Endocrine disruptors are chemicals that may interfere with the hormonal system and thereby produce harmful effects in both humans and wildlife.
In all organisms, hormones link the nervous system and bodily functions such as growth and development, immunity, metabolism, reproduction and behaviour.
Substances that interact with the hormonal system but do not cause harmful effects are called hormonally or endocrine active substances. However, the line between endocrine activity and endocrine disruption is not always clear because, in some cases, the effect may only become evident after a delay.
A wide range of substances, both natural and man-made, may cause endocrine disruption. Sometimes, the effects caused by an endocrine-disrupting substance are only seen long after the exposure. For example, the exposure of a foetus in the womb to an endocrine-disrupting substance may lead to effects that affect the health of the adult and possibly also future generations.
In wildlife, effects that may be related to endocrine disruption have been seen in molluscs, crustaceans, fish, reptiles, birds and mammals in various parts of the world. In some species, impaired reproduction has caused a decrease in the population.
In humans, public health studies have suggested that endocrine disruptors may have been responsible for changes in recent decades, including declining sperm counts, increased numbers of male children born with genital malformations, and rising cases of certain types of cancer that are known to be sensitive to hormones. More controversially, links have been suggested with impairment in neural development and sexual behaviour.
Under REACH, endocrine disruptors can be identified as substances of very high concern alongside chemicals known to cause cancer, mutations and toxicity to reproduction. The aim is to reduce their use and ultimately replace them with safer alternatives.
Under the Biocidal Products Regulation, active substances, which are considered as having endocrine-disrupting properties will not be approved unless the risk from exposure to the active substance is shown to be negligible or unless there is evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment.
The European Commission has requested ECHA and the European Food Safety Authority (EFSA) to develop, with the support of the Joint Research Centre (JRC), a common guidance document for implementing the hazard-based criteria to identify endocrine disruptors (EDs) in the context of the Plant Protection Products Regulation (EC) No 1107/2009 and the Biocidal Products Regulation (EU) No 528/2012.
The outline of this guidance document, including a plan of the drafting process, timelines and consultations with relevant parties, was published on 20 December 2016.
Drafting of the guidance has since been finalised and the final document will be published in the EFSA Journal by July 2018. A link to the pre-publication version is available in the ‘Related’ section below.
The guidance provides advice to applicants and assessors of competent regulatory authorities on how to identify EDs in accordance with the ED criteria. An approach is set out for analysing the information that needs to be provided in a dossier submitted for approval of a substance in the context of the Biocidal Products or Plant Protection Products Regulations.
Like the criteria to identify EDs, the guidance document is based on the WHO/IPCS definition of an endocrine disruptor. The assessment strategy is based on the requirements outlined in the ED criteria. It describes how to gather, evaluate and consider all relevant information for the assessment, conduct a mode of action (MoA) analysis, and apply a weight-of-evidence (WoE) approach, in order to establish whether the ED criteria are fulfilled. In addition, an overview is given on the information sources that may provide suitable information for ED identification and therefore should be considered for the assessment. In line with the general principle of desired reduction of unnecessary animal testing, the assessment strategy aims at making the most efficient use of the available data to reach a sufficiently robust conclusion.
The focus is on vertebrate organisms (including humans), for which the current understanding of the endocrine system and availability of test methods is most advanced, i.e. mammals, fish and amphibians. Due to the scarce knowledge on the endocrinology of invertebrate species, the guidance does not cover those organisms.
The guidance document has been drafted by a team of scientific staff of ECHA and EFSA, with support by the Joint Research Centre (JRC), following the request of the European Commission to develop a common guidance document for the implementation of the scientific criteria for the determination of endocrine-disrupting properties in biocidal products and plant protection products.
The guidance has been subject to several consultations. Comments received and responses to the comments will be made available in the context of the publication of the guidance in the EFSA Journal. In 2017, there were two consultations with an ad hoc consultation group of Member State experts and stakeholders, followed by a public consultation in December 2017–January 2018. A further consultation of risk assessors from competent authorities in the plant protection and biocidal product sectors in parallel with the EFSA Scientific Committee and the EFSA Panel on Plant Protection Products and their Residues was carried out in April 2018. Finally, the competent authorities for biocidal products and for plant protection products – the representatives of Member State competent authorities for the implementation of the Biocidal Products Regulation and the Phytopharmaceuticals – Plant Protection Products – Legislation section of the Standing Committee on Plants, Animals, Food and Feed – were consulted in May 2018, before adoption of the guidance by ECHA and EFSA.