EDCs or endocrine disrupting chemicals are chemicals that depending on the dose, can affect the hormone or endocrine system in mammals by causing tumors or birth defects, or by stimulating developmental disorders.
These disrupters can be harmful to any system in the body that is regulated by hormones. In order to better understand and regulate these chemicals, the European Commission has devised a roadmap to assist in providing information to help with determining chemicals as EDCs according to the EU legislation. This roadmap allows for both the proper classification of EDCs that are subject to control along with useful information regarding their regulation. This roadmap has generally been met with approval, although some options involve an overall risk-based approach with socio-economic assessments, which are viewed as unfavorable by some NGOs. In addition, the Health and Environment Alliance (HEAL) published a report in June 2014 that claims exposure to EDCs may cost over €30bn/year in the EU.
Although the main focus of the roadmap is on biocidal and plant protection products, it also tries to incorporate input from both the EU Council and Parliament to institute hazard-based criteria in order to help with endocrine disruptor classification. This roadmap also addresses EDC provisions in REACH and other regulations for cosmetics, medical devices, and the water framework Directive.
Four possible routes are proposed by this roadmap. The first would result in no change and the temporary criteria set in the biocidal and plant protection products would be utilized. The other three options relate to hazard classification principles which are defined by the World Health Organization (WHO) along with its International Programme on Chemical Safety (IPCS). For these three options, EDCs are determined by using existing information, experimental studies, or other methods such as Qsars. Any indication of endocrine-mediated adverse effects must be clearly presented and defined as well as the mechanism of endocrine action. The second option is composed of six steps focused on assessing adverse effects and mechanisms. The third route proposes categories with known endocrine disruptors as 1, suspected disruptors as 2, and endocrine active substances as 3. The fourth and final option incorporates potency in the hazard classification.
This roadmap presents three methods for EDC regulation. Along with the “no policy change,” option A, it also proposes option B, the implementation of other aspects of risk assessment into the sectoral legislation. Here the roadmap provides examples of exemption in the biocidal products cases where trivial risk can be seen. It states that this exception could also be presented to the plant protection products. The final option C, calls for the implementation of more socio-economic concerns, involving risk – benefit examination into sectoral legislation. The roadmap presents this strategy as needed if the ban on an endocrine disruptor results in an unbalanced negative effect. The roadmap provides some basic analysis on the four different options.
A more thorough assessment will commence this year with the help of a public consultation that will gather feedback from other involved parties. In addition, the discussion around the roadmap will be watched by ECHA’s recently established Endocrine Disruptor (ED) Expert Group whose mandate is to “provide informal and non-binding scientific advice on questions related to the identification of endocrine disrupting properties of chemicals”. The significance for REACH is in regards to the identification of EDCs as SVHC with their addition to the candidates list with possible authorisation