Nitrosamines risk assessments for Topical herbal extracts

Dear all,

We are working in our pharmaceutical factory on topical product including herbal extracts as Sandal wood oil , etc) .

My Question is; Is it enough to ask for Declaration from the supplier of these extracts or request nitrosamines risk assessments from them?.

The other question; is there any upcoming nitrosamines guidance about topical products (Creams and gels including herbal extracts) ?.

My regards,

The Regulatory Authorities make no distinction between oral and topical products when it comes to nitrosamine risk.
However I did an assessment for nitrosamine presence in a large number of herbal raw materials and the vast majority do not present any risk

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