CEA offers customised advice on the evaluation of substances for endocrine activity and CEA experts can conduct hazard, exposure, and risk assessments in relation to endocrine disrupting properties.
Endocrine disruptors (EDs) are a topic of significant current debate and concern. There is a growing interest in understanding EDs and progress has been made in both the science and policy in this area. Endocrine disruption (ED) is a relatively new area of toxicology. The term ED first came to prominence in 1987, however, no significant development in the area was seen for the first twenty years with most of the research activity and knowledge generation occurring in the last 14 years. This is illustrated in Figure 1 which shows the number of publications in the area of ED over the last 50 years. The subject is still under scientific debate and continues to evolve. In terms of legislation and policy, there are significant challenges ahead, particularly as there is difficulty in evaluating the precise impact of endocrine disrupting chemicals on the health of humans and other organisms.
Figure 1 Literature search with key words “endocrine and disruptor” ~2000 compared with ~1000 entries “skin sensitizer”. Source: pubmed
The EU response to endocrine disruptors has developed over the last twenty years (Community Strategy for endocrine disruptors, 1999). The most recent guidance document produced jointly by ECHA and the European Food Safety Authority (EFSA), and applicable to Biocidal Products (BP) and Plant Protection Products (PPP), provides a detailed methodology for gathering, evaluating and considering all relevant information and fulfilling these regulatory obligations.
Within the US, Section 408(p) of the Federal Food Drug and Cosmetic Act (FFDCA) has required the Environmental Protection Agency (EPA) to develop a screening program using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an ED effect in humans.
Recent amendments have been made to BP Regulation (Regulation (EU) 528/2012) and the PPP Regulation (Regulation (EC) 1107/2009). Regulation (EU) 2017/2100 and Regulation (EU) 2018/605 set out the scientific criteria for the assessment of endocrine-disrupting properties and came into force during 2018. This means that new BP and PPP actives and BP and PPP actives currently going through the authorisation process will need to have an endocrine disrupter assessment included as part of their application.
For BP, exceptions can be made when it can be demonstrated that there is negligible risk, the necessity to combat serious pests or the likelihood of disproportionate negative impacts on society. For PPP, exceptions can be made when it can be demonstrated that there is negligible exposure or that there is a need to combat serious pests.
Under the REACH regulation (EC 1907/2006), Chapter R.7a details the assays that may be used to indicate endocrine activity (Uterotrophic and Hershberger Assays). A substance that is considered to have endocrine disrupting properties is considered to be a Substance of Very High Concern (SVHC) and may become subject to authorisation and restriction. Recently the number of substances recognised as ED increased to 18 after a recently published update (July 2019).
This Regulation is under review, so far EDs are not yet restricted but this may be facilitated via REACH.
Currently the EPA is managing a science-based Endocrine Disruptor Screening Program (EDSP) that uses a two tiered approach to screen pesticides, chemicals, and environmental contaminants for their potential effect on oestrogen, androgen and thyroid hormone systems.
EPA has not published any official list of confirmed EDs and are taking a risk based approach to the management of EDs by assessing the typical exposure levels experienced by humans and wildlife and determining whether it is necessary to limit or ban the use of certain chemicals.
How CEA can help you with endocrine disruptor assessments
Our team includes experts in the area of ED. This expertise can be leveraged for the full spectrum of potential ED needs that you may have, from early stage assessment, literature and database review, QSAR evaluation and scheduling, managing and reviewing ED assays.
CEA experts have experience working with the template (Appendix E1 “Excel template for reporting effect”) that is recommended by the ECHA/EFSA guidance. Expert assessment of the resultant “Lines of evidence” for adversity and endocrine activity is then undertaken. We have a long-established expertise in conducting comprehensive literature and database searches, selecting relevant studies and judging their scientific adequacy and quality.
Please contact us if you would like further information on our services in this area or if you have a specific enquiry concerning the assessment of endocrine disruption potential of one of your products.
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We have undertaken several plant protection product evaluations with regards to endocrine disruptor potential in humans and wildlife to comply with the amendment to the plant protection products regulation (Regulation (EU) 2018/605). The information was collated and evaluated according to the guidance of the European Chemicals Agency (ECHA) and European Food Safety Authority (EFSA).
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products; https://eur-lex.europa.eu/eli/reg/2012/528/oj
Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009; https://www.efsa.europa.eu/en/efsajournal/pub/5311