Science in the Service FEDERAL INSTITUTE FOR …...BfR endeavours to be a pioneer in science-based risk assessment for the purposes of consumer health protection. The Institute identifies

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Science in the Serviceof Humanity

BfR_Image_ENGLISCH_copy 15.06.2005 11:28 Uhr Seite 27

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Imprint

Science in the Service of Humanity

Publisher: BfR Communication and Public Relations Office

Editorial office: BfR

Photos: BfR, Günter Friedmann-Marohn

Distribution: 5.000 Copies

Layout and typesetting: Leipziger & Partner, Frankfurt a.M.

Printing: Werbedruck Schreckhase, Spangenberg

This brochure is printed on chlorine-free bleached paper.


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Table of Contents

Focus on Precaution 2

Consumer Health Protection 4

Food Safety 6

Substances and Products 10

Animal Welfare 15

Statutory Tasks 16

International Cooperation 17

Risk Assessment 18

Research 19

Risk Communication 22


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Federal Institute for Risk Assessment

Focus on Precaution

Food hall, perfumes, household goods, children'sclothes – a stroll around a department store reveals just how many products consumers comeinto contact with or eat every day.

The Federal Institute for Risk Assessment (BfR) isresponsible for assessing the risks associated withthese products and for issuing recommendationson how to minimise them. In this way it makes amajor contribution to the safety of foods, sub-stances and products and, by extension, to con-sumer health protection.

Protecting consumers from health risks


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The main tasks of BfR are scientific risk assess-ment, the proposal of measures designed to minimise these risks and the communication ofthis process to its target groups. At three locationsin Berlin around 250 scientists from different disciplines assess the risks from foods, sub-stances and products which could impair con-sumer health. These risks may stem from sub-stances but also from micro-organisms.

The Federal Institute for Risk Assessment makes a major contribution torendering foods, substances and consumer products safer. Humanbeings as consumers are the focal point of its work.

BfR endeavours to be a pioneer in science-based risk assessment for thepurposes of consumer health protection.

The Institute identifies potential risks, assesses them using scientific criteria and makes an active contribution to minimising them.

Taking action upstream of concrete hazards!

According to BfR the precautionary principle iscentre stage of consumer health protection.Consumers expect public authorities to take actionwell in advance of concrete health hazards and tointroduce protective measures.

More than 600 members of staff, including around 250 scientists, are involved in consumer health protection at threeBfR locations in Berlin.


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Consumer Health Protection

In order to implement the concept of precautionary consumer protection, BfR assesses for instance the constituents and additives infoods, residues of pesticides and veterinary drugs as well as otherundesirable substances which may constitute a risk to health. In thiswork it draws on the latest scientific findings. Materials which come intocontact with food must also be safe.

Within the framework of the marketing authorisa-tion procedure, BfR is responsible for the healthassessment of novel foods and products madefrom genetically modified organisms. In the caseof these foods, a nutritional-medical assessment is necessary in addition to the toxicologicalassessment.

The latter is also undertaken, when required,within the framework of the notification procedurefor foods for special dietary purposes.

Food constituents, food additives, residues of pesticides and contaminants

in food must be safe!


Today, manyfoods are pre-packaged whenthey reach thehands of con-sumers. No sub-stances thatcould constitutea risk to healthmay migratefrom the packag-ing to the food.

Pesticides contribute to the production offoods of plant origin of a higher standard, atcheaper prices and in sufficient amounts. Themaximum levels laid down for residues ensurethat the treated fruit, vegetables or cereals donot constitute a threat to health and that they arecultivated under the conditions of "good agricultur-al practice".

Food additives like preservativesand antioxidants prolong the shelflife of foods. They give the prod-ucts the appearance which con-sumers expect. Additives of thiskind must also be safe when theyare consumed daily throughout alifetime. The health assessment offood additives is an important task for BfR.

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Food Safety

How much mercury can be tolerated in fish?

Mercury is a heavy metal which can causedamage to health if high amounts are in-gested. Mercury is widespread in the environ-ment and also occurs as a natural constituentin all inland waterways and world oceans. Asa consequence of industrial activity, the levelsmay vary considerably from region to region.

Mercury also accumulates in the food chainvia fish. There it mainly occurs in its moretoxic form as methyl mercury. Methyl mercurycan lead to developmental disorders in theunborn child. BfR, therefore, advises pregnantwomen and breastfeeding mothers to restricttheir consumption of types of fish known tohave high levels of mercury that may containup to 1.0 mg mercury per kg according to theMaximum Levels Regulation. This group main-ly encompasses large and old predatory fishlike sharks, halibut or certain types of tuna.Common fish like rock salmon, her-ring, salmon, carp or trout are notincluded in this group. Fish which may contain up to 1 mg mercury per kilogram and

whose consumption should be restricted during pregnancy andwhilst breastfeeding:

AnglerfishAtlantic catfishBonito (Sarda sarda)EelEmporor, orangy roughy,rosy soldierfishGrenadierHalibutMarlinMegrimMulletPikePlain bonito (Orcynopsis unicolor)

Poor codRaysRedfishSail fishScabbard fishSeabream, pandoraShark (all species)Snake mackerel, butterfishSturgeonSwordfishTuna (Thunnus species,Euthynnus spec)


The BSE crisis: Risk assessment despite open questions

The BSE problem presents a special chal-lenge to consumer health protection. It is true that research has made considerableprogress since the first occurrence of the dis-ease in England but it is still not possible todetect the infection in live animals.

Scientists at today's BfR already pointed outat the beginning of the 1990s that a transmis-sion of the disease to man could not be ruledout and had recommended measures in orderto prevent transmission of this kind.

In 2000 uniform regulations were issuedthroughout Europe in order to protect con-sumers and agricultural livestock from infec-tion. Some of these measures followed therecommendations of the then BgVV, todayBfR. Since then, they have been graduallyadapted to emerging scientific findings.

When it became clear towards the end of2000 that BSE also occurred in German cattleherds, scientists in today's BfR recommendedmore extensive measures to protect con-sumers in Germany. The lowering of the agelimit for the BSE rapid test in cattle from 30 to24 months was one such measure as werethe recommendations on how to make the slaughter process and the slaughter chainsafer. Some of the recommendations havebeen taken over into European law like themodified techniques used during the slaughter process.

The assessment of the risks to consumersfrom BSE highlights the challenge facing sci-

entists again and again: without sufficientlyreliable risk assessment data, they are called on to comment on the scale of apotential hazard. Even if far more knowledgeis available today about the infection andcourse of the BSE disease than was thecase 10-15 years ago, many questions arestill unanswered and there is a need for considerable research.

Safe foods from animals can only be guaran-teed if the highest level of hygiene is upheldfrom breeding right down to the consumer'splate. This is the only way of preventing or atleast reducing food infections.

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Food Safety

Veterinary medicine initially plays an importantrole in the case of foods of animal origin. Afterall, the goal is to already prevent the spread ofand control any pathogens, that can cross overfrom animals to human beings, in the animalsheds. During food production, processing andtreatment there is also a need for food technolo-gists and molecular biologists who can makevaluable contributions on questions to do withmethods and the diagnosis of pathogens. Onlywith safety concepts extending from the animalshed to the consumer's plate, is it possible toprevent and reduce food infections and intoxica-tions.

Salmonella in pork and eggs, Campylobacter inpoultry, Listeria in meat, dairy and meat prod-

ucts, novoviruses in drinking water – theseare just a few of the pathogens in

foods which frequently lead to diseasein man. Each year around 200,000

cases of food infections are notified tothe health authorities in Germany. The

real number of cases is probably farhigher (more than 2 million) sincemany are not reported. One ext-remely important area of food safety

is, therefore, minimising health risksfrom micro-organisms or parasites whichmay have contaminated foods of plantor animal origin. Pathogens of this kind

may have already reached animals in thesheds and then the foods made from

them. Poor hygiene during processing canalso lead to the contamination of foods with

germs. What’s more, any germs already pres-ent in foods may multiply and form toxic sub-

stances. BfR endeavours to reduce thesemicrobial risks through research intozoonoses, by developing diagnostic meth-

ods suitable for daily use and correspondinghygiene concepts both in the animal sheds andduring processing. Safe foods can only beobtained from healthy animals. The identificationof diseases in animal stocks and wildlife popula-tions is, therefore, one of the tasks of BfR as isassessing the resulting risks for human beings.

Safe food can only be obtained from healthy animals!

Food safety from the stable to the plate!

Foods from animals will only be safe if the highest levelof hygiene is upheld from breeding right down to the

consumer’splate. This is theonly way of pre-venting or atleast reducingfood infections.

The Trichinella infesta-tion of pigs hasbecome very rarethanks to good shedhygiene, intensiveexamination of the meatafter slaughter and cor-responding hygieneprovisions during theprocessing of pork.From time to time, thereare however cases of transmission of trichina to man. AtBfR research is done into diseases (zoonoses) whichcan be transmitted from animals via food to humanbeings. Together with experts in Germany and abroad,scientists in BfR endeavour to determine the cause ofthese infections and to estimate the health risks for man.

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cold meats, smoked fish and raw milk cheese,and sometimes even in pasta and ready-to-eatsalads. Vacuum packaging but also refrigera-tion over longer periods promotes the growth ofListeria more than that of other bacteria.

Aside from individual sensitivity, the risk ofsomeone becoming ill depends on the numberof bacteria ingested. The level of 100 germsper gram or millilitre food recommended by BfRyears ago, which may not be exceeded up tothe end of the shelf life of the food, is nowbeing discussed on the international level as aguidance value for the safety of ready-to-eatfoods.

Lower exposure to germs reduces the risk ofListeria infections

Again and again there are reports of cases ofdisease which are quite obviously linked to theconsumption of specific foods like, for instance,vacuum-packed products. The causes of theseinfections are bacteria of the species Listeriamonocytogenes. They are very widespread andmay be transmitted during milking or slaughterfrom animals to milk or meat and from there tohuman beings. Frequently, contamination doesnot take place until processing or treatment ofthe food, for instance when cheese is cut. Liste-ria are frequently detected in poultry meat, pâté,

With state-of-the-art molecular biologi-cal methods, BfR searches for thecauses of foodborne infections

Bacterial pathogens like Listeria are aparticular problem in foods of animalorigin. However, they may also occurin raw plant products like salads andsoya beans.


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Substances and Products

Controlling disease in animals which supplyfoods is a special challenge for consumer healthprotection. Veterinary drugs used here shouldnot only restore the health of the animals. Theirresidues after treatment and their metabolites infoods must also be safe for human beings.Hence BfR is responsible for assessing the risksfrom residues of pharmacological substances.The same applies to the health assessment offeed additives where there must be a guaranteethat the foods obtained from food-producing ani-mals are safe.

The tasks of BfR also include documenting theresistance of zoonosis pathogens to antibioticsthat are used both in veterinary and in humanmedicine.

Protection for animals without this involvingany risk for human beings


The assessment of substances which consumerscome into contact with is a key task of consumerhealth protection. Here it is not important whetherthe substances are of natural origin or are syntheti-cally produced substances. The latter are gener-ally called chemicals. BfR is the central Institutionfor the health assessment of substances in Ger-many. The range of substances extends fromindustrial chemicals to natural food ingredients like

THC (tetrahydro-cannabinolic acid),known as a narcoticin hemp-containingfoods, or glycerine inliquorice. The scien-tific assessment of thesubstance propertiesand the potential risksis also the basis forclassification andlabelling, for safetymeasures like the lay-ing down of limit val-ues, for constraints

on application and also bans issued by the author-ities responsible for management.

No consumer protection without an assess-ment of substances and products

BfR has also been assigned the special task inaccordance with the Chemicals Act of undertak-ing the basic toxicological assessment and thepreparation of scientifically backed proposals forthe classification of chemicals. This assessmentserves to develop and lay down rules for the safehandling of the chemical substances. The assess-ment of new industrially manufactured substancesis of particular importance since every year a fewhundred substances are developed in the labora-tories of the chemical industry. Furthermore, thereare around one hundred thousand chemical com-pounds which were already on the market prior tothe entry into force of the Chemicals Act. Theynow have to be reviewed or even assessed for thefirst time within the framework of the existing sub-

stance programme of the European Union. Chemi-cal assessment is a task which requires that thescientists of BfR are familiar with the available toxi-cological data on a substance. But not only that,they must also assess whether the stud-ies and experiments conducted byindustry in conjunction with toxicologi-cal tests are or were reliable, which isparticularly problematic in the case ofexisting substances. By means of itsown experimental research, BfR exam-ines the reliability of individual testmethods. It has the statutory task oftaking part in the further developmentof toxicological test methods.

Practical consumer health protection: The assessment of dyes in textiles

For textiles there are around 600 different auxiliaries and treat-ment agents. Furthermore, there are more than 1,000 dyes,most of which are azo dyes. A few hundred substances in thisdye group are produced from carcinogenic parent sub-stances, specific aromatic amines. Under certain circum-stances dyes of this kind may pass through the skin and thenbe broken down during metabolism into their parent sub-stances, the aromatic amines. Splitting on the skin by skinbacteria is another possibility.

Of the group of azo dyes, which can split potentially carcino-genic aromatic amines, around 150 are still commerciallyavailable. German industry stopped using them several yearsago. BfR made a major contribution to these dyes beingbanned throughout Europe today. The supervisory authoritiesstill detect dyes of this kind in individual cases particularly intextiles from third world countries.

Overall BfR has a positive track record: contact allergies haveonly been observed in conjunction with poorly dyed, non-colour fast textiles. It is assumed that allergies triggered in thisway account for 1-2% of contact allergy cases. Chemical sub-stances in clothing only have worrying effects in exceptionalcases.

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Safe handling by the consumer ofhousehold chemicals, dyes and otherproducts is a goal of chemicalassessment.

Once BfR has concluded the basic toxicologicaltests of a substance based on documents sup-plied by industry and submitted a proposal forclassification based on toxicity, other institutionslike the Federal Environmental Agency or theFederal Institute for Occupational Safety andHealth use these data for the risk assessmentand classification for which they are, in turn,responsible. BfR itself uses the assessment inorder to estimate the health risk from chemicalsand products for consumers. As the statutorynotification office, BfR collects information onhealth impairments which can be attributed toconsumer products and chemicals.

Chemical safety involvesassessing the harmfulnessof chemical substancesand products as well asproviding information onany related health hazards.By collecting and process-ing data of this kind, BfRcontributes to the safe han-dling of these substancesand products.


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Cosmetics:Safe even when used lifelong!

Cosmetics are frequently used by consumersthroughout their lives. The term cosmetics encom-passes not only decorative cosmetics like eyeshadow or foundationbut also skin creams,soaps and tooth-paste. Any ingredi-ents used in cos-metics may not,therefore, harm healtheven when usedthroughout an entirelifetime. BfR collectsdata and also obtainsknowledge about thetoxicity of ingredients of this kind from its ownstudies. When assessing substances in cos-metics it must also be borne in mind how theindividual substances interact with other in-gredients in cosmetics and whether their impactis altered by environmental factors.

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Practical consumer health protection: Caution should beexercised in the case of tattoos and permanent make-up!

Almost one in ten Germans has a tattoo nowadays and the num-ber of people opting for permanent make-up is also on theincrease. In contrast to the application of cream or lipstick, thecolour pigments in these cases are not applied onto but intothe skin. From there they can reach theblood stream via deeper skin layers,spread through the body and be con-verted. Severe allergic skin reactionsand inflammations are just some of theadverse effects. Allergic reactions alsooccur in the case of temporary hennatattoos. In many cases they are attrib-uted to the substance paraphenylenediamine (PPD). It is used to darkenhenna and during the application ofblack henna tattoos, it reaches the sur-face or even penetrates the skin. PPDcan trigger serious cases of dermato-sis. People who become sensitive toPPD can continue to react allergicallyto the substance or to dyes with a sim-ilar chemical structure throughout theirlives.

BfR explicitly draws the attention of con-sumers, more particularly the parents ofadolescents and children, to the risks linked to tattoosand permanent make-up. The health impact of dyesused for tattoos and permanent make-up has notbeen examined. Nor is anything known as yet abouttheir lifelong effect. There are no statutory provi-sions concerning the purity, quality or safety test-ing of tattoo dyes. BfR, therefore, recommendsthat until there is a statutory regulation onlythose dyes should be used for tattoos and per-manent make-up which comply with therequirements of the European CosmeticsDirective or the German Cosmetics Ordi-nance. This ensures that they have beentested and authorised for use in cosmetics.

Sun cream remains on the skin whilstswimming. It must, therefore, beexamined whether and, if so, howthe substances change whenexposed to chlorine, water or lightand whether harmless substancespossibly turn into harmful ones.



The substances which must be carefully exam-ined in respect of their health impact include

biocides (today this term is used for woodpreservatives and insecticides) and

pesticides.

Pesticides may affect thehealth of the human being

who uses them, the peopleliving next to the fields andcultivation areas or walk-ers who come into con-tact with them in a morerandom manner. Their cor-

rect use is, therefore,

Biocides and pesticides must be safe when

used properly!

an important contribution to health protection.Residues of pesticides in foods must not harmconsumers either. Hence, it is important to knowwhich levels are safe. BfR is responsible forundertaking health assessments of this kind.They are an important foundation for the layingdown of maximum levels for pesticides that afood may contain.

In the case of wood preservatives and insecti-cides, it is important that when used correctlyand properly these biocidal products do notimpair the health either of the residents of abuilding treated with them or the users.

The health assessment of the products used inthis area, therefore, also encompasses aspectslike their long-term impact and disposal (decon-tamination), for instance once an insecticideapplication has been completed.

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Animal Welfare

For regulatory testing, national and internationalguidelines are based on animal experiments.At the same time, the EU regulations stipulatethat an experiment may not be performed if apracticable and scientifically sound method isavailable that does not entail the use of an animal. The assessment and development ofalternatives to animal experiments is, therefore,a task of BfR. At ZEBET (Centre for Documenta-tion and Evaluation of Alternatives to AnimalExperiments) alternative methods are docu-mented, collected and also assessed. Anotherfocus is on BfR’s own experimental research onalternatives and the promotion of research in thisarea. Furthermore, the Institute has endeavouredfor several years to improve animal husbandry,particularly of experimental animals.

Chicken egg instead of rab-bit eye – replacement of theDraize test with the HETCAMtest to examine the irritantand corrosive effect of sub-stances. This is just one ofmany alternative methods toanimal experiments currentlyavailable. In the ZEBET data-base scientists and publicauthorities can find out aboutthe current level of knowl-edge in this area. This data-base can also be accessedvia the Internet.

Improved animal welfare: An important goal of BfR


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Statutory Tasks

The legal status of BfR

BfR is a scientifically-oriented, legally respon-sible federal authority in the portfolio of the Fed-eral Ministry of Consumer Protection, Food andAgriculture. The Institute mainly plays an advi-sory role. It assesses health risks on the basis ofthe latest available scientific findings. BfR is theonly institution of this kind on the federal level.

In order to ensure that its work cannot be influ-enced by political, economic or social interests,the expert independence of the Institute hasbeen anchored in law. With its health riskassessments BfR makes a major contribution tothe safety of foods, substances and productsand, by extension, a direct contribution to con-sumer health protection. BfR does not assume

any monitoring duties. However, it is involved in aseries of marketing authorisation and notificationprocedures.

First and foremost, the Institute advises the FederalMinistry to which it reports. Its specialist scientistsdo, however, also work for other ministries on thefederal level like the Federal Ministry of Health, theFederal Ministry for the Environment, Nature Con-servation and Nuclear Safety and the Federal Min-istry of Transport. Frequently, other public authori-ties in the Federal States ask BfR for advisoryexpert opinions on questions of consumer healthprotection.

Not monitoring but scientific advice!

Shared burden: The system of consumerhealth protection in Germany

In a country like Germany with a federal struc-ture, responsibility for consumer health protec-tion falls to the Federal Government and theFederal States.

Laws and ordinances, which serve the pur-poses of consumer health protection, are enactedby the Federal Government and Parliament. BfRadvises the Federal Ministries on the elabo-ration of statutory provisions. It undertakes thescientific assessment of health risks and identi-fies action options for risk minimisation. Theseare implemented on the federal level by man-agement as protection measures for consumers.Many statutory provisions for consumer protec-tion are now laid down on the European level.Regulations of the European Union immediatelyapply directly in all Member States; directives ofthe European Union, by contrast, must first betaken over into each member state’s national

law. BfR is also involved in the elaboration ofEuropean provisions for consumer protection.Its experts sit on numerous scientific advisorybodies of the EU.

In Germany the public authorities of the Federal States are responsible for monitoringcompliance with national and European statu-tory provisions of consumer health protection.BfR supports the Federal States in this task bydeveloping and establishing, for instance,analytical methods for monitoring purposes or by issuing expert opinions on topical issuesof consumer health protection.

BfR holds a dialogue with different targetgroups interested in the results of its work.In this way it complies with its statutory remitfor risk communication. This is how the Insti-tute contributes to more transparency and toimproving consumer health protection in Germany.


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International Cooperation

In the course of European unification and global-isation, consumer health protection cannot andshould not stop at national borders. As thenational peer agency to the European Food SafetyAuthority (EFSA), BfR sees itself as part of aninternational network and as a strong partner onthe highest scientific level. BfR inputs its expert-ise into the work of EFSA, into the bodies of theEuropean Union, into the Organisation for Eco-nomic Co-operation and Development (OECD)and into other national and international bodies.

BfR is also involved in the work of the Codex Ali-mentarius System of the Food and Agriculture

Organisation (FAO) and the World Health Organi-sation (WHO). The task of the Codex Alimentar-ius Commission is to draw up standards for food(for instance maximum levels for harmful sub-stances) which, within the framework of theWorld Trade Organisation, should promote unim-peded and fair world trade.

In the field of food safety BfR is active as theFAO/WHO Collaborating Centre. It runs the pro-gramme for the control of foodborne infectionsand intoxications in Europe and co-ordinates fur-ther training measures for experts and managersfrom developing and Eastern European countries.Every six years BfR stages a World Congress onFoodborne Infections and Intoxications.

Consumer protection moves beyond national borders


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Risk Assessment

Risk management: Research, assessment, communication

What is a risk? In science a risk is described asthe probability that an event will occur which isdetrimental to health and the expected scale ofhealth impairment. A health risk can never becompletely ruled out. By means of a package ofsuitable measures, which are described as riskmanagement, efforts are however made to mini-mise the risk as far as possible and to preventany threat to health. BfR’s task is to provide the

Lamp oils in children's hands

Cases of poisoning withcoloured lamp oils affectingabove all small childrenprompted scientists in today'sBfR to take a look at the data.The results: coloured andperfumed lamp oil is the mostdangerous household chemi-cal for children aged between1 and 3 years. Their lemon-ade-like colour and specialaroma make lamp oils particu-larly attractive to children.

They are tempted into tasting them. In just onegulp children take in 8-15 millilitre lamp oil. Inindividual cases the mere sucking of the lampwick was enough to allow 1 millilitre to enter thechild’s body. Already 0.1 millilitre lamp oil perkilogram body weight is sufficient to triggersevere lung damage.

Scientists at BfR then issued a series of recom-mendations for risk-reduction measures whichwere implemented in the space of a few years:child-resistant closures, warnings (on refill packsand burners), new labelling ("harmful: maycause lung damage if swallowed"), standardised

people responsible with a solid scientific basisfor risk management. The identification and evaluation of a risk – these two elements aredescribed as "risk assessment" – is the first stepin consumer health protection. Ideally, this stepis taken in a dialogue with all the stakeholdersand leads to a consensus on the degree ofacceptance of a risk. Once this agreement hasbeen achieved, risk management can orientitself towards this and corresponding measurescan be taken.

proposals for safe lamp construction and therestriction of the sale and the use of colouredand perfumed lamp oils to those on a paraffin orpetroleum basis. This led to the development ofreplacement substances. In 2000 the sale ofthese lamp oils was banned in containers with a capacity of less than 15 litres throughout Europe.

Risk communication has accompanied thisprocess since 1990 starting with the identifica-tion of the risk down to the implementation ofthe individual measures. The dialogue with dif-ferent target groups was supported in publica-tions, press releases and numerous interviewson the radio, TV and in the daily press.

Cases of severe damage to lungs in childrencaused by lamp oils have become a rare event.The less serious cases which have occurred caneither be attributed to residues of old productsor to the, as yet non-prohibited, dangerous clearlamp oils or grill lighters. In order to effectivelyward off these dangers too, the Federal Govern-ment, based on the BfR data and risk assess-ment, has formulated and submitted an applica-tion for a ban on all dangerous lamp oils andgrill lighters to the EU.


Research

The BSE crisis revealed just how important itcan be for consumer protection to reliablyknow whether a sausage contains constituentsof pig or cattle, too. Proof of origin is also ofimportance when it comes to protecting con-sumers from misleading information. Thisensures that the Bordeaux wine does indeedcome from the region of that name. When itcomes to developing methods to determinethe origin of products down to the specifica-tion of animal species, BfR is the leadingauthority in Europe.

Research in BfR

The expertise of the Federal Institute resultsfrom scientific exchange and, to a largedegree, from its research. Its own experimentalresearch enables BfR to carry out its statutorytasks without being influenced by externalinterests. BfR scientists are mostly engaged inapplied research. Some experimental studiesare particularly important in areas in whichother institutions are not active. One exampleis a comparative study on the allergenic poten-tial of organically and conventionally cultivatedtypes of vegetables. The project aims toanswer the question whether monocultures, asa stress factor, promote the formation of aller-gens in plants. Under defined conditionsplants of the same species are cultivatedunder organic and conventional conditions.With the help of immunological and molecular-biological methods, the allergenic potential ofboth is then compared.

In order to identify and assess risks, suitableanalytical methods are needed by means ofwhich the harmful substances or micro-organ-isms can be identified and quantified in routinetests. One important task is, therefore, thedevelopment of standard analytical methodswhich is done within BfR. Methods of this kindare needed, for instance, by the public authori-ties of the Federal States in order to monitorcompliance with statutory provisions and pre-vent risks for consumers. For the purposes ofstandardisation, the analytical methods areexamined jointly by the Federal States and theindustry concerned. They are then taken overinto the official collection of test methods. Oneexample is methods for the identification ofgenetically modified organisms (GMO) andfood products made from them. They are firstdeveloped in BfR, then standardised and usedby the supervisory authorities in order to moni-tor compliance with labelling obligations.

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Research

Does the Bordeaux bottle really containwine from Bordeaux?

Consumer protection increasingly encompassesprotection from misleading advertising. Theconsumer would like to be sure that the bottleof Bordeaux which he has bought doesindeed contain wine from the Bordeaux regionand not a wine from any other region. Today,thanks to modern analytical methods likenuclear magnetic resonance spectroscopy andisotope ratio mass spectrometer (IRMS), it ispossible to determine the ratio of variousstable isotopes, i.e. the same elementswith different atomic weights. Forinstance, the ratio of the oxygen iso-topes 18O to 16O in foods and food ingre-dients is an important indication of theorigin of a product. Stable isotoperatios of this kind are dependent onthe earth's rotation and on climaticand biological fac-tors. This ratio is,therefore, alsoexpressed inplants whichgrow at differentlatitudes. Scien-tists in the"Senior expertoffice for the controlof foreign wines" basedat BfR have succeededin developing a detectionmethod for the origin ofwines which is based onthe different ratios ofthe oxygen isotopes.

Pollutants in foods: The problem of furan

Foods, which undergo heating during production,may contain the harmful substance, furan.The colourless, highly volatile liquid hasproved to be carcinogenic and mutagenic inanimal experiments. This substance has beendetected, for instance, in canned vegetablesand meat, bottled food, coffee and bread. It

has not yet been clarified what conditions andmechanisms lead to the formation of furan dur-

ing the production of these foods. Theavailable data are not sufficient in

order to estimate the overallexposure of consumers to

furan from foods and othersources and the resultinghealth risk. There is, there-fore, a need for clarificationof the effect of the substance

in the low dose range and ofthe mechanism of action. BfR is

the leading authority when it comesto developing improved methods for the

detection of furan levels in foods. After theirstandardisation they can, for instance, be used by the

official food control bodies. These standardised methodscan then be used in the Federal States to collect data whichpermit better assessment of the health risk to consumersfrom furan and provide a basis for risk-reducing measures.


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densely bound in a defined order. Themicroarrays are used, for instance, todevelop new medicines and alternatives toanimal experiments. BfR uses this techno-logy to develop rapid methods for thedetection and characterisa-tion of pathogenic germs in afood in order to rapidly iden-tify a risk to the population.These new methods are validated, standardised andthen made available for wide-spread use.

Innovative research and basic research

Besides applied research BfR also engages ininnovative research and basic research. Theseprojects are mainly conducted under the Euro-pean framework programme.

In recent years a new, efficient technology hasbeen developed which makes it possible tosimultaneously examine the different proper-ties of biological material. Microarrays or"DNA chips", as they are called, are miniatur-ised carriers on which a high number ofnucleic acid molecules (so-called probes) are

The use of gene expression analyses inthe risk assessment of chemicals

For the marketing authorisation of newchemicals and the health assessment of so-called "existing substances", reliable toxico-logical data are needed. If the annual pro-duction of the substance in questionexceeds a certain volume, long-term animalexperiments must be conducted in labora-tory rodents in order to collect these data.The sub-acute toxicity test in rats, alsocalled the "28-day test", is an importantbasic test for chemical substances which isfollowed by further tests. Thanks to the useof gene expression analysis, it was alreadypossible on the level of a sub-acute toxicitytest to rapidly obtain reliable information onthe toxicity mechanisms of substances. Inthis way, the number of stressful long-termanimal studies may be reduced. BfR testsbiotechnological methods of this kind, toxi-cogenomics, in order to be able to identifypotentially hazardous substances far morequickly.

Once the mechanism of action of a sub-stance is known, this permits conclusionsabout its toxic properties. Whenever there is

contact with a substance,genes and proteins ormetabolites "react" in a cer-tain form, the specific "fingerprint". Vice versa,this fingerprint permits conclusions about themechanism of action, the path of the toxiceffect. Knowledge of the mechanism ofaction is of great importance for the assess-ment of the toxic potential and risk, which thesubstance may constitute to man.

For toxicogenomic analysis, tissue samplesare examined, for instance, from the 28-daytest in laboratory rodents. Using toxicoge-nomics, thousands of sequences of thehereditary substance and cellular proteins canbe investigated at the same time. In this waychanges in the complex activity pattern whenexposed to an admixed substance can beobserved. By means of this analysis of com-plex cellular responses, reactions to as yetnon-toxic levels can already be registered.

Insight into molecular mechanisms of actionconstitutes major progress in respect of trans-ferring results obtained from animal studies tohuman beings. It is expected that this devel-opment will revolutionise the risk assessmentof substances.


Risk Communication

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Communication as an important part ofrisk prevention

BfR is the only Federal Institute in Germanywith a statutory remit for risk communication.This means the ongoing and interactiveprocess of opening up communication to thepublic at large, science, other stakeholders inthe process and interested groups. Informa-tion is to be provided as early as possible

about potential health risksand access given to assess-ments and work results.Within the framework of riskcommunication, informationis to be collected, the ex-pectations of consumersand interest groups are tobe identified and, whereverit is scientifically defensible,they are to be involved in therisk assessment process.

Risk communication accom-panies the overall process ofrisk analysis and, therefore,encompasses the questionin hand, the laying down ofprotection targets, scientificassessment and any relevantexplanations, risk manage-ment, control and evaluation

of measures. In this process BfR’s statutorytask includes the sub-aspect of the communi-cation of aspects of risk assessment and theevaluation of measures.

The Institute sees risk communication as a participative dialogue involving qualitativeand quantitative factors. The primary targetgroup is risk-conscious citizens. They are tobe supported in their decision-making effortsby giving them the available information inorder to allow them to assess for themselvesthe risks in full awareness of the variousuncertainties.


By means of its understanding of risk communi-cation, BfR would like to contribute to• disseminating perception competence and rais-

ing awareness of the problem,• improving understanding and knowledge,• improving judgement skills and supporting deci-

sion-making abilities,• changing attitudes, acceptance and behaviour,• managing conflicts and risks of crisis,• strengthening the credibility of and trust in regu-

latory bodies.

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The Internet has developed into an importantmedium for providing information to the publicat large and for the dialogue with the varioustarget groups. This is where BfR provides com-prehensive information on its work. Every monthmore than 65,000 people visit the Institute’shomepage and there are more than 1.5 millionhits on the information stored there. BfR seesthis as convincing proof of the interest in theInstitute's work.

Besides the classical paths of press and publicrelations work, the Federal Institute also embarkson new paths. It actively involves consumers andother "stakeholders" (all those who make use ofthe risk assessments of BfR) in its work. Thiscan be done for example by means of hearingsor consumer surveys. In this way the Instituteguarantees transparent and confidence-buildingcommunication in the interests of health protec-tion.

The Institute also undertakes scientific work onrisk communication issues. The focus is onmethods to quantify risk perception and theelaboration of scientifically backed strategies forearly risk identification. The Institute examines,within the framework of the assessment of risksand consequences, how effective its communi-cation is, what messages reach consumers andother stakeholders and whether they influencetheir behaviour.

Only a clearly and comprehensively informed consumer can decide

whether he wishes to consciously accept a risk or not.

www.bfr.bund.de




Federal Institute for Risk AssessmentThielallee 88-92D-14195 Berlinwww.bfr.bund.de

Tel. + 49 - 30 - 84 12 -0Fax + 49 - 30 - 84 12 [email protected]


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Science in the Service FEDERAL INSTITUTE FOR …...BfR endeavours to be a pioneer in science-based risk assessment for the purposes of consumer health protection. The Institute identifies