The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published an analytical method for the determination of polar N-nitrosamines in cosmetic products, which was validated within the European Network of Official Cosmetics Control Laboratories (OCCLs).
The method is suitable for the determination of N-nitroso-diethanolamine (NDELA), N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), N-nitroso-morpholine (NMOR), N-nitrosomethylethylamine (NMEA), N-nitrosopyrrolidine (NPYR) and N-nitroso-piperidine (NPIP) in cosmetics and tattoo inks, in the concentration range 10-1 000 µg/kg. It was subjected to peer-review within the European OCCL Network and inter-laboratory validation data are reported in an annex to the published method.
Nitrosamines are known as possible carcinogens for humans. In the European Union, Regulation (EC) No. 1223/2009 prohibits their presence in cosmetic products and bans or restricts nitrosamine precursors to prevent their formation.
A detailed description of the method using liquid chromatography coupled to mass spectrometry can be downloaded for FREE from the EDQM Freepub website.