Proposal for a regulatory definition of an endocrine disrupter in relation to human health

Scientific experts in Germany and the UK have prepared a joint proposal to aid EU discussions on the establishment of regulatory definition of an endocrine disrupting substance in relation to human health.  The following article has recently been published on the UK regulatory authority’s (CRD) website.  There is a link to the full proposal at the end of the article.

“Endocrine disrupters are chemicals that may cause harm to the body by interfering with hormones.  There is increasing concern that these chemicals may have widespread uses and should be regulated appropriately."

The UK and German regulatory authorities have developed this proposal for the criteria used to identify endocrine disrupters of very high concern concern, which can be regulated within the provisions of the new EU Plant Protection Products (PPP) Regulation (1109/2009), the proposed draft Biocidal Products Regulation and REACH (1907/2006). The UK and German authorities have worked together to voice their views on these provisions and initiate a debate with other relevant stakeholders, including other member states and the European Commission.

In brief, in relation to potential human health concerns, it is proposed that a substance is regarded as an endocrine disrupter of very high regulatory concern when it satisfies the following definition and associated criteria:

• it should be a substance or mixture that alters the functions of the endocrine system and consequently causes adverse effects in an intact organism, or its offspring.

 And in doing so satisfies the following criteria:

• adverse effects to have been seen in one or more toxicity studies of acceptable quality, in which the substance was administered by a route relevant to human exposure;
• a plausible mode of action/mechanistic link between the toxic effects of concern and endocrine disruption to have been inferred;
• the effects seen in experimental animals to be judged to be of potential relevance to human health;
• serious adverse effects related to endocrine disruption to have been produced at a dose at or below the relevant guidance value for the application of Category 1 "Specific Target Organ Toxicity-Repeated Exposure, STOT-RE" classification and labelling.

Further details of the proposal are available in the linked pdf document: Joint DE-UK proposal for a regulatory definition of an endocrine disrupter in relation to human health 

For further information contact JSC on +44(0)1423 520245   enquiries@jsci.co.uk