Guidance on interpreting endocrine disrupting effects within the constraints of REACH and the revised 91/414 directive

The finding of this Task force were published as Technical Report No. 106 (published June 2009).

Background

REACH has indicated that substances (e.g. intermediates, raw materials and formulation inerts) having endocrine disrupting properties will require further investigation. A number of factors will be taken into account (e.g. substitution, exposure control) before such compounds can be authorised for use. Therefore, continued use of such substances will be restricted.

In the draft revision of the 91/414 pesticide directive, active substances in a plant protection product considered to have endocrine disrupting properties that may be of toxicological significance in humans or non-target organisms will not be approved.

For both chemicals and pesticides, a definition of endocrine disruption is not supplied in either of these documents. Therefore, there is a significant possibility that different interpretations of what is or is not an endocrine disruption effect would lead to inappropriate classification of chemicals/pesticides as endocrine disruptors. This would have a serious impact on the registration, use and movement of such substances and, hence, it is critical that the term ‘endocrine disruption’ is defined in a scientifically sound way. Moreover, clear guidance is needed on the nature and quality of technical data required to conclude that a chemical induces an endocrine disruption leading to adverse effects through modes of action relevant to humans and non-target organisms.

Terms of Reference

  1. Critically review all available definitions of endocrine disruption which apply to both human health and other organisms in the environment.
  2. Identify key and common themes from all definitions, as well as the relevance of these to chemical classification and risk assessment.
  3. Provide guidance on the nature and quality of data required to conclude the induction of endocrine disruption and causation of any adverse effects. This should include the ability to evaluate the potency of any endocrine disruption observed.