The latest version of 21 September 2021 includes an update of
This value was derived using structure-activity-relationship (SAR) /read-across approach using the TD50 of N-nitroso-1,2,3,6-tetrahydropyridine as point of departure.
The Step 2-template for responses to the EMA to confirm that a nitrosamine has been detected was updated, as well. It provides two options for alternative indication of limit values of newer nitrosamines not considered in the "Assessment report" (according to Article 5(3) of Regulation EC 726/2004) of the CHMP of June 2020:
All documents can be accessed via the EMA website on nitrosamine impurities.
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