The meeting was supported by a number of research consortia, e. g. Cosmetics Europe (formerly COLIPA), the Institute for In Vitro Sciences (IIVS), the European Chemical Industry Council (cefic), the European Consensus-Platform for Alternatives (ecopa), the In Vitro Testing Industrial Platform (IVTIP), the Humane Society International (HSI) and others.



Atomium in Brussels. Photo: iStockphoto


This meeting is significant because in March 2012 the European Commission wanted to inform the European Parliament about its consultations — whether or not the second stage of the sales ban of cosmetic ingredients tested on animals (according to the seventh Amendment of the Cosmetics Directive) is now being maintained and under what conditions / exceptions. According to the testimony of Rob Taalman, director of research and science of Cosmetics Europe (formerly Colipa), the decision about the sales ban will be expected after the summer break. Observers expect that the ban is maintained, however, exceptions are allowed.

The background for the deliberations on the status of the cosmetic sales ban is that until now, there were not sufficient new methods are available for the most complex of human health effects caused by cosmetic substances (including these toxicological endpoints: carcinogenicity, repeated dose, toxic kinetics, reproductive toxicity and skin sensitization).

The discussion focused on the “Roadmap,” a strategic plan which lists the need for new techniques and test strategies to replace animal testing completely. Since - and this is where all parties agree - the animals often not only lead to false-positive or false-negative results, but the results are often not transferable to humans due to species differences. For some of the complex investigation targets (so-called toxicological endpoints), there is no clear timeline of when the animal experiments can be replaced. Only in the case of skin sensitization will it be a complete replacement by new methods tangible in the foreseeable future. The method of this endpoint will then serve as a model for the other missing complex health effects.

The first section of the research project (cluster SEURAT, for example, in which 70 international research groups are collaborating) aims to study the "Mechanism of Action" (MoA), the biochemical interaction of a substance with a molecule of the body (e. g. an enzyme) to exert its effect, set with in vitro systems. The strategy is based on a kind of framework which describes a sequence causally linked biochemically and biological key events leading to an adverse impact on human health. In case studies, well-known toxic substances will be tested initially and later this approach extended to unknown substances. Then so-called "fit for purpose" in vitro tests are developed, with which a variety of samples can be analyzed simultaneously with high-throughput methods. Seurat-1 is divided into six project areas: stem cell research for in vitro target organ development, bioreactor development for simulation of the human liver, biomarker discovery, integrated in silicon model development for predictive toxicity, development of systemic computer models with the aim to predict long-term toxic effects as well as identification / analysis of metabolic pathways with toxic relevance, and ToxBank which deals with the data management and the cell and tissue banking.

In the United States, people are treading a very progressive path. The dubious nature of the transferability of animal studies in toxicology, as well as the traditional validation approaches and the need for time and resources until their recognition of rapidly evolving new methods, are observed as not suitable. However, a new concept has been developed. Based on the report of the National Academy of Sciences “Toxicity Testing in the 21st Century” of 2007, the concept of "evidence-based toxicology" approach (EBT) is focused. Here several authorities, such as the Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), the Hamner Institutes for Health Sciences and the Johns Hopkins Center for Alternatives to Animal Testing (CAAT USA) work together, but also companies like Agilent are involved. In this process, with its ToxCast program the U.S. EPA work on biological signatures, the Hamner Institutes concentrates on a "proof-of-principle" concept and the CAAT U.S. mainly works on the Human Toxome Project, using the material of human cells with high-throughput methods to map the "pathways of toxicity" (InVitroJobs will soon report on at this point). In integrated testing strategies (ITS), all available methods (in vitro, in silico, biokinetic methods, etc.) are used before any one animal experiment is considered. By comparing the different results the strategies can validate themselves, therefore they don´t need lengthy recognition processes any more.