ECVAM's Response to the Changing Political Environment for Alternatives: Consequences of the European Union Chemicals and Cosmetics Policies

Abstract

The European Centre for the Validation of Alternative Methods (ECVAM) has restructured its services by directly targeting the animal tests that need to be replaced. In view of the short time-lines for making available and implementing validated methods, ECVAM is offering to steer the process by bringing together the inputs of stakeholders and encouraging the early involvement of regulators. In essence, steering groups formed by ECVAM senior staff, and complemented with external experts, will carry out the project management and will coordinate the various inputs.

The REACH concept and its impact on toxicological sciences

“…Towards this goal, an integrated publicly funded research program supplementary to REACH is required. Many techniques have been recommended (Hartung et al, 2003;Gennari et al, 2004;Zuang and Hartung, 2005) that could be included into such a scientific research program. Here we summarize some methods we consider to be among the most promising:…”

“…For instance Greenpeace principally appreciates the REACH concept, but demands an acceleration of the introduction of non-animal alternatives (Greenpeace, 2005). In principle this seems reasonable, but non-animal alternative techniques must be successfully validated before they can replace conventional animal studies (Hartung et al, 2003. This process unavoidably requires several years.…”

Skin irritation: prevalence, variability, and regulatory classification of existing in vivo data from industrial chemicals

“…In addition, animal welfare and more recently political pressure in Europe, e.g., chemicals and cosmetics legislation, decree the development of appropriate and validated alternative in vitro test methods (Hartung et al, 2003). Therefore, in the last 10 years, considerable scientiWc eVort has been directed at developing valid in vitro skin models as a replacement for the animal test.…”

Availability, Standardization and Safety of Human Cells and Tissues for Drug Screening and Testing

“…These stages refl ect the sequence of activities to be performed for a prospective validation exercise and are documented in detail in several publications [32][33][34][35]. This validation process has proved effective in establishing regulatory acceptance of several alternative tests [36]. Furthermore, these principles are generic and can be applied to any type of test, including in-vivo tests.…”