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EU roadmap for establishing endocrine disrupting chemicals criteria

July 14th, 2014

Endocrine disrupting (ED) properties means the potential to interfere with the hormonal systems of organisms and cause harmful effects. There are a variety of European legislations that include specific reference to the need to control substances that have ED properties, such as REACH, the Water Framework Directive, Cosmetics Directive, Medical Devices Directive, Plant Protection Products Regulation, and Biocidal Products Regulation.

However, the various legislations differ in their indications for the assessment of the impacts of ED substances. In the Biocidal Protection Products Regulation (BPR) and the Plant Protection Products Regulation (PPPR) there is currently no specific way to identify substances with ED properties or a methodology for assessing adverse effects of exposure of humans and/or the environment to substances with ED effects.

The  European Commission have recently published a proposal ‘roadmap’ for assessing the impact of introducing different options of identification and assessment of ED chemicals (EDCs) into the BPR and PPPR so that they fulfil the legislative requirements to assess substances for ED effects. This also gives the opportunity for ‘horizontal’ or cross legislation alignment of the BPR and PPPR with other legislation that controls substances in other sectors, with respect to the control of ED substances.

The different policy options which are presented in the roadmap include the evaluation of adverse effects, categorisation of EDCs and the relevance of potency in hazard identification. Consideration is also given to the socio-economic effect of potential withdrawal of EDCs from the market. Furthermore, a basic evaluation of the impact of the different policy options is included, with a more comprehensive impact assessment expected later in 2014, after feedback from industry and other affected entities.  There are a number of uncertainties on the assessment of EDCs, including whether threshold effects can be established and when it is appropriate to do so.

PFA is able to provide consultancy in defining the approach to hazard and risk assessment of EDCs, with the current developments in European legislation in mind.