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New methods for tiny particles

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Copyright BfRshort forGerman Federal Institute for Risk Assessment
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NAMs4NANO aims to make animal-free tests for the health risk assessment of nanomaterials available even before validation.

Dr Andrea Haase leads a key part of the project, which is funded by the European Food Safety Authority (EFSAshort forEuropean Food Safety Authority).

Dr Haase, what is special about tests for nanomaterials? 

Although nanomaterials often consist of known substances, they occur in extremely small particle sizes. Due to their small size, they can behave differently in the body – for example, by overcoming barriers more easily – but they can also impair the measurements themselves. Many traditional testing methods are not designed to account for these specific characteristics. 

You propose the use of alternative methods even without validation – that is, demonstrating that a method is relevant and reliable. Can that work? 

Qualification should under no circumstances replace validation. Our proposal is that experts should assess for which specific applications a method already works reliably. In such cases, data from qualified methods could then – together with other data – be used for assessments even without validation.

What has been the response to your proposal – and what happens next? 

Our approach has received a great deal of attention and support worldwide. We are currently testing the qualification procedure in case studies and are drawing up a proposal for EFSAshort forEuropean Food Safety Authority on how a qualification system can be implemented in practice.

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