Technical Report 130

References to Appendix A: Background information

Bars R, Broeckaert F, Fegert I, Gross M, Hallmark N, Kedwards T, Lewis D, O'Hagan S, Panter GH, Weltje L, Weyers A, Wheeler JR, Galay-Burgos M. 2011. Science based guidance for the assessment of endocrine disrupting properties of chemicals. Regul Toxicol Pharmacol 59:37-46. Erratum in: Regul Toxicol Pharmacol 60:411-2.

Bars R, Fegert I, Gross M, Lewis D, Weltje L, Weyers A, Wheeler JR, Galay-Burgos M. 2012. Risk assessment of endocrine active chemicals: identifying chemicals of regulatory concern. Regul Toxicol Pharmacol 64:143-54.

Boobis AR, Cohen SM, Dellarco V, McGregor D, Meek ME, Vickers C, Willcocks D, Farland W. 2006. IPCS framework for analyzing the relevance of a cancer mode of action for humans. Crit Rev Toxicol 36:781-92.

Boobis AR, Doe JE, Heinrich-Hirsch B, Meek ME, Munn S, Ruchirawat M, Schlatter J, Seed J, Vickers C. 2008. IPCS framework for analyzing the relevance of a noncancer mode of action for humans. Crit Rev Toxicol 38:87-96.

Boobis AR, Daston GP, Preston RJ, Olin SS. 2009. Application of key events analysis to chemical carcinogens and noncarcinogens. Crit Rev Food Sci Nutr 49(8):690-707.

Bradford Hill A. 1965. The Environment and Disease: Association or Causation? Proc Royal Soc Med 58:295-300.

Commission. 1999. Communication from the Commission to the Council and the European Parliament - Community strategy for endocrine disrupters - A range of substances suspected of interfering with the hormone systems of humans and wildlife. COM(1999)0706 final, Brussels, 17.12.1999.

Commission. 2013a. Commission Regulation (EC) No 284/2013 setting out the data requirements for plant protection products in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. Official Journal L 93, 85-152, 03.04.2013. (Cited in Appendix B of this ECETOC Report.)

Commission. 2013b. Commission Communication in the framework of the implementation of Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Text with EEA relevance. Official Journal C 95, 1–20, 03.04.2013. (Cited in Appendix B of this ECETOC Report.)

Commission. 2016a. Communication from the Commission to the European Parliament and the Council on endocrine disruptors and the draft Commission acts setting out scientific criteria for their determination in the context of the EU legislation on plant protection products and biocidal products (SWD(2016) 211 final and SWD (2016) 212 final). COM(2016) 350 final, Brussels, 15.06.2016.

Commission. 2016b. Commission staff working document. Executive summary of the impact assessment accompanying the document Impact Assessment defining criteria for identifying endocrine disruptors in the context of the implementation of the plant protection products Regulation and biocidal products regulation (COM(2016) 350 final; SWD(2016) 211 final). SWD(2016) 212 final. Brussels, 15.06.2016.

Commission. 2016c. Draft Commission delegated Regulation (EC) setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012. C(2016) 3752 project.

Commission. 2017. Draft Commission Regulation (EU) setting out scientific criteria for the determination of endocrine disrupting properties and amending Annex II to Regulation (EC) 1107/2009. SANTE-2016-12020-REV 2; C(2016) 3751 project.

ECETOC. 2009a. European Centre for Ecotoxicology and Toxicology of Chemicals. Technical Report No. 106. Guidance on identifying endocrine disrupting effects. ISSN-0773-8072-106 Brussels, June 2009.

ECETOC. 2009b. European Centre for Ecotoxicology and Toxicology of Chemicals. Workshop Report No. 16 and addendum. Guidance on interpreting endocrine disrupting effects. 29-30 June 2009, Barcelona.

ECETOC. 2011. European Centre for Ecotoxicology and Toxicology of Chemicals. Workshop Report No. 21. Risk assessment of endocrine disrupting chemicals. 9-10 May 2011, Florence.

ECETOC. 2016. European Centre for Ecotoxicology and Toxicology of Chemicals. Technical Report No. 128. Guidance on assessment and application of adverse outcome pathways (AOPs) relevant to the endocrine system. ISSN-2079-1526-128. December 2016.

ECHA and EFSA. 2016. European Chemicals Agency and European Food Authority. Draft ECHA and EFSA Guidance Document for the implementation of the hazard-based criteria to identify endocrine disruptors. Published 20.12.2016; available at:

Outline of Draft Guidance Document for the Implementation of the Hazard-based Criteria to Identify Endocrine Disruptors

EFSA. 2013. European Food Safety Authority Scientific Committee. Scientific Opinion on the hazard assessment of endocrine disruptors: Scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment. EFSA Journal 11:3132.

EP and Council of the EU. 2006. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. OJ L 396/1, 30.12.2006.

EP and Council of the EU. 2008. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353, 1–1355, 31.12.2008.

EP and Council of the EU. 2009. Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. OJ L 309, 1–50, 24.11.2009.

EP and Council of the EU. 2012. Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. OJ L 167/1, 27.06.2012.

Fenner-Crisp PA, Dellarco VL. 2016. Key elements for judging the quality of a risk assessment. Environ Health Perspect 124:1127-35.

Lewis RW. 2013. Risk assessment of 'endocrine substances': guidance on identifying endocrine disruptors. Toxicol Lett 223:287-90.

Munn S, Goumenou M. 2013. Report of the Endocrine Disrupters Expert Advisory Group. Key scientific issues relevant to the identification and characterisation of endocrine disrupting substances. JRC Scientific and Policy Reports. EUR 25919 EN, 34 pages.

NRC. 2007. National Research Council. Toxicity Testing in the 21st Century: A Vision and a Strategy. The National Academies Press, Washington DC, USA.

OECD. 2007. Organisation for Economic Co-operation and Development. Detailed review paper for avian two-generation toxicity test. ENV/JM/MONO(2007)21, 13.08.2007. Paris, France.

OECD. 2012a. Organisation for Economic Co-operation and Development. Conceptual Framework for testing and assessment of endocrine disruptors (as revised in 2012); available at:

OECD Conceptual Framework for Testing and Assessment of Endocrine Disrupters (as revised in 2012)

OECD. 2012b. Organisation for Economic Co-operation and Development. Series on testing and assessment No. 150. Guidance document on standardised test guidelines for evaluating chemicals for endocrine disruption. ENV/JM/MONO(2012)22. Paris, France, 24.08.2012 (cancels and replaces same document of 26.07.2012).

OECD. 2012c. Organisation for Economic Co-operation and Development. Series on testing and assessment No. 181. Guidance document on standardised test guidelines for evaluating chemicals for endocrine disruption: Case studies using example chemicals. ENV/JM/MONO(2012)34. Paris, France, 08.10.2012.

Sonich-Mullin C, Fielder R, Wiltse J, Baetcke K, Dempsey J, Fenner-Crisp P, Grant D, Hartley M, Knaap A, Kroese D, Mangelsdorf I, Meek E, Rice JM, Younes M; International Programme on Chemical Safety. 2001. IPCS conceptual framework for evaluating a mode of action for chemical carcinogenesis. Regul Toxicol Pharmacol 34:146-52.

Weltje L, Wheeler JR, Weyers A, Galay-Burgos M. 2013. Refinement of the ECETOC approach to identify endocrine disrupting properties of chemicals in ecotoxicology. Toxicol Lett 223:291-4.

WHO/IPCS. 2002. International Programme on Chemical Safety. Global assessment of the state-of-the-science of endocrine disruptors. World Health Organisation, Geneva, Switzerland; available at:

http://www.who.int/ipcs/publications/new_issues/endocrine_disruptors/en/

WHO/IPCS. 2009. International Program on Chemical Safety, Principles and methods for the risk assessment of chemicals in food. (Environmental Health Criteria), World Health Organisation, Geneva, Switzerland.

WHO/UNEP. 2012. State of the science of endocrine disrupting chemicals – 2012: An assessment of the state of the science of endocrine disruptors prepared by a group of experts for the United Nations Environment Programme (UNEP) and World Health Organization (WHO). Edited by
Å Bergman, JJ Heindel, S Jobling, KA Kidd, RT Zoeller; available at: http://www.who.int/ceh/publications/endocrine/en/