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REGULATORY ACCEPTANCE OBJECTIVES /AIMS
What is the Long Range Science Strategy?
Our research programme on alternatives to animal testing has grounds in multidisciplinary partnerships between Cosmetics Europe’s member companies and other groups having a deep interest in non-animal approaches — including the international regulatory community, validating bodies, academia, research institutes, and industry partners.
This research programme is the Long Range Science Strategy (LRSS). A consortium of Cosmetics Europe members supports and funds it. The programme started in 2016 and is scheduled to run until 2022. Numerous partners bring their expertise together across the five most relevant areas for evaluating the safety of cosmetic ingredients: (i) ocular toxicity, (ii) genotoxicity/mutagenicity, (iii) skin sensitisation, (iv) toxicokinetics, and (v) toxicodynamics. The data and outcomes generated in each of the five research areas have already allowed us to develop several robust safety assessment approaches based on alternative methods.
Why are we doing it?
The LRSS has a clear regulatory acceptance orientation. Its goal is to enable animal-free safety assessment of chemicals and cosmetic ingredients after repeated exposure, thereby entirely replacing repeat dose toxicity animal tests.
To meet this goal, the LRSS has three pillars:
- Develop non-animal methods, testing strategies, and alternative approaches
- Use them in a risk assessment paradigm, to show that safety assessments are possible on a broad spectrum of effects — with a focus on systemic toxicity
- Support the regulatory acceptance of these approaches and the data generated by applying them
The LRSS intends to employ these pillars throughout several case studies. The LRSS will implement these pillars along a well-established scientific workflow to complete a series of case studies on chemicals with defined exposure scenarios.
Cosmetics Europe LRSS Members
Cosmetics Europe LRSS Associative Members
SCIENTIFIC ADVISORY BOARD MEMBERS
Bob van de Water,
Bob van de Water (Leiden University) received his PhD from Leiden University in 1995. Since 2006 he is professor Drug Safety Sciences at the Leiden Academic Centre for Drug Research and heads the Research Cluster Drug Discovery and Safety. His research is focused on the mechanistic uncovering of adverse drug reactions through the application of omics approaches with a focus on liver and kidney toxicity. The molecular insights are used to establish fluorescent reporter cell models for 2D and 3D application to quantitatively monitor adverse drug action using automated live cell microscopy; these data are integrated in quantitative systems biology modelling approaches for safety testing. He is coordinator of the H2020 EU-ToxRisk project, a European flagship project for alternative-to-animal testing strategies for quantitative human chemical safety assessment and partner in the Innovative Medicine Initiative projects TransQST and eTRANSAFE. He also leads the Eu-BioImaging Dutch High Throughput Microscopy Node, a screening facility for systematic imaging-based automated quantitative cell biological 2D and 3D phenotyping.
Maurice Whelan,
Maurice Whelan,
Prof. Maurice Whelan is head of the Chemical Safety and Alternative Methods Unit of the Directorate for Health, Consumers and Reference Materials of the European Commission's Joint Research Centre (JRC), based in Ispra, Italy. He also heads the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) of the JRC, established under EU Directive 2010/63 on the protection of animals used for scientific purposes, which builds on the 20 years of activities of ECVAM, the European Centre for the Validation of Alternative Methods. Priorities of his work include the development, validation and promotion of alternative approaches to animal testing both for regulatory safety assessment of chemicals and for applications in biomedical research. Whelan is the EU co-chair of the OECD Advisory Group on Molecular Screening and Toxicogenomics that is responsible for the OECD programme on Adverse Outcome Pathways, and he is a member of the Steering Committee of the European Partnership for Alternative Approaches to Animal Testing (EPAA).
Alan Boobis,
Alan Boobis is currently Professor of Toxicology (part-time), Imperial College London. He retired from his full-time position at the College as Professor of Biochemical Pharmacology and Director of the Public Health England/Department of Health-supported Toxicology Unit in June of 2017, after over 40 years. His main research interests lie in mechanistic toxicology, drug metabolism, mode of action and chemical risk assessment. He has published around 250 original research papers (h-index 80). He is a member of several national and international advisory committees, the UK Committee on Toxicity (chair), the WHO Study Group on Tobacco Product Regulation (TobReg), JECFA (veterinary residues – previous chair) and JMPR (previous chair). He has been a member of the UK Advisory Committee on Pesticides, Committee on Carcinogenicity, the EFSA CONTAM Panel and the EFSA PPR Panel. He is a member and has chaired the Board of Trustees of ILSI (International Life Sciences Institute) and ILSI HESI, and is immediate past president of ILSI Europe. He is involved in several HESI and ILSI Europe projects. He is a fellow of several learned societies and has received a number of awards recognising his contributions to toxicological sciences, including the Arnold J. Lehman Award from the US Society of Toxicology, and the civilian award of Officer of the British Empire (OBE).
Suzanne Fitzpatrick,
Suzanne Fitzpatrick, PhD, DABT, ERT is the Senior Science Advisor for Toxicology in in the US food and Drug Administration Center for Food Safety and Applied Nutrition. A board-certified toxicologist in the U.S. and in Europe, Dr. Fitzpatrick is the FDA lead for the federal collaboration among FDA, EPA, NCATS, and NIH, Toxicology Testing in the 21st Century (Tox 21), which looks to develop alternatives to animal testing as well as chair of the FDA Predictive Toxicology Roadmap Committee. Dr. Fitzpatrick played a pivotal role in helping launch the organs-on-a-chip tool, a revolutionary testing technology being evaluated by FDA. Dr. Fitzpatrick is the FDA lead to the Interagency Coordinating Committee on Alternative Test methods (ICCVAM) and the chair of the ICCVAM Developmental and Reproductive Testing Work Group. She is also an Adjunct Professor at Johns Hopkins University, the FDA representative to the Johns Hopkins Center for Alternatives to Animal Testing Board, and past president of the American College of Toxicology and of the Nation’s Capital Chapter of the Society of Toxicology. Dr. Fitzpatrick received her B.A. from the University of California at San Diego and her Ph.D. from Georgetown University.
Bas Blaauboer,
Bas Blaauboer (1949) studied biology at Utrecht University and did a PhD in toxicology at the same university (1978). He spent a postdoctoral year at the MRC Toxicology Unit in the UK (1979), and when he returned to Utrecht led a group on in vitro toxicology (biochemical and cellular toxicology), first in the Department of Veterinary Pharmacology and Toxicology. Later the research in toxicology was moved to the interfacultary Research Institute for Toxicology (RITOX), which after a merger in 2000 became a part of the Institute of Risk Assessment Sciences (IRAS).
He was named 2006 American Industrial Health Council Visiting Scholar at the CIIT Centers for Health Research, Research Triangle Park, NC, USA. This selection specifically acknowledges Dr. Blaauboer’s significant contributions in using quantitative modeling techniques along with in vitro toxicity studies to draw inferences about dose-response characteristics of chemicals in humans.
In 2008 he was appointed to the Doerenkamp-Zbinden Chair on “Alternatives to Animal Testing in Toxicological Risk Assessment”, which is located in IRAS. His research focuses on the use of in vitro toxicity data in combination with physiologically based biokinetic (PBBK) modelling as tools in risk assessments.
He is author or co-author of over 160 publications (peer-reviewed papers or book chapters), reports and editorials.
Among his other tasks: Editor for Toxicology in Vitro; Director/coordinator for the Dutch Programme for Postgraduate Education in Toxicology
CONTACT
Avenue Herrmann Debroux 40
B-1160 Brussels Belgium
LRSSinfo@cosmeticseurope.eu
Tel: +32 2 227 66 10
Fax: +32 2 227 66 27