At the request of the European Commission, the European Food Safety Authority (EFSA) is preparing a scientific opinion on the human health and environmental risks associated with the possible presence of endocrine disruptors in the food chain. In co-operation with other European scientific advisory bodies, EFSA’s Scientific Committee is undertaking a review of all the current scientific information on endocrine active substances (not all of which may have disrupting properties), with a view to evaluating possible approaches for their identification and methods to assess the hazards they may pose. The opinion will also feed into EFSA’s ongoing and future scientific work in such areas as food contact materials, pesticides and contaminants in food and feed, and help to inform the decisions of risk managers with regard to endocrine active substances.
The endocrine (or hormonal) system plays a crucial role in maintaining the physiological equilibrium of the human body as well as in regulating body growth, metabolism and sexual development and function. Endocrine active substances can be both man-made (including hormone substitutes) and naturally-occurring (for example phytoestrogens which are present in plants such as soy and nuts). They may behave similarly to human hormones or influence the hormone levels in the body and thereby have effects on human health and organisms in the environment, particularly at critical stages of development.
Scheduled for March 2013, the opinion of EFSA’s Scientific Committee will take stock of the available scientific information and seek to answer three key questions: i) what scientific criteria are used for identifying endocrine disruptors, ii) what criteria can be applied to distinguish potential adverse effects of an endocrine disruptor from the normal regulation of body function in humans and the ecosystem (for example, changes in body temperature in humans and animals, or changes in photosynthetic activity in plants), and iii) do existing toxicity testing methods appropriately cover the effects of endocrine active substances.
The opinion will be based on an evaluation of existing information, current insights and scientific work on endocrine active substances, including ongoing work by the Organisation for Economic Co-operation and Development, the European Commission’s 2012 report on “State of the Art Assessment of Endocrine Disrupters” and the proceedings from EFSA’s June 2012 Scientific Colloquium on low dose response in toxicology and risk assessment. With a view to ensuring consistency, other EU scientific advisory bodies involved in the risk assessment of endocrine active substances will participate in the development of this opinion: the European Medicines Agency, the European Chemicals Agency, the European Environment Agency, the European Commission’s Scientific Committees and the Joint Research Centre.
The human endocrine system consists of hormone-producing glands that regulate and control our bodies in various ways. Hormones play a crucial role in regulating body growth, metabolism and sexual development and function. Population groups such as unborn babies, infants, and children are particularly sensitive to hormonal activity due to their being at critical stages of development, so-called “windows of susceptibility”.
“In this report, ‘Endocrine active substance (EAS)’ is used to describe any chemical that can interact directly or in-directly with the endocrine system, and subsequently result in an effect on the endocrine system, target organs and tissues. Whether the effect is adverse (“disruptive”) or not will depend on the type of effect, the dose and the background physiological situation.” Scientific report of the Endocrine Active Substances Task Force, 2010, European Food Safety Authority, Parma, Italy.
“An endocrine disrupter is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations.”, International Programme on Chemical Safety, 2002. Global Assessment of the State-of-the-Science of Endocrine Disruptors. World Health Organization, Geneva, Switzerland.
Examples of endocrine disrupting chemicals sometimes found in regulated food and feed products include several pesticides, environmental pollutants like dioxins and PCBs. Examples of substances naturally present in food which may exert hormonal effects are plant phytoestrogens such as isoflavones, which are often present in nuts, oilseeds and soy products, and glycyrrhetic acid in liquorice, which may disrupt the hormonal regulation of the balance of minerals and fluids (or ‘electrolytic balance’) in blood and various organs, important for the regulation of blood pressure.
In 2010, EFSA’s Scientific Committee established an Endocrine Active Substances Task Force, with the support of EFSA’s Advisory Forum of national competent authorities, to clarify the state-of-play on endocrine active substances and to provide recommendations for scientific and communication issues. Scientific report of the Endocrine Active Substances Task Force.
Endocrine activity is only one of a number of different toxicological effects which EFSA’s scientists regularly take into consideration during the four stages of the Risk Assessment Process:
1. Hazard identification – the identification of adverse health effects caused by biological, chemical, and physical agents that may be present in a particular food and feed or group of foods and feeds.
2. Hazard characterisation – the qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents that may be present in food and feed.
3. Exposure assessment – the quantitative estimation of the likely exposure of humans and animals to the food and feed derived from the biological, chemical and physical agents that may be present in food and feed.
4. Risk characterisation – the qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment.