EFSA published a report related to the risk assessment of nitrosamines in food. Their decision could have the strong impact on the pharmaceutical fields the same as they did for titanium oxide. We should pay attention to their movements in the future.
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.7884
Thanks you!
If it is a risk, it is for everything and all industries. From what I see they have only started with the classic ones… thinking about the secondary amines in food, they should apply the same criteria. Perhaps the prohibition of nitrite as a preservative will be seen…
There was a study on the risk of processed meat and cancer and it may be the tip of the iceberg.
Thanks for sharing this @Yosukemino.
It looks EFSA handling food-nitrosamines little different. But altogether it looks EFSA may consider not such a stringent value -what Pharmaceutical regulatory considers!
Interesting to see how the nitrosamines concern in food unfolds and the cascading effect it has on pharmaceuticals…
What remains to be seen in the language of Dr. @AndyTeasdale is if this is “End of the Beginning or Beginning of the End?”
The N-Nitrosamine contamination in food is something known since the 1950s & 60s. People have been exposed to N-Nitrosamine impurities for few decades now through sources other than pharmaceuticals.
The real break-through would be when
(i) the regulators start accepting a negative “modified Ames assay” as the sole evidence to rule-out carcinogenicity risk from N-nitrosamine impurities
(ii) LTL limits calculated based on duration of product use are accepted by regulators and
(ii) the pharma industry and regulators come to a consensus on “the safe and practically achievable limits for NSDRIs” that are mutagenic in the Ames assay. The current limit of 18 ng/day for NDSRIs in pharmaceuticals is untenable especially when the cancer risk from endogenous formation and exposure to exogenous nitrosamines cannot be ignored, more importantly when the actual life-time cancer risk from all other sources is 1:3.
The European Commission has introduced more rigorous limits on the use of nitrites and nitrates as food additives to minimize consumer exposure to nitrosamines, some of which have carcinogenic properties. These new measures are designed to ensure food safety while reducing the risk of nitrosamine exposure. European Union food businesses are granted a two-year transition period to adapt to these updated regulations.
It’s good to see this regulatory movement in the food industry. Certainly, it’s a discussion that will also have consequences for the pharmaceutical sector.
A commentary from the Senate Commission on Food Safety (SKLM) of the German Research Foundation (DFG) on the EFSA risk assessment of nitrosamines in food in now also available:
It bridges exogenous and endogenous nitrosamine and nitrosating agent formation and faith, thus providing food for thought on balancing endogenous and exogenous risks (in general see also The role of endogenous versus exogenous sources in the exposome of putative genotoxins and consequences for risk assessment | Archives of Toxicology (springer.com) on this balance).
At the same time, the European funded research on endogenous formation of NDSRIs seems now 1 year delayed (report expected June 2023):
Endogenous formation of nitrosamines from drug substance (GITox) | HMA-EMA Catalogues of real-world data sources and studies (europa.eu)
this commentary is very interesting. And i cannot resist to comment on the data which is presented in the monitoring of endogenous formation of NOC.
It is impressive that the endogenous formation of NDMA was calculated from 670ÎĽg/day up to 1mg/day!!! This is approximately from 7000 up to 10000 times more than the AI of NDMA in EMA and FDA (96ng/day).