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Scientific leaders strongly disagree with EU’s proposed approach to regulate endocrine active substances

Criticism of the EU’s proposed approach to regulating endocrine active substances reached new heights this summer when senior scientists — editors of 14 leading toxicology and pharmacology journals — emphasized the European Commission’s approach is being driven by unscientific precaution, “defying common sense [and] well-established science and risk assessment principles.” Read the jointly authored editorial here.

70 scientists from Europe and North America also united earlier this summer to write an open letter to Dr. Anne Glover, chief scientific adviser to the president of the European Commission, expressing their concerns with the proposed regulatory framework, saying:

We are concerned that the approach proposed could rewrite well-accepted scientific and regulatory principles in the areas of toxicology and ecotoxicology without adequate scientific evidence justifying such a departure from existing practices.

Prof. Dr. Bas J. Blaauboer, Editor of Toxicology in Vitro spelled out a similar argument in the joint editorial:

Regulations… should not be based on irrelevant tests forced to be regarded as relevant by administrative dictates, and on arbitrary default assumptions of no thresholds. Such standards would be contrary not only to science, but to the very principles of an enlightened governance and social contract.

And as Dr. Daniel Dietrich, professor of human and environmental toxicology at the University of Konstanz and editor-in-chief of the journal Chemico Biological Interactions, told Chemical Watch:

What we are saying is that we cannot create a regulation that is completely distinct from that for all other compounds that we regulate today. We must use the same system, with the same transparency and scrutiny. We cannot jump in at the deep end just because people are emotional about it [endocrine disruption].

Dr. Bjorn Lomborg, director of Copenhagen Consensus Center and adjunct professor at Copenhagen Business School, took to social media to express his view of the EU’s troublesome regulatory approach, tweeting: “Once again, the EU is making policies on the basis of fear while completely ignoring the science.” Lomborg has been listed as one of the 100 most influential people in the world by TIME Magazine.

Where the U.S. and EU differ

Endocrine disruption is an example of potential regulatory divergence between the U.S. and EU. As it stands now, the EU is considering a narrow, hazard-based approach to regulating endocrine active substances that provides an incomplete and biased view of potential health and environmental risks of such substances while the U.S. is following a tiered, risk-based approach.

As emphasized in the jointly authored editorial:

‘Endocrine disruption’ is not a toxicologically defined endpoint but a mode-of-action that may or may not result in an adverse effect…[and] the identification and regulation of such substances should depend on (a) the definition of adverse effects that are relevant to whole human or animal organisms…and (b) on a characterization of real-life potency and therefore of thresholds of concern.

ACC and our members support risk-based programs intended to develop, standardize and validate methods to study substances for endocrine activity and to assess potential risks from exposures to environmentally relevant levels. .

Decisions not based on the best science and on established risk assessment and management procedures can misallocate limited resources, limit the use of beneficial chemicals, and create potentially unnecessary public health and environmental concerns.

To learn more about ACC’s position on regulating endocrine disruptors, visit our policy page.

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