European Union’s strategy on endocrine disrupting chemicals and the current position of Slovenia

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Abstract

In view of the European Union regulations 1107/2009 and 528/2012, which say that basic substances in plant protection and biocidal products marketed in the European Union (EU) should not have an inherent capacity to cause endocrine disruption, an initiative was started to define scientific criteria for the identification of endocrine disruptors (EDs). The objectives of the EU strategy on EDs are to protect human health and the environment, to assure the functioning of the market, and to provide clear and coherent criteria for the identification of EDs that could have broad application in the EU legislation. Policy issues were to be addressed by the Ad-hoc group of Commission Services, EU Agencies and Member States established in 2010, whereas the scientific issues were to be addressed by the Endocrine Disruptors Expert Advisory Group (ED EAG), established in 2011. The ED EAG adopted the 2002 World Health Organization (WHO) definition of endocrine disruptor and agreed that for its identification it is necessary to produce convincing evidence of a biologically plausible causal link between an adverse effect and endocrine disrupting mode of action. In 2014, the European Commission proposed four ED identification criteria options and three regulatory options, which are now being assessed for socio-economic, environmental, and health impact. Slovenia supports the establishing of identification criteria and favours option 4, according to which ED identification should be based on the WHO definition with the addition of potency as an element of hazard characterisation. As for regulatory options, Slovenia favours the risk-based rather than hazard-based regulation.

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  • 1. Commission of the European Communities (CEC). Commission staff working on the implementation of the “Community Strategy for Endocrine Disrupters” - a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706) (COM (2001) 262) and (SEC (2004) 1372) Brussels 2007. [displayed 4 November 2010]. Available at http://ec.europa.eu/environment/chemicals/endocrine/pdf/sec_2007_1635.pdf

  • 2. Damstra T Barlow S Bergman A Kavlock R Van Der Kraak G editors. Global Assessment of the State-of-the-Science of Endocrine Disruptors. Geneva: Word Health Organization International Programme on Chemical Safety; 2002.

  • 3. Word Health Organization/International Programme on Chemical Safety (WHO/IPCS). Principles and methods for the risk assessment of chemicals in food. Environmental Health Criteria 240 Annex I Glossary of terms. Geneva: WHO; 2009. [displayed 14 December 2010]. Available at http://www.who.int/foodsafety/publications/chemical-food/en/

  • 4. Regulation (EC) No. 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJL 309 24.11.2009. p. 1-50.

  • 5. 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 Text with EEA relevance. OJ L 167 27.6.2012. p. 1-123.

  • 6. 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 (Text with EEA relevance). OJ L 353 31.12.2008. p. 1-1355.

  • 7. 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 (Text with EEA relevance). OJ L 396 30.12.2006 p.1-520.

  • 8. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Text with EEA relevance) OJ L 342 22. 12 2009. p. 59-209.

  • 9. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ L 169 12. 7. 1993. p. 1-43.

  • 10. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market. OJ L 247 21.9.2007. p. 21-35.

  • 11. Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy. OJ L 327 22. 12. 2000. p. 1-73.

  • 12. European Commission (EC). Roadmap. Defining criteria for identifying Endocrine Disruptors in the context of the implementation of the Plant Protection Product Regulation and Biocidal Products Regulation. Brussels: European Commission; 2014 [displayed 30 November 2014]. Available at http://ec.europa.eu/smart-regulation/impact/planned_ia/docs/2014_env_009_endocrine_disruptors_en.pdf

  • 13. Munn S Goumenou M. Key scientific issues relevant to the identification and characterisation of endocrine disrupting substances. Report of the Endocrine Disrupters Expert Advisory Group. European Commission. Joint Research Centre. Institute for Health and Consumer Protection. Ispra; 2013. [displayed 1 June 2013]. Available at http://publications.jrc.ec.europa.eu/repository/bitstream/JRC79981/lbna25919enn.pdf

  • 14. Kortenkamp A Martin O Faust M Evans R McKinlay R Orton F Rosivatz E. State of the art assessment of endocrine disrupters Final Report 2011 [displayed 1 March 2012]. Available at http://ec.europa.eu/environment/chemicals/endocrine/pdf/sota_edc_final_report.pdf

  • 15. Munn S Goumenou M. Thresholds for Endocrine Disrupters and Related Uncertainties Report of the Endocrine Disrupters. Expert Advisory Group. European Commission. Joint Research Centre. Institute for Health and Consumer Protection. Ispra; 2013. [displayed 10 December 2013]. Available at http://publications.jrc.ec.europa.eu/repository/bitstream/JRC83204/lb-na-26-068-en-n.pdf

  • 16. European food safety authority (EFSA) Scientific Committee. Scientific opinion on the hazard assessment of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment. EFSA J 2013;11:3132. doi: 10.2903/j.efsa.2013.313

  • 17. European Commission (EC). Report on public consultation on defining criteria for identifying endocrine disruptors in the context of the implementation of the Plant Protection Product Regulation and Biocidal Products Regulation. Brussels: European Commission Directorate general for health and food safety; 2015 [displayed 2 September 2015]. Available at http://ec.europa.eu/health/endocrine_disruptors/docs/2015_public_consultation_report_en.pdf

  • 18. European Commission (EC). EP Plenary - Commission statement - Commission action to comply with Judgement in case T-521/14: Sweden vs the Commission; 2016 [displayed 2 February 2016]. Available at https://ec.europa.eu/commission/2014-2019/andriukaitis/announcements/ep-plenary-commission-statement-commission-action-comply-judgement-case-t-52114-sweden-vs-commission_en

  • 19. European food safety authority (EFSA). Opinion of the Scientific panel on food additives flavourings processing aids and material in contact with food (AFC) on a request from the Commission related to Di-butylphtalate (DBP) for use in food contact materials. Question No EFSA-Q-2003-192. The EFSA J 2005;242:1-17.

  • 20. European Food safety authority (EFSA) Conclusion on the peer review of the pesticide risk assessment of the active substance prochloraz. EFSA Journal 2011; 9:2323.

  • 21. Scientific committee on toxicity ecotoxicity and the environment (CSTEE). Opinion on the results of a second risk assessment of bis(2-ethylhexyl) phtalate (DEHP) Human health part. Adopted by the CSTEE during the 41st CSTEE plenary meeting Brussels 2004.

  • 22. SCHER (Scientific Committee on Health and Environmental Risks) SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks) SCCS (Scientific Committee on Consumer Safety). Toxicity and Assessment of Chemical Mixtures. European Comission. Directorate General for health and comsumers: Brussels; 2012. [displayed 3 February 2013] Available at http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_155.pdf

  • 23. Bundesinstitut für Risikobewertung (BfR). Joint DE-UK Position Paper: Regulatory definition of an endocrine disrupter in relation to potential threat to human health. BfR Berlin; 2011. [displayed 5 November 2011] Available at: http://www.bfr.bund.de/cm/343/regulatory_definition_of_an_endocrine_disrupter_in_relation_to_potential_threat_to_human_health.pdf

  • 24. Zorn B Virant-Klun I Verdenik I Meden-Vrtovec H Semen quality changes among 2343 healthy Slovenian men included in an IVF-ET programme from 1983 to 1996. Int J Androl 1999; 22:178-83.

  • 25. Slob W. Thresholds in Toxicology and Risk Assessment. Int J Toxicol 1999;18:259-68. doi: 10.1080/109158199225413.

  • 26. Guo YL Hsu PC Hsu CC Lambert GH. Semen quality after prenatal exposure to polychlorinated biphenyls and dibenzofurans. Lancet 2000; 356:1240-1.

  • 27. Jouannet P Wang C Eustache F Kold-Jensen T Auger J. Semen quality and male reproductive health: the controversy about human sperm decline. APMIS 2001; 109:333-44.

  • 28. National Toxicology Program (NTP). National Toxicology Program’s report of the endocrine disruptors low dose peer review. Research Triangle Park North Carolina: National Institute of Environmental Health Sciences. 2001.

  • 29. Walkowiak J Wiener JA Fastabend A Heinzow B Krämer U Schmidt E J Steingrübe HJ Wundram S Winneke G. Environmental exposure to polychlorinated biphenyls and quality of the home environment: effects on psychodevelopment in early childhood. Lancet 2001; 358:1602-7.

  • 30. Langer P Tatjakova M Kocan Trnovec T Sobokova E Kliems I. From naturally occuring goitrogens to the effects of anthropogenic endocrine disruptors on the thyroid in Slovakia. Bratisl Lek Listy 2003; 104:101-7.

  • 31. Gill U Chu I Ryan JJ in Feely M. Polybrominated diphenyl ethers: human tissue levels and toxicology. Rev Environ Contam Toxicol 2004; 183:55-97.

  • 32. Pliškova M Vondraček J Fernandez Canton R Nera J Kočan A Petrík J Trnovec T Sanderson T van den Berg M Machala M. Impact of Polychlorinated Biphenyl Contamination on Estrogenic Activity in Human Male Serum. Environ Hlth Perspec 2005; 113:1277-84.

  • 33. Seed J Carney EW Corley RA Crofton KM DeSesso JM Foster PM Kavlock R Kimmel G Klaunig J Meek ME Preston RJ Slikker W Jr Tabacova S Williams GM Wiltse J Zoeller RT Fenner-Crisp P Patton DE. Overview: Using mode of action and life stage information to evaluate the human relevance of animal toxicity data. Crit Rev Toxicol 2005; 35:663-72.

  • 34. Hamers T Kamstra JH Sonneveld E Murk AJ Kester MHA Andersson PL Legler J Brouwer A. In vitro profiling of the endocrine disrupting potency of brominated flame retardants. Toxicol Sci 2006; 92:157-73.

  • 35. Jan J Sovcikova E Kočan A Wsolova L Trnovec T. Developmental dental defects in children exposed to PCBs in eastern Slovakia. Chemosphere 2007; 67:S350-4. doi: 1016/j.chmeosphere.2006.05.148.

  • 36. Sheenan DM. No-threshold dose-response curves for nongenotoxic chemicals: Findings and applications for risk assessment. Environ Res 2006;100:93-9.

  • 37. UNEP/ILO/WHO/IOPSMC (United Nations Environment Programme/International Labour Organization/World Health Organization/Inter-Organization Programme for the Sound Management of Chemicals). Principles for evaluating health risks in children associated with exposure to chemicals. Environmental Health Criteria Series 237. Geneva: World Health Organization; 2006.

  • 38. Harvey PW Everett DJ Springall CJ. Adverse effects of prolactin in rodents and humans: breast and prostate cancer. J Psychopharmacol 2008;22:20-7. doi: 10.1177/0269881107082624

  • 39. Harvey PW Everett DJ Springall J. Adrenal toxicology: a strategy for assessment of functional toxicity to the adrenal cortex and steroidogenesis. J Appl Toxicol 2007;27:103-15.

  • 40. Meeker JD Calafat AM Hauser R. Di(2-ethylhexyl) phtalate metabolites may alter thyroid hormone levels in men. Environ Hlth Perspec 2007;115:1029-234.

  • 41. Van der Ven LT Van de Kuil T Verhoef A Verwer CM Lilienthal H Leonards PE Schauer UM Cantón RF Litens S De Jong FH Visser TJ Dekant W Stern N Håkansson H Slob W Van den Berg M Vos JG Piersma AH. Endocrine effects of tetrabromobisphenol-A (TBBPA) in Wistar rats as tested in a one-generation reproduction study and a subacute toxicity study. Toxicol 2007;245:76-89.

  • 42. Slob W. What is a Practical Threshold? Toxicol Pathol 2007;35:848-9. doi: 10.1080/01926230701714844

  • 43. Boobis AR Ossendrop BC Bansiak U Hamy PY Sebestyen I Moetto A. Cumulative risk assessment of pesticide residues in food. Toxicol Lett 2008;180:137-150.

  • 44. Calabrese EJ. Hormesis and medicine. Br J Clin Pharmacol 2008;66:594-617. doi: 10.1111/j.1365-2125.2008.03243.x

  • 45. Leijs MM Koppe JG Olie K van Aalderen WM Voogt P Vulsma T Westra M ten Tusscher GW. Delayed initiation of breast development in girls with higher prenatal dioxin exposure; a longitudinal cohort study. Chemosphere 2008;73:999-1004.

  • 46. Sonneborn D Park HY Petrik J Kocan A Palkovicova L Trnovec T Nguyen D Hertz-Picciotto I. Prenatal polychlorinated biphenyl exposures in eastern Slovakia modify effects of social factors on birthweight. Paediatr Perinat Epidemiol 2008;22:202-13.

  • 47. Boobis AR Datson GP Preston RJ Olin SS. Application of key events analysis to chemical carcinogens and noncarcinogens. Crit Rev Food Sci Nutr 2009;49: 690-707. doi: 10.1080/10408390903098673

  • 48. Verhulst SL Nelen V Hond ED Koppen G Beunckens C Vael C Schoeters G Desager K. Intrauterine exposure to environmental pollutants and body mass index during the first 3 years of life. Environ Hlth Perspec 2009;117:122-126.

  • 49. White RH Cote I Zeise L Fox M Dominici F Burke TA White PD Hattis DB Samet JM. State-of-the-Science Workshop Report: Issues and Approaches in Low-Dose-Response Extrapolation for Environmental Health Risk Assessment. Environ Hlth Perspec 2009;117:283-287.

  • 50. Boobis A Budinsky R Collie S Crofton K Embry M Felter S Hertzberg R Kopp D Mihlan G Mumtaz M Price P Solomon K Teuschler L Yang R Zaleski R. Critical analysis of the literature on low-dose synergy for use in screening chemical mixtures for risk assessment. Crit Rev Toxicol 2011;41:369-83.

  • 51. Crump KS. Use of threshold and mode of action in risk assessment. Crit Rev Toxicol 2011;41: 637-650. doi: 10.3109/10408444.2011.566258.

  • 52. Kristensen DM Hass U Laurianne L Lottrup G Jacobsen GR P Desdoits-Lethimonier C Boberg J Petersen JH Toppari J Kold Jensen J Brunak S Skakkebæk NE Nellemann C Main KM Jégou BM Leffers H. Intrauterine exposure to mild analgesics is a risk factor for development of male reproductive disorders in human and rat. Hum Rep 2011;26:235-44. doi: 10.1093/humrep/deq323.

  • 53. Kristensen DM Skalkam ML Audouze K Lesné L Desdoits-Lethimonier C Frederiksen H Brunak S Skakkebæk NE Jégou B Hansen JB Junker S Leffers H. Many Putative Endocrine Disruptors Inhibit Prostaglandin Synthesis. Environ Hlth Perspec 2011;119:534-41.

  • 54. Rhomberg LR Goodman JE Haber LT Dourson M Andersen ME Klaunig JE Meek B Price PS McClellan RO Cohen SM. Linear low-dose extrapolation for noncancer health effects is the exception not the rule. Crit Rev Toxicol 2011;41:1-19. doi: 10.3109/10408444.2010.536524

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

  • 56. Bergman Å Heindel JJ Jobling S Kidd KA Zoeller T editors. State of the science of endocrine disrupting chemicals. Geneva: World Health Organization / United Nations Environment Programme; 2012 [displayed 1 February 2013]. Available at http://www.who.int/ceh/publications/endocrine/en/.

  • 57. Rhomberg LR Goodman JE. Low-dose effects and nonmonotonic dose-responses of endocrine disrupting chemicals: Has the case been made? Regul Toxicol Pharmacol 2012;64:130-33.

  • 58. Vandenberg LN Colborn T Hayes TB Heindel JJ Jacobs DR Jr. Lee D-H Shioda T Soto AM vom Saal FS Welshons WV Zoeller RT Myers JP. Hormones and endocrine-disrupting chemicals: low-dose effects and nonmonotonic dose responses. Endocr Rev 2012;33:378-455. doi:10.1210/er.2011-1050

  • 59. Zoeller RT Brown TR Doan LL Gore AC Skakkebaek NE Soto Woodruff TJ F. S. Vom Saal FS. Endocrine-Disrupting Chemicals and Public Health Protection: A Statement of Principles from The Endocrine Society. Endocrinol 2012;153:4097-110. doi: 10.1210/en.2012-1422

  • 60. Nohynek GJ Borgert CJ Dietrich D Rozman KK. Endocrine disruption: Fact or urban legend? Toxicol Lett 2013;223:295-305.

  • 61. Tinwell H Colombel S Blanck O Bars R. The screening of everyday life chemicals in validated assays targeting the pituitary-gonadal axis. Regul Toxicol Pharmacol 2013;66:184-96.

  • 62. Environmental health and toxicology U.S. Department of health and human Services. IUPAC Glossary of Terms Used in Toxicology 2016 [displayed 10 May 2016]. Available at https://sis.nlm.nih.gov/enviro/iupacglossary/glossaryp.html

  • 63. Munro IC A.G. Renwick AG Danielewska-Nikiel D. The Threshold of Toxicological Concern (TTC) in risk assessment. Tox Lett 2008; 180:151-6.

  • 64. Černe K Kužner J Perharič L Sollner Dolenc M Tišler T editors. 2nd Congress of the Slovenian Society of Toxicology. Endocrine disrupting chemicals - from molecule to man. Book of abstracts. Ljubljana: Slovensko toksikološko društvo; 2015. [displayed 12 May 2015]. Available at http://www.tox.si/attachments/article/189/merged_document.pdf

  • 65. Haines J editor. An Integrated Approach to Sound Management of Chemicals and Waste. Initiation of Implementation of SAICM in Slovenia. Ljubljana: Intersectorial Committee for Chemical Safety; 2009.

  • 66. Ministry of Health of the Republic of Slovenia (MoH). Areas of work and priorities [displayed 20 April 2015]. Available at http://www.mz.gov.si/en/areas_of_work_and_priorities/

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