Endocrine disruption: linking cause and effect

Since the mid-1990s the issue of substances that may cause endocrine disruption (ED) in wildlife and humans has attracted much attention. ED active substances interact or mimic hormone systems. In  some cases, they lead to adverse health effects - notably in reproduction, brain development and the decline of certain animal species. There have been calls for all substances that have the potential to cause ED to be withdrawn under the Precautionary Principle. ED substances are often referred to as “gender bender” chemicals in the media. 

Cefic and latest European Commission report on endocrine disrupters

Committed to support the environmental safety of chemical substances, including endocrine-related effects, Cefic acknowledges the report published on May 16 of The European Commission titled "Summary of the State of the Science on Endocrine Disrupters, Part 1" as a contribution to the ongoing discussion. As this interim report is designated by the Commission as a "work in progress," Cefic will continue to contribute its expertise and proposals during the development of an adequate approach to this issue. Cefic, in collaboration with academia, supports the work of the European Commission, OECD and EU member states to develop a framework for systematically identifying substances with endocrine properties of concern.

Defining Endocrine Disruption

In 1996, a workshop in Weybridge, UK organised by the European Commission defined an ED substance as “an exogenous substance (i.e. a substance not originating in an organism) that causes adverse health effects in an intact organism, or its progeny, secondary (consequent) to changes in endocrine function. A potential endocrine disrupter is a substance that possesses properties that might be expected to lead to ED in an intact organism.” This definition has also been adopted by the World Health Organisation (WHO).

ED is an issue of global interest. It is mentioned in many regulations and policies, including REACH, the Water Framework Directive, Biocides Directive etc., and often discussed in the context of uncertainty - due to the complexity and low level of understanding of the magnitude of ED effects. 

Cefic Position on Endocrine Disruption

Cefic supports the Weybridge definition of ED that links the mechanism of action with an adverse effect. This robust definition also needs to be accompanied by a validated testing and assessment strategy that can be implemented and accepted globally. Cefic supports the view that ED is not an endpoint in itself, but one of a number of potential mechanisms that may (or may not) lead to adverse effects. Risk management must be based on both hazard assessment (the adverse effect) and an appropriate assessment of exposure.

It is critical that any discussion on ED substances is based on science. A substance should only be termed  an endocrine disrupter if the mode of action (its interaction with the endocrine system) actually results in an adverse effect such as impairment of reproduction. This can be the basis for a coherent approach for regulation and policy.

Tiered assessment

Cefic is engaged in the development of a reliable tiered framework for the testing and assessment of potential ED substances with the OECD, through the Long-range Research Programme (LRI). Industry representatives are involved in the OECD Endocrine Disrupter Testing and Assessment (EDTA) task force and in validation management groups. In late 2009, OECD convened a workshop on a conceptual framework for the identification and evaluation of ED substances.
Cefic is a member of the EU stakeholder group for the “Community Strategy for Endocrine Disruptors”. It has contributed significantly to discussions, including a workshop organized in Helsinki in 2006: “Weybridge+10”.

From a global perspective, industry activity is coordinated by the International Council of Chemical Associations (ICCA), which has developed and published testing strategies for mammalian toxicology and ecotoxicology.