EUROPEAN COMMISSION Brussels, 7.11.2018 COM(2018) 734 final COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Towards a comprehensive European Union framework on endocrine disruptors



INTRODUCTION Endocrine disruptors are chemical substances that alter the functioning of the endocrine system and negatively affect the health of humans and animals. They may either be of synthetic or natural origin. Exposure to endocrine disruptors can occur from different sources, such as residues of pesticides or consumer products used or present in our daily life. What is the endocrine system? The endocrine system is a messenger system of the body. It uses hormones, signalling molecules which travel through the bloodstream, as a communication tool and to produce effects on distant cells, tissues and organs. Hormones are essential for controlling a large number of processes in the body, from early ones such as embryonic development and organ formation, to the control of tissue and organ functions in adulthood. Concerns about endocrine disruptors have been growing since the 1990s. Following the adoption by the European Parliament of a Resolution on endocrine disruptors in 1998, in December 1999 the Commission adopted the Community Strategy for endocrine disruptors, which has been taken forward since then through action in the fields of research, regulation and international cooperation. Significant progress in understanding and regulating endocrine disruptors has been made, and the EU is today recognised as one of the global leaders in dealing with these chemicals. At the same time, societal concerns remain high. The Commission has always been and will remain committed to protect EU citizens and the environment from all hazardous chemicals. In this context, almost twenty years after the adoption of the Community Strategy of 1999, there is a need to update the EU approach on endocrine disruptors so that it remains state-of-the-art and continues to coherently address these substances across different areas, building on the increased knowledge, the achieved results and gained experience. To this end, the Commission is today outlining its strategic approach to endocrine disruptors for the years to come, with the ultimate overall goal to ensure a high level of protection of EU citizens and the environment and, at the same time, to preserve an internal market which delivers for consumers and where all EU business can thrive. This Communication addresses the requests of the European Parliament and the Council, follows up from the 7th Environment Action Programme and is framed by the international commitments to act on hazardous chemicals. Section 1 describes the scientific progress made on endocrine disruptors in the past twenty years. Section 2 summarizes the actions the EU has taken so far and section 3 outlines the Commission’s proposed approach to effectively take forward the EU's policy on endocrine disruptors in the future. 1. THE SCIENCE OF ENDOCRINE DISRUPTORS In the past decades, science on endocrine disruption has advanced significantly. Many thousands of peer-reviewed scientific publications have become available since the adoption of the Community Strategy of 1999, investigating the nature of endocrine disruption, its causes and its consequences for human health and wildlife populations. Progress has also been reported in publications by the European Commission, EU agencies, or in the context of activities co-ordinated by the Commission. Since 1999, the scientific evidence linking exposure to endocrine disruptors with human diseases or negative impact on wildlife has become stronger. Furthermore, scientific progress has brought agreement on a number of issues which are relevant to understand endocrine disruption. There is now broad consensus on the definition provided in 2002 by the International Programme on Chemical Safety, a joint programme of various United Nations Agencies, including the World Health Organisation, whereby an endocrine disruptor is defined as "an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations". Consensus also exists that the most sensitive window of exposure to endocrine disruptors is during important periods of development, such as foetal development and puberty. Exposure to endocrine disruptors during these periods may cause permanent effects and result in increased susceptibility to diseases later in life. It is also generally recognised that endocrine disruptors can interfere with the endocrine system in different ways. So far, science has focused mainly on a limited number of endocrine modalities. However, in recent years, it has been shown that other aspects of the endocrine system can be sensitive to endocrine disruptors as well. There is also increasing evidence showing that endocrine disruptors can work together to produce additive effects ("mixture effect", or "cocktail effect") so that exposure to a combination of endocrine disruptors may produce an adverse effect at concentrations at which individually no effect has been observed (even if this effect is not specific to endocrine disruptors). However, knowledge gaps still exist. These relate in particular to: ·the impact that exposure to endocrine disruptors has on the development of diseases and on wildlife. In this context, there is limited understanding of the specific contribution of chemical exposure and the way to separate it from other possible causes of the negative impacts being investigated. Other factors are indeed also at play in the development of such endocrine-related disorders (such as genetics, nutrition, lifestyle, or other environmental factors) or impacts on wildlife (e.g. overexploitation, climate change); ·the existing controversy as to whether and how certain toxicological principles, such as the “safe threshold” principle – i.e. the dose below which no adverse effect is expected to occur – are applicable to assess the safety of endocrine disruptors. A share of scientists is of the view that a safe threshold cannot be established for endocrine disruptors; ·fully understanding combined exposure ("mixture/cocktail effect"); ·the development of safer alternatives (including non-chemical approaches) to substitute endocrine disruptors; ·the mechanism of endocrine disruption.

Testing and the extent to which the science is able to inform regulators Another area where science has significantly progressed but needs to advance further is that related to the development and validation of tests methods. Reliable testing is indeed necessary to identify endocrine disruptors, taking account of the different ways in which endocrine disruptors can interfere with the endocrine system, and manage them appropriately. The Organisation for Economic Co-operation and Development is the leading recognised body for developing internationally agreed test guidelines, which are transposed into relevant EU legislation as appropriate. The European Food Safety Authority looked into existing test guidelines for endocrine disruptors in 2013. It concluded that a variety of tests were (or would soon be) available for certain endocrine modalities that can be affected by endocrine disruptors in mammals and fish, with fewer tests available for birds and amphibians. The Authority also found that: tests covering other aspects of the endocrine system or other animal groups still needed to be developed and/or validated; that there are no suitable predictive models for some endocrine-related diseases such as certain hormonal cancers, or metabolic disorders/obesity and that no single study existed to assess the effects of exposure of mammals through the complete life cycle. Furthermore, as in other fields of scientific research, also for endocrine disruptors there is the need to progress in the development of alternatives to animal testing: this would imply better reliance on existing data (and further using extrapolation techniques) and giving more weight to mathematical modelling and new in vitro methods. 2. EU policy and REGULATION OF endocrine disruptors SO FAR Following the Community Strategy of 1999, the EU has developed a policy response to endocrine disruptors that is focused on promoting scientific research, effectively regulating endocrine disruptors and developing international cooperation in the field. EU research and development of test guidelines on endocrine disruptors Since 1999, the European Union's Framework Programmes for Research and Technological Development have been key instruments for supporting scientific progress in the field of endocrine disruptors. Over 50 multinational collaborative projects have been funded, receiving over €150 million from the EU. These projects aim to improve understanding of the endocrine mechanism of action, to identify adverse effects on human health and wildlife from exposure to endocrine disruptors, and to develop tools for identification of endocrine disruptors and exposure assessment. A further €52 million has been allocated under Horizon 2020 for projects on new testing methods for endocrine disruptors, to be attributed by the end of the year. In addition to research funded under Horizon 2020, a special effort was made in recent years to further improve the availability of test guidelines for identification of endocrine disruptors and address the testing weaknesses identified at EU and international level, under the auspices of the Organisation for Economic Co-operation and Development. More authoritative testing is an important way to improve the effectiveness of control. The European Commission has funded several activities focusing on identifying gaps in test guidelines, on identifying possible ways to fill in these gaps, on setting priorities for further development of test guidelines, and on enhancing existing test guidelines or designing new ones. How EU legislation addresses endocrine disruptors In parallel with scientific progress, in the past decades the EU has progressively updated its body of laws regulating chemicals, with the aim of ensuring a high level of protection of human health, animal health and the environment, while ensuring the smooth functioning of the internal market. EU legislation is today recognised as among the most protective in the world and applies to all chemical substances, including those with endocrine disrupting properties. The EU approach is based on high-level scientific advice from the relevant EU risk assessment bodies, such as the European Chemicals Agency, the European Food Safety Authority or the Scientific Committee on Consumer Safety, and risk management decisions taken by the Commission, in agreement with Member States. When scientific evaluation cannot conclude with sufficient certainty, the Commission is guided by the so-called precautionary principle to take protective measures for its citizens and the environment. Enforcement of legislation is carried out by the Member States, and the Commission facilitates exchange of information between national competent authorities to improve their enforcement activities. Over recent years, the Commission has taken action against endocrine disruptors in line with the different requirements laid down in the relevant legislation. Specific provisions on how to address endocrine disruptors are now included in the legislation on pesticides and biocides, chemicals in general ("REACH Regulation"), medical devices and water. These requirements vary depending on the specific legislation. Other legislation, such as that on food contact materials, cosmetics, toys or protecting workers at the workplace, does not contain specific provisions for endocrine disruptors. However, substances with endocrine disrupting properties are subject to case-by-case regulatory action on the basis of the general requirements of the legislation. Regulating endocrine disruptors: a few examples ·The Commission has recently established criteria for identifying endocrine disruptors under the legislation on pesticides and biocides, based on the definition of the World Health Organisation. This development constitutes a milestone, as criteria to identify endocrine disruptors had never been set before in a regulatory context. In principle, no identified endocrine disruptor will be allowed to be used in these product categories in the future, except when very limited derogation possibilities apply. ·Under REACH, two endocrine disruptors have been placed in the list of substances requiring a specific authorisation to be placed on the market. Another 13 substances have been identified as endocrine disruptors and are included in the Candidate list of substances for possible inclusion in the authorisation list in the future. Substances with endocrine disrupting properties are also subject to restrictions. For example, the Commission has recently obtained Member States' support on a proposal to forbid the presence of four phthalates – chemicals broadly used to make plastics softer- in a variety of everyday products at levels of 0.1% or higher. Furthermore, more than 80 chemical substances are currently being evaluated due to concerns on their potential endocrine disrupting properties. ·Under the legislation on water, the Commission has included several endocrine disruptors in the list of “priority substances” of particular concern for which environmental quality standards and emission controls apply. Furthermore, the Commission has included three endocrine disruptors in the "watch list" of substances for which Union-wide monitoring data should be gathered. ·Due to concerns of endocrine disruption, the chemical bisphenol A is banned from use in baby bottles and other containers for foods for infants and young children, and very low migration limits are set for other food contact materials. Bisphenol A is also subject to limit values in toys for young children under 36 months or intended to be placed in the mouth and paper used in receipts. Very low limits for bisphenol A have also been set to protect workers from exposure through inhalable dust. ·Under the legislation on cosmetics, specific restrictions or bans have been set on a number of preservatives with endocrine disrupting properties, in particular to protect infants and young children. In addition, a substance used in sunscreens as a filter for ultraviolet radiation has also been banned taking into account in particular its potential endocrine disrupting properties. In order to realise the full potential of EU legislation that is relevant for endocrine disruptors, the Commission is currently working on actions in a number of areas. These include: ·aiming to develop a horizontal approach for the identification of endocrine disruptors across EU legislation building on the criteria developed for pesticides and biocides;

·updating data requirements in the different legislative frameworks to improve identification of endocrine disruptors; ·assessing how to improve the communication through the supply chain for endocrine disruptors under REACH in the context of the work on Safety Data Sheets; ·taking forward the scientific assessment of endocrine disruptors in order to take further regulatory action; ·supporting data sharing and monitoring activities; ·preparing guidance documents and reports; ·and organising training for risk assessors and risk managers. Furthermore, a number of ongoing Commission initiatives currently being considered by the European Parliament and Council, or in the process of being implemented, will provide additional tools to deal with endocrine disruptors once fully in place. These include: ·the proposal for a Regulation on transparency and sustainability of risk assessment under EU food law, which aims at increasing trust in the regulatory process, including for the assessment of substances suspected to be endocrine disruptors; ·the European Plastics Strategy, which aims to accelerate the substitution of substances of concern, including endocrine disruptors, in order to promote recycling; ·the proposal to revise the Drinking Water Directive, which adds three endocrine disruptors to the list of parameters for determining the safety of drinking water; ·the New Deal for Consumers and the Goods package, which will improve enforcement of product safety requirements and will address the illegal presence of endocrine disruptors in a variety of products; ·and the update of the existing legal framework on Occupational Safety and Health on the basis of robust scientific advice to protect workers exposed to hazardous chemicals, some of which have endocrine disrupting properties. International cooperation on endocrine disruptors The Commission and Member States actively participate to the work of the Organisation for Economic Co-operation and Development, thus contributing to the Organisation’s efforts in developing internationally agreed test guidelines on endocrine disruptors and improving coordination on the international scene. The Commission and Member States support the work of the World Health Organisation, the Strategic Approach to International Chemicals Management and the United Nations Environment Programme. The Commission and Member States also cooperate and exchange information with international partners under the auspices of the World Trade Organisation as regards EU regulatory developments which might affect trade. In addition, on a bilateral basis, information exchanges have taken place with international partners, in particular the United States, Canada, Japan and recently also China. While having different approaches on how to deal with endocrine disruptors, all partners agree on the importance of addressing the matter as a priority. Bilateral co-operation agreements with trade partners have also included setting up discussions on matters related to endocrine disruptors. 3. Taking forward the EU's policy on endocrine disruptors The Commission has always been and will remain committed to ensuring a high level of protection of EU citizens and the environment from endocrine disruptors and, at the same time, to preserve an internal market which delivers for consumers and where all EU business can thrive. The implementation of the Community Strategy of 1999 has put the EU at the forefront in understanding and regulating these hazardous chemicals. But in order to further progress and maintain the expected high level of protection, it is important to ensure that the EU framework continues to coherently address endocrine disruptors across different areas. The EU strategic approach on endocrine disruptors for the years to come should be based on the application of the precautionary principle and aim at: ·minimising overall exposure of humans and the environment to endocrine disruptors, paying particular attention to exposures during important periods of development of an organism, such as foetal development and puberty;

·accelerating the development of a thorough research basis for effective and forward-looking decision-making; ·and promoting an active dialogue allowing all stakeholders to be heard and to work together. An approach that is coherent in regulating endocrine disruptors The legislative measures constituting the EU legal framework regulating chemicals have been developed at different points in time and have, in certain cases, different objectives. This has resulted in different approaches to endocrine disruptors, depending on the sector being regulated, and has raised questions as to whether the EU legal framework regulating endocrine disruptors is sufficiently coherent. Two points in particular deserve special attention: Horizontal approach to the identification of endocrine disruptors: the Commission considers that there should be a coherent approach to the identification of endocrine disruptors across all relevant Union legislation, based on the broadly accepted definition of the World Health Organisation. The recently established criteria for pesticides and biocides constitute a first step in that direction but EU legislation in other fields does not contain such criteria. It has been argued that horizontal criteria for the identification of endocrine disruptors should be laid down in the legislation, for reasons of legal certainty and to avoid the potential risk that a substance is identified as endocrine disruptor under one piece of legislation and not under another one. This matter should be further considered. Regulatory consequences for endocrine disruptors: different regulatory approaches exist in different pieces of legislation for substances identified as endocrine disruptors. For pesticides and biocides, the co-legislators adopted specific provisions “underpinned by the precautionary principle” and based on a number of considerations. Taking for example into account the specific nature of the products in question, that endocrine disruptors are substances of particular concern, and that scientific uncertainty remains regarding their assessment (for example as regards the existence of a safe limit of exposure), they decided that once it is proven that a substance is an endocrine disruptor, the substance in principle cannot be authorised for use. There are very limited derogation possibilities. Under REACH, endocrine disruptors are specifically mentioned as substances that can be identified as Substances of Very High Concern and, if prioritised, are subject to authorisation requirements. Restrictions can also apply to endocrine disruptors. Other legislative instruments, such as for example the Regulation on cosmetics, although they do not mention endocrine disruptors specifically, consider them like other substances that can negatively affect human health. Some stakeholders have argued that, in some areas, EU legislation does not provide adequate regulatory approaches to address endocrine disruptors effectively. This matter deserves further examination. In line with the Commission's Better Regulation agenda and the commitment to ensure that EU laws remain fit for purpose, different evaluations have been carried out or are under way which are relevant, to different extents, for the topic of endocrine disruptors. However, no single evaluation has so far covered all the different vertical and horizontal aspects of endocrine disruptors. → The Commission will launch a Fitness Check to assess whether relevant EU legislation on endocrine disruptors delivers its overall objective to protect human health and the environment by minimising exposure to these substances. The Fitness Check will for the first time take a cross-cutting look at endocrine disruptors, building on scientific evidence and the significant amount of data already collected and analysed in the context of finalised and on-going evaluations. It will allow an analysis of how the different provisions/approaches on endocrine disruptors interact, identify any possible gaps, inconsistencies or synergies, and assess their collective impact in terms of costs and benefits for human health and the environment, the competitiveness of EU farmers and industry, and international trade. It will pay particular attention to those areas where legislation does not contain specific provisions for endocrine disruptors, such as toys, cosmetics and food contact materials. Particular attention will be paid to the consistency and intensity of actions to protect vulnerable population groups that are particularly sensitive to endocrine disruptors, such as the foetus or adolescents. The Fitness Check will allow for a comprehensive consultation of EU citizens and stakeholders, including through a public consultation. Overall, it will help assess whether legislation is fit for purpose in line with Better Regulation requirements and feed into the reflection on whether legislative changes are necessary. An approach based on the most up-to-date scientific evidence EU decision-making is evidence-based. Continued support to research is therefore essential if the EU wants to further deepen understanding of endocrine disruptors and constitute a strong basis for effective policy-making. → In its future framework programme for research and innovation, Horizon Europe, the Commission will continue to ensure the necessary support to research on protecting citizens and environment from exposure to harmful chemicals, including endocrine disruptors, building on the work under the current framework programme, Horizon 2020.