White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.
Identifieur interne : 000094 ( PubMed/Corpus ); précédent : 000093; suivant : 000095White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.
Auteurs : M F Wilks ; N. Roth ; L. Aicher ; M. Faust ; P. Papadaki ; A. Marchis ; M. Calliera ; A. Ginebreda ; S. Andres ; R. Kühne ; G. SchüürmannSource :
- The Science of the total environment ; 2015.
English descriptors
- KwdEn :
- MESH :
- chemical , toxicity : Environmental Pollutants, Hazardous Substances.
- legislation & jurisprudence : Environmental Monitoring.
- methods : Environmental Monitoring, Risk Assessment.
- Environmental Policy, European Union.
Abstract
The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more effective risk evaluation and consideration of the risks and benefits associated with the use of chemicals.
DOI: 10.1016/j.scitotenv.2015.03.065
PubMed: 25841074
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pubmed:25841074Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.</title><author><name sortKey="Wilks, M F" sort="Wilks, M F" uniqKey="Wilks M" first="M F" last="Wilks">M F Wilks</name><affiliation><nlm:affiliation>Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Switzerland. Electronic address: martin.wilks@unibas.ch.</nlm:affiliation></affiliation></author><author><name sortKey="Roth, N" sort="Roth, N" uniqKey="Roth N" first="N" last="Roth">N. Roth</name><affiliation><nlm:affiliation>Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Aicher, L" sort="Aicher, L" uniqKey="Aicher L" first="L" last="Aicher">L. Aicher</name><affiliation><nlm:affiliation>Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Faust, M" sort="Faust, M" uniqKey="Faust M" first="M" last="Faust">M. Faust</name><affiliation><nlm:affiliation>Faust & Backhaus Environmental Consulting GbR (F+B), Bremen, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Papadaki, P" sort="Papadaki, P" uniqKey="Papadaki P" first="P" last="Papadaki">P. Papadaki</name><affiliation><nlm:affiliation>Department of Pesticides Control & Phytopharmacy, Benaki Phytopathological Institute (BPI), Athens, Greece.</nlm:affiliation></affiliation></author><author><name sortKey="Marchis, A" sort="Marchis, A" uniqKey="Marchis A" first="A" last="Marchis">A. Marchis</name><affiliation><nlm:affiliation>OPERA Research Center, Catholic University of the Sacred Heart (UCSC), Piacenza, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Calliera, M" sort="Calliera, M" uniqKey="Calliera M" first="M" last="Calliera">M. Calliera</name><affiliation><nlm:affiliation>Institute of Agricultural and Environmental Chemistry, Catholic University of the Sacred Heart (UCSC), Piacenza, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Ginebreda, A" sort="Ginebreda, A" uniqKey="Ginebreda A" first="A" last="Ginebreda">A. Ginebreda</name><affiliation><nlm:affiliation>Institute of Environmental Assessment and Water Research, Spanish Council of Scientific Research (CSIC), Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Andres, S" sort="Andres, S" uniqKey="Andres S" first="S" last="Andres">S. Andres</name><affiliation><nlm:affiliation>French National Institute for Industrial Environment and Risks (INERIS), Parc Technologique Alata, Verneuil-en-Halatte, France.</nlm:affiliation></affiliation></author><author><name sortKey="Kuhne, R" sort="Kuhne, R" uniqKey="Kuhne R" first="R" last="Kühne">R. Kühne</name><affiliation><nlm:affiliation>UFZ Department of Ecological Chemistry, Helmholtz Centre for Environmental Research, Leipzig, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Schuurmann, G" sort="Schuurmann, G" uniqKey="Schuurmann G" first="G" last="Schüürmann">G. Schüürmann</name><affiliation><nlm:affiliation>UFZ Department of Ecological Chemistry, Helmholtz Centre for Environmental Research, Leipzig, Germany; Institute for Organic Chemistry, Technical University Bergakademie Freiberg, Germany.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:25841074</idno><idno type="pmid">25841074</idno><idno type="doi">10.1016/j.scitotenv.2015.03.065</idno><idno type="wicri:Area/PubMed/Corpus">000094</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.</title><author><name sortKey="Wilks, M F" sort="Wilks, M F" uniqKey="Wilks M" first="M F" last="Wilks">M F Wilks</name><affiliation><nlm:affiliation>Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Switzerland. Electronic address: martin.wilks@unibas.ch.</nlm:affiliation></affiliation></author><author><name sortKey="Roth, N" sort="Roth, N" uniqKey="Roth N" first="N" last="Roth">N. Roth</name><affiliation><nlm:affiliation>Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Aicher, L" sort="Aicher, L" uniqKey="Aicher L" first="L" last="Aicher">L. Aicher</name><affiliation><nlm:affiliation>Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Faust, M" sort="Faust, M" uniqKey="Faust M" first="M" last="Faust">M. Faust</name><affiliation><nlm:affiliation>Faust & Backhaus Environmental Consulting GbR (F+B), Bremen, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Papadaki, P" sort="Papadaki, P" uniqKey="Papadaki P" first="P" last="Papadaki">P. Papadaki</name><affiliation><nlm:affiliation>Department of Pesticides Control & Phytopharmacy, Benaki Phytopathological Institute (BPI), Athens, Greece.</nlm:affiliation></affiliation></author><author><name sortKey="Marchis, A" sort="Marchis, A" uniqKey="Marchis A" first="A" last="Marchis">A. Marchis</name><affiliation><nlm:affiliation>OPERA Research Center, Catholic University of the Sacred Heart (UCSC), Piacenza, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Calliera, M" sort="Calliera, M" uniqKey="Calliera M" first="M" last="Calliera">M. Calliera</name><affiliation><nlm:affiliation>Institute of Agricultural and Environmental Chemistry, Catholic University of the Sacred Heart (UCSC), Piacenza, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Ginebreda, A" sort="Ginebreda, A" uniqKey="Ginebreda A" first="A" last="Ginebreda">A. Ginebreda</name><affiliation><nlm:affiliation>Institute of Environmental Assessment and Water Research, Spanish Council of Scientific Research (CSIC), Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Andres, S" sort="Andres, S" uniqKey="Andres S" first="S" last="Andres">S. Andres</name><affiliation><nlm:affiliation>French National Institute for Industrial Environment and Risks (INERIS), Parc Technologique Alata, Verneuil-en-Halatte, France.</nlm:affiliation></affiliation></author><author><name sortKey="Kuhne, R" sort="Kuhne, R" uniqKey="Kuhne R" first="R" last="Kühne">R. Kühne</name><affiliation><nlm:affiliation>UFZ Department of Ecological Chemistry, Helmholtz Centre for Environmental Research, Leipzig, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Schuurmann, G" sort="Schuurmann, G" uniqKey="Schuurmann G" first="G" last="Schüürmann">G. Schüürmann</name><affiliation><nlm:affiliation>UFZ Department of Ecological Chemistry, Helmholtz Centre for Environmental Research, Leipzig, Germany; Institute for Organic Chemistry, Technical University Bergakademie Freiberg, Germany.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Science of the total environment</title><idno type="e-ISSN">1879-1026</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Environmental Monitoring (legislation & jurisprudence)</term><term>Environmental Monitoring (methods)</term><term>Environmental Policy</term><term>Environmental Pollutants (toxicity)</term><term>European Union</term><term>Hazardous Substances (toxicity)</term><term>Risk Assessment (methods)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="toxicity" xml:lang="en"><term>Environmental Pollutants</term><term>Hazardous Substances</term></keywords><keywords scheme="MESH" qualifier="legislation & jurisprudence" xml:lang="en"><term>Environmental Monitoring</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Environmental Monitoring</term><term>Risk Assessment</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Environmental Policy</term><term>European Union</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more effective risk evaluation and consideration of the risks and benefits associated with the use of chemicals.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">25841074</PMID><DateCreated><Year>2015</Year><Month>05</Month><Day>08</Day></DateCreated><DateCompleted><Year>2015</Year><Month>09</Month><Day>30</Day></DateCompleted><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1879-1026</ISSN><JournalIssue CitedMedium="Internet"><Volume>521-522</Volume><PubDate><Year>2015</Year><Month>Jul</Month><Day>15</Day></PubDate></JournalIssue><Title>The Science of the total environment</Title><ISOAbbreviation>Sci. Total Environ.</ISOAbbreviation></Journal><ArticleTitle>White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.</ArticleTitle><Pagination><MedlinePgn>211-8</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.scitotenv.2015.03.065</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0048-9697(15)00340-X</ELocationID><Abstract><AbstractText>The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more effective risk evaluation and consideration of the risks and benefits associated with the use of chemicals.</AbstractText><CopyrightInformation>Copyright © 2015 Elsevier B.V. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Wilks</LastName><ForeName>M F</ForeName><Initials>MF</Initials><AffiliationInfo><Affiliation>Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Switzerland. Electronic address: martin.wilks@unibas.ch.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Roth</LastName><ForeName>N</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aicher</LastName><ForeName>L</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Faust</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Faust & Backhaus Environmental Consulting GbR (F+B), Bremen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Papadaki</LastName><ForeName>P</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Pesticides Control & Phytopharmacy, Benaki Phytopathological Institute (BPI), Athens, Greece.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marchis</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>OPERA Research Center, Catholic University of the Sacred Heart (UCSC), Piacenza, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Calliera</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Institute of Agricultural and Environmental Chemistry, Catholic University of the Sacred Heart (UCSC), Piacenza, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ginebreda</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Institute of Environmental Assessment and Water Research, Spanish Council of Scientific Research (CSIC), Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Andres</LastName><ForeName>S</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>French National Institute for Industrial Environment and Risks (INERIS), Parc Technologique Alata, Verneuil-en-Halatte, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kühne</LastName><ForeName>R</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>UFZ Department of Ecological Chemistry, Helmholtz Centre for Environmental Research, Leipzig, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schüürmann</LastName><ForeName>G</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>UFZ Department of Ecological Chemistry, Helmholtz Centre for Environmental Research, Leipzig, Germany; Institute for Organic Chemistry, Technical University Bergakademie Freiberg, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>HEROIC consortium</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>04</Month><Day>01</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Sci Total Environ</MedlineTA><NlmUniqueID>0330500</NlmUniqueID><ISSNLinking>0048-9697</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004785">Environmental Pollutants</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015386">Hazardous Substances</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004784">Environmental Monitoring</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000331">legislation & jurisprudence</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000379">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D058735">Environmental Policy</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004785">Environmental Pollutants</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000633">toxicity</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005062">European Union</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D015386">Hazardous Substances</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000633">toxicity</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D018570">Risk Assessment</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000379">methods</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Chemicals</Keyword><Keyword MajorTopicYN="N">Environmental risk assessment</Keyword><Keyword MajorTopicYN="N">Human health risk assessment</Keyword><Keyword MajorTopicYN="N">Integrated risk assessment</Keyword><Keyword MajorTopicYN="N">Regulatory framework</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>12</Month><Day>9</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2015</Year><Month>3</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>3</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="aheadofprint"><Year>2015</Year><Month>4</Month><Day>1</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>4</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>4</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>10</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">25841074</ArticleId><ArticleId IdType="pii">S0048-9697(15)00340-X</ArticleId><ArticleId IdType="doi">10.1016/j.scitotenv.2015.03.065</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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