The carcinogenicity of nitrosamines has been well researched and approximately 90% of the compounds tested have been shown to be carcinogenic in a number of animal species. As a result of these findings, nitrosamines are considered to be carcinogenic to humans.
The most likely sources of nitrosatable agents are dialkanomanides used in the production of dialkanolamides, and diethanolamide is the most widely used in cosmetic products. Under certain conditions, nitrosation of diethanolamide yields nitrosamine, N-nitrosodiethanolamine (NDELA), a polar, non-volatile N-nitrosamine compound. NDELA is generally considered one of the most potent carcinogens among the N-nitrosamine family of chemicals.
To allow reliable safety assessments to be conducted and to demonstrate compliance with European Cosmetics regulatory requirements, products should be tested for NDELA using appropriate analytical methodology.
In the European cosmetic regulation, nitrosamines are covered by the European Cosmetics Directive method II and III. Annex II states that nitrosamines should not be part of the composition of the cosmetic product. Annex III sets the maximum limits (50 µg.kg-1 or 50
ppb) is used for the level of mono and tri-alkylamines and alkanolamines and nitrosamines in fatty acid dialkylamines and dialkanolamides.
EUOROLAB has extensive knowledge and experience in the analysis of cosmetics and personal care products and provides NDELA testing services with LC MS MS device, special column and technical infrastructure within the scope of In-house method ISO 10130 standard, within the limits of the customer in your products and raw materials.
ISO 10130 Test Standard
ISO 10130 describes a method for the detection and quantification of N‑nitrosodiethanolamine (NDELA) in cosmetics and raw materials used in cosmetics by High Performance Liquid Chromatography (HPLC) combined with post-column photolysis and derivatisation.
This method is not applicable for the detection and/or quantification of nitrosamines other than NDELA, or for the detection or quantification of NDELA in products other than cosmetics or cosmetic raw materials.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
