EMA's Revision of the Acceptance Limit for N-Nitroso-N-desmethyl-diphenhydramine

Limits of Nitrosamines
1

Hello，everyone！

I would like to ask: What is the basis for EMA’s revision of the limit for N-Nitroso-N-desmethyl-diphenhydramine from 18 ng/day to 100 ng/day? Where can I find the relevant supporting documentation?

2

based on EMA’s justification/note: Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NNK as point of departure.

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