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Toxic Inheritance – More Than 300 Pollutants In Breast Milk – Time For A New Chemicals Policy
 

Toxic Inheritance – More Than 300 Pollutants In Breast Milk – Time For A New Chemicals Policy

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    Toxic Inheritance – More Than 300 Pollutants In Breast Milk – Time For A New Chemicals Policy Toxic Inheritance – More Than 300 Pollutants In Breast Milk – Time For A New Chemicals Policy Document Transcript

    • Toxic inheritance More than 300 pollutants in breast milk - time for a new chemicals policy
    • IMPRINT This report has been produced by Friends of the Earth Europe in cooperation with Friends of the Earth Germany (BUND). This report was previously published in German as “Endstation Mensch”. Authors: Patricia Cameron and Susanne Smolka Translation: Kenneth Richter Acknowledgments: The authors would like to thank Mary Taylor for conscientious editing of the English version Layout: www.agencea3.be Images: Petra Nyenhuis Friends of the Earth Europe gratefully acknowledges financial support from the European Commission's DG Environment and our 31 European member groups, with particular thanks to BUND (Friends of the Earth Germany). Sole responsibility for content lies with the authors of the report. The European Commission cannot be held responsible for any further use that may bemade of the information contained therein. Copyright: Friends of the Earth Europe, December 2005 Printed on recycled paper by Imprimerie Fortemps, Belgium © Friends of the Earth Europe
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    • Dr. Martin Rocholl |Chair, Friends of the Earth Europe Political Foreword The evidence is alarming - more than 300 differ- missing. The system is therefore not able to guar- ent chemical pollutants have been found in antee adequate protection from dangerous breast milk. Enough to be a worry even without a chemicals for humans and the environment. virtually impossible assessment of the risks. And the cause? A misguided chemicals policy. The new EU chemicals legislation (REACH) is sup- posed to address this deficiency once and for all. Since the beginning of mass production of syn- It is the most significant reform of health and thetic chemicals in the 1940s we have been environmental protection in Europe to date. Fol- exposed to thousands of new substances. Back lowing an opinion given by the European Parlia- then nobody thought about any long-term ment, it is currently being discussed by European harmful effects: chemical substances were governments, and it is expected to enter into released into the environment without official force in early 2007. From then on, it will be the testing. Not until 1981 did chemical legislation responsibility of the chemicals industry to prescribe mandatory testing for environmental account for the safety of its products before they and health risks before a new substance could be are placed on the market. And thus it will no placed on the market. And even after this new longer be the authorities’ job to prove the dan- law, around 100,000 different “existing sub- gers after the damage has been done. stances” already in use still did not have to undergo any risk assessment. A crucial component of this new system would be the obligation on chemical producers or In 1993, the EU attempted to ensure, belatedly, importers to register details about the safety of the protection of humans and the environment all substances that are being produced or from risks posed by the older chemicals by intro- imported in a quantity over one tonne per year ducing a new law, the Existing Substances Regu- before placing them on the market. But the lation. Under this law, substances were to be chemicals industry deems this approach too tested and then either approved for use or expensive. Through aggressive lobbying (“high restricted. By 2005, the risk assessment (a neces- costs endanger jobs”) the industry has achieved sary precursor for any legislative measures) had significant weakening of this element. We are been completed for only 300 substances. As a calling upon the European policy-makers to take result, more than 10 years after the introduction the opportunity to protect children from pollu- of this legislation, fundamental information tants in breast milk by ensuring that REACH will concerning the risks and applications of the vast help to both identify and replace hazardous majority of substances on the market is still chemicals. 4
    • The cost argument, exaggerated in an unparal- leled fashion by corporate and industry federa- tions, has been refuted even by an industry- sponsored study. Nevertheless, so far, large chemical industry has managed to convince the EU’s Parliamentarians to support weaker requirements for safety data on chemicals instead of championing effective health protec- tion for the constituents. This contradicts the more positive approach of the European Parlia- ment to the mandatory substitution of danger- ous chemicals. Equally worryingly, there are indi- cations that the interests of Europe’s large chemical industry will dominate political action amongst the EU governments, leading them to discount the potential long-term risks of irre- versible damage to our health. We are glad to say that various impact assess- ments have shown that REACH will not con- tribute to job loss. On the contrary, the policy would foster innovation and create new jobs, allowing Europe to become the largest producer of environmentally friendly and healthy prod- ucts. But this can only happen if industry finally gives up its resistance and takes up this opportu- nity for development. Friends of the Earth Europe urges the European Parliament and the EU's governments to establish a strong REACH legislation which protects citizens and the environment and creates business oppor- tunities for healthy products made in Europe. 5
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    • GLOSSARY Chemicals metabolite break-down products DDE dichloro-diphenyldichloroethylene NOAEL no observed adverse effect level (break-down product of DDT) persistent long-lived DDT dichloro-diphenyltrichloroethane pesticides chemicals toxic to pests BBP butyl benzyl phthalate REACH registration, evaluation and authorisation of DBP dibutyl phthalate chemicals DEHP diethyl hexyl phthalate TDI/TWI Tolerable Daily Intake/Tolerable Weekly DIBP di-iso-butyl phthalate Intake DIDP di-iso-decyl phthalate TEQ/TEF Toxic Equivalency/Toxic Equivalency Factor DINP di-iso-nonyl phthalate (i.e. normalised to the toxicity of dioxin 2,3,7,8-TCDD DNOP di-n-octyl phthalate with a TEF of 1) HCB hexachlorobenzene HCH hexachlorocyclohexane Institutions PBDE polybrominated diphenyl ethers AGLBM Ausschuss für Umwelthygiene der Arbeits- (polybrominated flame retardants) gemeinschaft der Leitenden Medizinalbeamten; Ger- Deca-BDE deca-bromodiphenyl ether man Committee for Environmental Hygiene of the Octa-BDE octa-bromodiphenyl ether Working Group of Leading Medical Civil Servants Penta-BDE penta-bromodiphenyl ether APUG Aktionsprogramm Umwelt und Gesundheit; Tetra-BDE tetra-bromodiphenyl ether Environment and Health Action Program HBCD hexabromocyclododecane BfR Bundesinstitut für Risikobewertung; TBBA tetrabromobisphenol A National [German] Institute for Risk Assesment PCB polychlorinated biphenyls (formerly BgVV) PCDD/PCDF polychlorinated dibenzo BgVV Bundesinstitut für gesundheitlichen Ver- p-dioxins/polychlorinated dibenzo furans braucherschutz und Veterinärmedizin; [German] TCDD tetrachlorodibenzo-para-dioxin Institute for Consumer Health Protection and Veteri- POPs persistent organic pollutants nary Medicine (now BfR) BMU Bundesministerium für Umwelt, Naturschutz Definitions und Reaktorsicherheit; [German] Ministry for the BCF bio-concentration factor Environment, Environmental Protection and Reactor bioaccumulating the property to accumulate in Safety organic tissue CTSEE Wissenschaftlicher Ausschuss für Toxizität, biocide pesticide in non-agricultural use Ökotoxizitat und Umwelt der EU; CMR substance with at least one of the following EU Scientific Committee for Toxicity, Ecotoxicity and properties: carcinogen (cancer causing), mutagen the Environment (damaging to the genotype), reprotoxic (damaging to DFG Deutsche Forschungsgemeinschaft ; reproduction) German Research Foundation congener single substance (as part of a number of HBM-Commission Human Bio-monitoring structurally similar substances) Commission endocrine hormonal IRK Innenraumlufthygiene-Kommission; exposure to be exposed to pollutants Indoor Air Hygiene Commission half-life time required to break down half the SCF EU Scientific Committee on Food quantity of a substance UBA Umweltbundesamt; [German] Environment inherent properties properties that belong to Ministry a substance; chemical and physical properties US EPA US Environmental Protection Agency lipophile fat loving WHO World Health Organisation 7
    • Toxic inheritance Summary The production of synthetic chemicals in Europe breast feeding, but in the womb. Many of the has exploded since the 1940s. By 1980, over chemicals the mother is exposed to can transfer 100,000 substances had been placed on the mar- from her blood into the unborn child. Unborn ket. By 1950 the insecticide DDT had been babies and infants are particularly vulnerable as detected in breast milk. But it was not until 1981 they are in a sensitive development phase when that chemicals legislation requiring an assess- substances can cause long-term damage. The ment of environmental and health risks prior to consequences are diverse and may range from the placing of chemicals on the market was allergies, disturbances of the immune system, introduced. Nevertheless, the substances that diminished fertility and cancer to behavioural were already in existence at that time (the so- anomalies due to impaired brain development. called “existing substances”) still did not have to Hormonal pollutants may interfere with critical undergo any risk assessment. Shockingly, these metabolic processes, even in minute amounts. amount to around 97% of substances currently Along with the persistent and bio-accumulative on the market. This means that even today near- substances, this group of substances is particu- ly all substances used in cosmetics, furniture, larly worrying. electronics, etc., have never been tested for the risks they may pose to humans and the environ- Breast milk provides the baby with vital nutrients ment. and strengthens its immune system. Moreover breast feeding ensures close mother-child bond- Many of these chemicals are today detectable in ing, an important prerequisite for a healthy humans. Particularly worrying are the persistent development. The contamination of breast milk (long-lived) and lipophilic (fat-loving) substances with synthetic chemicals is therefore a particu- that are not broken down and which accumulate larly delicate subject. Breast feeding should NOT in fatty tissue. Breast milk is a particularly well- be discouraged - information on contamination suited indicator for contamination with these in this report is to emphasise the urgency of chemicals, as the accumulated substances are reform of chemicals policy. transported from the fatty tissues into the milk during milk production. More than 40,000 breast This study is based on an extensive review of sci- milk samples have been tested for chemical entific literature. It compiles, analyses and pre- residues in Germany since 1980. Many toxic sub- sents recent scientific studies conducted by vari- stances that have been banned since the 1970s – ous bodies such as the German National Institute e.g. PCBs – are still being detected, even if in for Consumer Health Protection and Veterinary declining amounts. At the same time there is an Medicine or Germany’s National Breast Feeding ever-expanding group of substances which are Commission on the topic of breast milk contami- giving rise to concerns and that are still in wide- nation. spread use today, such as flame retardants, fra- grances and plasticisers (softening agents). A NEW CHEMICALS POLICY UNFOLDS For most of the older (“existing”) substances the Through breast feeding, mothers transfer a potential damage they may cause to humans is majority of the stored substances to their chil- not known – since they have never been tested. dren. To date more than 350 pollutants have been The proposed new EU chemicals legislation, detected that a baby can take up with the breast REACH (Registration, Evaluation, and Authorisa- milk. And the exposure doesn’t just start with tion of CHemicals), is supposed to address this 8
    • problem once and for all. It is the most significant tonne per year per manufacturer. Only those sub- reform of health and environmental protection in stances that turn out to be safe following the Europe to date. It is currently being discussed by assessments could continue to be distributed. For European governments, and is expected to enter the most hazardous substances applications for into force in early 2007. special permits (called authorisations) for specif- ic uses must be submitted to and approved by the REACH (as drafted currently) would require authorities. REACH offers a great opportunity to industry to notify the authorities with details correct old mistakes and finally to lay down a about the safety of substances on the market, legal framework for health and environment pro- where these are produced in quantities over one tection according to the precautionary principle. The Environmental, Health, Consumer and Women’s NGOs’ key priorities for the REACH 2nd reading. REACH is at risk of becoming a wasted opportu- 2. INFORMATION improves trust: Provide sufficient nity for making chemicals safe in the EU as safety information to identify dangerous chemicals there is little left from the already weak original and safer alternatives. proposal. Environmental, Health, Consumer and Transparent safety and use (exposure) information Women’s NGOs call for the following four points via the Registration process is essential to enable to be safeguarded in the REACH legislation to companies and the authorities to take informed deliver a minimum level of protection to citizens decisions on the safe management of chemicals and the environment. and identify safer alternatives. Under REACH, companies should: 1. PLAY IT SAFE: Replace hazardous chemicals with safer • Provide information on long-term effects, includ- alternatives whenever they exist. ing reproductive toxicity, at higher tonnage The REACH system needs to systematically pro- bands (>10tpa) (as proposed by the Council). mote safer alternatives, which are suitable to • Provide good quality use and exposure informa- replace chemicals which cause cancer, affect tion (scenarios) (as proposed by the Council) DNA, or the reproductive system or those that • Define risk management measures as required build up in our bodies and the environment or in the Chemical Safety Report from 1 tpa interfere with the hormone system. The continued onwards (as proposed by the European Parlia- use (Authorisation) of the most hazardous chem- ment), otherwise the safety information will not icals should: result in any practical improvements. • Only be granted if no safer alternatives are available and the use is essential to society (as 3. A LEGAL GUARANTEE: Ensure the chemical industry’s proposed by the European Parliament). responsibility for the safety of their products (Duty • Be time-limited to a maximum of five years in of Care). order to foster innovation and the development Chemical manufacturers, importers and users of safer alternatives (as proposed by the Euro- must be responsible for the safety of their prod- pean Parliament). ucts (as proposed by the European Parliament). • take into account the analysis of alternatives They should guarantee that these products do not and a concrete substitution plan to be submit- negatively affect human health or the environ- ted by the applicant as well as substitution ment. Clear legal provisions must apply for all information provided by third parties (as pro- chemicals, regardless of production volume, posed by the European Parliament). which would simply codify existing voluntary commitments by industry. 9
    • Toxic inheritance 4. TRANSPARENCY for consumer products: Establish a right to know for citizens. Sufficient information to allow chemical users and consumers to make informed choices must be publicly available. Information must be hand- ed down the supply chain to enable retailers and consumers to find out about hazardous chemicals in products. • Citizens must have the right to ask about sub- stances present in EU-made and imported products they buy; all articles which contain chemicals of very high concern need to be labelled (as proposed by the European Parlia- ment). • The list of non-confidential information in REACH needs to be extended to all information relevant for the environment and human health, in line with the Aarhus Convention. • Industry should always be obliged to give transparent justifications when applying for information to be kept confidential. 10
    • Index 1. Introduction ............................................................................................................................................................................................................ 12 2. Sins of the past ...................................................................................................................................................................................................... 14 3. Risk assessment of pollutants ........................................................................................................................................................................ 21 3.1 How does a chemical get into the body? ........................................................................................................................................ 21 3.2 Factors influencing the residue content .......................................................................................................................................... 23 3.3 The handling of uncertainty .................................................................................................................................................................. 23 3.4 Conclusion ...................................................................................................................................................................................................... 26 4. New sins .................................................................................................................................................................................................................... 28 4.1 Flame retardants ...................................................................................................................................................................................... 28 4.2 Fragrances ...................................................................................................................................................................................................... 32 4.3 Plasticisers ...................................................................................................................................................................................................... 35 5. The danger to children’s health .................................................................................................................................................................... 41 6. The reform of EU chemicals policy - a solution? .................................................................................................................................. 43 6.1 Prehistory ...................................................................................................................................................................................................... 43 6.2 REACH – the new EU chemicals legislation .................................................................................................................................. 45 6.3 The NGOs’ essential proposals for amendments ........................................................................................................................ 46 7. References .............................................................................................................................................................................................................. 49 11
    • Toxic inheritance 1. Introduction Both we humans and our environment have been The higher a creature is in the food chain the exposed to thousands of synthetic chemicals that greater the contamination, as these pollutants did not exist before the industrial revolution. are passed on through food. Piecemeal bans and Mostly we only realise this when extreme pollu- regulations can decrease the production and use tion events become scandals – e.g. PCB-contam- of some of these chemicals causes some decline inated school buildings or extremely high pesti- in contamination by older substances – neverthe- cide residues in strawberries or salad leaves. less they are still present worldwide. Even worse, There are numerous indications that the increase many substances with similar properties continue in certain illnesses in industrialised countries is to be produced and used. They can be found in connected to the vast cocktail of synthetic sub- consumer goods as well as human and animal stances that we are exposed to on a daily basis: tissue and so far most are subject to no or only allergies, certain forms of cancer and behaviour- minor restrictions. al disorders in children are on the increase, sperm counts and fertility are decreasing. A big problem is also that some chemicals can interfere with the hormonal systems of humans In Europe, the production of synthetic chemicals and animals. They represent dangers that are lit- has exploded since about 1940. The “European tle known or understood and that defy tradition- Inventory of Existing Commercial Substances” al risk assessment. These substances cause effects states that, in just the four decades until 1980, at extremely low levels. Particularly insidious is 100,000 chemicals were put on the European the fact that they might interfere with sensitive market. By 1950 the insecticide DDT was found in metabolic and developmental processes in the breast milk. But not until 1981 did chemical leg- womb and in early child development. islation came into force that, for the first time, demanded obligatory testing for environmental Breast milk is a particularly suitable bio-indicator and health risks before placing a chemical on the for contamination with persistent or lipophilic market. The older, so-called “existing substances” chemicals as the accumulated substances are – i.e. almost all substances brought into circula- transported from the fatty tissues into the milk tion before this chemical legislation – had not during milk production. Mothers transfer a con- gone through prior risk assessment. This means siderable amount of the substances to their child: that nearly all chemicals in cosmetics, furniture, the mother is being detoxified, the child becomes electrical goods, etc., have never been examined contaminated. So far more than 350 pollutants for risks to humans and the environment. Many have been found that the baby can ingest chemicals are today detectable in various human through breast milk (Lyons, 1999). This number is organs. Particularly worrying are the long-lasting worrying even without assessment of health risks. (persistent) and fat-loving (lipophilic) chemicals Additionally the potential interactions of the var- that are not broken down in nature and which ious substances are virtually unexplored. accumulate in fatty tissue. Some are known under the name of POPs (Persistent Organic Pol- The “Nationale Stillkommission” (Germany’s lutants). These are distributed throughout the National Breast Feeding Commission) has been whole world, carried through air, water or in analysing the contamination of German women’s organisms themselves. It is not just people in breast milk since 1994, assessing the health risks industrial nations but also residents of more and publishing breast feeding recommendations. remote regions who are contaminated with POPs. Until 1995 women were recommended to have 12
    • their breast milk examined for residues if they data is presented for a number of substances that were feeding for more than four months. Because have only comparatively recently been identified lower concentrations of pesticides, dioxins and as problematic. A further chapter is dedicated to PCBs were being detected in breast milk, the the dangers to children’s health. Breast Feeding Commission has recommended breast feeding without such caution since 1995. European chemicals policy currently faces pro- In principle it is welcome that - decades after found reform. The EU Commission has drafted a they have been banned - such older chemicals law that is supposed to reorganise the regulation are only present in concentrations that are of chemicals. As drafted, under the Regulation on deemed acceptable by this recommendation. But, REACH (the Registration, Evaluation, and Autho- as with many other decisions in environmental risation of CHemicals), manufacturers must reg- politics, this advice is based on a cost-benefit ister and supply data on substances produced or analysis. That means that according to the cur- imported in quantities over 1 tonne per year (per rent scientific knowledge experts assess the registrant), including those placed on the market health and emotional benefits of breast feeding before 1981. Failure to comply with the deadlines for babies to be more valuable then the current- may result in a marketing ban. Chemicals that ly known dangers. However risks that cannot yet turn out to be harmless following the assessment be tested for and those that are yet unknown are may continue to be distributed, but particularly not included in the assessment. Therefore the hazardous substances will need special authori- Commission emphasises that synthetic chemicals sation for specific uses only. are generally undesirable in breast milk. This is particularly important against the backdrop that Therefore in future it will be the industry’s job to recently new synthetic substances with compara- account for the safety of its chemicals before ble risks have been identified in breast milk. they are placed on the market, reversing the bur- Therefore by no means should the all clear be giv- den of proof which used to fall onto the author- en. The goal must be to achieve less persistent ities, who had to prove the dangers only after the and lipophilic chemicals in the environment, in substances were in use. In particular, the conta- order to reduce the effects of these substances on mination of breast milk with synthetic chemicals humans and minimise these in breast milk. The demonstrates the urgent need for reform. At this favoured path of action remains to develop sen- moment there is a great opportunity to correct sible strategies that avoid such contamination in the old mistakes and to lay down a legal frame- the first place. work for health and environment protection according to the precautionary principle. This study summarises up-to-date data on breast milk contamination by a number of substances The final part of this study discusses necessary that are mostly banned today, but that can still improvements to the reforms that are vital from be found in humans. It describes the general con- the point of view of environmental and consumer ditions that enable the uptake of chemicals and protection. their accumulation in the body and it demon- strates those factors that influence the amount of pollutants in breast milk. Using the example of PCBs, the long-term effects of substances with special attributes are addressed and the problems of current risk assessment procedures as well as the uncertainties concerning substance evalua- tion are presented. In the chapter on “New sins”, 13
    • Toxic inheritance 2. Sins of the past Over 350 pollutants in total have already been More than 40,000 breast milk samples have been detected in breast milk (Lyons, 1999). There are rela- analysed since1980. In nearly all samples many tively few chemicals or groups of substances for substances are still detectable in measurable which data from regular and long-term breast milk concentrations despite bans on most of these analysis are available and which would allow us to substances in the 1970s. Σ DDT, HCB, β-HCH, paint a relatively robust picture of the population’s and Σ PCBs are such chemicals. α-HCH and contamination and allow trend predictions. Particu- γ-HCH (lindane), cis-heptachloroxide (a break larly well examined are certain representatives of the down product of the pesticide heptachlor) and so-called POPs (Persistent Organic Pollutants) such dieldrin (another pesticide) are also still measur- as the polychlorinated biphenyls (PCBs), the insecti- able in 10-50% of breast milk samples today. cide DDT, hexachlorobenzene (HCB) and the toxic Many other chemicals (not listed here) are also combustion by-products dioxins and furans. These still detectable in many samples in measurable were the first chemicals that were banned world- concentration ranges. wide by the United Nations under the POPs Conven- tion (also known as the Stockholm Convention) in However at the same time a continuous decrease 2004 due to their persistency, potential for bio-accu- in contamination levels of breast milk is notice- mulation, global distribution and high toxicity. able in Germany (Table 1). Between 1980 and 1997 the contamination with organochlorine In Germany, breast milk, urine and blood samples pesticides and PCBs decreased, and since the have been examined by federal investigation 1990s a decrease in dioxins and furans is also offices for certain pesticides like DDT and PCBs noticeable. The ban on PCBs for example has led as well as dioxins and furans for a long time1. The to a 70% reduction of PCB content in breast data has been collated since 2000 in the central milk, to a mean of 0.49 milligrams per kilogram (but not public) federal and national “Breast Milk (mg/kg) fat. However 4.3% of samples examined and Dioxins in Humans Database” at the BgVV in 1997 still exceeded the set reference value of (Bundesinstitut für gesundheitlichen Verbrauch- 1.2 mg/kg fat. This means that 4.3% of the erschutz und Veterinärmedizin, now the German examined women had significantly higher National Institute for Consumer Health Protec- contamination than the upper range of back- tion and Veterinary Medicine (BfR)). ground contamination (BwG, 2000; Vieth, 2002). Table 1: Residue Mean content Mean content 95 percentile Reference 3) Mean values and 1979/81 1997 1997 reference values of persistent 0.30 1) 0.86 1) Σ DDT 1.83 0.9 1) organochlorine compounds in HCB 1.14 0.07 0.17 0.3 German breast milk (in mg/kg β-HCH 0.33 0.04 0.11 0.1 milk fat). Σ PCB 1.72 0.49 1) 0.94 1) 1.2 1) PCDD/PCDF 30.6 2) 12.9 3) 23.0 3) no data ng I-TEQ/kg ng I-TEQ/kg ng I-TEQ/kg 1) Only values from the original [German] federal states are included ; 2) Data for the time from 1986-1990; 3) Data from 1998 14
    • To distinguish whether an individual residue times less toxic than the most toxic dioxin, the content lies within the typical range of back- so-called Seveso dioxin. ground contamination for Germany, the Depart- ment for the Environment’s Commission on Dioxins have a wide spectrum of toxic and bio- Human Biomonitoring (HBM) sets a reference chemical effects; some of them are known to be value (HBM-Kommission, 2000). It is based on human carcinogens. Their hormonal (endocrine) the 95 percentile values determined in 1994, effects are also well known. In laboratory ani- which mirror the upper range of breast milk con- mals a connection has been observed between tamination in the German population. However, dioxins and endometriosis (a proliferation on the such reference values (which also exist for ovaries), development disorders and neurologi- residues in blood), do not in principle allow eval- cally determined behavioural disorders (learning uations related to questions of health. disabilities), effects on development and repro- duction (low sperm count, genital deformity) as 1. The DDT measure- PCBs were used en masse by industry as a mul- well as immunotoxic effects. These effects occur ments represent total-DDT content ti-purpose chemical in Germany and many other at much lower levels of exposure than the car- (Σ DDT) including its countries during the 1950s to 1970s. They were cinogenic effects (European Union, 2001). persistent disinte- gration product, DDE, used for example as plasticisers (softening which is formed from agents) in plastics and sealants, in buildings The toxicity of dioxin-like PCBs is similar to DDT in the human body through meta- made out of concrete slabs, as flame retardants those of the highly toxic dioxins, as they both bolic processes. The in paints and varnishes, as dielectric fluids in bind to the same sub-cellular units and therefore PCBs represent a capacitors (e.g. in fluorescent lights) and trans- influence the same processes in the cell. In ani- mixture of sub- stances including formers, in insulating, cooling and hydraulic flu- mal experiments they are carcinogenic, neuro- 209 potential single ids and as additives in nail varnish and textiles. toxic, immunotoxic, toxic to reproduction and substances (con- geners) that differ in Following a number of serious accidents in Asia development and they can affect hormone sys- the number of chlo- in the 1970s, where PCB-contaminated rice oil tems. For example, they can disrupt thyroid rine atoms and their position on the caused serious diseases (chloracne and cancer) in function, reproduction and carbohydrate metab- biphenyl ring. For the many people and following the realisation that olism. measurements of PCBs six main con- by then PCBs could be traced globally in all envi- geners (PCB 28, 52, ronmental and human samples, an initial ban on The effects of non-dioxin-like PCBs as a group 101, 138, 153, 180) are analysed using open uses was passed in 1978. Since 1989, all are much less researched. They seem to affect standard measure- production, distribution and use of PCBs has different sub-cellular processes but the resulting ment procedures and then the results finally been banned in Germany. In May 2004 the effects are again very similar (Schoeters & Birn- extrapolated to the global ban on the production and use of all PCBs baum, 2004; Schrenk, 2004). Apart from the overall PCB content (Σ PCB) using a mul- was agreed under the auspices of the UN. effects already mentioned they can cause behav- tiplication factor ioural disorders (Schrenk, 2003). The [German] (according to the PCBs can be separated into two groups: the National Environment Ministry (Gies et al., 2001) German DIN 51527 and pollutant limits dioxin-like and the non-dioxin-like PCBs. Twelve and the WHO (2002) offer extensive reviews and decree). The overall of the 209 PCBs (see footnote 1) are similar to assessments of the hormonal effects of PCBs and PCB content in the breast milk and dioxins due to their chemical structure and form. other environmental pollutants. blood samples refer For these dioxin-like PCBs a World Health only to the content of the three PCB Organisation group of experts have defined Tox- Shorter terms of pregnancy have been observed congeners 138,153 ic Equivalency Factors (TEF) that weight the in women with job-related PCB contamination and 180 each. The 17 dioxins and furans dioxin-like potency in relation to the most toxic (Taylor et al., 1989). But damage to human stored in human dioxin, 2,3,7,8-TCDD (Körner, 2003). According to health appears at concentration levels that occur body fat are summed up as International this, PCB 126 is on the same level of toxic poten- in the environment. For example, a long term Toxicity Equivalents cy as most dioxins and furans and it is only ten study in Michigan (USA) showed that children of (I-TEQ). 15
    • Toxic inheritance mothers who had eaten highly contaminated Largely unknown is the state of exposure in fish had reduced birth weight as well as neuro- detail. However this information is much needed psychological abnormalities in intelligence, lan- as PCBs can be divided into different groups that guage and memory tests (Jacobson et al., 1985; behave differently in air, soil, water and organ- Jacobson & Jacobson, 1996). Two epidemiologi- isms. Moreover the ratio of low chlorinated (few cal studies from Germany (“Düsseldorfer chlorine atoms) to highly chlorinated (many Kohorte”) and Holland examined the prenatal chlorine atoms) PCBs differs between interior air, and postnatal influences of PCB background blood and fatty tissue and is no longer identical contamination on children up to 72 months. with the ratio in the original PCB product. The Both studies detected mental development dis- residue contents of the different dioxin-like PCBs orders in the infants. in human, environmental and food samples are usually not analysed separately. Around 90% of PCB uptake takes place through food; the uptake through respiration is estimat- The Tolerable Daily Intake (TDI) is expressed in ed as 10%. In 25-year olds, 12-14% of PCBs Toxic Equivalents (TEQ), calculated from the Tox- stored in the body can be traced back to uptake ic Equivalency Factors (TEF). The TDI value esti- through breast milk (Patandin et al., 1999). PCBs mates the acceptable daily intake of a substance are not blocked by the so-called placental barri- that a human can consume lifelong without suf- er, therefore humans are exposed to these sub- fering harm. The basis for the determination of stances at the foetal stage even before birth. this value is usually through feeding tests using rats and mice. The background contamination of the ambient air is 1-10 nanograms per cubic meter (ng/m3). A report of the European Commission’s Direc- In the past years and decades the consequences torate General (DG) for Health and Consumer of the use of PCBs in buildings became apparent Protection has summarised all available data on in the form of increased contamination of inte- residues of dioxin-like PCBs and dioxins in food rior air, in particular in public buildings like (European Commission, 2000). The data suggest schools and nurseries. Often the concrete walls that dioxin-like PCBs contribute a share of TEQ were not plastered on the inside, which enabled that is between one and two-fold that of dioxins PCBs to leak from the sealants into the interior (Table 2). More recent studies of milk products air, or PCB-containing flame retardant slabs or from Germany come to the conclusion that diox- fluorescent lights had been installed (VUA & ins only contribute 30% of the total TEQ; the BUB, 1999). remainder is contributed by the dioxin-like PCBs (Malsch, 2003). Table 2: Food stuff PCDD/PCDF Dioxin-like PCBs Mean contami- (pg TEQ/g fat) (pg TEQ/g fat) nation of food stuff in the EU Fish 10 30 with dioxins Meat 0.4–0.7 0.3–1.5 (PCDD/PCDF) and Milk/dairy products 0.6–1.0 0.6–1.3 dioxin-like PCBs. Vegetable food stuff, eggs Insufficient data 16
    • In the various Member States of the EU the mean PCBs have been analysed in parallel the mean content of dioxins and furans in breast milk PCB-TEQ content varies between being of the amounts to 8-16 picograms international toxic same order and up to three times higher. In com- equivalents per gram fat (pg I-TEQ/g) according parison with a number of other countries, Ger- to DG Health and Consumer Protection. The con- many has the fourth and fifth highest levels for tamination of breast milk is therefore of the dioxins/furans and dioxin-like PCBs respectively same order as that of fish, the most highly con- with regards to breast milk contamination taminated food. Where dioxins and dioxin-like (Malisch, 2003) (Figures 1 and 2). 80 Figure 1: PCDD/PCDF Content of 70 dioxins and furans in breast 60 milk. Maximum WHO-TEQ (pg/g fat) 50 Median 40 30 20 10 0 Brazil Spain New Zealand Slovakia Ireland Hungary Ukraine Finland Norway Russia Croatia Germany Romania Australia Bulgaria Sweden Egypt Netherlands Czech Republic Italy 45 Figure 2: Content of 40 Dioxin-like PCBs dioxin-like PCBs 35 in breast milk. 30 WHO-TEQ (pg/g fat) Maximum Median 25 20 15 10 5 0 Ireland Russia Romania Bulgaria Australia Sweden Egypt Brazil Netherlands Spain New Zealand Slovakia Czech Republic Hungary Italy Ukraine Norway Finland Croatia Germany 17
    • Toxic inheritance During the period of breast feeding a baby takes up relation to age can be seen in Figure 3. All sub- two to four times more total PCBs than the provi- stances and substance groups show a distinct sional limit for the tolerable daily intake (TDI) of increase with rising age between 9 and 69 years, a PCBs and the contamination with dioxins and clear indication for the persistence and the poten- dioxin-like PCBs is approximately one order tial for bio-accumulation of these substances. greater than in adults. Officially this is considered not to be worrying as a six-month long breast The comparatively high DDE reference values in feeding period represents less than 1% of the the blood of residents of the new German federal mean life expectancy and the TDI-limit is based on states (two to four times higher than in the origi- life-long pollutant intake (Vieth & Przyrembel, nal federal states) can presumably be attributed to 2003). But this view disregards the highly sensitive the extended use of DDT in the GDR up until 1989. phases of development in children and thus com- Even though a ban on DDT was passed there in the pletely different and grave consequences of cont- 1970s, as in West Germany (1972), the substance amination (see Chapter 5). continued to be used because of a number of exemptions. The PCB and HCB reference values A German study has examined for the first time dropped up to 30% compared to the assessment in both the blood and breast milk of 169 pregnant 1999 for the age group under 49 (HBM-Kommis- women about two weeks after giving birth sion, 2003). (Wittsiepe et al., 2004). The scientists found levels of contaminants comparable to other studies and Studies from Germany and other countries also found good correlations between blood and milk prove the occurrence of a number of other “old concentrations for both the dioxins as well as for generation” pesticides and biocides in breast milk the dioxin-like PCBs (Table 3). The main congeners and other human samples. These too are listed as (structural variants of the molecules) found in global environmental pollutants in the UN POPs blood and milk are PCB 126 (the most toxic PCB convention, have been banned in Germany for a congener) and 156. In relation to the toxic equiv- long time or had no importance here as a pesticide alent the share of PCBs is 40% in blood and 48% agent. They are classified as toxic or very toxic and in breast milk. hormonal effects have been demonstrated for most of them. Breast fed babies have an average blood content of DDE and PCBs that is 0.25 and 0.4 micrograms per The DDT content in German breast milk is illustrat- litre (µg/l) respectively, higher than that of babies ed in Table 1. The values have decreased signifi- that are not breast fed (0.17 and 0.27 µg/l). Sta- cantly between 1979 and 1997. In addition to the tistical analyses prove a significant positive rela- numerous other toxic properties that ultimately tionship between the values for residues in the led to the ban of DDT, its hormonal effects have babies’ blood and the length of the breast feeding now been shown. period, particularly for PCBs, DDE and HCB; i.e. the Table 3: longer the breast feeding period, the higher the In a study of blood samples of Members of the Concentration contamination. The reference values for blood in European Parliament, DDE could be found in all of dioxins and furans as well as PCBs in blood and milk of WHO-TEQ Blood Milk German mothers (pg/g fat) Median Min. Max. Median Min. Max. between PCDD/PCDF 15.32 2.73 55.07 13.30 1.80 34.70 September 2000 PCBs 10.81 1.40 42.23 13.00 1.21 50.10 and January PCDD/PCDF+PCBs 26.13 4.13 97.30 26.30 3.01 84.80 2003. 18
    • 35 30 25 20 15 DDE (original [German] federal states) 10 DDE (new [German] federal states) 5 HCB HCH 0 PCB 9–11 18–19 20–29 30–39 40–49 50–59 60–69 Figure 3: Reference values (µg/l) for various organochlorine compounds in blood in relation to age. 47 volunteers. It exhibited the highest average tives. But it is still found world-wide today, concentration in blood serum (as opposed to including in Germany, as a biocide agent in anti- whole blood) of all the 76 substances found lice remedies for humans (mostly used as a (WWF, 2004). shampoo for children) and in insecticides for pets, e.g. in “Jacutin” products. HCH residues are Technical grade hexachlorocyclohexane (HCH) found in numerous animal food products (see consists of approximately 65-70% α-HCH, 7- food monitoring report of the German Institute 10% β-HCH, 10-15% γ-HCH and 10% of other for Health and Consumer Protection and Veteri- isomers. The pesticide lindane consists of more nary Medicine and Institute for Risk Assessment than 99% γ-HCH and is extracted from HCH (BgVV and BfR, 1998). Lindane residues could through a purification process. Lindane can be also be found in vegetable food of German origin contaminated with traces of β-HCH. In animal until 1998 (PAN, 2001). The Committee for the tests lindane has been shown to cause cancer (a Environment, Public Health and Consumer Pro- carcinogen), to damage genes (a mutagen) and tection of the EU Parliament has pushed for an to be toxic to reproduction (a reprotoxic sub- immediate ban on HCH including lindane in their stance). Studies on β-HCH point to development statement on the implementation of the UN of breast cancer. According to the European POPs Convention in EU legislation. Commission, lindane has been proven to be hor- monally active and it is therefore to be made a In breast milk and blood β-HCH dominates, as it high priority within the scope of the assessment is the isomer with the highest persistence and of hormonal pollutants (Gies et al., 2001; WWF, the strongest bio-accumulation. The values for 2002). Since 1998 lindane has not been Germany can be seen in Table 1. In the German approved as a pesticide for the German market. human monitoring study α-HCH was found in According to EU pesticide law (Directive 91/414), the blood of 1.7% of adults, γ-HCH (lindane) was lindane may not be authorised as a plant protec- found in 5.2% and β-HCH was found in 34%. tion agent in the EU since June 2002. In the β-HCH was found in nearly all blood samples of 1980s lindane was still used in wood preserva- children (92.3%) (HBM-Kommission, 2003). In 19
    • Toxic inheritance the study on MEPs, more than 90% of the 47 The consumption of HCB-dressed wheat seeds people examined showed β-HCH in the blood caused cases of severe poisoning and deaths in serum samples (WWF, 2004). Turkey in the 1950s. Very high HCB concentra- tions of 15-20 micrograms per gram (µg/g) were Hexachlorobenzene (HCB) was used directly as a found in the breast milk of affected mothers pesticide (fungicide), but it is also found as a (Jensen & Slorach, 1991). contaminant in other pesticides. It was also used as an industrial chemical, e.g. in rubber produc- A dramatic reduction of residues in breast milk tion, and it is still being used today in the pro- and blood has been achieved in Germany duction of solvents. In the UK, releases into the through the pesticide ban and technical atmosphere of at least 0.9 tons were reported in improvements in industrial production processes 1998 (WWF, 2004). As a pesticide it has been (Table 1). Nevertheless, even with the current banned in Germany and in the EU since 1988. residue contents in breast milk, the daily HCB The substance is classified as very toxic and a intake of a baby can exceed the Tolerable Daily probable carcinogen. Studies point to hormonal Intake (Vieth & Przyrembel, 2003). In the recent effects (WHO, 2002) and - in this context - to an study with MEPs, HCB was found in the blood increased risk of breast cancer (Glas et al., 2001). serum of all individuals (WWF, 2004). 20
    • 3. Risk assessment of pollutants When chemicals are detected in humans and they still enter the environment), but the animals they must first have entered the body unwanted and often unplanned release of syn- and been taken up by certain tissues. This thetic chemicals from everyday products is very process of “coming into contact” is called expo- little understood. On the whole such releases are sure. The concentration of pollutants found in not regulated by law because of this ignorance the tissue is not just dependent on the amount and because they are regarded as negligible or taken up through contact, but is also dependent non-existent. But it is a fact that many chemi- on the chemical and physical properties, the so- cals are not firmly bound in an article, but dis- called inherent properties. If a substance can be engage from it through a number of different excreted and/or if it can be degraded through mechanisms (outgassing, exuding, washing out, metabolic processes (biodegradable) it will be etc) and then can be taken up by humans via res- found in smaller amounts or not at all. If these Figure 4: processes cannot happen, or happen to a lesser Accumulation extent (it is persistent), its continued uptake will of pollutants lead to ever higher concentrations in the tissue: Baby – x? along the food i.e. the substance is “bio-accumulative”. The chain. combination of (potential) exposure together with certain properties of the substance there- fore results in the chemical’s potential for dan- ger or risk. Thus an openly deployed substance with bio-accumulative properties will certainly be found in tissues it comes into contact with – one only has to look for it (assuming the analyt- Woman –x? ical methods exist). 3.1 How does a chemical get into the body? Trout – x 2,800.000 The basic requirement for uptake of a pollutant into the body is contact with it – i.e. the expo- sure to the chemical substance. Synthetic sub- stances arrive in the environment in different Smelt – x 835.000 ways and for different reasons. These include production as a by-product, as a degradation product or waste product of chemical manufac- ture, through accidental release (e.g. during Crustaceans – x 45.000 transport) or through improper storage or dis- posal. Furthermore they are often released dur- ing the daily use of products and objects that Zooplankton – x 500 contain synthetic substances or through their deliberate release into the environment - as in the use of herbicides and insecticides in agricul- ture or in the use of biocides (pest control agents in non-agricultural areas). Use of pesticides and Phytoplankton–x 250 biocides is subject to legal controls (although 21
    • Toxic inheritance piration (inhalative), through the skin (dermally) example, in water, the organic phase can be and/or via food (orally). organic components in sediments or in suspended solids but also organisms themselves – such as Although the longevity of a chemical (its persis- algae, fish, crustaceans and all other aquatic life. tence) is a desirable property in many applica- The terms “bio-concentration” and “bio-concen- tions, this property also becomes a great problem tration factor” (BCF) refer to the tendency of a under these circumstances of release into the chemical to stay in the water phase or to accu- environment. Persistent substances are only very mulate in an organism. The bio-concentration slowly transformed and degraded chemically or potential can either be theoretically estimated biologically (e.g. through the action of micro- (e.g. with the help of the KOW) or it can be prac- organisms or through metabolic processes or tically determined through experiments with test chemical reactions) in water bodies, in the soil or organisms. For convenience sake, the BCF, which in tissues. The measure of this process is the is strictly speaking only applicable to aquatic “half-life period”, the time that is needed to organisms, can also be used as a measurement for reduce the amount of a substance by half. There bio-accumulability, i.e. the tendency of a chemical is also the problem that products of metabolic or substance to accumulate in an organism. degradation processes (metabolites) may be even more persistent than the original substance and At a bio-concentration factor of more than 2000 even possess different, possibly even more toxic, it is assumed that the substance has an ability for properties. A half-life of 40-60 days is currently bio-accumulation that could lead to the accumu- considered the EU criterion for undesirable per- lation of potentially dangerous substances sistence. through the food chain (European Commission, 2001). For example, pollutants contained in a Another chemical property that is often manipu- crustacean build up further in a fish according to lated beneficially in products is the ability of the amount of crustaceans it has eaten, and sim- some chemicals to dissolve more easily in organ- ilarly the seal and the polar bear will further ic solvents than in water. Substances with this accumulate such pollutants as the bear eats the property are called lipophilic (literally “fat lov- seal that ate the fish that ate the crustaceans. ing”) or hydrophobic (“water hating”). This prop- The higher an organism is in the food chain, the erty can easily be determined in the laboratory. higher is its contamination (Figure 4). The substance is put in a test tube filled in equal parts with water and the organic solvent octanol The distribution mechanism described above and (which does not mix with the water). After shak- the accumulation through the food chain are ing and waiting until equilibrium is reached the responsible for persistent, lipophilic substances concentration of the substance can be measured ending up on the plates of the population in fat- in each of the solvents. The more lipophilic the ty food such as dairy products, meat and fish and substance the higher is the concentration in therefore inside the human body. This distribu- octanol compared to the concentration in water. tion mechanism is also responsible for different This standard measurement is known as the concentrations inside the human body according octanol-water partition coefficient (or KOW). A to the fat content of the organs. The liver and KOW of 1000 means that the substance ends up brain have a high fat content, as does breast in the octanol phase at a 1000 times higher than milk. Milk fat, which constitutes about 3.5% of in the water phase. breast milk, is produced from the body’s fat tis- sue during pregnancy and in this way lipophilic This phenomenon regarding the distribution of substances stored in the mother’s fat deposits substances can also be observed in nature. For are transported into her milk. 22
    • 3.2 Factors influencing the residue content the number of breast-fed children. Therefore the Dietary habits play a significant role as a major- first born children of older mothers are particu- ity of synthetic substances relevant for breast larly affected. The mother detoxifies herself milk are taken up through food. In particular the through her child. regular and continuous consumption of fatty food leads to increased contamination. The con- Mean values from official publications are often tamination of fruit and vegetables with pesti- taken as a basis for assessment of the German cides adds to this. Pollutants also get into food- population’s contamination with extrinsic sub- stuffs through packaging materials. And syn- stances. But the mean values hide contamina- thetic chemicals can also be taken up through tion peaks such as those found around some breathing or through the skin. For example, waste sites or former production sites like Bitter- brominated flame retardants (see Chapter 4.1) feld (in Germany) (Benkwitz et al., 2002). Simi- released from electronic devices such as TVs or larly, individuals from rural areas with low agri- computers or synthetic musk compounds (see cultural usage are usually less contaminated Chapter 4.2) contained in body lotions and then individuals from industrialised areas. Thus cleaning fluids can come into direct contact with the contamination values can vary considerably the skin. The significance of these paths for con- between individuals from different areas tamination is insufficiently known for most sub- (Schmid et al., 1997). Moreover distinct differ- stances. Therefore they are often ignored by the ences could be observed in the 1990s between official substance classifications, e.g. in the those living in the new and old federal states of determination of the acceptable daily intake Germany. The citizens of the old German Demo- (ADI) by the World Health Organisation. cratic Republic (GDR) for example were spared from high PCB contamination as no PCBs were Time also plays a significant role. Environmental used there. On the other hand the insecticide chemicals are usually found in higher concentra- DDT was still in use in forestry areas in the GDR tions in the body fat and blood of elderly people until the end of the1980s, while in West Ger- than in younger people. Mothers over 39 years of many it had already been banned in 1972. An age statistically exhibit a three times higher con- individual’s level of contamination will be affect- tamination with pollutants than mothers under ed by their origin and travel history. 25 years, because they have accumulated the toxins during the course of their life (Nieder- 3.3 The handling of uncertainty sächsisches Landesgesundheitsamt, 2003). A fur- Problematic properties of chemicals include per- ther cause of these values could be the higher sistence (P), bio-accumulability (B) and toxicity levels of general contamination in the past. (T), as well as the potential for movement around the world (global transport) and therefore for the Chemicals are transferred from mother to child contamination of distant, non-industrialised during pregnancy as well as at breast feeding. regions. Acute or short-term toxicity is usually The highest amounts of substances are fed to the stated with the help of a threshold value such as child in the first weeks of breast feeding – 10- the “no observed effect concentration” (NOEC) or 20% of all stored organochlorine compounds the “no observed adverse effect level” (NOAEL). during the first three months of breast feeding Thus the higher the NOEC or NOAEL the less tox- according to one study (Mersch-Sundermann et ic the chemical – at least for the particular effect al., 2000). The contaminant levels in the baby or “end-point” being observed. Besides acute rise with longer breast feeding periods. The toxic effects, chronic longer-term effects of amount of extrinsic substances in the breast milk chemicals are mainly assessed as cancer induc- decreases with the length of breast feeding and ing (carcinogenic), damaging the genotype 23
    • Toxic inheritance (mutagenic) or toxic for reproduction (reprotox- ronment as – once released – they stay in the ic). Such substances are collectively referred to environment for decades, if not centuries. And as the CMR substances. they cannot be removed from the environment at some later date should high toxicity be It is particularly problematic if substances com- detected in the future. bine a number of adverse properties. From the combination of these properties arise the various There are also cases in which the three criteria substance groups that are often referred to such are not fulfilled or not explicitly fulfilled but as the POPs (persistent organic pollutants), PBTs which nevertheless give cause for concern. This (persistent, bio-accumulating, and toxic sub- includes for example substances that do not stances) as well as the vPvBs (very persistent, absolutely fulfil the persistence and bio-accu- very bio-accumulating substances). mulation criteria according to the above defini- tions, but which are released in such high quan- The POPs currently comprise twelve pollutants tities that critical concentrations can be reached (the list may be extended at a later date) for in organisms. The plasticiser DEHP is a case in which a worldwide ban was agreed under the point (chapter 4.3). 2001 Stockholm Convention (POPs Convention). One of the best known is pentachlorophenol, PCP. Hormonally active substances are a good exam- The POPs, which belong to different chemical ple of how quickly the state of knowledge on the groups, are extremely long-lived and are spread- toxicology of chemicals can change. This partic- ing worldwide through the atmosphere, inland ular incidental property of some substances was water and oceans. Their accumulation in organ- virtually unknown up until a decade ago and isms and their toxic properties can lead to dam- toxicological science attached no importance to age in organisms and their offspring or can be it. These are substances that may affect the hor- manifested in the disturbance of whole ecosys- monal system of humans and animals in very tems. Some of the POPs were banned long before small quantities. These substances imitate natu- the Stockholm Convention, at least in Western rally occurring hormones, blocking them or industrialised regions. But the accumulation of interfering with the hormone synthesis. A POPs demonstrates that, even if their production change in the hormonal system may cause last- is stopped or strongly reduced, they can still be ing damage, particular during sensitive stages of found for decades after in animals and humans. life. Contamination during the embryonic devel- opment or in early childhood is particularly dan- PBTs and vPvBs have been defined in the EU’s gerous as during these stages important physio- technical guidance on the risk assessment of logical and morphological development process- chemicals. They differ in persistence and bio- es are taking place with the help of the hormon- accumulability; the PBTs are additionally known al system. Reproductive organs, parts of the to be toxic. A number of newer chemicals can be brain and a working immune system are being counted here, e.g. the brominated flame retar- formed, so that deformities, infertility, immun- dants (see Chapter 4.1). But also extremely long- odeficiency or modification of behaviour can be lived and bio-accumulative substances, known the result (WWF, 2002). A list published by the as vPvBs (very persistent, very bio-accumulative) European Commission names 564 chemical harbour significant potential dangers for people compounds that are suspected to be hormonally and the environment as their risk consists in the active (European Commission, 2000a). possible but unknown toxic effects. In line with the precautionary principle these substances Synthetic musk compounds are a further exam- should not be allowed to escape into the envi- ple. Until recently these were still regarded as 24
    • relatively safe for human health as compared to The German Federal Environment Ministry some other chemical groups due to a lack of sci- (Umweltbundesamt, UBA) criticised the raising entific insight. In recent times new test results of the TDI by the SCF as they thought the uncer- have been published showing the whole group in tainties were insufficiently regarded (UBA, 2002; a very different light (Luckenbach & Epel, 2005). Gies et al., 2004). They made a number of points. According to this work nitromusks and polycyclic The uptake of substances into the body was set musk compounds are allegedly able to inhibit the at 50%, even though studies show significantly transport of dangerous substances out of the higher rates (up to 89%) and it is known that cell, enabling these to unleash their harmful children take up substances in their body partic- effects (chapter 4.2). ularly efficiently and quickly. Data from tests on (male) rat reproduction effects form the assess- As an example of how extremely difficult can be ment basis for the limit. Other studies on the the risk assessment of a dangerous chemical hormonal and immunological effects, behaviour- (particularly with regard to the inadequacy of al studies, epidemiological studies and the car- scientific knowledge) we will take a more inten- cinogenic properties of the substances were dis- sive look at polychlorinated biphenyls (PCBs). The regarded. Sensitive sub-populations were not PCBs are divided into two groups, the dioxin-like considered, neither was the high contamination PCBs and the non-dioxin-like PCBs. Whether of children through breast milk and the danger separate principles for their assessment are nec- that a reservoir is formed in the body that could essary and which group is ultimately more dan- contribute to the later daily uptake. Moreover gerous for humans and the environment is not calculations are based on a half-life of fifteen yet established. Even though the PCBs have been years. New German studies show that breast-fed relatively well studied the assessment is not yet children are still 20% more contaminated at the fully completed due to constant new insights age of 9-11 years than non-breast-fed children into their mode of action. A toxicological re- of the same age (BMU, 2002). Moreover the TEQ assessment of PCBs is currently taking place on currently only takes into account dioxins, furans part of the EU and the WHO (BgVV, 2001; and dioxin-like PCBs, so underestimating the Bayrisches Landesamt für Umweltschutz, 2003; true TEQ uptake as there are more dioxin-like Vieth & Przyrembel, 2003). compounds, e.g. hexachlorobenzene (HCB), poly- chlorinated naphthalenes and polybrominated Currently recommended limits for dioxins and diphenylethers. These underestimates should be dioxin-like compounds are set on the basis of considered in the assessment process by allow- toxicity equivalents (TEQs). After consulting with ing for further safety margins. experts, the WHO proposed a tolerable daily intake of 1-4 picograms TEQ per kilogram body For the above reasons the UBA and the BfR weight per day (pg TEQ/kg bw/day) in 1998 favour the lower TDI proposed by the WHO of 1 (WHO, 2000). The EU Scientific Committee on pg TEQ/kg bw/day. Moreover this would be in line Food (SCF) recommended a similar provisional with the WHO’s own goal to reduce the popula- value, which refers though to a tolerable weekly tion’s de facto daily intake of dioxins and dioxin- intake (TWI) of 7 pg TEQ/kg bw (SCF, 2000). Only like substances to under 1 pg TEQ/kg bw/day six months later the value was doubled and (Gies at al., 2004; Mathar, 2003; UBA, 2001). relaxed to 14 pg TEQ/kg per week (SCF, 2001) due to the inclusion of further studies. The WHO According to more recent data (post-1995) the too changed their value and arrived at a recom- average dietary intake of total TEQ in the EU is mendation of 70 pg TEQ/kg per month (JECFA, 1.2 - 3 pg TEQ/kg bw/day (European Commission, 2001). 2001). Therefore, the current EU limit can be 25
    • Toxic inheritance regarded as relatively high (Mathar, 2003) and is are still missing for concentrations relevant to only cutting cases of unacceptable peak risk. The environmental medicine. These values are called residue limits for dioxins and furans in food were HBM (Human Biomonitoring) values and they reconsidered by the SCF, taking into account the are set by the Human Biomonitoring Commission dioxin-like PCBs as well, by the end of 2004. of the Federal Environment Ministry (UBA). In Unfortunately the stronger German position and the case of PCBs the Commission currently does the WHO’s goal were not followed. The permit- not feel it is in a position to set HBM values that ted residues in food remain on the basis of the would be sufficiently scientifically justifiable TDI at 2 pg TEQ/kg bw/day. because this would need verified insights into the relationship between dose and effect. In the A review and necessary amendment are also Commission’s view the available studies show imminent for the recommendations regarding that the difference between current reference PCB contamination of indoor air. Currently a pre- values (in blood) and the beginning of the range cautionary value of 300 ng/m3 and a danger val- of effects is probably small (HBM Commission, ue of 3000 ng/m3 apply for total PCBs (accord- 2003). It must be stressed here that this worry- ing to DIN, the German industry norm). In a ing statement refers to the current state of con- study by Körner & Kerst (2003), dioxin-like PCBs tamination of the population even after 25 years only were measured separately in indoor air. of a ban on PCBs and significantly declining con- Based on the TDI of 1 pg TEQ/kg bw/day pro- tamination levels. posed by the UBA it was calculated that the dan- ger value for dioxin-like PCBs was already Another example from the younger generation of exceeded when the level of total PCBs was only substances are the phthalates (plasticisers used 40% of their danger value. To what extent the in plastics) and DEHP (diethyl hexyl phthalate) in consideration of dioxin-like PCBs will influence particular (chapter 4.3). Even though there are the new recommendations on these reference few new substances that have been so well stud- points is so far uncertain (Schwenk, 2003; Körn- ied experts have argued for a long time (and still er & Kerst, 2003). But the recommendations are do) about the indications for human health of under close scrutiny since the understanding of the diverse scientific studies. This has led to the risks of the non-dioxin-like PCBs is still lim- completely insufficient regulation to this day ited. This group is not yet included in the assess- despite massive problems for human health and ment concept and it is not known whether the the environment. The TDI values calculated from health risks posed by total PCBs are being under- animal experiments vary by a 1000-fold depend- estimated. For example there is so far no TDI val- ing on which species has been used and which ue for non-dioxin-like PCBs. At the moment the type of paramenter was under study. How effec- German authorities as well as experts of the EU tive health protection is supposed to be carried and the WHO are working on the question of out based on such a risk assessment remains whether and which separate assessment stan- more than dubious. The precautionary principle dards are necessary here. should be employed, and measures should already be adopted if the science has not clari- As a certified toxicological assessment of PCBs is fied beyond doubt to what extent detrimental still unavailable there is also no adequate risk effects can occur. management in place that would be capable of protecting humans and the environment from 3.4 Conclusion potential dangers. Warning or intervention PCBs are some of the most studied environmen- threshold values (at which measures to minimise tal pollutants of all. But they are not just an contamination would need to be implemented) example to show how long persistent and 26
    • lipophilic substances can contaminate humans and the environment. They represent an impres- sive example of how much time science needs to work out a certified assessment regarding the health effects of this contamination. This process will not end for a long time yet and it must be assumed that certain limitations to scientific understanding may never be overcome. PCBs are also an example showing how political decision makers shy away from measures which would make an explicit commitment to the precaution- ary principle due to the potential economic con- sequences. For example, stricter limits would have economic consequences for the fishing industry or a drastic reduction of indoor air ref- erence values would have to lead to extensive refurbishment measures in public buildings. The declining contamination in Germany is a positive sign, as can be seen in breast milk (chapter 2), but this is not a total success story and by no means the end of the story. 27
    • Toxic inheritance 4. New sins While levels of PCBs and other “old” substances humans today and have been detected in breast continue to decline due to bans on their produc- milk and other human samples, so far no com- tion and usage, new groups of substances (such prehensive bans or regulations have been passed. as the brominated flame retardants (Figure 5)) It is therefore apparent that the current chemi- are being detected with increasing values and cal policy is not yet capable of protecting con- now these are coming into the focus of scientif- sumers and the environment from hazardous ic and public concern. One reason for this is that chemicals. some chemicals serve as replacements for the dangerous older substances. The new substances 4.1 Flame retardants often have the same or similar properties as the For the purpose of fire prevention polybrominat- older existing substances, i.e. they are persistent, ed diphenylethers (PBDEs) are added to plastics lipophilic or bio-accumulative. Many have as “additive flame retardants”. They are found already turned out to be toxic and/or hormonal- mainly in electronic products, e.g. in computers, ly active. In contrast to the older chemicals TVs and cables, but they can also be present in though they are still currently used in numerous other consumer articles, like textiles or fabric products and consumer goods. Even though such toys. The PBDE substance group is made up of substances are seen to be contaminating compounds of the same structure but with a 4,000 100 PBDE Total TEQ (PCDD/PCDF/PCP) 3,000 80 PBDE (pg/g fat) TEQ (pg/g fat) 2,000 60 1,000 40 0 20 1972 1976 1980 1984 1990 1992 1996 Year Figure 5: Comparison of brominated flame retardants (PBDE) and toxicity equivalents (TEQ) for PCBs, dioxins and furans in breast milk, 1972-1996. 28
    • variable number of bromine atoms. Of commer- washed out from artificial textiles during wash- cial significance are the compounds with 5,8 and ing processes they are also found in sewage 10 bromine atoms (penta-, octa- and deca-BDE). sludge and through agricultural fertilisation can Like PCB products they each consist of a mixture also end up in our food. The estimated daily of several congeners: penta-BDE with the main intake of penta-BDE through food, drinking congeners 47, 99, 100, 153, 154, octa-BDE with water and respiration adds up to a daily intake of the main congeners 183 and 153 and deca-BDE 0.8 µg/kg body weight. Besides other brominat- with the main congener 209. In Europe 75% of ed flame retardants penta-BDE has been detect- the yearly consumption of PBDEs is attributed to ed with concentrations up to 100 µg/kg in deca-BDE; this corresponds to 8,200 tons. The human fat tissue. remaining share is in about equal parts penta- BDE (10%) and octa-BDE (15%). Also significant Tetra-BDE – a component of the commercial in Europe are the brominated flame retardants product penta-BDE – is taken up through the tetrabromobisphenol A (TBBA) and hexabromo- intestines and, by passing through the blood- cyclododecane (HBCD). brain barrier (the brain’s natural protective bar- rier) it is transported into the brain and the These substances were only detected in breast spinal marrow (Burreau & Broman, 1998). Tests milk in 1999 - to much surprise - as a new class with mice suggest that brominated flame retar- of lipophilic environmental chemicals. But this dants can deeply disrupt the development of the was despite the fact that there had already been brain. Mice that were given a single dose at the indications at the beginning of the 1980s that age of ten days showed learning difficulties and polybrominated flame retardants are persistent behavioural disorders like hyperactivity and dif- and bio-accumulative substances. At that time ficulties in adapting to new environments. The they had been detected in the Arctic, including in disorders increased with progressing age (Erikson seals and whales, far away from their production et al., 1998). In liver cells of male rats a chemi- and usage (de Wit et al., 2004). Despite these cal change of the female hormone estradiol has results no systematic studies on the contamina- been observed – a trigger for the start of cancer tion of the natural world and humans took place. (Segura-Aguilar et al., 1997). For octa-BDE a dis- But by now, PBDEs are counted amongst the most ruption of the reproduction processes has been omnipresent of environmental pollutants. They observed in animal tests. It resulted in for exam- are found everywhere - in the air, in house dust, ple reduced birth weight, deformities and death in soil samples, in water, in sediments, in organ- of the offspring. isms and in food such as fish, meat, milk and eggs – and increasingly so. That these chemicals can Deca-BDE was not considered dangerous as it now also be detected in breast milk does not was assumed that it would not easily pass come as quite such a surprise now. PBDEs have through biological cell membranes of the lung, the ability to accumulate in fatty tissue. Once the intestines and the skin due to the large size released into the environment they accumulate of the molecule and, unlike penta-BDE and octa- because of this intrinsic property in organic, fat- BDE, so far it has not been regulated by law. But rich tissue – therefore also in breast milk. this is despite experiments that show that deca- BDE can disintegrate into lesser brominated The main route of intake for humans is through compounds (i.e. with a lower number of bromine food. Brominated flame retardants have been atoms) under the influence of sun light (Sell- found in fish and other sea food, but also in ström et al., 1998). These smaller molecules can cow’s milk (3.6 micrograms per kilogram (µg/kg then accumulate more easily in organisms. fat)) (IPCS, 1994). As flame retardants can be Breakdown of deca-DBE can also take place in 29
    • Toxic inheritance Figure 6: 4,5 Concentration 4,0 of polybromi- nated flame 3,5 retardants in Swedish breast 3,0 milk between µg/kg milk fat 1972 and 2,5 1997. 2,0 1,5 1,0 0,5 0,0 72 76 80 84 85 90 94 96 97 organisms through the metabolic processes Tests on blood serum show a very wide range of (Kierkegaard et al., 1997). As it is quantitatively PBDE levels. The cause of this cannot yet be cor- the most widely used brominated flame retar- related with different factors such as diet, age or dant, the industry’s resistance against potential employment situation. More recent studies on legal restrictions on this substances is particular- house dust also have not shown a straightfor- ly strong. ward connection between dust contamination and the type of house, its furnishings or the Breast milk was first analysed by a Swedish number of TVs or computers. But in smaller flats group of scientists when they examined stored with younger residents who used their comput- samples from the years 1972-1997 with respect ers regularly (more than five hours per week), to this group of substances. The results were deca-BDE had a higher share of the total conta- alarming - the contamination doubled every five mination. A general principle is that the domes- years. The total concentration rose from 0.07 to tic environment and/or house dust can play a 4 µg/kg fat (Norén & Meironyté, 1998; significant role in the contamination of the pop- Meironyté et al., 1998, 1999; Figure 6). Darnerud ulation (Stapleton et al., 2004). In a US-wide et al. (1998) detected a mean concentration of analysis of dust on computers in universities and 3.4 µg/kg fat in 39 breast milk samples from offices, PBDEs were found in all samples. Of Swedish women. A peak concentration of 28.17 these, deca-BDE was in the highest concentra- µg/kg was measured. tions, up to 213 picograms per cubic metre (pg/m3) (McPherson & Blake, 2004). Particularly alarming were the results from the USA where very strict regulations on fire preven- In 2003 the blood serum of 155 volunteers were tion are in place. Numerous products in daily use tested for PBDEs and other organohalogens in a - such as mattresses, curtains and even bedding number of British towns (WWF UK, 2004). In - are treated with flame retardants. The conse- contrast to other studies, significant regional quence is a PBDE concentration in the breast differences were found in penta-BDE levels, milk of USA women some 10 to 70 times higher although in line with the known wide spectrum than in European women (She et al., 2004). of concentrations. There seems to be one group 30
    • of lesser contaminated and one group of higher ng/g) (Schröter-Kermani et al., 2000) (Figure 4). contaminated individuals, although the reasons According to the German National Agency for for this are still unknown. Mothers with several Consumer Health Protection and Veterinary children exhibited a slightly lower contamination Medicine (Bundesinstitut für gesundheitlichen level compared to women in the same age group Verbraucherschutz und Veterinärmedizin, BgVV), without children. The concentrations of penta- the mean content in 1999 was 5.5 µg/kg fat and BDE and octa-BDE were comparable to those therefore higher than in the Swedish blood sam- found in other European countries and substan- ples (BgVV, 2002). tiated widespread contamination. In a small group of eleven individuals, but from five differ- In 2001, the BgVV initiated a study to investigate ent towns, residues of deca-BDE were also the PBDE content in breast milk in the Berlin detected. Here the peak value of 240 nanograms area. One aim was to gain insights into possible per gram fat lay within the range of the Swedish influences (e.g. profession) and the relevant tests, but with the difference that these were not routes of exposure (e.g. food). The study also individuals who had come into contact with the aimed to pursue the question of whether breast substance through their jobs. This result is feeding reduces the overall contamination of alarming in as far as it indicates - independent- women, i.e. whether significant amounts of the ly of regional differences - an unspecific deca- stored pollutants are transferred from mother to BDE contamination of the general public at sig- child. So far 93 samples from the years 2001 to nificant levels (Figure 4). This finding was con- 2003 from both vegetarians/vegans and non- firmed by a European-wide examination of blood vegetarians have been examined for 9 BDE con- samples for 101 substances: deca-BDE was geners (Figure 5). An average PBDE value of 2.2 found in 34% of the volunteers and furthermore ng/g fat (in a range of 0.6 - 7.25 ng/g fat) can be exhibited the highest concentrations of all sub- assessed as the background contamination of stances. It is particularly alarming that the levels German women. This lies within the range of found were 10 times higher than in individuals other European studies (Table 4) and below the who are exposed to BDEs through their jobs. (The US American finding by a factor of 10-100 (Vieth same result was incidentally also found for et al., 2004). The averages are comparable to one TBBA; and HBCD was detected for the first time other German study (2.4 ng/g fat), while a third in a human blood sample in this study (WWF, study found a higher average (7.2 ng/g fat) 2004)). (Fürst, 2001; Weber & Heseker, 2004). A further study of blood samples used three gen- From Table 5 it is evident that dietary habits erations of each family volunteering for the influence the PBDE levels in humans. Vegetari- study. It was found that chemicals that have only ans/vegans exhibit a 30% lower mean PBDE con- recently been found in our environment (like tamination. However a significant reduction of PBDEs) were present in higher concentrations in the levels during the 10 weeks of breast feeding the children than in the adult members of the could not be observed. Yet the findings indicate family. 75% of individuals in whom deca-BDEs that women exhibit a significantly lower PBDE were found were children (WWF UK, 2004a). concentration in their breast milk while feeding their second or third child. In Germany only little data is available so far on the contamination of the population with PBDEs. The detection of deca-BDE (BDE 209) is again However the measurements that do exist for significant. In 40% of the 62 samples examined German blood samples also show an increase in the values exceeded the detection limit. This is levels between 1985 (3.1 ng/g) and 1999 (3.9 the first proof of background contamination 31
    • Toxic inheritance Table 4: Region Year Sample Median (range) PBDE concentra- Σ BDE Octa-BDE 183 Deca-BDE 209 tion in breast milk, Great Britain 2003 Serum 4.6 (0.52-420) 0.59 (0.19-1.8) a 83 (35-240) b blood and serum of London & Lancaster 2001-2003 Milk 6.6 (0.3-69) ** the population of Sweden 2001/2002 Blood 4.9* c several European Finland 1994-1998 Milk 2.1* countries (ng/g) Germany d 1985 Blood 3.1* 1990 3.6* 1995 3.7* 1999 3.9* Sweden 1972 Milk 0.07* 1980 0.45* 1990 1.2* 2000 2.6* Norway 1977 Serum 0.44* 1986 1.1* 1995 3.1* 1999 3.1* Sweden 1997 Serum 11 (3.0-25) E 4,8 (<0.29-9.5) E 1999 1.2 (0.23) C 1,5 (<0.96-6.8) C 2000 < 1.9 G 34 (6.7-280) G Σ BDE = BDE 47, 99, 100, 153, 154; a = only samples with a positive result for BDE (n=85); b = only samples with a positive result for BDE (n=11); c = Σ BDE 47, 99, 153; d = BDE 47; * = arithmetic mean; ** = 95 percentile; volun- teers: E = electronic scrap disassembly workers, C = computer technicians, G = rubber cable production workers. with deca-BDE, as previously this congener had tence, bio-accumulability and their distribution only been detected in isolated human samples of and transport over long distances – the charac- occupationally contaminated individuals or in teristic properties of the persistent organic pol- isolated breast milk samples in the USA. This lutants (POPs). Blood tests on European volun- again brings home the message about the poten- teers also showed higher concentrations for tial folly of substitution from within the same deca-BDE than for penta- and octa-BDE (WWF, group of substances. 2004). The legislature should urgently prohibit further releases with the help of bans on pro- So far the EU has banned the use of the techni- duction and use of these flame retardants. Pen- cal products penta- and octa-BDEs as of August ta-BDE is already being treated as a candidate 15th 2004. Regulations concerning deca-BDE for an extended UN POPs Convention, but in our are still missing. This is being justified by a lack opinion other representatives of the brominated of data and by contradictory or unfinished final flame retardants should also be included. evaluations as part of the EU risk assessment. The latest studies from Germany on the amount 4.2 Fragrances of measurable residues in breast milk (Vieth et A further group of products that can be detect- al., 2004), on the occurrence in house dusts (Sta- ed in breast milk and other human samples are pleton et al., 2004) and computer dusts synthetic musks. Natural musk has become an (McPherson & Blake, 2004), as well as their pres- increasingly expensive fragrance of the perfume ence in the sediments of Arctic lakes (de Wit et and cosmetic industry and since the musk deer, al., 2004) and in the blood of polar bears (WWF, whose glands are used to produce the musk, was 2005), are explicit indications for their persis- nearly eradicated in Asia, the chemical industry 32
    • Dietary habits Meat eaters and Meat eaters Vegetarians/Vegans Table 5: of women Vegetarians/Vegans Mean PBDE Number of samples 62 37 25 concentration in BDE-28 0.04 0.05 0.04 German breast BDE-47 0.82 0.99 0.58 milk (ng/g fat) BDE-66 0.01 0.02 0.01 differentiated BDE-99 0.25 0.30 0.16 according to BDE-100 0.21 0.23 0.18 dietary habits, BDE-153 0.63 0.66 0.57 November 2001 BDE-154 0.02 0.03 0.02 to December BDE-183 0.09 0.10 0.07 2003 BDE-209 0.17 0.17 0.17 Σ BDE 2.23 2.54 1.78 developed synthetic musk compounds as a sub- levels Table 7 shows the amounts a baby takes up stitution. Today there are about 1000 substitute on average during breast feeding. The data substances with musk-like scent, but of these assumes an age of 4 months for the baby, an aver- only about 30 are economically significant. The age feeding amount of 821 ml (fully breast feed- two economically most important substance ing), a body weight of 6.5 kg and a 3.5% fat con- groups among the synthetic musk compounds tent of the breast milk (Vieth & Przyrembel, 2003). are nitromusk compounds (musk xylol and musk ketone) and the polycyclic musk compounds Studies on 105 breast milk samples from women galaxolide (HHCB) and tonalide (AHTN). The from Bitterfeld-Wolfen in Saxony-Anhalt in musk compounds are used in cosmetics, washing 1999/2000 came up with data comparable to agents, fabric softeners, domestic and industrial the results from 1997 and confirmed the cleaners and many other fragrant products. They decreasing trend of residue amounts of nitro- enter the body mainly through the skin. musk compounds. The means were 12 µg/kg milk fat for musk xylol and 6 µg/kg fat for musk Nitromusk compounds have been detected in ketone (Benkewitz et al., 2002). In the study by indoor air and in dust particles in nurseries and Ott et al. (1999) breast milk samples from cen- flats in Berlin (Fromme et al., 2004). In 1993 musk tral Hesse were tested for nitromusk compounds. xylol and musk ketone were detected for the first Musk xylol was detected in 100% of the 55 test- time in breast milk samples. The concentrations ed samples from the year 1995. The mean con- lay between 5 - 190 µg/kg milk fat (Rimkus et al., tent was 41 µg/kg fat. The samples are therefore 1993, 1994). In 1995 Eschke et al. succeeded in about 58% above the national average of 26 identifying the second class of synthetic fra- µg/kg fat. In 87% of samples musk ketone was grances, the polycyclic musk compounds. also found with a mean content of 10 µg/kg fat. The data on mean levels of synthetic musk com- These findings reflect widespread contamination pounds in German breast milk in Table 6 originate of the population with nitromusk compounds. In from the surveys of BgVV’s database on breast the scientific literature several reasons are given milk and dioxin in humans (Vieth, 2002). The lev- as to why musk ketone is not found in all sam- els of nitromusk compounds, decreasing between ples or only in small concentrations. On the one 1993 and 1997 as compared to the increasing hand a quick bio-transformation as well as polycyclic musk compounds, clearly reflect the excretion seems to take place, on the other hand shift in market share. On the basis of these residue musk ketone is six times less lipophilic than 33
    • Toxic inheritance Table 6: Year Nitromusk compounds Polycyclic musk compounds Mean content of Musk xylol Musk ketone Galaxolide (HHCB) Tonalide (AHTN) synthetic musk 1993 56 18 compounds in 1995 26 12 03 78 German breast 1997 18 10 39 36 milk (µg/kg fat) musk xylol, which leads to a smaller accumula- drawal of its use by the members of the German tion. Moreover xylol compounds represent a industry federation for cosmetics and detergents share of 1-20% of synthetic scents, ketone com- since 1994. The withdrawal was a result of the pounds only a share of 0.5 - 10%, so that the detection of musk xylol and musk ketone in the released amounts differ in quantity. food chain, in drinking water and in breast milk samples in the early 1990s. The authors calculated the amount of musk xylol that a breast fed baby takes up from milk during In 1998 the Senate Commission of the German its first few weeks. With 0.742 µg/kg fat per day Science Community (Deutsche Forschungsgemein- the reference value for an “acceptable risk” of schaft, DFG) pointed out that potentially toxic sub- 0.003 µg/kg body weight per day is exceeded by stances that accumulate in the body are generally a factor of 250. But as the acceptable risk figure undesirable. Therefore the contamination of refers to a lifelong uptake for which one person humans with synthetic musk compounds should in a million would suffer damages to their health, be avoided or reduced as far as possible for the the authors deem this excess of little relevance, purpose of preventive environmental protection. as the breast feeding period represents only 1% of a human life. Unfortunately in this purely By now musk xylol and musk ketone are no longer mathematical calculation they disregard other produced and used in the EU. This is due to indi- and later exposures to the chemical, they do not cations that after take up through the skin they consider the possibility of combined effects with probably have a damaging effect on reproduction other substances and they totally ignore the spe- and development (EU Risk Assessment Reports for cial sensitivity of children (see Chapter 5). musk xylene and musk ketone, 2001). Additional- ly they are persistent and bio-accumulative. The clear decrease in the content of musk xylol in breast milk is credited to the voluntary with- Table 7: Calculated daily Nitromusk compound residues Polycyclic musk Daily uptake of uptake compound residues synthetic musk Musk xylol Musk ketone Galaxolide (HHCB) Tonalide (AHTN) compounds in a Mean 0.08 0.04 0.17 0.16 four months old 95 percentile 0.18 0.14 0.40 0.26 fully breast fed baby (µg/kg body weight) 34
    • A further indication of detrimental health effects Reliable statements on the trend of the general is provided by a study that analysed five differ- contamination by polycyclic compounds are not ent musk compounds in the blood of 152 women yet possible in Germany due to the low number of who were being treated for gynaecological prob- samples and the short time period of observation. lems in the university clinic of Heidelberg in But higher concentrations of these compounds 1994-1996 (Eisenhardt et al., 2001). Here too detected in breast milk reflect their increased 95% of all samples were contaminated with market share. As they are increasingly used as musk xylol (mean: 65.5 nanograms per litre substitutes for nitromusk compounds, contamina- (ng/l), maximum: 1183 ng/l) and 85% with musk tion could rise in future. Additionally the potential ketone (mean: 55.5 ng/l, maximum: 518 ng/l). for consumers to come into contact with musk This finding is important as a significant correla- xylol and musk ketone continues despite the end tion between the concentrations of these sub- of EU production as they continue to come onto stances and various diseases of the hormonal the European market without control through system could be established. The compounds imports from China (the main current producer) as seem to disrupt the relation between the hor- admixtures with other products (EU Risk Assess- monal regulatory systems of the diencephalon ment Report for musk ketone, 2001). In general, (interbrain) and the ovaries and therefore lead to studies to monitor the contamination situation their malfunctioning. Also reported are effects in should be conducted on synthetic musk com- animal experiments at low concentrations. For pounds continuously and these should also con- example, sperm maturation is disrupted in male sider a wider spectrum of substances. animals that have been treated with musk ambrette, a further nitromusk compound. Musk 4.3 Plasticisers ambrette also acts as a neurotoxin and musk 90% of the plasticisers used in the EU are used in xylol and musk ketone can cause skin allergies. PVC products to make them softer and more flex- ible. Among the plasticisers DEHP (diethyl hexyl According to the authorities no indications can phthalate) is the most common compound, be taken from these animal observations to say responsible for about 45% of consumption that the amounts detected in breast milk could (about 475,000 tons per year). Further phthalates be dangerous for the breast-fed baby (Vieth & often used as plasticiser are DBP (dibutyl phtha- Przyrembel, 2003). Also no TDI value was set as late) and DINP (diisononyl phthalate) as well as the musk compounds are taken up through the DIDP (diisodecyl phthalate). But phthalates are skin (dermally) and not through food (orally). also used in many other areas. They are used as a However the state of knowledge concerning their carrier for fragrances, deodorants and other cos- dangers is still very limited in all synthetic musk metics. They are components in nail varnish and compounds and a final assessment is not yet pos- hairsprays and they are used in formulation sible. A recent discovery is very worrying though: agents in pesticides, as industrial solvents, as both groups of synthetic musk compounds (nitro- lubricants and as additives in the textile industry. and polycyclic) are said to have the ability to inhibit the transport mechanisms which remove As softening agents the substances are found in other dangerous substances on a long term basis, rain coats, toys, flooring, medical products, food so that their harmful effects are prolonged (Luck- wrappings, paints and glues and other products. enbach & Epel, 2005). But such combination Flooring, toys and medical products can contain effects are not taken into consideration given the up to 50% plasticisers. As they are not bound to single substance testing during the risk assess- other compounds in the plastic they leach out of ment process for individual chemical substances. the objects and find their way into domestic dust particles for example. It is estimated that out of the total of DEHPs escaping into the environ- 35
    • Toxic inheritance ment in the EU only 1.5% originate from releas- between 3,200-7,100 µg/kg in carpets and es during production and 2% from industrial 3,100-5,400 µg/kg were measured in cushioning usage. More than 90% of the yearly environ- fabrics (Bruns-Weller & Pfordt, 1999). mental contamination of 30,000 tonnes is caused by outgassing, abrasion, washing out and Apart from uptake through the skin and by res- other diffuse losses from consumer goods (EU piration, internal uptake of phthalates is also RAR for DEHP (2000)). This leads to an caused by contaminated food. In particular, fat- omnipresent distribution in the environment and ty food packaged in wrapping that contains continuous exposure of the general public to phthalates shows high residues. (See Bruns- phthalates. They can be detected in a number of Weller & Pfordt (1999) for a literature review.) environmental and human samples. Even in Arc- The front-runner for total phthalate content is tic ice one can find concentrations of up to 0.53 cheese; a (wrapped) soft cheese sample was micrograms per litre (µg/l) (Desideri et al., 1994). measured at 114,000 µg/kg, followed by peanuts with 38,000 µg/kg and poultry with 8,800 µg/kg. Humans can take up phthalates from the air, Tests on cow milk showed different contamina- through the skin and with food. Measurements tion levels in various EU states, which may be of indoor air in offices, schools and nurseries in dependent on different methods of packaging. Denmark resulted in values of 0.86 µg/m3 DEHP Cow milk from Germany was contaminated with on average. In a room with new PVC flooring the 20-150 µg DEHP/kg, Norwegian milk with 60- values were 200-300 µg/m3; and in a car heat- 380 µg DEHP/kg and English with <10-90 µg ed up by the sun DEHP concentrations of up to DEHP/kg. Baby food in the form of formula milk 1,000 µg/m3 could be measured. Even in ambi- (powder) in Germany contained <50-200 µg ent air DEHP can be detected in concentrations DEHP/kg, values for soft food in jars were of 0.0003 - 0.3 µg/m3 in some European regions between 50-210 µg/kg (Gruber et al., 1998). (EU RAR for DEHP (draft), 2000). Many toys for babies and toddlers are made from The Bavarian Federal Authority for Health and soft PVC. Babies and toddlers suck and chew on Food Safety examined the presence of phtha- these products, and saliva acts as a solvent sup- lates in 59 flats and in 74 play schools in porting the release of phthalates. This is a signif- 2000/2001 (Fromme et al., 2004). Bibuthyl- icant source of phthalate uptake via the mouth. phalete (DBP) caused the highest residues in the indoor air of flats and play schools (1.083 µg/m3 Even though phthalates only disintegrate slowly and 1.188 µg/m3). DEHP was identified in house in the environment, a relatively quick break- dust with a mean content of 703 mg/kg (with a down is assumed in the human body with a half- range of 231-1,763 mg/kg). Thus it makes up life of eight to ten hours (Bruns-Weller & Pfordt, 80% of the phthalates. 1999). While phthalates exhibit lipophilic behav- iour, bio-accumulation in fat tissue or breast By wearing clothes, using cosmetics or just milk is rather unlikely according to the current touching soft platics phtnalates can be uptaken state of knowledge. The big problem of phtha- through the skin. In an analysis of clothing tex- lates is the continuous and high exposure that tiles it was detected that the phthalate content humans, particularly children, are confronted depends on the material used. While textiles with on a daily basis. made from pure cotton had a total phthalate content of 4,100-8,900 µg/kg, in mixed fabrics concentrations of 10,200-16,300 µg/kg were detected. The total phthalate content varied 36
    • Analyses of German breast milk samples have the ones that are hormone-like – can cause far shown residue contents of 70-160 micrograms more serious damage to children’s health than to per kilogram (µg/kg) for DEHP (Gruber, 1998), that of adults (see Chapter 5). 10-110 µg DEHP/kg, 50 µg DBP/kg as well as evi- dence for DIBP in traces (Bruns-Weller & Pfordt, A study by Binder & Obenland (2004) also shows 1999). From this data and on the basis of a max- that toddlers are exposed to DEHP to a far high- imum DEHP value of 160 µg/kg, the BgVV calcu- er degree than adults. This insight is all the more lated an exposure of 21 µg/kg bw/day at age up worrying given that babies already take up a to 3 months and 8 µg/kg bw/day at age 3 to 12 considerable amount per day through breast months. In the younger age group these values feeding. Their daily DEHP absorption of 12 µg/kg exceed the lowest TDI value of 4 µg/kg bw/day bw/day exceeds that of adults by a factor of 6. quoted in the literature five-fold and two-fold in the older group (Table 8). Other authors also confirm this result. Meek & Chan (1994) estimated the daily uptake in 0.5 – In a study of blood samples of EU Members of 4 year olds as 19 µg/kg bw/day. According to Parliament, DEHP was detected in all 45 tested their calculations this age group (and most sen- individuals. The median concentration was the sitive sub-population) is the most highly conta- highest of all 76 residues detected. The maxi- minated at 3.3-fold the contamination level of mum value was 1,152 µg/kg; the mean was adults. With a base level contamination of 155 µg/kg blood. DIBP was present in 84% of all 12 µg/kg bw/day the TDI of the Dutch National samples and DINP in 38% of samples (Figure 7; Institute for Public Health and the Environment WWF, 2004). is exceeded by a factor of 2 (Table 8). Not includ- ed in this estimate is contamination caused by New test methods and results from the Universi- sucking or chewing on toys that contain DEHP or ty of Erlangen attracted world wide attention as by wearing clothes made from PVC like rain- they indicated that all other previous studies had coats, wellington boots or sandals. The DEHP underestimated the contamination of humans released and taken up through this route exceeds considerably. In the study by Koch et al. (2003), the base level of contamination several-fold urine samples from 85 individuals from Erlangen even in normal use: up to 200 µg/kg bw/day can and the surrounding area were examined. The be taken up by sucking and chewing on toys method did not measure the DEHP itself but (CSTEE 1998) and up to 79 (rain coats) and analysed three of its breakdown products 340 (sandals) µg/kg bw/day per day respectively (metabolites), making a new and more reliable can be taken up via the skin. And note that these method. From the data the individual daily figures are not calculated in the way that Koch uptake of DEHP was calculated. The values for and his colleagues did so may still be an under- daily DEHP uptake were 2.6 – 166 µg/kg bw/day estimate (see above). with a mean of 13.8 and a 95% percentile of 52.1 µg/kg bw/day. These results for contamina- The level of contamination of the population is tion of the German public with DEHP exceeded very alarming in respect to the hormone-like hitherto published values by at least a factor of (endocrine) effects of phthalates and the toxic ten. The Erlangen scientists also examined chil- effects on reproduction and development. This dren in play schools and their teachers and par- substance group is suspected to be linked to - ents (Koch et al., 2003a). From urine samples the among other things - increasing infertility in children’s DEHP contamination was found to be men. Animal tests have shown a reduction in the twice as high as that of the adults. This gives number and weight of offspring, slowed bone cause for concern since pollutants – particularly development and deformities particularly in male 37
    • Toxic inheritance Figure 7: 100 Occurrence of various 90 phthalates in 80 blood samples of European 70 volunteers % of volunteers 60 50 40 30 20 10 0 DMP DBP BBP DIDP DEP DINP DIBP DEHP Phthalates reproductive organs as well as in kidneys and eyes highest priority, and special emphasis should be (Bruns-Weller & Pfordt, 1998; WWF, 2000; WHO, placed on the examination of food (and its pack- 2002). The EU classifies them as priority sub- aging) and consumer goods. This would also help stances in respect of their hormonal effects and clarify the sources of high dust contamination their potential for exposure (Gies et al., 2001). indoors (BfR, 2003). Further regulation measures are not spelled out. A risk assessment for DEHP is taking place at present within the scope of the European “exist- On the basis of studies on animals various insti- ing chemicals” programme (under the Existing tutions have calculated amounts of DEHP that Chemicals Regulation 793/93). So far advanced they consider still tolerable in humans. But the measures to minimise risks have only been results differ by more than a factor of ten (Table deemed necessary for children, and not for adult 8). The BfR names further studies that result in consumers - despite the detrimental effects that TDI values that vary by a factor of as much as DEHP may have. Based on the new results of the 1000 (BfR, 2003). The lowest TDI of 4 µg/kg University of Erlangen, the German Institute for bw/day is quoted by the Dutch National Institute Risk Assessment (BfR) has deemed necessary a for Public Health and the Environment (RIVM). It review of the current DEHP risk assessment at is based on a study by Poon et al. (1997) that had European level (BfR, 2003). The BfR sees indica- determined a NOAEL (no observed adverse effect tions that the general public’s exposure to DEHP level) of 3.7 µg/kg bw/day in tests with rats. (The (and potentially other phthalates with similar NOAEL states the concentration below which toxic effects) is higher than assumed so far, negative effects are not observed in the animal although it notes the difficulties in assessing the tests.) Damage to testicular cells was examined multitude of toxicological data which can be as an end point in this study. As this result was interpreted differently among experts. The BfR deemed relevant by the RIVM to both young and concludes that clarification of the potentially adult male animals a safety factor of 10 was relevant sources of exposure should be of the used to extrapolate to lifelong exposure. A safe- 38
    • Country - Institution Reference value Label End point Author Table 8: (µg/kg bw/day) Reference values Netherlands - Rijksinstituut 4 TDI (MPR) Reproduction toxicity Baars et al 2001 of various voor Volksgezondheid en institutions en Millieu (RIVM) regarding tolerable USA - Environmental 20 RfD Increased liver weight IRIS 2004 DEHP uptake Protection Agency (EPA) World Health Organisation 25 TDI Peroxisome proliferation WHO 1996, cited (WHO) in the liver according to Baars et al. 2001 EU: Scientific Committee 48 TDI Development toxicity and CSTEE 2004 on Toxicity, Ecotoxicity and testicular toxicity the Environment (CSTEE) TDI: Tolerable Daily Intake; MPR: Maximum Permissible Risk Level; RfD: Reference Dose (for chronic oral exposure); ty factor of 100 was used to allow for the varia- such and chemical preparations containing more tion between species and within a species. Using than 0.5% DEHP must be labelled with the skull these factors they arrived at the TDI value of 4 symbol and the warning “toxic” (Table 9). But µg/kg bw/day (Baars et al., 2001). Binder & this does not apply to consumer goods, some of Obenland (2004) consider this approach legiti- which contain DEHP in considerably higher con- mate as DEHP is so far the only plasticiser which centrations (e.g. toys and flooring with up to has been subject to proper observations with 50%). respect to uptake by humans. Therefore for the time being it is not an isolated figure but also As CMR (carcinogenic, mutagenic or reprotoxic) has the function of being representative for a substances in cosmetic products pose a serious multitude of industrially used phthalates. Koch risk to consumer health, DEHP was banned due et al. (2003) have shown that other phthalates to its classification as reprotoxic by the cosmet- can often be found in high concentrations ics Directive 2003/15/EEC. At EU level certain alongside DEHP in urine. Koch et al. assume phthalate plasticisers have been banned in toys additive toxic effects of these compounds when intended for children up to three years of age as they act in the same way. A potentially overesti- well as in teething rings since 1999 due to the mated safety margin in DEHP could compensate suspected hormonal effects (EU Commission’s for a potentially underestimated total phthalate preliminary decision). Since March 2000 a corre- uptake. sponding regulation has been in force in Ger- many. In September 2004 the European Council Despite the numerous scientific findings on the spoke out in favour of a ban on DBP, BBP (butyl detrimental effects of some phthalates they are benzyl phthalate) and DEHP in toys for all age still being used widely in a large number of con- groups; for another three phthalates DINP, DIDP sumer goods, although there are now some legal and DNOP (di-n-octyl phthalate) the ban is sup- regulations. According to Directive 67/548/EEC posed to remain in place only for the age group on the classification and labelling of dangerous up to three years as well as for toys that are substances, DEHP has been classified as detri- being mouthed. The EU Parliament’s resolution mental to reproduction (reprotoxic) since 2002. for an environment and health action plan in To indicate the danger risk phrases have been February 2005 calls for a restriction on the mar- assigned: R60 – “May impair fertility” and R61 – keting and use of six phthalates (DEHP, DINP, “May cause harm to the unborn child”. DEHP as DBP, DIDP, DNOP, BBP) in domestic products for 39
    • Toxic inheritance Table 9: Danger label Risk phrases Symbol Classification and labelling T toxic R60 - May impair fertility of DEHP. R61 - May cause harm to the unborn child indoor use and in medical devices to which new- Environmental Agency regards the substitution borns, children, pregnant women, elderly individ- of DEHP in plastics as necessary (UBA, 2003). uals and workers are particularly exposed. A pre- Various alternatives are already available on the condition is that safe alternatives should be avail- market: e.g. adipates, citrates, phosphoric acid able and that the restriction would have no neg- ester, alkyl sulphonic acid ester and cyclohexene ative impact on medical treatment. In July 2005 dicarbonic acid ester. the European Parliament banned manufacturers from using these six toxic chemicals in plastic From the point of view of a precautionary pro- toys. In Austria phthalates are banned – with tection of the environment and human health exceptions – in food packaging (EU 2003). The BfR the use of phthalates must be banned in all plastics Commission advises an end to the use of products when exposure to humans and the cling-film containing soft PVC which could come environment can be expected. This would partic- into contact with foodstuffs (BfR 2003). ularly include baby and children’s goods, food packaging, medical products, textiles and fur- According to guidance on the use of environ- nishings as well as goods used in outdoor appli- mentally safe substances the German Federal cations and exposed to the weather. 40
    • 5. The danger to children’s health Children are affected by pollutants in particular can be traced back to environmental causes, ways. The contamination does not start with including, amongst others, the effects of danger- breast feeding after birth, but already occurs in ous chemicals. The rise in allergies in children, the the womb. Many of the chemicals that contami- increase in asthma, leukaemia and brain tumours nate the mother can penetrate the placental bar- as well as neurological developmental disorders rier, i.e. they can travel from the mother’s blood must count among these illnesses (Landrigan et into the unborn child. For the growing and devel- al., 1999). oping foetus this can lead to detrimental and irre- versible harm. Particular mention must be made of Children are not “small adults”: many aspects of the recently discovered so-called endocrine or their contact with chemicals differ from the situ- hormone disruptors that - even in small quantities ation with adults. In Germany particular attention – may interfere with crucial metabolic processes is being paid to this issue within the scope of the by imitating or blocking natural hormones that Environment and Health Action Programme serve to control vital functions in the body. This (Aktionsprogramm Umwelt und Gesundheit, can lead to impairment of growth, of the immune APUG). The programme was presented in 1999 by system, of the future ability to reproduce as well the Federal Environment Ministry and the Federal as of the brain’s development and therefore of Health Ministry. Within its scope a study was pro- future mental abilities and behaviour. After the duced on “the consideration of the high-risk breast feeding period the contamination contin- group children in the derivation of environmental ues through the consumption of food contami- standards concerning health issues” (Schneider et nated with pesticides, through the contamination al., 2002). The following aspects are to be consid- of indoor and ambient air or through the exposure ered: to chemicals that are “hidden” in everyday goods, - children are more exposed to environmental some of which children come into contact with pollutants than adults; intensively (and more so than adults), e.g. by - at an age of one to five years children eat three chewing or mouthing their toys. to four times more food and drink five times more than adults in relation to their On the one hand children in Western industrial body weight; nations are mostly better off compared to children - the consumption of milk in relation to their in historic times and to those in developing coun- body weight is nine times that of an adult; tries. The incidence of dangerous infectious dis- - children have a more unbalanced diet than eases is much lower, nutrition has been improved adults, e.g. the consumption of apples can be up and access to clean drinking water is ensured. The to 20 times higher than in adults. life expectancy of a baby born today is more than These nutritional habits can - in children - lead to twenty years higher than that of a baby born at an uptake of pesticides exceeding the TDI value the beginning of the 20th century. On the other (BgVV, 1999). hand children today live with the risk of being exposed to maybe 30,000 synthetic chemicals The intensity of respiration is also higher in babies that were all placed on the market within the last and children. Based on the respiratory volume and 50 years without prior testing of their potential body weight a baby takes up an air volume 1.5 toxicity. The increase in certain chronic diseases times greater than that of an adult. The relatively and new forms of illnesses needs to be mentioned larger body surface and the fact that substances here because it is thought that a quarter of them are taken up more easily and quickly though chil- 41
    • Toxic inheritance dren’s skin needs to be kept in mind when consid- mental Hygiene of the Working Group of Leading ering dermal uptake. By now it is certain that Medical Civil Servants (AGLMB) pay attention to mouthing (putting objects into their mouths) as the special situation of children. The Commission well as the swallowing of dust and other ground ruled that for the purpose of deriving reference particles leads to a higher uptake of substances. values for indoor air quality, in addition to using a factor of ten to take into account the variance The rates of metabolism and excretion differ with within one species an additional factor of two age. Therefore during the first year of life sub- should be employed to take into account the stances stay in the body for much longer than in higher respiration rate in relation to the body adults due to the immature kidneys. Moreover weight of children (IRK, 1996). children up to year five have - as a general rule - a higher rate of metabolism than adults. Children One EU directive regulates the legal limit of pes- grow and develop very quickly. From birth to ticide residues in baby food and it sets a limit of puberty they pass through a succession of differ- 0.01 mg/kg. But what is not taken into account ent developmental phases. With respect to the the fact that after a few months toddlers are toxic effects of environmental chemicals, the often fed supplementary freshly blended fruit and maturation phases of organs (e.g. kidneys, central vegetables for which “adult values” apply. By con- nervous system or sexual organs) are always crit- trast USA food law from 1996 sets an additional ical phases. Important developmental processes safety margin of a factor of ten for residue limits can be interrupted, delayed or altered. During for pesticides in food for children (Olin, 1998). these sensitive phases vital systems are being formed in the body. If cells of the developing Further studies on exposure and potential health brain, of the immune system or the reproductive risks in children are necessary. On the grounds of organs are being destroyed by toxic substances or precaution, children should be assessed as a high- if their development is disrupted - for example by risk group until the questions are resolved due to hormone disrupting substances - the risk of a per- the life span still in front of them. Limits and ref- manent malfunction looms. Depending on the erence values for the purpose of protecting affected organ a loss of intelligence, a malfunc- human health should be aimed at the most sensi- tion of the immune system or problems in repro- tive groups of the population and those most in duction can occur. need of protection. Children have in general more years of their life still in front of them and therefore more time to develop chronic illnesses years later triggered by exposure early on in their lives. A contamination with pesticides for example in babyhood is more likely to lead to an illness than a comparable con- tamination during adulthood. Because of this nature of children it is obvious that the risk assessment of chemicals should include special assessment standards for children and babies. Currently only the Indoor Air Hygiene Commission (Innenraumluft-Innenranmlufthy- giene-Kommission, IRK) of the German, Environ- ment Ministry and the Committee for Environ- 42
    • 6. The reform of EU chemicals policy – a solution? There should be socio-political consensus that received as much attention in continuous moni- humans and the environment must be protected toring as the polychlorinated naphthalenes, from dangerous, toxic substances. It should also which have been used since the beginning of the be agreed that synthetic chemicals should not last century as a substitute for PCBs. They too enter the environment and/or the human body if can already be found in breast milk and they they possess the property to accumulate there behave in their effects like dioxins (Lundé & for years, decades or even forever. This principle Norén, 1998). Furthermore there are numerous should apply independently of toxicological chemicals that are not yet the focus of research, insights about the substances, particularly con- i.e. which have not been looked for yet and sidering that scientific insights into the effects where little information is available to the on humans and the environment are only a authorities. Yet any persistent, lipophilic and bio- snapshot of the current state of knowledge. The accumulating substance in open use will be traditional risk assessment system therefore detectable in breast milk sooner or later once the needs to be reviewed and an adequate handling progress in scientific analysis enables this and of uncertainty needs to be developed. The new where the financial resources of research pro- research into the properties of endocrine pollu- grammes permits it. tants as well as the latest insights into the health risks of synthetic musk compounds (chap- 6.1 Prehistory ter 4.2) must be taken into account, not just in When mass production of chemicals began individual cases but in the general handling of nobody thought of the potentially dangerous the problem. The still prevailing disagreement long-term effects of chemical substances: chem- concerning the assessment of PCBs (which have icals were released into the environment without been in circulation for decades and have been any testing by the authorities or the industry. In banned globally) as well as the numerous con- the 1960s and 1970s the first surprising findings tradictory scientific findings concerning the of residues were made in environmental and plasticiser DEHP (chapter 4.3) underpin this human samples. With respect to pesticides the demand. need for an approval system based on safety tests was recognised relatively early since these The old sins of the PCBs (chapter 2) are a partic- compounds are explicitly designed to kill ularly good example that shows the importance unwanted weeds and pests. For biocides other of comprehensive testing on risks for human than those used in agriculture an EU directive health and the environment ahead of commer- has also been issued. Following its implementa- cial marketing. Furthermore the case provides tion into German law in 2002, now biocides also evidence that persistent and lipophilic sub- have to be specifically authorised for use. stances should not be authorised for open uses in the first place. But so far there are no legal For all other chemicals – the so-called “industri- instruments for this purpose. It should also not al chemicals” – regulations have only been be forgotten that by now a large number of fur- issued in certain individual cases. For example, ther industrial chemicals have been detected in there are restrictions on the use of various dan- human samples. And not all of them have gerous substances in electrical and electronic 43
    • Toxic inheritance goods (2002/95/EC), regulations concerning cos- the (belated) protection of humans and the envi- metics (76/768/EEC and amendments) as well as ronment from risks posed by these chemical sub- concerning the safety of toys (88/378/EEC and stances. Under this Regulation, prioritised sub- amendments). stances are now being assessed in a time-con- suming process and either approved for free use Usually regulations to reduce certain dangers are or subjected to certain restrictions. But by 2005 only issued when problems which have occurred in only 300 substances had completed the risk the environment or to human health require action assessment process even though this is a neces- to restrict the use of the culprit chemical. In such sary precursor for any legislative measures. The cases the burden of proof rests with the aggrieved system is therefore not able to guarantee party or with the authorities who are expected to humans and the environment adequate protec- deliver a complete line of evidence for the causal tion from dangerous chemicals, as more than 10 connection between the substance and the harm years after the introduction of the system funda- before the industry side agrees to restriction. mental information about the risks and applica- tions of most substances on the market is still The first fundamental shift in tackling this prob- not available. lem took place in the context of the negotiations on the protection of the marine environment, On May 17th 2004 a milestone in the regulation particularly the Convention for the Protection of of dangerous chemicals was reached with the the Marine Environment of the North-East coming into force of the United Nations’ Stock- Atlantic (OSPAR Convention). In 1998 the envi- holm Convention (or POPs Convention). As men- ronment ministers of the adjacent states of the tioned before, this international agreement bans North-East Atlantic (including a representative or restricts twelve globally occurring long-lived of the European Commission) issued the so- toxic substances known as Persistent Organic called “one generation target”, namely an end to Pollutants or POPs. The politics needed nearly emissions and accidental releases of dangerous half a century to respond adequately to the glob- substances into the marine environment by the al threat, and without the tough endeavours of year 2020. For the first time the persistent, bio- numerous environmental organisations this accumulating and hormone disrupting sub- important agreement would probably not have stances in particular were identified as danger- materialised in this form. NGOs are also striving ous substances. This agreement was very ambi- to extend the number of substances in the Con- tious due to the number of potential candidate vention, e.g. to include hexachlorocyclohexane substances, but eventually led to the precaution- (HCH) and pentabromodiphenyl ether (PBDE). ary approach on which the current draft of the EU chemicals policy reform is based. In parallel to the Convention negotiations, in April 1998, environment ministers of several In 1981 chemical legislation came into force that Member States came together in Europe to for the first time prescribed mandatory testing express their concern about EU chemicals policy. for chemicals for environmental and health risks Following the demand of the Environment Coun- before they could be placed on the market. All cil for a new approach to improve regulation of 100,195 chemicals that had been marketed in the numerous substances on the EU market, the Europe prior to this date (the “existing sub- EU Commission presented the chemicals White stances”) had not undergone such risk assess- Paper (“Strategy for a Future Chemicals Policy”) ment but could continue to be marketed. Not in February 2001. In the same year this found the until 1993 was the EU’s Existing Substances support of the Council of Ministers and the Euro- Regulation passed which was supposed to ensure pean Parliament, with some supplementary pro- 44
    • The twelve chemicals of the UN POPs Convention Pesticides aldrin, chlordane, dieldrin, DDT, endrin, heptachlor, hexachlorobenzene (HCB), mirex, toxaphene Chemicals polychlorinated biphenyls (PCBs) and hexachlorobenzene (HCB) Undesirable byproducts dioxins and furans posals. The text revised by the Commission was A brief description of the draft legislation as it then posted on the internet for all stakeholders stands at present follows. to comment on (May to July 2003). But the pol- icy, which in principle was a good approach, was Reg istration : Manufacturers and importers of significantly weakened due to unparalleled chemicals will be obliged to collect the most aggressive lobbying by the chemical industry – important information about a substance in a who used totally exaggerated arguments on the registration dossier which is then sent to a cen- cost of the reforms. Now the first draft for tral Chemicals Agency. The amount of the data REACH in its current form (presented in October that needs to be included depends on the quan- 2003) no longer guarantees sufficient protection tity of the substance manufactured or imported for the environment and human health, and and on its hazardous properties. Besides the sub- needs improving in many vital areas. stances’ inherent properties and data on toxicity tests, the dossier also includes information about 6.2 REACH – the new EU chemicals legislation the use of the substance and its entire life cycle. The new EU chemicals legislation on the regis- This information is passed on through the supply tration, evaluation and authorisation of chemi- chain. REACH will only apply to an estimated cals, REACH, is to date the most far-reaching 30,000 substances that are produced or import- and significant reform of environmental and ed in amounts of more than one tonne per year. health protection law in Europe. As the current The new system will be introduced step by step. draft stands, a central component of the new Substances have highest priority if they are system is the duty for all companies to harm nei- manufactured in very large quantities (over ther human health nor the environment during 1,000 tonnes per year per manufacturer) and if production, import and use of chemicals. As not- their carcinogenic, mutagenic and/or reprotoxic ed above, until now the authorities have had the potential is already established. Eleven years responsibility of proving the dangers of a chem- after coming into force at the latest all sub- ical in order to restrict use. In the new regulation stances should be registered. Non-compliance it will be up to the companies to demonstrate with the given deadlines leads to a marketing the safety of a chemical before it is placed on the ban. market. The manufacturer will be obliged to assess the potential risks along the entire chain Evaluatio n: The registration dossiers are checked of use (including waste production and disposal). for completeness and a conclusion is drawn from Moreover REACH includes a new mechanism to the submitted data. This inquiry may lead to limit the uses of the most dangerous substances. either a ban or restrictions to minimise the risks In the future, approval (an authorisation) will be or it may not result in any measures, depending needed for the use of a substance with a very on the risk assessment. high danger potential, otherwise uses are auto- matically banned. Until now such bans could Auth orisation : Chemicals that meet the criteria only be introduced on a case-by-case basis and of “very high concern” have to undergo an only if the authorities could prove a relevant risk. authorisation procedure if the manufacturer 45
    • Toxic inheritance wishes to market the chemical despite the (Friends of the Earth Germany) and its European potential dangers. CMR chemicals are of very representative Friends of the Earth Europe, high concern as are very persistent and very bio- together with the European Environmental accumulative substances or substances that are Bureau, Greenpeace International and WWF as persistent, bio-accumulative and toxic. A further well as European NGOs for health (EPHA Envi- clause in the draft legislation paves the way for ronment Network), women (Women in Europe inclusion of endocrine disrupting substances and for a Common Future) and consumers (Euro- substances that are identified as being of equiv- coop). The four main demands of the NGOs can alent concern. be found on page 9. Currently the draft law is being discussed in the It must be noted that REACH does not apply to EU Council of Ministers, following first reading in some 70,000 chemicals that are produced or the European Parliament in November 2005. The imported in amounts of less than one tonne per revised text – also know as the Council Common year. To close this loophole a legally binding Position - will be subject to the second reading obligation for duty of care is needed for all man- when both Parliament and Council have to adopt ufacturers and users of chemicals, which would it jointly – presumably at the end of 2006 or ear- bind them by law to be responsible for the safe- ly 2007, although if necessary, a conciliation pro- ty of their products. Under REACH it is up to cedure between Parliament and Council could manufacturers, importers and users of chemicals delay this further. to make sure that the products they produce, import or use do not harm human health or the 6.3 The NGOs’ essential proposals for amendments environment. The regulation is reinforced by the The current REACH draft has unacceptable omis- precautionary principle: in the choice of chemi- sions caused in particular by the massive inter- cals for production or use the manufacturer and vention of industry interests during the 2003 succeeding users should choose the safest avail- internet consultation. For example: able alternative. • For chemicals of less than a tonne per year (per manufacturer) no information at all will The REACH draft proposes that the registration be available. This is unacceptable, particularly of substances prioritised according to manufac- from the point of view of industrial safety. tured or imported tonnage and also be includes • The data to be provided for chemicals that are CMR substances as first priority. This is a realis- produced in amounts between 1 - 10 t/year tic and legally certain measure and is the best will not be sufficient to derive appropriate proposal for phasing-in the registration of the safety measures. huge number of chemicals. (In our view, all sub- • Chemicals in consumer goods are excluded stances of very high concern should have priori- from effective controls. Substances which ty here, i.e. including the PBT and vPvB need authorisation may continue to be sold if substances - not just the CMR substances as the risk is “adequately controlled” – even if proposed by the Commission.) The proposal of safer alternatives are available at a compara- some industry representatives to carry out “risk- ble price. This is exactly the flawed approach based” prioritisation is unworkable - without of the past. sufficient safety information the risk cannot in • The chemical industry’s excessive demands for fact be assessed and this information is only secrecy prevent appropriate public access to generated during the registration process. information about the safety of products. In consequence, a number of proposals for amendments have been drawn up by BUND 46
    • The information requested for chemicals at a The data submitted for evaluation should be yearly production volume of 1 - 10 tonnes is not spot-checked to ensure a generally high quality. sufficient to identify particularly hazardous sub- The Member States themselves should also eval- stances of very high concern. REACH must not uate a sample of the registration dossiers and downgrade the current level of information safety data submitted by industry. required in the system for evaluation and labelling of dangerous chemicals. Information on The authorisation procedure must be designed in long-term effects, including reproductive toxici- a way that encourages innovation and the search ty, at high tonnage bands (tpa) as well as good for alternatives. Chemicals of very high concern quality use and exposure information (scenarios) must only receive an authorisation if no safer should be provided. A chemical safety report alternatives are available, if the social benefit should be mandatory so that customers can outweighs the dangers to the environment and become aware of the hazards and exposures and human health and if emissions as well as acci- so that the producers can pass on conditions for dental spillages into the environment are kept at safe use to successive downstream users. a minimum. In an improvement from the original Commission proposal, a consistent autorisation With respect to the registration of substances in procedure now applies at least to bioaccumula- consumer goods, the current REACH proposal tive and persistent chemicals, which should does not ensure sufficient protection of con- reduce the use of such chemicals in everyday sumers and the environment. The threshold for products and encourage innovation towards safer mandatory registration of chemicals in imported alternatives. For other chemicals of very high products should be regarded as per importer concern, however, an authorisation can still be rather than per product. Registration also granted if the industry can prove that it “ade- depends on importers knowing if the release of a quately controls” the substance, that the social substance from a product is likely and knowing benefit outweighs the risk or that no safe alter- its estimated toxicity. This clause should be natives are available. Where an authorisation is removed - the importer should urge its subcon- granted it should always be temporary and it tractors to only use chemicals registered within should include a review clause. The possibility of the scope of REACH. including chemicals of “equivalent” concern in the authorisation process must also be made eas- At the moment REACH does not sufficiently take ier - in the current REACH proposal serious and into consideration the particular sensitivity of irreversible damage to humans or the environ- children and does not account for exposure at ment must first be identified. This could of course various stages of development. Appropriate pro- take a very long time (if it is at all ever possible tection of children must be ensured to rule out beyond doubt) and contradicts the precautionary detrimental effects on behaviour, learning, motor principle. capabilities, the immune system and future fer- tility. Even though chemicals may cause the It should be guaranteed that everyone has access same effects in adults and children this can hap- to information concerning chemicals that they pen at different levels of contamination. More- are handling or buying. Information about sub- over substances can lead to effects that only stances in consumer goods should be available occur in children and that are connected to the to all commercial users, retailers and consumers. development of organs and organ systems. In Products that incorporate chemicals of very high particular, changes that originate in exposure concern that need authorisation should be during development and that are only manifest- labelled in order to inform all downstream users ed in later life can easily remain undiscovered. including retailers and consumers and to enable 47
    • Toxic inheritance them to seek alternatives. The procedure for obtaining information held by Deca-BDE as a case study for the need for the authorities is extremely cumbersome and the chemicals reform slow and provides industry with significant rights to veto the release of information. The Concerns about deca-BDE (deca-bro- public interest in access to information must modiphenyl ether) have resulted in it receive more consideration. The list of perma- being a priority substance in the current nently accessible information must be extended “existing chemicals” programme and it to include the entire registration dossier, the has been under scrutiny for many years substance safety report, information on amounts by experts of the Member States. Within this system the authorities of the Mem- of production and import and the name of the ber States have to investigate all the registering person. All data on toxicity, life cycle, data about this substance before regula- exposure, categories of use and risk assessment tory decisions can be made. And if the must be publicly accessible. The list of confiden- uses are to be restricted, the authorities tial information should not contain any data sig- have to know if safe alternatives are nificant for protection of human health or the available for all applications - not nec- environment. Any decision to withhold such essarily an easy task for regulators. So information should be preceded by an evaluation far it has been concluded that the accu- of public interest in this data. mulation in animals and humans and the current knowledge of its toxicity does not warrant the imposition of controls (Chapter 4.1). Even though deca-BDE contaminates animals and humans in regions far away from civilisation it does not fully fulfil the current criteria for very persistent, very bio-accumulating (vPvB) sub- stances. Therefore within the scope of REACH it could only be included in the authorisation process through being declared as a substance of “equivalent concern”. But it is doubtful whether at this stage the current criterion of “seri- ous and irreversible effects” could be demonstrated. Thus to ensure an effec- tive mechanism through the authorisa- tion process, this condition needs to be removed from the REACH text. Under the current system industry could try to obtain an authorisation by arguing that the risk posed by the chemical was “ade- quately controlled” and the authorities would have to grant an authorisation even if alternatives exist. 48
    • 7. References • CSTEE, 2004. Opinion on the results of a second Risk Assess- ment of: Bis(2-ethylhexyl)phthalate [DEHP] Human Health Part, 41th plenary meeting of 8 January 2004. • Darnerud, P., Atuma, S., Aune, M., Cnattingius, S., Wernroth, M-L. & Wicklund-Glynn, A., 1998. PBDPEs in breast milk from • Baars A.J., Theelen R.M.C., Janssen P.J.C.M., Hesse J.M., van primiparous women in Uppsala county, Sweden. Dioxin 98, Apeldoorn M.E., Meijerink M.C.M., Verdam L., Zeilmaker M.J., Organohalogen compounds 35, Stockholm. 2001. Re-evaluation of human toxicological Maximum Permis- • de Wit, C., Alaee, M. & Muir, D., 2004. Brominated flame sible Risk levels. Rijksinstituut voor Volksgezondheid en Milieu retardants in the Arctic – an overview of spatial and temporal (RIVM), Bilthoven. RIVM report 711701025. trends. Organohalogen Compounds, 66, 3811-3816. • Bayerisches Landesamt für Umweltschutz, 2003. Dioxinähn- • DFG (Deutsche Forschungsgemeinschaft), 1998. 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