Endocrine disruptors, also referred to as endocrine active substances, hormonally active substances endocrine modulating substances or sometimes estrogenic substances are chemicals that may alter the function of the endocrine system. Some scientists have suggested that chemicals in the environment may be disrupting the endocrine systems (which includes the ovaries, testes, thyroid, etc.) of humans and wildlife. This contention is very controversial and is currently being studied by scientists in many countries. Although a variety of chemicals have been found to disrupt the endocrine system in studies of laboratory animals at very high doses and in some populations of fish and wildlife, there is no convincing evidence that ingredients used in cosmetic and personal care products cause endocrine disruption in humans. As yet, scientists continue to conduct research to establish appropriate criteria for assessing the potential endocrine disruptive effects of substances.
The Food and Drug Administration does not allow the use of biologically significant levels of estrogen and related substances in cosmetic products. The agency is continuing to evaluate new data on this complicated issue to monitor the safety of these products. To date, the FDA has found no convincing evidence that ingredients used in cosmetic and personal care products have caused endocrine disruption effects. See http://www.fda.gov/ora/inspect_ref/igs/cosmet.html
FDA has published a notice that describes the safe levels of certain hormone-active ingredients that can be used in products.
The endocrine system is found in all humans and many other animals. The endocrine system regulates many biological processes such as metabolism, blood sugar levels, growth and function of the reproductive system, and the development of the many organs. It consists of glands such as the thyroid, testes and ovaries, hormones such testosterone and estrogen, and cell receptors that recognize and respond to the hormones. Estrogens (for example estradiol) are a group of steroid compounds, named for their importance in the menstrual cycle and function as a primary female sex hormone. Estrogens are used in some contraceptives and in estrogen replacement therapy of postmenopausal women. Testosterone is the hormone that is associated with the development and function of male properties in humans.
In 1996 the US Congress directed the US Environmental Protection Agency, through the Food Quality Protection Act and amendments to the Safe Drinking Water Act, to develop a screening program for evaluating the potential of substances to induce hormone-related health effects. The US EPA is in the process of validating endocrine disruptor screening and testing methods. The European Union has a large research program aimed at better understanding the question of endocrine disruption. The governments of Japan and other countries are also sponsoring research in this area. The chemical industry, working in collaboration with academic and government researchers, has over the past ten years conducted research to determine whether low level substances interfere with naturally occurring hormones or with the normal function of the endocrine system to cause possible adverse health effects.
Many substances, both naturally occurring and man-made, may have some potential to mimic natural hormones under laboratory conditions. For example, plant estrogens (also known as phytoestrogens) found in soybeans and other foodstuffs have been shown to have weak endocrine activity. However, the estrogenic activity of these materials, as measured under laboratory conditions, is generally far below that which is observed for estradiol – the naturally occurring form of estrogen in the human body. In addition, the levels at which these ingredients with potential hormonal properties occur in cosmetic and personal care products is significantly below levels that have been associated with the laboratory demonstrated endocrine activity.
Click on the following links to find out more about endocrine disruptors.
The European Union
The US EPA research activities
The US EPA screening and prioritization activities
FDA Statement about Parabens and estrogenic activity:
FDA Statement about Phthalates and health affects: