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Endocrine Disrupting Chemicals: A Scientific and Regulatory Open Matter

Antonio Conto

The so called Endocrine Disrupting Chemicals, in brief EDCs, are a wide family of substances. Although not yet well defined, we know that they may have a harmful effect on organisms of both humans and animals by acting upon the hormonal system. In the mid-‘90s, the scientific community began the discussion on how to define and characterise the EDC activity, and followed with some regulatory bodies in the US and in Europe beginning to draft positive lists. From those years up to now, such a discussion was kept alive by the debate between regulatory bodies and the chemical and pharmaceutical industry; in 2006, EDC substances have been mentioned in the REACH Regulation (EC1907/2006) within the group of the Substances of Very High Concern (SVHC). Recently, the EDC category was also discussed in regard to the regulations governing agrochemical and biocide products and active substances. In particular, in relation to ‘cut-off’ criteria which may carry special regulations. Regarding the pharmaceutical area, the assessment of a potential ED properties (Endocrine Disruption properties) can heavily affect the ERA (Environmental Risk Assessment) of medicine when placed to the EU market. This paper aims to summarise the approaches to identify ED and EAS (Endocrine Active Substances) and will inform about the recent EU specific regulation.

Dr. Antonio Conto is the actual manager of Chemsafe, a Regulatory Affairs Company. He got a degree in Biological Sciences and a Master in Experimental Toxicology in 1990. In 2011 he was recognised as ERT® (European Registered Toxicologist) within Eurotox. He published more than 60 papers on regulatory and scientific matters and attended to more than 70 events as a speaker. He is member of several institutions.


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