Regulatory identification of BPA as an endocrine disruptor: Context and methodology

Abstract

BPA is one of the most investigated substances for its endocrine disruptor (ED) properties and it is at the same time in the center of many ED-related controversies. The analysis on how BPA fits to the regulatory identification as an ED is a challenge in terms of methodology. It is also a great opportunity to test the regulatory framework with a uniquely data-rich substance and learn valuable lessons for future cases. From this extensive database, it was considered important to engage in a detailed analysis so as to provide specific and strong evidences of ED while reflecting accurately the complexity of the response as well the multiplicity of adverse effects. An appropriate delineation of the scope of the analysis was therefore critical. Four effects namely, alterations of estrous cyclicity, mammary gland development, brain development and memory function, and metabolism, were considered to provide solid evidence of ED-mediated effects of BPA.

Chronic exposure to a pollutant mixture at low doses led to tissue-specific metabolic alterations in male mice fed standard and high-fat high-sucrose diet

“…In addition, they are considered as metabolism disrupting chemicals (Casals-Casas and Desvergne, 2011;Heindel et al, 2017). Notably, BPA whom worldwide production reached millions of tons yearly and which is mainly used in the manufacture of 6 plastics and resins, has been well identified as triggering metabolic disturbances acting among others through estrogeno-mimetic activities (Alonso-Magdalena et al, 2011;Vandenberg et al, 2012;Vom Saal et al, 2012;Beausoleil et al, 2018;Le Magueresse-Battistoni et al, 2018b). Phthalates are massively produced to soften plastics.…”

Assessment of the endocrine disrupting properties of Bisphenol AF according to the EU criteria and ECHA/EFSA guidance

“…Under the European regulation of chemicals REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), substances having ED properties have to be identified as Substances of Very High Concern (SVHC) as first step towards regulation and appropriate risk management. The use of SVHC is controlled by temporary authorisations conditioning its uses and strongly encouraging its substitution (European Union, ; Beausoleil et al., ). Although REACH regulation does not provide any specific ED criteria, the European Commission last communication on EDs claimed the development of a horizontal approach for ED identification across EU legislation built on the pesticides criteria (EC Communication, ).…”

“…Accordingly, an ED substance has to show (i) endocrine adverse health effects in individuals and/or their offspring, (ii) endocrine activity through an endocrine mode of action (MoA) and (iii) a plausible and clear‐established link between the adverse effects and the endocrine MoA (Munn and Goumenou, ). However, to demonstrate that a given substance is an ED represents a huge challenge due to the complex and critical roles of the endocrine system in maintaining the homeostasis of all biological processes, as well as the multiple pathways and mechanisms involved (Beausoleil et al., ). Scientific criteria to identify substances with ED properties have been recently implemented in plant protection products (PPP) regulation (European Union, ), and biocidal products (BP) regulation (European Union, ) applying from June 2018 and November 2018, respectively.…”

Bacteria enhanced lignocellulosic activated carbon for biofiltration of bisphenols in water

“…4). The endocrine system is vital for body physiology as it is made up of certain glands that secrete hormones that help normal metabolic function and biochemical reactions (Beausoleil et al 2018 ). The glands that secrete hormones regulate all biochemical reactions in different life stages.…”