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REPORT     
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23 July 1998
PE 226.409/fin. A4-0281/98
on endocrine-disrupting chemicals
Committee on the Environment, Public Health and Consumer Protection
Rapporteur: Mrs Kirsten Jensen
At the request of the Conference of Committee Chairmen, the President of Parliament announced at the sitting of 19 September 1997 that the Committee on the Environment, Public Health and Consumer Protection had been authorized to draw up a report on endocrine-disrupting chemicals. At the sitting of 1 October 1997, the President of Parliament announced that the Committee on Agriculture and Rural Development, the Committee on Economic and Monetary Affairs and Industrial Policy, the Committee on Research, Technological Development and Energy, the Committee on Employment and Social Affairs and the Committee on Women's Rights had been asked for their opinions.
 A MOTION FOR A RESOLUTION
 B EXPLANATORY STATEMENT
 OPINION
 OPINION
 OPINION

 At the request of the Conference of Committee Chairmen, the President of Parliament announced at the sitting of 19 September 1997 that the Committee on the Environment, Public Health and Consumer Protection had been authorized to draw up a report on endocrine-disrupting chemicals. At the sitting of 1 October 1997, the President of Parliament announced that the Committee on Agriculture and Rural Development, the Committee on Economic and Monetary Affairs and Industrial Policy, the Committee on Research, Technological Development and Energy, the Committee on Employment and Social Affairs and the Committee on Women's Rights had been asked for their opinions.

The Committee on the Environment, Public Health and Consumer Protection had appointed Mrs Kirsten Jensen rapporteur at its meeting of 22 July 1997.

It considered the draft report at its meetings of 22 April 1997 and 21 July 1998.

At the latter meeting it adopted the motion for a resolution unanimously.

The following took part in the vote: Ken Collins, chairman; Lannoye, vice-chairman; Kirsten Jensen, rapporteur; Blokland, Bowe, Breyer, Eisma, Flemming, González Álvarez, Graenitz, Grossetête, Hulthén, Kestelijn-Sierens (for Dybkjær), Kronberger, Kuhn, Liese (for Florenz), McKenna, Needle, Olsson, Oomen-Ruijten, Pollack, Roth-Behrendt, Schlechter (for Lienemann), Schleicher, Schnellhardt, Tamino, Trakatellis, Valverde López, Virgin, White and Whitehead.

The opinions of the Committee on Agriculture and Rural Development, the Committee on Research, Technological Development and Energy and the Committee on Women's Rights are attached. The Committee on Economic and Monetary Affairs and Industrial Policy and the Committee on Employment and Social Affairs decided on 29 October and 26 November 1997 respectively not to deliver an opinion.

The report was tabled on 23 July 1998.

The deadline for tabling amendments will be indicated in the draft agenda for the relevant partsession.


 A MOTION FOR A RESOLUTION

Resolution on endocrine-disrupting chemicals

The European Parliament,

- having regard to Rule 148 of its Rules of Procedure,

- having regard to the opinions of the European Parliament* of 14 January 1977 on the sixth directive amending Directive 67/548/EEC on the

approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (evaluation of new chemical substances before they are placed on the market)(1)

* of 18 November 1992 on Regulation No 793/93 on the evaluation and control of the risks of existing substances(2)

* the extensive European legislation on the use of dangerous substances at work,

- having regard to the report of the Committee on the Environment, Public Health and Consumer Protection and the opinions of the Committee on Agriculture and Rural Development, the Committee on Research, Technological Development and Energy and the Committee on Women's Rights (A4-0281/98),

A. having regard to the list of chemical substances known or thought to be hazardous to the endocrine system drawn up under the Convention for the Protection of the Marine Environment of the North East Atlantic (OSPAR Convention),

B. having regard to the OSCE working group on the guidelines for new tests to identify chemical substances hazardous to the endocrine system,

C. having regard to the findings of the Commission's Scientific Committee on Toxicity and Ecotoxicity and in view of the health hazards posed by the transfer of phthalates, known endocrine disrupters, from soft plastic toys made of PVC to the mouths of children,

Risk assessment, recommendations

1. Notes that a slavish risk assessment of each of the substances on the market, of which there are some 100 000, may seem very well to environmental perfectionists and to those in the chemical industry which would like an excuse for making changes either very slowly or not at all;

2. Considers that there is a greater need to develop and apply group classification when substances with similar characteristics or the same area of application are to be assessed. The EU uses groups as the basis for classification in individual cases, for example in the case of organic mercury compounds, benzidine and benzidine salts;

3. Calls for all EINECS substances to be divided into groups defined on the basis of a chemical or biochemical structure or affinity which is known to have a significance for their toxic or ecotoxic effects. The synergistic effects and different possibilities should also be included, and combined exposure must be considered;

4. Recalls that, in the case of plant protection products with a hormone-mimicking effect, the waste products (metabolites) are to be unequivocally taken into account in the authorization procedure;

5. Considers that particular emphasis should be place on substances which are carcinogenic, mutagenic or have effects on reproduction and the foetus. In the case of medicaments, marketing should be monitored over time in order to ascertain how the substances are used and whether the toxicological predictions were correct;

6. Considers that the screening in groups of chemicals about which there is already concern could be one way of sorting chemicals. Since the current toxicological and risk tests are based on a final point at which a cancer develops, these methods are not particularly useful for hormone-mimicking substances;

7. Considers that it is hardly possible to set limit values for hormone-mimicking substances. If a product contains substances which belong to groups of organic solvents, pesticides, metals and metal compounds or carcinogens, they should be regarded as harmful to reproduction. The precautionary principle should be applied specifically to the regulation of chemicals;

8. Considers that substances which are persistent and which accumulate in the organism, with serious and irreversible effects on health and the environment, should be phased out and that the Commission should submit a proposal to this effect;

9. Demands that the Commission submit a list of substances which may be regarded as hormonemimicking. Substances with a hormone-mimicking effect which are on the market should be phased out and new substances not be granted marketing licences;

10. Calls on the Commission and the Member States to introduce integrated programmes, based on the current programmes in Member States, which will lead to a reduction in the use of plant protection products, and to promote ecological farming;

11. Calls on the Commission to amend the Directive concerning the placing of plant protection products on the market (91/414/EEC, Annex II) so that an environmental impact assessment of the hormonal effect of pesticides is expressly required before a product is authorized;

Exposure, recommendations:

12. Calls on the Commission and the Council to take account of the hormonal effect of certain chemical substances in the directive establishing a framework for Community action in the field of water policy (COM(97)0049 and/or COM(97)0614) and, with regard to those substances, to stipulate strict compliance with the precautionary principle.

13. Considers, in the light of the time vs. dosage debate, that there is a great deal of uncertainty surrounding the setting of limit values;

14. Points out that legislation and agreements on the working and external environment have led to industrial innovations which have conferred benefits in terms of earnings and new jobs;

15. Calls on industry to use chemicals primarily in closed processes;

16. Considers that the chemical industry as a whole ought to be able to afford to reorientate itself towards the future, given that it is still a high-growth sector in Europe;

17. Urges the Commission in particular to use Directive 96/61/EC, on Integrated Pollution Prevention and Control, for the control of endocrine-disrupting chemicals;

18. Stresses the important role which should be played in this context by the recently re-organized Scientific Committee for Toxicity, Ecotoxicity and the Environment, especially with respect to the co-ordination of regulatory activities within the Member States, and the application of the precautionary principle, linked to empirical data obtained on a scientific basis, to all existing, possibly endocrine-disrupting chemicals, as well as new ones;

19. Urges the Commission and the Council to ensure that the above Committee operates with the maximum of transparency and openness, via the publication of agendas, minutes, and committee documents, and the holding of at least some public hearings.

20. Calls on Member States and the Commission to make information on endocrine disruptors widely available, with a focus on male and female reproductive health problems, on the basis that the 'right-to-know' principle is the best way to enable people to maintain control over their own reproductive health rights, as guaranteed at the UN Population Conference in Cairo;

21. Calls on the Commission and the Member States to make coordinated efforts with a view to developing standardized tests for subsequent incorporation in the authorization procedure set out in Directive 91/414/EEC;

Research, recommendations

22. Considers that there is a serious shortage of independent research in this area. By far the majority of expertise is concentrated in industry and the authorities, including firms of consultants working on contracts for industry or the authorities;

23. Urges the Commission to draw up a comprehensive research strategy to reduce the uncertainties surrounding the issue of endocrine disruption. This research should be focused on an improved understanding of the endocrine system and the role of hormones and hormone-mimics on women´s health;

24. Recognizes that research into sperm quality and reproduction problems in Europe means devoting a high level of resources to long-term research. Research projects should be interdisciplinary and cross-border and should involve participants from differing scientific backgrounds;

25. Calls on the Commission to consider the use of the budget allocated to life sciences within the Fifth Framework Programme in order to continue research into identifying endocrine disruptors, particularly those pertaining to foetal damage and other reproductive factors;

26. Considers that knowledge about cell changes is the only certain indicator of whether a chemical is hormone-mimicking;

27. Notes that there is a pressing need for methods to show whether a substance combines with all hormone receptors, not only those for sex hormones. The research process should be a permanent one as new methods are constantly being discovered;

28. Also considers that it is at least as important to validate the existing methods and assess the findings produced so far;

29. Demands that the EU should ensure that international sperm counts and the collection of data on sperm quality are carried out, as well as international surveys of studies on hypospadias and undescended testicles, more coordinated and intensive neurological and behavioural research (particularly on prenatal exposure and links to reduced intelligence and/or immune reactions among children), and research on the increased incidence of hormone-driven forms of cancer of the breast, prostate and testicles;

30. Recognizes the importance of developing a research strategy at European level aimed at boosting knowledge of their adverse effects not only on the quality of sperm but also on the nervous system, on behaviour or on the various endocrine glands (e.g. the thyroid) since an endocrine-mimicking effect has been proven for some of these substances which is different from the xenoestrogenic effect more often described for such products;

31. Proposes that such research efforts should address, inter alia, the need for:

- improved understanding of the endocrine and reproductive systems, and the detailed mechanisms of actions, including the role of hormones in relation to reproduction,

- epidemiological studies on links between sexual abnormalities and their effects on other biological functions, including investigations of the effects on mothers and children of hormone disruptors and the role of other factors such as diet, location, and socio-cultural origin on human reproductive health;

- long-term epidemiological studies, in different environments and geographical areas, for reproductive effects, including sperm quality,

Other recommendations to the EU and the Member States

32. Notes that international attempts are currently being made to define POPs (persistent organic pollutants); calls on the Commission to take part in this work and to work towards the rapid implementation of the POP protocol and towards keeping the list open so that new substances can continually be added;

33. Demands that the scientific committees assess the following areas with regard to hormonemimicking substances: health - cosmetics directive (foam baths, creams), PVC and toys, washing powders; foodstuffs - values for pesticide residues and the migration of hormonemimicking substances to foodstuffs;

34. Is convinced that an overall attempt should be made to replace the most dangerous substances with less dangerous ones, and that the EU should therefore have an approval procedure for dangerous substances in the working environment, corresponding to the approval plus alternative assessment system for pesticides, as used in the biocides directive;

35. Points to the existing legislation on the marketing of new chemicals in the European Union and calls on the Commission to examine whether this legislation is adequate, in view of the findings concerning the possible effects of hormone-mimicking substances, and if necessary to put forward a proposal to amend it;

36. Demands that the Commission go through the labelling regulations to ensure that each product is labelled in an easily understandable way to show what level of substances not occurring in the natural environment it contains. Substances should be divided into categories from 0 to 5, where 0 means harmless. Substances which have not been subjected to a risk assessment should be labelled to the effect that the product has not been tested for its harmful substance content, since people have a right to live without being poisoned;

37. Instructs its President to forward this resolution to the Commission and Council and the governments and parliaments of the Member States.

(1)() OJ C 30, 7.2.1977, p. 35
(2)() OJ C 337, 21.12.1992, p. 106


 B EXPLANATORY STATEMENT

Hormone-mimicking substances

The background to this report is the increasing unease about chemical substances with hormonemimicking effects and examples of changes to the environment and to fertility levels.

Thousands of man-made chemicals are in use and very few have been investigated as to their hormone-mimicking effect.

Researchers agree that a number of chemical substances have a hormone-mimicking effect on animals, but no such consensus exists about humans. A debate on this subject is now going on in international fora. A European workshop on the consequences of hormone-mimicking substances for human and animal health, held in Weybridge in 1996 with the participation of the Commission, the EU Environmental Agency, the WHO, the OECD and others, concluded that enough material existed with regard to effects on human health to show that testicular cancer was increasing and that the apparent deterioration of sperm quality in some areas could not be attributed to the interaction of known factors.

The Weybridge workshop also concluded that there was not as yet sufficient data to prove a link between the health effects on humans and exposure to chemicals. Finally it was recommended that policy should be based on scientific principles and that the emphasis should be place on evidence. If it was felt necessary, consideration should be given to practicable ways of reducing exposure to hormone-mimicking substances, in accordance with the precautionary principle set out in the Rio Declaration (Weybridge report).

Hormone-mimicking substances are substances which arise or are formed outside an organism, and which have unfavourable health effects on an intact organism or its progeny as a result of changes to endocrine functions (Weybridge). Industry (ICCA) considers that there is still a lack of a commonly accepted definition of the term 'hormone-mimicking substances', since there is uncertainty among scientists about their effects on humans and the environment.

Human beings can be affected by hormone-mimicking substances through drinking water or food containing chemical residues. Chemicals can survive for long periods in the environment and accumulate in an organism's adipose tissue. Many of the substances which react like hormonemimicking substances or are suspected of doing so have in fact been known for a long time, and include familiar substances with toxic, brain-damaging and carcinogenic effects.

Chemical compounds can make it hard to ascertain exactly what chemical has affected the hormone system. In research and political fora new approaches to the ways in which chemicals work are being discussed. In particular the relationship between dose and time of exposure has been identified as a new area which needs to be considered in a future evaluation of chemical substances.

EU legislation on chemicals is largely based on the assumption that the human organism can tolerate a certain dose of a chemical.

How do chemical substances mimic hormones?

Some chemical substances affect humans' or animals' fertility and their immune, nervous and hormone systems. When chemicals behave like hormones, this disturbs the normal hormonal balance.

Hormone-mimicking substances can disturb normal hormone functions in several ways:

Stimulation: The variety of signals sent out by hormone-mimicking substances can enhance the natural hormonal effect.

Blocking: Hormone-mimicking substances can block communication from the natural hormones and cause the level of hormones to artificially increase or decrease.

Hormone inhibition: Hormone-mimicking substances can cancel out the effect or the quantity of natural hormones, so that their effect is reduced.

Effect on enzymes: Hormone-mimicking substances can affect the enzymes which break down the natural hormones in the body. If such enzymes are affected, hormones accumulate in the body.

Destruction: Hormone-mimicking substances can directly destroy the cells which form natural hormones in the body.

Harmful effects on animals

In Canada, near the Great Lakes, hormonal damage has been found to 16 different species of animals, including fish, birds, otters and mink. The damage is caused by a variety of chemicals. It is probable that the damage caused in the 1960s and 1970s (thinning of eggshells) was the fault of DDT, which is now banned. DDT can still come through the air from Mexico and South America, where it is still permitted. DDT can be transported just as easily through the air as through the food chain in the water. Damage in the 1980s was connected with PCBs or dioxin-mimicking substances.

In England male fish living in rivers polluted by waste water were observed to have developed feminine characteristics (Purdom CE et al. Estrogenic effects of effluents from sewage treatment works. Chem. Ecol., 8, 275-285, 1994).

A 1988 study in England and Wales showed that seashore snails (periwinkles) exposed to a tri-nbutylene (TBT) mixture, used for anti-fouling treatment on ships, developed male sexual organs and became sterile. There was a direct correlation between the level of TBT exposure and changes to sexual characteristics. The widespread use of anti-fouling treatment made it impossible to find snail populations which were not affected. The number of snails in many areas was also falling at an unusual rate as a result of TBT (G:W: Bryan et al 'A comparison of the effectiveness of tri-n-butyltin chloride and five other organotin compounds in promoting the development of imposex in the dogwhelk, 'nucella lapillus', 68 Journal of the Marine Biology Association UK (1988) 733-744).

In the district of Århus in Denmark an investigation of pollution from pleasure boat ports showed a concentration of the weedkillers Diuron and Irgarol of between 0.034 and 1.07 μg/L. Snails and shellfish were found with a concentration of organic tin compounds. Periwinkles in the area were affected and developed deformed sexual organs (Arbeidsnotat, Status for nye undersøgelser i 1997 af miljøproblemer ved brugen af giftig bundmaling - New studies from 1997 on environmental problems connected with the use of toxic hull paint).

Harmful effects on men

The studies showing the effect of hormone-mimicking substances on humans are still in their infancy. The results of research indicate that the known effects on animals are comparable to effects on humans. Men's sperm quality has diminished and there are substances in the environment which can mimic the effect of female sex hormones. It is the link between these two phenomena which is still a hypothesis. In the 1990s there were reports in Belgium, Denmark, France and the UK of a drop in sperm quality. It is uncertain whether this will have an effect on the fertility of the population.

The drastic drop in men's sperm quality is seen inter alia in a 1994 study by Niels Skakkebæk, confirmed by Shanna Swan from the USA (Environmental Health Perspectives, 1997). The study covered 15 000 men from 20 countries and showed that their sperm count had dropped by half over the past 50 years. Over the same period testicular cancer had risen by 300%. Oestrogen-mimicking substances are known to produce similar types of damage in animals.

A French study of 1 351 healthy men showed a 2.1% drop in sperm count from 89 million/ml in 1973 to 60 million/ml in 1992 (Auger et al., 1995, Male Reproductive Health and Environment Chemicals with Estrogenic Effect, p. 16).

Hormone-mimicking substances may possibly affect men:

- at the embryo stage, when it has been shown in the case of animals that very small doses lead to deformations of the sexual organs and a predisposition to of testicular cancer;

- as new-born babies, when they take in chemicals with their mothers' milk;- as adults, when poisoning can lead to reduced sperm quality.

A study in Sweden (published data from January 1998) shows a connection between exposure to PVC and testicular cancer. Many men who contracted testicular cancer had been exposed to PVC by working with the production of the substance on a daily basis. The authors of the study consider that this points to the hormone-mimicking effect of phthalates used as softeners in PVC. The study itself will not appear until the end of 1998 (Occupational Exposure to Polyvinyl Chloride as a Risk Factor for Testicular Cancer, Lennart Hardell). All this points to the hormone-mimicking effect of phthalates used as PVC softeners, some of the most common of which are known to be carcinogens in rats and mice (cf. WHO/IARC, cited in US Health and Safety Data Base, 1997).

Harmful effects on women and children

The incidence of breast cancer in many countries has risen in recent decades. In Finland there has been an increase in breast cancer from 25 per 100 000 inhabitants in 1953 to 40 per 100 000 in 1980. In Denmark the figures are 40 per 100 000 in 1945 and 60 per 100 000 in 1980. Even if this is partly caused by life-style changes (smoking, stress and fatty foods), by no means all the factors which may play a part have been established. Other studies have found abnormally high levels of synthetic chemicals in women who developed breast cancer (edc.: A Challenge for EU Environment Legislation, p.11).

Many studies have found a link between DDT levels and breast cancer. A comprehensive study showed this link to exist for Afro-American and white women, but not for Asian women. Research based on over 11 000 tests of breast cancer clusters in the USA found an both an increase in oestrogen-respondent forms of breast cancer and a high density of oestrogen receptors in these clusters.

One comprehensive study on the effects of PCBs on humans concerned children. These were the children of Taiwanese women who had consumed edible oil containing high levels of PCBs and furan in 1979. The study covered both foetuses and children. The children weighed less, had malformations of the penis, reduced motor functions and concentration difficulties (M. Yu et al., 'Disordered Behaviour in the Early Born Taiwan Yucheng Children').

A study of the children of women who had eaten fish from Lake Michigan containing PCBs and other chemicals showed that the more fish the mothers had eaten, the lower the birth weight and head size of their babies. These babies had poor reflexes and unbalanced movements. They had learning difficulties and attained fewer points on the speech and memory tests. It is not, however, certain that the PCB was solely responsible for these effects, since the mothers had been exposed to a whole range of chemicals (Y. Guo et al. 'Growth abnormalities in the population exposed to PCBs and Dibenzofuranes').

Time or dosage?

Processes are activated at particular times in our lives, in the womb, pregnancy or at puberty. If the process is disturbed at a decisive moment in pregnancy, the 56th day, this may mean that the process for developing the male genitals is not activated in boy babies (GLOBE). The time of exposure may be important for pregnant women or people with poor immune defences. The timing may clearly play a more important role in the effect than the actual dose.

In the cocktail effect, a number of substances work together. This makes it harder to comply with industry's demand for conclusive proof. By way of a get-out clause, a director of Philip Morris maintained that, if it could be proved which chemical made smoking fatal, Philip Morris would stop producing cigarettes. However, cigarette smoke consists of a variety of chemicals, and it could very well be the combination which has the fatal effect.

Accidents and disasters

In July 1976 in Seveso in Northern Italy, trichorophenol was being produced with dioxin as a byproduct. The process got out of control and there was an explosion in the factory. In the immediate area a level of 370 μg/km2 of TCDD (the most toxic of 200 dioxin compounds) was measured (source: Berlingske Tidende, 18 Oct. 1997). Dioxin affects animal embryos by causing disruption to the male reproductive organs, e.g. malformation of the genitals, underdeveloped testicle tissue, reduced sperm production capacity, cysts of the epididymis and undescended testicles. Many pregnant women in Seveso requested abortions, and since there was no central register of birth defects in the area before the accident, it is not entirely clear how the leak affected reproductive capacity. An investigation has now begun.

In Lake Apopka in Florida, male alligators hatched with unusually small sexual organs after the lake was polluted in 1980 by a leak from the Tower Chemical Company of the pesticide Dicofol, a chemical related to DDT. The alligators' penises were only half or a quarter of their normal size. There was a distortion in their hormonal balance whereby the males showed typical feminine characteristics. The females from Lake Apopka had double the normal proportion of oestrogen to testosterone. Only 5%-20% of the lake's alligator eggs hatched, rather than the usual 65%-80%. The mortality of newly hatched alligators was ten times normal. The number of young alligators in Lake Apopka fell by 90% between 1980 ands 1987 (source: L :Guillette:'Developmental Abnormalities in Juvenile Alligators from Contaminated and Control Lakes in Florida').

Current thinking about chemical regulations

The EU's general principles in the environmental field are: the precautionary principle; prevention is better than cure; environmental consequences should be taken into account at the earliest possible stage in the decision-making process; significant damage to the ecological balance should be avoided; scientific knowledge should be improved; and the polluter should pay. The EU's regulation of chemical substances relates to the environment, the working environment, industry, agriculture, health and food and is administered by a variety of Commission directorates.

The EU legislation on chemicals principally regulates the use of chemicals in production processes rather than in products. There is frequently talk of the harmonization of rules since there are chemicals in foodstuffs, machines, fuels and building materials which form part of the single market, resulting in legislation on the same substances in several different areas.

The first generation of chemical regulations focussed on the question of whether chemicals had a direct toxic effect. The next generation considered whether chemicals led to cancer, corrosion, allergies or brain damage. The chemicals are regulated with a view to reducing the harmful effects through setting compulsory limit values, limiting their use and in some cases banning them altogether.

Present regulations on chemicals use the following methods:

- registration of new chemical substances,- risk assessment,

- rules concerning use, i.e. limiting the marketing in the form of a ban or a requirement for prior approval,

- classification, labelling and instructions for use,- waste disposal and treatment, including the transport of hazardous waste,- voluntary agreements,

- substitution (now introduced as a principle in the biocides directive).

In the Treaty establishing the European Community the precautionary principle appears in Article 130r. It does not appear in Article 100a on the internal market or in the articles on the working environment, health or foodstuffs. Article 130r was introduced with the adoption of the Single European Act in 1986 and the precautionary principle entered the Treaty in 1992. The precautionary principle is referred to in Directive 96/82/EC on the control of major-accident hazards involving dangerous substances and Directive 97/11/EC amending the directive on the assessment of the effects of certain public and private projects on the environment. In other directives the principle is applied when limit values are set on the basis of a safety factor.

Labelling is typically used for organic solvents and paints. However, the EU has been reluctant to label substances as carcinogenic. In 1994, 72 out of 189 chemical substances were classified as suspected carcinogens. The labelling used was 'serious risk to health in cases of long-term exposure'.

Some 100 000 different chemical substances are marketed in the EU. Many of them already existed before the EU even started regulating chemicals. 5000 substances are included on the list of classified substances: most of these are classified as a risk to health, very few on the grounds of the risk they pose to the environment. A number of the substances are classified by the producers themselves, but there is no control over these classifications, and researchers claim that the data are insufficiently complete and that there are too many gaps in the documentation to permit a reliable hazardousness and risk assessment.

Directive 793/93 and Commission directive 1488/94 deal with risk assessments. It is taking an inordinately long time to assess the most frequently used chemicals, (High Production Volume Chemicals) which number around 3000.

ECB/Ispra planned to carry out risk assessments on some 50 a year, but have so far assessed only 20 in all.

International agreements

There are no international agreements dealing exclusively and expressly with hormone-mimicking substances. Nevertheless, many conventions contain regulations on substances which may have a hormone-mimicking effect, because these substances are harmful for other reasons.

In connection with a number of conventions, working groups have begun to look more closely at hormone-mimicking substances. These are the following:

OSPAR and the Esbjerg Declaration

In 1990 the parties to the conference (Norway, Sweden, Denmark, Iceland, Belgium, Germany, Ireland, The Netherlands, Portugal, Spain, the UK; Luxembourg, Switzerland and France) agreed to reduce by 50% (70% for dioxin) emissions of substances which accumulate in the organism, are hard to break down and are toxic.

In 1995 the parties decided that, before the year 2000, they would work within the relevant international bodies to replace the use of the following dangerous substance with less dangerous substances or where possible with non-dangerous substances:

- high-chlorine, short-chain paraffins (10-13 carbon atoms)- trichlorobenzene

- musk xylenes

- nonylphenols, nonylphenolethoxylates and related substances- brominated flame-inhibitors

The Commission is working together with the OECD and OSPAR to improve the basis of knowledge on the consequences of hormone-mimicking substances. At the expert group meeting in Brussels it was agreed that the OSPAR list of relevant substances should be included as the basis for drafting a priority list of substances in conjunction with the Framework Directive on water.

The UN

Under the ECE Convention on long-distance cross-border air pollution, negotiations are currently under way on a special protocol for POPs (persistent organic pollutants), inert organic substances, such as PCBs and DDT. This should be ready for signature in June at the pan-European conference in Århus. This will be the first time these substances have been discussed at international level.

The UNEP follow-up to the section in Agenda 21 dealing with POPs means that there will be negotiation on a global POP convention in Montreal in 1998. The protocol now lists 16 substance, regarding which the signatories will commit themselves at Århus in June to eliminating leaks, emissions and spills. PCPs are not yet included in the protocol, but are mentioned as an area for research. POPs include the following:

Pesticides:

Aldrin+, chlordan+, chlordecone+, DDT, dieldrin+, endrin +, heptachloride, hexachlorobenzene (HCB), mirex+, toxaphene+, hexachlorocyclohexane (HCH) (including lindane).

Industrial chemicals

Hexabromobiphenyl+, polychlorinated biphenyls (PCBS)by-products or impurities: dioxin, furans, PAH.

+ means that production and use are currently forbidden.

In addition there is provision for Prior Informed Consent (PIC) on the import and export of chemicals, with a requirement to inform the country of destination if the chemical is prohibited or subject to severe restrictions with regard to its effect on human health or the environment.

OECD

The OECD is working to find appropriate methods of measuring hormone-mimicking substances. At present it is a matter of working out a consensus on appropriate methods for the identification of hormone-mimicking substances. The OECD has a basis reporting system, which works as a guideline for governments. The USA, Canada and the UK already use this system, which gives access to information about industrial leaks, and helps industry to locate and minimize its leaks. Hormonemimicking substances could be included in this system.

National action plans

In Austria, Belgium, France, Germany, Sweden and the UK expert committees have been set up on hormone-mimicking substances. The UK made the first move with a strategic paper from the Environment Agency in January 1998. Italy and Greece entered the planning stage in September 1997.

Some Member States have already proposed controls on known hormone-mimicking substances. These are:

Phasing out of phthalates (Denmark)

Control of the use of hormone-mimicking substances such as nonylphenolethoxylates (NPEOs) used inter alia as pesticides (Denmark Belgium, France, Sweden and Finland).Teething rings for babies which give off phthalates have been withdrawn from the market (Denmark, Spain, Italy and Sweden).

In the USA the EPA is carrying out a study, which began in December 1996, to ascertain the harmful effects on health of chlorine with a view to limiting its use or banning it altogether. The aim is to develop a screening programm which can show whether certain chemicals act on the body in the same way as natural oestrogen. These substances are chemical pesticides and substances which mimic the action of hormones when taken in combination (the cocktail effect), or substances in drinking water, to which many people are exposed. The EPA is also developing a strategy to screen and test typical chemicals in the next two years. The current legislation calls for all pesticides to be screened and for hormone-mimicking substances in water to be identified.

Substances such as nonylphenols and phthalates are not regulated in the EU. National bans in this area are possible for countries which want to act quickly.

New thinking on the use of chemicals

The working environment could benefit from a new look at chemicals control. Doubts have been expressed on the extent to which damage can occur in late pregnancy and at various points in men's and women's lives. The effect on men's sperm production and the risk of accumulating substances in the bodies of women who then pass them on through their milk, are examples of the effects which arise through constant exposure at the workplace.

People are exposed to these substances both in their external environment and at work, which is subject to differing regulations. In both cases the precautionary principle should be applied.

.ANNEXES

See Kirsten Jensen's homepage athttp://home.socialdemokratiet.dk/Kirsten-Jensen

24 June 1998


 OPINION

(Rule 147)

for the Committee on the Environment, Public Health and Consumer Protection

on endocrine-disrupting chemicals (own-initiative report by Mrs Kirsten Jensen)

Committee on Agriculture and Rural Development

Draftsman: Mr Friedrich-Wilhelm Graefe zu Baringdorf

PROCEDURE

At its meeting of 25/26 November 1997 the Committee on Agriculture and Rural Development appointed Mr Graefe zu Baringdorf draftsman.

It considered the draft opinion at its meetings of 19/20 May and 23/24 June 1998.

At the latter meeting it adopted the following conclusions unanimously.

The following took part in the vote: Colino Salamanca, chairman; Happart, vice-chairman; Graefe zu Baringdorf, vice-chairman and draftsman; Anttila, Böge (for Ebner), Botz (for Rehder), Cabezón Alonso (for Fantuzzi), Filippi, Fraga Estévez, Funk, Garot, Gillis, Goepel, Hallam, Jové Peres, Keppelhoff-Wiechert, Kindermann, Mayer, des Places, Redondo Jiménez, Rosado Fernandes, Santini, Schierhuber and Sonneveld.

1. Hormone-mimicking environmental pollutants - current state of knowledge

In recent years, there has been an increase in indications that the health of Europeans is being endangered by hormone-mimicking substances. Some European countries have recorded a sharp reduction in sperm count and a significant increase in the incidence of breast cancer which may be linked to certain environmental pollutants. For example, the sperm count of males from the Paris area has fallen by 32% within a 20-year period (Auger et al., 1995). An international study carried out in Denmark (Carlsen et al., 1992) reported a 45% drop in sperm count between 1938 and 1990. Other Danish figures show a 50% increase in the incidence of breast cancer between 1945 and 1980. Davis et al. (1993) suggest that these developments are connected with an increase in the ingestion of xenoestrogens (substances which are not found naturally in the body but which mimic estrogen).

Scientific proof of fertility levels and hormonal balance being disrupted by various environmental pollutants is based on observations of a number of fauna in the aquatic environment. It provides admittedly indirect but, given the similarity of the hormone systems involved, nonetheless disconcerting indications of similar effects on humans.

Mrs Jensen's draft report for the Committee on the Environment gives a comprehensive overview of the current scientific debate about hormone-mimicking substances.However, at this juncture it would be appropriate to highlight some of the facts which are relevant to the opinion of the Committee on Agriculture:

- the consistent application of the precautionary principle in matters connected with the hormonal effects of environmental pollutants is particularly urgent because, in the past, distinct effects had been observed below the level of proof (for example, in the case of TBT - tri-n-butyltin, a supposedly innocuous substance deliberately and continuously released from anti-fouling treatment on ships);

- the precautionary principle must apply when such chemical substances are manufactured and/or authorized because, given that exposure to a very low dose of hormone-mimicking substances has a harmful effect, subsequent regulation by means of monitoring residues and setting maximum permissible levels is ineffective;

- risk assessment is made more difficult in the case of hormone-mimicking substances because there are significant synergetic effects. These cocktail effects, currently the subject of major controversy in scientific debates, mean that individual substances show up very weakly in the laboratory, but their combined presence may result in an impact greater by two to three powers of ten (e.g. Arnold et al., 1996);

- experience with the strongly hormone-mimicking phthalates used as PVC softeners shows that it is not only the actual products and/or the substances which need to be subjected to an appropriate environmental impact assessment but also technical process materials such as inert ingredients and solvents for such substances.

Against this background, we must

- initiate and promote comprehensive research into hormone-mimicking substances, in particular with a view to establishing standardized test-systems, and

- enshrine in the European Union's environmental legislation (especially in the directive establishing a framework for Community action in the field of water policy) a policy concerning these substances which makes the cautionary principle binding, and we must incorporate that policy in international environmental and water protection agreements, especially at the OSPAR Conference and in the International Convention on the Protection of the Oceans.

Sources:

- Arnold et al., 1996 Synergistic activation of estrogen receptor with combinations of environmental chemicals, Science 272: 1489-1492

- Auger et al., 1994: Significant decrease of semen characteristics of fertile men from the Paris area during the last 20 years. Paper 175, Abst., 10th Ann. Meet. ESHRE, Brussels

- Carlsen et al., 1992: Evidence of the decreasing quality of semen during the past 50 years, British Medical Journal 304

- Davis et al., 1993: Medical Hypothesis: Xenoestrogens as Preventable Causes of Breast Cancer. Environmental Health Persp., Vol. 101(5)

- EP's DG IV: Endocrine-disrupting chemicals: A challenge for EU environmental regulation? Working Document 25

- European Environmental Bureau / C. Wattiez: Arguments for the exclusion from Annex I to Directive 91/414/EEC of pesticides presently being revised. Doc. No 1

- Umweltbundesamt: Substanzen mit endokriner Wirkung in Oberflächengewässern (Federal Environmental Office: Endocrine-disrupting chemicals in surface waters). UBA Texte Nr. 46/97

- Home page of the Federal Environmental Office which gives a summary of European research into hormone-mimicking substances: http.//www.liwa.de/iis/rneed/welcome.htm

- Home page of the authors of 'Our Stolen Future': http://www.osf-facts.org- Home page of the GLOBE Working Group on 'Hormone-disrupting chemicals':

http://globeint.org/html/working-groups/chemicals-wg.html.

2. Hormone-mimicking environmental pollutants in agriculture

Your draftsman intends to concentrate on the aspects of hormone-mimicking substances relevant to agriculture and, in particular, to discuss the suspicion that certain plant protection products contain hormone-mimicking substances.

In addition to industrial chemicals and consumer goods, a large number of plant protection products are suspected of disrupting the hormone system. Many of these substances have also fallen into disrepute because of their toxicity or carcinogenicity, to such an extent that their authorization (Annex I to Directive 91/414/EEC) is currently being reviewed.

The following is a - non-exhaustive - list of the suspect plant protection products:

Aldicarb

Dichlorvos

Metiram

Amitrol

Endosulfan

Paraquat

Benomyl

Fentin acetate

Parathion (Ethyl-Methyl)

Bromoxynil

Imazalil

Permethrin

Carbendazim

Iprodione

Procymidone

Chlorpyrifos

Lindane

Simazine

Cypermethrin

Mancozeb

Thiram

2,4-D

Maneb

Zineb

Since the Federal Environmental Office has unequivocally established the hormone-mimicking effect of Atrazine, Diuron, Linuron, Methoxychlor and Vinclozolin, those products should be withdrawn from the market forthwith.

The legislation on plant protection products in individual Member States does to some extent recognize the dangers arising from hormone-mimicking environmental pollutants, but increased efforts are required if we are to take commensurate account of these substances in European and national law.

Conclusions

The Committee on Agriculture and Rural Development calls on the Committee on the Environment, Public Health and Consumer Protection, as the committee responsible, to incorporate the following conclusions in its report:

The Committee on Agriculture and Rural Development

1. Is concerned that hormone-mimicking substances constitute a threat to human health and the environment;

2. Believes that even the smallest concentrations of hormone-mimicking substances have an effect and that the synergetic effects of various chemical substances have been observed;

3. Calls on the Commission to amend the Directive concerning the placing of plant protection products on the market (91/414/EEC, Annex II) so that an environmental impact assessment of the hormone-mimicking effect of pesticides is expressly required before a product is authorized;

4. Points out that Directive 96/46/EC of 16 July 1996 amending Directive 91/414/EEC states that, in Annexes II and III, applicants are required to indicate clearly the conditions and technical protocols under which they obtain certain data relating to their application for authorization and that analytical methods for the active substance have been specified in more detail;

5. Points out that, in the case of plant protection products with a hormone-mimicking effect, the waste products (metabolites) are to be clearly indicated in the authorization procedure;

6. Believes that, apart from the actual substances, additives such as softeners, emulsifiers, etc. (phthalates, nonylphenols) may also be demonstrably endocrine-disrupting chemicals and calls, therefore, for those substances and their waste products to be reviewed in the authorization procedure pursuant to Directive 91/414/EEC and, in addition, to be subject to the appropriate labelling requirement;

7. Calls on the Commission and the Member States to make coordinated efforts with a view to developing standardized tests which would then be incorporated in the authorization procedure set out in Directive 91/414/EEC;

8. Calls on the Commission to investigate plant protection products as soon as possible pursuant to Directive 91/414/EEC as last amended;

9. Calls on the Commission and the Member States to introduce integrated programmes, based on the current programmes in Member States, which will lead to a reduction in the use of plant protection products, and to promote ecological farming;

10. Calls on the Commission and the Council to take account of the hormone-mimicking effect of certain chemical substances in the directive establishing a framework for Community action in the field of water policy (COM(97)0049 and/or COM(97)0614) and, with regard to those substances, to stipulate strict compliance with the precautionary principle.

12 June 1998


 OPINION

(Rule 147)

for the Committee on the Environment, Public Health and Consumer Protection

on endocrine disrupters (own-initiative report by Mrs Kirsten Jensen)

Committee on Research, Technological Development and Energy

Draftsman: Mr Alain Pompidou

PROCEDURE

At its meeting of 8 October 1997 the Committee on Research, Technological Development and Energy appointed Mr Alain Pompidou draftsman.

It considered the draft opinion at its meetings of 27 April and 19-20 May 1998.

At the latter meeting it adopted the following conclusions unopposed, with 2 abstentions.

The following were present for the vote: Scapagnini, chairman; Quisthoudt-Rowohl, Adam and Lange, vice-chairmen; Pompidou, draftsman; Aelvoet (for Ahern pursuant to Rule 138(2)), Bloch von Blottnitz, Chichester, Desama, Elchlepp (for Linkohr pursuant to Rule 138(2)), Ferber, García Arias (for Denys), Gomolka (for Estevan Bolea), Graenitz (for McNally), Heinisch (for MatikainenKallström), McAvan, Malerba, Marset Campos, Rothe, Rovsing, Stockmann, Tannert and W.G. van Velzen.

INTRODUCTION(1)

The environment and endocrine-disrupting chemicals

The findings of a number of studies suggest that various chemical substances released into the environment may affect humans and animals by interfering with their endocrine systems. The substances implicated (sometimes called 'endocrine disrupters') act mainly by mimicking the action of natural hormones or interfering with their metabolism (interacting directly with receptors).The main culprits are believed to be pesticides (chiefly DDT and its derivatives), industrial products, medicinal products (e.g. diethylstilboestrol) and pollutants (such as dioxins).

The findings of studies which implicate the direct effects of potential endocrine disrupters are sometimes contradictory, and more detailed analysis is often required for their evaluation. As in many areas, the recommendations made by various groups stress the need to:- conduct epidemiological studies to assess the actual impact of the substances believed to be

responsible;

- accurately characterize the effects such substances have on the endocrine system, more particularly on reproduction and embryo and foetal development;

- assess the whether such substances could cause cancer;

- assess the way in which such substances act and any effects they produce in combination with other substances (and, where they are demonstrated to produce an effect, to establish the dose/effect relationship).

There is a particular need for more accurate data on the possible effects of endocrine disrupters on male fertility.

I. Four main types of biological effect could it seems be linked in humans to exposure to environmental endocrine disrupters

Ia. Carcinogenic effects

The possibility that endocrine disrupters might be carcinogenic was mentioned after cancers of the genital tract were found in girls whose mothers had taken diethylstilboestrol during pregnancy. There is no doubt that prenatal exposure to diethylstilboestrol results in pre-cancerous lesions of the adenosis vaginae type in female foetuses. The lesions become cancerous usually during adolescence.

Another finding suggesting that endocrine disrupters may be carcinogenic is the increase in the incidence of certain cancers, primarily breast cancer in women and prostate and testicular cancer in men, during the last 20 years .

However, the role actually played by environmental endocrine disrupters remains hypothetical. Many factors could be responsible for the increased incidence of the cancers mentioned above (e.g. the taking of drugs such as oestrogens, in the case of breast cancer), and no direct link has been established between exposure to exogenous substances and the occurrence of such cancers (in particular testicular and prostate cancer). The studies that have noted a link between pesticide residue concentrations in fatty tissue and the occurrence of breast cancer in women are highly controversial. Moreover, clinical and paraclinincal screening methods have improved markedly during the period in question, which may have contributed to an increase in the number of diagnoses (as opposed to actual incidence) of such cancers. Lastly, the incidence of such cancers has not increased identically in countries with similar environmental conditions or amongst different population groups in the same country (for example, testicular cancer is less common in Finland than it is in Denmark, and less common amongst the black population than it is amongst the white population in the USA).

Ib. Effects on reproduction

Exposure to environmental endocrine disrupters has not yet been shown to have a clear and direct effect on human reproduction.

Several studies have looked into the effects of accidental exposure to high doses of endocrine disrupters, especially dioxins. Accounts exist of an increase in the frequency with which baby girls were born in the nine months following the accident at Seveso and a greater frequency of abnormalities of the male genital tract (underdeveloped penis) in boys born to women contaminated during the accident at Yucheng. Nevertheless, the way in which dioxins affect reproduction has still to be determined.

One of the most controversial subjects in this area today concerns the results of sperm counts and the possible impact of endocrine disrupters on male fertility. One of the effects described in men accidentally exposed to toxic substances (especially pesticides) is a reduced sperm count.

The possible role of endocrine disrupters was highlighted above all following the publication of findings by a number of research teams indicating a declining sperm count (cf. initial findings published by Skakkebæk in Denmark in 1992, followed by others such as those by Jouannet in France). The first study, for example, analysed 61 scientific articles and indicated a 'significant' decline in sperm count in semen, from 113x106ml-1 to 66x106ml-1, between 1938 and 1990. This finding, along with the increase in the incidence of testicular cancer during the same period, suggested that endocrine disrupters could be to blame. It was subsequently argued that oestrogenic agents or oestrogen mimics might be responsible.

The findings of other studies that have been published are contradictory (no change or even an increase in sperm count), and vary greatly on this point. It now appears that these highly divergent findings could have been influenced by a great many factors (geographical variations, the use of medicines or toxic substances, temperatureCOMM2COMM1Another amendment?<@, seasonal variations, sexual activity).

Moreover, a recent study published by Fisch et al. (1997) indicates substantial annual variations within a series of tests extending over a 24-year period, between extremes of 47x106ml-1 in 1974 and 124x106ml- 1 in 1980. The fact that the results vary so much affects the significance of the other, earlier studies.

Once again, no direct link between exposure to oestrogen-mimicking environmental substances and sperm counts (let alone a dose/effect relationship) has ever been established.

Similarly, there is no proven increased risk of malformations of the genital canal as a result of exposure to endocrine disrupters. Only a few studies, whose significance is highly debatable, note the occurrence of cryptorchidism and hypospadias.

Ic. Effect on the nervous system

Whilst many products which are sometimes present in the environment have clearly proved to have neurotoxic properties, it is in no way certain that the way in which such substances act has a direct effect on the functioning of the endocrine system. On the other hand, it could be that abnormal functioning of the endocrine system occurs as a secondary effect of the neurotoxic action.

The finger may be pointed at many substances (DDT, pesticides, dioxins, metals). Regardless of how they act, it would seem particularly important to determine whether environmental exposure to them (frequency and dose) is likely to have a toxic effect.

Id. Effect on the immune system

Effects on the immune system have occasionally been mentioned following exposure to substances such as dioxins or pesticides. No link has been established between possible changes in the various lymphocyte counts (with the possible consequences they entail) and abnormal functioning of the endocrine system.

II. All in all, very varied scientific data suggest that environmental endocrine disrupters do affect humans

Nevertheless, interpretation of the various clinical or biological findings appears to be fraught with controversy, and it does not seem possible, given the current level of knowledge, to draw final conclusions as to the actual effect on humans of environmental exposure to endocrine disrupters.

This is especially true in the case of risks concerning reproduction, where no actual effect has been definitively proven (in particular as regards the risks of testicular cancer, diminished fertility owing to reduced sperm production, or the occurrence of genital canal malformations in offspring).

What is certain, however, is that there is a real risk of exposure of humans to substances which are present in the environment and which can interfere with the functioning of the endocrine system.

There are a many ways in which exposure can occur: in food (many substances could be present in foodstuffs, for instance pesticides, or be passed on in breast milk; high levels of oestrogens may be present in unpurified water), at work (e.g. in the food, paper and plastics industries), at home (e.g. when gardening and in pesticides) or in medicinal products (e.g. the contraceptive pill).

It is therefore essential, as recommended by several groups, to conduct further scientific studies subject to the customary precautions and/or rules:

- epidemiological studies to assess the actual impact of the substances believed responsible and their presence in the environment;

- assessment of the way in which possible endocrine disrupters act: clinical and experimental studies (in vivo and in vitro in animals);

- where a substance has a particular action, it must be established whether there is a dose/effect relationship;

- the effects of such substances in combination with other substances must be studied.

Conclusions:

The Committee on Research, Technological Development, and Energy proposes the following amendments to the draft resolution prepared by the Committee on the Environment, Public Health and Consumer Protection:-

add the following new recitals and paragraphs:

A. Whereas research on endocrine disruption is characterized by pervasive uncertainties;

B. Whereas further research is needed across a whole range of topics, in order to reduce such scientific uncertainties;

C. Whereas accordingly it is right and proper to take account of the precautionary principle in dealing with the possible risks posed by endocrine disrupters, to complement this by taking into account experience acquired on a scientific basis and to maintain constant vigilance;

1. Notes the pervasive uncertainties which characterize the science of endocrine disruption:

2. Proposes therefore that the Commission draw up a comprehensive research strategy, both at the European level, and via the co-ordination of national research efforts pursuant to Article 130h of the EC Treaty, which is aimed at reducing these uncertainties;

3. Calls on the Commission to set up an EU research network on endocrine disrupters, which is, where possible, to include industrial research;

4. Calls on the Commission to set up a coordination unit at the JRC for research into endocrine disrupters which would, in particular, establish a database;

5. Calls for a provisional definition of endocrine disrupters to be introduced in the EU by the end of 1998 so as to improve the comparability of research findings; takes the view that the definition should as far as possible be harmonized from the outset with that used in the OECD countries and should relate to both humans and animals;

6. Proposes that such research efforts should address, inter alia, the need for:

- improved understanding of the endocrine and reproductive systems, and the detailed mechanisms of actions, including the role of hormones at key stages of life cycles;

- epidemiological studies on links between abnormalities and their effects on biological functions, including investigations of maternal/offspring effects and the role of other factors such as diet, location, socio-cultural origin, etc., on human reproductive health;

- epidemiological studies, in different environments and geographical areas, for reproductive effects, including surveys of reproductive and behavioural effects;

- improving test methods, including the enhancement of routine test protocols, the development of test systems and bio-markers, and the identification and use of indicator species;

- the development of guidelines for short- and long-term testing for suspected endocrine disrupting substances, including their pre-natal effects;

- the development and maintenance of a list of priority chemicals for study, and the enhancement of risk assessment methodologies to cope with endocrine disrupting chemicals (EDCs);

7. Proposes that exposure scenarios be classified for endocrine disrupters whose effects have been shown to be reproducible and that the possibilities of preventing the various classes of exposure subsequently be indicated;

8. Emphasizes the importance of the precautionary principle, linked to empirical data obtained on a scientific basis, in dealing with (possibly) endocrine disrupting chemicals, be they new substances or existing ones;

9. Notes that a considerable range of EC legislation is already in place, which can be used to monitor and control the use of endocrine disrupting chemicals; stresses, however, that a new framework Directive is needed to deal with endocrine disrupting chemicals and that it must be based on a scientific and empirical approach;

10. Urges the Commission in particular to use Directive 96/61 EC, on Integrated Pollution Prevention and Control, for the control of endocrine disrupting chemicals;

11. Stresses the important role which should be played in this context by the recently re-organized Scientific Committee for Toxicity, Ecotoxicity, and the Environment, especially with respect to the co-ordination of regulatory activities within the Member States, and the application of the precautionary principle, linked to empirical data obtained on a scientific basis, to all existing possibly endocrine disrupting chemicals, as well as new ones;

12. Urges the Commission and the Council to ensure that the above Committee operates with the maximum of transparency and openness, via the publication of agendas, minutes, and committee documents, and the holding of at least some public hearings.

19 May 1998

(1)() The draftsman found the document on this subject drawn up by Mr Tobias King and published by DG IV of the European Parliament in October 1997 (doc. W-25) very useful; it contains almost one hundred references from scientific articles and reviews on the subject.


 OPINION

(Rule 147)

for the Committee on the Environment, Public Health and Consumer Protection

on endocrine-disrupting chemicals (report by Mrs Kirsten Jensen)

Committee on Women's Rights

Letter from the committee chairperson to Mr Kenneth Collins, chairperson of the Committee on the Environment, Public Health and Consumer Protection

Brussels, 19 May 1998

Dear Mr Collins,

At its meetings of 25 November 1997, 16 April 1998 and 19 May 1998 the Committee on Women's Rights considered the above subject and at the last meeting approved the following text and conclusions unanimously (1).

Considerable concern has been expressed in recent years at the growing number of organic pollutants which have been shown to disrupt the endocrine systems of animals, and an increasing number of reports suggest that these endocrine disruptors may be linked to health and behavioural problems in humans.

There is no doubt that synthetic chemicals have radically altered our lifestyles in recent decades, in many cases for the better: by increasing crop yield; reducing death to diseases carried by insects; and in more tangible ways like the development of photographic film, or the protective coatings on food cans. However, there is increasing evidence that these same chemicals have damaging side effects whose magnitude is as yet unclear. Many of these chemicals are known to have a direct impact on the hormonal or endocrine system, some acting as mimics of natural hormones, others as triggers for greater hormonal activity, others blocking the natural production of hormones.

Several scientific studies have shown that minimising exposure to such chemicals does not necessarily solve the problem since the minutest doses can cause havoc in the endocrine system. It is suggested that the timing of exposure is a more significant factor, and in this respect pregnant women are most vulnerable. During pregnancy, a woman's endocrine system is constantly evolving, so exposure to endocrine disrupting chemicals at a critical stage is likely to open up the risk of affecting the endocrine system of the developing foetus, or the new-born baby through breast-feeding. The consequences may not be apparent in the pregnant woman herself or be immediately visible in her child: tests on some animals have suggested that the effects may be carried across generations and only become visible when the second generation reaches child-bearing age.

Much research and much speculation on the effects of endocrine disruptors has focused on the impact on male fertility, with headline stories of male fish carrying ovaries in polluted rivers, various other male species having reproductive disorders after exposure to certain chemicals and, among humans, growing concern over alarming drops in sperm counts in several countries. Although in the latter case there is no established link with endocrine disruptors, it is natural that this should form part of the same discussion, particularly as males are more likely to be affected by endocrine disruptors which on the whole mimic oestrogens.

The Committee on Women's Rights is concerned, however, that the debate should focus also on women's health. In agreeing the Platform for Action resulting from the UN World Conference on Women in 1995, Member States acknowledged that women have a different susceptibility to environmental hazards...and they suffer different consequences from exposure to them (paragraph 102). Indeed, a number of health problems specific to women have been found to result from excessive exposure to oestrogen, including breast cancer, endometrial cancer and endometriosis. Moreover, according to one report (2), levels of PCBs in the blood are higher in women who suffer miscarriages. The latter suggests a direct link between endocrine disrupting chemicals and damage to women's reproductive systems, which would fly in the face of commitments made at the UN Beijing Conference and the Cairo Population Conference to the effect that women should have the right to control their own bodies, and in particular their own reproductive health.

The chemical industry argues that there is little conclusive evidence to show that industrial chemicals have a perceptible impact on the endocrine system of humans. Where there is evidence, the industry has cooperated in work to seek alternatives. However, to wait for final, conclusive proof of a causal link may take many generations, by which time serious, irreparable damage may have been caused to our endocrine systems.

This committee takes the view, therefore, that further action must be taken now. Directives do exist at EU level for controlling and monitoring reproductive toxicity (Directives 67/548/EEC and 76/769/EEC(3)), but more and more industrial chemicals are produced every year and there is no regular screening method as yet, nor is there a proper risk-assessment looking at various combinations of chemicals, at their effects over a long, even multi-generational time-scale, and at their possible link to a whole range of health problems including reproductive health.

Given women's vulnerability, particularly in pregnancy, the Committee on Women's Rights strongly supports the 'right-to-know' principle so that women have some measure of choice in protecting themselves against undesired exposure to chemicals that may disrupt their hormonal or endocrine systems. This involves better labelling of consumer products and information being made available by government authorities on endocrine disrupting chemicals, which is not the case in all Member States to date. Research clearly needs to continue, also, with a focus on possible links to specific women's health problems as well as looking more generally at the impact of endocrine disrupting chemicals on male and female fertility and reproductive health. In the meantime, work should begin, in collaboration with the chemical industry, on controlling and phasing out known endocrine disruptors.

The Committee on Women's Rights therefore calls on the Committee on the Environment, Public Health and Consumer Protection, as the committee responsible, to include the following paragraphs in its resolution:

1. Notes with concern that a number of health problems specific to women result , among other factors, from excessive exposure to oestrogens, including breast cancer, endometrial cancer and endometriosis. As the science of endocrine disruption is characterised by many uncertainties, it has to be clarified whether and how oestrogen mimics influence these processes. This necessity is underlined by the presumption that women in pregnancy are most vulnerable to the potentially damaging effects of endocrine disrupting chemicals;

2. Urges the Commission to draw up a comprehensive research strategy to reduce the uncertainties surrounding the issue of endocrine disruption. This research should be focused on an improved understanding of the endocrine system and the role of hormones and hormone-mimics on women´s health;

3. Calls on the Commission, in line with the precautionary principle laid down in Article 130r TEU, to systematically control and, in conjunction with the industry, begin the phasing out of known endocrine disrupting chemicals and development of safe alternatives as soon as the science-based risk assessment process proves a sufficient link between endocrine disrupting properties of certain chemicals and adverse effects on human health and environment;

4. Calls on the Commission to consider the use of the budget allocated to life sciences within the Fifth Framework Programme in order to continue research into identifying endocrine disruptors, particularly those pertaining to fetal damage and other reproductive factors;

5. Calls on Member States and the Commission to make information on endocrine disruptors widely available, with a focus on male and female reproductive health problems, on the basis that the 'right-to-know' principle is the best way to enable people to maintain control over their own reproductive health rights, as guaranteed at the UN Population Conference in Cairo.

Yours sincerely,

(Sgd) Astrid LULLING

(1)() The following were present for the vote: Lulling, President-in-office; Banotti; Cars (for Larive); Colombo Svevo; Eriksson; Gröner; Hautala; Lenz (for T. Mann); Marinucci; Mouskouri (for Peijs); Sornosa Martínez and Waddington.
(2)() Background information on environmental endocrine disruptors, Dr. Dmitri Brékine
(3)() OJ L 196, 16.8.1967, p. 1 and OJ L 262, 27.9.1976, p. 201

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