Join the second FREIA webinar

EDC IDENTIFICATION: HOW DOES IT WORK?

27 October 2020, 15PM in Brussels.

In 2018, the European Commission adopted criteria to assess whether a biocide or pesticide is an endocrine disruptor. A guidance document was written on how to do this in practice. FREIA partner Julie Boberg (Technical University of Denmark) will explain the process of ED identification, using butylparaben as an example. 

Butylparaben is often used in cosmetics to prevent microbial growth. It is on the candidate list of substances of very high concern of the European Chemicals Agency for its endocrine disrupting properties.

Not only will Dr Boberg show that butylparaben has more negative effects on reproduction than previously thought. It is also a great example that current criteria and EDC identification tools may also be suitable for other chemical regulations.

This webinar is organised by the FREIA project, with support from the Health and Environment Alliance (HEAL). Participation is free. For more details, please contact info@freiaproject.eu

Participation is free. You can register here.

A new FREIA newsletter is out

The October 2020 FREIA newsletter is released today. We are proud to share some of our research updates, recently published papers, future activities, and introduce you to our talented researcher Hanna Johansson.

Despite the covid-19 pandemic, the FREIA team has done a great job to continue working towards the FREIA goal: provide better test methods for identification of EDCs harmful for female reproductive health.

We warmly invite you to read our latest newsletter or subscribe to future newsletters at www.freiaproject.eu/subscribe

FIGO, UCSF and HEAL share 10 tips to avoid toxic chemicals during and after pregnancy

The Federation of Gynecology and Obstetrics (FIGO), the University of California – San Francisco (UCSF) and the Health and Environment Alliance (HEAL) have launched  easy-to-use infographics for obstetricians, gynecologists and health groups to create awareness around toxic chemicals and pregnancy in a one-week social media campaign.

Exposure to toxic chemicals before, during and after pregnancy jeopardizes women’s health. The infographics launched today (in English, French, German and Spanish) illustrates 10 tips that women can use for individual lifestyle and routine changes in efforts to avoid health-harming substances, as well as advice for policymakers.

You can download the infographics here on the HEAL website.

New scientific study highlights non-monotonic dose-response curves and low-dose effects of bisphenol A

A new scientific study, undertaken as part of the US CLARITY-BPA project [1], developed a quantitative assessment of the effects of bisphenol A (BPA) exposure on mammary gland development and found a consistent pattern of non-monotonic dose response relationships [2] on a set of over 90 measurements. This demonstrates a causal relationship between exposure to BPA and the health effects observed.

“A combined morphometric and statistical approach to assess non-monotonicity in the developing mammary gland of rats in the CLARITY-BPA study” [3] was published today in the journal Environmental Health Perspectives.

The study is striking because it uses both novel and standard quantitative as well as standard semiquantitative methods to analyse the effects of BPA exposure over critical windows of development: one set of experiments from gestation to weaning, and another one from gestation until tissue harvesting up to 6 months of age. Both quantitative methods reveal clear non-monotonic dose response curves, with the administration of lower doses resulting in larger effects on the development of the mammary gland at all-time points. In addition, the study tested several hypotheses regarding whether BPA and ethinyl oestradiol (EE2, a reference estrogen) produced similar effects, and compared their respective dose-response curves.

Striking findings of the study include the following: 

  • Clear statistical evidence of non-monotonic dose response curves of developmental exposure to BPA for multiple measurements;
  • break point in the dose-response curves between doses of 25 and 250 ug BPA/kg body weight/day;
  • Occurrence of non-monotonic dose response curves at all ages of the animals studied, with the same breaking point;
  • Using the same set of animals as the CLARITY-BPA core study, a statistical demonstration that the low-dose effects of BPA (e.g. mammary cancer already at 2.5 ug/kg/day) observed in the CLARITY-BPA core study are due to a causal relationship between the dose of BPA administered and its effect. This provides a counterpoint to the earlier statements according to which the low-dose effects observed were due to random events.
  • Clear statistical evidence that different estrogens can produce either similar or very different effects, depending on the endpoints being measured. This contradicts the hypothesis that BPA and ethinyl estradiol would always have similar effects.
  • Clear added-value of the novel methodology used for the mammary gland in detecting the non-monotonicity of the dose-response curve and expanding the number of properties observed in mammary glands.
  • Clear illustration of the importance of developing and using statistical methods that are appropriate to detect the non-monotonic dose responses that are relevant for endocrine disruptors, since they are not caught adequately by tools developed to exhibit linear responses.

The quantitative method elaborated in the study responds to one of the CLARITY-BPA objectives to develop software tools fit for performing automatic evaluation of aspects of the mammary glands and determining dose-response curves. In other words, this method allows to assess several aspects of mammary gland morphology that are not accessible by manual assessments.

The mammary gland has been considered a particularly sensitive endpoint for endocrine disruption, with measurable effects seen at low levels of exposure and earlier than cancer occurrence. Testing of this endpoint as part of animal studies is thus of particular relevance for the regulatory safety assessment of EDCs.

Natacha Cingotti, senior health and chemicals policy officer at the Health and Environment Alliance (HEAL) said: “This study is yet another confirmation that exposure to even low doses of bisphenol A can be harmful to health and that it is not possible to set safe doses of exposure to this widely-used endocrine disruptor. BPA should be fully banned from consumer products and food packaging, and the tolerable daily intake needs to be further reduced.” 

“As European institutions are drafting proposals for a revised framework to regulate endocrine disruptors, the promise to effectively protect people from their potential health effects must be based on the assumption that there are no safe levels of exposure, and that avoiding human exposure to such substances must be the top priority.”

A ‘questions and answers’ in relation to this study have been made available for download here.

Background

Bisphenol A is registered in Europe as a high-volume chemical and it is used in the production of numerous plastic products or coatings that are applied in a myriad of applications for packaging or industrial processes [4]. Exposure to BPA has been linked to several significant health conditions such as reproductive disorders, increased cancer risks (e.g. breast and prostate cancer), metabolic disorders such as obesity and diabetes, altered immune system, effects on the nervous, immune, and effects on brain development and behaviour, including in children.

BPA is on the European Chemical’s Agency (ECHA)’s candidate list of substances of very high concern, due to its reproductive toxicity and its endocrine disrupting properties for human health and the environment [5].

The European Food Safety Authority (EFSA) is currently re-assessing the potential hazards of BPA in food. The conclusion of its assessment is expected later in 2020 [6].

Notes

This article is re-posted from the HEAL website. View the original post here.

[1] The CLARITY-BPA project is a US research project designed in 2012 to examine differences between academic-led studies and test results and those carried out under Good Laboratory Practices, which are heavily relied on by regulatory agencies, when it comes to the safety assessment of bisphenol A. Bringing together the National Institute of Environmental Health Sciences, the US National Toxicology Program, the US Food and Drug Agency, as well as independent academics, the aim of the project was to overcome recurring differences in test results about the safety of bisphenol A

[2] Non-monotonic dose response curves (NMDRs) describe a dose-response relationship characterized by a curve, of which slope changes direction within the range of tested doses. For more information, see: https://www.endocrine.org/advocacy/position-statements/endocrine-disrupting-chemicals ; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6137554/pdf/10.1177_1559325818798282.pdf ; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4429934/pdf/12940_2014_Article_851.pdf

[3] Maël R. Montévil et al. “A combined morphometric and statistical approach to assess non-monotonicity in the developing mammary gland of rats in the CLARITY-BPA study”, Environmental Health Perspectives,  https://dx.doi.org/10.1289/EHP6301

[4] https://echa.europa.eu/substance-information/-/substanceinfo/100.001.133

[5] https://echa.europa.eu/candidate-list-table/-/dislist/details/0b0236e180e22414

[6] EFSA, BPA update: working group to start reviewing new studies, 4 September 2018, https://www.efsa.europa.eu/en/press/news/180904

FREIA FACTSHEET out now!

With great pleasure, we announce the release of our first FREIA factsheet and infographic on endocrine disrupting chemicals (EDCs) and women’s reproductive health. Both are available in multiple languages.

It is beyond a doubt that endocrine disrupting chemicals (EDCs) impact the health of humans and the environment globally. Surprisingly, we still don’t know exactly how EDCs can harm female reproductive health.

With this factsheet and infographic, we hope to help people understand better what EDCs are and the impact EDCs have on women’s health“, says Majorie van Duursen – coordinator of FREIA. “It also addresses where the challenges lie with regulating EDCs in Europe and how FREIA aims to contribute to protective chemical regulations“.

The factsheet was written together with Health and Environment Alliance (HEAL) and is endorsed by the International Federation of Gynecology and Obstetrics (FIGO) and the International Federation of Fertility Societies (IFFS).

We are extremely happy with such strong partners in communication and advocacy on women’s health issues. It shows the wide-spread concern about environmental impact on women’s health, beyond the academic community. By joining forces we can reach a broader audience and create more awareness for this pressing matter“, according to Van Duursen.

EC asks input from public on EDCs

As part of their strategy for endocrine disruptors, the European Commission will take a cross-cutting look at the approach to endocrine disruptors’ assessment and management in a broad range of legislation.

This “Fitness Check”  includes two public consultations: a public consultation (designed from a citizen’s perspective) and a stakeholder consultation (designed for stakeholders and experts).

You can have your say! The online survey can be found here and is open for comments until 31 January 2020.

FREIA is well on track

The FREIA consortium met on 29-30 October 2019 to share updates on the work progress. All partners were represented by one or more researchers at the meeting that was hosted by VU Amsterdam.

The first results from the laboratory experiments and computational modelling were presented to the partners. There was some exchange of views on which EDCs should be measured in the human samples that are available within FREIA.

Coordinator Majorie van Duursen: “it was so great to see the enthusiasm and dedication of this wonderful group. We are well on schedule with the planned work”.

Besides the experimental work, the FREIA consortium is working on a review paper to describe how EDCs cause female reproductive health issues. The paper is expected to be published early 2020. Future activities to communicate FREIA goals were also on the agenda. Many great ideas were formed on newsletters and webinars.

All in all, it was a very productive meeting with great promise to achieve FREIA goals.

EC organises forum on EDCs

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The European Commission is organising the first annual Forum on Endocrine Disruptors on 8 November at the EC Conference Centre Albert Borschette.

The Forum will bring together scientists, public and private stakeholders with expertise on endocrine disruptors to exchange information and best practices, identify challenges and build synergies, in order to inform the Commission’s reflections.

The programme will include presentations on the latest state of science and human health protection, on national action plans on endocrine disruptors, and on the European Commission’s work on the fitness check to assess whether relevant EU legislation on endocrine disruptors delivers its overall objective to protect human health and the environment.

This Forum is one of the actions in the Commission Communication of November 2018 « Towards a comprehensive European Union Framework on Endocrine Disruptors », outlining a strategic approach to endocrine disruptors for the years to come, with the ultimate goal of ensuring a high level of protection of EU citizens and the environment as well as to preserve an internal market.

There is the possibility to follow the event via webcast or watch the video of the event afterwards. Both services will be made available here.

European regions call for higher level of protection against EDCs

JUNE 27, 2019 Two months after the European Parliament resolution on the negative impact of a number of chemicals used in food and cosmetics production in the EU, local and regional representatives have called on the European Commission to provide a higher level of protection from hazardous chemicals. According to studies, endocrine disruptors, or EDCs, have a harmful effect on the work of the body’s hormones, leading to infertility, obesity and cancers. In children, they are increasingly linked to autism and other conditions.

FREIA kick-off!

JANUARY 28, 2019 | The FREIA project has started with a kick-off meeting in Hotel Zuiderduin (Egmond aan Zee, The Netherlands) on 28 and 29 January 2019. The sister projects ATHENA, ENDpoiNTs, and GOLIATH were having their kick-off meeting at the same venue. The official EU launch was held adjacently in Brussels on 31 January.