26 September 2022 is around the corner!

With the Step 2 (Confirmatory testing) deadline rapidly approaching [26 September 2022], what are your most important challenge? Methods/Instrumentation/Resources/Regulatory Guidance/other?

Analytical challenges during method development and validation.
Time left till September for the amount of risk products left without testing.

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3 topics:

  1. Risk assessment is continuing to be a challenge. The where and the when is not only related to the nitrosamine itself, but also to the precursors. How to identify and quantify them seems to be a good topic
  2. Analytical challenges for the precursors but also for reaching in a accurate and reproducible way the LoQ and going beyond, especially if trace analysis are requested
  3. New species together with the precursors. Method optimization is key