samples from cats, dogs and wild animals were taken from individuals. Sampling of food: Food samples were collected at retail, except for carcass swabs which were taken at meat cutting plants and raw milk which was taken in a dairy plant. Water samples were taken from tabs in distribution systems. Analysis of samples. All samples were analysed according to the Nordic method for detection of Campylobacter in foods („Nordisk Metodikkommitte för Livsmedel. Campylobacter jejuni/coli. Detection in foods. Nr. 119, 1990 2 nd ed.“). In each case 11 g of sample were weighed for culture. Air and water samples were filtered through 0,2 µm filter. The filter was then cultured. Table 1 – Analysis for Campylobacter in food prior to 1999. (Hvr: Environmental & Food Agency of Iceland, HÍ: University of Iceland, Rf: Icelandic Fisheries Laboratories og Hes: Municipal competent authorities). Prior to 1999 only seven surveys on prevalence of Campylobacter in foods and drinking water had been performed, as outlined in table 1. These surveys indicate that since 1986 approximately 60-88% of broilers was positive when tested for the presence of Campylobacter. Very limited number of samples of ground beef and fish do not indicate the presence of the organism in these commodities. A fairly large survey on drinking water from public water works indicates that the organism is not normally present in drinking water. Its presence has, however, been demonstrated in untreated surface water.

[1] Environmental & Food Agency of Iceland, tel: + 354 585 1000, email: [email protected], [2] Environmental & Food Agency of Iceland, tel: + 354 585 1000, email: [email protected], [3] Institute for Experimental Pathology, tel: +354 567 47 00, email: [email protected] and [4] Chief Veterinary Office, tel: +354 567 47 00, email: [email protected]

Foods Year Number of samples

Campylobacter % positive

Fresh poultry (Hvr-HÍ) ‘86 159 74 Frozen poultry (Hvr-HÍ) ‘86 20 60 Ground beef (Hvr-HÍ) ‘86 34 0 Fresh fish (Rf) ‘89 50 0 Frozen poultry (Hvr-Hes) ‘91 99 88 Drinking water (Hvr-Hes) ‘93-’94 246 0 Fresh poultry (Hes) ‘98 22 64

Species No. positive

Percentage (%) Campylobacter spp.

Poultry Broilers 71 flocks 18 25 C. jejuni (17), C. coli (1) Turkeys 10 flocks 2 20 C. jejuni (2) Ducks 14 flocks 10 71 C. jejuni (7), C. coli (3) Geese 2 flocks 1 * C. jejuni (1) Laying hens 2 flocks 1 * C. coli (1) Pork 26 farms 18 69 C. jejuni (5), C. coli (8),

C. hyointestinalis (3), C. spp. (2) Lamb 40 farms 11 28 C. jejuni (4), C. coli (7) Canine 33 animals 0 0 Feline 24 animals 0 0 Vild animals Mice 2 animals 0 * Geese 2 birds 1 * C. jejuni (1) Ducks 1 bird 1 * C. jejuni (1) “Rjúpur” 6 birds 0 * * Percentage not calculated due to limited number of samples.

145 Annex F-5 - Campylobacter in animals and food in Iceland

Table 2 – Results from the analysis of fecal samples from animals in August through November 1999. The organism was highly prevalent in poultry, lamb and pork. The organism was also found in wild birds. Further studies have demonstrated that the organism is highly prevalent in cattle. Table 3 – Flocks on broiler farms (*Percentage not calculated due to limited number of samples). Out of 71 broiler flocks sampled, 18 (25%) were confirmed positive for Campylobacter. The samples were collected from 17 farms and 4 of those had positive flocks. These 4 farms have in total more than 60% market share. Table 4 – Results from analysis for Campylobacter of samples from foods, drinking water and the environment (* swab samples from carcasses). A total of 423 samples from foods, drinking water and air in abattoirs were collected. In the food samples, Campylobacter was only found in poultry. The organism was also found in drinking water derived from a surface water source, surface water not intended for drinking and air samples taken at hanging in one abattoir.

Farm No. of flocks No. of Campylobacter positive flocks

Market share (poultry 1998)

Reykjagarður hf 21 10 (48%) 43.7% Móar hf 20 5 (25%) 20.8% Bræðraból 3 2 ( * ) 3.3% Helluvað 2 1 ( * ) 1.4% 13 other farms 25 0 (0%) 30.9%

Samples No. of producers (sampling site)

No. of samples

No of positives

(%) Broilers 4 slaughterhourse/brands 99 44(44) Pork 13 producers 44 (4)* 0(0) Beef 19 producers 51 (5)* 0(0) Lamb 19 producers 55 (11)* 0(0) Other raw meat 11 producers 13 0(0) Other foods 3 producers 3 0(0) Seafood 22 producers 33 0(0) Vegetables 17 producers 46 0(0) Raw milk at the farm 10 0(0) at the dairy 18 0(0) Drinking water ground water 18 0(0) surface water 6 2(33) Surface water (brooks, ponds, lakes) 18 4(22) Sewage 3 1(33) Air samples poultry slaughterhouse 6 3(50)

Total 423 54(13)

146 Annex F-6

ANNEX F-6 Workshop on Risk Analysis, Helsingør, June 12-13, 2000

Campylobacter Risk Assessment

Consumption data

0 10 20 30 40 50

Broiler Turkey Duck Cattle Pig Lamb

gr./day

N O D ATA

A VAILABLE

Poster layout by Asger Johansen The Danish Veterinary And Food Administration

N O D ATA

A VAILABLE

N O D ATA

AVAILABLE

N/A N/AN/A0

10

20

30

40

50

Broiler Turkey Duck Cattle Pig Lamb

gr./day

Human disease

Dose-response

NO DATAAVAILABLE

Incidence per 100,000 citizens

81 78 46 56 80

N O DATAA VAILABLE

N O DATA A VAILABLE

N O D ATA A VAILABLE

NO D ATA AVAILABLE

147 Annex F-7

This poster presents an abstract of the data from surveys aiming to find Campylobacter in food and water during the past 20 years in Norway.

Poultry 1984, 1995, 1996, 1997, 1998, 1999, 1992-1996

a) Swabs from fresh carcasses. b) Samples representing heat treated meat. c) Samples representing chilledmeat. d) Samples representing frozen meat. e) Samples from processing water collected from each herd at slaughter.

* A dramatic decrease in the number of bacteria isolated from the carcasses was observed after five weeks of freezing.

Pork 1981, 1985

a) Swabbing of gallbladder and organs from fresh carcasses. b) Swabbing of different organs/regions from fresh and chilled carcasses, c) Meat samples of fresh and cooked pork *The contamination rate was reduced from 56% to 32% in four days of chilling

Survival in normal and modified atmosphereA study in1999 indicated that the ability of Campylobacter to survive on the surface of fresh poultry meat packed in normal and modified atmosphere, was not significantly different (8). Campylobacters were isolated from all inoculated samples and from all naturally contaminated samples throughout the shelf-life of the products when stored at 4oC.

Location

No. of

samples

%

positive

C. jejuni

C. coli

C. lari

Ref.

Plant

691a

38

217*

44

-

1

Nationwide

255b 1 1 - - 3

143c 11 15 - -

176c 10 18 - -

358c 5 13 - 3

271d 3 7 - 4

101c,d 9 8 1 -

Plant 540e 7 36 - - 4

Material

No. of herds

No. of

samples

%

positive

C. jejuni

Ref.

Pig carcassesa

22

50

58

29

5

Pig carcassesb

-

310

42

131*

6

Productsc - 152 0 - 7

CAMPYLOBACTER ISOLATED FROM FOOD AND WATER IN NORWAY

MARIANNE SANDBERG1,3, GEORG KAPPERUD1,2 AND EYSTEIN SKJERVE1,3

The Norwegian School of Veterinary Sciences1, National Institute of Public Health2 and National Veterinary Institute3 Oslo, Norway

ANNEX F-7

148 Annex F-8

CAMPYLOBACTER ISOLATED FROM FOOD AND WATER IN NORWAY

MARIANNE SANDBERG1,3, GEORG KAPPERUD1,2 AND EYSTEIN SKJERVE1,3

The Norwegian School of Veterinary Sciences1, National Institute of Public Health2 and National Veterinary Institute3 Oslo, Norway

Water Drinking water supply in NorwayNorwegian households are supplied with drinking water from approximately 1800 water-works. Of this total, 33% obtain their water from ground-water wells while 67% use surface water sources (9).

Surveys 1986-87, 1997

a), b) Sampled every fortnight in a 14 months period. The proportion of positive samples was highest in the autumn and at temperatures between 2-12°C. c) A prevalence study conducted in the region of Sunnmøre.

SummaryThe occurrence of Campylobacter in Norwegian poultry meat has been investigated since the early 1980's and has varied from 38 to 1% in different kinds of products. Surveys performed in recent years have indicated that theprevalence in raw poultry products at retail sale is between 5 to10%. Campylobacter was isolated from fresh pigcarcasses but not from chilled pork products in the 1980’s. The bacterium was frequenlty encountered in surfacewater sources, including drinking water, throughout the year.

References1. Rosef O, Gondrosen B, Kapperud G. Campylobacter jejuni and Campylobacter coli as surface contaminants of fresh and frozen poultry carcasses. Int J Food Microbiol 1984;1: 205-15.2. Anon. ”Campylobacter i skyllevann”. Næringsmiddeltilsynet i Tønsberg 1992-1996. Personal commuication, 2000.3. Anon. Forekomst av Campylobacter i fjørfekjøtt i Norge 1995-1997. SNT reportnr. 3, 1998. Oslo: Statens næringsmiddeltilsyn, 1998.4. Anon. Campylobacter i rått fjørfekjøtt. Næringsmiddeltilsynet i Bergen og omland, 2000.5.Rosef O. Isolation of Campylobacter fetus subsp. jejuni from the gallbladder of normal slaughter pigs, using an enrichment procedure. Acta vet Scand 1981;22: 149-51.6. Rosef O, Gonrosen B, Kapperud G. Campylobacter fetus subsp. jejuni som overflatekontaminant på nyslaktede og kjølte griseslakt. Nord Vet Med 1981;33: 535-38.7. Nesbakken T, Gondrosen B, Kapperud G. Investigation of Yersinia enterocolitica and Yersinia enterocolitica-like bacteria and thermotolerant campylobacters in Norwegian pork products. Int J Food Microbiol 1985;1: 311-20.8. Fossum H, Kapperud G, Underdal B, Nordal J. Overlevelse av Campylobacter i fjørfeprodukter pakket i normal og modifisert atmosfære. Rapport fra Fagseksjon for næringsmiddelhygiene ved Norges veterinærhøgskole, 1999. Oslo: Norges veterinærhøgskole, 1999.9. Anon. Vannverkstatus 1998/99 (II). Nytt fra miljø- og samfunnsmedisin, 2000; 4: no 5. Oslo: Statens institutt for folkehelse, 2000. 10. Brennhovd O, Kapperud G, Langeland G. Survey of thermotolerant Campylobacter spp. and Yersinia spp. in three surface water sources in Norway. Int J Food Microbiol 1992;15: 327-38.11. Brennhovd O, Kapperud G. Forekomst av Campylobacter spp. og Yersinia spp. i et vassdrag påvirket av forurensing fra jordbruk og avløpsvann. Forskningsoppgave for graden doctor scientiarium. Institutt for næringmiddelhygiene, Norges veterinærhøgskole, 1991.12. Anon. Campylobacter fra ubehandlet drikkevann. Næringsmiddeltilsynet i Ålesund 1997. Personal communication, 2000.

Material

No. of

samples

%

positive

C. jejuni biotype 1

C. jejuni biotype 2

C. coli

C. lari

Other

Ref.

Surface watera

96 44 31 12 13 2 2 10

Private wells

100 0 - - - - -

Riverb 248 34 45 18 38 1 2 11 Water- worksc

62 0 - - - - - 12

ANNEX F-8

149 Annex F-9

Prevalence, incidence and quantitative data related to Campylobacter in Sweden by Sofia Lundström and Lars Plym Forshell, National Food Administration, Sweden

Primary production In 1998, 3561 flocks, with a total of 61.2 million broilers (98% of all broilers slaughtered that year in Sweden) were tested at the slaughterhouse. In all, 325 flocks were found to be positive, representing 9.1% of all flocks. A prevalence study in which 987 faecal samples were taken from sheep and lamb was conducted in 1998. The samples were taken at slaughter and 114 yielded growth of Campylobacter spp. Slaughter In 1999 samples were taken at meat cutting plants in Sweden and analysed for Campylobacter spp. A total of 366 samples, 241 were samples from pork, 91 from beef, 18 from broilers, 3 from moose and 13 were mixed (pork/beef) minced meat, were analysed. There were 2 positive samples, 1 from pork and 1 from broiler.

Retail level In 1999 a study were made in which samples were taken from grocery stores in the city of Uppsala, Sweden. The samples were taken at two different periods of the year, August-September and February-May. A total of 245 samples from seven different food categories were analysed. Campylobacter was found in 24 samples, 1 from pork and the rest from chicken.

Mapping of Campylobacter 1999 in Uppsala, Sweden Samples were taken from grocery stores in the city of Uppsala

February until May

August and September

Food category

Samples

Positive samples

Food

category

Samples

Positive samples

Chicken

45

4

Chicken

53

19

(Hen)

2

0

(Hen)

-

-

(Turkey)

-

-

(Turkey)

2

0

ANNEX F-9

150 Annex F-9

Pork

25

0

Pork

30

1

Beef

15

0

Beef

30

0

Lamb

3

0

Lamb

10

0

Vegetables

-

-

Vegetables

30

0

Total

90

4

Total

155

20

Environment In 1998 a study was conducted in which faecal samples from wild animals, shot by hunters, were collected. 40 hares, 127 deer, 22 wild boars and 82 moose were investigated for the presence of Campylobacter spp. Samples from 1-3 animals were pooled before analysing. A total of 10 pooled samples yielded growth of Campylobacter spp., 4 from deer, 5 from wild boar and 1 from moose. All data collected from the zoonotic report of 1998, National Veterinary Institute, Sweden and from studies made at National Food Administration, Sweden.

151 Annex F-10

ANNEX F-10

152 Annex G - Information on caffeine

Annex G - Information on caffeine

Table 1. Sources of caffeine (Gilbert RM, 1984) Natural source, part of Amount (average) (%) plant used, species

Coffee, seed Coffea arabica 1.2 Coffea canephora 2.2 Coffea liberica 1.4 Tea, leaf Camellia sinensis 3.5 Chocolate, seed Theobroma cacao 0.03 Colanut, seed Cola acuminata 1.5 (other Colaspecies) Guarana, seed Paullinia cupana 4 Yoko, bark Paullinia yoco 3 Maté, leaf Ilex paraguensis 0.7 (other Ilexspecies)


Table 2 Caffeine in beverages (Barone JJ, Roberts HR, 1996) Food source Average amount caf-

feine/dl Amount caffeine per serving

Natural sources

Coffee, brewed 76 mg 115 mg/1.5 dL cup

Coffee, boiled 60 mg 90 mg/1.5 dL cup Hot chocolate 3 mg 7.5 mg / 2.5 dL cup

Tea 26 mg 65 mg/2.5 dl cup

Instant coffee 40 mg 60 mg/1.5 dl cup

Additives etc.

Soft drinks max 13.5 mg* Max 27 mg/2 dl glass

Energy drinks max 32 mg** max 80 mg/2.5 dl can * According to Swedish legislation; ** Excemptions

Table 3. The total daily caffeine exposure from foods and beverages in some countries.

Average caffeine exposure and/or range (mg)

Country Population size

Caffeine sources

Reference

462.91,2

Australia 17 Coffee, tea Lelo et al. (1985) 240 Australia 4,757 All foods Shirlow et al. (1983) 238 Canada Per capita All foods Gilbert (1984) 49-1022 Canada 58 Coffee, tea Stavric et al. (1988) 490

2,3 Denmark All foods Barone and Roberts

(1996) 280

2,3 UK All foods Barone and Roberts

(1996) 444 UK Per capita All foods Gilbert (1984) 327 (0-1055)

UK 142 All foods James et al. (1989)

359 UK 174 All foods Scott et al. (1989) 211 USA Per capita All foods Gilbert (1984) 186 USA 202 Coffee, tea

soft drinks Hughes et al. (1997)

2103 USA All foods Barone and Roberts

(1996) 227

2 USA All foods Kalow (1993)

156.0-301.6 USA 2,714 All foods Schreiber (1988) 186 USA All foods Graham (1978) 171 Brazil 600 All foods Camargo et al., 1999425 Sweden Per capita All foods Gilbert (1984) 1)

Heavy consumers; 2)

Calculated on consumers only; 3) Recalculated from mg/kg body weight for a person of 70 kg.


Table 4 Total daily caffeine exposure in children of different nationalities. (Andersson C., Hallström H., and Kihlman B.A., (in press) Caffeine exposure (mg) (mg/kg b.w.)

Country Caffeine sources Reference

1.3 Australia All foods Gilbert (1984) <2.5 Denmark All foods Gilbert (1984) 230 (girls) 310 (boys)

Finland Coffee Hemminki et al. (1988)

<3 UK All foods Gilbert (1984) 37.4 USA All foods Morgan et al. (1982) 2.1-11.9 (½yo) 22-44 (1 yo) 35-95 (2 yo) 41-94 (3 yo) 39-72 (4 yo) 22-62 (10 yo) 26-138 (13 yo) 26-108 (15 yo) 45-147 (17 yo)

0.3-1.5 (½yo) 2.2-4.6 (1 yo) 2.5-7.8 (2 yo) 2.8-6.4 (3 yo) 2.3-4.5 (4 yo) 0.7-2.0 (10 yo) 0.6-2.8 (13 yo) 0.5-2.0 (15 yo) 0.7-2.5 (17 yo)

USA All foods Arbeit et al. (1988)

29 USA All foods Kalow (1993) 12.3 (7 yo) 13.9 (8 yo) 17.9 (9 yo) 24.8 (10 yo)

0.44 (7 yo) 0.46 (8 yo) 0.53 (9 yo) 0.68 (10 yo)

USA All foods Ellison et al. (1995)

1 USA All foods Barone and Roberts (1996)

28 (median) USA All foods Goldstein et al. (1997)

1) Intake in mg/kg body weight.

155 Annex H - Hazard Identification of zoonoses

Annex H - Hazard Identification of zoonoses

Hazard identification of zoonoses can, in general, be described in Figure 1 below. (Campylobacter)

Table 1. Incidence of infections with Campylobacter by age and sex in Denmark 1999 (Statens Serum Institut).

Number of cases Cases perAge group (years) Female Male Unknown Total 100,000<1 33 39 6 78 117.81-4 180 258 42 480 172.45-14 132 200 32 364 58.415-24 431 343 84 858 134.625-44 647 663 157 1467 93.345-64 301 293 45 639 47.565+ 116 133 29 278 35.2Total 1840 1929 395 4164 78.4

Hazard identification of zoonoses

Risks, which are not detected

In-house control programmes

Monitoring, surveillanceand control

Reported cases in humans and animals

Reportedoutbreaks

Zoonosesdirective

156 Annex H - Hazard Identification of zoonoses

Danish products sold in

Denmark (tons) Imported products sold in

Denmark (tons) Chickens whole - chilled 4612 Chickens whole - frozen 12182 Chickens whole - total 16794 6141 Chicken parts - chilled 5620 Chicken parts - frozen 14371 Chicken parts – total 19991 4562 Other chicken products 16089 poultry products 631 Other products total 16720 9266 Turkey products 8838 5850 Duck products 3267 3360 Total 65610 29179

Table 2. Retail sale of poultry products in Denmark in 1998 (Statistics Denmark and the Danish Poultry Council, unpublished data).

157 Annex I - List of Participants

Annex I - List of Participants

Nordic workshop on risk analysis illustrated with two examples caffeine and Cam-pylobacter Sweden

Swedish Food Administration

1. Göran Engström

2. Lars Plym Forsell

3. Leif Busk

4. Christer Andersson

5. Kierstin Peterson Gravé

6. Sofia Lundström

7. Per Mattsson

8. Ulla Beckman Sundh

9. Helena Hallström

10. Ulla Nordström

Smiitskyddsinstitutet; S – 171 82 Solna,

11. Birgitta de Jond

12. Yvonne Anderson

Hushållnings Sällskapet, Residensgatan 36, 462 30 Vänersborg 17 (representant för Sveriges konsumentråd)

13. Herbert Lundström, Konsumenter i samverkan, Box 88, S – 577 22 Hultsfred, Sverige

14. Martin Frid Kronfågel

15. Eva Berntsson Finland National Veterinary and Food Research Institute, P.O.Box 45, FIN – 00581, Helsinki

16. Riitta Maijala 17. Tuula Honkanen – Buzalski


18. Anna-Maija Grömlund University og Helsinki, Faculty of veterinary medicine, P.O.Box 57, FIN – 00014, University of Helsinki

19. Marja – Liisa Hänninen National Food Administration, P.O.Box 5, FIN – 00531 Helsinki

20. Anna-Maija Grönlund 21. Maija Hatakka 22. Pekka Pakkala 23. Pirjo – Liisa Penttilä 24. Anja Hallikainen

Ministry of Social Affairs and Health, P.O.Box 157, FIN – 00531 Helsinki

25. Marjatta Rahkio Ruoka – Saarioinen OY, FIN – 36420 Sahalahti

26. Tuija Lilja Norway Statens Næringsmiddeltilsyn, Ullevålsveg 76, Postbox 8187 Dep., N – 0034 Oslo 1

27. Bjørn Gondrosen 28. Nina Aas 29. Arne Vidnes 30. Bente Mangschou 31. Nina Vedhold 32. Kjertil Berg 33. Christin Schulz

Norges veterinærhøyskole, Institutt for FMN, Postbox 8186 Dep., N – 0033 Oslo

34. Edel Holene Iceland Hollustuvernd Rikisins, Armuli 1A, P:O:Box 8080, IS – 128 Reykjavik

35. Franklin Georgson 36. Ásmundur Thorkelson 37. Jon Gislason

Institut for Farmaci, Farmakologi og Toksikologi, Islands Universitet, Armula 30, P.O.Box 8216, IS – 128 Reykjavik

40. Jakob Kristinsson Denmark Danish Veterinary and Food Administration, Mørkhøj Bygade 19, 2860 Søborg


41. Ib Knudsen 42. Jan Wiuff 43. Karin Møller – Olsen 44. Jens Jørgen Larsen 45. John Larsen 46. Gudrun Sandø 47. Kristina Bockhahn 48. Niels L. Nielsen 49. Jørn Gry 50. Anna Charlotte Schulz 51. Bente Fabech 52. Bodil Thiim Hansen

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