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Which substances are of concern?

What is the basis for concern?

Reports of adverse changes in the physiology and behaviour of wildlife apparently linked to exposure to chemical pollutants released into the environment, and the suggestion that humans may also be at similar risk of adverse health effects, have fuelled growing concern about the extent of the risk posed by chemical EDs and calls for action to reduce such risks.

However, modern civilised life involves the use of thousands of chemicals in various processes and products, many of which could eventually find their way into the environment through various routes (e.g. from disposal methods such as landfills, by entering the food chain, from consuming products such as sprays), and at present it is generally unclear which chemicals or processes pose an appreciable risk.

Concerns about the continued uncertainty regarding the extent of exposure to chemical pollutants in the environment and the effects that they might be having on the human population (particularly with regard to reproductive health) were highlighted during discussions at a major European workshop on EDs held in December 1996, jointly sponsored by the European Commission (DGXII), the European Environmental Agency, the European Centre for Environment and Health and the World Health Organisation.

How are the concerns being addressed?

Over the years, many organisations have published lists of 'suspected EDs', but frequently the basis for inclusion of a particular chemical, or for considering some chemicals of high priority, has not been clearly stated. Further scientific data collection and research was therefore considered necessary to identify selection criteria for placing substances on a 'list of suspected endocrine disruptors'. In addition, it is necessary to assess the quantities of the substances present in the environment (based on consideration of production volumes, subsequent processing, and final product and import/export volumes). To this end, the DG Environment commissioned series of studies in order to develop a coherent approach to establish a list of priority substances for further evaluation of their role in endocrine disruption.

Priority list

It is intended that the priority list of chemicals developed within the EU-Strategy for Endocrine Disruptors will be used to prioritise further detailed review of the information. However, it is important that the listings produced are not regarded as final and unchangeable: addition and removal of chemicals may be required in response to either developments in scientific knowledge or changes in chemical usage patterns.

The priority list was to be established in two phases, first an independent review of evidence of endocrine disrupting effects and human/wildlife exposure and second a priority-setting exercise in consultations with stakeholders and the Commission Scientific Committees.

The different steps of the process include:

  • Step 1: A working list of chemicals was compiled from lists of 'suspected endocrine disruptors' published by various organisations, supplemented by a search of the scientific literature to identify reports and papers describing effects suggestive of endocrine disrupting activity for specific chemicals. To try to ensure that the list was as comprehensive as possible, a draft of the list was discussed at a meeting with key stakeholders (including representatives from government, industry and non-governmental organisations (NGOs)). Data on the effects of chemicals in humans, other vertebrates and invertebrates that might be due to endocrine disruption, were collected and included in a database to facilitate the analysis of findings. Information on each chemical's persistence in the environment and the likelihood that its levels might build up in exposed organisms (i.e. bioaccumulate) were also collected, where available.
  • Step 2: The available information was reviewed to identify those chemicals that might be either highly persistent in the environment (i.e. resistant to breakdown) or that are produced by industry at high volumes (HPV chemicals, i.e. more than 1000 tonnes each year) since, in either case, it was assumed that both humans and animals would be more likely to be exposed to them and, hence, to be at potentially greater risk to any harmful effects.
  • Step 3: Using expert advice, information on the subset of chemicals identified by Step 2 as either persistent or HPV chemicals were reviewed to determine the strength of evidence for endocrine disruption and chemicals were assigned to one of three categories: Category 1 - evidence of endocrine disrupting activity in at least one species using intact animals; Category 2 - at least some in vitro evidence of biological activity related to endocrine disruption; Category 3 - no evidence of endocrine disrupting activity or no data available. (In this priority-setting exercise Commission Scientific Committees and Stakeholders were consulted and considered that a differentiation between both categories should be done).
  • Step 4: For the chemicals assigned to Category 1 in Step 3 (i.e. those for which there was evidence of endocrine disrupting activity in at least one intact animal species), the available information was reviewed to decide, if it was possible, that humans or wildlife might actually be exposed. Highest concern was allotted to those where human or wildlife were expected to be exposed, medium concern related to those where humans were not expected to be exposed but wildlife could be, and lowest concern was scored for those where neither humans or wildlife were exposed.

The results of these studies are compiled in a database. To extract the database, please, follow these instructions:

1. Download the zipped file to your hard-disk 2. Unzip the file and run the database (by a double-click on EDS_2003_DHI2006.mdb). 3. Minimum requirement: MS Access 2003 or later.

How many and what types of chemicals are included in the list?

From a total of 564 chemicals that had been suggested by various organisations or in published papers or reports as being suspected EDs, 147 were considered likely to be either persistent in the environment or produced at high volumes. Of these, however, in a first assessment clear evidence of endocrine disrupting activity was noted for only 66 (assigned Category 1 using the criteria adopted in the study). A further 52 chemicals showed some evidence suggesting potential activity (Category 2). In total 118 substances were categorised in the first exercise of priority setting. Of the 66 chemicals in Category 1, humans were considered likely to be exposed to 60.

Complete final report and annexes:

  • BKH Report (pdf ~140Kb)
  • Annex 1 - Candidate list of 553 substances (pdf ~140Kb)
  • Annex 2 - Background documents (pdf ~90Kb)
  • Annex 3 - Contacted organizations (pdf ~90Kb)
  • Annex 4 - Framework of the database (pdf ~60Kb)
  • Annex 5 - Effect parameters included in the database (pdf ~60Kb)
  • Annex 6 - List of 146 substances evaluated in the Expert meeting (pdf ~800Kb)
  • Annex 7 - Human health and wildlife relevant data on endocrine disruption included in the database on the 146 substances evaluated in the Expert meeting (pdf ~360Kb)
  • Annex 8 - Human health and wildlife relevant data on endocrine disruption included in the database on the remaining substances (pdf ~320Kb)
  • Annex 9 - Working list of 564 chemicals with their literature source (pdf ~170Kb)
  • Annex 10 - List of 564 substances with their selection criteria (pdf ~160Kb)
  • Annex 11 - References of studies and reports on endocrine disruption incorporated in the database (pdf ~390Kb)
  • Annex 12 - Scientific evidence used in the Expert meeting for the evaluation of the 146 selected substances (pdf ~360Kb)
  • Annex 13 - List of 146 substances with endocrine disruption categorizations prepared in the Expert meeting (pdf ~80Kb)
  • Annex 14 - Summary profiles of chemicals with information on use, production, emission, monitoring and legal status (pdf ~910Kb)
  • Annex 15 - List of 66 Category 1 substances with categorisation high, medium or low exposure concern (pdf ~70Kb)

In a follow-up to the first prioritising exercise, priority was being given to the conduction of an in-depth evaluation of 12 substances. Nine are industrial compounds for which there is scientific evidence of endocrine disruption or potential endocrine disruption and which were not restricted or being addressed under existing EU legislation. This evaluation intended to address in-depth and up-to-date evidence on endocrine disrupting activity (including dose-response, potency, effects at key stages), the chemicals' 'general' toxicological profile, and information on exposure (including specific cases of consumer or ecosystem exposures). Three natural/synthetic hormones (oestrone, ethinyl oestradiol and oestradiol) are also being considered in this study.

In parallel, priority was also given to gathering data/information on persistence, production volumes and legal status of 435 candidate substances for which there were insufficient data for the BKH Report to decide on ED or potential ED.

Thus in 2001, the two studies were launched simultaneously. The first one, entitled "Study on the scientific evaluation of 12 substances in the context of endocrine disruptor priority list of actions", was carried out by WRc-NSF (UK) and the "Study on gathering information on 435 substances with insufficient data", was carried out by BKH-RPS Group (NL), under contract to the European Commission, DG Environment.

"Study on the scientific evaluation of 12 substances in the context of endocrine disruptor priority list of actions",

Complete final report and annexes:

(pdf~2M)

"Study on gathering information on 435 substances with insufficient data"

The study has addressed the remaining 435 substances for which there was insufficient data in the 2000 report to assess endocrine disruption or potential for endocrine disruption (due not to lack of data but to lack of resources to gather the data). Of these, however, clear evidence of endocrine disrupting activity was noted only for 94 (assigned Category 1 using the criteria adopted in the study). A further 53 chemicals showed some evidence suggesting potential activity (Category 2). The assessment of the legal status of the 147 substances showed that 129 were already subject to bans or restriction or were being addressed under existing Community legislation, although for reasons not necessarily related to endocrine disruption. 18 substances are neither restricted nor being addressed under the existing Community legislation (directive 76/769/EEC, directive 793/93/EEC, directive 91/414/EEC as well as different legislation dealing with chemicals in food and feed).

Complete final report and annexes:

  • BKH-RPS report
  • Annex 1. Description and evaluation of earlier work (BKH 2000 report)
  • Annex 2. Evaluation of the alternative approach of CEFIC/EMSG
  • Annex 3. ECB non-exhaustive list of biocidal substances with possible existing active substances
  • Annex 4. Working list of 435 chemicals, grouping of chemicals.
  • Annex 5. 204 selected chemicals with their applied selection criteria.
  • Annex 6. Human health relevant data on endocrine disruption on the 204 substances evaluated in the Expert meeting of 9-10 September 2002. (A database with this information has been prepared and will be available to the public in the future).
  • Annex 7. Wildlife relevant data on endocrine disruption on the 204 substances evaluated in the Expert meeting of 9-10 September 2002. (A database with this information has been prepared and will be available to the public in the future).
  • Annex 8. References of studies and reports on endocrine disruption incorporated in the database.
  • Annex 9. Results of categorisation and qualifying remarks in the Expert meeting of 9-10 September 2002.
  • Annex 10. Entries excluded from the candidate list.
  • Annex 11. Overview of the systemic toxicity data of Category 1 substances
  • Annex 12. Overview of the ED effects data of Category 1 substances.
  • Annex 13. The summary profiles of (41) Category 1 chemical groups.

(pdf~1M)

"Study on enhancing the endocrine disruptor priority list with a focus on low production volume chemicals"

This study has addressed the remaining substances, which were not evaluated in the previous studies, as well as additional 22 substances, identified by stakeholders and experts.

34 of the newly evaluated chemicals showed clear evidence of endocrine disrupting activity (Category 1 using the criteria adopted in the previous study). Further 21 substances showed some evidence suggesting potential activity (Category 2). With this, all 553 substances of the original candidate list have been subject to evaluation. Next step shall be the conversion from the priority list to an iterative dynamic working list.