Professor Anne Glover CBE Chief Scientific Adviser to the President of the European Commission
Berlaymont 08/039 Rue de la Loi 200 B-‐-‐-‐1049 Brussels/Belgium
RE: Draft regulation on endocrine active chemicals
Dear Prof. Glover,
We, the undersigned are writing to draw your attention to imminent decisions by the European
Commission to set a regulatory framework for so-‐ called endocrine disrupting chemicals. 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.
First of all, we want to emphasize that “endocrine disruption” is not a toxicological endpoint, but
one of many mechanisms which may cause adverse effects. In addition, we recognise that such a
policy initiative is highly technical and complex and requires an understanding of the modes of
action for endocrine disruption and their significance. It also implies the in-‐ depth involvement not
only of toxicological disciplines but also of environmental sciences and thus requires scientific
input from experts in this area. The undersigned are disturbed that the Commission’s scientific
committees have so far not been consulted by the Commission when drafting such regulations.
What is even more disturbing is that, where a scientific advisory body such as EFSA has been
consulted, critical elements of this body’s opinion are ignored. For example, in assessment of
chemicals with endocrine activity, EFSA supported a substance specific risk assessment approach
integrating exposure and adverse effects instead of developing horizontal criteria for defining
whether a substance is an “endocrine disruptor”. Development of horizontal lists ignores the long-‐
-‐standing principle that an assessment of a substance should be based on data obtained from
toxicity testing on this specific substance and derived information on potency.
If the Commission will adopt a policy stating that it is impossible to define a safe limit or threshold
for a substance with classified as endocrine disruptor, this would reverse current scientific and
regulatory practices and, more importantly, ignore broadly developed and accepted scientific
development and accepted knowledge regarding thresholds of adversity. Moreover, the latter
approach may not only apply to potential EDCs but rather would apply to all chemical substances
and thus nullify decades of experience and repeatable observations in exposure-‐ response
relationships in pharmacology and toxicology and well-‐ established and widely proven procedures
in hazard and risk assessment.
It also appears that the Commission will propose that identification of an in vitro effect without a
causal relationship to adversity in an intact organism may be sufficient to classify a substance as
an “endocrine disruptor”. This would not only represent a rewriting of the rules and accepted
practices of toxicology, which rely on well-‐ defined adverse effects observed in adequately
performed studies, but also would be contrary to all accumulated physiological understanding.
This leaves us concerned that there is neither a scientific basis nor broad support by scientists
established in risk assessment behind the approach of setting horizontal criteria and the lists of
confirmed and suspected “endocrine disruptors”.
We have noted your important interventions on the need for scientific evidence to be at the heart
of EU policy and are therefore writing to urge your review of the emerging policy to ensure that
the opinion of relevant scientific committees and member states authorities are taken into
account.
The following individuals are supporting this initiative:
Antero Aitio, Dr. Med. Sc., professor h.c., former scientist/medical officer at the International
Programme on Chemical Safety, World Health Organization; former team leader, Finnish Institute of
Occupational Health; former Unit Chief of the Monographs Programme, International Agency for
Research on Cancer
Herman Autrup, Professor, PhD ATS, President International Union of Toxicologists, former member
SCHER, AFC-‐ Panel of EFSA, Institute of Public Health, University of Aarhus, Denmark
Susan, Barlow, Ph.D., former member of EFSA Scientific Committee (2003-‐ 2012), Brighton, UK
Diane Benford, Dr., member, chair CONTAM Panel of EFSA, Head of Chemical Risk Assessment
Unit, Food Standards Agency, London, UK
Sir Colin Berry, Prof. Emeritus of Pathology, Queen Mary, University of London, UK
Bas J. Blaauboer, Prof. Dr., Doerenkamp-‐ Zbinden Chair on Alternatives to Toxicity Testing,
Institute for Risk Assessment Sciences, Division of Toxicology, Utrecht University, The
Netherlands
Hermann M. Bolt, Prof. Dr. med., Dr. rer. nat., Chair of the Scientific Committee for
Occupational Exposure Limits, SCOEL (DG Employment), Leibniz Research Centre for Working
Environment and Human Factors (IfADo) at the TU Dortmund, Germany
Alan Boobis, Prof., OBE, PhD, FSB, FBTS, member CONTAM Panel of EFSA, Centre for Pharmacology
& Therapeutics, Department of Medicine, Imperial College London, UK
Alexander Bürkle, Prof. Dr., Chair of Molecular Toxicology Department of Biology, University of
Konstanz, Germany
Thomas Colnot, Ph.D., ERT, CiS Toxicology, Castro, Chile
Brian Cummings, Ph.D., Assistant Professor, Department of Pharmaceutical and Biomedical Sciences,
University of Georgia, Athens, GA, USA
Slawomir Czerczak, Prof. Dr., Chair for Group of Experts for Chemical Agents of Polish Intersectoral
Commission for MAC and MAI Values, Head of Department of Chemical Safety, Nofer Institute of
Occupational Medicine Lodz, Poland
Gisela H. Degen, Prof. Dr., member SCCS, Leibniz Research Centre for Working Environment and
Human Factors (IfADo) at the TU Dortmund, Germany
Wolfgang Dekant, PhD, Professor of Toxicology, former member SCHER, CSTEE, member SCHENIHR,
Department of Toxicology, University of Würzburg, Germany
Lennart Dencker, Prof. Dr., Department of Pharmaceutical Biosciences, Uppsala University,
Uppsala, Sweden
Daniel Dietrich, Prof. Dr., Ph.D., Professor of Human and Environmental Toxicology, Member of
SCENIHR, Former Chair of the OECD Endocrine Disruption and Ecotoxicology EDTA-‐VMG Non-‐Animal of
the OECD, Member Presidential Expert Group AOAC, Faculty of Biology, University of Konstanz,
Germany
Daniel R. Doerge, Ph.D., National Center for Toxicological Research, Jefferson, AR, USA (affiliation
is given for identification purposes only)
Eugenia Dogliotti, Dr., Member CONTAM Panel of EFSA, Istituto Superiore di Sanità, Environment
& Primary Prevention Dept., Unit of Molecular Epidemiology, Roma, Italy
Jose L. Domingo, Professor and Director, Laboratory of Toxicology and Environmental Health,
School of Medicine, Universitat "Rovira i Virgili", Reus, Spain
Johanna Fink-‐ Gremmels, Prof. Dr., Utrecht University, Faculty of Veterinary Medicine, Institute
for Risk Assessment Sciences, Division Toxicology, Veterinary Pharmacology, Pharmacotherapy
and Toxicology, Utrecht, The Netherlands
Hermann Fromme, Prof. Dr., Department of Chemical Safety and Toxicology, Bavarian Health and
Food Safety Authority, Munich
Corrado Galli, Pof. Dr., Dean, Faculty of Pharmaceutical Sciences, Lab. Toxicology, Department of
Pharmacological and Biomolecular Sciences, University of Milan, Italy
David Gott, Dr., member ANS Panel of EFSA, Head of Toxicology Team, Chemical Risk Assessment
Unit, Food Standards Agency, London, UK
Bettina Grasl-‐ Kraupp, Prof. Dr., ERT, Institute for Cancer Research -‐-‐ Medical University o f
Vienna, Austria
Helmut Greim, Prof. Dr., member RAC ECHA, former chair MAK Commission, former chair
SCHER, former member CSTEE, member SCHER, Technische Universität München,
Senatskommission der DFG zur Prüfung gesundheitsschädlicher Arbeitsstoff, Freising, Germany
Heidrun Greim, Dr., Wissenschaftliches Kommissionssekretariat der Ständigen Senatskommission
der DFG zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Karlsruher Institut für Technologie (KIT),
Abteilung Lebensmittelchemie und Toxikologie, Institut für Angewandte Biowissenschaften,
Freising-‐-‐-‐ Weihenstephan, Germany
Wolfgang Heger, Prof. Dr., Berlin, Germany
Jan G. Hengstler, Prof. Dr., Leibniz Research Centre for Working Environment and Human
Factors, IfADo, Dortmund, Germany
Magnus Ingelman-‐ Sundberg, PhD, BSc.Med, Professor and Section Head, Vice Dean
(Recruitment), Karolinska Institutet, Section of Pharmacogenetics, Department of Physiology
and Pharmacology, Stockholm, Sweden
Colin Janssen, Prof. Dr., former member CSTEE, member SCHER, Ghent University, Department
Applied Ecology and Environmental Biology, Laboratory of Environmental Toxicology and
Aquatic Ecology, Ghent, Belgium
Risto Juvonen, PhD, School of Pharmacy Faculty of Health Sciences University of Eastern Finland,
Kuopio, Finland
James Kehrer, Professor and Dean, Faculty of Pharmacy & Pharmaceutical Sciences, Katz Centre for
Pharmacy & Health Research, University of Alberta, Edmonton, AB, Canada
Hannu Kiviranta, Ph.D., Unit head, National Institute for Health and Welfare/ Department of
Environmental Health / Chemical Exposure, Kuopio, Finland
Hannu Komulainen, Research professor, former member SCHER, National Institute for Health and
Welfare, Department of Environmental Health, Kuopio, Finland
Hans Lepper, Dr., Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, SG
K3: Forschungskoordination/Zentralstelle Risikoanalyse, Erlangen, Germany
Jan Linders, Prof. Dr., member SCHER, formerly National Institute for Public Health and the
Environment (RIVM), The Netherlands
Marina Marinovich, Prof. Dr., Faculty of Pharmaceutical Sciences, Lab. Toxicology, Department of
Pharmacological and Biomolecular Sciences, University of Milan, Italy
Angelo Moretto, Prof. Dr., Department of Biomedical and Clinical Sciences, Università degli Studi di
Milano, Milano, Italy
Paquale Mosesso, Associate Professor of Genetics, member ANS Panel of EFSA, Department of
Ecological and Biological Sciences, University of Tuscia, Viterbo, Italy
Marc Pallardy, Prof. Dr., INSERM UMR 996, University Paris-‐Sud, Faculty of Pharmacy, Chatenay-‐
Malabry, France
Markku Pasanen, Prof. Dr., University of Eastern Finland, Faculty of Health Sciences, School of
Pharmacy, Kuopio, Finland
Olavi Pelkonen, Professor of Pharmacology, Department of Pharmacology and Toxicology,
University of Oulu, Oulu, Finland
Hannu Raunio, Prof. Dr., University of Eastern Finland, Faculty of Health Sciences, School of
Pharmacy, Kuopio, Finland
Ivonne M.C.M. Rietjens, Prof. dr. ir., Professor in Toxicology, member ANS Panel of EFSA,
Wageningen University AFSG/ Division of Toxicology, Wageningen, The Netherlands
Konrad Rydzynski, Prof. Dr. med., Coordinator of the European Network of Excellence ECNIS
(Environmental Cancer Risks, Nutrition and the Individual Susceptibility), member SCENIHR,
Director of the Nofer Institute of Occupational Medicine, Lodz, Poland
Tinaa Santonen, MD, PhD, MSc in Applied Toxicology Team Leader, Chemical Safety, Finnish
Institute of Occupational Health, Finland
Josef Schlatter, Dr., member of EFSA Scientific Committee, Zürich, Switzerland
Dieter Schrenk, MD PhD, Professor of Toxicology, member CONTAM Panel of EFSA, Food
Chemistry and Toxciology University of Kaiserslautern, Germany
Richard M Sharpe, Prof. Dr., MRC Centre for Reproductive Health, The Queen's Medical Research
Institute, University of Edinburgh, Scotland, UK
Andrzej C Skladanowski, PhD, Prof. Dr., Medical University of Gdansk Intercollegiate Faculty of
Biotechnology UG-‐ MUG, Department of Molecular Enzymology, Gdansk, Poland
Frank M. Sullivan, BsC (Hons), FBTS, formerly UK Specialist in Reproductive Toxicology
Emanuela Testai, Dr., former member SCHER, CSTEE, member SCHENIHR, Istituto Superiore di
Sanità, Environment & Primary Prevention Dept., Mechanisms of Toxicity Unit, Roma, Italy
Marco Vighi, Prof. Dr., former member SCHER, Department of Earth and Environmental
Sciences, University of Milano Bicocca, Milano, Italy
Matti Viluksela, Prof. Dr., former member SCHER, National Institute for Health and Welfare
Department of Environmental Health, Kuopio, Finland and University of Eastern Finland
Department of Environmental Science Kuopio, Finland
Wolfgang Völkel, PD Dr., Ph.D., ERT, Bayerisches Landesamt für Gesundheit und
Lebensmittelsicherheit, Sachgebiet Chemikaliensicherheit und Toxikologie/Biomonitoring,
München, Germany
Wojciech Wasowicz, Prof. Dr., President of the Polish Society of Toxicology, Nofer Institute of
Occupational Medicine, Lodz, Poland