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New limits for nitrosamines from 2021

Nitrosamines are found in cosmetics, pesticides, tobacco products, and most rubber products. These chemical compounds are formed when nitrites and amines come into contact with acid (e.g. stomach acid) or during production of e.g. pharmaceuticals. Another possibility is the release from the breakdown of specific organic substances. High temperatures encourage the growth of nitrosamines (e.g. frying bacon increases formation speed). They can also be found in cured meat, preserved cheese, beer, and fish. To stress the danger of these chemicals, small dosages cause diabetes, fatty liver disease, and obesity. When exposed in large quantities, nitrosamines have been linked to cancer and Alzheimer’s disease.

In the summer of 2018, several pharmaceuticals were contaminated with nitrosamine NDMA. It also became clear that other antihypertensives from the Sartan family were possibly contaminated.

As a prevention mechanism, the Federal Institute for Drugs and Medical Devices in Germany completed a risk assessment according to Article 31 of Directive 2001/83/EC. The opinion of the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency (EMA) thus became legally binding.

As of August 2019, the EMA announced that all chemically synthetic active ingredients in medicines must be tested for nitrosamine contamination.


New NDMA and NDEA limits


Companies producing Sartans had to review their manufacturing processes to ensure that nitrosamine contamination does not occur.

Also, new limits for N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) have been incorporated into the European Pharmacopoeia.

By this time companies must prove that their products contain less than 0.030 ppm. These limits will go into effect by January 1, 2021.

To adjust to the new manufacturing limits, a two-year transition period was implemented. The legislation explains that products which exceed the allotted nitrosamine limits may not be sold in the EU.

Research on harmful nitrosamine limits will continue to be done. EU authorities are still making considerations on what steps can be taken to reduce impurities in medicinal products. Unexpected impurities may be overlooked, which can have health implications for the consumer. Therefore, it is important to regularly review manufacturing processes and perform analyses

To help pharmaceutical companies apply these new regulations to their products, Tentamus examines pharmaceuticals and medical devices to see if all the criteria according to the respective regulation are met. Performing analytical testing for nitrosamines is one of Tentamus’ specialties, and we therefore encourage you to make use of our capabilities.


Tobias Wiezorek
+1 951 549 96 57

Dr. Serap Acikgöz
+49 151 185 682 25

Mr. Jayapal Reddy
+91 905 222 21 54


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