Communication from the Commission to the Council and the European Parliament on the implementation of the Community Strategy for Endocrine Disrupters - a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706) /* COM/2001/0262 final */
COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT on the implementation of the Community Strategy for Endocrine Disrupters - a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706)
SUMMARY
Following the adoption by the Commission of a Communication to Council and European Parliament on a Community Strategy for Endocrine Disrupters in December 1999 (COM(1999)706), the Council invited the Commission to report regularly on the progress of work, and for the first time in early 2001.
A key short-term action of the Community Strategy is the establishment of a priority list of substances for further evaluation of their role in endocrine disruption. During 2000, a candidate list of 553 man-made substances and 9 synthetic/natural hormones has been identified. The candidate list has been divided into three separate groupings of substances depending on the level of information available, and a priority list of actions has been developed in order to further evaluate the role of these substances in endocrine disruption. Actions, timeframes and groupings of substances are presented in Annex 1 of this Communication.
Regarding other short-term actions, the Commission is planning a European workshop on endocrine disrupters, with the sponsorship of the Swedish Ministry for Environment, Swedish National Chemicals Inspectorate (KEMI), OECD, WHO and the European Environment Agency. The workshop will take place on 18-20 June 2001 in Sweden and will focus on monitoring, research and development, test methods/testing strategy and international cooperation. The Commission has also held meetings with WHO and the US EPA during 2000 with a view to enhancing international cooperation.
The Commission and Member States continue to participate in the OECD Endocrine Disrupter Testing and Assessment Task Force, which was set up in 1998 with the goal of developing agreed test methods for endocrine disrupters. The latest estimates are that agreed test methods for human health would be available in 2002 while tests for environmental effects are expected in the timeframe of 2003 to 2005.
Under the 5th Community Framework Programme for R&D (1999-2002), research into endocrine disruption has been prioritised in the latest revisions of the relevant workprogrammes. In addition, a dedicated call for research proposals on the health and environmental implications of endocrine disrupters was published in May 2001 with a budgetary envelope of 20 MEURO.
Finally, regarding legislative action, the proposed revision of the General Product Safety Directive proposes, inter-alia, a simplification of conditions and procedures for urgent measures at Community level. In addition, the issue of endocrine disrupters is addressed specifically in the context of new and existing legislation in the field of water policy and in the recent White Paper on a strategy for a future chemicals policy.
1. A range of chemical substances, designed for use in industry, agriculture and consumer products, are suspected of interfering with the endocrine systems of humans and wildlife and of causing adverse health effects such as cancer, behavioural changes and reproductive abnormalities. These substances are known as 'endocrine disrupters'.
2. In December 1999, the Commission adopted a Communication to the Council and European Parliament on a Community Strategy for Endocrine Disrupters. The strategy addresses the key requirements of further research; international co-operation; communication to the public; and appropriate policy action. Recommendations are made for short-, medium- and long-term actions.
3. On 30 March 2000 the Environment Council adopted Conclusions on the Commission Communication in which it stressed the precautionary principle, the need to develop quick and effective risk management strategies and the need for consistency with the overall chemicals policy. The Council invited the Commission to report back on the progress of the work at regular intervals, and for the first time in early 2001
4. On 26 October 2000, the European Parliament adopted a Resolution on endocrine disrupters, emphasising the application of the precautionary principle and calling on the Commission to identify substances for immediate action.
2.
Progress on short-term action
Establishment of a priority list of substances for further evaluation of their role in endocrine disruption
5. One of the first key short-term actions identified in the Communication is the establishment of a priority list of substances for further evaluation of their role in endocrine disruption. The priority list was to be established in two steps, first an independent review of evidence of endocrine disrupting effects and human/wildlife exposure and second a priority-setting exercise in consultation with stakeholders and the Commission Scientific Committees. The two-step process is illustrated in Figure 1 attached.
6. The first step resulted in a study report entitled 'Towards the establishment of a priority list of substances for further evaluation of their role in endocrine disruption - preparation of a candidate list of substances as a basis for priority-setting'. The study was carried out by BKH Consulting Engineers, NL, under contract to the European Commission, DG Environment. The report focused on man-made chemicals used primarily in industry, agriculture and consumer goods and was completed in June 2000.
7. The study report identified a candidate list of 553 substances which were grouped into three groups according to different levels of available information for four selection criteria. The selection criteria, chosen in consultation with stakeholders, were as follows:
* Production volume
* Persistence in the environment
* Evidence of endocrine disruption from scientific literature, and
* Exposure considerations
8. For the second step, priority-setting, the Commission Scientific Committee for Toxicity, Ecotoxicty and the Environment, in association with the Scientific Committee for Plants, was consulted on the scientific relevance of the BKH Report. The Opinion adopted on 5 September 2000 supported the stepwise approach for the selection of substances for prioritisation and further evaluation. It concluded however that there were important scientific shortcomings in the BKH report, and identified namely the need to address dose-response/potency considerations, synthetic hormones, quantification of exposure as well as cut-off points for production volume and persistence criteria.
9. In parallel, stakeholders, including EU Member and Associated States, industry associations and non-governmental organisations were consulted. The majority view of Member States and NGOs was that the BKH approach was a pragmatic one which was reasonable for a first cut of the data and that it could be used as a first step in developing the priority list. At the same time, the need for additional work to improve and develop the list was emphasised.
10. The chemical industry expressed its concern that the BKH process might be perceived as a valid risk assessment because it appeared to combine hazard and exposure in a single assessment in a simplistic way. In addition, the chemical industry submitted a document described as 'an alternative to the approach used by BKH'.
11. On 8-9 November 2000, a stakeholder meeting was held in Brussels. Priority-setting was discussed in the light of the Opinion of the Scientific Committee, comments from stakeholders and an analysis of the legal status of substances under existing Community legislation. Several points relating to the BKH Report and to the list to be established were noted:
* The study carried out by BKH was designed as a starting point in a priority-setting exercise.
* All 553 candidate substances would be retained for further evaluation.
* A more in-depth study of specific candidate substances than that contained in the BKH Report would be necessary before any proposals for restrictions could be envisaged.
* Of 118 candidate substances deemed to have evidence of endocrine disruption or potential endocrine disruption, 109 were already subject to bans or restrictions or were being addressed under existing Community legislation, although for reasons not necessarily related to endocrine disruption.
* In addition to the man-made substances identified in the BKH Report, natural, identical to natural and synthetic hormones would also be considered as candidate substances. These substances are already subject to a ban for growth promotion in stock-farming in the European Union.
* In the context of the Community Strategy for Endocrine Disrupters, the Commission does not intend to duplicate work on candidate substances for which risk assessments are underway or due under existing Community legislation.
* The process of identifying candidate substances is iteractive and allows for inclusion and exclusion of substances as new evidence comes to light.
12. As a result of the two-step process described above, the Commission intends to implement a priority list of actions relating to specific groupings of candidate substances. These actions are listed in Annex 1, Table 1. Of particular importance are the following actions:
* Priority in the short-term (within 12-18 months) will be given to conducting an in-depth evaluation of 12 candidate substances. Nine (9) of these are industrial or other substances for which there is scientific evidence of endocrine disruption or potential endocrine disruption and which are neither restricted nor currently being addressed under existing Community legislation (see Annex 1, Table 2). In order to address the scientific shortcomings of the BKH Report, the evaluation will consider up-to-date ED evidence, including dose/response/potency/timing/synergy considerations, comparison with normal toxicity data, and quantitative exposure assessment where appropriate. Exposure assessment will include the identification of specific cases of consumer or ecosystem exposure which might warrant special consideration in the short-term. In addition, three (3) synthetic/natural hormones, oestrone, ethinyl oestradiol and oestradiol, will be evaluated in order to gather up-to-date evidence of environmental exposure and effects related to these substances. The Commission intends to launch a study in order to undertake this work.
* Priority will also be given in the next 12-18 months to gathering data/information on persistence, production volumes and legal status of 435 candidate substances (see Annex 1, Table 4) for which there was insufficient data in the BKH Report to decide on ED or potential for ED. The Commission intends to launch a second study in order to undertake this work.
* For 46 candidate substances for which there is deemed to be evidence of ED or potential ED and which are subject to risk assessment under existing Community legislation (see Annex 1, Table 3, shaded substances) the Commission will invite Member State Competent Authorities to take available evidence of endocrine disruption into account during the risk assessment process. The Commission will invite Member States Competent Authorities to speed up the risk assessments and risk reduction strategies for 15 candidate ED substances which are priority substances under Regulation 793/93 and to speed up the risk assessment and authorisation process for 31 candidate ED substances which are under review under Directive 91/414 for plant protection products. This work is estimated to require a timeframe of between 1-4 years.
* For 2 candidate substances for which there is scientific evidence of ED or potential ED and which are neither restricted, classified nor being addressed under existing Community legislation, (see Annex 1, Table 2, shaded substances), the Commission will invite the Member State Competent Authorities to carry out classification under Dir 67/548 using existing test results for carcinogenicity, reproductive toxicity and danger to the environment. This is estimated to require a 1-2 year timeframe.
13. The Commission has recently launched a study concerning the exposure of human beings to endocrine disrupters through drinking water. This study has been launched at the request of the Council in the context of Directive 98/83/EC on the quality of water intended for human consumption (Drinking Water Directive). The goal of the study is to gather evidence on which to base parametric values for endocrine-disrupting chemicals which might be used in a future revision of the Directive.
3.
Information exchange and international cooperation
14. The Commission and WHO held a joint seminar on 19-20 September 2000 with a view to enhancing cooperation between the two organisations. Regarding endocrine disrupters, the Commission and WHO, through the International Programme for Chemical Safety, are already cooperating on the maintenance of a global research inventory which is housed at the Commission Joint Research Centre in Ispra and on the compilation of a global state-of-the-science assessment report.
15. The development of agreed test methods is addressed within the forum of the OECD. Both the Commission and WHO are committed to supporting this process, WHO in the framework of the Inter-Organisation Programme for the Sound Management of Chemicals (IOMC) and the Commission by working closely with EU Member States to coordinate EU input at OECD. In the longer-term, it is expected that both organisations could work jointly on evaluating the impact of test methods on current risk assessment approaches.
16. Endocrine disruption was also addressed at the EU-US High Level Consultation on the Environment on 10-11 May 2000. The Commission and US EPA agreed to share information on a regular basis on priority-setting, screening and testing as well as on research activities.
17. Endocrine disruption is one of the chapters within the frame of the EU-US agreement on cooperation in science and technology. In this context, a joint workshop was organized in Ispra by the Commission JRC in April 1999 at which common research priorities were identified. Recently, the US EPA published two calls for research proposals focused on ecological and human health effects of EDs and is due to publish another in 2001. In addition, the Commission launched a dedicated call for proposals on health and environmental implications of EDs on 31 May 2001.
4.
Other short-term action
18. The use of substances having an oestrogenic, gestagenic or androgenic effect is restricted under Directive 96/22/EC concerning the prohibition on the use in stock-farming of certain substances having a hormonal or thyrostatic action and beta-agonists. In April 1999, the Scientific Committee on Veterinary matters relating to Public Health concluded that for all six hormones endocrine, developmental, immunological, neurobiological, immunotoxic, genotoxic and carcinogenic effects could be envisaged and that of the various susceptible risk groups, prepubertal children is the group of greatest concern. Moreover, the Scientific Committee concluded that oestradiol 17 beta is a complete carcinogen. In the light of these conclusions, confirmed in May 2000, the Commission has proposed to definitively ban the use of oestradiol 17 beta and its ester-like derivatives in farm animals and to maintain provisionally the prohibition for growth promotion of all other substances having an oestrogenic, gestagenic or androgenic effect until more complete scientific information becomes available (COM (2000) 320 and COM (2001) 131).
19. The Commission is planning to hold a European workshop on endocrine disrupters on 18-20 June 2001 in Aronsborg (Bålsta), Sweden, with sponsorship from Swedish Ministry from Environment, Swedish National Chemicals Inspectorate (KEMI), OECD, WHO and the European Environment Agency. The workshop is intended as a means to follow up on several elements of the Community strategy on endocrine disrupters (COM(1999)706), including the establishment of monitoring programmes, information exchange and international coordination, development of test methods/testing strategy, and research and development. Further information on the detailed objectives of the workshop are provided in Annex 2.
5.
Progress on medium-term action
Identification and assessment of endocrine disrupters
20. As indicated in the Commission Communication, the availability of agreed test strategies/methods to identify and assess endocrine disrupting chemicals is a basic requirement for comprehensive legislative action aimed at protecting people and the environment from the potential dangers posed by these chemicals.
21. The Commission participates in the OECD Endocrine Disrupters Testing and Assessment Task Force (EDTA) which was set up in 1998 under the authority of the National Co-ordinators for the Test Guidelines Programme. The main duties of the Task Force are to develop an internationally harmonised testing strategy and to co-ordinate and oversee the work of different sub-groups charged to develop new test guidelines or revise existing ones to assess the potential endocrine disrupting properties of chemicals. The Task force has met four times and has outlined a first conceptual framework for a possible testing strategy and defined a set of test methods to be developed/validated.
22. For the development/validation of test methods for human health effects, the Task Force set up a working group in 1998. This group, which includes Commission and Member State experts, has been focusing on the development of two new tests and the enhancement of an existing guideline and it is expected that agreed tests for human health could be available in 2002. In parallel the revision of Test Guideline 416 (Two Generation Reproductive Toxicity) and OECD TG 414 (Teratogenicity) are currently in the final phase of adoption by the Member countries. These revisions include many additions relevant to the detection of sex hormone disruption, although there is still a need in the future to consider additional endpoints, particularly those relating to the central nervous system and thyroid hormone system.
23. For the development/validation of test methods for environmental effects, a second working group was established in late 2000, in which Commission and Member State experts participate. Suitable tests regarding environmental effects are not well-developed. Tests are required which assess the effects of chemicals on a variety of key taxonomic groups from all the relevant environmental compartments (fish, avians, invertebrates, amphibians). In view of the different degrees of knowledge on each compartment and test development, it is necessary to identify relevant toxicity endpoints in order to obtain a representative picture of the effects on the environment. Due to the lack of development of these tests, it is unlikely that the first agreed methods will be available before 2003 and some of them not before 2005.
6.
Research and Development
24. In the Fourth Community Framework Programme for Research and Technological Development (1994-1998), successful projects were funded in the areas of identification and detection of endocrine disrupting substances in waste water treatment, biosensor development, the impacts of endocrine disrupters on human and ecosystems health and development of test methods. The Community funding for these projects was circa 8 million Euros. In addition the Commission (Joint Research Centre/DG Research) is funding a scientific project which aims to screen the EU high production volume existing chemicals for potential endocrine modulating chemicals.
25. In the Fifth Community Framework Programme for Research and Technological Development (FP5) (1999-2002), ED is addressed under several key actions of the 'Quality of Life and Management of Living Resources' and the 'Energy, Environment and Sustainable Development' programmes. However, the calls for proposals in 1999 yielded only one project clearly dedicated to ED in the Quality of Life programme (Key Action: Environment and Health), with a European contribution of 2.45 MEUR. This project addresses male reproductive health.
26. For the year 2000, 4 proposals specifically dedicated to endocrine disruption have reached the funding stage in the Quality of Life Programme (Key Action: Environment and Health). These proposals address essentially male reproductive health and the effects of phytoestrogens in the human diet. The total Community contribution to these projects is around 8 MEUR. Several other projects in the same programme investigate human health effects of substances suspected of being endocrine disrupters (e.g. dioxins, PCB, PAH, flame retardants) without focussing specifically on this single issue. These projects receive a total European contribution in excess of 10 MEUR.
27. In the Energy, Environment and Sustainable Development Programme, several projects, focusing not only on endocrine disruption but also on ecotoxicological research of possible endocrine substances in freshwater and marine ecosystems, have been selected for funding under the key actions 'Sustainable management and quality of water' and ' Marine ecosystems'.
28. In order to better cater for the research needs related to ED, the profile of the issue has been raised throughout the relevant programmes of FP5 for years 2001 and 2002. Specific research priorities focused on endocrine disrupters have been included in the revised workprogramme of the Environment and Sustainable Development Programme to cover the last two calls for proposals in FP5. Under the key action 'Sustainable management and quality of water' these priorities include research on endocrine disrupters in the following fields: ecosystem functioning, quality of drinking water, combating diffuse pollution, pre-normative and co-normative research including standardization. Under the key action 'Marine ecosystems' special priority for endocrine disrupters has been emphasized in the sub-area related to the assessment of nutrient and pollutant impacts on the marine environment.
29. Additionally, to further improve the policy support and in order to create a pool of research to help resolve the large remaining uncertainties, the Commission (DG Research) has published a dedicated call for proposals on the health and environmental implications of endocrine disrupters on 31 May 2001 with a deadline of 14 September 2001. The allocated budget is 20 M euros.
7.
Progress on long-term action
Legislative action
30. As outlined in Point 12 of this Communication, a key priority action in 2001 is the in-depth evaluation of 12 candidate ED substances, which will include the identification of specific cases of consumer or ecosystem exposure which might warrant special consideration in the short-term. In the context of consumer exposure, Directive 92/59/EC on general product safety has been identified in the Commission Communication (COM(1999)706) as a key risk management instrument for short-term emergency action. It should be noted that this Directive is under revision, with proposed amendments covering a clarification and enlargement of the scope of the Directive, a stronger role for European standards, additional obligations for producers and distributors, a ban on export of prohibited products, reinforcement of the obligations and powers of the Member States for market surveillance, collaboration between Member States and the Commission, improvement of the RAPEX system, a simplification of conditions and procedures for urgent measures at Community level and last but not least an improvement in transparency to the general public.
31. Directive 2000/60/EC, the Water Framework Directive, was adopted in September 2000. Following this, on 16 January 2001, the Commission adopted an amended Proposal for a Council/European Parliament Decision establishing the list of priority substances in the field of water policy (COM(2001)17). Directive 2000/60/EC stipulates that, following adoption of this Decision, the Commission shall produce proposals for emission controls and quality standards within two years. For so-called 'priority hazardous substances', the proposals for emission controls shall aim to end or phase out emissions, discharges and losses within 20 years. It should be noted that, of the 32 priority substances proposed in the field of water policy, 11 are candidate ED substances for which evidence of ED or potential ED was found in the BKH Report.
32. On 13 February 2001, the Commission adopted a White Paper on a Strategy for a Future Chemicals Policy. One of the key elements of the proposed strategy is an authorisation procedure for substances of very high concern, namely, substances that are carcinogenic, mutagenic or toxic to reproduction and substances with POPs characteristics. The procedure would require authorities to give specific permission before such a substance could be used for a particular purpose, marketed as such or as a component of a product. Given that many of the serious human health effects which have so far been associated with endocrine disrupting chemicals are testicular cancer, breast cancer, prostate cancer, decrease in sperm concentration and semen volume, cryptorchidism and hypospadia, it is likely that many ED candidate substances would fall under this authorisation procedure. Furthermore, adverse effects on the endocrine system of wildlife species have been causally linked to certain POPs, which would be subject to authorisation. In addition, the need for particular research efforts on endocrine disruption are highlighted in the White Paper. These include research into the development and validation of in-vivo and in-vitro test methods as well as modelling (e.g. QSAR) and screening methods, and research into the effect of low doses, long term exposure and exposure to mixtures of chemicals. Other issues pertinent to the issue of endocrine disruption, which are addressed in the context of the overall chemicals policy, include the rigorous testing for long-term effects of substances exceeding a production volume of 100 t and the obligation of manufacturers/importers and downstream users to carry out appropriate risk assessments.
8.
Conclusions and next steps
33. The year 2000 has been dedicated to a number of preparatory activities towards the implementation of the Community Strategy for Endocrine Disrupters as adopted by the Commission in December 1999 (COM(1999)706). These include the identification and prioritisation of a candidate list of ED substances for further evaluation, the preparation of research priorities to feed into a dedicated call for research proposals on ED under the 5th Community Framework Programme on R&D and the planning of a European workshop on endocrine disrupters. Ongoing activities during 2000 included the development of test methods in the context of the OECD Task Force for the Assessment and Testing of endocrine disrupters.
34. The year 2001 will be dedicated to the further evaluation of the role of candidate substances in endocrine disruption, with first priority given to those substances with evidence of ED or potential ED which are neither restricted nor currently being addressed under existing Community legislation. The evaluation will include the identification of specific cases of consumer or ecosystem exposure which might warrant special consideration from a consumer and environmental policy point of view in the short-term.
35. Equally, priority will be given during 2001-2002 to gathering data on a range of candidate ED substances and to launching a series of research projects aimed at filling the gaps in knowledge and understanding of the phenomenon of endocrine disruption. In addition, the Commission invites the Member States to speed up the current risk assessment processes for existing substances and plant protection products which appear on the ED candidate list and which are being addressed under existing Community legislation.
36. A European workshop on endocrine disrupters will take place on 18-20 June 2001 in Aronsborg (Bålsta), Sweden. The workshop will address the establishment of monitoring programmes, the development of agreed test methods/testing strategy, international cooperation and research and development.
37. In parallel with the above specific activities in the context of the Community Strategy for Endocrine Disrupters, the issue of endocrine disruption is also addressed, either directly or indirectly, in a new legislative proposal in the field of water policy, in the recent White Paper on a strategy for a future chemicals policy and in the proposed revision of the General Product Safety Directive.
>REFERENCE TO A GRAPHIC>
9.
Annex 1
Table 1: Priority List of Actions with groupings of substances and estimated timeframes
>TABLE POSITION>
Table 2: Substances with evidence of ED or potential ED which are neither restricted nor currently being addressed under existing Community legislation (= 9)
>TABLE POSITION>
* Substances are broadly grouped into industrial chemicals, pesticides, metals, other substances and natural/synthetic hormones.
Dir 76/769 = Directive 76/769/EEC relating to restrictions on marketing and use of certain dangerous substances and preparations
Reg 793/93 =Regulation (EEC) No.793/93 for Risk Assessment of Existing Substances
Dir 91/414 = Directive 91/414/EEC concerning the placing on the market of Plant Protection Products
Dir 67/548 = Directive 67/548/EEC on classification, packaging and labelling of dangerous substances
Table 3: Substances with evidence of ED or evidence of potential ED, already regulated or being addressed under existing legislation (= 115)
>TABLE POSITION>
* Substances are broadly grouped into industrial chemicals, pesticides, metals, other substances and natural/synthetic hormones.
** Dir 76/769 = Directive 76/769/EEC relating to restrictions on marketing and use of certain dangerous substances and preparations Reg 793/93 =Regulation (EEC) No.793/93 for Risk Assessment of Existing Substances Dir 91/414 = Directive 91/414/EEC concerning the placing on the market of Plant Protection Products Dir 67/548 = Directive 67/548/EEC on classification, packaging and labelling of dangerous substances
*** Restricted under Directive 96/22/EEC concerning the prohibition on the use in stock-farming of certain substances having a hormonal or thyrostatic action and beta-agonists.
Table 4: Substances with insufficient data in the BKH Report (= 435)
European Workshop on Endocrine Disrupters 18-20 June 2001, Aronsborg (Bålsta), Sweden
Objectives of the Workshop
* Information exchange and international coordination
- To exchange information and to stocktake on areas where international coordination can speed up and make efficient use of resources
- To identify ways and means to facilitate international coordination
* Development of test methods/testing strategy
- To review progress on test method development in the framework of OECD
- To discuss with EU Member and Associated States an appropriate testing strategy in the light of existing EU legislation and the current discussions on a future EU chemicals policy
- To identify research requirements to underpin the development of test methods/testing strategies at OECD
* Research and Development
- To review recent findings on the range of effects associated with endocrine disruption
- To share results/help create synergies and coordinate work amongst European researchers involved in national and Community research projects as well as in industry-funded research work.
* Establishment of monitoring programmes
- To define monitoring objectives, information needs, and design requirements for monitoring programmes, in relation to both human health/wildlife effects and to specific substances
- To review available information from Member States/organisations/inventories
- To review availability and identify research/development/validation requirements for appropriate environmental tools and models for estimation of exposure.
