Proposal of how to update the standard information requirements in REACH, PPPR and BPR – a testing strategy for identification of endocrine disruptors

Henrik Holbech, Poul Bjerregaard, Ulla Hass, Sofie Christiansen

Research output: Contribution to conference without publisher/journalConference abstract for conferenceCommunication

Abstract

This presentation is based on a project prepared by the Danish Centre on Endocrine Disrupters (CEHOS) for the Danish EPA. The project aim to provide a science based input to the on-going work in EU with regard to endocrine disruptors, i.e. the development of criteria for identification, REACH review on EDs and the revised strategy for the future work on endocrine disruptors, focusing on adequate detection of substances with endocrine disrupting properties under various legislative frameworks, including REACH (EC No 1907/2006), the Plant Protection Products Regulation (PPPR) (EC No 1107/2009) and the Biocidal Products Regulation (BPR) (EC No 528/2012). There are currently no specific information requirements or testing strategies with regard to endocrine disruption in REACH and other relevant legislations. However, in relation to biocides and recently also to plant protection products, indications of endocrine disrupting properties of a substance trigger additional information/testing requirements. With regard to plant protection products a new regulation from 1 March 2013 (EU 283/2013 (active substances) + EU 284/2013 (products)) sets out the general data requirements from 1 January 2014. According to these, new test methods that include endocrine sensitive endpoints have been included with regard to human health and the environment. Similar data requirements and new test methods that include endocrine sensitive endpoints are included in the guidance on Regulation (EU) No 528/2012 on how to fulfil data requirements for biocides. To a limited extent in vivo test methods that include endocrine sensitive endpoints have also been included in the standard information requirements for substances regulated under REACH. The existing information/data requirements in REACH, PPPR and BPR are not sufficient to adequately detect substances with endocrine disrupting properties. Proposals for changes in the existing REACH, PPPR and BPR information/data requirements are therefore provided. The proposals include enhancement of standard test methods as well inclusion of new methods and recommendations are given for a testing strategy. For all substances (prioritized by tonnage and exposure scenario), QSAR studies and testing using in vitro assays for interaction with different ED modalities e.g. ER, AR and steroidogenesis interference, should be conducted to elucidate whether there are alert(s) for further testing for ED effects
Original languageEnglish
Publication date2014
Publication statusPublished - 2014
EventSETAC Europe 24th Annual Meeting - Basel, Switzerland
Duration: 11. May 201415. May 2014

Conference

ConferenceSETAC Europe 24th Annual Meeting
CountrySwitzerland
CityBasel
Period11/05/201415/05/2014

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endocrine disruptor
pesticide
plant protection product
regulation
product
legislation
method
test

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title = "Proposal of how to update the standard information requirements in REACH, PPPR and BPR – a testing strategy for identification of endocrine disruptors",
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Proposal of how to update the standard information requirements in REACH, PPPR and BPR – a testing strategy for identification of endocrine disruptors. / Holbech, Henrik; Bjerregaard, Poul; Hass, Ulla; Christiansen, Sofie.

2014. Abstract from SETAC Europe 24th Annual Meeting, Basel, Switzerland.

Research output: Contribution to conference without publisher/journalConference abstract for conferenceCommunication

TY - ABST

T1 - Proposal of how to update the standard information requirements in REACH, PPPR and BPR – a testing strategy for identification of endocrine disruptors

AU - Holbech, Henrik

AU - Bjerregaard, Poul

AU - Hass, Ulla

AU - Christiansen, Sofie

PY - 2014

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N2 - This presentation is based on a project prepared by the Danish Centre on Endocrine Disrupters (CEHOS) for the Danish EPA. The project aim to provide a science based input to the on-going work in EU with regard to endocrine disruptors, i.e. the development of criteria for identification, REACH review on EDs and the revised strategy for the future work on endocrine disruptors, focusing on adequate detection of substances with endocrine disrupting properties under various legislative frameworks, including REACH (EC No 1907/2006), the Plant Protection Products Regulation (PPPR) (EC No 1107/2009) and the Biocidal Products Regulation (BPR) (EC No 528/2012). There are currently no specific information requirements or testing strategies with regard to endocrine disruption in REACH and other relevant legislations. However, in relation to biocides and recently also to plant protection products, indications of endocrine disrupting properties of a substance trigger additional information/testing requirements. With regard to plant protection products a new regulation from 1 March 2013 (EU 283/2013 (active substances) + EU 284/2013 (products)) sets out the general data requirements from 1 January 2014. According to these, new test methods that include endocrine sensitive endpoints have been included with regard to human health and the environment. Similar data requirements and new test methods that include endocrine sensitive endpoints are included in the guidance on Regulation (EU) No 528/2012 on how to fulfil data requirements for biocides. To a limited extent in vivo test methods that include endocrine sensitive endpoints have also been included in the standard information requirements for substances regulated under REACH. The existing information/data requirements in REACH, PPPR and BPR are not sufficient to adequately detect substances with endocrine disrupting properties. Proposals for changes in the existing REACH, PPPR and BPR information/data requirements are therefore provided. The proposals include enhancement of standard test methods as well inclusion of new methods and recommendations are given for a testing strategy. For all substances (prioritized by tonnage and exposure scenario), QSAR studies and testing using in vitro assays for interaction with different ED modalities e.g. ER, AR and steroidogenesis interference, should be conducted to elucidate whether there are alert(s) for further testing for ED effects

AB - This presentation is based on a project prepared by the Danish Centre on Endocrine Disrupters (CEHOS) for the Danish EPA. The project aim to provide a science based input to the on-going work in EU with regard to endocrine disruptors, i.e. the development of criteria for identification, REACH review on EDs and the revised strategy for the future work on endocrine disruptors, focusing on adequate detection of substances with endocrine disrupting properties under various legislative frameworks, including REACH (EC No 1907/2006), the Plant Protection Products Regulation (PPPR) (EC No 1107/2009) and the Biocidal Products Regulation (BPR) (EC No 528/2012). There are currently no specific information requirements or testing strategies with regard to endocrine disruption in REACH and other relevant legislations. However, in relation to biocides and recently also to plant protection products, indications of endocrine disrupting properties of a substance trigger additional information/testing requirements. With regard to plant protection products a new regulation from 1 March 2013 (EU 283/2013 (active substances) + EU 284/2013 (products)) sets out the general data requirements from 1 January 2014. According to these, new test methods that include endocrine sensitive endpoints have been included with regard to human health and the environment. Similar data requirements and new test methods that include endocrine sensitive endpoints are included in the guidance on Regulation (EU) No 528/2012 on how to fulfil data requirements for biocides. To a limited extent in vivo test methods that include endocrine sensitive endpoints have also been included in the standard information requirements for substances regulated under REACH. The existing information/data requirements in REACH, PPPR and BPR are not sufficient to adequately detect substances with endocrine disrupting properties. Proposals for changes in the existing REACH, PPPR and BPR information/data requirements are therefore provided. The proposals include enhancement of standard test methods as well inclusion of new methods and recommendations are given for a testing strategy. For all substances (prioritized by tonnage and exposure scenario), QSAR studies and testing using in vitro assays for interaction with different ED modalities e.g. ER, AR and steroidogenesis interference, should be conducted to elucidate whether there are alert(s) for further testing for ED effects

M3 - Conference abstract for conference

ER -