The TGA in Australia 
have updated their limits for nitrosamines today.
Nitrosamine impurities acceptable intakes update | Therapeutic Goods Administration (TGA)
Some mirror the new EMA limits, but there may well be new ones included as well.
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In case useful…
Updates in line with EMA (mirroring, no deviation)
x2 updated
N-Nitroso-ambroxol (source Ambroxol) AI 1500 ng/day (previous 400ng/day)
N-nitroso-dabigatran (NDAB) (source Dabigatran etexilate) AI 1500 ng/day (previous 400ng/day)
x34 newly added
1-(2,3-dichlorophenyl)-4-nitrosopiperazine (source Aripiprazole) AI 400 ng/day, CPCA Category 3
N-nitroso-azacyclonol (source Azacyclonol) AI 400 ng/day, CPCA Category 3
N-Nitroso-desmethyl-azelastine (source Azelastine) AI 100 ng/day, CPCA Category 2
N-nitroso-betaxolol (source Betaxolol) AI 1500 ng/day, CPCA Category 4
N-Nitroso-celiprolol (source Celiprolol) AI 1500 ng/day, CPCA Category 5
N-nitroso-cinacalcet (source Cinacalcet) AI 400 ng/day, CPCA Category 3
5-Chloro-4-methyl-2-[(2S)-2-methyl-1-nitrosopyrrolidin-2-yl]-1H-benzimidazole (IDOR-1135-8758) (source Daridorexant) AI 1500 ng/day, CPCA Category 5
N-Nitroso-desmethyl-citalopram (source Citalopram) AI 18 ng/day, CPCA Category 1
N-Nitroso-desvenlafaxine (source Desvenlafaxine) AI 18 ng/day, CPCA Category 1
N-nitroso-dorzolamide (source Dorzolamide) AI 1500 ng/day
N-Nitroso-esmolol (source Esmolol) AI 1500 ng/day, CPCA Category 4
N-Nitroso-calcium folinate (source Calcium folinate / Calcium Levofolinate) NMI
N-Nitroso imatinib (source Imatinib) AI 1500 ng/day, CPCA Category 5
Indapamide impurity A / 2-Methyl-1-nitroso-2,3-dihydroindole (source Indapamide) AI 1500 ng/day, CPCA Category 5
N-Nitroso-ethylenediamine-triacetic acid (862542-34-5) (source Isosorbide mononitrate) AI 1500 ng/day, CPCA Category 4
N-Nitroso-iminodiacetic acid (25081-31-6) (source Isosorbide mononitrate) AI 1500 ng/day, CPCA Category 4
N-Nitroso-leniolisib (source Leniolisib) AI 1500 ng/day, CPCA Category 5
N-Nitroso-desethyllidocaine (source Lidocaine / Lignocaine) AI 100 ng/day, CPCA Category 2
N-nitroso-mirtazapine (source Mirtazapine) AI 400 ng/day, CPCA Category 3
N-nitroso desmethyl nintedanib (source Nintedanib) AI 400 ng/day, CPCA Category 3
N-Nitroso-N-methylaniline / N-Methyl-N-phenylnitrous amide (614-00-6, NMPA) AI 100 ng/day, CPCA Category 2
N-Nitroso quetiapine HEEP impurity / 2-(2-(4-Nitrosopiperazin-1-yl)ethoxy)ethan-1-ol (source Quetiapine) AI 1500 ng/day
N-nitroso ranolazine impurity 1 / 1-(2-Methoxyphenoxy)-3-(4-nitrosopiperazin-1-yl)propan-2-ol (source Ranolazine) AI 400 ng/day, CPCA Category 3
N-nitroso-ribociclib impurity 1 / 7-Cyclopentyl-N,N-dimethyl-2-((5-(4-nitrosopiperazin-1-yl)pyridine-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide (source Ribociclib) AI 400 ng/day, CPCA Category 3
N-nitroso-rivaroxaban amide / (S)-5-Chloro-N-(2-hydroxy-3-(nitroso (4-(3-oxomorpholino)phenyl)amino) propyl)thiophene-2-carboxamide (source Rivaroxaban) AI 1500 ng/day, CPCA Category 4
N-nitroso-rivaroxaban open-ring acid (S)-2-(2-((4-(5-((5-Chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)(nitroso)amino)ethoxy) acetic acid (source Rivaroxaban) AI 1500 ng/day, CPCA Category 4
N-nitroso-desmethyl-sildenafil (source Sildenafil) AI 400 ng/day, CPCA Category 3
N-nitroso-desmethyl-sumatriptan (source Sumatriptan) AI 18 ng/day, CPCA Category 1
N-nitroso-desmethyl-terbinafine / (E)-N-(6,6-Dimethylhept-2-en-4-yn-1-yl)-N-(naphthalen-1-ylmethyl)nitrous amide (NDT / NHNA) (source Terbinafine) AI 18 ng/day, CPCA Category 1
N-nitroso-terbinafine degradant N-[(2E)-6,6-dimethyl-2-hepten-4-yn-1-yl]-N-nitrosomethanamine (NTD / NHMA) (source Terbinafine) AI 18 ng/day, CPCA Category 1
N-nitroso-terbinafine impurity A N-methyl-N-(napthalen-1-ylmethyl)nitrous amide (296760-88-8, NTA / NMNA) (source Terbinafine) AI 18 ng/day, CPCA Category 1
N-Nitroso-tetracaine (source Tetracaine) AI 400 ng/day, CPCA Category 3
N-Nitroso-ticagrelor (2476859-55-7) (source Ticagrelor) AI 1500 ng/day, CPCA Category 5
N-nitroso-urapidil (source Urapidil) AI 1500 ng/day, CPCA Category 4
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Super helpful, thank you…
Thanks a lot - it really helps 