In the Spotlight
European Government-Industry Project Aims to Develop Non-animal Alternatives for Repeated Dose Systemic Toxicity Testing
Published: March 29, 2011
The 7th Amendment to the Cosmetics Directive (Directive 2003/15/EC), adopted by the European Parliament in 2003, imposed deadlines that ban animal testing for cosmetics and cosmetic ingredients to be marketed within EU countries. Finished cosmetic product testing on animals has been banned since September 11, 2004. Animal testing of ingredients has been banned since March 11, 2009 for all toxicity endpoints except those for assessing repeated dose toxicity, reproductive toxicity, and toxicokinetics. The ban on animal testing for these more biologically-complex toxicity endpoints is slated to go into force on March 11, 2013, regardless of the availability of non-animal test methods.
A European Commission (EC) report describing progress made in replacing animal experiments for the safety testing of cosmetic products during the period of 2007 and 2008 concluded that there were still no replacement alternative methods available for the three endpoints subject to the 2013 deadline. Furthermore, none were foreseen to be in place by 2013. This report also described plans for a collaborative project by the EC’s FP7-HEALTH-2010-Alternative Testing programme and the European Cosmetics Association (COLIPA) to jointly fund a €50 million research program to develop replacement methods for repeated dose systemic toxicity testing.
The European research initiative “Safety Evaluation Ultimately Replacing Animal Testing” (SEURAT), as its name implies, is based on the long-term goal of replacing animals in safety testing. The first 5-year phase, SEURAT-1, is the €50 million EC and COLIPA-funded program with the goal of “replacement of current repeated dose systemic toxicity testing in human safety assessment.”
To address this goal, SEURAT-1 is organized into six research projects that will be coordinated for the “development of knowledge and technologies required for repeated dose systemic toxicity testing without animals.”
Project Name | Project Topic | Project Coordinator and Organization (Country) |
| SCR&Tox | Stem Cells for Relevant efficient extended and normalized Toxicology | Prof. Marc Peschanski, INSERM (France) |
| HeMiBio | Hepatic Microfluidic Bioreactor | Prof. Catherine Verfaillie, Katholieke Universiteit Leuven (Belgium) |
| DETECTIVE | Detection of endpoints and biomarkers of repeated dose toxicity using in vitro systems | Prof. Jürgen Hescheler, Universität zu Köln – Universitätsklinikum (Germany) |
| COSMOS | Integrated in silico models for the prediction of human repeated dose toxicity of COSMetics to Optimise Safety | Prof. Mark Cronin, Liverpool John Moores University (UK) |
| NOTOX | Predicting long-term toxic effects using computer models based on systems characterization of organotypic cultures | Prof. Elmar Heinzle, Saarland University – Biochemical Engineering Institute (Germany) |
| ToxBank | Supporting integrated data analysis and servicing of alternative testing methods in toxicology | Prof. Emilio Benfenati, Istituto di Ricerche Farmacologiche Mario Negri (Italy) and Dr. Barry Hardy, Douglas Connect (Switzerland) |
COLIPA announced that almost 100 scientists from over 70 European organizations participated in the SEURAT-1 kick-off meeting on March 1-3, 2011 in Cascais, Portugal. The purpose of the event, which was limited to project participants, was to introduce project collaborators and provide a platform for discussing proposed research. The main features of the program included the following:
Day 1 – introductions to the sponsoring and research organizations and overviews of the research program and strategy
Day 2 – four focus workshops and a plenary session:
Workshop 1: Mechanisms relevant to repeated dose toxicity
Workshop 2: Data management and analysis
Workshop 3: Definitions and ontology for generation of a common SEURAT-1 database
Workshop 4: Test substances for projects and criteria of chemicals selection
Plenary session: Practical issues related to in vitro toxicity testing
Day 3 – concluded the meeting with 3 sessions: feedback from the focus workshops, the 5-year research strategy for SEURAT-1, and roadmaps for future research
Another EC project, COACH, has been established to provide coordination and optimize cooperation among the SEURAT-1 cluster projects. COLIPA noted that “the installation of a Coordinating Action right from the start of the research initiative is unique; with its coordination mechanisms it will provide a maximum of synergy between participants and therefore optimise the output of this cluster of projects.”
The development of alternative methods to replace animals in repeated dose systemic toxicity testing is a considerable scientific challenge. Stakeholders look forward to the anticipated progress to be made by innovative research programs such as SEURAT-1.
