EU Commissioner for Health and Food Safety, Dr Vytenis Andriukaitis (left) discussing risk assessment with Pat Heslop-Harrison
BRUSSELS, May 11, 2016 /PRNewswire/
A meeting was held between Dr Vytenis Andriukaitis, Commissioner of Health & Food Safety and well established and respected scientists (Prof. Sir Colin Berry, Prof. Alan Boobis, Prof. Wolfgang Dekant, Prof. Daniel Dietrich, Prof. Helmut Greim, Prof. Pat Heslop-Harrison and Prof. Richard Sharpe) in the fields of human risk assessment and endocrine active compounds (“endocrine disrupting chemicals” or EDCs). Amongst the topics discussed by the group was how the presentation of the issue of EDCs to the public and to the Commission by some scientists has been deliberately selective and has proposed courses of action that: (1) are not supported by a robust scientific evidence base, and (2) run counter to the huge database and detailed understanding of the therapeutic effects of (endocrine active) hormones in human patients. The group emphasized that management of EDCs should be based on robust scientific evidence, as is common to all legal procedures (e.g. criminal law).
In discussion, the concern was raised that public perceptions about EDCs are currently dominated by certain scientists, NGOs and well-funded pressure groups, who categorically assert that EDCs contribute to human cancer, reproductive disorders, obesity and type 2 diabetes. The reality is that there is no robust, consistent scientific evidence to support such a dogmatic stance, and indeed most of the robust evidence points in the opposite direction. The group highlighted that the current level of knowledge about EDC and hormone action is such that it allows scientists and the regulatory bodies to identify compounds with potential endocrine activity and to address their potential to cause harm to humans or to the environment via well-established processes.
Pressure groups have advocated that EDCs should be treated as a “special case” when considering their potential to do harm, on the basis that EDCs (and hormones in general) can have unexpected effects at low level exposures and that they do not have thresholds of effect, with the result that their exposure-response curves are non-monotonic. The reality is that these assumptions are not supported by robust (i.e. reproducible) scientific data and are unlikely to occur in humans, because there is extensive knowledge on the human effects of endocrine active substances from the speciality of clinical endocrinology. Endocrine disorders, extending from diabetes through Graves disease to osteoporosis, that result from hormone levels that are too high or too low are managed by treatment with endocrine-active compounds, which has built a huge level of understanding of the relationships between levels of exposure and resulting health effects in humans. For all of these hormone-mediated functions in humans, thresholds are observed, there are no non-monotonic exposure response curves and no ‘unexpected’ effects at low-level exposures.
In the recent consensus document regarding EDCs developed at the BfR in Berlin (April 12-13, 2016; seehttp://www.bfr.bund.de/en/home.html) it was emphasized that identification of EDCs is only the first step in the risk assessment of EDCs, but that potency and consideration of likely human exposure are necessary for any adequate evaluation of the human or environmental effects of EDCs. As EDCs comprise both natural and synthetic (i.e. manufactured) compounds, sugar in our foods which, when ingested will immediately trigger the release of the hormone insulin, will, if the opinion of some observers is consistently applied, have to be identified as an EDC and be subject to potential regulation. The natural component of sweet mustard (bisphenol F), that has nearly identical endocrine mediated activities as the bisphenol A that was banned from certain uses in France and Germany, would also have to be subject to restriction as would the many estrogenic chemicals present in many plants and vegetables (and presumably thus the plants themselves). This would clearly be nonsensical.
In view of the conclusions reported in the thoughtful consensus document (http://www.bfr.bund.de/en/home.html) and the importance of potency and human exposures in assessing the effects of EDCs, the scientists who met Commissioner Andriukaitis are confident that the current regulatory criteria for all potential EDCs can be developed by the Commission with the input of experienced toxicologists, endocrinologists and risk assessment professionals to enable the safe use of many compounds in a range of applications. In so doing, this will be achieved in a manner that ensures protection of human health and the environment, whilst maintaining the sustainability and competitiveness of the European economy.
From: Concerned Toxicologists for Better Science and Regulation
Prof. Daniel Dietrich, +49-7531-883518, Daniel.Dietrich@uni-konsanz.de, University of Konstanz; Germany
Prof. Helmut Greim, +49-8161-715600, firstname.lastname@example.org, TU Munich, Germany
Prof. Alan Boobis, +44-(0)20-7594-6806, email@example.com, Imperial College London, UK
Prof. Richard Sharp, +44-(0)131-242-6387, firstname.lastname@example.org, University of Edinburgh, UK
For environmental and genetic perspective, contact Prof. Pat Heslop-Harrison +44(0) 7413 292 754 email@example.com University of Leicester, UK
Risk Delegation with EU Commissioner Vytenis Andriukaitis [From the left: Prof. Richard Sharp (back), Prof. Helmut Greim (middle) ,Prof. Sir Colin Berry (front), Prof. Pat Heslop-Harrison (back), Dr. Vytenis Andriukaitis, Commissioner of Health & Food Safety (middle), Prof. Daniel Dietrich (front), Prof. Wolfgang Dekant (back), and Prof. Alan Boobis (front)]
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