Endocrine Disruption

BP and PPP

Biocidal Products (BP) and Plant Protection Products (PPP) are  regulated in the European Union (EU) by the BPR (Regulation (EU) 528/2012) and the PPPR (Regulation (EC) 1107/2009), each of which aims to harmonise the registration of BP and PPP, respectively, throughout the EU. The use of such products should be acceptable to potentially-exposed humans and other non-target animals, and to the environment.

Recent amendments to both regulations (Regulation (EU) 2017/2100 and Regulation (EU) 2018/605, respectively) set out the scientific criteria for the assessment of endocrine-disrupting properties and came into force during 2018. A guidance document produced jointly by ECHA and the European Food Safety Authority (EFSA), and applicable to BP and PPP, provides a detailed methodology for gathering, evaluating and considering all relevant information and fulfilling these regulatory obligations. It recommends the use of a template (Appendix E1 “Excel template for reporting effect”) and provides accompanying instructions (Appendix E2 “Guidance to fill in the ‘Data’ sheet template”), both available by clicking on “Supplements” in the top left-hand corner of the guidance webpage. Expert assessment of the resultant “Lines of evidence” for adversity and endocrine activity is then undertaken.

Bibra has experience in the use of the Appendix E1 Excel template and subsequent assessment of the Lines of evidence.

 

REACH

Endocrine disruption is not, in isolation, a standard information requirement under the REACH regulation (EC 1907/2006). However, the REACH Endpoint specific guidance (Chapter R.7a) discusses the information provided by the Uterotrophic and Hershberger Assays, and how these can support a REACH registration. Evidence of endocrine-mediated effects in standard repeated-dose or reproductive/developmental toxicity studies can be a trigger for further testing, for example the inclusion of additional cohorts in the extended one-generation reproductive toxicity study (EOGRTS). Further, 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.

 

EASIS

The European Commission has made available a web-based application through which the key studies (both in vitro and in vivo) on a chemical’s endocrine-disrupting properties can be identified. The Endocrine Active Substances Information System (EASIS) can be searched by Chemical Abstract Service Registry Number (CAS RN) or by name and lists critical effect levels (such as no-observed-adverse-effect levels (NOAELs)) and bibliographic references.

 

Recent work in this field

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