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Endocrine Society

The Endocrine Society is a global organization for hormone research and clinical endocrinology.

Lobbying Activity

Meeting with Alina Nedea (Cabinet of Executive Vice-President Teresa Ribera Rodríguez), Petra Nemeckova (Cabinet of Executive Vice-President Teresa Ribera Rodríguez) and European Society of Endocrinology

5 Mar 2025 · To hear interest representative’s view on the impact of Endocrine Disrupting Chemicals on health.

Meeting with Jessika Roswall (Commissioner) and

5 Mar 2025 · REACH and the regulation of endocrine disruptors

Meeting with Giuseppe Casella (Head of Unit Internal Market, Industry, Entrepreneurship and SMEs)

4 Mar 2025 · endocrine disrupting qualities of PFAS and risk assessment of EDC

Meeting with Javi López (Member of the European Parliament, Rapporteur) and European Society of Endocrinology

4 Mar 2025 · Water pollutants

Response to Commission Roadmap to phase out animal testing

14 Oct 2024

The Endocrine Society appreciates the opportunity to provide input on the forthcoming Commission Roadmap to phase out animal testing. As the worlds oldest, largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology our membership consists of over 18,000 scientists, physicians, educators, nurses, and students in more than 100 countries, including the worlds leading experts on the health effects of endocrine-disrupting chemicals (EDCs). Our Society welcomes the development of new approach methodologies (NAMs) defined as technologies and approaches (including computational modeling, in vitro assays, and testing using alternative animal species) to reduce the use of vertebrate animals in regulatory assessments and ensure a high level of human health protection . However, we caution that NAMs have not been sufficiently developed to comprehensively assess biological complexity. Moreover, certain biological processes, including many developmental pathways that, if perturbed, result in later-life effects, may never be sufficiently replicated via NAMs to achieve the high level of protection required. To be clear, the Endocrine Society supports the adoption of new or non-animal test methods when they demonstrably reflect human biological understanding as well as or better than traditional methods. Currently, most non-animal methods do not achieve this standard for important endocrine endpoints. For example, non-animal methods do not adequately address the critical role of thyroid hormone in neurodevelopment. At present, NAMs are suitable for screening to identify hazards currently uncharacterized by animal studies. However, due to their limitations NAMs should not be used to invalidate positive results from human or animal studies, nor should they be used in isolation to determine that a chemical is safe. This position is consistent with the assessments of multidisciplinary scientific bodies, such as the United States National Academies of Science, Engineering and Medicine. To achieve the stated goals of the Roadmap, we argue that regulatory agencies should make more efficient use of data that currently exists by: 1. Adopting group-based approaches to chemical assessments that utilize read-across to apply positive hazard data from one chemical to others in the same group. 2. Systematically incorporating data from academic labs. 3. Harmonizing assessments across agencies for chemicals that often have multiple exposure scenarios e.g., bisphenols, phthalates, PFAS. 4. Supporting observational research in humans (e.g. cohort studies) is a way to provide relevant information for issues related to the impact of environmental factors on health. Finally, we note that policies to adopt NAMs to the exclusion of traditional methods may be inconsistent with legal text requiring that EDCs be identified based on an adverse effect in an intact organism. We therefore urge regulatory agencies to clearly describe how hazard data from NAMs will be accepted and used as a basis for restrictions and other controls before policies mandating their use are adopted. Thank you for considering these comments; our members look forward to working with the Commission as the Roadmap takes shape to ensure that assessments for endocrine disruption are science-based and health protective, while minimizing the use of animals in testing.
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Endocrine Society urges broader ban on bisphenols in packaging

7 Mar 2024
Topic — European Commission proposal restricting bisphenol A and similar chemicals in food packaging.
Message — The Society supports banning BPA and urges restrictions on suspected hazards to prevent regrettable substitutions. They caution against exempting recycled materials and call for assessments that account for low-dose effects.12
Why — Stricter regulations would validate their scientific research and better protect public hormonal health.3
Impact — The recycling industry faces higher costs if hazardous bisphenols are not exempt.4
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Response to 8th Environment Action Programme – Mid-term Review

26 Jan 2024

The Endocrine Society appreciates the opportunity to comment on the mid-term review of the 8th Environment Action Programme (EAP) in support of the vision of living well, within planetary boundaries. Founded in 1916, the Endocrine Society is the worlds oldest, largest, and most active organization dedicated to the understanding of hormone systems and the clinical care of patients with endocrine diseases and disorders. Our membership of over 18,000 includes researchers who are making significant contributions to the advancement of knowledge in toxicology, especially in the field of endocrine‐disrupting chemicals (EDCs). Within the EAP as described, we enthusiastically welcome the prioritization of a transition to a non-toxic circular economy and pursuing zero pollution, including in relation to harmful chemicals and protecting the health and well-being of people, animals, and ecosystems. Minimizing exposure to hazardous EDCs is central to these priorities, and while we are encouraged that the EAP recognizes the need to swiftly substitute endocrine disruptors and other substances of very high concern and address combination effects of chemicals on health and the environment there is a need for regulation to effect such actions, and these legislative proposals have not yet been presented by the Commission. To ensure that the Commission can meet these priorities and objectives related to chemicals, headline indicators should be developed that will provide an estimate or measure of the totality of hazardous chemicals used across the economy and introduced to the environment. For example, an estimate of the combined production volumes of classes of chemicals, inclusive of chemicals that have been shown to have adverse effects on endocrine systems such as bisphenols, phthalates, flame retardants (including novel brominated and chlorinated chemicals), PFAS and other fluorinated compounds, would provide a benchmark value that authorities could measure against to assess effectiveness at reducing chemical exposures to human health and wildlife. We stress that recycling, while necessary to achieve a circular economy, does not eliminate the potential exposure to hazardous chemicals used e.g., in plastics, which include EDCs; therefore indicators assessing human population and environmental chemical exposures themselves are necessary in the context of the priorities and objectives addressing chemicals. Consistent with needs and objectives identified through the HBM4EU project, indicators should include human and environmental biomonitoring for chemical exposures, including EDCs, in combination with health examination studies. Such indicators should be measured on a regular basis to assess progress in improving public and environmental health. Thank you for considering our comments, we look forward to engaging with the Commission and agencies in pursuit of the vision of the EAP.
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Endocrine Society urges rapid adoption of chemical hazard classes

30 Mar 2023
Topic — The EU is updating rules for classifying and labeling hazardous chemical substances.
Message — The Society supports the rapid implementation of new hazard classes and categories for endocrine disrupters. They argue these categories are critical for assessing substances that negatively impact public health.12
Why — This would help medical professionals reduce the incidence of hormone-linked chronic diseases.3
Impact — Manufacturers of bisphenols and PFAS would face more difficult chemical substitution processes.4
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Meeting with Elena Montani (Cabinet of Commissioner Virginijus Sinkevičius)

1 Feb 2023 · To discuss the latest science on the harmful impacts of exposure to endocrine disruptors (EDCs)

Endocrine Society urges broader definitions for endocrine disruptor classification

18 Oct 2022
Topic — Revision of EU rules for classification, labeling, and packaging of hazardous chemicals.
Message — The Society requests aligning definitions with the WHO to ensure all endocrine alterations are captured. They also recommend removing concentration limits for mixtures, arguing there are no safe exposure thresholds.12
Why — Stricter classifications would help the organization achieve its mission of minimizing exposure to hazardous chemicals.3
Impact — Chemical companies would lose the ability to market mixtures containing low-level endocrine disruptors without labels.4
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Meeting with Maria Arena (Member of the European Parliament)

18 May 2022 · Rencontre

Meeting with Martin Hojsík (Member of the European Parliament)

17 May 2022 · Chemicals policy, EDCs, media activities

Response to Revision of EU legislation on hazard classification, labelling and packaging of chemicals

1 Jun 2021

For references please see the attached document. A. Context and Problem The Endocrine Society welcomes the proposal to revise the European Union (EU) legislation on Classification, Labeling and Packaging of chemicals (CLP) to align legislation with the objectives described in the Chemicals Strategy for Sustainability (CSS). As the world’s leading experts on the subject of chemical interference with endocrine systems, our comments propose several recommendations that would allow EU regulators to more effectively minimize exposure to endocrine-disrupting chemicals (EDCs) and thereby reduce the incidence of chronic diseases associated with EDC exposure such as cancer, diabetes, neurodevelopmental disease and infertility. B. Objectives and Policy Options EDCs should be included as a critical hazard class: There are several features of EDCs that require special consideration by regulatory agencies when evaluating these chemicals for health effects . For example, the effects of EDCs can be seen at extremely low levels, often display non-monotonic dose responses (NMDR) , and may act on multiple generations through epigenetic effects . In addition to a special hazard class for known EDCs, a separate class of suspected EDCs should be included with regulatory consequences to allow protective actions to apply to many more EDCs. The suspected category is necessary because despite abundant information generated about individual and classes of chemicals, only 20 chemicals have met regulatory thresholds for identification as EDCs. Improved data requirements for EDCs are necessary: For revisions to the CLP regulation to have the desired effect, these changes must be coupled to updates to REACH requirements to improve and update data provisions for effects on endocrine systems and other particularly concerning hazards such as neurodevelopment and immune systems in order to provide sufficient data for accurate identification. Newer testing and screening methods should be developed and implemented that take advantage of the latest science to make use of more sensitive, clinically relevant endpoints within these hazard domains, such as mammary gland and brain development. C. Assessment and Impacts Our members were extremely encouraged by important commitments in the CSS to improve public health by minimizing exposures to EDCs. Revisions to CLP should advance these commitments and prioritize protections from EDCs. In doing so, regulations will be better able to advance the social benefits of the CSS and achieve more equitable public health outcomes in particular for susceptible populations such as infants, pregnant women, and adolescents; and also low-income communities and other marginalized groups who may face disproportionate EDC exposures and effects. In conclusion, we believe that by addressing the recommendations above the revision to CLP legislation will better protect public health and reduce the impact of disease on EU citizens. Any forthcoming impact assessment studies need to adequately consider these significant benefits. We thank the Commission for considering our comments and look forward to engaging further during the open public consultation.
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Response to Revision of EU legislation on registration, evaluation, authorisation and restriction of chemicals

1 Jun 2021

Please see the attached document for additional references A. Context and problem The Endocrine Society welcomes the proposal to revise the European Union (EU) legislation on registration, evaluation, authorization, and restriction of chemicals (REACH) to align legislation with the objectives of the Chemicals Strategy for Sustainability (CSS). As the world’s experts on chemical interference with endocrine systems, we propose recommendations that will allow regulators to more effectively minimize exposure to endocrine-disrupting chemicals (EDCs) and reduce the incidence of chronic diseases linked to EDCs such as cancer, diabetes, neurodevelopmental disease and infertility. B. Objectives and Policy Options 1. Reforming authorization and restriction processes a. Extend the generic approach to risk management to EDCs: We agree with the CSS assertion that consumer products should not contain hazardous EDCs. EDCs effects are often seen at extremely low doses consistent with routine exposure and often effects at low levels are different or more harmful than effects seen at higher doses. Biomonitoring studies consistently show widespread exposure to a variety of hazardous EDCs at levels that would be expected to influence the development of disease . We support extension of the generic approach, i.e. a hazard-based approach, to EDCs similar to the approach for CMRs. A rapid response or fast-track mechanism for acting on suspected EDCs would provide more certainty for consumers. b. Move towards grouping approaches: The exponential growth in chemicals used in commercial products has created a complex set of background exposures and entire classes of EDCs with similar structure or properties (e.g., phthalates, bisphenols) . We are concerned about the potential for regrettable substitutions and endorse advancing grouping approaches to chemical regulation, as supported by the Environment Council conclusions. 2. A protective mixture assessment factor (MAF) is needed: Endocrine systems often involve complex communication networks between different organ systems where chemicals may act synergistically on the same or closely related pathways to produce new or additive effects . Disadvantaged or marginalized communities may also have different or heightened background exposure profiles that put them at greater overall risk of toxicant exposure. We support the inclusion of a protective MAF that takes into account these myriad exposure profiles and scenarios. 3. Revision of the registration requirements: There is an urgent need to improve and update data provisions for effects on endocrine systems and other particularly concerning hazards e.g., to neurodevelopment and immune systems. New testing and screening methods should be developed and implemented that take advantage of the latest science to use more sensitive, clinically relevant endpoints within these hazard domains, such as mammary gland and brain development to provide sufficient data for accurate identification. C. Assessment and Impacts Our members are encouraged by commitments in the CSS to improve health by minimizing EDC exposures. Revisions to REACH should advance these commitments and prioritize protections from EDCs. In doing so, regulations will be able to advance the social benefits of the CSS and achieve more equitable public health outcomes in particular for susceptible populations such as infants, pregnant women, and adolescents; and also low-income communities and other marginalized groups who may face disproportionate EDC exposures and effects. By addressing the recommendations above the revision to REACH legislation will better protect public health and reduce the impact of disease on EU citizens. Any forthcoming impact assessment studies need to adequately consider these benefits.
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Meeting with Thierry Breton (Commissioner) and European Environmental Bureau and

5 May 2021 · Implementation of the chemicals strategy for sustainability

Meeting with Helena Braun (Cabinet of Executive Vice-President Frans Timmermans)

8 Jul 2020 · Green Deal and EU Chemicals Strategy

Meeting with Camilla Bursi (Cabinet of Commissioner Virginijus Sinkevičius)

8 Jul 2020 · VC meeting to discuss the Green Deal and EU Chemicals Strategy

Meeting with Stella Kyriakides (Commissioner)

30 Jun 2020 · VC Meeting on Endocrine Disruptors and Health Policy

Response to Chemicals strategy for sustainability

18 Jun 2020

The Endocrine Society appreciates the opportunity to comment on the Roadmap for the Chemicals Strategy for Sustainability. The Endocrine Society is the world’s oldest, largest, and most active organization dedicated to research on hormones and the clinical treatment of patients with endocrine disease. Our global membership of over 18,000 includes expert researchers advancing our understanding of interference with hormonal systems by manufactured chemicals, called endocrine disrupting chemicals (EDCs). In 2015 an expert group examined over 1500 studies and published the Endocrine Society’s second scientific statement on EDCs. This comprehensive review concluded that EDCs are ubiquitous, and a robust convergence of scientific evidence from animal, human, mechanistic and epidemiological studies has established strong links between EDC exposure and health impacts such as obesity, diabetes, and hormone-sensitive cancers; as well as adverse impacts on neurodevelopment and neuroendocrine systems, reproductive health, and the thyroid gland. It is therefore essential that the Chemicals Strategy for Sustainability includes measures that will reduce EDC exposures and thereby improve public health. To protect the health of EU citizens the Commission should propose ambitious legislative measures as soon as possible to address common sources of EDC exposures such as cosmetics and personal care products, household products, and food packaging. Proposals need to address existing regulatory gaps in EU chemicals legislation and encourage the rapid substitution of hazardous chemicals with demonstrably safer alternatives. The Chemicals Strategy should also reflect the need to evaluate groups of chemicals that have effects on the same biological pathways, assess cumulative exposures, and the presence of mixture effects from multiple exposures. A forward-thinking strategy must incorporate the latest scientific knowledge on chemical interference with endocrine systems. Consistent with endocrine science, EDCs may display non-monotonic dose responses, have effects at extremely low levels, and one chemical may affect several endocrine pathways simultaneously. EDCs may also have transgenerational effects through epigenetic mechanisms. The Chemicals Strategy should therefore acknowledge that there may be no safe threshold of exposure for EDCs. The Strategy should also reflect the need to comprehensively protect all populations, including individuals who may be uniquely susceptible to EDC exposures. This can include susceptibility due to genetic predisposition or unusual exposure patterns, as well as individuals whose hormonal systems are not yet fully developed (e.g., infants and adolescents) or are otherwise vulnerable (e.g., women who are or may become pregnant). In the context of the current pandemic, we note that EDCs can have effects on the immune system, and that many of the chronic diseases and endocrine cancers that are linked to EDC exposures are threatening comorbidities for COVID-19. Finally, the Chemicals Strategy must recognize gaps in testing strategies and the need for an accelerated and more coherent identification process for EDCs. Current EU assessments often remain inconclusive, preventing protective measures to reduce exposures. The current battery of guideline tests are largely insufficient for identifying EDCs as they often fail to use the most sensitive endpoints. The EU should work with scientists, including endocrinologists, to identify more sensitive testing methods to detect endocrine disruption at environmentally-relevant dose ranges and incorporate these methods into testing strategies. New and alternative testing methodologies should be validated against these more sensitive methods before more widespread adoption. In conclusion, biomonitoring studies increasingly reveal the body burden of harmful EDCs in EU citizens and the EU Chemicals Strategy must accelerate measures to reduce EDC exposures.
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Meeting with Virginijus Sinkevičius (Commissioner)

3 Dec 2019 · To discuss the state of play of the science on Endocrine Disrupting Chemicals (EDC)

Response to Fitness Check on endocrine disruptors

9 Jul 2019

Please see the attached document
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Meeting with Sebastien Paquot (Cabinet of Vice-President Karmenu Vella)

20 Nov 2018 · Endocrine Disruptor Communication

Meeting with Marika Lautso-Mousnier (Cabinet of Vice-President Jyrki Katainen)

26 Sept 2017 · EU policy on endocrine disruptors

Response to Criteria to identify endocrine disruptors for biocidal products

27 Jul 2016

The Endocrine Society expresses disappointment and concern that the European Commission’s regulatory criteria published on June 15, 2016 are too narrow to effectively protect the public from endocrine-disrupting chemicals. The Endocrine Society includes over 18,000 physicians, scientists, and health care professionals devoted to the study of hormone-related diseases and disorders that affect health and quality of life for large numbers of people. Ten of our members have received Nobel Prizes for their contributions to science and medicine. We have contributed to the European Commission process of setting criteria for the definition of EDC since 2013; our detailed comments can be found at http://press.endocrine.org/edc. Our concerns have been matched by the United Nations/World Health Organization State of the Science 2012 (9) and consensus statements made by a variety of experts and expert societies (1,2,3) related to neuro-development (4), obesity (5), metabolic disorders including diabetes (6), as well as reproductive disorders and aiming at chemicals such as flame retardants (7, 8). The economic costs of these chemical-related diseases and disorders have been conservatively estimated to be in the billions of euros per year (10), but the human costs are incalculable. Despite this, the Commission has proposed criteria to identify EDCs requiring a level of certainty that are nearly unachievable scientifically. For instance, changing the WHO/IPCS definition from a chemical “altering the function of the endocrine system” to a chemical with a specific “mode of action” represents a fundamental misunderstanding of how endocrine signaling works by connecting different organ systems within the body. The criteria will inappropriately exclude chemicals that interfere with hormone actions through secondary effects on e.g., the liver. Moreover, with a single category approach, regulatory agencies will be unable to rank chemicals of concern based on the strength of the scientific evidence. Because health effects can take years or even generations to become apparent, this proposal will not protect public health; mandating that a chemical be “known” to cause adverse effects in humans suggests that a chemical would already have caused severe and obvious harms to populations, irrespective of strong preexisting scientific evidence in animals or in vitro systems. We therefore have strong concerns about the scientific validity of the Commission’s proposal. Finally, the proposed criteria exclude precautionary action on such chemicals, putting the criteria at odds with the provisions of Article 191 of the Treaty on the Functioning of the European Union which requires protecting the environment and human health. It is obvious that endocrine-related diseases and disorders are multicausal; therefore, evidence from biochemical and animal studies must be employed and prioritized to interpret human epidemiological information. Further, guideline studies should not have precedence over other reliable sources of information. A consistent approach and criteria should be applied in the same way to all studies in the regulatory process, including peer-reviewed academic literature. This manner of integration for categorization of chemicals has been well developed by IARC as we have pointed out previously (12, 13). Thus, identification based on the original WHO/IPCS definition and categorization based on the Commission’s Option 3 are the most logical and scientifically relevant approach. For a list of references used in the current statement, please see https://www.endocrine.org/advocacy-and-outreach/letters-and-alerts/society-letters
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Response to Criteria to identify endocrine disruptors for plant protection products

27 Jul 2016

The Endocrine Society expresses disappointment and concern that the European Commission’s regulatory criteria published on June 15, 2016 are too narrow to effectively protect the public from endocrine-disrupting chemicals. The Endocrine Society includes over 18,000 physicians, scientists, and health care professionals devoted to the study of hormone-related diseases and disorders that affect health and quality of life for large numbers of people. Ten of our members have received Nobel Prizes for their contributions to science and medicine. We have contributed to the European Commission process of setting criteria for the definition of EDC since 2013; our detailed comments can be found at http://press.endocrine.org/edc. Our concerns have been matched by the United Nations/World Health Organization State of the Science 2012 (9) and consensus statements made by a variety of experts and expert societies (1,2,3) related to neuro-development (4), obesity (5), metabolic disorders including diabetes (6), as well as reproductive disorders and aiming at chemicals such as flame retardants (7, 8). The economic costs of these chemical-related diseases and disorders have been conservatively estimated to be in the billions of euros per year (10), but the human costs are incalculable. Despite this, the Commission has proposed criteria to identify EDCs requiring a level of certainty that are nearly unachievable scientifically. For instance, changing the WHO/IPCS definition from a chemical “altering the function of the endocrine system” to a chemical with a specific “mode of action” represents a fundamental misunderstanding of how endocrine signaling works by connecting different organ systems within the body. The criteria will inappropriately exclude chemicals that interfere with hormone actions through secondary effects on e.g., the liver. Moreover, with a single category approach, regulatory agencies will be unable to rank chemicals of concern based on the strength of the scientific evidence. Because health effects can take years or even generations to become apparent, this proposal will not protect public health; mandating that a chemical be “known” to cause adverse effects in humans suggests that a chemical would already have caused severe and obvious harms to populations, irrespective of strong preexisting scientific evidence in animals or in vitro systems. We therefore have strong concerns about the scientific validity of the Commission’s proposal. A second point of concern is the introduction of negligible risk in the derogation of the EU pesticide law. This is de facto opening the door for potency considerations, which was criticized as a problematic concept elsewhere (11). Finally, the proposed criteria exclude precautionary action on such chemicals, putting the criteria at odds with the provisions of Article 191 of the Treaty on the Functioning of the European Union which requires protecting the environment and human health. It is obvious that endocrine-related diseases and disorders are multicausal; therefore, evidence from biochemical and animal studies must be employed and prioritized to interpret human epidemiological information. Further, guideline studies should not have precedence over other reliable sources of information. A consistent approach and criteria should be applied in the same way to all studies in the regulatory process, including peer-reviewed academic literature. This manner of integration for categorization of chemicals has been well developed by IARC as we have pointed out previously (12, 13). Thus, identification based on the original WHO/IPCS definition and categorization based on the Commission’s Option 3 are the most logical and scientifically relevant approach. For a list of references used in the current statement, please see https://www.endocrine.org/advocacy-and-outreach/letters-and-alerts/society-letters
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Meeting with Vytenis Andriukaitis (Commissioner) and

29 Feb 2016 · Criteria for endocrine disruptors