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Setting criteria to identify endocrine disrupters: proposed option ‘4b’ from German BfR is not a solution

The European Commission is currently investigating the potential impacts of different ways of setting criteria to identify Endocrine (or Hormone) Disrupting Chemicals (EDCs) and has proposed four options. At a recent European Commission conference at the beginning of June the German Risk Assessment Institute (BfR) presented an additional option, which they called ‘option 4b’. CHEM Trust has now analysed this proposal, and finds that it is not a good method to set criteria, from both a scientific and policy point of view.

CHEM Trust’s analysis, published today in a short briefing, finds that though this 4b proposal may at first sight look like a reasonable way of identifying those EDs of regulatory concern, it actually has several fundamental flaws in its approach to the science and policy around EDCs.

In CHEM Trust’s view the main impact of “option 4b” will be to result in fewer EDCs being affected by regulation. We consider that this will not provide adequate protection for human health and the environment.

Our main concerns are:

  • It uses a potency based approach, coupled with the severity of the effect seen in the test, which will not be protective of human health and the environment. This approach will not identify all relevant EDCs, and introduces additional complex decision elements at the early identification stage


  • It mixes science and policy. It mixes the scientific question of the most appropriate criteria for identifying chemicals with endocrine disrupting properties with the policy question of how these chemicals are to be regulated


  • It is not in line with the advice from the EU’s expert groups on EDCs.


  • It is not in line with the relevant legislative text. The BfR proposal fails to identify all chemicals with ED properties, and instead suggests a a risk assessment for some weak and some likely EDCs, that is the “suspected EDCs

For full details see our briefing, including a one page executive summary.

As we stated in our evidence to the Commission’s consultation, CHEM Trust considers that the best way forward to achieve a high level of protection for human health is the Commission’s option 3, which identifies EDCs based on their intrinsic hazard properties, and then puts chemicals into one of three categories based on the level of available evidence.