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Commission documents

Introduction

In October 1998, the European Parliament adopted a Resolution calling upon the Commission to take action on the issue of endocrine disruptors (EDs). Among the aims of the Resolution were:

  • an improvement in the legislative framework,
  • reinforcement of research efforts and
  • an increased effort to make information available to the public.

In March 1999, the Scientific Committee for Toxicity, Ecotoxicity and the Environment (SCTEE) issued a report, 'Human and wildlife health effects of endocrine disrupting chemicals with emphasis on wildlife and on ecotoxicology test methods'. The report identified a 'potential global problem' for wildlife. It also stated that 'impaired reproduction and development causally linked to endocrine disrupting substances are well-documented in a number of wildlife species and have caused local and population changes'.

In December 1999, the Commission published the 'Community Strategy for Endocrine Disruptors - a range of substances suspected of interfering with the hormone systems of humans and wildlife' - COM(1999) 706 - which set out a general framework for studying ED.

In June 2001, the Commission adopted a Communication on the implementation of the "Community Strategy for Endocrine Disruptors - a range of substances suspected of interfering with the hormone systems of humans and wildlife", COM(2001) 262, which covers the time period 1999 to 2001.

In October 2004, the Commission published a Staff Working Document on the implementation of the "Community Strategy for Endocrine Disruptors - a range of substances suspected of interfering with the hormone systems of humans and wildlife", SEC(2004) 1372, which covers the time period 2001 to 2003.

In November 2007, the Commission published a Staff Working Document on the implementation of the "Community Strategy for Endocrine Disruptors - a range of substances suspected of interfering with the hormone systems of humans and wildlife", SEC (2007) 1635, which is the third progress report on the implementation of the Strategy during the period 2004-2006. 

In August 2011, the Commission published a Staff Working Document on the implementation of the Community Strategy for Endocrine Disruptors-a range of substances suspected of interfering with the hormone syatems of humans and wildlife SEC (2011) 1001. This is the fourth report on the implementation of the strategy.

Com (1999) 706

Community Strategy for Endocrine Disruptors - a range of substances suspected of interfering with the hormone systems of humans and wildlife' (Download)

The main objectives of this paper were:

  • To identify the problem of endocrine disruption, its causes and consequences
  • To identify appropriate policy action on the basis of the precautionary principle1 in order to respond quickly and effectively to the problem, thereby alleviating public concern

The paper identified four key requirements to address the phenomenon of endocrine disruption:

  • The need for further research on: exposure assessment; identification of susceptible populations; the mechanisms of action in the endocrine system; development and validation of test and screening methodologies; links between adverse health effects in humans and wildlife and exposure to specific substances or mixtures of substances.
  • The need for international co-ordination and co-operation in order to pool knowledge and avoid duplication of effort.
  • The need for communication with the public in order to address their concerns in this area.
  • The need for policy action for the control and regulation of chemicals in three phases: hazard identification, risk assessment and risk management.

The implementation of the strategy includes short, medium and long-term actions:

  1. Short-term actions (1-2 years),
    • Establish a priority list of substances for further evaluation of their role in endocrine disruption including the identification of a) substances for priority testing b) substances addressed/regulated under existing Community legislation, c) gaps in knowledge d) specific cases of consumer use e.g. by vulnerable groups such as children
    • Establish monitoring programmes to estimate exposure to and the effects of the substances on the ED priority list
    • Information exchange and international co-ordination in order to make best use of available resources and to avoid duplication of effort
    • Collect, exchange, assess and provide information on EDs to the public
    • Consultation with the stakeholders
  2. Medium-term actions (2-4 years)
    • Identify and assess EDs: include harmonisation of the development and validation of new improved testing methods
    • Research and development to provide greater understanding of the mechanisms of endocrine disruption, causal links between exposure to substances and adverse effects in humans and wildlife, investigation of risk assessment concepts, exposure assessment and the development of environmental monitoring tools
  3. Long-term actions (4 years or more)
    • Adapt and/or amend of present EU legislative instruments which cover chemical as well as consumer, health and environmental protection to take account of endocrine disrupting effects

1This states that where there is uncertainty as to the existence or extent of risks to human health, the Commission may take protective measures without having to wait until the reality and seriousness of those risks become apparent

Com (2001) 262

'On the implementation of the Community Strategy for Endocrine Disruptors - a range of substances suspected of interfering with the hormone systems of humans and wildlife'. (Download)

This document, published in June 2001, was the first progress report following the adoption of a Community Strategy for Endocrine Disruptors (EDs) in December 1999 (COM(1999) 706).

Progress on short-term actions

  • Establishment of a priority list of substances for further evaluation of their role in endocrine disruption. A study report has been produced entitled 'Towards the establishment of a priority list of substances for further evaluation of their role in endocrine disruption - preparation of a candidate list as a basis for priority-setting. This report identified a candidate list of 553 substances. In this priority-setting exercise, the Commission Scientific Committees and stakeholders, including EU Member and Associated States, industry associations and non-governmental organisations were consulted on the scientific relevance of the study and different priorities were identified to implement this action, which includes: Priority in short-term will be given to conducting and in depth study of 12 candidate substances, which includes up-to-date ED evidence, including dose-response/potency/timing/synergy considerations, comparison with non-endocrine disruption toxic effects and quantitative exposure assessment where appropriate. Nine (9) of the chemicals are industrial or other substances for which there is scientific evidence of endocrine disruption or potential endocrine disruptions and which are neither restricted nor currently being addressed under existing Community legislation. 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. Priority will also be 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.
  • Information exchange and international co-operation.
  • Other short-term actions. A European workshop on EDs was held in Sweden June 2001 focusing on monitoring, research and development, test methods, testing strategy and international co-operation. There was also a move towards banning the use in stock farming of certain substances having hormonal activity.

Progress on medium-term action

  • Research and development. Within the Community 4th Framework Programmes for R&D (1994-1998), and the 5th Framework Programme (1999-2002), research was funded with a budget of €20 M.
  • Identification and assessment of EDs

Progress on long-term action

  • Legislative action. The issue of ED has been addressed, either directly or indirectly in different legislative proposals 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.

Commission Staff Working Document SEC(2004)1372

on the implementation of the Community Strategy for Endocrine Disruptors - a range of substances suspected of interfering with the hormone systems of humans and wildlife (Download).

This document, published in October 2004, was the second progress report following the adoption of a Community Strategy for Endocrine Disruptors (EDs) in December 1999 (COM(1999) 706). It covers the time period 2001 to 2003.

SEC (2007) 1635

Commission Staff Working Document on the implementation of the 'Community Strategy for Endocrine Disruptors - a range of substances suspected of interfering with the hormone systems of humans and wildlife'. (Download)

This document, published in November 2007 is the third progress report on the implementation of the Strategy and covers the period 2004–2006. The "Community Strategy for Endocrine Disruptors" contains activities in the short, medium and long term. The short and medium term actions focus on gathering scientific data on "candidate substances" with a view to prioritising testing, guide research and monitoring efforts and to identify specific cases of consumer use and ecosystem exposure. The long-term actions focus on review and possible adaptation of policy and Community legislation.

Progress on short-term actions

The key short-term action is the establishment of a priority list of substances for further evaluation of their endocrine disrupting effects. This prioritisation work started in the year 2000. In total 575 chemical substances were screened and evaluated as to their endocrine disrupting (ED) effects and  a preliminary priority list was established at the end of 2006. The list is now available as an Access-Database.

The list on the database was elaborated in a stepwise approach and is based on the outcomes of the four studies contracted by the Commission. It is not yet final and is not a negative list substances either. It is meant to provide a basis for gathering further data on endocrine disrupting effects of those substances and for their subsequent evaluation under the individual pieces of the Community legislation in order to address public concerns about this type of substances.

In terms of prioritisation, it was found that, out of 575 substances, 320 substances showed evidence or potential evidence for ED effects, while in total, 109 substances were not retained in the priority list, either due to insufficient data on ED effects or insufficient scientific evidence. 147 substances have been excluded from the evaluation during the process as they were identified as double entries, mixtures or of doubtful relevance.

An assessment of the legal status of the substances with evidence or potential evidence of endocrine disrupting effects showed, that the majority of them are already subject to a ban or restriction or are addressed under existing Community legislation, although for reasons not necessarily related to endocrine disruption.

Progress on medium-term action

The Commission and Member States continue to participate in the OECD - Endocrine Disruptor Testing and Assessment Task Force (EDTA), which was set up in 1998 with the goal of developing agreed test methods for endocrine disruptors. Furthermore, endocrine disruptors were addressed under the 6th (FP6 - 2002-2006) EU Research Framework Programmes and will also be addressed under the 7th Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (FP7 - 2007-2013).

Progress on long-term action

Relevant developments since 2004 were the adoption of the regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), formally adopted on 18 December 2006, the proposal for a directive setting environmental quality standards for priority substances under the water framework directive (2006) or the proposal for a regulation revising directive 91/414/EC on plant protection products (2006).