A4-0281/98

Resolution on endocrine-disrupting chemicals

The European Parliament,

- having regard to its opinion of 14 January 1977 on the proposal for a Directive amending for the sixth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances ((OJ C 30, 7.2.1977, p. 35.)), its decision of 18 November 1992 on the common position adopted by the Council with a view to adopting a Regulation on the evaluation and control of the environmental risks of existing substances ((OJ C 337, 21.12.1992, p. 106.)) and its resolutions on 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 OECD working group on the guidelines for new tests to identify chemical substances hazardous to the endocrine system,

C. whereas it is necessary to take account of the precautionary principle when examining the potential risks associated with endocrine disrupters, to have regard to this principle while bearing in mind the experience gained by scientific methods and to exercise constant vigilance;

Risk assessment: recommendations

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

2. Considers that there is instead a 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. Points out that, in the case of plant protection products with a hormone-mimicking effect, the waste products (metabolites) may have an effect and calls for specific account to be taken of this fact in the authorisation procedure pursuant to Directive 91/414/EEC concerning the placing of plant protection products on the market ((OJ L 230, 19.8.1991, p. 1.));

5. Considers that particular emphasis should be placed on substances which are carcinogenic, mutagenic or have effects on reproduction and the foetus. As 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 hormone-mimicking. 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 Directive 91/414/EEC, in particular Annex II thereof, so that an environmental impact assessment of the hormonal effect of pesticides is expressly required before a product is authorised;

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

Exposure: recommendations

13. 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;

14. Considers, in the light of the time vs. dosage debate, that there is a great deal of uncertainty surrounding the setting of limit values; sounder scientific data is therefore needed before relevant legislation can be drawn up;

15. 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;

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

17. 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;

18. Urges the Commission in particular to use Directive 96/61/EC on integrated pollution prevention and control ((OJ L 257, 10.10.1996, p. 26.)) for the control of endocrine-disrupting chemicals;

19. Stresses the important role which should be played in this context by the recently re-organised Scientific Committee for Toxicity, Ecotoxicity and the Environment, especially with respect to the coordination 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;

20. 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;

21. 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;

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

Research: recommendations

23. 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;

24. 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;

25. Asks the Commission to set up a network at EU level for research into disrupters of the endocrine system; takes the view that it must be possible for industry's research departments to be involved in such research;

26. Calls for the adoption of a provisional definition of endocrine disrupters in the EU by the end of 1998 in order to improve the comparability of research findings, for this definition to be harmonised from the outset as far as possible with that adopted by the OECD member countries and for it to apply both to man and wild species;

27. Recognises 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;

28. 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;

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

30. 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;

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

32. Demands that the EU should ensure that international sperm count surveys and the collection of data on sperm quality are carried out, as well as more epidemiological 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;

33. Recognises 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;

34. 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

35. 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;

36. Demands that the scientific committees assess the following areas with regard to hormone-mimicking substances: health - cosmetics directive (foam baths, creams), PVC and toys, dry-cleaning agents; foodstuffs - values for pesticide residues and the migration of hormone-mimicking substances to foodstuffs;

37. 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;

38. 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;

39. Demands that the Commission go through the labelling regulations to ensure that each chemical product is labelled in an easily understandable way to show what level of substances not occurring in the natural environment it contains and that the risk category for these substances is displayed; substances which have been subjected to a risk analysis should be labelled to show their effects;

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