Acceptable Intake N-Nitrosobiotin (N-Nitrosamide)

Hello together,

I am currently also looking for limit values for N-nitrosamides, especially for 1-nitrosobiotin. The CPCA approach of the Q&A document explicitly excludes N-nitrosamides and I couldn’t find any other real limit values for this substance class online. I have also seen that there are already 2 topics here in the forum that N-nitrosamides should not be treated like N-nitrosamines, but there are still frequent inquiries from customers and authorities about N-nitrosobiotin. For this reason, I would like to have a “limit value” to be able to compare the measured content. I have also been looking for a surrogate, in my opinion nitrosoimidazolidone could possibly serve as such. In PubMed I found TD50 values of 28.2 mg/kg. Or do you have an idea for a better surrogate?

Thank you very much for your help,

Kevin

Hi,

N-Nitroso Biotin is indicated in the EMA Appendix 1 with a limit of 1500 ng/day in the sheet “Other N-nitroso structures”.

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Many, many thanks for the quick reply. I have not yet seen the tab with “Other N-Nitroso structures” in the EMA Appendix 1. That helps me a lot.

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