Endocrine disruptors

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.

Guidance for the identification of endocrine disruptors

The European Commission has requested both ECHA and the European Food Safety Authority (EFSA) with support by the Joint Research Centre (JRC) to develop a common guidance document for implementing the hazard-based criteria to identify endocrine disruptors 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 were published on 20 December 2016.

Public consultation

A public consultation on the draft Guidance document for identification of endocrine disruptors in the context of the Biocides and Plant Protection Products regulations was started on 7 December 2017 and ended on 31 January 2018.

The draft guidance document is currently subject to revision whereby the comments received in public consultation (more than
2 000) are taken into account as well as feedback received on the practical applicability of the guidance at a workshop with Member State competent authorities and stakeholders from industry and public interest organisations (held in Brussels on 1-2 February).

The revised guidance document will be subject to two further consultations of the relevant scientific risk assessment bodies (i.e. the ECHA Biocidal Products Committee, the EFSA Scientific Committee and PPR Panel, and the EFSA Pesticides Steering Network) and of the risk management bodies (the representatives of Member State competent authorities for the implementation of the Biocidal Products Regulation and the Standing Committee on Plants, Animals, Food and Feed Section Phytopharmaceuticals – Plant Protection Products – Legislation).

The final guidance document will be published in June - when the ED-criteria for biocides become applicable.