AOAC SPIFAN Stakeholder Panel Meeting Book (September 7, 2019)

Response - CEN TC 275 WG9

Expected Non-Compliance

This figure based on one that was developed by CEN TC 275 WG 9 in its deliberations on the EU regulation and is predicated “on the assumption that a product is manufactured in the middle of the regulatory limits and a single analysis is performed for compliance purposes. The probability of non-compliance will increase further, significantly so, when other variabilities (i. e. process variability and loss over shelf-life) are taken into consideration.” [2] - CEN TC275 WG9 Recommendation 173, July 2019

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133 rd Annual Meeting & Exposition | Denver, Colorado | September 6-12, 2019