The report on the regulatory applicability of non-animal approaches reviews their current status under the three EU chemicals regulations coordinated by ECHA (REACH, CLP and BPR). It states there have been significant scientific developments in the past 10 years regarding the replacement of animal testing for chemical safety assessment with non-animal approaches. Concepts such as the integrated approach to testing and assessment and the adverse outcome pathways now enable a better use of data from non-animal approaches. This has already reduced the need for animal testing.

For lower tier endpoints such as skin corrosion/irritation, serious eye damage/eye irritation and skin sensitization, companies already use in vitro tests as the default method. But for more complex endpoints, for example repeated dose toxicity or reproductive toxicity, non-animal approaches are not yet foreseeable. Methods such as grouping and read-across or weight of evidence use existing test data to predict toxicity of substances and can therefore reduce the need for new tests on animals. These alternative methods can be supported by in vitro tests and in silico predictions.

New approaches, such as in vitro microsystems and high-throughput/high-content methods, are under development. They aim to provide better insight into the mechanisms of toxicity. However, they require further standardization and validation before they can be accepted for regulatory use. A continuous dialogue between researchers and regulatory authorities is necessary to ensure that innovations in non-animal approaches to chemical safety assessment can be considered for regulatory use without undue delay. An inventory of non-animal approaches at different stages of development and regulatory applicability would help to identify current gaps and determine future steps to enhance their use.

ECHA encourages industry to use reliable non-animal approaches to adequately comply with the information obligations of the regulations. To support this, ECHA provides tools and advice through updated guidance, practical guides, IT tools, case studies and webinars.