In an article published on July 30, 2015 by the UK-based advocacy group for chemical safety CHEM Trust, Ninja Reineke reports on a proposal by the German Federal Institute for Risk Assessment (BfR) for an additional option to identify endocrine disrupting chemicals (EDCs) under EU regulations. BfR presented its decision matrix – or “option 4b” – at the EU conference on “Endocrine disruptors: criteria for identification and related impacts” held on June 1, 2015 in Brussels (FPF reported). Option 4b supplements the four options for setting criteria to identify EDCs in the EU as laid out in the European Commission (EC) roadmap for EDCs (FPF reported).

CHEM Trust has now analyzed the BfR proposal and found that it is not an adequate method for setting EDC criteria. Option 4b uses a potency-based approach which will not identify all relevant EDCs, Reineke writes. EDC identification should be based on endocrine activity and linked to adverse effects. Consideration of potency or irreversibility of effects should be taken into account after identification, Reineke explains. CHEM Trust’s opinion is backed by the positions of both the European Food Safety Authority (EFSA) and the EC Joint Research Centre’s (JRC) Endocrine Disruptors Expert Advisory Group. Further, option 4b mixes scientific considerations for identifying EDCs with policy aspects and adds complex decision elements to the identification stage, Reineke writes. According to the Plant Protection Product Regulation (EC 1107/2009) and the Biocidal Products Regulation (EU 528/2012), all chemicals with endocrine disrupting properties need to be identified, with additional risk management steps to follow. The decision matrix proposed in option 4b would fail to meet this legal requirement, Reineke states. CHEM Trust supports EC option 3, which identifies EDCs based on intrinsic hazard properties and therefore provides a high level of protection for human health and the environment. CHEM Trust published their analysis of option 4b in a short briefing.

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Ninja Reineke (July 30, 2015). “Setting criteria to identify endocrine disrupters: proposed option ‘4b’ from German BfR is not a solution.CHEM Trust

CHEM Trust (July 2015). “Criteria for identifying endocrine disrupters: CHEM Trust’s view on the proposed ‘4b’ option from the German Federal Institute for Risk Assessment.(pdf)


BfR (July 3, 2015). “BfR proposes further EU criteria to identify endocrine disruptors.