Commission must act 'jointly with stakeholders' to find alternatives to animal testing

Written by Tzutzuy Ramirez-Hernandez and Renate Weissenhorn on 26 February 2014 in News
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Collaboration between the EU, industry and researchers is needed to keep up the momentum in finding alternatives to animal testing, write Tzutzuy Ramirez-Hernandez and Renate Weissenhorn.

The safety of the products must be ensured. To date, most of the safety testing relies on animal testing, an approach required by regulations and considered to be predictive of the adverse effects in humans.

However, with the advance in technology and societal driven needs to move towards animal-free alternatives, scientists worldwide are looking for reliable alternatives to reduce, refine and replace (3R's) the use of animals for toxicological testing.

The EU has progressed animal welfare regulations since 1986, an example of which is the implementation of the seventh amendment of the cosmetic directive and the creation the European centre for validation of alternative methods.

In November 2005, the European commission began the set-up of the European partnership for alternatives approaches to animal testing (EPAA) as a unique public-private partnership, with the overall aim to promote alternatives to animal testing based on scientific progress.

Since its creation, EPAA has facilitated the dialogue between industry partners that need to comply with regulatory safety requirements and services of the commission.

A fundamental understanding has evolved within the partnership, that an effective reduction of animal testing can only be achieved if all aspects of the 3R concept are taken into account. This means that although the ultimate goal is to replace animal testing with in-vitro methods, we also need to focus on refinement and reduction of animal testing.

EPAA operates through its platform in science (PoS) and regulation (PoR). Both coordinate projects addressing gaps in advancing the 3R's principle. An example of a PoS activity is the stem cells research project which is performed to identify the potential use of non-embryonic stem cells in safety testing.

At the same time the project establishes an international network of experts in stem cells research in order to increase awareness for the development of safety assessment tools with high relevance to the human situation but also of high reliability. Other PoR projects are dedicated to the optimization of non-animal alternatives application on the field of skin allergies.

This project tries to move forward non-animal testing strategies for the identification of skin allergens for regulatory purposes in the EU. To achieve this, the EPAA has led meetings with experts from regulatory agencies, the commission, industry and academia.

EPAA has also played a role in advancing the concept of the extended 1-generation study, as a replacement of the 2-generation study.

This alternative is an example of reduction through refinement, reducing the number of animals tested by approximately 1000, for each study.

A number of toxicological end points are now addressed with non-animal alternatives, particularly those related to topical application for skin and eye irritation.

The next level of replacement would be related to systemic toxicity and reproduction toxicity, which are much more complex. To achieve an in-vitro replacement through such studies, a change of our current approach to the development of alternative methods is necessary.

First we need to better understand the processes which cause toxicity. This will require a significant amount of dedicated and focused research.

We then need to develop in-vitro methods that address key points in the adverse outcome pathway. Combining a number of in-vitro assays, addressing these key events in the pathway may then result in a model that could replace the animal test.

At the same time we will need to develop mathematical models which help to translate in-vitro concentrations into in vivo dose levels.

Therefore, it is important that collaboration among stakeholders is continued and that researchers, industry and regulators jointly discuss the best path forward. The European research and innovation horizon 2020 program contains the potential for EU funding.

About the author

Tzutzuy Ramirez-Hernandez is head of the laboratory for development of alternative methods for BASF SE and EPAA industry co-chair

Renate Weissenhorn is adviser for the EPAA secretariat, European commission DG ENTR

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