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Endocrine disruptors as they are regulated in the EU

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Implementation of regulatory issues C. Rovida CAAT Europe – University of Konstanz
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Implementation of regulatory issues

C. Rovida

CAAT Europe – University of Konstanz

Regulating Chemicals

• Chemicals:Regulation 1907/2006

• Plant Protection Product:Regulation 1107/2009

• Biocidal products:Regulation 528/2012

History of the Endocrine disruptors concept

• 1936, Dodds & LawsonDodds E.C., Lawson W. (1936). Synthetic estrogenic agents without the phenanthrene nucleus. Nature 137: 996

History of the Endocrine disruptors concept

• 1936, Dodds & LawsonDodds E.C., Lawson W. (1936). Synthetic estrogenic agents without the phenanthrene nucleus. Nature 137: 996

• 1946, Study on the effect of DDTMitchell, R.T. (1946). Effects of DDT spray on eggs and nestlings of birds. Journal of Wildlife Management 10(3): 192

History of the Endocrine disruptors concept

• 1936, Dodds & LawsonDodds E.C., Lawson W. (1936). Synthetic estrogenic agents without the phenanthrene nucleus. Nature 137: 996

• 1946, Study on the effect of DDTMitchell, R.T. (1946). Effects of DDT spray on eggs and nestlings of birds. Journal of Wildlife Management 10(3): 192

• 1962, Silent SpringRachael Carson, 1962, Silent Spring

1991 – Wingspring conferenceWe are certain of the following:

• A large number of man-made chemicals that have been released into the environment, as well as a few natural ones, have the potential to disrupt the endocrine system

• Many wildlife populations are already affected by these compounds.

• The pattern for effects vary among species and among compounds.

• Laboratory studies corroborate the abnormal sexual development observed in the field and provide biological mechanisms to explain the observations in wildlife.

• Humans have been affected by compounds of this nature, too.

Definition of "endocrine disruptor"

(WHO, 2002): “… an exogenous substance or mixture that alters function(s) of the endocrinesystem and consequently causes adverse health effects in an intact organism, or its progeny, or(sub)populations.”.

WHO, 2002, Global assessment of the state-of-the-science of endocrine disruptors

REGULATION (EC) 1107/2009 on plant protection products

• Article 3: ?

• Article 23: Approval criteria for basic substances…(b) does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxiceffects

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, L309

REGULATION (EC) No 528/2012 on biocidal products

• Article 3: ?

• Article 5: Exclusion criteria…(d) active substances which … are considered as having endocrine-disrupting properties that may cause adverse effects in humans or which are identified in accordance with Articles 57(f) and 59(1) of Regulation(EC) No 1907/2006 as having endocrine disrupting properties

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

Article 3: ?

Article 57: Substances to be included in Annex XIV…(f) substances — such as those having endocrine disrupting properties … for which there is scientific evidence of probable serious effects to human health or the environment

Information requirements:12.6. Other adverse effects - If available, include information on any other adverse effects on the environment, e.g. ozone depletion potential, photochemical ozone creation potential, endocrine disrupting potential and/or global warming potential.

REGULATION (EC) No 1907/2006 - REACH

Regulation 1272/2008 - CLP

Reproductive toxicity, Category 2

H361: Suspected of damaging fertility or the unborn child

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 CouncilRegulation (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, L136REGULATION (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, L353

ECHA Database on registered substances

http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances

Resumee: The available data show different results when investigating the estrogenic activity of 4,4'-sulphonyldiphenol. … In mammalian cellular systems (reporter gene assay in MCF7 cells), 4,4'-sulphonyldiphenol shows a similar estrogenic activity as bisphenol A. Nevertheless, the biological relevance of these results remains questionable, as for a lot of chemicals with similar findings (positive effects in such screening assays) no effects (or effects at severely systemic toxic doses) were noted in well accepted state of the art in vivo tests according to OECD/EU guidelines.

Resumee: The available data show different results when investigating the estrogenic activity of 4,4'-sulphonyldiphenol. … In mammalian cellular systems (reporter gene assay in MCF7 cells), 4,4'-sulphonyldiphenol shows a similar estrogenic activity as bisphenol A. Nevertheless, the biological relevance of these results remains questionable, as for a lot of chemicals with similar findings (positive effects in such screening assays) no effects (or effects at severely systemic toxic doses) were noted in well accepted state of the art in vivo tests according to OECD/EU guidelines.

Resumee: The available data show different results when investigating the estrogenic activity of 4,4'-sulphonyldiphenol. … In mammalian cellular systems (reporter gene assay in MCF7 cells), 4,4'-sulphonyldiphenol shows a similar estrogenic activity as bisphenol A. Nevertheless, the biological relevance of these results remains questionable, as for a lot of chemicals with similar findings (positive effects in such screening assays) no effects (or effects at severely systemic toxic doses) were noted in well accepted state of the art in vivo tests according to OECD/EU guidelines.

Candidate list for SVHC(Substance of Very High Concern)

• 25 out of 84 substances are included as toxic for reproduction

CoRAP list of substances

• 20 out of 90 are suspected endocrine disruptors

• 26 out of 90 are suspected PBT (Persistent Bioaccumulative and Toxic)

• 46 out of 90 are suspected CMR (Carcinogenic, Mutagenic, toxic for Reproduction)

General rules for the adaptation of the data requirements

ANNEX IV, Biocides

1.4. In vitro methods:

Where such in vitro tests are positive, it is necessary to confirm the dangerous property by adequate in vivo tests. However, such confirmation may be waived if the following conditions are met

In the case of negative results, these exemptions do not apply. A confirmation test may be requested on a case- by-case basis

ANNEX XI, REACH

1.4. In vitro methods:

If the results obtained from the use of such in vitro methods do not indicate a certain dangerous property, the relevant test shall nevertheless be carried out at the appropriate tonnage level to confirm the negative result


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