EMA has updated its AI limits on 01 Aug 2025

The updates are as follows:

Appendix 1: Acceptable intakes established for N-nitrosamines

Nitrosamine Source CPCA AI(ng/day)
N-nitroso-berotralstat Berotralstat 2 100
N-nitroso-desmethyl-doxylamine Doxylamine -(Read across from NNK) 100
N-nitroso-doravirine dimer Doravirine -(Mutagenicity test negative) 1500
N-nitroso hydroxychloroquine EP Impurity C Hydroxychloroquine 2 100
N-nitroso hydroxychloroquine EP Impurity D Hydroxychloroquine 1 18
N-nitroso-hydroxyzine Impurity A Hydroxyzine 3 400
N-nitroso-methylaminoantipyrine Metamizole 2 100
N-nitroso-methylethanolamine Nefopam 2 100
N-nitroso-mirdametinib Mirdametinib -(Read across from NDPh) 78000
N-nitroso-nirogacestat Nirogacestat -(Mutagenicity test negative) 1500
N-nitroso-nirogacestat impurity 1 Nirogacestat 5 1500
N-nitroso-propafenone impurity B Propafenon 2 100
N-nitroso venlafaxine EP Impurity D Venlafaxine 1 18
N-nitroso venlafaxine EP Impurity H Venlafaxine 2 100
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