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Regulatory acceptance of tests ‘needs a rethink’

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The process of regulatory acceptance of chemical tests needs rethinking, a European Commission official told a webinar, held this week by Chemical Watch and the Peta International Science Consortium (PISC), on the uptake of non-animal testing.


Karin Kilian, who is responsible for data requirements under REACH and the test method Regulation in the chemicals unit of DG Environment, said that new processes are needed as a result of the paradigm shift in chemical testing. The shift, she said, is from the one end-point, one test approach to alternative testing, including methods to address individual mechanistic steps.


The resulting integrated approaches to testing and assessment, she said, present a challenge for setting regulatory acceptance of test methods. Key questions that need to be addressed include:


    • how can information requirements be set for such approaches? For example, what type of information and how much is needed?; and


    • how can regulatory authorities assess submissions, based on such approaches, and what resources and expertise are needed?



Ms Kilian said discussions are just starting on the need to “rethink” how new alternative approaches are accepted by regulators.



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